Agency Information Collection Activities: Proposed Collection; Comment Request, 57876-57877 [2019-23572]
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57876
Federal Register / Vol. 84, No. 209 / Tuesday, October 29, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10631]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid 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 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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 must be received by
December 30, 2019.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number llll , Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
SUMMARY:
VerDate Sep<11>2014
17:05 Oct 28, 2019
Jkt 250001
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10631 The PACE Organization
Application Process in 42 CFR Part 460
Under the 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
requires federal agencies to publish a
60-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.
Information Collection
1. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: The PACE
Organization Application Process in 42
CFR part 460; Use: The Programs of AllInclusive Care for the Elderly (PACE)
consist of pre-paid, capitated plans that
provide comprehensive health care
services to frail, older adults in the
community who are eligible for nursing
home care according to State standards.
PACE organizations (PO) must provide
all Medicare and Medicaid covered
services; financing of this model is
accomplished through prospective
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
capitation of both Medicare and
Medicaid payments. Upon approval of a
PACE application, CMS executes a 3way program agreement with the
applicant entity and the applicable State
Administering Agency (SAA). CMS
regulations at 42 CFR 460.98(b)(2)
require a PO to provide PACE services
in at least the PACE center, the home,
and inpatient facilities. The PACE
center is the focal point for the delivery
of PACE services; the center is where
the interdisciplinary team (IDT) is
located, services are provided, and
socialization occurs with staff that is
consistent and familiar to participants.
Collection of this information is
mandated by statute under sections
1894(f) and 1934(f) of the Act and at 42
CFR part 460, subpart B, which
addresses the PO application and
waiver process. In general, PACE
services are provided through a PO. An
entity wishing to become a PO must
submit an application to CMS that
describes how the entity meets all the
requirements in the PACE program. An
entity’s application must be
accompanied by an assurance from the
SAA of the State in which the PO is
located.
CMS recently issued a final PACE rule
(CMS–4168–F), effective August 2,
2019, which updates and modernizes
the PACE program. This final rule
codifies CMS’ existing practice of
relying on automated review systems for
processing initial applications to
become a PACE organization and
expansion applications for existing
PACE organizations. In addition, the
final rule will modify the PACE
regulations to eliminate the need for
PACE organizations to request waivers
for a number of the most commonly
waived provisions. This latter change is
expected to reduce burden and improve
efficiency for POs, state administering
agencies, and CMS.
In addition to codifying the current
automated processes for the submission
and review of both initial and service
area expansion applications, this rule
modifies existing regulatory provisions
and requirements. As a result, certain
attestations associated with the
application are no longer applicable,
and others need to be updated to reflect
updated regulatory requirements. We
are also making minor tweaks to certain
document upload requirements for
clarification purposes based on
experience reviewing applications.
Form Number: CMS–10631 (OMB
control number: 0938–1326); Frequency:
Yearly; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 72; Total Annual
Responses: 109; Total Annual Hours:
E:\FR\FM\29OCN1.SGM
29OCN1
Federal Register / Vol. 84, No. 209 / Tuesday, October 29, 2019 / Notices
7,226. (For policy questions regarding
this collection contact Debbie Vanhoven
at 410–786–6625.)
Dated: October 24, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–23572 Filed 10–28–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4258]
Type V Drug Master Files for Center for
Drug Evaluation and Research-Led
Combination Products Using Device
Constituent Parts With Electronics or
Software; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Type V
DMFs for CDER-Led Combination
Products Using Device Constituent Parts
With Electronics or Software.’’ A drug
master file (DMF) is a voluntary
submission to FDA that may be used to
provide confidential detailed
information about facilities, processes,
or articles used in the manufacturing,
processing, packaging, and storing of
one or more human drugs. This draft
guidance explains when a Type V DMF
may be used to submit information
regarding a combination product for
which the Center for Drug Evaluation
and Research (CDER) has primary
jurisdiction (i.e., a CDER-led
combination product) and which
features a device constituent part with
electronics and/or software that is
planned to be used as a platform, that
is, may be used in multiple CDER-led
combination products. The draft
guidance also describes the
administrative process and outlines the
recommended content for these Type V
DMF submissions and amendments.
