19–006 

112TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 2d Session 112–495 

FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012 

MAY 25, 2012.—Committed to the Committee of the Whole House on the State of 

the Union and ordered to be printed 

Mr. UPTON, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 5651] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 5651) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs 

for generic drugs and biosimilars, and for other purposes, having 

considered the same, report favorably thereon without amendment 

and recommend that the bill do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 1 

Background and Need for Legislation .................................................................... 2 

Hearings ................................................................................................................... 3 

Committee Consideration ........................................................................................ 6 

Committee Votes ...................................................................................................... 6 

Committee Oversight Findings ............................................................................... 8 

Statement of General Performance Goals and Objectives .................................... 8 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 8 

Earmark ................................................................................................................... 8 

Committee Cost Estimate ....................................................................................... 8 

Congressional Budget Office Estimate ................................................................... 8 

Applicability to Legislative Branch ........................................................................ 17 

Section-by-Section Analysis of the Legislation ...................................................... 17 

Changes in Existing Law Made by the Bill, as Reported ..................................... 42 

PURPOSE AND SUMMARY

H.R. 5651, the ‘‘Food and Drug Administration Reform Act of 

2012,’’ was introduced on May 9, 2012, by Chairman Fred Upton 

(R–MI), Ranking Member Henry Waxman (D–CA), Subcommittee 


jbell on DSK7SPTVN1PROD with REPORTS
2 

1The Council commented as follows: ‘‘Today, however, our medical innovation ecosystem is in 

jeopardy. Investment in the life sciences area is declining at an alarming rate because of the 

escalating cost, time, and risk of developing new drugs and devices. While many factors have 

contributed to this decline . . . an important factor is the uncertain FDA regulatory environment.’’ President’s Council on Jobs and Competitiveness, Interim Report, Building Confidence: 

Five Common-Sense Initiatives to Boost Jobs and Competitiveness (29). 

on Health Chairman Joseph R. Pitts (R–PA), Subcommittee on 

Health Ranking Member Frank Pallone, Jr. (D–NJ), Chairman 

Emeritus Joe Barton (R–TX), and Chairman Emeritus John D. 

Dingell (D–MI) and referred to the Committee on Energy and Commerce. 

The legislation would reauthorize the prescription drug user fee 

and medical device user fee, authorize a generic drug user fee and 

biosimilar user fee, reauthorize the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act, institute reforms at 

the Food and Drug Administration (FDA) to improve the predictability, consistency, and transparency of its regulation of drugs and 

devices, and establish policies to address the drug shortage crisis. 

BACKGROUND AND NEED FOR LEGISLATION

The United States (U.S.) has led the global medical device and 

biopharmaceutical industries for decades. This leadership has made 

the U.S. the medical innovation capital of the world, bringing hundreds of thousands of high-paying jobs to our country and life-saving devices and drugs to our nation’s patients. The Prescription 

Drug User Fee Act and Medical Device User Fee and Modernization Act, enacted in 1992 and 2002, respectively, were essential in 

giving FDA the resources it needed to expedite device and drug reviews and thus help foster medical innovation. 

Unfortunately, our nation’s device and biopharmaceutical leadership is under threat. According to President Obama’s Job Council, 

this threat comes, in part, from ‘‘the uncertain FDA regulatory environment.’’ 1 The Jobs Council acknowledges, of course, that 

‘‘[p]rotecting patients from harm is without question an essential 

element of what the public expects from the FDA’’ and notes that 

enabling the timely development of new therapies and technologies 

is another important such element, concluding that ‘‘[a]chieving 

both goals simultaneously is the critical challenge for the new drug 

and device approval process.’’ 

The Committee believes that the significant policy reforms contained in H.R. 5651, along with the additional resources and accountability measures in the user fee agreements, will address the 

regulatory uncertainty at FDA so the U.S. remains the world leader in medical innovation, device and drug jobs remain in the U.S., 

and U.S patients continue to benefit from new devices and drugs, 

without compromising FDA’s appropriately stringent standards 

that protect patients from unsafe or ineffective devices and drugs. 

H.R. 5651 also would authorize two new user fees. The new generic drug user fee would provide additional resources for the review and regulation of generic drugs. These resources would bring 

faster and more predictable review of generic drug applications and 

increased inspections of generic drug facilities, bringing parity to 

the frequency of inspections of foreign and domestic generic drug 

facilities. The new biosimilar user fee would provide additional resources to FDA for the review of biosimilar applications. 


jbell on DSK7SPTVN1PROD with REPORTS
3 

H.R. 5651 also would take important steps to address the current 

drug shortage crisis affecting the U.S. Although the root causes of 

drug shortages are complex and multi-faceted, the result is clear: 

patients, physicians, nurses, and pharmacists across the country 

face daily challenges in obtaining the drugs they need. 

Finally, H.R. 5651 would modernize the Federal Food, Drug, and 

Cosmetic Act (FFDCA) to give FDA the tools necessary to deal with 

the increased globalization of the pharmaceutical supply chain. 

HEARINGS

IMPACT OF MEDICAL DEVICE REGULATION ON JOBS AND PATIENTS

On February 17, 2011, the Subcommittee on Health held a hearing to examine the state of the medical device industry and the impact of regulations on job creation and patient access. The Subcommittee received testimony from Dr. Jeffrey E. Shuren, Director, 

Center for Devices and Radiological Health, FDA; ExploraMed Development, Limited Liability Company; the Foundry; Ralph Hall; 

Dr. Rita Redberg; and Dr. Steven E. Nissen. 

IMPORT SAFETY: STATUS OF FDA’S SCREENING EFFORTS AT THE

BORDER

On April 13, 2011, the Subcommittee on Oversight and Investigations held a hearing entitled ‘‘Import Safety: Status of FDA’s 

Screening Efforts at the Border.’’ The purpose of this hearing was 

to examine the current state of FDA’s import screening processes 

and the pace of FDA’s nationwide rollout of the automated entry 

review system, known as PREDICT. The witness for this hearing 

was the Honorable Margaret A. Hamburg, M.D., Commissioner of 

FDA. 

PDUFA V: MEDICAL INNOVATION, JOBS, AND PATIENTS

On July 7, 2011, the Subcommittee on Health held a hearing entitled ‘‘PDUFA V: Medical Innovation, Jobs, and Patients.’’ The 

purpose of the hearing was to examine issues expected to be discussed as part of the reauthorization of the Prescription Drug User 

Fee Act. The Subcommittee received testimony from Janet 

Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA; OncoMed Pharmaceuticals Incorporation on behalf of 

the Biotechnology Industry Organization; Warburg Pincus Limited 

Liability Company; National Health Council; Friends of Cancer Research; and the Pew Charitable Trusts. 

REGULATORY REFORM SERIES #5—FDA MEDICAL DEVICE REGULATION: 

IMPACT ON AMERICAN PATIENTS, INNOVATION AND JOBS

On July 20, 2011, the Subcommittee on Oversight and Investigations held a hearing entitled ‘‘Regulatory Reform Series #5—FDA 

Medical Device Regulation: Impact on American Patients, Innovation and Jobs.’’ The purpose of the hearing was to examine the 

state of the medical device industry and the impact regulations and 

policies at the Center for Devices and Radiological Health have on 

patient access, innovation, and job creation. The Subcommittee received testimony from Dr. Jeffrey E. Shuren, Director, Center for 

Devices and Radiological Health, FDA; Fischell Biomedical; TranVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
4 

scend Medical Inc.; Progressive Policy Institute; New England 

Journal of Medicine; Marti Conger; Carol Murphy; and Pam Sagan. 

EXAMINING THE INCREASE IN DRUG SHORTAGES

On September 23, 2011, the Subcommittee on Health held a 

hearing entitled ‘‘Examining the Increase in Drug Shortages.’’ The 

hearing examined the causes and effects of drug shortages in the 

U.S. health care system. The Subcommittee heard testimony from 

the Honorable Howard K. Koh, M.D., Assistant Secretary for 

Health, U.S. Department of Health and Human Services; Teva 

Health Systems; Healthcare Distribution Management Association; 

American Society of Health-System Pharmacists; Premier, Inc.; 

American Society of Clinical Oncology; Lancaster General Health; 

and the Cancer Institute of New Jersey. 

IMPACT OF MEDICAL DEVICE AND DRUG REGULATION ON INNOVATION, 

JOBS AND PATIENTS: A LOCAL PERSPECTIVE

On September 26, 2011, the Subcommittee on Health held a field 

hearing entitled ‘‘Impact of Medical Device and Drug Regulation on 

Innovation, Jobs and Patients: A Local Perspective.’’ The Subcommittee investigated how Federal regulations are impacting the 

medical device community. The Subcommittee received testimony 

from the California Healthcare Institute; Conatus Pharmaceuticals, 

Inc.; National Venture Capital Association; West Wireless Health 

Institute; BIOCOM, CONNECT; and TherOx, Inc. 

REAUTHORIZATION OF PDUFA: WHAT IT MEANS FOR JOBS, INNOVATION

AND PATIENTS

On February 1, 2012, the Subcommittee on Health held a hearing entitled ‘‘Reauthorization of PDUFA: What It Means for Jobs, 

Innovation, and Patients.’’ The Subcommittee examined issues pertaining to the reauthorization of the Prescription Drug User Fee 

Act (PDUFA). This hearing also focused on the reauthorization of 

the Best Pharmaceuticals for Children Act (BPCA) and Pediatric 

Research Equity Act (PREA) and pharmaceutical supply chain 

issues. The Subcommittee received testimony from the Honorable 

Margaret A. Hamburg, M.D., Commissioner, FDA; Pfizer, Inc.; 

California Health Institute; Biotechnology Industry Organization; 

Pharmaceutical Research and Manufacturers of America; the Pew 

Charitable Trusts; National Organization for Rare Disorders; and 

American Academy of Pediatrics. 

REVIEW OF THE PROPOSED GENERIC DRUG AND BIOSIMILARS, USER

FEES AND FURTHER EXAMINATION OF DRUG SHORTAGES

On February 9, 2012, the Subcommittee on Health held a hearing entitled ‘‘The Review of the Proposed Generic Drug and 

Biosimilars User Fees and Further Examination of Drug Shortages.’’ The Subcommittee examined issues pertaining to the proposed generic and biosimilars user fees and drug shortages. The 

Subcommittee received testimony from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA; Mylan, 

Inc.; Generic Pharmaceutical Association; and St. Jude Children’s 

Research Hospital. 


jbell on DSK7SPTVN1PROD with REPORTS
5 

REAUTHORIZATION OF MDUFA: WHAT IT MEANS FOR JOBS, INNOVATION

AND PATIENTS

On February 15, 2012, the Subcommittee on Health held a hearing entitled ‘‘Reauthorization of MDUFA: What It Means for Jobs, 

Innovation, and Patients.’’ The Subcommittee examined issues pertaining to the reauthorization of medical device user fees. The Subcommittee received testimony from Dr. Jeffrey E. Shuren, Director, 

Center for Devices and Radiological Health, FDA; Terumo BCT; 

Philips Healthcare; Versant Ventures; Consumers Union; Ralph 

Hall; Art Sedrakyan, M.D., Ph.D.; Aaron S. Kesselheim, M.D., J.D., 

M.P.H.; and Jim Shull. 

FDA USER FEES 2012: HEARING ON ISSUES RELATED TO ACCELERATED

APPROVAL, MEDICAL GAS, ANTIBIOTIC DEVELOPMENT AND DOWNSTREAM PHARMACEUTICAL SUPPLY CHAIN

On March 8, 2012, the Subcommittee on Health held a hearing 

entitled ‘‘FDA User Fees 2012: Hearing on Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain.’’ The Subcommittee examined issues pertaining to the reauthorization of FDA user fees. The 

Subcommittee received testimony from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA; Alnylam 

Pharmaceuticals; Friends of Cancer Research; Cubist Pharmaceuticals; John H. Powers, MD; Compressed Gas Association; Generic Pharmaceutical Association; Healthcare Distribution Management Association; National Community Pharmacists Association; 

and the Pew Charitable Trusts. 

EXAMINING THE CURRENT STATE OF COSMETICS

On March 27, 2012, the Subcommittee on Health held a hearing 

entitled ‘‘Examining the Current State of Cosmetics.’’ The Subcommittee evaluated the current state of the cosmetic industry. 

The Subcommittee received testimony from Michael M. Landa, 

J.D., Director, Center for Food Safety and Applied Nutrition, FDA; 

Personal Care Products Council; Jack Black Skincare; Peter Barton 

Hutt; Wholesale Supplies Plus; and California Department of Public Health. 

FDA USER FEES 2012: HOW INNOVATION HELPS PATIENTS AND JOBS

On April 18, 2012, the Subcommittee on Health held a hearing 

entitled ‘‘FDA User Fees 2012: How Innovation Helps Patients and 

Jobs.’’ The Subcommittee examined the impact of FDA user fees on 

patients and jobs. The Subcommittee received testimony from Dr. 

Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA; Dr. Jeffrey E. Shuren, Director, Center for Devices 

and Radiological Health, FDA; Pharmaceutical Research and Manufacturers of America; Biotechnology Industry Organization; Generic Pharmaceutical Association; Advanced Medical Technology 

Association; and Pew Charitable Trusts. 


jbell on DSK7SPTVN1PROD with REPORTS
6 

COMMITTEE CONSIDERATION

The Subcommittee on Health held a legislative hearing on April 

18, 2012, entitled, ‘‘FDA User Fees 2012: How Innovation Helps 

Patients and Jobs.’’ 

On May 8, 2012, the Subcommittee met in open markup session 

to consider a Committee Print to reauthorize various FDA user fee 

programs. The Subcommittee adopted an amendment, which included technical changes recommended by the FDA. Thereafter, the 

Subcommittee forwarded the Committee Print to the full Committee for consideration. 

H.R. 5651, the ‘‘Food and Drug Administration Reform Act of 

2012,’’ was introduced on May 9, 2012, by Fred Upton (R–MI), 

Ranking Member Henry Waxman (D–CA), Subcommittee on Health 

Chairman Joseph R. Pitts (R–PA), Subcommittee on Health Ranking Member Frank Pallone, Jr. (D–NJ), Chairman Emeritus Joe 

Barton (R–TX), and Chairman Emeritus John D. Dingell (D–MI) 

and was referred to the Committee on Energy and Commerce. 

On May 10, 2012, the Committee on Energy and Commerce met 

in open markup session to consider H.R. 5651, as introduced. The 

full Committee ordered H.R. 5651 to be reported to the House, 

without amendment, by a recorded vote of 46 yeas and 0 nays. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. A motion by Mr. 

Upton to order H.R. 5651 reported to the House, without amendment, was agreed to by a record vote of 46 yeas and 0 nays. 

The following reflects the recorded votes taken during the Committee’s consideration of the bill: 


jbell on DSK7SPTVN1PROD with REPORTS
7 


jbell on DSK7SPTVN1PROD with REPORTSInsert graphic folio 10 HR495.001
8 

COMMITTEE OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee held legislative and oversight 

hearings and made findings that are reflected in this report. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

In accordance with clause 3(c)(4) of rule XIII of the Rules of the 

House of Representatives, the performance goals and objectives of 

the Committee are reflected in the descriptive portions of this report. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee finds that H.R. 5651, the 

‘‘Food and Drug Administration Reform Act of 2012,’’ would result 

in no new or increased budget authority, entitlement authority, tax 

expenditures or revenues. 

EARMARK

In compliance with clause 9(e), 9(f), and 9(g) of rule XXI of the 

Rules of the House of Representatives, the Committee finds that 

H.R. 5651, the ‘‘Food and Drug Administration Reform Act of 

2012,’’ contains no earmarks, limited tax benefits, or limited tariff 

benefits. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate provided by 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974: 

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, May 24, 2012. 

Hon. FRED UPTON, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN:, The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 5651, the Food and Drug 

Administration Reform Act of 2012. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Julia Christensen. 

Sincerely, 

DOUGLAS W. ELMENDORF, 

Director. 

Enclosure. 


jbell on DSK7SPTVN1PROD with REPORTS
9 

H.R. 5651—Food and Drug Administration Reform Act of 2012 

Summary: H.R. 5651 would authorize the collection and spending 

of fees by the Food and Drug Administration (FDA) for certain activities to expedite the marketing approval of prescription drugs 

and medical devices and to regulate drugs after they enter the 

market. The bill would provide the FDA with additional regulatory 

authority to improve the safety of the drug supply chain and establish an early warning notification system to mitigate or prevent 

critical drug shortages. It also would create a new approval procedure for breakthrough drug therapies and offer financial incentives 

to drug sponsors to produce certain antimicrobial drugs. The legislation would require FDA to publish the scientific or regulatory rationale for significant decisions issued by the agency regarding a 

device and establish an expedited process to appeal such decisions. 

In addition, the bill would permanently reauthorize FDA’s programs that evaluate the use of drugs by children. 

CBO expects that enacting the bill would affect the average price 

of prescription drugs available in the market. Some provisions in 

the bill would result in higher average prices for certain drugs; 

other provisions would accelerate the entry of generic versions of 

some drugs, which would lead to lower average prices. CBO estimates that the net effect of enacting H.R. 5651 would be to reduce 

the average price of prescription drugs slightly through 2017 and 

to increase prices in subsequent years. 

CBO estimates that enacting H.R. 5651 would: 

• Reduce direct spending, on net, by $72 million over the 2013– 2017 period but increase direct spending by $244 million over the 

2013–2022 period. • Increase federal revenues by less than $500,000 over the 2013– 2017 period but lower revenues, on net, by about $3 million over 

the 2013–2022 period. 

Considering both the direct spending and revenue effects, we estimate that enacting H.R. 5651 would reduce budget deficits by approximately $72 million over the 2013–2017 period and increase 

them by $247 million over the 2013–2022 period. Pay-as-you-go 

procedures apply because enacting the legislation would affect direct spending and revenues. 

Pursuant to section 504 of H. Con. Res. 112, the Concurrent Resolution on the Budget—Fiscal Year 2013, CBO estimates H.R. 5651 

would increase direct spending by more than $5 billion in at least 

one of the four consecutive 10-year periods starting in 2023. 

Implementing H.R. 5651 would also have several effects on 

spending subject to appropriation. The bill would authorize increased funding for a variety of FDA activities, but CBO estimates 

that the majority of the gross increase in FDA spending would be 

offset by increased collections of fees that would be credited against 

discretionary spending. On balance, CBO estimates that net discretionary spending (primarily by FDA) would rise by $337 million 

over the 2013–2017 period, assuming appropriation actions consistent with the bill. 

H.R. 5651 contains both intergovernmental and private-sector 

mandates as defined in the Unfunded Mandates Reform Act 

(UMRA). Extending the requirement to pay fees for medical devices 

and expanding the registration standards applied to drug manufacturers would be intergovernmental mandates as defined in UMRA 


jbell on DSK7SPTVN1PROD with REPORTS
10 

for state, local, or tribal governments that manufacture medical devices for commercial purposes. However, CBO estimates that the 

costs of complying with those mandates would be minimal and well 

below the threshold established in UMRA for intergovernmental 

mandates ($73 million in 2012, adjusted annually for inflation). 

The legislation contains several mandates on the private sector 

as defined in UMRA. The most costly of those mandates would require that manufacturers of different types of drug and medical device products pay fees to the FDA. CBO estimates that the direct 

cost of all private-sector mandates in the bill would greatly exceed 

the annual threshold specified in UMRA ($146 million in 2012, adjusted annually for inflation) in each of the first five years that the 

mandates would be effective. 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 5651 is shown in the following table. The effects of this legislation fall primarily within budget functions 550 

(health) and 570 (Medicare). 

By fiscal year, in millions of dollars— 

2013 2014 2015 2016 2017 2013–2017 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Collections from Fees: 

Prescription Drugs ..................................... ¥720 ¥756 ¥800 ¥847 ¥945 ¥4,068 

Medical Devices ......................................... ¥98 ¥115 ¥129 ¥133 ¥134 ¥609 

Generic Drugs ............................................ ¥299 ¥306 ¥315 ¥323 ¥332 ¥1,575 

Biosimilar Biological Products .................. ¥20 ¥21 ¥23 ¥28 ¥36 ¥128 

Priority Review Vouchers ........................... 0 ¥6 ¥6 ¥6 ¥6 ¥23 

Subtotal, Estimated Authorization Level ¥1,137 ¥1,204 ¥1,273 ¥1,337 ¥1,453 ¥6,403 

Subtotal, Estimated Outlays ................. ¥1,137 ¥1,204 ¥1,273 ¥1,337 ¥1,453 ¥6,403 

Spending of Fees: 

Prescription Drugs ..................................... 720 756 800 847 945 4,068 

Medical Devices ......................................... 98 115 129 133 134 609 

Generic Drugs ............................................ 299 306 315 323 332 1,575 

Biosimilar Biological Products .................. 20 21 23 28 36 128 

Priority Review Vouchers ........................... 0 6 6 6 6 23 

Subtotal, Estimated Authorization Level 1,137 1,204 1,273 1,337 1,453 6,403 

Subtotal, Estimated Outlays ................. 721 1,043 1,329 1,446 1,481 6,021 

Net Changes from Fees: 

Estimated Authorization Level ................... 0 0 0 0 0 0 

Estimated Outlays ..................................... ¥416 ¥160 57 109 28 ¥383 

Other Proposed Changes: 

Provisions Affecting Prescription Drugs 

(Titles VIII and IX): 

Estimated Authorization Level .......... 59 68 77 77 77 359 

Estimated Outlays ............................ 31 58 72 75 76 313 

Provisions Affecting Pediatric Populations 

(Title V): 

Estimated Authorization Level .......... 46 61 62 63 71 303 

Estimated Outlays ............................ 24 52 59 62 69 266 

Provisions Affecting Medical Devices 

(Title VII): 

Estimated Authorization Level .......... 14 23 32 32 33 134 

Estimated Outlays ............................ 10 18 27 31 33 118 

Other Provisions and Effects: 

Estimated Authorization Level .......... 3 5 5 6 6 25 

Estimated Outlays ............................ 3 4 4 6 6 23 

Total Changes in Discretionary Spending: 

Estimated Authorization Level ................... 122 157 176 178 187 821 

Estimated Outlays ..................................... ¥349 ¥28 219 283 212 337 


jbell on DSK7SPTVN1PROD with REPORTS
11 

By fiscal year, in millions of dollars— 

2013 2014 2015 2016 2017 2013–2017 

CHANGES IN DIRECT SPENDING a

Estimated Budget Authority ............................... ¥14 ¥12 ¥15 ¥16 ¥14 ¥72 

Estimated Outlays .............................................. ¥14 ¥12 ¥15 ¥16 ¥14 ¥72 

CHANGE IN REVENUES a

Estimated Revenues ........................................... 0 * * * * * 

a CBO estimates that enacting the bill would increase direct spending, on net, by $244 million over the 2013–2022 period and decrease 

revenues by about $3 million over that period. There would be a small effect on spending for health benefits by the United States Postal 

Service, which is classified as off budget. CBO estimates those amounts would be between ¥$500,000 and $500,000 annually over the 

2013–2022 period. 

Note: * = less than $500,000; components may not sum to totals because of rounding. 

Basis of Estimate: For this estimate, CBO assumes that the legislation will be enacted by the end of fiscal year 2012 and that the 

Congress will take appropriation actions consistent with the bill for 

the funding of FDA activities and for triggering the collections of 

fees to offset the costs of some of those activities. 

H.R. 5651 would reauthorize FDA’s branded prescription drug 

and medical device fee programs through 2017 and would establish 

new fee programs covering generic drugs and biosimilar biological 

products. (Biological drugs are products derived from living organisms; biosimilars are those products that meet certain statutory 

requirements and are determined by FDA to be highly similar to 

drugs for which licenses were originally granted to innovator drug 

companies.) The bill also would establish a new fee program that 

provides vouchers for priority drug reviews to sponsors of marketing applications for drugs that treat rare pediatric diseases. 

In addition, the legislation would authorize a number of other activities that are not supported by fees that would modify how the 

FDA regulates drugs and devices in a broad range of areas. 

Spending Subject to Appropriation 

Assuming appropriation action consistent with the bill, CBO estimates that implementing H.R. 5651 would reduce net discretionary 

outlays, primarily for FDA, by $349 million in 2013 and $28 million 

in 2014, mostly because the spending of fees lags somewhat behind 

their collection. CBO estimates that gross FDA spending in subsequent years would exceed the amounts collected from fees (because 

some of the spending under the bill would not be offset by fees) and 

that the net discretionary cost of implementing the bill would 

amount to $337 million over the 2013–2017 period. 

Fee Programs Administered by FDA. H.R. 5651 would authorize 

five different fee programs within FDA to cover specific costs relating to the approval and marketing of prescription drugs (branded, 

generic, and biosimilar biological products) and medical devices, 

and to cover costs of conducting priority drug reviews through an 

incentive program that awards redeemable vouchers for such reviews to sponsors of certain applications for drugs that treat rare 

pediatric diseases. In fiscal year 2012, CBO estimates that FDA 

will collect $760 million in fees associated with the existing branded prescription drug and medical device fee programs that expire 

at the end of the year. 

Under the bill, CBO estimates that FDA would assess about $6.4 

billion in aggregate fees over the 2013–2017 period. Of that 

amount, $1.7 billion in collections would be generated by the new 


jbell on DSK7SPTVN1PROD with REPORTS
12 

fee programs for generic and biosimilar biological drugs and for priority review vouchers created under the legislation, and $4.7 billion 

in collections would be generated by the fee programs for branded 

prescription drugs and medical devices reauthorized by the bill. Except for the voucher program, the fee programs authorized under 

the bill would expire at the end of fiscal year 2017. The authority 

to award vouchers expires one year after the third voucher is 

awarded, but there is no limit on when the voucher can be redeemed. 

H.R. 5651 specifies that drug and medical device fees would be 

collected and made available for obligation only to the extent, and 

in the amounts, provided in advance in appropriation acts, with 

one exception. The bill would allow certain new fees authorized for 

generic and biosimilar biological drugs to be collected and spent 

during the first program year (fiscal year 2013) until the date of 

enactment of a law providing appropriations through September 

30, 2013. By allowing the assessment and spending of fee collections outside of an appropriation action, H.R. 5651 could generate 

increases in revenue or direct spending attributable to such fees. 

However, for this estimate, CBO assumes that both enactment of 

H.R. 5651 and the necessary appropriation action will occur before 

the end of fiscal year 2012. As a result, we expect that any fees 

assessed and spent in fiscal year 2013 would be classified as offsetting collections (that is, as an offset to discretionary spending). 

CBO estimates that appropriation action consistent with the 

bill’s authorizations for fee programs would reduce net discretionary outlays for FDA by $383 million over the 2013–2017 period. 

Because FDA would have the authority to spend the collections, the 

estimated budget authority for collections and spending would offset each other exactly for each fiscal year, while the spending of fee 

collections would initially lag behind the collections and thus generate net discretionary savings over the 2013–2017 period. 

Costs for Activities Not Supported by Fees. H.R. 5651 would require that FDA modify certain agency procedures relating to the 

oversight of prescription drugs and devices; costs for many of the 

new activities would not be covered by fees. CBO estimates that activities not supported by fees under the bill would cost $720 million 

over the 2013–2017 period, assuming the appropriation of the necessary amounts. 

Provisions Affecting Prescription Drugs (Titles VIII and IX). H.R. 

5651 would enhance FDA’s regulatory authorities relating to prescription drugs in several key areas. It would expand advance notification requirements for potential drug shortages and strengthen 

FDA’s authority to expedite drug reviews and inspections of facilities that address critical drug shortages. The bill would increase 

FDA’s oversight authority of the drug supply chain both in the 

United States and overseas through new registration and inspection requirements. The bill also would allow FDA to destroy certain 

counterfeit or adulterated imports valued at less than $2,000. To 

advance the development of breakthrough drug therapies, H.R. 

5651 would create a new approval procedure for such products. 

CBO estimates that implementing such provisions and complying 

with other requirements contained in titles VIII and IX would increase FDA’s costs by about $313 million over the 2013–2017 period. 


jbell on DSK7SPTVN1PROD with REPORTS
13 

1During such periods of pediatric exclusivity, FDA will not permit another manufacturer to 

market a version of the drug. 

Provisions Affecting Pediatric Populations (Title V). H.R. 5651 

would permanently authorize FDA’s pediatric drug programs. The 

bill would make permanent: 

• An incentive program that grants market exclusivity to 

manufacturers that voluntarily conduct specified studies on the 

use of drugs in certain pediatric populations, the so-called pediatric exclusivity program;1 and 

• FDA’s authority to require that drug manufacturers conduct tests on drugs for pediatric populations and make necessary labeling changes to reflect the appropriate information. 

The legislation also would authorize the appropriation of $25 million per year to extend the research program at the National Institutes of Health for pediatric studies on drugs for each year from 

2013 through 2017. The bill would also authorize the appropriation 

of $30 million annually over the 2013–2017 period to extend FDA’s 

grant and contracts program for orphan products. 

Assuming the appropriation of the necessary amounts, CBO estimates that implementing provisions that affect pediatric populations in title V of the bill would have a discretionary cost of $266 

million the over 2013–2017 period. 

Provisions Affecting Medical Devices (Title VII). Title VII would 

modify regulatory procedures under which FDA evaluates and approves medical device applications and tracks the safety of such devices. Among those changes the bill would: 

• Include devices in FDA’s system for identifying risks after 

a product is on the market; 

• Require FDA to publish the scientific and regulatory rationale for any significant decision regarding a report or application; 

• Establish a process for manufacturers that are seeking to 

submit or that have submitted a report or application to review 

with FDA the agency’s documentation of significant decisions; 

• Require FDA to regularly publish detailed decision summaries for each clearance of certain devices; and 

• Extend and enhance the incentive program for device manufacturers to develop medical devices specifically designed for 

pediatric patients. 

CBO estimates that the provisions affecting the regulation of 

medical devices under title VII would increase FDA’s costs by 

about $118 million over the 2013–2017 period, assuming the appropriation of the necessary amounts. 

Other Provisions and Effects. CBO estimates that implementing 

title VI and preparing certain regulatory science reports not covered by fees would cost $31 million over the 2013–2017 period, assuming the appropriation of the necessary amounts. 

Several provisions in the bill would affect when lower-priced 

drugs enter the market. Changing the timing of availability of 

lower-priced drugs affects spending in federal health programs that 

pay for prescription drugs and biological products. We expect that 

enacting the bill would reduce the average price of drugs in the 

market slightly over the 2013–2017 period. CBO estimates that 

spending for federal health programs subject to appropriation— 


jbell on DSK7SPTVN1PROD with REPORTS
14 

2 Enantiomers are a class of molecules that are arranged as mirror images to one another. 

Such molecules can be found together in a mixture that forms the basis of many drugs. 

such as those operated by the Departments of Veterans Affairs and 

Defense—would fall by $8 million over that period, assuming that 

appropriation actions reflect the estimated reductions in costs. 

Direct Spending 

CBO estimates that enacting H.R. 5651 would reduce direct 

spending for federal health programs by $72 million over the 2013– 

2017 period but would increase direct spending by $244 million 

over the 2013–2022 period. That net impact reflects an increase in 

direct spending owing to provisions that would delay market entry 

of certain drugs (causing some federal health programs to have 

higher spending than under current law) and a decrease in direct 

spending owing to other provisions that would lower average prices 

paid for some drugs (allowing federal health programs to reduce 

their costs). CBO estimates that direct spending, on net, would 

begin to increase starting in 2018, when the effects of provisions 

that would delay the entry of lower-priced drugs exceeds the effects 

of provisions that would lead to earlier entry of lower-priced drugs. 

Provisions that are expected to delay entry of lower-priced generic or biosimilar biological drugs are those that provide market 

exclusivity—periods during which FDA will not permit another 

manufacturer to market a version of the drug. Those provisions are 

aimed at encouraging the development of certain types of anti-microbial medications, innovative single enantiomer drugs, and pediatric indications and formulations for drugs.2

Section 862 would change the rules governing when a generic 

drug manufacturer forfeits its rights to market exclusivity because 

of failure to receive tentative approval from FDA. The legislation 

would increase the allowable time period to obtain such approval— 

now set at 30 months after filing an application—before forfeiture 

occurs. Thus, the bill would allow affected firms to retain sole marketing rights. In cases where fewer generic firms compete on products because a forfeiture is avoided, we anticipate that higher average prices would be charged in the market. Because CBO expects 

that the implementation of the fee program for the review of generic drugs will accelerate review times and lead to fewer forfeitures, holding all else equal, the estimated costs for section 862 reflect the incremental effect of this provision beyond the effect of the 

fee program. 

Taken together, CBO estimates that provisions delaying the 

entry of generic or biosimilar biological drugs would increase the 

average prices of certain drugs and thereby increase direct spending for mandatory health programs such as Medicare, Medicaid, 

subsidies for enrollees in health insurance exchanges, and the Federal Employees Health Benefits and TRICARE-for-Life programs, 

by $412 million over the 2013–2022 period. 

CBO expects that other provisions of H.R. 5651 would reduce the 

average price charged for drugs in the market. We estimate that 

the provision with the greatest effect on market entry by lowerpriced generic drugs is section 863. It would reduce by 30 days the 

statutory timeframe for final agency action relating to certain citizen petitions that ask for a stay of FDA approval on a pending geVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00014 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
15 

neric drug application. (Under the bill, the limitation on the determination period would be 150 days.) 

When both approval of the generic application and marketing of 

the drug hinge on the final determination date, earlier administrative action under the bill could lead to earlier generic entry. (Sometimes patents or market exclusivities delay entry of generics regardless of the date on which a citizen petition is resolved.) Thus, 

in certain cases, CBO expects that reducing the statutory timeframe by 30 days could lead to earlier marketing of lower-priced 

drugs. 

CBO estimates that implementing section 863 and other provisions that shorten administrative timeframes for review of certain 

petitions would reduce direct spending for mandatory health programs by $168 million over the 2013–2022 period. CBO anticipates 

that the implementation of the fee program in title III would allow 

FDA to use its resources in such a manner that we can reasonably 

expect that the average review times for certain petitions would 

also fall over time because of that program. Thus, estimated savings generated by provisions that would shorten administrative 

timeframes in the bill reflect the incremental effect of such provisions beyond the effect of the fee program. 

Revenues 

H.R. 5651 would affect revenues in two ways. First, CBO expects 

that enacting H.R. 5651 would result in slightly higher costs for 

private health insurance plans over the 2013–2022 period. In turn, 

raising the costs of health insurance plans would increase federal 

subsidies for health insurance purchased through an exchange. The 

portion of those tax credits that exceed taxpayers’ liabilities are 

classified as outlays (and those effects are included in the direct 

spending estimate above), while the portions that reduce taxpayers’ 

liabilities are recorded as changes in revenues. CBO estimates that 

H.R. 5651 would lower federal revenues by $3 million over the 

2013–2022 period. 

In addition, the bill would make certain violations of new requirements subject to criminal and civil money penalties. Collections of such penalties are classified as federal revenues. Criminal 

fines are deposited in the Crime Victims Fund, and later spent; 

however, CBO estimates that any net effects would not be significant in each year because of the small number of cases likely to 

be affected. 

Pay-as-you-go considerations: The Statutory Pay-As-You-Go Act 

of 2010 establishes budget-reporting and enforcement procedures 

for legislation affecting on-budget direct spending or revenues. The 

net changes in outlays and revenues that are subject to those payas-you-go procedures are shown in the following table. 


jbell on DSK7SPTVN1PROD with REPORTS
16 

CBO ESTIMATE OF PAY-AS-YOU-GO EFFECTS FOR H.R. 5651 AS ORDERED REPORTED BY THE 

HOUSE COMMITTEE ON ENERGY AND COMMERCE ON MAY 10, 2012 

By fiscal year, in millions of dollars— 

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2012– 

2017 

2012– 

2022 

NET INCREASE OR DECREASE (¥) IN THE ON-BUDGET DEFICIT 

Statutory PayAs-You-Go 

Impact ...... 0 ¥14 ¥12 ¥15 ¥16 ¥15 7 73 61 66 112 ¥73 247 

Note: Components may not sum to totals because of rounding. 

Estimated impact on state, local, and tribal governments: By continuing FDA’s fee program, the bill would extend a requirement to 

pay fees on state, local, or tribal governments that manufacture 

medical devices for commercial purposes. That requirement would 

be an intergovernmental mandate as defined in UMRA, but CBO 

is unaware of any case in which a state, local, or tribal entity manufactures such devices for commercial purposes. CBO is aware of 

public institutions of higher education that manufacture drugs and 

are subject to FDA’s registration and inspection standards. Thus, 

the provisions in the bill that increase the stringency of those 

standards would impose an intergovernmental mandate. Because 

few public institutions of higher education would be required to 

comply with the new standards, CBO estimates that the costs of 

complying with the mandates in H.R. 5651 would be minimal and 

well below the threshold established in UMRA ($73 million in 

2012, adjusted annually for inflation). 

Because the bill’s requirements would result in lower costs for 

prescription drugs provided under the Medicaid program, CBO estimates that state spending for Medicaid would decrease by about $6 

million over the 2013–2017 period. 

Estimated impact on the private sector: The legislation contains 

several mandates on the private sector as defined in UMRA. The 

most costly of those mandates would require that manufacturers of 

branded prescription drugs, generic drugs, biosimilar biological 

products, and medical devices pay fees to FDA. CBO estimates that 

the direct cost of all private-sector mandates in the bill would 

greatly exceed the annual threshold specified in UMRA ($146 million in 2012, adjusted annually for inflation) in each of the first five 

years that the mandates would be effective. 

In addition to imposing an increase in fees, H.R. 5651 also would 

impose a number of other mandates on the private sector. For example, several provisions in the bill would grant periods of market 

exclusivity for certain types of drugs. Those provisions impose a 

mandate by preventing manufacturers of generic or biosimilar 

versions of the drug from entering the market during that period. 

The bill also would expand requirements relating to the approval 

of pediatric drugs and would expand registration requirements on 

certain entities involved in the manufacture, preparation, propagation, compounding, or processing of drugs. Title VIII also would authorize the Secretary of Health and Human Services to destroy certain drugs intended for import that are refused admission to the 

United States. Title IX would require that manufacturers of certain 

drugs notify the FDA before discontinuing production of those 

drugs. 


jbell on DSK7SPTVN1PROD with REPORTS
17 

Previous CBO estimate: On May 11, 2012, CBO transmitted a 

cost estimate for S. 2516, the Food and Drug Administration Safety 

and Innovation Act, as reported by the Senate Committee on 

Health, Education, Labor, and Pensions on May 7, 2012. Both the 

House and Senate bills would make significant changes to the regulatory authority of the Food and Drug Administration relating to 

prescription drugs and devices. Although the bills contain many 

similar provisions, H.R. 5651 would address certain regulatory 

issues in different ways. CBO’s cost estimates reflect those differences. 

Estimate prepared by: Federal Costs: Julia Christensen, Lisa Ramirez-Branum, Daniel Hoople, Jamease Miles, Kalyani 

Parthasarathy, Ellen Werble, and Rebecca Yip; Impact on State, 

Local, and Tribal Governments: Lisa Ramirez-Branum; Impact on 

the Private Sector: Jimmy Jin. 

Estimate approved by: Holly Harvey, Deputy Assistant Director 

for Budget Analysis. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 

2012 

The first title would authorize the Prescription Drug User Fee 

Amendments of 2012 (PDUFA). 

Section 101—Short title; findings 

In this section, Congress would find that the prescription drug 

user fee funds must go toward, as set forth in the goals identified 

in the letters from the Secretary of Health and Human Services to 

the Chairman of the House Committee on Energy and Commerce 

and Chairman of the Senate Committee on Health, Education, 

Labor, and Pensions, expediting the drug development process and 

review of human drug applications, including postmarket safety activities. These goals would include meeting time goals regarding 

the review of priority and standard drug applications, fostering 

greater interaction between drug sponsors and FDA, and increasing engagement with patients, including those with rare diseases. 

Section 102—Definitions 

This section would amend a statutory definition associated with 

the user fee. 

Section 103—Authority to assess and use drug fees 

This section would establish the user fee amounts for fiscal years 

2013 through 2017 and adjustments to, and methodologies for calculating, those fees. FDA would collect these funds through application, establishment, and product fees. The section also would require FDA to contract with an independent firm to analyze the adeVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00017 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
18 

quacy of those adjustments and methodologies. Finally, based on 

such analysis, FDA could adopt changes to the methodologies. 

Section 104—Reauthorization; reporting requirements 

This section would require FDA to report, not later than 120 

days after the end of each fiscal year, on its success in achieving 

the goals set forth in the letter from the Secretary of Health and 

Human Services to the Chairman of the House Committee on Energy and Commerce and Chairman of the Senate Committee on 

Health, Education, Labor, and Pensions. This report would include 

the status of the independent assessment of the Program for New 

Molecular Entities. This report also would include the progress of 

the review divisions of FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research on the following topics: (1) number of original standard new drug applications and biologics license applications filed per fiscal year; (2) 

number of original priority new drug applications and biologics license applications filed per fiscal year; (3) number of standard efficacy supplements filed per fiscal year; (4) number of priority efficacy supplements filed per fiscal year; (5) number of applications 

filed for review under accelerated approval per fiscal year; (6) number of applications filed for review as fast track products per fiscal 

year; and (7) number of applications filed for orphan-designated 

products per fiscal year. The section also would require FDA to 

submit a fiscal report on the use of the fees collected under the authority granted under Title I. 

The section would authorize FDA to develop and present recommendations to Congress on the reauthorization of the user fee 

program by January 15, 2017. 

Section 105—Sunset dates 

The section would establish sunset dates for the user fee and related programs and provide technical clarifications for previous 

user fee legislation. 

Section 106—Effective date 

The title would take effect on October 1, 2012, or the date of enactment, whichever is later. 

Section 107—Savings clause 

This section would limit the effect of Title I on those applications 

and supplements filed before enactment of the title and clarify that 

the prescription drug user fee provisions in effect prior to October 

1, 2012 would apply to such submissions. 

TITLE II—MEDICAL DEVICE USER AMENDMENTS OF 2012 

The second title would authorize the Medical Device User Fee 

Amendments of 2012. 

Section 201—Short title; finding 

In this section, Congress would find that the medical device user 

fee funds must go toward, as set forth in the goals identified in the 

letters from the Secretary of Health and Human Services to the 

Chairman of the House Committee on Energy and Commerce and 

Chairman of the Senate Committee on Health, Education, Labor, 


jbell on DSK7SPTVN1PROD with REPORTS
19 

and Pensions, expediting the process for the review of device applications and assuring the safety and effectiveness of devices. 

Section 202—Definitions 

This section would amend certain definitions in Section 737 of 

the FFDCA. 

Section 203—Authority to assess and use device fees 

This section would reauthorize the user fee program and set 

forth changes in the fees beginning in 2013. Under this section, 

FDA would collect the following amounts under the medical device 

user fee program: $97,722,301 for fiscal year 2013; $112,580,497 for 

fiscal year 2014; $125,767,107 for fiscal year 2015; $129,339,949 for 

fiscal year 2016; and $130,184,348 for fiscal year 2017. FDA would 

collect these funds through fees associated with submissions and 

establishment registration. 

Section 204—Reauthorization; reporting requirements 

This section would require FDA to report, not later than 120 

days after the end of each fiscal year, on its success in achieving 

the goals set forth in the letter from the Secretary of Health and 

Human Services to the Chairman of the House Committee on Energy and Commerce and Chairman of the Senate Committee on 

Health, Education, Labor, and Pensions. The section also would require FDA to submit a fiscal report on the use of the fees collected 

under the authority granted under Title II. 

The user fee agreement would include the following improvements: (1) FDA would have to report its total time for reviewing 

devices; (2) FDA’s review process would include greater interaction 

between sponsors and the Agency; and (3) an independent entity 

would assess the device approval and clearance processes, and FDA 

would have to implement a corrective action plan to address deficiencies. In addition to the annual report referenced above, FDA 

would have to post certain information on its success in achieving 

the goals on a quarterly basis, including the status of the independent assessment. 

Part of the user fee agreement includes the development of a 

transitional In Vitro Diagnostics (IVD) approach. The Committee 

applauds FDA for its commitment, as expressed in the MDUFA III 

Commitment Letter, to work with industry to develop a transitional IVD approach for the regulation of emerging diagnostic tests. 

The Committee is highly interested in developments with respect 

to the Agency’s plans to develop a transitional IVD approach and 

looks forward to reviewing steps taken related to its implementation. 

The section would authorize FDA to develop and present recommendations to Congress on the reauthorization of the user fee 

program by January 15, 2017. 

Section 205—Savings Clause 

This section would limit the effect of Title II on those applications and supplements filed before enactment of the Title, and clarify that the medical device user fee provisions in effect prior to October 1, 2012 would apply to such submissions. 


jbell on DSK7SPTVN1PROD with REPORTS
20 

Section 206—Effective date 

Under this section, Title II would take effect on October 1, 2012, 

or the date of enactment, whichever is later. 

Section 207—Sunset Clause 

This section would set the expiration dates of the medical device 

user fee as October 1, 2017, and the expiration of the reporting requirement as January 31, 2018. 

Section 208—Streamlined hiring authority to support activities related to the process for the review of device applications 

This section would authorize FDA to streamline the hiring process to expedite the hiring of personnel necessary to achieve the performance goals. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

This title would authorize the Generic Drug User Fee Amendments of 2012 (GDUFA). 

Section 301—Short title; findings 

In this section, Congress would find that the generic drug user 

fee funds must go toward, as set forth in the goals identified in the 

letters from the Secretary of Health and Human Services to the 

Chairman of the House Committee on Energy and Commerce and 

Chairman of the Senate Committee on Health, Education, Labor, 

and Pensions, human generic drug activities, which include the review of abbreviated new drug applications and facility inspections. 

Section 302—Authority to assess and use human generic drug fees 

This section would codify definitions key to implementing this 

new user fee, including the types of activities that FDA could fund 

with these fees. With respect to user fees, the section would authorize the following: one-time backlog fee; drug master file fee; abbreviated new drug application and prior approval supplement filing 

fee; and generic drug and active pharmaceutical facility fee. These 

fees would generate approximately $299,000,000 per year for fiscal 

years 2013 to 2017. For fiscal year 2013, $50,000,000 would come 

from the one-time backlog fee for applications pending with FDA 

on October 1, 2012, and the rest would come from the remaining 

user fees as follows: 6 percent from drug master file fees; 24 percent from abbreviated new drug and prior approval supplement filing fees; 56 percent from generic facility fees; and 14 percent from 

active pharmaceutical ingredient filing fees. In the fiscal years 

2014 to 2017, there would be no backlog fee; the approximately 

$299,000,000 would come in each year from the remaining user 

fees in the percentages outlined in the previous sentence. 

Section 303—Reauthorization; reporting requirements 

This section would require FDA to report, not later than 120 

days after the end of each fiscal year, on its success in achieving 

the goals set forth in the letter from the Secretary of Health and 

Human Services to the Chairman of the House Committee on Energy and Commerce and Chairman of the Senate Committee on 

Health, Education, Labor, and Pensions. The section also would reVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00020 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
21 

quire FDA to submit a fiscal report on the use of the fees collected 

under the authority granted under Title III. Finally, the section 

would authorize FDA to develop and present recommendations to 

Congress on the reauthorization of the user fee by January 15, 

2017. 

Section 304—Sunset dates 

This section would set the expiration dates of the generic drug 

user fee program as October 1, 2017, and the expiration of the reporting requirement, described in section 303, as January 31, 2018. 

Section 305—Effective date 

Under this section, Title III would take effect on October 1, 2012, 

or the date of enactment, whichever is later. 

Section 306—Amendment with respect to misbranding 

This section would subject a manufacturer to a misbranding violation of the FFDCA for, if required, not paying a facility fee under 

section 744B(a)(4) or failing to provide a facility identification required under section 744B(f). 

Section 307—Streamlined hiring authority to support activities related to the process for the review of generic drug applications 

This section would authorize FDA to streamline its hiring process so it could hire the personnel necessary to achieve the performance goals. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL 

PRODUCTS 

Title IV contains language that would authorize the Biosimilars 

User Fee Amendments of 2012 (BSUFA). 

Section 401—Short title; findings 

In this section, Congress would find that the user fee funds must 

go toward, as set forth in the goals identified in the letters from 

the Secretary of Health and Human Services to the Chairman of 

the House Committee on Energy and Commerce and Chairman of 

the Senate Committee on Health, Education, Labor, and Pensions, 

expediting the process for the review of biosimilar biological product applications, including postmarket safety activities. 

Section 402—Fees relating to biosimilar biological products 

This section would codify definitions key to implementing these 

new user fees, including the types of activities that FDA could fund 

with these fees. This section also would authorize the following 

four types of user fees: application, product, establishment, and biosimilar product development. The first three would be set equal to 

the PDUFA rate for each type of fee. The product development fee 

would be set at 10 percent of the PDUFA application fee. 

Section 403—Reauthorization; reporting requirements 

This section would require FDA to report, not later than 120 

days after the end of each fiscal year, on its success in achieving 

the goals set forth in the letter from the Secretary of Health and 

Human Services to the Chairman of the House Committee on EnVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00021 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
22 

ergy and Commerce and Chairman of the Senate Committee on 

Health, Education, Labor, and Pensions. The section also would require FDA to submit a fiscal report on the use of the fees collected 

under the authority granted under Title IV. Under the section, a 

third party assessment will study the workload volume and full 

costs associated with biosimilar product applications. Finally, the 

section would authorize FDA to develop and present recommendations to Congress on the reauthorization of the user fee program 

by January 15, 2017. 

Section 404—Sunset dates 

This section would set the expiration date of the biosimilar user 

fee program as October 1, 2017, and the expiration of the reporting 

requirement, described in section 403, as January 31, 2018. 

Section 405—Effective date 

Under this section, Title IV would take effect on October 1, 2012, 

or the date of enactment, whichever is later. 

Section 406—Savings clause 

This section would limit the effect of Title IV on those applications and supplements filed before enactment of the title and clarify that the prescription drug user fee provisions in effect prior to 

October 1, 2012 would apply to such submissions. 

Section 407—Conforming amendment 

This section would conform section 735 of FFDCA to reflect the 

new biosimilars user fee. 

TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT 

(BPCA) AND PEDIATRIC RESEARCH EQUITY ACT (PREA) 

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) foster the development of prescription drugs for children and safe use of drugs by children. 

BPCA was established in 1997. It provides FDA with the authority to add six months to existing marketing exclusivity periods and 

listed patents for a drug or biologic in return for FDA-requested 

submission of pediatric studies. 

PREA requires a manufacturer of a drug or biologic who submits 

an application to market a new active ingredient, new indication, 

new dosage form, new dosing regimen, or new route of administration to also submit a pediatric assessment for that product. 

BPCA has been very successful in spurring research in the pediatric population for rare conditions and encouraging companies to 

undertake research where there was no incentive to do so. The 

Committee commends the evaluation of promising pediatric cancer 

therapies for children with cancer through the pediatric preclinical 

testing program established in 2002 under BPCA. The Committee 

encourages the Department of Health and Human Services to continue to report to Congress on patient access to new therapeutic 

agents for pediatric cancer. 


jbell on DSK7SPTVN1PROD with REPORTS
23 

Section 501—Permanent extension of Best Pharmaceuticals for Children Act and Pediatric Research Equity Act 

This section would reauthorize BPCA and PREA. It also would 

clarify that exclusivity under BPCA can only be granted based on 

a written request issued by FDA and that studies conducted under 

PREA could be included in a written request. It also would ensure 

safety-related labeling changes made for branded drugs as a result 

of BPCA are included on generic labels in all appropriate sections. 

With respect to PREA, it would create a deferral extension pathway and require FDA to publicly report each deferral and deferral 

extension issued under PREA, including the name of the product 

sponsor and the date the drug was initially approved. The section 

also would remove a requirement that declined Written Requests 

be referred to the National Institutes of Health (NIH) Foundation, 

instead allowing these studies to be immediately referred to the 

National Institute for Child Health and Human Development. In 

addition, the section would allow FDA to issue a non-compliance 

letter to a product sponsor who fails to meet its post-marketing requirements under PREA and would require the product sponsor to 

respond to FDA’s allegations in writing. These letters would be 

made public. Finally, regarding PREA, the section would require 

product sponsors to submit an ‘‘Initial Pediatric Plan’’ as part of 

the drug application process and outlines the process for submission. The plan would be submitted no later than 60 days after the 

end of phase 2 clinical trials or such other time negotiated between 

FDA and the sponsor and would include an outline of proposed pediatric studies and any request for a waiver or deferral of PREA 

requirements. 

In addition to that described above, the section would require 

FDA to conduct a public meeting regarding the impact of BPCA 

and PREA on the development of new therapies for children with 

cancer. 

Finally, this section would reauthorize the NIH fund, which is 

used to study ‘‘off-patent’’ drugs, at $25,000,000 for each fiscal year 

2013 to 2017. This is the appropriated level in fiscal year 2012. 

Section 502—Food and Drug Administration Report 

The section would require FDA to submit a report to the Chairman of the House Committee on Energy and the Commerce and 

Chairman of the Senate Committee on Health, Education, Labor, 

and Pensions within 4 years of enactment and every 5 years thereafter. The report would have to include the following information: 

the number of waivers, deferrals, and non-compliance letters issued 

under PREA; an assessment of the effectiveness of pediatric study 

plans under PREA; the number of Written Requests issued, accepted, and declined under BPCA; an assessment of the effectiveness 

of studying drugs for rare diseases under BPCA; an assessment of 

the effectiveness of studying pediatric oncology drugs under BPCA 

and PREA; an assessment of the effectiveness of studying drugs in 

neonates under BPCA and PREA; an assessment of the effectiveness of studying biologics in pediatric populations under BPCA and 

PREA; and any suggestions for modification to BPCA and PREA 

that would improve pediatric drug research. Prior to submitting 

this report, FDA would have to consult with stakeholders. 


jbell on DSK7SPTVN1PROD with REPORTS
24 

Section 503—Internal Committee for Review of Pediatric Plans, 

Assessments, Deferrals, Deferral Extensions, and Waivers 

The section would clarify the authority of FDA’s Pediatric Review 

Committee (PeRC) to review deferral extensions under PREA. The 

section also would require the PeRC to include a neonatologist. 

Section 504—Staff of Office of Pediatric Therapeutics 

The section would require FDA’s Office of Pediatric Therapeutics 

to have a neonatologist and pediatric epidemiologist on staff. 

Section 505—Continuation of operation of Pediatric Advisory Committee 

The section would reauthorize FDA’s Pediatric Advisory Committee. 

Section 506—Pediatric Subcommittee of the Oncologic Drugs Advisory Committee 

The section would reauthorize the Pediatric Subcommittee of 

FDA’s Oncologic Drugs Advisory Committee (ODAC). 

TITLE VI—FDA ADMINISTRATIVE REFORMS 

Title VI includes sections that would apply to the issuance of 

FDA guidance documents, conflicts of interest, electronic submission of applications, and regulation of laboratory developed tests. 

Section 601—Public Participation in issuance of FDA guidance documents 

The section would improve FDA’s guidance document process by 

encouraging public participation in development of the draft guidance documents FDA utilizes to explain the agency’s positions. The 

Committee believes that some draft guidance documents, in part 

due to lack of public participation in the development process, have 

created uncertainty and significant implementation issues. One example is the draft guidance entitled ’’Guidance for Industry and 

FDA Staff—510(k) Device Modifications: Deciding When to Submit 

a 510(k) for a Change to an Existing Device’’ issued on July 27, 

2011. 

The section would require that, for certain guidance documents, 

FDA would have to provide at least 30 days notice of its intent to 

issue the guidance document. During that 30-day period, FDA 

could meet with interested stakeholders. If FDA were to decide 

that such pre-issuance notice and involvement is impracticable, unnecessary, or contrary to the public interest, FDA would have to 

provide a reason why pre-issuance public notice and involvement is 

impracticable, unnecessary, or contrary to the public interest and 

publish the reason in the Federal Register. 

Upon the issuance of a draft guidance document under the section, FDA would have to finalize the document within 18 months 

of the close of the comment period or the document would be null 

and void. Such time period could be extended by 180 days if FDA 

publishes a notification of such an extension in the Federal Register. 

Every 5 years after the issuance of a final guidance under this 

section, the section would require FDA to analyze the guidance docVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00024 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
25 

2Marc Boutin, Testimony before the Committee on Energy and Commerce, Subcommittee on 

Oversight and Investigations, Hearing: ‘‘Regulatory Reform Series #5—FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs’’ (July 20, 2011), available at: http:// 

energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=8806. 

ument and if warranted by its analysis, modify, streamline, expand 

or repeal the document. 

With respect to devices, the process set forth above would apply 

to notice to industry guidance letters and notice to industry advisory letters that meet the definition of a guidance document. 

