Agency Information Collection Activities: Submission for OMB Review; Comment Request, 70502-70503 [2021-26816]
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70502
Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices
++ The Joint Commission’s capacity
to adequately fund required surveys.
++ The Joint Commission’s policies
with respect to whether surveys are
announced or unannounced, to assure
that surveys are unannounced.
++ The Joint Commission’s policies
and procedures to avoid conflicts of
interest, including the appearance of
conflicts of interest, involving
individuals who conduct surveys or
participate in accreditation decisions.
++ The Joint Commission’s
agreement to provide CMS with a copy
of the most current accreditation survey
together with any other information
related to the survey as we may require
(including corrective action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Lynette Wilson, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
jspears on DSK121TN23PROD with NOTICES1
Dated: December 7, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2021–26822 Filed 12–9–21; 8:45 am]
BILLING CODE 4120–01–P
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17:03 Dec 09, 2021
Jkt 256001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–R–153, CMS–
10561 and CMS–10657]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by January 10, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at: https://
www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
DATES:
PO 00000
Frm 00073
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FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Use Review (DUR) Program; Use: States
must provide for a review of drug
therapy before each prescription is filled
or delivered to a Medicaid patient. This
review includes screening for potential
drug therapy problems due to
therapeutic duplication, drug-disease
contraindications, drug-drug
interactions, incorrect drug dosage or
duration of drug treatment, drug-allergy
interactions, and clinical abuse/misuse.
Pharmacists must make a reasonable
effort to obtain, record, and maintain
Medicaid patient profiles. These profiles
must reflect at least the patient’s name,
address, telephone number, date of
birth/age, gender, history, e.g., allergies,
drug reactions, list of medications, and
pharmacist’s comments relevant to the
individual’s drug therapy.
The States must conduct RetroDUR
which provides for the ongoing periodic
examination of claims data and other
records in order to identify patterns of
fraud, abuse, inappropriate or medically
unnecessary care. Patterns or trends of
drug therapy problems are identified
and reviewed to determine the need for
intervention activity with pharmacists
and/or physicians. States may conduct
interventions via telephone,
correspondence, or face-to-face contact.
Annual reports are submitted to CMS
for the purposes of monitoring
compliance and evaluating the progress
of States’ DUR programs. The
SUPPLEMENTARY INFORMATION:
E:\FR\FM\10DEN1.SGM
10DEN1
jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices
information submitted by States is
reviewed and results are compiled by
CMS in a format intended to provide
information, comparisons, and trends
related to States’ experiences with DUR.
States benefit from the information and
may enhance their programs each year
based on State reported innovative
practices that are compiled by CMS
from the DUR annual reports.
In this 2021 collection of information
request, we revised certain FFS, MCO,
and Abbreviated MCO survey questions.
While a few questions were added to the
surveys to address GAO (U.S.
Government Accountability Office)
recommendations, other aspects of the
survey changes include grammar and
formatting edits. Overall, we are not
revising our currently approved burden
estimates.
Form Number: CMS–R–153 (OMB
control number: 0938–0659); Frequency:
Yearly, quarterly, and occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 663; Total
Annual Hours: 41,004. (For policy
questions regarding this collection
contact Mike Forman at 410–786–2666.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Supporting
Statement for Essential Community
Provider Data Collection to Support
QHP Certification for PYs 2022–2024;
Use: Standards for Essential Community
Provider (ECP) requirements are
codified at 45 CFR 156.235. Issuers must
contract with a certain percentage, as
determined by HHS, of the available
ECPs in the plan’s service area. For plan
years 2022–2024, Health and Human
Services (HHS) will continue to solicit
qualified ECPs to complete and submit
the HHS ECP provider petition in order
to be added to the HHS ECP list, or
update required data fields to remain on
the list, resulting in a more robust and
accurate listing of the universe of
available ECPs from which issuers select
to satisfy the ECP standard. HHS will
continue to collect such data directly
from providers through the online ECP
provider petition. Form Number: CMS–
10561; Frequency: Annually; Affected
Public: Private sector, Business or other
for-profits, and Not-for-profit
Institutions; Number of Respondents:
12,408; Number of Responses: 12,408;
Total Annual Hours: 3,140. (For
questions regarding this collection,
contact Deborah Hunter at 443–386–
3651).
