Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations

Federal Register · Notice · Nov 1, 2013

FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and … These collections of information were previously approved by OMB under control numbers 0910-0515 and 0910-0395 respectively, however the approval periods for these collections have expired.

Medical Devices; Reclassification of Polymethylmethacrylate (PMMA) Bone Cement

Federal Register · Rule · Jul 17, 2002

Subsequently, as permitted by section 520(l)(5)(C) of the act, in the Federal Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations … Thus, continued, periodic followup is advised for all patients. d.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Conference Attendees' Observations About Prescription Drug Promotion

Federal Register · Notice · Jul 14, 2021

the provisions of the FD&C Act. … (Comment 3) One comment suggested adding a control arm comprised of physicians who have not attended a medical conference during the same period and asking them about their perceptions of the same products

Direct and Secondary Direct Food Additives; Sodium Mono- and Dimethyl Naphthalene Sulfonates

Federal Register · Rule · Feb 12, 1998

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. … Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition

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

Federal Register · Notice · Feb 3, 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 … Enrolled jurisdictions must conduct the work described in Tables 1, 2, and 3 over a 5-year period.

Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove

Federal Register · Proposed Rule · Mar 22, 2016

Some studies include the period before the amount of NRL protein in surgical and examination gloves was reduced. … However, the sterile procedure, NRL-powdered glove use index changed only from 84.6 percent to 48.9 percent over this 15-year period.

Product-Specific Guidances; Revised Draft Guidances for Industry; Availability

Federal Register · Notice · Oct 31, 2024

Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Paperwork Reduction Act of 1995 While these guidances contain no collection of information, they do refer to previously approved FDA collections of information.

Advisory Committee; Notice of Meeting

Federal Register · Uncategorized Document · Jul 7, 1994

emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees. Dated: June 30,1994.

Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection

Federal Register · Proposed Rule · Nov 17, 2015

Mandates Reform Act of 1995 (Pub. … The costs of the proposed rule, when finalized, will be due to manufacturers ensuring that product labeling is consistent with the special controls guideline document as well as conducting likely periodic

Advisory Committees; Notice of Meetings

Federal Register · Uncategorized Document · Dec 23, 1994

emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.

Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment

Federal Register · Rule · Mar 10, 2004

FDA, therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary. … If the change is required to be reported to FDA in a periodic report, the change may be made before it is reported to FDA.

Food Additives Permitted in Feed and Drinking Water of Animals; Selenium Yeast

Federal Register · Rule · Sep 3, 2003

The notice of filing provided for a 60-day comment period on the petitioner's environmental assessment. No substantive comments have been received. … Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended

Administrative Detention; Corrections

Federal Register · Rule · Feb 19, 2014

FDA therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) that notice and public comment are unnecessary, and under 5 U.S.C. 553(d)(3) that the rule can become effective upon publication. … , or establish, and maintain adequate records relating to how the detained devices may have become adulterated or misbranded, records on any distribution of the devices before and after the detention period

Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports

Federal Register · Proposed Rule · Dec 1, 1999

DATES: Submit written comments on the proposed rule by February 14, 2000. Submit written comments on the information collection provisions by January 3, 2000. … act.

Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

Federal Register · Proposed Rule · Feb 25, 2013

Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 27, 2013, (see the “Paperwork Reduction Act of 1995” section of this document). … (d) Retention period.

Substantial Evidence of Effectiveness of New Animal Drugs

Federal Register · Proposed Rule · Nov 5, 1997

DATES: Submit written comments on the proposed rule by February 3, 1998. Submit written comments on the information collection requirements by December 5, 1997. … Act of 1995 (PRA of 1995) (44 U.S.C. 3501-3520).

Advisory Committee; Notice of Meeting

Federal Register · Notice · Jun 19, 1997

Elsewhere in this issue of the Federal Register, FDA is also extending the comment period on a proposed rule regarding labeling requirements for OTC drug products that appeared in the Federal Register … the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.I11Notice of this meeting is given under the Federal Advisory Committee Act

Emergency Permit Control Regulations; Technical Amendments

Federal Register · Rule · Jul 19, 2016

Public Comments We received one comment on the proposed rule. … This comment alerted us to the omission of the word “and” in the name of the Federal Agency that administers the meat and poultry inspection programs under the Federal Meat Inspection Act and the Poultry

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

Federal Register · Notice · May 7, 1998

An additional 30-minute time period will be given for public comment at the end of the panel discussion on the 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: April 30, 1998. Michael A. Friedman, Deputy Commissioner for Operations.

Advisory Committees; Notice of Meetings

Federal Register · Notice · May 16, 1995

If necessary, comments may be limited to 5 minutes. Open working group discussion. … If necessary, comments may be limited to 5 minutes. Open committee discussion.