Section 602—Conflicts of interest 

The Food and Drug Administration Amendments Act of 2007 

(FDAAA, Public Law 110–85), included a provision designed to 

limit conflicts of interest and restrict those eligible to serve on FDA 

advisory committees. The Committee believes this provision has 

discouraged the use of the most qualified experts from serving on 

FDA advisory committees, thus preventing the advisory committees 

from providing the best guidance to FDA on important scientific 

issues. According to the testimony of Marc Boutin of the National 

Health Council before the Health Subcommittee in July, 2011, at 

the time of the testimony, FDA had a vacancy rate of 23 percent 

for its advisory committees, and this was attributable in part to the 

conflicts of interest policy.2

This section is intended to improve FDA’s conflict of interest 

rules so the Agency’s advisory committees have better access to the 

most knowledgeable experts. The section would strike the current 

statutory provisions governing recruitment and limits on waivers. 

In their place, the section would require FDA to actively recruit to 

fill the advisory committees so FDA has access to the most current 

expert advice. It also would require FDA to provide transparency 

regarding the type, nature, and magnitude of relevant financial interests of advisory committee members. Finally, the section would 

require FDA to provide an annual report on the implementation of 

the section and to update as necessary the guidance on disclosure 

of advisory committee conflicts of interest. 

Section 603—Electronic submission of applications 

This section would require electronic submission of drug, generic 

drug, biologic, and biosimilar applications following issuance of a 

final guidance by FDA. This section also would require an electronic copy for device pre-submissions and submissions following 

issuance of a final guidance by FDA 

Section 604—Notification of FDA intent to regulate laboratory-developed tests 

The section would prohibit FDA from issuing both draft and final 

guidance on the regulation of laboratory developed tests unless it 

notifies the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor, and Pensions of its intent to take such action at least 60 days prior to the issuance of 

such guidance. 

TITLE VII—MEDICAL DEVICE REGULATORY REFORMS 

Title VII includes significant reforms to premarket and 

postmarket device regulation. 


jbell on DSK7SPTVN1PROD with REPORTS
26 

Subtitle A—Premarket Predictability 

The Committee believes the sections in Subtitle A would add predictability, consistency, and transparency to the medical device premarket review process. 

Sections 701—Investigational Device Exemption 

The goal of section 701 is to address concerns that FDA may be 

disapproving pivotal investigations of new technologies solely because the output of the investigation will not yield a classification 

or approval status that could result in the marketing of a device. 

On the other hand, the Committee also heard reports from FDA 

that FDA had, in the past, permitted studies to go forward that 

FDA believed would not support approval, and when sponsors completed those trials, FDA was unable to approve the device. Nonetheless, as reflected in Section 701, the Committee believes manufacturers should be free to assume the risk that their studies may 

not support approval of a marketing application if the studies will 

provide useful information, so long as the study is conducted ethically and with reasonable risk to patients. 

Because the investigation of a device may involve many steps to 

optimize its design, its intended use, and ultimately, its safety and 

effectiveness, the Committee sees little merit in limiting device investigations only to those that would likely support a marketing 

decision. A clinical investigation that would not demonstrate a reasonable assurance of safety and effectiveness to justify an approval, 

and yet provide valuable information to optimize the design and 

development of the device, should be approved and undertaken to 

develop that data and information. Under the section, FDA’s approval of an IDE would signify that regulatory requirements have 

been met, and would not reflect FDA’s judgment of the adequacy 

of the study design or the likelihood that the study will support a 

marketing application. 

Accordingly, the sections would amend section 520(g) to prohibit 

FDA from disapproving an investigational device application because it may not support or meet the requirements of a substantial 

equivalence determination or a premarket approval if the investigational device application otherwise meets the requirements in 

section 520(g). Additionally, FDA would be barred from disapproving an investigational device application solely because additional or different investigations may be necessary to support a 

marketing application. 

Section 702—Clarification of the Least Burdensome Standard 

This section would reaffirm the least burdensome provisions 

added during the Food and Drug Administration Modernization Act 

of 1997 (FDAMA) and codify in statute the least burdensome concept as expressed in FDA’s 2002 Guidance Document, ‘‘The Least 

Burdensome Provisions of the FDA Modernization Act of 1997: 

Concept and Principles; Final Guidance for FDA and Industry.’’ 

Specifically, section 702 would define the word ‘‘necessary’’ for purposes of ensuring that the information requested in the premarket 

notification and premarket approval contexts is only that information required to make a regulatory determination and does not include information that is merely of interest. This provision was 


jbell on DSK7SPTVN1PROD with REPORTS
27 

prompted by reports that despite FDA’s own guidance stating that 

information requests should be limited to those relevant to making 

a regulatory decision, FDA’s premarket notification and premarket 

approval reviews were becoming longer and more burdensome because some reviewers requested information that was unnecessary 

for regulatory decisions. 

The section would define ‘‘necessary’’ in the premarket notification context to mean ‘‘the minimum required information that 

would support a determination of substantial equivalence between 

a new device and a predicate device.’’ For example, in the premarket notification context, the Committee intends that FDA limit 

its requests for additional information to only that information that 

FDA needs to determine whether or not one device is substantially 

equivalent to a predicate device. 

Section 703—Agency Documentation and Review of Significant Decisions 

Section 703 would address concerns expressed by some in industry that significant premarket regulatory decisions are not adequately documented with a scientific or regulatory rationale. In 

some instances, FDA consideration of administrative appeals to supervisors sometimes takes longer than many original decisions. To 

address these concerns and problems, the section would require 

that the Agency completely document certain significant premarket 

decisions, including significant differences of opinion that occur 

during device reviews. Also, this section would clarify the process 

under 21 CFR 10.75 to persons who challenge significant premarket review decisions, that occur in the context of 510(k) submissions, and premarket approval and investigational device applications, and provide specific timelines for the reviews for those appeals. 

Section 704—Transparency in the Clearance Process 

Consistent with the direction in section 703 to require documentation of Agency decision-making, section 704 would require 

‘‘detailed decision summaries’’ of certain 510(k) determinations. 

Only by creating transparency in decision-making can we ensure 

the review process functions as intended. 

Section 705—Device Modifications Requiring Premarket Notification Prior to Marketing 

Section 705 addresses when premarket notifications are required 

for legally marketed devices that have been modified. The Committee is very interested in this important determination. On July 

27, 2011, FDA issued a draft guidance entitled ‘‘Guidance for Industry and FDA Staff–510(k) Device Modifications: Deciding When 

to Submit a 510(k) for a Change to an Existing Device,’’ that, when 

finalized, would replace the 1997 guidance on 510(k) device modification entitled ‘‘Deciding When to Submit a 510(k) for a Change 

to an Existing Device.’’ The FDA issued the 2011 draft guidance because some stakeholders advocated the need to provide greater 

clarity and certainty to the 510(k) modification process. However, 

the Committee heard reports from stakeholders and some companies that the 1997 guidance document was satisfactory in addressing the many very difficult device assessment issues associated 


jbell on DSK7SPTVN1PROD with REPORTS
28 

3Public Law 101–629; Government Accountability Office, MEDICAL DEVICES: FDA Should 

Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent 

Premarket Review Process (GAO–09–190) (January 2009), available at: http://www.gao.gov/ 

new.items/d09190.pdf. 

with modifications, and the new draft guidance created too much 

uncertainty in the device industry. 

Accordingly, the section would require that FDA submit a report 

to the House Committee on Energy and Commerce and the Senate 

Committee on Health, Education, Labor, and Pension within 18 

months. This report would include: (1) FDA’s interpretation of key 

terms in FDA’s regulations as specified in the section (see 21 CFR 

§ 807.81(a)(3)); (2) analysis on how to leverage design controls that 

are a part of FDA’s Quality System Regulation (see 21 CFR 

§ 820.30), to reduce premarket submission burdens for changes that 

do not merit FDA’s review resources; and (3) methods to ensure 

continued improvement of legally marketed devices. The section 

would require FDA to withdraw its July 27, 2011 draft device 

modification guidance and instead rely upon the January 10, 1997 

guidance on device modification. Finally, this section would prohibit a draft version of such guidance until the report is submitted 

to the Committee, and further would prohibit a final version of 

such a guidance or regulation until one year after the Committee’s 

receipt of the report. 

Subtitle B—Patients Come First 

This Subtitle would bring predictability, consistency, and transparency to device post-market activities of FDA. 

Section 711—Establishment of Schedule and Promulgation of Regulation 

The section would reaffirm the mandate of the Safe Medical Devices Act of 1990 (and recommendation of GAO) that FDA require 

premarket approval applications for pre-amendment Class III devices or reclassify them into Class I or Class II.3

Section 712—Program to Improve the Device Recall System 

The Committee believes that FDA must learn from recall experience to minimize harms related to devices. Accordingly, the section 

would require FDA to establish a program to assess recalls and 

identify strategies to mitigate health risks. In support of this goal, 

the section would require: clarification of recall audit procedures to 

improve recall effectiveness checks; development of criteria to assess the effectiveness of corrections or action plans associated with 

recalls; and documentation of recall terminations. The program 

would identify, at a minimum, recall trends, the devices most subject to recalls, and the underlying causes of recalls. 

Subtitle C—Novel Device Regulatory Relief 

Section 721—Modification of de novo application process 

This section would streamline the de novo classification process, 

which is used for novel, innovative devices of low to moderate risk. 

A device sponsor would no longer be required to submit a premarket notification and obtain a ‘‘not substantially equivalent’’ determination when it is clear that no predicate device exists for purVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00028 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
29 

poses of a substantial equivalence determination. Under these circumstances, the first submission could be a de novo request for 

classification. If FDA believes a predicate device exists, or that the 

device is not of low to moderate risk, or that special controls to 

mitigate the risks cannot be developed for the device (i.e., that the 

device requires a PMA), the Agency could decline to review the 

submission under its de novo authority. Also, to facilitate the de 

novo process, submitters seeking a class II de novo classification 

would be required to provide a ‘‘special controls’’ proposal for FDA’s 

consideration. By doing so, the Committee believes that the submitter could help identify the merits of a class II recommendation 

and assist prompt decisions by the FDA. 

Subtitle D—Keeping American Competitive Through 

Harmonization 

Section 731—Harmonization of device premarket review, inspection, 

and labeling symbols; report 

The section clarifies that FDA could enter into agreements, when 

appropriate, with foreign countries on harmonizing regulatory requirements for activities, including inspections and common international labeling symbols of medical devices. 

Section 732—Participation in International Fora 

The section clarifies that FDA could, to the extent appropriate, 

provide transparency regarding FDA’s involvement in international 

activities. 

Subtitle E—FDA Renewing Efficiency From Outsider Reviewer 

Management 

Section 741—Reauthorization of third party review 

Consistent with ensuring timely and thorough reviews of certain 

premarket notification submissions, section 741 would reauthorize 

third party review of 510(k) submissions until October 1, 2017. Persons accredited by FDA could carry some of the review burden associated with determining whether a device is substantially equivalent to a predicate device. 

Section 742—Reauthorization of third party inspection 

This section would reauthorize the third inspection program until 

2017. 

Subtitle F—Humanitarian Device Reform 

Section 751—Expanded access to humanitarian use devices 

This section would extend the exemption from the prohibition 

against profit-making for pediatric devices that have been granted 

Humanitarian Device Exemptions to include certain devices intended for use in adults, and would establish that distribution of 

these devices under the profit exception is limited to the ‘‘annual 

distribution number.’’ The Humanitarian Device Exemption would 

continue to be used to provide access to medical devices with conditions that affect 4,000 individuals or fewer. The ‘‘annual distribution number’’ in the section would mean the number of such devices needed to treat, diagnose, or cure a population of 4,000 indiVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00029 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
30 

4 Although not specifically part of this bill, over-the-counter (OTC) medicines play an increasingly vital role in America’s health care system, and applications to switch drugs from prescription to OTC status are the primary source for expanding self-care into additional health categories. The Committee encourages FDA to improve the prescription-to-OTC switch process by, 

for example, addressing communication issues during sponsor preparation for advisory committee meetings, and by working with stakeholders to finalize draft guidance on self-selection 

viduals in the United States. Under this section, the Secretary 

would determine the number of such devices necessary to treat 

each such individual when the Secretary grants such exemption, 

or, for existing devices for which an exemption was already approved, at the time of the ‘‘determination.’’ 

Subtitle H—Records and Reports on Devices 

Section 761—Unique Device identification system regulations 

In 2007, under FDAAA, FDA was required to develop a regulation that would allow for a unique identifier on each medical device. FDA has not yet promulgated the regulation. The section 

would require FDA to issue the regulations not later than 120 days 

after enactment. 

Section 762—Effective device sentinel system 

This section would extend FDA’s ‘‘Sentinel’’ postmarket risk identification and evaluation system to include medical devices and 

allow a broad use of data from a wide variety of sources in establishing the ‘‘Sentinel’’ system. The section would require FDA to 

engage stakeholders when developing the system for devices. 

Subtitle I—Miscellaneous 

Section 771—Custom Devices 

This section would clarify FDA’s policy on custom devices for the 

unique needs of individuals and would require FDA to issue a final 

guidance on replication of custom devices within two years. As a 

condition of being exempt from sections 514 and 515 of the FFDCA, 

the manufacturer of a custom device must notify the Secretary of 

such device in a manner prescribed by the Secretary. 

Section 772—Pediatric device reauthorization 

This section would reauthorize, at the current authorization 

level, demonstration grants for non-profit consortia to promote pediatric device development. 

Section 773—Report on regulation of health information technology 

Under this section the Secretary of Health and Human Services, 

in consultation with the FDA Commissioner, the National Coordinator of Health Information Technology, and the Chairman of the 

Federal Communication Commission, would be charged with developing a report containing (1) recommendations on an appropriate 

regulatory framework for health information technology that is risk 

based and (2) a strategy to avoid regulatory duplication. 

TITLE VIII—DRUG REGULATORY REFORMS 

The bill includes numerous provisions to modernize FDA’s drug 

authority to reflect the globalization of the pharmaceutical industry 

and to improve the drug review process.4


jbell on DSK7SPTVN1PROD with REPORTS
31 

studies for nonprescription drug products, since these studies are a critical part of prescriptionto-nonprescription switch applications. 

Subtitle A—Drug Supply Chain 

Section 801—Registration of producers of drugs 

This section would effectuate a change to the timing of drug establishment registration so that FDA has accurate and up-to-date 

information on domestic and foreign drug manufacturing facilities. 

Additionally, it would render misbranded drugs made in foreign facilities that are not duly registered, treating them the same as domestically made drugs. 

Section 802—Inspection of Drugs 

This section would authorize FDA to inspect domestic and foreign drug facilities on a risk-based schedule based on multiple risk 

factors, such as compliance history of the establishment; the inspection frequency and history of the establishment, including 

whether the facility has been inspected within the last four years; 

recalls associated with such facility; and the inherent risk of the 

drug associated with the establishment. FDA also could consider 

other factors deemed appropriate for establishing the risk-based 

schedule. The section also would require FDA to issue an annual 

report on inspections and make the report available to the public. 

The Committee believes that this section would focus FDA resources on high-risk facilities that present the greatest risk to consumers and away from unnecessary or duplicative inspections of facilities with exceptional compliance histories. The Committee also 

believes a risk-based schedule would help to ensure inspection parity of domestic and foreign drug facilities. 

Section 803—Drug supply quality and safety 

This section would incorporate quality risk management oversight and controls into FDA’s good manufacturing practices (GMP) 

authority. 

Section 804—Prohibition against delaying, denying, limiting or refusing inspection 

This section would render misbranded drugs from an establishment that is deemed to have delayed, limited, or denied an FDA 

inspection, thereby authorizing FDA to bar entry of such drugs. 

This would allow FDA to deny such products entry to domestic 

commerce. The section also would require FDA to issue guidance 

that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. 

Section 805—Destruction of adulterated, misbranded, or counterfeit 

drugs offered for import 

This section would allow FDA to destroy counterfeit or adulterated imported drug products of minor monetary value or that have 

a reasonable probability of causing serious adverse health consequences or death. It is aimed at giving FDA a tool to address the 

large volume of small packages of misbranded, adulterated, or unapproved drugs coming through the country’s international mail faVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00031 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
32 

cilities. The section also would require FDA to issue regulations 

providing for notice and opportunity for a hearing on the destruction of such drugs either before or after destruction and establish 

an administrative process for restitution to ensure due process. 

Section 806—Administrative detention 

This section would allow FDA to detain, for a reasonable period, 

drugs found during inspection that the inspecting officer has reason to believe are adulterated or misbranded and require FDA to 

issue implementing regulations with respect to this authority. 

Section 807—Enhanced criminal penalty for counterfeit drugs 

This section would provide for up to 20 years of imprisonment for 

any person who knowingly holds, sells, or dispenses a counterfeit 

drug, and up to life imprisonment if the use of the counterfeit drug 

is the proximate cause of the consumer’s death. 

Section 808—Unique facility identification number 

This section would require drug facilities and commercial importers of drugs to have a unique facility identification number that 

will be submitted to FDA at registration and at import. It requires 

FDA to issue guidance specifying the unique facility identifier system to be used and to take into account the utilization of existing 

unique identifiers and compatibility with customs automated systems to aid facilities in achieving compliance with this section. The 

provision also would authorize refusal of admission for imports if 

the appropriate UFIs are not provided. 

Section 809—Documentation for admissibility of imports 

This section would allow FDA to require certain documentation 

and information from importers so FDA can implement a riskbased approach to import screening. This section also would require FDA to issue regulations specifying the documentation or 

other information necessary to achieve compliance with this section, including the authority to exempt drugs such as those imported for research purposes only from the requirements on this 

section. 

Section 810—Registration of commercial imports 

This section would require commercial drug importers to register 

with FDA and mandate that FDA issue regulations clarifying the 

registration requirement included in this section and establishing 

good importer practices that specify measures importers shall take 

to ensure imported drugs are in compliance. Good importer practice 

regulations also could provide for expedited clearance for importers 

who volunteer to participate in partnership programs for highly 

compliant companies. 

Section 811—Notification 

This section would require a manufacturer, commercial importer, 

wholesale distributor, or other distributor (other than someone distributing drugs exclusively for retail sale) to notify the FDA if it 

knows the use of the drug could lead to serious injury or death, or 

if the drug is subject to significant loss or stolen, or if it is counterVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00032 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
33 

feited. Further, such notification would be made in such manner 

and by such means as FDA may specify by regulation or guidance. 

Section 812—Exchange of information 

This section would allow the FDA to ensure protection of information received under this authority. This section also would 

allow, upon satisfaction of several procedural protections, the FDA 

to share certain information that is otherwise exempt from disclosure with trusted foreign countries to better leverage resources. 

The section also would require FDA to ensure protection of information exchanged under this authority. 

Section 813—Extraterritorial jurisdiction 

This section would provide for explicit extraterritorial federal jurisdiction over a violation of the FFDCA to aid U.S. authorities in 

holding accountable those violating the Act, regardless of where the 

violative acts occur. 

Section 814—Protection against international adulteration 

This section would increase penalties for intentional adulteration 

of drugs that could cause serious adverse health consequences or 

death. 

Section 815—Records for inspection 

This section would allow the FDA to require documents in lieu 

of or in advance of a physical inspection. 

Subtitle B—Medical Gas Safety 

Medical gases are a class of drug products that have been used 

for over 100 years to treat medical conditions. Sections 821, 822, 

and 823 would streamline and modernize the regulation of medical 

gases. 

Section 821—Regulation of medical gases 

The section would define the current core medical gases and provide FDA the authority to add additional medical gases as it deems 

appropriate. The term ‘‘Designated Medical Gas’’ would include: 

Oxygen; Nitrogen; Nitrous Oxide; Carbon Dioxide; Helium; Carbon 

Monoxide; and Medical Air. The Committee intends the section to 

allow the Secretary to add new medical gases that have a history 

of safe and effective use, but prohibit FDA from adding a medical 

gas to the Designated Medical Gas list if that gas is subject to exclusivity under a New Drug Application. Prior to adding a new 

Designated Medical Gas, FDA would have to assess whether any 

investigational new drug applications for medical gases intended 

for humans or animals were pending. 

The section would establish a process for the filing of a certification for a Designated Medical Gas. The FDA approval of a certification for a Designated Medical Gas would have the effect of deeming the Designated Medical Gas as approved under Section 505 or 

512 of the FFDCA. The certification would provide approval for the 

certified Designated Medical Gas and any combination of certified 

Designated Medical Gases, as medically appropriate. The Committee intends the certification process to include common mixtures 

of the core gases. The Designated Medical Gas would be approved 


jbell on DSK7SPTVN1PROD with REPORTS
34 

for specific uses listed in the statute. The section further provides 

that FDA would have the authority to add additional uses to the 

list of approved uses so long as the uses are not subject to exclusivity under a New Drug Application. 

The section also would do the following: (1) authorize FDA to 

promulgate warning statements for medical gases and set forth 

specific labeling requirements for medical gases because medical 

gas labels do not contain specific uses as is the case for other drug 

labels; (2) clarify the effect of certification on certain exclusivity 

rights traditionally granted for newly approved drugs; (3) guarantee FDA authority to withdraw or suspend a drug approval as 

provided under the FFDCA; (4) clarify the FFDCA prescription requirements as they are applied to Designated Medical Gases; and 

(5) ensure that Designated Medical Gases and combinations of Designated Medical Gases deemed to be approved under this Act would 

not be subject to FDA fees as the result of becoming approved 

through certification. 

Section 822—Changes to regulations 

This section would require FDA to, within 18 months, obtain 

input from medical gas manufacturers regarding the applicability 

of current federal drug regulations to medical gases, determine 

whether any changes are necessary to existing federal drug regulations, and submit a report to Congress regarding changes in the 

current federal drug regulations that the Secretary determines are 

necessary for medical gases. 

FDA would be required to issue final regulations addressing 

those items identified in the report to Congress with 48 months. 

The Committee expects this process to address longstanding regulatory issues faced by the medical gas industry based on the unique 

characteristics of medical gases. 

Section 823—Rules of construction 

This section would preserve the NDA process for medical gases. 

The Committee believes this section would maintain the incentive 

to innovate and develop new uses for a new medical gas added to 

the list of Designated Medical Gases. 

Subtitle C—Generating Antibiotic Incentives Now 

The goal of this Subtitle is to foster the development of antibacterial and antifungal drugs that treat pathogens that cause serious and life-threatening infections. The Committee expects that 

antibacterial and antifungal drugs that are directed against the 

qualified pathogens listed generally would qualify for FDA’s fast 

track and priority review process to speed drug approval because 

the Committee presumes that most of the new drugs generally 

would be intended to treat serious or life-threatening infections for 

which there is an unmet medical need. In five years, the Secretary 

would have to review the antibacterial and antifungal drugs that 

have been designated under this Subtitle to determine if the incentives listed are adequate to generate needed antibacterial and 

antifungal drugs. Additionally, at that time, the Secretary would 

review the list of qualifying pathogens to determine if changes are 

needed to address current unmet public health concerns. 


jbell on DSK7SPTVN1PROD with REPORTS
35 

Section 831—Extension of exclusivity period for drugs 

This section would extend the exclusivity period for drugs that 

are determined to be a qualified infectious disease product for five 

additional years. Any extension would be in addition to pediatric 

exclusivity. Limitations to the exclusivity extension are outlined. 

The Secretary would designate a qualified infectious disease product based on it being an antibacterial or antifungal drug for humans to treat or prevent an infection caused by a qualifying pathogen—a resistant gram-positive pathogen, multidrug resistant gramnegative bacteria, multi-drug resistant tuberculosis, or any other 

infectious pathogen identified by the Secretary. 

Section 832—Study on incentives for qualified infectious disease biological products 

This section would direct the Government Accountability Office 

(GAO) to conduct a study to determine the need for incentives to 

encourage research, development, and marketing for qualified infectious disease biological products. 

Section 833—Clinical trials 

This section would require the Secretary to review the guidance 

for clinical trials with respect to antibacterial and antifungal drugs, 

revise the guidance to reflect scientific and medical advancements, 

and clarify the procedures and requirements for approval. This provision will address appropriate animal models of infection, in vitro 

techniques, and clinical study design for antimicrobial agents. 

Section 834—Reassessment of qualified infectious disease product 

incentives in 5 years 

This section would require the Secretary, in conjunction with the 

FDA and CDC, to provide a reassessment report on qualified infectious disease product incentives in five years. Based on the information presented, recommendations would be made regarding 

changes in the list of pathogens, additional program or incentive 

enhancements, and ways to encourage stewardship programs. 

Section 835—Guidance on pathogen-focused antibacterial drug development 

This section would instruct the Secretary to provide draft guidance on pathogen-focused antibacterial drug development by December 31, 2013, and final guidance by December 31, 2014. 

Subtitle D—Accelerated Approval 

Section 841—Expedited approval of drugs for serious or life-threatening diseases or conditions 

The section would provide findings and a Sense of Congress that 

the accelerated approval and fast track provisions of Section 506 of 

the FFDCA should be enhanced and FDA should apply the provisions to help expedite the development and availability of treatments for serious or life-threatening diseases or conditions while 

maintaining existing safety and efficacy standards for such treatments. 

The section also would require FDA to facilitate the development 

and expedite review of a drug intended to treat a serious or lifeVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00035 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
36 

threatening disease or condition and demonstrating potential to address unmet medical needs through, among other processes, conducting a rolling review of a submission for a fast track product. 

A sponsor of such a drug, known as a ‘‘fast track product’’ in the 

section, would have the ability to request a designation as a fast 

track product after the submission of an application for investigation, and FDA would have 60 days to review such request. 

Under the section, FDA could approve an application for a product upon making a determination that, taking into account the severity or rarity of the disease or condition and the availability of 

alternative treatments, it has an effect on a surrogate endpoint 

that is reasonably likely to predict clinical benefit or a clinical endpoint that can be measured earlier than irreversible morbidity or 

mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality, or other clinical benefit. This provision 

is intended to clarify the existing standards for accelerated approval. 

The section also would grant FDA the authority to use expedited 

procedures as prescribed by regulation to withdraw approval of a 

product approved under section 506 under certain conditions. 

Finally, FDA would have to disseminate information to patients, 

doctors, and industry regarding the section and establish a program to foster the development of surrogate and clinical endpoints. 

The Committee believes this section is especially important to 

those patients with rare diseases. Rare diseases affect more than 

25 million Americans, yet only 5 percent of these diseases have 

FDA-approved treatments. The Committee recommends that FDA 

make use of the Agency’s accelerated approval process across all 

applicable review divisions to the greatest extent possible without 

compromising existing standards to ensure products are safe and 

effective, so that safe and effective treatments designed to treat serious or life-threatening rare diseases can be brought to the marketplace in the most expeditious manner. 

Section 842—Guidance; amended regulations 

The section would require FDA to issue draft guidance to implement section 841 within one year of enactment. Within 1 year of 

issuance of the draft guidance, FDA must issue final guidance implementing section 841 and amend the accelerated approval regulations in parts 341 and 601 of title 21 of the Code of Federal Regulations as necessary to conform such regulations with the amendments made by section 841. In developing the guidance, FDA must 

consider ‘‘how to incorporate novel approaches to the review of surrogate endpoints based on physiologic and pharmacologic evidence 

in such guidance, especially in instances where the low prevalence 

of a disease renders the existence or collection of other types of 

data unlikely or impractical.’’ 

Section 843—Independent review 

The section would allow FDA to authorize an independent assessment of the implementation of Section 841, including the impact on the development and timely availability of innovative treatments for patients suffering from serious or life-threatening conditions. 


jbell on DSK7SPTVN1PROD with REPORTS
37 

Subtitle E—Critical Path Reauthorization 

Section 851—Reauthorization of the Critical Path Program 

The section would reauthorize the Critical Path Public-Private 

Partnerships program at the current level of $6,000,000 per year. 

The Committee acknowledges the work being done by the FDA 

in partnership with universities and non-profit organizations to 

create collaborations among health care practitioners, researchers, 

medical product manufacturers, and others to help accelerate development of new medical products that are essential for public 

health and to foster innovation in the manufacturing of medical 

products. The Committee encourages the Commissioner to continue 

to explore and fund these partnerships including those whose work 

includes modernizing and improving pharmaceutical manufacturing in the United States. 

The Committee is aware of the important collaborative work that 

the FDA, Critical Path Institute (C-Path) and the Clinical Data 

Interchange Standards Consortium (CDISC) have done to establish 

the data standards for Alzheimer’s disease clinical research and 

also to create a publicly available database of 22 industry trials 

containing data on 6,100 individual patients with Alzheimer’s disease. In addition, 7 new testing methods have been designated by 

FDA as ‘‘qualified’’ for use in drug development and another 44 are 

in various stages of review by the FDA. We understand the FDA 

has asked CDISC and C-Path to work to develop data standards 

for additional, high priority, therapeutic areas. We encourage the 

FDA and its partners to continue this work on these important 

therapeutic areas because data standards and consensus on testing 

methods will speed the development and review of new medical 

products. 

Subtitle F—Miscellaneous 

Section 861—Reauthorization of provision relating to exclusivity of 

certain drugs containing single enantiomers 

This section would reauthorize for an additional 5 years the 

enantiomer exclusivity authorized in 2007 that otherwise expires in 

2012. 

Section 862—Extension of period for first applicant to obtain tentative approval without forfeiting 180–day exclusivity period 

Under current law, if a generic drug manufacturer challenges a 

brand manufacturer’s patent as being either invalid or will not be 

infringed, and if it is the first generic drug manufacturer to make 

such challenge or makes it on the same day as the first challenger, 

it can be awarded 180 days of exclusivity from other generic competition. Except in certain circumstances, if FDA does not grant 

tentative approval within 30 months of the filing of the generic 

drug application, the generic company forfeits the 180–day exclusivity period. The provision would temporarily increase that tentative approval time period to 45 months. (The current average 

time for FDA to approve a generic drug application is 31 months.) 

This 45–month period would be gradually phased back down to 30 

months as the FDA eliminates the backlog of pending generic applications pursuant to the generic drug user fee agreement. 


jbell on DSK7SPTVN1PROD with REPORTS
38 

Section 863—Final agency action relating to petitions and civil actions 

Certain citizen petitions ask the Agency for a stay of action related to FDA approval of a pending application submitted under 

section 505(b)(2) or 505(j) of the Act due to scientific or medical 

questions about the application. The FDA is required to take final 

agency action on the petition within 180 days. This section would 

require the FDA to take final agency action on the petition within 

150 days. 

Section 864—Deadline for determination of certain petitions 

Current law allows the FDA to deny a generic application if the 

drug that the generic application is referencing was withdrawn for 

safety or effectiveness reasons. Current FDA regulations allow a 

company to petition the FDA to determine if the reference drug 

was withdrawn for safety or effectiveness reasons. However, there 

is no timeframe under which the FDA must respond to the petition, 

and there have been instances of decision times lasting over 2 

years. This section would require the FDA to respond to these petitions within 270 days, which should result in the quicker approval 

of generic drugs. 

Section 865—Rare pediatric disease priority review voucher incentive program 

This section would create a demonstration project that provides 

priority review vouchers to companies that develop a drug for a pediatric rare disease. The voucher would be redeemed by the company for a subsequent application or could be transferred to another company. The section would require the GAO to conduct a 

study for Congress on the effectiveness of the program. The study 

would have to be completed 1 year after the third priority review 

voucher is issued. The Secretary could no longer issue new priority 

review vouchers 1 year after the third voucher is issued so Congress may determine whether to continue the incentive. 

Section 866—Combating prescription drug abuse 

This section would task the Secretary of HHS with reviewing and 

reporting to Congress on current federal initiatives and identifying 

gaps and opportunities with respect to ensuring the safe use of prescription drugs with the potential for abuse. 

Section 867—Assessment and modification of REMS 

This section would make the Risk Evaluation and Mitigation 

Strategy (REMS) system more efficient by facilitating minor modifications of a drug’s REMS with an adequate rationale to support 

such modification. Certain drugs are required to have REMS to ensure that the benefits of the drug outweigh the risks. Currently, 

the law is unclear as to whether sponsors can make minor modifications to the REMS without the need to have a full reassessment 

of the REMS. This provision would clarify the circumstances under 

which certain modifications could be initiated by sponsors and the 

FDA and made without a full assessment of the REMS. 


jbell on DSK7SPTVN1PROD with REPORTS
39 

Section 868—Consultation with external experts on rare diseases, 

targeted therapies, and genetic targeting of treatments 

This section would provide for the creation of a list of external 

experts on products for rare diseases with whom FDA may consult. 

Section 869—Breakthrough therapies 

This section would expedite the development and review of a 

drug designated a ‘‘breakthrough therapy’’ through increased interaction with the Agency during the development process. To achieve 

this designation, a drug would have to be intended to treat a serious or life-threatening disease or condition, and have preliminary 

clinical evidence indicating that it may demonstrate substantial 

improvement over existing therapies. 

Section 870—Grants and contracts for the development of orphan 

drugs 

This section would reauthorize FDA’s orphan drug grant program at the current level for five years. This grant program helps 

facilitate the development of orphan disease products. 

TITLE IX—DRUG SHORTAGES 

The frequency and impact of drug shortages have risen to critical 

levels, more than tripling since 2005. These shortages affect all 

segments of healthcare, including critically ill patients and patients 

undergoing surgery. There appear to be multiple causes of drug 

shortages, including issues involving manufacturing, raw materials, supply chain, consolidation, government regulations, and 

businesses decisions. Physicians, pharmacists, and patients are 

challenged daily to obtain the drugs they need. Title IX would aid 

in mitigating drug shortages and require a root cause analysis of 

the problem. 

Section 901—Discontinuance and interruptions of manufacturing of 

certain drugs 

This section would alter section 506C of the FFDCA to require 

manufacturers of certain drugs to notify FDA of a discontinuance 

of the manufacture of a drug, or an interruption of the manufacture of the drug that is likely to produce a meaningful disruption 

in market supply. The notification requirement would apply to 

drugs that are: (1) life-supporting, life-sustaining, intended for use 

in the prevention or treatment of a debilitating disease or condition; and (2) that are not radiopharmaceutical products or products 

derived from human plasma protein and their recombinant 

analogs. This section also would require the manufacturer to notify 

the Secretary at least six months prior to the date of the discontinuance or interruption, or if the discontinuance or interruption in manufacturing is impossible to predict 6 months in advance, 

as soon as practicable after the manufacturer learns of the discontinuance or interruption in manufacturing. 

The section would require the Secretary to distribute information 

on the discontinuation or interruption of the manufacture of such 

drugs to appropriate physician, provider, and patient organizations. 

The bill would not authorize the Secretary to disclose trade secret 

or confidential commercial information subject to section 552(b)(4) 


jbell on DSK7SPTVN1PROD with REPORTS
40 

5Drugs may fit into more than one of these definitions depending on the intended use. If a 

drug falls within any of the definitions listed, the drug must be reported if its manufacture is 

interrupted. 

of title 5, United States Code, or section 1905 of title 18, United 

States Code. 

Under the section, FDA would have to request that the Attorney 

General adjust the quotas of certain drugs and ingredients subject 

to the Controlled Substance Act if the Secretary receives a report 

under 506C and concludes that an adjustment is necessary to address shortages of these drugs. 

Also, the section would establish a process relating to a manufacturer’s failure to notify FDA under section 506C. If a manufacturer 

fails to submit information required, the Secretary would issue a 

letter, and a response would be required within 30 days. FDA 

would make the letter available to the public except for certain circumstances. 

Finally, the section would require FDA to issue final regulations 

on key terms within 18 months. 

As a whole, the Committee intends the terms ‘‘life-supporting, 

life-sustaining, or intended for use in the prevention or treatment 

of a debilitating disease or medical condition’’ to mean any drug 

that is used to treat or prevent a serious disease or medical condition. 

For example, the Committee considers any drug that is required 

during emergency or critical situations to stabilize organ systems 

or perform necessary procedures (such as resuscitation, surgery, 

ventilator support, etc.) to be a ‘‘life-supporting’’ drug for purposes 

of reporting to FDA a discontinuance or interruption in manufacturing of the product under this section. Examples include 5: 

Name of drug Use Type of drug 

Norepinephrine ....................................... Treatment of shock ................................ Autonomic neurotransmitter 

Etomidate ............................................... General anesthesia ................................ Anesthetic 

Amiodarone ............................................ Anti-arrhythmic ...................................... Cardiovascular 

Furosemide ............................................. Heart failure, hypertension .................... Cardiovascular 

Heparin ................................................... Treatment of thrombosis ....................... Hematology 

Phenytoin ................................................ Epilepsy .................................................. Neurology 

Sodium Chloride—IV ............................. Fluid resuscitation ................................. Electrolyte solution 

Morphine ................................................ Pain control ............................................ Narcotic 

Midazolam .............................................. Sedation ................................................. Anti-anxiety agent 

Diazepam ............................................... Treatment of Status Epilepticus ............ Neurology 

Additionally the Committee considers any drug that aims to treat 

serious illness or infection, is essential to, or that yields information that is essential to, the restoration or continuation of a bodily 

function important to the continuation of human life by restoring 

or taking over a vital bodily function to be a ‘‘life-sustaining’’ drug 

for the purposes of reporting to FDA a discontinuance or interruption in manufacturing of the product under this section. Examples 

include: 

Name of drug Use Type of drug 

Amikacin ................................................ Systemic infection .................................. Antibiotic 

Azithromycin ........................................... Infection ................................................. Antibiotic 

Agalsidase beta ..................................... Fabry disease ......................................... Enzyme replacement 

Cisplatin ................................................. Cancer .................................................... Oncology 

Haloperidol ............................................. Schizophrenia ......................................... Psychiatry 

Levothyroxine .......................................... Hypothyroidism ....................................... Endocrinology 


jbell on DSK7SPTVN1PROD with REPORTS
41 

Name of drug Use Type of drug 

Cyclosporine ........................................... Prevents rejection of transplants .......... Immunosuppressive agent 

Components of parenteral nutrition ...... Provides nutrition ................................... Parenteral nutrition 

Finally, the Committee considers prevention measures, such as 

vaccines, drugs that stabilize a debilitating disease or serious condition, and drugs used to treat chronic medical conditions, such as 

diabetes, to be included within the phrase ‘‘intended for use in the 

prevention or treatment of a debilitating disease or serious condition’’ for the purposes of reporting to FDA a discontinuance or 

interruption in manufacturing of the product under this section. 

Examples include: 

Name of drug Use Type of drug 

MMR & V vaccine live ........................... Measles, Mumps, etc. vaccine .............. Vaccine 

Dextroamphetamine and Amphetamine 

salts.

ADHD ...................................................... Amphetamine 

Fluoxetine ............................................... Depression .............................................. Psychiatry 

Albuterol ................................................. Asthma ................................................... Pulmonary 

Section 902—Drug shortage list 

The section would require FDA to maintain a drug shortage list 

and provide patients, providers, and the public with such information in order to prevent, mitigate, and manage drug shortages on 

the ground. The bill would include safeguards to prevent the release of trade secrets and confidential commercial information or 

information that could adversely affect public health, including if 

the release of the information would increase the possibility of 

hoarding. 

Section 903—Quotas applicable to drugs in shortage 

This section would amend section 306 of the Controlled Substances Act to require the Drug Enforcement Agency (DEA) to review requests to increase quotas of controlled substances and make 

a determination within 30 days if such a request pertains to a drug 

verified to be in shortage. 

Section 904. Expedited review of major manufacturing changes for 

potential and verified shortages of drugs that are life-supporting, life-sustaining, or intended for use in the prevention of 

a debilitating disease or condition 

This section would require FDA to expedite review of a supplemental application for a major manufacturing change if the manufacturer has submitted a notice to FDA under section 506C that a 

drug product is subject to a discontinuance or interruption in manufacturing and the manufacturer certifies that the major manufacturing change may prevent or alleviate the discontinuance or interruption in manufacturing of the drug. FDA would be required to 

complete the review within 60 days. The provision also would deny 

expedited review to manufacturers who make a certification in bad 

faith. 

Section 905—Study on drug shortages 

The section would authorize GAO to conduct a study to examine 

the causes of drug shortages and issue recommendations on how to 


jbell on DSK7SPTVN1PROD with REPORTS
42 

prevent or alleviate a drug shortage. This provision would provide 

needed data on how the regulatory framework, manufacturing challenges, drug pricing, or other factors contribute to drug shortages, 

as well as recommendations to address such issues. 

The Committee has heard concerns that drug shortages are having a significant impact on important advancements in basic, clinical, and translational biomedical research, including clinical trials. 

The Committee also has been notified of studies and clinical trials 

which have been delayed, suspended, or halted due to shortages of 

drugs required for these studies. For example, there have been instances where oncology drugs on drug shortage lists are urgently 

needed for cancer clinical trials and other forms of cancer research. 

Section 906—Annual report on drug shortages 

This section would require FDA to issue an annual report on 

drug shortages that describes communication between FDA field 

inspectors and the drug shortage program, as well as coordination 

between FDA and DEA, and detail uses of authorities to address 

drug shortages. 

Section 907—Attorney General report on drug shortages 

This section would require DEA to issue an annual report on controlled substances that are in shortage, DEA actions when a shortage is identified, and a description of the coordination between 

DEA and FDA in mitigating shortages of these controlled substances. 

Section 908—Hospital repackaging of drugs in shortage 

This section would provide that a hospital within a health system (or a collection of hospitals that are owned and operated by the 

same entity and share access to databases with drug order information for their patients) would not need to register with FDA 

under section 510, on the basis that it engages in a type of repackaging in which the hospital divides the volume of a drug into smaller amounts to extend the supply of a drug in shortage and facilitate access to that drug to other hospitals within the same health 

system. This would apply only to hospitals within the same health 

system, and the repackaging would have to comply with State 

rules. This section would not apply after FDA issues final guidance 

on this issue. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 

FEDERAL FOOD, DRUG, AND COSMETIC ACT 

* * * * * * * 

CHAPTER II—DEFINITIONS 

SEC. 201. For the purposes of this Act— 


jbell on DSK7SPTVN1PROD with REPORTS
43 

(a) * * * 

* * * * * * * 

(g)(1) * * * 

(2) The term ‘‘counterfeit drug’’ means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or 

any likeness thereof, of a drug manufacturer, processor, packer, or 

distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have 

been packed or distributed by, such other drug manufacturer, processor, packer, or distributor. The term ‘‘counterfeit drug’’ shall not 

include a drug or placebo intended for use in a clinical trial that 

is intentionally labeled or marked to maintain proper blinding of 

the study. 

* * * * * * * 

CHAPTER III—PROHIBITED ACTS AND PENALTIES 

PROHIBITED ACTS

SEC. 301. The following acts and the causing thereof are hereby 

prohibited: 

(a) * * * 

* * * * * * * 

(aaa) The failure to register in accordance with section 801(s). 

(bbb) The failure to notify the Secretary in violation of section 

568. 

* * * * * * * 

PENALTIES

SEC. 303. (a)(1) * * * 

* * * * * * * 

(3) Notwithstanding paragraph (2), any person who engages in 

any conduct described in section 301(i)(2) knowing or having reason 

to know that the conduct concerns the rendering of a drug as a 

counterfeit drug, or who engages in conduct described in section 

301(i)(3) knowing or having reason to know that the conduct will 

cause a drug to be a counterfeit drug or knowing or having reason 

to know that a drug held, sold, or dispensed is a counterfeit drug, 

shall be fined in accordance with title 18, United States Code, or 

imprisoned not more than 20 years, or both, except that if the use 

of the counterfeit drug by a consumer is the proximate cause of the 

death of the consumer, the term of imprisonment shall be any term 

of years or for life. 

(b)(1) * * * 

* * * * * * * 

(7) Notwithstanding subsection (a)(2), any person that knowingly and intentionally engages in an activity that results in a 

drug becoming adulterated under subsection (a)(1), (b), (c), or 

(d) of section 501 and having a reasonable probability of causing serious adverse health consequences or death shall be imVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00043 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
44 

prisoned for not more than 20 years or fined not more than 

$1,000,000, or both. 

* * * * * * * 

SEIZURE

SEC. 304. (a) * * * 

* * * * * * * 

(g)(1) If during an inspection conducted under section 704 of a facility or a vehicle, a device, drug, or tobacco product which the officer or employee making the inspection has reason to believe is 

adulterated or misbranded is found in such facility or vehicle, such 

officer or employee may order the device, drug, or tobacco product 

detained (in accordance with regulations prescribed by the Secretary) for a reasonable period which may not exceed twenty days 

unless the Secretary determines that a period of detention greater 

than twenty days is required to institute an action under subsection (a) or section 302, in which case he may authorize a detention period of not to exceed thirty days. Regulations of the Secretary prescribed under this paragraph shall require that before a 

device, drug, or tobacco product may be ordered detained under 

this paragraph the Secretary or an officer or employee designated 

by the Secretary approve such order. A detention order under this 

paragraph may require the labeling or marking of a device, drug, 

or tobacco product during the period of its detention for the purpose of identifying the device, drug, or tobacco product as detained. 

Any person who would be entitled to claim a device, drug, or tobacco product if it were seized under subsection (a) may appeal to 

the Secretary a detention of such device, drug, or tobacco product 

under this paragraph. Within five days of the date an appeal of a 

detention is filed with the Secretary, the Secretary shall after affording opportunity for an informal hearing by order confirm the 

detention or revoke it. 

(2)(A) Except as authorized by subparagraph (B), a device, drug, 

or tobacco product subject to a detention order issued under paragraph (1) shall not be moved by any person from the place at which 

it is ordered detained until— 

(i) * * * 

* * * * * * * 

whichever occurs first. 

(B) A device or drug subject to a detention order under paragraph (1) may be moved— 

(i) * * * 

(ii) if not in final form for shipment, at the discretion of the 

manufacturer of the device or drug for the purpose of completing the work required to put it in such form. 

* * * * * * * 

SEC. 311. EXTRATERRITORIAL JURISDICTION. 

There is extraterritorial jurisdiction over any violation of this Act 

relating to any article regulated under this Act if such article was 

intended for import into the United States or if any act in furtherance of the violation was committed in the United States. 

* * * * * * * 


jbell on DSK7SPTVN1PROD with REPORTS
45 

CHAPTER V—DRUGS AND DEVICES 

SUBCHAPTER A—DRUGS AND DEVICES

ADULTERATED DRUGS AND DEVICES

SEC. 501. A drug or device shall be deemed to be adulterated— 

(a)(1) If it consists in whole or in part of any filthy, putrid, or 

decomposed substance; or (2)(A) if it has been prepared, packed, or 

held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or 

the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety 

and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; 

or (C) if it is a compounded positron emission tomography drug and 

the methods used in, or the facilities and controls used for, its 

compounding, processing, packing, or holding do not conform to or 

are not operated or administered in conformity with the positron 

emission tomography compounding standards and the official 

monographs of the United States Pharmacopoeia to assure that 

such drug meets the requirements of this Act as to safety and has 

the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its 

container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to 

health; or (4) if (A) it bears or contains, for purposes of coloring 

only, a color additive which is unsafe within the meaning of section 

721(a), or (B) it is a color additive the intended use of which in or 

on drugs or devices is for purposes of coloring only and is unsafe 

within the meaning of section 721(a); or (5) if it is a new animal 

drug which is unsafe within the meaning of section 512; or (6) if 

it is an animal feed bearing or containing a new animal drug, and 

such animal feed is unsafe within the meaning of section 512. For 

purposes of subparagraph (2)(B), the term ‘‘current good manufacturing practice’’ includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including 

managing the risk of and establishing the safety of raw materials, 

materials used in the manufacturing of drugs, and finished drug 

products. 

* * * * * * * 

(j) If it is a drug and it has been manufactured, processed, 

packed, or held in any factory, warehouse, or establishment and the 

owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit 

entry or inspection. 

MISBRANDED DRUGS AND DEVICES

SEC. 502. A drug or device shall be deemed to be misbranded— 

(a) * * * 

* * * * * * * 


jbell on DSK7SPTVN1PROD with REPORTS
46 

(o) If it was manufactured, prepared, propagated, compounded, or 

processed in an establishment øin any State¿ not duly registered 

under section 510, if it is a drug and was imported or offered for 

import by a commercial importer of drugs not duly registered under 

section 801(s), if it was not included in a list required by section 

510(j), if a notice or other information respecting it was not provided as required by such section or section 510(k), or if it does not 

bear such symbols from the uniform system for identification of devices prescribed under section 510(e) as the Secretary by regulation 

requires. 

* * * * * * * 

(aa) If it is a drug, or an active pharmaceutical ingredient, and 

it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by 

section 744A(a)(4) or for which identifying information required by 

section 744B(f) has not been submitted, or it contains an active 

pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility. 

* * * * * * * 

NEW DRUGS

SEC. 505. (a) * * * 

* * * * * * * 

(j)(1) * * * 

* * * * * * * 

(5)(A) * * * 

* * * * * * * 

(D) FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.— 

(i) DEFINITION OF FORFEITURE EVENT.—In this subparagraph, the term ‘‘forfeiture event’’, with respect to an application under this subsection, means the occurrence of 

any of the following: 

(I) * * * 

* * * * * * * 

ø(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.— 

The first applicant fails to obtain tentative approval of 

the application within 30 months after the date on 

which the application is filed, unless the failure is 

caused by a change in or a review of the requirements 

for approval of the application imposed after the date 

on which the application is filed.¿ 

(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.—The 

first applicant fails to obtain tentative approval of the 

application within 45 months after the date on which— 

(aa) the application is filed and initially contains a certification described in paragraph 

(2)(A)(vii)(IV), or 

(bb) the application is amended to first contain 

such a certification, 

unless the failure is caused by a change in or a review of the requirements for approval of the appliVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00046 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
47 

cation imposed after the date on which the application is so filed or amended. 

[Effective on October 1, 2013, subclause (IV), (as amended by section 862(a)(1)), is 

further amended by subsection (b)(1)(A) of such section as follows:] 

(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.—The 

first applicant fails to obtain tentative approval of the 

application within ø45¿ 42 months after the date on 

which— 

(aa) the application is filed and initially contains a certification described in paragraph 

(2)(A)(vii)(IV), or 

(bb) the application is amended to first contain 

such a certification, 

unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is so filed or amended. 

[Effective on October 1, 2014, subclause (IV), (as amended by section 862(a)(1) and 

(b)(1)(A)), is further amended by subsection (b)(1)(B) of such section as follows:] 

(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.—The 

first applicant fails to obtain tentative approval of the 

application within ø42¿ 39 months after the date on 

which— 

(aa) the application is filed and initially contains a certification described in paragraph 

(2)(A)(vii)(IV), or 

(bb) the application is amended to first contain 

such a certification, 

unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is so filed or amended. 

[Effective on October 1, 2015, subclause (IV), (as amended by section 862(a)(1), 

(b)(1)(A), and (b)(1)(B)), is further amended by subsection (b)(1)(C) of such section 

as follows:] 

(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.—The 

first applicant fails to obtain tentative approval of the 

application within ø39¿ 36 months after the date on 

which— 

(aa) the application is filed and initially contains a certification described in paragraph 

(2)(A)(vii)(IV), or 

(bb) the application is amended to first contain 

such a certification, 

unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is so filed or amended. 


jbell on DSK7SPTVN1PROD with REPORTS
48 

[Effective on October 1, 2016, subclause (IV), (as amended by section 862(a)(1), 

(b)(1)(A), (b)(1)(B), and (b)(1)(C)), is further amended by subsection (b)(1)(D) of 

such section as follows:] 

(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.—The 

first applicant fails to obtain tentative approval of the 

application within ø36¿ 33 months after the date on 

which— 

(aa) the application is filed and initially contains a certification described in paragraph 

(2)(A)(vii)(IV), or 

(bb) the application is amended to first contain 

such a certification, 

unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is so filed or amended. 

[Effective on October 1, 2017, subclause (IV), (as amended by section 862(a)(1), 

(b)(1)(A), (b)(1)(B), (b)(1)(C), and (b)(1)(D)), is further amended by subsection 

(b)(1)(E) of such section as follows:] 

(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.—The 

first applicant fails to obtain tentative approval of the 

application within ø33¿ 30 months after the date on 

which— 

(aa) the application is filed and initially contains a certification described in paragraph 

(2)(A)(vii)(IV), or 

(bb) the application is amended to first contain 

such a certification, 

unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is so filed or amended. 

* * * * * * * 

(k)(1) * * * 

* * * * * * * 

(3) ACTIVE POSTMARKET RISK IDENTIFICATION.— 

(A) * * * 

* * * * * * * 

(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTIFICATION AND ANALYSIS SYSTEM.— 

(i) IN GENERAL.—The Secretary shall, not later than 

1 year after the development of the risk identification 

and analysis methods under subparagraph (B), establish and maintain procedures— 

(I) * * * 

ø(II) for the reporting (in a standardized form) 

of data on all serious adverse drug experiences (as 

defined in section 505–1(b)) submitted to the Secretary under paragraph (1), and those adverse 

events submitted by patients, providers, and drug 

sponsors, when appropriate;¿ 


jbell on DSK7SPTVN1PROD with REPORTS
49 

ø(III)¿ (II) to provide for active adverse event 

surveillance using the following data sources, as 

available: 

(aa) * * * 

(bb) private sector health-related electronic 

data (such as øpharmaceutical purchase data 

and health insurance claims data¿ medical 

device utilization data, health insurance 

claims data, and procedure and device registries); and 

* * * * * * * 

ø(IV)¿ (III) to identify certain trends and patterns with respect to data accessed by the system; 

ø(V)¿ (IV) to provide regular reports to the Secretary concerning adverse event trends, adverse 

event patterns, incidence and prevalence of adverse events, and other information the Secretary 

determines appropriate, which may include data 

on comparative national adverse event trends; and 

ø(VI)¿ (V) to enable the program to export data 

in a form appropriate for further aggregation, statistical analysis, and reporting. 

* * * * * * * 

(q) PETITIONS AND CIVIL ACTIONS REGARDING APPROVAL OF CER- TAIN APPLICATIONS.— 

(1) IN GENERAL.— 

(A) * * * 

* * * * * * * 

(F) FINAL AGENCY ACTION.—The Secretary shall take 

final agency action on a petition not later than ø180 days¿ 

150 days after the date on which the petition is submitted. 

The Secretary shall not extend such period for any reason, 

including— 

(i) * * * 

* * * * * * * 

(G) EXTENSION OF ø30-MONTH PERIOD¿ PERIOD.—If the 

filing of an application resulted in first-applicant status 

under subsection (j)(5)(D)(i)(IV) and approval of the application was delayed because of a petition, øthe 30-month 

period¿ the period under such subsection is deemed to be 

extended by a period of time equal to the period beginning 

on the date on which the Secretary received the petition 

and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether the Secretary grants, in whole or in 

part, or denies, in whole or in part, the petition. 

* * * * * * * 

(2) EXHAUSTION OF ADMINISTRATIVE REMEDIES.— 

(A) FINAL AGENCY ACTION WITHIN ø180¿ 150 DAYS.—The 

Secretary shall be considered to have taken final agency 

action on a petition if— 


jbell on DSK7SPTVN1PROD with REPORTS
50 

(i) during the ø180-day¿ 150-day period referred to 

in paragraph (1)(F), the Secretary makes a final decision within the meaning of section 10.45(d) of title 21, 

Code of Federal Regulations (or any successor regulation); or 

* * * * * * * 

(u) CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.— 

(1) * * * 

* * * * * * * 

(4) AVAILABILITY.—The election referred to in paragraph (1) 

may be made only in an application that is submitted to the 

Secretary after the date of the enactment of this subsection 

and before October 1, ø2012¿ 2017. 

* * * * * * * 

(w) DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.—The 

Secretary shall issue a final, substantive determination on a petition submitted pursuant to subsection (b) of section 314.161 of title 

21, Code of Federal Regulations (or any successor regulations), no 

later than 270 days after the date the petition is submitted. 

SEC. 505–1. RISK EVALUATION AND MITIGATION STRATEGIES. 

(a) * * * 

* * * * * * * 

(g) ASSESSMENT AND MODIFICATION OF APPROVED STRATEGY.— (1) VOLUNTARY ASSESSMENTS.—After the approval of a risk 

evaluation and mitigation strategy under subsection (a), the responsible person involved may, subject to paragraph (2), submit to the Secretary an assessment ofø, and propose a modification to,¿ the approved strategy for the drug involved at any 

time. 

(2) REQUIRED ASSESSMENTS.—A responsible person shallø, subject to paragraph (5),¿ submit an assessment ofø, and may 

propose a modification to,¿ the approved risk evaluation and 

mitigation strategy for a drug— 

(A) * * * 

* * * * * * * 

(C) within a time period to be determined by the Secretary, if the Secretary, in consultation with the offices described in subsection (c)(2), determines that ønew safety or 

effectiveness information indicates that— 

ø(i) an element under subsection (d) or (e) should be 

modified or included in the strategy; or 

ø(ii) an element under subsection (f) should be modified or included in the strategy; or¿ an assessment is 

needed to evaluate whether the approved strategy 

should be modified to— 

(i) ensure the benefits of the drug outweigh the risks 

of the drug; or 

(ii) minimize the burden on the health care delivery 

system of complying with the strategy. 

