[Federal Register Volume 68, Number 64 (Thursday, April 3, 2003)]
[Notices]
[Pages 16287-16292]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-8062]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 03034]
Public Health Laboratory Biomonitoring Implementation Program;
Notice of Availability of Funds
Application Deadline: July 2, 2003.
A. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under sections 301 and 317 of the Public
Health Service Act, 42 U.S.C. 241 and 247b, as amended. The catalog of
Federal Domestic Assistance number is 93.283.
B. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2003 funds for cooperative agreements
to establish or expand state public health laboratory biomonitoring
capacity. This program addresses the ``Healthy People 2010'' focus
areas of Environmental Health and Public Health Infrastructure. This
program builds upon biomonitoring planning conducted by State public
health laboratories during FY 2001 and FY 2002 under Program
Announcement (PA) 01072, Public Health Laboratory Biomonitoring
Planning Grant. PA 01072 can be viewed at http://
frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_
register&docid=01-11215-filed.
The purpose of this program is to implement and expand State
laboratory-based biomonitoring programs to assess human exposure to
environmental toxicants, help prevent disease resulting from exposure
to toxic substances, and determine estimates of background exposure to
naturally occurring and industrial chemicals that have the potential to
cause harm.
Measurable outcomes of the program will be in alignment with one or
more of the following performance goals for the National Center for
Environmental Health (NCEH):
1. Develop laboratory capacity to monitor human exposures to
environmental chemicals.
2. Periodically determine the number of Americans exposed to
environmental chemicals and the degree of their exposure.
3. Increase the capacity of State and local health departments to
deliver environmental health services in their communities.
C. Eligible Applicants
Assistance will be provided only to public health laboratories of
States or lead States of consortia that were recipients of CDC grants
for biomonitoring planning in FY2001 and FY2002 under PA 01072 (see
Attachment 3 as posted on the CDC Web site for a listing of funded
grantees under PA 01072). No other applications are solicited.
Applications are only sought from those grantees under PA 01072,
who have developed a biomonitoring plan and the necessary relationships
and contacts to implement their plan. These grantees have spent two
years on the development of their biomonitoring plans. New applicants
would not have those plans in place, and therefore would not be ready
to move into the implementation phase being funded by this new
announcement.
States, territories, or protectorates that do not meet the
preceding requirement may participate by entering into a consortium or
other agreement with an eligible State or an eligible consortium of
States.
Only one application per State or consortium may be submitted. A
State may apply as an individual State or as the lead member of a
consortium, but not both. Members of a consortium may not apply as
individual States.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501c(4) of the Internal Revenue
Code that engages in lobbying activities is not eligible to receive
Federal funds constituting an award, grant or loan.
[[Page 16288]]
D. Funding
Availability of Funds
Approximately $5,000,000 is available in FY 2003 to fund
approximately ten awards. Funding will range from $200,000, up to
$3,000,000 per award. Funding estimates may change. It is expected that
the awards will begin on or about September 15, 2003, and will be made
for an initial 9-month budget period, which will end on June 30, 2004.
Future budget periods will be 12 months in duration for a total project
period of up to four years and nine months.
Continuation awards within an approved project period will be made
on the basis of the availability of funds and satisfactory progress as
evidenced by required reports.
Funding will be awarded in two categories:
Individual States: Maximum award of up to $1,000,000 for individual
States.
Consortia: Maximum award of up to $3,000,000 based upon the number
of States within the consortium. A range of $200,000-$600,000 per State
consortium member is anticipated.
Applications exceeding the foregoing maxima will be returned
without review. Eligible applicants are only allowed to apply for one
of the two categories described above.
Use of Funds
Funds may be used to develop and implement a biomonitoring program,
conduct demonstration projects, purchase equipment and supplies, hire
and train personnel, conduct appropriate and relevant travel, hire
consultants, pay for services, and renovate or modify existing
laboratory areas. Funds provided by CDC under this cooperative
agreement may not be used for construction of new laboratory space.
