cdc-rfa-dd10-1006 final 05 06 10.doc

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC) Reducing Risks for Alcohol-Exposed Pregnancy (AEP) in Women Attending Federally Funded Community Health Centers and Title X Programs

Announcement Type: New – Type 1 Funding Opportunity Number: CDC-RFA-DD10-1006

Catalog of Federal Domestic Assistance Number: 93.283

Key Dates:

Letter of Intent Deadline Date: May 21, 2010 AFTER DATE OF PUBLICATION on Grants.gov Application Submission Date: June 21, 2010. Applications must be submitted at least 48 hours prior to the application deadline date to ensure the validation process is successfully completed (free of errors) and made available to the agency for download from Grants.gov. Application Deadline Date: June 21, 2010 AFTER DATE OF PUBLICATION on Grants.gov, 11:59pm Eastern Standard Time] I. Funding Opportunity Description

Authority: This program is authorized under sections 317C, 317(k) (2) of the Public Health Service Act, (42 U.S.C. Section 247b (k) (2), as amended and 42 U.S.C. Section 247b-4).

Background:

Alcohol is one of the leading causes of morbidity and mortality in the United States (U.S.). Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities. While surveys show high proportions of the adults know that alcohol use during pregnancy can be harmful to the fetus, the Behavioral Risk Factor Surveillance System (BRFSS) and the National Survey on Drug Use and Health (NSDUH), find that 12% of pregnant women report alcohol use during pregnancy and 2-3% report binge drinking. Prenatal alcohol exposure can lead to a spectrum of adverse consequences for the fetus defined as Fetal Alcohol Spectrum Disorders (FASD), with Fetal Alcohol Syndrome (FAS) representing one of the most severe outcomes. Children with FAS have facial abnormalities, pronounced neurodevelopmental disorders and growth deficits. Prevalence estimates of FAS range from 0.3 to 2 per 1,000 live births. Prevalence estimates of the number of children affected by conditions along the full spectrum (FASD) are as high as 1 in 100.

In 2007, there were approximately 62 million women of childbearing age (15-44 years) in the U.S. By the age of 25, approximately half will experience at least one birth and by the age of 44 approximately 85% will have experienced a birth. Approximately half of all pregnancies in the U.S. are unplanned. Many pregnancies are unrecognized until 6-8 weeks gestation and some women will continue to drink at high levels during the early, critical weeks of fetal development. Among non-pregnant women of childbearing age, 52% report they consume alcohol, and 12% report they binge drink. There is mounting evidence that the optimal time for identification and delivery of intervention for many risk factors and health conditions that can contribute to poor pregnancy outcomes is before conception occurs. Alcohol use is one such risk factor. In 2008, CDC published the results of an intervention aimed at identifying women at risk for an alcohol-exposed pregnancy (AEP) during the preconception period. Women at risk for AEP were those who were risky drinkers (8 or more drinks per week and/or 5 or more drinks on one occasion), sexually active, and not using effective contraception. The intervention, Project CHOICES, consisted of four motivational counseling sessions and one contraception consultation and services visit. At 3, 6, and 9 months follow-up, the odds for reducing risks for an AEP were 2-fold higher in the women receiving the intervention as compared to women in the control group. All women entering the study were at risk for AEP with 56% meeting the DSM criteria for alcohol dependence. Approximately 55% of women had annual incomes of <$20,000 and 51% had never been married.

Purpose:

