Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 6877 

use the document number 21003 and 

complete title to identify the guidance 

you are requesting. 

Dated: February 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02472 Filed 2–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0080] 

Formal Meetings Between the Food 

and Drug Administration and Sponsors 

or Requestors of Over-the-Counter 

Monograph Drugs; Draft Guidance for 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 draft 

guidance for industry entitled ‘‘Formal 

Meetings Between FDA and Sponsors or 

Requestors of Over-the-Counter 

Monograph Drugs.’’ This draft guidance 

provides recommendations to industry 

on formal meetings between FDA and 

sponsors or requestors of over-thecounter (OTC) monograph drugs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 8, 2022 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draft guidance before it begins work on 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 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– 

2022–D–0080 for ‘‘Formal Meetings 

Between FDA and Sponsors or 

Requestors of Over-the-Counter 

Monograph Drugs.’’ 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 the draft 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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research (HFD–600), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 240–402–7945. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Formal Meetings Between FDA and 

Sponsors or Requestors of Over-theCounter Monograph Drugs.’’ This draft 

guidance provides recommendations to 

industry on formal meetings between 

FDA and sponsors or requestors of 

nonprescription drugs without 

approved new drug applications that are 

governed by section 505G of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 355h) (hereafter referred 

to as OTC monograph drugs). 

Section 505G of the FD&C Act was 

added by the Coronavirus Aid, Relief, 

and Economic Security Act (CARES 

Act) (Pub. L. 116–136), which was 

enacted on March 27, 2020. As required 

by section 505G(l) of the FD&C Act, this 

draft guidance, when finalized, will 

discuss the procedures and principles 

for formal meetings between FDA and 

sponsors or requestors for an OTC 

monograph drug (hereafter referred to 

collectively as meeting requesters). In 

doing so, and as required by section 

505G(h) of the FD&C Act, this draft 


jspears on DSK121TN23PROD with NOTICES1
6878 Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 

guidance, when finalized, will describe 

procedures under which meeting 

requesters can meet with appropriate 

FDA officials to obtain 

recommendations on the studies and 

other information necessary to support 

submissions under section 505G of the 

FD&C Act, to obtain information on 

other matters relevant to the regulation 

of nonprescription drugs, and to obtain 

recommendations on the development 

of new OTC monograph drugs. As 

required by section 505G(i) of the FD&C 

Act, this draft guidance, when finalized, 

will also describe procedures to 

facilitate efficient participation in joint 

meetings by multiple meeting requestors 

and/or organizations nominated by 

them to represent their interests. 

This draft guidance does not apply to 

meetings for the development of 

nonprescription drug products intended 

for submission in new drug applications 

or abbreviated new drug applications 

under section 505 of the FD&C Act. This 

draft guidance does not apply to 

meetings between FDA and preinvestigational new drug or 

investigational new drug sponsors. For 

the purposes of this draft guidance, a 

formal meeting includes any meeting 

that is requested by a meeting requester 

following the procedures provided in 

this draft guidance and includes 

meetings conducted in any format (i.e., 

face to face, teleconference/ 

videoconference, or written response 

only). 

In support of the CARES Act, FDA 

agreed to specific performance goals and 

procedures described in the document 

‘‘Over-the-Counter Monograph User Fee 

Program Performance Goals and 

Procedures—Fiscal Years 2018–2022,’’ 

commonly referred to as the OMUFA 

Commitment Letter (the document can 

be accessed at https://www.fda.gov/ 

media/106407/download and the 

document with updated goal dates for 

fiscal years 2021–2025 can be accessed 

at https://www.fda.gov/media/146283/ 

download). The OMUFA Commitment 

Letter includes meeting management 

goals for formal meetings that occur 

between FDA and meeting requesters. In 

the OMUFA Commitment Letter, FDA 

committed to issuing this draft guidance 

under specific timelines. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Formal Meetings Between FDA and 

Sponsors or Requestors of Over-theCounter Monograph Drugs; Draft 

Guidance for Industry.’’ 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 

Under section 505G(o) of the FD&C 

Act, the Paperwork Reduction Act of 

1995 does not apply to collections of 

information made under section 505G of 

the FD&C Act. The information 

collections made in this guidance 

implement the provisions of three 

subsections of section 505G: (1) Section 

505G(l)(1), which requires FDA to issue 

guidance that specifies the procedures 

and principles for formal meetings 

between FDA and sponsors or 

requestors for drugs subject to section 

505G; (2) section 505G(h), which 

requires FDA to establish procedures 

under which meeting requestors can 

meet with appropriate FDA officials to 

obtain advice on the studies and other 

information necessary to support 

submissions under section 505G, other 

matters relevant to the regulation of 

nonprescription drugs, and the 

development of new nonprescription 

drugs under section 505G; and (3) 

section 505G(i), which requires FDA to, 

among other things, establish 

procedures to facilitate efficient 

participation in joint meetings by 

multiple meeting requesters and/or 

organizations nominated by them to 

represent their interests. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required 

for these collections of information. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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: February 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02446 Filed 2–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 and the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; NIH 

Support for Conferences and Scientific 

Meetings. 

Date: March 4, 2022. 

Time: 1:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Gerald L. McLaughlin, 

Ph.D., Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, NIH, 301 North 

Stonestreet Avenue, MSC 6021, Bethesda, 

MD 20892, (301) 827–5819, gm145a@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Fentanyl and its Analogs: Effects and 

Consequences for Treatment of Addiction 

and Overdose (UG3/UH3 Clinical Trial 

Optional). 

Date: March 9, 2022. 

Time: 9:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Preethy Nayar, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute on Drug Abuse, 

NIH, 301 North Stonestreet Avenue, MSC 

6021, Bethesda, MD 20892, 301–443–4577, 

nayarp2@csr.nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; SEP for 

Centers Review. 

Date: March 9, 2022. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Sheila Pirooznia, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute on Drug Abuse, 

NIH, 301 North Stonestreet Avenue, MSC 

6021, Bethesda, MD 20892, (301) 496–9350, 

sheila.pirooznia@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; for 

Avenir Review. 

Date: March 21, 2022. 

Time: 3:00 p.m. to 4:00 p.m. 


jspears on DSK121TN23PROD with NOTICES1