Funds may not be used to support activities otherwise funded, or
eligible to be funded, through the Superfund Program or the Agency for
Toxic Substances and Disease Registry. However, because toxicants from
Superfund sites may contribute to the total exposures of a given
population, funds may be used to assess the exposure status of
populations not already addressed under Superfund.
Funding Preferences
Preference for awards will be given to ensure geographic diversity,
distribution, and balance among laboratories which serve people living
in various settings such as urban, rural, agricultural, and industrial
communities; among laboratories that have various levels of expertise,
experience, capacity, and need for biomonitoring. Preference will be
given to applications with the greatest need for biomonitoring
expansion or implementation based on documented or suspected
environmental toxicant exposures among persons living within the
applicant's area of responsibility.
Recipient Financial Participation
Matching funds are not required for this program.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities listed under 1.
Recipient Activities, and CDC will be responsible for the activities
listed under 2. CDC Activities.
1. Recipient Activities:
a. Implement and apply biomonitoring laboratory capacity by
following, as closely as possible, the biomonitoring plan(s) that the
recipient developed with funding under PA 01072, Public Health
Laboratory Biomonitoring Planning Grant.
b.Address the needs for, and proposed application of, biomonitoring
within the community served by the applicant and distinguish between
those needs that are single issue and those that exist on an on-going
basis. Collaborate with other public health partners, including public
health physicians and epidemiologists, in making this needs assessment.
Special consideration should be given to evaluating exposures in under-
served population groups that may be at increased risk from exposure.
(E.g. minorities, the very young, and the elderly may have a greater
risk of exposure or harmful effects.)
c. Incorporate the application of laboratory data to respond to
important public health issues as listed in items 1. through 6. of
Attachment 2, ``Biomonitoring and Complementary Programs.'' Please see
all attachments referenced in this announcement as posted with the full
announcement on the CDC Web site: http://www.cdc.gov/od/pgo/funding/
grantmain.htm. Uses may include population based or targeted health
exposure surveys, health effects studies, sentinel monitoring of at-
risk populations, case-control studies, studies involving analyses of
stored specimens, or other recognized epidemiologic tools. The
applicant must develop complete study protocols after award of a
cooperative agreement and prior to commencing the study.
d. Meet requirements for local Institutional Review Board (IRB) or
Human Subjects review and obtain approval for any such projects which
constitute research as defined in 45 CFR part 46. (See http://
ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.102)
e. Biomonitoring research projects that the applicant plans to
undertake without substantial CDC involvement do not require CDC IRB
approval. However, the applicant will be required to submit a copy of
their proposed protocol and a copy of their IRB approval letter (and
all subsequent approval renewals) to CDC. Research projects that
applicants wish to undertake with substantial CDC involvement will
require joint development of detailed protocols with CDC and approval
from both CDC IRB and the applicant's local IRB. Note: CDC IRB may
defer to the local IRB or the local IRB may defer to CDC IRB. Because
funds currently available to support the biomonitoring implementation
program under this cooperative agreement are limited and are primarily
intended for biomonitoring capacity building, applicants are
discouraged from relying on this agreement to fund complex and costly
epidemiologic studies. Rather, activities should be limited to
demonstration projects, pilot surveys, and preliminary investigations.
More detailed and costly epidemiologic studies employing biomonitoring
should be developed jointly and in detail among the interested
laboratories, their epidemiology partners, and others with funding
sought from other sources as stand-alone projects.
f. Implement the plan for developing (or expanding) and applying
biomonitoring capacity in the public health laboratory. This
implementation must follow the specific, measurable, and time-framed
goals and objectives presented in the plan.
g. Develop an evaluation plan by which the recipient may conduct
periodic and on-going assessments of progress in expanding the
laboratory's biomonitoring capacity and to assess the impact of
biomonitoring measurements on addressing the identified public health
needs within the state(s) or community.
h. Participate in external proficiency testing and quality control
programs, perform biomonitoring pilot and demonstration studies
(including performance of biomonitoring analyses on previously
collected samples), participate in the prospective planning and conduct
of biomonitoring research projects or population exposure surveys, and
perform other activities that enhance the recipient's ability to
implement a biomonitoring program.
