[Federal Register: August 25, 2004 (Volume 69, Number 164)]
[Notices]
[Page 52291-52297]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au04-91]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Fetal Alcohol Syndrome Prevention and Surveillance in South
Africa: Developing Community-Level Strategies That Work
Announcement Type: New.
Funding Opportunity Number: RFA DD05-011.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Letter of Intent Deadline: September 24, 2004.
Application Deadline: November 23, 2004.
I. Funding Opportunity Description
Authority: This program is authorized under Sections 307,317(C),
and 317(k)(2) of the Public Health Service Act42 U.S.C., Sections 241,
242 (I), 247b-4 and 247b (k) (2) as amended].
Purpose: The purpose of this program is to develop a model
prevention program, successful in reducing hazardous alcohol use,
reducing unintended pregnancies and/or promote pregnancy delay among
childbearing age women at risk for an alcohol-exposed pregnancy in high
risk communities (urban and rural) for Fetal Alcohol Syndrome (FAS) in
SouthAfrica. This program should be conducted in three stages.
Stage 1: The formative research state is composed of qualitative
and quantitative research of knowledge, attitudes and practices in high
risk women (women of child-bearing age at high risk of an alcohol-
exposed pregnancy; women with children with FAS, spouses/partners,
health care providers, obstetricians and nurses, specialty providers
including alcohol treatment and substance abuse services, community
leaders, etc.) regarding use of alcohol in pregnancy, use of
contraception, knowledge of FAS, as well as issues such as
identification of services and barriers to services. The formative
research will describe the socio-demographic characteristics and
attributes of the targeted community at risk, identify constraints and
opportunities for behavior change, and allow the initiation and conduct
of community and person-level interventions under stage 2.
Stage 2: The protocol and intervention development stage will use
the information gathered in Stage 1 in combination with previous
evidence-based research in FAS and HIV prevention in the U.S. and South
Africa to develop a model intervention.
Stage 3: This stage will test the feasibility of the major
components of the program in the high risk FAS communities targeted in
this announcement.
The targeted communities should include geographic areas and/or
selected subpopulations of childbearing-age women at high risk for an
alcohol-exposed pregnancy in urban and rural areas of South Africa.
This program addresses the ``Healthy People 2010'' focus area of
Substance Abuse and Maternal, Infant, and Child Health.
Measurable outcomes of the program will be in alignment with one
(or more) of the following performance goal(s) for the National Center
on Birth Defects and Developmental Disabilities (NCBDDD): Prevent birth
defects and developmental disabilities.
Research Objectives and Background: FAS is caused by maternal
alcohol use during pregnancy and is one of the leading causes of
preventable birth defects and disabilities. Recently, the highest
prevalence of FAS worldwide was reported among children living in the
winery area of the Western and Northern Cape region of South Africa
with FAS prevalence rates ranging from 40.5 to 46.4 per 1,000 children.
In the Gauteng region of South Africa(outside the wine-growing region)
FAS prevalence rates range from 11.8 to 41.0 per 1,000 children. In
addition, CDC has implemented a monitoring system in the area of De
AAR, where the FAS prevalence rate was 80 per 1,000 live births. These
rates show that FAS is a serious public health problem in some areas or
subgroups of the South African population.
Important risk factors associated with heavy alcohol use among
childbearing-age women include use of tobacco and other drugs, co-
existing psychiatric conditions, history of sexual or physical abuse
during childhood and/or adulthood, and a previous alcohol-exposed
pregnancy. Studies have found that the strongest predictor of alcohol
use during pregnancy is the level of alcohol use prior to pregnancy.
Most of the same risk factors in women at risk of an alcohol-exposed
pregnancy are also found in women at high risk for HIV infection.
Essential strategies for preventing alcohol-exposed pregnancies
among high-risk women who are heavy alcohol users can include
individual, group and community level interventions. Examples of
individual level
[[Page 52292]]
interventions are: Provide one-on-one client services that offer
counseling to reduce or abstain from alcohol intake, assist clients in
assessing their own behavior and planning individual behavior change,
support and sustain behavior change, and facilitate linkages to
community health services (i.e., alcohol treatment services) in support
of behaviors and practices that prevent FAS. Such efforts must be
coupled with strategies which address pregnancy postponement until the
risk of prenatal alcohol use can be overcome. These approaches can be
enhanced by developing local capacity through education and training of
key public and private providers in the community.
