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:
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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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 expires|
|Disclosures in Professional and Consumer Prescription Drug Promotion||0910-0860||9/30/2020|
|Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads||0910-0861||9/30/2020|
|Reclassification Petitions for Medical Devices||0910-0138||9/30/2021|
|Request for Samples and Protocols||0910-0206||9/30/2021|
|Medical Device Recall Authority||0910-0432||9/30/2021|
|Food Safety, Health, and Diet Survey||0910-0345||10/31/2020|
|Medical Device Labeling Regulations||0910-0485||10/30/2021|
|GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees||0910-0581||10/31/2021|
|Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food||0910-0751||10/31/2021|
|Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals||0910-0789||10/31/2021|
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Dated: November 5, 2018.
Associate Commissioner for Policy.
[FR Doc. 2018-24609 Filed 11-9-18; 8:45 am]
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