The purpose of this Funding Opportunity Announcement (FOA) is to adapt and implement the Project CHOICES intervention broadly in diverse public health settings serving high proportions of women at-risk for an AEP. The Human Resources and Services Agency (HRSA) provides federal funding to support community health centers that deliver high quality services to medically underserved communities and vulnerable populations including gynecology and obstetrics, family planning, and STD services using a variety of state and federal funding sources. The targeted settings for this FOA are these community health centers (CHC) and/or Title X grantee agencies funded under Section 1001 of the Public Health Service Act. HRSA also administers the Title V Maternal-Child Health Block Grant to States to improve the health of mothers and children including providing prenatal and post-partum care for low income pregnant women. In 2008, Title V programs provided prenatal and obstetrical services to more than 2,500,000 women. Some HRSA-funded centers also house local Title X Family Planning programs, administered by the Office of Public Health and Science, Office of Population Affairs, that provide services to women aimed at reducing unintended pregnancies by providing contraception and other related prevention services for women. Title X programs also provides sexually transmitted disease (STD) services, with half of these being provided to women in the age range of 15-24 years. In 2005, the Behavioral Risk Factor Surveillance System (BRFSS) found that among all women aged 18-44 years; those aged 18-24 had the highest binge drinking rates (21%). Other studies have reported binge drinking rates among women in STD clinics of 21-30%. Many women served by HRSA-funded health centers are of low income, as were the women in the Project CHOICES Study, live in medically underserved communities, and require public housing. One previous CDC-funded study found that approximately 5% of non-pregnant women attending publicly-funded primary care clinics were at risk for an AEP. HRSA-funded community health centers and Title X funded agencies provide a broad range of reproductive health services to childbearing age women who may benefit from the Project CHOICES intervention and improve pregnancy outcomes.

This program addresses the “Healthy People 2010” focus area(s) of Prenatal Substance Exposure. This includes: Objective 16-17a: Increase in Reported Abstinence in Past Month From Alcohol Use in Pregnant Women from 86% to 94%; and Objective 16-17b: Increase in Reported Abstinence in Past Month From Binge Drinking in Pregnant Women from 99% to 100%.

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: To promote the health of babies, children, and adults, and enhance the potential for full, productive living.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm

II. PROGRAM IMPLEMENTATION

Recipient Activities:

Awardee activities (Title X applicants may obtain required data elements individually or through partnering with a CHC.) for this program are as follows:

· Identify specific CHC clinics and/or Title X family planning clinics where the Project CHOICES intervention will be implemented.

· Provide estimates of the size and characteristics of the non-pregnant female population, 18-44 years of age, who attend the proposed clinic settings.

· Estimate the proportion of women aged 18-44 in the proposed clinics who are at risk for an alcohol-exposed pregnancy (AEP) (i.e., fertile, sexually active, drinking more than 7 drinks per week and/or drinking more than 3 drinks on any one occasion, and not using effective contraception to avoid pregnancy).

· Submit an implementation plan that includes goals, S.M.A.R.T. objectives (specific, measurable, achievable, realistic, and time-phased), and performance measures as well as a timeline with milestones for all objectives at a minimum that should identify related activities, roles and responsibilities for all project staff, start and completion dates, and the name of person(s) responsible for each implementation activity. The timeline should be included in an appendix.

· Describe potential adaptations to the original Project CHOICES Intervention that may be needed in order to tailor it to targeted clinical settings.

· Describe proposed arrangements for providing family planning consultation and services to women receiving the Project CHOICES intervention.

· Clearly describe the management structure at the project level to ensure that all resources (human, material, financial and technology) are used in a highly efficient and cost-effective manner to reach the program’s goals and objectives.

· Provide a management and staffing plan describing the roles and responsibilities of key project staff.

· Provide letters of support from the participating clinic(s) collaborating with the implementation of the proposed intervention project that demonstrate knowledge of the main goals of the project, including its specific aims as well as state which tangible items/activities will be provided by the clinic(s) in support of the project.

· Describe outreach activities to clinic providers and women in the clinic population including how high risk women will be screened and referred to the Project CHOICES intervention.

· Describe the confidential area within the clinic(s) where the intervention will be delivered and procedures for maintaining confidentiality and security of information obtained from the clients.

· Describe the providers who will be providing the intervention and how they will be recruited (these should be individuals whose primary tasks are to conduct the Project CHOICES intervention).

· Provide a plan for delivering Project CHOICES that ensures fidelity to the original Project CHOICES intervention.

· Provide an evaluation plan that assesses the feasibility, impact, and the estimated costs incurred in delivering the Project CHOICES intervention at the individual level to women at risk for an AEP.

· Describe how women enrolled in the intervention will be tracked and monitored throughout the period of time they are receiving the intervention and the post-intervention follow-up period.

· Describe procedures for establishing linkages to other alcohol and substance abuse services for referral of women with alcohol use disorders beyond the scope of Project CHOICES.

· Collect data for estimating the cost incurred in recruiting, intervening with, and following-up women participating in the Project CHOICES intervention (see CDC activities).

· Participate in all scheduled conference calls and site visits.

