2018-12338. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    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, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov.

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    SUPPLEMENTARY INFORMATION:

    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 https://www.reginfo.gov/​public/​do/​PRAMain. An Agency may not conduct or sponsor, and a person is not required Start Printed Page 26699to 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
    Biological Products—General Records and Postmarket Adverse Experience Reporting0910-03084/30/2021
    Guidance for Industry: Fast Track, Drug Development Programs—Designation, Development, and Application Review0910-03894/30/2021
    Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 8020910-04984/30/2021
    Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling0910-06244/30/2021
    Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics0910-06294/30/2021
    Guidance of Industry: Expedited Programs for Serious Conditions—Drugs and Biologics0910-07654/30/2021
    Evaluation of the Food and Drug Administration's Point-of-Sale Campaign0910-08514/30/2021
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    Dated: June 4, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

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    [FR Doc. 2018-12338 Filed 6-7-18; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
06/08/2018
Department:
Health and Human Services Department
Agency:
Food and Drug Administration
EntryType:
Notice
Action:
Notice.
Document Number:
2018-12338
Pages:
26698-26699 (2 pages)
Docket Numbers:
Docket Nos. FDA-2011-N-0231, FDA-2014-N-0996, FDA-2010-N-0161, FDA-2017-N-5624, FDA-2011-N-0085, FDA-2013-D-0575, and FDA-2016-N-3710
SectionNoes:
PDF File:
2018-12338.pdf