45296 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Fee for Using a Tropical Disease 

Priority Review Voucher in Fiscal Year 

2018 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the fee rates for using a 

tropical disease priority review voucher 

for fiscal year (FY) 2018. The Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act), as amended by the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA), authorizes FDA to 

determine and collect priority review 

user fees for certain applications for 

approval of drug or biological products 

when those applications use a tropical 

disease priority review voucher 

awarded by the Secretary of Health and 

Human Services. These vouchers are 

awarded to the sponsors of certain 

tropical disease product applications, 

submitted after September 27, 2007, 

upon FDA approval of such 

applications. The amount of the fee 

submitted to FDA with applications 

using a tropical disease priority review 

voucher is determined each fiscal year 

based on the difference between the 

average cost incurred by FDA in the 

review of a human drug application 

subject to priority review in the 

previous fiscal year, and the average 

cost incurred in the review of an 

application that is not subject to priority 

review in the previous fiscal year. This 

notice establishes the tropical disease 

priority review fee rate for FY 2018. 

FOR FURTHER INFORMATION CONTACT: 

Robert J. Marcarelli, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14202F, Silver Spring, MD 

20993–0002, 301–796–7223. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1102 of FDAAA (Pub. L. 110– 

85) added section 524 to the FD&C Act 

(21 U.S.C. 360n). In section 524, 

Congress encouraged development of 

new drug and biological products for 

prevention and treatment of certain 

tropical diseases by offering additional 

incentives for obtaining FDA approval 

of such products. Under section 524, the 

sponsor of an eligible human drug 

application submitted after September 

27, 2007, for a tropical disease (as 

defined in section 524(a)(3) of the FD&C 

Act), shall receive a priority review 

voucher upon approval of the tropical 

disease product application. The 

recipient of a tropical disease priority 

review voucher may either use the 

voucher with a future submission to 

FDA under section 505(b)(1) of the 

FD&C Act (21 U.S.C. 355(b)(1)) or 

section 351 of the Public Health Service 

Act (42 U.S.C. 262), or transfer 

(including by sale) the voucher to 

another party. The voucher may be 

transferred (including by sale) 

repeatedly until it ultimately is used for 

a human drug application submitted to 

FDA under section 505(b)(1) of the 

FD&C Act or section 351(a) of the Public 

Health Service Act. A priority review is 

a review conducted with a Prescription 

Drug User Fee Act (PDUFA) goal date of 

6 months after the receipt or filing date, 

depending upon the type of application. 

Information regarding the PDUFA goals 

is available at: http://www.fda.gov/ 

downloads/forindustry/userfees/ 

prescriptiondruguserfee/ 

ucm511438.pdf. 

The applicant that uses a priority 

review voucher is entitled to a priority 

review but must pay FDA a priority 

review user fee in addition to any other 

fee required by PDUFA. FDA published 

guidance on its Web site about how this 

tropical disease priority review voucher 

program operates (available at: http://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

ucm080599.pdf). 

This notice establishes the tropical 

disease priority review fee rate for FY 

2018 as $2,830,579 and outlines FDA’s 

process for implementing the collection 

of the priority review user fees. This rate 

is effective on October 1, 2017, and will 

remain in effect through September 30, 

2018, for applications submitted with a 

tropical disease priority review voucher. 

The payment of this priority review user 

fee is required in addition to the 

payment of any other fee that would 

normally apply to such an application 

under PDUFA before FDA will consider 

the application complete and acceptable 

for filing. 

II. Tropical Disease Priority Review 

User Fee for FY 2018 

FDA interprets section 524(c)(2) of the 

FD&C Act as requiring that FDA 

determine the amount of the tropical 

disease priority review user fee each 

fiscal year based on the difference 

between the average cost incurred by 

FDA in the review of a human drug 

application subject to priority review in 

the previous fiscal year, and the average 

cost incurred by FDA in the review of 

a human drug application that is not 

subject to priority review in the 

previous fiscal year. 

A priority review is a review 

conducted with a PDUFA goal date of 6 

months after the receipt or filing date, 

depending on the type of application. 

