Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.23s
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
Federal Register · Rule · Feb 21, 2018
Act). … (d) Retention period.
83 FR 7366Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 29, 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. … ) 1 1 1 30 30 Subpart E—Postapproval Requirements: Postapproval requirements (814.82(a)(9)) 121 1 121 135 16,335 Periodic reports (814.84(b)) 764 1 764 10
88 FR 18552Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 13, 2000
The proposed rule also provided an opportunity for interested persons to submit comments on the proposed rule and the agency's findings. … The comment period closed November 16, 1998. FDA received no comments on the proposed rule.
65 FR 19833Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 17, 2015
Submit comments on the information collection issues under the Paperwork Reduction Act of 1995 by February 16, 2016. … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each
80 FR 78743Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 19, 2019
Comments on the Proposed Rule and FDA Response A. Introduction We received 12 total comments posted to the docket for the proposed rule by the close of the comment period. … The comment also noted that the FD&C Act recognizes the HPUS as “official” in 21 U.S.C. 358(b), and in the definitions at 21 U.S.C. 321, the FD&C Act defines “drug” to include articles recognized in the
84 FR 4696Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 2013
Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … One response over an 8-year period equates to an annual frequency of response equal to 0.125.
78 FR 44124Health and Human Services DepartmentFood and Drug AdministrationJapan Wax; Affirmation of GRAS Status as an Indirect Human Food Ingredient; Reproposed Rule
Federal Register · Proposed Rule · Jun 1, 1995
DATES: Written comments by August 15, 1995. … The requests were made in the period immediately following the passage of the Food Additives Amendment.
60 FR 28555Health and Human Services DepartmentFood and Drug AdministrationYong Sheng Jiao: Denial of Application for Termination of Debarment
Federal Register · Notice · Oct 1, 2025
ADDRESSES: Submit comments electronically at https://www.regulations.gov. … Jiao of its proposal to issue an order under section 306(b)(1)(D) of the FD&C Act debarring him for a period of 5 years from importing or offering to import any drug into the United States.
90 FR 47312Health and Human Services DepartmentFood and Drug AdministrationInformation Required in Prior Notice of Imported Food
Federal Register · Rule · May 5, 2011
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by June 6, 2011 (see the “Paperwork Reduction Act of 1995” section of this document (section IV of this document … FDA invites public comment on this interim final rule, and will consider modifications to it based on comments made during the comment period.
76 FR 25542Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 21, 2020
Section 130(a) of the Food and Drug Administration Modernization Act of 1997 amended the FD&C Act by adding section 506B of the FD&C Act (21 U.S.C. 356b). … • Period covered by the report. • PMR/PMC update for each “Open” PMR/PMC.
85 FR 66995Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 15, 2009
Unfunded Mandates Reform Act of 1995 IV. Federalism V. Environmental Impact VI. Paperwork Reduction Act of 1995 VII. Comments VIII. References I. Background A. … In response to a request to allow additional time to comment, FDA reopened the comment period on October 29, 2003 (68 FR 61639). The reopened comment period ended on January 27, 2004.
74 FR 2443Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2026
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 … The WEF program allows entry filers to file a single entry estimating the amount of merchandise anticipated to be removed from an FTZ and offered for U.S. consumption during a 7-day period.
91 FR 53259Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 7, 2007
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 … This notice contained an incorrect deadline for comments on the proposed collection of information in the DATES section. FDA is republishing the notice and providing a full 30-day comment period.
72 FR 10220Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 2, 2007
Comments : Submit written or electronic comments by June 22, 2007. … If so, over what time period? Which products should use electronic prescribing information first? V.
72 FR 15701Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 25, 2000
Under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug Availability Act of 1996 (ADAA), any person intending to file a new animal drug application (NADA) or supplemental … DATES: Submit written comments on the proposed rule by November 8, 2000. Submit written comments on the information collection provisions by September 25, 2000.
65 FR 51782Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2005
(the act) (21 U.S.C. 393(d)(2)). … The Nutrition Labeling and Education Act of 1990 (Public Law 101-535) amended the act. Section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)) was added under these amendments.
70 FR 48423Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2014
As a first step in developing these guidelines, FDA invited public comment on the potential impact of the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, August 1, 2011 … The comment period for this request ended November 30, 2011.
79 FR 44800Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 2019
As a first step in developing these guidelines, FDA invited public comment on the potential impact of the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, August 1, 2011 … The comment period for this request ended November 30, 2011.
84 FR 35872Health and Human Services DepartmentFood and Drug AdministrationCheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk
Federal Register · Proposed Rule · Oct 19, 2005
Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) Major Rule VII. Federalism VIII. Environmental Impact IX. Paperwork Reduction Act of 1995 X. Comments XI. References I. … in the comments.
70 FR 60751Health and Human Services DepartmentFood and Drug AdministrationSecondary Direct Food Additives Permitted in Food for Human Consumption
Federal Register · Rule · May 7, 2001
In the notice of filing, FDA gave interested parties an opportunity to submit comments on the petitioner’s environmental assessment. FDA received no comments in response to that notice. … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
66 FR 22921Health 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.