Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45859 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, email: 

CDERDataStandards@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 17, 2014, FDA 

published final guidance for industry 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized Study 

Data’’ (eStudy Data) posted on FDA’s 

Study Data Standards Resources Web 

page at http://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm. The eStudy Data guidance 

implements the electronic submission 

requirements of section 745A(a) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379k–1(a)) for study data 

contained in new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologics license 

applications (BLAs), and investigational 

new drug applications (INDs) to the 

Center for Biologics Evaluation and 

Research (CBER) or CDER by specifying 

the format for electronic submissions. 

The implementation of electronic 

submission requirements for study data 

became effective on December 17, 2016 

(24 months after issuance of final 

guidance for NDAs, BLAs, ANDAs, and 

36 months for INDs). The eStudy Data 

guidance states that a Federal Register 

notice will specify the transition date 

for all version updates (with the month 

and day for the transition date 

corresponding to March 15). 

The transition date for support of 

version 1.1 of ADaM 1G V 1.1 is March 

15, 2018. ADaM IG V.1.1 is supported 

as of this Federal Register notice and 

sponsors or applicants are encouraged 

to begin using it, the new version will 

only be required in submissions for 

studies that start after March 15, 2019. 

The Catalog will list March 15, 2019, 

which will be reflected in the Catalog, 

as the ‘‘date requirement begins.’’ When 

multiple versions of an FDA-supported 

standard are listed in the Catalog, 

sponsors or applicants can select any of 

those version to use. 

The transition date for the end of FDA 

support for ADaM IG V 1.0, is March 15, 

2018. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the referenced material at 

http://www.fda.gov/ectd. 

Dated: September 22, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21081 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Fee for Using a Material Threat Medical 

Countermeasure 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 rate for using a 

material threat medical countermeasure 

(MCM) priority review voucher for fiscal 

year (FY) 2018. The Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), as 

amended by the 21st Century Cures Act 

(Cures Act), authorizes FDA to 

determine and collect material threat 

MCM priority review user fees for 

certain applications for review of 

human drug products when those 

applications use a material threat MCM 

priority review voucher. These vouchers 

are awarded to the sponsors of material 

threat MCM applications that meet all of 

the requirements of this program upon 

FDA approval of such applications. The 

amount of the fee for using a material 

threat MCM priority review voucher is 

determined each FY 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 FY, and 

the average cost incurred in the review 

of an application that is not subject to 

priority review in the previous FY. This 

notice establishes the material threat 

MCM priority review fee rate for FY 

2018 and outlines the payment 

procedures for such fees. 

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 3086 of the Cures Act (Pub. L. 

114–255) added section 565A to the 

FD&C Act (21 U.S.C. 360bbb–4a). In 

section 565A of the FD&C Act, Congress 

encouraged development of material 

threat MCMs by offering additional 

incentives for obtaining FDA approval 

of such products. Under section 565A of 

the FD&C Act, the sponsor of an eligible 

material threat MCM application (as 

defined in section 565A(a)(4)) shall 

receive a priority review voucher upon 

approval of the material threat MCM 

application. The recipient of a material 

threat MCM priority review voucher 

may either use the voucher for a future 

human drug application submitted to 

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

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

section 351(a) of the Public Health 

Service Act (42 U.S.C. 262(a)), 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 on the type of application. 

Information regarding PDUFA goals is 

available at https://www.fda.gov/ 

downloads/forindustry/userfees/ 

prescriptiondruguserfee/ 

ucm511438.pdf. 

The applicant that uses a material 

threat MCM priority review voucher is 

entitled to a priority review of its 

eligible human drug application, but 

must pay FDA a material threat MCM 

priority review user fee in addition to 

any user fee required by PDUFA for the 

application. Information regarding the 

material threat MCM priority review 

voucher program is available at: https:// 

www.fda.gov/EmergencyPreparedness/ 

Counterterrorism/Medical

Countermeasures/MCMLegalRegulatory

andPolicyFramework/ 

ucm566498.htm#prv. 

This notice establishes the material 

threat MCM priority review fee rate for 

FY 2018 at $2,830,579 and outlines 

FDA’s procedures for payment of 

material threat MCM priority review 

user fees. This rate is effective on 

October 1, 2017, and will remain in 

effect through September 30, 2018. 


sradovich on DSK3GMQ082PROD with NOTICES
45860 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 

II. Material Threat Medical 

Countermeasure Priority Review User 

Fee for FY 2018 

FDA interprets section 565A(c)(2) of 

the FD&C Act as requiring that FDA 

determine the amount of the material 

threat MCM 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 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 has 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. 

As interpreted by FDA, section 565A 

of the FD&C Act requires that the fee 

amount should be based on the 

difference between the average cost 

incurred by the Agency in the review of 

a human drug application subject to a 

priority review in the previous fiscal 

year, and the average cost incurred by 

the Agency in the review of a human 

drug application not subject to a priority 

review in the previous fiscal year. FDA 

is setting a fee for FY 2018, which is to 

be based on standard cost data from the 

previous fiscal year, FY 2017. However, 

the FY 2017 submission cohort has not 

been closed out yet, thus 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 

publishes each year are: (1) New drug 

applications (NDAs) for a new 

molecular entity (NME) with clinical 

data and (2) biologics license 

applications (BLAs). 

The standard cost worksheets for FY 

2016 show standard costs (rounded to 

the nearest hundred dollars) of 

$5,929,100 for an 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 

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 

schedule 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 that 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 September 14, 2017 

(see 82 FR 43244 at 43245), 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 material threat MCM 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—MATERIAL THREAT MEDICAL COUNTERMEASURE PRIORITY REVIEW SCHEDULE FOR FY 2018 

Fee category Fee rate for 

FY 2018 

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

IV. Implementation of Material Threat 

Medical Countermeasure Priority 

Review User Fee 

Under section 565A(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 

565A(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, 

section 565A(c)(4)(C) specifies that FDA 

may not grant a waiver, exemption, 

reduction, or refund of any fees due and 

payable under this section of the FD&C 

Act. FDA’s appropriation for FY 2018, 

states specifically that ‘‘medical 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45861 

countermeasure priority review voucher 

user fees authorized by 21 U.S.C. 

360bbb–4a, shall be credited to this 

account, to remain available until 

expended.’’ (Pub. L. 115–31, Division A, 

Title VI). 

The material threat MCM 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 must 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 must 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 ‘‘Material Threat Medical 

Countermeasure Priority Review.’’ All 

paper checks must 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, 

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 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21191 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2245] 

Classification and Requirements for 

Laser Illuminated Projectors (Laser 

Notice No. 57); Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Classification and 

Requirements for Laser Illuminated 

Projectors (LIPs) (Laser Notice No. 57); 

Draft Guidance for Industry and Food 

and Drug Administration Staff.’’ When 

finalized, this guidance describes FDA’s 

policy with respect to certain LIPs that 

comply with International 

Electrotechnical Commission (IEC) 

standards during laser product 

classification under the Electronic 

Product Radiation Control provisions of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) that apply to 

electronic products. When finalized, 

this document will supersede the 

‘‘Immediately in Effect Guidance 

Document: Classification and 

Requirements for Laser Illuminated 

Projectors (LIPs); Guidance for Industry 

and Food and Drug Administration 

Staff,’’ issued February 18, 2015. This 

draft guidance is not final nor is it in 

effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 1, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic submissions as 

follows: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 


sradovich on DSK3GMQ082PROD with NOTICES