Medicare Program; Solicitation for Proposals for Medical Savings Account Demonstration Project, 39683-39684 [06-6192]
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Federal Register / Vol. 71, No. 134 / Thursday, July 13, 2006 / Notices
39683
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Centers for Medicare & Medicaid
Services
Designation of a Class of Employees
for Addition to the Special Exposure
Cohort
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panels (SEP): Avian
Influenza Cooperative Research
Centers—Studies at the Human-Animal
Interface, Request for Applications
(RFA) #CI06–009; and NonPharmaceutical Interventions for
Pandemic Influenza, RFA #CI06–010
[CMS–4123–N]
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Notice.
The Department of Health and
Human Services (HHS) gives notice of a
decision to designate a class of
employees at the Pacific Proving
Grounds, Enewetak Atoll, as an addition
to the Special Exposure Cohort (SEC)
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. On June 26, 2006,
the Secretary of HHS designated the
following class of employees as an
addition to the SEC:
SUMMARY:
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS C–46, Cincinnati, OH
45226, Telephone 513–533–6800 (this is
not a toll-free number). Information
requests can also be submitted by e-mail
to OCAS@CDC.GOV.
Name: ‘‘Avian Influenza Cooperative
Research Centers—Studies at the HumanAnimal Interface,’’ Request for Applications
(RFA) #CI06–009; and ‘‘Non-pharmaceutical
Interventions for Pandemic Influenza,’’ RFA
#CI06–010.
Times and Dates: 8 a.m.–8:30 a.m., August
17, 2006 (Open).
8:30 a.m.–4 p.m., August 17, 2006 (Closed).
8 a.m.–8:30 a.m., August 18, 2006 (Open).
8:30 a.m.–4 p.m., August 18, 2006 (Closed).
Place: Sheraton Gateway Atlanta Airport
Hotel, 1900 Sullivan Road, Atlanta, GA
30337, Telephone Number 770.997.1100.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to RFA #CI06–009, ‘‘Avian
Influenza Cooperative Research Centers—
Studies at the Human-Animal Interface’’; and
RFA #CI06–010, ‘‘Non-pharmaceutical
Interventions for Pandemic Influenza.’’
For Further Information Contact: Felix
Rogers, PhD, M.P.H., Scientific Review
Administrator, National Immunization
Program, CDC, 1600 Clifton Road, NE.,
Mailstop E–05, Atlanta, GA 30333,
Telephone Number 404.639.6101.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: July 5, 2006.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. E6–11029 Filed 7–12–06; 8:45 am]
Dated: July 6, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–11018 Filed 7–12–06; 8:45 am]
BILLING CODE 4160–17–P
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Department of Energy (DOE) employees or
DOE contractor or subcontractor employees
who worked at the Pacific Proving Grounds
(PPG) from 1946 through 1962 for a number
of work days aggregating at least 250 work
days, either solely under this employment or
in combination with work days within the
parameters (excluding aggregate work day
requirements) established for other classes of
employees included in the SEC, and who
were monitored or should have been
monitored.
This designation will become
effective on July 26, 2006, unless
Congress provides otherwise prior to the
effective date. After this effective date,
HHS will publish a notice in the
Federal Register reporting the addition
of this class to the SEC or the result of
any provision by Congress regarding the
decision by HHS to add the class to the
SEC.
sroberts on PROD1PC70 with NOTICES
FOR FURTHER INFORMATION CONTACT:
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17:46 Jul 12, 2006
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Medicare Program; Solicitation for
Proposals for Medical Savings
Account Demonstration Project
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice is to inform
interested parties of an opportunity to
apply to participate in the Medicare
Advantage (MA) Medical Savings
Account (MSA) demonstration project.
The MA MSA demonstration design
waives certain MA MSA plan
requirements under sections 1859(b)(3),
1853(e), and 1854(c) of the Social
Security Act. This waiver will allow
entities to offer products that more
closely resemble high deductible health
plans (HDHPs) that are offered with
Health Savings Accounts to the nonMedicare population. This
demonstration will be conducted in
accordance with the Secretary’s
demonstration authority under section
402(a)(1)(A) of the Social Security
Amendments of 1967, 42 U.S.C. 1395b–
1(a)(1)(A).
DATES: Applications will be considered
timely if we receive them by July 21,
2006.
FOR FURTHER INFORMATION CONTACT:
Yolanda Robinson at (410) 786–7627.
Interested parties can obtain a complete
solicitation, application, and supporting
information on the following CMS Web
site at https://www.cms.hhs.gov/
MedicareAdvantageApps/.
ADDRESSES: Mail or deliver applications
and NOIs to the following address:
Centers for Medicare and Medicaid
Services, Attn: Yolanda Robinson CBC/
MAG/DQPM, Mail Stop C4–23–07, 7500
Security Blvd., Baltimore, MD 21244.
