Documents

Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in the New Animal Drug Regulations; Drug Efficacy Study Implementation; Notice of Opportunity for Hearing

Federal Register · Notice · Aug 8, 2003

Under section 108(b)(2) of Public Law 90-399 (82 Stat. 353), the Animal Drug Amendments of 1968, any approval of a new animal drug granted prior to the law's effective date, whether through approval of … Treatment should continue 24 to 48 hours beyond remission of disease symptoms.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages

Federal Register · Notice · Feb 27, 2012

Willis, “A Review of European Research on Consumer Response to Nutrition Information on Food Labels,” Journal of Public Health, vol. 15, pp. 384-399, 2007. 11. Kellogg Company. … [FR Doc. 2012-4423 Filed 2-24-12; 8:45 am] BILLING CODE 4160-01-P

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066

Federal Register · Notice · Aug 24, 2026

These modifications to the list of recognized standards are applicable August 24, 2026. … 397 Dentistry—Test methods for machining accuracy of computer-aided milling machines ISO 23298 First edition 2023-05. 4-398 Dentistry—Excavators ISO 23940 First edition 2021-04. 4-399

Gastroenterology-Urology Devices: Reclassification of the Penile Rigidity Implant

Federal Register · Proposed Rule · Dec 16, 1997

Ludlow, ``Management of Infected Penile Implants,'' Techniques in Urology, 1(3):115-119, 1995. 24. Mulcahy, J. J., R. J. Krane, L. K. Lloyd, M. Edson, and M. B. … Carson, ``Patient Satisfaction in Scott and Small--Carrion Penile Implant Recipients: A Study of 52 Patients,'' Archives of Sexual Behavior, 15(5):393- 399, 1986. 35. Steidle, C. P., and J. J.

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051

Federal Register · Notice · Mar 14, 2019

:2018 Sterile Water for Irrigation Withdrawn and replaced with newer version. 6-398 6-419 USP 41-NF36:2018 Heparin Lock Flush Solution Withdrawn and replaced with newer version. 6-399 … Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality Title change. 7-178 CLSI M22-A3 Vol. 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for

New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor

Federal Register · Rule · Mar 8, 2021

Milk taken from cows within 24 hours (2 milkings) after calving must not be used for food. … Repeat once after 24 hours. (2) Indications for use.

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047

Federal Register · Notice · Aug 21, 2017

Sterile Water for Irrigation Withdrawn and replaced with newer version. 6-374 6-398 USP 40-NF35:2017, Heparin Lock Flush Solution Withdrawn and replaced with newer version. 6-375 6-399 … radio-frequency wireless coexistence for medical devices and systems AAMI TIR69: 2017. 19-23 Primary batteries—Part 4: Safety of lithium batteries IEC 60086-4 Edition 4.0 2014-09. 19-24

Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program

Federal Register · Notice · Jan 15, 2021

Rep. 105-399, at 96 (1997). B. … Of the 630 MAUDE reports analyzed, the majority (383 or 60.7%) involved product malfunctions with a limited number connected to death (24 or 3.8%).

Substances Affirmed as Generally Recognized as Safe: Menhaden Oil

Federal Register · Rule · Jun 5, 1997

Fanning, et al., ``Fish Oils in Hypertriglyceridemias: A Dose Response Study,'' American Journal of Clinical Nutrition, 51:399-406, 1990. 23. Atkinson, P. M., M. C. Wheeler, D. … , 1987. 24.