2. CDC Activities:
[[Page 16289]]
a. Provide technical assistance, guidance, and training in
biomonitoring, including information about analytical methods and
instrumentation used by CDC for biomonitoring.
b. Provide information about sources for reagents, supplies,
standards, quality assurance materials, equipment, etc. These sources
may include commercial vendors, other Federal, State, or international
agencies, professional societies or standard-setting bodies,
contractors to CDC, and CDC laboratories, as appropriate.
c. Provide analytical support as requested for biomonitoring
studies initiated by the recipient (subject to availability and
competing national priorities).
d. Assist in the development of a research protocol for projects in
which CDC provides a staff member to serve as principal investigator or
co-investigator or when CDC conducts sample analysis. IRB approval will
be required from all institutions participating in the research. CDC
IRB must review and approve the protocol initially and at least on an
annual basis until the research project is completed. For those
research projects that do not have a CDC staff member serving as the
principal investigator or co-investigator, technical assistance in the
form of advice, recommendations, and expert opinions will be provided.
F. Content
Letter of Intent (LOI)
A LOI is optional for this program. The Program Announcement title
and number must appear in the LOI. The narrative should be no more than
one page, single-spaced, printed on one side, with one-inch margins,
and unreduced 12-point font. The LOI will be used for CDC planning
purposes. The LOI must indicate whether the applicant plans to apply as
an individual state applicant or as the lead member of a consortium and
should identify the states that are anticipated to be consortium
partners.
Applications
The Program Announcement title and number must appear in the
application. Use the information in the Program Requirements, Content,
Other Requirements, and Evaluation Criteria sections to develop the
application content. The application will be evaluated on the criteria
listed, so it is important to follow them in laying out the program
plan. The narrative should be no more than 25 pages, double-spaced,
printed on one side, with one-inch margins, and unreduced 12-point
font.
The narrative should consist of, at a minimum, a Workplan,
Objectives, Methods, Personnel, Evaluation Scheme, and Budget. A two-
to three-page executive summary of the applicant's plan developed under
PA 01072 shall be included preceding the narrative. The application
must also include, as an attachment, a full copy of the plan from the
planning grant. The page limitation is exclusive of the attached copy
of the plan.
The application must also:
1. Discuss how the recipient will develop, implement, and apply
biomonitoring laboratory capacity by following the biomonitoring plan
that was developed with funding under PA 01072.
2. Outline how biomonitoring will be applied within the community
served by the applicant and distinguish between those needs that are
single issue and those that exist on an on-going basis. Describe how
collaboration with other public health partners, including public
health physicians and epidemiologists in making this needs assessment
will be accomplished. Special consideration should be given to
evaluating exposures in under-served population groups that may be at
increased risk from exposure.
3. Discuss how the program will use biomonitoring laboratory data
to answer the important public health questions as listed in items 1.
through 6. of Attachment 2 as posted on the CDC Web site. The
application should not include complete study protocols, as they will
be developed after award of a cooperative agreement and prior to
commencing the study.
4. Tell how requirements for local IRB or Human Subjects review
will be met and how approval for any such projects which constitute
research as defined in 45 CFR part 46 will be obtained. (See http://
ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.102.)
5. Provide an inventory of existing biomonitoring methods in use by
the applicant, and for each method specify: Toxic substance(s)
measured; method of measurement (e.g., GC-MS, atomic absorption);
current instrumentation used; the limit of detection for each analyte
(and how the limit of detection was determined); known interferences;
description of method's quality control; any external proficiency
testing program in which the laboratory currently participates for the
method; an approximate sample throughput per day; and the approximate
number of human specimens analyzed in the past 12 months. Emphasize in
this section how the existing biomonitoring capacity will be used to
address needs identified in the paragraphs above. As part of this
explanation, specify the collaborations with public health partners
(State and local health officials, schools of public health, academic
centers, community groups, etc.) who will work with the laboratory to
use biomonitoring data to help address these public health needs.
