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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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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,

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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
Disclosures in Professional and Consumer Prescription Drug Promotion0910-08609/30/2020
Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads0910-08619/30/2020
Reclassification Petitions for Medical Devices0910-01389/30/2021
Request for Samples and Protocols0910-02069/30/2021
Medical Device Recall Authority0910-04329/30/2021
Food Safety, Health, and Diet Survey0910-034510/31/2020
Medical Device Labeling Regulations0910-048510/30/2021
GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees0910-058110/31/2021
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food0910-075110/31/2021
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals0910-078910/31/2021
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Dated: November 5, 2018.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2018-24609 Filed 11-9-18; 8:45 am]