Group level interventions shift the delivery of service from
individual to groups of varying sizes. Group level interventions
provide education and support in group settings to promote and
reinforce safer behaviors and to provide interpersonal skills training
in negotiating and sustaining appropriate behavior change to
childbearing-age women at increased risk for FAS.
Community level interventions are directed at changing community
norms, and increasing community support of the behaviors known to
reduce the risk of FAS. Change in community attitudes, norms, and
practices are brought about through health communication, social
(prevention) marketing, community mobilization and organization, and
community wide events.
Under identification of target population(s), applicants must
identify urban and rural areas in which to conduct formative,
epidemiologic, and intervention study activities. An entire province
could be defined as a project geographical area or several regions or
counties could be combined (containing both urban and rural
populations) to establish the minimum eligibility criteria for FAS
cases or childbearing-age women at risk. Applicants must be able to
demonstrate that the area(s) selected include both urban and rural
populations (within one defined geographical area or in two or more
geographical areas with separate urban and rural populations).
In each case, the geographical area(s) selected must be
representative of the country with at least 350,000 urban and rural
childbearing-age women or a birth cohort of at least 25,000 births per
year; and with high proportions of childbearing-age women at risk for
an alcohol-exposed pregnancy [a minimum of 10 percent of non-pregnant,
childbearing age women (aged 12-44 years) reporting frequent or binge
drinking]; or a birth cohort with a minimum FAS prevalence rate of 10
per 1,000 live births; or communities with a high prevalence of HIV--
due to the fact that FAS populations share common behavior patterns of
substance abuse and sexual behavior; or by describing the high risk
targeted population with relevant socio-demographic and epidemiological
characteristics.
A woman who is at high risk for an alcohol-exposed pregnancy is one
who engages in moderate (7-13 drinks per week) to heavy alcohol use (14
or more drinks per week) or binge drinking (4 or more drinks in a
single occasion), is sexually active, and is not effectively practicing
contraception.
The development of a model FAS prevention program for high risk
communities in South Africa as specified in this announcement should
include the aforementioned 3 stages.
Stage I: Formative research will be undertaken in the first year of
the project, and should include conducting a community-based assessment
to determine the women who are at highest risk within the community.
This includes determining the characteristics of women at risk for an
alcohol-exposed pregnancy, but not limited to those who have already
had a child with FAS; and the risk characteristics of women at risk for
HIV. Identification of environmental factors that could contribute to
FAS; and potential venues for enrolling these populations for
intervention services to prevent FAS will also be identified. This
assessment could draw on existing data (through FAS surveillance
systems) or on newly collected population-based data. Included within
the scope of this work is conducting a needs assessment of health
providers as to the services provided to the targeted populations
including any perceived or real gaps between needs, expectations, and
services delivered.
Stage II: The protocol and intervention development stage should be
implemented during the first half of year two. Interventions should be
developed to address the specific priority needs identified in Stage 1
including preparation of a study protocol to test the feasibility,
acceptability, operational requirements of the interventions, and the
development of an intervention evaluation plan including appropriate
process and outcome measures. The protocol will include choices of
sites, selection criteria for childbearing-age women at risk of an
alcohol-exposed pregnancy, interventions and implementation methods,
and the study evaluation. Piloting the protocol should be included in
Stage II.
Stage III: The feasibility and evaluation stage is to be
accomplished in the second half of year two and during year three of
the project. It includes the implementation and evaluation of the model
intervention(s) to assess whether the intervention can be appropriately
utilized and replicated.
Activities: Awardee activities for this program are as follows:
1. Design an effective, innovative research approach that
identifies and prioritizes key elements that are essential to
community-based FAS prevention activities in the target populations.