· Attend required annual grantee meetings.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities:

· Provide training on the generic Project CHOICES protocol used in the efficacious clinical trial in collaboration with TKC Integration Services (TKCIS), LLC, and SciMetrika, LLC. TKCIS is currently providing CDC with expert services in support of translation of Project CHOICES protocols into a provider manual and training curriculum based on principles of adult learning and health and cultural literacy; training of healthcare providers to implement the Project CHOICES intervention; and evaluation of training and impact on practice behaviors of trainee. SciMetrika is currently providing CDC with support services for Project CHOICES training based on the training materials using expert trainers.

· Enhance communications by developing a listserv and providing contact information for all key project personnel funded by this announcement.

· Conduct conference calls, site visits, and grantee meetings to address additional technical assistance needs including tailoring of the Project CHOICES model to fit the needs of the clinic setting and population being served.

· Review and provide feedback on materials developed by the grantees for use in project implementation.

· Provide technical assistance to grantees in developing evaluation measures that address how workable the tailored Project CHOICES intervention was in STD clinics and if the intervention produced the intended outcomes including potential cost benefits.

III. AWARD INFORMATION AND REQUIREMENTS

Type of Award: Cooperative Agreement.

CDC’s involvement in this program is listed in the Activities Section above.

Award Mechanism: U84 Cooperative Agreements for Fetal Alcohol Syndrome Prevention Research Programs Fiscal Year Funds: 2010 Approximate Current Fiscal Year Funding: Up to $1,000,000 Approximate Total Project Period Funding: Up to $4,000,000 (This amount is an estimate, and is subject to availability of funds and includes both direct and indirect costs.)

Approximate Number of Awards: 4-5 Approximate Average Award: Up to $250,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Floor of Individual Award Range: None Ceiling of Individual Award Range: Up to $275,000 (This ceiling is for the first 12-month budget period and includes total cost.)

Anticipated Award Date: August 31, 2010 Budget Period Length: 12 months Project Period Length: 4 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.

IV. ELIGIBILITY

Eligible applicants that can apply for this funding opportunity are listed below:

· Local Health Departments (public health entities - city and/or county) that receive funding from HRSA under the Health Center Program Statute, Section 330 (e) of the Public Health Service (PHS) Act, 45 CFR and 42 CFR to support comprehensive community health centers and receive funding from Title X grantees funded under section 1001 of the Public Health Service Act. Grants under Section 1001 assist in the establishment and operation of voluntary family planning projects which provide a broad range of acceptable and effective family planning methods and related preventive health services.

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a letter from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

Justification for Limited Eligibility:

Eligible applicants include public health agencies that support community health centers funded by HRSA under the Health Center Program Statute, Section 330 of the Public Health Service (PHS) Act, 45 CFR and 42 CFR as well as Title X grantee agencies funded under section 1001 of the Public Health Service Act. These health centers are federally regulated and required to provide primary, preventive, and enabling health services to underserved communities and vulnerable populations using credentialed and licensed staff. In order to assure continuity of care, the health centers are required to provide additional health services as appropriate and necessary through established arrangements and referrals. Quality Improvement and Assurance Plans are required and monitored for clinical services and management and confidentiality of patient records. HRSA-funded health centers provide continuous and high quality primary care and have been shown to improve patient outcomes, reduce racial and ethnic disparities, and improve pregnancy outcomes. Given their access to risk populations, demonstrated effectiveness in service delivery and improved outcomes, and sustainability (40 years +), these community health centers have been targeted for participation as dissemination sites for reducing alcohol-exposed pregnancies using the Project CHOICES intervention. Eligibility is limited to these applicants because they have the necessary infrastructure in place to perform the activities required and have the experience needed to successfully complete the required functions.

Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

Maintenance of Effort

Maintenance of Effort is not required for this program.

Other

If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the eligibility requirements.

Special Requirements:

If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the 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.

· All applicants must have a minimum population base of 1,250,000 individuals in the catchment area they serve. Using data from the U.S. Census Bureau, applicants must clearly demonstrate that the proposed project site is located in a county (http://www.census.gov/popest/counties/tables/CO-EST2009-07.xls) and/or city (http://www.census.gov/popest/cities/tables/SUB-EST2008-01.xls) with a population not less than 1.25 million.

