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Code · REGISTER · 2019-07-23 · Food and Drug Administration, HHS · Notices

Notices. Notice

349 words·~2 min read·/register/2019/07/23/2019-15626

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BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2018-N-3138; FDA-2009-N-0232; FDA-2018-N-4465; FDA-2018-N-4206; FDA-2018-N-3758; FDA-2015-D-1163; FDA-2012-N-0559; FDA-2015-N-3815; FDA-2018-N-3353; and FDA-2018-N-2973] 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 *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 Experimental Study of an Accelerated Approval Disclosure 0910-0872 6/30/2020 Interstate Shellfish Dealer's Certificate 0910-0021 5/31/2022 Administrative Detention and Banned Medical Devices 0910-0114 5/31/2022 Medical Device User Fee Small Business Qualifications and Certifications 0910-0508 5/31/2022 Individual Patient Expanded Access Applications 0910-0814 5/31/2022 Electronic Forma for Submissions; Promotional labeling and Advertising Materials for Human Prescription Drugs 0910-0870 5/31/2022 Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation 0910-0456 6/30/2022 Electronic Submission of Medical Device Registration and Listing 0910-0625 6/30/2022 Antimicrobial Animal Drug Distribution Reports and Recordkeeping 0910-0659 6/30/2022 Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act 0910-0871 6/30/2022 Dated: July 16, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019-15626 Filed 7-22-19; 8:45 am]
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