Agency Information Collection Activities: Submission for OMB Review; Comment Request, 902-903 [E9-52]
Download as PDF
902
Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices
cooperative agreements are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act. If the proposed project
involves research on human subjects,
the applicants must comply with
Department of Health and Human
Services regulations (45 CFR part 46)
regarding the protection of human
subjects. The applicants must ensure
that the project will be subject to initial
and continuing review by the
appropriate institutional review
committees. Overall, by providing
additional scientific information for the
risk assessment process, data generated
from this research will support other
researchers who are conducting human
health assessments involving these two
substances.
The mechanisms for implementing
SSARP are discussed next. The status of
SSARP in addressing priority data needs
of the first 60 priority hazardous
substances through these mechanisms
was described in a Federal Register
Notice on December 13, 2005 (70 FR
73749).
mstockstill on PROD1PC66 with NOTICES
A. TSCA/FIFRA
In developing and implementing
SSARP, ATSDR and EPA established
procedures to identify priority data
needs of common interest to multiple
federal programs. Where practicable,
these data needs will be addressed
through a program of toxicologic testing
under TSCA or FIFRA. This part of the
research will be conducted according to
established TSCA/FIFRA procedures
and guidelines.
B. Private-Sector Voluntarism
As part of SSARP, on February 7,
1992, ATSDR announced a set of
proposed procedures for conducting
voluntary research (57 FR 4758).
Revisions based on public comments
were published on November 16, 1992
(57 FR 54160). ATSDR strongly
encourages private-sector organizations
to propose research to address priority
data needs at any time until ATSDR
announces that research has already
been initiated for a specific priority data
need. Private-sector organizations may
volunteer to conduct research to address
specific priority data needs identified in
this notice by submitting a letter of
intent.
The letter of intent should be a brief
statement (1–2 pages) that identifies the
priority data need(s) to be filled and the
methods to be used. TASARC will
review these proposals and recommend
to ATSDR the voluntary research
projects that should be pursued—and
how they should be conducted—with
the volunteer organizations. ATSDR will
VerDate Nov<24>2008
16:16 Jan 08, 2009
Jkt 217001
enter into only those voluntary research
projects that lead to high-quality, peerreviewed scientific work. Additional
details regarding the process for
voluntary research are in the Federal
Register Notices cited in this section.
C. CERCLA
Those priority data needs that are not
addressed by TSCA/FIFRA or initial
voluntarism will be considered for
funding by ATSDR through its CERCLA
budget. Much of this research program
is envisioned to be unique to CERCLA—
for example, research on substances not
regulated by other programs or research
needs specific to public health
assessments. A current example of the
direct use of CERCLA funds is a
cooperative agreement with the
Association of Minority Health
Professions Schools (AMHPS) that
supports the AMHPS Environmental
Health, Health Services, and Toxicology
Research programs.
Mechanisms to address these priority
data needs may include a second call for
voluntarism. Again, scientific peer
review of study protocols and results
would occur for all research conducted
under this auspice.
ATSDR encourages private-sector
organizations and other governmental
programs to use ATSDR’s priority data
needs to plan their research activities.
Dated: January 6, 2009.
Ken Rose,
Director, Office of Policy, Planning, and
Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. E9–189 Filed 1–8–09; 8:45 am]
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–262, CMS–
10142 and CMS–R–137]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
estimate 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 function;
(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.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: CY 2010 Plan
Benefit Package (PBP) and Formulary
Submission for Medicare Advantage
(MA) Plans and Prescription Drug Plans
(PDP) Use: Under the Medicare
Modernization Act (MMA), Medicare
Advantage (MA) and Prescription Drug
Plan (PDP) organizations are required to
submit plan benefit packages for all
Medicare beneficiaries residing in their
service area. The plan benefit package
submission consists of the formulary
file, Plan Benefit Package (PBP)
software, and supporting documentation
as necessary. MA and PDP organizations
will generate a formulary to illustrate
their list of drugs, including information
on prior authorization, step therapy,
tiering, and quantity limits.
Additionally, the PBP software will be
used to describe their organization’s
plan benefit packages, including
information on premiums, cost sharing,
authorization rules, and supplemental
benefits. CMS uses the formulary and
PBP data to review and approve the
plan benefit packages proposed by each
MA and PDP organization.
CMS requires that MA and PDP
organizations submit a completed
formulary and PBP as part of the annual
bidding process. During this process,
organizations prepare their proposed
plan benefit packages for the upcoming
contract year and submit them to CMS
for review and approval. Based on
operational changes and policy
clarifications to the Medicare program
and continued input and feedback by
the industry, CMS has made the
necessary changes to the plan benefit
package submission. Form Number:
CMS–R–262 (OMB# 0938–0763);
Frequency: Yearly; Affected Public:
Business or other for-profits b. Not-forprofit institutions; Number of
Respondents: 475; Total Annual
Responses: 4987.5; Total Annual Hours:
12112.5.