ø(D) within 15 days when ordered by the Secretary, in 

consultation with the offices described in subsection (c)(2), 


jbell on DSK7SPTVN1PROD with REPORTS
51 

if the Secretary determines that there may be a cause for 

action by the Secretary under section 505(e).¿ 

(3) REQUIREMENTS FOR ASSESSMENTS.—An assessment under 

paragraph (1) or (2) of an approved risk evaluation and mitigation strategy øfor a drug shall include— 

ø(A) with respect to any goal under subsection (f), an assessment of the extent to which the elements to assure 

safe use are meeting the goal or whether the goal or such 

elements should be modified; 

ø(B) with respect to any postapproval study required 

under section 505(o) or otherwise undertaken by the responsible person to investigate a safety issue, the status of 

such study, including whether any difficulties completing 

the study have been encountered; and 

ø(C) with respect to any postapproval clinical trial required under section 505(o) or otherwise undertaken by 

the responsible party to investigate a safety issue, the status of such clinical trial, including whether enrollment has 

begun, the number of participants enrolled, the expected 

completion date, whether any difficulties completing the 

clinical trial have been encountered, and registration information with respect to requirements under subsections (i) 

and (j) of section 402 of the Public Health Service Act.¿ for 

a drug shall include, with respect to each goal included in 

the strategy, an assessment of the extent to which the approved strategy, including each element of the strategy, is 

meeting the goal or whether 1 or more such goals or such 

elements should be modified. 

ø(4) MODIFICATION.—A modification (whether an enhancement or a reduction) to the approved risk evaluation and mitigation strategy for a drug may include the addition or modification of any element under subsection (d) or the addition, 

modification, or removal of any element under subsection (e) or 

(f), such as— 

ø(A) modifying the timetable for assessments of the 

strategy as provided in subsection (d)(3), including to 

eliminate assessments; or 

ø(B) adding, modifying, or removing an element to assure safe use under subsection (f).¿ 

(4) MODIFICATION.— 

(A) ON INITIATIVE OF RESPONSIBLE PERSON.—After the 

approval of a risk evaluation and mitigation strategy by 

the Secretary, the responsible person may, at any time, submit to the Secretary a proposal to modify the approved 

strategy. Such proposal may propose the addition, modification, or removal of any goal or element of the approved 

strategy and shall include an adequate rationale to support 

such proposed addition, modification, or removal of any 

goal or element of the strategy. 

(B) ON INITIATIVE OF SECRETARY.—After the approval of 

a risk evaluation and mitigation strategy by the Secretary, 

the Secretary may, at any time, require a responsible person to submit a proposed modification to the strategy within 120 days or within such reasonable time as the Secretary 

specifies, if the Secretary, in consultation with the offices 


jbell on DSK7SPTVN1PROD with REPORTS
52 

described in subsection (c)(2), determines that 1 or more 

goals or elements should be added, modified, or removed 

from the approved strategy to— 

(i) ensure the benefits of the drug outweigh the risks 

of the drug; or 

(ii) minimize the burden on the health care delivery 

system of complying with the strategy. 

(h) REVIEW OF PROPOSED STRATEGIES; REVIEW OF ASSESSMENTS

AND MODIFICATIONS OF APPROVED STRATEGIES.— (1) IN GENERAL.—The Secretary, in consultation with the offices described in subsection (c)(2), shall promptly review each 

proposed risk evaluation and mitigation strategy for a drug 

submitted under subsection (a) and each assessment of and 

proposed modification to an approved risk evaluation and mitigation strategy for a drug submitted under subsection (g), and, 

if necessary, promptly initiate discussions with the responsible 

person about such proposed strategy, assessment, or modification. 

ø(2) DISCUSSION.—The Secretary, in consultation with the offices described in subsection (c)(2), shall initiate discussions 

with the responsible person for purposes of this subsection to 

determine a strategy not later than 60 days after any such assessment is submitted or, in the case of an assessment submitted under subsection (g)(2)(D), not later than 30 days after 

such assessment is submitted.¿ 

ø(3)¿ (2) ACTION.— ø(A) IN GENERAL.—Unless the dispute resolution process 

described under paragraph (4) or (5) applies, the Secretary, 

in consultation with the offices described in subsection 

(c)(2), shall describe any required risk evaluation and mitigation strategy for a drug, or any modification to any required strategy— 

ø(i) as part of the action letter on the application, 

when a proposed strategy is submitted under subsection (a) or a modification to the strategy is proposed 

as part of an assessment of the strategy submitted 

under subsection (g)(1); or 

ø(ii) in an order issued not later than 90 days after 

the date discussions of such modification begin under 

paragraph (2), when a modification to the strategy is 

proposed as part of an assessment of the strategy submitted under subsection (g)(1) or under any of subparagraphs (B) through (D) of subsection (g)(2).¿ 

(A) IN GENERAL.— 

(i) TIMEFRAME.—Unless the dispute resolution process described under paragraph (3) or (4) applies, and, 

except as provided in clause (ii) or clause (iii) below, 

the Secretary, in consultation with the offices described 

in subsection (c)(2), shall review and act on the proposed risk evaluation and mitigation strategy for a 

drug or any proposed modification to any required 

strategy within 180 days of receipt of the proposed 

strategy or modification. 

(ii) MINOR MODIFICATIONS.—The Secretary shall review and act on a proposed minor modification, as deVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00052 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
53 

fined by the Secretary in guidance, within 60 days of 

receipt of such modification. 

(iii) REMS MODIFICATION DUE TO SAFETY LABEL

CHANGES.—Not later than 60 days after the Secretary 

receives a proposed modification to an approved risk 

evaluation and mitigation strategy to conform the 

strategy to approved safety label changes, including 

safety labeling changes initiated by the sponsor in accordance with FDA regulatory requirements, or to a 

safety label change that the Secretary has directed the 

holder of the application to make pursuant to section 

505(o)(4), the Secretary shall review and act on such 

proposed modification to the approved strategy. 

(iv) GUIDANCE.—The Secretary shall establish, 

through guidance, that responsible persons may implement certain modifications to an approved risk evaluation and mitigation strategy following notification to 

the Secretary. 

* * * * * * * 

ø(C) PUBLIC AVAILABILITY.—Any action letter described 

in subparagraph (A)(i) or order described in subparagraph 

(A)(ii) shall be made publicly available.¿ 

(C) PUBLIC AVAILABILITY.—Upon acting on a proposed 

risk evaluation and mitigation strategy or proposed modification to a risk evaluation and mitigation strategy under 

subparagraph (A), the Secretary shall make publicly available an action letter describing the actions taken by the 

Secretary under such subparagraph (A). 

ø(4)¿ (3) DISPUTE RESOLUTION AT INITIAL APPROVAL.—If a 

proposed risk evaluation and mitigation strategy is submitted 

under subsection (a)(1) in an application for initial approval of 

a drug and there is a dispute about the strategy, the responsible person shall use the major dispute resolution procedures 

as set forth in the letters described in section 101(c) of the 

Food and Drug Administration Amendments Act of 2007. 

ø(5)¿ (4) DISPUTE RESOLUTION IN ALL OTHER CASES.— 

(A) REQUEST FOR REVIEW.— 

(i) IN GENERAL.—øNot earlier than 15 days, and not 

later than 35 days, after discussions under paragraph 

(2) have begun, the¿ The responsible person may, after 

the sponsor is required to make a submission under 

subsection (a)(2) or (g), request in writing that a dispute about the strategy be reviewed by the Drug Safety Oversight Board under subsection (j), except that 

the determination of the Secretary to require a risk 

evaluation and mitigation strategy is not subject to review under this paragraph. The preceding sentence 

does not prohibit review under this paragraph of the 

particular elements of such a strategy. 

* * * * * * * 

(I) EFFECT ON ACTION DEADLINE.—With respect to a proposal or assessment referred to in paragraph (1), the Secretary shall be considered to have met the action deadline 

for the action letter on the application if the responsible 


jbell on DSK7SPTVN1PROD with REPORTS
54 

person requests the dispute resolution process described in 

this paragraph and øif the Secretary—¿ if the Secretary 

has complied with the timing requirements of scheduling 

review by the Drug Safety Oversight Board, providing a 

written recommendation, and issuing an action letter under 

subparagraphs (B), (F), and (G), respectively. 

ø(i) has initiated the discussions described under 

paragraph (2) not less than 60 days before such action 

deadline; and 

ø(ii) has complied with the timing requirements of 

scheduling review by the Drug Safety Oversight 

Board, providing a written recommendation, and 

issuing an action letter under subparagraphs (B), (F), 

and (G), respectively.¿ 

* * * * * * * 

ø(6)¿ (5) USE OF ADVISORY COMMITTEES.—The Secretary may 

convene a meeting of 1 or more advisory committees of the 

Food and Drug Administration to— 

(A) review a concern about the safety of a drug or class 

of drugs, including before an assessment of the risk evaluation and mitigation strategy or strategies of such drug 

or drugs is required to be submitted under any of subparagraphs (B) through (D) of subsection (g)(2); 

* * * * * * * 

(C) review a dispute under øparagraph (4) or (5)¿ paragraph (3) or (4). 

ø(7)¿ (6) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS.— (A) * * * 

* * * * * * * 

ø(8)¿ (7) INTERNATIONAL COORDINATION.—The Secretary, in 

consultation with the offices described in subsection (c)(2), may 

coordinate the timetable for submission of assessments under 

subsection (d), or a study or clinical trial under section 

505(o)(3), with efforts to identify and assess the serious risks 

of such drug by the marketing authorities of other countries 

whose drug approval and risk management processes the Secretary deems comparable to the drug approval and risk management processes of the United States. If the Secretary takes 

action to coordinate such timetable, the Secretary shall give 

notice to the responsible person. 

ø(9)¿ (8) EFFECT.—Use of the processes described in øparagraphs (7) and (8)¿ paragraphs (6) and (7). shall not be the 

sole source of delay of action on an application or a supplement 

to an application for a drug. 

* * * * * * * 

SEC. 505A. PEDIATRIC STUDIES OF DRUGS. 

(a) * * * 

* * * * * * * 

(d) CONDUCT OF PEDIATRIC STUDIES.— (1) REQUEST FOR STUDIES.— 

(A) IN GENERAL.—The Secretary may, after consultation 

with the sponsor of an application for an investigational 


jbell on DSK7SPTVN1PROD with REPORTS
55 

new drug under section 505(i), the sponsor of an application for a new drug under section 505(b)(1), or the holder 

of an approved application for a drug under section 

505(b)(1), issue to the sponsor or holder a written request 

for the conduct of pediatric studies for such drug. In 

issuing such request, the Secretary shall take into account 

adequate representation of children of ethnic and racial 

minorities. Such request to conduct pediatric studies shall 

be in writing and shall include a timeframe for such studies and a request to the sponsor or holder to propose pediatric labeling resulting from such studies. If a request 

under this subparagraph does not request studies in neonates, such request shall include a statement describing the 

rationale for not requesting studies in neonates. 

* * * * * * * 

ø(h) RELATIONSHIP TO PEDIATRIC RESEARCH REQUIREMENTS.— 

Notwithstanding any other provision of law, if any pediatric study 

is required by a provision of law (including a regulation) other than 

this section and such study meets the completeness, timeliness, 

and other requirements of this section, such study shall be deemed 

to satisfy the requirement for market exclusivity pursuant to this 

section.¿ 

(h) Relationship to Pediatric Research Requirements.—Exclusivity 

under this section shall only be granted for the completion of a 

study or studies that are the subject of a written request and for 

which reports are submitted and accepted in accordance with subsection (d)(3). Written requests under this section may consist of a 

study or studies required under section 505B. 

* * * * * * * 

(k) DISSEMINATION OF PEDIATRIC INFORMATION.— (1) * * * 

(2) DISSEMINATION OF INFORMATION REGARDING LABELING

CHANGES.—Beginning on the date of the enactment of the Best 

Pharmaceuticals for Children Act of 2007, the Secretary shall 

include as a requirement of a written request that the sponsors 

of the studies that result in labeling changes that are reflected 

in the annual summary developed pursuant to øsubsection 

(f)(3)(F)¿ subsection (f)(6)(F) distribute, at least annually (or 

more frequently if the Secretary determines that it would be 

beneficial to the public health), such information to physicians 

and other health care providers. 

* * * * * * * 

(l) ADVERSE EVENT REPORTING.— 

(1) REPORTING IN øYEAR ONE¿ FIRST 18-MONTH PERIOD.—Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, during the øone-year¿ 18- 

month period beginning on the date a labeling change is approved pursuant to subsection (i), the Secretary shall ensure 

that all adverse event reports that have been received for such 

drug (regardless of when such report was received) are referred 

to the Office of Pediatric Therapeutics established under section 6 of the Best Pharmaceuticals for Children Act (Public 

Law 107–109). In considering the reports, the Director of such 


jbell on DSK7SPTVN1PROD with REPORTS
56 

Office shall provide for the review of the reports by the Pediatric Advisory Committee, including obtaining any recommendations of such Committee regarding whether the Secretary should take action under this Act in response to such 

reports. 

(2) REPORTING IN SUBSEQUENT øYEARS¿ PERIODS.—Following 

the øone-year period¿ 18-month period described in paragraph 

(1), the Secretary shall, as appropriate, refer to the Office of 

Pediatric Therapeutics all pediatric adverse event reports for a 

drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office 

may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of 

such Committee regarding whether the Secretary should take 

action in response to such reports. 

(3) PRESERVATION OF AUTHORITY.—Nothing in this subsection 

shall prohibit the Office of Pediatric Therapeutics from providing for the review of adverse event reports by the Pediatric 

Advisory Committee prior to the 18-month period referred to in 

paragraph (1), if such review is necessary to ensure safe use of 

a drug in a pediatric population. 

ø(3)¿ (4) EFFECT.—The requirements of this subsection shall 

supplement, not supplant, other review of such adverse event 

reports by the Secretary. 

* * * * * * * 

(n) REFERRAL IF PEDIATRIC STUDIES NOT øCOMPLETED¿ SUB- MITTED.— 

(1) IN GENERAL.—Beginning on the date of the enactment of 

the Best Pharmaceuticals for Children Act of 2007, if pediatric 

studies of a drug øhave not been completed¿ have not been submitted by the date specified in the written request issued and 

agreed upon under subsection (d) and if the Secretary, through 

the committee established under section 505C, determines that 

there is a continuing need for information relating to the use 

of the drug in the pediatric population (including neonates, as 

appropriate), the Secretary shall carry out the following: 

ø(A) For a drug for which a listed patent has not expired, make a determination regarding whether an assessment shall be required to be submitted under section 

505B(b). Prior to making such a determination, the Secretary may not take more than 30 days to certify whether 

the Foundation for the National Institutes of Health has 

sufficient funding at the time of such certification to initiate and fund all of the studies in the written request in 

their entirety within the timeframes specified within the 

written request. Only if the Secretary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for 

the National Institutes of Health for the conduct of such 

studies, and such Foundation shall fund such studies. If no 

certification has been made at the end of the 30-day period, or if the Secretary certifies that funds are not sufficient to initiate and fund all the studies in their entirety, 

the Secretary shall consider whether assessments shall be 

required under section 505B(b) for such drug. 


jbell on DSK7SPTVN1PROD with REPORTS
57 

ø(B) For a drug that has no listed patents or has 1 or 

more listed patents that have expired, the Secretary shall 

refer the drug for inclusion on the list established under 

section 409I of the Public Health Service Act for the conduct of studies.¿ 

(A) For a drug for which there remains any listed patent 

or exclusivity protection eligible for extension under subsection (b)(1) or (c)(1) of this section, or any exclusivity protection eligible for extension under subsection (m)(2) or 

(m)(3) of section 351 of the Public Health Service Act, the 

Secretary shall make a determination regarding whether 

an assessment shall be required to be submitted under section 505B(b). 

(B) For a drug that has no remaining listed patents or 

exclusivity protection eligible for extension under subsection 

(b)(1) or (c)(1) of this section, or any exclusivity protection 

eligible for extension under subsection (m)(2) or (m)(3) of 

section 351 of the Public Health Service Act, the Secretary 

shall refer the drug for inclusion on the list established 

under section 409I of the Public Health Service Act for the 

conduct of studies. 

* * * * * * * 

(o) PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN

PEDIATRIC INFORMATION IS ADDED TO LABELING.— 

(1) * * * 

(2) LABELING.—Notwithstanding clauses (iii) and (iv) of section 505(j)(5)(F), the Secretary may require that the labeling of 

a drug approved under section 505(j) that omits a pediatric indication or other aspect of labeling as described in paragraph 

(1) include— 

(A) * * * 

ø(B) a statement of any appropriate pediatric contraindications, warnings, or precautions that the Secretary 

considers necessary.¿ 

(B) a statement of any appropriate pediatric contraindications, warnings, precautions, or other information 

that the Secretary considers necessary to assure safe use. 

* * * * * * * 

ø(q) SUNSET.—A drug may not receive any 6-month period under 

subsection (b) or (c) unless— 

ø(1) on or before October 1, 2012, the Secretary makes a 

written request for pediatric studies of the drug; 

ø(2) on or before October 1, 2012, an application for the drug 

is accepted for filing under section 505(b); and 

ø(3) all requirements of this section are met.¿ 

SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL PRODUCTS. 

(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.— 

(1) IN GENERAL.—A person that submits, on or after the date 

of the enactment of the Pediatric Research Equity Act of 2007, 

an application (or supplement to an application) for a drug— 

(A) * * * 

* * * * * * * 


jbell on DSK7SPTVN1PROD with REPORTS
58 

(3) DEFERRAL.— 

(A) * * * 

(B) DEFERRAL EXTENSION.—On the initiative of the Secretary or at the request of the applicant, the Secretary may 

grant an extension of a deferral under subparagraph (A) 

if— 

(i) the Secretary finds that the criteria specified in 

subclause (II) or (III) of subparagraph (A)(i) continue 

to be met; and 

(ii) the applicant submits the materials required 

under subparagraph (A)(ii). 

(C) CONSIDERATION DURING DEFERRAL PERIOD.—If the 

Secretary has under this paragraph deferred the date by 

which an assessment must be submitted, then until the 

date specified in the deferral under subparagraph (A) (including any extension of such date under subparagraph 

(B))— 

(i) the assessment shall not be considered late or delayed; 

(ii) the Secretary shall not classify the assessment as 

late or delayed in any report, database, or public posting. 

ø(B)¿ (D) ANNUAL REVIEW.— (i) * * * 

ø(ii) PUBLIC AVAILABILITY.—The information submitted through the annual review under clause (i) 

shall promptly be made available to the public in an 

easily accessible manner, including through the Web 

site of the Food and Drug Administration.¿ 

(ii) PUBLIC AVAILABILITY.—Not later than 60 days 

after the submission to the Secretary of the information 

submitted through the annual review under clause (i), 

the Secretary shall make available to the public in an 

easily accessible manner, including through the Web 

site of the Food and Drug Administration— 

(I) such information; 

(II) the name of the applicant for the product 

subject to the assessment; 

(III) the date on which the product was approved; and 

(IV) the date of each deferral or deferral extension under this paragraph for the product. 

(4) WAIVERS.— 

(A) * * * 

* * * * * * * 

(C) PEDIATRIC FORMULATION NOT POSSIBLE.—If a partial 

waiver is granted on the ground that it is not possible to 

develop a pediatric formulation, the waiver shall cover 

only the pediatric groups requiring that formulation. An 

applicant seeking øeither a full or partial waiver¿ a partial 

waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed and, 

if the waiver is granted, the applicant’s submission shall 

promptly be made available to the public in an easily acVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00058 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
59 

cessible manner, including through posting on the Web 

site of the Food and Drug Administration. 

* * * * * * * 

(b) MARKETED DRUGS AND BIOLOGICAL PRODUCTS.— 

(1) IN GENERAL.—øAfter providing notice in the form of a letter (that, for a drug approved under section 505, references a 

declined written request under section 505A for a labeled indication which written request is not referred under section 

505A(n)(1)(A) to the Foundation of the National Institutes of 

Health for the pediatric studies), the Secretary¿ The Secretary 

may (by order in the form of a letter) require the sponsor or 

holder of an approved application for a drug under section 505 

or the holder of a license for a biological product under section 

351 of the Public Health Service Act to submit by a specified 

date the assessments described in subsection (a)(2), if the Secretary finds that— 

(A) * * * 

* * * * * * * 

ø(d) SUBMISSION OF ASSESSMENTS.—If a person fails to submit an 

assessment described in subsection (a)(2), or a request for approval 

of a pediatric formulation described in subsection (a) or (b), in accordance with applicable provisions of subsections (a) and (b)— 

ø(1) the drug or biological product that is the subject of the 

assessment or request may be considered misbranded solely 

because of that failure and subject to relevant enforcement action (except that the drug or biological product shall not be 

subject to action under section 303); but 

ø(2) the failure to submit the assessment or request shall not 

be the basis for a proceeding— 

ø(A) to withdraw approval for a drug under section 

505(e); or 

ø(B) to revoke the license for a biological product under 

section 351 of the Public Health Service Act. 

ø(e) MEETINGS.—Before and during the investigational process 

for a new drug or biological product, the Secretary shall meet at 

appropriate times with the sponsor of the new drug or biological 

product to discuss— 

ø(1) information that the sponsor submits on plans and 

timelines for pediatric studies; or 

ø(2) any planned request by the sponsor for waiver or deferral of pediatric studies.¿ 

(d) FAILURE TO MEET REQUIREMENTS.—If a person fails to submit a required assessment described in subsection (a)(2), fails to 

meet the applicable requirements in subsection (a)(3), or fails to submit a request for approval of a pediatric formulation described in 

subsection (a) or (b), in accordance with applicable provisions of 

subsections (a) and (b)— 

(1)(A) the Secretary shall issue a letter to such person informing such person of such failure; 

(B) not later than 30 calendar days after the issuance of a letter under subparagraph (A), the person who receives such letter 

shall submit to the Secretary a written response to such letter; 

and 


jbell on DSK7SPTVN1PROD with REPORTS
60 

(C) not later than 45 calendar days after the issuance of a letter under subparagraph (A), the Secretary shall make such letter, and any response to such letter under subparagraph (B), 

available to the public on the Web site of the Food and Drug 

Administration, with appropriate redactions made to protect 

trade secrets and confidential commercial information, except 

that, if the Secretary determines that the letter under subparagraph (A) was issued in error, the requirements of this subparagraph shall not apply with respect to such letter; and 

(2)(A) the drug or biological product that is the subject of the 

required assessment, applicable requirements in subsection 

(a)(3), or required request for approval of a pediatric formulation may be considered misbranded solely because of that failure and subject to relevant enforcement action (except that the 

drug or biological product shall not be subject to action under 

section 303); but 

(B) the failure to submit the required assessment, meet the 

applicable requirements in subsection (a)(3), or submit the required request for approval of a pediatric formulation shall not 

be the basis for a proceeding— 

(i) to withdraw approval for a drug under section 505(e); 

or 

(ii) to revoke the license for a biological product under 

section 351 of the Public Health Service Act. 

(e) INITIAL PEDIATRIC PLAN.— (1) IN GENERAL.— (A) SUBMISSION.—An applicant who is required to submit an assessment under subsection (a)(1) shall submit an 

initial pediatric plan. 

(B) TIMING.—An applicant shall submit the initial pediatric plan under paragraph (1)— 

(i) before the date on which the applicant submits the 

assessments under subsection (a)(2); and 

(ii) not later than— 

(I) 60 calendar days after the date of end-ofPhase 2 meeting (as such term is used in section 

312.47 of title 21, Code of Federal Regulations, or 

successor regulations); or 

(II) such other time as may be agreed upon between the Secretary and the applicant. 

Nothing in this section shall preclude the Secretary from 

accepting the submission of an initial pediatric plan earlier 

than the date otherwise applicable under this subparagraph. 

(C) CONTENTS.—The initial pediatric plan shall include— 

(i) an outline of the pediatric studies that the applicant plans to conduct; 

(ii) any request for a deferral, partial waiver, or 

waiver under this section, along with supporting information; and 

(iii) other information the Secretary determines necessary, including any information specified in regulations under paragraph (5). 

(2) MEETING.— 


jbell on DSK7SPTVN1PROD with REPORTS
61 

(A) IN GENERAL.—Subject to subparagraph (B), not later 

than 90 calendar days after receiving an initial pediatric 

plan under paragraph (1), the Secretary shall meet with 

the applicant to discuss the plan. 

(B) WRITTEN RESPONSE.—If the Secretary determines 

that a written response to the initial pediatric plan is sufficient to communicate comments on the initial pediatric 

plan, and that no meeting is necessary the Secretary shall, 

not later than 90 days after receiving an initial pediatric 

plan under paragraph (1)— 

(i) notify the applicant of such determination; and 

(ii) provide to the applicant the Secretary’s written 

comments on the plan. 

(3) AGREED PEDIATRIC PLAN.— (A) SUBMISSION.—The applicant shall submit to the Secretary a document reflecting the agreement between the Secretary and the applicant on the initial pediatric plan (referred to in this subsection as an ‘‘agreed pediatric plan’’). 

(B) CONFIRMATION.—Not later than 30 days after receiving the agreed pediatric plan under subparagraph (A), the 

Secretary shall provide written confirmation to the applicant that such plan reflects the agreement of the Secretary. 

(C) DEFERRAL AND WAIVER.—If the agreed pediatric plan 

contains a request from the applicant for a deferral, partial 

waiver, or waiver under this section, the written confirmation under subparagraph (B) shall include a recommendation from the Secretary as to whether such request meets 

the standards under paragraphs (3) or (4) of subsection (a). 

(D) AMENDMENTS TO THE PLAN.—At the initiative of the 

Secretary or the applicant, the agreed pediatric plan may 

be amended at any time. The requirements of paragraph (2) 

shall apply to any such proposed amendment in the same 

manner and to the same extent as such requirements apply 

to an initial pediatric plan under paragraph (1). The requirements of subparagraphs (A) through (C) of this paragraph shall apply to any agreement resulting from such 

proposed amendment in the same manner and to the same 

extent as such requirements apply to an agreed pediatric 

plan. 

(4) INTERNAL COMMITTEE.—The Secretary shall consult the 

internal committee under section 505C on the review of the initial pediatric plan, agreed pediatric plan, and any amendments 

to such plans. 

(5) MANDATORY RULEMAKING.—Not later than one year after 

the date of enactment of the Food and Drug Administration Reform Act of 2012, the Secretary shall promulgate proposed regulations and guidance to implement the provisions of this subsection. 

(6) EFFECTIVE DATE.—The provisions of this subsection shall 

take effect 180 calendar days after the date of enactment of the 

Food and Drug Administration Reform Act of 2012, irrespective 

of whether the Secretary has promulgated final regulations to 

carry out this subsection by such date. 

(f) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, DEFERRAL EXTENSIONS, AND WAIVERS.— 


jbell on DSK7SPTVN1PROD with REPORTS
62 

(1) * * * 

* * * * * * * 

(4) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, 

DEFERRAL EXTENSIONS, AND WAIVERS.—Consultation on pediatric plans and assessments by the committee referred to in 

paragraph (1) pursuant to this section shall occur prior to approval of an application or supplement for which a pediatric assessment is required under this section. The committee shall 

review all requests for deferrals, deferral extensions, and waivers from the requirement to submit a pediatric assessment 

granted under this section and shall provide recommendations 

as needed to reviewing divisions, including with respect to 

whether such a supplement, when submitted, shall be considered for priority review. 

* * * * * * * 

(6) TRACKING OF ASSESSMENTS AND LABELING CHANGES.—The 

Secretary, in consultation with the committee referred to in 

paragraph (1), shall track and make available to the public in 

an easily accessible manner, including through posting on the 

Web site of the Food and Drug Administration— 

(A) * * * 

* * * * * * * 

(D) the total number of deferrals and deferral extensions 

requested and granted under this section and, if granted, 

the reasons for such deferrals and deferral extensions, the 

timeline for completion, and the number completed and 

pending by the specified date, as outlined in subsection 

(a)(3); 

* * * * * * * 

(g) LABELING CHANGES.— 

(1) DISPUTE RESOLUTION.— 

(A) REQUEST FOR LABELING CHANGE AND FAILURE TO

AGREE.—If, on or after the date of the enactment of the Pediatric Research Equity Act of 2007, the Commissioner determines that a sponsor and the Commissioner have been 

unable to reach agreement on appropriate changes to the 

labeling for the drug that is the subject of the application 

or supplement, not later than 180 days øafter the date of 

the submission of the application or supplement¿ after the 

date of the submission of an application or supplement that 

receives a priority review or 330 days after the date of the 

submission of an application or supplement that receives a 

standard review— 

(i) * * * 

* * * * * * * 

(2) OTHER LABELING CHANGES.—If, on or after the date of the 

enactment of the Pediatric Research Equity Act of 2007, the 

Secretary makes a determination that a pediatric assessment 

conducted under this section does or does not demonstrate that 

the drug that is the subject of such assessment is safe and effective in pediatric populations or subpopulations, including 

whether such assessment results are inconclusive, the SecVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00062 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
63 

retary shall order øthe label of such product¿ the labeling of 

such product to include information about the results of the assessment and a statement of the Secretary’s determination. 

(h) DISSEMINATION OF PEDIATRIC INFORMATION.— 

(1) IN GENERAL.—Not later than 210 days after the date of 

submission of an application (or supplement to an application) 

that contains a pediatric assessment under this section, if the 

application (or supplement) receives a priority review, or not 

later than 330 days after the date of submission of an application (or supplement to an application) that contains a pediatric 

assessment under this section, if the application (or supplement) 

receives a standard review, the Secretary shall make available 

to the public in an easily accessible manner the medical, statistical, and clinical pharmacology reviews of such pediatric assessments, and shall post such assessments on the Web site of 

the Food and Drug Administration. 

* * * * * * * 

(i) ADVERSE EVENT REPORTING.— (1) REPORTING IN øYEAR ONE¿ FIRST 18-MONTH PERIOD.—Beginning on the date of the enactment of the Pediatric Research 

Equity Act of 2007, during the øone-year¿ 18-month period beginning on the date a labeling change is made pursuant to subsection (g), the Secretary shall ensure that all adverse event 

reports that have been received for such drug (regardless of 

when such report was received) are referred to the Office of Pediatric Therapeutics. In considering such reports, the Director 

of such Office shall provide for the review of such reports by 

the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action under this Act in response to such 

reports. 

(2) REPORTING IN SUBSEQUENT øYEARS¿ PERIODS.—Following 

the øone-year period¿ 18-month period described in paragraph 

(1), the Secretary shall, as appropriate, refer to the Office of 

Pediatric Therapeutics all pediatric adverse event reports for a 

drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office 

may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of 

such Committee regarding whether the Secretary should take 

action in response to such reports. 

(3) PRESERVATION OF AUTHORITY.—Nothing in this subsection 

shall prohibit the Office of Pediatric Therapeutics from providing for the review of adverse event reports by the Pediatric 

Advisory Committee prior to the 18-month period referred to in 

paragraph (1), if such review is necessary to ensure safe use of 

a drug in a pediatric population. 

ø(3)¿ (4) EFFECT.—The requirements of this subsection shall 

supplement, not supplant, other review of such adverse event 

reports by the Secretary. 

* * * * * * * 

ø(m) INTEGRATION WITH OTHER PEDIATRIC STUDIES.—The authority under this section shall remain in effect so long as an appliVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00063 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
64 

cation subject to this section may be accepted for filing by the Secretary on or before the date specified in section 505A(q).¿ 

ø(n)¿ (m) NEW ACTIVE INGREDIENT.— (1) * * * 

* * * * * * * 

SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, 

ASSESSMENTS, DEFERRALS, DEFERRAL EXTENSIONS, AND 

WAIVERS. 

The Secretary shall establish an internal committee within the 

Food and Drug Administration to carry out the activities as described in sections 505A(f) and 505B(f). Such internal committee 

shall include employees of the Food and Drug Administration, with 

expertise in pediatrics (including representation from the Office of 

Pediatric Therapeutics), biopharmacology, statistics, chemistry, 

legal issues, pediatric ethics neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as 

expertise in child and adolescent psychiatry, and other individuals 

designated by the Secretary. 

* * * * * * * 

SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED 

INFECTIOUS DISEASE PRODUCTS. 

(a) EXTENSION.—If the Secretary approves an application pursuant to section 505 for a drug that has been determined to be a qualified infectious disease product under subsection (d), then the fourand five-year periods described in subsections (c)(3)(E)(ii) and 

(j)(5)(F)(ii) of section 505, the three-year periods described in clauses 

(iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, or the seven year period described in 

section 527, as applicable, shall be extended by five years. 

(b) RELATION TO PEDIATRIC EXCLUSIVITY.—Any extension under 

subsection (a) of a period shall be in addition to any extension of 

the period under section 505A with respect to the drug. 

(c) LIMITATIONS.—Subsection (a) does not apply to the approval 

of— 

(1) a supplement to an application under section 505(b) for 

any qualified infectious disease product for which an extension 

described in subsection (a) is in effect or has expired; 

(2) a subsequent application filed by the same sponsor or 

manufacturer of a qualified infectious disease product described 

in paragraph (1) (or a licensor, predecessor in interest, or other 

related entity) for— 

(A) a change (not including a modification to the active 

moiety of the qualified infectious disease product) that results in a new indication, route of administration, dosing 

schedule, dosage form, delivery system, delivery device, or 

strength; or 

(B) a modification to the active moiety of the qualified infectious disease product that does not result in a change in 

safety or effectiveness; or 

(3) a product that does not meet the definition of a qualified 

infectious disease product under subsection (f) based upon its 

approved uses. 

(d) DETERMINATION.—The manufacturer or sponsor of a drug 

may request that the Secretary designate a drug as a qualified inVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00064 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
65 

fectious disease product at any time in the drug development process 

prior to the submission of an application under section 505(b) for 

the drug, but not later than 45 days before the submission of such 

application. The Secretary shall, not later than 30 days after the 

submission of such request, determine whether the drug is a qualified infectious disease product. 

(e) REGULATIONS.—The Secretary shall promulgate regulations 

for carrying out this section. The Secretary shall promulgate the initial regulations for carrying out this section not later than 12 

months after the date of the enactment of this section. 

(f) DEFINITIONS.—In this section: 

(1) QUALIFIED INFECTIOUS DISEASE PRODUCT.—The term 

‘‘qualified infectious disease product’’ means an antibacterial or 

antifungal drug for human use that treats or prevents an infection caused by a qualifying pathogen. 

(2) QUALIFYING PATHOGEN.—The term ‘‘qualifying pathogen’’ 

means— 

(A) resistant gram-positive pathogens, including 

methicillin-resistant Staphylococcus aureus (MRSA), 

vancomycin-resistant Staphylococcus aureus (VRSA), and 

vancomycin-resistant enterococcus (VRE); 

(B) multidrug resistant gram-negative bacteria, including 

Acinetobacter, Klebsiella, Pseudomonas, and E. coli species; 

(C) multi-drug resistant tuberculosis; or 

(D) any other infectious pathogen identified for purposes 

of this section by the Secretary. 

øSEC. 506. FAST TRACK PRODUCTS. 

ø(a) DESIGNATION OF DRUG AS A FAST TRACK PRODUCT.— 

ø(1) IN GENERAL.—The Secretary shall, at the request of the 

sponsor of a new drug, facilitate the development and expedite 

the review of such drug if it is intended for the treatment of 

a serious or life-threatening condition and it demonstrates the 

potential to address unmet medical needs for such a condition. 

(In this section, such a drug is referred to as a ‘‘fast track product’’.) 

ø(2) REQUEST FOR DESIGNATION.—The sponsor of a new drug 

may request the Secretary to designate the drug as a fast track 

product. A request for the designation may be made concurrently with, or at any time after, submission of an application 

for the investigation of the drug under section 505(i) or section 

351(a)(3) of the Public Health Service Act. 

ø(3) DESIGNATION.—Within 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request 

meets the criteria described in paragraph (1). If the Secretary 

finds that the drug meets the criteria, the Secretary shall designate the drug as a fast track product and shall take such actions as are appropriate to expedite the development and review of the application for approval of such product. 

ø(b) APPROVAL OF APPLICATION FOR A FAST TRACK PRODUCT.— 

ø(1) IN GENERAL.—The Secretary may approve an application 

for approval of a fast track product under section 505(c) or section 351 of the Public Health Service Act upon a determination 

that the product has an effect on a clinical endpoint or on a 


jbell on DSK7SPTVN1PROD with REPORTS
66 

surrogate endpoint that is reasonably likely to predict clinical 

benefit. 

ø(2) LIMITATION.—Approval of a fast track product under 

this subsection may be subject to the requirements— 

ø(A) that the sponsor conduct appropriate post-approval 

studies to validate the surrogate endpoint or otherwise 

confirm the effect on the clinical endpoint; and 

ø(B) that the sponsor submit copies of all promotional 

materials related to the fast track product during the 

preapproval review period and, following approval and for 

such period thereafter as the Secretary determines to be 

appropriate, at least 30 days prior to dissemination of the 

materials. 

ø(3) EXPEDITED WITHDRAWAL OF APPROVAL.—The Secretary 

may withdraw approval of a fast track product using expedited 

procedures (as prescribed by the Secretary in regulations 

which shall include an opportunity for an informal hearing) 

if— 

ø(A) the sponsor fails to conduct any required post-approval study of the fast track drug with due diligence; 

ø(B) a post-approval study of the fast track product fails 

to verify clinical benefit of the product; 

ø(C) other evidence demonstrates that the fast track 

product is not safe or effective under the conditions of use; 

or 

ø(D) the sponsor disseminates false or misleading promotional materials with respect to the product. 

ø(c) REVIEW OF INCOMPLETE APPLICATIONS FOR APPROVAL OF A

FAST TRACK PRODUCT.— ø(1) IN GENERAL.—If the Secretary determines, after preliminary evaluation of clinical data submitted by the sponsor, that 

a fast track product may be effective, the Secretary shall evaluate for filing, and may commence review of portions of, an application for the approval of the product before the sponsor 

submits a complete application. The Secretary shall commence 

such review only if the applicant— 

ø(A) provides a schedule for submission of information 

necessary to make the application complete; and 

ø(B) pays any fee that may be required under section 

736. 

ø(2) EXCEPTION.—Any time period for review of human drug 

applications that has been agreed to by the Secretary and that 

has been set forth in goals identified in letters of the Secretary 

(relating to the use of fees collected under section 736 to expedite the drug development process and the review of human 

drug applications) shall not apply to an application submitted 

under paragraph (1) until the date on which the application is 

complete. 

ø(d) AWARENESS EFFORTS.—The Secretary shall— 

ø(1) develop and disseminate to physicians, patient organizations, pharmaceutical and biotechnology companies, and other 

appropriate persons a description of the provisions of this section applicable to fast track products; and 

ø(2) establish a program to encourage the development of 

surrogate endpoints that are reasonably likely to predict clinVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00066 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
67 

ical benefit for serious or life-threatening conditions for which 

there exist significant unmet medical needs.¿ 

SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFETHREATENING DISEASES OR CONDITIONS. 

(a) DESIGNATION OF A DRUG AS A BREAKTHROUGH THERAPY.— (1) IN GENERAL.—The Secretary shall, at the request of the 

sponsor of a drug, expedite the development and review of such 

drug if the drug is intended, alone or in combination with 1 or 

more other drugs, to treat a serious or life-threatening disease 

or condition and preliminary clinical evidence indicates that 

the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such 

as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a ‘‘breakthrough therapy’’.) 

(2) REQUEST FOR DESIGNATION.—The sponsor of a drug may 

request the Secretary to designate the drug as a breakthrough 

therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act. 

(3) DESIGNATION.— (A) IN GENERAL.—Not later than 60 calendar days after 

the receipt of a request under paragraph (2), the Secretary 

shall determine whether the drug that is the subject of the 

request meets the criteria described in paragraph (1). If the 

Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy 

and shall take such actions as are appropriate to expedite 

the development and review of the application for approval 

of such drug. 

(B) ACTIONS.—The actions to expedite the development 

and review of an application under subparagraph (A) may 

include, as appropriate— 

(i) holding meetings with the sponsor and the review 

team throughout the development of the drug; 

(ii) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the non-clinical and clinical data necessary for approval is as efficient as practicable; 

(iii) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; 

(iv) assigning a cross-disciplinary project lead for the 

Food and Drug Administration review team to facilitate an efficient review of the development program 

and to serve as a scientific liaison between the review 

team and the sponsor; and 

(v) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number 

of patients exposed to a potentially less efficacious 

treatment. 

(b) DESIGNATION OF DRUG AS A FAST TRACK PRODUCT.— 


jbell on DSK7SPTVN1PROD with REPORTS
68 

(1) IN GENERAL.—The Secretary shall, at the request of the 

sponsor of a new drug, facilitate the development and expedite 

the review of such drug if it is intended, whether alone or in 

combination with one or more other drugs, for the treatment of 

a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such 

a disease or condition. (In this section, such a drug is referred 

to as a ‘‘fast track product’’.) 

(2) REQUEST FOR DESIGNATION.—The sponsor of a new drug 

may request the Secretary to designate the drug as a fast track 

product. A request for the designation may be made concurrently with, or at any time after, submission of an application 

for the investigation of the drug under section 505(i) of this Act 

or section 351(a)(3) of the Public Health Service Act. 

(3) DESIGNATION.—Within 60 calendar days after the receipt 

of a request under paragraph (2), the Secretary shall determine 

whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the 

drug meets the criteria, the Secretary shall designate the drug 

as a fast track product and shall take such actions as are appropriate to expedite the development and review of the application for approval of such product. 

(c) ACCELERATED APPROVAL OF A DRUG FOR A SERIOUS OR LIFETHREATENING DISEASE OR CONDITION, INCLUDING A FAST TRACK

PRODUCT.— 

(1) IN GENERAL.—The Secretary may approve an application 

for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 

505(c) of this Act or section 351(a) of the Public Health Service 

Act upon making a determination that the product has an effect 

on— 

(A) a surrogate endpoint that is reasonably likely to predict clinical benefit; or 

(B) a clinical endpoint that can be measured earlier than 

irreversible morbidity or mortality, that is reasonably likely 

to predict an effect on irreversible morbidity or mortality or 

other clinical benefit, 

taking into account the severity or rarity of the disease or condition and the availability of alternative treatments. The evidence 

to support that an endpoint is reasonably likely to predict clinical benefit may include epidemiological, pathophysiologic, 

pharmacologic, therapeutic or other evidence developed using, 

for example, biomarkers, or other scientific methods or tools. 

(2) LIMITATION.—Approval of a product under this subsection 

may, as determined by the Secretary, be subject to the following 

requirements— 

(A) that the sponsor conduct appropriate post-approval 

studies to verify and describe the predicted effect of the 

product on irreversible morbidity or mortality or other clinical benefit; and 

(B) that the sponsor submit copies of all promotional materials related to the product, at least 30 days prior to dissemination of the materials— 

(i) during the preapproval review period; and 


jbell on DSK7SPTVN1PROD with REPORTS
69 

(ii) following approval, for a period that the Secretary determines to be appropriate. 

(3) EXPEDITED WITHDRAWAL OF APPROVAL.—The Secretary 

may withdraw approval of a product approved pursuant to this 

subsection using expedited procedures (as prescribed by the Secretary in regulations, which shall include an opportunity for an 

informal hearing) if— 

(A) the sponsor fails to conduct any required post-approval study of the product with due diligence; 

(B) a study required to verify and describe the predicted 

effect on irreversible morbidity or mortality or other clinical 

benefit of the product fails to verify and describe such effect 

or benefit; 

(C) other evidence demonstrates that the product is not 

safe or effective under the conditions of use; or 

(D) the sponsor disseminates false or misleading promotional materials with respect to the product. 

(d) REVIEW OF INCOMPLETE APPLICATIONS FOR APPROVAL OF A

FAST TRACK PRODUCT.— 

(1) IN GENERAL.—If the Secretary determines, after preliminary evaluation of clinical data submitted by the sponsor, that 

a fast track product may be effective, the Secretary shall evaluate for filing, and may commence review of portions of, an application for the approval of the product before the sponsor submits a complete application. The Secretary shall commence 

such review only if the applicant— 

(A) provides a schedule for submission of information 

necessary to make the application complete; and 

(B) pays any fee that may be required under section 736. 

(2) EXCEPTION.—Any time period for review of human drug 

applications that has been agreed to by the Secretary and that 

has been set forth in goals identified in letters of the Secretary 

(relating to the use of fees collected under section 736 to expedite the drug development process and the review of human 

drug applications) shall not apply to an application submitted 

under paragraph (1) until the date on which the application is 

complete. 

(f) AWARENESS EFFORTS.—The Secretary shall— 

(1) develop and disseminate to physicians, patient organizations, pharmaceutical and biotechnology companies, and other 

appropriate persons a description of the provisions of this section applicable to breakthrough therapies, accelerated approval, 

and and fast track products; and 

(2) establish a program to encourage the development of surrogate and clinical endpoints, including biomarkers, and other 

scientific methods and tools that can assist the Secretary in determining whether the evidence submitted in an application is 

reasonably likely to predict clinical benefit for serious or lifethreatening conditions for which there exist significant unmet 

medical needs. 

(g) REPORT.—Beginning in fiscal year 2013, the Secretary shall 

annually prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on 

Energy and Commerce of the House of Representatives, and make 


jbell on DSK7SPTVN1PROD with REPORTS
70 

publicly available, with respect to this section for the previous fiscal 

year— 

(1) the number of drugs for which a sponsor requested designation as a breakthrough therapy; 

(2) the number of products designated as a breakthrough 

therapy; and 

(3) for each product designated as a breakthrough therapy, a 

summary of the actions taken under subsection (a)(3). 

* * * * * * * 

SEC. 506A. MANUFACTURING CHANGES. 

(a) * * * 

* * * * * * * 

(c) MAJOR MANUFACTURING CHANGES.— (1) * * * 

* * * * * * * 

(3) CHANGES ADDRESSING A DRUG SHORTAGE.— (A) CERTIFICATION.— (i) DESCRIPTION.—A certification is described in this 

subparagraph if the manufacturer, having notified the 

Secretary of an interruption or discontinuance of a 

drug in accordance with Section 506C, certifies (in 

such certification) that the major manufacturing 

change for which approval is being sought may prevent 

or alleviate a discontinuance or interruption of such 

drug. 

(ii) BAD FAITH EXCEPTION.—Subparagraphs (B) and 

(C) do not apply in the case of a certification which the 

Secretary determines to be made in bad faith. 

(B) EXPEDITED REVIEW.—If a certification described in 

subparagraph (A) is submitted in connection with a supplemental application for a major manufacturing change, the 

Secretary shall— 

(i) expedite any technical review or inspection necessary for consideration of the supplemental application; 

(ii) provide any technical assistance necessary to facilitate approval of the supplemental application; and 

(iii) not later than 60 days after receipt of the certification, complete review of the supplemental application. 

* * * * * * * 

SEC. 506B. REPORTS OF POSTMARKETING STUDIES. 

(a) * * * 

* * * * * * * 

(e) NOTIFICATION.—With respect to studies of the type required 

under øsection 506(b)(2)(A)¿ section 506(c)(2)(A) or under section 

314.510 or 601.41 of title 21, Code of Federal Regulations, as each 

of such sections was in effect on the day before the effective date 

of this subsection, the Secretary may require that a sponsor who, 

for reasons not satisfactory to the Secretary, fails to complete by 

its deadline a study under any of such sections of such type for a 

drug or biological product (including such a study conducted after 


jbell on DSK7SPTVN1PROD with REPORTS
71 

such effective date) notify practitioners who prescribe such drug or 

biological product of the failure to complete such study and the 

questions of clinical benefit, and, where appropriate, questions of 

safety, that remain unanswered as a result of the failure to complete such study. Nothing in this subsection shall be construed as 

altering the requirements of the types of studies required under 

øsection 506(b)(2)(A)¿ section 506(c)(2)(A) or under section 314.510 

or 601.41 of title 21, Code of Federal Regulations, as so in effect, 

or as prohibiting the Secretary from modifying such sections of title 

21 of such Code to provide for studies in addition to those of such 

type. 

øSEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT. 

ø(a) IN GENERAL.—A manufacturer that is the sole manufacturer 

of a drug— 

ø(1) that is— 

ø(A) life-supporting; 

ø(B) life-sustaining; or 

ø(C) intended for use in the prevention of a debilitating 

disease or condition; 

ø(2) for which an application has been approved under section 505(b) or 505(j); and 

ø(3) that is not a product that was originally derived from 

human tissue and was replaced by a recombinant product, 

shall notify the Secretary of a discontinuance of the manufacture 

of the drug at least 6 months prior to the date of the discontinuance. 

ø(b) REDUCTION IN NOTIFICATION PERIOD.—The notification period required under subsection (a) for a manufacturer may be reduced if the manufacturer certifies to the Secretary that good cause 

exists for the reduction, such as a situation in which— 

ø(1) a public health problem may result from continuation of 

the manufacturing for the 6-month period; 

ø(2) a biomaterials shortage prevents the continuation of the 

manufacturing for the 6-month period; 

ø(3) a liability problem may exist for the manufacturer if the 

manufacturing is continued for the 6-month period; 

ø(4) continuation of the manufacturing for the 6-month period may cause substantial economic hardship for the manufacturer; 

ø(5) the manufacturer has filed for bankruptcy under chapter 7 or 11 of title 11, United States Code; or 

ø(6) the manufacturer can continue the distribution of the 

drug involved for 6 months. 

ø(c) DISTRIBUTION.—To the maximum extent practicable, the Secretary shall distribute information on the discontinuation of the 

drugs described in subsection (a) to appropriate physician and patient organizations.¿ 

SEC. 506C. DISCONTINUANCE AND INTERRUPTIONS OF MANUFACTURING OF CERTAIN DRUGS. 

(a) IN GENERAL.—A manufacturer of a drug subject to section 

503(b)(1)— 

(1) that is— 

(A) life-supporting; 

(B) life-sustaining; or 


jbell on DSK7SPTVN1PROD with REPORTS
72 

(C) intended for use in the prevention or treatment of a 

debilitating disease or condition; and 

(2) that is not a radio pharmaceutical drug product, a product derived from human plasma protein and their recombinant 

analogs, or any other product as designated by the Secretary, 

shall notify the Secretary of a discontinuance of the manufacture of 

the drug, or an interruption of the manufacture of the drug that is 

likely to lead to a meaningful disruption in the manufacturer’s supply of the drug, and the reason for such discontinuance or interruption, in accordance with subsection (b). 

(b) TIMING.—A notice required by subsection (a) shall be submitted to the Secretary— 

(1) at least 6 months prior to the date of the discontinuance 

or interruption; or 

(2) if compliance with paragraph (1) is not possible, as soon 

as practicable. 

(c) DISTRIBUTION.—To the maximum extent practicable, the Secretary shall distribute information on the discontinuation or interruption of the manufacture of the drugs described in subsection (a) 

to appropriate organizations, including physician, health provider, 

and patient organizations, as described in section 506D. 

(d) CONFIDENTIALITY.—Nothing in this section shall be construed 

as authorizing the Secretary to disclose any information that is a 

trade secret or confidential information subject to section 552(b)(4) 

of title 5, United States Code, or section 1905 of title 18, United 

States Code. 

(e) COORDINATION WITH ATTORNEY GENERAL.—Not later than 30 

days after the receipt of a notification described in subsection (a), 

the Secretary shall— 

(1) determine whether the notification pertains to a controlled 

substance subject to a production quota under section 306 of the 

Controlled Substances Act; and 

(2) if necessary, as determined by the Secretary— 

(A) notify the Attorney General that the Secretary has received such a notification; 

(B) request that the Attorney General increase the aggregate and individual production quotas under section 306 of 

the Controlled Substances Act applicable to such controlled 

substance and any ingredient therein to a level the Secretary deems necessary to address a shortage of a controlled 

substance based on the best available market data; and 

(C) if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide to the 

Secretary a written response detailing the basis for the Attorney General’s determination. 

The Secretary shall make the written response provided under 

subparagraph (C) available to the public on the Web site of the 

Food and Drug Administration. 

(f) FAILURE TO MEET REQUIREMENTS.—If a person fails to submit 

information required under subsection (a) in accordance with subsection (b)— 

(1) the Secretary shall issue a letter to such person informing 

such person of such failure; 


jbell on DSK7SPTVN1PROD with REPORTS
73 

(2) not later than 30 calendar days after the issuance of a letter under paragraph (1), the person who receives such letter 

shall submit to the Secretary a written response to such letter 

setting forth the basis for noncompliance and providing information required under subsection (a); and 

(3) not later than 45 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter 

and any response to such letter under paragraph (2) available 

to the public on the Web site of the Food and Drug Administration, with appropriate redactions made to protect information 

described in subsection (d), except that, if the Secretary determines that the letter under paragraph (1) was issued in error 

or, after review of such response, the person had a reasonable 

basis for not notifying as required under subsection (a), the requirements of this paragraph shall not apply. 

SEC. 506D. DRUG SHORTAGE LIST. 

(a) ESTABLISHMENT.—The Secretary shall maintain an up-to-date 

list of drugs that are determined by the Secretary to be in shortage 

in the United States. 

(b) CONTENTS.—For each drug on such list, the Secretary shall include the following information: 

(1) The name of the drug in shortage. 

(2) The name of each manufacturer of such drug. 

(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories: 

(A) Requirements related to complying with good manufacturing practices. 

(B) Regulatory delay. 

(C) Shortage of an active ingredient. 

(D) Shortage of an inactive ingredient component. 

(E) Discontinuation of the manufacture of the drug. 

(F) Delay in shipping of the drug. 

(G) Demand increase for the drug. 

(4) The estimated duration of the shortage as determined by 

the Secretary. 

(c) PUBLIC AVAILABILITY.— 

(1) IN GENERAL.—Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available. 

(2) TRADE SECRETS AND CONFIDENTIAL INFORMATION.—Nothing in this section alters or amends section 1905 of title 18, 

United States Code, or section 552(b)(4) of title 5 of such Code. 

(3) PUBLIC HEALTH EXCEPTION.—The Secretary may choose 

not to make information collected under this section publicly 

available under paragraph (1) if the Secretary determines that 

disclosure of such information would adversely affect the public 

health (such as by increasing the possibility of hoarding or 

other disruption of the availability of drug products to patients). 

SEC. 506E. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE. 

(a) DEFINITIONS.—In this section: 

(1) DRUG.—The term ‘‘drug’’ excludes any controlled substance (as such term is defined in section 102 of the Controlled 

Substances Act). 


jbell on DSK7SPTVN1PROD with REPORTS
74 

(2) HEALTH SYSTEM.—The term ‘‘health system’’ means a collection of hospitals that are owned and operated by the same 

entity and that share access to databases with drug order information for their patients. 

(3) REPACKAGE.—For the purposes of this section only, the 

term ‘‘repackage’’, with respect to a drug, means to divide the 

volume of a drug into smaller amounts in order to— 

(A) extend the supply of a drug in response to the placement of the drug on a drug shortage list described in subsection (b); and 

(B) facilitate access to the drug by hospitals within the 

same health system. 

(b) EXCLUSION FROM REGISTRATION.—Notwithstanding any other 

provision of this Act, a hospital shall not be considered an establishment for which registration is required under section 510 solely because it repackages a drug and transfers it to another hospital within the same health system in accordance with the conditions in subsection (c)— 

(1) during any period in which the drug is listed on the Drug 

Shortage List of the Food and Drug Administration; or 

(2) during the 60-day period following any period described 

in paragraph (1). 

(c) CONDITIONS.—Subsection (b) shall only apply to a hospital, 

with respect to the repackaging of a drug for transfers to another 

hospital within the same health system, if the following conditions 

are met: 

(1) DRUG FOR INTRASYSTEM USE ONLY.—In no case may a 

drug that has been repackaged in accordance with this section 

be sold or otherwise distributed by the health system or a hospital within the system to an entity or individual that is not a 

hospital within such health system. 

(2) COMPLIANCE WITH STATE RULES.—Repackaging of a drug 

under this section shall be done in compliance with applicable 

State requirements in which the health system is located. 

(d) TERMINATION.—This section shall not apply on or after the 

date on which the Secretary issues final guidance that clarifies the 

policy of the Food and Drug Administration regarding hospital 

pharmacies repackaging and safely transferring repackaged drugs 

to other hospitals within the same health system during a drug 

shortage. 

* * * * * * * 

SEC. 510. (a) * * * 

(b)(1) øOn or before¿ During the period beginning on October 1 

and ending on December 31 of each year every person who owns 

or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a 

drug or drugs shall register with the Secretary his name, places of 

business, øand all such establishments¿ all such establishments, 

and the unique facility identifier of each such establishment. 

* * * * * * * 

(c) Every person upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs 

or a device or devices in any establishment which he owns or operates in any State shall immediately register with the Secretary his 


jbell on DSK7SPTVN1PROD with REPORTS
75 

name, place of business, øand such establishment¿ such establishment, and the unique facility identifier of such establishment. 

* * * * * * * 

(h)(1) Every establishment in any State registered with the Secretary pursuant to this section with respect to the manufacture, 

preparation, propagation, compounding, or processing of a device 

shall be subject to inspection pursuant to section 704 and every 

such establishment engaged in the manufacture, propagation, 

compounding, or processing øof a drug or drugs or¿ of a device or 

devices classified in class II or III shall be so inspected by one or 

more officers or employees duly designated by the Secretary, or by 

persons accredited to conduct inspections under section 704(g), at 

least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least 

once in every successive 2-year period thereafter. 

