Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 4313 

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, PRAStaff@

fda.hhs.gov. 

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 

Title of collection OMB control 

No. 

Date approval 

expires 

Temporary Marketing Permit Applications .............................................................................................................. 0910–0133 1/31/2027 

State Petitions for Exemption from Preemption ...................................................................................................... 0910–0277 1/31/2027 

FDA Focus Groups and Interviews ......................................................................................................................... 0910–0497 1/31/2027 

Product Jurisdiction and Combination Products ..................................................................................................... 0910–0523 1/31/2027 

Cosmetic Labeling and Cosmetic Registration ....................................................................................................... 0910–0599 1/31/2027 

Registration of Human Drug Compounding Outsourcing Facilities under Section 503B of the FFDCA and Associated Fees under Section 744K ...................................................................................................................... 0910–0776 1/31/2027 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[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. 

SUMMARY: 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://

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. 

FOR FURTHER INFORMATION CONTACT: 

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. 

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. 

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 

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 


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