Under the PDUFA goals letter, FDA has 

committed to reviewing and acting on 

90 percent of the applications granted 

priority review status within this 

expedited timeframe. Normally, an 

application for a human drug or 

biological product will qualify for 

priority review if the product is 

intended to treat a serious condition 

and, if approved, would provide a 

significant improvement in safety or 

effectiveness. An application that does 

not receive a priority designation will 

receive a standard review. Under the 

PDUFA goals letter, FDA committed to 

reviewing and acting on 90 percent of 

standard applications within 10 months 

of the receipt or filing date, depending 

on the type of application. A priority 

review involves a more intensive level 

of effort and a higher level of resources 

than a standard review. 

FDA is setting fees for FY 2018, and 

the previous fiscal year is FY 2017. 

However, the FY 2017 submission 

cohort has not been closed out yet, and 

the cost data for FY 2017 are not 

complete. The latest year for which FDA 

has complete cost data is FY 2016. 

Furthermore, because FDA has never 

tracked the cost of reviewing 

applications that get priority review as 

a separate cost subset, FDA estimated 

this cost based on other data that the 

Agency has tracked. FDA uses data that 

the Agency estimates and publishes on 

its Web site each year—standard costs 

for review. FDA does not publish a 

standard cost for ‘‘the review of a 

human drug application subject to 

priority review in the previous fiscal 

year.’’ However, we expect all such 

applications would contain clinical 

data. The standard cost application 

categories with clinical data that FDA 

does publish each year are: (1) New 

drug applications (NDAs) for a new 

molecular entity (NME) with clinical 

data and (2) biologics license 

applications (BLAs). 

The worksheets for standard costs for 

FY 2016, show a standard cost (rounded 

to the nearest hundred dollars) of 

$5,929,100 for a NME NDA and 

$4,887,100 for a BLA. Based on these 

standard costs, the total cost to review 

the 49 applications in these two 

categories in FY 2016 (27 NME NDAs 

with clinical data and 22 BLAs) was 

$267,601,900. (Note: These numbers 

exclude the President’s Emergency Plan 

for AIDS Relief NDAs; no 

Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45297 

investigational new drug review costs 

are included in this amount.) Twentythree of these applications (14 NDAs 

and 9 BLAs) received priority review, 

which would mean that the remaining 

26 received standard reviews. Because a 

priority review compresses a review that 

ordinarily takes 10 months into 6 

months, FDA estimates that a multiplier 

of 1.67 (10 months divided by 6 months) 

should be applied to non-priority 

review costs in estimating the effort and 

cost of a priority review as compared to 

a standard review. This multiplier is 

consistent with published research on 

this subject which supports a priority 

review multiplier in the range of 1.48 to 

2.35 (Ref. 1). Using FY 2016 figures, the 

costs of a priority and standard review 

are estimated using the following 

formula: 

(23 a × 1.67) + (26 a) = $267,601,900 

where ‘‘a’’ is the cost of a standard 

review and ‘‘a times 1.67’’ is the cost of 

a priority review. Using this formula, 

the cost of a standard review for NME 

NDAs and BLAs is calculated to be 

$4,154,664 (rounded to the nearest 

dollar) and the cost of a priority review 

for NME NDAs and BLAs is 1.67 times 

that amount, or $6,938,289 (rounded to 

the nearest dollar). The difference 

between these two cost estimates, or 

$2,783,625, represents the incremental 

cost of conducting a priority review 

rather than a standard review. 

For the FY 2018 fee, FDA will need 

to adjust the FY 2016 incremental cost 

by the average amount by which FDA’s 

average costs increased in the 3 years 

prior to FY 2017, to adjust the FY 2016 

amount for cost increases in FY 2017. 

That adjustment, published in the 

Federal Register on July 28, 2016 (see 

81 FR 49674 at 49676), setting FY 2018 

PDUFA fees, is 1.6868 percent for the 

most recent year, not compounded. 