Because of staff and resource
limitations, we cannot accept
applications by facsimile (FAX)
transmission or by e-mail.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1851(a)(2)(C) and 1859(b)(3)
of the Social Security Act (the Act)
authorize Medicare Advantage plans to
offer Medical Savings Accounts (MSAs)
to beneficiaries. However, the required
benefit structure is not perceived by
insurance organizations as easily
marketable. Similar to Health Savings
Accounts (HSAs) accounts currently
E:\FR\FM\13JYN1.SGM
13JYN1
39684
Federal Register / Vol. 71, No. 134 / Thursday, July 13, 2006 / Notices
available in the commercial market, the
MSA demonstration allows more
flexible benefits that will allow
beneficiaries the freedom to exercise
control over their health care spending
while providing important protection
against catastrophic health care costs.
CMS is providing flexibility with this
MSA demonstration project to make the
increasingly popular consumer-directed
plans available to Medicare
beneficiaries. The demonstration
framework includes the flexibility we
are allowed under our demo authority.
The goal of the demonstration is to
test whether the consumer directed
health plans in Medicare will help
lower health care cost for enrollees
without adversely affecting the quality
of health care services. We expect that
this demonstration will make ‘‘HSA
like’’ MSAs available to Medicare
beneficiaries beginning January 1, 2007.
We are establishing this
demonstration under section
402(a)(1)(A) of the Social Security
Amendments of 1967, 42 U.S.C.
§ 1395b–1(a)(1)(A), which authorizes the
Secretary to conduct demonstrations
designed to test whether changes in
methods of payment under Medicare
would have the effect of increasing the
efficiency and economy of Medicare
services without adversely affecting the
quality of services.
sroberts on PROD1PC70 with NOTICES
II. Provisions of the Notice
The purpose of this notice is to inform
Medicare Advantage organizations of an
opportunity to apply to participate in
the Medicare Advantage (MA) Medical
Savings Account (MSA) demonstration
project. To assist in the planning
process, we have posted the MA MSA
plan demonstration framework as well
as the MA MSA application on our Web
site at https://www.cms.hhs.gov/
MedicareAdvantageApps/. The
framework outlines specific parameters
for design flexibilities. The MA MSA
application must be completed and the
benefit design must stay within the
boundaries of the MA MSA plan
demonstration framework. The
applicant must provide an operational
discussion of the following:
• Product offering;
• Deposit calculations;
• Recovery policy for the current-year
deposit, and procedures for members
who are disenrolled from the plan
before the end of the contract year.
(Note that disenrollment may occur only
for the reasons such as death or moving
out of the service area as specified in
section 1851(e)(5)(B) of the Act);
• Items and services to be counted
toward the member’s deductible;
VerDate Aug<31>2005
17:46 Jul 12, 2006
Jkt 208001
• Whether a Prescription Drug Plan
will be offered by your organization and
marketed to potential MSA enrollees;
• Policy and procedures on
portability of the member’s account;
• Use of networks and whether/how
cost sharing and the member out-ofpocket maximum will vary in-network
versus out-of-network;
• Service area for product offering
and whether it is individual and/or
employer group; and
• Any other aspects making the
product offering different from the
statutory requirements of an MSA plan
and as allowed under the framework.
Medicare Advantage organizations
interested in participating in 2007 must
submit a complete MA MSA
application, which is available on the
CMS Web site at https://
www.cms.hhs.gov/
MedicareAdvantageApps/, no later than
July 21, 2006. Your organization’s bid
and benefit submission is due no later
than August 10, 2006. Organizations
interested in participating for 2008 are
requested to submit an NOI to CMS as
soon as possible for us to understand
the level of future interest in the
product. Submitting an NOI does not
require your organization to apply, nor
is it required to apply. The NOI form is
posted at the above Web site.
III. Collection of Information
Requirements
Authority: Section 402(a)(1)(A) of the
Social Security Act, 42 U.S.C. 1395b–1.
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: May 30, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 06–6192 Filed 7–10–06; 4:07 pm]
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. 1998D–0315]
Guidance for Industry on Providing
Regulatory Submissions to the Center
for Biologics Evaluation and Research
in Electronic Format—Lot Release
Protocols; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Providing
Regulatory Submissions to the Center
for Biologics Evaluation and Research
(CBER) in Electronic Format—Lot
Release Protocols’’ dated July 2006. The
guidance is intended to provide
manufacturers of biological products
regulated by CBER with
recommendations for submitting lot
release protocols in electronic format to
CBER Product Release Branch. This
guidance document finalizes the draft
guidance entitled ‘‘Guidance for
Industry: Instructions for Submitting
Electronic Lot Release Protocols to the
Center for Biologics Evaluation and
Research’’ dated May 1998.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of the guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Astrid Szeto, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N,Rockville,
MD 20852–1448, 301–827–6210.
ADDRESSES:
This information collection
requirement is subject to the Paperwork
Reduction Act of 1995 (PRA); however,
the collection is currently approved
under OMB control number 0938–0935
entitled ‘‘Medicare Advantage
Applications’’ with a current expiration
date of July 31, 2006.