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
E:\FR\FM\09JAN1.SGM
09JAN1
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices
Information Collection: CY 2010 Bid
Pricing Tool (BPT) for Medicare
Advantage (MA) Plans and Prescription
Drug Plans (PDP). Use: Under the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA), and implementing
regulations at 42 CFR, Medicare
Advantage organizations (MAO) and
Prescription Drug Plans (PDP) are
required to submit an actuarial pricing
‘‘bid’’ for each plan offered to Medicare
beneficiaries for approval by CMS.
MAOs and PDPs use the Bid Pricing
Tool (BPT) software to develop their
actuarial pricing bid. The information
provided in the BPT is the basis for the
plan’s enrollee premiums and CMS
payments for each contract year. The
tool collects data such as medical
expense development (from claims data
and/or manual rating), administrative
expenses, profit levels, and projected
plan enrollment information. By statute,
completed BPTs are due to CMS by the
first Monday of June each year. CMS
reviews and analyzes the information
provided on the Bid Pricing Tool.
Ultimately, CMS decides whether to
approve the plan pricing (i.e., payment
and premium) proposed by each
organization. Form Number: CMS–
10142 (OMB# 0938–0944); Frequency:
Yearly; Affected Public: Business or
other for-profits b. Not-for-profit
institutions; Number of Respondents:
550; Total Annual Responses: 6050;
Total Annual Hours: 42,350.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Internal
Revenue Service (IRS)/Social Security
Administration (SSA)/Centers for
Medicare and Medicaid Services (CMS)
Data Match and Supporting Regulations
in 42 CFR 411.20–491.206 Use:
Medicare Secondary Payer (MSP) is
essentially the same concept known in
the private insurance industry as
coordination of benefits; it refers to
those situations where Medicare
assumes a secondary payer role to
certain types of private insurance for
covered services provided to a Medicare
beneficiary.
Congress sought to reduce the losses
to the Medicare program by requiring in
42 U.S.C. 1395y(b)(5) that the Internal
Revenue Service (IRS), the Social
Security Administration (SSA), and
CMS perform an annual data match (the
IRS/SSA/CMS Data Match, or ‘‘Data
Match’’ for short). CMS uses the
information obtained through Data
Match to contact employers concerning
possible application of the MSP
provisions by requesting information
about specifically identified employees
VerDate Nov<24>2008
16:16 Jan 08, 2009
Jkt 217001
(either a Medicare beneficiary or the
working spouse of a Medicare
beneficiary). This statutory data match
and employer information collection
activity enhances CMS’s ability to
identify both past and present MSP
situations. Form Number: CMS–R–137
(OMB# 0938–0763); Frequency:
Annually; Affected Public: Business or
other for-profit, not-for-profit
institutions, farms, State, Local or Tribal
Governments; Number of Respondents:
326,597; Total Annual Responses:
326,597; Total Annual Hours: 1,900,795.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on February 9, 2009: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: December 28, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–52 Filed 1–8–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10062, CMS–
10275, and CMS–10137]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
903
comments regarding this burden
estimate 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.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Collection of
Diagnostic Data from Medicare
Advantage Organizations for Risk
Adjusted Payments: Use: CMS requires
hospital inpatient, hospital outpatient
and physician diagnostic data from
Medicare Advantage (MA) organizations
to continue making payment under the
risk adjustment methodology as
required by the Social Security Act, as
amended by the Balanced Budget Act;
the Medicare, Medicaid and SCHIP
Benefits Improvement and Protection
Act; and the Medicare Prescription Drug
Benefit, Improvement and
Modernization Act. CMS will use the
data to make risk adjusted payment
under Parts C. MA and MA–PD plans
will use the data to develop their Parts
C bids. As required by law, CMS also
annually publishes the risk adjustment
factors for plans and other interested
entities in the Advance Notice of
Methodological Changes for MA
Payment Rates (every February) and the
Announcement of Medicare Advantage
Payment Rates (every April). Lastly,
CMS issues monthly reports to each
individual plan that contains the CMSHierarchical Condition Category (HCC)
and RxHCC models’ output and the risk
scores and reimbursements for each
beneficiary that is enrolled in their plan.
Form Number: CMS–10062 (OMB#
0938–0878); Frequency: Quarterly;
Affected Public: Business or other forprofit and not-for-profit institutions;
Number of Respondents: 852; Total
Annual Responses: 22,097,070; Total
Annual Hours: 10,826.1.
2. Type of Information Collection
Request: New collection; Title of
Information Collection: CAHPS Home
Health Care Survey: Use: As part of the
Department of Health and Human
Services (DHHS) Transparency Initiative
on Quality Reporting, CMS plans to
implement a process to measure and
publicly report home health care patient
experiences through the CAHPS
(Consumer Assessment of Healthcare
E:\FR\FM\09JAN1.SGM
09JAN1
Agencies
[Federal Register Volume 74, Number 6 (Friday, January 9, 2009)]
[Notices]
[Pages 902-903]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-52]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-262, CMS-10142 and CMS-R-137]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS), Department of Health and Human Services, is publishing
the following summary of proposed collections for public comment.
