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Federal Register · Notice · Mar 14, 2008
Additional Equipment Forced-air oven, Fisher Isotemp ® , regulated to 99 ± 1.0 °C. Suggested dimensions: 18 x 18 x 20.” E. Chromatographic Conditions 8 9 1. … Accurately pipette 0.5 mL of IS from stock solution (II.A.1) to five clean, dry 50 mL volumetric flasks.
73 FR 13903Health and Human Services DepartmentCenters for Disease Control and PreventionFederal Register · Notice · Jul 8, 2003
The types of validation data include cleaning and sterilization data, and functional performance data. … Under MDUFMA, manufacturers of reprocessed SUDs have a limited time period during which they can develop and submit this validation data.
68 FR 40679Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 30, 2013
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. … Records are maintained on file at each farm site and examined there periodically by FDA inspectors.
78 FR 32400Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 23, 2013
Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. … Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period: a.
78 FR 58386Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesFederal Register · Notice · Apr 19, 1999
CGMP Regulations for Finished Pharmaceuticals--21 CFR Parts 210 and 211 (OMB Control Number 0910-0139)--Reinstatement 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
64 FR 19180Health and Human Services DepartmentFood and Drug AdministrationFluorinated Polyethylene Containers for Food Contact Use; Request for Information
Federal Register · Notice · Jul 20, 2022
Current data and information on these topics will help us advance our public health mission and further support the current Administration's comprehensive approach to addressing PFAS and advancing clean … air, water, and food (Ref. 4).
87 FR 43274Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule
Federal Register · Proposed Rule · Dec 30, 2003
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).
68 FR 75179Health and Human Services DepartmentFood and Drug AdministrationProposed Data Collections Submitted for Public Comment and Recommendations
Federal Register · Notice · Sep 11, 2009
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 Centers for Disease Control and Prevention … (CDC) will publish periodic summaries of proposed projects.
74 FR 46777Health and Human Services DepartmentCenters for Disease Control and PreventionPremarket Tobacco Product Applications and Recordkeeping Requirements
Federal Register · Rule · Oct 5, 2021
the comment is suggesting go to TPSAC within the 180-day review period required by section 910(c) of the FD&C Act. … • Pressure drop through air valve (mm H 2 O). • Air flow through air valve (cc/min).
86 FR 55300Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 22, 2024
with comment period. 4. … with comment period.
89 FR 59186Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesFederal Register · Notice · Sep 4, 2018
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years.
83 FR 44884Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 7, 2022
(FD&C Act) regarding safety, identity, strength, quality, and purity and are issued under the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … Five comments were received and are summarized here.
87 FR 61070Health and Human Services DepartmentFood and Drug AdministrationSterility Requirements for Inhalation Solution Products
Federal Register · Proposed Rule · Sep 23, 1997
DATES: Written comments by December 22, 1997. Submit written comments on the information collection requirements by October 23, 1997. … FDA finds that the cost of building a new clean room may amount to almost $600 per square foot. The size of pharmaceutical clean rooms is reported to vary widely, from 200 to 2,500 square feet.
62 FR 49638Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2022
(FD&C Act) regarding safety, identity, strength, quality, and purity and are issued under the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … Annual Recordkeeping Incoming Acceptance Tests Records (§§ 212.20(c), 212.40(a) and (b)) 23 24 552 0.5 276 Annual Recordkeeping Batch Testing (creating testing records for sterility, periodic
87 FR 20420Health and Human Services DepartmentFood and Drug AdministrationMedicare Program; Medicare Ambulance MMA Temporary Rate Increases Beginning July 1, 2004
Federal Register · Rule · Jul 1, 2004
ACTION: Interim final rule with comment period. … Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By hand or courier.
69 FR 40288Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesAgency Forms Undergoing Paperwork Reduction Act Review
Federal Register · Notice · Jul 7, 2023
CDC did not receive comments related to the previous notice This notice serves to allow an additional 30 days for public and affected agency comments. … State BRFSS Coordinators submit de-identified data files to CDC on a monthly or quarterly basis for cleaning and weighting.
88 FR 43353Health and Human Services DepartmentCenters for Disease Control and PreventionFederal Register · Proposed Rule · Feb 13, 2012
Timetable: Action Date FR Cite Notice: Public Meeting, Framework Document Availability 08/28/09 74 FR 44306 Comment Period End 09/20/09 Direct Final Rule 12/00 … Completed: Reason Date FR Cite NPRM 06/27/11 76 FR 37549 Direct Final Rule 06/27/11 76 FR 37408 Direct Final Rule Comment Period End 10/17/11 Direct Final
77 FR 7942Energy DepartmentHealth and Human Services DepartmentFederal Register · Notice · Mar 27, 2013
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. … Records are maintained on file at each farm site and examined there periodically by FDA inspectors.
78 FR 18605Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 17, 2000
periods. … of 1972 (16 U.S.C. §§ 1451 et seq. ); (f) conformity of Federal actions to State (Clean Air) Implementations Plans under Section 176(c) of the Clean Air Act of 1955, as amended (42 U.S.C. §§ 7401
65 FR 14574Health and Human Services DepartmentChildren and Families AdministrationFederal Register · Rule · Apr 17, 2013
associated with the exposures resulting from the September 11, 2001, terrorist attacks, and provide advice on whether to add cancer, or a certain type of cancer, to the List specified in the Zadroga Act … NTP has not yet examined the evidence for an association of shiftwork and breast cancer, however, NTP recently requested comment from the public on whether shiftwork involving light at night should be
78 FR 22794Health and Human Services Department
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