Increasing the FY 2016 incremental 

priority review cost of $2,783,625 by 

1.6868 percent (or 0.016868) results in 

an estimated cost of $2,830,579 

(rounded to the nearest dollar). This is 

the tropical disease priority review user 

fee amount for FY 2018 that must be 

submitted with a priority review 

voucher for a human drug application in 

FY 2018, in addition to any PDUFA fee 

that is required for such an application. 

III. Fee Schedule for FY 2018 

The fee rate for FY 2018 is set out in 

table 1: 

TABLE 1—TROPICAL DISEASE PRIORITY REVIEW SCHEDULE FOR FY 2018 

Fee category Fee rate for 

FY 2018 

Application submitted with a tropical disease priority review voucher in addition to the normal PDUFA fee .................................... $2,830,579 

IV. Implementation of Tropical Disease 

Priority Review User Fee 

Under section 524(c)(4)(A) of the 

FD&C Act, the priority review user fee 

is due upon submission of a human 

drug application for which the priority 

review voucher is used. Section 

524(c)(4)(B) of the FD&C Act specifies 

that the application will be considered 

incomplete if the priority review user 

fee and all other applicable user fees are 

not paid in accordance with FDA 

payment procedures. In addition, FDA 

may not grant a waiver, exemption, 

reduction, or refund of any fees due and 

payable under section 524 of the FD&C 

Act (see section 524(c)(4)(C)) and FDA 

may not collect priority review voucher 

fees ‘‘except to the extent provided in 

advance in appropriation Acts.’’ 

(Section 524(c)(5)(B) of the FD&C Act.) 

Beginning with FDA’s appropriation for 

FY 2009, the annual appropriation 

language states specifically that 

‘‘priority review user fees authorized by 

21 U.S.C. 360n [i.e., section 524 of the 

FD&C Act] may be credited to this 

account, to remain available until 

expended.’’ (Pub. L. 111–8, Section 5, 

Division A, Title VI). 

The tropical disease priority review 

fee established in the new fee schedule 

must be paid for any application that is 

received on or after October 1, 2017, and 

submitted with a priority review 

voucher. This fee must be paid in 

addition to any other fee due under 

PDUFA. Payment should be made in 

U.S. currency by electronic check, 

check, bank draft, wire transfer, credit 

card, or U.S. postal money order 

payable to the order of the Food and 

Drug Administration. The preferred 

payment method is online using 

electronic check (Automated Clearing 

House (ACH) also known as eCheck). 

Secure electronic payments can be 

submitted using the User Fees Payment 

Portal at https://userfees.fda.gov/pay. 

(NOTE: Only full payments are accepted. 

No partial payments can be made 

online). Once you search for your 

invoice, select ‘‘Pay Now’’ to be 

redirected to Pay.gov. Note that 

electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances that are less 

than $25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments should be made 

using U.S bank accounts as well as U.S. 

credit cards. 

FDA has partnered with the U.S. 

Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA Web site after the 

user fee ID number is generated. 

If paying with a paper check the user 

fee identification (ID) number should be 

included on the check, followed by the 

words ‘‘Tropical Disease Priority 

Review.’’ All paper checks should be in 

U.S. currency from a U.S. bank made 

payable and mailed to: Food and Drug 

Administration, P.O. Box 979107, St. 

Louis, MO 63197–9000. 

If checks are sent by a courier that 

requests a street address, the courier can 

deliver the checks to: U.S. Bank, 

Attention: Government Lockbox 979107, 

1005 Convention Plaza, St. Louis, MO 

63101. (Note: This U.S. Bank address is 

for courier delivery only.) If you have 

any questions concerning courier 

delivery, contact the U.S. Bank at 314– 

418–4013. (This telephone number is 

only for questions about courier 

delivery). The FDA post office box 

number (P.O. Box 979107) must be 

written on the check. If needed, FDA’s 

tax identification number is 53– 

0196965. 

If paying by wire transfer, please 

reference your unique user fee ID 

number when completing your transfer. 

