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

 
CONTENT
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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