Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 4313 [2024-01153]

Download as PDF Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices Food and Drug Administration [Docket Nos. FDA–2023–N–2562; FDA– 2023–N–2707; FDA–2023–N–1005; FDA– 2023–N–2459; FDA–2023–N–1029; and FDA–2023–N–3007] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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. SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES The following is a list of FDA information SUPPLEMENTARY INFORMATION: Notice. 4313 collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Temporary Marketing Permit Applications .............................................................................................................. State Petitions for Exemption from Preemption ...................................................................................................... FDA Focus Groups and Interviews ......................................................................................................................... Product Jurisdiction and Combination Products ..................................................................................................... Cosmetic Labeling and Cosmetic Registration ....................................................................................................... Registration of Human Drug Compounding Outsourcing Facilities under Section 503B of the FFDCA and Associated Fees under Section 744K ...................................................................................................................... Dated: January 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. 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 0910–0409. Also include the FDA docket number found in brackets in the heading of this document. [FR Doc. 2024–01153 Filed 1–22–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2023–N–3848] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 February 22, 2024. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:41 Jan 22, 2024 Jkt 262001 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring—21 CFR Part 315 OMB Control Number 0910–0409— Extension This information collection supports our regulations in part 315 (21 CFR part 315) that require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of (1) a new diagnostic radiopharmaceutical or (2) a new indication for use of an approved PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Date approval expires 0910–0133 0910–0277 0910–0497 0910–0523 0910–0599 1/31/2027 1/31/2027 1/31/2027 1/31/2027 1/31/2027 0910–0776 1/31/2027 diagnostic radiopharmaceutical. Information about the safety or effectiveness of a diagnostic radiopharmaceutical enables FDA to evaluate properly the safety and effectiveness profiles of such radiopharmaceuticals. The information, which is usually submitted as part of a new drug application (NDA) or biologics license application or as a supplement to an approved application typically includes, but is not limited to, nonclinical and clinical data on the pharmacology; toxicology; adverse events; radiation safety assessments; and chemistry, manufacturing, and controls. The content and format of an application for approval of a new drug are set forth in § 314.50 (21 CFR 314.50) and have been approved under OMB control number 0910–0001. In table 1, row 1, we estimate the annual reporting burden for preparing the safety and effectiveness sections of an application. This estimate does not include the time needed to conduct studies and clinical trials or other research from which the reported information is obtained. Based on past submissions of human drug applications, new indication supplements for diagnostic radiopharmaceuticals, or both, we estimate that three submissions will be received annually from three applicants and that 2,000 hours would be spent preparing the portions of the application that would be affected by this E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Page 4313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01153]



[[Page 4313]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2023-N-2562; FDA-2023-N-2707; FDA-2023-N-1005; FDA-
2023-N-2459; FDA-2023-N-1029; and FDA-2023-N-3007]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the internet at 
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Temporary Marketing Permit Applications.       0910-0133       1/31/2027
State Petitions for Exemption from             0910-0277       1/31/2027
 Preemption.............................
FDA Focus Groups and Interviews.........       0910-0497       1/31/2027
Product Jurisdiction and Combination           0910-0523       1/31/2027
 Products...............................
Cosmetic Labeling and Cosmetic                 0910-0599       1/31/2027
 Registration...........................
Registration of Human Drug Compounding         0910-0776       1/31/2027
 Outsourcing Facilities under Section
 503B of the FFDCA and Associated Fees
 under Section 744K.....................
------------------------------------------------------------------------


    Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01153 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P

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