Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45291 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Total burden 

hours 

CCDF QPR ...................................................................................................... 56 1 60.0 3,360 

Estimated Total Annual Burden 

Hours: 3,360 hours. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 330 

C Street SW., Washington, DC 20201. 

Attention Reports Clearance Officer. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–20765 Filed 9–27–17; 8:45 am] 

BILLING CODE 4184–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Fee for Using a Rare Pediatric 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 rate for using a rare 

pediatric 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 Safety and 

Innovation Act (FDASIA), authorizes 

FDA to determine and collect rare 

pediatric disease priority review user 

fees for certain applications for review 

of human drug or biological products 

when those applications use a rare 

pediatric disease priority review 

voucher. These vouchers are awarded to 

the sponsors of rare pediatric disease 

product applications that meet all of the 

requirements of this program and that 

are submitted 90 days or more after July 

9, 2012, upon FDA approval of such 

applications. The amount of the fee for 

using a rare pediatric disease 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 rare pediatric disease 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 908 of FDASIA (Pub. L. 112– 

144) added section 529 to the FD&C Act 

(21 U.S.C. 360ff). In section 529 of the 

FD&C Act, Congress encouraged 

development of new human drugs and 

biological products for prevention and 

treatment of certain rare pediatric 

diseases by offering additional 

incentives for obtaining FDA approval 

of such products. Under section 529 of 

the FD&C Act, the sponsor of an eligible 

human drug application submitted 90 

days or more after July 9, 2012, for a rare 

pediatric disease (as defined in section 

529(a)(3)) shall receive a priority review 

voucher upon approval of the rare 

pediatric disease product application. 

The recipient of a rare pediatric disease 

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 

http://www.fda.gov/downloads/ 

forindustry/userfees/prescriptiondrug

userfee/ucm511438.pdf. 

The applicant that uses a rare 

pediatric disease priority review 

voucher is entitled to a priority review 

of its eligible human drug application, 

but must pay FDA a rare pediatric 

disease priority review user fee in 

addition to any user fee required by 

PDUFA for the application. Information 

regarding the rare pediatric disease 

priority review voucher program is 

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

DevelopmentApprovalProcess/ 

DevelopmentResources/ 

ucm375479.htm. 

This notice establishes the rare 

pediatric disease priority review fee rate 

for FY 2018 at $2,830,579 and outlines 

FDA’s procedures for payment of rare 

pediatric disease priority review user 

fees. This rate is effective on October 1, 

2017, and will remain in effect through 

September 30, 2018. 

II. Rare Pediatric Priority Review User 

Fee for FY 2018 

Under section 529(c)(2) of the FD&C 

Act, the amount of the rare pediatric 

disease priority review user fee 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 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 

45292 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 

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 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. 

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 (IND) review 

costs are included in this amount.) 23 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 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 September 14, 2017 

(82 FR 43244), setting the FY 2018 

PDUFA fee, 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 rare pediatric 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—RARE PEDIATRIC DISEASE PRIORITY REVIEW SCHEDULE FOR FY 2018 

Fee category Fee rate for 

FY 2018 

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

IV. Implementation of Rare Pediatric 

Disease Priority Review User Fee 

Under section 529(c)(4)(A) of the 

FD&C Act, the priority review user fee 

is due (i.e. the obligation to pay the fee 

is incurred) when a sponsor notifies 

FDA of its intent to use the voucher. 

Section 529(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 529(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. Beginning with FDA’s 

appropriation for FY 2015, 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] and 360ff 

[i.e., section 529 of the FD&C Act] shall 

be credited to this account, to remain 

available until expended.’’ (Pub. L. 113– 

235, Section 5, Division A, Title VI). 

The rare pediatric 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. In order to comply 

with this requirement, the sponsor must 

notify FDA 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. 

Upon receipt of this notification, FDA 

will issue an invoice to the sponsor who 

has incurred a rare pediatric disease 

priority review voucher fee. The invoice 

will include instructions on how to pay 

the fee via wire transfer or check. 

As noted in section II, if a sponsor 

uses a rare pediatric disease priority 

review voucher for a human drug 

application, the sponsor would incur 

the rare pediatric disease priority review 

voucher fee in addition to any PDUFA 

fee that is required for the application. 

The sponsor would need to follow 

Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45293 

FDA’s normal procedures for timely 

payment of the PDUFA fee for the 

human drug application. 

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. 

If paying with a paper check the 

invoice number should be included on 

the check, followed by the words ‘‘Rare 

Pediatric Disease 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 invoice 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 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20798 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–2013–N–1119] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food Canning 

Establishment Registration, Process 

Filing, and Recordkeeping for Acidified 

Foods and Thermally Processed LowAcid Foods in Hermetically Sealed 

Containers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 30, 

2017. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0037. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

I. Background 

Food Canning Establishment 

Registration, Process Filing, and 

Recordkeeping for Acidified Foods and 

Thermally Processed Low-Acid Foods 

in Hermetically Sealed Containers 21 

CFR 108.25 and 108.35, and Parts 113 

and 114 

OMB Control Number 0910–0037— 

Extension 

Section 402 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 342) deems a food to be 

adulterated, in part, if the food bears or 

contains any poisonous or deleterious 

substance that may render it injurious to 

health. Section 301(a) of the FD&C Act 

(21 U.S.C. 331(a)) prohibits the 

introduction or delivery for introduction 

into interstate commerce of adulterated 

food. Under section 404 of the FD&C 

Act (21 U.S.C. 344), our regulations 

require registration of food processing 

establishments, filing of process or other 

data, and maintenance of processing 

and production records for acidified 

foods and thermally processed low-acid 

foods in hermetically sealed containers. 

These requirements are intended to 

ensure safe manufacturing, processing, 

and packing procedures, and to permit 

us to verify that these procedures are 

being followed. Improperly processed 

low-acid foods present life-threatening 

hazards if contaminated with foodborne 

microorganisms, especially Clostridium 

botulinum. The spores of C. botulinum 

need to be destroyed or inhibited to 

avoid production of the deadly toxin 

that causes botulism. This is 

accomplished with good manufacturing 

procedures, which must include the use 

of adequate heat processes or other 

means of preservation. 

To protect the public health, our 

regulations require that each firm that 

manufactures, processes, or packs 

acidified foods or thermally processed 

low-acid foods in hermetically sealed 

containers for introduction into 

interstate commerce register the 

establishment with us using Form FDA 

2541 (§§ 108.25(c)(1) and 108.35(c)(2) 

(21 CFR 108.25(c)(1) and 108.35(c)(2)). 

In addition to registering the plant, each 

firm is required to provide data on the 

processes used to produce these foods, 

using Forms FDA 2541d, FDA 2541e,