30230 Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Keith F. Verrett Jr., Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Rm. 2179, Silver 

Spring, MD 20993–0002, 301–796–7900, 

CDERCollections@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Assessing User Fees Under the Generic 

Drug User Fee Amendments of 2017.’’ 

GDUFA II (Pub. L. 115–52, Title III), was 

signed into law on August 18, 2017. 

GDUFA II extends FDA’s authority to 

assess and collect generic drug user fees 

from fiscal year (FY) 2018 through FY 

2022. The extension of this user fee 

authority under GDUFA II continues 

FDA’s and industry’s ability to meet the 

goals of improving public access to safe 

and effective generic drugs and 

enhancing the predictability of the 

review process. 

The guidance announced in this 

notice replaces the draft guidance for 

industry on ‘‘Assessing User Fees Under 

the Generic Drug User Fee Amendments 

of 2017,’’ dated October 2019 and 

published in November 2019. This 

guidance addresses changes in user fee 

assessments from GDUFA I, user fees 

incurred by industry under GDUFA II, 

payment procedures, reconsideration 

and appeals, and other additional 

information to assist industry in 

complying with GDUFA II. This 

guidance also describes how FDA 

determines affiliation for purposes of 

assessing generic drug user fees. 

FDA has reviewed the comments 

submitted to the docket and determined 

that the comments do not require 

substantive changes from the draft 

guidance. Clarifying language was, 

however, added to this final guidance 

largely based on the public comments 

and to update the Agency’s treatment of 

sponsor requests for ‘‘transfer’’ of 

certain user fee payments eligible for 

refund toward applicable user fee 

liabilities. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Assessing User 

Fees Under the Generic Drug User Fee 

Amendments of 2017.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in Form FDA 3913 (User 

Fee Payment Refund Request) have been 

approved under OMB control number 

0910–0805 and the collections of 

information in Form FDA 3914 (User 

Fee Payment Transfer Request) have 

been approved under OMB control 

number 0910–0805. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10702 Filed 5–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier OS–0990–xxxx] 

Agency Father Generic Information 

Collection Request. 60-Day Public 

Comment Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before July 18, 2022. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–New– 

60D, and project title for reference, to 

Sherrette Funn, the Reports Clearance 

Officer, Sherrette.funn@hhs.gov, or call 

202–795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: National 

Strategy for a Resilient Public Health 

Supply Chain Paper Reduction Act 

Clearance. 

Type of Collection: Father Generic 

ICR. 

OMB No. 0990–XXXX—Assistant 

Secretary for Preparedness and 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 30231 

Response—Office of Strategy, Policy, 

Planning, and Requirements. 

Abstract 

The Department of Health and Human 

Services, HHS, Assistant Secretary for 

Preparedness and Response, within 

Office of Strategy, Policy, Planning, and 

Requirements is seeking approval by 

OMB on a new Generic clearance. HHS, 

is working with the White House and 

across the federal interagency to launch 

a multiyear implementation involving 

the identification and coordination of 

measurable activities across the U.S. 

government, SLTT (State, Local, Tribal, 

and Territorial) jurisdictions, and 

private sector partners. Cross-sectoral 

engagement is the underpinning of 

many of the interdependent 

implementation activities. For example, 

one such activity involves information 

collection from SLTT partners on 

facility, local, and state stockpiling 

plans to ensure coordinated plans are in 

place for a future public health 

emergency. Potential engagements 

include surveys, stakeholder meetings, 

RFI’s, town hall meetings, and 

workshops. With each of these different 

mechanisms of engagement, there is a 

varied frequency ranging from single 

engagements to regularly recurring 

meetings. 

In July 2021, the White House 

published the National Strategy for a 

Resilient Public Health Supply Chain. 

The strategy calls out strategic goals and 

recommendations for building 

immediate and long-term resilience 

through increased visibility, agility, and 

robustness in the public health supply 

chain to prepare for and mitigate future 

public health emergencies. 

HHS is requesting a 3-year PRA 

clearance and will engage with SLTT, 

trade groups, mixed cross-sector 

audiences, non-governmental 

organizations, manufacturers, academia, 

healthcare providers and facilities, and 

local communities. 

ANNUALIZED BURDEN HOUR TABLE

Forms (if necessary) Respondents (if necessary) Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

Stakeholder Meetings ....................... Private Sector, Manufacturers, U.S. 

Government Supply Chain Inventory Holders.

30 6 6 1080 

RFIs ................................................... Private Sector, Mixed Cross-Sector 

Audience, Manufacturers, SLTT 

partners.

40 1 40 1600 

Workshops ........................................ Private Sector, SLTT partners, 

Trade Groups, Manufacturers, 

Academia, Healthcare Providers/ 

Facilities, Public.

50 4 8 1600 

Surveys ............................................. Private Sector, SLTT partners, 

Trade Groups, Manufacturers, 

Academia.

75 1 1 75 

Total ........................................... ........................................................... ........................ 12 ........................ 4355 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–10700 Filed 5–17–22; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development Initial 

Review Group; Health, Behavior, and Context 

Study Section. 

Date: June 13, 2022. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health 

6710B Rockledge Drive, Room 2137C, 

Bethesda, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Kimberly L. Houston, MD, 

Scientific Review Officer, Scientific Review 

Branch, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2137C, 

Bethesda, MD 20892, (301) 827–4902, 

kimberly.houston@nih.gov. 

Name of Committee: National Institute of 

Child Health and Human Development Initial 

Review Group; Function, Integration, and 

Rehabilitation Sciences Study Section. 

Date: June 17, 2022. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2137D, 

Bethesda, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Helen Huang, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2137D, 

Bethesda, MD 20892, (301) 435–8207, 

Helen.Huang@nih.gov. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; NIH Pathway to 

Independence Award (Parent K99/R00 

Independent Clinical Trial Not Allowed)/ 

Member Conflict. 

Date: June 24, 2022. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2127D, 

Bethesda, MD 20892 (Video Assisted 

Meeting). 


lotter on DSK11XQN23PROD with NOTICES1