· Only one application from each Local Health Department (public health entities - city or county) with documented minimum population base of 1.25 million in the catchment area served may be submitted. If multiple eligible applicants are identified within a Local Health Department system, the official public health agency or agencies that are identified as Eligible Applicants should collaborate to determine the most appropriate applicant.

· Applicants must demonstrate they serve and have access to populations of women of reproductive age (18-44 years) who are being targeted in this announcement and the necessary infrastructure in place to perform the activities required to identify fertile, sexually active women who are consuming 8 or more drinks per week and /or 4 or more drinks on one occasion and not using effective contraception to prevent pregnancy.

· Applicants must document a prevalence of 15% or greater for risk drinking which is defined as 8 or more drinks per week [and/or] 4 or more drinks on a single occasion in the last month and a clinic population of at least 150 women seen annually in an individual clinic and 250 women for more than one clinic who meet the criteria for “at-risk for an alcohol-exposed pregnancy.” The applicant must describe how risk estimates were calculated. Sources of information may be summaries and reports from local data collection systems and clinics, CDC surveillance reports, BRFSS reports, PRAMS reports, or other credible information sources.

· The applicant must upload all additional documentation in Grants.gov under “Other Attachment Forms,” and label each document appropriately (i.e., Documentation of prevalence rates for risk drinking, Documentation of Target Population, or Letters of Support, etc.).

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 a grant, loan, or an award.

Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

V. Application Content

Unless specifically indicated, this announcement requires submission of the following information:

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:

· Maximum number of pages 25. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

· Font size: 12 point unreduced, Times New Roman

· Double spaced

· Paper size: 8.5 by 11 inches

· Page margin size: One inch

· Printed only on one side of page.

· Number all narrative pages; not to exceed the maximum number of pages.

· Paper application should be held together only by rubber bands or metal clips; not bound in any other way.

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:

1. Background and Need

a. Describe the population served by the proposed clinic or clinics including the number of women of childbearing age (18-44 years) served and their socio-demographic characteristics.

b. Provide this information overall and by age categories: 18-24; 25-34; and 35-44 years.

c. Describe the clinic setting including geographic location, when it was established, total clinic load, staffing pattern, services provided on site, stability of funding support, access to family planning consultation and services, and other information deemed relevant such as trends in patient utilization of services, proportion on Medicaid.

d. Provide evidence of an integrated program (funded by both HRSA and Title X) that provide services to women of childbearing age that include obstetrics and gynecology, family planning and STD services.

e. Provide available information about the stability of the population attending the clinics (i.e. stable or transient, patterns of inward and outward migration, and other relevant perspectives).

f. Estimate the population of non-pregnant women of childbearing age who engage in risky drinking and the annual number estimated to be at-risk of an alcohol-exposed pregnancy including a description of how these estimates were arrived at.

g. Describe previous experiences in delivering behavioral interventions in the clinic setting.

h. Describe previous experience in long-term follow-up of individuals receiving behavioral interventions.

2. Plan for Implementation

a. Describe potential adaptations to the original Project CHOICES Intervention that may be needed in order to tailor it to targeted clinical settings.

b. Describe how the Project CHOICES Intervention will be introduced and marketed to providers and staff in the targeted clinics that will participate in the project.

c. Provide information detailing outreach activities in the community aimed at reaching women at risk for AEP.

d. Describe the procedures to be used for screening, identification, and referral to the intervention for women who are at risk for an AEP.

e. Describe how Project CHOICES will be integrated into the clinic settings.

f. Make certain a secure area has been identified for use by interventionists that will assure confidentiality of the woman being served.

g. Provide details as to how clients will be referred to and receive family planning consultation and services.

h. Describe procedures for assuring that confidential information obtained from the client will be kept confidential and protected.

i. Describe how clients receiving the intervention will be tracked and monitored for response to the intervention.

j. Describe linkages that will be used to connect women in need of more intensive services for substance use with appropriate resources.

k. Provide a discussion of community and key provider involvement and organizational partnerships and include letters of support from the CHC clinics and the Title V Maternal-Child Block Grants to States and Title X Family Planning provider or other resources selected for family planning resources for consultation and services.

l. Applicant must provide documentation of effective and well-defined working relationships with any organization and/or outside entities expected to participate in the implementation of the proposed project activities proposed. This should be demonstrated by letters of support detailing the nature and extent of the involvement from the performing organization and outside entities (include in the appendices).

