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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, 10A63, 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
Agreement for Shipments of Devices for Sterilization0910-01319/30/2019
Export of Medical Devices—Foreign Letters of Approval0910-02649/30/2019
Mammography Facilities, Standards, and Lay Summaries for Patients0910-03099/30/2019
Medicated Fee Mill License Application0910-03379/30/2019
Substances Generally Recognized as Safe: Notification Procedure0910-03429/30/2019
Prescription Drug Product Labeling; Medication Guide Requirements0910-03939/30/2019
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug is Invalid or Will Not be Infringed0910-05139/30/2016
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed0910-033910/31/2019
Investigational Device Exemptions Reports and Records—21 CFR 8120910-007811/30/2019
Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway0910-045411/30/2019
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Dated: December 9, 2016.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2016-30035 Filed 12-13-16; 8:45 am]