[Federal Register Volume 70, Number 94 (Tuesday, May 17, 2005)]
[Notices]
[Pages 28306-28311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9767]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Implementing Community-Level Strategies for Fetal Alcohol 
Syndrome Prevention and Surveillance in South Africa

    Announcement Type: New.
    Funding Opportunity Number: RFA DD05-118.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates: Letter of Intent Deadline: June 16, 2005.
    Application Deadline: July 1, 2005.

I. Funding Opportunity Description

    Authority: This program is authorized under sections 307, 
317(k)(2), and 317(C) of the Public Health Service Act [42 U.S.C., 
sections 242(I), 247b(k)2 and 247b-4], as amended].
    Purpose: The purpose of this program is to: (a) Identify urban and 
rural communities in South Africa with high proportions of 
childbearing-aged women who are at risk for an alcohol exposed 
pregnancy that could result in Fetal Alcohol Syndrome (FAS); and (b) to 
develop a model prevention program aimed at reducing hazardous alcohol 
use and/or promoting pregnancy delay until alcohol abuse is resolved in 
those women at highest risk. The model prevention program should have 
three stages.
    Stage 1: The formative research stage is composed of qualitative 
and quantitative research documenting the knowledge, attitudes and 
practices among all groups described: (a) Women of childbearing-age at 
high risk of an alcohol-exposed pregnancy and women with children with 
FAS: (b) spouses and partners of high risk women; (c) community health 
care providers, obstetricians and nurses, especially providers 
including alcohol treatment and substance abuse services; and (d) 
community leaders, social support organizations and networks addressing 
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 conclude with a description of the 
socio-demographic characteristics and attributes of the targeted 
community(ies) at risk, identification of constraints and opportunities 
for behavior change, and allow the initiation and conduct of community 
and person-level interventions under Stage 2.
    Stage 2: This 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 model program 
in the high risk FAS community(ies) targeted by the applicant in this 
announcement, including outcome measures.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center on Birth Defects and 
Developmental Disabilities (NCBDDD): Prevent birth defects and 
developmental disabilities.
    Background and Research Objectives: 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 [sime]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.

[[Page 28307]]

    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 interventions are: (a) Provide one-on-one client 
services that offer counseling to reduce or abstain from alcohol 
intake; (b) assist clients in assessing their own behavior and planning 
individual behavior change; (c) support and sustain behavior change; 
and (d) 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 
individuals to groups of varying sizes. Group level interventions 
should (a) provide education and support in group settings to promote 
and reinforce safer behaviors; and (b) 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: (a) Changing community norms; and (b) 
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 this announcement, applicants must identify urban and rural 
areas in which they will conduct formative, epidemiologic, and 
intervention study activities as described under Purpose. Geographic 
areas proposed for inclusion in this study should demonstrate high 
rates of alcohol misuse, unintended pregnancy, and HIV/STD among 
childbearing-age women. An entire province could be defined as a 
project geographical area or several regions or counties could be 
combined (containing applicant-selected urban or rural populations) in 
meeting the announcement requirement for FAS cases or populations 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).
    The geographical area(s) selected must include both urban and rural 
settings and one or more of the populations described below in a-c:
    (a) A population with at least 350,000 urban and rural 
childbearing-age women (aged 12-44 years) with at least 10% reporting 
hazardous alcohol use (greater than 7 drinks per week and/or binge 
drinking which is defined as 4 or more drinks on any one occasion);
    (b) A birth cohort comprising at least 25,000 births a year with a 
minimum FAS prevalence rate of 10 per 1,000 live births;
    (c) Defined communities with a 10% prevalence of HIV--recognizing 
the fact that FAS populations share common behavior patterns of 
substance abuse and sexual behavior.
    It is the responsibility of the applicant to clearly document their 
basis and rationale for selecting at least one of these three areas 
(a,b,c). That documentation will be a factor in the evaluation of your 
proposal.
    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 (four 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 three 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 childbearing-aged women who are at highest risk within the 
community. This assessment could draw on existing data (through FAS 
surveillance systems) or on newly collected population-based data. 
Within the scope of this work, applicants should be conducting a needs 
assessment of the spouses and partners of high-risk women. It should 
also reach out to health providers as to the services provided to the 
targeted populations including any perceived or real gaps between 
needs, expectations, and services delivered.
    This process includes determining the characteristics of women who 
already had a child with FAS; those engaging in alcohol misuse, are 
sexually active, and are not effectively using contraception; and women 
at risk for an HIV/STD infection.
    Environmental factors that could contribute to FAS and potential 
venues for enrolling these populations for intervention services to 
prevent FAS must also be identified.
    Stage II: The protocol and intervention development stage is 
expected to begin in the first year and 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, coherent research approach and methods that 
identify and prioritize key elements that are essential to FAS 
prevention activities in the target populations (i.e., individual, 
group, and community levels).
    2. Develop a protocol to conduct community-based epidemiological 
and behavioral data gathering in childbearing-age women populations 
that can include maternal alcohol exposure, drinking behavior, sexual 
behavior patterns, social networks, substance abuse behavior, 
perceptions of social sexual norms, attitudes, self-efficacy, 
perception of current FAS prevention interventions, healthcare and 
health information seeking behaviors, and identifying influences on

