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Revision of the Requirements for Spore-Forming Microorganisms
Federal Register · Rule · Dec 30, 2003
The comment period for the direct final rule runs concurrently with the companion proposed rule. … We are providing a comment period on the direct final rule of 75 days after date of publication in the Federal Register .
68 FR 75116Health and Human Services DepartmentFood and Drug AdministrationGeneral Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
Federal Register · Rule · May 4, 2018
The period for public comment on the proposed order closed on January 8, 2018. FDA received and has considered two comments on the proposed order, as discussed in section II. II. … (2) Validation of cleaning and disinfection instructions must demonstrate that the device can be safely and effectively reprocessed after use per the recommended cleaning and disinfection protocol in
83 FR 19626Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 22, 1998
However, marketing of such a product generally may not proceed until after the comment period has ended on the proposal and a subsequent notice is published in the Federal Register setting forth the agency's … The delayed marketing period was rejected because similar products currently exist in the marketplace.
63 FR 56584Health and Human Services DepartmentFood and Drug AdministrationPediculicide Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph
Federal Register · Rule · Dec 31, 2003
The Agency's Conclusion on the Comments A. Comments in Agreement with the Proposed Rule (Comment 1) One comment agreed completely with the proposed recommended label changes. … section 505(a) of the act.
68 FR 75414Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 1, 2004
(Comment 60) One comment recommends a simplification of the question about cleaning bottle nipples used to feed formula. … (Response) The agency rejects the suggestion that the time period for formula brand switching be lengthened to any period of time.
69 FR 58915Health and Human Services DepartmentFood and Drug AdministrationTobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products
Federal Register · Proposed Rule · Jan 23, 2017
If your comment is submitted after the expiration of the comment period, it will not be reviewed and considered by FDA unless you apply for, and receive, an extension of the comment period pursuant to … In addition, air-curing during periods of high relative humidity produces tobacco with higher amounts of TSNAs and nitrite (Ref. 46).
82 FR 8004Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 9, 2008
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
73 FR 52358Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 13, 2003
The comment period for this companion proposed rule runs concurrently with the comment period of the direct final rule. … Request for Comments This comment period runs concurrently with the comment period for the direct final rule; any comments received will be considered as comments regarding the direct final rule.
68 FR 35346Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 6, 1997
Subsequently, as permitted by section 520(l)(5)(C) of the act, in the Federal [[Page 30986]] Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing … Written comments were requested by June 17, 1996. II. Summary and Analysis of Comments and FDA's Responses Only one person from the public commented on the proposal.
62 FR 30985Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems
Federal Register · Proposed Rule · Mar 10, 2016
Reform Act of 1995 (Pub. … We invite comments on this analysis. VII.
81 FR 12607Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
Federal Register · Proposed Rule · Apr 24, 2019
Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol … (v) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol
84 FR 17116Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 21, 2016
Records are maintained on file at each farm site and examined there periodically by FDA inspectors. … FDA received two comments in response, both of which supported the collection of information by FDA to ensure that farms are in compliance with the FD&C Act and regulations, and that adequate control measures
81 FR 40312Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems
Federal Register · Rule · Apr 1, 2019
Specific Comments and FDA Response V. Effective Date VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. … Comments on the Proposed Rule and FDA Response A. Introduction FDA received four sets of comments on the proposed rule by the close of the comment period.
84 FR 12088Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 26, 2019
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. … Records are maintained on file at each farm site and examined there periodically by FDA inspectors.
84 FR 11309Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2002
a medical washer-disinfector intended to clean and provide either a low or intermediate level of disinfection for medical devices. … The public comment period closed February 3, 1999. FDA reviewed the comments and revised the draft guidance as appropriate.
67 FR 5833Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2004
The two agencies now will refer to the time period of August 13, 2004, until November 1, 2004, as “Phase IV (revised)” and the time period on or after November 1, 2004, as “Phase V.” … • In June 2005, we intend to issue a prior notice final rule that responds to the comments we received on the prior notice IFR, including this revised joint plan, during the two open comment periods.
69 FR 50389Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 28, 2016
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. … Records are maintained on file at each farm site and examined there periodically by FDA inspectors.
81 FR 4923Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2002
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA by for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 26, 2002.
67 FR 8547Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 28, 2003
ACTION: Proposed rule; reopening of the comment period. … Act (the act) (21 U.S.C. 350a).
68 FR 22341Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 29, 2015
DATES: Fax written comments on the collection of information by March 2, 2015. … Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years.
80 FR 4928Health and Human Services DepartmentFood and Drug Administration
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