Agency Information Collection Activities: Proposed Collection; Comment Request, 13929-13930 [2019-06884]

Download as PDF 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? VerDate Sep<11>2014 17:45 Apr 05, 2019 Jkt 247001 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: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 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 E:\FR\FM\08APN1.SGM 08APN1 13930 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: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 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 E:\FR\FM\08APN1.SGM 08APN1

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]


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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


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