2. Independent of the funding agency, develop a protocol to conduct
community-based epidemiological and behavioral information gathering in
childbearing age women populations that can include risky drinking
behavior, sexual behavior patterns, social networks, substance abuse
behavior, perceptions of social sexual norms, attitudes, self-efficacy,
perception of current FAS prevention interventions, health-care and
health-information seeking behaviors, and structural influences on
behavior in order to determine the most appropriate intervention
strategies to be used.
3. Identify, recruit, obtain informed consent forms and enroll and
follow to completion participants as determined by the project-
developed study protocol. Ensure that the protocol developed by the
recipient details the study design, includes sample size calculations,
denotes a study timeline, and conveys provisions to maintain
confidentiality of study subjects.
4. Based on the recipient's independently developed protocol,
assess maternal alcohol exposure through surveys and interviews with a
sample of pregnant and non-pregnant women in the targeted population.
5. Perform tests as determined by the study protocol, and follow
study participants over time as determined by the project-developed
protocol.
6. Conduct needs assessment of health providers and other services
provided to these populations. Determine the needs gap between the
population and the services they receive.
7. Design and implement a provider education component for health
personnel involved in intervention and surveillance and monitoring
activities.
8. Develop and implement a feasibility protocol for prevention of
FAS in a targeted geographic region as determined by the project that
has increased rates of women at high risk for an alcohol-exposed
pregnancy and/or increased rates of infants and children with FAS.
Strengthen and improve
[[Page 52293]]
public health infrastructure to prevent FAS supporting additional
services and links with existing, community-based programs that provide
preventive health services.
9. Collect and evaluate information that could generate hypotheses
about barriers to or opportunities for more efficacious innovations in
FAS prevention including linkages with other populations at risk such
as women at risk of HIV.
10. Collaborate with CDC as needed by requesting assistance in
process and operational procedures.
11. Conduct project-developed research activities to answer
specific research questions.
12. Provide appropriate privacy protections in accordance with the
research protocol and informed consent stipulations for all
participants.
13. Promote the peer-review of the study findings in the
publication of study results.
14. Collect and analyze study data and prepare a final report of
the outcomes of the study with recommendations for future research and
prevention efforts.
CDC Responsibilities: In a cooperative agreement, CDC staff is
substantially involved in the program activities, above and beyond
routine grant monitoring. In this cooperative agreement, CDC Scientists
(Scientific Liaisons) within the National Center on Birth Defects and
Developmental Disabilities (NCBDDD) are an equal partner with
scientific and programmatic involvement during the conduct of the
project through technical assistance, advice, and coordination. These
Scientific Liaisons will:
(1) Use their experience in studies of this nature to advise the
project on specific questions regarding the project-developed protocol.
(2) As requested, assist the project in responding to inquiries
regarding such areas as data management, data analysis, formats for
presenting research findings, and in comparing project-developed
evaluation formats with other research projects and activities known to
CDC.
(3) Provide scientific consultation and technical assistance as
requested on questions related to epidemiology, statistical and power
calculations, and data storage and tracking formats used in other CDC
sponsored research that could be advantageous to the project.
(4) Suggest to the project, upon request; processes for analysis,
interpretation, and reporting of findings in the literature that can
serve domestic and international scientific interests.
(5) In working with the selected foreign entity, provide technical
assistance and advice, and participate as an advisor in the collecting
of information from the government's nationals.
CDC Scientific Program Administrator (SPA): The CDC NCBDDD will
appoint an SPA, apart from the NCBDDD Scientific Liaisons who will:
(1) Serve as the Program Official for the funded research
institutions.
(2) Carry out continuous review of all activities to ensure
objectives are being met.
(3) Attend Coordination Committee meetings for purposes of
assessing overall progress and for program evaluation purposes.
(4) Provide scientific consultation and technical assistance in the
conduct of the project as requested.
(5) Conduct site visits to recipient institutions to determine the
adequacy of the research and to monitor performance against approved
project objectives.
Collaborative Responsibilities: The planning and implementation of
the cooperative aspects of the study will be effected by a Coordination
Committee consisting of the Principal Investigator from the
participating institution and the CDC Scientific Liaisons. This
Coordinating Committee will formulate a plan for cooperative research.
