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

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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
Reporting Associated with New Animal Drug Applications0910-00328/31/2019
Administrative Detention and Banned Medical Devices0910-01148/31/2019
Registration of Food Facilities0910-05028/31/2019
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 20020910-05108/31/2019
Medical Device User Fee Cover Sheet—FDA Form 36010910-05118/31/2019
Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens That Are Not Individually Identifiable0910-05828/31/2019
Guidance for Reagents for Detection of Specific Novel Influenza A Viruses0910-05848/31/2019
Guidance: Emergency Use Authorization of Medical Products0910-05958/31/2019
Prevention of Salmonella Enteritidis in Shell Eggs During Production—Recordkeeping and Registration Provisions0910-06608/31/2019
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements0910-06618/31/2019
Guidance for Center for Devices and Radiological Health Appeals Processes0910-07388/31/2019
Deeming Tobacco Products To Be Subject to the FD&C Act0910-07688/31/2019
Food Labeling: Revision of the Nutrition Facts Label and Supplement Facts Label0910-08137/31/2019
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Dated: September 6, 2016.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2016-21877 Filed 9-9-16; 8:45 am]