Skip to Content


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

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

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


Food and Drug Administration, HHS.




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


FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852,

End Further Info End Preamble Start Supplemental 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​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
Bar Code Label Requirements for Human Drug Products and Biological Products0910-05379/30/2019
Clinical Laboratory Improvement Amendments Waiver Applications0910-05989/30/2019
Current Good Manufacturing Practices for Positron Emission Tomography Drugs0910-06679/30/2019
Medical Devices: Use of Certain Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling0910-07409/30/2019
Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act0910-07469/30/2019
Start Printed Page 91940
Medical Device Accessories0910-08239/30/2019
Market Claims in Direct-to-Consumer Prescription Drug Print Ads0910-08249/30/2019
Abbreviated New Animal Drug Applications0910-066910/31/2019
Abbreviated New Drug Applications and 505(b)(2) Applications0910-078611/30/2019
Start Signature

Dated: December 13, 2016.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2016-30351 Filed 12-16-16; 8:45 am]