3. Proposed Objectives

a. Objectives should relate directly to the overall stated purpose of the FOA and the goals of the project as stated by the applicant.

b. Objectives should address all aspects of the implementation and evaluation of the program including program outreach, screening and referral of women recruited from the clinic to the Project CHOICES intervention, as well as follow-up data collection and outcomes.

c. Objectives should be specific, measurable, achievable, relevant, and time-referenced (S.M.A.R.T.) and address the needs discussed in the previous sections (Background and Need).

4. Program Evaluation

a. Monitoring of activities aimed at achieving program goals and objectives should be ongoing.

b. Process evaluation measures should focus on the activities and operations of the project (including but not limited to outreach identification and referral to the project), address how well the project is working, and answer questions such as: “Did the interventionists feel properly prepared to deliver the intervention?”, Were all components of the intervention delivered and were they delivered correctly?” “Was the intervention acceptable and accessible to the women who needed it?”, and “Was the project well organized and managed?”

c. Impact assessment performance measures rely on quantifiable data that measures changes in the targeted behaviors from the time a woman enters the program, throughout the intervention, and post-intervention phases. These measures are used to determine if the project outcomes were the intended ones and include information such as: average drinks per week, average number of binge drinking episodes per week or month, use of effective contraception, and episodes when the woman was sexually active, and not using effective contraception while engaging in risky drinking.

d. Evaluation measures (process and/or impact) should be included that cover each objective.

e. A description should be provided of the procedures to be used in collecting and analyzing data for process and outcome evaluation.

Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:

· “Other Attachments Forms” should be clearly and appropriately titled/named when uploaded under Mandatory Documents into Grants.gov (i.e., Curriculum vitae, Letters of Support, Indirect Cost Rate Agreement, etc.)

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

· Curriculum Vitae for key staff on the project

· Letters of support from partners and stakeholders

· Data tables supporting or documenting needs discussed in the narrative

· Project Timeline

· Copies of key publications

Additional requirements for additional documentation with the application are listed in Section VII. Award Administration Information; subsection entitled “Administrative and National Policy Requirements.”

APPLICATION SUBMISSION

Registering your organization through www.Grants.gov, the official agency-wide E-grant website, is the first step in submitting an application online. Registration information is located on the “Get Registered” screen of www.Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, the Grants.gov registration process also requires that you register your organization with the Central Contractor Registry (CCR) annually. The CCR registration can require an additional one to two days to complete.

Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO-TIMS) staff at (770) 488-2700 for further instruction.

Note: Application submission is not concluded until successful completion of the validation process.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. Applicants are strongly encouraged check the status of their application to ensure submission of their application package is complete and no submission errors exists. To guarantee that you comply with the application deadline published in the Funding Opportunity Announcement, applicants are also strongly encouraged to allocate additional days prior to the published deadline to file their application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a “validation” email within two (2) business days of application submission, please contact Grants.gov. Refer to the email message generated at the time of application submission for instructions on how to track your application or the Application User Guide, Version 3.0 page 57.

Other Submission Requirements

Letter of Intent (LOI):

Your LOI must be written in the following format:

· Maximum number of pages: Two pages

· Font size: 12-point unreduced

· Single spaced

· Paper size: 8.5 by 11 inches

· Page margin size: One inch

· Printed only on one side of page

· Written in plain language, avoid jargon

Prospective applicants are asked to submit a letter of intent that includes the following information:

· Descriptive title of proposed project.

· Name, address, and telephone number of the Principal Investigator/Project Director.

· Names of other key personnel.

· Participating institutions.

· Number and title of this funding opportunity.

· Brief description of target population and site(s) to be included in project.

· Brief description of the catchment size.

LOI Submission Address: Submit the LOI by express mail, delivery service, fax, or E-mail to:

Kendall R. Anderson, Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

National Center on Birth Defects & Developmental Disabilities

1600 Clifton Road, NE, MS E-86 Atlanta GA 30333

Telephone: 404-498-3950

Fax: 404-498-3040

E-mail: KRAnderson@cdc.gov

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate and plan the review of submitted applications.

LOIs should be provided not later than by the date indicated in the Section I entitled “Authorization and Intent”.

