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Sterility 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 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 AdministrationFederal Register · Notice · Oct 8, 1997
DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health Proposed Data Collection: Public Comment; Leukemia and Other Cancers Among Chernobyl Clean-up Workers in Lithuania … SUMMARY: In compliance with the requirement of Section 3506 (c) (2) (A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Institutes
62 FR 52568Health and Human Services DepartmentPublic Health ServiceInterstate Shipment of Etiologic Agents
Federal Register · Proposed Rule · Jan 3, 2007
(IATA), for air, and the U.S. … The ICAO Technical Instructions (ICAO TI) govern virtually all shipments transported internationally by air, and the majority of U.S. domestic air shipments.
72 FR 92Health and Human Services DepartmentFederal Register · Notice · Jan 27, 2015
L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). … Submission of Comments and Effective Date Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
80 FR 4274Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 21, 2009
fumigant), in the production of paraformaldehyde and chelating agents, embalming and fixative or preservative in the medical and research fields, and as a preservative in numerous consumer products such as cleaning … Formaldehyde has been detected in indoor and outdoor air, surface water and groundwater, soil and food products and is generally considered to be ubiquitous in the environment.
74 FR 67883Health and Human Services DepartmentFederal Register · Notice · Jan 7, 2009
Such revisions would trigger a notice and comment process under the Administrative Procedure Act.” … Accurately pipette 0.5 mL of IS from stock solution (II.A.1) to five clean, dry 50 mL volumetric flasks.
74 FR 712Health and Human Services DepartmentCenters for Disease Control and PreventionDetermination of Concentration of Respirable Coal Mine Dust
Federal Register · Proposed Rule · Jul 7, 2000
mine dust per cubic meter of air (mg/m 3 ). … Using a modified HEPA filtration system, the environment is maintained at a clean room classification of 1000 (near optimum for clean room cleanliness).
65 FR 42068Labor DepartmentMine Safety and Health AdministrationFederal Register · Notice · Jun 11, 2012
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … FDA has determined that the applicable regulatory review period for Progel Pleural Air Leak Sealant is 3,854 days.
77 FR 34389Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2015
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.
80 FR 10117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 21, 2017
FQHCs were paid under the same AIR methodology until October 1, 2014, when, in accordance with section 1834(o) of the Act (as added by section 10501(i)(3) of the Affordable Care Act), they began to transition … and in the CY 2016 PFS final rule with comment period.
82 FR 33950Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesFederal Register · Proposed Rule · Jul 6, 1999
Paperwork Reduction Act of 1995 IX. Comments X. References I. Background A. … After the eggs are washed, they are dried with forced ambient air and then packed.
64 FR 36492Proposed RulePreliminary Regulatory Impact Analysis and Initial RegulatoryFederal Register · Proposed Rule · Dec 12, 2000
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … Flexibility Act (5 U.S.C. 601-612) and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
65 FR 77532Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 14, 2017
Specifically, under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the methods used in or the facilities or controls … Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1.
82 FR 58811Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 6, 2018
Thereafter, SOPs need to be periodically updated. A combined estimate for routine maintenance of SOPs is provided in table 1. … This notice is intended to solicit such public comment.
83 FR 14861Health and Human Services DepartmentFood and Drug AdministrationUnified Agenda of Federal Regulatory and Deregulatory Actions
Federal Register · Proposed Rule · Jun 18, 2015
Availability 09/03/13 78 FR 54197 Framework Document Comment Period End 10/18/13 Preliminary Analysis 11/20/14 79 FR 69066 Preliminary Analysis Comment Period End 01/20/15 … Timetable: Action Date FR Cite NPRM and Notice of Public Meeting Date 03/23/15 02/09/15 80 FR 7082 NPRM Comment Period End 04/10/15 NPRM Comment Period Extended
80 FR 35012Energy DepartmentHealth and Human Services DepartmentFederal Register · Rule · Feb 27, 2002
ACTION: Final rule with comment period. … Comment: One commenter recommended a third air rate for air ambulance services furnished in remote, frontier areas such as Alaska.
67 FR 9100Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesFederal Register · Notice · Sep 24, 2008
Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (OMB Control Number 0910-0139)—Extension Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) ( … FDA has the authority under section 701(a) of the act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the act regarding CGMP procedures for manufacturing, processing, and holding
73 FR 55108Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 19, 2000
Comments on the Proposed Categorical Exclusions The NIH received one comment on its proposed categorical exclusions. CEQ did not provide any comments. … Actions taken to comply with requirements of applicable legislation or regulations ( e.g., meet emissions requirements established pursuant to Clean Air Act). 17.
65 FR 2977Health and Human Services DepartmentNational Institutes of HealthNational Toxicology Program; Announcement of Intent To Conduct Toxicological Studies of 22 Chemicals
Federal Register · Uncategorized Document · Sep 12, 1994
DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Toxicology Program; Announcement of Intent To Conduct Toxicological Studies of 22 Chemicals Request for Comments: As part of … Cresols are on the list of Hazardous Air Pollutants in the Clean Air Act Amendments of 1990 and on the Superfund Priority List of Hazardous Substances.
Health and Human Services DepartmentPublic Health Service
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