Documents

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

Federal Register · Notice · Nov 3, 1999

Act. … The committee will discuss and comment on the proposed rule and on the presentations made during the public hearing.

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures

Federal Register · Rule · Dec 3, 1999

Although the March 1994 proposal provided a 60-day comment period under the Paperwork Reduction Act of 1980, and this final rule responds to the comments received, FDA is providing [[Page 67755]] an … additional opportunity for public comment under the Paperwork Reduction Act of 1995, which became effective after the expiration of the comment period and applies to this final rule.

Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products

Federal Register · Rule · Jul 30, 1998

``The product delivers in each 800 milliliters of air 0.04 to 0.150 milligrams of levmetamfetamine. Adults: 2 inhalations in each nostril not more often than every 2 hours. … The agency considered but rejected several labeling alternatives: (1) A longer implementation period, and (2) an exemption for small entities.

Medical Gas Regulation; Public Workshop; Request for Comments

Federal Register · Proposed Rule · Mar 29, 2018

Background On May 5, 2017, President Trump signed the Consolidated Appropriations Act of 2017 (Pub. L. 115-31). … anticipated scope of the medical gas rulemaking, as well as three regulations to which stakeholders have previously requested changes: Part 201 (21 CFR part 201) (labeling generally and labeling for medical air

International Conference on Harmonisation; Guidance on Impurities: Residual Solvents

Federal Register · Notice · Dec 24, 1997

Submit written comments at any time. … The comments in the docket will be periodically reviewed, and, where appropriate, the guidance will be amended.

Furan in Food, Thermal Treatment; Request for Data and Information

Federal Register · Notice · May 10, 2004

Submit electronic comments, data, and information to http://www.fda.gov/dockets/ecomments. … Three copies of all comments, data, and information are to be submitted. Individuals submitting written information or anyone submitting electronic comments may submit a single copy.

Lung Cancer Patient-Focused Drug Development; Public Meeting

Federal Register · Notice · Jun 5, 2013

Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). … Lung cancer is a disease caused by uncontrolled growth of abnormal cells in the tissues of the lung, usually in the cells lining air passages.

Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex

Federal Register · Rule · Nov 10, 2008

The comments stated that the degree of risk reduction is higher during a single act compared to cumulative risk reduction over many acts of intercourse. … air out of condom tip.

Clarifying Edits to Existing Special Controls Guidance Documents; Availability

Federal Register · Notice · Mar 28, 2011

Transcutaneous Air Conduction Hearing Aid System (TACHAS), 19. Intraoral Devices for Snoring and/or Obstructive Sleep Apnea, 20. Cutaneous Carbon Dioxide and Oxygen Monitors, 21. … David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2011-7211 Filed 3-25-11; 8:45 am] BILLING CODE 4160-01-P

Biologics License Applications and Master Files

Federal Register · Rule · Feb 12, 2024

We update guidances periodically. … (Response 6) FDA notes that, after the comment period for the proposed rule closed, section 605 of the FCA Act further amended the definition of a “biological product” in section 351(i) of the PHS Act

New Animal Drugs For Use in Animal Feeds; Decoquinate

Federal Register · Rule · Dec 5, 2002

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 558 is amended … eggs for human consumption. 046573 (vii) 27.2 Chlortetracycline 200 to 400 Chickens: As in paragraph (e)(1)(i) of this section; and for control of chronic respiratory disease (CRD) and air

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation

Federal Register · Notice · Jun 14, 2004

DATES: Fax written comments on the collection of information by July 14, 2004. … To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for

Laser Products; Proposed Amendment to Performance Standard

Federal Register · Proposed Rule · Mar 24, 1999

Four comments noted that the amendments to reduce the AEL for repetitively pulsed lasers should only be made if the change to reduce the time period for classification discussed in comment 1 of section … FDA agrees with these comments and believes that the wording of the proposed amendments addresses the concern relating to the time period for classification.

Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficiency; Public Meeting

Federal Register · Notice · Jun 1, 2015

Patient-Focused Drug Development is an FDA performance commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). … Affected individuals often develop emphysema, which is a lung disease caused by damage to the small air sacs in the lung.

Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports

Federal Register · Proposed Rule · Apr 2, 2019

Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 2, 2019. ADDRESSES: You may submit comments as follows. … FDA requests comment on what a reasonable period of time would be within which such refusal to accept or acknowledgement of receipt letters should be issued.

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 029

Federal Register · Notice · Aug 20, 2012

Submit electronic comments by email: standards@cdrh.fda.gov . … L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d).

New Animal Drugs; Zilpaterol

Federal Register · Rule · Sep 8, 2006

Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning August 10, 2006. … Withdrawal period: 3 days. Dated: August 29, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6-14899 Filed 9-7-06; 8:45 am] BILLING CODE 4160-01-S

Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone

Federal Register · Rule · Nov 22, 2013

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 558 is amended … 45.4 Chlortetracycline 200 to 400 Growing chickens: For increased rate of weight gain, improved feed efficiency, and improved pigmentation; and for control of chronic respiratory disease (CRD) and air

Carbohydrase and Protease Enzyme Preparations Derived From Bacillus Subtilis or Bacillus Amyloliquefaciens; Affirmation of GRAS Status as Direct Food Ingredients

Federal Register · Rule · Apr 23, 1999

Comments VI. Conclusions VII. Environmental Considerations VIII. Analysis for Executive Order 12866 IX. Regulatory Flexibility Analysis X. Paperwork Reduction Act of 1995 XI. Effective Date XII. … Comments FDA received seven comments in response to the filing notice and none in response to the amendment notices.

Draft Guidance for Industry; Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996

Federal Register · Notice · Jun 12, 1998

DATES: Written comments on the draft guidance document may be submitted by August 26, 1998. General comments on the agency's guidance documents may be submitted at any time. … The agency will begin the 60 day period on the date that it receives a complete petition containing the certification and evidence required by the act. VII.