Termination of Listing of Color Additive Exempt From Certification; Lead Acetate

Federal Register · Rule · Oct 31, 2018

Regarding the assertion that Moore et al. did not use the “worst-case scenario” by excluding in its final analysis results from whole-body monitoring collected from 12 to 24 hours, results from the 24- … “The Percutaneous Absorption of Lead-203 in Humans From Cosmetic Preparations Containing Lead Acetate, as Assessed by Whole-Body Counting and Other Techniques,” Food and Cosmetics Toxicology, 18:399

Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents

Federal Register · Proposed Rule · Aug 19, 1999

1,338 19.38 80,407 60 199 200 to 692 20.99 87,095 126 299 300 to 361 16.24 67,398 187 399 … $8,282 $74.803 0.01 200 to 299 $17,346 $153.988 0.01 300 to 399

Substances Prohibited From Use in Animal Food or Feed; Specified Offal From Adult Sheep and Goats Prohibited in Ruminant Feed; Scrapie

Federal Register · Uncategorized Document · Aug 29, 1994

Hueston, W., ``Clinical Signs of BSE,'' in ``Animal Health Insight,'' Summer:4, 1991. 24. Wilesmith, J. W., G. A. H. Wells, M. P. Cranwell, and J. B. M. … Wells, ``Spongiform Encephalopathy in a Nyala,'' Veterinary Pathology, 25:398-399, 1988. 33. Kirkwood, J.

Gastroenterology and Urology Devices; Reclassification of the Extracorporeal Shock Wave Lithotripter

Federal Register · Proposed Rule · Feb 8, 1999

L., ``Pediatric Urolithiasis,'' Urologic Clinics of North America, 24(1):173-184, 1997. 54. … Butler, ``Acute and Chronic Bioeffects of Single and Multiple Doses of Piezoelectric Shockwaves (EDAP LT.01),'' Journal of Urology, 145:399-404, 1991. 87. Schmidt, A., J. Seibold, P. Bub, and F.

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 041

Federal Register · Notice · Apr 4, 2016

8-189 8-398 ASTM F1108-14 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) Withdrawn and replaced with newer version. 8-190 8-399 … newer version. 15-22 15-43 ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions Withdrawn and replaced with newer version. 15-24

Draft Compliance Policy Guide Sec. 555.320 Listeria monocytogenes; Notice of Public Meeting

Federal Register · Notice · Feb 7, 2008

Lexington Mill & Elevator Co. , 232 U.S. 399, 411 (1914). 1 L. monocytogenes is an added deleterious substance in food. United States of America v. Union Cheese Co. , 902 F. … Available in Docket No. 1999N-1168, vol. 0018 bkg1 (15 of 17), Tab 374. 24. U.S.

Irradiation in the Production, Processing and Handling of Food

Federal Register · Proposed Rule · Apr 4, 2007

Rep. 105-399, 105th Cong., 1st sess., at 98-99) stated that FDA should seek public comment on whether additional changes should be made to current regulations relating to the labeling of foods treated … Both tables show estimated costs under compliance periods of 12, 24, and 36 months.

Beverages: Bottled Water

Federal Register · Rule · Nov 13, 1995

Section 165.110(a)(2)(iii) provides accordingly. 24. … International Bottled Water Association, Model Bottled Water Regulation, January 24, 1991. 16.

Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition

Federal Register · Proposed Rule · Jan 5, 1998

of 40 to 60 raw material aluminum analyses would cost approximately $150,000 and require 700 man-hours for each plant, and a second study for sampling and testing of 25 to 30 unit operations for all 24 … Solutions, ``Parenteral Drug Products Containing Aluminum as an Ingredient or a Contaminant: Response to FDA Notice of Intent and Request for Information,'' American Journal of Clinical Nutrition, 53:399

Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act

Federal Register · Rule · Jan 5, 1999

[[Page 399]] PART 12--FORMAL EVIDENTIARY PUBLIC HEARING 14. … Sec. 25.5 [Amended] 24. Section 25.5 Terminology is amended by removing the phrase ``, an abbreviated antibiotic application,'' from paragraph (b)(1). Sec. 25.31 [Amended] 25.

Termination of Listing of Color Additives Exempt From Certification; Lead Acetate

Federal Register · Rule · Oct 8, 2021

Lead absorption was measured after 12 hours and 24 hours of exposure, and the test formulation was washed off after the first 12 hours. … Food and Cosmetics Toxicology, 18:399-405. *2. Memorandum from M.K. Wyatt, Cosmetics Division, Office of Cosmetics and Colors, CFSAN, FDA to M.