Proposed Data Collections Submitted for Public Comment and Recommendations, 12449-12451 [E8-4492]
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Federal Register / Vol. 73, No. 46 / Friday, March 7, 2008 / Notices
such as this one, now constitute the
only notification of revisions in CONUS
per diem rates to agencies.
Dated: March 3, 2008.
Russell H. Pentz,
Assistant Deputy Associate Administrator,
Office of Travel, Transportation and Asset
Management.
[FR Doc. E8–4593 Filed 3–6–08; 8:45 am]
BILLING CODE 6820–14–P
GENERAL SERVICES
ADMINISTRATION
Notice of Intent To Prepare a
Supplemental Environmental Impact
Statement for the Proposed Update to
the Master Plan for the Consolidation
of the Food and Drug Administration
Headquarters at the Federal Research
Center at White Oak in Silver Spring,
MD
General Service Administration
(GSA); National Capital Region.
ACTION: Notice.
AGENCY:
sroberts on PROD1PC70 with NOTICES
SUMMARY: Pursuant to the requirements
of the National Environmental Policy
Act of 1969 (NEPA), the Council on
Environmental Quality Regulations (40
CFR parts 1500–1508), GSA Order PBS
P1095.1F (Environmental
considerations in decisionmaking, date
October 19, 1999), and the GSA Public
Buildings Service NEPA Desk Guide,
GSA plans to prepare a Supplemental
Environmental Impact Statement (SEIS)
for the proposed update to the Master
Plan to support the consolidation of the
Food and Drug Administration (FDA)
Headquarters at the Federal Research
Center at White Oak in Silver Spring,
Maryland.
FOR FURTHER INFORMATION CONTACT:
Suzanne Hill, NEPA Lead, General
Services Administration, National
Capital Region, at (202) 205–5821.
Please also call this number if special
assistance is needed to attend and
participate in the scoping meeting.
SUPPLEMENTARY INFORMATION: The notice
of intent is as follows:
Notice of Intent To Prepare a
Supplement Environmental Impact
Statement
The General Services Administration
intends to prepare a Supplemental
Environmental Impact Statement (SEIS)
to analyze the potential impacts
resulting from the proposed Master Plan
update to support the FDA Headquarters
consolidation at the Federal Research
Center (FRC) at White Oak in Silver
Spring, Maryland.
This SEIS is a supplement to the
analyses presented in the U.S. Food and
VerDate Aug<31>2005
18:46 Mar 06, 2008
Jkt 214001
Drug Administration Consolidation,
Montgomery County, Final
Environmental Impact Statement, April
1997 and the U.S. Food and Drug
Administration Headquarters
Consolidation, Final Supplemental
Environmental Impact Statement,
March 2005.
Background
In 1997, GSA completed an
environmental impact statement that
analyzed the impacts from the
consolidation of 5,974 FDA employees
at the FRC. In 2005, GSA also completed
a supplemental environmental impact
statement that analyzed the impacts of
increasing the number of employees
from 5,947 to 7,720 and the impacts of
creating a new eastern access point into
the FRC. In September 2007, new
legislation was enacted that expanded
FDA’s mandate to support the
Prescription Drug User Fee Act
(PDUFA) and the Medical Device User
Fee and Modernization Act (MDUFMA).
In order for FDA to fulfill the legislated
mandates, additional employees may be
needed, and the new legislation will
likely result in an increase of employees
at the FRC from 7,720 to 8,889. The
increase in the campus population is
needed to conduct the complex and
comprehensive reviews necessary for
new drugs and medical devices.
The purpose of the proposed action is
to update the Master Plan for the FDA
Campus at FRC to accommodate
employee growth from 7,720 to 8,889
within the 130 acres appropriated by
Congress for the FDA Campus. Need for
the proposed action is to continue to
support FDA Headquarters
consolidation at FRC and provide the
necessary office and laboratory space to
support the expanded PDUFA and
MDUFMA programs.
