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 |
|---|---|---|
| Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution | 0910-0045 | 12/31/2021 |
| Biosimilar User Fee Program | 0910-0718 | 12/31/2021 |
| Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act | 0910-0863 | 12/31/2021 |
| Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion | 0910-0864 | 12/31/2021 |
| Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products | 0910-0572 | 1/31/2022 |
| General Licensing Provisions; Section 351(k) Biosimilar Applications | 0910-0719 | 1/31/2022 |
| Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA | 0910-0728 | 1/31/2022 |
| Implementation of the Drug Supply Chain Security Act—Identification of Suspect Product and Notification | 0910-0806 | 1/31/2022 |
| Reclassification Petitions for Medical Devices | 0910-0138 | 2/28/2022 |
Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-07467 Filed 4-15-19; 8:45 am]
BILLING CODE 4164-01-P