Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Proposal To Establish Procedures for the Safe Processing and Importing of Fish and Fishery Products
Federal Register · Uncategorized Document · Jan 28, 1994
Air-packaged. … Air-packaged products.
Proposal To Establish Procedures for the Safe Processing and ImportingHealth and Human Services DepartmentFederal Register · Uncategorized Document · Nov 15, 1994
) is extending to June 19, 1995, the period for comments; to December 15, 1995, the period for new data; and to February 13, 1996, the period for comments on the new data for the notice of proposed rulemaking … Thus, the agency finds an extension of the periods for comments, new data, and comments on the new data to be appropriate.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Jun 17, 1994
Interested persons were invited to submit comments by November 12, 1974. Reply comments in response to comments filed in the initial comment period could be submitted by December 12, 1974. … The hands were allowed to air dry for 3 minutes prior to a pretreatment sampling.
Proposed RuleHealth and Human Services DepartmentAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Sep 19, 1994
The committee will initiate the review of the report analyzing the 1992 health examination of participants in the Air Force Health study entitled ``An Epidemiologic Investigation of Health Effects in Air … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.
Health and Human Services DepartmentFood and Drug AdministrationLabeling of Drug Products for Over-The-Counter Human Use
Federal Register · Uncategorized Document · Aug 3, 1994
published in the Federal Register of January 28, 1994 (59 FR 3998), the agency allowed the following terms to be used interchangeably: (1) ``Ask'' or ``consult,'' (2) ``assistance'' or ``help,''(3) ``clean … Therefore, under the Regulatory Flexibility Act, no further analysis is required.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · May 19, 1994
The exclusivity period for this application expires on June 6, 1994. … FDA could only review NDA 20-242 as an application submitted under section 505(b)(1) of the act because until the exclusivity period of Eldepryl expires, no application submitted under section 505(b)(2
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Mar 31, 1994
DATES: Written comments on the proposed regulation by May 31, 1994; written comments on the agency's economic impact determination by May 31, 1994. … A male patient with a previously normal serum calcium was admitted to the hospital for treatment of hypocalcemia after taking sodium phosphate/sodium biphosphate oral solution to clean the bowel of fecal
Health and Human Services DepartmentFood and Drug Administration21 CFR Parts 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 886, 888, 890, and 892
Federal Register · Uncategorized Document · Dec 7, 1994
Interested persons were given until October 19, 1994 to comment on the proposed rule. II. … Comments During the comment period, FDA received comments requesting that various devices be added to the list of devices that the agency was proposing be exempt from the requirement of premarket
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Aug 23, 1994
Interested persons were invited to submit comments by December 8, 1976. Reply comments in response to comments filed in the initial comment period could be submitted by January 7, 1977. … The product delivers in each 800 milliliters of air 0.40 to 0.50 milligrams of propylhexedrine.
Health and Human Services DepartmentFood and Drug AdministrationFoods and Drugs; Technical Amendments
Federal Register · Uncategorized Document · Mar 28, 1994
21 CFR Part 1030 Electronic products, Microwave ovens, Radiation protection. 21 CFR Part 1240 Communicable diseases, Public health, Travel restrictions, Water supply. 21 CFR Part 1250 Air … Section 60.20 FDA action on regulatory review period determinations is amended in paragraph (b) by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn Dr.,''.
Health and Human Services DepartmentFood and Drug AdministrationOral Dosage Form New Animal Drugs; Tetracycline Hydrochloride Soluble Powder
Federal Register · Uncategorized Document · Apr 14, 1994
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals do not qualify for exclusivity periods because their applications do not contain … Control of chronic respiratory disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli; control of infectious synovitis caused by M. synoviae susceptible to tetracycline.
Food and Drug AdministrationLead in Food and Color Additives and GRAS Ingredients; Request for Data
Federal Register · Uncategorized Document · Feb 4, 1994
Lead exposure occurs through pathways such as food, air, dust, soil, and water. … Under the National Environmental Policy Act, FDA must consider the environmental impact of its actions.
Health and Human Services DepartmentFood and Drug AdministrationAdverse Experience Reporting Requirements for Licensed Biological Products
Federal Register · Uncategorized Document · Oct 27, 1994
NCVIA created a new Title XXI of the Public Health Service Act (the PHS Act). … Periodic Reports Three comments on proposed Sec. 600.80(c)(2) noted a discrepancy on when the reporting period begins.
Adverse Experience Reporting Requirements For Licensed BiologicalHealth and Human Services DepartmentFederal Register · Uncategorized Document · Jul 22, 1994
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act became effective: July 14, 1982.
Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SemprexSUPTM-D Capsules
Federal Register · Uncategorized Document · Sep 21, 1994
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: September 6, 1984.
Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Teslascan
Federal Register · Uncategorized Document · Jan 31, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: May 5, 1989.
65 FR 4615Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ImagentRegister GI
Federal Register · Uncategorized Document · Mar 3, 1994
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: February 8, 1973.
Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CertivaTM
Federal Register · Uncategorized Document · Jan 31, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
65 FR 4614Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Lumbar I/F Cage®
Federal Register · Uncategorized Document · Jan 31, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
65 FR 4616Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AviaxRegister
Federal Register · Uncategorized Document · Sep 6, 1994
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act became effective: July 9, 1987.
Health and Human Services DepartmentFood and Drug Administration
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