At periodic coordination committee meetings, the group will: (1)
Make recommendations on the study protocol and data collection
approaches; (2) discuss the target populations that have been or will
be recruited; (3) identify and recommend solutions to unexpected study
problems; and (4) discuss ways to efficiently coordinate study
activities and best practices.
II. Award Information
Type of Award: Cooperative Agreement
CDC involvement in this program is listed in the Activities Section
above.
Mechanism of Support: U84.
Fiscal Year Funds: 2005.
Approximate Total Funding: $300,000 (The estimated funding amount
is pending availability of FY 2005 funds, and is subject to change.)
Approximate Number of Awards: One.
Approximate Average Award: $300,000. This amount is for the first
12-month budget period, and includes both direct and indirect costs.
Floor of Award Range: $285,000.
Ceiling of Award Range: $315,000. If you request a funding amount
greater than the upper threshold, your application will not be eligible
for review. You will be notified that you did not meet the submission
requirements.
Anticipated Award Date: June 1, 2005.
Budget Period Length: 12 months.
Project Period Length: Four years. Throughout the project period,
CDC's commitment to continuation of awards will be conditioned on the
availability of funds, evidence of satisfactory progress by the
recipient (as documented in required reports), and the determination
that continued funding is in the best interest of the Federal
government.
III. Eligibility Information
III.1. Eligible Applicants: Support will be provided only to non-
profit NGOs or Universities in South Africa that can perform this
activity. Applicants must identify and document their capacity to
address urban and rural populations and meet the required volume of
childbearing age women or birth cohort size, and the proportions of
childbearing age women at risk or a birth cohort with a minimum FAS
prevalence rate or communities with high HIV prevalence or the high
risk targeted populations noted under the ``Identification of Target
Populations'' discussion in this announcement. Providing precise
information as to how these requirements will be met is essential to
the consideration of your application for review.
III.2. Cost Sharing or Matching: Matching funds are not required
for this program.
III.3. Other Eligibility Requirements: If your application is
incomplete or non-responsive to the requirements listed below, it will
not be entered into the review process. You will be notified that your
application did not meet submission requirements.
Applicants must document their present infrastructure, capacity,
expertise, and experience (within organization or within organizations
of collaborators) in conducting research directly related to the
awardee activities cited in this announcement. Applicants must provide
specific evidence to substantiate this capacity, experience, and
expertise. Through documentation of a maximum of three pages in length,
applicants must demonstrate that they can fully meet all eligibility
criteria in order to be considered for formal review, and that they can
conduct all project operations as noted under the listed stages for
this program. This information must be included as part of the
application and inserted immediately after the Face Page of the
application.
Individuals Eligible to Become Principal Investigators: Any
individual with the skills, knowledge, and resources necessary to carry
out the
[[Page 52294]]
proposed research is invited to work with their institution to develop
an application for support. Individuals from under-represented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for CDC programs.
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.
IV. Application and Submission Information
IV.1. Address to Request Application Package: To apply for this
funding opportunity, use application form PHS 398 (OMB number 0925-0001
rev. 5/2001). Forms and instructions are available in an interactive
format on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm
.
Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html
.
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) staff at: (770) 488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Application Submission:
Letter of Intent (LOI): The LOI must be written in the following
format:
Maximum number of pages: Two.
Font size: 12-point unreduced.
Paper size: 8.5 by 11 inches.
Page margin size: One-inch margins.
Printed only on one side of page.
Single spaced.
Written in English; avoid jargon.
The LOI must contain the following information: Name, address, and
telephone number of the proposed Principal Investigator, number and
title of this program announcement, names of other key personnel,
designations of collaborating institutions and entities, and an outline
of the proposed work, recruitment approach, and expected outcomes.
