Documents

Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing; Request for Comments

Federal Register · Notice · Jan 15, 2013

Often this will involve studies that expose a large number of patients to the drug, normally for an extended period of time. … Comments Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this document to the Division of Dockets Management (see ADDRESSES

Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide

Federal Register · Rule · Nov 1, 2018

From the NHANES data, Colorcon determined that 2 dietary supplements are consumed in a 24-hour period at the mean, and 4 at the 90th percentile. … We have not received any new information or comments that would affect our previous determination. VIII. Paperwork Reduction Act of 1995 This final rule contains no collection of information.

Institutional Review Boards; Cooperative Research

Federal Register · Proposed Rule · Sep 28, 2022

(Cures Act). … Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by October 28, 2022.

Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants; Confirmation of Effective Date

Federal Register · Rule · Jan 31, 2020

Within the 30-day objection period following publication of the final rule, we received approximately 50 comments concerning the final rule. … With the exception of one submission, the comments did not purport to raise objections and did not provide or identify any relevant new evidence. We will not address these comments further.

Developing Specifications for In-Home Disposal Systems for Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments

Federal Register · Notice · Mar 6, 2026

SUPPORT Act and REMS Authority The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. … FDA Previously Exercised SUPPORT Act Authority FDA previously exercised its SUPPORT Act authority to expand disposal options through the OA REMS.

Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register · Notice · Jun 26, 1998

An additional 30-minute time period will be given for public comment at the end of committee discussion and prior to voting on each PMA. Time allotted for each presentation may be limited. … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 18, 1998. Michael A. Friedman, Deputy Commissioner for Operations.

Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice; Public Hearing; Request for Comments

Federal Register · Proposed Rule · Mar 7, 2012

The Agency is also evaluating its framework for periodically analyzing existing rules. 5 4  76 FR 23520; April 27, 2011. 5  76 FR 3821. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012-5476 Filed 3-6-12; 8:45 am] BILLING CODE 4160-01-P

Medical Devices; Reclassification of the Daily Wear Soft and Daily Wear Nonhydrophilic Plastic Contact Lenses; Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses; Availability

Federal Register · Uncategorized Document · Mar 4, 1994

Written comments on the guidance document may be submitted at any time. … However, as permitted by section 520(l)(5)(c) of the act, the agency, in the Federal Register of November 30, 1992 (57 FR 56586), published a notice extending the period for issuing such regulations until

Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Meal

Federal Register · Rule · Jun 22, 2015

Follow the instructions for submitting comments. … The notice of filing provided for a 30-day comment period on the petitioner's environmental assessment. II.

Electronic Submissions; Establishment of Public Docket

Federal Register · Notice · Mar 20, 1997

Part 11 applies to any required records submissions under the Federal Food, Drug, and Cosmetic Act (the act), the Public Health Service Act (the PHS Act), or Title 21 of the Code of Federal Regulations … The agency will update the public docket periodically as FDA units acquire the ability to accept electronic submissions.

State Health Fraud Task Force Grants; Availability of Funds; Request for Applications; Correction; Funding Opportunity Number: FDA-ORA-04-2; Catalog of Federal Domestic Assistance Number: 93.447

Federal Register · Notice · Jul 12, 2005

FDA does not guarantee to accommodate or explain SPOC comments that are received after the 60-day cutoff. 5. … An annual financial status report (FSR) is due 90 days after the end of each budget period. The final FSR is due 90 days after the end of the project period.

Topical Drug Products for Over-the-Counter Human Use; Products for the Prevention of Swimmer's Ear and for the Drying of Water-Clogged Ears; Final Rule

Federal Register · Rule · Feb 15, 1995

Interested persons were invited to submit comments by March 16, 1978. Reply comments in response to comments filed in the initial comment period could be submitted by April 14, 1978. … One comment contended that products for the treatment of ``water-clogged ears'' are not drugs within the meaning of section 201(g) of the act (21 U.S.C. 321(g)) and, thus, are not the proper subject of

Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887

Federal Register · Notice · Jul 10, 2003

A deficient request or objection will be returned; however, the deficient submission may be supplemented and subsequently filed if submitted within the 30-day time period (§ 12.22(c)). … This notice is issued under section 351 of the Public Health Service Act (42 U.S.C. 262) and sections 201, 501, 502, 505, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355,

Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments

Federal Register · Notice · Jun 1, 2020

(iii) of the FD&C Act). … These letters demonstrated how FDA's thinking on the appropriateness of the listing of certain patents evolved, even after a short period following the implementation of the Hatch-Waxman Amendment's patent

Draft Guidance on Equivalence Criteria for Food

Federal Register · Notice · Jun 4, 1997

DATES: Submit written comments by August 4, 1997. … The agency invites public comment on this issue. V.

Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2021

Federal Register · Notice · Aug 3, 2020

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.

Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards

Federal Register · Notice · Feb 21, 2020

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 … Enrolled jurisdictions must conduct the work described in tables 1, 2, and 3 over a 5-year period.

Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair

Federal Register · Rule · Nov 20, 2015

This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. … FDA received no comments.

Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation

Federal Register · Proposed Rule · Jan 18, 2001

DATES: Submit written comments on this proposed rule on or before April 18, 2001. Submit written comments on the information collection provisions by February 20, 2001. … Request for Comments Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this proposal by April 18, 2001.

Medical Devices; Performance Standard for Diagnostic X-Ray Systems; Amendment

Federal Register · Rule · Jul 2, 1999

Response to Comments All three comments supported the actions proposed in the rule. … None of the comments include any recommendations on the timeframe for implementation of the final rule or suggest that FDA does not have good cause for shortening the customary 1-year period.