Solicitation for Members of the National Vaccine Advisory Committee, 53505-53507 [E9-25079]
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53505
Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
responses
per
respondent
Number of
respondents
Average
burden hours
per response
Total burden
hours
Forms
Type of respondent
Interview Protocol .............................
Interview Protocol .............................
Faculty ..............................................
Doctoral Student Graduates ............
100
100
1
1
2
2
200
200
Total ...........................................
...........................................................
........................
........................
........................
400
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E9–25028 Filed 10–16–09; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology; HIT
Standards Committee’s
Implementation Workgroup Meeting;
Notice of Meeting
sroberts on DSKD5P82C1PROD with NOTICES
AGENCY: Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meeting.
This notice announces a forthcoming
meeting of a public advisory
subcommittee of the Office of the
National Coordinator for Health
Information Technology (ONC). The
meeting will be open to the public.
Name of Committee: HIT Standards
Committee’s Implementation
Workgroup.
General Function of the Committee:
To provide recommendations to the
National Coordinator on standards,
implementation specifications, and
certification criteria for the electronic
exchange and use of health information
for purposes of adoption, consistent
with the implementation of the Federal
Health IT Strategic Plan, and in
accordance with policies developed by
the HIT Policy Committee. The
Implementation Workgroup is charged
with benchmarking adoption rates for
proposed standards across diverse
settings; soliciting public input on what
stakeholders need to lower the barriers
to standards adoption; evaluating the
degree to which proposed standards
achieve policy objectives; and
establishing an ongoing process to
gather public input to inform future
standards development, revisions to
existing standards, or guidance on tools
to minimize the cost of adoption.
Date and Time: The meeting will be
held on October 29, 2009, from 9 a.m.
to 3 p.m./Eastern Time.
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Location: The Omni Shoreham Hotel,
2500 Calvert Street, NW., Washington,
DC. The hotel telephone number is 202–
234–0700.
Contact Person: Judy Sparrow, Office
of the National Coordinator, HHS, 330 C
Street, SW., Washington, DC 20201,
202–205–4528, Fax: 202–690–6079, email: judy.sparrow@hhs.gov. Please call
the contact person for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Agenda: The Implementation
Workgroup will be hearing testimony
from stakeholder groups, such as
purchasers, vendors, and users, on
health information technology adoption
experiences with the proposed
standards. The Workgroup intends to
monitor the adoption rate of proposed
standards, identify opportunities to
accelerate implementation, and
establish a continuous feedback loop on
the development of new or revised
standards.
In addition to soliciting verbal and
formal written comments at the hearing,
the Workgroup will use a Web-based
tool to engage the public. The ONC is
setting up a Web-based tool to engage
the public in the topic; please visit the
ONC Web site closer to the meeting date
for additional information.
ONC intends to make background
material available to the public no later
than two (2) business days prior to the
meeting. If ONC is unable to post the
background material on its Web site
prior to the meeting, it will be made
publicly available at the location of the
advisory subcommittee meeting, and the
background material will be posted on
ONC’s Web site after the meeting, at
https://healthit.hhs.gov. The meeting
will be available via Webcast; visit
https://healthit.hhs.gov for instructions
on how to listen via telephone or Web.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person from October 29th until
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November 12, 2009. Oral comments
from the pubic will be scheduled at the
close of the meeting on October 29,
2009. Time allotted for each
presentation may be limited. If the
number of speakers requesting to
comment is greater than can be
reasonably accommodated during the
scheduled open public hearing session,
ONC will take written comments after
the meeting until close of business on
that day.
Persons attending Committee
meetings are advised that the agency is
not responsible for providing access to
electrical outlets.
ONC welcomes the attendance of the
public at its advisory committee
meetings. Seating is limited at the
location, and ONC will make every
effort to accommodate persons with
physical disabilities or special needs. If
you require special accommodations
due to a disability, please contact Judy
Sparrow at least seven (7) days in
advance of the meeting.
ONC is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://healthit.hhs.gov for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: October 13, 2009.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. E9–25051 Filed 10–14–09; 4:15 pm]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation for Members of the
National Vaccine Advisory Committee
AGENCY: Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
ACTION: Notice.