[[Page 28308]]

behavior in order to determine the most appropriate intervention 
strategies to be used.
    3. Conduct needs assessment of health providers and other services 
provided to childbearing-aged women. Identify gaps between the needs of 
high risk women and the services they receive.
    4. 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.
    5. 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.
    6. Design and implement a provider education component for health 
personnel involved in intervention and surveillance and monitoring 
activities.
    7. Strengthen and improve public health infrastructure to prevent 
FAS supporting additional services and links with existing, community-
based programs that provide preventive health services.
    8. Collaborate with CDC as needed by requesting assistance in 
process and operational procedures.
    9. Collect and analyze study data and prepare a final report of the 
outcomes of the study with recommendations for future research and 
prevention efforts, including the development of peer review and 
publication of study findings.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring. CDC 
Activities for this program are as follows:
    CDC Scientists (Scientific Collaborators) within the National 
Center on Birth Defects and Developmental Disabilities (NCBDDD) will be 
an equal partner with scientific and programmatic involvement during 
the conduct of the project through technical assistance, advice, and 
coordination. These Scientific Collaborators 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.
    (6) Work with the Principal Investigator from the awardee 
institution on coordination activities. This coordinating function will 
help formulate a plan for cooperative research. This work can include: 
(a) Making recommendations on the study protocol and data collection 
approaches; (b) discussing the target populations that have been or 
will be recruited; (c) identifying and recommending solutions to 
unexpected study problems; and (d) discussing 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. (Includes direct and indirect 
costs; this amount is an estimate, and is subject to availability of 
funds.)
    Approximate Number of Awards: One.
    Approximate Average Award: $300,000. (This amount is for the first 
12-month budget period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $300,000.
    Anticipated Award Date: August 31, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Three 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 to non-profit non-government organizations 
(NGOs), including faith-based organizations, or Universities in South 
Africa or those NGOs or Universities located outside of South Africa 
that can perform this activity. Applicants must identify and document 
their capacity to address all of the components of work as contained in 
the Activities section of this announcement. Furthermore, applicants 
must provide evidence of their ability to effectively demonstrate 
capacity to progress through all Stages of the project. Providing 
precise information as to how these data and other requirements will be 
met is essential to the consideration of your application for review.
    Applicants located outside of South Africa must provide 
documentation of their experience and performance in implementing 
health services research in South Africa and demonstrate their capacity 
to reach the target populations specified in this announcement.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you request a funding amount greater than the ceiling of the 
award range, your application will be considered non-responsive, and 
will not be entered into the review process. You will be notified that 
your application did not meet the submission requirements.
    Special Requirements:
     If your application is incomplete or non-responsive to the 
requirements listed in this section, it will not be entered into the 
review process. You will be notified that your application did not meet 
submission requirements.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     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

[[Page 28309]]

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.
     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.
    Individuals Eligible To Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the 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.
    Additional Principal Investigator qualifications are as follows:
     One of the Principal Investigators with responsibility for 
directing this research must reside in South Africa.

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. 9/2004). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: 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 online, 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:
     Descriptive title of the proposed research.
     Name, address, e-mail address, telephone number, and FAX 
number of the Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Announcement.
     Designations of collaborating institutions and entities.
     An outline of the proposed work.
     Recruitment approach.
     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 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/pubcommt1.htm
    This announcement uses the non-modular budgeting format. Follow the 
PHS 398 instructions for non-modular budget research grant 
applications.
    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: June 16, 2005.
    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: July 1, 2005.
    Explanation of Deadlines: Applications must be received in the CDC 
Office of Public Health Research and Applications must be received in 
the CDC Procurement and Grants Office by 4 p.m. eastern time on the 
deadline date. If you submit your application by the United States 
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 
content, submission addresses and deadlines. It supersedes information 
provided in the PHS Form 398 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 about your 
application, contact the PGO-TIM staff at: 770-488-2700. If you still 
have a question about your LOI, contact OPHR staff at 414-371-5253. 
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. Equipment may be 
purchased if deemed necessary to accomplish program objectives; 
however, prior approval by CDC officials must be requested in writing.

[[Page 28310]]

     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.

IV.6. Other Submission Requirements:

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Mary Lerchen, DrPH, Scientific Review 
Administrator, CDC, Office of Public Health Research, One West Court 
Square, Suite 7000, Mailstop D-72, Decatur, Georgia 30030, United 
States of America. Telephone Number 404-371-5277. Fax 404-371-5215. 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 DD05-118, 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 by express mail to: Mary 
Lerchen, DrPH, Scientific Review Administrator, CDC, Office of Public 
Health Research, One West Court Square, Suite 7000, Mailstop D-72, 
Decatur, Georgia 30030, United States of America.

