Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 103841 

§ 571.6 Amendment of Petition: For a 

food additive petition amendment, the 

estimated time requirement per petition 

is approximately 1,300 hours. We 

estimate that, annually, 5 respondents 

will each submit 1 such amendment, for 

a total of 6,500 hours. 

§ 570.17 Moderate Category: For an 

investigational food additive file 

without complex chemistry, 

manufacturing, efficacy and/or safety 

issues, the estimated time requirement 

per file is approximately 1,500 hours. 

We estimate that, annually, 8 

respondents will each submit 1 such 

file, for a total of 12,000 hours. 

§ 570.17 Complex Category: For an 

investigational food additive file with 

complex chemistry, manufacturing, 

efficacy and/or safety issues, the 

estimated time requirement per file is 

approximately 5,000 hours. We estimate 

that, annually, 10 respondents will each 

submit 1 such file, for a total of 50,000 

hours. 

Consultation Category: We estimate 

developers of animal food ingredients 

will spend 3,000 hours consulting with 

FDA on an ingredient. We estimate that, 

annually, 12 respondents will consult 

with FDA, for a total of 36,000 hours. 

The labeling requirements for food 

and color additives were designed to 

specify the minimum information 

needed for labeling in order that food 

and color manufacturers may comply 

with all applicable provisions of the 

FD&C Act and other specific labeling 

acts administered by FDA. Label 

information does not require any 

additional information gathering beyond 

what is already required to assure 

conformance with all specifications and 

limitations in any given food or color 

additive regulation. Label information 

does not have any specific 

recordkeeping requirements unique to 

preparing the label. Therefore, because 

labeling requirements for a particular 

color additive or food additive involve 

information required as part of the 

safety review process, the burden hours 

for labeling are included in the estimate 

for 21 CFR 501.22(k) and 571.1. 

We base our estimate of the total 

annual responses on submissions 

received over the last 3 years. We base 

our estimate of the hours per response 

on our experience with the labeling, 

food additive petition, and filing 

processes. 

Based on review of the information 

collection, there was a decrease of food 

additive petition (FAP) responses and a 

corresponding decrease in burden hours 

for FAPs. We attribute this adjustment 

to an increase in the number of GRAS 

notices (21 CFR part 570, subpart E) 

received, which tend to substitute for 

FAP submissions due to a similar 

quantity and quality of data and 

information requirement. These 

numbers can fluctuate year to year. We 

also note that investigational food 

additive file responses have increased 

due to more respondents providing 

information during the pre-market 

process prior to providing a more formal 

regulatory response (e.g., FAP or GRAS 

notice). We did not adjust the number 

of responses received for the declaration 

of color additives on animal food labels 

from the previous collection. 

Our estimated burden for the 

information collection reflects an 

overall increase of 40,600 total hours 

and 24 responses. We attribute this to 

accounting for the consultation process 

for firms developing animal food 

ingredients. 

Dated: December 12, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30227 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–1055] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request Data To Support 

Social and Behavioral Research as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, us, 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 January 21, 

2025. 

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 0910–0847. 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. 

Data To Support Social and Behavioral 

Research as Used by the Food and Drug 

Administration 

OMB Control Number 0910–0847— 

Extension 

This information collection is 

intended to support FDA-conducted 

research. Understanding patients, 

consumers, and healthcare 

professionals’ perceptions and 

behaviors plays an important role in 

improving FDA’s regulatory decisionmaking processes and communications 

that affect various stakeholders. FDA 

uses the following methodology to 

achieve these goals: (1) creation and 

validation of survey instruments; (2) use 

of techniques to evaluate sampling and 

recruitment methods; (3) evaluation of 

the validity and reliability of survey 

instruments; (4) individual in-depth 

interviews, (5) general public focus 

group interviews, (6) intercept 

interviews, (7) self-administered 

surveys, (8) gatekeeper surveys, and (9) 

focus group interviews. These methods 

serve the narrowly defined need for 

direct and informal opinion on a 

specific topic and serve as a qualitative 

and quantitative research tool having 

two major purposes: 

• Obtaining useful, valid, and reliable 

information for the development of 

variables and measures for formulating 

the basic objectives of social and 

behavioral research and 

• Successfully communicating and 

addressing behavioral changes with 

intended audiences to assess the 

potential effectiveness of FDA 

communications, behavioral 

interventions, and other materials. 

While FDA will use these methods to 

test and refine its ideas and help 

develop communication and behavioral 

strategies research, the Agency will 

generally conduct further research 

before making important decisions 

(such as adopting new policies and 

allocating or redirecting significant 

resources to support these policies). 


lotter on DSK11XQN23PROD with NOTICES1
103842 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

FDA’s Center for Drug Evaluation and 

Research (CDER), Center for Biologics 

Evaluation and Research, Office of the 

Commissioner, and any other Centers 

will use this mechanism to test 

communications and social and 

behavioral methods about regulated 

drug products on a variety of subjects 

related to consumer, patient, or 

healthcare professional perceptions, 

beliefs, attitudes, behaviors, and use of 

drug and biological products and related 

materials. These subjects include social 

and behavioral research, decisionmaking processes, and communication 

and behavioral change strategies. 