Alternatives Under Consideration
GSA will analyze a range of
alternatives including the no action
alternative for the proposed Master Plan
update of the FDA headquarters to
support PDUFA and MDUFMA
programs. As part of the SEIS, GSA will
study the impacts of each alternative on
the human environment.
Scoping Process
In accordance with NEPA, a scoping
process will be conducted to aid in
determining the alternatives to be
considered and the scope of issues to be
addressed, as well as for identifying the
significant issues related to the
proposed update of the Master Plan to
accommodate the additional increase in
employees at the FDA Headquarters at
White Oak, Maryland. Scoping will be
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
12449
accomplished through a public scoping
meeting, direct mail correspondence to
potentially interested persons, agencies,
and organizations, and meetings with
agencies having an interest in the FRC.
It is important that Federal, regional,
State, and local agencies, and interested
individuals and groups take this
opportunity to identify environmental
concerns that should be addressed
during the preparation of the Draft SEIS.
Public Scoping Meeting
The public scoping meeting will be
held on Thursday, March 27, 2008, from
6:30 until 8:30 p.m. at the CHI Center
(Multipurpose Room) located at 10501
New Hampshire Avenue, Silver Spring,
Maryland. The meeting will be an
informal open house along with a brief
presentation, where visitors may come,
receive information, and give
comments. GSA will publish notices in
the Washington Post and local
newspapers announcing this meeting
approximately two weeks prior to the
meeting. GSA will prepare a scoping
report, available to the public, that will
summarize the comments received and
facilitate their incorporation into the
SEIS process.
Written Comments: Agencies and the
public are encouraged to provide
written comments on the scoping issues
in addition to or in lieu of giving their
comments at the public scoping
meeting. Written comments regarding
the environmental analysis for the
proposed Master Plan update must be
postmarked no later than April 7, 2008,
and sent to the following address:
General Services Administration,
Attention: Suzanne Hill, NEPA Lead,
301 7th Street, SW., Room 7600,
Washington, DC 20407, (202) 205–5821.
E-mail: Suzanne.Hill@gsa.gov.
Dated: March 3, 2008.
Patricia T. Ralston,
Director, Portfolio Management.
[FR Doc. E8–4579 Filed 3–6–08; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–08–08AR]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
E:\FR\FM\07MRN1.SGM
07MRN1
12450
Federal Register / Vol. 73, No. 46 / Friday, March 7, 2008 / Notices
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 or send
comments to Maryam Daneshvar, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
CDC Cervical Cancer Study—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Breast and Cervical
Cancer Early Detection Program
(NBCCEDP) is the only organized
national screening program in the
United States that offers breast and
cervical cancer screening to
underserved women. Given resource
limitations, the screening policies for
cervical cancer in the program include
an annual Pap test until a woman has
had three consecutive normal Pap tests,
at which time the Pap test frequency is
reduced to every three years. Human
papillomavirus (HPV) DNA testing has
been approved in the U.S. as a
secondary screening tool for Atypical
Squamous Cells of Undetermined
Significance (ASCUS), and as a primary
screening tool for women 30 years of age
and older, but it is not currently a
reimbursable expense under NBCCEDP
guidelines. Adopting HPV DNA testing
along with Pap testing in women over
30 could help the program better utilize
resources by extending the screening
interval of women who are cytology
negative and HPV test negative, which
is estimated to be 80–90% of women.
In 2005, the NBCCEDP convened an
expert panel to evaluate policies on
reimbursement of the HPV DNA test as
an adjunct to the Pap test for primary
screening. The panel recommended that
the program not reimburse for the HPV
DNA test but instead requested that
pilot studies be performed to measure
the feasibility, acceptability and barriers
to use of the test.
