2018-13098. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals  

  • Start Preamble

    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.

    Start Further Info

    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.

    End Further Info End Preamble Start Supplemental Information

    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 to respond to, a collection of information unless it displays a currently valid OMB control number.Start Printed Page 28431

    Table 1—List of Information Collections Approved By OMB

    Title of collectionOMB control No.Date approval expires
    Infant Formula Requirements0910-02565/31/2021
    Premarket Notification for a New Dietary Ingredient0910-03305/31/2021
    Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring0910-04095/31/2021
    Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice0910-05635/31/2021
    Requests for Inspection by an Accredited Person Under the Inspection for Accredited Persons Program0910-05695/31/2021
    Substances Prohibited from Use in Animal Food or Feed0910-06275/31/2021
    Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.53000910-06335/31/2021
    Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic0910-07015/31/2021
    Guidance on Consultation Procedures: Foods Derived From New Plant Varieties0910-07045/31/2021
    Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices0910-07415/31/2021
    Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments0910-07825/31/2021
    Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with the Office of Orphan Products Development0910-07875/31/2021
    Food Allergen Labeling and Reporting0910-07925/31/2021
    Transfer of a Premarket Notification Clearance0910-08525/31/2021
    Start Signature

    Dated: June 13, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2018-13098 Filed 6-18-18; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
06/19/2018
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2018-13098
Pages:
28430-28431 (2 pages)
Docket Numbers:
Docket Nos. FDA-2013-N-0545, FDA-2013-N-0878, FDA-2014-N-0998, FDA-2014-N-1076, FDA-2017-N-6162, FDA-2011-N-0510, FDA-2014-N-1414, FDA-2008-D-0610, FDA-2010-D-0073, FDA-2013-N-0080, FDA-2017-N-6397, FDA-2014-D-0313, FDA-2014-N-1030, and FDA-2014-D-1837
PDF File:
2018-13098.Pdf