(2) INSPECTIONS WITH RESPECT TO DRUG ESTABLISHMENTS.— 

With respect to the manufacture, preparation, propagation, 

compounding, or processing of a drug: 

(A) IN GENERAL.—Every establishment that is required to be 

registered with the Secretary under this section shall be subject 

to inspection pursuant to section 704. 

(B) RISK-BASED SCHEDULE.—In the case of an establishment 

that is engaged in the manufacture, preparation, propagation, 

compounding, or processing of a drug or drugs (referred to in 

this subsection as a ‘‘drug establishment’’), the inspections required under subparagraph (A) shall be conducted by officers 

or employees duly designated by the Secretary, on a risk-based 

schedule established by the Secretary. 

(C) RISK FACTORS.—In establishing the risk-based schedule 

under subparagraph (B), the Secretary shall allocate resources 

to inspect establishments according to the known safety risks of 

such establishments, based on the following factors: 

(i) The compliance history of the establishment. 

(ii) The inspection frequency and history of the establishment, including whether it has been inspected pursuant to 

section 704 within the last four years. 

(iii) The record, history, and nature of recalls linked to 

the establishment. 

(iv) The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment. 

(v) Any other criteria deemed necessary and appropriate 

by the Secretary for purposes of allocating inspection resources. 

(D) EFFECT OF STATUS.—In determining the risk associated 

with an establishment for purposes of establishing a risk-based 

schedule under subparagraph (B), the Secretary shall not consider whether the drugs manufactured, prepared, propagated, 

compounded, or processed by such establishment are drugs described in section 503(b)(1). 

(E) ANNUAL REPORT ON INSPECTIONS OF ESTABLISHMENTS.— 

Not later than February 1 of each year, the Secretary shall submit to Congress a report that contains the following: 


jbell on DSK7SPTVN1PROD with REPORTS
76 

(i) The number of domestic and foreign establishments 

registered pursuant to this section in the previous calendar 

year. 

(ii) The number of such registered domestic and foreign 

establishments that the Secretary inspected in the previous 

calendar year. 

(iii) The number of such registered establishments that 

list one or more drugs approved pursuant to an application 

filed under section 505(j). 

(iv) The number of such registered establishments that 

list one or more drugs approved pursuant to an application 

filed under section 505(b). 

(v) The number of registered establishments that list both 

drug products approved pursuant to an application filed 

under section 505(j) and drug products approved pursuant 

to an application filed under section 505(b). 

(vi) A description of how the Secretary implemented the 

risk-based schedule under subparagraph (B) utilizing the 

factors under subparagraph (C). 

(F) PUBLIC AVAILABILITY OF ANNUAL REPORTS.—The Secretary 

shall make the report required under subparagraph (E) available to the public on the Internet Web site of the Food and Drug 

Administration. 

(i)(1) Any establishment within any foreign country engaged in 

the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into 

the United States shall, through electronic means in accordance 

with the criteria of the Secretary— 

(A) upon first engaging in any such activity, immediately 

register with the Secretary the name and place of business of 

the establishment, the unique facility identifier of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the 

United States that is known to the establishment, and the 

name of each person who imports or offers for import such 

drug or device to the United States for purposes of importation; 

and 

(B) each establishment subject to the requirements of subparagraph (A) shall thereafter— 

(i) with respect to drugs, register with the Secretary øon 

or before¿ during the period beginning on October 1 and 

ending on December 31 of each year; and 

* * * * * * * 

ø(n)¿ (n)(1) The Secretary shall review the report required in 

subsection (k) and make a determination under section 513(f)(1) 

not later than 90 days after receiving the report. 

(2)(A) Not later than 18 months after the enactment of this 

paragraph, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the 

Committee on Health, Education, Labor, and Pensions of the 

Senate a report regarding when a premarket notification under 

subsection (k) should be submitted for a modification or change 

to a legally marketed device. The report shall include the Secretary’s interpretation of the following terms: ‘‘could significantly affect the safety or effectiveness of the device’’, ‘‘a signifiVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00076 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
77 

cant change or modification in design, material, chemical composition, energy source, or manufacturing process,’’, and ‘‘major 

change or modification in the intended use of the device’’. The 

report also shall discuss possible processes for industry to use 

to determine whether a new submission under subsection (k) is 

required and shall analyze how to leverage existing quality system requirements to reduce premarket burden, facilitate continual device improvement. and provide reasonable assurance of 

safety and effectiveness of modified devices. In developing such 

report, the Secretary shall consider the input of interested stakeholders. 

(B) The Secretary shall withdraw the Food and Drug Administration draft guidance entitled ‘‘Guidance for Industry and 

FDA Staff—510(k) Device Modifications: Deciding When to 

Submit a 510(k) for a Change to an Existing Device’’, dated 

July 27, 2011, and shall not use this draft guidance as part of, 

or for the basis of, any premarket review or any compliance or 

enforcement decisions or actions. The Secretary shall not 

issue— 

(i) any draft guidance or proposed regulation that addresses when to submit a premarket notification submission 

for changes and modifications made to a manufacturer’s 

previously cleared device before the receipt by the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, 

and Pensions of the Senate of the report required in subparagraph (A); and 

(ii) any final guidance or regulation on that topic for one 

year after date of receipt of such report by the Committee 

on Energy and Commerce of the House of Representatives 

and the Committee on Health, Education, Labor, and Pensions of the Senate. 

(C) The Food and Drug Administration guidance entitled 

‘‘Deciding When to Submit a 510(k) for a Change to an Existing 

Device’’, dated January 10, 1997, shall be in effect until the 

subsequent issuance of guidance or promulgation, if appropriate, of a regulation described in subparagraph (B), and the 

Secretary shall interpret such guidance in a manner that is 

consistent with the manner in which the Secretary has interpreted such guidance since 1997. 

* * * * * * * 

(q) GUIDANCE ON SUBMISSION OF UNIQUE FACILITY IDENTI- FIERS.— 

(1) IN GENERAL.—Not later than 2 years after the date of the 

enactment of this subsection, the Secretary shall, by guidance, 

specify— 

(A) the unique facility identifier system to be used to meet 

the requirements of— 

(i) subsections (b)(1), (c), and (i)(1)(A) of this section; 

and 

(ii) section 801(s) (relating to registration of commercial importers); and 

(B) the form, manner, and timing of submissions of 

unique facility identifiers under the provisions specified in 

subparagraph (A). 


jbell on DSK7SPTVN1PROD with REPORTS
78 

(2) CONSIDERATION.—In developing the guidance under paragraph (1), the Secretary shall take into account the utilization 

of existing unique identification schemes and compatibility with 

customs automated systems. 

* * * * * * * 

CLASSIFICATION OF DEVICES INTENDED FOR HUMAN USE

Device Classes 

SEC. 513. (a)(1) * * * 

* * * * * * * 

(3)(A) * * * 

* * * * * * * 

(D)(i) * * * 

* * * * * * * 

(iii) For purposes of clause (ii), the term ‘‘necessary’’ 

means the minimum required information that would 

support a determination by the Secretary that an application provides reasonable assurance of the effectiveness of the device. 

(iv) Nothing in this subparagraph shall alter the criteria for evaluating an application for premarket approval of a device. 

ø(iii)¿ (v) The determination of the Secretary with respect to the 

specification of valid scientific evidence under clauses (i) and (ii) 

shall be binding upon the Secretary, unless such determination by 

the Secretary could be contrary to the public health. 

* * * * * * * 

Initial Classification and Reclassification of Certain Devices 

(f)(1) Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for 

commercial distribution before the date of the enactment of this 

section is classified in class III unless— 

(A) the device— 

(i) * * * 

(ii) is substantially equivalent to another device within 

such typeø, or¿; 

(B) the Secretary in response to a petition submitted under 

paragraph (3) has classified such device in class I or IIø.¿; or 

(C) the device is classified pursuant to a request submitted under paragraph (2). 

* * * * * * * 

(2)(A)(i) Any person who submits a report under section 510(k) 

for a type of device that has not been previously classified under 

this Act, and that is classified into class III under paragraph (1), 

may request, within 30 days after receiving written notice of such 

a classification, the Secretary to classify the device øunder the criteria set forth in subparagraphs (A) through (C) of subsection 

(a)(1). The person may, in the request, recommend to the Secretary 

a classification for the device. Any such request shall describe the 


jbell on DSK7SPTVN1PROD with REPORTS
79 

device and provide detailed information and reasons for the recommended classification.¿. (ii) In lieu of submitting a report under section 510(k) and submitting a request for classification under clause (i) for a device, if 

a person determines there is no legally marketed device upon which 

to base a determination of substantial equivalence (as defined in 

subsection (i)), a person may submit a request under this clause for 

the Secretary to classify the device. 

(iii) Upon receipt of a request under clause (i) or (ii), the Secretary 

shall classify the device subject to the request under the criteria set 

forth in subparagraphs (A) through (C) of subsection (a)(1) within 

120 days. 

(iv) Notwithstanding clause (iii), the Secretary may decline to undertake a classification of a device pursuant to a request under 

clause (ii) if the Secretary— 

(I) identifies a legally marketed device that would permit a 

substantial equivalence determination under paragraph (1) for 

the device; or 

(II) determines that the device submitted is not of low-moderate risk or special controls to mitigate the risks cannot be developed for the device. 

(v) The person submitting the request for classification under this 

subparagraph may recommend to the Secretary a classification for 

the device and shall, if recommending classification in class II, include in the request an initial draft proposal for applicable special 

controls, as described in subsection (a)(1)(B), that are necessary, in 

conjunction with general controls, to provide reasonable assurance 

of safety and effectiveness and a description of how the special controls provide such assurance. Any such request shall describe the device and provide detailed information and reasons for the recommended classification. 

(B)(i) øNot later than 60 days after the date of the submission 

of the request under subparagraph (A), the Secretary¿ The Secretary shall by written order classify the device involved. Such classification shall be the initial classification of the device for purposes 

of paragraph (1) and any device classified under this paragraph 

shall be a predicate device for determining substantial equivalence 

under paragraph (1). 

* * * * * * * 

Substantial Equivalence 

(i)(1)(A) * * * 

* * * * * * * 

(D)(i) Whenever the Secretary requests information to demonstrate that devices with differing technological characteristics 

are substantially equivalent, the Secretary shall only request information that is necessary to making substantial equivalence determinations. In making such request, the Secretary shall consider 

the least burdensome means of demonstrating substantial equivalence and request information accordingly. 

(ii) For purposes of clause (i), the term ‘‘necessary’’ means the minimum required information that would support a determination of 

substantial equivalence between a new device and a predicate device. 


jbell on DSK7SPTVN1PROD with REPORTS
80 

(iii) Nothing in this subparagraph shall alter the standard for determining substantial equivalence between a new device and a predicate device. 

* * * * * * * 

PREMARKET APPROVAL

SEC. 515. (a) * * * 

* * * * * * * 

Application for Premarket Approval 

(c)(1) * * * 

* * * * * * * 

(4)(A) Prior to the submission of an application under this subsection, the Secretary shall accept and review any portion of the 

application that the applicant and the Secretary agree is complete, 

ready, and appropriate for review, except that such requirement 

does not apply, and the Secretary has discretion whether to accept 

and review such portion, during any period in which, under section 

ø738(g)¿ 738(h), the Secretary does not have the authority to collect fees under section 738(a). 

* * * * * * * 

SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT 

DECISIONS REGARDING DEVICES. 

(a) DOCUMENTATION OF RATIONALE FOR SIGNIFICANT DECI- SIONS.— 

(1) IN GENERAL.—The Secretary shall completely document 

the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 510(k), an 

application under section 515, or an application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the resolution of 

such controversies or differences of opinion. 

(2) PROVISION OF DOCUMENTATION.—Upon request, the Secretary shall furnish such complete documentation to the person 

who is seeking to submit, or who has submitted, such report or 

application. 

(b) REVIEW OF SIGNIFICANT DECISIONS.— 

(1) REQUEST FOR SUPERVISORY REVIEW OF SIGNIFICANT DECISION.—Any person may request a supervisory review of the significant decision described in subsection (a)(1). Such review 

may be conducted at the next supervisory level or higher above 

the individual who made the significant decision. 

(2) SUBMISSION OF REQUEST.—A person requesting a supervisory review under paragraph (1) shall submit such request to 

the Secretary not later than 30 days after such decision and 

shall indicate in the request whether such person seeks an inperson meeting or a teleconference review. 

(3) TIMEFRAME.— 

(A) IN GENERAL.—Except as provided in subparagraph 

(B), the Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after 


jbell on DSK7SPTVN1PROD with REPORTS
81 

such request is made. The Secretary shall issue a decision 

to the person requesting a review under this subsection not 

later than 45 days after the request is made under paragraph (1), or, in the case of a person who requests an inperson meeting or teleconference, 30 days after such meeting or teleconference. 

(B) EXCEPTION.—Subparagraph (A) shall not apply in 

cases that are referred to experts outside of the Food and 

Drug Administration. 

* * * * * * * 

SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM. 

(a) IN GENERAL.—The Secretary shall— 

(1) establish a program to routinely and systematically assess 

information relating to device recalls and use such information 

to proactively identify strategies for mitigating health risks presented by defective or unsafe devices; 

(2) clarify procedures for conducting device recall audit 

checks to improve the ability of investigators to perform those 

checks in a consistent manner; 

(3) develop detailed criteria for assessing whether a person 

performing a device recall has performed an effective correction 

or action plan for the recall; and 

(4) document the basis for each termination by the Food and 

Drug Administration of a device recall. 

(b) ASSESSMENT CONTENT.—The program established under subsection (a)(1) shall, at a minimum, identify— 

(1) trends in the number and types of device recalls; 

(2) devices that are most frequently the subject of a recall; 

and 

(3) underlying causes of device recalls. 

(c) DEFINITION.—In this section, the term ‘‘recall’’ means— 

(1) the removal from the market of a device pursuant to an 

order of the Secretary under subsection (b) or (e) of section 518; 

or 

(2) the correction or removal from the market of a device at 

the initiative of the manufacturer or importer of the device that 

is required to be reported to the Secretary under section 519(g). 

RECORDS AND REPORTS ON DEVICES

SEC. 519. (a) * * * 

* * * * * * * 

(h) INCLUSION OF DEVICES IN POSTMARKET RISK IDENTIFICATION

AND ANALYSIS SYSTEM.— 

(1) IN GENERAL.—The Secretary shall amend the procedures 

established and maintained under clauses (i), (ii), (iii), and (v) 

of section 505(k)(3)(C) in order to expand the postmarket risk 

identification and analysis system established under such section to include and apply to devices. 

(2) DATA.—In expanding the system as described in paragraph (1), the Secretary shall use relevant data with respect to 

devices cleared under section 510(k) or approved under section 

515, which may include claims data, patient survey data, and 


jbell on DSK7SPTVN1PROD with REPORTS
82 

standardized analytic files that allow for the pooling and analysis of data from disparate data environments. 

(3) STAKEHOLDER INPUT.—To help ensure effective implementation of the system as described in paragraph (1) with respect 

to devices, the Secretary shall engage outside stakeholders in 

development of the system, and gather information from outside 

stakeholders regarding the content of an effective sentinel program, through a public hearing, advisory committee meeting, 

maintenance of a public docket, or other similar public measures. 

(4) VOLUNTARY SURVEYS.—Chapter 35 of title 44, United 

States Code, shall not apply to the collection of voluntary information from health care providers, such as voluntary surveys or 

questionnaires, initiated by the Secretary for purposes of 

postmarket risk identification, mitigation, and analysis for devices. 

GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED

FOR HUMAN USE

SEC. 520. (a) * * * 

øCustom Devices 

ø(b) Sections 514 and 515 do not apply to any device which, in 

order to comply with the order of an individual physician or dentist 

(or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral 

hearing) necessarily deviates from an otherwise applicable performance standard or requirement prescribed by or under section 515 

if (1) the device is not generally available in finished form for purchase or for dispensing upon prescription and is not offered 

through labeling or advertising by the manufacturer, importer, or 

distributor thereof for commercial distribution, and (2) such device— 

ø(A)(i) is intended for use by an individual patient named in 

such order of such physician or dentist (or other specially 

qualified person so designated) and is to be made in a specific 

form for such patient, or 

ø(ii) is intended to meet the special needs of such physician 

or dentist (or other specially qualified person so designated) in 

the course of the professional practice of such physician or dentist (or other specially qualified person so designated), and 

ø(B) is not generally available to or generally used by other 

physicians or dentists (or other specially qualified persons so 

designated).¿ 

(b) CUSTOM DEVICES.— 

(1) IN GENERAL.—The requirements of sections 514 and 515 

shall not apply to a device that— 

(A) is created or modified in order to comply with the 

order of an individual physician or dentist (or any other 

specially qualified person designated under regulations 

promulgated by the Secretary after an opportunity for an 

oral hearing); 

(B) in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise apVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00082 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
83 

plicable performance standard under section 514 or requirement under section 515; 

(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution; 

(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat; 

(E)(i) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such 

physician or dentist (or other specially qualified person so 

designated); or 

(ii) is intended for use by an individual patient named 

in such order of such physician or dentist (or other specially qualified person so designated); 

(F) is assembled from components or manufactured and 

finished on a case-by-case basis to accommodate the unique 

needs of individuals described in clause (i) or (ii) of subparagraph (E); and 

(G) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices. 

(2) LIMITATIONS.—Paragraph (1) shall apply to a device only 

if— 

(A) such device is for the purpose of treating a sufficiently 

rare condition, such that conducting clinical investigations 

on such device would be impractical; and 

(B) production of such device under paragraph (1) is limited to no more than 5 units per year of a particular device 

type, provided that such replication otherwise complies 

with this section. 

(3) GUIDANCE.—Not later than 2 years after the date of enactment of this section, the Secretary shall issue final guidance on 

replication of multiple devices described in paragraph (2)(B). 

(4) NOTIFICATION TO THE SECRETARY.—The manufacturer of 

such device created or modified as described in paragraph (1) 

shall notify the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device. 

* * * * * * * 

Exemption for Devices for Investigational Use 

(g)(1) * * * 

(2)(A) * * * 

(B) The conditions prescribed pursuant to subparagraph (A) shall 

include the following: 

(i) * * * 

(ii) A requirement that the person applying for an exemption 

for a device assure the establishment and maintenance of such 

records, and the making of such reports to the Secretary of 

safety or effectiveness data obtained as a result of the investigational use of the device during the exemption, as the Secretary 

determines will enable him to assure compliance with such 


jbell on DSK7SPTVN1PROD with REPORTS
84 

conditions, review the progress of the investigation, and evaluate the safety and effectiveness of the device. 

* * * * * * * 

(4)(A) * * * 

* * * * * * * 

(C) Consistent with paragraph (1), the Secretary shall not disapprove an application under this subsection because the Secretary 

determines that— 

(i) the investigation may not support a substantial equivalence or de novo classification determination or approval of the 

device; 

(ii) the investigation may not meet a requirement, including 

a data requirement, relating to the approval or clearance of a 

device; or 

(iii) an additional or different investigation may be necessary 

to support clearance or approval of the device. 

Release of Safety and Effectiveness Information 

(h)(1) * * * 

* * * * * * * 

(5) Subject to subsection (c) and section 301(j), the Secretary shall 

regularly publish detailed decision summaries for each clearance of 

a device under section 510(k) requiring clinical data. 

* * * * * * * 

Humanitarian Device Exemption 

(m)(1) * * * 

* * * * * * * 

(6)(A) Except as provided in øsubparagraph (D)¿ subparagraph 

(C), the prohibition in paragraph (3) shall not apply with respect 

to a person granted an exemption under paragraph (2) if each of 

the following conditions apply: 

ø(i)(I) The device with respect to which the exemption is 

granted is intended for the treatment or diagnosis of a disease 

or condition that occurs in pediatric patients or in a pediatric 

subpopulation, and such device is labeled for use in pediatric 

patients or in a pediatric subpopulation in which the disease 

or condition occurs. 

ø(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation 

described in subclause (I) prior to the date of the enactment of 

the Pediatric Medical Device Safety and Improvement Act of 

2007. 

ø(ii) During any calendar year, the number of such devices 

distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number 

shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals 

likely to use the device, and the number of devices reasonably 

necessary to treat such individuals. In no case shall the annual 


jbell on DSK7SPTVN1PROD with REPORTS
85 

distribution number exceed the number identified in paragraph 

(2)(A).¿ 

(i) The device with respect to which the exemption is granted— 

(I) is intended for the treatment or diagnosis of a disease 

or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in 

pediatric patients or in a pediatric subpopulation in which 

the disease or condition occurs; or 

(II) is intended for the treatment or diagnosis of a disease 

or condition that does not occur in pediatric patients or 

that occurs in pediatric patients in such numbers that the 

development of the device for such patients is impossible, 

highly impracticable, or unsafe. 

(ii) During any calendar year, the number of such devices distributed during that year under each exemption granted under 

this subsection does not exceed the number of such devices needed to treat, diagnose, or cure a population of 4,000 individuals 

in the United States (referred to in this paragraph as the ‘‘annual distribution number’’). 

* * * * * * * 

(iv) The request for such exemption is submitted on or before 

October 1, ø2012¿ 2017. 

* * * * * * * 

ø(C) A person may petition the Secretary to modify the annual 

distribution number specified by the Secretary under subparagraph 

(A)(ii) with respect to a device if additional information on the 

number of individuals affected by the disease or condition arises, 

and the Secretary may modify such number but in no case shall 

the annual distribution number exceed the number identified in 

paragraph (2)(A).¿ 

ø(D)¿ (C) If a person notifies the Secretary, or the Secretary determines through an inspection under subparagraph (B), that the 

number of devices distributed during any calendar year exceeds the 

annual distribution number, as required under subparagraph 

(A)(iii), øand modified under subparagraph (C), if applicable,¿ then 

the prohibition in paragraph (3) shall apply with respect to such 

person for such device for any sales of such device after such notification. 

ø(E)¿ (D)(i) * * * 

* * * * * * * 

(7) The Secretary shall refer any report of an adverse event øregarding a device¿ regarding a device described in paragraph 

(6)(A)(i)(I) for which the prohibition under paragraph (3) does not 

apply pursuant to paragraph (6)(A) that the Secretary receives to 

the Office of Pediatric Therapeutics, established under section 6 of 

the Best Pharmaceuticals for Children Act (Public Law 107–109). 

In considering the report, the Director of the Office of Pediatric 

Therapeutics, in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic review of 

the report by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the 


jbell on DSK7SPTVN1PROD with REPORTS
86 

Secretary should take action under this Act in response to the report. 

(8) The Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, shall 

provide for an annual review by the Pediatric Advisory Committee 

øof all devices described in paragraph (6)¿ of all devices described 

in paragraph (6)(A)(i)(I) to ensure that the exemption under paragraph (2) remains appropriate for the pediatric populations for 

which it is granted. 

* * * * * * * 

SEC. 523. ACCREDITED PERSONS. 

(a) * * * 

(b) ACCREDITATION.— 

(1) * * * 

(2) ACCREDITATION.— 

(A) * * * 

* * * * * * * 

(E) PERIODIC REACCREDITATION.— (i) PERIOD.—Subject to suspension or withdrawal 

under subparagraph (B), any accreditation under this 

section shall be valid for a period of 3 years after its 

issuance. 

(ii) RESPONSE TO REACCREDITATION REQUEST.—Upon 

the submission of a request by an accredited person for 

reaccreditation under this section, the Secretary shall 

approve or deny such request not later than 60 days 

after receipt of the request. 

(iii) CRITERIA.—Not later than 120 days after the 

date of the enactment of this subparagraph, the Secretary shall establish and publish in the Federal Register criteria to reaccredit or deny reaccreditation to 

persons under this section. The reaccreditation of persons under this section shall specify the particular activities under subsection (a), and the devices, for which 

such persons are reaccredited. 

* * * * * * * 

(c) DURATION.—The authority provided by this section terminates 

øOctober 1, 2012¿ October 1, 2017. 

* * * * * * * 

SUBCHAPTER B—DRUGS FOR RARE DISEASES OR CONDITIONS

* * * * * * * 

SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE 

PEDIATRIC DISEASES. 

(a) DEFINITIONS.—In this section: 

(1) PRIORITY REVIEW.—The term ‘‘priority review’’, with respect to a human drug application as defined in section 735(1), 

means review and action by the Secretary on such application 

not later than 6 months after receipt by the Secretary of such 

application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identiVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00086 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
87 

fied in the letters described in section 101(b) of the Prescription 

Drug User Fee Amendments of 2012. 

(2) PRIORITY REVIEW VOUCHER.—The term ‘‘priority review 

voucher’’ means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles 

the holder of such voucher to priority review of a single human 

drug application submitted under section 505(b)(1) or section 

351(a) of the Public Health Service Act after the date of approval of the rare pediatric disease product application. 

(3) RARE PEDIATRIC DISEASE.—The term ‘‘rare pediatric disease’’ means a disease that meets each of the following criteria: 

(A) The disease primarily affects individuals aged from 

birth to 18 years, including age groups often called neonates, infants, children, and adolescents. 

(B) The disease is a rare disease or condition, within the 

meaning of section 526. 

(4) RARE PEDIATRIC DISEASE PRODUCT APPLICATION.—The 

term ‘‘rare pediatric disease product application’’ means a 

human drug application, as defined in section 735(1), that— 

(A) is for a drug or biological product— 

(i) that is for the prevention or treatment of a rare 

pediatric disease; 

(ii) that contains no active ingredient (including any 

ester or salt of the active ingredient) that has been previously approved in any other application under section 505(b)(1), 505(b)(2), or 505(j) of this Act or section 

351(a) or 351(k) of the Public Health Service Act; 

(B) is submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act; 

(C) the Secretary deems eligible for priority review; 

(D) that relies on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population; 

(E) that does not seek approval for an adult indication 

in the original rare pediatric disease product application; 

and 

(F) is approved after the date of the enactment of the Prescription Drug User Fee Amendments of 2012. 

(b) PRIORITY REVIEW VOUCHER.— 

(1) IN GENERAL.—The Secretary shall award a priority review 

voucher to the sponsor of a rare pediatric disease product application upon approval by the Secretary of such rare pediatric 

disease product application. 

(2) TRANSFERABILITY.— 

(A) IN GENERAL.—The sponsor of a rare pediatric disease 

product application that receives a priority review voucher 

under this section may transfer (including by sale) the entitlement to such voucher. There is no limit on the number 

of times a priority review voucher may be transferred before 

such voucher is used. 

(B) NOTIFICATION OF TRANSFER.—Each person to whom 

a voucher is transferred shall notify the Secretary of such 

change in ownership of the voucher not later than 30 days 

after such transfer. 


jbell on DSK7SPTVN1PROD with REPORTS
88 

(3) LIMITATION.—A sponsor of a rare pediatric disease product application may not receive a priority review voucher under 

this section if the rare pediatric disease product application was 

submitted to the Secretary prior to the date that is 90 days after 

the date of enactment of the Prescription Drug User Fee Amendments of 2012. 

(4) NOTIFICATION.— (A) IN GENERAL.—The sponsor of a human drug application shall notify the Secretary not later than 90 days prior 

to submission of the human drug application that is the 

subject of a priority review voucher of an intent to submit 

the human drug application, including the date on which 

the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the 

user fee to be assessed in accordance with this section. 

(B) TRANSFER AFTER NOTICE.—The sponsor of a human 

drug application that provides notification of the intent of 

such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher 

after such notification is provided, if such sponsor has not 

yet submitted the human drug application described in the 

notification. 

(5) TERMINATION OF AUTHORITY.—The Secretary may not 

award any priority review vouchers under paragraph (1) after 

the last day of the 1-year period that begins on the date that 

the Secretary awards the third rare pediatric disease priority 

voucher under this section. 

(c) PRIORITY REVIEW USER FEE.— (1) IN GENERAL.—The Secretary shall establish a user fee program under which a sponsor of a human drug application that 

is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be 

in addition to any fee required to be submitted by the sponsor 

under chapter VII. 

(2) FEE AMOUNT.—The amount of the priority review user fee 

shall be determined each fiscal year by the Secretary, based on 

the difference between— 

(A) the average cost incurred by the Food and Drug Administration in the review of a human drug application 

subject to priority review in the previous fiscal year; and 

(B) the average cost incurred by the Food and Drug Administration in the review of a human drug application 

that is not subject to priority review in the previous fiscal 

year. 

(3) ANNUAL FEE SETTING.—The Secretary shall establish, before the beginning of each fiscal year beginning after September 

30, 2012, the amount of the priority review user fee for that fiscal year. 

(4) PAYMENT.— (A) IN GENERAL.—The priority review user fee required by 

this subsection shall be due upon the notification by a 

sponsor of the intent of such sponsor to use the voucher, as 

specified in subsection (b)(4)(A). All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law. 


jbell on DSK7SPTVN1PROD with REPORTS
89 

(B) COMPLETE APPLICATION.—An application described 

under subparagraph (A) for which the sponsor requests the 

use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary’s procedures for paying such fees. 

(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR REFUNDS.—The Secretary may not grant a waiver, exemption, 

reduction, or refund of any fees due and payable under this 

section. 

(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to 

this subsection for any fiscal year— 

(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food 

and Drug Administration; and 

(B) shall not be collected for any fiscal year except to the 

extent provided in advance in appropriation Acts. 

(d) DESIGNATION PROCESS.— 

(1) IN GENERAL.—Upon the request of the manufacturer or the 

sponsor of a new drug, the Secretary may designate— 

(A) the new drug as a drug for a rare pediatric disease; 

and 

(B) the application for the new drug as a rare pediatric 

disease product application. 

(2) REQUEST FOR DESIGNATION.—The request for a designation under paragraph (1), shall be made at the same time a request for designation of orphan disease status under section 526 

or fast-track designation under section 506 is made. Requesting 

designation under this subsection is not a prerequisite to receiving a priority review voucher under this section. 

(3) DETERMINATION BY SECRETARY.—Not later than 60 days 

after a request is submitted under paragraph (1), the Secretary 

shall determine whether— 

(A) the disease or condition that is the subject of such request is a rare pediatric disease; and 

(B) the application for the new drug is a rare pediatric 

disease product application. 

(e) MARKETING OF RARE PEDIATRIC DISEASE PRODUCTS.— 

(1) IN GENERAL.—The Secretary shall deem a rare pediatric 

disease product application incomplete if such application does 

not contain a description of the plan of the sponsor of such application to market the product in the United States. 

(2) REVOCATION.—The Secretary may revoke any priority review voucher awarded under subsection (b) if the rare pediatric 

disease product for which such voucher was awarded is not 

marketed in the United States within the 365 day period beginning on the date of the approval of such drug under section 505 

of this Act or section 351 of the Public Health Service Act. 

(3) POSTAPPROVAL PRODUCTION REPORT.—The sponsor of an 

approved rare pediatric disease product shall submit a report 

to the Secretary not later than 5 years after the approval of the 

applicable rare pediatric disease product application. Such report shall provide the following information, with respect to 

each of the first 4 years after approval of such product: 


jbell on DSK7SPTVN1PROD with REPORTS
90 

(A) The estimated population in the United States suffering from the rare pediatric disease. 

(B) The estimated demand in the United States for such 

rare pediatric disease product. 

(C) The actual amount of such rare pediatric disease 

product distributed in the United States. 

(f) NOTICE AND REPORT.— (1) NOTICE OF ISSUANCE OF VOUCHER AND APPROVAL OF

PRODUCTS UNDER VOUCHER.—The Secretary shall publish a notice in the Federal Register and on the Web site of the Food and 

Drug Administration not later than 30 days after the occurrence of each of the following: 

(A) The Secretary issues a priority review voucher under 

this section. 

(B) The Secretary approves a drug pursuant to an application submitted under section 505(b) of this Act or section 

351(a) of the Public Health Service Act for which the sponsor of the application used a priority review voucher under 

this section. 

(2) REPORT.—If, after the last day of the 1-year period that 

begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section, a sponsor of 

an application submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act for a drug uses a 

priority review voucher under this section for such application, 

the Secretary shall submit to the Committee on Energy and 

Commerce of the House of Representatives and the Committee 

on Health, Education, Labor, and Pensions of the Senate a document— 

(A) notifying such Committees of the use of such voucher; 

and 

(B) identifying the drug for which such priority review 

voucher is used. 

(g) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing in this section 

precludes a sponsor who seeks a priority review voucher under this 

section from participating in any other incentive program, including 

under this Act. 

(h) RELATION TO OTHER PROVISIONS.—The provisions of this section shall supplement, not supplant, any other provisions of this Act 

or the Public Health Service Act that encourage the development of 

drugs for tropical diseases and rare pediatric diseases. 

(i) GAO STUDY AND REPORT.— 

(1) STUDY.— 

(A) IN GENERAL.—Beginning on the date that the Secretary awards the third rare pediatric disease priority 

voucher under this section, the Comptroller General of the 

United States shall conduct a study of the effectiveness of 

awarding rare pediatric disease priority vouchers under 

this section in the development of on human drug products 

that treat or prevent such diseases. 

(B) CONTENTS OF STUDY.—In conducting the study under 

subparagraph (A), the Comptroller General shall examine 

the following: 

(i) The indications for which each rare disease product for which a priority review voucher was awarded 


jbell on DSK7SPTVN1PROD with REPORTS
91 

was approved under section 505 or section 351 of the 

Public Health Service Act. 

(ii) Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric 

disease was met through the approval of such a rare 

disease product. 

(iii) The value of the priority review voucher if transferred. 

(iv) Identification of each drug for which a priority 

review voucher was used. 

(v) The length of the period of time between the date 

on which a priority review voucher was awarded and 

the date on which it was used. 

(2) REPORT.—Not later than 1 year after the date under paragraph (1)(A), the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives 

and the Committee on Health, Education, Labor, and Pensions 

of the Senate, a report containing the results of the study under 

paragraph (1). 

* * * * * * * 

SUBCHAPTER E—GENERAL PROVISIONS RELATING TO DRUGS AND

DEVICES

* * * * * * * 

SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 

(a) * * * 

* * * * * * * 

ø(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $5,000,000 for fiscal 

year 2008 and such sums as may be necessary for each of fiscal 

years 2009 through 2012.¿ 

(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there is authorized to be appropriated $6,000,000 for each of 

fiscal years 2013 through 2017. 

* * * * * * * 

SEC. 568 NOTIFICATION. 

(a) NOTIFICATION TO SECRETARY.—With respect to a drug, the 

Secretary may require notification to the Secretary by a regulated 

person if the regulated person knows— 

(1) that the use of such drug in the United States may result 

in serious injury or death; 

(2) of a significant loss or known theft of such drug intended 

for use in the United States; or 

(3) that— 

(A) such drug has been or is being counterfeited; and 

(B)(i) the counterfeit product is in commerce in the 

United States or could be reasonably expected to be introduced into commerce; or 

(ii) such drug has been or is being imported into the 

United States or may reasonably be expected to be offered 

for import into the United States. 


jbell on DSK7SPTVN1PROD with REPORTS
92 

(b) MANNER OF NOTIFICATION.—Notification under this section 

shall be made in such manner and by such means as the Secretary 

may specify by regulation or guidance. 

(c) SAVINGS CLAUSE.—Nothing in this section shall be construed 

as limiting any other authority of the Secretary to require notifications related to a drug under any other provision of this Act or the 

Public Health Service Act. 

(d) DEFINITION.—In this section, the term ‘‘regulated person’’ 

means— 

(1) a person who is required to register under section 510 or 

801(s); 

(2) a wholesale distributor of a drug product; or 

(3) any other person that distributes drugs except a person 

that distributes drugs exclusively for retail sale. 

SEC. 568. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING 

OF TREATMENTS. 

(a) IN GENERAL.—For the purpose of promoting the efficiency of 

and informing the review by the Food and Drug Administration of 

new drugs and biological products for rare diseases and drugs and 

biological products that are genetically targeted, the following shall 

apply: 

(1) CONSULTATION WITH STAKEHOLDERS.—Consistent with 

sections X.C and IX.E.4 of the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 

2017, as referenced in the letters described in section 101(b) of 

the Prescription Drug User Fee Amendments of 2012, the Secretary shall ensure that opportunities exist, at a time the Secretary determines appropriate, for consultations with stakeholders on the topics described in subsection (b). 

(2) CONSULTATION WITH EXTERNAL EXPERTS.— 

(A) IN GENERAL.—The Secretary shall develop and maintain a list of external experts who, because of their special 

expertise, are qualified to provide advice on rare disease 

issues, including topics described in subsection (c). The Secretary may, when appropriate to address a specific regulatory question, consult such external experts on issues related to the review of new drugs and biological products for 

rare diseases and drugs and biological products that are 

genetically targeted, including the topics described in subsection (b), when such consultation is necessary because the 

Secretary lacks the specific scientific, medical, or technical 

expertise necessary for the performance of the Secretary’s 

regulatory responsibilities and the necessary expertise can 

be provided by the external experts. 

(B) EXTERNAL EXPERTS.—For purposes of subparagraph 

(A), external experts are individuals who possess scientific 

or medical training that the Secretary lacks with respect to 

one or more rare diseases. 

(b) TOPICS FOR CONSULTATION.—Topics for consultation pursuant 

to this section may include— 

(1) rare diseases; 

(2) the severity of rare diseases; 

(3) the unmet medical need associated with rare diseases; 


jbell on DSK7SPTVN1PROD with REPORTS
93 

(4) the willingness and ability of individuals with a rare disease to participate in clinical trials; 

(5) an assessment of the benefits and risks of therapies to 

treat rare diseases; 

(6) the general design of clinical trials for rare disease populations and subpopulations; and 

(7) the demographics and the clinical description of patient 

populations. 

(c) CLASSIFICATION AS SPECIAL GOVERNMENT EMPLOYEES.—The 

external experts who are consulted under this section may be considered special government employees, as defined under section 202 of 

title 18, United States Code. 

(d) PROTECTION OF CONFIDENTIAL INFORMATION AND TRADE SECRETS.— 

(1) RULE OF CONSTRUCTION.—Nothing in this section shall be 

construed to alter the protections offered by laws, regulations, 

and policies governing disclosure of confidential commercial or 

trade secret information, and any other information exempt 

from disclosure pursuant to section 552(b) of title 5, United 

States Code, as such provisions would be applied to consultation with individuals and organizations prior to the date of enactment of this section. 

(2) CONSENT REQUIRED FOR DISCLOSURE.—The Secretary 

shall not disclose confidential commercial or trade secret information to an expert consulted under this section without the 

written consent of the sponsor unless the expert is a special government employee (as defined under section 202 of title 18, 

United States Code) or the disclosure is otherwise authorized by 

law. 

(e) OTHER CONSULTATION.—Nothing in this section shall be construed to limit the ability of the Secretary to consult with individuals and organizations as authorized prior to the date of enactment 

of this section. 

(f) NO RIGHT OR OBLIGATION.— 

(1) NO RIGHT TO CONSULTATION.—Nothing in this section 

shall be construed to create a legal right for a consultation on 

any matter or require the Secretary to meet with any particular 

expert or stakeholder. 

(2) NO ALTERING OF GOALS.—Nothing in this section shall be 

construed to alter agreed upon goals and procedures identified 

in the letters described in section 101(b) of the Prescription 

Drug User Fee Amendments of 2012. 

(3) NO CHANGE TO NUMBER OF REVIEW CYCLES.—Nothing in 

this section is intended to increase the number of review cycles 

as in effect before the date of enactment of this section. 

(g) NO DELAY IN PRODUCT REVIEW.—Prior to a consultation with 

an external expert, as described in this section, relating to an investigational new drug application under section 505(i), a new drug 

application under section 505(b), or a biologics license application 

under section 351 of the Public Health Service Act, the Director of 

the Center for Drug Evaluation and Research or the Director of the 

Center for Biologics Evaluation and Research (or appropriate Division Director), as appropriate, shall determine that— 

(1) such consultation will— 


jbell on DSK7SPTVN1PROD with REPORTS
94 

(A) facilitate the Secretary’s ability to complete the Secretary’s review; 

(B) address outstanding deficiencies in the application; 

and 

(C) increase the likelihood of an approval decision in the 

current review cycle; or 

(2) the sponsor authorized such consultation. 

* * * * * * * 

Subchapter G—Medical Gases 

SEC. 575. DEFINITIONS. 

In this subchapter: 

(1) The term ‘‘designated medical gas’’ means any of the following: 

(A) Oxygen that meets the standards set forth in an official compendium. 

(B) Nitrogen that meets the standards set forth in an official compendium. 

(C) Nitrous oxide that meets the standards set forth in an 

official compendium. 

(D) Carbon dioxide that meets the standards set forth in 

an official compendium. 

(E) Helium that meets the standards set forth in an official compendium. 

(F) Carbon monoxide that meets the standards set forth 

in an official compendium. 

(G) Medical air that meets the standards set forth in an 

official compendium. 

(H) Any other medical gas deemed appropriate by the 

Secretary, after taking into account any investigational new 

drug application or investigational new animal drug application for the same medical gas submitted in accordance 

with regulations applicable to such applications in title 21 

of the Code of Federal Regulations, unless any period of exclusivity under section 505(c)(3)(E)(ii) or section 

505(j)(5)(F)(ii), or the extension of any such period under 

section 505A, applicable to such medical gas has not expired. 

(2) The term ‘‘medical gas’’ means a drug that— 

(A) is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and 

(B) is administered as a gas. 

SEC. 576. REGULATION OF MEDICAL GASES. 

(a) CERTIFICATION OF DESIGNATED MEDICAL GASES.— 

(1) SUBMISSION.—Beginning 180 days after the date of enactment of this section, any person may file with the Secretary a 

request for certification of a medical gas as a designated medical gas. Any such request shall contain the following information: 

(A) A description of the medical gas. 

(B) The name and address of the sponsor. 

(C) The name and address of the facility or facilities 

where the medical gas is or will be manufactured. 


jbell on DSK7SPTVN1PROD with REPORTS
95 

(D) Any other information deemed appropriate by the 

Secretary to determine whether the medical gas is a designated medical gas. 

(2) GRANT OF CERTIFICATION.—The certification requested 

under paragraph (1) is deemed to be granted unless, within 60 

days of the filing of such request, the Secretary finds that— 

(A) the medical gas subject to the certification is not a 

designated medical gas; 

(B) the request does not contain the information required 

under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the medical 

gas is a designated medical gas; or 

(C) denying the request is necessary to protect the public 

health. 

(3) EFFECT OF CERTIFICATION.— 

(A) IN GENERAL.— 

(i) APPROVED USES.—A designated medical gas for 

which a certification is granted under paragraph (2) is 

deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases 

for which a certification or certifications have been 

granted, to have in effect an approved application 

under section 505 or 512, subject to all applicable postapproval requirements, for the following indications for 

use: 

(I) In the case of oxygen, the treatment or prevention of hypoxemia or hypoxia. 

(II) In the case of nitrogen, use in hypoxic challenge testing. 

(III) In the case of nitrous oxide, analgesia. 

(IV) In the case of carbon dioxide, use in 

extracorporeal membrane oxygenation therapy or 

respiratory stimulation. 

(V) In the case of helium, the treatment of upper 

airway obstruction or increased airway resistance. 

(VI) In the case of medical air, to reduce the risk 

of hyperoxia. 

(VII) In the case of carbon monoxide, use in lung 

diffusion testing. 

(VIII) Any other indication for use for a designated medical gas or combination of designated 

medical gases deemed appropriate by the Secretary, unless any period of exclusivity under 

clause (iii) or (iv) of section 505(c)(3)(E), clause (iii) 

or (iv) of section 505(j)(5)(F), or section 527, or the 

extension of any such period under section 505A, 

applicable to such indication for use for such gas 

or combination of gases has not expired. 

(ii) LABELING.—The requirements of sections 

503(b)(4) and 502(f) are deemed to have been met for 

a designated medical gas if the labeling on final use 

container for such medical gas bears— 

(I) the information required by section 503(b)(4); 


jbell on DSK7SPTVN1PROD with REPORTS
96 

(II) a warning statement concerning the use of 

the medical gas as determined by the Secretary by 

regulation; and 

(III) appropriate directions and warnings concerning storage and handling. 

(B) INAPPLICABILITY OF EXCLUSIVITY PROVISIONS.— 

(i) NO EXCLUSIVITY FOR A CERTIFIED MEDICAL GAS.— 

No designated medical gas deemed under subparagraph (A)(i) to have in effect an approved application 

is eligible for any period of exclusivity under section 

505(c), 505(j), or 527, or the extension of any such period under section 505A, on the basis of such deemed 

approval. 

(ii) EFFECT ON CERTIFICATION.—No period of exclusivity under section 505(c), 505(j), or section 527, or the 

extension of any such period under section 505A, with 

respect to an application for a drug product shall prohibit, limit, or otherwise affect the submission, grant, 

or effect of a certification under this section, except as 

provided in subsection (a)(3)(A)(i)(VIII) and section 

575(1)(H). 

(4) WITHDRAWAL, SUSPENSION, OR REVOCATION OF APPROVAL.— 

(A) WITHDRAWAL, SUSPENSION OF APPROVAL.—Nothing in 

this subchapter limits the Secretary’s authority to withdraw 

or suspend approval of a drug product, including a designated medical gas deemed under this section to have in 

effect an approved application under section 505 or section 

512 of this Act. 

(B) REVOCATION OF CERTIFICATION.—The Secretary may 

revoke the grant of a certification under paragraph (2) if 

the Secretary determines that the request for certification 

contains any material omission or falsification. 

(b) PRESCRIPTION REQUIREMENT.— 

(1) IN GENERAL.—A designated medical gas shall be subject 

to the requirements of section 503(b)(1) unless the Secretary exercises the authority provided in section 503(b)(3) to remove 

such medical gas from the requirements of section 503(b)(1), the 

gas is approved for use without a prescription pursuant to an 

application under section 505 or 512, or the use in question is 

authorized pursuant to another provision of this Act relating to 

use of medical products in emergencies. 

(2) OXYGEN.— 

(A) NO PRESCRIPTION REQUIRED FOR CERTAIN USES.— 

Notwithstanding paragraph (1), oxygen may be provided 

without a prescription for the following uses: 

(i) For use in the event of depressurization or other 

environmental oxygen deficiency. 

(ii) For oxygen deficiency or for use in emergency resuscitation, when administered by properly trained 

personnel. 

(B) LABELING.—For oxygen provided pursuant to subparagraph (A), the requirements of section 503(b)(4) shall 

be deemed to have been met if its labeling bears a warning 


jbell on DSK7SPTVN1PROD with REPORTS
97 

that the oxygen can be used for emergency use only and for 

all other medical applications a prescription is required. 

SEC. 577. INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL 

GASES. 

A designated medical gas, alone or in combination with another 

designated gas or gases (as medically appropriate) deemed under 

section 576 to have in effect an approved application shall not be 

assessed fees under section 736(a) on the basis of such deemed approval. 

* * * * * * * 

CHAPTER VII—GENERAL AUTHORITY 

SUBCHAPTER A—GENERAL ADMINISTRATIVE PROVISIONS

REGULATIONS AND HEARINGS

SEC. 701. (a) * * * 

* * * * * * * 

(h)(1)(A) * * * 

* * * * * * * 

ø(C) For guidance documents that set forth initial interpretations 

of a statute or regulation, changes in interpretation or policy that 

are of more than a minor nature, complex scientific issues, or highly controversial issues, the Secretary shall ensure public participation prior to implementation of guidance documents, unless the 

Secretary determines that such prior public participation is not feasible or appropriate. In such cases, the Secretary shall provide for 

public comment upon implementation and take such comment into 

account.¿ 

(C) For any guidance document that sets forth initial interpretations of a statute or regulation, sets forth changes 

in interpretation or policy that are of more than a minor 

nature, includes complex scientific issues, or covers highly 

controversial issues— 

(i) the Secretary— 

(I) at least 30 days before issuance of a draft of 

such guidance document, shall publish notice in 

the Federal Register of the Secretary’s intent to 

prepare such guidance document; and 

(II) during preparation and before issuance of 

such guidance document, may meet with interested 

stakeholders, including industry, medical, and scientific experts and others, and solicit public comment; 

(ii) if the Secretary for good cause finds that, with respect to such guidance document, compliance with 

clause (i) is impracticable, unnecessary, or contrary to 

the public interest— 

(I) the Secretary shall publish such finding and 

a brief statement of the reasons for such finding in 

the Federal Register; 

(II) clause (i) shall not apply with respect to such 

guidance document; and 


jbell on DSK7SPTVN1PROD with REPORTS
98 

(III) during a 90-day period beginning not later 

than the date of issuance of the draft of such guidance document, the Secretary may meet with interested stakeholders, including industry, medical, 

and scientific experts and others, and shall solicit 

public comment; 

(iii) beginning on the date of enactment of the Food 

and Drug Administration Reform Act of 2012, upon 

issuance of a draft guidance document under clause (i) 

or (ii), the Secretary shall— 

(I) designate the document as draft or final; and 

(II) not later than 18 months after the close of 

the comment period for such guidance, issue a 

final version of such guidance document in accordance with clauses (i) and (ii); 

(iv) the Secretary may extend the deadline for issuing 

final guidance under clause (iii)(II) by not more than 

180 days upon submission by the Secretary of a notification of such extension in the Federal Register; 

(v) if the Secretary issues a draft guidance document 

and fails to finalize the draft by the deadline determined under clause (iii)(II), as extended under clause 

(iv), the Secretary shall, beginning on the date of such 

deadline, treat the draft as null and void; and 

(vi) not less than every 5 years after the issuance of 

a final guidance document in accordance with clause 

(iii), the Secretary shall— 

(I) conduct a retrospective analysis of such guidance document to ensure it is not outmoded, ineffective, insufficient, or excessively burdensome; and 

(II) based on such analysis, modify, streamline, 

expand, or repeal the guidance document in accordance with what has been learned. 

(D) With respect to devices, a notice to industry guidance 

letter, a notice to industry advisory letter, and any similar 

notice that sets forth initial interpretations of a statute or 

regulation or sets forth changes in interpretation or policy 

shall be treated as a guidance document for purposes of 

subparagraph (C). 

(E) The following shall not be treated as a guidance document for purposes of subparagraph (C): 

(i) Any document that does not set forth an initial interpretation or a reinterpretation of a statute or regulation. 

(ii) Any document that sets forth or changes a policy 

relating to internal procedures of the Food and Drug 

Administration. 

(iii) Agency reports, general information documents 

provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, 

press materials, warning letters, memoranda of understanding, or communications directed to individual 

persons or firms. 

* * * * * * * 


jbell on DSK7SPTVN1PROD with REPORTS
99 

FACTORY INSPECTION

SEC. 704. (a)(1) * * * 

* * * * * * * 

(4)(A) Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug shall, upon the request of the Secretary, be provided to the Secretary by such person, 

in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and 

in either electronic or physical form, at the expense of such person. 

The Secretary’s request shall include a sufficient description of the 

records requested. 

(B) Upon receipt of the records requested under subparagraph (A), 

the Secretary shall provide to the person confirmation of receipt. 

(C) Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this Act in 

order to ensure compliance with this Act. 

* * * * * * * 

(g)(1) * * * 

* * * * * * * 

(11) The authority provided by this subsection terminates on 

øOctober 1, 2012¿ October 1, 2017. 

* * * * * * * 

CONFIDENTIAL INFORMATION

SEC. 708. øThe Secretary may provide¿ (a) CONTRACTORS.—The 

Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United 

States Code, by reason of subsection (b)(4) of such section to a person other than an officer or employee of the Department if the Secretary determines such other person requires the information in 

connection with an activity which is undertaken under contract 

with the Secretary, which relates to the administration of this Act, 

and with respect to which the Secretary (or an officer or employee 

of the Department) is not prohibited from using such information. 

The Secretary shall require as a condition to the provision of information under this section that the person receiving it take such security precautions respecting the information as the Secretary may 

by regulation prescribe. 

(b) ABILITY TO RECEIVE AND PROTECT CONFIDENTIAL INFORMATION.—Except pursuant to an order of a court of the United States, 

the Secretary shall not be required to disclose under section 552 of 

title 5, United States Code, or any other provision of law, any information relating to drugs obtained from a Federal, State, or local 

government agency, or from a foreign government agency, if the 

agency has requested that the information be kept confidential. For 

purposes of section 552 of title 5, United States Code, this subsection shall be considered a statute described in section 

552(b)(3)(B). 

(c) AUTHORITY TO ENTER INTO MEMORANDA OF UNDERSTANDING

FOR PURPOSES OF INFORMATION EXCHANGE.—The Secretary may 


jbell on DSK7SPTVN1PROD with REPORTS
100 

enter into written agreements regarding the exchange of information 

referenced in section 301(j) subject to the following criteria: 

(1) CERTIFICATION.—The Secretary may only enter into written agreements under this subsection with foreign governments 

that the Secretary has certified as having the authority and 

demonstrated ability to protect trade secret information from 

disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner 

of Food and Drugs. 

(2) WRITTEN AGREEMENT.—The written agreement under this 

subsection shall include a commitment by the foreign government to protect information exchanged under this subsection 

from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of 

a public health emergency pursuant to section 319 of the Public 

Health Service Act that is relevant to the information. 

(3) INFORMATION EXCHANGE.—The Secretary may provide to 

a foreign government that has been certified under paragraph 

(1), and that has executed a written agreement under paragraph (2), information referenced in section 301(j) in the following circumstances: 

(A) Information concerning the inspection of a facility 

may be provided if— 

(i) the Secretary reasonably believes, or the written 

agreement described in paragraph (2) establishes, that 

the government has authority to otherwise obtain such 

information; and 

(ii) the written agreement executed under paragraph 

(2) limits the recipient’s use of the information to the 

recipient’s civil regulatory purposes. 

(B) Information not described in subparagraph (A) may 

be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, 

if the Secretary has reasonable grounds to believe that a 

drug has a reasonable probability of causing serious adverse health consequences or death. 

(d) NO LIMITATION ON AUTHORITY.—This section shall not affect 

the authority of the Secretary to provide or disclose information 

under any other provision of law. 

* * * * * * * 

SEC. 712. CONFLICTS OF INTEREST. 

(a) * * * 

ø(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 

ø(1) RECRUITMENT.— 

ø(A) IN GENERAL.—The Secretary shall— 

ø(i) develop and implement strategies on effective 

outreach to potential members of advisory committees 

at universities, colleges, other academic research centers, professional and medical societies, and patient 

and consumer groups; 

ø(ii) seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities; and 


jbell on DSK7SPTVN1PROD with REPORTS
101 

ø(iii) take into account the advisory committees with 

the greatest number of vacancies. 

ø(B) RECRUITMENT ACTIVITIES.—The recruitment activities under subparagraph (A) may include— 

ø(i) advertising the process for becoming an advisory 

committee member at medical and scientific society 

conferences; 

ø(ii) making widely available, including by using existing electronic communications channels, the contact 

information for the Food and Drug Administration 

point of contact regarding advisory committee nominations; and 

ø(iii) developing a method through which an entity 

receiving funding from the National Institutes of 

Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or 

the Veterans Health Administration can identify a 

person who the Food and Drug Administration can 

contact regarding the nomination of individuals to 

serve on advisory committees. 

ø(2) EVALUATION AND CRITERIA.—When considering a term 

appointment to an advisory committee, the Secretary shall review the expertise of the individual and the financial disclosure 

report filed by the individual pursuant to the Ethics in Government Act of 1978 for each individual under consideration for 

the appointment, so as to reduce the likelihood that an appointed individual will later require a written determination as 

referred to in section 208(b)(1) of title 18, United States Code, 

a written certification as referred to in section 208(b)(3) of title 

18, United States Code, or a waiver as referred to in subsection 

(c)(2) of this section for service on the committee at a meeting 

of the committee. 

ø(c) DISCLOSURES; PROHIBITIONS ON PARTICIPATION; WAIVERS.— ø(1) DISCLOSURE OF FINANCIAL INTEREST.—Prior to a meeting 

of an advisory committee regarding a ‘‘particular matter’’ (as 

that term is used in section 208 of title 18, United States 

Code), each member of the committee who is a full-time Government employee or special Government employee shall disclose to the Secretary financial interests in accordance with 

subsection (b) of such section 208. 

ø(2) PROHIBITIONS AND WAIVERS ON PARTICIPATION.— 

ø(A) IN GENERAL.—Except as provided under subparagraph (B), a member of an advisory committee may not 

participate with respect to a particular matter considered 

in an advisory committee meeting if such member (or an 

immediate family member of such member) has a financial 

interest that could be affected by the advice given to the 

Secretary with respect to such matter, excluding interests 

exempted in regulations issued by the Director of the Office of Government Ethics as too remote or inconsequential 

to affect the integrity of the services of the Government officers or employees to which such regulations apply. 

ø(B) WAIVER.—If the Secretary determines it necessary 

to afford the advisory committee essential expertise, the 

Secretary may grant a waiver of the prohibition in subVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00101 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
102 

paragraph (A) to permit a member described in such subparagraph to— 

ø(i) participate as a non-voting member with respect 

to a particular matter considered in a committee meeting; or 

ø(ii) participate as a voting member with respect to 

a particular matter considered in a committee meeting. 

