Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals, 1099-1100 [2024-00219]

Download as PDF Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 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. 1099 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 3year 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 Number of respondents Type of Interview Total annual responses Average burden per response Total hours In-Person Individual Indepth Interviews ................... Indepth Interview Screener ...................................... Focus Group Screener ............................................ Focus Group Discussion .......................................... Discussion Board Screener ..................................... Discussion Board Participation ................................ 4,500 22,500 56,000 252,000 8,000 100 1 1 1 1 1 1 4,500 22,500 56,000 252,000 8,000 100 1 ................................ 0.083 (5 minutes) ...... 0.25 (15 minutes) ...... 1.5 ............................. 0.083 (5 minutes) ...... 1.5 ............................. 4,500 1,875 14,000 378,000 667 150 Total .................................................................. ........................ ........................ ........................ .................................... 399,192 1 There khammond on DSKJM1Z7X2PROD with NOTICES Number of responses per respondent 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 VerDate Sep<11>2014 16:38 Jan 08, 2024 Jkt 262001 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. 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 SUMMARY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 E:\FR\FM\09JAN1.SGM 09JAN1 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 1 There 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. 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). khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: 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. DATES: 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 Number of respondents Activity Medical Device Fellowship Program ................................... VerDate Sep<11>2014 16:38 Jan 08, 2024 Jkt 262001 PO 00000 Frm 00041 Number of responses per respondent 250 Fmt 4703 Sfmt 4703 Total annual responses 1 E:\FR\FM\09JAN1.SGM 250 09JAN1 Average burden per response Total hours 1 250

Agencies

[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1099-1100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00219]


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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, 
[email protected].

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

[[Page 1100]]

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 Sec.  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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      21 CFR Section; activity                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
530.22(b); Submission(s) of analytical method......................               2                1                2            4,160            8,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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

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