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

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.

Digoxin Products for Oral Use; Revocation of Conditions for Marketing

Federal Register · Rule · Jun 26, 2002

Shrewsbury Township , 808 F.2d 1023, 1031 (3d Cir.), cert. denied, 482 U.S. 906 (1987) (no taking even given reduction in value from $800,000 to $60,000); Village of Euclid v. … Cir. 1986), cert. denied 479 U.S. 1053 (1987); see also Andrus v. Allard , 444 U.S. 51, 66 (1979).)

Current Good Manufacturing Practices for Blood and Blood Components: Notification of Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV Infection

Federal Register · Rule · Sep 9, 1996

The sources of this information may include the U.S. military, health departments or physicians of former donors now found to be HIV-infected or diagnosed as having AIDS. … This rule will affect all of the 3,015 registered U.S. blood establishments.

Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids

Federal Register · Rule · Apr 28, 2014

See Central Hudson, 447 U.S. at 563; see also In re R.M.J., 455 U.S. at 203. … (per curiam), cert denied, 423 U.S. 827 (1975); Continental Wax Corp. v. FTC, 330 F.2d 475, 480 (2d Cir. 1964); United States v.

Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables

Federal Register · Rule · May 9, 1997

FDA, 637 F.2d 877 (2d Cir.), cert. denied, 423 U.S. 827 (1975).) … \18\ U.S. Industrial Outlook, U.S.

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

Federal Register · Rule · Sep 17, 2015

U.S., 531 U.S. 159 (2001)). … (See section 423(a) of the FD&C Act (21 U.S.C. 350l).)

Securing Updated and Necessary Statutory Evaluations Timely

Federal Register · Rule · Jan 19, 2021

The U.S. … Assn. of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)).

Amendments to Registration of Food Facilities

Federal Register · Rule · Jul 14, 2016

FSMA also created section 423 of the FD&C Act (21 U.S.C. 3501), which provides a “responsible party” an opportunity to voluntarily cease distribution and recall a food under specified circumstances and … functions, with the passage of FSMA and FDAAA, food facility registration now also serves to determine the applicability of provisions in other sections of the FD&C Act, including sections 417, 418, 421, 423

Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007

Federal Register · Rule · Aug 2, 2012

year. 12 At a labor rate of $41 per hour, including benefits, registration and listing costs $103 per device or $520 per contract manufacturing establishment ($103 per listing × 5.05 listings) and $482 … According to the U.S.

Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body

Federal Register · Rule · Jan 6, 2000

Weinberger, 512 F.2d 688, 702 (2d Cir. 1975), cert. denied, 423 U.S. 827 (1975).) … Shrewsbury Township, 808 F.2d 1023, 1031 (3d Cir.), cert. denied, 482 U.S. 906 (1987) (citing Hadacheck v. Sebastian, 239 U.S. 394 (1915) (reduction in value from $800,000 to $60,000); Euclid v.

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

Federal Register · Rule · Sep 17, 2015

EPA U.S. Environmental Protection Agency. EU European Union. FDA U.S. Food and Drug Administration. FD&C Act Federal Food, Drug, and Cosmetic Act. … We also are partnering with the National Institute of Food and Agriculture (NIFA) of the U.S.

Food Labeling; Nutrient Content Claims, Definition of Sodium Levels for the Term “Healthy”

Federal Register · Rule · Sep 29, 2005

While the partial stay was pending, the U.S. … “Dietary Guidelines for Americans 2005” U.S. Department of Health and Human Services, U.S. Department of Agriculture www.healthierus.gov/dietaryguidelines . 4. MyPyramid.gov, U.S.

Laboratory Accreditation for Analyses of Foods

Federal Register · Rule · Dec 3, 2021

Establishing this program will help FDA improve the safety of the U.S. food supply and protect U.S. consumers by helping ensure that certain food testing of importance to public health is conducted subject … Section 415(b)(7) of the FD&C Act and section 423(h) of the FD&C Act contain explicit provisions limiting certain authority to the Commissioner.

Over-the-Counter Vaginal Contraceptive and Spermicide Drug Products Containing Nonoxynol 9; Required Labeling

Federal Register · Rule · Dec 19, 2007

(Ref. 15) surveyed 3,093 gay men from 6 U.S. cities who reported having anal intercourse during the previous 6 months. … Gross, M. et al., “Rectal Microbicides for U.S. Gay Men. Are Clinical Trials Needed?,” Sexually Transmitted Diseases , 25:6:296-302, 1998. 16.

Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices; Technical Amendment

Federal Register · Rule · Jul 25, 2001

The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. 423. … current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files. 482

Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor

Federal Register · Rule · Mar 25, 2014

865 FERREXTRAN 100 (iron dextran complex) Injection. 011-241 Promazine HCl Injectable Solution. 011-427 SYNOVEX H (estradiol benzoate and testosterone propionate) Implants. 011-482 … Imidocarb dipropionate is sold only under permit issued by the Director of the National Program Planning Staff, Veterinary Services, Animal and Plant Health Inspection Service, U.S.

Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Juice

Federal Register · Rule · Jan 19, 2001

NACMCF Public Meeting NACMCF is an advisory committee chartered under the U.S. … As of April 2000, a total of 423 cases, including one that contributed to a death, from S. Muenchen infection had been reported.

Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components

Federal Register · Rule · Jun 10, 2005

In addition, the U.S. standard reflects differences in common usage. … U.S. National Center for Health Statistics, Expectation of Life and Expected Death by Race, Sex, and Age, Vital Statistics of the United States , 1995. 37. U.S.