Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.20s
Federal Register · Notice · Dec 23, 2021
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection … Whether the 180-day transition period before FDA withdraws the guidances identified in List 1 would sufficiently allow for an appropriate transition period that avoids exacerbating product shortages and
86 FR 72973Health and Human Services DepartmentFood and Drug AdministrationSunscreen Drug Products for Over-the-Counter Human Use; Amendment to the Tentative Final Monograph
Federal Register · Proposed Rule · Sep 16, 1996
The comment estimated a total complaint rate of 0.0067 percent for this period (based on reported sales of ``more than one million packages''). … The agency is providing a period of 30 days from the date of publication of this proposed rulemaking in the Federal Register for comments to be developed and submitted.
61 FR 48645Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 15, 2009
have been issued by the National Oceanic and Atmospheric Administration Seafood Inspection Program (NOAA SIP) under the Agricultural Marketing Act. … The comment period was subsequently extended until January 25, 2005 (69 FR 78038, December 29, 2004). The agency considered and modified the guidance as appropriate.
74 FR 2600Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 12, 2013
(Comment 9) One comment questioned why the preamble to the proposed rule identified change in dosage form as an example of “inappropriate `evergreening' of exclusive approval periods” (76 FR 64868 at 64870 … Congress would not have prescribed a definite period of exclusivity and at the same time provided for means to indefinitely extend that period.
78 FR 35117Health and Human Services DepartmentFood and Drug AdministrationFrancis Esteban Matos: Final Debarment Order
Federal Register · Notice · Jul 24, 2026
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Francis Esteban Matos for a period of 5 years from … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Mr.
91 FR 46789Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2018
With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act AGENCY: Food and Drug Administration, HHS. … ERG will interview 1 to 3 sponsor representatives at a time for up to 150 INDs during the annual assessment period.
83 FR 40771Health and Human Services DepartmentFood and Drug AdministrationBiological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
Federal Register · Rule · Jan 5, 2004
During the comment period for the December 1985 proposal, FDA received no comments opposing the placement of AVA into Category I 2 . 2 On October 12, 2001, a group of individuals filed a … Flexibility Act (5 U.S.C 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
69 FR 255Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 15, 2016
Evaluation of FDA's Point-of-Sale Public Education Campaign OMB Control Number—0910-NEW The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … This outcome evaluation study will consist of three longitudinal data collection periods each lasting 3-4 months at 4 month intervals between data collection periods, with the first survey (Wave 1) occurring
81 FR 80075Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 8, 2008
FDA stated that the effective date of the direct final rule would be on February 19, 2008, 6 months after the end of the comment period, unless any significant adverse comment was submitted to FDA during … the comment period.
73 FR 7463Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date
Federal Register · Rule · Sep 17, 2008
FDA stated that the effective date of the direct final rule would be on October 27, 2008, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during … the comment period.
73 FR 53686Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 8, 2008
SUPPLEMENTARY INFORMATION: FDA periodically issues regulations requiring changes in the labeling of food. … FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
73 FR 74349Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 22, 2021
FDA is authorized to collect this information under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. … These characteristics include long latency periods and the ability to establish persistent infections.
86 FR 58666Health and Human Services DepartmentFood and Drug AdministrationLaboratory Accreditation for Analyses of Foods
Federal Register · Proposed Rule · Nov 4, 2019
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 3, 2020 (see the “Paperwork Reduction Act of 1995” section of this document). … period.
84 FR 59452Health and Human Services DepartmentFood and Drug AdministrationHuman Tissue Intended for Transplantation
Federal Register · Rule · Jul 29, 1997
Paperwork Reduction Act of 1995 Although the December 14, 1993, interim rule (58 FR 65514) provided a 90-day comment period under the Paperwork Reduction Act of 1980, and this final rule responds … to the comments received, FDA is providing an additional opportunity for public comment under the Paperwork Reduction Act of 1995, which was enacted after the expiration of the comment period and applies
62 FR 40429Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 11, 2003
of section 801(e) or 802 of the act, or other applicable requirements of the act. … In addition, CDRH's average salary has increased by 37 percent during the same time period.
68 FR 6925Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 23, 2021
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. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-03541 Filed 2-22-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 10975Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Sep 30, 2022
FDA-2011-N-0655 for “Animal Generic Drug User Fee Act; Public Meeting; Request for Comments.” … Section 742(d)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholders
87 FR 59441Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 16, 2018
(FD&C Act). … (FD&C Act).
83 FR 2092Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 6, 2000
It believes that the SOP's must be periodically reviewed and revised. FDA only requires the development of SOP's. … (Comment 4) One comment asserted that FDA had ignored the burden in part 11 that requires industry to maintain records in electronic format for the full retention period.
65 FR 18111Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Jul 19, 2016
PDUFA was originally enacted in 1992 as the Prescription Drug User Fee Act (Pub. L. 102-571) for a period of 5 years. In 1997, Congress passed the FDA Modernization Act (FDAMA, Pub. … FDA will also hold an open public comment period at the meeting to give the public an opportunity to present their comments.
81 FR 46929Health 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.