Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.35s
Federal Register · Notice · May 21, 2026
The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … This subsection requires that the FDA-approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect.
91 FR 29964Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2016
A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be … In the Federal Registe r of October 19, 2015 (80 FR 63228) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
81 FR 8723Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2013
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … Eleven public comments were received during the comment period and in nine of the letters the following two issues were raised.
78 FR 41064Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 26, 1995
Drug Administration (FDA) is announcing the availability of draft proposed regulations prepared by the Center for Devices and Radiological Health (CDRH) to implement the Mammography Quality Standards Act … Advanced drafts of proposed regulations are provided routinely to all members of the advisory committee for their advice and recommendation, and periodic public meetings of the advisory committee are being
60 FR 5152Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 2, 2004
All comments received during the comment period have been carefully reviewed and, where appropriate, incorporated in the guidance. … The guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
69 FR 53729Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
Federal Register · Rule · Aug 13, 2020
of the comment period that we published in the Federal Register of August 3, 2011 (76 FR 46671), we became aware that fermented or hydrolyzed foods, some of which are labeled as “gluten-free,” … period for the proposed rule for gluten-free food labeling of foods (76 FR 46671 at 46672).
85 FR 49240Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 26, 2024
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Planning for the local, territorial, and tribal information collections will commence during this period of renewal.
89 FR 20980Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 6, 2009
(the act) (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Pub. … of the act.
74 FR 51285Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 2021
Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 331) prohibits the misbranding of FDA-regulated products, including prescription drugs. … We appreciate all comments. No comment suggested a revision to our current estimate for the information collection.
86 FR 39033Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 9, 2006
The notice of availability for the February 27, 2003, draft guidance was published in the Federal Register of April 21, 2003 (68 FR 19549) and the comment period closed on July 21, 2003. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.
71 FR 6779Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 4, 2023
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … FDA marketing approval for that drug for the orphan indication for a period of 7 years; and, finally, section 528 is intended to encourage sponsors to make investigational orphan drugs available for treatment
88 FR 84148Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 12, 2001
Comments Interested persons may submit to the Dockets Management Branch (address above) written comments on the draft guidance. … Paperwork Reduction Act of 1995 This notice contains no new collections of information.
66 FR 14391Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 28, 2022
(FD&C Act) (21 U.S.C. 353b)) • 21 CFR 329.100 and section 760 of the FD&C Act (21 U.S.C. 379aa) (regarding nonprescription drug products marketed for human use without approved NDAs or ANDAs) This guidance … The collections of information in 21 CFR part 314 pertaining to postmarketing reporting of adverse drug experiences, including periodic and followup reports, have been approved under OMB control number
87 FR 25278Health and Human Services DepartmentFood and Drug AdministrationExocrine Pancreatic Insufficiency Drug Products; Extension to Obtain Marketing Approval
Federal Register · Notice · Oct 26, 2007
In response, FDA received a number of comments which the agency considered in finalizing the guidance. … act in “piecemeal fashion”)).
72 FR 60860Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 21, 2016
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … Under the statute, the records must be retained for a period of 6 years.
81 FR 3438Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 20, 2026
“3PLs”), as directed by the Drug Supply Chain Security Act (DSCSA). … Therefore, to keep its approval, FDA is proposing to require that an AO maintain certain records for a period of at least 5 years and these records must be readily available to FDA upon request.
91 FR 8247Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 26, 2023
will no longer be effective with the expiration of the PHE declaration, (2) guidances that FDA was revising to continue in effect for 180 days after the expiration of the PHE declaration to provide a period … The collections of information relating to the registration of human drug compounding outsourcing facilities under section 503B of the FD&C Act and associated fees under section 744K of the FD&C Act (21
88 FR 73602Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 2, 2006
DATES: Fax written comments on the collection of information by July 3, 2006. … To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:
71 FR 32101Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2021
Background Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(b)), amended by section 207 of the FDA Reauthorization Act of 2017 (Pub. … In addition, the Commitment Letter states that “[n]o later than 12 months after the close of the public comment period, the Agency will issue a final guidance.”
86 FR 53965Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Feb 17, 2023
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
88 FR 10354Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.