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: The State
VerDate Sep<11>2014
17:03 Dec 09, 2021
Jkt 256001
Flexibility to Stabilize the Market Cycle
I and II Grant Program Reporting; Use:
Section 1003 of the Affordable Care Act
(ACA) adds a new section 2794 to the
Public Health Service Act (PHS Act)
entitled, ‘‘Ensuring That Consumers Get
Value for Their Dollars.’’ Specifically,
section 2794(a) requires the Secretary of
the Department of Health and Human
Services (the Secretary) (HHS), in
conjunction with the States, to establish
a process for the annual review of health
insurance premiums to protect
consumers from unreasonable rate
increases. Section 2794(c) directs the
Secretary to carry out a program to
award grants to States. Section
2794(c)(2)(B) specifies that any
appropriated Rate Review Grant funds
that are not fully obligated by the end
of FY 2014 shall remain available to the
Secretary for grants to States for
planning and implementing the
insurance market reforms and consumer
protections under Part A of title XXVII
of the (PHS Act. States that are awarded
funds under this funding opportunity
are required to provide CMS with four
quarterly reports and one annual report
(except for the last year of the grant)
until the end of the grant period
detailing the state’s progression towards
planning and/or implementing the preselected market reforms under Part A of
Title XXVII of the PHS Act. A final
report is due at the end of the grant
period. Form Number: CMS–10657
(OMB control number: 0938–1366);
Frequency: Annually and Quarterly;
Affected Public: State, Local or Tribal
Governments; Number of Respondents:
34; Total Annual Responses: 170; Total
Annual Hours: 2,312. (For policy
questions regarding this collection
contact Jim Taing at James.Taing@
cms.hhs.gov.)
70503
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Development of Anti-Infective Drug
Products for the Pediatric Population.’’
The purpose of this guidance is to
provide general recommendations on
the development of anti-infective drug
products for pediatric patients. The
guidance addresses enrollment
strategies, extrapolation of efficacy,
safety database, and other
considerations to help facilitate
pediatric anti-infective drug product
development. This guidance finalizes
the draft guidance of the same title
issued on June 30, 2020.
DATES: The announcement of the
guidance is published in the Federal
Register on December 10, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
Written/Paper Submissions
[Docket No. FDA–2020–D–1518]
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Dated: December 7, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–26816 Filed 12–9–21; 8:45 am]
BILLING CODE 4120–01–P
Development of Anti-Infective Drug
Products for the Pediatric Population;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice of availability.
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]]>Agencies
[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70502-70503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26816]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-R-153, CMS-10561 and CMS-10657]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by January 10, 2022.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug Use
Review (DUR) Program; Use: States must provide for a review of drug
therapy before each prescription is filled or delivered to a Medicaid
patient. This review includes screening for potential drug therapy
problems due to therapeutic duplication, drug-disease
contraindications, drug-drug interactions, incorrect drug dosage or
duration of drug treatment, drug-allergy interactions, and clinical
abuse/misuse. Pharmacists must make a reasonable effort to obtain,
record, and maintain Medicaid patient profiles. These profiles must
reflect at least the patient's name, address, telephone number, date of
birth/age, gender, history, e.g., allergies, drug reactions, list of
medications, and pharmacist's comments relevant to the individual's
drug therapy.
The States must conduct RetroDUR which provides for the ongoing
periodic examination of claims data and other records in order to
identify patterns of fraud, abuse, inappropriate or medically
unnecessary care. Patterns or trends of drug therapy problems are
identified and reviewed to determine the need for intervention activity
with pharmacists and/or physicians. States may conduct interventions
via telephone, correspondence, or face-to-face contact.
