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Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
Federal Register · Rule · Nov 18, 2016
(Comment 5) Some comments express concerns with FDA's proposal to add medical air to the list of gases at § 201.161(a) without providing a warning statement specific to medical air. … (Comment 25) FDA received several comments that the 60-day time period proposed for implementation of the proposed rule is insufficient.
81 FR 81685Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Removal of Essential-Use Designations
Federal Register · Proposed Rule · Jun 11, 2007
The 1990 Amendments to the Clean Air Act In 1990, Congress amended the Clean Air Act to, among other things, better protect stratospheric ozone (Public Law No. 101-549, November 15, 1990) (the 1990 … Section 614(b) of the Clean Air Act provides that, in the case of a conflict between any provision of the Clean Air Act and any provision of the Montreal Protocol, the more stringent provision will govern
72 FR 32030Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 7, 2007
Government to meet their obligations under the Clean Air Act (42 U.S.C. 7401 et seq. ) and the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) (September 16, 1987, … Air Act (42 U.S.C. 7671c).
72 FR 44037Health and Human Services DepartmentFood and Drug AdministrationCurrent Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements
Federal Register · Proposed Rule · Feb 6, 1997
(2) Effective hand-cleaning and sanitizing preparations. (3) Air driers, sanitary towel service or suitable drying devices. … Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning.
62 FR 5700Current Good Manufacturing Practice in Manufacturing, Packing, orHealth and Human Services DepartmentFederal Register · Rule · Jun 18, 2024
(Comment 36) One comment suggests revising § 213.182 to state that cleaning and maintenance is performed on a periodic basis or when there is suspected contamination and is not associated with a batch … (Comment 63) One comment maintains that entering a specific percentage of oxygen in the distribution records for each medical air cylinder is not necessary, because medical air contains a range of oxygen
89 FR 51738Health and Human Services DepartmentFood and Drug AdministrationProposal To Establish Procedures for the Safe Processing and Importing of Fish and Fishery Products
Federal Register · Uncategorized Document · Jan 28, 1994
Air-packaged. … Air-packaged products.
Proposal To Establish Procedures for the Safe Processing and ImportingHealth and Human Services DepartmentUse of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
Federal Register · Rule · Nov 19, 2008
The 1990 Amendments to the Clean Air Act In 1990, Congress amended the Clean Air Act to, among other things, better protect stratospheric ozone (Public Law No. 101-549, November 15, 1990) (the 1990 … Section 614(b) of the Clean Air Act provides that, in the case of a conflict between any provision of the Clean Air Act and any provision of the Montreal Protocol, the more stringent provision will govern
73 FR 69532Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 3, 2011
(Comment 28) One comment suggested that the statement that air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air is misplaced in the regulations … Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.
76 FR 11892Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances
Federal Register · Proposed Rule · Oct 26, 2016
Air Act. … The social benefits of the proposed rule derive from greater compliance with the Clean Air Act.
81 FR 74368Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Request for Comment Concerning Essential-Use Designations
Federal Register · Proposed Rule · Jun 29, 2015
FDA is seeking public comment because it is responsible for determining which FDA-regulated products that release CFCs or other ODSs are essential uses under the Clean Air Act. … Firms that wish to use CFCs manufactured after the phase-out date in medical devices (as defined in section 601(8) of the Clean Air Act) covered under section 610 of the Clean Air Act must receive exemptions
80 FR 36937Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
Federal Register · Proposed Rule · Sep 20, 2007
The 1990 Amendments to the Clean Air Act In 1990, Congress amended the Clean Air Act to, among other things, better protect stratospheric ozone (Public Law No. 101-549, November 15, 1990) (the 1990 … Section 614(b) of the Clean Air Act provides that, in the case of a conflict between any provision of the Clean Air Act and any provision of the Montreal Protocol, the more stringent provision will govern
72 FR 53711Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 9, 1996
gross particulates in the intake air. … (g) Compressed air or other gases that are mechanically introduced into infant formula, that are used to clean any equipment, or that come into contact with any other surface that contacts ingredients,
61 FR 36154Current Good Manufacturing Practice, Quality Control Procedures,Quality Factors, Notification Requirements, and Records and Reports,Federal Register · Rule · Apr 27, 2007
comment period. … Therefore, under the Federal Food, Drug, and Cosmetic Act, the Clean Air Act, and under authority delegated to the Commissioner of Food and Drugs, after consultation with the Administrator of the Environmental
72 FR 20942Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 10, 2014
, and the period of time between cleaning and subsequent use of the equipment and utensils. … Another comment suggested that records should be required to document equipment cleaning but not cleaning of utensils.
79 FR 7934Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 14, 2007
Paperwork Reduction Act VII. Federalism VIII. Comments IX. References I. … Air-operated temperature controllers should have adequate filter systems to ensure a supply of clean, dry air.
72 FR 11990Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 8, 2001
act and/or section 351 of the PHS Act. … units), cleaning agents and equipment lubricants, and air flows from activities in adjacent areas of the building.
66 FR 1508Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 19, 2016
Summary of Comments to the Proposed Rule FDA requested comments on the proposed rule (80 FR 60809), and the comment period closed on December 7, 2015. … The Agency received 11 comments on the proposed rule by the close of the comment period; some of the comments contained comments on more than one issue.
81 FR 91731Health and Human Services DepartmentFood and Drug AdministrationTransportation and Storage Requirements for Potentially Hazardous Foods
Federal Register · Proposed Rule · Nov 22, 1996
These included the cleaning and precooling of trucks, proper packaging of foods, loading patterns and partial loading or unloading of trucks, adequacy of refrigeration units, air circulation, humidity, … The AFDO guideline states that frozen food should be held at an air temperature of 0 deg.F or below and should not exceed a product temperature of 10 deg.F for more than a short period of time during
61 FR 59372Agriculture DepartmentFood Safety and Inspection ServiceFederal Register · Notice · Dec 11, 2018
The comment period on the initial draft guidance ended on September 2, 2014. FDA received 26 comments on the draft guidance. … schedules, methods, equipment, and materials to be used in cleaning buildings and facilities.
83 FR 63651Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 3, 1996
Most contamination can be controlled to an acceptable level through measures such as proper planning and implementation of cleaning processes, employee training, gowning, and air filtration. … This change will clarify that the act of cleaning component containers is done for a particular purpose, to prevent the introduction of contaminants, and that purpose must, in all cases, be achieved.
61 FR 20104Health and Human Services DepartmentFood and Drug Administration
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