[Federal Register Volume 66, Number 87 (Friday, May 4, 2001)]
[Notices]
[Pages 22582-22585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11215]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 01072]
Public Health Laboratory Biomonitoring Planning Grant; Notice of
Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2001 funds for a grant program to
promote planning for the development, implementation, and expansion of
State-
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based biomonitoring programs to help prevent disease resulting from
exposure to toxic substances. This program addresses ``Healthy People
2010'' focus areas of Environmental Health and Public Health
Infrastructure.
In this announcement, the term ``biomonitoring'' refers to the
assessment of exposure to toxic substances in people by the laboratory
measurement of these substances (or their metabolites) in specimens
from humans such as blood, urine and saliva. Biomonitoring measurements
assess the concentration of the toxic substance in people and are often
referred to as ``internal dose'' measurements.
Biomonitoring measurements can assess the exposure of a single
person or by aggregating data of many people, a population.
Biomonitoring measurements complement environmental measurements of
toxic substances in air, water, food, soil and dust. Specific uses of
biomonitoring measurements in public health include:
1. To measure the prevalence of elevated levels of toxic substances
in a population group (e.g., the prevalence of blood lead levels
10 g/dL in children living in an inner-city
environment);
2. To determine levels of exposure in population groups who may be
at increased risk of exposure;
3. To provide levels of human exposure in studies examining the
relationship between exposure to a toxic substance (or toxic
substances) and adverse health effects;
4. To determine whether levels of toxic substances are higher in
potentially more vulnerable population groups such as children, the
elderly, or women of childbearing age than in the general population;
5. To track over time, trends in the levels of exposure of a
population group to specific toxic substances (e.g., levels of exposure
to mercury in a population who consume fish as a major portion of their
diet);
6. To assess the effectiveness of public health efforts to reduce
the exposure of specific populations to toxic substances.
For biomonitoring measurements to be effective in addressing these
public health needs, they should be accurate, precise, sensitive,
specific, rugged, and have adequate throughput to complete measurements
in a timely manner. For more information about the concept of
biomonitoring, please see the references at the website: http://www.cdc.gov/nceh/publications/at-a-glance/Biomonitor/Default.htm
To effectively apply biomonitoring measurements, laboratories must
interface with other public health partners, including physicians,
epidemiologists, and health professionals at the State and local
levels, in academic centers, and in communities. In addition,
collaboration with other public health laboratories can be beneficial.
B. Eligible Applicants
Applications may be submitted only by public health laboratories of
States, the District of Columbia, the Commonwealth of Puerto Rico, the
Virgin Islands, the Commonwealth of the Northern Mariana Islands,
American Samoa, Guam, federally recognized Indian tribal governments,
the Federated States of Micronesia, the Republic of the Marshall
Islands, and the Republic of Palau.
In some States, territories, and protectorates, environmental
health testing and biomonitoring responsibilities are under the
jurisdiction of an agency other than the Public Health Laboratory. In
those cases, application for funding under this program announcement
will be accepted from other agencies, provided that the Public Health
Laboratory in that State, territory, or protectorate is in agreement
and submits written documentation of such agreement as part of the
application.
Note: Only one application per State, territory, or protectorate
may be submitted.
Eligible laboratories may form consortia. Applications from
consortia must provide documentation from each member of the consortium
of their willingness to collaborate and pool data from each site in
their proposed consortium. One laboratory of the consortium must be
identified as the designated lead on a multi-site application. The lead
laboratory must submit the application and administer the award.
For interested applicants, a telephone conference call for pre-
application technical assistance will be held on Thursday, May 24,
2001, from 1:30 p.m. to 3:30 p.m., Eastern Standard Time. The bridge
number for the conference call is 1-800-713-1971, and the pass code is
509361. For further information, please contact Charles Buxton at (770)
488-4160.
Note: Effective January 1, 1996, Public Law 104-65 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code of 1986, which engages in lobbying activities shall not
be eligible to receive Federal funds constituting an award, grant
(cooperative agreement), contract, loan, or any other form.
C. Availability of Funds
Approximately $5,000,000 is available in FY 2001 to fund
approximately 25 awards. It is expected that the average award will be
$200,000, ranging from $100,000 to $300,000. It is expected that the
awards will begin on or about September 1, 2001, and will be made for a
12-month budget period within a project period of up to two years.
Funding estimates may change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the availability of funds.
Use of Funds
Funds may be used to develop a biomonitoring plan, to conduct
surveys, hire consultants, hire and train personnel, conduct needs
assessments and evaluations, conduct travel related to this project,
pay for relevant and appropriate services, and perform other activities
that enhance the recipient's ability to develop a biomonitoring program
plan. Project funds may not be used for the development of testing
methods or programs for environmental samples.
Funds may not be used to support activities which would otherwise
be under the jurisdiction of Superfund and/or the Agency for Toxic
Substances and Disease Registry. However, because toxicants from
Superfund sites contribute to the total of human exposure sources,
funds may be used for planning purposes to examine the interface
between Superfund activities and public health laboratory biomonitoring
programs.
Future Plans: CDC anticipates that during the second year of this
grant program, a Cooperative Agreement program announcement will be
issued with the intent to provide in FY 2003, the funding for
approximately five public health laboratories at an anticipated level
of $1,000,000 per laboratory, per year (for up to five years) to
implement biomonitoring programs.
Eligibility for these Cooperative Agreement funds will be limited
to those laboratories that have received funds under this grant
program. Criteria for funding under the future Cooperative Agreement
Program will include: the quality of the plan developed during this
planning grant period; the degree to which the applicant demonstrates
cooperation and integration with other public health resources (e.g.,
epidemiologists, schools of public health, medicine and science); and
the assessment of the need for biomonitoring.