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Agencies
[Federal Register Volume 71, Number 134 (Thursday, July 13, 2006)]
[Notices]
[Pages 39683-39684]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6192]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-4123-N]
Medicare Program; Solicitation for Proposals for Medical Savings
Account Demonstration Project
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice is to inform interested parties of an opportunity
to apply to participate in the Medicare Advantage (MA) Medical Savings
Account (MSA) demonstration project. The MA MSA demonstration design
waives certain MA MSA plan requirements under sections 1859(b)(3),
1853(e), and 1854(c) of the Social Security Act. This waiver will allow
entities to offer products that more closely resemble high deductible
health plans (HDHPs) that are offered with Health Savings Accounts to
the non-Medicare population. This demonstration will be conducted in
accordance with the Secretary's demonstration authority under section
402(a)(1)(A) of the Social Security Amendments of 1967, 42 U.S.C.
1395b-1(a)(1)(A).
DATES: Applications will be considered timely if we receive them by
July 21, 2006.
FOR FURTHER INFORMATION CONTACT: Yolanda Robinson at (410) 786-7627.
Interested parties can obtain a complete solicitation, application, and
supporting information on the following CMS Web site at https://
www.cms.hhs.gov/MedicareAdvantageApps/.
ADDRESSES: Mail or deliver applications and NOIs to the following
address: Centers for Medicare and Medicaid Services, Attn: Yolanda
Robinson CBC/MAG/DQPM, Mail Stop C4-23-07, 7500 Security Blvd.,
Baltimore, MD 21244.
Because of staff and resource limitations, we cannot accept
applications by facsimile (FAX) transmission or by e-mail.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1851(a)(2)(C) and 1859(b)(3) of the Social Security Act
(the Act) authorize Medicare Advantage plans to offer Medical Savings
Accounts (MSAs) to beneficiaries. However, the required benefit
structure is not perceived by insurance organizations as easily
marketable. Similar to Health Savings Accounts (HSAs) accounts
currently
[[Page 39684]]
available in the commercial market, the MSA demonstration allows more
flexible benefits that will allow beneficiaries the freedom to exercise
control over their health care spending while providing important
protection against catastrophic health care costs. CMS is providing
flexibility with this MSA demonstration project to make the
increasingly popular consumer-directed plans available to Medicare
beneficiaries. The demonstration framework includes the flexibility we
are allowed under our demo authority.
The goal of the demonstration is to test whether the consumer
directed health plans in Medicare will help lower health care cost for
enrollees without adversely affecting the quality of health care
services. We expect that this demonstration will make ``HSA like'' MSAs
available to Medicare beneficiaries beginning January 1, 2007.
We are establishing this demonstration under section 402(a)(1)(A)
of the Social Security Amendments of 1967, 42 U.S.C. Sec. 1395b-
1(a)(1)(A), which authorizes the Secretary to conduct demonstrations
designed to test whether changes in methods of payment under Medicare
would have the effect of increasing the efficiency and economy of
Medicare services without adversely affecting the quality of services.
II. Provisions of the Notice
The purpose of this notice is to inform Medicare Advantage
organizations of an opportunity to apply to participate in the Medicare
Advantage (MA) Medical Savings Account (MSA) demonstration project. To
assist in the planning process, we have posted the MA MSA plan
demonstration framework as well as the MA MSA application on our Web
site at https://www.cms.hhs.gov/MedicareAdvantageApps/. The framework
outlines specific parameters for design flexibilities. The MA MSA
application must be completed and the benefit design must stay within
the boundaries of the MA MSA plan demonstration framework. The
applicant must provide an operational discussion of the following:
Product offering;
Deposit calculations;
Recovery policy for the current-year deposit, and
procedures for members who are disenrolled from the plan before the end
of the contract year. (Note that disenrollment may occur only for the
reasons such as death or moving out of the service area as specified in
section 1851(e)(5)(B) of the Act);
Items and services to be counted toward the member's
deductible;
Whether a Prescription Drug Plan will be offered by your
organization and marketed to potential MSA enrollees;
Policy and procedures on portability of the member's
account;
Use of networks and whether/how cost sharing and the
member out-of-pocket maximum will vary in-network versus out-of-
network;
Service area for product offering and whether it is
individual and/or employer group; and
Any other aspects making the product offering different
from the statutory requirements of an MSA plan and as allowed under the
framework.
Medicare Advantage organizations interested in participating in
2007 must submit a complete MA MSA application, which is available on
the CMS Web site at https://www.cms.hhs.gov/MedicareAdvantageApps/, no
later than July 21, 2006. Your organization's bid and benefit
submission is due no later than August 10, 2006. Organizations
interested in participating for 2008 are requested to submit an NOI to
CMS as soon as possible for us to understand the level of future
interest in the product. Submitting an NOI does not require your
organization to apply, nor is it required to apply. The NOI form is
posted at the above Web site.
III. Collection of Information Requirements
This information collection requirement is subject to the Paperwork
Reduction Act of 1995 (PRA); however, the collection is currently
approved under OMB control number 0938-0935 entitled ``Medicare
Advantage Applications'' with a current expiration date of July 31,
2006.
Authority: Section 402(a)(1)(A) of the Social Security Act, 42
U.S.C. 1395b-1.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplementary Medical Insurance Program)
Dated: May 30, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 06-6192 Filed 7-10-06; 4:07 pm]
BILLING CODE 4120-01-P