Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices 4257 

1FDA Reauthorization Act of 2017 (FDARA), 

Public Law 115–52 (2017). FDARA includes 

GDUFA II, and by reference, the GDUFA 

Continued 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6752] 

Information Requests and Discipline 

Review Letters Under Generic Drug 

User Fee Amendments; Guidance for 

Industry; 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 a final 

guidance for industry entitled 

‘‘Information Requests and Discipline 

Review Letters Under GDUFA.’’ This 

guidance explains how FDA will issue 

and use an information request (IR) and/ 

or a discipline review letter (DRL) 

during the assessment of an original 

abbreviated new drug application 

(ANDA) under the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act). This 

guidance finalizes the draft guidance of 

the same title issued on December 18, 

2017. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 27, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• 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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–6752 for ‘‘Information Requests 

and Discipline Review Letters Under 

GDUFA.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

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 or to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 3128, 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: 

David Coppersmith, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1673, 

Silver Spring, MD 20993–0002, 301– 

796–9193, david.coppersmith@

fda.hhs.gov; or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Information Requests and Discipline 

Review Letters Under GDUFA.’’ 

In negotiations held as part of the 

Generic Drug User Fee Amendments of 

2017 (GDUFA II), it was agreed that 

FDA will: (1) Issue an IR to request 

further information or clarification that 

is needed or would be helpful to allow 

completion of a discipline assessment 

and/or (2) issue a new type of letter for 

ANDAs, known as a DRL, to convey 

preliminary thoughts on possible 

deficiencies found by a discipline 

assessor and/or assessment team for its 

or their portion of the application under 

assessment at the conclusion of a 

discipline assessment.1


lotter on DSK11XQN23PROD with NOTICES1
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). 


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