Annual reports are submitted to CMS for the purposes of monitoring
compliance and evaluating the progress of States' DUR programs. The
[[Page 70503]]
information submitted by States is reviewed and results are compiled by
CMS in a format intended to provide information, comparisons, and
trends related to States' experiences with DUR. States benefit from the
information and may enhance their programs each year based on State
reported innovative practices that are compiled by CMS from the DUR
annual reports.
In this 2021 collection of information request, we revised certain
FFS, MCO, and Abbreviated MCO survey questions. While a few questions
were added to the surveys to address GAO (U.S. Government
Accountability Office) recommendations, other aspects of the survey
changes include grammar and formatting edits. Overall, we are not
revising our currently approved burden estimates.
Form Number: CMS-R-153 (OMB control number: 0938-0659); Frequency:
Yearly, quarterly, and occasionally; Affected Public: State, Local, or
Tribal Governments; Number of Respondents: 51; Total Annual Responses:
663; Total Annual Hours: 41,004. (For policy questions regarding this
collection contact Mike Forman at 410-786-2666.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Supporting
Statement for Essential Community Provider Data Collection to Support
QHP Certification for PYs 2022-2024; Use: Standards for Essential
Community Provider (ECP) requirements are codified at 45 CFR 156.235.
Issuers must contract with a certain percentage, as determined by HHS,
of the available ECPs in the plan's service area. For plan years 2022-
2024, Health and Human Services (HHS) will continue to solicit
qualified ECPs to complete and submit the HHS ECP provider petition in
order to be added to the HHS ECP list, or update required data fields
to remain on the list, resulting in a more robust and accurate listing
of the universe of available ECPs from which issuers select to satisfy
the ECP standard. HHS will continue to collect such data directly from
providers through the online ECP provider petition. Form Number: CMS-
10561; Frequency: Annually; Affected Public: Private sector, Business
or other for-profits, and Not-for-profit Institutions; Number of
Respondents: 12,408; Number of Responses: 12,408; Total Annual Hours:
3,140. (For questions regarding this collection, contact Deborah Hunter
at 443-386-3651).
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: The State
Flexibility to Stabilize the Market Cycle I and II Grant Program
Reporting; Use: Section 1003 of the Affordable Care Act (ACA) adds a
new section 2794 to the Public Health Service Act (PHS Act) entitled,
``Ensuring That Consumers Get Value for Their Dollars.'' Specifically,
section 2794(a) requires the Secretary of the Department of Health and
Human Services (the Secretary) (HHS), in conjunction with the States,
to establish a process for the annual review of health insurance
premiums to protect consumers from unreasonable rate increases. Section
2794(c) directs the Secretary to carry out a program to award grants to
States. Section 2794(c)(2)(B) specifies that any appropriated Rate
Review Grant funds that are not fully obligated by the end of FY 2014
shall remain available to the Secretary for grants to States for
planning and implementing the insurance market reforms and consumer
protections under Part A of title XXVII of the (PHS Act. States that
are awarded funds under this funding opportunity are required to
provide CMS with four quarterly reports and one annual report (except
for the last year of the grant) until the end of the grant period
detailing the state's progression towards planning and/or implementing
the pre-selected market reforms under Part A of Title XXVII of the PHS
Act. A final report is due at the end of the grant period. Form Number:
CMS-10657 (OMB control number: 0938-1366); Frequency: Annually and
Quarterly; Affected Public: State, Local or Tribal Governments; Number
of Respondents: 34; Total Annual Responses: 170; Total Annual Hours:
2,312. (For policy questions regarding this collection contact Jim
Taing at [email protected].)
Dated: December 7, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-26816 Filed 12-9-21; 8:45 am]
BILLING CODE 4120-01-P
