[Federal Register Volume 69, Number 164 (Wednesday, August 25, 2004)]
[Notices]
[Pages 52291-52297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19425]


-----------------------------------------------------------------------

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: 
[email protected]
    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: [email protected].
    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: 
[email protected].

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: 
[email protected], 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: [email protected].

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