Medicare Program; Approval of Application by The Compliance Team for Initial CMS-Approval of its Home Infusion Therapy Accreditation Program; Correction, 61953 [2020-21766]

Download as PDF 61953 Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Total burden (in hours) Form name Law enforcement officers .................. 60 1 30/60 30 60 60 60 60 60 60 60 60 1 2 2 2 1 42 1 1 15/60 5/60 1/60 2/60 2/60 2/60 150/60 5/60 15 10 2 4 2 84 150 5 Law enforcement officers .................. Law enforcement officers .................. phone call for recruitment & informed consent. Initial meeting ................................... Knowledge survey ............................ Epworth Sleepiness Scale ............... Pittsburgh Sleep Quality Index ........ Demographics and work experience Sleep diary ....................................... Online training .................................. Feedback about Training, Barriers, and Influential People. Changes in Behaviors after Training Actigraph fitting and return ............... 60 60 1 3 2/60 10/60 2 30 Total ........................................... ........................................................... ........................ ........................ ........................ 334 Law Law Law Law Law Law Law Law enforcement enforcement enforcement enforcement enforcement enforcement enforcement enforcement officers officers officers officers officers officers officers officers .................. .................. .................. .................. .................. .................. .................. .................. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–21731 Filed 9–30–20; 8:45 am] BILLING CODE 4163–18–P and corrected in this correcting document. The provision in this correction document is effective as if it had been included in the document published September 28, 2020. Accordingly, the correction is effective September 28, 2020. II. Summary of Error DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3386–CN] Medicare Program; Approval of Application by The Compliance Team for Initial CMS-Approval of its Home Infusion Therapy Accreditation Program; Correction Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final notice; correction. AGENCY: This document corrects a technical error that appeared in the final notice published in the Federal Register on September 28, 2020 entitled ‘‘Medicare Program; Approval of Application by The Compliance Team for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program.’’ SUMMARY: On page 60799, in the DATES section of the notice, the phrase ‘‘takes effect October 1, 2020 through October 1, 2024’’ should be replaced with the phrase ‘‘September 28, 2020-September 28, 2024.’’ The Use of Physiologically Based Pharmacokinetic Analyses— Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. SUMMARY: Dated: September 28, 2020. Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. [FR Doc. 2020–21766 Filed 9–28–20; 4:15 pm] BILLING CODE 4120–01–P Christina Mister-Ward, (410) 786–2441. Shannon Freeland, (410) 786–4348. Lillian Williams, (410) 786–8636. SUPPLEMENTARY INFORMATION: I. Background In FR Doc. 2020–21260 of September 28, 2020 (85 FR 60799–60800), there was a technical error that is identified Jkt 253001 [Docket No. FDA–2020–D–1517] In the Federal Register of September 28, 2020, in FR Doc. 2020–21260, on page 60799, in the 2nd column, in the DATES section, the phrase ‘‘takes effect October 1, 2020 through October 1, 2024’’ is corrected to read ‘‘September 28, 2020-September 28, 2024.’’ FOR FURTHER INFORMATION CONTACT: 22:13 Sep 30, 2020 Food and Drug Administration ACTION: This correction is effective September 28, 2020. VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES III. Correction of Error DATES: jbell on DSKJLSW7X2PROD with NOTICES Average burden per response (in hours) Number of responses per respondent Type of respondents PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘The Use of Physiologically Based Pharmacokinetic Analyses— Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls.’’ This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, new drug applications, or abbreviated new drug applications, and supplements to these applications, for oral drug product development, manufacturing changes, and controls. The guidance covers how to develop, evaluate, and apply PBPK models for biopharmaceutics-related uses, such as establishing clinically relevant dissolution specifications and quality risk assessment for postapproval manufacturing changes. E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Notices]
[Page 61953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3386-CN]


Medicare Program; Approval of Application by The Compliance Team 
for Initial CMS-Approval of its Home Infusion Therapy Accreditation 
Program; Correction

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice; correction.

-----------------------------------------------------------------------

SUMMARY: This document corrects a technical error that appeared in the 
final notice published in the Federal Register on September 28, 2020 
entitled ``Medicare Program; Approval of Application by The Compliance 
Team for Initial CMS-Approval of Its Home Infusion Therapy 
Accreditation Program.''

DATES: This correction is effective September 28, 2020.

FOR FURTHER INFORMATION CONTACT: Christina Mister-Ward, (410) 786-2441. 
Shannon Freeland, (410) 786-4348. Lillian Williams, (410) 786-8636.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2020-21260 of September 28, 2020 (85 FR 60799-60800), 
there was a technical error that is identified and corrected in this 
correcting document. The provision in this correction document is 
effective as if it had been included in the document published 
September 28, 2020. Accordingly, the correction is effective September 
28, 2020.

II. Summary of Error

    On page 60799, in the DATES section of the notice, the phrase 
``takes effect October 1, 2020 through October 1, 2024'' should be 
replaced with the phrase ``September 28, 2020-September 28, 2024.''

III. Correction of Error

    In the Federal Register of September 28, 2020, in FR Doc. 2020-
21260, on page 60799, in the 2nd column, in the DATES section, the 
phrase ``takes effect October 1, 2020 through October 1, 2024'' is 
corrected to read ``September 28, 2020-September 28, 2024.''

    Dated: September 28, 2020.
Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and 
Human Services.
[FR Doc. 2020-21766 Filed 9-28-20; 4:15 pm]
BILLING CODE 4120-01-P

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