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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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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, PRAStaff@fda.hhs.gov.
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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 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
|Reporting Associated with New Animal Drug Applications||0910-0032||8/31/2019|
|Administrative Detention and Banned Medical Devices||0910-0114||8/31/2019|
|Registration of Food Facilities||0910-0502||8/31/2019|
|Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002||0910-0510||8/31/2019|
|Medical Device User Fee Cover Sheet—FDA Form 3601||0910-0511||8/31/2019|
|Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens That Are Not Individually Identifiable||0910-0582||8/31/2019|
|Guidance for Reagents for Detection of Specific Novel Influenza A Viruses||0910-0584||8/31/2019|
|Guidance: Emergency Use Authorization of Medical Products||0910-0595||8/31/2019|
|Prevention of Salmonella Enteritidis in Shell Eggs During Production—Recordkeeping and Registration Provisions||0910-0660||8/31/2019|
|Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements||0910-0661||8/31/2019|
|Guidance for Center for Devices and Radiological Health Appeals Processes||0910-0738||8/31/2019|
|Deeming Tobacco Products To Be Subject to the FD&C Act||0910-0768||8/31/2019|
|Food Labeling: Revision of the Nutrition Facts Label and Supplement Facts Label||0910-0813||7/31/2019|
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Dated: September 6, 2016.
Associate Commissioner for Policy.
[FR Doc. 2016-21877 Filed 9-9-16; 8:45 am]
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