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Briefs, oral arguments, agency decisions and the Federal Register.
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Use of Ozone-Depleting Substances
Federal Register · Rule · Feb 28, 2017
Air Act. … FDA did not receive any significant adverse comments regarding the direct final rule, which was published with an effective date of February 23, 2017.
82 FR 12067Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 8, 2015
the plastic material of the basket or bed component with inappropriate cleaning solutions. … Reform Act of 1995 (Pub.
80 FR 60809Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 23, 2014
Paperwork Reduction Act of 1995 V. Federalism VI. Environmental Impact VII. Analysis of Impacts VIII. Comments IX. References I. … Poor Air Quality, available at http://www.epa.gov/iaq/pubs/insidestory.html . 6. U.S.
79 FR 3742Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 29, 2005
Under section 610 of the Clean Air Act (42 U.S.C. 7671(i)), MDIs that are not the subject of an essential-use designation cannot be legally distributed in interstate commerce. … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 17, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations.
70 FR 71538Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Net Quantity of Contents; Compliance
Federal Register · Proposed Rule · Mar 4, 1997
The comments maintained that overpacking during these time periods would have large economic consequences. … For example, water may be introduced by: (1) Storing the shucked oysters in an ice slush before packing; (2) Cleaning the shucked oysters for a several-hour period with aerated water; and (
62 FR 9826Health and Human Services DepartmentFood and Drug AdministrationReinvention of Administrative Procedures Regulations
Federal Register · Proposed Rule · Jun 4, 1996
FDA is seeking public comment on ways to streamline its administrative procedures regulations. DATES: Written comments by September 3, 1996. … Air Act ons (CFC's) in and to correspond self-pressurized with the containers.
61 FR 28116Health and Human Services DepartmentFood and Drug AdministrationQuality Mammography Standards; Correction
Federal Register · Rule · Nov 10, 1997
(d) Air kerma means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy). … (ii) The facility shall document that all cleaning procedures are performed at the frequencies specified in the protocols. (12) Calibration of air kerma measuring instruments.
62 FR 60614Health and Human Services DepartmentFood and Drug AdministrationPhysical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
Federal Register · Rule · Apr 16, 2026
The comment period on the proposed order closed on October 16, 2020. … Comments received by the close of the comment period were from Congressional representatives, a trade organization, an orthopaedic scientist-surgeon, and other interested parties.
91 FR 20352Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 17, 2015
(Comment 184) Two comments note that the proposed rule includes explicit requirements for wet cleaning, but none for dry cleaning. … Proposed § 507.22(e)—Compressed Air We proposed that compressed air or other gases mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment must be used in such
80 FR 56170Health and Human Services DepartmentFood and Drug AdministrationPrevention of Salmonella Enteritidis in Shell Eggs During Production; Reopening of Comment Period
Federal Register · Proposed Rule · May 10, 2005
ACTION: Proposed rule; reopening of comment period. … The proposed rule had a 90-day comment period, which ended December 21, 2004.
70 FR 24490Health and Human Services DepartmentFood and Drug AdministrationSubstances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Federal Register · Rule · Jun 5, 1997
clean-out and solicit public comment. … (Comment 92). A small number of comments would revise proposed Sec. 589.2000(h)(1) to extend the time period.
62 FR 30936Health and Human Services DepartmentFood and Drug AdministrationPrevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation
Federal Register · Rule · Jul 9, 2009
The proposed rule had a 90-day comment period, which ended on December 21, 2004. … In addition, approximately 20 timely submissions were received in response to the reopened comment period.
74 FR 33030Health and Human Services DepartmentFood and Drug AdministrationRevision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents
Federal Register · Rule · Dec 12, 2000
The comment period for the direct final rule runs concurrently with the companion proposed rule. … FDA has provided a comment period on the direct final rule of 75 days after December 12, 2000.
65 FR 77497Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 1, 1996
DATES: Written comments by June 17, 1996. … aids and accessory cleaning pads).
61 FR 14277Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 10, 2003
The comment period on this interim final rule will open today for a period of 75 days. … , FDA intends to reopen the comment period for an additional 30 days in March 2004.
68 FR 58974Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 7, 2008
not consider comments submitted outside of the open comment periods. … (Comments) Some comments request that FDA issue a final prior notice rule only after there has been a period of full enforcement followed by an additional comment period.
73 FR 66294Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets
Federal Register · Rule · Nov 22, 2021
The comment periods for both proposed orders closed on June 1, 2016. … The March 3, 2016, 513(e) Proposed Order received approximately 150 comments from industry, professional societies, trade organizations, and individual consumers by the close of the comment period.
86 FR 66180Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2005
Revisions to Attachment 1 (List of SUDs Known To Be Reprocessed or Considered for Reprocessing) FDA has evaluated the comments received regarding section 510(o) of the act. … Since that time, the agency has received comments on various MDUFMA provisions, including several on its implementation of section 510(o) of the act.
70 FR 56911Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 10, 2014
The FDA has the authority under section 701(a) of the FD&C Act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the FD&C Act regarding CGMP procedures for manufacturing, processing … Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1.
79 FR 66724Health and Human Services DepartmentFood and Drug AdministrationSterility Requirement for Aqueous-Based Drug Products for Oral Inhalation
Federal Register · Rule · May 26, 2000
Clean Rooms 10. Another comment stated that the proposed rule would limit the use of each clean room to one product and questioned the necessity of this. … SBA stated that allowing a 1-year transition period, as proposed, was not sufficient. The comment requested a transition period of 2 years.
65 FR 34082Health and Human Services DepartmentFood and Drug Administration
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