Agency Information Collection Activities: Proposed Collection; Comment Request, 23705-23706 [2016-09425]
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Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
knowledge of beneficiaries’ experiences
with the care, as well as information on
any potential health consequences due
to changes in IG medication or
participation in the Demonstration.
Lastly, we will gather the physicians
and nurses’ views of the degree to
which beneficiaries believe the program
is effective, including the cost
effectiveness for beneficiaries who use
the services provided under the
Demonstration. Form Number: CMS–
10600 (OMB control number: 0938–
NEW); Frequency: Annually; Affected
Public: Individuals and Households;
State, Local or Tribal Governments;
Private Sector (Business or other forprofit); Number of Respondents: 2,488;
Total Annual Responses: 2,488; Total
Annual Hours: 483. (For policy
questions regarding this collection
contact Pauline Karikari-Martin at 410–
786–1040).
Dated: April 19, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–09415 Filed 4–21–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–1490S and
CMS–10458]
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 require; 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
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
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(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) 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 21, 2016.
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
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
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:
Reports Clearance Office at (410) 786–
1326.
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–1490S Patient’s Request for
Medicare Payment
CMS–10458 Consumer Research
Supporting Outreach for Health
Insurance Marketplace
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
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23705
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.
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Patient’s
Request for Medicare Payment; Use: The
Form CMS–1490S form provides
beneficiaries with a relatively easy form
to use when filing their claims. Without
the collection of this information,
claims for reimbursement relating to the
provision of Part B medical services/
supplies could not be acted upon. This
would result in a nationwide paralysis
of the operation of the Federal
Government’s Part B Medicare program,
and major problems for the patients/
beneficiaries inflicting severe physical
and financial hardship on beneficiaries.
This form was explicitly developed for
easy use by beneficiaries who file their
own claims. The CMS–1490S form can
be obtained from any Social Security
office or Medicare Administrative
Contractors or CMS. When the CMS–
1490S is used, the beneficiary must
attach to it his/her bills from physicians
or suppliers. The form is, therefore,
designed specifically to aid beneficiaries
who cannot get assistance from their
physicians or suppliers for completing
claim forms. The form is currently
approved under 0938–1197; however,
we are submitting for approval as a
standalone information collection
request. Once a new OMB control
number is issued, we will remove the
burden for the CMS–1490S that is
currently approved under OMB control
number 0938–1197. Form Number:
CMS–1490 (OMB control number:
0938–NEW); Frequency: Occasionally
Affected Public: Individuals and
Households; Number of Respondents:
167,839; Total Annual Responses:
167,839; Total Annual Hours: 83,920.
(For policy questions regarding this
collection contact Sumita Sen at 410–
786–5755.)
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22APN1
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Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
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2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Consumer
Research Supporting Outreach for
Health Insurance Marketplace; Use: The
Centers for Medicare and Medicaid
Services is requesting reapproval for
two surveys that aid in understanding
levels of awareness and customer
service needs associated with the Health
Insurance Marketplace established by
the Affordable Care Act. Because the
Marketplace will provide coverage to
the almost 50 million uninsured in the
United States through individual and
small employer programs, we have
developed one survey to be
administered to individual consumers
most likely to use the Marketplace and
another to be administered to small
employers most likely to use the Small
Business Health Options portion of the
Marketplace. These brief surveys,
designed to be conducted quarterly, give
CMS the ability to obtain a rough
indication of the types of outreach and
marketing that will be needed to
enhance awareness of and knowledge
about the Marketplace for individual
and business customers. CMS’ biggest
customer service need is likely to be
providing sufficient education so
consumers: (a) Can take advantage of the
Marketplace and (b) know how to access
CMS’ customer service channels. The
surveys will provide information on
media use, concept awareness, and
conceptual or content areas where
education for customer service delivery
can be improved. Awareness and
knowledge gaps are likely to change
over time based not only on
effectiveness of CMS’ marketing efforts,
but also of those of state, local, private
sector, and nongovernmental
organizations. Form Number: CMS–
10458 (OMB control number: 0938–
1203): Frequency: Quarterly; Affected
Public: Individuals or households,
Private Sector (business or other forprofits); Number of Respondents:
40,200; Total Annual Responses:
40,200; Total Annual Hours: 2,480. (For
policy questions regarding this
collection contact Frank Funderburk at
410–786–1820.)
Dated: April 19, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–09425 Filed 4–21–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Notice of Approval of ASHI as an
Accreditation Organization
Centers for Medicare & Medicaid
Services
In this notice, we approve ASHI as an
organization that may accredit
laboratories for purposes of establishing
its compliance with CLIA requirements
for the subspecialty of General
Immunology, the specialty of
Histocompatibility, and the subspecialty
of ABO/Rh typing. We have examined
the initial ASHI application and all
subsequent submissions to determine its
accreditation program’s equivalency
with the requirements for approval of an
accreditation organization under
subpart E of part 493. We have
determined that ASHI meets or exceeds
the applicable CLIA requirements. We
have also determined that ASHI will
ensure that its accredited laboratories
will meet or exceed the applicable
requirements in subparts H, I, J, K, M,
Q, and the applicable sections of R.
Therefore, we grant ASHI approval as an
accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for the subspecialty of General
Immunology, the specialty of
Histocompatibility, and the subspecialty
of ABO/Rh typing. As a result of this
determination, any laboratory that is
accredited by ASHI during the time
period stated in the DATES section of this
notice will be deemed to meet the CLIA
requirements for the listed
subspecialties and specialties, and
therefore, will generally not be subject
to routine inspections by a state survey
agency to determine its compliance with
CLIA requirements. The accredited
laboratory, however, is subject to
validation and complaint investigation
surveys performed by CMS, or its
agent(s).
