Document ID: FDA-2012-D-0530-0030
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals
Posted Date: 2017-05-30T04:00Z

[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Page 24722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-N-2544; FDA-2013-N-0823; FDA-2013-N-0795; FDA-
2013-N-1147; FDA-2013-N-1064; FDA-2008-D-0150; FDA-2013-N-0663; FDA-
2010-D-0319; FDA-2013-N-0403; FDA-2012-D-0530; FDA-2016-N-0544]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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, 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 Sec.  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
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                                            OMB control    Date approval
           Title of collection                  No.           expires
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Current Good Manufacturing Practice;           0910-0073       1/31/2020
 Quality System Regulation..............
Format and Content Requirements for Over-      0910-0340       1/31/2020
 the-Counter Drug Product Labeling......
Medical Devices; Third Party Review            0910-0375       1/31/2020
 Under FDAMA............................
Preparing a Claim of Categorical               0910-0541       1/31/2020
 Exclusion or an Environmental
 Assessment for Submission to the Center
 for Food Safety and Applied Nutrition..
Application for Participation in the           0910-0551       1/31/2020
 Medical Device Fellowship Program; Form
 FDA 3608...............................
GFI: Hypertension Indication; Drug             0910-0670       1/31/2020
 Labeling for Cardiovascular Outcome
 Claims.................................
Investigational New Drug Safety                0910-0672       1/31/2020
 Reporting Requirements for Human Drug
 and Biological Products and Safety
 Reporting Requirements for
 Bioavailability and Bioequivalence
 Studies in Humans......................
GFI: Dear Health Care Provider Letters;        0910-0754       1/31/2020
 Improving Communication of Important
 Safety Information.....................
Protection of Human Subjects: Informed         0910-0755       1/31/2020
 Consent; Institutional Review Boards...
Requests for Feedback on Medical Device        0910-0756       1/31/2020
 Submissions............................
National Direct-to-Consumer Advertising        0910-0828       1/31/2020
 Survey.................................
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    Dated: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11011 Filed 5-26-17; 8:45 am]
 BILLING CODE 4164-01-P