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

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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.

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Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852,301-796-7726,

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The following is a list of FDA information collections recently approved by OMB under § 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
Current Good Manufacturing Practice; Quality System Regulation0910-00731/31/2020
Format and Content Requirements for Over-the-Counter Drug Product Labeling0910-03401/31/2020
Medical Devices; Third Party Review Under FDAMA0910-03751/31/2020
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition0910-05411/31/2020
Application for Participation in the Medical Device Fellowship Program; Form FDA 36080910-05511/31/2020
GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims0910-06701/31/2020
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans0910-06721/31/2020
GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information0910-07541/31/2020
Protection of Human Subjects: Informed Consent; Institutional Review Boards0910-07551/31/2020
Requests for Feedback on Medical Device Submissions0910-07561/31/2020
National Direct-to-Consumer Advertising Survey0910-08281/31/2020
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Dated: May 23, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

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[FR Doc. 2017-11011 Filed 5-26-17; 8:45 am]