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:
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St, North Bethesda, MD 20852, 301-796-7726, 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 |
---|---|---|
Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet | 0910-0511 | 10/31/2024 |
Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials | 0910-0902 | 10/31/2024 |
Medical Device Labeling Regulations | 0910-0485 | 11/30/2024 |
Establishment and Operation of Clinical Trial Data Monitoring Committees | 0910-0581 | 11/30/2024 |
Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product | 0910-0673 | 11/30/2024 |
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food for Animals | 0910-0751 | 11/30/2024 |
Federal-State Regulatory Program Standards | 0910-0760 | 11/30/2024 |
Electronic User Fee Payment Form | 0910-0805 | 11/30/2024 |
Dated: December 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28362 Filed 12-29-21; 8:45 am]
BILLING CODE 4164-01-P