ø(C) LIMITATION ON WAIVERS AND OTHER EXCEPTIONS.— 

ø(i) DEFINITION.—For purposes of this subparagraph, the term ‘‘exception’’ means each of the following with respect to members of advisory committees: 

ø(I) A waiver under section 505(n)(4) (as in effect on the day before the date of the enactment 

of the Food and Drug Administration Amendments Act of 2007). 

ø(II) A written determination under section 

208(b) of title 18, United States Code. 

ø(III) A written certification under section 

208(b)(3) of such title. 

ø(ii) DETERMINATION OF TOTAL NUMBER OF MEMBERS

SLOTS AND MEMBER EXCEPTIONS DURING FISCAL YEAR

2007.—The Secretary shall determine— 

ø(I)(aa) for each meeting held by any advisory 

committee during fiscal year 2007, the number of 

members who participated in the meeting; and 

ø(bb) the sum of the respective numbers determined under item (aa) (referred to in this subparagraph as the ‘‘total number of 2007 meeting 

slots’’); and 

ø(II)(aa) for each meeting held by any advisory 

committee during fiscal year 2007, the number of 

members who received an exception for the meeting; and 

ø(bb) the sum of the respective numbers determined under item (aa) (referred to in this subparagraph as the ‘‘total number of 2007 meeting 

exceptions’’). 

ø(iii) DETERMINATION OF PERCENTAGE REGARDING

EXCEPTIONS DURING FISCAL YEAR 2007.—The Secretary 

shall determine the percentage constituted by— 

ø(I) the total number of 2007 meeting exceptions; divided by 

ø(II) the total number of 2007 meeting slots. 

ø(iv) LIMITATION FOR FISCAL YEARS 2008 THROUGH

2012.—The number of exceptions at the Food and Drug 

Administration for members of advisory committees 

for a fiscal year may not exceed the following: 

ø(I) For fiscal year 2008, 95 percent of the percentage determined under clause (iii) (referred to 

in this clause as the ‘‘base percentage’’). 

ø(II) For fiscal year 2009, 90 percent of the base 

percentage. 


jbell on DSK7SPTVN1PROD with REPORTS
103 

ø(III) For fiscal year 2010, 85 percent of the 

base percentage. 

ø(IV) For fiscal year 2011, 80 percent of the 

base percentage. 

ø(V) For fiscal year 2012, 75 percent of the base 

percentage. 

ø(v) ALLOCATION OF EXCEPTIONS.—The exceptions 

authorized under clause (iv) for a fiscal year may be 

allocated within the centers or other organizational 

units of the Food and Drug Administration as determined appropriate by the Secretary. 

ø(3) DISCLOSURE OF WAIVER.—Notwithstanding section 

107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the 

following shall apply: 

ø(A) 15 OR MORE DAYS IN ADVANCE.—As soon as practicable, but (except as provided in subparagraph (B)) not 

later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in 

section 208(b)(1) of title 18, United States Code, a written 

certification as referred to in section 208(b)(3) of title 18, 

United States Code, or a waiver as referred to in paragraph (2)(B) applies, the Secretary shall disclose (other 

than information exempted from disclosure under section 

552 of title 5, United States Code, and section 552a of title 

5, United States Code (popularly known as the Freedom of 

Information Act and the Privacy Act of 1974, respectively)) 

on the Internet Web site of the Food and Drug Administration— 

ø(i) the type, nature, and magnitude of the financial 

interests of the advisory committee member to which 

such determination, certification, or waiver applies; 

and 

ø(ii) the reasons of the Secretary for such determination, certification, or waiver. 

ø(B) LESS THAN 30 DAYS IN ADVANCE.—In the case of a 

financial interest that becomes known to the Secretary less 

than 30 days prior to a meeting of an advisory committee 

to which a written determination as referred to in section 

208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United 

States Code, or a waiver as referred to in paragraph (2)(B) 

applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, 

United States Code, and section 552a of title 5, United 

States Code) on the Internet Web site of the Food and 

Drug Administration, the information described in clauses 

(i) and (ii) of subparagraph (A) as soon as practicable after 

the Secretary makes such determination, certification, or 

waiver, but in no case later than the date of such meeting.¿ 

(b) RECRUITMENT FOR ADVISORY COMMITTEES.— 

(1) IN GENERAL.—The Secretary shall— 

(A) develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, profesVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00103 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
104 

sional and medical societies, and patient and consumer 

groups; 

(B) seek input from professional medical and scientific 

societies to determine the most effective informational and 

recruitment activities; 

(C) at least every 180 days, request referrals for potential 

members of advisory committees from a variety of stakeholders, including— 

(i) product developers, patient groups, and disease 

advocacy organizations; and 

(ii) relevant— 

(I) professional societies; 

(II) medical societies; 

(III) academic organizations; and 

(IV) governmental organizations; and 

(D) in carrying out subparagraphs (A) and (B), take into 

account the levels of activity (including the numbers of annual meetings) and the numbers of vacancies of the advisory committees. 

(2) RECRUITMENT ACTIVITIES.—The recruitment activities 

under paragraph (1) may include— 

(A) advertising the process for becoming an advisory committee member at medical and scientific society conferences; 

(B) making widely available, including by using existing 

electronic communications channels, the contact information for the Food and Drug Administration point of contact 

regarding advisory committee nominations; and 

(C) developing a method through which an entity receiving funding from the National Institutes of Health, the 

Agency for Healthcare Research and Quality, the Centers 

for Disease Control and Prevention, or the Veterans Health 

Administration can identify a person whom the Food and 

Drug Administration can contact regarding the nomination 

of individuals to serve on advisory committees. 

(3) EXPERTISE.—In carrying out this subsection, the Secretary 

shall seek to ensure that the Secretary has access to the most 

current expert advice. 

(c) DISCLOSURE OF DETERMINATIONS AND CERTIFICATIONS.—Notwithstanding section 107(a)(2) of the Ethics in Government Act of 

1978, the following shall apply: 

(1) 15 OR MORE DAYS IN ADVANCE.—As soon as practicable, 

but (except as provided in paragraph (2)) not later than 15 days 

prior to a meeting of an advisory committee to which a written 

determination as referred to in section 208(b)(1) of title 18, 

United States Code, or a written certification as referred to in 

section 208(b)(3) of such title, applies, the Secretary shall disclose (other than information exempted from disclosure under 

section 552 or section 552a of title 5, United States Code (popularly known as the Freedom of Information Act and the Privacy 

Act of 1974, respectively)) on the Internet Website of the Food 

and Drug Administration— 

(A) the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination or certification applies; and 


jbell on DSK7SPTVN1PROD with REPORTS
105 

(B) the reasons of the Secretary for such determination or 

certification, including, as appropriate, the public health 

interest in having the expertise of the member with respect 

to the particular matter before the advisory committee. 

(2) LESS THAN 30 DAYS IN ADVANCE.—In the case of a financial interest that becomes known to the Secretary less than 30 

days prior to a meeting of an advisory committee to which a 

written determination as referred to in section 208(b)(1) of title 

18, United States Code, or a written certification as referred to 

in section 208(b)(3) of such title applies, the Secretary shall disclose (other than information exempted from disclosure under 

section 552 or 552a of title 5, United States Code) on the Internet Website of the Food and Drug Administration, the information described in subparagraphs (A), (B), and (C) of paragraph 

(1) as soon as practicable after the Secretary makes such determination or certification, but in no case later than the date of 

such meeting. 

(d) PUBLIC RECORD.—The Secretary shall ensure that the public 

record and transcript of each meeting of an advisory committee includes the disclosure required under øsubsection (c)(3)¿ subsection 

(c) (other than information exempted from disclosure under section 

552 of title 5, United States Code, and section 552a of title 5, 

United States Code). 

ø(e) ANNUAL REPORT.—Not later than February 1 of each year, 

the Secretary shall submit to the Committee on Appropriations and 

the Committee on Health, Education, Labor, and Pensions of the 

Senate, and the Committee on Appropriations and the Committee 

on Energy and Commerce of the House of Representatives a report 

that describes— 

ø(1) with respect to the fiscal year that ended on September 

30 of the previous year, the number of vacancies on each advisory committee, the number of nominees received for each committee, and the number of such nominees willing to serve; 

ø(2) with respect to such year, the aggregate number of disclosures required under subsection (c)(3) for each meeting of 

each advisory committee and the percentage of individuals to 

whom such disclosures did not apply who served on such committee for each such meeting; 

ø(3) with respect to such year, the number of times the disclosures required under subsection (c)(3) occurred under subparagraph (B) of such subsection; and 

ø(4) how the Secretary plans to reduce the number of vacancies reported under paragraph (1) during the fiscal year following such year, and mechanisms to encourage the nomination of individuals for service on an advisory committee, including those who are classified by the Food and Drug Administration as academicians or practitioners.¿ 

(e) ANNUAL REPORT.— 

(1) IN GENERAL.—Not later than February 1 of each year, the 

Secretary shall submit to the Committee on Appropriations and 

the Committee on Health, Education, Labor, and Pensions of 

the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives, a report that describes— 


jbell on DSK7SPTVN1PROD with REPORTS
106 

(A) with respect to the fiscal year that ended on September 30 of the previous year, the number of persons nominated for participation at meetings for each advisory committee, the number of persons so nominated, and willing to 

serve, the number of vacancies on each advisory committee, 

and the number of persons contacted for service as members on each advisory committee meeting for each advisory 

committee who did not participate because of the potential 

for such participation to constitute a disqualifying financial interest under section 208 of title 18, United States 

Code; 

(B) with respect to such year, the number of persons contacted for services as members for each advisory committee 

meeting for each advisory committee who did not participate because of reasons other than the potential for such 

participation to constitute a disqualifying financial interest 

under section 208 of title 18, United States Code; 

(C) with respect to such year, the number of members attending meetings for each advisory committee; and 

(D) with respect to such year, the aggregate number of 

disclosures required under subsection (d) and the percentage of individuals to whom such disclosures did not apply 

who served on such committee. 

(2) PUBLIC AVAILABILITY.—Not later than 30 days after submitting any report under paragraph (1) to the committees specified in such paragraph, the Secretary shall make each such report available to the public. 

(f) PERIODIC REVIEW OF GUIDANCE.—Not less than once every 5 

years, the Secretary øshall review guidance of the Food and Drug 

Administration regarding conflict of interest waiver determinations 

with respect to advisory committees and update such guidance as 

necessary.¿ shall— 

(1) review guidance of the Food and Drug Administration 

with respect to advisory committees regarding disclosure of conflicts of interest and the application of section 208 of title 18, 

United States Code; and 

(2) update such guidance as necessary to ensure that the Food 

and Drug Administration receives appropriate access to needed 

scientific expertise, with due consideration of the requirements 

of such section 208. 

* * * * * * * 

SEC. 714. STREAMLINED HIRING AUTHORITY. 

(a) IN GENERAL.—In addition to any other personnel authorities 

under other provisions of law, the Secretary may, without regard to 

the provisions of title 5, United States Code, governing appointments in the competitive service, appoint employees to positions in 

the Food and Drug Administration to perform, administer, or support activities described in subsection (b), if the Secretary determines that such appointments are needed to achieve the objectives 

specified in subsection (c). 

(b) ACTIVITIES DESCRIBED.—The activities described in this subsection are— 

(1) activities under this Act related to the process for the review of device applications (as defined in section 737(8)); and 


jbell on DSK7SPTVN1PROD with REPORTS
107 

(2) activities under this Act related to human generic drug activities (as defined in section 744A). 

(c) OBJECTIVES SPECIFIED.—The objectives specified in this subsection are— 

(1) with respect to the activities under subsection (b)(1), the 

goals referred to in section 738A(a)(1); and 

(2) with respect to the activities under subsection (b)(2), the 

goals referred to in section 744C(a). 

(d) INTERNAL CONTROLS.—The Secretary shall institute appropriate internal controls for appointments under this section. 

(e) SUNSET.—The authority to appoint employees under this section shall terminate on the date that is three years after the date 

of enactment of this section. 

* * * * * * * 

SUBCHAPTER C—FEES

* * * * * * * 

PART 2—FEES RELATING TO DRUGS 

SEC. 735. DEFINITIONS. 

For purposes of this part: 

(1) The term ‘‘human drug application’’ means an application 

for— 

(A) * * * 

(B) licensure of a biological product under subsection (a) 

øor (k)¿ of section 351 of the Public Health Service Act. 

* * * * * * * 

(7) The term ‘‘costs of resources allocated for the process for 

the review of human drug applications’’ means the øexpenses 

incurred in connection with¿ expenses in connection with the 

process for the review of human drug applications for— 

(A) * * * 

* * * * * * * 

SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES. 

(a) TYPES OF FEES.—Beginning in øfiscal year 2008¿ fiscal year 

2013, the Secretary shall assess and collect fees in accordance with 

this section as follows: 

(1) HUMAN DRUG APPLICATION AND SUPPLEMENT FEE.— 

(A) IN GENERAL.—Each person that submits, on or after 

September 1, 1992, a human drug application or a supplement shall be subject to a fee as follows: 

(i) A fee established under subsection ø(c)(5)¿ (c)(4) 

for a human drug application for which clinical data 

(other than bioavailability or bioequivalence studies) 

with respect to safety or effectiveness are required for 

approval. 

(ii) A fee established under subsection ø(c)(5)¿ (c)(4) 

for a human drug application for which clinical data 

with respect to safety or effectiveness are not required 

or a supplement for which clinical data (other than 

bioavailability or bioequivalence studies) with respect 


jbell on DSK7SPTVN1PROD with REPORTS
108 

to safety or effectiveness are required. Such fee shall 

be half of the amount of the fee established under 

clause (i). 

* * * * * * * 

(2) PRESCRIPTION DRUG ESTABLISHMENT FEE.— (A) IN GENERAL.—Except as provided in subparagraphs 

(B) and (C), each person that— 

(i) is named as the applicant in a human drug application; and 

(ii) after September 1, 1992, had pending before the 

Secretary a human drug application or supplement, 

shall be assessed an annual fee established under subsection ø(c)(5)¿ (c)(4) for each prescription drug establishment listed in its approved human drug application as an 

establishment that manufactures the prescription drug 

product named in the application. The annual establishment fee shall be assessed in each fiscal year in which the 

prescription drug product named in the application is assessed a fee under paragraph (3) unless the prescription 

drug establishment listed in the application does not engage in the manufacture of the prescription drug product 

during the fiscal year. The establishment fee shall be 

øpayable on or before October 1 of each year¿ due on the 

later of the first business day on or after October 1 of such 

fiscal year or the first business day after the enactment of 

an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Each 

such establishment shall be assessed only one fee per establishment, notwithstanding the number of prescription 

drug products manufactured at the establishment. In the 

event an establishment is listed in a human drug application by more than one applicant, the establishment fee for 

the fiscal year shall be divided equally and assessed 

among the applicants whose prescription drug products are 

manufactured by the establishment during the fiscal year 

and assessed product fees under paragraph (3). 

* * * * * * * 

(3) PRESCRIPTION DRUG PRODUCT FEE.— 

(A) IN GENERAL.—Except as provided in subparagraph 

(B), each person who is named as the applicant in a 

human drug application, and who, after September 1, 

1992, had pending before the Secretary a human drug application or supplement, shall pay for each such prescription drug product the annual fee established under øsubsection (c)(5)¿ subsection (c)(4). Such fee shall be øpayable 

on or before October 1 of each year.¿ due on the later of 

the first business day on or after October 1 of each such fiscal year or the first business day after the enactment of an 

appropriations Act providing for the collection and obligation of fees for each such fiscal year under this section. 

Such fee shall be paid only once for each product for a fiscal year in which the fee is payable. 

ø(B) EXCEPTION.—A prescription drug product shall not 

be assessed a fee under subparagraph (A) if such product 


jbell on DSK7SPTVN1PROD with REPORTS
109 

is identified on the list compiled under section 505(j)(7)(A) 

with a potency described in terms of per 100 mL, or if such 

product is the same product as another product approved 

under an application filed under section 505(b) or 505(j), 

under an abbreviated application filed under section 507 

(as in effect on the day before the date of enactment of the 

Food and Drug Administration Modernization Act of 1997), 

or under an abbreviated new drug application pursuant to 

regulations in effect prior to the implementation of the 

Drug Price Competition and Patent Term Restoration Act 

of 1984.¿ 

(B) EXCEPTION.—A prescription drug product shall not be 

assessed a fee under subparagraph (A) if such product is— 

(i) identified on the list compiled under section 

505(j)(7)(A) with a potency described in terms of per 

100 mL; 

(ii) the same product as another product that— 

(I) was approved under an application filed 

under section 505(b) or 505(j); and 

(II) is not in the list of discontinued products 

compiled under section 505(j)(7)(A); 

(iii) the same product as another product that was 

approved under an abbreviated application filed under 

section 507 (as in effect on the day before the date of 

enactment of the Food and Drug Administration Modernization Act of 1997); or 

(iv) the same product as another product that was 

approved under an abbreviated new drug application 

pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term 

Restoration Act of 1984. 

(b) FEE REVENUE AMOUNTS.— (1) IN GENERAL.—For each of the øfiscal years 2008 through 

2012¿ fiscal years 2013 through 2017, fees under subsection (a) 

shall, except as provided in subsections (c), (d), (f), and (g), be 

established to generate a total revenue amount under such 

subsection that is equal to the sum of— 

(A) ø$392,783,000; and¿ $693,099,000; 

ƒ(B) an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)).≈ 

(B) the dollar amount equal to the inflation adjustment 

for fiscal year 2013 (as determined under paragraph 

(3)(A)); and 

(C) the dollar amount equal to the workload adjustment 

for fiscal year 2013 (as determined under paragraph 

(3)(B)). 

* * * * * * * 

ø(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL

YEAR 2007.—For purposes of paragraph (1)(B), the Secretary 

shall determine the modified workload adjustment factor by 

determining the dollar amount that results from applying the 

methodology that was in effect under subsection (c)(2) for fiscal 

year 2007 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the 


jbell on DSK7SPTVN1PROD with REPORTS
110 

change in the total number of commercial investigational new 

drug applications, the Secretary shall count the number of 

such applications that were active during the most recent 12- 

month period for which data on such submissions is available. 

ø(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY.— ø(A) IN GENERAL.—For each of the fiscal years 2008 

through 2012, paragraph (1)(A) shall be applied by substituting the amount determined under subparagraph (B) 

for ‘‘$392,783,000’’. 

ø(B) AMOUNT DETERMINED.—For each of the fiscal years 

2008 through 2012, the amount determined under this 

subparagraph is the sum of— 

ø(i) $392,783,000; plus 

ø(ii)(I) for fiscal year 2008, $25,000,000; 

ø(II) for fiscal year 2009, $35,000,000; 

ø(III) for fiscal year 2010, $45,000,000; 

ø(IV) for fiscal year 2011, $55,000,000; and 

ø(V) for fiscal year 2012, $65,000,000. 

ø(c) ADJUSTMENTS.— ø(1) INFLATION ADJUSTMENT.—For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b) 

shall be adjusted by the Secretary by notice, published in the 

Federal Register, for a fiscal year to reflect the greater of— 

ø(A) the total percentage change that occurred in the 

Consumer Price Index for all urban consumers (all items; 

U.S. city average) for the 12 month period ending June 30 

preceding the fiscal year for which fees are being established, 

ø(B) the total percentage change for the previous fiscal 

year in basic pay under the General Schedule in accordance with section 5332 of title 5, United States Code, as 

adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees 

stationed in the District of Columbia, or 

ø(C) the average annual change in the cost, per full-time 

equivalent position of the Food and Drug Administration, 

of all personnel compensation and benefits paid with respect to such positions for the first 5 years of the preceding 

6 fiscal years. 

The adjustment made each fiscal year by this subsection will 

be added on a compounded basis to the sum of all adjustments 

made each fiscal year after fiscal year 2008 under this subsection. 

ø(2) WORKLOAD ADJUSTMENT.—For fiscal year 2009 and subsequent fiscal years, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted 

further for such fiscal year to reflect changes in the workload 

of the Secretary for the process for the review of human drug 

applications. With respect to such adjustment: 

ø(A) The adjustment shall be determined by the Secretary based on a weighted average of the change in the 

total number of human drug applications (adjusted for 

changes in review activities, as described in the notice that 

the Secretary is required to publish in the Federal RegVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00110 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
111 

ister under this subparagraph), efficacy supplements, and 

manufacturing supplements submitted to the Secretary, 

and the change in the total number of active commercial 

investigational new drug applications (adjusted for 

changes in review activities, as so described) during the 

most recent 12-month period for which data on such submissions is available. The Secretary shall publish in the 

Federal Register the fee revenues and fees resulting from 

the adjustment and the supporting methodologies. 

ø(B) Under no circumstances shall the adjustment result 

in fee revenues for a fiscal year that are less than the fee 

revenues for the fiscal year established in subsection (b), 

as adjusted for inflation under paragraph (1). Any adjustment for changes in review activities made in setting fees 

and revenue amounts for fiscal year 2009 may not result 

in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities. 

ø(C) The Secretary shall contract with an independent 

accounting firm to study the adjustment for changes in review activities applied in setting fees and revenue amounts 

for fiscal year 2009 and to make recommendations, if warranted, for future changes in the methodology for calculating the adjustment. After review of the recommendations, the Secretary shall, if warranted, make appropriate 

changes to the methodology, and the changes shall be effective for each of the fiscal years 2010 through 2012. The 

Secretary shall not make any adjustment for changes in 

review activities for any fiscal year after 2009 unless such 

study has been completed. 

ø(3) RENT AND RENT-RELATED COST ADJUSTMENT.—For fiscal 

year 2010 and each subsequent fiscal year, the Secretary shall, 

before making adjustments under paragraphs (1) and (2), decrease the fee revenue amount established in subsection (b) if 

actual costs paid for rent and rent-related expenses for the preceding fiscal year are less than estimates made for such year 

in fiscal year 2006. Any reduction made under this paragraph 

shall not exceed the amount by which such costs fall below the 

estimates made in fiscal year 2006 for such fiscal year, and 

shall not exceed $11,721,000 for any fiscal year. 

ø(4) FINAL YEAR ADJUSTMENT.— 

ø(A) INCREASE IN FEES.—For fiscal year 2012, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), further increase the 

fee revenues and fees established in subsection (b) if such 

an adjustment is necessary to provide for not more than 3 

months of operating reserves of carryover user fees for the 

process for the review of human drug applications for the 

first 3 months of fiscal year 2013. If such an adjustment 

is necessary, the rationale for the amount of the increase 

shall be contained in the annual notice establishing fee 

revenues and fees for fiscal year 2012. If the Secretary has 

carryover balances for such process in excess of 3 months 

of such operating reserves, the adjustment under this subparagraph shall not be made. 


jbell on DSK7SPTVN1PROD with REPORTS
112 

ø(B) DECREASE IN FEES.— 

ø(i) IN GENERAL.—For fiscal year 2012, the Secretary may, in addition to adjustments under this 

paragraph and paragraphs (1), (2), and (3), decrease 

the fee revenues and fees established in subsection (b) 

by the amount determined in clause (ii), if, for fiscal 

year 2009 or 2010— 

ø(I) the amount of the total appropriations for 

the Food and Drug Administration for such fiscal 

year (excluding the amount of fees appropriated 

for such fiscal year) exceeds the amount of the 

total appropriations for the Food and Drug Administration for fiscal year 2008 (excluding the 

amount of fees appropriated for such fiscal year), 

adjusted as provided under paragraph (1); and 

ø(II) the amount of the total appropriations expended for the process for the review of human 

drug applications at the Food and Drug Administration for such fiscal year (excluding the amount 

of fees appropriated for such fiscal year) exceeds 

the amount of appropriations expended for the 

process for the review of human drug applications 

at the Food and Drug Administration for fiscal 

year 2008 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided 

under paragraph (1). 

ø(ii) AMOUNT OF DECREASE.—The amount determined in this clause is the lesser of— 

ø(I) the amount equal to the sum of the 

amounts that, for each of fiscal years 2009 and 

2010, is the lesser of— 

ø(aa) the excess amount described in clause 

(i)(II) for such fiscal year; or 

ø(bb) the amount specified in subsection 

(b)(4)(B)(ii) for such fiscal year; or 

ø(II) $65,000,000. 

ø(iii) LIMITATIONS.— 

ø(I) FISCAL YEAR CONDITION.—In making the determination under clause (ii), an amount described 

in subclause (I) of such clause for fiscal year 2009 

or 2010 shall be taken into account only if subclauses (I) and (II) of clause (i) apply to such fiscal 

year. 

ø(II) RELATION TO SUBPARAGRAPH (A).—The Secretary shall limit any decrease under this paragraph if such a limitation is necessary to provide 

for the 3 months of operating reserves described 

in subparagraph (A). 

ø(5) ANNUAL FEE SETTING.—The Secretary shall, 60 days before the start of each fiscal year that begins after September 

30, 2007, establish, for the next fiscal year, application, product, and establishment fees under subsection (a), based on the 

revenue amounts established under subsection (b) and the adjustments provided under this subsection. 


jbell on DSK7SPTVN1PROD with REPORTS
113 

ø(6) LIMIT.—The total amount of fees charged, as adjusted 

under this subsection, for a fiscal year may not exceed the total 

costs for such fiscal year for the resources allocated for the 

process for the review of human drug applications.¿ 

(3) FISCAL YEAR 2013 INFLATION AND WORKLOAD ADJUST- MENTS.—For purposes of paragraph (1), the dollar amount of 

the inflation and workload adjustments for fiscal year 2013 

shall be determined as follows: 

(A) INFLATION ADJUSTMENT.—The inflation adjustment 

for fiscal year 2013 shall be the sum of— (i) $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the 

methodology described in subsection (c)(1)(B); and (ii) $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the 

methodology described in subsection (c)(1)(C). 

(B) WORKLOAD ADJUSTMENT.—Subject to subparagraph 

(C), the workload adjustment for fiscal 2013 shall be— (i) $652,709,000 plus the amount of the inflation adjustment calculated under subparagraph (A); multiplied by 

(ii) the amount (if any) by which a percentage workload adjustment for fiscal year 2013, as determined 

using the methodology described in subsection (c)(2)(A), 

would exceed the percentage workload adjustment (as 

so determined) for fiscal year 2012, if both such adjustment percentages were calculated using the 5-year base 

period consisting of fiscal years 2003 through 2007. 

(C) LIMITATION.—Under no circumstances shall the adjustment under subparagraph (B) result in fee revenues for 

fiscal year 2013 that are less than the sum of the amount 

under paragraph (1)(A) and the amount under paragraph 

(1)(B). 

(c) ADJUSTMENTS.— 

(1) INFLATION ADJUSTMENT.—For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection (b) 

shall be adjusted by the Secretary by notice, published in the 

Federal Register, for a fiscal year by the amount equal to the 

sum of— 

(A) one; 

(B) the average annual percent change in the cost, per 

full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid 

with respect to such positions for the first 3 years of the 

preceding 4 fiscal years, multiplied by the proportion of 

personnel compensation and benefits costs to total costs of 

the process for the review of human drug applications (as 

defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years, and 

(C) the average annual percent change that occurred in 

the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the 

preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and 


jbell on DSK7SPTVN1PROD with REPORTS
114 

benefits costs to total costs of the process for the review of 

human drug applications (as defined in section 735(6)) for 

the first 3 years of the preceding 4 fiscal years. 

The adjustment made each fiscal year under this paragraph 

shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this 

paragraph. 

(2) WORKLOAD ADJUSTMENT.—For fiscal year 2014 and subsequent fiscal years, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of 

the Secretary for the process for the review of human drug applications. With respect to such adjustment: 

(A) The adjustment shall be determined by the Secretary 

based on a weighted average of the change in the total 

number of human drug applications (adjusted for changes 

in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under 

this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the 

change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12- 

month period for which data on such submissions is available. The Secretary shall publish in the Federal Register 

the fee revenues and fees resulting from the adjustment and 

the supporting methodologies. 

(B) Under no circumstances shall the adjustment result 

in fee revenues for a fiscal year that are less than the sum 

of the amount under subsection (b)(1)(A) and the amount 

under subsection (b)(1)(B), as adjusted for inflation under 

paragraph (1). 

(C) The Secretary shall contract with an independent accounting or consulting firm to periodically review the adequacy of the adjustment and publish the results of those reviews. The first review shall be conducted and published by 

the end of fiscal year 2013 (to examine the performance of 

the adjustment since fiscal year 2009), and the second review shall be conducted and published by the end of fiscal 

year 2015 (to examine the continued performance of the adjustment). The reports shall evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity and present options to discontinue, retain, or modify any elements of the adjustment. The reports 

shall be published for public comment. After review of the 

reports and receipt of public comments, the Secretary shall, 

if warranted, adopt appropriate changes to the methodology. If the Secretary adopts changes to the methodology 

based on the first report, the changes shall be effective for 

the first fiscal year for which fees are set after the Secretary 

adopts such changes and each subsequent fiscal year. 

(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2017, the Secretary may, in addition to adjustments under this paragraph 

and paragraphs (1) and (2), further increase the fee revenues 


jbell on DSK7SPTVN1PROD with REPORTS
115 

and fees established in subsection (b) if such an adjustment is 

necessary to provide for not more than 3 months of operating 

reserves of carryover user fees for the process for the review of 

human drug applications for the first 3 months of fiscal year 

2018. If such an adjustment is necessary, the rationale for the 

amount of the increase shall be contained in the annual notice 

establishing fee revenues and fees for fiscal year 2017. If the 

Secretary has carryover balances for such process in excess of 

3 months of such operating reserves, the adjustment under this 

subparagraph shall not be made. 

(4) ANNUAL FEE SETTING.—The Secretary shall, not later than 

60 days before the start of each fiscal year that begins after September 30, 2012, establish, for the next fiscal year, application, 

product, and establishment fees under subsection (a), based on 

the revenue amounts established under subsection (b) and the 

adjustments provided under this subsection. 

(5) LIMIT.—The total amount of fees charged, as adjusted 

under this subsection, for a fiscal year may not exceed the total 

costs for such fiscal year for the resources allocated for the process for the review of human drug applications. 

* * * * * * * 

(g) CREDITING AND AVAILABILITY OF FEES.— (1) IN GENERAL.—øFees authorized¿ Subject to paragraph 

(2)(C), fees authorized under subsection (a) shall be collected 

and available for obligation only to the extent and in the 

amount provided in advance in appropriations Acts. Such fees 

are authorized to remain available until expended. Such sums 

as may be necessary may be transferred from the Food and 

Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the 

process for the review of human drug applications. 

(2) COLLECTIONS AND APPROPRIATION ACTS.— 

(A) IN GENERAL.—The fees authorized by this section— 

(i) øshall be retained¿ shall be collected and available in each fiscal year in an amount not to exceed the 

amount specified in appropriation Acts, or otherwise 

made available for obligation, for such fiscal year, and 

(ii) øshall only be collected and available¿ shall be 

available to defray increases in the costs of the resources allocated for the process for the review of 

human drug applications (including increases in such 

costs for an additional number of full-time equivalent 

positions in the Department of Health and Human 

Services to be engaged in such process) over such 

costs, excluding costs paid from fees collected under 

this section, for fiscal year 1997 multiplied by the adjustment factor. 

* * * * * * * 

(C) PROVISION FOR EARLY PAYMENTS.—Payment of fees 

authorized under this section for a fiscal year, prior to the 

due date for such fees, may be accepted by the Secretary in 


jbell on DSK7SPTVN1PROD with REPORTS
116 

accordance with authority provided in advance in a prior 

year appropriations Act. 

(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 

øfiscal years 2008 through 2012¿ fiscal years 2013 through 

2017, there is authorized to be appropriated for fees under this 

section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or 

otherwise affected under subsection (c) and paragraph (4) of 

this subsection. 

(4) OFFSET.—If the sum of the cumulative amount of fees collected under this section for the øfiscal years 2008 through 

2010¿ fiscal years 2013 through 2015 and the amount of fees 

estimated to be collected under this section for øfiscal year 

2011¿ fiscal year 2016 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2008 through 

2011, the excess shall be credited to the appropriation account 

of the Food and Drug Administration as provided in paragraph 

(1), and shall be subtracted from the amount of fees that would 

otherwise be authorized to be collected under this section pursuant to appropriation Acts for øfiscal year 2012¿ fiscal year 

2017. 

* * * * * * * 

[Effective October 1, 2017, section 105(a) of H.R. 5651 provides for a repeal of 

sections 735 and 736 (as amended by the bill).] 

øSEC. 735. DEFINITIONS. 

øFor purposes of this part: 

ø(1) The term ‘‘human drug application’’ means an application for— 

ø(A) approval of a new drug submitted under section 

505(b), or 

ø(B) licensure of a biological product under subsection 

(a) of section 351 of the Public Health Service Act. 

Such term does not include a supplement to such an application, does not include an application with respect to whole 

blood or a blood component for transfusion, does not include an 

application with respect to a bovine blood product for topical 

application licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic biologic product licensed 

under section 351 of the Public Health Service Act, does not include an application with respect to a large volume parenteral 

drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for 

further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. 

Such term does include an application for licensure, as described in subparagraph (B), of a large volume biological product intended for single dose injection for intravenous use or infusion. 

ø(2) The term ‘‘supplement’’ means a request to the Secretary to approve a change in a human drug application which 

has been approved. 

ø(3) The term ‘‘prescription drug product’’ means a specific 

strength or potency of a drug in final dosage form— 


jbell on DSK7SPTVN1PROD with REPORTS
117 

ø(A) for which a human drug application has been approved, 

ø(B) which may be dispensed only under prescription 

pursuant to section 503(b), and 

ø(C) which is on the list of products described in section 

505(j)(7)(A) (not including the discontinued section of such 

list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 351 of the Public Health Service Act 

(not including the discontinued section of such list). 

Such term does not include whole blood or a blood component 

for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic biologic product 

licensed under section 351 of the Public Health Service Act. 

Such term does not include a biological product that is licensed 

for further manufacturing use only, and does not include a 

drug that is not distributed commercially and is the subject of 

an application or supplement submitted by a State or Federal 

Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion. 

ø(4) The term ‘‘final dosage form’’ means, with respect to a 

prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized 

products before reconstitution). 

ø(5) The term ‘‘prescription drug establishment’’ means a foreign or domestic place of business which is at one general 

physical location consisting of one or more buildings all of 

which are within five miles of each other and at which one or 

more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term ‘‘manufactured’’ does not include packaging. 

ø(6) The term ‘‘process for the review of human drug applications’’ means the following activities of the Secretary with respect to the review of human drug applications and supplements: 

ø(A) The activities necessary for the review of human 

drug applications and supplements. 

ø(B) The issuance of action letters which approve human 

drug applications or which set forth in detail the specific 

deficiencies in such applications and, where appropriate, 

the actions necessary to place such applications in condition for approval. 

ø(C) The inspection of prescription drug establishments 

and other facilities undertaken as part of the Secretary’s 

review of pending human drug applications and supplements. 

ø(D) Activities necessary for the review of applications 

for licensure of establishments subject to section 351 of the 

Public Health Service Act and for the release of lots of biologics under such section. 

ø(E) Monitoring of research conducted in connection with 

the review of human drug applications. 


jbell on DSK7SPTVN1PROD with REPORTS
118 

ø(F) Postmarket safety activities with respect to drugs 

approved under human drug applications or supplements, 

including the following activities: 

ø(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event 

reports. 

ø(ii) Developing and using improved adverse-event 

data-collection systems, including information technology systems. 

ø(iii) Developing and using improved analytical tools 

to assess potential safety problems, including access to 

external data bases. 

ø(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and 

labeling changes) and section 505(p) (relating to risk 

evaluation and mitigation strategies). 

ø(v) Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activities). 

ø(7) The term ‘‘costs of resources allocated for the process for 

the review of human drug applications’’ means the expenses in 

connection with the process for the review of human drug applications for— 

ø(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with 

such contractors, 

ø(B) management of information, and the acquisition, 

maintenance, and repair of computer resources, 

ø(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary 

materials and supplies, and 

ø(D) collecting fees under section 736 and accounting for 

resources allocated for the review of human drug applications and supplements. 

ø(8) The term ‘‘adjustment factor’’ applicable to a fiscal year 

is the Consumer Price Index for all urban consumers (all 

items; United States city average) for October of the preceding 

fiscal year divided by such Index for October 1996. 

ø(9) The term ‘‘person’’ includes an affiliate thereof. 

ø(10) The term ‘‘active’’, with respect to a commercial investigational new drug application, means such an application to 

which information was submitted during the relevant period. 

ø(11) The term ‘‘affiliate’’ means a business entity that has 

a relationship with a second business entity if, directly or indirectly— 

ø(A) one business entity controls, or has the power to 

control, the other business entity; or 

ø(B) a third party controls, or has power to control, both 

of the business entities. 

øSEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES. 

ø(a) TYPES OF FEES.—Beginning infiscal year 2013, the Secretary 

shall assess and collect fees in accordance with this section as follows: 


jbell on DSK7SPTVN1PROD with REPORTS
119 

ø(1) HUMAN DRUG APPLICATION AND SUPPLEMENT FEE.— ø(A) IN GENERAL.—Each person that submits, on or after 

September 1, 1992, a human drug application or a supplement shall be subject to a fee as follows: 

ø(i) A fee established under subsection for a human 

drug application for which clinical data (other than 

bioavailability or bioequivalence studies) with respect 

to safety or effectiveness are required for approval. 

ø(ii) A fee established under subsection for a human 

drug application for which clinical data with respect to 

safety or effectiveness are not required or a supplement for which clinical data (other than bioavailability 

or bioequivalence studies) with respect to safety or effectiveness are required. Such fee shall be half of the 

amount of the fee established under clause (i). 

ø(B) PAYMENT.—The fee required by subparagraph (A) 

shall be due upon submission of the application or supplement. 

ø(C) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR

SUPPLEMENT.—If a human drug application or supplement 

was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not 

approved or was withdrawn (without a waiver), the submission of a human drug application or a supplement for 

the same product by the same person (or the person’s licensee, assignee, or successor) shall not be subject to a fee 

under subparagraph (A). 

ø(D) REFUND OF FEE IF APPLICATION REFUSED FOR FILING

OR WITHDRAWN BEFORE FILING.—The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for 

any application or supplement which is refused for filing 

or withdrawn without a waiver before filing. 

ø(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR

FILING OR WITHDRAWN BEFORE FILING.—A human drug application or supplement that was submitted but was refused for filing, or was withdrawn before being accepted or 

refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection 

(d). 

ø(F) EXCEPTION FOR DESIGNATED ORPHAN DRUG OR INDICATION.—A human drug application for a prescription drug 

product that has been designated as a drug for a rare disease or condition pursuant to section 526 shall not be subject to a fee under subparagraph (A), unless the human 

drug application includes an indication for other than a 

rare disease or condition. A supplement proposing to include a new indication for a rare disease or condition in a 

human drug application shall not be subject to a fee under 

subparagraph (A), if the drug has been designated pursuant to section 526 as a drug for a rare disease or condition 

with regard to the indication proposed in such supplement. 

ø(G) REFUND OF FEE IF APPLICATION WITHDRAWN.—If an 

application or supplement is withdrawn after the application or supplement was filed, the Secretary may refund the 


jbell on DSK7SPTVN1PROD with REPORTS
120 

fee or a portion of the fee if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the 

sole discretion to refund a fee or a portion of the fee under 

this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable. 

ø(2) PRESCRIPTION DRUG ESTABLISHMENT FEE.— ø(A) IN GENERAL.—Except as provided in subparagraphs 

(B) and (C), each person that— 

ø(i) is named as the applicant in a human drug application; and 

ø(ii) after September 1, 1992, had pending before 

the Secretary a human drug application or supplement, 

shall be assessed an annual fee established under subsection (c)(4) for each prescription drug establishment listed in its approved human drug application as an establishment that manufactures the prescription drug product 

named in the application. The annual establishment fee 

shall be assessed in each fiscal year in which the prescription drug product named in the application is assessed a 

fee under paragraph (3) unless the prescription drug establishment listed in the application does not engage in the 

manufacture of the prescription drug product during the 

fiscal year. The establishment fee shall be due on the later 

of the first business day on or after October 1 of such fiscal 

year or the first business day after the enactment of an appropriations Act providing for the collection and obligation 

of fees for such fiscal year under this section. Each such 

establishment shall be assessed only one fee per establishment, notwithstanding the number of prescription drug 

products manufactured at the establishment. In the event 

an establishment is listed in a human drug application by 

more than one applicant, the establishment fee for the fiscal year shall be divided equally and assessed among the 

applicants whose prescription drug products are manufactured by the establishment during the fiscal year and assessed product fees under paragraph (3). 

ø(B) EXCEPTION.—If, during the fiscal year, an applicant 

initiates or causes to be initiated the manufacture of a prescription drug product at an establishment listed in its 

human drug application— 

ø(i) that did not manufacture the product in the previous fiscal year; and 

ø(ii) for which the full establishment fee has been 

assessed in the fiscal year at a time before manufacture of the prescription drug product was begun; 

the applicant will not be assessed a share of the establishment fee for the fiscal year in which the manufacture of 

the product began. 

ø(C) SPECIAL RULES FOR POSITRON EMISSION TOMOG- RAPHY DRUGS.— 

ø(i) IN GENERAL.—Except as provided in clause (ii), 

each person who is named as the applicant in an apVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00120 Fmt 6659 Sfmt 6602 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
121 

proved human drug application for a positron emission 

tomography drug shall be subject under subparagraph 

(A) to one-sixth of an annual establishment fee with 

respect to each such establishment identified in the 

application as producing positron emission tomography drugs under the approved application. 

ø(ii) EXCEPTION FROM ANNUAL ESTABLISHMENT

FEE.—Each person who is named as the applicant in 

an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if 

the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified 

by the Secretary, that— 

ø(I) the person is a not-for-profit medical center 

that has only 1 establishment for the production 

of positron emission tomography drugs; and 

ø(II) at least 95 percent of the total number of 

doses of each positron emission tomography drug 

produced by such establishment during such fiscal 

year will be used within the medical center. 

ø(iii) DEFINITION.—For purposes of this subparagraph, the term ‘‘positron emission tomography drug’’ 

has the meaning given to the term ‘‘compounded 

positron emission tomography drug’’ in section 201(ii), 

except that paragraph (1)(B) of such section shall not 

apply. 

ø(3) PRESCRIPTION DRUG PRODUCT FEE.— 

ø(A) IN GENERAL.—Except as provided in subparagraph 

(B), each person who is named as the applicant in a 

human drug application, and who, after September 1, 

1992, had pending before the Secretary a human drug application or supplement, shall pay for each such prescription drug product the annual fee established under subsection (c)(4). Such fee shall be due on the later of the first 

business day on or after October 1 of each such fiscal year 

or the first business day after the enactment of an appropriations Act providing for the collection and obligation of 

fees for each such fiscal year under this section. Such fee 

shall be paid only once for each product for a fiscal year 

in which the fee is payable. 

ø(B) EXCEPTION.—A prescription drug product shall not 

be assessed a fee under subparagraph (A) if such product 

is— 

ø(i) identified on the list compiled under section 

505(j)(7)(A) with a potency described in terms of per 

100 mL; 

ø(ii) the same product as another product that— 

ø(I) was approved under an application filed 

under section 505(b) or 505(j); and 

ø(II) is not in the list of discontinued products 

compiled under section 505(j)(7)(A); 

ø(iii) the same product as another product that was 

approved under an abbreviated application filed under 

section 507 (as in effect on the day before the date of 


jbell on DSK7SPTVN1PROD with REPORTS
122 

enactment of the Food and Drug Administration Modernization Act of 1997); or 

ø(iv) the same product as another product that was 

approved under an abbreviated new drug application 

pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent 

Term Restoration Act of 1984. 

ø(b) FEE REVENUE AMOUNTS.— ø(1) IN GENERAL.—For each of the fiscal years 2013 through 

2017, fees under subsection (a) shall, except as provided in 

subsections (c), (d), (f), and (g), be established to generate a 

total revenue amount under such subsection that is equal to 

the sum of— 

ø(A) $693,099,000; 

ø(B) the dollar amount equal to the inflation adjustment 

for fiscal year 2013 (as determined under paragraph 

(3)(A)); and 

ø(C) the dollar amount equal to the workload adjustment for fiscal year 2013 (as determined under paragraph 

(3)(B)). 

ø(2) TYPES OF FEES.—Of the total revenue amount determined for a fiscal year under paragraph (1)— 

ø(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and 

supplements); 

ø(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and 

ø(C) one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products). 

ø(3) FISCAL YEAR 2013 INFLATION AND WORKLOAD ADJUSTMENTS.—For purposes of paragraph (1), the dollar amount of 

the inflation and workload adjustments for fiscal year 2013 

shall be determined as follows: 

ø(A) INFLATION ADJUSTMENT.—The inflation adjustment 

for fiscal year 2013 shall be the sum of— 

ø(i) $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the 

methodology described in subsection (c)(1)(B); and 

ø(ii) $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the 

methodology described in subsection (c)(1)(C). 

ø(B) WORKLOAD ADJUSTMENT.—Subject to subparagraph 

(C), the workload adjustment for fiscal 2013 shall be— 

ø(i) $652,709,000 plus the amount of the inflation 

adjustment calculated under subparagraph (A); multiplied by 

ø(ii) the amount (if any) by which a percentage 

workload adjustment for fiscal year 2013, as determined using the methodology described in subsection 

(c)(2)(A), would exceed the percentage workload adjustment (as so determined) for fiscal year 2012, if 

both such adjustment percentages were calculated 

using the 5-year base period consisting of fiscal years 

2003 through 2007. 


jbell on DSK7SPTVN1PROD with REPORTS
123 

ø(C) LIMITATION.—Under no circumstances shall the adjustment under subparagraph (B) result in fee revenues 

for fiscal year 2013 that are less than the sum of the 

amount under paragraph (1)(A) and the amount under 

paragraph (1)(B). 

ø(c) ADJUSTMENTS.— ø(1) INFLATION ADJUSTMENT.—For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection (b) 

shall be adjusted by the Secretary by notice, published in the 

Federal Register, for a fiscal year by the amount equal to the 

sum of— 

ø(A) one; 

ø(B) the average annual percent change in the cost, per 

full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid 

with respect to such positions for the first 3 years of the 

preceding 4 fiscal years, multiplied by the proportion of 

personnel compensation and benefits costs to total costs of 

the process for the review of human drug applications (as 

defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years, and 

ø(C) the average annual percent change that occurred in 

the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the 

preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and 

benefits costs to total costs of the process for the review of 

human drug applications (as defined in section 735(6)) for 

the first 3 years of the preceding 4 fiscal years. 

The adjustment made each fiscal year under this paragraph 

shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this 

paragraph. 

ø(2) WORKLOAD ADJUSTMENT.—For fiscal year 2014 and subsequent fiscal years, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted 

further for such fiscal year to reflect changes in the workload 

of the Secretary for the process for the review of human drug 

applications. With respect to such adjustment: 

ø(A) The adjustment shall be determined by the Secretary based on a weighted average of the change in the 

total number of human drug applications (adjusted for 

changes in review activities, as described in the notice that 

the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and 

manufacturing supplements submitted to the Secretary, 

and the change in the total number of active commercial 

investigational new drug applications (adjusted for 

changes in review activities, as so described) during the 

most recent 12-month period for which data on such submissions is available. The Secretary shall publish in the 

Federal Register the fee revenues and fees resulting from 

the adjustment and the supporting methodologies. 


jbell on DSK7SPTVN1PROD with REPORTS
124 

ø(B) Under no circumstances shall the adjustment result 

in fee revenues for a fiscal year that are less than the sum 

of the amount under subsection (b)(1)(A) and the amount 

under subsection (b)(1)(B), as adjusted for inflation under 

paragraph (1). 

ø(C) The Secretary shall contract with an independent 

accounting or consulting firm to periodically review the 

adequacy of the adjustment and publish the results of 

those reviews. The first review shall be conducted and 

published by the end of fiscal year 2013 (to examine the 

performance of the adjustment since fiscal year 2009), and 

the second review shall be conducted and published by the 

end of fiscal year 2015 (to examine the continued performance of the adjustment). The reports shall evaluate whether the adjustment reasonably represents actual changes in 

workload volume and complexity and present options to 

discontinue, retain, or modify any elements of the adjustment. The reports shall be published for public comment. 

After review of the reports and receipt of public comments, 

the Secretary shall, if warranted, adopt appropriate 

changes to the methodology. If the Secretary adopts 

changes to the methodology based on the first report, the 

changes shall be effective for the first fiscal year for which 

fees are set after the Secretary adopts such changes and 

each subsequent fiscal year. 

ø(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2017, the Secretary may, in addition to adjustments under this paragraph 

and paragraphs (1) and (2), further increase the fee revenues 

and fees established in subsection (b) if such an adjustment is 

necessary to provide for not more than 3 months of operating 

reserves of carryover user fees for the process for the review 

of human drug applications for the first 3 months of fiscal year 

2018. If such an adjustment is necessary, the rationale for the 

amount of the increase shall be contained in the annual notice 

establishing fee revenues and fees for fiscal year 2017. If the 

Secretary has carryover balances for such process in excess of 

3 months of such operating reserves, the adjustment under this 

subparagraph shall not be made. 

ø(4) ANNUAL FEE SETTING.—The Secretary shall, not later 

than 60 days before the start of each fiscal year that begins 

after September 30, 2012, establish, for the next fiscal year, 

application, product, and establishment fees under subsection 

(a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection. 

ø(5) LIMIT.—The total amount of fees charged, as adjusted 

under this subsection, for a fiscal year may not exceed the total 

costs for such fiscal year for the resources allocated for the 

process for the review of human drug applications. 

ø(d) FEE WAIVER OR REDUCTION.— ø(1) IN GENERAL.—The Secretary shall grant to a person who 

is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) where the Secretary finds that— 

ø(A) such waiver or reduction is necessary to protect the 

public health, 


jbell on DSK7SPTVN1PROD with REPORTS
125 

ø(B) the assessment of the fee would present a significant barrier to innovation because of limited resources 

available to such person or other circumstances, 

ø(C) the fees to be paid by such person will exceed the 

anticipated present and future costs incurred by the Secretary in conducting the process for the review of human 

drug applications for such person, or 

ø(D) the applicant involved is a small business submitting its first human drug application to the Secretary for 

review. 

ø(2) CONSIDERATIONS.—In determining whether to grant a 

waiver or reduction of a fee under paragraph (1), the Secretary 

shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant. 

ø(3) USE OF STANDARD COSTS.—In making the finding in 

paragraph (1)(C), the Secretary may use standard costs. 

ø(4) RULES RELATING TO SMALL BUSINESSES.— ø(A) DEFINITION.—In paragraph (1)(D), the term ‘‘small 

business’’ means an entity that has fewer than 500 employees, including employees of affiliates, and that does 

not have a drug product that has been approved under a 

human drug application and introduced or delivered for introduction into interstate commerce. 

ø(B) WAIVER OF APPLICATION FEE.—The Secretary shall 

waive under paragraph (1)(D) the application fee for the 

first human drug application that a small business or its 

affiliate submits to the Secretary for review. After a small 

business or its affiliate is granted such a waiver, the small 

business or its affiliate shall pay— 

ø(i) application fees for all subsequent human drug 

applications submitted to the Secretary for review in 

the same manner as an entity that does not qualify as 

a small business; and 

ø(ii) all supplement fees for all supplements to 

human drug applications submitted to the Secretary 

for review in the same manner as an entity that does 

not qualify as a small business. 

ø(e) EFFECT OF FAILURE TO PAY FEES.—A human drug application or supplement submitted by a person subject to fees under 

subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person 

have been paid. 

ø(f) LIMITATIONS.— 

ø(1) IN GENERAL.—Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 1997 unless 

appropriations for salaries and expenses of the Food and Drug 

Administration for such fiscal year (excluding the amount of 

fees appropriated for such fiscal year) are equal to or greater 

than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 

1997 (excluding the amount of fees appropriated for such fiscal 

year) multiplied by the adjustment factor applicable to the fiscal year involved. 

ø(2) AUTHORITY.—If the Secretary does not assess fees under 

subsection (a) during any portion of a fiscal year because of 


jbell on DSK7SPTVN1PROD with REPORTS
126 

paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for human 

drug applications and supplements, prescription drug establishments, and prescription drug products at any time in such 

fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid. 

ø(g) CREDITING AND AVAILABILITY OF FEES.— 

ø(1) IN GENERAL.—Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for 

obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary 

may be transferred from the Food and Drug Administration 

salaries and expenses appropriation account without fiscal year 

limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred 

shall be available solely for the process for the review of 

human drug applications. 

ø(2) COLLECTIONS AND APPROPRIATION ACTS.— 

ø(A) IN GENERAL.—The fees authorized by this section— 

ø(i) shall be collected and available in each fiscal 

year in an amount not to exceed the amount specified 

in appropriation Acts, or otherwise made available for 

obligation, for such fiscal year, and 

ø(ii) shall be available to defray increases in the 

costs of the resources allocated for the process for the 

review of human drug applications (including increases in such costs for an additional number of fulltime equivalent positions in the Department of Health 

and Human Services to be engaged in such process) 

over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor. 

ø(B) COMPLIANCE.—The Secretary shall be considered to 

have met the requirements of subparagraph (A)(ii) in any 

fiscal year if the costs funded by appropriations and allocated for the process for the review of human drug applications— 

ø(i) are not more than 3 percent below the level 

specified in subparagraph (A)(ii); or 

ø(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the 

fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which 

such costs fell below the level specified in such subparagraph; and 

ø(II) such costs are not more than 5 percent below 

the level specified in such subparagraph. 

ø(C) PROVISION FOR EARLY PAYMENTS.—Payment of fees 

authorized under this section for a fiscal year, prior to the 

due date for such fees, may be accepted by the Secretary 

in accordance with authority provided in advance in a 

prior year appropriations Act. 


jbell on DSK7SPTVN1PROD with REPORTS
127 

ø(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 

fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equal to the total 

revenue amount determined under subsection (b) for the fiscal 

year, as adjusted or otherwise affected under subsection (c) and 

paragraph (4) of this subsection. 

ø(4) OFFSET.—If the sum of the cumulative amount of fees 

collected under this section for the fiscal years 2013 through 

2015 and the amount of fees estimated to be collected under 

this section for fiscal year 2016 exceeds the cumulative amount 

appropriated under paragraph (3) for the fiscal years 2008 

through 2011, the excess shall be credited to the appropriation 

account of the Food and Drug Administration as provided in 

paragraph (1), and shall be subtracted from the amount of fees 

that would otherwise be authorized to be collected under this 

section pursuant to appropriation Acts for fiscal year 2017. 

ø(h) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 days after it is due, such fee shall be treated as a 

claim of the United States Government subject to subchapter II of 

chapter 37 of title 31, United States Code. 

ø(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, AND RE- FUNDS.—To qualify for consideration for a waiver or reduction 

under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a 

written request for such waiver, reduction, or refund not later than 

180 days after such fee is due. 

ø(j) CONSTRUCTION.—This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, 

and advisory committees not engaged in the process of the review 

of human drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged. 

ø(k) ORPHAN DRUGS.— 

ø(1) EXEMPTION.—A drug designated under section 526 for a 

rare disease or condition and approved under section 505 or 

under section 351 of the Public Health Service Act shall be exempt from product and establishment fees under this section, 

if the drug meets all of the following conditions: 

ø(A) The drug meets the public health requirements contained in this Act as such requirements are applied to requests for waivers for product and establishment fees. 

ø(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue during the previous year. 

ø(2) EVIDENCE OF QUALIFICATION.—An exemption under 

paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months 

before the exemption was requested.¿ 

* * * * * * * 

SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS. 

ø(a) PERFORMANCE REPORT.—Beginning with fiscal year 2008, 

not later than 120 days after the end of each fiscal year for which 


jbell on DSK7SPTVN1PROD with REPORTS
128 

fees are collected under this part, the Secretary shall prepare and 

submit to the Committee on Energy and Commerce of the House 

of Representatives and the Committee on Health, Education, 

Labor, and Pensions of the Senate a report concerning the progress 

of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(c) of the Food and Drug 

Administration Amendments Act of 2007 during such fiscal year 

and the future plans of the Food and Drug Administration for 

meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not 

given a complete response on all human drug applications and supplements in the cohort.¿ 

(a) PERFORMANCE REPORT.— (1) IN GENERAL.—Beginning with fiscal year 2013, not later 

than 120 days after the end of each fiscal year for which fees 

are collected under this part, the Secretary shall prepare and 

submit to the Committee on Energy and Commerce of the House 

of Representatives and the Committee on Health, Education, 

Labor, and Pensions of the Senate a report concerning— 

(A) the progress of the Food and Drug Administration in 

achieving the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments 

of 2012 during such fiscal year and the future plans of the 

Food and Drug Administration for meeting the goals, including the status of the independent assessment described 

in such letters; and 

(B) the progress of the Center for Drug Evaluation and 

Research and the Center for Biologics Evaluation and Research in achieving the goals, and future plans for meeting 

the goals, including, for each review division— 

(i) the number of original standard new drug applications and biologics license applications filed per fiscal year for each review division; 

(ii) the number of original priority new drug applications and biologics license applications filed per fiscal 

year for each review division; 

(iii) the number of standard efficacy supplements 

filed per fiscal year for each review division; 

(iv) the number of priority efficacy supplements filed 

per fiscal year for each review division; 

(v) the number of applications filed for review under 

accelerated approval per fiscal year for each review division; 

(vi) the number of applications filed for review as 

fast track products per fiscal year for each review division; and 

(vii) the number of applications filed for orphan-designated products per fiscal year for each review division. 