Include documentation from each public health partner of its
willingness to collaborate. Acceptable documentation may be letters of
support or formal agreements among partners.
6. For each new biomonitoring method needed, describe additional
requirements for personnel, instrumentation, and facilities
modification or expansion. Provide cost estimates for facilities
modification or expansion, if applicable.
7. Describe specimen management and security protocols that are in
place or that are to be implemented to support the biomonitoring
program.
8. Describe the data management and communications resources and
plans available or needed to support the biomonitoring program. The
relationship (or lack thereof) with other public health data management
and communications initiatives (e.g., National Electronic Disease
Surveillance System, Health Alert Network, etc.) should be discussed.
9. Discuss requirements for compliance with the Clinical Laboratory
Amendments of 1988 (CLIA).
10. Develop an evaluation plan to provide periodic and on-going
assessment of progress in expanding the laboratory's biomonitoring
capacity and to assess the impact of biomonitoring measurements on
addressing the identified public health needs within the State(s) or
community.
11. Applications from consortia must provide documentation from
each member of the consortium of their willingness to collaborate, to
share resources, and/or to perform work within the consortium under
reciprocal arrangements, to pool data from each site in their proposed
consortium as appropriate to the goals of the consortium, and to
participate in periodic meetings (or conferences via electronic media)
among consortium laboratories for the purpose of planning, conduct of
consortium business, training, and technology transfer. Acceptable
documentation may be letters of support or formal agreements among the
consortium members.
12. Discuss anticipated problems with the implementation of the
biomonitoring plan and outline proposed solutions. Potential problems
might include state restrictions on
[[Page 16290]]
hiring of personnel, travel restrictions, and shortages of qualified
personnel.
G. Submission and Deadline
Letter of Intent (LOI) Submission
On or before May 5, 2003, submit the LOI to the Grants Management
Specialist identified in the ``Where to Obtain Additional Information''
section of this announcement.
Application Forms
Submit the signed original and two copies of PHS Form 5161--
1. Forms are available at the following Internet address: http://
www.cdc.gov/od/pgo/forminfo.htm.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.
Submission Date, Time, and Address
The application must be received by 4 p.m. eastern time on July 2,
2003. Submit the application to: Technical Information Management--
PA03034, Procurement and Grants Office, Centers for Disease Control and
Prevention, 2920 Brandywine Rd, Atlanta, GA 30341-4146. Applications
may not be submitted electronically.
CDC Acknowledgement of Application Receipt
A postcard will be mailed by PGO-TIM, notifying you that CDC has
received your application.
Deadline
Letters of intent and applications shall be considered as meeting
the deadline if they are received before 4 p.m. eastern time on the
deadline date. Any applicant who sends their application by the United
States Postal Service or commercial delivery services must ensure that
the carrier will be able to guarantee delivery of the application by
the closing date and time. If an application is received up to two
weeks after the closing date, due to (1) carrier error, when the
carrier accepted the package with a guarantee for delivery by the
closing date and time, or (2) significant weather delays or natural
disasters, CDC will upon receipt of proper documentation, consider the
application as having been received by the deadline.
Any application that does not meet the above criteria will not be
eligible for competition, and will be discarded. The applicant will be
notified of their failure to meet the submission requirements.
H. Evaluation Criteria
Application
Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the cooperative agreement. Measures of effectiveness must
relate to the performance goals as stated in section ``A. Purpose'' of
this announcement. Measures must be objective and quantitative and must
measure the intended outcome. These measures of effectiveness shall be
submitted with the application and shall be an element of evaluation.
