Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Medical Devices; Hearing Aids; Technical Data Amendments
Federal Register · Rule · Nov 3, 1999
30 days after the comment period on this direct final rule ends. … The comment period runs concurrently with the comment period for the companion proposed rule. Two copies of any comments are to be submitted, except that individuals may submit one copy.
64 FR 59618Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 30, 2016
The 30-month enforcement discretion period was selected based on the following factors: (1) The 2014 Proposed Order initially called for PMAs containing clinical performance data to be submitted within … (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
81 FR 96366Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Sep 19, 1994
The committee will initiate the review of the report analyzing the 1992 health examination of participants in the Air Force Health study entitled ``An Epidemiologic Investigation of Health Effects in Air … 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.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 20, 2016
Background Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 6B4815), submitted … Section 201(s) of the FD&C Act exempts prior-sanctioned materials from the definition of a food additive (21 U.S.C. 321(s)).
81 FR 31877Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 9, 2004
For example, the air cargo industry currently establishes and maintains industry air waybills, bills of lading and commercial invoices, which are required by CBP to be maintained for a period of 5 years … Moreover, given the purpose of the Bioterrorism Act, FDA believes a 7-year compliance period is excessive.
69 FR 71562Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2005
The device is intended for the cleaning and maintenance debridement of wounds. … This device is intended for the cleaning and maintenance debridement of wounds.
70 FR 67489Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Hearing Aids; Technical Data Amendments
Federal Register · Proposed Rule · Nov 3, 1999
30 days after the comment period on the direct final rule ends. … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
64 FR 59695Health and Human Services DepartmentFood and Drug AdministrationLabeling of Drug Products for Over-the-Counter Human Use
Federal Register · Proposed Rule · Mar 4, 1996
This has occurred because various OTC advisory review panels recommended different wording, and OTC drug rulemakings have been completed over a period of years. … Therefore, under the Regulatory Flexibility Act, no further analysis is required.
61 FR 8450Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 16, 2001
Section 801.410(f) requires that results of impact tests and description of the test method and apparatus be kept for a period of 3 years. … In the Federal Register of July 11, 2001 (66 FR 36285), the agency requested comments on the proposed collection of information. No comments were received.
66 FR 52630Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 30, 2008
During a PTCA procedure it is possible that air embolization may occur as a result of incomplete aspiration of the guiding catheter, balloon rupture, or insinuation of air with the PTCA catheter during … Air embolization may cause a stroke.
73 FR 31123Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 20, 1999
Comments received and FDA's responses to the comments are discussed below. … (a) * * * (3) A lot may be subdivided into clean, sterile vessels. Each subdivision shall constitute a sublot.
64 FR 56441Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 4, 2009
Comments and FDA's Responses As stated previously, in addition to the comment period provided when the proposed rule was issued in 2002, FDA reopened the comment period on the rule in July 2002 and … and air pollution.
74 FR 38686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 15, 2000
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d … Submission of Comments and Effective Date Interested persons may, at any time, submit to the contact person (address above) written comments regarding this document.
65 FR 69022Health and Human Services DepartmentFood and Drug AdministrationWithdrawal of Two Proposed Rules
Federal Register · Proposed Rule · Nov 14, 2016
As FDA removed many proposed rules that had not been finalized, the Agency was able to clean out the backlog and implement a process of reviewing these proposed rules every 5 years. … Should we decide to undertake such rulemakings in the future, we will re-propose the actions and provide new opportunities for comment.
81 FR 79400Health and Human Services DepartmentFood and Drug AdministrationUse of Materials Derived From Cattle in Human Food and Cosmetics
Federal Register · Rule · Sep 7, 2005
The comment period for the interim final rule closed on October 12, 2004. … FDA invites public comment on these amendments to the interim final rule. The comment period will be 60 days.
70 FR 53063Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables
Federal Register · Rule · May 9, 1997
The comment suggested that ``like the patient cable, an adapter can trap blood and other contaminants during use. A reusable adapter must be easily and thoroughly cleaned and sterilized. … At the close of the 60-day comment period, FDA will review the comments received, revise the information collection provision as necessary, and submit these provisions to OMB for review.
62 FR 25477Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Gluten-Free Labeling of Foods
Federal Register · Rule · Aug 5, 2013
The comment period closed on March 20, 2012, and FDA's Center for Drug Evaluation and Research is reviewing those comments. … line and by cleaning and sanitation of equipment between production runs.
78 FR 47154Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2019
Our CGMP regulations at part 212 (21 CFR part 212) are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding safety, identity, … Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-04716 Filed 3-13-19; 8:45 am] BILLING CODE 4164-01-P
84 FR 9347Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 20, 2022
Summary of Comments to the Proposed Rule The proposed rule provided a 60-day comment period. We received more than 90 comments. … The comment suggested FDA state publicly that bottled water produced under the current standard will not adversely influence consumers health so that the consumer can keep buying in the period between
87 FR 23434Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 4, 2019
Our CGMP regulations at part 212 (21 CFR part 212) are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding safety, identity, … Three comments were received and are summarized here. One comment questioned the necessity of this proposed collection.
84 FR 46537Health and Human Services DepartmentFood and Drug Administration
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