[Federal Register Volume 68, Number 103 (Thursday, May 29, 2003)]
[Notices]
[Pages 32050-32053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13378]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement Number 03087]


Polychlorinated Biphenyls Exposure and Adverse Health Effects in 
Anniston, Alabama; Notice of Availability of Funds

    Application Deadline: June 30, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized in Sections 104(i)(1)(E), (7) and (15) 
of the Comprehensive Environmental Response, Compensation, and 
Liability Act (CERCLA) as amended by the Superfund Amendments and 
Reauthorization Act (SARA) (42 U.S.C. 9604 (i)(1)(E), (7) and (15)). 
The Catalog of Federal Domestic Assistance number is 93.206.

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B. Purpose

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 2003 funds for a 
cooperative agreement program to conduct research on the impact of 
polychlorinated biphenyls (PCBs) exposure on human health in Anniston, 
Alabama. This program addresses the ``Healthy People 2010'' focus area 
of Environmental Health.
    The purpose of this program is to: (1) Collect baseline information 
and serum PCBs from a sample of Anniston residents; (2) study the 
relationship between exposure to PCBs and adverse health effects, such 
as cancer, neurobehavioral disorders, birth defects, and immune 
function; and (3) inform and educate residents about PCB exposure in 
their community.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goals for the ATSDR: (1) develop and 
provide reliable and understandable information for people in affected 
communities and tribes, and for stakeholders, and (2) ascertain the 
relationship between exposure to toxic substances and disease.

C. Eligible Applicants

    Applications may be submitted by:
    [sbull] Health departments of States or their bona fide agents, 
including the District of Columbia, the Commonwealth of Puerto Rico, 
the Virgin Islands, the Commonwealth of the Northern Mariana Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, and the Republic of Palau.
    [sbull] Federally recognized Indian tribal governments.
    [sbull] State-based institutions (this includes universities, 
colleges, and research institutions.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

Special Requirements

Minimal Applicant Requirements
    1. A documented link between the Anniston community and the 
applicant.
    2. Experience with community outreach and health education to 
provide support and information.
    3. The investigators should be prepared to work collaboratively 
with ATSDR and community leaders to achieve the goals of this 
solicitation.
    4. The investigators should be prepared to meet on a periodic basis 
with community representatives.

D. Funding

Availability of Funds

    Approximately $1,500,000 is available in FY 2003 to fund up to two 
awards. It is expected that the average award will be $750,000, ranging 
from $600,000 to $1,500,000. It is expected that the awards will begin 
on or about August 1, 2003, and will be made for a 12-month budget 
period within a project period of up to three 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 expended for reasonable program purposes, such as, 
personnel, travel, supplies and services. Funds for contractual 
services may be requested; however, the primary recipient of ATSDR 
funds must perform a substantive role in carrying out project 
activities and not merely serve as a conduit for an award to another 
party or provide funds to an ineligible party. Equipment may be 
purchased with these funds; however, the equipment proposed should be 
appropriate and reasonable for the research activity to be conducted. 
Equipment may be acquired only when authorized and the application 
should provide a justification of the need to acquire equipment, the 
description, and the cost of purchase versus lease. To the greatest 
extent practicable, equipment and products purchased with ATSDR funds 
should be American made. ATSDR retains the right to request the return, 
at the completion of the project period, of all equipment in operable 
condition purchased with grant funds.

Recipient Financial Participation

    Matching funds are not required for this program.

Funding Preferences

    Preference will be given to the following: applicants who are 
located in the southeastern region of the United States, applicants who 
have support from the Anniston community as evidenced by letters of 
support, applicants who demonstrate collaborative effort with other 
institutions, or projects which avoid a duplication of study 
objectives.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities listed in 1. 
Recipient Activities, and ATSDR will be responsible for the activities 
listed in 2. ATSDR Activities.

1. Recipient Activities

    a. Develop a study proposal that examines the relationship between 
exposure to PCBs and an adverse health effect, such as cancer, 
neurobehavioral disorders, birth defects, and/or immune function. 
Protocol (study design and end point(s) under investigation) and data 
collection instruments will be developed by applicant, in consultation 
with ATSDR, and approved prior to project implementation. A recommended 
time line is available in Attachment IV. All attachments referenced in 
this announcement are posted with the announcement on the CDC Web site.
    b. Meet in Anniston, Alabama, at least twice in the first year with 
ATSDR and Environmental Protection Agency Region IV staff to review 
available exposure data to help define the exposed population(s).
    c. At the conclusion of the study, share all data collected through 
these activities with ATSDR. These data may be used by ATSDR to further 
characterize potential exposure pathways.
    d. Through letters of support, provide evidence of on-going 
collaborative efforts with community representatives, local elected 
officials, state and local health departments, etc., to enhance 
communication and information exchange with the Anniston community 
(Attachment V).
    e. Establish a mechanism to work with community leaders in 
Anniston, Alabama, on a periodic basis throughout the study period to 
gather input on study design issues, and receive feedback regarding 
outreach, participation, and education.
    f. Meet annually with ATSDR and other awardee(s) in Atlanta, 
Georgia, to coordinate planned efforts and review progress.
    g. Disseminate research results to community members, and publish 
in written format for distribution.