Authority: 42 U.S.C. 300aa–5, Section
2105 of the Public Health Service (PHS)
E:\FR\FM\19OCN1.SGM
19OCN1
sroberts on DSKD5P82C1PROD with NOTICES
53506
Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices
Act, as amended. The Committee is
governed by the provisions of Public
Law 92–463, as amended (5 U.S.C.
Appendix 2), which sets forth standards
for the formation and use of advisory
committees.
SUMMARY: The National Vaccine
Program Office (NVPO), a program
office within the Office of Public Health
and Science, DHHS, is soliciting
nominations of qualified candidates to
be considered for appointment as public
members to the National Vaccine
Advisory Committee (NVAC). The
activities of this Committee are
governed by the Federal Advisory
Committee Act (FACA). Management
support for the activities of this
Committee is the responsibility of the
NVPO.
Consistent with the National Vaccine
Plan, the Committee advises and makes
recommendations to the Assistant
Secretary for Health in his capacity as
the Director of the National Vaccine
Program, on matters related to the
Program’s responsibilities. Specifically,
the Committee studies and recommends
ways to encourage the availability of an
adequate supply of safe and effective
vaccination products in the United
States; recommends research priorities
and other measures to enhance the
safety and efficacy of vaccines. The
Committee also advises the Assistant
Secretary for Health in the
implementation of Sections 2102 and
2103 of the PHS Act; and identifies
annually the most important areas of
government and non-government
cooperation that should be considered
in implementing Sections 2102 and
2103 of the PHS Act.
DATES: Nominations for membership on
the Committee must be received no later
than 5 p.m. EDT on November 16, 2009,
at the address below.
ADDRESSES: All nominations should be
mailed or delivered to: Bruce G. Gellin,
M.D., M.P.H., Executive Secretary,
NVAC, Office of Public Health and
Science, Department of Health and
Human Services, 200 Independence
Avenue, SW., Room 715–H, Hubert H.
Humphrey Building, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT: Ms.
Andrea Krull, Public Health Advisor,
National Vaccine Program Office,
Department of Health and Human
Services, 200 Independence Avenue,
SW., Room 715–H, Hubert H. Humphrey
Building, Washington, DC 20201; (202)
690–5566; nvpo@hhs.gov.
A copy of the Committee charter
which includes the Committee’s
structure and functions as well as a list
of the current membership can be
VerDate Nov<24>2008
16:51 Oct 16, 2009
Jkt 220001
obtained by contacting Ms. Krull or by
accessing the NVAC Web site at:
www.hhs.gov/nvpo/nvac.
SUPPLEMENTARY INFORMATION:
Committee Function, Qualifications,
and Information Required: As part of an
ongoing effort to enhance deliberations
and discussions with the public on
vaccine and immunization policy,
nominations are being sought for
interested individuals to serve on the
Committee as public members.
Individuals selected for appointment to
the Committee will serve as voting
members. The Committee is composed
of 15 public members, including the
Chair, and two representative members.
In accordance with the Committee
charter, public members shall be
selected from individuals who are
engaged in vaccine research or the
manufacture of vaccines, or who are
physicians, members of parent
organizations concerned with
immunizations, representatives of state
or local health agencies or public health
organizations. Representative members
shall be selected from the vaccine
manufacturing industry who are
engaged in vaccine research or the
manufacture of vaccines. Individuals
selected for appointment to the
Committee can be invited to serve terms
of up to four years.
All NVAC members are authorized to
receive the prescribed per diem
allowance and reimbursement for travel
expenses that are incurred to attend
meetings and conduct authorized
Committee-related business, in
accordance with Standard Government
Travel Regulations. Individuals who are
appointed to serve as public members
are authorized also to receive
honorarium for attending Committee
meetings and to carry out other
authorized Committee-related business.
Individuals who are appointed to serve
as representative members for a
particular interest group or industry are
not authorized to receive honorarium
for the performance of these duties.
This announcement is to solicit
nominations of qualified candidates to
fill positions on the NVAC that are
scheduled to be vacated in the public
member category. The positions are
scheduled to be vacated on March 31,
2010.
