Documents

Regulatory Clean Up Initiative

Federal Register · Rule · Nov 16, 2020

PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT 68. The authority citation for part 423 continues to read as follows: Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh. … PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS 80.

Regulatory Clean Up Initiative; Correction

Federal Register · Rule · Dec 17, 2020

0991-AC19 Food and Drug Administration 21 CFR Parts 1, 5, 12, 14, 25, 81, 133, 172, 178, 184, 201, 310, 369, 501, and 582 Centers for Medicare & Medicaid Services 42 CFR Parts 411, 412, 422, 423 … , 426, 440, 441, 447, 482, and 485 Office of Inspector General 42 CFR Parts 1004 and 1008 Administration for Children and Families 45 CFR Parts 305, 307, 1324, 1325, 1326, and 1328 Regulatory

Merck & Co., Inc., et al.; Withdrawal of Approval of 32 New Drug Applications and 48 Abbreviated New Drug Applications

Federal Register · Notice · Jun 10, 1999

Inc., U.S. … ANDA 85-482 LIBRITABS (Chlordiazepoxide Do.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2015

Federal Register · Notice · Aug 1, 2014

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2020

Federal Register · Notice · Jul 25, 2019

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016

Federal Register · Notice · Aug 3, 2015

states that the fee is to be paid by the responsible party for a domestic facility (as defined in section 415(b) of the FD&C Act) and an importer who does not comply with a recall order under section 423 … Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019

Federal Register · Notice · Jul 27, 2018

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2018

Federal Register · Notice · Aug 2, 2017

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2014

Federal Register · Notice · Aug 2, 2013

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Disqualification of a Clinical Investigator

Federal Register · Rule · Apr 30, 2012

Family Publications Service, Inc., 411 U.S. 356 (1973), and National Petroleum Refiners Association v. FTC, 482 F.2d 672 (DC Cir. 1973). See also Weinberger v. … Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973); National Nutritional Foods Association v. Weinberger, 512 F.2d 688, cert denied, 423 U.S. 827 (1975); United States v.

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 043

Federal Register · Notice · Jun 27, 2016

controlled environments—Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration Withdrawn and replaced with newer version. 14-283 14-482 … Materials 8-423 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications ASTM F2565-13. 8-424

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2024

Federal Register · Notice · Jul 28, 2023

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 30 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2025

Federal Register · Notice · Jul 31, 2024

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 30 days of the invoice date in U.S. currency by electronic check, credit card, check, bank draft, U.S. postal money order, or wire transfer payable to the order of the Food

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2026

Federal Register · Notice · Jul 30, 2025

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … states that the fee is to be paid by the responsible party for a domestic facility (as defined in section 415(b) of the FD&C Act) and an importer who does not comply with a recall order under section 423

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2023

Federal Register · Notice · Jul 28, 2022

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 30 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2017

Federal Register · Notice · Aug 1, 2016

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022

Federal Register · Notice · Jul 28, 2021

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated … Payment must be made within 30 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2021

Federal Register · Notice · Aug 3, 2020

The payment must be made in U.S. currency from a U.S. bank by one of the following methods: Wire transfer, electronically, check, bank draft, or U.S. postal money order made payable to the Food and Drug … Payments must be made using U.S. bank accounts as well as U.S. credit cards. When paying by check, bank draft, or U.S. postal money order, please include the invoice number in the check stub.

Determination of Regulatory Review Period for Purposes of Patent Extension; BeneFIXSUPTM/SUP

Federal Register · Notice · Aug 4, 1998

Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for BeneFIXTM (U.S. … In its application for patent extension, this applicant seeks 423 days of patent term extension.

Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012

Federal Register · Notice · Aug 1, 2011

If FDA authorizes a request for reconditioning, the reconditioning operations are carried out under the supervision of either FDA or U.S. … Payment must be made within 30 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.