cdc-rfa-dd10-1010 new final 4 30 10.doc

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC) Surveillance of Neural Tube Defects (NTDs) and Other Birth Defects in Low and Middle Income Countries

I. AUTHORIZATION AND INTENT

Announcement Type: New – Type 1 Funding Opportunity Number: CDC-RFA-DD10-1010 Catalog of Federal Domestic Assistance Number: 93.073; Birth Defects and Developmental Disabilities – Prevention and Surveillance Key Dates:

Letter of Intent Deadline Date: May 17, 2010 AFTER DATE OF PUBLICATION on Grants.gov]

Application Deadline Date: June 1, 2010 on grants.gov 11:59pm Eastern Standard Time Authority:

This program is authorized under sections 307, 311, 317(k)(2), and 317(C) of the Public Health Service Act [42 U.S.C. 242l, 243, 247(k)(2), and 247b-4], as amended.

Background:

Worldwide, the March of Dimes estimates that there are over 4.9 million pregnancies affected by birth defects annually with the majority occurring in low- and middle-income countries. Specifically, there are an estimated 300,000 neural tube defect (NTD)-affected pregnancies annually with over 90% occurring in low- and middle-income countries. Most low- and middle-income countries do not have established population-based birth defects surveillance programs which can provide accurate and reliable estimates of the prevalence of NTDs and other major birth defects.

CDC recognizes that surveillance of NTDs and other major birth defects in low- and middle-income countries, especially those exhibiting population risk factors for birth defects, is critically important to the future development of birth defects prevention activities. Strengthening of birth defects surveillance in the United States helped identify disparities in NTD prevalence and evaluation of the effectiveness of interventions, such as fortification of enriched cereal grain products with folic acid at the level of 140 µg/100 grams of grain. A similar investment in the infrastructure of birth defects surveillance in low- and middle- income countries is essential for the ultimate development, implementation, and evaluation of birth defects prevention activities in at-risk populations around the world.

Purpose:

The purpose of the program is to support: (1) the development, implementation, expansion, and evaluation of population-based birth defects surveillance systems in low- or middle-income countries; and (2) planning for the development and implementation of population-based programs to prevent birth defects. This program addresses the “Healthy People 2010” focus area(s) of Maternal, Infant and Child Health.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center on Birth Defects and Developmental Disabilities (NCBDDD): 1) Prevent or Reduce Birth Defects and Developmental Disabilities, and 2) Improve the Health and Development of All People with Disabilities or Potentially Disabling Conditions.

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:

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the following activities:

a. Develop, implement, or enhance a population-based surveillance system to ascertain cases and generate timely population-based data of NTDs and other major birth defects. Countries with existing surveillance systems should broaden their methodologies and approaches which will improve and expand the capacity of their population-based surveillance system to ascertain cases and generate timely population-based data of major birth defects. Applicants are encouraged to conduct verification of the specific NTD and other birth defect diagnoses through medical record review, autopsy, and/or cytogenetic studies. Applicants are strongly encouraged to develop or enhance a population-based surveillance system and not rely on clinic or hospital-based selection of cases, unless evidence is presented that the approach would result in a population representative of the area population of children with NTDs and other included birth defects with respect to race-ethnicity, socioeconomic status, sex, and other relevant demographic characteristics. Applicants are strongly encouraged to follow the National Birth Defects Prevention Network’s Guidelines for Conducting Birth Defects Surveillance (http://www.nbdpn.org/current/resources/bdsurveillance.html).

b. Analyze and widely disseminate NTD and other birth defects surveillance data (prevalence and trends) generated by the system in a timely fashion (e.g., publish an annual or biannual report on the surveillance data).

c. Use the surveillance data to inform partner organizations about NTDs and other birth defects in the country or region.

d. Identify and engage appropriate partners within the country to plan, develop, and implement birth defects prevention activities (e.g., neural tube defects occurrence and recurrence prevention, targeting prevention messages and activities to various race/ethnic populations). Disseminate results with appropriate organizations within the country and with other countries.

e. Collaborate with other countries or regions on specific projects related to surveillance or prevention of NTDs and other major birth defects. Describe proposed or existing collaborations with other countries or regions.

f. Develop and implement an evaluation plan using the CDC developed logic model templates and resources. The CDC developed logic model and resources can be accessed at www.cdc.gov/ncbddd/bd. This plan will include action steps for evaluating the birth defects surveillance methodology and its impact on accuracy and completeness of the surveillance data, and planning for prevention activities.

g. Document the availability of information for the surveillance population on modifiable risk factors for birth defects within already existing data sources including medical records, birth certificates, death certificates, laboratory reports, published articles and reports, and other databases. These potential risk factors may include, but are not limited to:

1) Biochemical indicators of folate and vitamin B12 status and other micronutrients.

2) Prepregnancy overweight and obesity.

3) Pre-existing (type 1 or type 2) and gestational diabetes mellitus.

4) Rubella virus and toxoplasmosis.

5) Cigarette smoking.

6) Alcohol consumption.

