2016-30351. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

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:

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

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 http://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
Bar Code Label Requirements for Human Drug Products and Biological Products	0910-0537	9/30/2019
Clinical Laboratory Improvement Amendments Waiver Applications	0910-0598	9/30/2019
Current Good Manufacturing Practices for Positron Emission Tomography Drugs	0910-0667	9/30/2019
Medical Devices: Use of Certain Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling	0910-0740	9/30/2019
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 Act	0910-0746	9/30/2019
Medical Device Accessories	0910-0823	9/30/2019
Market Claims in Direct-to-Consumer Prescription Drug Print Ads	0910-0824	9/30/2019
Abbreviated New Animal Drug Applications	0910-0669	10/31/2019
Abbreviated New Drug Applications and 505(b)(2) Applications	0910-0786	11/30/2019

Dated: December 13, 2016.

Leslie Kux,

Associate Commissioner for Policy.