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Code · REGISTER · 2018-04-09 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Notice

341 words·~2 min read·/register/2018/04/09/2018-07146

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BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2014-N-0075; FDA-2011-N-0015; FDA-2011-N-0076; FDA-2017-N-0932; FDA-2016-N-4487; FDA-2014-N-0345; FDA-2013-N-0523; FDA-2017-N-2428; FDA-2008-N-0312; and FDA-2014-N-1072] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals 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. 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.* 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. Table 1—List of Information Collections Approved by OMB Title of collection OMB Control No. Date approval expires Good Laboratory Practice Regulations for Nonclinical Studies 0910-0119 1/31/2021 Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation 0910-0167 1/31/2021 Electronic Records: Electronic Signatures 0910-0303 1/31/2021 Experimental Study on Warning Statements for Cigarette Graphic Health Warnings 0910-0848 1/31/2021 Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion 0910-0849 1/31/2021 Data to Support Drug Product Communications 0910-0695 2/28/2021 Applications for FDA Approval to Market a New Drug 0910-0001 3/31/2021 Animal Drug Adverse Event Reporting and Recordkeeping 0910-0284 3/31/2021 Extralabel Drug Use in Animals 0910-0325 3/31/2021 Application for Participation in FDA Fellowship Programs 0910-0780 3/31/2021 Dated: April 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07146 Filed 4-6-18; 8:45 am]
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