CDC anticipates that the awards during the Cooperative Agreement
phase will be made with the goal of achieving geographic distribution
and
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balance among laboratories which serve people living in diverse
settings such as urban, rural, agricultural, and industrial
communities.
Funding Preferences
Preference for awards will be given to ensure geographic diversity.
D. Program Requirements
The program areas of interest focus on the development of a plan by
which recipients will be able to achieve the following by the end of
the two-year project period:
1. Assess the need for biomonitoring within the community served by
the applicant. The laboratory should collaborate with other public
health partners, including public health physicians and epidemiologists
to make this needs assessment. Special consideration should be given to
evaluating exposures in racial and ethnic population groups that may be
at increased risk from exposure.
2. Develop a plan for implementing or expanding biomonitoring
capacity in the public health laboratory. This plan should:
a. Define specific, measurable, and time-framed goals and
objectives.
b. Inventory existing biomonitoring methods available to the
applicant and specify for each method: 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 method sample throughput per day, and
approximate number of human specimens analyzed in the past 12 months.
(If an applicant is not currently performing biomonitoring testing, but
anticipates this need, these needs should be stated as outlined in
2.c.)
c. Identify new biomonitoring capacity needed to address additional
toxic substances or expand current methods. Emphasize in this section
how the new biomonitoring capacity will be used to address needs
identified in 1. 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 lab to use biomonitoring data to
help address these public health needs.
d. 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.
e. Describe requirements for local Institution Review Board (IRB)
or Human Subjects review and approval.
f. Discuss requirements for compliance with the Clinical Laboratory
Amendments (CLIA) 1988.
3. Develop an evaluation plan to assess 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 or community.
E. Application Content
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria Sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out your program
plan. Please follow the directions indicated in the application kit.
F. Submission and Deadline
Submit the original and five copies of PHS 398 (OMB Number 0925-
0001) Forms are in the application kit.
On or before July 2, 2001, submit the application to the Grants
Management Specialist identified in the ``Where to Obtain Additional
Information'' section of this announcement.
Deadline: Applications shall be considered as meeting the deadline
if they are either:
(a) Received on or before the deadline date; or
(b) Sent on or before the deadline date and received in time for
submission to the Objective Review Panel. (Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or U.S. Postal Service. Private
metered postmarks shall not be acceptable as proof of timely mailing.)
Late applications: Applications which do not meet the criteria in
(a) or (b) above are considered late applications, will not be
reviewed, and will be returned to the applicant.
G. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent review group appointed by CDC.
1. Understanding the Problem (30 Percent)
The extent to which the applicant understands the need for planning
a biomonitoring program and 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.
a. The analytical challenges associated with identifying 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.
b. 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 more
meaningful information.
2. Goals and Objectives (20 Percent)
The extent to which the applicant clearly states planning 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 preparing the biomonitoring plan.
3. Description of Program and Methodology (20 Percent)
Describe in detail how the biomonitoring plan will be developed,
what sources of information and expertise will be utilized in
establishing the plan. Describe a phased time line of activities
leading to completion of the plan, and anticipated uses of the plan.
4. Collaborative Efforts (15 Percent)
Describe anticipated collaborative efforts related to this planning
among the applicant laboratory, 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 should be provided as
attachments to the application package.
5. Evaluation Plan (10 Percent)
The extent to which the applicant describes how progress towards
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achieving the applicant's goals and objectives will be evaluated, and
how, once the plan has been completed, its impact on environmental
health and human exposure issues in the applicant's community will be
assessed.
6. Staffing, Management System, and Facilities (5 Percent)
The extent to which the applicant describes the staff available or
anticipated to conduct the planning activities and how they will be
managed. The applicant must describe the organizational setting and
facilities available to support the development of the plan, to
accumulate and analyze data and other information related to planning.
Applicants should also describe planning to provide IRB review when
biomonitoring programs are implemented and discuss the impact of the
requirements of the Clinical Laboratory Improvement Amendments of 1988
(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 planned
program activities.
H. Other Requirements
Provide CDC with the original plus two copies of:
1. Annual progress reports, no more than 30 days after the end of
the report period;
2. Financial status report, no more than 90 days after the end of
the budget period;
3. Final financial report and performance report, no more than 90
days after the end of the project period; and
4. Completed planning document, no later than the end of the third
quarter of year two.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I in the
application kit.
AR-7 Executive Order 12372 Review
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
I. 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. sections 241 and 247b, as amended. The
catalog of Federal Domestic Assistance number is 93.283.
J. Where To Obtain Additional Information
This and other CDC announcements can be found on the CDC home page
Internet address--http://www.cdc.gov Click on ``Funding'' then ``Grants
and Cooperative Agreements.''
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked
to leave your name and address and will be instructed to identify the
Announcement number of interest.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from: Sonia V. Rowell, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention, 2920 Brandywine Road, Room 3000, (MS E-13), Atlanta, GA
30341-4146, Telephone: (770) 488-2724, E-mail address: [email protected].
For program technical assistance contact: Dayton T. Miller, Ph.D.,
National Center for Environmental Health, Centers for Disease Control
and Prevention, 4770 Buford Highway, NE (MS F-18), Atlanta, GA 30341-
3724, Telephone: (770) 488-4452, E-mail address: [email protected].
Dated: April 30, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 01-11215 Filed 5-3-01; 8:45 am]
BILLING CODE 4163-19-P