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:
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:
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 |
---|---|---|
Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey | 0910–0912 | 3/31/2024 |
Electronic Products Requirements | 0910–0025 | 2/28/2026 |
Investigational Device Exemptions | 0910–0078 | 2/28/2026 |
General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions | 0910–0340 | 2/28/2026 |
Prescription Drug Product Labeling; Medication Guide Requirements | 0910–0393 | 2/28/2026 |
Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing | 0910–0458 | 2/28/2026 |
Designation of New Animal Drugs for Minor Use or Minor Species | 0910–0605 | 2/28/2026 |
Tobacco Retailer Training Programs | 0910–0745 | 2/28/2026 |
Q-Submission and Early Payor Feedback Request Programs for Medical Devices | 0910–0756 | 2/28/2026 |
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration | 0910–0847 | 2/28/2026 |
Protection of Human Subjects and Institutional Review Boards | 0910–0130 | 3/31/2026 |
Mammography Standards Quality Act Requirements | 0910–0309 | 3/31/2026 |
Biologics License Applications; Procedures & Requirements | 0910–0338 | 3/31/2026 |
Procedures for the Safe Processing and Importing of Fish and Fishery Products | 0910–0354 | 3/31/2026 |
Medical Device Labeling Regulations; Unique Device Identification | 0910–0485 | 3/31/2026 |
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09401 Filed 5–3–23; 8:45 am]
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