An independent review group appointed by CDC will evaluate each
application against the following criteria:
1. Understanding the Requirements for Implementing a Biomonitoring Plan
(30 Percent)
Does the application reflect the biomonitoring plan developed by
the applicant and is a copy of the biomonitoring plan included as an
attachment? (Note: If the application is from a consortium that
includes members previously funded as individual planning grantees, the
application must reflect the planning of those consortium members and
discuss how those plans will be integrated.) The extent to which the
applicant describes the need for a biomonitoring program, and an
understanding of the purpose of conducting exposure assessment by
measurement of human biological samples (blood, hair, urine, saliva) to
identify internal human dose from contact with hazardous environmental
chemicals. The applicant's understanding of the analytical challenges
associated with identifying the extent of exposure based on data
obtained from human samples, especially challenges presented by the
differences in physiological makeup of individuals, specimen
collection, and pharmacokinetic and pharmacodynamic factors. The
demonstration of understanding the problems related to estimating or
extrapolating ``internal dose'' from ``external dose'' data, and the
value of biomonitoring through direct measurement of samples from
humans to provide information that is more meaningful.
2. Goals and Objectives (20 Percent)
The extent to which the applicant clearly states biomonitoring
program goals and objectives which are consistent with the Purpose and
Program Requirements sections as presented in this announcement, and
the degree to which the goals and objectives reflect an understanding
of the need to reach beyond the laboratory to achieve balanced input
from the broader public health community in implementation of the
biomonitoring plan. These goals and objectives shall include a
discussion of the implementation of biomonitoring laboratory capacity
and application of this capacity to specific environmental chemical
exposure problems.
3. Program and Methodology (20 Percent)
Describe in detail how the biomonitoring laboratory plan will be
implemented. This must include a description of space allocation,
staffing requirements and training, instrumentation and instrumentation
maintenance, analytical methods, specimen storage and security, supply
accession, facilities, quality assurance and quality control,
logistical support and data management. The applicant shall provide a
phased timeline of activities leading to implementation or expansion of
a biomonitoring program by the applicant. Does this description of
activities fully cover the anticipated four-year, nine-month project
period? Does the application adequately address the CDC Policy
requirements regarding the inclusion of women, ethnic, and racial
groups in the proposed research? This includes:
a. The proposed plan for the inclusion of both sexes and under-
served populations for appropriate representation.
b. The proposed justification when representation is limited or
absent.
c. A statement as to whether the design of the study is adequate to
measure differences when warranted.
d. A statement as to whether the plans for recruitment and outreach
for study participants include the process of establishing partnerships
with community(ies) and recognition of mutual benefits.
4. Collaborative Efforts (15 Percent)
Describe anticipated collaborative efforts related to this program
among the applicant laboratory(ies), other components of the public
health structure of the community, including epidemiologists,
environmental health professionals, other state or local health
agencies, health services providers, and academic institutions such as
schools of public health, medicine, university departments of chemistry
or biochemistry, community and citizens groups, and other interested
parties. Letters of support from anticipated collaborators must be
provided as
[[Page 16291]]
attachments to the application package. The page limitation is
exclusive of the attached letters of support. The applicant must
discuss how collaborators propose to employ biomonitoring to address
public health issues/concerns. The applicant shall discuss
complementary and competing programs if applicable, such as
environmental testing programs, terrorism preparedness programs,
environmental public health tracking programs, and other activities
that may add to or detract from biomonitoring capacity.
5. Evaluation Plan (10 Percent)
The extent to which the applicant describes how progress towards
achieving the applicant's goals and objectives will be evaluated, and
how, during the implementation phase, new public health needs will be
assessed and the program (and the underlying plan) will be modified to
adjust to these changing public health needs and priorities. The
application's approach to evaluating the impact of the program on
environmental health and human exposure issues in the applicant's
community will also be evaluated.
