Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 84887 

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual total 

burden hours 

Recommended States List (Form L–11) ......................................................... 60 10.0 0.33 198 

Child Advocate Referral (Form L–12A)-Respondents ..................................... 300 19.0 0.25 1,425 

Child Advocate Referral (Form L–12A)-Recordkeepers .................................. 1 5,601.0 0.33 1,848 

Acknowledgment of Receipt of Legal Resource Guide (LRG–4)-Unaccompanied Children ............................................................................................ 121,669 2.0 0.25 60,835 

Acknowledgment of Receipt of Legal Resource Guide (LRG–4)-Care Providers ............................................................................................................ 300 817.0 0.25 61,275 

Notice of Administrative Review (Form P–18) ................................................ 200 1.0 .83 166 

Estimated Annual Burden Hours Total ..................................................... ........................ ........................ ........................ 259,664 

Authority: 6 U.S.C. 279; 8 U.S.C. 

1232; Flores v. Reno Settlement 

Agreement, No. CV85–4544–RJK (C.D. 

Cal. 1996). 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–24588 Filed 10–23–24; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4470] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Antimicrobial 

Animal Drug Sales and Distribution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 of our reporting 

and recordkeeping requirements for 

antimicrobial animal drug sales and 

distribution. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

December 23, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

December 23, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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– 

2024–N–4470 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Antimicrobial Animal Drug Sales and 

Distribution.’’ 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. 


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84888 Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 

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. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Antimicrobial Animal Drug Sales and 

Distribution—21 CFR 514.87 

OMB Control Number 0910–0659— 

Extension 

This information collection helps 

support implementation of Agency 

statutory and regulatory requirements 

regarding new animal drugs containing 

an antimicrobial active ingredient. 

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. 

Description of Respondents: Animal 

drug manufacturers (sponsors). 

Respondents include individuals and 

the private sector (for-profit businesses). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section 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 ..................................... 1 1 1 62 62 

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

Applications—Electronic Submission ............................... 15 10.1 152 52 7,904 

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

Applications—Paper Submission ..................................... 2 3.5 7 2 14 

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

Applications—Electronic Submission ............................... 10 17.9 179 2 358 

Total .............................................................................. ........................ ........................ ........................ ........................ 8,338 

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 

sponsors with active applications, who 

submit an annual antimicrobial annual 

drug sales and distribution report on 

paper, will spend 62 hours to assemble 

the necessary information, prepare, and 

submit to FDA. We estimate sponsors 

with active applications, who submit an 

annual antimicrobial animal drug sales 

and distribution report electronically, 

will spend 52 hours to assemble the 


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Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 84889 

necessary information, prepare, and 

submit to FDA. We estimate that 

sponsors with inactive applications will 

spend 2 hours preparing their annual 

antimicrobial animal drug sales and 

distribution reports, whether 

electronically or on paper. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

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

Act .................................................................................... 23 1 23 2 46 

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

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 46 hours for 

further compliance with section 

512(l)(3), as detailed in table 2. 

After a review of the information 

collection since our last request for 

OMB approval, we have adjusted our 

estimates based on our experience with 

the antimicrobial animal drug 

distribution reports program. Our 

estimated burden for the information 

collection reflects a decrease of 54 

burden hours and a corresponding 

decrease of 27 total annual responses. 

We attribute this to respondents who 

submitted by paper in previous years 

and are now reporting electronically. 

Dated: October 18, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24721 Filed 10–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3768] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adherence 

Potential and Patient Preference in 

Prescription Drug Promotion 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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 November 

25, 2024. 

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 title 

of this information collection is 

‘‘Adherence Potential and Patient 

Preference in Prescription Drug 

Promotion.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Adherence Potential and Patient 

Preference in Prescription Drug 

Promotion 

OMB Control Number 0910—NEW 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA-regulated products 

in carrying out the provisions of the 

FD&C Act. 

The mission of the Office of 

Prescription Drug Promotion (OPDP) is 

to protect the public health by helping 

to ensure that prescription drug 

promotion is truthful, balanced, and 

accurately communicated so that 

patients and healthcare providers can 

make informed decisions about 

treatment options. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have consistently 

conducted research to evaluate the 

aspects of prescription drug promotion 

that are most central to our mission, 

focusing in particular on three main 

topic areas: advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and the 

characteristics of the disease and 

product impact the communication and 

understanding of prescription drug risks 

and benefits. Focusing on target 

populations allows us to evaluate how 

understanding of prescription drug risks 

and benefits may vary as a function of 

audience. Our focus on research quality 

aims at maximizing the quality of 

research data through analytical 

methodology development and 

investigation of sampling and response 


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