Documents
Briefs, oral arguments, agency decisions and the Federal Register.
254 results
1.26s
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
63 FR 176Health and Human Services DepartmentFood and Drug AdministrationDraft Guideline for Infection Control in Health Care Personnel, 1997
Federal Register · Notice · Sep 8, 1997
In one study, nearly 50% (11/24) of the lots of hypoallergenic gloves tested had measurable latex allergen (504). … MMWR 1997; 46(RR-8):1-24. 19. Centers for Disease Control and Prevention.
62 FR 47276Justice DepartmentHealth and Human Services DepartmentConforming 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.
64 FR 396Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 10, 1999
Illinois........ 16,699 399 264 17,362 1,957,424 19 Polk County.......... … Michigan........ 1,785 440 289 2,514 283,433 24 Kent County..........
64 FR 43388Health and Human Services DepartmentRefugee Resettlement OfficeFederal Register · Proposed Rule · Dec 21, 2022
Hospitals, 2021; accessed 5/24/2021 at: https://www.aha.org/statistics/fast-facts-us-hospitals. … (e) For the period from January 1, 2012— (1) Through [24 months from effective date of the final rule], the standard identified in paragraph (b)(2)(ii) of this section; (2) On and after [24 months from
87 FR 78438Health and Human Services DepartmentOffice of the SecretaryMedicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2008
Federal Register · Notice · Jun 27, 2008
-6019 904-399-6381 Memorial Hospitals Association 1700 Coffee Road Modesto CA 95355 209-526-4500 ext. 6084 209-572-7017 Memorial Medical Center 701 N. … 21st Avenue West, Bradenton, FL 34209 1225064520 08/08/2006 FL Nebraska Methodist Hospital, 8303 Dodge Street, Omaha, NE 68114 280040 08/08/2006 NE PET/CT Center of Richardson, 399
73 FR 36596Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesNational Vaccine Injury Compensation Program; List of Petitions Received
Federal Register · Notice · Feb 5, 2003
Melanie Gorneault on behalf of Ryan Gorneault; Boston, Massachusetts; Court of Federal Claims Number 02-0804V 24. … Annette Cvengros on behalf of Aaron Cvengros; Vienna, Virginia; Court of Federal Claims Number 02-1270V 399.
68 FR 5892Health and Human Services DepartmentHealth Resources and Services AdministrationTermination 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.
86 FR 56183Health and Human Services DepartmentFood and Drug AdministrationBiological Products: Reporting of Biological Product Deviations in Manufacturing
Federal Register · Rule · Nov 7, 2000
0.21 2.6 0 25 to 49 906 2.02 24.6 0 150 to 99 1,128 6.03 73.3 0 100 to 199 1,338 19.38 235.9 0 200 to 299 692 20.99 255.4 0 300 to 399 … (Comment 33) One comment to OMB and 24 comments submitted to the docket state that the estimated time of 0.5 hours to complete a deviation report is underestimated.
65 FR 66621Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 20, 2008
J.L. & Med. 399; Blended Payment Methods in Physician Organizations Under Managed Care, James C. … The plan covers 80 percent of the cost of the stay for the first 24-hour period and 50 percent of the cost of the stay for the second 24-hour period.
73 FR 62410Treasury DepartmentInternal Revenue ServiceFederal Register · Rule · Oct 3, 2018
Removal of Four Measures From the Hospital VBP Program”. 24. … Geographic Location (n = 3,201): d Urban hospitals 2,416 628 26.0 1-99 beds 622 133 21.4 100-199 beds 728 182 25.0 200-299 beds 430 119 27.7 300-399
83 FR 49836Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesDissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
Federal Register · Rule · Nov 20, 1998
The latter extension cannot exceed 24 months. … No. 399, 105th Cong., 1st sess. at 100 (1997); 143 Congressional Record S9,837 (daily ed. Sept. 24, 1997) (Statement of the Managers)).
63 FR 64556Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 14, 1997
B. et al., ``Acetaminophen Hepatotoxicity in Alcoholics,'' Annals of Internal Medicine, 104:399-404, 1986. 27. Villeneuve, J. … S, ``Interaction of Alcohol and Drugs,'' Practical Gastroenterology, 7:23-24, 29-30, and 48, 1983. 43.
62 FR 61041Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 15, 1995
Stephenson, ``An Assessment of the Complications of the Brantley Scott Artificial Sphincter,'' British Journal of Urology, 60(2):119- 121, 1987. 24. Khoury, A. E., and B. M. … Retik, ``The Long-Term Results of Artificial Sphincters in Children,'' The Journal of Urology, 146(2):396-399, 1991. 99.
60 FR 8595Health and Human Services DepartmentFood and Drug AdministrationNational Vaccine Injury Compensation Program; List of Petitions Received
Federal Register · Notice · Aug 8, 2005
Jennifer and Edward McGinley on behalf of Shane McGinley, Philadelphia, Pennsylvania, Court of Federal Claims Number 04-1573V. 24. … Ranju Kohli on behalf of Angud Kohli, Baltimore, Maryland, Court of Federal Claims Number 05-0334V. 399.
70 FR 45724Health and Human Services DepartmentHealth Resources and Services AdministrationVaginal Contraceptive Drug Products for Over-the-Counter Human Use
Federal Register · Proposed Rule · Feb 3, 1995
J., ``Spermicide Use and Down's Syndrome,'' American Journal of Public Health, 72:399-401, 1982. 4. Citizen Petition, submitted by A. … Food and Drug Administration, ``General Guidelines for OTC Drug Combination Products, September 1978,'' Docket No. 78D-0322, Dockets Management Branch. 24.
60 FR 6892Proposed RuleHealth and Human Services DepartmentFood Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease
Federal Register · Rule · Oct 2, 2002
No. 105-399, at 98 (1997)). … Engstrom, “Intestinal Contents Supernatant Viscosity of Rats Fed Oat-Based Muffins and Cereal Products,” Cereal Chemistry , 76:21-24, 1999. 22. Gallaher, D.
67 FR 61773Health and Human Services DepartmentFood and Drug AdministrationAnnual Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register · Notice · Mar 28, 2006
Standard for Laser Products; Guidance for Industry and FDA 1412 07/12/2002 (8) Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use 399 … 2005 05/24/05 177.
71 FR 15422Health and Human Services DepartmentFood and Drug AdministrationUnique Device Identification System
Federal Register · Rule · Sep 24, 2013
(citing Sunshine Anthracite, 310 U.S. at 399, United States v. Frame, 885 F.2d 1119, 1129 (3d Cir. 1989), cert. denied, 493 U.S. 1094 (1990))). … PART 820—QUALITY SYSTEM REGULATION 24.
78 FR 58786Health and Human Services DepartmentFood and Drug AdministrationComprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register · Notice · Aug 9, 2010
Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 315 KB) Final 9/29/2004 PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399 … Multiple Prescriptions (PDF - 114KB) Draft 1/11/2010 Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials (PDF - 399
75 FR 48180Health and Human Services DepartmentFood and Drug Administration
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