In response to the expert panel’s
recommendations, CDC proposes to
conduct a pilot study at 18 clinics in the
state of Illinois. The proposed study will
examine whether or not there is an
increase in the cervical cancer screening
interval to three years for women in the
target age range with a normal Pap test
and a negative HPV DNA test. Primary
goals of the study are to: (1) Assess
whether provider and patient education
will lead to extended screening intervals
for women who have negative screening
results; (2) identify facilitators and
barriers to acceptance and appropriate
use of the HPV test and longer screening
intervals; (3) track costs associated with
HPV testing and educational
interventions; and (4) identify the HPV
genotypes among this sample of low
income women. Secondary goals of the
study are to: (1) Assess follow-up of
women with positive test results and (2)
determine provider knowledge and
acceptability of the HPV vaccine.
Approximately 8,000 women between
the ages of 35 and 60 who are visiting
one of 18 participating clinics for
routine cervical cancer screening will be
recruited for the study. Approximately
10,000 women must be screened in
order to identify 8,000 who are both
eligible and willing to be enrolled in the
study. The study design calls for data
collection over a five-year period.
Information will be collected primarily
from a total of 70 clinical care providers,
18 clinic coordinators, and a sample of
2,600 patients.
CDC plans to request OMB approval
for data collection activities to be
conducted during the first three years
(Phase I) of the five-year project. The
results of this study will provide
information about knowledge, attitudes,
beliefs, and cervical cancer screening
practices involving low-income,
underserved women, who represent the
demographic most needy of highly
sensitive screening methodologies that
can increase the likelihood of detecting
cervical dysplasia at less frequent
screening intervals. The findings from
this study will help inform policy
regarding the HPV DNA test on a
national level for cervical cancer
screening in the NBCCEDP.
There are no costs to respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Health Care Providers ..........
Baseline Survey for Providers.
Follow-up Survey for Providers.
Screening Script for Patients
Enrollment Form ...................
Baseline Survey for Patients
Follow-up Survey for Patients.
Baseline Survey for Clinic
Coordinators.
Follow-up Survey for Clinic
Coordinators.
...............................................
Patients .................................
sroberts on PROD1PC70 with NOTICES
Clinic Coordinators ...............
Total ...............................
VerDate Aug<31>2005
18:46 Mar 06, 2008
Jkt 214001
PO 00000
Number of
responses per
respondent
Number of
respondents
Type of respondents
Frm 00084
Average burden
per response
(in hr)
Total burden
(in hr)
23
1
30/60
12
23
2
30/60
23
3,333
2,667
867
624
1
1
1
1
5/60
5/60
15/60
10/60
278
222
217
104
6
1
2
12
6
11
1
66
..............................
..............................
..............................
934
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Federal Register / Vol. 73, No. 46 / Friday, March 7, 2008 / Notices
Dated: February 28, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–4492 Filed 3–6–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Statement of Organization, Functions,
and Delegations of Authority
Part F of the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services, Centers for Medicare &
Medicaid Services (CMS), (Federal
Register, Vol. 72, No. 248, pp. 73847–
73850, dated Friday, December 28,
2007) is amended to reflect updates to
the functions for the Center for
Beneficiary Choices and the Office of EHealth Standards and Services.
Part F. is described below:
• Section F. 20. (Functions) reads as
follows:
sroberts on PROD1PC70 with NOTICES
Center for Beneficiary Choices (FAE)
• Serves as Medicare Beneficiary
Ombudsman, as well as the focal point
for all Agency interactions with
beneficiaries, their families, care givers,
health care providers, and others
operating on their behalf concerning
improving beneficiary’s ability to make
informed decisions about their health
and about program benefits
administered by the Agency. These
activities include strategic and
implementation planning, execution,
assessment and communications.
• Assesses beneficiary and other
consumer needs, develops and oversees
activities targeted to meet these needs,
and documents and disseminates results
of these activities. These activities focus
on Agency beneficiary service goals and
objectives and include: Development of
baseline and ongoing monitoring
information concerning populations
affected by Agency programs;
development of performance measures
and assessment programs; design and
implementation of beneficiary services
initiatives; development of
communications channels and feedback
mechanisms within the Agency and
between the Agency and its
beneficiaries and their representatives;
and close collaboration with other
Federal and State agencies and other
stakeholders with a shared interest in
better serving our beneficiaries.