2. ATSDR Activities

    a. Provide epidemiologic guidance and administrative support to 
achieve program goals.
    b. In collaboration with the recipient, develop a research protocol 
for Institutional Review Board (IRB) review by all cooperating 
institutions

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participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.
    c. Develop and provide to recipient a number of baseline questions 
for data collection related to the participant's exposure history.
    d. In collaboration with the Environmental Protection Agency Region 
IV and the recipient(s), coordinate meetings in Anniston, Alabama, at 
least twice in the first year to review available exposure data to 
better define exposed population(s).
    e. Participate in periodic meetings with community leaders in 
Anniston, Alabama, to gather input on study design issues, and receive 
feedback regarding outreach, participation, and education throughout 
the study period.
    f. Facilitate external peer review of the study protocol and the 
final report.
    g. Provide assistance with the dissemination of information 
resulting from this project, including the review and publication of a 
final report.
    h. Facilitate an annual meeting between awardee(s) in Atlanta, 
Georgia, to coordinate planned efforts and review progress.

F. Content

Applications

    The Program Announcement title and number must appear in the 
application. 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.
    The narrative should be no more than 45 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 Proposed 
Research Plan, Objectives, Methods, Evaluation, Budget, and Time line. 
The program plan should address activities to be conducted over the 
entire three-year project period.

G. Submission and Deadline

Application Forms

    Submit the signed original and two copies of PHS 5161-1 (OMB 0920-
0428). 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 June 30, 
2003. Submit the application to: Technical Information Management--PA 
03087, Procurement and Grants Office, Centers for Disease 
Control and Prevention, 2920 Brandywine Rd, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgment of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    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 after closing 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

    An independent review group appointed by ATSDR will evaluate each 
application against the following criteria:
1. Goals and Objectives (20 percent)
    The extent to which the applicant clearly identifies specific, 
measurable, and scientifically sound goals and objectives.
2. Study Design and Methods (20 percent)
    a. Adequacy of the study design and methodology for accomplishing 
the stated goals and objectives.
    b. The degree to which efficient and innovative approaches are 
proposed in collaboration with other institutions.
    c. The extent to which the applicant's plans and schedule proposed 
for accomplishing the activities to be carried out in this project are 
clearly stated, are realistic given the length of the funding period, 
and can be achieved within the proposed budget.
    d. Applicant provides opportunities to collaborate with Anniston 
community leaders to develop final study protocol.
3. Community Involvement, Education, and Dissemination of Results (20 
percent)
    a. Adequacy of plan to address community concerns by establishing 
partnerships with community representatives, local environmental and 
health agencies, and other relevant public and private groups and 
organizations prior to project implementation.
    b. Adequacy of plans to create formal lines of communication with 
Anniston leaders on a periodic basis, including representation from 
various disciplines and backgrounds.
    c. The degree to which efficient and innovative approaches are 
proposed to educate the community about PCB exposure.
    d. Adequacy of methods to work with the community to disseminate 
study results.
4. Understanding of the Problem (10 percent)
    a. The applicant's understanding of the problems facing the 
residents of Anniston, Alabama.
    b. The applicant should demonstrate an understanding of scientific 
and epidemiologic issues when conducting environmental research.
    c. Relevance of the proposed program to these and related problems.
5. Program Personnel (10 percent)
    a. Applicant's technical experience and understanding in the areas 
of PCBs, environmental epidemiology, health education/community 
outreach, etc.
    b. Qualifications and time allocation of the professional staff to 
be assigned to this project.
    c. Extent to which the management staff and their working partners 
are clearly described.
6. Facilities and Resources (10 percent)
    The adequacy of the applicant's facilities, equipment, and other 
resources available for performance of this project.
7. Measures of Effectiveness (10 percent)
    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the

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cooperative agreement. Measures of effectiveness must relate to the 
performance goals as stated in the Purpose section 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.
8. Human Subjects: does the application adequately address the 
requirements of 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.)
9. Budget Justification (Not Scored)
    The budget will be evaluated to the extent that it is reasonable, 
clearly justified, and consistent with the intended use of funds.
10. Does the application adequately address the CDC Policy requirements 
regarding the inclusion of women, ethnic, and racial groups in the 
proposed research? (Not scored.) This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority 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.

I. Other Requirements

Technical Reporting Requirements

    1. Provide CDC with an original plus two copies of an interim 
progress report, no less than 90 days before the end of the budget 
period. The progress report will serve as your 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 I of the 
program announcement as posted on the CDC Web site.

AR-1 Human Subjects Requirements
AR-2 Requirements of Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7 Executive Order 12372 Review
AR-9 Paper Work Reduction Act
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-17 Peer Review and Technical Reviews of Final Reports of Health 
Studies--ATSDR
AR-18 Cost Recovery--ATSDR
AR-19 Third Party Agreements--ATSDR
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 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: Edna Green, 
Grants Management Specialist, Procurement and Grants Office, Centers 
for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 
30341-4146. Telephone: 770-488-2743. e-mail address: [email protected].
    For program technical assistance, contact: Sherri Berger-Frank, 
Agency for Toxic Substances and Disease Registry, 1600 Clifton Road, 
NE., Mail Stop E-28, Atlanta, Georgia 30333. Telephone: (404) 498-0522. 
E-mail address: [email protected]; or Scott Bowen, Agency for Toxic 
Substances and Disease Registry, 1600 Clifton Road, NE., Mail Stop E-
31, Atlanta, Georgia 30333. Telephone: (404) 498-3457. E-mail address: 
[email protected].

    Dated: May 19, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 03-13378 Filed 5-28-03; 8:45 am]
BILLING CODE 4163-70-P