[Federal Register: May 29, 2003 (Volume 68, Number 103)]
[Notices]
[Page 32050-32053]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my03-91]
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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
[[Page 32052]]
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: EGreen@cdc.gov. 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: SBerger@cdc.gov; 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:
msb4@cdc.gov.
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