Further, in addition to overseeing the 

safety of drug products when used 

according to approved drug labeling or 

as directed by a healthcare provider, 

CDER conducts studies on topics related 

to the safe and effective use of drug 

products, and emerging safety issues in 

areas such as: (1) nonmedical use of 

approved drug products; (2) use of 

unapproved and falsified (i.e., 

counterfeit, fake) drug products; (3) use 

of botanical substances (e.g., cannabis 

derived products); (4) controlled 

substance prescribing decisions; (5) 

bystander response to drug overdoses; 

and (6) potentially false or misleading 

information about drug products. 

Reliable data on these and related topics 

are a critical first step to understanding 

whether further studies or action is 

needed to protect public health. 

Because often data on these topics are 

not collected as part of routine 

healthcare delivery or via established 

Federal surveys, FDA requires the 

development and validation of novel 

instruments (i.e., interview and focus 

group guides, questionnaires) and 

approaches to gathering data on 

emerging safety issues the methods used 

to create and validate these instruments 

may include interviews, focus groups, 

small group discussions, pilot and test/ 

re-test survey launches, and external 

validation against benchmark surveys. 

In conducting research in these areas, 

FDA will need to employ the following 

validation methodology: (1) research to 

assess knowledge, perceptions, and 

experiences related to topics in the 

above-mentioned areas with specific 

target populations; (2) techniques to 

evaluate sampling and recruitment 

methods; and (3) evaluations of the 

validity and reliability of survey 

questionnaires in target populations. 

In accordance with 5 CFR 1320.8(d), 

FDA published a 60-day notice for 

public comment on the proposed 

collection of information in the Federal 

Register of April 23, 2024 (89 FR 

30381). Although one comment was 

received, it was not responsive to the 

four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

Annually, FDA projects about 25 

social and behavioral studies using the 

variety of test methods listed in this 

document. FDA is revising this burden 

to account for the number of studies we 

have received in the last 3 years and to 

better reflect the scope of the 

information collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Interviews and Surveys ........................................ 126,770 1 126,770 0.25 (15 minutes) .......... 31,693 

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

Based on a review of the information 

collection since our last request for 

OMB approval, our burden estimate for 

this information collection reflects an 

overall increase of 17,300 responses 

with a corresponding increase of 4,325 

hours. We attribute this adjustment to 

the need to validate information in 

specific areas. 

Dated: December 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30224 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meetings of the Council on Graduate 

Medical Education 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Council on 

Graduate Medical Education (COGME or 

Council) will hold public meetings for 

the 2025 calendar year (CY). 

Information about COGME, agendas, 

and materials for these meetings can be 

found on the COGME website at: 

https://www.hrsa.gov/advisorycommittees/graduate-medical-edu. 

DATES: COGME meetings will be held 

on: 

• April 10, 2025, 8 a.m.–5 p.m. 

eastern time (ET) and April 11, 2025, 8 

a.m.–2 p.m. ET. 

• September 11, 2025, 8 a.m.–5 p.m. 

ET and September 12, 2025, 8 a.m.–4 

p.m. ET. 

ADDRESSES: Meetings will be held inperson, by teleconference, and/or on a 

video conference platform. In-person 

meetings will be held at 5600 Fishers 

Lane, Rockville, Maryland 20857. For 

updates on how the meetings will be 

held, instructions for joining meetings, 

and any other updates, visit the COGME 

website 30 business days before the date 

of the meeting at https://www.hrsa.gov/ 

advisory-committees/graduate-medicaledu/meetings. 

FOR FURTHER INFORMATION CONTACT: 

Shane Rogers, Designated Federal 

Officer, Division of Medicine and 

Dentistry, Bureau of Health Workforce, 

HRSA, 5600 Fishers Lane, Room 15N39, 

Rockville, Maryland 20857; 301–443– 

5260; or SRogers@hrsa.gov. 

SUPPLEMENTARY INFORMATION: COGME 

provides advice and recommendations 

to the Secretary of HHS and Congress on 

policy, program development, and other 

matters of significance regarding the 

issues listed in section 762(a)(1) of the 

Public Health Service Act. Issues 

addressed by the COGME include the 

supply and distribution of the physician 

workforce in the United States, 

including any projected shortages or 

excesses, issues related to foreign 

medical school graduates, the nature 

and financing of undergraduate and 

graduate medical education, 

appropriation levels for certain 

programs under title VII of the Public 

Health Service Act, and deficiencies in 

databases concerning the supply and 

distribution of the physician workforce 

and postgraduate programs for training 


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