Application: Follow the PHS 398 application instructions for
content and formatting of your application. For further assistance with
the PHS 398 application form, contact PGO-TIM staff at (770) 488-2700,
or contact GrantsInfo, Telephone (301) 435-0714, e-mail:
GrantsInfo@nih.gov
Your research plan should address activities to be conducted over
the entire project period.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. The DUNS
number is a nine-digit identification number, which uniquely identifies
business entities. Obtaining a DUNS number is easy and there is no
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com
or call 1-866-705-5711. For more information, see the CDC Web site at:
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
This announcement uses the non-modular budgeting format. The PHS
398 grant application form requires the applicant to enter the project
title on page 1 (Form AA, ``Face Page'') and the project description
(abstract on page 2).
The main body of the application narrative should not exceed 25
single-spaced pages. This narrative research plan should address
activities to be conducted over the entire project period.
Additional information may be included in the application
appendices. The appendices will not be counted toward the narrative
page limit. This additional information may include curriculum vitae
and resumes for key project staff, organizational charts, letters of
commitment and support, graphic work plan with time intervals related
to goals and objectives, etc.; and should be limited to those items
relevant to the requirements of this announcement. Applicants must
provide a graphic work plan that outlines major goals and objectives
with timelines established for each calendar quarter covering the
entire project period.
All material must be typewritten, with 10 characters per inch type
(12 point) on 8\1/2\ by 11 inch white paper with one inch margins, no
headers or footers (except for applicant-produced forms such as
organizational charts, c. vitae, graphs and tables, etc.). Applications
must be held together only by rubber bands or metal clips, and not
bound together in anyway (including attachments/appendices).
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Time:
Letter of Intent (LOI) Deadline Date: September 24, 2004.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and will allow CDC
to plan the application review.
Application Deadline Date: November 23, 2004.
Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline
date. If you send your application by the appropriate postal service or
commercial delivery service, you must ensure that the carrier will be
able to guarantee delivery of the application by the closing date and
time. If CDC receives your application 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, you will be given the opportunity to
submit documentation of the carrier's guarantee. If the documentation
verifies a carrier problem, CDC will consider the application as having
been received by the deadline.
This announcement is the definitive guide on LOI and Application
submission address and deadline. It supersedes information provided in
the application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your submission. If you
have a question about the receipt of your LOI or application, first
contact your courier. If you still have a question, contact the PGO-TIM
staff at: (770) 488-2700. Before calling, please wait two to three days
after the submission deadline. This will allow time for submissions to
be processed and logged.
IV.4. Intergovernmental Review of Applications: Executive Order
12372 does not apply to this program.
IV.5. Funding Restrictions: Restrictions, which must be taken into
account while writing your budget are:
Project funds cannot be used to supplant other available
applicant or collaborating agency funds for construction or for lease
or purchase of facilities or space.
Funds may be spent for reasonable program purposes,
including personnel, travel, supplies, and services.
[[Page 52295]]
Equipment may be purchased if deemed necessary to accomplish program
objectives, however, prior approval by CDC officials must be requested
in writing.
The costs that are generally allowable in grants to
domestic organizations are allowable to foreign institutions and
international organizations, with the following exception: With the
exception of the American University, Beirut and the World Health
Organization, Indirect Costs will not be paid (either directly or
through sub-award) to organizations located outside the territorial
limits of the United States or to international organizations
regardless of their location.
The applicant may contract with other organizations under
this program; however the applicant must perform a substantial portion
of the activities (including program management and operations, and
delivery of prevention services for which funds are required.)
All requests for funds contained in the budget, shall be
stated in U.S. dollars. Once an award is made, CDC will not compensate
foreign grantees for currency exchange fluctuations through the
issuance of supplemental awards.
You must obtain annual audit of these CDC funds (program-
specific audit) by a U.S.-based audit firm with international branches
and current licensure/authority in-country, and in accordance with
International Accounting Standards or equivalent standard(s) approved
in writing by CDC.
A fiscal Recipient Capability Assessment may be required,
prior to or post award, in order to review the applicant's business
management and fiscal capabilities regarding the handling of U.S.
Federal funds.
If you are requesting indirect costs in your budget, you
must include a copy of your indirect cost rate agreement. If your
indirect cost rate is a provisional rate, the agreement must be less
than 12 months from the application due date.