6. Staffing, Management System, and Facilities (5 Percent)
The extent to which the applicant describes the staff that is
available or anticipated to conduct these activities and how they will
be managed and evaluated. The applicant must describe the
organizational setting and facilities available to support the
biomonitoring program; to access, transport, store, inventory, process
and manage biological specimens from people; and to accumulate,
process, store, and analyze data and other information related to the
implementation of this program. Applicants must also describe planning
to provide IRB review when biomonitoring programs are implemented, and
discuss the impact of the requirements of CLIA on their plan.
7. Budget (Not Scored)
The extent to which the applicant provides a detailed budget and
narrative justification consistent with stated objectives and program
activities.
You are encouraged to use Out-of-State travel funds to send one
staff person to attend the sixth National Environmental Health
Conference to be held on December 3-5, 2003, at the Hilton Atlanta, 255
Courtland Street, NE., Atlanta, GA. If additional written justification
is needed to support attendance at the above meeting, please contact
your project officer. Review the CDC/NCEH Web site for additional
information concerning the conference: http://www.cdc.gov/nceh/
default.htm.
8. Human Subjects (Not Scored)
Does the application adequately address the requirements of title
45 CFR part 46 for the protection of human subjects? Not scored;
however, an application can be disapproved if the research risks are
sufficiently serious and protection against risks is so inadequate as
to make the entire application unacceptable.
I. Other Requirements
OMB Clearance Requirements
Projects that involve the collection of information from 10 or more
individuals and funded by the cooperative agreement will be subject to
review and approval by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act.
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. Interim progress report, no less than 90 days before the end of
the budget period. The progress report will serve as a non-competing
continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Detailed Line-Item Budget and Justification.
e. Additional Requested Information.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
Additional Requirements
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment 1 of the
program announcement as posted on the CDC Web site.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-7 Executive Order 12372 Review
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-22 Research Integrity
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
associated forms can be found on the CDC Web site, Internet address:
http://www.cdc.gov.
Click on ``Funding'' then ``Grants and Cooperative Agreements''.
For interested applicants, a telephone conference call for pre-
application technical assistance will be held on April 21, 2003, at 1
p.m. eastern time. Potential applicants are requested to call in using
only one telephone line. The conference can be accessed by calling 1-
800-311-3437 or 404-639-3277 and entering conference code 824087 when
prompted. The purpose of the conference call is to help potential
applicants to:
1. Understand the scope and intent of the Program Announcement for
the Public Health Laboratory Biomonitoring Implementation Program.
2. Be familiar with the Public Health Services funding policies and
application and review procedures.
Participation in this conference call is not mandatory. At the time
of the call, if problems are encountered accessing the conference call,
please call 404-639-7550. For further information, please contact
Charles Buxton at (770) 488-4160 or Barry E. Smith at (770) 488-7968.
For general questions about this announcement, contact: Technical
Information Management, CDC Procurement and Grants Office, 2920
Brandywine Rd, Atlanta, GA 30341-4146. Telephone: 770-488-2700.
For business management and budget assistance, contact: Mildred S.
Garner, Grants Management Officer, Procurement and Grants Office,
Centers for Disease Control and Prevention, 2920 Brandywine Road, (MS
E-13), Atlanta, GA 30341-4146. Telephone: (770) 488-2745. E-mail
address: mqg4@cdc.gov.
For program technical assistance, contact: Charles H. Buxton,
MT(ASCP)SBB, National Center for Environmental Health, Centers for
Disease Control and Prevention, 4770 Buford Highway, NE. (MS F-20),
Atlanta, GA 30341-3724. Telephone: (770) 488-4160. E-mail address:
zpl1@cdc.gov.
Or:
Barry E. Smith, National Center for Environmental Health, Centers for
Disease Control and Prevention, 4770 Buford Highway, NE. (MS F-20),
[[Page 16292]]
Atlanta, GA 30341-3724. Telephone: (770) 488-7968. E-mail address:
bas4@cdc.gov.
Dated: March 27, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 03-8062 Filed 4-2-03; 8:45 am]
BILLING CODE 4163-18-P