26764 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 

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copies of the draft guidance to the 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access to the draft guidance document.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: 

Anuradha Ramamoorthy, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903, anuradha.ramamoorthy@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Clinical Pharmacology Considerations 

for Human Radiolabeled Mass Balance 

Studies.’’ A human radiolabeled mass 

balance study is the single most direct 

method to obtain quantitative and 

comprehensive information on the 

absorption, distribution, metabolism, 

and excretion (ADME) of an 

investigational drug in the human body. 

The mass balance study can provide 

information to determine the overall 

pathways of metabolism and excretion 

of an investigational drug, identify 

circulating metabolites, and determine 

the abundance of metabolites relative to 

the parent or total drug-related 

exposure. This guidance provides FDA’s 

recommendations for clinical 

pharmacology considerations in 

conducting human radiolabeled mass 

balance studies, including: (1) Deciding 

whether and when to conduct the study, 

(2) designing the study, and (3) 

reporting results. 

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 ‘‘Clinical Pharmacology 

Considerations for Human Radiolabeled 

Mass Balance Studies.’’ 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 for submission of 

investigational new drug applications in 

21 CFR part 312 have been approved 

under OMB control number 0910–0014, 

and the collections of information for 

submission of new drug applications in 

21 CFR part 314 have been approved 

under OMB control number 0910–0001. 

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: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09608 Filed 5–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3353] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Antimicrobial 

Animal Drug Distribution Reports and 

Recordkeeping 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by June 6, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0659. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 


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Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 26765 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Antimicrobial Animal Drug 

Distribution Reports and 

Recordkeeping—21 CFR 514.87 

OMB Control Number 0910–0659— 

Extension 

Sponsors of approved or conditionally 

approved applications for new animal 

drugs containing an antimicrobial active 

ingredient are required by section 512 of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360b) to 

submit to FDA an annual report on the 

amount of each such ingredient in the 

drug that is sold or distributed for use 

in food-producing animals. Sponsors are 

also required to maintain distribution 

records for their animal drug products, 

including separate information for each 

month of the calendar year, under 

section 512(l)(3) of the FD&C Act. These 

provisions were enacted to assist FDA 

in our continuing analysis of the 

interactions (including drug resistance), 

efficacy, and safety of antimicrobials 

approved for use in both humans and 

food-producing animals for the purpose 

of mitigating the public health risk 

associated with antimicrobial resistance. 

Section 514.87 of our regulations (21 

CFR 514.87) codifies the reporting 

requirements established in the FD&C 

Act. Sponsors submit antimicrobial 

animal drug sales and distribution 

reports to us on Form FDA 3744. Each 

report must specify: (1) The amount of 

each antimicrobial active ingredient by 

container size, strength, and dosage 

form; (2) quantities distributed 

domestically and quantities exported; 

and (3) a listing of the target animals, 

indications, and production classes that 

are specified on the approved label of 

the product. The report must cover the 

period of the preceding calendar year 

and include separate information for 

each month of the calendar year. Each 

report must also provide a speciesspecific estimate of the percentage of 

each product that was sold or 

distributed domestically in the reporting 

year for use in cattle, swine, chickens, 

or turkeys for such species that appear 

on the approved label. 

In the Federal Register of November 

9, 2021 (86 FR 62178), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

514.87(a)–(e)—Annual Reports for Sponsors With Active Applications—Paper 

Submission ........................................... 3,744 4 1.5 6 62 372 

514.87(a)–(e)—Annual Reports for Sponsors With Active Applications—Electronic Submission ................................. 3,744 16 9.1 146 52 7,592 

514.87(a)–(e)—Annual Reports for Sponsors With Inactive Applications—Paper 

Submission ........................................... 3,744 5 3 15 2 30 

514.87(a)–(e)—Annual Reports for Sponsors With Inactive Applications—Electronic Submission ................................. 3,744 16 12.6 201 2 402 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 8,396 

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

We base our estimate of the average 

burden per response on our recent 

experience with the existing 

antimicrobial animal drug distribution 

reports program. We base our estimate 

of the number of affected respondents 

reported in tables 1 and 2 and the 

average number of responses per 

respondent in table 1 on a review of our 

records of sponsors with active and 

inactive applications. We estimate that 

20 sponsors will have active 

applications, and we assume that 75 

percent of the respondents will report 

electronically, while the other 25 

percent will report on paper. We 

estimate that 4 sponsors with active 

applications will spend 62 hours 

annually to assemble the necessary 

information, prepare, and submit an 

annual antimicrobial animal drug sales 

and distribution report on paper and 16 

sponsors with active applications will 

spend 52 hours annually to assemble 

the necessary information, prepare, and 

electronically submit an annual 

antimicrobial animal drug sales and 

distribution report. We estimate that 21 

sponsors will have inactive 

applications, and we assume that 93 

percent of these respondents will report 

electronically, while the other 7 percent 

will report on paper. We estimate that 

sponsors with inactive applications will 

spend 2 hours to prepare their annual 

antimicrobial animal drug sales and 

distribution reports, whether 

electronically or on paper. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

respondents 

Number of 

records per 

respondent 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Recordkeeping required by section 512(l)(3) of the FD&C 

Act .................................................................................... 21 1 21 2 42 

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


lotter on DSK11XQN23PROD with NOTICES1
26766 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Notices 

Animal drug manufacturers are 

already required to maintain 

distribution records for their animal 

drug products to comply with FDA’s 

current good manufacturing regulations 

for periodic drug reports under 

§ 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), 

approved under OMB control number 

0910–0284. Section 512(l)(3) of the 

FD&C Act differs from § 514.80(b)(4)(i) 

in that it requires that records include 

separate information for each month of 

the calendar year. In addition, under 21 

CFR 211.196 (approved under OMB 

control number 0910–0139), 

manufacturers currently are required to 

maintain distribution records that 

include dosage form, and date drug is 

distributed. Based on these 

requirements, FDA believes that 

manufacturers already keep detailed 

records of the dates when antimicrobial 

drugs are distributed for marketing and 

recall purposes from which monthly 

reports can be prepared as part of usual 

and customary business practices. 

However, FDA estimates an additional 

recordkeeping burden of 42 hours for 

further compliance with section 

512(l)(3) of the FD&C Act, as detailed in 

table 2. 

We have adjusted our burden 

estimate, which has resulted in a 

decrease to the currently approved 

burden. We attribute this to respondents 

who reported by paper in previous years 

and are now reporting electronically. 

We also note a decrease in 

recordkeeping respondents. We attribute 

this to the mergers of sponsors over the 

years. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09632 Filed 5–4–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0350] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Retailer 

Training Programs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions associated with 

‘‘Tobacco Retailer Training Programs.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by July 5, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before July 5, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of July 5, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2010–D–0350 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Tobacco 

Retailer Training Programs.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 


lotter on DSK11XQN23PROD with NOTICES1