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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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.
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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 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|
|Current Good Manufacturing Practice; Quality System Regulation||0910-0073||1/31/2020|
|Format and Content Requirements for Over-the-Counter Drug Product Labeling||0910-0340||1/31/2020|
|Medical Devices; Third Party Review Under FDAMA||0910-0375||1/31/2020|
|Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition||0910-0541||1/31/2020|
|Application for Participation in the Medical Device Fellowship Program; Form FDA 3608||0910-0551||1/31/2020|
|GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims||0910-0670||1/31/2020|
|Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans||0910-0672||1/31/2020|
|GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information||0910-0754||1/31/2020|
|Protection of Human Subjects: Informed Consent; Institutional Review Boards||0910-0755||1/31/2020|
|Requests for Feedback on Medical Device Submissions||0910-0756||1/31/2020|
|National Direct-to-Consumer Advertising Survey||0910-0828||1/31/2020|
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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]
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