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

• Citation: 85 FR 61953
• Record Number: 2020-21766
• Published date: 01 October 2020
• Section: Notices
• Court: Centers For Medicare & Medicaid Services

61953

Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices

E

STIMATED

A

NNUALIZED

B

URDEN

H

OURS

Type of respondents Form name Number of

respondents

Number of

responses per

respondent

Average

burden per

response

(in hours)

Total burden

(in hours)

Law enforcement officers .................. phone call for recruitment & in-

formed consent. 60 1 30/60 30

Law enforcement officers .................. Initial meeting ................................... 60 1 15/60 15

Law enforcement officers .................. Knowledge survey ............................ 60 2 5/60 10

Law enforcement officers .................. Epworth Sleepiness Scale ............... 60 2 1/60 2

Law enforcement officers .................. Pittsburgh Sleep Quality Index ........ 60 2 2/60 4

Law enforcement officers .................. Demographics and work experience 60 1 2/60 2

Law enforcement officers .................. Sleep diary ....................................... 60 42 2/60 84

Law enforcement officers .................. Online training .................................. 60 1 150/60 150

Law enforcement officers .................. Feedback about Training, Barriers,

and Influential People. 60 1 5/60 5

Law enforcement officers .................. Changes in Behaviors after Training 60 1 2/60 2

Law enforcement officers .................. Actigraph fitting and return ............... 60 3 10/60 30

Total ........................................... ........................................................... ........................ ........................ ........................ 334

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

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA–2020–D–1517]

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.

ACTION

: Notice of availability.

SUMMARY

: 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.

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