Nominations
In accordance with the charter,
persons nominated for appointment as
members of the NVAC should be among
authorities knowledgeable in areas
related to vaccine safety, vaccine
effectiveness, and vaccine supply.
Nominations should be typewritten. The
following information should be
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included in the package of material
submitted for each individual being
nominated for consideration: (1) A letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination (i.e., specific
attributes which qualify the nominee for
service in this capacity), and a statement
that the nominee is willing to serve as
a member of the Committee; (2) the
nominator’s name, address and daytime
telephone number, and the home and/
or work address, telephone number, and
e-mail address of the individual being
nominated; and (3) a current copy of the
nominee’s curriculum vitae.
Individuals can nominate themselves
for consideration of appointment to the
Committee. All nominations must
include the required information.
Incomplete nominations will not be
processed for consideration. The letter
from the nominator and certification of
the nominated individual must bear
original signatures; reproduced copies
of these signatures are not acceptable.
Applications cannot be submitted by
facsimile. The names of Federal
employees should not be nominated for
consideration of appointment to this
Committee.
The Department makes every effort to
ensure that the membership of HHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the committee’s
function. Every effort is made that a
broad representation of geographic
areas, gender, ethnic and minority
groups, and the disabled are given
consideration for membership on HHS
Federal advisory committees.
Appointment to this committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status.
The Standards of Ethical Conduct for
Employees of the Executive Branch are
applicable to individuals who are
appointed as public members of Federal
advisory committees. Individuals
appointed to serve as public members of
Federal advisory committees are
classified as special Government
employees (SGEs). SGEs are
Government employees for purposes of
the conflict of interest laws. Therefore,
individuals appointed to serve as public
members of NVAC are subject to an
ethics review. The ethics review is
conducted to determine if the
individual has any interests and/or
activities in the private sector that may
conflict with performance of their
official duties as a member of the
Committee. Individuals appointed to
serve as public members of the
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Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices
Committee will be required to disclose
information regarding financial
holdings, consultancies, and research
grants and/or contracts.
Dated: October 6, 2009.
Bruce Gellin,
Director, National Vaccine Program Office,
Executive Secretary, National Vaccine
Advisory Committee.
[FR Doc. E9–25079 Filed 10–16–09; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0302] (formerly
Docket No. 2007D–0185)
Guidance for Industry and Review Staff
on Labeling for Human Prescription
Drug and Biological Products—
Determining Established
Pharmacologic Class for Use in the
Highlights of Prescribing Information;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
and review staff entitled ‘‘Labeling for
Human Prescription Drug and Biological
Products—Determining Established
Pharmacologic Class for Use in the
Highlights of Prescribing Information.’’
This guidance is intended to provide
applicants and review staff with a
definition of established pharmacologic
class and to help them identify the most
appropriate word (term) or phrase that
describes the established pharmacologic
class for a drug or biological product for
inclusion in the Indications and Usage
section of Highlights of Prescribing
Information (Highlights) of approved
labeling. This guidance finalizes the
draft guidance published in the Federal
Register on May 16, 2007.
DATES: Submit electronic or written
comments on agency guidances at any
time.
Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach, and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
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ADDRESSES:
VerDate Nov<24>2008
16:51 Oct 16, 2009
Jkt 220001
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that 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. Submit
electronic comments to https://
www.regulations.gov. 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. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Laurie B. Burke, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6462,
Silver Spring, MD 20993–0002,
301–796–0136; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration,1401
Rockville Pike, suite 200N,
Rockville, MD 20852–1448, 301–
827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and review staff
entitled ‘‘Labeling for Human
Prescription Drug and Biological
Products—determining Established
Pharmacologic Class for Use in the
Highlights of Prescribing Information.’’
This guidance is intended to provide
applicants and review staff with a
definition of established pharmacologic
class and to help them identify the most
appropriate word (term) or phrase that
describes the established pharmacologic
class for a drug or biological product for
inclusion in the Indications and Usage
section of Highlights of approved
labeling, as required under 21 CFR
201.57(a)(6).