IV.6. Other Submission Requirements:
LOI Submission Address: Lisa T. Garbarino, Public Health Analyst
National Center on Birth Defects and Developmental Disabilities, CDC,
1600 Clifton Road, Mailstop E-87, Atlanta, Georgia 30333, United States
of America, e-mail address: lgt1@cdc.gov.
Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management--RFA DD05-011, Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, Georgia 30341, United States of
America.
Applications may not be submitted by fax or e-mail at this time.
At the time of submission, four additional copies of the
application, and all appendices must be sent to: Lisa T. Garbarino,
Public Health Analyst, National Center on Birth Defects and
Developmental Disabilities, CDC, 1600 Clifton Road, Mailstop E-87,
Atlanta, Georgia 30333, United States of America, e-mail address:
lgt1@cdc.gov.
V. Application Review Information
V.1. Criteria: You are required to provide measures of outcome and
effectiveness that will demonstrate the accomplishment of the various
identified objectives for each stage of the cooperative agreement.
Measures of effectiveness must relate to the performance goals stated
in the ``Purpose'' section of this announcement. Measures must be
objective and quantitative, and must measure the intended outcome.
These measures of effectiveness must be submitted with the application
and will be an element of evaluation.
The goals of CDC-supported research are to advance the
understanding of biological systems, improve the control and prevention
of disease and injury, and enhance health. In the written comments,
reviewers will be asked to evaluate the application in order to judge
the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals. The scientific review group will
address the applications' overall score, weighting them as appropriate
for each application. The application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score.
Under the evaluation criteria noted below, applicants must describe
how they will address the program components as they relate to the
Purpose and Research Objectives, and Recipient Activities as cited in
this Announcement.
Your application will be evaluated against the following criteria:
1. Resources and Organizational Capacity:
Does the applicant have experience, within its
organization or the organization of partners to meet all the
requirements of this announcement?
Does the applicant have an existing infrastructure, within
its organization or the organization of partners, sufficient to carry
out the screening and follow-up in the proposal?
Does the applicant have the ability to promptly assemble
an effective team with the experience and time commitments to promote
full attention to the planning, implementation and evaluation of the
project?
Does the applicant, together with its partner
organizations, have the capability to conduct the project, taking into
account its institutional experience and current activities related to
FAS?
Does the applicant have the capacity to provide effective
organizational collaborations, partnerships and formal agreements
(including contractual), enabling the applicant to meet all project
implementation and operational requirements?
2. Methods and Activities:
Do the proposed methods and activities convincingly and
comprehensively meet the intention of the announcement?
Is the overall plan for planning, implementation and
evaluation comprehensive and appropriate to accomplish the stated goals
and objectives?
Are methods and activities feasible within programmatic
and fiscal restrictions?
Will the methods and activities produce accurate, valid
and reliable data?
Are the calculated statistical power and the potential
capacity of the research design adequate to generate meaningful results
during the study period?
Can the design be easily replicated for future use by
sponsoring organizations and entities and an adequate plan presented
for the dissemination of findings and recommendations for the benefit
of other public health agencies?
Does the applicant have a plan that will assure the
privacy of all data collected, and that the identity of all
participants will be protected from disclosure as specified through the
project protocol and informed consent process?
3. Management, Staffing, and Objectives:
Does the applicant have sufficient scientific resources
for project planning and data management/analysis within the
applicant's organization or through collaboration with universities or
other agencies?
Are the proposed staffing, staff qualifications and
experience, and project organization sufficient to accomplish the
objectives of the program?
Does the proposed management and staffing include the
specified tasks and responsibilities to be assigned for key positions
proposed for financial
[[Page 52296]]
assistance, and for other personnel contributing to the project?
Are the project goals and objectives relevant, specific,
achievable, and measurable and can they be addressed through the
proposed methods and within the proposed timeline?
4. Evaluation Plan:
Have the evaluation components described in the
announcement been addressed in the proposal?
Are measurable objectives included in the proposal, and
are the methods proposed appropriate for the measurable objectives?
Does the evaluation plan include a process for overall
evaluation of sub-components and the entire project, including the
assignment of responsibility for ongoing review of specified
components?
