Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.98s
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Sep 20, 2011
; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's Web site. … In general, the meeting format will include presentations by FDA followed by an open public comment period.
76 FR 58277Health and Human Services DepartmentFood and Drug AdministrationMedical Device Reporting: Electronic Submission Requirements
Federal Register · Rule · Feb 14, 2014
(the FD&C Act) (21 U.S.C. 360i). … The Safe Medical Devices Act of 1990 (SMDA) (Pub.
79 FR 8832Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 18, 2003
Another comment suggested that we limit the time during which NDA holders can submit patent information to a defined time period after we have approved their NDAs. … (Comment 19) Numerous comments challenged our proposed interpretation of the act to permit only one 30-month stay per ANDA or 505(b)(2) application.
68 FR 36676Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 23, 2016
within 3 years of the close of the comment period and for the remaining 20 percent, within 5 years. … Looking forward, in FY 2017, CDRH will strive to finalize, withdraw, or re-open the comment period for 50 percent of existing draft guidances issued prior to October 1, 2011.
81 FR 94382Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Jan 4, 2021
Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C … availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1.
86 FR 106Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 15, 2003
Ca-DTPA and Zn-DTPA Diethylenetriaminepentaacetate (DTPA) is a ligand that acts as a chelator with a very high affinity for plutonium, americium, and curium. … However, we welcome comments on the guidance, and if comments are submitted, we will review them and revise the guidance if appropriate.
68 FR 53984Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 31, 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. … (Comment) The commenter stated that they believed the study should include children as young as age 10 years.
88 FR 6261Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 1, 2019
The Food and Drug Administration Amendments Act of 2007 created section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1), which authorizes FDA to require a REMS for certain … When appropriate, the data should be reported for the reporting period and cumulatively, and trends in performance compared to previous periods should be reported and discussed; (9) a discussion including
84 FR 1153Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 31, 2024
Background We periodically issue regulations requiring changes in the labeling of food. … Paperwork Reduction Act of 1995 This final action contains no collections of information.
89 FR 106996Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2003
Section 505(j)(5)(B)(iv) of the act provides for a 180-day period of marketing protection for certain ANDA products as follows: If the [ANDA] contains a [paragraph IV certification] and is for a drug … Same day patent challenges generally occur when the expiration of 4 years of a 5-year exclusivity period under section 505(j)(5)(D)(ii) of the act permits submission of ANDAs containing a paragraph IV
68 FR 45252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 19, 2013
In order to be considered during the preparation of the Draft EIS, all comments must be received prior to the close of the public scoping period. … FDA has previously sought comment on potential environmental effects as part of the public comment period for the proposed rule, including specific questions regarding agricultural water, biological soil
78 FR 50358Health and Human Services DepartmentFood and Drug AdministrationReauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · Aug 11, 2026
The FD&C Act directs FDA, following negotiations with the regulated industry and periodic consultations with other stakeholders, to present recommendations for reauthorization of the GDUFA program to the … This notice, the 30-day comment period, and the public meeting described in this notice will satisfy certain of these statutory requirements.
91 FR 51718Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2022
period. … period.
87 FR 4240Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 26, 2018
Because ECT devices were classified in 1979, the 30-month period has expired (44 FR 51776, September 4, 1979), and the later of these two time periods is the 90-day period. … The comment period on the proposed order closed on March 28, 2016.
83 FR 66103Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 8, 2007
The Paperwork Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX. Request for Comments X. References I. Introduction A. … The act punishes both misdemeanor and felony violations of the act.
72 FR 63416Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 2010
On September 15, 2009 (74 FR 47257), FDA published a notice correcting the length of the comment period, keeping it open until October 1, 2009. … On October 13, 2009 (74 FR 52495), FDA published a notice reopening the comment period until October 26, 2009. On January 7, 2010, FDA received emergency approval for this information collection.
75 FR 41210Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act; Public Meeting
Federal Register · Notice · Sep 12, 2011
Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for … This notice, the 30-day comment period, and the public meeting will satisfy some of these requirements.
76 FR 56201Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 6, 2022
We issued this guidance without prior public comment under section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2) because we determined that prior public participation is … Because we believe that routine procedures, which allow for a 60-day comment period, would prevent our ability to immediately implement the information collection, we requested a waiver from the requirement
87 FR 60689Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and Pectin
Federal Register · Rule · Mar 16, 1999
Lengthen the Compliance Period FDA also considered the option of providing small entities with a longer compliance period. … encourage comments from small businesses.
64 FR 12887Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Nov 28, 2012
Background FDA periodically issues regulations requiring changes in the labeling of food. … We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub.
77 FR 70885Health 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.