Dun and Bradstreet Universal Number (DUNS)

The applicant is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) identifier to apply for grants or cooperative agreements from the Federal government. The DUNS is a nine-digit number which uniquely identifies business entities. There is no charge associated with obtaining a DUNS number. Applicants may obtain a DUNS number by accessing the Dun and Bradstreet website or by calling 1-866-705-5711.

Electronic Submission of Application:

Applications must be submitted electronically at www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully submitted electronically by the applicant organization’s Authorized Organizational representative (AOR) to Grants.gov on or before the deadline date and time.

The application package can be downloaded from www.Grants.gov. Applicants can complete the application package off-line, and then upload and submit the application via the Grants.gov Web site. The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.

Applications submitted through Grants.gov (http://www.grants.gov), are electronically time/date stamped and assigned a tracking number. The AOR will receive an e-mail notice of receipt when HHS/CDC receives the application. The tracking number serves as a receipt of submission.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

Submission Dates and Times

This announcement is the definitive guide on LOI and application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the applicant will be notified the application did not meet the submission requirements. The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance.

Letter of Intent (LOI) Deadline Date: May 21, 2010 AFTER DATE OF PUBLICATION IN GRANTS.GOV.

Application Submission Date: June 21, 2010 AFTER DATE OF PUBLICATION] (See full explanation in note found in Section V. Application Submission) Application Deadline Date: June 21, 2010 AFTER DATE OF PUBLICATION ON GRANTS.GOV, 11:59pm Eastern Standard Time.

VI. Application Review Information

Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the CDC-RFA-DD10-1006. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

Evaluation Criteria Eligible applications will be evaluated against the following criteria:

The application will be evaluated against the following criteria:

1. Background (20 points): To what extent does the applicant provide an overview of (a) women of childbearing age (i.e., 18-44 years of age), by socio-demographic characteristics, alcohol use, and other relevant health risk behaviors (i.e., smoking); (b) the CHC clinic setting(s) including location, size, staffing, and evidence of an integrated program (funded by both HRSA and Title X) that provide services to women of childbearing age that include obstetrics and gynecology, family planning and STD services as well as use of an electronic medical records systems; (c) information about the stability of the client population; (d) an estimate of the proportion of childbearing aged women who are at-risk for an alcohol-exposed pregnancy; (e) the infrastructure and capacity of the clinics selected to undertake the project; and (f) previous experience implementing behavioral interventions, and (g) a description of the staffing and management plan for the project.

2. Plan for Implementation (30 points): How well does the plan describe how the Project CHOICES intervention will be implemented including: (a) describe the intervention including any adaptations to the original Project CHOICES Intervention that may be needed in order to tailor it to targeted clinical settings; (b) how the intervention will be marketed to clinic staff and clients; (c) how will women be screened for eligibility for the program, (d) the process for referral to a CHOICES interventionist; (e) how confidentiality will be maintained during intervention delivery and the storing of client records; (f) how arrangements will be made for the family planning consultation and services visit; (g) the procedures to be used for tracking and monitoring the women who receive the intervention; and (h) support from partners in the community with letters of support from the CHC clinics and the family planning providers.

3. Objectives (25 points): To what extent does the applicant provide objectives that: (a) directly address the purpose of the FOA and the goals of the project; (b) address all aspects of the implementation and evaluation of the program including program outreach, screening and referral of high risk women into the intervention from the clinic, intervention delivery, and follow-up of outcomes; (c) are specific, measurable, achievable, relevant, and time-referenced (S.M.A.R.T.).

4. Evaluation (25 points): To what extent does the applicant: (a) describe how activities connected to goals and objectives will be monitored in an ongoing way; (b) include both process and outcome measures; (c) use performance measures that are quantifiable to measure the effect of the intervention on reducing risks for alcohol-exposed pregnancies and must include alcohol use (quantity and frequency) per week/month, average number of binge episodes per week or month and the number of episodes when the client was sexually active, engaging in risky drinking, and not using effective contraception; (d) a description of data collection procedures to be used and how the data will be analyzed; and (e) provide an overview of the final report.

5. Budget [(SF-424A) (Reviewed but not Scored)]. Although the budget is not scored applicants should consider the following in development of their budget. Is the itemized budget for conducting the project, and justification reasonable and consistent with stated objectives and planned program activities?

