Agency Information Collection Activities: Proposed Collection; Comment Request, 13929-13930 [2019-06884]
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jbell on DSK30RV082PROD with NOTICES
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
from the public on the potential
usefulness of a registry and potential
approaches to establishing and
operating it. Accordingly, NIOSH seeks
input and advice from all interested
parties in response to the following
questions:
1. Would a registry be an effective tool
in improving mesothelioma patient
care? If yes, please describe how a
registry could be used to improve
current care.
2. Would a registry be an effective tool
in facilitating clinical mesothelioma
research? If yes, please describe how a
registry could be used to facilitate
clinical mesothelioma research.
3. Would a registry be an effective tool
in facilitating basic or epidemiological
mesothelioma research? If yes, please
describe how a registry could be used to
facilitate basic or epidemiological
research.
4. What are the best potential
approaches to recruiting and enrolling
mesothelioma patients in a registry as
soon as possible after diagnosis? What
barriers can be anticipated? How can
these barriers be overcome?
5. What information should be
collected by a mesothelioma registry?
How would that information be useful
for improving patient care or facilitating
clinical, basic, or epidemiological
research?
6. What services should a registry
provide to mesothelioma patients,
clinicians, researchers, and other
interested stakeholders?
7. Who should have access to
information gathered by a mesothelioma
registry?
8. How could a mesothelioma registry
protect the confidentiality of
information about registry participants
yet still be used for patient care and
research? Please describe how
personally identifiable information
should be protected.
9. Are there particular types of
organizations that would be best suited
to host or manage a National
Mesothelioma Registry? If so, please
explain the advantages and
disadvantages of the recommended
types of organizations.
10. What types of resources would be
needed to establish and maintain or
participate in a National Mesothelioma
Registry, including for clinical sites that
diagnose patients, cancer registries and
state public health departments, a
central data center, and potentially
other participants involved in recruiting
and enrolling patients, gathering and
storing information, providing various
services, and following patients over
time?
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11. Is there other information that
NIOSH should consider in assessing the
potential usefulness, feasibility, and
potential approaches to establishing and
operating a National Mesothelioma
Registry? If yes, please describe.
Dated: April 2, 2019.
Frank J. Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention, Department
of Health and Human Services.
[FR Doc. 2019–06784 Filed 4–5–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–R–64 and CMS–
10699]
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
June 7, 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://
SUMMARY:
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13929
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 lll, 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
website address at https://www.cms.gov/
Regulations-and-Guidance/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–R–64 Indirect Medical Education
and Direct Graduate Medical
Education
CMS–10699 Information Collection
Requirements Associated with Drug
Pricing Transparency and Supporting
Regulations in 42 CFR 403.1202
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
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Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
jbell on DSK30RV082PROD with NOTICES
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 of a currently
approved collection; Title of
Information Collection: Indirect Medical
Education and Direct Graduate Medical
Education; Use: Section 1886(d)(5)(B) of
the Social Security Act requires
additional payments to be made under
the Medicare Prospective Payment
System (PPS) for the indirect medical
educational costs a hospital incurs in
connection with interns and residents
(IRs) in approved teaching programs. In
addition, Title 42, Part 413, sections 75
through 83 implement section 1886(d)
of the Act by establishing the
methodology for Medicare payment for
the costs of direct graduate medical
educational activities. These payments,
which are adjustments (add-ons) to
other payments made to a hospital
under PPS, are largely determined by
the number of full-time equivalent (FTE)
IRs that work at a hospital during its
cost reporting period. In Federal fiscal
year (FY) 2018, the estimated Medicare
program payments for indirect medical
education (IME) costs was $6.4 billion.
Medicare program payment for direct
graduate medical education (GME) is
also based upon the number of FTE–IRs
that work at a hospital. In FY 2018, the
estimated Medicare program payments
for GME costs was $3.1 billion. Since it
is important to accurately count the
number of IRs FTEs working at each
hospital, original approval was obtained
from the Office of Management and
Budget (OMB) in 1985 to collect the IR
information required in 42 CFR
412.105(f) and timeframes for filing. All
Medicare health plans are required to
use these standardized notices. Form
Number: CMS–R–64 (OMB control
number: 0938–0456); Frequency: Yearly;
Affected Public: Private Sector (Business
or other for-profits, Not-for-profit
institutions); Number of Respondents:
1,245; Total Annual Responses: 1,245;
Total Annual Hours: 2,490. (For policy
questions regarding this collection
contact Owen Osaghae at 410–786–
7550.)
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Information
Collection Requirements Associated
with Drug Pricing Transparency and
Supporting Regulations in 42 CFR
403.1202; Use: The Department of
Health and Human Services proposed a
rule (78 FR 52789) to revise the Federal
VerDate Sep<11>2014
17:45 Apr 05, 2019
Jkt 247001
Health Insurance Programs for the Aged
and Disabled by amending regulations
for the Medicare and Medicaid program,
to require direct-to-consumer (DTC)
television advertisements of
prescription drugs and biological
products for which payment is available
through or under Medicare or Medicaid
to include the Wholesale Acquisition
Cost (WAC, or list price) of that drug or
biological product. This rule is intended
to improve the efficient administration
of the Medicare and Medicaid programs
by ensuring that beneficiaries are
provided with relevant information
about the costs of prescription drugs
and biological products so they can
make informed decisions that minimize
not only their out-of-pocket costs, but
also expenditures borne by Medicare
and Medicaid, both of which are
significant problems. It is necessary for
manufacturers to display the list price
in direct-to-consumer television
advertisements of prescription drugs
and biological products to provide
relevant information to beneficiaries to
allow them to work with their
prescribers to select the best overall
treatment. Form Number: CMS–10699
(OMB control number: 0938–New);
Frequency: Occasionally; Affected
Public: Private Sector (Business or other
for-profits); Number of Respondents: 25;
Total Annual Responses: 1,200; Total
Annual Hours: 300. (For policy
questions regarding this collection
contact Cheri Rice at 410 786–6499.)
