Documents

Briefs, oral arguments, agency decisions and the Federal Register.

5,436 results

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  • Irradiation in the Production, Processing and Handling of Food

    Federal Register · Rule · Apr 14, 2014

    Follow the instructions for submitting comments. … Act (21 U.S.C. 331( ll )).

    79 FR 20771Health and Human Services DepartmentFood and Drug Administration
  • Food and Drug Administration Modernization Act of 1997; Modifications to the List of Recognized Standards, Recognition List Number: 012

    Federal Register · Notice · May 27, 2005

    DATES: Submit written or electronic comments concerning this document at any time. … Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d

    70 FR 30756Health and Human Services DepartmentFood and Drug Administration
  • Amendments to Registration of Food Facilities

    Federal Register · Proposed Rule · Apr 9, 2015

    ADDRESSES: You may submit comments by any of the following methods, except that comments on the information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office … holding facility: A facility that holds or stores food for human consumption at ambient air temperatures (approximately 21 °C/70 °F).

    80 FR 19160Health and Human Services DepartmentFood and Drug Administration
  • General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products

    Federal Register · Proposed Rule · Dec 22, 2015

    Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 22, 2016. … Reform Act of 1995 (Pub.

    80 FR 79493Health and Human Services DepartmentFood and Drug Administration
  • 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 Administration
  • New Animal Drugs for Use in Animal Feeds; Chlortetracycline

    Federal Register · Rule · Jun 27, 2002

    (d) Special considerations . (1) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. … (iii) 200 to 400 g/ton Chickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline.

    67 FR 43248Health and Human Services DepartmentFood and Drug Administration
  • FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 007

    Federal Register · Notice · Oct 2, 2002

    Submit written comments concerning this document at any time. … Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d

    67 FR 61893Health and Human Services DepartmentFood and Drug Administration
  • Importation of Prescription Drugs

    Federal Register · Proposed Rule · Dec 23, 2019

    FDA seeks comment on this approach, including whether 2 years is the appropriate initial period of time for a SIP, whether 2-year re-authorization periods are appropriate, and whether there should be a … period.

    84 FR 70796Health and Human Services DepartmentFood and Drug Administration
  • Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 023

    Federal Register · Notice · May 5, 2010

    Submit electronic comments by e-mail: standards@cdrh.fda.gov . … Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d

    75 FR 24711Health and Human Services DepartmentFood and Drug Administration
  • Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034

    Federal Register · Notice · Jan 30, 2014

    Submit electronic comments by email: standards@cdrh.fda.gov. … L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d).

    79 FR 4913Health and Human Services DepartmentFood and Drug Administration
  • Listing of Color Additives Subject to Certification; D&C Black No. 4

    Federal Register · Rule · Jun 7, 2018

    We have not received any new information or comments that would affect our previous determination. VII. Paperwork Reduction Act of 1995 This final rule contains no collection of information. … WHO Guidelines for Indoor Air Quality: Selected Pollutants . Geneva: World Health Organization; 2010. 3. Brune H., R. P. Deutsch-Wenzel, M.

    83 FR 26356Health and Human Services DepartmentFood and Drug Administration
  • Irradiation in the Production, Processing and Handling of Food

    Federal Register · Rule · Jul 21, 2000

    Safety Evaluation Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s)), a source of radiation used to treat food is defined as a food additive. … chemical reactions (hereinafter referred to as “radiolysis products”) depend on the chemical constituents of the food and on the conditions of irradiation (e.g., temperature and presence or absence of air

    65 FR 45280Health and Human Services DepartmentFood and Drug Administration
  • FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 006

    Federal Register · Notice · Jan 14, 2002

    Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d … Submission of Comments and Effective Date Interested persons may, at any time, submit to the contact person (address above) written comments regarding this document.

    67 FR 1774Health and Human Services DepartmentFood and Drug Administration
  • Lead 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 Administration
  • Amendments to General Regulations of the Food and Drug Administration

    Federal Register · Proposed Rule · Nov 30, 2010

    If we receive any significant adverse comment regarding the direct final rule, we will withdraw the direct final rule within 30 days after the comment period ends and proceed to respond to all of the comments … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.

    75 FR 73984Health and Human Services DepartmentFood and Drug Administration
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Periods

    Federal Register · Proposed Rule · Apr 26, 2013

    Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). … period on the provisions of the proposed rule and a 30-day comment period on the information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C

    78 FR 24692Health and Human Services DepartmentFood and Drug Administration
  • Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods

    Federal Register · Proposed Rule · Apr 26, 2013

    Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). … period on the provisions of the proposed rule and a 30-day comment period on the information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C

    78 FR 24691Health and Human Services DepartmentFood and Drug Administration
  • Ophthalmic Devices; Reclassification of Neodymium:Yttrium: Aluminum:Garnet (Nd:YAG) Laser for Peripheral Iridotomy

    Federal Register · Proposed Rule · Mar 8, 1996

    DATES: Written comments by June 6, 1996. … Request for Comments Interested persons may, on or before June 6, 1996, submit to the Dockets Management Branch (address above) written comments regarding this proposal.

    61 FR 9373Health and Human Services DepartmentFood and Drug Administration
  • Dietary Supplements; Establishment of Date of Application

    Federal Register · Rule · Jan 4, 1994

    The comments reported many examples of the difficulties in meeting a 6-month compliance period. … period.

    59 FR 350Health and Human Services DepartmentFood and Drug Administration
  • New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address

    Federal Register · Rule · Mar 10, 2023

    Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of “notice[ … For the treatment of air sacculitis (air-sac disease, chronic respiratory disease) caused by Mycoplasma gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella multocida; infectious

    88 FR 14893Health and Human Services DepartmentFood and Drug Administration

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