In January 2006, FDA published a
final rule that amended the
requirements for the content and format
of labeling for human prescription drug
and biological products.1
The new labeling format is intended
to make it easier for health care
professionals to access, read, and use
the information in prescription drug
labeling, thereby facilitating
professionals’ use of labeling to make
prescribing decisions.
The rule requires that the following
statement appear under the Indications
and Usage section of Highlights if a drug
1 See ‘‘Requirements on Content and Format of
Labeling for Human Prescription Drug and
Biological Products’’ (71 FR 3922, January 24, 2006;
21 CFR parts 201, 314, 601).
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53507
is a member of an established
pharmacologic class:2
‘‘(Drug) is a (name of class) indicated
for (indication(s)).’’
If the drug is not a member of an
established pharmacologic class, the
name of class component of this
statement should be omitted.
Knowing the established
pharmacologic class can provide health
care professionals with important
information about what to expect from
a drug and how it relates to other
therapeutic options. Such information
can also help reduce the risk of
duplicative therapy and drug
interactions. This guidance provides
recommendations for identifying the
established pharmacologic class and its
appropriate term for inclusion in the
Indications and Usage section of
Highlights.
A draft version of this guidance was
made available for public comment in
2007 (72 FR 27576, May 16, 2007). All
of the public comments we received
have been considered and the guidance
has been revised as appropriate.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The information collection
associated with the final rule entitled
‘‘Requirements on Content and Format
of Labeling for Human Prescription
Drug and Biological Products’’ is
approved by OMB under Control
Number 0910–0572. The submission of
prior-approval labeling supplements, as
described in section VI of the guidance,
is approved by OMB under Control
Numbers 0910–0001 and 0910–0338.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document.
Submit a single copy of electronic
2 See
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§ 201.57(a)(6).
19OCN1
]]>Agencies
[Federal Register Volume 74, Number 200 (Monday, October 19, 2009)]
[Notices]
[Pages 53505-53507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation for Members of the National Vaccine Advisory
Committee
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of Public Health and Science.
ACTION: Notice.
-----------------------------------------------------------------------
Authority: 42 U.S.C. 300aa-5, Section 2105 of the Public Health Service
(PHS)
[[Page 53506]]
Act, as amended. The Committee is governed by the provisions of Public
Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth
standards for the formation and use of advisory committees.
SUMMARY: The National Vaccine Program Office (NVPO), a program office
within the Office of Public Health and Science, DHHS, is soliciting
nominations of qualified candidates to be considered for appointment as
public members to the National Vaccine Advisory Committee (NVAC). The
activities of this Committee are governed by the Federal Advisory
Committee Act (FACA). Management support for the activities of this
Committee is the responsibility of the NVPO.
Consistent with the National Vaccine Plan, the Committee advises
and makes recommendations to the Assistant Secretary for Health in his
capacity as the Director of the National Vaccine Program, on matters
related to the Program's responsibilities. Specifically, the Committee
studies and recommends ways to encourage the availability of an
adequate supply of safe and effective vaccination products in the
United States; recommends research priorities and other measures to
enhance the safety and efficacy of vaccines. The Committee also advises
the Assistant Secretary for Health in the implementation of Sections
2102 and 2103 of the PHS Act; and identifies annually the most
important areas of government and non-government cooperation that
should be considered in implementing Sections 2102 and 2103 of the PHS
Act.
DATES: Nominations for membership on the Committee must be received no
later than 5 p.m. EDT on November 16, 2009, at the address below.
ADDRESSES: All nominations should be mailed or delivered to: Bruce G.
Gellin, M.D., M.P.H., Executive Secretary, NVAC, Office of Public
Health and Science, Department of Health and Human Services, 200
Independence Avenue, SW., Room 715-H, Hubert H. Humphrey Building,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ms. Andrea Krull, Public Health
Advisor, National Vaccine Program Office, Department of Health and
Human Services, 200 Independence Avenue, SW., Room 715-H, Hubert H.
Humphrey Building, Washington, DC 20201; (202) 690-5566; nvpo@hhs.gov.
