Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 6875 

TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.40(a) and (c) ................................................................... 9 1 9 2,160 19,440 

Total .............................................................................. ........................ ........................ ........................ ........................ 22,860 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

VI. Estimated Annual Reporting Burden 

for Tobacco Products 

Under sections 905, 910, and 911 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 387e, 387j, and 387k), 

product applications and supplements, 

premarket tobacco applications 

(PMTAs), substantial equivalences 

(SEs), exemption from SEs, and 

modified risk tobacco product 

applications (MRTPAs) must contain a 

claim for categorical exclusion or an EA. 

The majority of the EA burden for 

tobacco products is covered under 

already existing information collections. 

The burden for SEs is currently 

approved under OMB control number 

0910–0673; the burden for PMTAs are 

currently approved under OMB control 

number 0910–0768; and the burden for 

SE exemptions are currently approved 

under OMB control number 0910–0684. 

FDA’s estimates are based on actual 

report data from fiscal year (FY) 2018 to 

FY 2020. On average, FDA estimated it 

received approximately 14 MRTPAs 

from 14 respondents. Based on updated 

data for this collection, FDA estimates 

14 EAs from 14 respondents. A total of 

14 respondents will submit an average 

of 1 application for environmental 

assessment. Based on FDA’s experience, 

previous information provided by 

potential sponsors and knowledge that 

part of the EA information has already 

been produced in one of the tobacco 

product applications, FDA estimates 

that it takes approximately 80 hours to 

prepare an EA. Based on recent MRTPA 

numbers, we now estimate a total of 14 

annual responses and 1,120 hours for 

Tobacco Products (a decrease of 13 

responses and 1,040 hours). 

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.40(a) and (c) ................................................................... 14 1 14 80 1,120 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Since the last OMB approval, we have 

adjusted our burden estimate. We 

estimate the total burden for this 

information collection to be 30,315 

annual responses, and 314,736 hours. 

These estimates reflect an overall 

increase of 13,463 responses and 94,078 

hours. We attribute the adjustments to 

expected fluctuations in the number of 

responses the various centers in FDA 

have received over the last few years. 

Dated: February 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02475 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–0053] 

Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, 

Drug, and Cosmetic Act; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability that appeared in 

the Federal Register of January 11, 

2022. In the notice of availability, FDA 

requested comments on draft guidance 

for industry and FDA staff entitled 

‘‘Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, Drug, 

and Cosmetic Act.’’ The Agency is 

taking this action in response to a 

request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the document published 

January 11, 2022 (87 FR 1417). Submit 

either electronic or written comments 

on the draft guidance by April 11, 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 


jspears on DSK121TN23PROD with NOTICES1
6876 Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices 

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–0053 for ‘‘Notifying the Food 

and Drug Administration of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the 

Federal Food, Drug, and Cosmetic Act.’’ 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Notifying the Food 

and Drug Administration of a 

Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the 

Federal Food, Drug, and Cosmetic Act’’ 

to the Office of Policy, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002 or the 

Center for Biologics Evaluation and 

Research, Office of Communication, 

Outreach, and Development, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Brittany Caldwell, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5556, Silver Spring, 

MD 20993–0002, 301–796–5900 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, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 11, 

2022, FDA published a notice of 

availability with a 60-day comment 

period to request comments on draft 

guidance for industry and FDA staff 

entitled ‘‘Notifying FDA of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, Drug, 

and Cosmetic Act.’’ 

The Agency has received a request for 

an extension of the comment period. 

The request conveyed concern that the 

current 60-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response. 

FDA has considered the request and 

is extending the comment period for the 

notice of availability for 30 days, until 

April 11, 2022. The Agency believes 

that a 30-day extension allows adequate 

time for interested persons to submit 

comments without significantly 

delaying guidance on these important 

issues. 

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 ‘‘Notifying FDA of a Permanent 

Discontinuance or Interruption in 

Manufacturing of a Device Under 

Section 506J of the Federal Food, Drug, 

and Cosmetic Act.’’ 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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This draft 

guidance document is also available at 

https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Notifying FDA of 

a Permanent Discontinuance or 

Interruption in Manufacturing of a 

Device Under Section 506J of the 

Federal Food, Drug, and Cosmetic Act’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 


jspears on DSK121TN23PROD with NOTICES1
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