VerDate Aug<31>2005
18:46 Mar 06, 2008
Jkt 214001
• Develops national policy for all
Medicare Parts A, B, C and D
beneficiary eligibility, enrollment,
entitlement; premium billing and
collection; coordination of benefits;
rights and protections; dispute
resolution process; as well as policy for
managed care enrollment and
disenrollment to assure the effective
administration of the Medicare program,
including the development of related
legislative proposals.
• Coordinates beneficiary-centered
information, education, and service
initiatives.
• Develops and tests new and
innovative methods to improve
beneficiary aspects of health care
delivery systems through Title XVIII,
XIX, and XXI demonstrations and other
creative approaches to meeting the
needs of Agency beneficiaries.
• Assures, in coordination with other
Centers and Offices, the activities of
Medicare contractors, including
managed care plans, agents, and State
Agencies meet the Agency’s
requirements on matters concerning
beneficiaries and other consumers.
• Plans and administers the contracts
and grants related to beneficiary and
customer service, including the State
Health Insurance Assistance Program
grants.
• Formulates strategies to advance
overall beneficiary communications
goals and coordinates the design and
publication process for all beneficiarycentered information, education, and
service initiatives.
• Builds a range of partnerships with
other national organizations for effective
consumer outreach, awareness, and
education efforts in support of Agency
programs.
• Serves as the focal point for all
Agency interactions with managed
health care organizations for issues
relating to Agency programs, policy and
operations.
• Develops national policies and
procedures related to the development,
qualification and compliance of health
maintenance organizations, competitive
medical plans and other health care
delivery systems and purchasing
arrangements (such as prospective pay,
case management, differential payment,
selective contracting, etc.) necessary to
assure the effective administration of
the Agency’s programs, including the
development of statutory proposals.
• Handles all phases of contracts with
managed health care organizations
eligible to provide care to Medicare
beneficiaries.
• Coordinates the administration of
individual benefits to assure appropriate
focus on long term care, where
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
12451
applicable, and assumes responsibility
for the operational efforts related to the
payment aspects of long term care and
post-acute care services.
• Serves as the focal point for all
Agency interactions with employers,
employees, retirees and others operating
on their behalf pertaining to issues
related to Agency policies and
operations concerning employer
sponsored prescription drug coverage
for their retirees.
• Develops national policies and
procedures to support and assure
appropriate State implementation of the
rules and processes governing group
and individual health insurance markets
and the sale of health insurance policies
that supplement Medicare coverage.
• Primarily responsible for all
operations related to Medicare
Prescription Drug Plans and Medicare
Advantage Prescription Drug (Part D)
plans.
• Performs activities related to the
Medicare Parts A & B processes (42 CFR
part 405, subparts G and H), part C (42
CFR part 422, subpart M), part D (42
CFR part 423, subpart M) and the PACE
program for claims-related hearings,
appeals, grievances and other dispute
resolution processes that are
beneficiary-centered.
• Develops, evaluates, and reviews
regulations, guidelines, and instructions
required for the dissemination of
appeals policies to Medicare
beneficiaries, Medicare contractors,
Medicare Advantage (MA) plans,
Prescription Drug Plans (PDPs), CMS
regional offices, beneficiary advocacy
groups and other interested parties.
Office of E-Health Standards and
Services (FHA)
• Develops and coordinates
implementation of a comprehensive
e-health strategy for CMS. Coordinates
and supports internal and external
technical activities related to e-health
services and ensures that individual
initiatives tie to the overall agency and
Federal
e-health goals strategies.
• Promotes and leverages innovative
component initiatives. Facilitates crosscomponent awareness of various
e-health projects.
• Develops regulations and guidance
materials, and provides technical
assistance on the Administrative
Simplification provisions of the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA),
including transactions, code sets,
identifiers, and security.