Interested persons are invited to send comments regarding this burden
estimate 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 function; (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.
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: CY 2010 Plan
Benefit Package (PBP) and Formulary Submission for Medicare Advantage
(MA) Plans and Prescription Drug Plans (PDP) Use: Under the Medicare
Modernization Act (MMA), Medicare Advantage (MA) and Prescription Drug
Plan (PDP) organizations are required to submit plan benefit packages
for all Medicare beneficiaries residing in their service area. The plan
benefit package submission consists of the formulary file, Plan Benefit
Package (PBP) software, and supporting documentation as necessary. MA
and PDP organizations will generate a formulary to illustrate their
list of drugs, including information on prior authorization, step
therapy, tiering, and quantity limits. Additionally, the PBP software
will be used to describe their organization's plan benefit packages,
including information on premiums, cost sharing, authorization rules,
and supplemental benefits. CMS uses the formulary and PBP data to
review and approve the plan benefit packages proposed by each MA and
PDP organization.
CMS requires that MA and PDP organizations submit a completed
formulary and PBP as part of the annual bidding process. During this
process, organizations prepare their proposed plan benefit packages for
the upcoming contract year and submit them to CMS for review and
approval. Based on operational changes and policy clarifications to the
Medicare program and continued input and feedback by the industry, CMS
has made the necessary changes to the plan benefit package submission.
Form Number: CMS-R-262 (OMB 0938-0763); Frequency: Yearly;
Affected Public: Business or other for-profits b. Not-for-profit
institutions; Number of Respondents: 475; Total Annual Responses:
4987.5; Total Annual Hours: 12112.5.
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of
[[Page 903]]
Information Collection: CY 2010 Bid Pricing Tool (BPT) for Medicare
Advantage (MA) Plans and Prescription Drug Plans (PDP). Use: Under the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA), and implementing regulations at 42 CFR, Medicare Advantage
organizations (MAO) and Prescription Drug Plans (PDP) are required to
submit an actuarial pricing ``bid'' for each plan offered to Medicare
beneficiaries for approval by CMS. MAOs and PDPs use the Bid Pricing
Tool (BPT) software to develop their actuarial pricing bid. The
information provided in the BPT is the basis for the plan's enrollee
premiums and CMS payments for each contract year. The tool collects
data such as medical expense development (from claims data and/or
manual rating), administrative expenses, profit levels, and projected
plan enrollment information. By statute, completed BPTs are due to CMS
by the first Monday of June each year. CMS reviews and analyzes the
information provided on the Bid Pricing Tool. Ultimately, CMS decides
whether to approve the plan pricing (i.e., payment and premium)
proposed by each organization. Form Number: CMS-10142 (OMB
0938-0944); Frequency: Yearly; Affected Public: Business or other for-
profits b. Not-for-profit institutions; Number of Respondents: 550;
Total Annual Responses: 6050; Total Annual Hours: 42,350.
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Internal Revenue
Service (IRS)/Social Security Administration (SSA)/Centers for Medicare
and Medicaid Services (CMS) Data Match and Supporting Regulations in 42
CFR 411.20-491.206 Use: Medicare Secondary Payer (MSP) is essentially
the same concept known in the private insurance industry as
coordination of benefits; it refers to those situations where Medicare
assumes a secondary payer role to certain types of private insurance
for covered services provided to a Medicare beneficiary.
Congress sought to reduce the losses to the Medicare program by
requiring in 42 U.S.C. 1395y(b)(5) that the Internal Revenue Service
(IRS), the Social Security Administration (SSA), and CMS perform an
annual data match (the IRS/SSA/CMS Data Match, or ``Data Match'' for
short). CMS uses the information obtained through Data Match to contact
employers concerning possible application of the MSP provisions by
requesting information about specifically identified employees (either
a Medicare beneficiary or the working spouse of a Medicare
beneficiary). This statutory data match and employer information
collection activity enhances CMS's ability to identify both past and
present MSP situations. Form Number: CMS-R-137 (OMB 0938-
0763); Frequency: Annually; Affected Public: Business or other for-
profit, not-for-profit institutions, farms, State, Local or Tribal
Governments; Number of Respondents: 326,597; Total Annual Responses:
326,597; Total Annual Hours: 1,900,795.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS Web
Site address at https://www.cms.hhs.gov/PaperworkReductionActof1995, or
E-mail your request, including your address, phone number, OMB number,
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786-1326.
To be assured consideration, comments and recommendations for the
proposed information collections must be received by the OMB desk
officer at the address below, no later than 5 p.m. on February 9, 2009:
OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, New Executive Office Building, Room 10235, Washington, DC
20503, Fax Number: (202) 395-6974.
Dated: December 28, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-52 Filed 1-8-09; 8:45 am]
BILLING CODE 4120-01-P