A copy of the Committee charter which includes the Committee's
structure and functions as well as a list of the current membership can
be obtained by contacting Ms. Krull or by accessing the NVAC Web site
at: www.hhs.gov/nvpo/nvac.
SUPPLEMENTARY INFORMATION:
Committee Function, Qualifications, and Information Required: As
part of an ongoing effort to enhance deliberations and discussions with
the public on vaccine and immunization policy, nominations are being
sought for interested individuals to serve on the Committee as public
members. Individuals selected for appointment to the Committee will
serve as voting members. The Committee is composed of 15 public
members, including the Chair, and two representative members. In
accordance with the Committee charter, public members shall be selected
from individuals who are engaged in vaccine research or the manufacture
of vaccines, or who are physicians, members of parent organizations
concerned with immunizations, representatives of state or local health
agencies or public health organizations. Representative members shall
be selected from the vaccine manufacturing industry who are engaged in
vaccine research or the manufacture of vaccines. Individuals selected
for appointment to the Committee can be invited to serve terms of up to
four years.
All NVAC members are authorized to receive the prescribed per diem
allowance and reimbursement for travel expenses that are incurred to
attend meetings and conduct authorized Committee-related business, in
accordance with Standard Government Travel Regulations. Individuals who
are appointed to serve as public members are authorized also to receive
honorarium for attending Committee meetings and to carry out other
authorized Committee-related business. Individuals who are appointed to
serve as representative members for a particular interest group or
industry are not authorized to receive honorarium for the performance
of these duties.
This announcement is to solicit nominations of qualified candidates
to fill positions on the NVAC that are scheduled to be vacated in the
public member category. The positions are scheduled to be vacated on
March 31, 2010.
Nominations
In accordance with the charter, persons nominated for appointment
as members of the NVAC should be among authorities knowledgeable in
areas related to vaccine safety, vaccine effectiveness, and vaccine
supply. Nominations should be typewritten. The following information
should be included in the package of material submitted for each
individual being nominated for consideration: (1) A letter of
nomination that clearly states the name and affiliation of the nominee,
the basis for the nomination (i.e., specific attributes which qualify
the nominee for service in this capacity), and a statement that the
nominee is willing to serve as a member of the Committee; (2) the
nominator's name, address and daytime telephone number, and the home
and/or work address, telephone number, and e-mail address of the
individual being nominated; and (3) a current copy of the nominee's
curriculum vitae.
Individuals can nominate themselves for consideration of
appointment to the Committee. All nominations must include the required
information. Incomplete nominations will not be processed for
consideration. The letter from the nominator and certification of the
nominated individual must bear original signatures; reproduced copies
of these signatures are not acceptable. Applications cannot be
submitted by facsimile. The names of Federal employees should not be
nominated for consideration of appointment to this Committee.
The Department makes every effort to ensure that the membership of
HHS Federal advisory committees is fairly balanced in terms of points
of view represented and the committee's function. Every effort is made
that a broad representation of geographic areas, gender, ethnic and
minority groups, and the disabled are given consideration for
membership on HHS Federal advisory committees. Appointment to this
committee shall be made without discrimination on the basis of age,
race, ethnicity, gender, sexual orientation, disability, and cultural,
religious, or socioeconomic status.
The Standards of Ethical Conduct for Employees of the Executive
Branch are applicable to individuals who are appointed as public
members of Federal advisory committees. Individuals appointed to serve
as public members of Federal advisory committees are classified as
special Government employees (SGEs). SGEs are Government employees for
purposes of the conflict of interest laws. Therefore, individuals
appointed to serve as public members of NVAC are subject to an ethics
review. The ethics review is conducted to determine if the individual
has any interests and/or activities in the private sector that may
conflict with performance of their official duties as a member of the
Committee. Individuals appointed to serve as public members of the
[[Page 53507]]
Committee will be required to disclose information regarding financial
holdings, consultancies, and research grants and/or contracts.
Dated: October 6, 2009.
Bruce Gellin,
Director, National Vaccine Program Office, Executive Secretary,
National Vaccine Advisory Committee.
[FR Doc. E9-25079 Filed 10-16-09; 8:45 am]
BILLING CODE 4150-44-P