7) Use of potentially teratogenic medications (e.g,. thalidomide, isotretinoin, trimethoprin-sulfonamide, anticonvulsants, lithium, antihypertensive medications).

h. Applicants should only engage in surveillance activities as described and authorized in this funding opportunity announcement. Applicants may not use the birth defects surveillance data to engage in research activities or activities that compromise the confidentiality or trust of the families affected by birth defects whose data will be collected under this cooperative agreement.

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

CDC Activities:

b. Provide advisory technical assistance such as presenting the need, benefits, and description of a birth defects surveillance, prevention, and intervention program, describing the advantages and disadvantages of the different types of birth defects programs, reviewing draft birth defects program language, and other guidance to applicants and interested parties.

b. Assist in designing, developing, and evaluating methodologies and approaches used for population-based birth defects surveillance. Discuss the advantages and disadvantages of different case ascertainment methods.

c. Assist in analyzing surveillance data related to birth defects.

d. Assist in designing, developing, and evaluating plans for prevention programs.

e. Assist in designing, developing, and evaluating plans to improve the access of children with birth defects to health services and intervention programs.

f. Provide a reference point for sharing grantee and non-grantee surveillance data and contact information pertinent to the surveillance and prevention of birth defects.

g. Disseminate the CDC evaluation model and resources and assist in the development of specific evaluation models and tools as well as provide technical assistance with implementing the evaluation plan and activities.

III. AWARD INFORMATION AND REQUIREMENTS

Type of Award: Cooperative Agreement. CDC’s substantial involvement in this program appears in the Activities Section above.

Award Mechanism: U50 – Special Cooperative Health Investigations and Assessments of Control and Prevention Methods Fiscal Year Funds: 2010 Approximate Current Fiscal Year Funding: Up To $300,000

Approximate Total Project Period Funding: Up To $900,000 (includes both direct and indirect costs)

Approximate Number of Awards: 1 - 3 Approximate Average Award: Up To $125,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Floor of Individual Award Range: Up To $100,000 Ceiling of Individual Award Range: Up To $150,000 (This ceiling is for the first 12-month budget period. This includes total cost, which would include indirect costs.)

Anticipated Award Date: September 1, 2010 Budget Period Length: 1 year; 9/1/2010 – 8/31/2011 Project Period Length: 3 years; 9/1/2010 – 8/31/2013 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:

· Nonprofit with 501C3 IRS status (other than institution of higher education)

· Nonprofit without 501C3 IRS status (other than institution of higher education)

· For-profit organizations (other than small business)

· Small, minority, and women-owned businesses

· Universities

· Colleges

· Research institutions

· Hospitals

· Community-based organizations

· Faith-based organizations

· Federally recognized or state-recognized American Indian/Alaska Native tribal governments

· American Indian/Alaska native tribally designated organizations

· Alaska Native health corporations

· Urban Indian health organizations

· Tribal epidemiology centers

· State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)

· Political subdivisions of States (in consultation with States)

· Non-domestic (non-US) entity A Bona Fide Agent is an agency/organization identified by the state or country government as eligible to submit an application under the state/country eligibility in lieu of a state/country application. If applying as a bona fide agent of a state or country government, a letter from the state agency or country Ministry of Health as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

SPECIAL ELIGIBILITY CRITERIA: Licensing/Credential/Permits

Limitation on Number of Applications Per Country

There is a maximum of two (2) applications allowed per eligible country: one (1) application for birth defects surveillance within a country (i.e. city, region, or country-wide surveillance) and one (1) application for multi-country collaboration of birth defects surveillance. The applicant’s Ministry of Health or relevant Ministries of Health should provide a Bona Fide Agent letter or letter of support in each application.

Birth Coverage Area

Population-based birth defects surveillance coverage area for the defined geographic area of the city, region, country, or multi-country area should have a minimum of 100,000 annual births. Using 2007 annual birth data from UNICEF, we have listed the eligible countries with over 100,000 annual births in Attachment I. Any country listed as ineligible due to less than 100,000 births in 2007 may be reclassified as eligible if the country can document they had over 100,000 annual births in 2008 or 2009, or they partner with another country to achieve the 100,000 annual birth coverage area.

Low or Middle-Income Countries

Using the July 2009 World Bank Income Classification, we have listed the eligible countries that were classified as low- or middle-income in Attachment I.

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.

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.

· 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

· Single spaced

· Paper size: 8.5 by 11 inches

· Page margin size: One inch

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

· Printed only on one side of page.

The narrative should address activities to be conducted over the entire project period and must include the following Evaluation Criteria items in the order listed. See Section VI entitled “Application Review Information” for the detailed Evaluation Criteria.

1. Birth Defects Surveillance System: Case Ascertainment, Data Analysis and Dissemination, Evaluation (30 points) The accuracy and completeness of the applicant’s description of the anticipated level of impact this cooperative agreement will have on any current NTD and birth defects surveillance activities in their country.

2. Performance Measures (30 points)

Does the plan include quantitative process and outcome measures? Do the performance measures enable the applicant to determine the appropriateness and effectiveness of the project? Did the applicant provide performance measures addressing the Recipient Activities? Are the performance measures realistic and achievable?

