Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.25s
Federal Register · Notice · Apr 23, 2014
The public comment period closed on October 25, 1999. … Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES ) or electronic comments to http://www.regulations.gov
79 FR 22693Health and Human Services DepartmentFood and Drug AdministrationFood Additives: Food Contact Substance Notification That Is No Longer Effective
Federal Register · Rule · Mar 22, 2024
Summary of Comments to the Proposed Rule The proposed rule provided a 60-day comment period. We received fewer than 20 comments on the proposed rule. … Another comment asserted that the FD&C Act limits FDA's food additive review to safety.
89 FR 20306Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 2019
FDA received one comment that was Paperwork Reduction Act (PRA) related. The commenter noted that they would like to see the associated collections that the deeming rule revised. … 21 U.S.C. 387o)) with enough time for manufacturers to report, given the original 3-year compliance period.
84 FR 35875Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 8, 2020
The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin MDUFA reauthorization by publishing a notice in the Federal Register requesting public input and holding a public meeting … This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on FDA's website will satisfy these requirements.
85 FR 55462Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 1998
Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs);'' Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. … the comment period for [[Page 35938]] a notice announcing the availability of a draft guidance for industry entitled ``Promoting Medical Products in a Changing Healthcare Environment; I.
63 FR 35937Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 18, 1998
After the comment period, comments may be submitted to one of the centers at the address below. FOR FURTHER INFORMATION CONTACT: Andrea C. … FDA is, therefore, emphasizing that it is soliciting comment from all interested persons and is providing a 90-day comment period and establishing a docket for receipt of comments.
63 FR 64093Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 16, 2018
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 … New Animal Drugs for Investigational Use OMB Control Number 0910-0117—Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs.
83 FR 32877Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 13, 2018
A draft guidance was announced in the Federal Register on July 8, 2016 (81 FR 44611) and made available for public comment. The comment period closed on October 6, 2016. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information.
83 FR 16110Health and Human Services DepartmentFood and Drug AdministrationDesignation of New Animal Drugs for Minor Uses or Minor Species
Federal Register · Proposed Rule · Sep 27, 2005
Such designation establishes eligibility for the incentives provided by the MUMS act. DATES: Submit written or electronic comments on this document by December 12, 2005. … To ensure timely processing of electronic comments, FDA is no longer accepting comments submitted to the agency by e-mail.
70 FR 56394Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2014
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 … There were an estimated 92,470 15-day Alert reports, 132,667 periodic reports, and 334 lot distribution reports submitted to FDA.
79 FR 19097Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 17, 2014
for public comment in response to the notice. … The sample for each data collection period will be evenly distributed among Specialists.
79 FR 75158Health and Human Services DepartmentFood and Drug AdministrationMedical Device User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · Jun 17, 2015
public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments … This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on FDA's Web site will satisfy these requirements.
80 FR 34679Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2012
(42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq. ). … FDA received one comment from the public.
77 FR 65560Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 10, 2003
U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq. ). … These characteristics include long latency periods and the ability to establish persistent infections.
68 FR 41153Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 22, 2006
U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq. ). … These characteristics include long latency periods and the ability to establish persistent infections.
71 FR 35911Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2019
DATES: Fax written comments on the collection of information by May 31, 2019. … 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
84 FR 18551Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 17, 2026
This notification is a periodic proposal pursuant to section 513(f)(6)(D)(i) of the FD&C Act, and FDA is seeking feedback on this proposal through public comment. … Once the comment period ends, FDA will consider the comments and publish in the Federal Register a final action distinctly classifying suitable accessories into class I, if any. III.
91 FR 53205Health and Human Services DepartmentFood and Drug AdministrationMisleading Containers; Nonfunctional Slack-Fill
Federal Register · Rule · Jan 5, 1994
The 30-month period established by the 1990 amendments expired on May 9, 1993. … The comment period on the proposal to withdraw the May 10, 1993, regulation closed on December 17, 1993. FDA received no comments on this proposed action.
59 FR 536Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 10, 2018
Some comments requested up to 7 days to provide the notification, but several others suggested that FDA revise the notification period to 3 business days. … Most comments on the 2013 draft 503A guidance said this period was too short, but did not recommend a specific alternative.
83 FR 45631Health and Human Services DepartmentFood and Drug AdministrationFood Additives: Food Contact Substance Notification That Is No Longer Effective
Federal Register · Proposed Rule · Jan 26, 2022
Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by March 28, 2022. … Act of 1995 (Pub.
87 FR 3949Health 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.