(2) INCLUSION.—The report under this subsection for a fiscal 

year shall include information on all previous cohorts for which 

the Secretary has not given a complete response on all human 

drug applications and supplements in the cohort. 

(b) FISCAL REPORT.—Beginning with fiscal year ø2008¿ 2013, not 

later than 120 days after the end of each fiscal year for which fees 


jbell on DSK7SPTVN1PROD with REPORTS
129 

are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of 

Representatives and the Committee on Health, Education, Labor, 

and Pensions of the Senate a report on the implementation of the 

authority for such fees during such fiscal year and the use, by the 

Food and Drug Administration, of the fees collected for such fiscal 

year. 

* * * * * * * 

(d) REAUTHORIZATION.— 

(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals, and plans for 

meeting the goals, for the process for the review of human 

drug applications for the first 5 fiscal years after fiscal year 

ø2012¿ 2017, and for the reauthorization of this part for such 

fiscal years, the Secretary shall consult with— 

(A) * * * 

* * * * * * * 

(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, ø2012¿ 2017, the Secretary shall transmit to the 

Congress the revised recommendations under paragraph (4), a 

summary of the views and comments received under such 

paragraph, and any changes made to the recommendations in 

response to such views and comments. 

* * * * * * * 

[Effective January 31, 2018, section 105(b) of H.R. 5651 provides for a repeal of 

section 736B (as amended by the bill).] 

øSEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS. 

ø(a) PERFORMANCE REPORT.— ø(1) IN GENERAL.—Beginning with fiscal year 2013, not later 

than 120 days after the end of each fiscal year for which fees 

are collected under this part, the Secretary shall prepare and 

submit to the Committee on Energy and Commerce of the 

House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning— 

ø(A) the progress of the Food and Drug Administration 

in achieving the goals identified in the letters described in 

section 101(b) of the Prescription Drug User Fee Amendments of 2012 during such fiscal year and the future plans 

of the Food and Drug Administration for meeting the 

goals, including the status of the independent assessment 

described in such letters; and 

ø(B) the progress of the Center for Drug Evaluation and 

Research and the Center for Biologics Evaluation and Research in achieving the goals, and future plans for meeting 

the goals, including, for each review division— 

ø(i) the number of original standard new drug applications and biologics license applications filed per fiscal year for each review division; 

ø(ii) the number of original priority new drug applications and biologics license applications filed per fiscal year for each review division; 


jbell on DSK7SPTVN1PROD with REPORTS
130 

ø(iii) the number of standard efficacy supplements 

filed per fiscal year for each review division; 

ø(iv) the number of priority efficacy supplements 

filed per fiscal year for each review division; 

ø(v) the number of applications filed for review 

under accelerated approval per fiscal year for each review division; 

ø(vi) the number of applications filed for review as 

fast track products per fiscal year for each review division; and 

ø(vii) the number of applications filed for orphandesignated products per fiscal year for each review division. 

ø(2) INCLUSION.—The report under this subsection for a fiscal year shall include information on all previous cohorts for 

which the Secretary has not given a complete response on all 

human drug applications and supplements in the cohort. 

ø(b) FISCAL REPORT.—Beginning with fiscal year, not later than 

120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to 

the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and 

Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the 

Food and Drug Administration, of the fees collected for such fiscal 

year. 

ø(c) PUBLIC AVAILABILITY.—The Secretary shall make the reports 

required under subsections (a) and (b) available to the public on 

the Internet Web site of the Food and Drug Administration. 

ø(d) REAUTHORIZATION.— 

ø(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals, and plans for 

meeting the goals, for the process for the review of human 

drug applications for the first 5 fiscal years after fiscal year, 

and for the reauthorization of this part for such fiscal years, 

the Secretary shall consult with— 

ø(A) the Committee on Energy and Commerce of the 

House of Representatives; 

ø(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

ø(C) scientific and academic experts; 

ø(D) health care professionals; 

ø(E) representatives of patient and consumer advocacy 

groups; and 

ø(F) the regulated industry. 

ø(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the regulated industry on the reauthorization of this part, 

the Secretary shall— 

ø(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

ø(B) hold a public meeting at which the public may 

present its views on the reauthorization, including specific 

suggestions for changes to the goals referred to in subsection (a); 


jbell on DSK7SPTVN1PROD with REPORTS
131 

ø(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

ø(D) publish the comments on the Food and Drug Administration’s Internet Web site. 

ø(3) PERIODIC CONSULTATION.—Not less frequently than once 

every month during negotiations with the regulated industry, 

the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of 

their views on the reauthorization and their suggestions for 

changes to this part as expressed under paragraph (2). 

ø(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

ø(A) present the recommendations developed under 

paragraph (1) to the Congressional committees specified in 

such paragraph; 

ø(B) publish such recommendations in the Federal Register; 

ø(C) provide for a period of 30 days for the public to provide written comments on such recommendations; 

ø(D) hold a meeting at which the public may present its 

views on such recommendations; and 

ø(E) after consideration of such public views and comments, revise such recommendations as necessary. 

ø(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2017, the Secretary shall transmit to the Congress 

the revised recommendations under paragraph (4), a summary 

of the views and comments received under such paragraph, 

and any changes made to the recommendations in response to 

such views and comments. 

ø(6) MINUTES OF NEGOTIATION MEETINGS.— 

ø(A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) 

to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted 

under this subsection between the Food and Drug Administration and the regulated industry. 

ø(B) CONTENT.—The minutes described under subparagraph (A) shall summarize any substantive proposal made 

by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations 

and their resolution.¿ 

* * * * * * * 

PART 3—FEES RELATING TO DEVICES 

* * * * * * * 

SEC. 737. DEFINITIONS. 

For purposes of this part: 

(1) * * * 

* * * * * * * 


jbell on DSK7SPTVN1PROD with REPORTS
132 

(9) The term ‘‘costs of resources allocated for the process for 

the review of device applications’’ means the expenses øincurred¿ in connection with the process for the review of device 

applications for— 

(A) * * * 

* * * * * * * 

(10) The term ‘‘adjustment factor’’ applicable to a fiscal year 

is the Consumer Price Index for all urban consumers (all 

items; United States city average) for October of the preceding 

fiscal year divided by such Index for øOctober 2001¿ October 

2011. 

* * * * * * * 

(13) The term ‘‘establishment subject to a registration fee’’ 

means an establishment that øis required to register with the 

Secretary under section 510 and is one of the following types 

of establishments: 

ø(A) MANUFACTURER.—An establishment that makes by 

any means any article that is a device, including an establishment that sterilizes or otherwise makes such article for 

or on behalf of a specification developer or any other person. 

ø(B) SINGLE-USE DEVICE REPROCESSOR.—An establishment that, within the meaning of section 201(ll)(2)(A), performs additional processing and manufacturing operations 

on a single-use device that has previously been used on a 

patient. 

ø(C) SPECIFICATION DEVELOPER.—An establishment that 

develops specifications for a device that is distributed 

under the establishment’s name but which performs no 

manufacturing, including an establishment that, in addition to developing specifications, also arranges for the 

manufacturing of devices labeled with another establishment’s name by a contract manufacturer.¿ is registered (or 

is required to register) with the Secretary under section 510 

because such establishment is engaged in the manufacture, 

preparation, propagation, compounding, or processing of a 

device. 

SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

(a) TYPES OF FEES.— 

(1) IN GENERAL.—Beginning in øfiscal year 2008¿ fiscal year 

2013, the Secretary shall assess and collect fees in accordance 

with this section. 

(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLEMENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR PERIODIC REPORTING CONCERNING A CLASS III DEVICE.— 

(A) IN GENERAL.—Except as provided in subparagraph 

(B) and øsubsections (d) and (e)¿ subsections (d), (e), and 

(f), each person who submits any of the following, on or 

after øOctober 1, 2002¿ October 1, 2012, shall be subject 

to a fee established under øsubsection (c)(1)¿ subsection (c) 

for the fiscal year involved in accordance with the following: 


jbell on DSK7SPTVN1PROD with REPORTS
133 

(i) * * * 

* * * * * * * 

(viii) For a premarket notification submission, a fee 

equal to ø1.84¿ 2 percent of the fee that applies under 

clause (i). 

* * * * * * * 

(3) ANNUAL ESTABLISHMENT REGISTRATION FEE.— 

(A) IN GENERAL.—Except as provided in subparagraph 

(B) and subsection (f), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 510 beginning with its registration for fiscal year 2008. 

* * * * * * * 

(C) PAYMENT.—The fee required under subparagraph (A) 

shall be due once each fiscal year, upon the øinitial registration of the establishment or upon the annual registration under section 510.¿ later of— 

(i) the initial or annual registration (as applicable) of 

the establishment under section 510; or 

(ii) the first business day after the date of enactment 

of an appropriations Act providing for the collection 

and obligation of fees for such year under this section. 

ø(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), 

(e), and (h) the fees under subsection (a) shall be based on the following fee amounts: 

øFee Type 

Fiscal 

Year 

2008 

Fiscal 

Year 

2009 

Fiscal 

Year 

2010 

Fiscal 

Year 

2011 

Fiscal 

Year 

2012 

Premarket Application .... $185,000 $200,725 $217,787 $236,298 $256,384

Establishment Registration ................................ $1,706 $1,851 $2,008 $2,179 $2,364.¿ 

(b) FEE AMOUNTS.— 

(1) IN GENERAL.—Subject to subsections (c), (d), (e), (f), and 

(i), for each of fiscal years 2013 through 2017, fees under subsection (a) shall be derived from the base fee amounts specified 

in paragraph (2), to generate the total revenue amounts specified in paragraph (3). 

(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of paragraph (1), the base fee amounts specified in this paragraph are 

as follows: 

Fee Type 

Fiscal 

Year 

2013 

Fiscal 

Year 

2014 

Fiscal 

Year 

2015 

Fiscal 

Year 

2016 

Fiscal 

Year 

2017 

Premarket Application .... $248,000 $252,960 $258,019 $263,180 $268,443 

Establishment Registration ................................ $2,575 $3,200 $3,750 $3,872 $3,872 


jbell on DSK7SPTVN1PROD with REPORTS
134 

(3) TOTAL REVENUE AMOUNTS.—For purposes of paragraph 

(1), the total revenue amounts specified in this paragraph are 

as follows: 

(A) $97,722,301 for fiscal year 2013. 

(B) $112,580,497 for fiscal year 2014. 

(C) $125,767,107 for fiscal year 2015. 

(D) $129,339,949 for fiscal year 2016. 

(E) $130,184,348 for fiscal year 2017. 

(c) ANNUAL FEE SETTING; ADJUSTMENTS.— 

ø(1) IN GENERAL.—The Secretary shall, 60 days before the 

start of each fiscal year after September 30, 2002, publish in 

the Federal Register fees under subsection (a). 

ø(2) ADJUSTMENT.— 

ø(A) IN GENERAL.—When setting fees for fiscal year 

2010, the Secretary may increase the fee under subsection 

(a)(3)(A) (applicable to establishments subject to registration) only if the Secretary estimates that the number of establishments submitting fees for fiscal year 2009 is fewer 

than 12,250. The percentage increase shall be the percentage by which the estimate of establishments submitting 

fees in fiscal year 2009 is fewer than 12,750, but in no case 

may the percentage increase be more than 8.5 percent over 

that specified in subsection (b) for fiscal year 2010. If the 

Secretary makes any adjustment to the fee under subsection (a)(3)(A) for fiscal year 2010, then such fee for fiscal years 2011 and 2012 shall be adjusted so that such fee 

for fiscal year 2011 is equal to the adjusted fee for fiscal 

year 2010 increased by 8.5 percent, and such fee for fiscal 

year 2012 is equal to the adjusted fee for fiscal year 2011 

increased by 8.5 percent. 

ø(B) PUBLICATION.—For any adjustment made under 

subparagraph (A), the Secretary shall publish in the Federal Register the Secretary’s determination to make the 

adjustment and the rationale for the determination.¿ 

(1) IN GENERAL.—The Secretary shall, 60 days before the 

start of each fiscal year after September 30, 2012, establish fees 

under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, 

and publish such fees, and the rationale for any adjustments to 

such fees, in the Federal Register. 

(2) INFLATION ADJUSTMENTS.— 

(A) ADJUSTMENT TO TOTAL REVENUE AMOUNTS.—For fiscal year 2014 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in 

subsection (b)(3) for such fiscal year by multiplying such 

amount by the applicable inflation adjustment under subparagraph (B) for such year. 

(B) APPLICABLE INFLATION ADJUSTMENT TO TOTAL REVENUE AMOUNTS.—The applicable inflation adjustment for a 

fiscal year is— 

(i) for fiscal year 2014, the base inflation adjustment 

under subparagraph (C) for such fiscal year; and 

(ii) for fiscal year 2015 and each subsequent fiscal 

year, the product of— 


jbell on DSK7SPTVN1PROD with REPORTS
135 

(I) the base inflation adjustment under subparagraph (C) for such fiscal year; and 

(II) the product of the base inflation adjustment 

under subparagraph (C) for each of the fiscal years 

preceding such fiscal year, beginning with fiscal 

year 2014. 

(C) BASE INFLATION ADJUSTMENT TO TOTAL REVENUE

AMOUNTS.— 

(i) IN GENERAL.—Subject to further adjustment 

under clause (ii), the base inflation adjustment for a 

fiscal year is the sum of one plus— 

(I) the average annual percent change in the 

cost, per full-time equivalent position of the Food 

and Drug Administration, of all personnel compensation and benefits paid with respect to such 

positions for the first 3 years of the preceding 4 fiscal years, multiplied by 0.60; and 

(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; 

Not Seasonally Adjusted; All items; Annual Index) 

for the first 3 years of the preceding 4 years of 

available data multiplied by 0.40. 

(ii) LIMITATIONS.—For purposes of subparagraph (B), 

if the base inflation adjustment for a fiscal year under 

clause (i)— 

(I) is less than 1, such adjustment shall be considered to be equal to 1; or 

(II) is greater than 1.04, such adjustment shall 

be considered to be equal to 1.04. 

(D) ADJUSTMENT TO BASE FEE AMOUNTS.—For each of 

fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a 

uniform proportionate basis, to generate the total revenue 

amounts under subsection (b)(3), as adjusted for inflation 

under subparagraph (A). 

(3) VOLUME-BASED ADJUSTMENTS TO ESTABLISHMENT REGISTRATION BASE FEES.—For each of fiscal years 2014 through 

2017, after the base fee amounts specified in subsection (b)(2) 

are adjusted under paragraph (2)(D), the base establishment 

registration fee amounts specified in such subsection shall be 

further adjusted, as the Secretary estimates is necessary in 

order for total fee collections for such fiscal year to generate the 

total revenue amounts, as adjusted under paragraph (2). 

ø(3)¿ (4) LIMIT.—The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed 

the total costs for such fiscal year for the resources allocated 

for the process for the review of device applications. 

ø(4)¿ (5) SUPPLEMENT.— (A) * * * 

* * * * * * * 

(f) FEE WAIVER OR REDUCTION.— 

(1) IN GENERAL.—The Secretary may, at the Secretary’s sole 

discretion, grant a waiver or reduction of fees under subsection 


jbell on DSK7SPTVN1PROD with REPORTS
136 

(a)(2) or (a)(3) if the Secretary finds that such waiver or reduction is in the interest of public health. 

(2) LIMITATION.—The sum of all fee waivers or reductions 

granted by the Secretary in any fiscal year under paragraph (1) 

shall not exceed 2 percent of the total fee revenue amounts established for such year under subsection (c). 

(3) DURATION.—The authority provided by this subsection terminates October 1, 2017. 

ø(f)¿ (g) EFFECT OF FAILURE TO PAY FEES.— 

(1) * * * 

* * * * * * * 

ø(g)¿ (h) CONDITIONS.— 

(1) PERFORMANCE GOALS; TERMINATION OF PROGRAM.—With 

respect to the amount that, under the salaries and expenses 

account of the Food and Drug Administration, is appropriated 

for a fiscal year for devices and radiological products, fees may 

not be assessed under subsection (a) for the fiscal year, and the 

Secretary is not expected to meet any performance goals identified for the fiscal year, if— 

(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, 

is more than 1 percent less than ø$205,720,000¿ 

$280,587,000 multiplied by the adjustment factor applicable to such fiscal year; or 

* * * * * * * 

ø(h)¿ (i) CREDITING AND AVAILABILITY OF FEES.— 

(1) IN GENERAL.—øFees authorized¿ Subject to paragraph 

(2)(C), fees authorized under subsection (a) shall be collected 

and available for obligation only to the extent and in the 

amount provided in advance in appropriation Acts. Such fees 

are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred 

from the Food and Drug Administration salaries and expenses 

appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal 

year limitation. The sums transferred shall be available solely 

for the process for the review of device applications. 

(2) COLLECTIONS AND APPROPRIATION ACTS.— 

(A) IN GENERAL.—The fees authorized by this section— 

(i) øshall be retained¿ subject to subparagraph (C), 

shall be collected and available in each fiscal year in 

an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and 

(ii) shall only be øcollected and¿ available to defray 

increases in the costs of the resources allocated for the 

process for the review of device applications (including 

increases in such costs for an additional number of 

full-time equivalent positions in the Department of 

Health and Human Services to be engaged in such 

process) over such costs, excluding costs paid from fees 


jbell on DSK7SPTVN1PROD with REPORTS
137 

collected under this section, for øfiscal year 2002¿ fiscal year 2009 multiplied by the adjustment factor. 

* * * * * * * 

(C) PROVISION FOR EARLY YEAR PAYMENTS.—Payment of 

fees authorized under this section for a fiscal year, prior to 

the due date for such fees, may be accepted by the Secretary 

in accordance with authority provided in advance in a 

prior year appropriations Act. 

ø(3) AUTHORIZATIONS OF APPROPRIATIONS.—There are authorized to be appropriated for fees under this section— 

ø(A) $48,431,000 for fiscal year 2008; 

ø(B) $52,547,000 for fiscal year 2009; 

ø(C) $57,014,000 for fiscal year 2010; 

ø(D) $61,860,000 for fiscal year 2011; and 

ø(E) $67,118,000 for fiscal year 2012.¿ 

(3) AUTHORIZATIONS OF APPROPRIATIONS.—For each of the fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equal to the total 

revenue amount specified under subsection (b)(3) for the fiscal 

year, as adjusted under subsection (c) and, for fiscal year 2017 

only, as further adjusted under paragraph (4). 

(4) OFFSET.—If the cumulative amount of fees collected during øfiscal years 2008, 2009, and 2010¿ fiscal years 2013, 2014, 

and 2015, added to the amount estimated to be collected for 

øfiscal year 2011¿ fiscal year 2016, which estimate shall be 

based upon the amount of fees received by the Secretary 

through øJune 30, 2011¿ June 30, 2016, exceeds øthe amount 

of fees specified in aggregate in¿ the cumulative amount appropriated pursuant to paragraph (3) for these four fiscal years, 

the øaggregate amount in¿ excess shall be credited to the appropriation account of the Food and Drug Administration as 

provided in paragraph (1), and shall be subtracted from the 

amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for 

øfiscal year 2012¿ fiscal year 2017. 

ø(i)¿ (j) COLLECTION OF UNPAID FEES.—In any case where the 

Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated 

as a claim of the United States Government subject to subchapter 

II of chapter 37 of title 31, United States Code. 

ø(j)¿ (k) WRITTEN REQUESTS FOR REFUNDS.—To qualify for consideration for a refund under subsection (a)(2)(D), a person shall 

submit to the Secretary a written request for such refund not later 

than 180 days after such fee is due. 

ø(k)¿ (l) CONSTRUCTION.—This section may not be construed to 

require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, 

and advisory committees not engaged in the process of the review 

of device applications, be reduced to offset the number of officers, 

employees, and advisory committees so engaged. 

SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS. 

(a) REPORTS.— 

ø(1) PERFORMANCE REPORT.—For fiscal years 2008 through 

2012, not later than 120 days after the end of each fiscal year 


jbell on DSK7SPTVN1PROD with REPORTS
138 

during which fees are collected under this part, the Secretary 

shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives, a 

report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described 

in section 201(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans 

of the Food and Drug Administration for meeting the goals. 

The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete 

response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.¿ 

(1) PERFORMANCE REPORT.— (A) IN GENERAL.—Beginning with fiscal year 2013, for 

each fiscal year for which fees are collected under this part, 

the Secretary shall prepare and submit to the Committee on 

Health, Education, Labor, and Pensions of the Senate and 

the Committee on Energy and Commerce of the House of 

Representatives annual reports concerning the progress of 

the Food and Drug Administration in achieving the goals 

identified in the letters described in section 201(b) of the 

Medical Device User Fee Amendments of 2012 during such 

fiscal year and the future plans of the Food and Drug Administration for meeting the goals. 

(B) PUBLICATION.—With regard to information to be reported by the Food and Drug Administration to industry on 

a quarterly and annual basis pursuant to the letters described in section 201(b) of the Medical Device User Fee 

Amendments Act of 2012, the Secretary shall make such information publicly available on the Internet Website of the 

Food and Drug Administration not later than 60 days after 

the end of each quarter or 120 days after the end of each 

fiscal year, respectively, to which such information applies. 

This information shall include the status of the independent assessment identified in the letters described in 

such section 201(b). 

(C) UPDATES.—The Secretary shall include in each report 

under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, 

supplements, and premarket notifications in the cohort. 

(2) FISCAL REPORT.—For fiscal years ø2008 through 2012¿ 

2013 through 2017, not later than 120 days after the end of 

each fiscal year during which fees are collected under this part, 

the Secretary shall prepare and submit to the Committee on 

Health, Education, Labor, and Pensions of the Senate and the 

Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority 

for such fees during such fiscal year and the use, by the Food 

and Drug Administration, of the fees collected during such fiscal year for which the report is made. 

* * * * * * * 

(b) REAUTHORIZATION.— 


jbell on DSK7SPTVN1PROD with REPORTS
139 

(1) CONSULTATION.—In developing recommendations to 

present to Congress with respect to the goals, and plans for 

meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year ø2012¿ 

2017, and for the reauthorization of this part for such fiscal 

years, the Secretary shall consult with— 

(A) * * * 

* * * * * * * 

(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, ø2012¿ 2017, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a 

summary of the views and comments received under such 

paragraph, and any changes made to the recommendations in 

response to such views and comments. 

* * * * * * * 

[Effective January 31, 2018, section 207(a) of H.R. 5651 provides for a repeal of 

section 738A (as amended by the bill).] 

øSEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS. 

ø(a) REPORTS.— ø(1) PERFORMANCE REPORT.— ø(A) IN GENERAL.—Beginning with fiscal year 2013, for 

each fiscal year for which fees are collected under this 

part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the 

Senate and the Committee on Energy and Commerce of 

the House of Representatives annual reports concerning 

the progress of the Food and Drug Administration in 

achieving the goals identified in the letters described in 

section 201(b) of the Medical Device User Fee Amendments of 2012 during such fiscal year and the future plans 

of the Food and Drug Administration for meeting the 

goals. 

ø(B) PUBLICATION.—With regard to information to be reported by the Food and Drug Administration to industry 

on a quarterly and annual basis pursuant to the letters described in section 201(b) of the Medical Device User Fee 

Amendments Act of 2012, the Secretary shall make such 

information publicly available on the Internet Website of 

the Food and Drug Administration not later than 60 days 

after the end of each quarter or 120 days after the end of 

each fiscal year, respectively, to which such information 

applies. This information shall include the status of the 

independent assessment identified in the letters described 

in such section 201(b). 

ø(C) UPDATES.—The Secretary shall include in each report under subparagraph (A) information on all previous 

cohorts for which the Secretary has not given a complete 

response on all device premarket applications and reports, 

supplements, and premarket notifications in the cohort. 

ø(2) FISCAL REPORT.—For fiscal years 2013 through 2017, not 

later than 120 days after the end of each fiscal year during 

which fees are collected under this part, the Secretary shall 

prepare and submit to the Committee on Health, Education, 


jbell on DSK7SPTVN1PROD with REPORTS
140 

Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report 

on the implementation of the authority for such fees during 

such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which 

the report is made. 

ø(3) PUBLIC AVAILABILITY.—The Secretary shall make the reports required under paragraphs (1) and (2) available to the 

public on the Internet Web site of the Food and Drug Administration. 

ø(b) REAUTHORIZATION.— ø(1) CONSULTATION.—In developing recommendations to 

present to Congress with respect to the goals, and plans for 

meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2017, and 

for the reauthorization of this part for such fiscal years, the 

Secretary shall consult with— 

ø(A) the Committee on Energy and Commerce of the 

House of Representatives; 

ø(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

ø(C) scientific and academic experts; 

ø(D) health care professionals; 

ø(E) representatives of patient and consumer advocacy 

groups; and 

ø(F) the regulated industry. 

ø(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the regulated industry on the reauthorization of this part, 

the Secretary shall— 

ø(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

ø(B) hold a public meeting at which the public may 

present its views on the reauthorization, including specific 

suggestions for changes to the goals referred to in subsection (a)(1); 

ø(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

ø(D) publish the comments on the Food and Drug Administration’s Internet Web site. 

ø(3) PERIODIC CONSULTATION.—Not less frequently than once 

every month during negotiations with the regulated industry, 

the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of 

their views on the reauthorization and their suggestions for 

changes to this part as expressed under paragraph (2). 

ø(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

ø(A) present the recommendations developed under 

paragraph (1) to the Congressional committees specified in 

such paragraph; 

ø(B) publish such recommendations in the Federal Register; 

ø(C) provide for a period of 30 days for the public to provide written comments on such recommendations; 


jbell on DSK7SPTVN1PROD with REPORTS
141 

ø(D) hold a meeting at which the public may present its 

views on such recommendations; and 

ø(E) after consideration of such public views and comments, revise such recommendations as necessary. 

ø(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2017, the Secretary shall transmit to Congress the 

revised recommendations under paragraph (4), a summary of 

the views and comments received under such paragraph, and 

any changes made to the recommendations in response to such 

views and comments. 

ø(6) MINUTES OF NEGOTIATION MEETINGS.— ø(A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) 

to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted 

under this subsection between the Food and Drug Administration and the regulated industry. 

ø(B) CONTENT.—The minutes described under subparagraph (A) shall summarize any substantive proposal made 

by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations 

and their resolution.¿ 

* * * * * * * 

PART 7—FEES RELATING TO GENERIC DRUGS 

SEC. 744A. DEFINITIONS. 

For purposes of this part: 

(1) The term ‘‘abbreviated new drug application’’— 

(A) means an application submitted under section 505(j), 

an abbreviated application submitted under section 507 (as 

in effect on the day before the date of enactment of the Food 

and Drug Administration Modernization Act of 1997), or 

an abbreviated new drug application submitted pursuant to 

regulations in effect prior to the implementation of the 

Drug Price Competition and Patent Term Restoration Act 

of 1984; and 

(B) does not include an application for a positron emission tomography drug. 

(2) The term ‘‘active pharmaceutical ingredient’’ means— 

(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended— 

(i) to be used as a component of a drug; and 

(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, 

or prevention of disease, or to affect the structure or 

any function of the human body; or 

(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A). 

(3) The term ‘‘adjustment factor’’ means a factor applicable to 

a fiscal year that is the Consumer Price Index for all urban conVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00141 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
142 

sumers (all items; United States city average) for October of the 

preceding fiscal year divided by such Index for October 2011. 

(4) The term ‘‘affiliate’’ means a business entity that has a relationship with a second business entity if, directly or indirectly— 

(A) one business entity controls, or has the power to control, the other business entity; or 

(B) a third party controls, or has power to control, both 

of the business entities. 

(5)(A) The term ‘‘facility’’— 

(i) means a business or other entity— 

(I) under one management, either direct or indirect; 

and 

(II) at one geographic location or address engaged in 

manufacturing or processing an active pharmaceutical 

ingredient or a finished dosage form; and 

(ii) does not include a business or other entity whose only 

manufacturing or processing activities are one or more of 

the following: repackaging, relabeling, or testing. 

(B) For purposes of subparagraph (A), separate buildings 

within close proximity are considered to be at one geographic location or address if the activities in them are— 

(i) closely related to the same business enterprise; 

(ii) under the supervision of the same local management; 

and 

(iii) capable of being inspected by the Food and Drug Administration during a single inspection. 

(C) If a business or other entity would meet the definition of 

a facility under this paragraph but for being under multiple 

management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph. 

(6) The term ‘‘finished dosage form’’ means— 

(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or 

topical application; 

(B) a drug product in a form in which reconstitution is 

necessary prior to administration to a patient, such as oral 

suspensions or lyophilized powders; or 

(C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B). 

(7) The term ‘‘generic drug submission’’ means an abbreviated 

new drug application, an amendment to an abbreviated new 

drug application, or a prior approval supplement to an abbreviated new drug application. 

(8) The term ‘‘human generic drug activities’’ means the following activities of the Secretary associated with generic drugs 

and inspection of facilities associated with generic drugs: 

(A) The activities necessary for the review of generic drug 

submissions, including review of drug master files referenced in such submissions. 

(B) The issuance of— 


jbell on DSK7SPTVN1PROD with REPORTS
143 

(i) approval letters which approve abbreviated new 

drug applications or supplements to such applications; 

or 

(ii) complete response letters which set forth in detail 

the specific deficiencies in such applications and, where 

appropriate, the actions necessary to place such applications in condition for approval. 

(C) The issuance of letters related to Type II active pharmaceutical drug master files which— 

(i) set forth in detail the specific deficiencies in such 

submissions, and where appropriate, the actions necessary to resolve those deficiencies; or 

(ii) document that no deficiencies need to be addressed. 

(D) Inspections related to generic drugs. 

(E) Monitoring of research conducted in connection with 

the review of generic drug submissions and drug master 

files. 

(F) Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities: 

(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports. 

(ii) Developing and using improved adverse-event 

data-collection systems, including information technology systems. 

(iii) Developing and using improved analytical tools 

to assess potential safety problems, including access to 

external data bases. 

(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk 

evaluation and mitigation strategies) insofar as those 

activities relate to abbreviated new drug applications. 

(v) Carrying out section 505(k)(5) (relating to adverse-event reports and postmarket safety activities). 

(G) Regulatory science activities related to generic drugs. 

(9) The term ‘‘positron emission tomography drug’’ has the 

meaning given to the term ‘‘compounded positron emission tomography drug’’ in section 201(ii), except that paragraph (1)(B) 

of such section shall not apply. 

(10) The term ‘‘prior approval supplement’’ means a request 

to the Secretary to approve a change in the drug substance, 

drug product, production process, quality controls, equipment, 

or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have 

an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product. 

(11) The term ‘‘resources allocated for human generic drug activities’’ means the expenses for— 

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, 


jbell on DSK7SPTVN1PROD with REPORTS
144 

advisory committees, and costs related to such officers and 

employees and to contracts with such contractors; 

(B) management of information, and the acquisition, 

maintenance, and repair of computer resources; 

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, 

furniture, scientific equipment, and other necessary materials and supplies; and 

(D) collecting fees under subsection (a) and accounting 

for resources allocated for the review of abbreviated new 

drug applications and supplements and inspection related 

to generic drugs. 

(12) The term ‘‘Type II active pharmaceutical ingredient drug 

master file’’ means a submission of information to the Secretary 

by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of 

a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant. 

SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 

FEES. 

(a) TYPES OF FEES.—Beginning in fiscal year 2013, the Secretary 

shall assess and collect fees in accordance with this section as follows: 

(1) ONE-TIME BACKLOG FEE FOR ABBREVIATED NEW DRUG AP- PLICATIONS PENDING ON OCTOBER 1, 2012.— (A) IN GENERAL.—Each person that owns an abbreviated 

new drug application that is pending on October 1, 2012, 

and that has not received a tentative approval prior to that 

date, shall be subject to a fee for each such application, as 

calculated under subparagraph (B). 

(B) METHOD OF FEE AMOUNT CALCULATION.—The amount 

of each one-time backlog fee shall be calculated by dividing 

$50,000,000 by the total number of abbreviated new drug 

applications pending on October 1, 2012, that have not received a tentative approval as of that date. 

(C) NOTICE.—Not later than October 31, 2012, the Secretary shall cause to be published in the Federal Register 

a notice announcing the amount of the fee required by subparagraph (A). 

(D) FEE DUE DATE.—The fee required by subparagraph 

(A) shall be due no later than 30 calendar days after the 

date of the publication of the notice specified in subparagraph (C). 

(2) DRUG MASTER FILE FEE.— 

(A) IN GENERAL.—Each person that owns a Type II active 

pharmaceutical ingredient drug master file that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a drug master file fee. 

(B) ONE-TIME PAYMENT.—If a person has paid a drug 

master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required to 

pay a subsequent drug master file fee when that Type II active pharmaceutical ingredient drug master file is subsequently referenced in generic drug submissions. 


jbell on DSK7SPTVN1PROD with REPORTS
145 

(C) NOTICE.— 

(i) FISCAL YEAR 2013.—Not later than October 31, 

2012, the Secretary shall cause to be published in the 

Federal Register a notice announcing the amount of the 

drug master file fee for fiscal year 2013. 

(ii) FISCAL YEAR 2014 THROUGH 2017.—Not later than 

60 days before the start of each of fiscal years 2014 

through 2017, the Secretary shall cause to be published 

in the Federal Register the amount of the drug master 

file fee established by this paragraph for such fiscal 

year. 

(D) AVAILABILITY FOR REFERENCE.— 

(i) IN GENERAL.—Subject to subsection (g)(2)(C), for a 

generic drug submission to reference a Type II active 

pharmaceutical ingredient drug master file, the drug 

master file must be deemed available for reference by 

the Secretary. 

(ii) CONDITIONS.—A drug master file shall be deemed 

available for reference by the Secretary if— 

(I) the person that owns a Type II active pharmaceutical ingredient drug master file has paid 

the fee required under subparagraph (A) within 20 

calendar days after the applicable due date under 

subparagraph (E); and 

(II) the drug master file has not failed an initial 

completeness assessment by the Secretary, in accordance with criteria to be published by the Secretary. 

(iii) LIST.—The Secretary shall make publicly available on the Internet Web site of the Food and Drug Administration a list of the drug master file numbers that 

correspond to drug master files that have successfully 

undergone an initial completeness assessment, in accordance with criteria to be published by the Secretary, 

and are available for reference. 

(E) FEE DUE DATE.— 

(i) IN GENERAL.—Subject to clause (ii), a drug master 

file fee shall be due no later than the date on which the 

first generic drug submission is submitted that references the associated Type II active pharmaceutical 

ingredient drug master file. 

(ii) LIMITATION.—No fee shall be due under subparagraph (A) for a fiscal year until the later of— 

(I) 30 calendar days after publication of the notice provided for in clause (i) or (ii) of subparagraph (C), as applicable; or 

(II) 30 calendar days after the date of enactment 

of an appropriations Act providing for the collection and obligation of fees under this section. 

(3) ABBREVIATED NEW DRUG APPLICATION AND PRIOR APPROVAL SUPPLEMENT FILING FEE.— 

(A) IN GENERAL.—Each applicant that submits, on or 

after October 1, 2012, an abbreviated new drug application 

or a prior approval supplement to an abbreviated new drug 


jbell on DSK7SPTVN1PROD with REPORTS
146 

application shall be subject to a fee for each such submission in the amount established under subsection (d). 

(B) NOTICE.— (i) FISCAL YEAR 2013.—Not later than October 31, 

2012, the Secretary shall cause to be published in the 

Federal Register a notice announcing the amount of the 

fees under subparagraph (A) for fiscal year 2013. 

(ii) FISCAL YEARS 2014 THROUGH 2017.—Not later 

than 60 days before the start of each of fiscal years 

2014 through 2017, the Secretary shall cause to be 

published in the Federal Register the amount of the 

fees under subparagraph (A) for such fiscal year. 

(C) FEE DUE DATE.— (i) IN GENERAL.—Except as provided in clause (ii), 

the fees required by subparagraphs (A) and (F) shall be 

due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies. 

(ii) SPECIAL RULE FOR 2013.—For fiscal year 2013, 

such fees shall be due on the later of— 

(I) the date on which the fee is due under clause 

(i); 

(II) 30 calendar days after publication of the notice referred to in subparagraph (B)(i); or 

(III) if an appropriations Act is not enacted providing for the collection and obligation of fees 

under this section by the date of submission of the 

application or prior approval supplement for 

which the fees under subparagraphs (A) and (F) 

apply, 30 calendar days after the date that such an 

appropriations Act is enacted. 

(D) REFUND OF FEE IF ABBREVIATED NEW DRUG APPLICA- TION IS NOT CONSIDERED TO HAVE BEEN RECEIVED.—The 

Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application or 

prior approval supplement to an abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 505(j)(5)(A) for a cause 

other than failure to pay fees. 

(E) FEE FOR AN APPLICATION THE SECRETARY CONSIDERS

NOT TO HAVE BEEN RECEIVED, OR THAT HAS BEEN WITHDRAWN.—An abbreviated new drug application or prior approval supplement that was submitted on or after October 

1, 2012, and that the Secretary considers not to have been 

received, or that has been withdrawn, shall, upon resubmission of the application or a subsequent new submission 

following the applicant’s withdrawal of the application, be 

subject to a full fee under subparagraph (A). 

(F) ADDITIONAL FEE FOR ACTIVE PHARMACEUTICAL INGRE- DIENT INFORMATION NOT INCLUDED BY REFERENCE TO TYPE

II ACTIVE PHARMACEUTICAL INGREDIENT DRUG MASTER

FILE.—An applicant that submits a generic drug submission on or after October 1, 2012, shall pay a fee, in the 

amount determined under subsection (d)(3), in addition to 

the fee required under subparagraph (A), if— 


jbell on DSK7SPTVN1PROD with REPORTS
147 

(i) such submission contains information concerning 

the manufacture of an active pharmaceutical ingredient at a facility by means other than reference by a 

letter of authorization to a Type II active pharmaceutical drug master file; and 

(ii) a fee in the amount equal to the drug master file 

fee established in paragraph (2) has not been previously paid with respect to such information. 

(4) GENERIC DRUG FACILITY FEE AND ACTIVE PHARMACEUTICAL

INGREDIENT FACILITY FEE.— 

(A) IN GENERAL.—Facilities identified, or intended to be 

identified, in at least one generic drug submission that is 

pending or approved to produce a finished dosage form of 

a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject 

to fees as follows: 

(i) GENERIC DRUG FACILITY.—Each person that owns 

a facility which is identified or intended to be identified in at least one generic drug submission that is 

pending or approved to produce one or more finished 

dosage forms of a human generic drug shall be assessed an annual fee for each such facility. 

(ii) ACTIVE PHARMACEUTICAL INGREDIENT FACILITY.— 

Each person that owns a facility which produces, or 

which is pending review to produce, one or more active 

pharmaceutical ingredients identified, or intended to 

be identified, in at least one generic drug submission 

that is pending or approved or in a Type II active 

pharmaceutical ingredient drug master file referenced 

in such a generic drug submission, shall be assessed 

an annual fee for each such facility. 

(iii) FACILITIES PRODUCING BOTH ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED DOSAGE

FORMS.—Each person that owns a facility identified, or 

intended to be identified, in at least one generic drug 

submission that is pending or approved to produce 

both one or more finished dosage forms subject to 

clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject to fees 

under both such clauses for that facility. 

(B) AMOUNT.—The amount of fees established under subparagraph (A) shall be established under subsection (d). 

(C) NOTICE.— 

(i) FISCAL YEAR 2013.—For fiscal year 2013, the Secretary shall cause to be published in the Federal Register a notice announcing the amount of the fees provided for in subparagraph (A) within the timeframe 

specified in subsection (d)(1)(B). 

(ii) FISCAL YEARS 2014 THROUGH 2017.—Within the 

timeframe specified in subsection (d)(2), the Secretary 

shall cause to be published in the Federal Register the 

amount of the fees under subparagraph (A) for such 

fiscal year. 

(D) FEE DUE DATE.— 


jbell on DSK7SPTVN1PROD with REPORTS
148 

(i) FISCAL YEAR 2013.—For fiscal year 2013, the fees 

under subparagraph (A) shall be due on the later of— 

(I) not later than 45 days after the publication of 

the notice under subparagraph (B); or 

(II) if an appropriations Act is not enacted providing for the collection and obligation of fees 

under this section by the date of the publication of 

such notice, 30 days after the date that such an 

appropriations Act is enacted. 

(ii) FISCAL YEARS 2014 THROUGH 2017.—For each of 

fiscal years 2014 through 2017, the fees under subparagraph (A) for such fiscal year shall be due on the later 

of— 

(I) the first business day on or after October 1 of 

each such year; or 

(II) the first business day after the enactment of 

an appropriations Act providing for the collection 

and obligation of fees under this section for such 

year. 

(5) DATE OF SUBMISSION.—For purposes of this part, a generic drug submission or Type II pharmaceutical master file is 

deemed to be ‘‘submitted’’ to the Food and Drug Administration— 

(A) if it is submitted via a Food and Drug Administration electronic gateway, on the day when transmission to 

that electronic gateway is completed, except that a submission or master file that arrives on a weekend, Federal holiday, or day when the Food and Drug Administration office 

that will review that submission is not otherwise open for 

business shall be deemed to be submitted on the next day 

when that office is open for business; and 

(B) if it is submitted in physical media form, on the day 

it arrives at the appropriate designated document room of 

the Food and Drug Administration. 

(b) FEE REVENUE AMOUNTS.— (1) IN GENERAL.— (A) FISCAL YEAR 2013.—For fiscal year 2013, fees under 

subsection (a) shall be established to generate a total estimated revenue amount under such subsection of 

$299,000,000. Of that amount— (i) $50,000,000 shall be generated by the one-time 

backlog fee for generic drug applications pending on 

October 1, 2012, established in subsection (a)(1); and 

(ii) $249,000,000 shall be generated by the fees under 

paragraphs (2) through (4) of subsection (a). 

(B) FISCAL YEARS 2014 THROUGH 2017.—For each of the 

fiscal years 2014 through 2017, fees under paragraphs (2) 

through (4) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to $299,000,000, as adjusted pursuant 

to subsection (c). 

(2) TYPES OF FEES.—In establishing fees under paragraph (1) 

to generate the revenue amounts specified in paragraph 

(1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of 

fiscal years 2014 through 2017, such fees shall be derived from 


jbell on DSK7SPTVN1PROD with REPORTS
149 

the fees under paragraphs (2) through (4) of subsection (a) as 

follows: 

(A) 6 percent shall be derived from fees under subsection 

(a)(2) (relating to drug master files). 

(B) 24 percent shall be derived from fees under subsection 

(a)(3) (relating to abbreviated new drug applications and 

supplements). The amount of a fee for a prior approval supplement shall be half the amount of the fee for an abbreviated new drug application. 

(C) 56 percent shall be derived from fees under subsection 

(a)(4)(A)(i) (relating to generic drug facilities). The amount 

of the fee for a facility located outside the United States 

and its territories and possessions shall be not less than 

$15,000 and not more than $30,000 higher than the 

amount of the fee for a facility located in the United States 

and its territories and possessions, as determined by the 

Secretary on the basis of data concerning the difference in 

cost between inspections of facilities located in the United 

States, including its territories and possessions, and those 

located outside of the United States and its territories and 

possessions. 

(D) 14 percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located 

outside the United States and its territories and possessions 

shall be not less than $15,000 and not more than $30,000 

higher than the amount of the fee for a facility located in 

the United States, including its territories and possessions, 

as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States and its territories and possessions and those located outside of the United States and 

its territories and possessions. 

(c) ADJUSTMENTS.— 

(1) INFLATION ADJUSTMENT.— For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection (b) 

shall be adjusted by the Secretary by notice, published in the 

Federal Register, for a fiscal year, by an amount equal to the 

sum of— 

(A) one; 

(B) the average annual percent change in the cost, per 

full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid 

with respect to such positions for the first 3 years of the 

preceding 4 fiscal years multiplied by the proportion of personnel compensation and benefits costs to total costs of 

human generic drug activities for the first 3 years of the 

preceding 4 fiscal years; and 

(C) the average annual percent change that occurred in 

the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the 

preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and 


jbell on DSK7SPTVN1PROD with REPORTS
150 

benefits costs to total costs of human generic drug activities 

for the first 3 years of the preceding 4 fiscal years. 

The adjustment made each fiscal year under this subsection 

shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this 

subsection. 

(2) FINAL YEAR ADJUSTMENT.—For fiscal year 2017, the Secretary may, in addition to adjustments under paragraph (1), 

further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not 

more than 3 months of operating reserves of carryover user fees 

for human generic drug activities for the first 3 months of fiscal 

year 2018. Such fees may only be used in fiscal year 2018. If 

such an adjustment is necessary, the rationale for the amount 

of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2017. If the Secretary has carryover balances for such activities in excess of 3 

months of such operating reserves, the adjustment under this 

subparagraph shall not be made. 

(d) ANNUAL FEE SETTING.— 

(1) FISCAL YEAR 2013.—For fiscal year 2013— 

(A) the Secretary shall establish, by October 31, 2012, the 

one-time generic drug backlog fee for generic drug applications pending on October 1, 2012, the drug master file fee, 

the abbreviated new drug application fee, and the prior approval supplement fee under subsection (a), based on the 

revenue amounts established under subsection (b); and 

(B) the Secretary shall establish, not later than 45 days 

after the date to comply with the requirement for identification of facilities in subsection (f)(2), the generic drug facility 

fee and active pharmaceutical ingredient facility fee under 

subsection (a) based on the revenue amounts established 

under subsection (b). 

(2) FISCAL YEARS 2014 THROUGH 2017.—Not more than 60 days 

before the first day of each of fiscal years 2014 through 2017, 

the Secretary shall establish the drug master file fee, the abbreviated new drug application fee, the prior approval supplement 

fee, the generic drug facility fee, and the active pharmaceutical 

ingredient facility fee under subsection (a) for such fiscal year, 

based on the revenue amounts established under subsection (b) 

and the adjustments provided under subsection (c). 

(3) FEE FOR ACTIVE PHARMACEUTICAL INGREDIENT INFORMATION NOT INCLUDED BY REFERENCE TO TYPE II ACTIVE PHARMACEUTICAL INGREDIENT DRUG MASTER FILE.—In establishing the 

fees under paragraphs (1) and (2), the amount of the fee under 

subsection (a)(3)(F) shall be determined by multiplying— 

(A) the sum of— 

(i) the total number of such active pharmaceutical ingredients in such submission; and 

(ii) for each such ingredient that is manufactured at 

more than one such facility, the total number of such 

additional facilities; and 

(B) the amount equal to the drug master file fee established in subsection (a)(2) for such submission. 


jbell on DSK7SPTVN1PROD with REPORTS
151 

(e) LIMIT.—The total amount of fees charged, as adjusted under 

subsection (c), for a fiscal year may not exceed the total costs for 

such fiscal year for the resources allocated for human generic drug 

activities. 

(f) IDENTIFICATION OF FACILITIES.— 

(1) PUBLICATION OF NOTICE; DEADLINE FOR COMPLIANCE.— 

Not later than October 1, 2012, the Secretary shall cause to be 

published in the Federal Register a notice requiring each person 

that owns a facility described in subsection (a)(4)(A), or a site 

or organization required to be identified by paragraph (4), to 

submit to the Secretary information on the identity of each such 

facility, site, or organization. The notice required by this paragraph shall specify the type of information to be submitted and 

the means and format for submission of such information. 

(2) REQUIRED SUBMISSION OF FACILITY IDENTIFICATION.— 

Each person that owns a facility described in subsection 

(a)(4)(A) or a site or organization required to be identified by 

paragraph (4) shall submit to the Secretary the information required under this subsection each year. Such information 

shall— 

(A) for fiscal year 2013, be submitted not later than 60 

days after the publication of the notice under paragraph 

(1); and 

(B) for each subsequent fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous 

year. 

(3) CONTENTS OF NOTICE.—At a minimum, the submission required by paragraph (2) shall include for each such facility— 

(A) identification of a facility identified or intended to be 

identified in an approved or pending generic drug submission; 

(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both; 

(C) whether or not the facility is located within the 

United States and its territories and possessions; 

(D) whether the facility manufactures positron emission 

tomography drugs solely, or in addition to other drugs; and 

(E) whether the facility manufactures drugs that are not 

generic drugs. 

(4) CERTAIN SITES AND ORGANIZATIONS.— 

(A) IN GENERAL.—Any person that owns or operates a site 

or organization described in subparagraph (B) shall submit 

to the Secretary information concerning the ownership, 

name, and address of the site or organization. 

(B) SITES AND ORGANIZATIONS.—A site or organization is 

described in this subparagraph if it is identified in a generic drug submission and is— 

(i) a site in which a bioanalytical study is conducted; 

(ii) a clinical research organization; 

(iii) a contract analytical testing site; or 

(iv) a contract repackager site. 

(C) NOTICE.—The Secretary may, by notice published in 

the Federal Register, specify the means and format for submission of the information under subparagraph (A) and 


jbell on DSK7SPTVN1PROD with REPORTS
152 

may specify, as necessary for purposes of this section, any 

additional information to be submitted. 

(D) INSPECTION AUTHORITY.—The Secretary’s inspection 

authority under section 704(a)(1) shall extend to all such 

sites and organizations. 

(g) EFFECT OF FAILURE TO PAY FEES.— (1) GENERIC DRUG BACKLOG FEE.—Failure to pay the fee 

under subsection (a)(1) shall result in the Secretary placing the 

person that owns the abbreviated new drug application subject 

to that fee on an arrears list, such that no new abbreviated new 

drug applications or supplement submitted on or after October 

1, 2012, from that person, or any affiliate of that person, will 

be received within the meaning of section 505(j)(5)(A) until such 

outstanding fee is paid. 

(2) DRUG MASTER FILE FEE.— (A) Failure to pay the fee under subsection (a)(2) within 

20 calendar days after the applicable due date under subparagraph (E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall result in the Type II active 

pharmaceutical ingredient drug master file not being 

deemed available for reference. 

(B)(i) Any generic drug submission submitted on or after 

October 1, 2012, that references, by a letter of authorization, a Type II active pharmaceutical ingredient drug master file that has not been deemed available for reference 

shall not be received within the meaning of section 

505(j)(5)(A) unless the condition specified in clause (ii) is 

met. 

(ii) The condition specified in this clause is that the fee 

established under subsection (a)(2) has been paid within 20 

calendar days of the Secretary providing the notification to 

the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active 

pharmaceutical ingredient drug master file to pay the drug 

master file fee as specified in subparagraph (C). 

(C)(i) If an abbreviated new drug application or supplement to an abbreviated new drug application references a 

Type II active pharmaceutical ingredient drug master file 

for which a fee under subsection (a)(2)(A) has not been paid 

by the applicable date under subsection (a)(2)(E), the Secretary shall notify the sponsor of the abbreviated new drug 

application or supplement of the failure of the owner of the 

Type II active pharmaceutical ingredient drug master file 

to pay the applicable fee. 

(ii) If such fee is not paid within 20 calendar days of the 

Secretary providing the notification, the abbreviated new 

drug application or supplement to an abbreviated new drug 

application shall not be received within the meaning of 

505(j)(5)(A). 

(3) ABBREVIATED NEW DRUG APPLICATION FEE AND PRIOR AP- PROVAL SUPPLEMENT FEE.—Failure to pay a fee under subparagraph (A) or (F) of subsection (a)(3) within 20 calendar days of 

the applicable due date under subparagraph (C) of such subsection shall result in the abbreviated new drug application or 

the prior approval supplement to an abbreviated new drug apVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00152 Fmt 6659 Sfmt 6603 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
153 

plication not being received within the meaning of section 

505(j)(5)(A) until such outstanding fee is paid. 

(4) GENERIC DRUG FACILITY FEE AND ACTIVE PHARMACEUTICAL

INGREDIENT FACILITY FEE.— (A) IN GENERAL.—Failure to pay the fee under subsection 

(a)(4) within 20 calendar days of the due date as specified 

in subparagraph (D) of such subsection shall result in the 

following: 

(i) The Secretary shall place the facility on a publicly 

available arrears list, such that no new abbreviated 

new drug application or supplement submitted on or 

after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that person, 

will be received within the meaning of section 

505(j)(5)(A). 

(ii) Any new generic drug submission submitted on 

or after October 1, 2012, that references such a facility 

shall not be received, within the meaning of section 

505(j)(5)(A) if the outstanding facility fee is not paid 

within 20 calendar days of the Secretary providing the 

notification to the sponsor of the failure of the owner 

of the facility to pay the facility fee under subsection 

(a)(4)(C). 

(iii) All drugs or active pharmaceutical ingredients 

manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed 

misbranded under section 502(aa). 

(B) APPLICATION OF PENALTIES.—The penalties under 

this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility. 

(C) NONRECEIVAL FOR NONPAYMENT.— 

(i) NOTICE.—If an abbreviated new drug application 

or supplement to an abbreviated new drug application 

submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the 

applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay 

the facility fee. 

(ii) NONRECEIVAL.—If the facility fee is not paid 

within 20 calendar days of the Secretary providing the 

notification under clause (i), the abbreviated new drug 

application or supplement to an abbreviated new drug 

application shall not be received within the meaning of 

section 505(j)(5)(A). 

(h) LIMITATIONS.— 

(1) IN GENERAL.—Fees under subsection (a) shall be refunded 

for a fiscal year beginning after fiscal year 2012, unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees 

appropriated for such fiscal year) are equal to or greater than 

the amount of appropriations for the salaries and expenses of 

the Food and Drug Administration for the fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year) 


jbell on DSK7SPTVN1PROD with REPORTS
154 

multiplied by the adjustment factor (as defined in section 744A) 

applicable to the fiscal year involved. 

(2) AUTHORITY.—If the Secretary does not assess fees under 

subsection (a) during any portion of a fiscal year and if at a 

later date in such fiscal year the Secretary may assess such fees, 

the Secretary may assess and collect such fees, without any 

modification in the rate, for Type II active pharmaceutical ingredient drug master files, abbreviated new drug applications 

and prior approval supplements, and generic drug facilities and 

active pharmaceutical ingredient facilities at any time in such 

fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid. 

(i) CREDITING AND AVAILABILITY OF FEES.— (1) IN GENERAL.—Fees authorized under subsection (a) shall 

be collected and available for obligation only to the extent and 

in the amount provided in advance in appropriations Acts, subject to paragraph (2). Such fees are authorized to remain available until expended. Such sums as may be necessary may be 

transferred from the Food and Drug Administration salaries 

and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses 

with such fiscal year limitation. The sums transferred shall be 

available solely for human generic drug activities. 

(2) COLLECTIONS AND APPROPRIATION ACTS.— (A) IN GENERAL.—The fees authorized by this section— 

(i) subject to subparagraphs (C) and (D), shall be collected and available in each fiscal year in an amount 

not to exceed the amount specified in appropriation 

Acts, or otherwise made available for obligation for 

such fiscal year; and 

(ii) shall be available for a fiscal year beginning 

after fiscal year 2012 to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the 

Department of Health and HumanServices to be engaged in such activities), only if the Secretary allocates 

for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) 

no less than $97,000,000 multiplied by the adjustment 

factor defined in section 744A(3) applicable to the fiscal 

year involved. 

(B) COMPLIANCE.—The Secretary shall be considered to 

have met the requirements of subparagraph (A)(ii) in any 

fiscal year if the costs funded by appropriations and allocated for human generic activities are not more than 10 

percent below the level specified in such subparagraph. 

(C) FEE COLLECTION DURING FIRST PROGRAM YEAR.— 

Until the date of enactment of an Act making appropriations through September 30, 2013 for the salaries and expenses account of the Food and Drug Administration, fees 

authorized by this section for fiscal year 2013, may be collected and shall be credited to such account and remain 

available until expended. 

(D) PROVISION FOR EARLY PAYMENTS IN SUBSEQUENT

YEARS.—Payment of fees authorized under this section for 


jbell on DSK7SPTVN1PROD with REPORTS
155 

a fiscal year (after fiscal year 2013), prior to the due date 

for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act. 

(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equivalent to the 

total revenue amount determined under subsection (b) for the 

fiscal year, as adjusted under subsection (c), if applicable, or as 

otherwise affected under paragraph (2) of this subsection. 

(j) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 calendar days after it is due, such fee shall be treated 

as a claim of the United States Government subject to subchapter 

II of chapter 37 of title 31, United States Code. 

(k) CONSTRUCTION.—This section may not be construed to require 

that the number of full-time equivalent positions in the Department 

of Health and Human Services, for officers, employees, and advisory 

committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged. 

