Documents

Determination of Regulatory Review Period for Purposes of Patent Extension; PRECOSESUPTM

Federal Register · Notice · May 30, 1996

A subsequent NDA for PRECOSETM (NDA 20-482) was received on September 6, 1994. … FDA verified the applicant's claim that NDA 20-482 was approved on September 6, 1995.

Medicare Program; Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures

Federal Register · Rule · May 7, 2019

These procedures are set forth in regulations at part 423, subparts M and U. … PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT 21.

Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures

Federal Register · Rule · Jan 17, 2017

Current § 405.1016 does not address delays that result from stays ordered by U.S. Courts. … OMHA stands for the Office of Medicare Hearings and Appeals within the U.S.

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.

Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures

Federal Register · Proposed Rule · Jul 5, 2016

U.S. Mail or commercial delivery. … OMHA stands for the Office of Medicare Hearings and Appeals within the U.S.

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.

Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register · Notice · Apr 7, 2009

However, the five-year relative survival rates of patients diagnosed with CRC have been steadily increasing since 1975 and there are now over one million CRC survivors in the U.S. … Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Physicians List of Potential Study Participants 1,950 1 13/60 423

Medicare and Medicaid Program; Revisions to Certain Patient's Rights Conditions of Participation and Conditions for Coverage

Federal Register · Proposed Rule · Dec 12, 2014

Windsor, 570 U.S.12, 133 S.Ct. 2675 (2013), and HHS policy. … Windsor, 570 U.S. 12, 133 S.

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 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 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 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 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 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.

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 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 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