[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-

[[Page 22583]]

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 
<gr-thn-eq> 10 <greek-m>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

[[Page 22584]]

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

[[Page 22585]]

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: <a href="/cdn-cgi/l/email-protection#6a191c1a5b2a090e09440d051c"><span class="__cf_email__" data-cfemail="e7949197d6a7848384c9808891">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#e783938ad6a7848384c9808891"><span class="__cf_email__" data-cfemail="9cf8e8f1addcfff8ffb2fbf3ea">[email protected]</span></a>.

    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


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