DATES: Submit either electronic or
written comments on the draft guidance
by December 30, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
VerDate Sep<11>2014
17:05 Oct 28, 2019
Jkt 250001
Electronic Submissions
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’’).
Written/Paper Submissions
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
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–4258 for ‘‘Type V DMFs for
CDER-Led Combination Products Using
Device Constituent Parts With
Electronics or Software.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
57877
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Kimberly Peters, Center for Drug
Evaluation and Research, Food and
Drug Administration, Bldg. 51, Rm.
4314, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301–796–
6350.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Type V DMFs for CDER-Led
Combination Products Using Device
E:\FR\FM\29OCN1.SGM
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Agencies
[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Notices]
[Pages 57876-57877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23572]
[[Page 57876]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10631]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid 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 (the 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 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates 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 must be received by December 30, 2019.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number ____ , Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10631 The PACE Organization Application Process in 42 CFR Part 460
Under the 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 requires federal agencies
to publish a 60-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.
Information Collection
1. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection: The
PACE Organization Application Process in 42 CFR part 460; Use: The
Programs of All-Inclusive Care for the Elderly (PACE) consist of pre-
paid, capitated plans that provide comprehensive health care services
to frail, older adults in the community who are eligible for nursing
home care according to State standards. PACE organizations (PO) must
provide all Medicare and Medicaid covered services; financing of this
model is accomplished through prospective capitation of both Medicare
and Medicaid payments. Upon approval of a PACE application, CMS
executes a 3-way program agreement with the applicant entity and the
applicable State Administering Agency (SAA). CMS regulations at 42 CFR
460.98(b)(2) require a PO to provide PACE services in at least the PACE
center, the home, and inpatient facilities. The PACE center is the
focal point for the delivery of PACE services; the center is where the
interdisciplinary team (IDT) is located, services are provided, and
socialization occurs with staff that is consistent and familiar to
participants.
Collection of this information is mandated by statute under
sections 1894(f) and 1934(f) of the Act and at 42 CFR part 460, subpart
B, which addresses the PO application and waiver process. In general,
PACE services are provided through a PO. An entity wishing to become a
PO must submit an application to CMS that describes how the entity
meets all the requirements in the PACE program. An entity's application
must be accompanied by an assurance from the SAA of the State in which
the PO is located.
CMS recently issued a final PACE rule (CMS-4168-F), effective
August 2, 2019, which updates and modernizes the PACE program. This
final rule codifies CMS' existing practice of relying on automated
review systems for processing initial applications to become a PACE
organization and expansion applications for existing PACE
organizations. In addition, the final rule will modify the PACE
regulations to eliminate the need for PACE organizations to request
waivers for a number of the most commonly waived provisions. This
latter change is expected to reduce burden and improve efficiency for
POs, state administering agencies, and CMS.
In addition to codifying the current automated processes for the
submission and review of both initial and service area expansion
applications, this rule modifies existing regulatory provisions and
requirements. As a result, certain attestations associated with the
application are no longer applicable, and others need to be updated to
reflect updated regulatory requirements. We are also making minor
tweaks to certain document upload requirements for clarification
purposes based on experience reviewing applications. Form Number: CMS-
10631 (OMB control number: 0938-1326); Frequency: Yearly; Affected
Public: State, Local, or Tribal Governments; Number of Respondents: 72;
Total Annual Responses: 109; Total Annual Hours:
[[Page 57877]]
7,226. (For policy questions regarding this collection contact Debbie
Vanhoven at 410-786-6625.)
Dated: October 24, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-23572 Filed 10-28-19; 8:45 am]
BILLING CODE 4120-01-P