Skip to Content

Notice

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

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 collectionOMB control No.Date approval expires
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution0910-004512/31/2021
Biosimilar User Fee Program0910-071812/31/2021
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 Act0910-086312/31/2021
Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion0910-086412/31/2021
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products0910-05721/31/2022
General Licensing Provisions; Section 351(k) Biosimilar Applications0910-07191/31/2022
Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA0910-07281/31/2022
Implementation of the Drug Supply Chain Security Act—Identification of Suspect Product and Notification0910-08061/31/2022
Reclassification Petitions for Medical Devices0910-01382/28/2022
Start Signature

Dated: April 10, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2019-07467 Filed 4-15-19; 8:45 am]

BILLING CODE 4164-01-P