The originating financial institution 

may charge a wire transfer fee. If the 

financial institution charges a wire 

transfer fee, it is required to add that 

amount to the payment to ensure that 

the invoice is paid in full. The account 

information is as follows: U.S. Dept. of 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Account Number: 

75060099, Routing Number: 021030004, 

SWIFT: FRNYUS33, Beneficiary: FDA, 

8455 Colesville Rd., 14th Floor, Silver 

Spring, MD 20993–0002. 

V. Reference 

The following reference is on display 

in the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

45298 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852, and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday. 

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, 

‘‘Developing Drugs for Developing 

Countries,’’ Health Affairs, vol. 25, no. 2, 

pp. 313–324, 2006. 

Dated: September 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20799 Filed 9–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0001] 

Request for Nominations on Public 

Advisory Panels of the Medical 

Devices Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on certain panels of the Medical 

Devices Advisory Committee (MDAC or 

Committee) in the Center for Devices 

and Radiological Health (CDRH) notify 

FDA in writing. FDA is also requesting 

nominations for nonvoting industry 

representatives to serve on certain 

device panels of the MDAC in the 

CDRH. A nominee may either be selfnominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current and 

upcoming vacancies effective with this 

notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

the FDA by October 30, 2017 (see 

sections I and II of this document for 

further details). Concurrently, 

nomination materials for prospective 

candidates should be sent to FDA by 

October 30, 2017. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nomination should be sent to Margaret 

Ames (see FOR FURTHER INFORMATION

CONTACT). All nominations for 

nonvoting industry representatives 

should be submitted electronically by 

accessing the FDA Advisory Committee 

Membership Nomination Portal: https:// 

www.accessdata.fda.gov/scripts/FACT

RSPortal/FACTRS/index.cfm or by mail 

to Advisory Committee Oversight and 

Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s Web site at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Division of Workforce 

Management, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5264, Silver Spring, 

MD 20993, 301–796–5960, Fax: 301– 

847–8505, email: margaret.ames@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency is requesting nominations for 

nonvoting industry representatives to 

the panels listed in the table in this 

document. 

I. Medical Devices Advisory Committee 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational devices 

and makes recommendations for their 

regulation. The panels engage in a 

number of activities to fulfill the 

functions the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) envisions 

for device advisory panels. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, advises 

the Commissioner of Food and Drugs 

(the Commissioner) regarding 

recommended classification or 

reclassification of devices into one of 

three regulatory categories; advises on 

any possible risks to health associated 

with the use of devices; advises on 

formulation of product development 

protocols; reviews premarket approval 

applications for medical devices; 

reviews guidelines and guidance 

documents; recommends exemption of 

certain devices from the application of 

portions of the FD&C Act; advises on the 

necessity to ban a device; and responds 

to requests from the agency to review 

and make recommendations on specific 

issues or problems concerning the safety 

and effectiveness of devices. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, may also 

make appropriate recommendations to 

the Commissioner on issues relating to 

the design of clinical studies regarding 

the safety and effectiveness of marketed 

and investigational devices. The 

Committee also provides 

recommendations to the Commissioner 

or designee on complexity 

categorization of in vitro diagnostics 

under the Clinical Laboratory 

Improvement Amendments of 1988. 

Panels Function 

Circulatory System Devices Panel Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the circulatory and vascular systems and makes appropriate recommendations to the 

Commissioner of Food and Drugs. 

Clinical Chemistry and Clinical 

Toxicology Devices Panel.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in 

vitro devices for use in clinical laboratory medicine including clinical toxicology, clinical chemistry, endocrinology, and oncology and makes appropriate recommendations to the Commissioner of Food and 

Drugs. 

Gastroenterology and Urology Devices Panel.Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gastroenterology, urology, and nephrology devices and makes appropriate recommendations to the Commissioner of Food and Drugs. 

General Hospital and Personal Use 

Devices Panel.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational general hospital, infection control, and personal use devices and makes appropriate recommendations to the 

Commissioner of Food and Drugs. 

Obstetrics and Gynecology Devices 

Panel.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in obstetrics and gynecology and makes appropriate recommendations to the Commissioner of Food and Drugs.