05-9767. 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 ≃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 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 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 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 [phone], or contact GrantsInfo, Telephone [phone], e-mail: [e-mail].

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.
• 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 [phone]. E-mail address: [e-mail].

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 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: [phone].

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: [e-mail]. Telephone: [phone].

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: [phone]. E-mail: [e-mail].

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: [phone]. E-mail: [e-mail].

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.