[CMS–3330–N]
Announcement of the Re-Approval of
the American Society of
Histocompatibility and
Immunogenetics (ASHI) as an
Accreditation Organization Under the
Clinical Laboratory Improvement
Amendments of 1988
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
application of the American Society for
Histocompatibility and Immunogenetics
(ASHI) for approval as an accreditation
organization for clinical laboratories
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program for the following
specialty and subspecialty areas:
General Immunology;
Histocompatibility; and ABO/Rh typing.
We have determined that the ASHI
accreditation meets or exceeds the
applicable CLIA requirements. We are
announcing the approval and grant
ASHI deeming authority for a period of
6 years.
DATES: Effective Date: This notice is
effective from April 22, 2016 to April
21, 2022.
FOR FURTHER INFORMATION CONTACT:
Penelope Meyers, (410) 786–3366.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) (Pub. L. 100–578). CLIA
amended section 353 of the Public
Health Service Act. We issued a final
rule implementing the accreditation
provisions of CLIA on July 31, 1992 (57
FR 33992). Under those provisions, we
may grant deeming authority to an
accreditation organization if its
requirements for laboratories accredited
under its program are equal to or more
stringent than the applicable CLIA
program requirements in 42 CFR part
493 (Laboratory Requirements). Subpart
E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption Under an Approved State
Laboratory Program) specifies the
requirements an accreditation
organization must meet to be approved
by us as an accreditation organization
under CLIA.
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III. Evaluation of ASHI Commission
Request for Approval as an
Accreditation Organization Under
CLIA
The following describes the process
used to determine that ASHI
accreditation program meets the
necessary requirements to be approved
by us and that, as such, we may approve
ASHI as an accreditation program with
deeming authority under the CLIA
program. ASHI formally applied to us
for approval as an accreditation
organization under CLIA for the
subspecialty of General Immunology,
the specialty of Histocompatibility, and
the subspecialty of ABO/Rh typing. In
reviewing these materials, we reached
the following determinations for each
applicable part of the CLIA regulations:
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Agencies
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23705-23706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09425]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-1490S and CMS-10458]
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 require; 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 any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) 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 21, 2016.
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' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
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: Reports Clearance Office at (410) 786-
1326.
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-1490S Patient's Request for Medicare Payment
CMS-10458 Consumer Research Supporting Outreach for Health Insurance
Marketplace
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.
1. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Patient's Request for Medicare Payment; Use: The Form CMS-1490S form
provides beneficiaries with a relatively easy form to use when filing
their claims. Without the collection of this information, claims for
reimbursement relating to the provision of Part B medical services/
supplies could not be acted upon. This would result in a nationwide
paralysis of the operation of the Federal Government's Part B Medicare
program, and major problems for the patients/beneficiaries inflicting
severe physical and financial hardship on beneficiaries. This form was
explicitly developed for easy use by beneficiaries who file their own
claims. The CMS-1490S form can be obtained from any Social Security
office or Medicare Administrative Contractors or CMS. When the CMS-
1490S is used, the beneficiary must attach to it his/her bills from
physicians or suppliers. The form is, therefore, designed specifically
to aid beneficiaries who cannot get assistance from their physicians or
suppliers for completing claim forms. The form is currently approved
under 0938-1197; however, we are submitting for approval as a
standalone information collection request. Once a new OMB control
number is issued, we will remove the burden for the CMS-1490S that is
currently approved under OMB control number 0938-1197. Form Number:
CMS-1490 (OMB control number: 0938-NEW); Frequency: Occasionally
Affected Public: Individuals and Households; Number of Respondents:
167,839; Total Annual Responses: 167,839; Total Annual Hours: 83,920.
(For policy questions regarding this collection contact Sumita Sen at
410-786-5755.)
[[Page 23706]]
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Consumer Research
Supporting Outreach for Health Insurance Marketplace; Use: The Centers
for Medicare and Medicaid Services is requesting reapproval for two
surveys that aid in understanding levels of awareness and customer
service needs associated with the Health Insurance Marketplace
established by the Affordable Care Act. Because the Marketplace will
provide coverage to the almost 50 million uninsured in the United
States through individual and small employer programs, we have
developed one survey to be administered to individual consumers most
likely to use the Marketplace and another to be administered to small
employers most likely to use the Small Business Health Options portion
of the Marketplace. These brief surveys, designed to be conducted
quarterly, give CMS the ability to obtain a rough indication of the
types of outreach and marketing that will be needed to enhance
awareness of and knowledge about the Marketplace for individual and
business customers. CMS' biggest customer service need is likely to be
providing sufficient education so consumers: (a) Can take advantage of
the Marketplace and (b) know how to access CMS' customer service
channels. The surveys will provide information on media use, concept
awareness, and conceptual or content areas where education for customer
service delivery can be improved. Awareness and knowledge gaps are
likely to change over time based not only on effectiveness of CMS'
marketing efforts, but also of those of state, local, private sector,
and nongovernmental organizations. Form Number: CMS-10458 (OMB control
number: 0938-1203): Frequency: Quarterly; Affected Public: Individuals
or households, Private Sector (business or other for-profits); Number
of Respondents: 40,200; Total Annual Responses: 40,200; Total Annual
Hours: 2,480. (For policy questions regarding this collection contact
Frank Funderburk at 410-786-1820.)
Dated: April 19, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2016-09425 Filed 4-21-16; 8:45 am]
BILLING CODE 4120-01-P