Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Permanent Listing of Color Additive Lakes
Federal Register · Proposed Rule · Mar 4, 1996
Paperwork Reduction Act XII. Comments XIII. References I. … until the period for filing objections is over.
61 FR 8372Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · May 15, 1997
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 … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
62 FR 26804Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · May 7, 1996
that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time [[Page 20528]] for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
61 FR 20527Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · Apr 18, 1997
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 … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
62 FR 19120Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Classification/Reclassification of Immunohistochemistry Reagents and Kits
Federal Register · Rule · Jun 3, 1998
One comment asked FDA to discuss with the Health Care Financing Administration (HCFA) and announce the Medicare reimbursement status of: (1) IHC reagents in the interim period while manufacturers prepared … Regulatory Enforcement Fairness Act of 1966 (Pub.
63 FR 30132Health and Human Services DepartmentFood and Drug AdministrationAmendments to Sterility Test Requirements for Biological Products
Federal Register · Proposed Rule · Jun 21, 2011
This verification activity may be necessary periodically or each time a sample is tested, depending upon the test method used. … Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
76 FR 36019Health and Human Services DepartmentFood and Drug AdministrationCenter for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program
Federal Register · Notice · Nov 26, 2019
The EtO Pilot Program participants may comment on and discuss their experiences with the Center. II. … Paperwork Reduction Act of 1995 This notice refers to previously approved collections of information found in FDA regulations.
84 FR 65162Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · May 22, 1997
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 … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
62 FR 28053Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · Apr 23, 1997
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 … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
62 FR 19764Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · Apr 21, 1997
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 … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
62 FR 19325Health and Human Services DepartmentFood and Drug AdministrationAnnual Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register · Notice · Oct 24, 2001
DATES: We welcome general comments on this list and on agency guidance documents at any time. … PB96-127287) or via Internet at: www.fda.gov/ora/inspect—;ref/igs/iglist.html Guide to Inspections of Validation of Cleaning Processes July 1993 Do Do (NTIS Order No.
66 FR 53836Health and Human Services DepartmentFood and Drug AdministrationDraft Compliance Policy Guide Sec. 555.320 Listeria monocytogenes; Notice of Public Meeting
Federal Register · Notice · Feb 7, 2008
Stakeholders will have an opportunity to ask questions about the draft CPG and provide oral comments on the draft CPG. … Under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(1)), a food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance
73 FR 7298Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Rates for Fiscal Year 2021
Federal Register · Notice · Aug 3, 2020
This iterative, continuous improvement approach to the CPA methodology was recommended by the independent evaluation and in the public comments. … As table 12 shows, the average number of fee-paying FAEs received annually in the most recent 3-year period is 77 FAEs.
85 FR 46651Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 23, 1998
The Agency's Conclusions on the Comments A. Comments to the TFM 1. … Section 502(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352(f)) states that a drug shall be deemed misbranded: ``Unless its labeling bears (1) adequate directions for use; and (
63 FR 56802Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committee; Notice of Meeting
Federal Register · Notice · May 8, 1996
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.
61 FR 20831Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 3, 2005
Meetings covered by this notice will be supported under sections 1701-1706 (42 USC 300u-300u-5) of the Public Health Service Act. … The FDA does not guarantee availability to accommodate or explain SPOC comments that are received after the 60-day cut-off.
70 FR 22889Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 4, 2025
We have not received any new information or comments regarding this claim of categorical exclusion. … Section 301(ll) of the Federal Food, Drug, and Cosmetic Act Our review of this petition was limited to section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348).
90 FR 42699Health and Human Services DepartmentFood and Drug AdministrationRegulations Regarding “Intended Uses”
Federal Register · Proposed Rule · Sep 23, 2020
Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 23, 2020. … Benefits, Costs, and Distributional Effects of Proposed Rule Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (percent) Period
85 FR 59718Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 31, 2019
This notice is issued under the Controlled Substances Act (CSA). DATES: Submit either electronic or written comments by January 30, 2020. … The short time period for the submission of comments is needed to ensure that Health and Human Services (HHS) may, in a timely fashion, carry out the required action and be responsive to the United Nations
84 FR 72370Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt from Certification; Canthaxanthin
Federal Register · Rule · Mar 27, 1998
The petition was filed under section 721(d) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(d)). II. … FDA received one comment on the petition. This comment endorsed the petitioned use of canthaxanthin. III. Stability FDA finds that canthaxanthin is relatively unstable.
63 FR 14814Health and Human Services DepartmentFood and Drug Administration
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