5. Budget Description and Justification: This includes the
comprehensiveness and adequacy of the proposed budget in relation to
program operations, collaborations, and services; and the extent to
which the budget is reasonable, clearly justified, accurate, and
consistent with the purposes of this research.
6. Protections: Does the application adequately address the
requirements of Title 45 CFR part 46 for the protection of human
subjects? This criteria will not be 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.
7. Inclusion: 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 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.
V.2. Review and Selection Process: Applications will be reviewed
for completeness by the Procurement and Grants Office (PGO) and for
responsiveness by NCBDDD. Incomplete applications and applications that
are non-responsive as to the eligibility criteria and other eligibility
requirements will not advance through the review process. Applicants
will be notified that their application did not meet submission
requirements and will not receive further consideration.
Applications, which are complete and responsive, will be subjected
to a preliminary evaluation (triage) by the scientific review group
(Special Emphasis Panel--SEP) composed of external (non-CDC) peer
reviewers to determine if the application is of sufficient technical
and scientific merit to warrant further review by the SEP. Applications
that are determined to be non-competitive will not be considered.
Subsequent to the review meeting CDC will notify the investigator/
program director and the official signing for the applicant
organization of that determination.
Applications determined to be competitive will then be reviewed and
scored under the formal SEP peer review process. The review of these
fully competitive applications will result in the determination of the
score and ranking for those applications.
Subsequent to the formal peer review by the SEP, a second level of
review will be conducted by senior CDC program staff. This review is
not intended to revisit the scientific merit of the applications. It is
designed to review and discuss issues related to the adequacy and
justification of the proposed budgets and funding ceilings, and to
review the overall rating and ranking of all recommended applications.
This will be done in order to prepare recommendations for funding based
on the scientific merit as determined by the SEP; and to ensure that
the recommendations are consistent and compatible with the Review and
Selection section of the original program announcement.
V.3. Anticipated Award Date: June 1, 2005.
VI. Award Administration Information
VI.1. Award Notices: If your application is to be funded, you will
receive a Notice of Grant Award (NGA) from the CDC Procurement and
Grants Office. The NGA shall be the only binding, authorizing document
between the recipient and CDC. The NGA will be signed by an authorized
Grants Management Officer, and mailed to the recipient fiscal officer
identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
VI.2. Administrative and National Policy Requirements: 45 CFR parts
74 and 92.
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
The following additional requirements apply to this project:
AR-1 Human Subjects Requirements
AR-2 Requirement for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting Systems Requirements
AR-15 Proof of Non-Profit Status
AR-22 Research Integrity
AR-25 Release and Sharing of Data
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting Requirements: You must provide CDC with an
original, plus two copies of the following reports:
1. Interim progress report, (PHS 2590, OMB Number 0925-0001, rev.
5/2001), on a date to be determined for your project for each
subsequent budget year. The progress report will serve as your non-
competing continuation application, and must contain the following
elements:
a. Current Budget Period Activities and Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activities and
d. Objectives.
e. Budget.
f. Additional Requested Information.
g. Measures of Effectiveness.
2. Financial status report and annual 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.
These reports must be sent to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.
VII. Agency Contacts
We encourage inquiries concerning this announcement.
For general questions contact: Technical Information Management
Section (PGO-TIM), CDC Procurement and Grants Office, 2920 Brandywine
Road, Atlanta, Georgia 30341, United States of America, Telephone:
(770) 488-2700.
[[Page 52297]]
For program technical assistance, contact: Lisa T. Garbarino,
Public Health Analyst, National Center on Birth Defects and
Developmental Disabilities, CDC, 1600 Clifton Road, Mailstop E-
87,Atlanta, Georgia 30333, United States of America, e-Mail Address:
lgt1@cdc.gov, Telephone: (404) 498-3979.
For budget assistance, contact: Vincent Falzone, Grants Management
Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, Georgia 30341, United States of America, Telephone: (770) 488-
2763, e-mail: Vfalcone@cdc.gov.
VIII. Other Information
This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on
``Funding'' then ``Grants and Cooperative Agreements.''
Dated: August 19, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-19425 Filed 8-24-04; 8:45 am]
BILLING CODE 4163-18-P