4258 Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices 

Reauthorization Performance Goals and Program 

Enhancements Fiscal Years 2018–2022 (GDUFA II 

Commitment Letter). 

This guidance explains how FDA will 

issue and use an IR and a DRL during 

the assessment of an original ANDA 

under section 505(j) of the FD&C Act (21 

U.S.C. 355(j)), as contemplated under 

GDUFA II. This guidance does not apply 

to an amendment made in response to 

a Complete Response Letter, a 

supplement, or an amendment to a 

supplement. 

This guidance identifies the timing of 

FDA’s issuance of an IR or a DRL and 

the effect FDA’s issuance of an IR or a 

DRL will have on the assessment clock 

for a given assessment cycle. 

This guidance finalizes the draft 

guidance entitled ‘‘Information Requests 

and Discipline Review Letters Under 

GDUFA’’ issued on December 18, 2017 

(82 FR 60018). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Minor changes were made from the draft 

to the final guidance, primarily to reflect 

current terminology. 

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 ‘‘Information 

Requests and Discipline Review Letters 

Under GDUFA.’’ 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 21 CFR 314 for approval 

of abbreviated new drug applications 

have been approved under OMB control 

number 0910–0001. The collections of 

information that support FDA’s 

guidance for industry on controlled 

correspondence related to generic drug 

development have been approved under 

OMB control number 0910–0797. 

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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: January 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01605 Filed 1–26–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group; Microbiology and Infectious Diseases 

B Research Study Section. 

Date: February 28–March 2, 2022. 

Time: 11:00 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F30, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Mario Cerritelli, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3F58, Rockville, MD 

20852, 240–669–5199, cerritem@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: January 21, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–01549 Filed 1–26–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 on 

Aging Special Emphasis Panel; NIA Multisite Clinical Trial Implementation. 

Date: February 22, 2022. 

Time: 2:00 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Isis S. Mikhail, MD, MPH, 

DrPH, National Institute on Aging, Gateway 

Building, 7201 Wisconsin Avenue, Suite 

2C212, Bethesda, MD 20892, 301–402–7704, 

MIKHAILI@MAIL.NIH.GOV. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; Improving 

skin wounds’ healing in aging. 

Date: February 24, 2022. 

Time: 9:30 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Maurizio Grimaldi, MD, 

Ph.D., Scientific Review Officer, National 

Institute on Aging, National Institutes of 

Health, 7201 Wisconsin Avenue, Room 

2C218, Bethesda, MD 20892, 301–496–9374, 

grimaldim2@mail.nih.gov. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; ADNI 4. 

Date: February 25, 2022. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 


lotter on DSK11XQN23PROD with NOTICES1