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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Rule · Jul 20, 1995
701(e)(2) of the act). … Finally, they asked that FDA issue an affirmative statement on enforcement policy with respect to the disclaimer during the period of May 8, 1993, to May 8, 1994.
60 FR 37502Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 29, 2004
with the act. … Moreover, consumers who purchase food expect it to be clean and sanitary.
69 FR 23460Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 6, 2009
Manufacturers that make voluntary market-driven changes to their labeling during the implementation period can implement the regulatory requirements for a nominal cost. … We received no comments from any States on the final rulemaking.
74 FR 9759Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition
Federal Register · Rule · Jan 6, 2012
In response to publication of this order, the Agency received requests for a 60-day extension of the comment period. … Section 530.25 provides for a public comment period of not less than 60 days.
77 FR 735Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 22, 2015
Act (Pub. … For promotional labeling submitted for advisory comments, including resubmissions, a submission generally includes correspondence stating that it is a request for advisory comments, a clean version of
80 FR 22529Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 29, 2015
FDA's CGMP regulations at 21 CFR part 212 are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding safety, identity, strength … The CGMP requirements for PET drugs are issued under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).
80 FR 81332Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2015
Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
80 FR 58488Health and Human Services DepartmentFood and Drug AdministrationProposed Quality Standards for Mammography Equipment and Quality Assurance
Federal Register · Proposed Rule · Apr 3, 1996
FDA encourages comments regarding the necessity and appropriateness of this section in light of the requirements currently imposed by the Americans with Disabilities Act of 1990. 5. … 354 of the Public Health Service Act (42 U.S.C. 263b). 2.
61 FR 14908Health and Human Services DepartmentHealth and Human Services DepartmentFederal Register · Proposed Rule · Jan 5, 2005
Bismuth subsalicylate acts in the stomach to relieve upset stomach/indigestion symptoms such as nausea, heartburn, and fullness, while simethicone acts in the stomach to break up gas bubbles resulting … Each subject received three bottles of each formulation with a computer-generated random sequence of use for treating six episodes over a 7-month period.
70 FR 741Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 23, 2006
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 … Sterility 191 Aseptic Processing of Health Care Products—Part 4: Clean-in-Place Technologies ISO 13408-4:2005 IV.
71 FR 36121Health and Human Services DepartmentFood and Drug Administration2013 Assuring Radiation Protection
Federal Register · Notice · Jan 28, 2013
pollutants; and (5) implementing the Indoor Radon Abatement Act (15 U.S.C. 53, Subchapter III). … The recipient will provide a periodic newsletter that will be made available to member States and relevant Federal personnel on the Web site.
78 FR 5813Health and Human Services DepartmentFood and Drug AdministrationRequirements for Liquid Medicated Animal Feed and Free-Choice Medicated Animal Feed
Federal Register · Proposed Rule · May 28, 2003
DATES: We invite you to comment on this proposed rule. We will consider all comments that we receive by August 26, 2003. Send comments on the information collection provisions by July 28, 2003. … (the act) (21 U.S.C 331(j)).
68 FR 31645Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 11, 2006
These records would include plans to prevent cross-contamination and cleaning and disinfection records. … Another comment suggested that records be retained for 40 years after the date they were created because variant Creutzfeldt-Jakob disease (vCJD) has a long incubation period, and the records retention
71 FR 59653Health and Human Services DepartmentFood and Drug AdministrationLaser Products; Proposed Amendment to Performance Standard
Federal Register · Proposed Rule · Jun 24, 2013
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by July 24, 2013 (see section VIII, the “Paperwork Reduction Act of 1995” section of this document). … Paperwork Reduction Act of 1995 IX. Comments X. References I. Background A. Laser Standards and the Laser Industry The Safe Medical Devices Act of 1990 (SMDA) (Pub.
78 FR 37723Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 10, 2022
This notice solicits comments on information collection associated with the Mammography Quality Standards Act. … FDA-2013-N-0134 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements.”
87 FR 48678Health and Human Services DepartmentFood and Drug AdministrationQuality Mammography Standards; General Preamble and Proposed Alternative Approaches
Federal Register · Proposed Rule · Apr 3, 1996
(the PHS Act)(42 U.S.C. 263b(f)). … Costs were determined for a 10-year analysis period.
61 FR 14856Health and Human Services DepartmentFood and Drug AdministrationExternal Penile Rigidity Devices; Proposed Classification for the External Penile Rigidity Devices
Federal Register · Proposed Rule · Jan 4, 1999
The directions for use should contain comprehensive instructions on how to size, place, operate, remove, and clean the device; 4. … Submission of Comments Interested persons may, on or before April 5, 1999, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
64 FR 62Health and Human Services DepartmentFood and Drug AdministrationSunlamp Products; Proposed Amendment to Performance Standard
Federal Register · Proposed Rule · Dec 22, 2015
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 21, 2016. … requiring a period of 3 to 4 weeks.
80 FR 79505Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Drug Products; Safety and Efficacy Review
Federal Register · Notice · Dec 31, 2003
(the act). … Data submitted after the closing of the comment period (see DATES section) will not be considered except by petition under 21 CFR 10.30.
68 FR 75585Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2025
This notice solicits comments on information collection associated with the Mammography Quality Standards Act. … FDA-2025-N-4942 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Standards Quality Act Requirements.”
90 FR 57070Health and Human Services DepartmentFood and Drug Administration
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