Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 1099 

knowledge, attitudes, beliefs, and 

behaviors—and use these in the 

development of appropriate survey/ 

research questions, study stimuli, or 

communications; (2) more efficiently 

and effectively design survey/research 

questions and study stimuli; and (3) 

more efficiently and effectively design 

experimental studies. 

FDA is requesting approval of an 

extension of this generic clearance for 

collecting information using qualitative 

methods (e.g., interviews, focus groups, 

asynchronous discussion boards, etc.) 

for studies involving all tobacco 

products regulated by FDA. This 

information will be used to explore 

concepts of interest and assist in the 

development of quantitative study 

proposals, complementing other 

important research efforts in the 

Agency. This information may also be 

used to help identify and develop 

communication messages, which may 

be used in education campaigns. 

Qualitative research plays an important 

role in gathering information because it 

allows for an indepth understanding of 

individuals’ attitudes, beliefs, 

motivations, and feelings. Qualitative 

research serves the narrowly defined 

need for direct and informal public 

opinion on a specific topic. 

The number of respondents to be 

included in each new study may vary, 

depending on the nature of the study 

(e.g., foundational, formative, etc.), 

approach (synchronous vs. 

asynchronous, or virtual vs. in person) 

and the intended audience. Table 1 

provides examples of the types of 

studies that may be administered and 

estimated burden levels during the 3- 

year period. Time to read, view, or 

listen to the message being tested is 

built into the ‘‘Average Burden per 

Response’’ figures. FDA estimates the 

burden of this collection of information 

as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of Interview Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

In-Person Individual Indepth Interviews ................... 4,500 1 4,500 1 ................................ 4,500 

Indepth Interview Screener ...................................... 22,500 1 22,500 0.083 (5 minutes) ...... 1,875 

Focus Group Screener ............................................ 56,000 1 56,000 0.25 (15 minutes) ...... 14,000 

Focus Group Discussion .......................................... 252,000 1 252,000 1.5 ............................. 378,000 

Discussion Board Screener ..................................... 8,000 1 8,000 0.083 (5 minutes) ...... 667 

Discussion Board Participation ................................ 100 1 100 1.5 ............................. 150 

Total .................................................................. ........................ ........................ ........................ .................................... 399,192 

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

Our estimated burden for the 

information collection reflects an 

overall increase of 384,258 hours and a 

corresponding increase of 314,926 

responses. We attribute this adjustment 

to the number of study responses used 

during the current approval and now 

estimated for the next 3 years. A greater 

number of qualitative studies will be 

conducted over the next 3 years due to 

the need to develop new creative 

messages and content. Recent years 

have seen a dramatic change in media. 

With the shift to digital media, FDA 

must adapt to communicate effectively 

in a digital environment. As digital 

tobacco use prevention/interventions 

are still in their infancy, we must better 

understand the types of digital channels 

available. To impact public health 

outcomes, we need to understand how 

to reach our intended audience. New 

foundational studies are needed 

(including those on digital metrics, 

measurement, and implementation). As 

a result, we have adjusted our burden 

estimate and revised the number of 

respondents to the information 

collection. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00221 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3168] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Extralabel Drug 

Use in Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 February 8, 

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 OMB 

control number for this information 

collection is 0910–0325. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

Extralabel Drug Use in Animals—21 

CFR Part 530 

OMB Control Number 0910–0325— 

Extension 

This information collection supports 

FDA implementation of section 512 of 

the Federal Food, Drug, and Cosmetic 

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

governs new animal drugs. Agency 

regulations in 21 CFR part 530 permit 

FDA, if we find that there is a 

reasonable probability that the 

extralabel use of an animal drug may 

present a risk to public health, to 

establish a safe level for a residue from 


khammond on DSKJM1Z7X2PROD with NOTICES
1100 Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 

the extralabel use of the drug, and to 

require the development of an analytical 

method for the detection of residues 

above that established safe level. This 

requirement is codified at § 530.22(b) 

(21 CFR 530.22(b)). 

Although to date, we have not 

established a safe level for a residue 

from the extralabel use of any new 

animal drug and, therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are, 

therefore, estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. Respondents to the 

information collection are private sector 

drug sponsors or veterinary 

associations, or veterinarians, State, 

local, and tribal governments, and 

Federal Agencies. 

In the Federal Register of August 31, 

2023 (88 FR 60213), FDA 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; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

530.22(b); Submission(s) of analytical method ................... 2 1 2 4,160 8,320 

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, we have made no 

adjustments to our burden estimate. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00219 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3490] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Application for 

Participation in Food and Drug 

Administration Fellowship and 

Traineeship Programs 

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 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 8, 

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 OMB 

control number for this information 

collection is 0910–0780. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Application for Participation in FDA 

Fellowship and Traineeship Programs 

OMB Control Number 0910–0780— 

Extension 

This information collection supports 

FDA fellowship and traineeship 

programs. Sections 1104, 1302, 3301, 

3304, 3320, 3361, 3393, and 3394 of 

Title 5 of the United States Code 

authorize Federal Agencies to rate 

applicants for Federal jobs. The 

information collection involves brief 

online applications completed by 

applicants applying to FDA’s 

Fellowship and Traineeship programs. 

These voluntary online applications 

will allow the Agency to easily and 

efficiently elicit and review information 

from students and healthcare 

professionals who are interested in 

becoming involved in FDA-wide 

activities. The process will reduce the 

time and cost of submitting written 

documentation to the Agency and lessen 

the likelihood of applications being 

misrouted within the Agency mail 

system. It will assist the Agency in 

promoting and protecting the public 

health by encouraging outside persons 

to share their expertise with FDA. 

In the Federal Register of September 

19, 2023 (88 FR 64438), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. We received two 

comments, which were not PRA related 

and will not be addressed in this 

document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Medical Device Fellowship Program ................................... 250 1 250 1 250 


khammond on DSKJM1Z7X2PROD with NOTICES