Dated: April 3, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–06884 Filed 4–5–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Building
Evidence on Employment Strategies
for Low-Income Families (BEES) (New
Collection)
Office of Planning, Research,
and Evaluation; Administration for
Children and Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) is
proposing a data collection activity as
part of the Building Evidence on
Employment Strategies for Low-Income
Families (BEES). The purpose of BEES
SUMMARY:
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is to evaluate the effectiveness of a
broad range of innovative programs
designed to boost employment and
earnings among low-income Americans.
Within this general focus area, ACF has
a particular interest in programs that
serve adults whose employment
prospects have been affected by
substance use disorder (SUD), opioid
use disorder (OUD), mental health
conditions, and justice involvement.
ACF expects that a subset of programs
to be evaluated will serve these specific
target populations. To meet these
objectives, this study will include
impact and implementation evaluations
for up to 21 sites, as well as descriptive
work focused on other sites that have a
focus on clients with opioid use and
other substance abuse disorders. When
possible, a randomized control trial
research design will be used for the
impact evaluations. The purpose of the
current submission is to request
approval for data collection needed for
the BEES study.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV. Attn:
Desk Officer for the Administration for
Children and Families.
Copies of the proposed collection may
be obtained by emailing OPREinfo
collection@acf.hhs.gov. Alternatively,
copies can also be obtained by writing
to the Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The BEES impact studies
call for multiple data collection points
with study participants. Data will be
collected from study participants
through the following methods: (1)
Baseline information form completed by
study participants at study entry, (2)
study participants will also be asked to
periodically update their contact
information, (3) interview administered
to participants in non-behavioral health
sites 6 months after study entry to learn
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]]>Agencies
[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13929-13930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06884]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-R-64 and CMS-10699]
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 June 7, 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 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-R-64 Indirect Medical Education and Direct Graduate Medical
Education
CMS-10699 Information Collection Requirements Associated with Drug
Pricing Transparency and Supporting Regulations in 42 CFR 403.1202
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
[[Page 13930]]
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 of a currently
approved collection; Title of Information Collection: Indirect Medical
Education and Direct Graduate Medical Education; Use: Section
1886(d)(5)(B) of the Social Security Act requires additional payments
to be made under the Medicare Prospective Payment System (PPS) for the
indirect medical educational costs a hospital incurs in connection with
interns and residents (IRs) in approved teaching programs. In addition,
Title 42, Part 413, sections 75 through 83 implement section 1886(d) of
the Act by establishing the methodology for Medicare payment for the
costs of direct graduate medical educational activities. These
payments, which are adjustments (add-ons) to other payments made to a
hospital under PPS, are largely determined by the number of full-time
equivalent (FTE) IRs that work at a hospital during its cost reporting
period. In Federal fiscal year (FY) 2018, the estimated Medicare
program payments for indirect medical education (IME) costs was $6.4
billion. Medicare program payment for direct graduate medical education
(GME) is also based upon the number of FTE-IRs that work at a hospital.
In FY 2018, the estimated Medicare program payments for GME costs was
$3.1 billion. Since it is important to accurately count the number of
IRs FTEs working at each hospital, original approval was obtained from
the Office of Management and Budget (OMB) in 1985 to collect the IR
information required in 42 CFR 412.105(f) and timeframes for filing.
All Medicare health plans are required to use these standardized
notices. Form Number: CMS-R-64 (OMB control number: 0938-0456);
Frequency: Yearly; Affected Public: Private Sector (Business or other
for-profits, Not-for-profit institutions); Number of Respondents:
1,245; Total Annual Responses: 1,245; Total Annual Hours: 2,490. (For
policy questions regarding this collection contact Owen Osaghae at 410-
786-7550.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Information Collection Requirements Associated with Drug Pricing
Transparency and Supporting Regulations in 42 CFR 403.1202; Use: The
Department of Health and Human Services proposed a rule (78 FR 52789)
to revise the Federal Health Insurance Programs for the Aged and
Disabled by amending regulations for the Medicare and Medicaid program,
to require direct-to-consumer (DTC) television advertisements of
prescription drugs and biological products for which payment is
available through or under Medicare or Medicaid to include the
Wholesale Acquisition Cost (WAC, or list price) of that drug or
biological product. This rule is intended to improve the efficient
administration of the Medicare and Medicaid programs by ensuring that
beneficiaries are provided with relevant information about the costs of
prescription drugs and biological products so they can make informed
decisions that minimize not only their out-of-pocket costs, but also
expenditures borne by Medicare and Medicaid, both of which are
significant problems. It is necessary for manufacturers to display the
list price in direct-to-consumer television advertisements of
prescription drugs and biological products to provide relevant
information to beneficiaries to allow them to work with their
prescribers to select the best overall treatment. Form Number: CMS-
10699 (OMB control number: 0938-New); Frequency: Occasionally; Affected
Public: Private Sector (Business or other for-profits); Number of
Respondents: 25; Total Annual Responses: 1,200; Total Annual Hours:
300. (For policy questions regarding this collection contact Cheri Rice
at 410 786-6499.)
Dated: April 3, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-06884 Filed 4-5-19; 8:45 am]
BILLING CODE 4120-01-P