V. Application Review Information

V.1. Criteria

    Applicants are required to provide measures of effectiveness that 
relate to the performance goals stated in the ``Purpose'' section of 
this announcement, and that will demonstrate the accomplishment of the 
various identified objectives for each stage of the model prevention 
program and for the Awardee Activities. 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 and consider each of the 
following criteria equally in assigning the application's 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. For example, an investigator may propose to carry out important 
work that by its nature is not innovative but is essential to move a 
field forward.
    The review criteria are as follows:
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge or 
clinical practice be advanced? What will be the effect of these studies 
on the concepts, methods, technologies, treatments, services, or 
preventative interventions that drive this field?
    Approach: Are the conceptual or clinical framework, design, 
methods, and analyses adequately developed, well integrated, well 
reasoned, and appropriate to the aims of the project? The applicant's 
research plan must adequately address the Purpose, Research Objectives, 
and Awardee Activities as cited in the announcement. The research plan 
must describe the work that will be done, and how and through what 
tasks and activities the work will be undertaken. Does the applicant 
acknowledge potential problem areas and consider alternative tactics?
    Innovation: Is the project original and innovative? For example: 
Does the project challenge existing paradigms or clinical practice; 
address an innovative hypothesis or critical barrier to progress in the 
field? Does the project develop or employ novel concepts, approaches, 
methodologies, tools, or technologies for this area?
    Investigators: Are the investigators appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers? 
Does the investigative team bring complementary and integrated 
expertise to the project (if applicable)? One of the Principal 
Investigators with responsibility for directing this research must 
reside in South Africa.
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
studies employ useful collaborative arrangements or benefit from unique 
features of the scientific environment, or subject populations? Do the 
geographic areas and populations proposed for inclusion in the study 
meet the requirements under ``Purpose'' and ``Objectives'' in the 
announcement? Is there evidence of institutional support? Are letters 
of support included, if appropriate?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 CFR part 46 
for the protection of human subjects? The involvement of human subjects 
and protections from research risk relating to their participation in 
the proposed research will be assessed.
    Inclusion of Women and Minorities in Research: Does the application 
adequately address the CDC Policy requirements regarding the inclusion 
of women, ethnic, and racial groups in the proposed research? This 
includes: (1) The proposed plan for the inclusion of both sexes and 
racial and ethnic minority populations for appropriate representation; 
(2) The proposed justification when representation is limited or 
absent; (3) A statement as to whether the design of the study is 
adequate to measure differences when warranted; and (4) A statement as 
to whether the plans for recruitment and

[[Page 28311]]

outreach for study participants include the process of establishing 
partnerships with community(ies) and recognition of mutual benefits.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research. Does the 
proposed budget comply with the requirements in IV.5. ``Funding 
Restrictions'' in the announcement?

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) and for responsiveness by the Office of Public 
Health Research. Incomplete applications and applications that are non-
responsive to the eligibility criteria will not advance through the 
review process. Applicants will be notified that their application did 
not meet submission requirements.
    Applications that are complete and responsive to the announcement 
will be evaluated for scientific and technical merit by an appropriate 
peer review group or charter study section convened by the Office of 
Public Health Research in accordance with the review criteria listed 
above. As part of the initial merit review, all applications may:
     Undergo a process in which only those applications deemed 
to have the highest scientific merit by the review group, generally the 
top half of the applications under review, will be discussed and 
assigned a priority score.
     Receive a written critique.
     Receive a second programmatic level review by the 
Scientific Program Administrator in the National Center for Birth 
Defects and Developmental Disabilities.
    Award Criteria: Criteria that will be used to make award decisions 
during the programmatic review include:
     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.

V.3. Anticipated Award Date

    August 31, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Award (NOA) from the 
CDC Procurement and Grants Office. The NOA shall be the only binding, 
authorizing document between the recipient and CDC. The NOA 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-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. 
9/2004), 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 
additional elements:
    a. Current budget period progress toward meeting all objectives.
    b. Problems identified and solutions applied.
    c. Discussion of financial expenditures and impact on project 
operations.
    d. Discussion of staffing and collaborations to enhance performance 
toward meeting goals.
    e. Progress toward Measures of Effectiveness.
    f. Additional Information requested by Program
    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.
    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, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, Georgia 
30341, United States of America. Telephone: 770-488-2700.
    For scientific/research issues, contact: Don Lollar, Ed.D., 
Extramural Program Official, 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: 404-498-3041.
    For questions about peer review, contact: Mary Lerchen, DrPH, 
Scientific Review Administrator, CDC, Office of Public Health Research, 
One West Court Square, Suite 7000, Mailstop D-72, Decatur, GA 30030, 
United States of America. Telephone: 404-371-5277. E-mail: 
[email protected].
    For financial, grants management, or budget assistance, contact: 
Steward Nichols, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, Georgia 30341, United 
States of America. Telephone: 770-488-2788. E-mail: [email protected].

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address: www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.''

    Dated: May 11, 2005.
Alan A. Kotch,
Acting Deputy Director, Procurement and Grants Office, Centers for 
Disease Control and Prevention.
[FR Doc. 05-9767 Filed 5-16-05; 8:45 am]
BILLING CODE 4163-18-P