(l) POSITRON EMISSION TOMOGRAPHY DRUGS.— (1) EXEMPTION FROM FEES.—Submission of an application for 

a positron emission tomography drug or active pharmaceutical 

ingredient for a positron emission tomography drug shall not 

require the payment of any fee under this section. Facilities that 

solely produce positron emission tomography drugs shall not be 

required to pay a facility fee as established in subsection (a)(4). 

(2) IDENTIFICATION REQUIREMENT.—Facilities that produce 

positron emission tomography drugs or active pharmaceutical 

ingredients of such drugs are required to be identified pursuant 

to subsection (f). 

(m) DISPUTES CONCERNING FEES.—To qualify for the return of a 

fee claimed to have been paid in error under this section, a person 

shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid. 

(n) SUBSTANTIALLY COMPLETE APPLICATIONS.—An abbreviated 

new drug application that is not considered to be received within 

the meaning of section 505(j)(5)(A) because of failure to pay an applicable fee under this provision within the time period specified in 

subsection (g) shall be deemed not to have been ‘‘substantially complete’’ on the date of its submission within the meaning of section 

505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application that is 

not substantially complete on the date of its submission solely because of failure to pay an applicable fee under the preceding sentence shall be deemed substantially complete and received within 

the meaning of section 505(j)(5)(A) as of the date such applicable fee 

is received. 

SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS. 

(a) PERFORMANCE REPORT.— 

(1) IN GENERAL.—Beginning with fiscal year 2013, not later 

than 120 days after the end of each fiscal year for which fees 

are collected under this part, the Secretary shall prepare and 

submit to the Committee on Energy and Commerce of the House 

of Representatives and the Committee on Health, Education, 


jbell on DSK7SPTVN1PROD with REPORTS
156 

Labor, and Pensions of the Senate a report concerning the 

progress of the Food and Drug Administration in achieving the 

goals identified in the letters described in section 301(b) of the 

Generic Drug User Fee Amendments of 2012 during such fiscal 

year and the future plans of the Food and Drug Administration 

for meeting the goals. 

(2) REGULATORY SCIENCE ACCOUNTABILITY METRICS.—The report required by paragraph (1) shall describe the amounts 

spent, data generated, and activities undertaken, including any 

FDA Advisory Committee consideration, by the Secretary for 

each of the local acting bioequivalence topics (Topics 1–3) in the 

Regulatory Science Plan described in the letters described in 

section 301(b) of the Generic Drug User Fee Amendments of 

2012. 

(b) FISCAL REPORT.—Beginning with fiscal year 2013, not later 

than 120 days after the end of each fiscal year for which fees are 

collected under this part, the Secretary shall prepare and submit to 

the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority 

for such fees during such fiscal year and the use, by the Food and 

Drug Administration, of the fees collected for such fiscal year. 

(c) PUBLIC AVAILABILITY.—The Secretary shall make the reports 

required under subsections (a) and (b) available to the public on the 

Internet Web site of the Food and Drug Administration. 

(d) REAUTHORIZATION.— (1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals, and plans for 

meeting the goals, for human generic drug activities for the first 

5 fiscal years after fiscal year 2017, and for the reauthorization 

of this part for such fiscal years, the Secretary shall consult 

with— 

(A) the Committee on Energy and Commerce of the House 

of Representatives; 

(B) the Committee on Health, Education, Labor, and Pensions of the Senate; 

(C) scientific and academic experts; 

(D) health care professionals; 

(E) representatives of patient and consumer advocacy 

groups; and 

(F) the generic drug industry. 

(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the generic drug industry on the reauthorization of this 

part, the Secretary shall— 

(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

(B) hold a public meeting at which the public may 

present its views on the reauthorization, including specific 

suggestions for changes to the goals referred to in subsection (a); 

(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

(D) publish the comments on the Food and Drug Administration’s Internet Web site. 


jbell on DSK7SPTVN1PROD with REPORTS
157 

(3) PERIODIC CONSULTATION.—Not less frequently than once 

every month during negotiations with the generic drug industry, the Secretary shall hold discussions with representatives of 

patient and consumer advocacy groups to continue discussions 

of their views on the reauthorization and their suggestions for 

changes to this part as expressed under paragraph (2). 

(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the generic drug industry, the Secretary shall— 

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such 

paragraph; 

(B) publish such recommendations in the Federal Register; 

(C) provide for a period of 30 days for the public to provide written comments on such recommendations; 

(D) hold a meeting at which the public may present its 

views on such recommendations; and 

(E) after consideration of such public views and comments, revise such recommendations as necessary. 

(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2017, the Secretary shall transmit to the Congress 

the revised recommendations under paragraph (4), a summary 

of the views and comments received under such paragraph, and 

any changes made to the recommendations in response to such 

views and comments. 

(6) MINUTES OF NEGOTIATION MEETINGS.— (A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) 

to the Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted 

under this subsection between the Food and Drug Administration and the generic drug industry. 

(B) CONTENT.—The minutes described under subparagraph (A) shall summarize any substantive proposal made 

by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations 

and their resolution. 

[Effective October 1, 2017, section 304(a) of H.R. 5651 provides for a repeal of 

sections 744A and 744B (as added by the bill).] 

øSEC. 744A. DEFINITIONS. 

øFor purposes of this part: 

ø(1) The term ‘‘abbreviated new drug application’’— 

ø(A) means an application submitted under section 

505(j), an abbreviated application submitted under section 

507 (as in effect on the day before the date of enactment 

of the Food and Drug Administration Modernization Act of 

1997), or an abbreviated new drug application submitted 

pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and 

ø(B) does not include an application for a positron emission tomography drug. 

ø(2) The term ‘‘active pharmaceutical ingredient’’ means— 


jbell on DSK7SPTVN1PROD with REPORTS
158 

ø(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended— 

ø(i) to be used as a component of a drug; and 

ø(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or 

ø(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A). 

ø(3) The term ‘‘adjustment factor’’ means a factor applicable 

to a fiscal year that is the Consumer Price Index for all urban 

consumers (all items; United States city average) for October 

of the preceding fiscal year divided by such Index for October 

2011. 

ø(4) The term ‘‘affiliate’’ means a business entity that has a 

relationship with a second business entity if, directly or indirectly— 

ø(A) one business entity controls, or has the power to 

control, the other business entity; or 

ø(B) a third party controls, or has power to control, both 

of the business entities. 

ø(5)(A) The term ‘‘facility’’— 

ø(i) means a business or other entity— 

ø(I) under one management, either direct or indirect; and 

ø(II) at one geographic location or address engaged 

in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and 

ø(ii) does not include a business or other entity whose 

only manufacturing or processing activities are one or 

more of the following: repackaging, relabeling, or testing. 

ø(B) For purposes of subparagraph (A), separate buildings 

within close proximity are considered to be at one geographic 

location or address if the activities in them are— 

ø(i) closely related to the same business enterprise; 

ø(ii) under the supervision of the same local management; and 

ø(iii) capable of being inspected by the Food and Drug 

Administration during a single inspection. 

ø(C) If a business or other entity would meet the definition 

of a facility under this paragraph but for being under multiple 

management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph. 

ø(6) The term ‘‘finished dosage form’’ means— 

ø(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, 

or topical application; 

ø(B) a drug product in a form in which reconstitution is 

necessary prior to administration to a patient, such as oral 

suspensions or lyophilized powders; or 

ø(C) any combination of an active pharmaceutical ingredient with another component of a drug product for purVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00158 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
159 

poses of production of a drug product described in subparagraph (A) or (B). 

ø(7) The term ‘‘generic drug submission’’ means an abbreviated new drug application, an amendment to an abbreviated 

new drug application, or a prior approval supplement to an abbreviated new drug application. 

ø(8) The term ‘‘human generic drug activities’’ means the following activities of the Secretary associated with generic drugs 

and inspection of facilities associated with generic drugs: 

ø(A) The activities necessary for the review of generic 

drug submissions, including review of drug master files 

referenced in such submissions. 

ø(B) The issuance of— 

ø(i) approval letters which approve abbreviated new 

drug applications or supplements to such applications; 

or 

ø(ii) complete response letters which set forth in detail the specific deficiencies in such applications and, 

where appropriate, the actions necessary to place such 

applications in condition for approval. 

ø(C) The issuance of letters related to Type II active 

pharmaceutical drug master files which— 

ø(i) set forth in detail the specific deficiencies in 

such submissions, and where appropriate, the actions 

necessary to resolve those deficiencies; or 

ø(ii) document that no deficiencies need to be addressed. 

ø(D) Inspections related to generic drugs. 

ø(E) Monitoring of research conducted in connection with 

the review of generic drug submissions and drug master 

files. 

ø(F) Postmarket safety activities with respect to drugs 

approved under abbreviated new drug applications or supplements, including the following activities: 

ø(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event 

reports. 

ø(ii) Developing and using improved adverse-event 

data-collection systems, including information technology systems. 

ø(iii) Developing and using improved analytical tools 

to assess potential safety problems, including access to 

external data bases. 

ø(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and 

labeling changes) and section 505(p) (relating to risk 

evaluation and mitigation strategies) insofar as those 

activities relate to abbreviated new drug applications. 

ø(v) Carrying out section 505(k)(5) (relating to adverse-event reports and postmarket safety activities). 

ø(G) Regulatory science activities related to generic 

drugs. 

ø(9) The term ‘‘positron emission tomography drug’’ has the 

meaning given to the term ‘‘compounded positron emission toVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00159 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
160 

mography drug’’ in section 201(ii), except that paragraph (1)(B) 

of such section shall not apply. 

ø(10) The term ‘‘prior approval supplement’’ means a request 

to the Secretary to approve a change in the drug substance, 

drug product, production process, quality controls, equipment, 

or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have 

an adverse effect on the identity, strength, quality, purity, or 

potency of the drug product as these factors may relate to the 

safety or effectiveness of the drug product. 

ø(11) The term ‘‘resources allocated for human generic drug 

activities’’ means the expenses for— 

ø(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers and employees and to contracts with such contractors; 

ø(B) management of information, and the acquisition, 

maintenance, and repair of computer resources; 

ø(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary 

materials and supplies; and 

ø(D) collecting fees under subsection (a) and accounting 

for resources allocated for the review of abbreviated new 

drug applications and supplements and inspection related 

to generic drugs. 

ø(12) The term ‘‘Type II active pharmaceutical ingredient 

drug master file’’ means a submission of information to the 

Secretary by a person that intends to authorize the Food and 

Drug Administration to reference the information to support 

approval of a generic drug submission without the submitter 

having to disclose the information to the generic drug submission applicant. 

øSEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 

FEES. 

ø(a) TYPES OF FEES.—Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section 

as follows: 

ø(1) ONE-TIME BACKLOG FEE FOR ABBREVIATED NEW DRUG APPLICATIONS PENDING ON OCTOBER 1, 2012.— 

ø(A) IN GENERAL.—Each person that owns an abbreviated new drug application that is pending on October 1, 

2012, and that has not received a tentative approval prior 

to that date, shall be subject to a fee for each such application, as calculated under subparagraph (B). 

ø(B) METHOD OF FEE AMOUNT CALCULATION.—The 

amount of each one-time backlog fee shall be calculated by 

dividing $50,000,000 by the total number of abbreviated 

new drug applications pending on October 1, 2012, that 

have not received a tentative approval as of that date. 

ø(C) NOTICE.—Not later than October 31, 2012, the Secretary shall cause to be published in the Federal Register 

a notice announcing the amount of the fee required by subparagraph (A). 


jbell on DSK7SPTVN1PROD with REPORTS
161 

ø(D) FEE DUE DATE.—The fee required by subparagraph 

(A) shall be due no later than 30 calendar days after the 

date of the publication of the notice specified in subparagraph (C). 

ø(2) DRUG MASTER FILE FEE.— ø(A) IN GENERAL.—Each person that owns a Type II active pharmaceutical ingredient drug master file that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a drug master file fee. 

ø(B) ONE-TIME PAYMENT.—If a person has paid a drug 

master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required to 

pay a subsequent drug master file fee when that Type II 

active pharmaceutical ingredient drug master file is subsequently referenced in generic drug submissions. 

ø(C) NOTICE.— ø(i) FISCAL YEAR 2013.—Not later than October 31, 

2012, the Secretary shall cause to be published in the 

Federal Register a notice announcing the amount of 

the drug master file fee for fiscal year 2013. 

ø(ii) FISCAL YEAR 2014 THROUGH 2017.—Not later 

than 60 days before the start of each of fiscal years 

2014 through 2017, the Secretary shall cause to be 

published in the Federal Register the amount of the 

drug master file fee established by this paragraph for 

such fiscal year. 

ø(D) AVAILABILITY FOR REFERENCE.— ø(i) IN GENERAL.—Subject to subsection (g)(2)(C), for 

a generic drug submission to reference a Type II active 

pharmaceutical ingredient drug master file, the drug 

master file must be deemed available for reference by 

the Secretary. 

ø(ii) CONDITIONS.—A drug master file shall be 

deemed available for reference by the Secretary if— 

ø(I) the person that owns a Type II active pharmaceutical ingredient drug master file has paid 

the fee required under subparagraph (A) within 

20 calendar days after the applicable due date 

under subparagraph (E); and 

ø(II) the drug master file has not failed an initial completeness assessment by the Secretary, in 

accordance with criteria to be published by the 

Secretary. 

ø(iii) LIST.—The Secretary shall make publicly available on the Internet Web site of the Food and Drug 

Administration a list of the drug master file numbers 

that correspond to drug master files that have successfully undergone an initial completeness assessment, in 

accordance with criteria to be published by the Secretary, and are available for reference. 

ø(E) FEE DUE DATE.— ø(i) IN GENERAL.—Subject to clause (ii), a drug master file fee shall be due no later than the date on 

which the first generic drug submission is submitted 


jbell on DSK7SPTVN1PROD with REPORTS
162 

that references the associated Type II active pharmaceutical ingredient drug master file. 

ø(ii) LIMITATION.— No fee shall be due under subparagraph (A) for a fiscal year until the later of— 

ø(I) 30 calendar days after publication of the notice provided for in clause (i) or (ii) of subparagraph (C), as applicable; or 

ø(II) 30 calendar days after the date of enactment of an appropriations Act providing for the 

collection and obligation of fees under this section. 

ø(3) ABBREVIATED NEW DRUG APPLICATION AND PRIOR APPROVAL SUPPLEMENT FILING FEE.— 

ø(A) IN GENERAL.—Each applicant that submits, on or 

after October 1, 2012, an abbreviated new drug application 

or a prior approval supplement to an abbreviated new 

drug application shall be subject to a fee for each such submission in the amount established under subsection (d). 

ø(B) NOTICE.— 

ø(i) FISCAL YEAR 2013.—Not later than October 31, 

2012, the Secretary shall cause to be published in the 

Federal Register a notice announcing the amount of 

the fees under subparagraph (A) for fiscal year 2013. 

ø(ii) FISCAL YEARS 2014 THROUGH 2017.—Not later 

than 60 days before the start of each of fiscal years 

2014 through 2017, the Secretary shall cause to be 

published in the Federal Register the amount of the 

fees under subparagraph (A) for such fiscal year. 

ø(C) FEE DUE DATE.— 

ø(i) IN GENERAL.—Except as provided in clause (ii), 

the fees required by subparagraphs (A) and (F) shall 

be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies. 

ø(ii) SPECIAL RULE FOR 2013.—For fiscal year 2013, 

such fees shall be due on the later of— 

ø(I) the date on which the fee is due under 

clause (i); 

ø(II) 30 calendar days after publication of the 

notice referred to in subparagraph (B)(i); or 

ø(III) if an appropriations Act is not enacted 

providing for the collection and obligation of fees 

under this section by the date of submission of the 

application or prior approval supplement for 

which the fees under subparagraphs (A) and (F) 

apply, 30 calendar days after the date that such 

an appropriations Act is enacted. 

ø(D) REFUND OF FEE IF ABBREVIATED NEW DRUG APPLICATION IS NOT CONSIDERED TO HAVE BEEN RECEIVED.—The 

Secretary shall refund 75 percent of the fee paid under 

subparagraph (A) for any abbreviated new drug application or prior approval supplement to an abbreviated new 

drug application that the Secretary considers not to have 

been received within the meaning of section 505(j)(5)(A) for 

a cause other than failure to pay fees. 


jbell on DSK7SPTVN1PROD with REPORTS
163 

ø(E) FEE FOR AN APPLICATION THE SECRETARY CONSIDERS

NOT TO HAVE BEEN RECEIVED, OR THAT HAS BEEN WITHDRAWN.—An abbreviated new drug application or prior approval supplement that was submitted on or after October 

1, 2012, and that the Secretary considers not to have been 

received, or that has been withdrawn, shall, upon resubmission of the application or a subsequent new submission 

following the applicant’s withdrawal of the application, be 

subject to a full fee under subparagraph (A). 

ø(F) ADDITIONAL FEE FOR ACTIVE PHARMACEUTICAL INGREDIENT INFORMATION NOT INCLUDED BY REFERENCE TO

TYPE II ACTIVE PHARMACEUTICAL INGREDIENT DRUG MASTER

FILE.—An applicant that submits a generic drug submission on or after October 1, 2012, shall pay a fee, in the 

amount determined under subsection (d)(3), in addition to 

the fee required under subparagraph (A), if— 

ø(i) such submission contains information concerning the manufacture of an active pharmaceutical 

ingredient at a facility by means other than reference 

by a letter of authorization to a Type II active pharmaceutical drug master file; and 

ø(ii) a fee in the amount equal to the drug master 

file fee established in paragraph (2) has not been previously paid with respect to such information. 

ø(4) GENERIC DRUG FACILITY FEE AND ACTIVE PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

ø(A) IN GENERAL.—Facilities identified, or intended to be 

identified, in at least one generic drug submission that is 

pending or approved to produce a finished dosage form of 

a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject 

to fees as follows: 

ø(i) GENERIC DRUG FACILITY.—Each person that 

owns a facility which is identified or intended to be 

identified in at least one generic drug submission that 

is pending or approved to produce one or more finished dosage forms of a human generic drug shall be 

assessed an annual fee for each such facility. 

ø(ii) ACTIVE PHARMACEUTICAL INGREDIENT FACILITY.—Each person that owns a facility which produces, 

or which is pending review to produce, one or more active pharmaceutical ingredients identified, or intended 

to be identified, in at least one generic drug submission that is pending or approved or in a Type II active 

pharmaceutical ingredient drug master file referenced 

in such a generic drug submission, shall be assessed 

an annual fee for each such facility. 

ø(iii) FACILITIES PRODUCING BOTH ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED DOSAGE

FORMS.—Each person that owns a facility identified, or 

intended to be identified, in at least one generic drug 

submission that is pending or approved to produce 

both one or more finished dosage forms subject to 

clause (i) and one or more active pharmaceutical inVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00163 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
164 

gredients subject to clause (ii) shall be subject to fees 

under both such clauses for that facility. 

ø(B) AMOUNT.—The amount of fees established under 

subparagraph (A) shall be established under subsection 

(d). 

ø(C) NOTICE.— ø(i) FISCAL YEAR 2013.—For fiscal year 2013, the Secretary shall cause to be published in the Federal Register a notice announcing the amount of the fees provided for in subparagraph (A) within the timeframe 

specified in subsection (d)(1)(B). 

ø(ii) FISCAL YEARS 2014 THROUGH 2017.—Within the 

timeframe specified in subsection (d)(2), the Secretary 

shall cause to be published in the Federal Register the 

amount of the fees under subparagraph (A) for such 

fiscal year. 

ø(D) FEE DUE DATE.— ø(i) FISCAL YEAR 2013.—For fiscal year 2013, the fees 

under subparagraph (A) shall be due on the later of— 

ø(I) not later than 45 days after the publication 

of the notice under subparagraph (B); or 

ø(II) if an appropriations Act is not enacted providing for the collection and obligation of fees 

under this section by the date of the publication 

of such notice, 30 days after the date that such an 

appropriations Act is enacted. 

ø(ii) FISCAL YEARS 2014 THROUGH 2017.—For each of 

fiscal years 2014 through 2017, the fees under subparagraph (A) for such fiscal year shall be due on the 

later of— 

ø(I) the first business day on or after October 1 

of each such year; or 

ø(II) the first business day after the enactment 

of an appropriations Act providing for the collection and obligation of fees under this section for 

such year. 

ø(5) DATE OF SUBMISSION.—For purposes of this part, a generic drug submission or Type II pharmaceutical master file is 

deemed to be ‘‘submitted’’ to the Food and Drug Administration— 

ø(A) if it is submitted via a Food and Drug Administration electronic gateway, on the day when transmission to 

that electronic gateway is completed, except that a submission or master file that arrives on a weekend, Federal holiday, or day when the Food and Drug Administration office 

that will review that submission is not otherwise open for 

business shall be deemed to be submitted on the next day 

when that office is open for business; and 

ø(B) if it is submitted in physical media form, on the day 

it arrives at the appropriate designated document room of 

the Food and Drug Administration. 

ø(b) FEE REVENUE AMOUNTS.— ø(1) IN GENERAL.— 

ø(A) FISCAL YEAR 2013.—For fiscal year 2013, fees under 

subsection (a) shall be established to generate a total estiVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00164 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
165 

mated revenue amount under such subsection of 

$299,000,000. Of that amount— 

ø(i) $50,000,000 shall be generated by the one-time 

backlog fee for generic drug applications pending on 

October 1, 2012, established in subsection (a)(1); and 

ø(ii) $249,000,000 shall be generated by the fees 

under paragraphs (2) through (4) of subsection (a). 

ø(B) FISCAL YEARS 2014 THROUGH 2017.—For each of the 

fiscal years 2014 through 2017, fees under paragraphs (2) 

through (4) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to $299,000,000, as adjusted pursuant 

to subsection (c). 

ø(2) TYPES OF FEES.—In establishing fees under paragraph 

(1) to generate the revenue amounts specified in paragraph 

(1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of 

fiscal years 2014 through 2017, such fees shall be derived from 

the fees under paragraphs (2) through (4) of subsection (a) as 

follows: 

ø(A) 6 percent shall be derived from fees under subsection (a)(2) (relating to drug master files). 

ø(B) 24 percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications and supplements). The amount of a fee for a prior approval supplement shall be half the amount of the fee for 

an abbreviated new drug application. 

ø(C) 56 percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The 

amount of the fee for a facility located outside the United 

States and its territories and possessions shall be not less 

than $15,000 and not more than $30,000 higher than the 

amount of the fee for a facility located in the United States 

and its territories and possessions, as determined by the 

Secretary on the basis of data concerning the difference in 

cost between inspections of facilities located in the United 

States, including its territories and possessions, and those 

located outside of the United States and its territories and 

possessions. 

ø(D) 14 percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than 

$30,000 higher than the amount of the fee for a facility located in the United States, including its territories and 

possessions, as determined by the Secretary on the basis 

of data concerning the difference in cost between inspections of facilities located in the United States and its territories and possessions and those located outside of the 

United States and its territories and possessions. 

ø(c) ADJUSTMENTS.— 

ø(1) INFLATION ADJUSTMENT.— For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection (b) 

shall be adjusted by the Secretary by notice, published in the 


jbell on DSK7SPTVN1PROD with REPORTS
166 

Federal Register, for a fiscal year, by an amount equal to the 

sum of— 

ø(A) one; 

ø(B) the average annual percent change in the cost, per 

full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid 

with respect to such positions for the first 3 years of the 

preceding 4 fiscal years multiplied by the proportion of 

personnel compensation and benefits costs to total costs of 

human generic drug activities for the first 3 years of the 

preceding 4 fiscal years; and 

ø(C) the average annual percent change that occurred in 

the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the 

preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and 

benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years. 

The adjustment made each fiscal year under this subsection 

shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this 

subsection. 

ø(2) FINAL YEAR ADJUSTMENT.—For fiscal year 2017, the Secretary may, in addition to adjustments under paragraph (1), 

further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not 

more than 3 months of operating reserves of carryover user 

fees for human generic drug activities for the first 3 months of 

fiscal year 2018. Such fees may only be used in fiscal year 

2018. If such an adjustment is necessary, the rationale for the 

amount of the increase shall be contained in the annual notice 

establishing fee revenues and fees for fiscal year 2017. If the 

Secretary has carryover balances for such activities in excess 

of 3 months of such operating reserves, the adjustment under 

this subparagraph shall not be made. 

ø(d) ANNUAL FEE SETTING.— ø(1) FISCAL YEAR 2013.—For fiscal year 2013— 

ø(A) the Secretary shall establish, by October 31, 2012, 

the one-time generic drug backlog fee for generic drug applications pending on October 1, 2012, the drug master file 

fee, the abbreviated new drug application fee, and the 

prior approval supplement fee under subsection (a), based 

on the revenue amounts established under subsection (b); 

and 

ø(B) the Secretary shall establish, not later than 45 days 

after the date to comply with the requirement for identification of facilities in subsection (f)(2), the generic drug facility fee and active pharmaceutical ingredient facility fee 

under subsection (a) based on the revenue amounts established under subsection (b). 

ø(2) FISCAL YEARS 2014 THROUGH 2017.—Not more than 60 

days before the first day of each of fiscal years 2014 through 

2017, the Secretary shall establish the drug master file fee, the 

abbreviated new drug application fee, the prior approval supVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00166 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
167 

plement fee, the generic drug facility fee, and the active pharmaceutical ingredient facility fee under subsection (a) for such 

fiscal year, based on the revenue amounts established under 

subsection (b) and the adjustments provided under subsection 

(c). 

ø(3) FEE FOR ACTIVE PHARMACEUTICAL INGREDIENT INFORMA- TION NOT INCLUDED BY REFERENCE TO TYPE II ACTIVE PHARMA- CEUTICAL INGREDIENT DRUG MASTER FILE.—In establishing the 

fees under paragraphs (1) and (2), the amount of the fee under 

subsection (a)(3)(F) shall be determined by multiplying— 

ø(A) the sum of— 

ø(i) the total number of such active pharmaceutical 

ingredients in such submission; and 

ø(ii) for each such ingredient that is manufactured 

at more than one such facility, the total number of 

such additional facilities; and 

ø(B) the amount equal to the drug master file fee established in subsection (a)(2) for such submission. 

ø(e) LIMIT.— The total amount of fees charged, as adjusted under 

subsection (c), for a fiscal year may not exceed the total costs for 

such fiscal year for the resources allocated for human generic drug 

activities. 

ø(f) IDENTIFICATION OF FACILITIES.— ø(1) PUBLICATION OF NOTICE; DEADLINE FOR COMPLIANCE.— Not later than October 1, 2012, the Secretary shall cause to be 

published in the Federal Register a notice requiring each person that owns a facility described in subsection (a)(4)(A), or a 

site or organization required to be identified by paragraph (4), 

to submit to the Secretary information on the identity of each 

such facility, site, or organization. The notice required by this 

paragraph shall specify the type of information to be submitted 

and the means and format for submission of such information. 

ø(2) REQUIRED SUBMISSION OF FACILITY IDENTIFICATION.— Each person that owns a facility described in subsection 

(a)(4)(A) or a site or organization required to be identified by 

paragraph (4) shall submit to the Secretary the information required under this subsection each year. Such information 

shall— 

ø(A) for fiscal year 2013, be submitted not later than 60 

days after the publication of the notice under paragraph 

(1); and 

ø(B) for each subsequent fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous 

year. 

ø(3) CONTENTS OF NOTICE.—At a minimum, the submission 

required by paragraph (2) shall include for each such facility— 

ø(A) identification of a facility identified or intended to 

be identified in an approved or pending generic drug submission; 

ø(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both; 

ø(C) whether or not the facility is located within the 

United States and its territories and possessions; 

ø(D) whether the facility manufactures positron emission 

tomography drugs solely, or in addition to other drugs; and 


jbell on DSK7SPTVN1PROD with REPORTS
168 

ø(E) whether the facility manufactures drugs that are 

not generic drugs. 

ø(4) CERTAIN SITES AND ORGANIZATIONS.— ø(A) IN GENERAL.—Any person that owns or operates a 

site or organization described in subparagraph (B) shall 

submit to the Secretary information concerning the ownership, name, and address of the site or organization. 

ø(B) SITES AND ORGANIZATIONS.—A site or organization 

is described in this subparagraph if it is identified in a generic drug submission and is— 

ø(i) a site in which a bioanalytical study is conducted; 

ø(ii) a clinical research organization; 

ø(iii) a contract analytical testing site; or 

ø(iv) a contract repackager site. 

ø(C) NOTICE.—The Secretary may, by notice published in 

the Federal Register, specify the means and format for 

submission of the information under subparagraph (A) and 

may specify, as necessary for purposes of this section, any 

additional information to be submitted. 

ø(D) INSPECTION AUTHORITY.—The Secretary’s inspection 

authority under section 704(a)(1) shall extend to all such 

sites and organizations. 

ø(g) EFFECT OF FAILURE TO PAY FEES.— ø(1) GENERIC DRUG BACKLOG FEE.—Failure to pay the fee 

under subsection (a)(1) shall result in the Secretary placing the 

person that owns the abbreviated new drug application subject 

to that fee on an arrears list, such that no new abbreviated 

new drug applications or supplement submitted on or after October 1, 2012, from that person, or any affiliate of that person, 

will be received within the meaning of section 505(j)(5)(A) until 

such outstanding fee is paid. 

ø(2) DRUG MASTER FILE FEE.— ø(A) Failure to pay the fee under subsection (a)(2) within 

20 calendar days after the applicable due date under subparagraph (E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall result in the Type II active 

pharmaceutical ingredient drug master file not being 

deemed available for reference. 

ø(B)(i) Any generic drug submission submitted on or 

after October 1, 2012, that references, by a letter of authorization, a Type II active pharmaceutical ingredient 

drug master file that has not been deemed available for 

reference shall not be received within the meaning of section 505(j)(5)(A) unless the condition specified in clause (ii) 

is met. 

ø(ii) The condition specified in this clause is that the fee 

established under subsection (a)(2) has been paid within 

20 calendar days of the Secretary providing the notification to the sponsor of the abbreviated new drug application 

or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the 

drug master file fee as specified in subparagraph (C). 

ø(C)(i) If an abbreviated new drug application or supplement to an abbreviated new drug application references a 


jbell on DSK7SPTVN1PROD with REPORTS
169 

Type II active pharmaceutical ingredient drug master file 

for which a fee under subsection (a)(2)(A) has not been 

paid by the applicable date under subsection (a)(2)(E), the 

Secretary shall notify the sponsor of the abbreviated new 

drug application or supplement of the failure of the owner 

of the Type II active pharmaceutical ingredient drug master file to pay the applicable fee. 

ø(ii) If such fee is not paid within 20 calendar days of 

the Secretary providing the notification, the abbreviated 

new drug application or supplement to an abbreviated new 

drug application shall not be received within the meaning 

of 505(j)(5)(A). 

ø(3) ABBREVIATED NEW DRUG APPLICATION FEE AND PRIOR AP- PROVAL SUPPLEMENT FEE.—Failure to pay a fee under subparagraph (A) or (F) of subsection (a)(3) within 20 calendar days of 

the applicable due date under subparagraph (C) of such subsection shall result in the abbreviated new drug application or 

the prior approval supplement to an abbreviated new drug application not being received within the meaning of section 

505(j)(5)(A) until such outstanding fee is paid. 

ø(4) GENERIC DRUG FACILITY FEE AND ACTIVE PHARMA- CEUTICAL INGREDIENT FACILITY FEE.— ø(A) IN GENERAL.—Failure to pay the fee under subsection (a)(4) within 20 calendar days of the due date as 

specified in subparagraph (D) of such subsection shall result in the following: 

ø(i) The Secretary shall place the facility on a publicly available arrears list, such that no new abbreviated new drug application or supplement submitted 

on or after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that 

person, will be received within the meaning of section 

505(j)(5)(A). 

ø(ii) Any new generic drug submission submitted on 

or after October 1, 2012, that references such a facility 

shall not be received, within the meaning of section 

505(j)(5)(A) if the outstanding facility fee is not paid 

within 20 calendar days of the Secretary providing the 

notification to the sponsor of the failure of the owner 

of the facility to pay the facility fee under subsection 

(a)(4)(C). 

ø(iii) All drugs or active pharmaceutical ingredients 

manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed 

misbranded under section 502(aa). 

ø(B) APPLICATION OF PENALTIES.—The penalties under 

this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility. 

ø(C) NONRECEIVAL FOR NONPAYMENT.— ø(i) NOTICE.—If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been 

paid by the applicable date under subsection (a)(4)(C), 


jbell on DSK7SPTVN1PROD with REPORTS
170 

the Secretary shall notify the sponsor of the generic 

drug submission of the failure of the owner of the facility to pay the facility fee. 

ø(ii) NONRECEIVAL.—If the facility fee is not paid 

within 20 calendar days of the Secretary providing the 

notification under clause (i), the abbreviated new drug 

application or supplement to an abbreviated new drug 

application shall not be received within the meaning of 

section 505(j)(5)(A). 

ø(h) LIMITATIONS.— ø(1) IN GENERAL.—Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2012, unless 

appropriations for salaries and expenses of the Food and Drug 

Administration for such fiscal year (excluding the amount of 

fees appropriated for such fiscal year) are equal to or greater 

than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 

2009 (excluding the amount of fees appropriated for such fiscal 

year) multiplied by the adjustment factor (as defined in section 

744A) applicable to the fiscal year involved. 

ø(2) AUTHORITY.—If the Secretary does not assess fees under 

subsection (a) during any portion of a fiscal year and if at a 

later date in such fiscal year the Secretary may assess such 

fees, the Secretary may assess and collect such fees, without 

any modification in the rate, for Type II active pharmaceutical 

ingredient drug master files, abbreviated new drug applications and prior approval supplements, and generic drug facilities and active pharmaceutical ingredient facilities at any time 

in such fiscal year notwithstanding the provisions of subsection 

(a) relating to the date fees are to be paid. 

ø(i) CREDITING AND AVAILABILITY OF FEES.— ø(1) IN GENERAL.—Fees authorized under subsection (a) shall 

be collected and available for obligation only to the extent and 

in the amount provided in advance in appropriations Acts, subject to paragraph (2). Such fees are authorized to remain available until expended. Such sums as may be necessary may be 

transferred from the Food and Drug Administration salaries 

and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses 

with such fiscal year limitation. The sums transferred shall be 

available solely for human generic drug activities. 

ø(2) COLLECTIONS AND APPROPRIATION ACTS.— 

ø(A) IN GENERAL.—The fees authorized by this section— 

ø(i) subject to subparagraphs (C) and (D), shall be 

collected and available in each fiscal year in an 

amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and 

ø(ii) shall be available for a fiscal year beginning 

after fiscal year 2012 to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the 

Department of Health and HumanServices to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year 


jbell on DSK7SPTVN1PROD with REPORTS
171 

(excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor defined in section 744A(3) applicable 

to the fiscal year involved. 

ø(B) COMPLIANCE.—The Secretary shall be considered to 

have met the requirements of subparagraph (A)(ii) in any 

fiscal year if the costs funded by appropriations and allocated for human generic activities are not more than 10 

percent below the level specified in such subparagraph. 

ø(C) FEE COLLECTION DURING FIRST PROGRAM YEAR.— Until the date of enactment of an Act making appropriations through September 30, 2013 for the salaries and expenses account of the Food and Drug Administration, fees 

authorized by this section for fiscal year 2013, may be collected and shall be credited to such account and remain 

available until expended. 

ø(D) PROVISION FOR EARLY PAYMENTS IN SUBSEQUENT

YEARS.—Payment of fees authorized under this section for 

a fiscal year (after fiscal year 2013), prior to the due date 

for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year 

appropriations Act. 

ø(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 

fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equivalent to the 

total revenue amount determined under subsection (b) for the 

fiscal year, as adjusted under subsection (c), if applicable, or as 

otherwise affected under paragraph (2) of this subsection. 

ø(j) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 calendar days after it is due, such fee shall be treated 

as a claim of the United States Government subject to subchapter 

II of chapter 37 of title 31, United States Code. 

ø(k) CONSTRUCTION.—This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, 

and advisory committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and 

advisory committees so engaged. 

ø(l) POSITRON EMISSION TOMOGRAPHY DRUGS.— 

ø(1) EXEMPTION FROM FEES.—Submission of an application 

for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug 

shall not require the payment of any fee under this section. Facilities that solely produce positron emission tomography drugs 

shall not be required to pay a facility fee as established in subsection (a)(4). 

ø(2) IDENTIFICATION REQUIREMENT.—Facilities that produce 

positron emission tomography drugs or active pharmaceutical 

ingredients of such drugs are required to be identified pursuant to subsection (f). 

ø(m) DISPUTES CONCERNING FEES.—To qualify for the return of 

a fee claimed to have been paid in error under this section, a person shall submit to the Secretary a written request justifying such 

return within 180 calendar days after such fee was paid. 


jbell on DSK7SPTVN1PROD with REPORTS
172 

ø(n) SUBSTANTIALLY COMPLETE APPLICATIONS.—An abbreviated 

new drug application that is not considered to be received within 

the meaning of section 505(j)(5)(A) because of failure to pay an applicable fee under this provision within the time period specified in 

subsection (g) shall be deemed not to have been ‘‘substantially complete’’ on the date of its submission within the meaning of section 

505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application that is 

not substantially complete on the date of its submission solely because of failure to pay an applicable fee under the preceding sentence shall be deemed substantially complete and received within 

the meaning of section 505(j)(5)(A) as of the date such applicable 

fee is received.¿ 

[Effective January 31, 2018, section 304(b) of H.R. 5651 provides for a repeal of 

section 744C (as added by the bill).] 

øSEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS. 

ø(a) PERFORMANCE REPORT.— ø(1) IN GENERAL.—Beginning with fiscal year 2013, not later 

than 120 days after the end of each fiscal year for which fees 

are collected under this part, the Secretary shall prepare and 

submit to the Committee on Energy and Commerce of the 

House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning 

the progress of the Food and Drug Administration in achieving 

the goals identified in the letters described in section 301(b) of 

the Generic Drug User Fee Amendments of 2012 during such 

fiscal year and the future plans of the Food and Drug Administration for meeting the goals. 

ø(2) REGULATORY SCIENCE ACCOUNTABILITY METRICS.—The 

report required by paragraph (1) shall describe the amounts 

spent, data generated, and activities undertaken, including any 

FDA Advisory Committee consideration, by the Secretary for 

each of the local acting bioequivalence topics (Topics 1–3) in 

the Regulatory Science Plan described in the letters described 

in section 301(b) of the Generic Drug User Fee Amendments 

of 2012. 

ø(b) FISCAL REPORT.—Beginning with fiscal year 2013, not later 

than 120 days after the end of each fiscal year for which fees are 

collected under this part, the Secretary shall prepare and submit 

to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and 

Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the 

Food and Drug Administration, of the fees collected for such fiscal 

year. 

ø(c) PUBLIC AVAILABILITY.—The Secretary shall make the reports 

required under subsections (a) and (b) available to the public on 

the Internet Web site of the Food and Drug Administration. 

ø(d) REAUTHORIZATION.— ø(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals, and plans for 

meeting the goals, for human generic drug activities for the 

first 5 fiscal years after fiscal year 2017, and for the reauthorization of this part for such fiscal years, the Secretary shall 

consult with— 


jbell on DSK7SPTVN1PROD with REPORTS
173 

ø(A) the Committee on Energy and Commerce of the 

House of Representatives; 

ø(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

ø(C) scientific and academic experts; 

ø(D) health care professionals; 

ø(E) representatives of patient and consumer advocacy 

groups; and 

ø(F) the generic drug industry. 

ø(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the generic drug industry on the reauthorization of this 

part, the Secretary shall— 

ø(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

ø(B) hold a public meeting at which the public may 

present its views on the reauthorization, including specific 

suggestions for changes to the goals referred to in subsection (a); 

ø(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

ø(D) publish the comments on the Food and Drug Administration’s Internet Web site. 

ø(3) PERIODIC CONSULTATION.—Not less frequently than once 

every month during negotiations with the generic drug industry, the Secretary shall hold discussions with representatives 

of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph 

(2). 

ø(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the generic drug industry, the Secretary shall— 

ø(A) present the recommendations developed under 

paragraph (1) to the congressional committees specified in 

such paragraph; 

ø(B) publish such recommendations in the Federal Register; 

ø(C) provide for a period of 30 days for the public to provide written comments on such recommendations; 

ø(D) hold a meeting at which the public may present its 

views on such recommendations; and 

ø(E) after consideration of such public views and comments, revise such recommendations as necessary. 

ø(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2017, the Secretary shall transmit to the Congress 

the revised recommendations under paragraph (4), a summary 

of the views and comments received under such paragraph, 

and any changes made to the recommendations in response to 

such views and comments. 

ø(6) MINUTES OF NEGOTIATION MEETINGS.— ø(A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) 

to the Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00173 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
174 

ducted under this subsection between the Food and Drug 

Administration and the generic drug industry. 

ø(B) CONTENT.—The minutes described under subparagraph (A) shall summarize any substantive proposal made 

by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations 

and their resolution.¿ 

* * * * * * * 

PART 8—FEES RELATING TO BIOSIMILAR 

BIOLOGICAL PRODUCTS 

SEC. 744G. DEFINITIONS. 

For purposes of this part: 

(1) The term ‘‘adjustment factor’’ applicable to a fiscal year 

that is the Consumer Price Index for all urban consumers 

(Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) of the preceding fiscal year divided by such 

Index for September 2011. 

(2) The term ‘‘affiliate’’ means a business entity that has a relationship with a second business entity if, directly or indirectly— 

(A) one business entity controls, or has the power to control, the other business entity; or 

(B) a third party controls, or has power to control, both 

of the business entities. 

(3) The term ‘‘biosimilar biological product’’ means a product 

for which a biosimilar biological product application has been 

approved. 

(4)(A) Subject to subparagraph (B), the term ‘‘biosimilar biological product application’’ means an application for licensure 

of a biological product under section 351(k) of the Public Health 

Service Act. 

(B) Such term does not include— 

(i) a supplement to such an application; 

(ii) an application filed under section 351(k) of the Public 

Health Service Act that cites as the reference product a bovine blood product for topical application licensed before 

September 1, 1992, or a large volume parenteral drug product approved before such date; 

(iii) an application filed under section 351(k) of the Public Health Service Act with respect to— 

(I) whole blood or a blood component for transfusion; 

(II) an allergenic extract product; 

(III) an in vitro diagnostic biological product; or 

(IV) a biological product for further manufacturing 

use only; or 

(iv) an application for licensure under section 351(k) of 

the Public Health Service Act that is submitted by a State 

or Federal Government entity for a product that is not distributed commercially. 

(5) The term ‘‘biosimilar biological product development meeting’’ means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, 


jbell on DSK7SPTVN1PROD with REPORTS
175 

including a proposed design for, or data from, a study intended 

to support a biosimilar biological product application. 

(6) The term ‘‘biosimilar biological product development program’’ means the program under this part for expediting the 

process for the review of submissions in connection with biosimilar biological product development. 

(7)(A) The term ‘‘biosimilar biological product establishment’’ 

means a foreign or domestic place of business— 

(i) that is at one general physical location consisting of 

one or more buildings, all of which are within five miles of 

each other; and 

(ii) at which one or more biosimilar biological products 

are manufactured in final dosage form. 

(B) For purposes of subparagraph (A)(ii), the term ‘‘manufactured’’ does not include packaging. 

(8) The term ‘‘biosimilar initial advisory meeting’’— 

(A) means a meeting, if requested, that is limited to— 

(i) a general discussion regarding whether licensure 

under section 351(k) of the Public Health Service Act 

may be feasible for a particular product; and 

(ii) if so, general advice on the expected content of the 

development program; and 

(B) does not include any meeting that involves substantive review of summary data or full study reports. 

(9) The term ‘‘costs of resources allocated for the process for 

the review of biosimilar biological product applications’’ means 

the expenses in connection with the process for the review of biosimilar biological product applications for— 

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, 

advisory committees, and costs related to such officers employees and committees and to contracts with such contractors; 

(B) management of information, and the acquisition, 

maintenance, and repair of computer resources; 

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, 

furniture, scientific equipment, and other necessary materials and supplies; and 

(D) collecting fees under section 744H and accounting for 

resources allocated for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements. 

(10) The term ‘‘final dosage form’’ means, with respect to a 

biosimilar biological product, a finished dosage form which is 

approved for administration to a patient without substantial 

further manufacturing (such as lyophilized products before reconstitution). 

(11) The term ‘‘financial hold’’— 

(A) means an order issued by the Secretary to prohibit 

the sponsor of a clinical investigation from continuing the 

investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product 

application and the sponsor has failed to pay any fee for 


jbell on DSK7SPTVN1PROD with REPORTS
176 

the product required under subparagraph (A), (B), or (D) of 

section 744H(a)(1); and 

(B) does not mean that any of the bases for a ‘‘clinical 

hold’’ under section 505(i)(3) have been determined by the 

Secretary to exist concerning the investigation. 

(12) The term ‘‘person’’ includes an affiliate of such person. 

(13) The term ‘‘process for the review of biosimilar biological 

product applications’’ means the following activities of the Secretary with respect to the review of submissions in connection 

with biosimilar biological product development, biosimilar biological product applications, and supplements: 

(A) The activities necessary for the review of submissions 

in connection with biosimilar biological product development, biosimilar biological product applications, and supplements. 

(B) Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the 

actions necessary to place such applications in condition for 

approval. 

(C) The inspection of biosimilar biological product establishments and other facilities undertaken as part of the 

Secretary’s review of pending biosimilar biological product 

applications and supplements. 

(D) Activities necessary for the release of lots of biosimilar biological products under section 351(k) of the Public Health Service Act. 

(E) Monitoring of research conducted in connection with 

the review of biosimilar biological product applications. 

(F) Postmarket safety activities with respect to biologics 

approved under biosimilar biological product applications 

or supplements, including the following activities: 

(i) Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports. 

(ii) Developing and using improved adverse-event 

data-collection systems, including information technology systems. 

(iii) Developing and using improved analytical tools 

to assess potential safety problems, including access to 

external data bases. 

(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk 

evaluation and mitigation strategies). 

(v) Carrying out section 505(k)(5) (relating to adverse-event reports and postmarket safety activities). 

(14) The term ‘‘supplement’’ means a request to the Secretary 

to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological 

product meets the standards for interchangeability described in 

section 351(k)(4) of the Public Health Service Act. 


jbell on DSK7SPTVN1PROD with REPORTS
177 

SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL 

PRODUCT FEES. 

(a) TYPES OF FEES.—Beginning in fiscal year 2013, the Secretary 

shall assess and collect fees in accordance with this section as follows: 

(1) BIOSIMILAR DEVELOPMENT PROGRAM FEES.— 

(A) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEE.— 

(i) IN GENERAL.—Each person that submits to the 

Secretary a meeting request described under clause (ii) 

or a clinical protocol for an investigational new drug 

protocol described under clause (iii) shall pay for the 

product named in the meeting request or the investigational new drug application the initial biosimilar biological product development fee established under subsection (b)(1)(A). 

(ii) MEETING REQUEST.—The meeting request defined 

in this clause is a request for a biosimilar biological 

product development meeting for a product. 

(iii) CLINICAL PROTOCOL FOR IND.—A clinical protocol for an investigational new drug protocol described 

in this clause is a clinical protocol consistent with the 

provisions of section 505(i), including any regulations 

promulgated under section 505(i), (referred to in this 

section as ‘‘investigational new drug application’’) describing an investigation that the Secretary determines 

is intended to support a biosimilar biological product 

application for a product. 

(iv) DUE DATE.—The initial biosimilar biological 

product development fee shall be due by the earlier of 

the following: 

(I) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting. 

(II) The date of submission of an investigational 

new drug application describing an investigation 

that the Secretary determines is intended to support a biosimilar biological product application. 

(v) TRANSITION RULE.—Each person that has submitted an investigational new drug application prior to 

the date of enactment of the Biosimilars User Fee Act 

of 2012 shall pay the initial biosimilar biological product development fee by the earlier of the following: 

(I) Not later than 60 days after the date of the 

enactment of the Biosimilars User Fee Act of 2012, 

if the Secretary determines that the investigational 

new drug application describes an investigation 

that is intended to support a biosimilar biological 

product application. 

(II) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting. 

(B) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEE.— 


jbell on DSK7SPTVN1PROD with REPORTS
178 

(i) IN GENERAL.—A person that pays an initial biosimilar biological product development fee for a product shall pay for such product, beginning in the fiscal 

year following the fiscal year in which the initial biosimilar biological product development fee was paid, 

an annual fee established under subsection (b)(1)(B) for 

biosimilar biological product development (referred to 

in this section as ‘‘annual biosimilar biological product 

development fee’’). 

(ii) DUE DATE.—The annual biosimilar biological 

product development program fee for each fiscal year 

will be due on the later of— 

(I) the first business day on or after October 1 of 

each such year; or 

(II) the first business day after the enactment of 

an appropriations Act providing for the collection 

and obligation of fees for such year under this section. 

(iii) EXCEPTION.—The annual biosimilar development program fee for each fiscal year will be due on 

the date specified in clause (ii), unless the person has— 

(I) submitted a marketing application for the biological product that was accepted for filing; or 

(II) discontinued participation in the biosimilar 

biological product development program for the 

product under subparagraph (C). 

(C) DISCONTINUATION OF FEE OBLIGATION.—A person 

may discontinue participation in the biosimilar biological 

product development program for a product effective October 1 of a fiscal year by, not later than August 1 of the preceding fiscal year— 

(i) if no investigational new drug application concerning the product has been submitted, submitting to 

the Secretary a written declaration that the person has 

no present intention of further developing the product 

as a biosimilar biological product; or 

(ii) if an investigational new drug application concerning the product has been submitted, by withdrawing the investigational new drug application in 

accordance with part 312 of title 21, Code of Federal 

Regulations (or any successor regulations). 

(D) REACTIVATION FEE.— 

(i) IN GENERAL.—A person that has discontinued 

participation in the biosimilar biological product development program for a product under subparagraph (C) 

shall pay a fee (referred to in this section as ‘‘reactivation fee’’) by the earlier of the following: 

(I) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting for the product (after the date 

on which such participation was discontinued). 

(II) Upon the date of submission (after the date 

on which such participation was discontinued) of 

an investigational new drug application describing 

an investigation that the Secretary determines is 


jbell on DSK7SPTVN1PROD with REPORTS
179 

intended to support a biosimilar biological product 

application for that product. 

(ii) APPLICATION OF ANNUAL FEE.—A person that 

pays a reactivation fee for a product shall pay for such 

product, beginning in the next fiscal year, the annual 

biosimilar biological product development fee under 

subparagraph (B). 

(E) EFFECT OF FAILURE TO PAY BIOSIMILAR DEVELOPMENT

PROGRAM FEES.— 

(i) NO BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT MEETINGS.—If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or 

a reactivation fee as required under subparagraph (D), 

the Secretary shall not provide a biosimilar biological 

product development meeting relating to the product 

for which fees are owed. 

(ii) NO RECEIPT OF INVESTIGATIONAL NEW DRUG APPLICATIONS.—Except in extraordinary circumstances, 

the Secretary shall not consider an investigational new 

drug application to have been received under section 

505(i)(2) if— 

(I) the Secretary determines that the investigation is intended to support a biosimilar biological 

product application; and 

(II) the sponsor has failed to pay an initial or 

annual biosimilar biological product development 

fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required 

under subparagraph (D). 

(iii) FINANCIAL HOLD.—Notwithstanding section 

505(i)(2), except in extraordinary circumstances, the 

Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if— 

(I) the Secretary determines that the investigation is intended to support a biosimilar biological 

product application; and 

(II) the sponsor has failed to pay an initial or 

annual biosimilar biological product development 

fee for the product as required under subparagraph (A) or (B), or a reactivation fee for the product as required under subparagraph (D). 

(iv) NO ACCEPTANCE OF BIOSIMILAR BIOLOGICAL

PRODUCT APPLICATIONS OR SUPPLEMENTS.—If a person 

has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required 

under subparagraph (D), any biosimilar biological 

product application or supplement submitted by that 

person shall be considered incomplete and shall not be 

accepted for filing by the Secretary until all such fees 

owed by such person have been paid. 

(F) LIMITS REGARDING BIOSIMILAR DEVELOPMENT PROGRAM FEES.— 


jbell on DSK7SPTVN1PROD with REPORTS
180 

(i) NO REFUNDS.—The Secretary shall not refund any 

initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any 

reactivation fee paid under subparagraph (D). 

(ii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.—The 

Secretary shall not grant a waiver, exemption, or reduction of any initial or annual biosimilar biological 

product development fee due or payable under subparagraph (A) or (B), or any reactivation fee due or payable 

under subparagraph (D). 

(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION AND SUPPLEMENT FEE.— 

(A) IN GENERAL.—Each person that submits, on or after 

October 1, 2012, a biosimilar biological product application 

or a supplement shall be subject to the following fees: 

(i) A fee for a biosimilar biological product application that is equal to— 

(I) the amount of the fee established under subsection (b)(1)(D) for a biosimilar biological product 

application; minus 

(II) the cumulative amount of fees paid, if any, 

under subparagraphs (A), (B), and (D) of paragraph (1) for the product that is the subject of the 

application. 

(ii) A fee for a biosimilar biological product application for which clinical data (other than comparative 

bioavailability studies) with respect to safety or effectiveness are not required, that is equal to— 

(I) half of the amount of the fee established 

under subsection (b)(1)(D) for a biosimilar biological product application; minus 

(II) the cumulative amount of fees paid, if any, 

under subparagraphs (A), (B), and (D) of paragraph (1) for that product. 

(iii) A fee for a supplement for which clinical data 

(other than comparative bioavailability studies) with 

respect to safety or effectiveness are required, that is 

equal to half of the amount of the fee established under 

subsection (b)(1)(D) for a biosimilar biological product 

application. 

(B) REDUCTION IN FEES.—Notwithstanding section 404 of 

the Biosimilars User Fee Act of 2012, any person who pays 

a fee under subparagraph (A), (B), or (D) of paragraph (1) 

for a product before October 1, 2017, but submits a biosimilar biological product application for that product after 

such date, shall be entitled to the reduction of any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product 

application is submitted, by the cumulative amount of fees 

paid under subparagraphs (A), (B), and (D) of paragraph 

(1) for that product. 

(C) PAYMENT DUE DATE.—Any fee required by subparagraph (A) shall be due upon submission of the application 

or supplement for which such fee applies. 


jbell on DSK7SPTVN1PROD with REPORTS
181 

(D) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR

SUPPLEMENT.—If a biosimilar biological product application or supplement was submitted by a person that paid the 

fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a 

waiver), the submission of a biosimilar biological product 

application or a supplement for the same product by the 

same person (or the person’s licensee, assignee, or successor) 

shall not be subject to a fee under subparagraph (A). 

(E) REFUND OF APPLICATION FEE IF APPLICATION RE- FUSED FOR FILING OR WITHDRAWN BEFORE FILING.—The 

Secretary shall refund 75 percent of the fee paid under this 

paragraph for any application or supplement which is refused for filing or withdrawn without a waiver before filing. 

(F) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR

FILING OR WITHDRAWN BEFORE FILING.—A biosimilar biological product application or supplement that was submitted but was refused for filing, or was withdrawn before 

being accepted or refused for filing, shall be subject to the 

full fee under subparagraph (A) upon being resubmitted or 

filed over protest, unless the fee is waived under subsection 

(c). 

(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTABLISHMENT FEE.— (A) IN GENERAL.—Except as provided in subparagraph 

(E), each person that is named as the applicant in a biosimilar biological product application shall be assessed an 

annual fee established under subsection (b)(1)(E) for each 

biosimilar biological product establishment that is listed in 

the approved biosimilar biological product application as 

an establishment that manufactures the biosimilar biological product named in such application. 

(B) ASSESSMENT IN FISCAL YEARS.—The establishment 

fee shall be assessed in each fiscal year for which the biosimilar biological product named in the application is assessed a fee under paragraph (4) unless the biosimilar biological product establishment listed in the application does 

not engage in the manufacture of the biosimilar biological 

product during such fiscal year. 

(C) DUE DATE.—The establishment fee for a fiscal year 

shall be due on the later of— 

(i) the first business day on or after October 1 of such 

fiscal year; or 

(ii) the first business day after the enactment of an 

appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. 

(D) APPLICATION TO ESTABLISHMENT.— 

(i) Each biosimilar biological product establishment 

shall be assessed only one fee per biosimilar biological 

product establishment, notwithstanding the number of 

biosimilar biological products manufactured at the establishment, subject to clause (ii). 

(ii) In the event an establishment is listed in a biosimilar biological product application by more than 

one applicant, the establishment fee for the fiscal year 


jbell on DSK7SPTVN1PROD with REPORTS
182 

shall be divided equally and assessed among the applicants whose biosimilar biological products are manufactured by the establishment during the fiscal year 

and assessed biosimilar biological product fees under 

paragraph (4). 