• Develops and implements the
enforcement program for HIPAA
E:\FR\FM\07MRN1.SGM
07MRN1
]]>Agencies
[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Pages 12449-12451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4492]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-08-08AR]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
[[Page 12450]]
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960 or
send comments to Maryam Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
CDC Cervical Cancer Study--New--National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Breast and Cervical Cancer Early Detection Program
(NBCCEDP) is the only organized national screening program in the
United States that offers breast and cervical cancer screening to
underserved women. Given resource limitations, the screening policies
for cervical cancer in the program include an annual Pap test until a
woman has had three consecutive normal Pap tests, at which time the Pap
test frequency is reduced to every three years. Human papillomavirus
(HPV) DNA testing has been approved in the U.S. as a secondary
screening tool for Atypical Squamous Cells of Undetermined Significance
(ASCUS), and as a primary screening tool for women 30 years of age and
older, but it is not currently a reimbursable expense under NBCCEDP
guidelines. Adopting HPV DNA testing along with Pap testing in women
over 30 could help the program better utilize resources by extending
the screening interval of women who are cytology negative and HPV test
negative, which is estimated to be 80-90% of women.
In 2005, the NBCCEDP convened an expert panel to evaluate policies
on reimbursement of the HPV DNA test as an adjunct to the Pap test for
primary screening. The panel recommended that the program not reimburse
for the HPV DNA test but instead requested that pilot studies be
performed to measure the feasibility, acceptability and barriers to use
of the test.
In response to the expert panel's recommendations, CDC proposes to
conduct a pilot study at 18 clinics in the state of Illinois. The
proposed study will examine whether or not there is an increase in the
cervical cancer screening interval to three years for women in the
target age range with a normal Pap test and a negative HPV DNA test.
Primary goals of the study are to: (1) Assess whether provider and
patient education will lead to extended screening intervals for women
who have negative screening results; (2) identify facilitators and
barriers to acceptance and appropriate use of the HPV test and longer
screening intervals; (3) track costs associated with HPV testing and
educational interventions; and (4) identify the HPV genotypes among
this sample of low income women. Secondary goals of the study are to:
(1) Assess follow-up of women with positive test results and (2)
determine provider knowledge and acceptability of the HPV vaccine.
Approximately 8,000 women between the ages of 35 and 60 who are
visiting one of 18 participating clinics for routine cervical cancer
screening will be recruited for the study. Approximately 10,000 women
must be screened in order to identify 8,000 who are both eligible and
willing to be enrolled in the study. The study design calls for data
collection over a five-year period. Information will be collected
primarily from a total of 70 clinical care providers, 18 clinic
coordinators, and a sample of 2,600 patients.
CDC plans to request OMB approval for data collection activities to
be conducted during the first three years (Phase I) of the five-year
project. The results of this study will provide information about
knowledge, attitudes, beliefs, and cervical cancer screening practices
involving low-income, underserved women, who represent the demographic
most needy of highly sensitive screening methodologies that can
increase the likelihood of detecting cervical dysplasia at less
frequent screening intervals. The findings from this study will help
inform policy regarding the HPV DNA test on a national level for
cervical cancer screening in the NBCCEDP.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response (in Total burden (in
respondents respondent hr) hr)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Health Care Providers....................... Baseline Survey for Providers. 23 1 30/60 12
Follow-up Survey for Providers 23 2 30/60 23
Patients.................................... Screening Script for Patients. 3,333 1 5/60 278
Enrollment Form............... 2,667 1 5/60 222
Baseline Survey for Patients.. 867 1 15/60 217
Follow-up Survey for Patients. 624 1 10/60 104
Clinic Coordinators......................... Baseline Survey for Clinic 6 1 2 12
Coordinators.
Follow-up Survey for Clinic 6 11 1 66
Coordinators.
-----------------------------------------------------------------------------------------------------------
Total................................... .............................. ................. ................. ................. 934
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 12451]]
Dated: February 28, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-4492 Filed 3-6-08; 8:45 am]
BILLING CODE 4163-18-P