If the applicant requests indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

Funding Restrictions Restrictions, which must be taken into account while writing the budget, are as follows:

· Recipients may not use funds for research.

· Recipients may not use funds for clinical care.

· Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

· Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

· The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

· Reimbursement of pre-award costs is not allowed.

The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:

http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Application Review Process

All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness by National Center on Birth Defects and Developmental Disabilities and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified the application did not meet eligibility and/or published submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in Section VI. Application Review Information, subsection entitled “Evaluation Criteria”. The objective review panel will consist of CDC employees outside of the funding division who will be randomly assigned applications to review and score.

Applications Selection Process

The following factors may affect the funding decision:

Applications will be funded in order by score and rank determined by the review panel as well as by geographical region to maintain geographic diversity.

CDC will provide justification for any decision to fund out of rank order.

VII. Award Administration Information 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 e-mailed to the program director. A hard copy of the NoA will be mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. The following additional requirements apply to this project:

· AR-4

HIV/AIDS Confidentiality Provisions

· AR-5

HIV Program Review Panel Requirements

· AR-6

Patient Care

· AR-7

Executive Order 12372

· AR-8

Public Health System Reporting Requirements

· AR-9

Paperwork Reduction Act Requirements

· AR-10

Smoke-Free Workplace Requirements

· AR-11

Healthy People 2010

· AR-12

Lobbying Restrictions

· AR-13

Prohibition on Use of CDC Funds for Certain Gun Control Activities

· AR-14

Accounting System Requirements

· AR-15

Proof of Non-Profit Status

· AR-16

Security Clearance Requirement

· AR-21

Small, Minority, and Women-Owned Business

· AR-23

States and Faith-Based Organizations

· AR-24

Health Insurance Portability and Accountability Act Requirements

· AR-25

Release and Sharing of Data

· AR-26

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

· AR-27

Conference Disclaimer and Use of Logos

· AR-29

Compliance with EO13513, “Federal Leadership on Reducing Text Messaging while Driving”, October 1, 2009 Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

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 CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

TERMS AND CONDITIONS

Reporting Requirements

Each funded applicant must provide CDC with an annual Interim Progress Report submitted via www.grants.gov:

1. The interim progress report is due no less than 150 days before the end of the budget period. The Interim Progress Report will serve as the non-competing continuation application, and must contain the following elements:

a. Standard Form (“SF”) 424S Form

b. SF-424A Budget Information-Non-Construction Programs

c. Project Narrative

d. Current Budget Period Activity Objectives

e. Current Budget Period Financial Progress

f. Identify Estimated Unobligated Funds in the current budget period by component separately on the 424A Forms and provide detail actions to be taken to obligate the funds

g. New Budget Period Program Proposed Activity Objectives.

h. Budget and Budget Narrative.

i. Indirect Cost Rate Agreement.

j. Additional Requested Information.

Additionally, the applicant must provide CDC with an original, plus two hard copies of the following reports:

2. Annual progress report, due 90 days after the end of the budget period. The annual progress report must contain the following elements:

a. Background and Update Narrative

b. Goals and Objectives Narrative

c. Program Evaluation Narrative

3. Financial status report and annual progress report, no more than 90 days after the end of the budget period.

4. Final performance and Financial Status reports, no more than 90 days after the end of the project period.

These reports must be submitted to the attention of the Grants Management Specialist listed in the Section VIII below entitled “Agency Contacts”.

VIII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For programmatic technical assistance, contact:

Kendall R. Anderson, Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

National Center on Birth Defects & Developmental Disabilities

Telephone: 404-498-3950

E-mail: KRAnderson@cdc.gov or

Louise Floyd, Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

National Center on Birth Defects & Developmental Disabilities

Telephone: 404-498-3923

E-mail: LFloyd@cdc.gov

For financial, grants management, or budget assistance, contact:

Dana Dudley, Grants Management Officer

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-09

Atlanta, GA 30341

Telephone: 770-488-2906

E-mail: ioo0@cdc.gov For general questions, contact:

Technical Information Management Section

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

Telephone: 770-488-2700

Email:

pgotim@cdc.gov CDC Telecommunications for the hearing impaired or disabled is available at: TTY 770-488-2783.

Other Information

Other CDC funding opportunity announcements can be found on the Grants.gov website, Internet address: http://www.GRANTS.gov

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