(E) EXCEPTION FOR NEW PRODUCTS.—If, during the fiscal 

year, an applicant initiates or causes to be initiated the 

manufacture of a biosimilar biological product at an establishment listed in its biosimilar biological product application— 

(i) that did not manufacture the biosimilar biological 

product in the previous fiscal year; and 

(ii) for which the full biosimilar biological product 

establishment fee has been assessed in the fiscal year 

at a time before manufacture of the biosimilar biological product was begun, 

the applicant shall not be assessed a share of the biosimilar 

biological product establishment fee for the fiscal year in 

which the manufacture of the product began. 

(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— (A) IN GENERAL.—Each person who is named as the applicant in a biosimilar biological product application shall 

pay for each such biosimilar biological product the annual 

fee established under subsection (b)(1)(F). 

(B) DUE DATE.—The biosimilar biological product fee for 

a fiscal year shall be due on the later of— 

(i) the first business day on or after October 1 of each 

such year; or 

(ii) the first business day after the enactment of an 

appropriations Act providing for the collection and obligation of fees for such year under this section. 

(C) ONE FEE PER PRODUCT PER YEAR.—The biosimilar biological product fee shall be paid only once for each product for each fiscal year. 

(b) FEE SETTING AND AMOUNTS.— (1) IN GENERAL.—Subject to paragraph (2), the Secretary 

shall, 60 days before the start of each fiscal year that begins 

after September 30, 2012, establish, for the next fiscal year, the 

fees under subsection (a). Except as provided in subsection (c), 

such fees shall be in the following amounts: 

(A) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEE.—The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall 

be equal to 10 percent of the amount established under section 736(c)(4) for a human drug application described in 

section 736(a)(1)(A)(i) for that fiscal year. 

(B) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOP- MENT FEE.—The annual biosimilar biological product development fee under subsection (a)(1)(B) for a fiscal year 

shall be equal to 10 percent of the amount established 

under section 736(c)(4) for a human drug application described in section 736(a)(1)(A)(i) for that fiscal year. 

(C) REACTIVATION FEE.—The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to 20 percent of the amount of the fee established under section 


jbell on DSK7SPTVN1PROD with REPORTS
183 

736(c)(4) for a human drug application described in section 

736(a)(1)(A)(i) for that fiscal year. 

(D) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION FEE.— The biosimilar biological product application fee under 

subsection (a)(2) for a fiscal year shall be equal to the 

amount established under section 736(c)(4) for a human 

drug application described in section 736(a)(1)(A)(i) for that 

fiscal year. 

(E) BIOSIMILAR BIOLOGICAL PRODUCT ESTABLISHMENT

FEE.—The biosimilar biological product establishment fee 

under subsection (a)(3) for a fiscal year shall be equal to 

the amount established under section 736(c)(4) for a prescription drug establishment for that fiscal year. 

(F) BIOSIMILAR BIOLOGICAL PRODUCT FEE.—The biosimilar biological product fee under subsection (a)(4) for a 

fiscal year shall be equal to the amount established under 

section 736(c)(4) for a prescription drug product for that fiscal year. 

(2) LIMIT.—The total amount of fees charged for a fiscal year 

under this section may not exceed the total amount for such fiscal year of the costs of resources allocated for the process for the 

review of biosimilar biological product applications. 

(c) APPLICATION FEE WAIVER FOR SMALL BUSINESS.— (1) WAIVER OF APPLICATION FEE.—The Secretary shall grant 

to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that person under subsection (a)(2)(A) for the first biosimilar biological 

product application that a small business or its affiliate submits to the Secretary for review. After a small business or its 

affiliate is granted such a waiver, the small business or its affiliate shall pay— 

(A) application fees for all subsequent biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small 

business; and 

(B) all supplement fees for all supplements to biosimilar 

biological product applications submitted to the Secretary 

for review in the same manner as an entity that is not a 

small business. 

(2) CONSIDERATIONS.—In determining whether to grant a 

waiver of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant. 

(3) SMALL BUSINESS DEFINED.—In this subsection, the term 

‘‘small business’’ means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a 

drug product that has been approved under a human drug application (as defined in section 735) or a biosimilar biological 

product application (as defined in section 744G(4)) and introduced or delivered for introduction into interstate commerce. 

(d) EFFECT OF FAILURE TO PAY FEES.—A biosimilar biological 

product application or supplement submitted by a person subject to 

fees under subsection (a) shall be considered incomplete and shall 

not be accepted for filing by the Secretary until all fees owed by 

such person have been paid. 


jbell on DSK7SPTVN1PROD with REPORTS
184 

(e) CREDITING AND AVAILABILITY OF FEES.— 

(1) IN GENERAL.—Subject to paragraph (2), fees authorized 

under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance 

in appropriations Acts. Such fees are authorized to remain 

available until expended. Such sums as may be necessary may 

be transferred from the Food and Drug Administration salaries 

and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses 

with such fiscal year limitation. The sums transferred shall be 

available solely for the process for the review of biosimilar biological product applications. 

(2) COLLECTIONS AND APPROPRIATION ACTS.— 

(A) IN GENERAL.—Subject to subparagraphs (C) and (D), 

the fees authorized by this section shall be collected and 

available in each fiscal year in an amount not to exceed the 

amount specified in appropriation Acts, or otherwise made 

available for obligation for such fiscal year. 

(B) USE OF FEES AND LIMITATION.—The fees authorized 

by this section shall be available for a fiscal year beginning 

after fiscal year 2012 to defray the costs of the process for 

the review of biosimilar biological product applications (including such costs for an additional number of full-time 

equivalent positions in the Department of Health and 

Human Services to be engaged in such process), only if the 

Secretary allocates for such purpose an amount for such 

fiscal year (excluding amounts from fees collected under 

this section) no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved. 

(C) FEE COLLECTION DURING FIRST PROGRAM YEAR.— 

Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees 

authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain 

available until expended. 

(D) PROVISION FOR EARLY PAYMENTS IN SUBSEQUENT

YEARS.—Payment of fees authorized under this section for 

a fiscal year (after fiscal year 2013), prior to the due date 

for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act. 

(3) AUTHORIZATION OF APPROPRIATIONS.—For each of fiscal 

years 2013 through 2017, there is authorized to be appropriated 

for fees under this section an amount equivalent to the total 

amount of fees assessed for such fiscal year under this section. 

(f) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 days after it is due, such fee shall be treated as a 

claim of the United States Government subject to subchapter II of 

chapter 37 of title 31, United States Code. 

(g) WRITTEN REQUESTS FOR WAIVERS AND REFUNDS.—To qualify 

for consideration for a waiver under subsection (c), or for a refund 

of any fee collected in accordance with subsection (a)(2)(A), a person 


jbell on DSK7SPTVN1PROD with REPORTS
185 

shall submit to the Secretary a written request for such waiver or 

refund not later than 180 days after such fee is due. 

(h) CONSTRUCTION.—This section may not be construed to require 

that the number of full-time equivalent positions in the Department 

of Health and Human Services, for officers, employers, and advisory 

committees not engaged in the process of the review of biosimilar biological product applications, be reduced to offset the number of officers, employees, and advisory committees so engaged. 

SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS. 

(a) PERFORMANCE REPORT.—Beginning with fiscal year 2013, not 

later than 120 days after the end of each fiscal year for which fees 

are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and 

Pensions of the Senate a report concerning the progress of the Food 

and Drug Administration in achieving the goals identified in the 

letters described in section 401(b) of the Biosimilar User Fee Act of 

2012 during such fiscal year and the future plans of the Food and 

Drug Administration for meeting such goals. The report for a fiscal 

year shall include information on all previous cohorts for which the 

Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort. 

(b) FISCAL REPORT.—Not later than 120 days after the end of fiscal year 2013 and each subsequent fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the 

Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions 

of the Senate a report on the implementation of the authority for 

such fees during such fiscal year and the use, by the Food and Drug 

Administration, of the fees collected for such fiscal year. 

(c) PUBLIC AVAILABILITY.—The Secretary shall make the reports 

required under subsections (a) and (b) available to the public on the 

Internet Web site of the Food and Drug Administration. 

(d) STUDY.— 

(1) IN GENERAL.—The Secretary shall contract with an independent accounting or consulting firm to study the workload 

volume and full costs associated with the process for the review 

of biosimilar biological product applications. 

(2) INTERIM RESULTS.—Not later than June 1, 2015, the Secretary shall publish, for public comment, interim results of the 

study described under paragraph (1). 

(3) FINAL RESULTS.—Not later than September 30, 2016, the 

Secretary shall publish, for public comment, the final results of 

the study described under paragraph (1). 

(e) REAUTHORIZATION.— 

(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals described in 

subsection (a), and plans for meeting the goals, for the process 

for the review of biosimilar biological product applications for 

the first 5 fiscal years after fiscal year 2017, and for the reauthorization of this part for such fiscal years, the Secretary shall 

consult with— 

(A) the Committee on Energy and Commerce of the House 

of Representatives; 


jbell on DSK7SPTVN1PROD with REPORTS
186 

(B) the Committee on Health, Education, Labor, and Pensions of the Senate; 

(C) scientific and academic experts; 

(D) health care professionals; 

(E) representatives of patient and consumer advocacy 

groups; and 

(F) the regulated industry. 

(2) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such 

paragraph; 

(B) publish such recommendations in the Federal Register; 

(C) provide for a period of 30 days for the public to provide written comments on such recommendations; 

(D) hold a meeting at which the public may present its 

views on such recommendations; and 

(E) after consideration of such public views and comments, revise such recommendations as necessary. 

(3) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2017, the Secretary shall transmit to the Congress 

the revised recommendations under paragraph (2), a summary 

of the views and comments received under such paragraph, and 

any changes made to the recommendations in response to such 

views and comments. 

[Effective October 1, 2017, section 404(a) of H.R. 5651 provides for a repeal of 

sections 744G and 744H (as added by the bill).] 

øSEC. 744G. DEFINITIONS. 

øFor purposes of this part: 

ø(1) The term ‘‘adjustment factor’’ applicable to a fiscal year 

that is the Consumer Price Index for all urban consumers 

(Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) of the preceding fiscal year divided by such 

Index for September 2011. 

ø(2) The term ‘‘affiliate’’ means a business entity that has a 

relationship with a second business entity if, directly or indirectly— 

ø(A) one business entity controls, or has the power to 

control, the other business entity; or 

ø(B) a third party controls, or has power to control, both 

of the business entities. 

ø(3) The term ‘‘biosimilar biological product’’ means a product for which a biosimilar biological product application has 

been approved. 

ø(4)(A) Subject to subparagraph (B), the term ‘‘biosimilar biological product application’’ means an application for licensure 

of a biological product under section 351(k) of the Public 

Health Service Act. 

ø(B) Such term does not include— 

ø(i) a supplement to such an application; 

ø(ii) an application filed under section 351(k) of the Public Health Service Act that cites as the reference product 

a bovine blood product for topical application licensed beVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00186 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
187 

fore September 1, 1992, or a large volume parenteral drug 

product approved before such date; 

ø(iii) an application filed under section 351(k) of the 

Public Health Service Act with respect to— 

ø(I) whole blood or a blood component for transfusion; 

ø(II) an allergenic extract product; 

ø(III) an in vitro diagnostic biological product; or 

ø(IV) a biological product for further manufacturing 

use only; or 

ø(iv) an application for licensure under section 351(k) of 

the Public Health Service Act that is submitted by a State 

or Federal Government entity for a product that is not distributed commercially. 

ø(5) The term ‘‘biosimilar biological product development 

meeting’’ means any meeting, other than a biosimilar initial 

advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study 

intended to support a biosimilar biological product application. 

ø(6) The term ‘‘biosimilar biological product development program’’ means the program under this part for expediting the 

process for the review of submissions in connection with biosimilar biological product development. 

ø(7)(A) The term ‘‘biosimilar biological product establishment’’ means a foreign or domestic place of business— 

ø(i) that is at one general physical location consisting of 

one or more buildings, all of which are within five miles 

of each other; and 

ø(ii) at which one or more biosimilar biological products 

are manufactured in final dosage form. 

ø(B) For purposes of subparagraph (A)(ii), the term ‘‘manufactured’’ does not include packaging. 

ø(8) The term ‘‘biosimilar initial advisory meeting’’— 

ø(A) means a meeting, if requested, that is limited to— 

ø(i) a general discussion regarding whether licensure under section 351(k) of the Public Health Service 

Act may be feasible for a particular product; and 

ø(ii) if so, general advice on the expected content of 

the development program; and 

ø(B) does not include any meeting that involves substantive review of summary data or full study reports. 

ø(9) The term ‘‘costs of resources allocated for the process for 

the review of biosimilar biological product applications’’ means 

the expenses in connection with the process for the review of 

biosimilar biological product applications for— 

ø(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers employees and committees and to contracts with such 

contractors; 

ø(B) management of information, and the acquisition, 

maintenance, and repair of computer resources; 

ø(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00187 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
188 

tures, furniture, scientific equipment, and other necessary 

materials and supplies; and 

ø(D) collecting fees under section 744H and accounting 

for resources allocated for the review of submissions in 

connection with biosimilar biological product development, 

biosimilar biological product applications, and supplements. 

ø(10) The term ‘‘final dosage form’’ means, with respect to a 

biosimilar biological product, a finished dosage form which is 

approved for administration to a patient without substantial 

further manufacturing (such as lyophilized products before reconstitution). 

ø(11) The term ‘‘financial hold’’— 

ø(A) means an order issued by the Secretary to prohibit 

the sponsor of a clinical investigation from continuing the 

investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee 

for the product required under subparagraph (A), (B), or 

(D) of section 744H(a)(1); and 

ø(B) does not mean that any of the bases for a ‘‘clinical 

hold’’ under section 505(i)(3) have been determined by the 

Secretary to exist concerning the investigation. 

ø(12) The term ‘‘person’’ includes an affiliate of such person. 

ø(13) The term ‘‘process for the review of biosimilar biological 

product applications’’ means the following activities of the Secretary with respect to the review of submissions in connection 

with biosimilar biological product development, biosimilar biological product applications, and supplements: 

ø(A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and 

supplements. 

ø(B) Actions related to submissions in connection with 

biosimilar biological product development, the issuance of 

action letters which approve biosimilar biological product 

applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the 

actions necessary to place such applications in condition 

for approval. 

ø(C) The inspection of biosimilar biological product establishments and other facilities undertaken as part of the 

Secretary’s review of pending biosimilar biological product 

applications and supplements. 

ø(D) Activities necessary for the release of lots of biosimilar biological products under section 351(k) of the Public Health Service Act. 

ø(E) Monitoring of research conducted in connection with 

the review of biosimilar biological product applications. 

ø(F) Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities: 

ø(i) Collecting, developing, and reviewing safety information on biosimilar biological products, including 

adverse-event reports. 


jbell on DSK7SPTVN1PROD with REPORTS
189 

ø(ii) Developing and using improved adverse-event 

data-collection systems, including information technology systems. 

ø(iii) Developing and using improved analytical tools 

to assess potential safety problems, including access to 

external data bases. 

ø(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and 

labeling changes) and section 505(p) (relating to risk 

evaluation and mitigation strategies). 

ø(v) Carrying out section 505(k)(5) (relating to adverse-event reports and postmarket safety activities). 

ø(14) The term ‘‘supplement’’ means a request to the Secretary to approve a change in a biosimilar biological product 

application which has been approved, including a supplement 

requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 351(k)(4) of the Public Health Service Act. 

øSEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL 

PRODUCT FEES. 

ø(a) TYPES OF FEES.—Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section 

as follows: 

ø(1) BIOSIMILAR DEVELOPMENT PROGRAM FEES.— ø(A) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOP- MENT FEE.— 

ø(i) IN GENERAL.—Each person that submits to the 

Secretary a meeting request described under clause 

(ii) or a clinical protocol for an investigational new 

drug protocol described under clause (iii) shall pay for 

the product named in the meeting request or the investigational new drug application the initial biosimilar biological product development fee established 

under subsection (b)(1)(A). 

ø(ii) MEETING REQUEST.—The meeting request defined in this clause is a request for a biosimilar biological product development meeting for a product. 

ø(iii) CLINICAL PROTOCOL FOR IND.—A clinical protocol for an investigational new drug protocol described in this clause is a clinical protocol consistent 

with the provisions of section 505(i), including any regulations promulgated under section 505(i), (referred to 

in this section as ‘‘investigational new drug application’’) describing an investigation that the Secretary 

determines is intended to support a biosimilar biological product application for a product. 

ø(iv) DUE DATE.—The initial biosimilar biological 

product development fee shall be due by the earlier of 

the following: 

ø(I) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting. 

ø(II) The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended 


jbell on DSK7SPTVN1PROD with REPORTS
190 

to support a biosimilar biological product application. 

ø(v) TRANSITION RULE.—Each person that has submitted an investigational new drug application prior 

to the date of enactment of the Biosimilars User Fee 

Act of 2012 shall pay the initial biosimilar biological 

product development fee by the earlier of the following: 

ø(I) Not later than 60 days after the date of the 

enactment of the Biosimilars User Fee Act of 

2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar biological product application. 

ø(II) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting. 

ø(B) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEE.— 

ø(i) IN GENERAL.—A person that pays an initial biosimilar biological product development fee for a product shall pay for such product, beginning in the fiscal 

year following the fiscal year in which the initial biosimilar biological product development fee was paid, 

an annual fee established under subsection (b)(1)(B) 

for biosimilar biological product development (referred 

to in this section as ‘‘annual biosimilar biological product development fee’’). 

ø(ii) DUE DATE.—The annual biosimilar biological 

product development program fee for each fiscal year 

will be due on the later of— 

ø(I) the first business day on or after October 1 

of each such year; or 

ø(II) the first business day after the enactment 

of an appropriations Act providing for the collection and obligation of fees for such year under this 

section. 

ø(iii) EXCEPTION.—The annual biosimilar development program fee for each fiscal year will be due on 

the date specified in clause (ii), unless the person 

has— 

ø(I) submitted a marketing application for the 

biological product that was accepted for filing; or 

ø(II) discontinued participation in the biosimilar 

biological product development program for the 

product under subparagraph (C). 

ø(C) DISCONTINUATION OF FEE OBLIGATION.—A person 

may discontinue participation in the biosimilar biological 

product development program for a product effective October 1 of a fiscal year by, not later than August 1 of the 

preceding fiscal year— 

ø(i) if no investigational new drug application concerning the product has been submitted, submitting to 

the Secretary a written declaration that the person 


jbell on DSK7SPTVN1PROD with REPORTS
191 

has no present intention of further developing the 

product as a biosimilar biological product; or 

ø(ii) if an investigational new drug application concerning the product has been submitted, by withdrawing the investigational new drug application in 

accordance with part 312 of title 21, Code of Federal 

Regulations (or any successor regulations). 

ø(D) REACTIVATION FEE.— 

ø(i) IN GENERAL.—A person that has discontinued 

participation in the biosimilar biological product development program for a product under subparagraph (C) 

shall pay a fee (referred to in this section as ‘‘reactivation fee’’) by the earlier of the following: 

ø(I) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting for the product (after the 

date on which such participation was discontinued). 

ø(II) Upon the date of submission (after the date 

on which such participation was discontinued) of 

an investigational new drug application describing 

an investigation that the Secretary determines is 

intended to support a biosimilar biological product 

application for that product. 

ø(ii) APPLICATION OF ANNUAL FEE.—A person that 

pays a reactivation fee for a product shall pay for such 

product, beginning in the next fiscal year, the annual 

biosimilar biological product development fee under 

subparagraph (B). 

ø(E) EFFECT OF FAILURE TO PAY BIOSIMILAR DEVELOPMENT PROGRAM FEES.— 

ø(i) NO BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT MEETINGS.—If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), 

or a reactivation fee as required under subparagraph 

(D), the Secretary shall not provide a biosimilar biological product development meeting relating to the 

product for which fees are owed. 

ø(ii) NO RECEIPT OF INVESTIGATIONAL NEW DRUG APPLICATIONS.—Except in extraordinary circumstances, 

the Secretary shall not consider an investigational 

new drug application to have been received under section 505(i)(2) if— 

ø(I) the Secretary determines that the investigation is intended to support a biosimilar biological 

product application; and 

ø(II) the sponsor has failed to pay an initial or 

annual biosimilar biological product development 

fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required 

under subparagraph (D). 

ø(iii) FINANCIAL HOLD.—Notwithstanding section 

505(i)(2), except in extraordinary circumstances, the 


jbell on DSK7SPTVN1PROD with REPORTS
192 

Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if— 

ø(I) the Secretary determines that the investigation is intended to support a biosimilar biological 

product application; and 

ø(II) the sponsor has failed to pay an initial or 

annual biosimilar biological product development 

fee for the product as required under subparagraph (A) or (B), or a reactivation fee for the product as required under subparagraph (D). 

ø(iv) NO ACCEPTANCE OF BIOSIMILAR BIOLOGICAL

PRODUCT APPLICATIONS OR SUPPLEMENTS.—If a person 

has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required 

under subparagraph (D), any biosimilar biological 

product application or supplement submitted by that 

person shall be considered incomplete and shall not be 

accepted for filing by the Secretary until all such fees 

owed by such person have been paid. 

ø(F) LIMITS REGARDING BIOSIMILAR DEVELOPMENT PROGRAM FEES.— 

ø(i) NO REFUNDS.—The Secretary shall not refund 

any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or 

any reactivation fee paid under subparagraph (D). 

ø(ii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.— 

The Secretary shall not grant a waiver, exemption, or 

reduction of any initial or annual biosimilar biological 

product development fee due or payable under subparagraph (A) or (B), or any reactivation fee due or 

payable under subparagraph (D). 

ø(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION AND SUPPLEMENT FEE.— 

ø(A) IN GENERAL.—Each person that submits, on or after 

October 1, 2012, a biosimilar biological product application 

or a supplement shall be subject to the following fees: 

ø(i) A fee for a biosimilar biological product application that is equal to— 

ø(I) the amount of the fee established under 

subsection (b)(1)(D) for a biosimilar biological 

product application; minus 

ø(II) the cumulative amount of fees paid, if any, 

under subparagraphs (A), (B), and (D) of paragraph (1) for the product that is the subject of the 

application. 

ø(ii) A fee for a biosimilar biological product application for which clinical data (other than comparative 

bioavailability studies) with respect to safety or effectiveness are not required, that is equal to— 

ø(I) half of the amount of the fee established 

under subsection (b)(1)(D) for a biosimilar biological product application; minus 


jbell on DSK7SPTVN1PROD with REPORTS
193 

ø(II) the cumulative amount of fees paid, if any, 

under subparagraphs (A), (B), and (D) of paragraph (1) for that product. 

ø(iii) A fee for a supplement for which clinical data 

(other than comparative bioavailability studies) with 

respect to safety or effectiveness are required, that is 

equal to half of the amount of the fee established 

under subsection (b)(1)(D) for a biosimilar biological 

product application. 

ø(B) REDUCTION IN FEES.—Notwithstanding section 404 

of the Biosimilars User Fee Act of 2012, any person who 

pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits 

a biosimilar biological product application for that product 

after such date, shall be entitled to the reduction of any 

biosimilar biological product application fees that may be 

assessed at the time when such biosimilar biological product application is submitted, by the cumulative amount of 

fees paid under subparagraphs (A), (B), and (D) of paragraph (1) for that product. 

ø(C) PAYMENT DUE DATE.—Any fee required by subparagraph (A) shall be due upon submission of the application 

or supplement for which such fee applies. 

ø(D) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR

SUPPLEMENT.—If a biosimilar biological product application 

or supplement was submitted by a person that paid the fee 

for such application or supplement, was accepted for filing, 

and was not approved or was withdrawn (without a waiver), the submission of a biosimilar biological product application or a supplement for the same product by the same 

person (or the person’s licensee, assignee, or successor) 

shall not be subject to a fee under subparagraph (A). 

ø(E) REFUND OF APPLICATION FEE IF APPLICATION RE- FUSED FOR FILING OR WITHDRAWN BEFORE FILING.—The 

Secretary shall refund 75 percent of the fee paid under 

this paragraph for any application or supplement which is 

refused for filing or withdrawn without a waiver before filing. 

ø(F) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR

FILING OR WITHDRAWN BEFORE FILING.—A biosimilar biological product application or supplement that was submitted but was refused for filing, or was withdrawn before 

being accepted or refused for filing, shall be subject to the 

full fee under subparagraph (A) upon being resubmitted or 

filed over protest, unless the fee is waived under subsection (c). 

ø(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTABLISHMENT FEE.— 

ø(A) IN GENERAL.—Except as provided in subparagraph 

(E), each person that is named as the applicant in a biosimilar biological product application shall be assessed an 

annual fee established under subsection (b)(1)(E) for each 

biosimilar biological product establishment that is listed in 

the approved biosimilar biological product application as 

an establishment that manufactures the biosimilar biological product named in such application. 


jbell on DSK7SPTVN1PROD with REPORTS
194 

ø(B) ASSESSMENT IN FISCAL YEARS.—The establishment 

fee shall be assessed in each fiscal year for which the biosimilar biological product named in the application is assessed a fee under paragraph (4) unless the biosimilar biological product establishment listed in the application does 

not engage in the manufacture of the biosimilar biological 

product during such fiscal year. 

ø(C) DUE DATE.—The establishment fee for a fiscal year 

shall be due on the later of— 

ø(i) the first business day on or after October 1 of 

such fiscal year; or 

ø(ii) the first business day after the enactment of an 

appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. 

ø(D) APPLICATION TO ESTABLISHMENT.— 

ø(i) Each biosimilar biological product establishment 

shall be assessed only one fee per biosimilar biological 

product establishment, notwithstanding the number of 

biosimilar biological products manufactured at the establishment, subject to clause (ii). 

ø(ii) In the event an establishment is listed in a biosimilar biological product application by more than 

one applicant, the establishment fee for the fiscal year 

shall be divided equally and assessed among the applicants whose biosimilar biological products are manufactured by the establishment during the fiscal year 

and assessed biosimilar biological product fees under 

paragraph (4). 

ø(E) EXCEPTION FOR NEW PRODUCTS.—If, during the fiscal year, an applicant initiates or causes to be initiated the 

manufacture of a biosimilar biological product at an establishment listed in its biosimilar biological product application— 

ø(i) that did not manufacture the biosimilar biological product in the previous fiscal year; and 

ø(ii) for which the full biosimilar biological product 

establishment fee has been assessed in the fiscal year 

at a time before manufacture of the biosimilar biological product was begun, 

the applicant shall not be assessed a share of the biosimilar biological product establishment fee for the fiscal 

year in which the manufacture of the product began. 

ø(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 

ø(A) IN GENERAL.—Each person who is named as the applicant in a biosimilar biological product application shall 

pay for each such biosimilar biological product the annual 

fee established under subsection (b)(1)(F). 

ø(B) DUE DATE.—The biosimilar biological product fee for 

a fiscal year shall be due on the later of— 

ø(i) the first business day on or after October 1 of 

each such year; or 

ø(ii) the first business day after the enactment of an 

appropriations Act providing for the collection and obligation of fees for such year under this section. 


jbell on DSK7SPTVN1PROD with REPORTS
195 

ø(C) ONE FEE PER PRODUCT PER YEAR.—The biosimilar 

biological product fee shall be paid only once for each product for each fiscal year. 

ø(b) FEE SETTING AND AMOUNTS.— ø(1) IN GENERAL.—Subject to paragraph (2), the Secretary 

shall, 60 days before the start of each fiscal year that begins 

after September 30, 2012, establish, for the next fiscal year, 

the fees under subsection (a). Except as provided in subsection 

(c), such fees shall be in the following amounts: 

ø(A) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOP- MENT FEE.—The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall 

be equal to 10 percent of the amount established under 

section 736(c)(4) for a human drug application described in 

section 736(a)(1)(A)(i) for that fiscal year. 

ø(B) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOP- MENT FEE.—The annual biosimilar biological product development fee under subsection (a)(1)(B) for a fiscal year 

shall be equal to 10 percent of the amount established 

under section 736(c)(4) for a human drug application described in section 736(a)(1)(A)(i) for that fiscal year. 

ø(C) REACTIVATION FEE.—The reactivation fee under 

subsection (a)(1)(D) for a fiscal year shall be equal to 20 

percent of the amount of the fee established under section 

736(c)(4) for a human drug application described in section 

736(a)(1)(A)(i) for that fiscal year. 

ø(D) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION

FEE.—The biosimilar biological product application fee 

under subsection (a)(2) for a fiscal year shall be equal to 

the amount established under section 736(c)(4) for a 

human drug application described in section 736(a)(1)(A)(i) 

for that fiscal year. 

ø(E) BIOSIMILAR BIOLOGICAL PRODUCT ESTABLISHMENT

FEE.—The biosimilar biological product establishment fee 

under subsection (a)(3) for a fiscal year shall be equal to 

the amount established under section 736(c)(4) for a prescription drug establishment for that fiscal year. 

ø(F) BIOSIMILAR BIOLOGICAL PRODUCT FEE.—The biosimilar biological product fee under subsection (a)(4) for a 

fiscal year shall be equal to the amount established under 

section 736(c)(4) for a prescription drug product for that 

fiscal year. 

ø(2) LIMIT.—The total amount of fees charged for a fiscal 

year under this section may not exceed the total amount for 

such fiscal year of the costs of resources allocated for the process for the review of biosimilar biological product applications. 

ø(c) APPLICATION FEE WAIVER FOR SMALL BUSINESS.— 

ø(1) WAIVER OF APPLICATION FEE.—The Secretary shall grant 

to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that 

person under subsection (a)(2)(A) for the first biosimilar biological product application that a small business or its affiliate 

submits to the Secretary for review. After a small business or 

its affiliate is granted such a waiver, the small business or its 

affiliate shall pay— 


jbell on DSK7SPTVN1PROD with REPORTS
196 

ø(A) application fees for all subsequent biosimilar biological product applications submitted to the Secretary for 

review in the same manner as an entity that is not a small 

business; and 

ø(B) all supplement fees for all supplements to biosimilar biological product applications submitted to the 

Secretary for review in the same manner as an entity that 

is not a small business. 

ø(2) CONSIDERATIONS.—In determining whether to grant a 

waiver of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant. 

ø(3) SMALL BUSINESS DEFINED.—In this subsection, the term 

‘‘small business’’ means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a 

drug product that has been approved under a human drug application (as defined in section 735) or a biosimilar biological 

product application (as defined in section 744G(4)) and introduced or delivered for introduction into interstate commerce. 

ø(d) EFFECT OF FAILURE TO PAY FEES.—A biosimilar biological 

product application or supplement submitted by a person subject to 

fees under subsection (a) shall be considered incomplete and shall 

not be accepted for filing by the Secretary until all fees owed by 

such person have been paid. 

ø(e) CREDITING AND AVAILABILITY OF FEES.— ø(1) IN GENERAL.—Subject to paragraph (2), fees authorized 

under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance 

in appropriations Acts. Such fees are authorized to remain 

available until expended. Such sums as may be necessary may 

be transferred from the Food and Drug Administration salaries 

and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses 

with such fiscal year limitation. The sums transferred shall be 

available solely for the process for the review of biosimilar biological product applications. 

ø(2) COLLECTIONS AND APPROPRIATION ACTS.— ø(A) IN GENERAL.—Subject to subparagraphs (C) and 

(D), the fees authorized by this section shall be collected 

and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year. 

ø(B) USE OF FEES AND LIMITATION.—The fees authorized 

by this section shall be available for a fiscal year beginning 

after fiscal year 2012 to defray the costs of the process for 

the review of biosimilar biological product applications (including such costs for an additional number of full-time 

equivalent positions in the Department of Health and 

Human Services to be engaged in such process), only if the 

Secretary allocates for such purpose an amount for such 

fiscal year (excluding amounts from fees collected under 

this section) no less than $20,000,000, multiplied by the 

adjustment factor applicable to the fiscal year involved. 

ø(C) FEE COLLECTION DURING FIRST PROGRAM YEAR.— 

Until the date of enactment of an Act making appropriaVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00196 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
197 

tions through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees 

authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain 

available until expended. 

ø(D) PROVISION FOR EARLY PAYMENTS IN SUBSEQUENT

YEARS.—Payment of fees authorized under this section for 

a fiscal year (after fiscal year 2013), prior to the due date 

for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year 

appropriations Act. 

ø(3) AUTHORIZATION OF APPROPRIATIONS.—For each of fiscal 

years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equivalent to the 

total amount of fees assessed for such fiscal year under this 

section. 

ø(f) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 days after it is due, such fee shall be treated as a 

claim of the United States Government subject to subchapter II of 

chapter 37 of title 31, United States Code. 

ø(g) WRITTEN REQUESTS FOR WAIVERS AND REFUNDS.—To qualify 

for consideration for a waiver under subsection (c), or for a refund 

of any fee collected in accordance with subsection (a)(2)(A), a person shall submit to the Secretary a written request for such waiver 

or refund not later than 180 days after such fee is due. 

ø(h) CONSTRUCTION.—This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, 

and advisory committees not engaged in the process of the review 

of biosimilar biological product applications, be reduced to offset 

the number of officers, employees, and advisory committees so engaged.¿ 

[Effective January 31, 2018, section 404(b) of H.R. 5651 provides for a repeal of 

section 744I (as added by the bill).] 

øSEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS. 

ø(a) PERFORMANCE REPORT.—Beginning with fiscal year 2013, 

not later than 120 days after the end of each fiscal year for which 

fees are collected under this part, the Secretary shall prepare and 

submit to the Committee on Energy and Commerce of the House 

of Representatives and the Committee on Health, Education, 

Labor, and Pensions of the Senate a report concerning the progress 

of the Food and Drug Administration in achieving the goals identified in the letters described in section 401(b) of the Biosimilar User 

Fee Act of 2012 during such fiscal year and the future plans of the 

Food and Drug Administration for meeting such goals. The report 

for a fiscal year shall include information on all previous cohorts 

for which the Secretary has not given a complete response on all 

biosimilar biological product applications and supplements in the 

cohort. 

ø(b) FISCAL REPORT.—Not later than 120 days after the end of 

fiscal year 2013 and each subsequent fiscal year for which fees are 

collected under this part, the Secretary shall prepare and submit 

to the Committee on Energy and Commerce of the House of RepVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00197 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
198 

resentatives and the Committee on Health, Education, Labor, and 

Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the 

Food and Drug Administration, of the fees collected for such fiscal 

year. 

ø(c) PUBLIC AVAILABILITY.— The Secretary shall make the reports required under subsections (a) and (b) available to the public 

on the Internet Web site of the Food and Drug Administration. 

ø(d) STUDY.— 

ø(1) IN GENERAL.—The Secretary shall contract with an independent accounting or consulting firm to study the workload 

volume and full costs associated with the process for the review of biosimilar biological product applications. 

ø(2) INTERIM RESULTS.—Not later than June 1, 2015, the 

Secretary shall publish, for public comment, interim results of 

the study described under paragraph (1). 

ø(3) FINAL RESULTS.—Not later than September 30, 2016, the 

Secretary shall publish, for public comment, the final results of 

the study described under paragraph (1). 

ø(e) REAUTHORIZATION.— 

ø(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals described in 

subsection (a), and plans for meeting the goals, for the process 

for the review of biosimilar biological product applications for 

the first 5 fiscal years after fiscal year 2017, and for the reauthorization of this part for such fiscal years, the Secretary shall 

consult with— 

ø(A) the Committee on Energy and Commerce of the 

House of Representatives; 

ø(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

ø(C) scientific and academic experts; 

ø(D) health care professionals; 

ø(E) representatives of patient and consumer advocacy 

groups; and 

ø(F) the regulated industry. 

ø(2) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

ø(A) present the recommendations developed under 

paragraph (1) to the congressional committees specified in 

such paragraph; 

ø(B) publish such recommendations in the Federal Register; 

ø(C) provide for a period of 30 days for the public to provide written comments on such recommendations; 

ø(D) hold a meeting at which the public may present its 

views on such recommendations; and 

ø(E) after consideration of such public views and comments, revise such recommendations as necessary. 

ø(3) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2017, the Secretary shall transmit to the Congress 

the revised recommendations under paragraph (2), a summary 

of the views and comments received under such paragraph, 


jbell on DSK7SPTVN1PROD with REPORTS
199 

and any changes made to the recommendations in response to 

such views and comments.¿ 

* * * * * * * 

SUBCHAPTER D—INFORMATION AND EDUCATION

* * * * * * * 

SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 

(a) DRUGS AND BIOLOGICS.— (1) IN GENERAL.—Beginning no earlier than 24 months after 

the issuance of a final guidance issued after public notice and 

opportunity for comment, submissions under subsection (b), (i), 

or (j) of section 505 of this Act or subsection (a) or (k) of section 

351 of the Public Health Service Act shall be submitted in such 

electronic format as specified by the Secretary in such guidance. 

(2) GUIDANCE CONTENTS.—In the guidance under paragraph 

(1), the Secretary may— 

(A) provide a timetable for establishment by the Secretary 

of further standards for electronic submission as required 

by such paragraph; and 

(B) set forth criteria for waivers of and exemptions from 

the requirements of this subsection. 

(3) EXCEPTION.—This subsection shall not apply to submissions described in section 561. 

(b) DEVICES.— 

(1) IN GENERAL.—Beginning after the issuance of final guidance implementing this paragraph, pre-submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 

515(d), 515(f), 520(g), 520(m), or 564 of this Act or section 351 

of the Public Health Service Act, and any supplements to such 

pre-submissions or submissions, shall include an electronic copy 

of such pre-submissions or submissions. 

(2) GUIDANCE CONTENTS.—In the guidance under paragraph 

(1), the Secretary may— 

(A) provide standards for the electronic copy required 

under such paragraph; and 

(B) set forth criteria for waivers of and exemptions from 

the requirements of this subsection. 

* * * * * * * 

CHAPTER VIII—IMPORTS AND EXPORTS 

IMPORTS AND EXPORTS

SEC. 801. (a) The Secretary of the Treasury shall deliver to the 

Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which 

are being imported or offered for import into the United States, giving notice thereof, except as otherwise described in the sixth and 

seventh sentences of this subsection, to the owner or consignee, who 

may appear before the Secretary of Health and Human Services 

and have the right to introduce testimony. The Secretary of Health 

and Human Services shall furnish to the Secretary of the Treasury 

a list of establishments registered pursuant to subsection (i) of section 510 or section 905(h) and shall request that if any drugs, deVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00199 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
200 

vices, or tobacco products manufactured, prepared, propagated, 

compounded, or processed in an establishment not so registered are 

imported or offered for import into the United States, samples of 

such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery 

to the owner or consignee, who may appear before the Secretary of 

Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or 

packed under insanitary conditions or, in the case of a device, the 

methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform 

to the requirements of section 520(f), or (2) such article is forbidden 

or restricted in sale in the country in which it was produced or 

from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 505, or prohibited from introduction or delivery for introduction into interstate commerce under 

section 301(ll), or (4) the recordkeeping requirements under section 

204 of the FDA Food Safety Modernization Act (other than the requirements under subsection (f) of such section) have not been complied with regarding such article, or (5) for an article that is a 

drug, the appropriate unique facility identifiers under subsection (s) 

(relating to commercial importers) and section 510(i) (relating to 

foreign establishments), as specified by the Secretary, are not provided, then such article shall be refused admission, except as provided in subsection (b) of this section. With respect to an article of 

food, if importation of such food is subject to, but not compliant 

with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets 

applicable requirements of this Act, then such article shall be refused admission. If such article is subject to a requirement under 

section 760 or 761 and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such 

section 760 or 761) has not complied with a requirement of such 

section 760 or 761 with respect to any such article, or has not allowed access to records described in such section 760 or 761, then 

such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause 

the destruction of any such article refused admission unless such 

article is exported, under regulations prescribed by the Secretary 

of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant 

to such regulations, except that the Secretary of Health and Human 

Services, in consultation with the Secretary of Homeland Security, 

may cause the destruction, without the opportunity for export, of any 

drug refused admission that has reasonable probability of causing 

serious adverse health consequences or death, as determined by the 

Secretary of Health and Human Services, or that is valued at an 

amount that is $2,000 or less (or such higher amount as the Secretary of Homeland Security may set by regulation pursuant to section 1498 of title 19, United States Code). The Secretary of Health 

and Human Services shall issue regulations providing for notice 

and an opportunity for a hearing on the destruction of a drug under 

the previous sentence. For a drug with a value less than and or 

equal to $2,000 (or, as described in the sixth sentence of this subVerDate Mar 15 2010 06:26 May 26, 2012 Jkt 019006 PO 00000 Frm 00200 Fmt 6659 Sfmt 6601 E:\HR\OC\HR495.XXX HR495

jbell on DSK7SPTVN1PROD with REPORTS
201 

section, such higher amount as the Secretary of Homeland Security 

may set by regulation pursuant to section 1498 of title 19, United 

States Code) the regulations under the previous sentence shall provide for prompt notice and an opportunity for a hearing for the 

owner or consignee before or after the destruction has occurred. For 

a drug with a value greater than $2,000 (or, as described in the 

sixth sentence of this subsection, such higher amount as the Secretary of Homeland Security may set by regulation pursuant to section 1498 of title 19, United States Code) that has reasonable probability of causing serious adverse health consequences or death as 

determined by the Secretary of Health and Human Services, the regulations under the seventh sentence of this subsection shall provide 

for notice and an opportunity for a hearing to the owner or consignee before the destruction occurs. Clause (2) of the third sentence 

of this paragraph shall not be construed to prohibit the admission 

of narcotic drugs the importation of which is permitted under the 

Controlled Substances Import and Export Act. 

* * * * * * * 

(r) DOCUMENTATION.— (1) SUBMISSION.—The Secretary may require, in consultation 

with the Secretary of Homeland Security acting through U.S. 

Customs and Border Protection as determined appropriate by 

the Secretary, the submission of documentation or other information for a drug that is imported or offered for import into the 

United States. 

(2) REFUSAL OF ADMISSION.—A drug imported or offered for 

import into the United States shall be refused admission unless 

all documentation and information the Secretary requires 

under this Act, the Public Health Service Act, or both, as appropriate, for such article is submitted. 

(3) REGULATIONS.— (A) DOCUMENTS AND INFORMATION.—The Secretary shall 

issue a regulation to specify the documentation or other information that is described in paragraph (1). Such information may include— 

(i) information demonstrating the regulatory status 

of the drug, such as the new drug application, abbreviated new drug application, or investigational new 

drug or Drug Master File number; 

(ii) facility information, such as proof of registration 

and the unique facility identifier; and 

(iii) indication of compliance with current good manufacturing practice, such as satisfactory testing results, 

certifications relating to satisfactory inspections, and 

compliance with the country of export regulations. 

(B) EXEMPTION.—The Secretary may, by regulation, exempt drugs imported for research purposes only and other 

types of drug imports from some or all of the requirements 

of this subsection. 

(4) EFFECTIVE DATE.—The final rule under paragraph (3)(A) 

shall take effect not less than 180 days after the Secretary promulgates such final rule. 

(s) REGISTRATION OF COMMERCIAL IMPORTERS.— (1) REGISTRATION.—The Secretary shall require a commercial 

importer of drugs— 


jbell on DSK7SPTVN1PROD with REPORTS
202 

(A) to be registered with the Secretary in a form and 

manner specified by the Secretary; and 

(B) consistent with the guidance under section 510(q), to 

submit, at the time of registration, a unique identifier for 

the principal place of business for which the importer is required to register under this subsection. 

(2) REGULATIONS.— (A) IN GENERAL.—The Secretary, in consultation with the 

Secretary of Homeland Security acting through U.S. Customs and Border Protection, shall promulgate regulations 

to establish good importer practices that specify the measures an importer shall take to ensure imported drugs are 

in compliance with the requirements of this Act and the 

Public Health Service Act. 

(B) EXPEDITED CLEARANCE FOR CERTAIN IMPORTERS.—In 

promulgating good importer practice regulations under 

subparagraph (A), the Secretary may, as appropriate, take 

into account differences among importers and types of imports, and, based on the level of risk posed by the imported 

drug, provide for expedited clearance for those importers 

that volunteer to participate in partnership programs for 

highly compliant companies. 

(3) DISCONTINUANCE OF REGISTRATION.—The Secretary shall 

discontinue the registration of any commercial importer of 

drugs that fails to comply with the regulations promulgated 

under this subsection. 

(4) EXEMPTIONS.—The Secretary, by notice in the Federal 

Register, may establish exemptions from the requirements of 

this subsection. 

* * * * * * * 

OFFICE OF INTERNATIONAL RELATIONS

SEC. 803. (a) * * * 

* * * * * * * 

(c)(1) * * * 

* * * * * * * 

(3)(A) The Secretary shall regularly participate in meetings with 

representatives of other foreign governments to discuss and reach 

agreement on methods and approaches to harmonize regulatory requirements. 

(B) In carrying out subparagraph (A), the Secretary may participate in appropriate fora, including the International Medical Device 

Regulators Forum, and may— 

(i) provide guidance to such fora on strategies, policies, directions, membership, and other activities of a forum as appropriate; 

(ii) to the extent appropriate, solicit, review, and consider 

comments from industry, academia, health care professionals, 

and patient groups regarding the activities of such fora; and 

(iii) to the extent appropriate, inform the public of the Secretary’s activities within such fora, and share with the public 

any documentation relating to a forum’s strategies, policies, and 

other activities of such fora. 


jbell on DSK7SPTVN1PROD with REPORTS
203 

ø(4) The Secretary shall, not later than 180 days after the date 

of enactment of the Food and Drug Administration Modernization 

Act of 1997, make public a plan that establishes a framework for 

achieving mutual recognition of good manufacturing practices inspections.¿ 

(4) With respect to devices, the Secretary may, when appropriate, 

enter into arrangements with nations regarding methods and approaches to harmonizing regulatory requirements for activities, including inspections and common international labeling symbols 

* * * * * * * 

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 

* * * * * * * 

TITLE I—PRESCRIPTION DRUG USER 

FEE AMENDMENTS OF 2007 

* * * * * * * 

øSEC. 106. SUNSET DATES. 

ø(a) AUTHORIZATION.—The amendments made by sections 102, 

103, and 104 cease to be effective October 1, 2012. 

ø(b) REPORTING REQUIREMENTS.—The amendment made by section 105 ceases to be effective January 31, 2013.¿ 

* * * * * * * 

SECTION 508 OF THE PRESCRIPTION DRUG USER FEE 

AMENDMENTS ACT OF 2002 

øSEC. 508. EFFECTIVE DATE. 

øThe amendments made by this subtitle shall take effect October 

1, 2002.¿ 

SECTION 107 OF THE FOOD AND DRUG 

ADMINISTRATION MODERNIZATION ACT OF 1997 

øSEC. 107. TERMINATION OF EFFECTIVENESS. 

øThe amendments made by sections 102 and 103 cease to be effective October 1, 2002, and section 104 ceases to be effective 120 

days after such date.¿ 

SECTION 105 OF THE PRESCRIPTION DRUG USER FEE 

ACT OF 1992 

øSEC. 105. SUNSET. 

øThe amendments made by section 103 shall not be in effect 

after October 1, 1997 and section 104 shall not be in effect after 

120 days after such date.¿ 


jbell on DSK7SPTVN1PROD with REPORTS
204 

MEDICAL DEVICE USER FEE AMENDMENTS OF 2007 

* * * * * * * 

TITLE II—MEDICAL DEVICE USER FEE 

AMENDMENTS OF 2007 

* * * * * * * 

Subtitle A—Fees Related to Medical 

Devices 

* * * * * * * 

øSEC. 217. SUNSET CLAUSE. 

øThe amendments made by this subtitle cease to be effective October 1, 2012, except that section 738A of the Federal Food, Drug, 

and Cosmetic Act (regarding annual performance and financial reports) ceases to be effective January 31, 2013.¿ 

MEDICAL DEVICE USER FEE AND MODERNIZATION ACT 

OF 2002 

* * * * * * * 

TITLE I—FEES RELATED TO MEDICAL 

DEVICES 

* * * * * * * 

øSEC. 107. SUNSET CLAUSE. 

øThe amendments made by this title cease to be effective October 

1, 2007, except that section 103 with respect to annual reports 

ceases to be effective January 31, 2008.¿ 

* * * * * * * 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 

PART F—LICENSING—BIOLOGICAL PRODUCTS AND CLINICAL

LABORATORIES

Subpart 1—Biological Products 

REGULATION OF BIOLOGICAL PRODUCTS

SEC. 351. (a) * * * 

* * * * * * * 


jbell on DSK7SPTVN1PROD with REPORTS
205 

(m) PEDIATRIC STUDIES.— 

(1) APPLICATION OF CERTAIN PROVISIONS.—The provisions of 

subsections (a), (d), (e), ø(f), (i), (j), (k), (l), (p), and (q)¿ (f), (h), 

(i), (j), (k), (l), (n), and (p) of section 505A of the Federal Food, 

Drug, and Cosmetic Act shall apply with respect to the extension of a period under paragraphs (2) and (3) to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of 

section 505A of the Federal Food, Drug, and Cosmetic Act. 

* * * * * * * 

TITLE IV—NATIONAL RESEARCH INSTITUTES 

* * * * * * * 

PART B—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH

INSTITUTES

* * * * * * * 

SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 

(a) * * * 

* * * * * * * 

(c) PROCESS FOR PROPOSED PEDIATRIC STUDY REQUESTS AND LABELING CHANGES.— 

(1) SUBMISSION OF PROPOSED PEDIATRIC STUDY REQUEST.— 

The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric 

studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be 

made in a manner equivalent to a written request made under 

subsection (b) or (c) of section 505A of the Federal Food, Drug, 

and Cosmetic Act, or section 351(m) of this Act, including with 

respect to the information provided on the pediatric studies to 

be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric 

study request for a drug for which— 

(A)(i) there is an approved application under section 

505(j) of the Federal Food, Drug, and Cosmetic Act or section 351(k) of this Act; or 

* * * * * * * 

ø(B) there is no patent protection or market exclusivity 

protection for at least one form of the drug under the Federal Food, Drug, and Cosmetic Act; and¿ 

(B)(i) there remains no patent listed pursuant to section 

505(b)(1) of the Federal Food, Drug, and Cosmetic Act; and 

(ii) every three-year and five-year period referred to in 

subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E(iv), (j)(5)(F)(ii), 

(j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal 

Food, Drug and Cosmetic Act, or applicable twelve-year period referred to in section 351(k)(7) of this Act, and any 

seven-year period referred to in section 527 of the Federal 


jbell on DSK7SPTVN1PROD with REPORTS
206 

Food, Drug, and Cosmetic Act, has ended for at least one 

form of the drug; and 

* * * * * * * 

(2) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICATIONS øFOR DRUGS LACKING EXCLUSIVITY¿.—The Commissioner 

of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based 

on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) 

to all holders of an approved application for the drug øunder 

section 505 of the Federal Food, Drug, and Cosmetic Act¿. 

Such a written request shall be made in a manner equivalent 

to the manner in which a written request is made under subsection (b) or (c) of section ø505A of such Act¿ 505A of the Federal Food, Drug, and Cosmetic Act or section 351(m) of this Act, 

including with respect to information provided on the pediatric 

studies to be conducted pursuant to the request and using appropriate formulations for each age group for which the study 

is requested. 

* * * * * * * 

(e) AUTHORIZATION OF APPROPRIATIONS.— 

(1) IN GENERAL.—There are authorized to be appropriated 

øto carry out this section— 

ø(A) $200,000,000 for fiscal year 2008; and 

ø(B) such sums as are necessary for each of the four succeeding fiscal years.¿ $25,000,000 for each of fiscal years 

2013 through 2017. 

* * * * * * * 

PART I—FOUNDATION FOR THE NATIONAL 

INSTITUTES OF HEALTH 

SEC. 499. ESTABLISHMENT AND DUTIES OF FOUNDATION. 

(a) * * * 

* * * * * * * 

(c) CERTAIN ACTIVITIES OF FOUNDATION.— 

(1) IN GENERAL.—In carrying out subsection (b), the Foundation may solicit and accept gifts, grants, and other donations, 

establish accounts, and invest and expend funds in support of 

the following activities with respect to the purpose described in 

such subsection: 

(A) * * * 

* * * * * * * 

(C) A program to collect funds for pediatric pharmacologic research and studies øfor which the Secretary issues 

a certification in the affirmative under section 


jbell on DSK7SPTVN1PROD with REPORTS
207 

505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic 

Act¿. 

* * * * * * * 

BEST PHARMACEUTICALS FOR CHILDREN ACT 

* * * * * * * 

SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS. 

(a) * * * 

* * * * * * * 

(c) STAFF.—The staff of the Office of Pediatric Therapeutics shall 

coordinate with employees of the Department of Health and 

Human Services who exercise responsibilities relating to pediatric 

therapeutics and shall include— 

(1) one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population; øand¿ 

(2) one or more additional individuals with expertise in 

neonatology; 

(3) one or more additional individuals with expertise in pediatric epidemiology; and 

ø(2)¿ (4) one or more additional individuals with expertise in 

pediatrics as may be necessary to perform the activities described in subsection (b). 

* * * * * * * 

SEC. 14. PEDIATRIC ADVISORY COMMITTEE. 

(a) * * * 

* * * * * * * 

(d) CONTINUATION OF OPERATION OF COMMITTEE.—Notwithstanding section 14 of the Federal Advisory Committee Act, the advisory committee shall continue to operate øduring the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007¿ to carry out the advisory committee’s responsibilities under sections 505A, 505B, and 520(m) of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c, 

and 360j(m)). 

* * * * * * * 

SEC. 15. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE. 

(a) CLARIFICATION OF AUTHORITIES.— 

(1) IN GENERAL.—The Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (referred to in this section as 

the ‘‘Subcommittee’’), in carrying out the mission of reviewing 

and evaluating the data concerning the safety and effectiveness of marketed and investigational human drug products for 

use in the treatment of pediatric cancers, shall— 

(A) * * * 

* * * * * * * 

(D) provide recommendations to the internal review committee created under øsection 505B(f)¿ section 505C of the 


jbell on DSK7SPTVN1PROD with REPORTS
208 

Federal Food, Drug, and Cosmetic Act regarding the implementation of amendments to sections 505A and 505B of 

the Federal Food, Drug, and Cosmetic Act with respect to 

the treatment of pediatric cancers. 

* * * * * * * 

(3) CONTINUATION OF OPERATION OF SUBCOMMITTEE.—Notwithstanding section 14 of the Federal Advisory Committee 

Act, the Subcommittee shall continue to operate øduring the 

five-year period beginning on the date of the enactment of the 

Best Pharmaceuticals for Children Act of 2007¿ to carry out the 

Subcommittee’s responsibilities under this section. 

* * * * * * * 

SECTION 305 OF THE PEDIATRIC MEDICAL DEVICE 

SAFETY AND IMPROVEMENT ACT OF 2007 

SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY. 

(a) * * * 

* * * * * * * 

(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to 

be appropriated to carry out this section $6,000,000 for each of fiscal years ø2008 through 2012¿ 2013 through 2017. 

ORPHAN DRUG ACT 

* * * * * * * 

GRANTS AND CONTRACTS FOR DEVELOPMENT OF DRUGS FOR RARE

DISEASES AND CONDITIONS

SEC. 5. (a) * * * 

(b) For purposes of subsection (a): 

(1) The term ‘‘qualified testing’’ means— 

(A) human clinical testing— 

(i) * * * 

(ii) which occurs øafter the date such drug is designated under section 526 of such Act and¿ before the 

date on which an application with respect to such drug 

is submitted under section 505(b) of such Act or under 

section 351 of the Public Health Service Act; and 

* * * * * * * 

ø(c) For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000 for each of fiscal years 

2008 through 2012.¿ 

(c) AUTHORIZATION OF APPROPRIATIONS.—For grants and contracts under subsection (a), there is authorized to be appropriated 

$30,000,000 for each of fiscal years 2013 through 2017. 

* * * * * * * 


jbell on DSK7SPTVN1PROD with REPORTS
209 

CONTROLLED SUBSTANCES ACT 

TITLE II—CONTROL AND ENFORCEMENT 

* * * * * * * 

PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND

DISPENSERS OF CONTROLLED SUBSTANCES; PIPERIDINE REPORTING

* * * * * * * 

QUOTAS APPLICABLE TO CERTAIN SUBSTANCES

SEC. 306. (a) * * * 

* * * * * * * 

(h)(1) Not later than 30 days after the receipt of a request described in paragraph (2), the Attorney General shall— 

(A) complete review of such request; and 

(B)(i) as necessary to address a shortage of a controlled substance, increase the aggregate and individual production quotas 

under this section applicable to such controlled substance and 

any ingredient therein to the level requested; or 

(ii) if the Attorney General determines that the level requested 

is not necessary to address a shortage of a controlled substance, 

the Attorney General shall provide a written response detailing 

the basis for the Attorney General’s determination. 

The Secretary shall make the written response provided under subparagraph (B)(ii) available to the public on the Web site of the Food 

and Drug Administration. 

(2) A request is described in this paragraph if— 

(A) the request pertains to a controlled substance on the list 

of drugs in shortage maintained under section 506D of the Federal Food, Drug, and Cosmetic Act; 

(B) the request is submitted by the manufacturer of the controlled substance; and 

(C) the controlled substance is in schedule II. 

* * * * * * * 

Æ 


jbell on DSK7SPTVN1PROD with REPORTS