Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5 results
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Oral 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 AdministrationFederal Register · Notice · Jul 12, 1996
Comment: Six commenters recommended that ORR determine country eligibility on an annual basis instead of the proposed three-year eligibility period. … One commenter recommended that ORR allow for a 90-day application period; another commenter recommended that there be a 60-day application period or that there be fewer application requirements, Response
61 FR 36739Food and Drug AdministrationRefugee Resettlement OfficeMedical Devices; Mammography Quality Standards Act of 1992; Inspection Fees
Federal Register · Notice · Jan 14, 1998
Submit written comments by March 16, 1998. … Request for Comments Although the MQSA does not require FDA to solicit comments on fee exemption, assessment and collection, FDA is inviting comments from interested persons in order to have the benefit
63 FR 2245Food and Drug AdministrationEvaporated Milk; Amendment of the Standard of Identity
Federal Register · Uncategorized Document · Apr 14, 1994
These data show that the yearly average milkfat content for all producers' milk, before standardization for beverage purposes, during the period 1970 to 1991 (Ref. 1) ranged between 3.64 percent and 3.68 … The Regulatory Flexibility Act requires that the agency analyze options for regulatory relief for small businesses.
Food and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Uncategorized Document · Feb 2, 1994
brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments … 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.
Food and Drug Administration
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