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Federal Register · Uncategorized Document · Aug 23, 1994
(the act) (21 U.S.C. 355(e)(2)). … Any other interested person may also submit comments on this notice.
Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Class I Surgeon's and Patient Examination Gloves
Federal Register · Notice · Jul 26, 2021
HHS and FDA sought comment on the matters discussed in the April 16 notice, and have considered the comments that were submitted to the docket. … event reports in the Manufacturer and User Facility Device Experience (MAUDE) as its basis for determining the products to be exempt from 510(k), and then only adverse event reports for a very narrow period
86 FR 40061Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 29, 2008
The notice of filing provided for a 60-day comment period on the petitioner's environmental information. No comments have been received. II. … Flynn, Acting Director, Center for Veterinary Medicine. [FR Doc. E8-25719 Filed 10-28-08; 8:45 am] BILLING CODE 4160-01-S
73 FR 64197Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 7, 2022
proposed rule entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water,” which was issued under the FDA Food Safety Modernization Act … These meetings will be held during the formal comment period on the proposed rule.
87 FR 913Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 2017
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 … The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114.
82 FR 45293Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 2, 2008
Fresh fruits and vegetables may be intact and whole, such as whole apples, or cut in the act of harvest, such as heads of lettuce and bunches of broccoli. … If not, please describe what would be most helpful and why, e.g., information about the record keeping regulation (21 CFR 1 subpart J), guidance on what makes a “good” record, guidance on periodic record
73 FR 51306Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
Federal Register · Rule · Sep 30, 2016
The Agency will review this copy, including the claimed confidential information, in its consideration of comments. … The notice of petition provided for a 30-day comment period on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement.
81 FR 67153Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 3, 2016
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 … For many studies, continuing review can be fairly straightforward, and the IRB should be able to complete its deliberations and approve the research within a brief period of time.
81 FR 76596Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 22, 2019
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 … about travel requests and authorizations/approvals: (1) Office/Division; (2) Research Project Title; (3) Mentor/Sponsor Name; (4) Mentor/Sponsor Email and Telephone; (5) Fellow's Name; (6) Appointment Period
84 FR 64536Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 13, 2005
This notice requesting comments is required by the Controlled Substances Act (CSA). DATES: Submit written or electronic comments by January 12, 2006. … The abbreviated comment period is necessary to allow sufficient time to prepare and submit the domestic information package by the deadline imposed by WHO.
70 FR 73775Health and Human Services DepartmentFood and Drug AdministrationBiosimilar User Fee Rates for Fiscal Year 2021
Federal Register · Notice · Aug 4, 2020
These fees apply to the period from October 1, 2020, through September 30, 2021. … This iterative, continuous improvement approach to the CPA methodology was recommended by the independent evaluation and in the public comments.
85 FR 47220Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 26, 1999
FDA received one comment in response to the notice. … during the culture period, and that the filtration step in the purification process would remove any viable production organisms from the final product (Ref. 7).
64 FR 28358Health and Human Services DepartmentFood and Drug AdministrationIndirect Food Additives: Polymers
Federal Register · Rule · Apr 28, 1997
No comments were received during the 30-day comment period specified in the filing notice for comments on the environmental assessment submitted with the petition. … The authority citation for 21 CFR part 177 continues to read as follows: Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e). 2.
62 FR 22886Health and Human Services DepartmentFood and Drug AdministrationFood Additive Regulations; Synthetic Flavoring Agents and Adjuvants
Federal Register · Rule · Oct 9, 2018
In response to a written request submitted to the docket, we extended the comment period to May 3, 2016 (81 FR 8867, February 23, 2016). … (Comment 12) One comment stated that the petitioner should follow the National Environmental Policy Act and submit an environmental assessment but did not provide any supporting data.
83 FR 50490Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 26, 2018
DATES: Fax written comments on the collection of information by March 28, 2018. … Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate.
83 FR 8286Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 21, 2002
Paperwork Reduction Act of 1995 X. Environmental Impact XI. Request for Comments XII. Proposed Effective Date XIII. References I. … (the act) (21 U.S.C. 321(p)).
67 FR 54139Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments
Federal Register · Rule · Sep 30, 2015
Follow the instructions for submitting comments. … We have not received any new information or comments that would affect our previous determination. VI. Paperwork Reduction Act of 1995 This final rule contains no collection of information.
80 FR 58600Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 28, 2008
(the act) (21 U.S.C. 355) or section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262), to make it clear that the regulation also applies to foreign clinical studies supporting abbreviated … The 56 small firms submitted a total of 76 NDAs during that period, which is about 1.5 applications each over a 3-year period (or 0.5 annually per small entity).
73 FR 22800Health and Human Services DepartmentFood and Drug AdministrationSubstances Generally Recognized as Safe
Federal Register · Proposed Rule · Apr 17, 1997
DATES: Written comments by July 16, 1997, except that comments regarding information collection should be submitted by May 19, 1997. … rather than on the open-ended review period of the GRAS petition process.
62 FR 18938Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 11, 2021
antimicrobial drugs important to human medicine (medically important antimicrobial drugs) approved for use in or on the feed or in the drinking water of food-producing animals worked with FDA over a 3-year period … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-00189 Filed 1-8-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 1979Health and Human Services DepartmentFood and Drug Administration
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