3. Understanding of the Public Health Impact of Birth Defects (20 points)

The accuracy and completeness of the applicant’s description of the requirements, objectives, and purpose of the cooperative agreement.

4. Current and Potential Future Collaborations (10 points)

The applicant’s description of any current and future collaborations or partnering organizations focused on birth defects surveillance or prevention with other countries or regions within their own country.

5. Organizational and Program Personnel Capability (10 points) The adequacy of the present staff and/or the capability to assemble competent staff to either implement or improve upon a birth defects surveillance system and develop programs for prevention.

6. Budget Justification and Adequacy of Facilities (not scored) The budget will be evaluated for the extent to which it is reasonable, clearly justified, and consistent with the intended use of the cooperative agreement funds.

Additional information may be included in the application appendices. The appendices will not be counted toward the project narrative page limit. Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named APPENDIX I, APPENDIX II, APPENDIX III, and so forth. This additional information can include:

· Bona fide agent letter from the country Ministry of Health

· Timeline clearly identifying all key milestones

· Most recent calendar year birth and birth defects surveillance data, stratified by race/ethnicity

· International Classification of Diseases codes covered by the existing or proposed surveillance system

· Memorandums of Understanding/Agreement with neighboring countries describing existing and proposed collaborations, and the data and activities to be shared.

· Folic acid and other birth defects prevention educational materials

· Curriculum vitae/resumes

· Organizational charts

· Letters of Support

· Letters of Commitment

· Subcontractor/Subawardee budget justification

· Scientific articles and publications

· Budget and Budget Justification: Provide a detailed budget which indicates the anticipated costs for personnel, fringe benefits, travel, supplies, equipment, contractual, consultants, indirect, and other items. Please provide detailed budget and budget justifications for each subcontractor/subawardee. An example of proper budget justification detail and format can be obtained from the following link: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

· Indirect Cost Rate Agreement or memorandum with current and future year Cost Allocation Plan indirect rates.

No more than 20 attachments should be uploaded per application.

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):

Prospective applicants are asked to submit a LOI. Although a LOI 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 the potential review workload and plan the review. Requested LOIs should be provided no later than by the date indicated in Section I entitled “Authorization and Intent”. The LOI does not need to be signed and should include the following information:

· This FOA title and number.

· The applicant’s name and address; project director’s name, phone number, and e-mail.

· A brief description of the planned statement of work. The narrative should be no more than two, double-spaced pages, printed on one side, with one-inch margins and 12-point unreduced, Times New Roman font.

Letter of Intent (LOI) Submission Address: Submit the LOI by fax or E-mail to:

William Paradies

CDC, NCBDDD

Telephone Number: 404.498.3919

Fax: 404.498.3040

E-mail address: Wparadies@cdc.gov 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 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 Deadline Date: May 17, 2010 AFTER DATE OF PUBLICATION on Grants.gov]

Application Deadline Date: June 01, 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 FOA #CDC-RFA-DD10-1010. 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:

1. Birth Defects Surveillance System: Case Ascertainment, Data Analysis and Dissemination, Evaluation (30 points) The accuracy and completeness of the applicant’s description of the anticipated level of impact this cooperative agreement will have on any current NTD and birth defects surveillance activities in their country including the applicant’s:

a) Ability to develop/improve/expand their population-based (or hospital or clinic-based, if representative of the birth population) birth defects surveillance program.

b) Case finding procedures, including case validation.

c) Technical infrastructure and organization of surveillance system (e.g.; database platform, variables collected, quality control and quality assurance protocols).

d) Timeliness of case ascertainment.

e) Level of coverage of the population and total birth population under surveillance. A complete description of the birth population will include the number of births per year, by relevant demographic characteristics such as maternal age, maternal race-ethnicity, sub-region, and location of delivery (hospital or home). The information regarding the proportion of births taking place in a hospital will be critical in evaluating the quality of an application based on hospital-based case ascertainment. This information should also be presented in tabular form in an appendix.

f) Specific birth defects ascertained using the International Classification of Diseases codes and definitions.

g) Ability to analyze and report surveillance data to appropriate health officials.

h) Ability to evaluate the surveillance methodology and quality of the surveillance data.

i) Documented policies and procedures for maintaining confidentiality of data collected by the surveillance program.

j) The feasibility and completeness of the applicant’s plans for using surveillance data to develop, implement, or expand existing or future birth defects prevention activities.

k) Ability to disseminate surveillance data.

2. Performance Measures (30 points)

Are the proposed project objectives relevant, specific, achievable, measurable, time-phased, and can be addressed through the proposed methods? Does the applicant include a reasonable and achievable timeline to complete the activities in the project period? How complete and comprehensive is the plan for the entire project period? Does the plan include quantitative process and outcome measures? Do the performance measures enable the applicant to determine the appropriateness and effectiveness of the project? Did the applicant provide performance measures addressing the Recipient Activities? Are the performance measures realistic and achievable?

3. Understanding of the Public Health Impact of Birth Defects (20 points) The accuracy and completeness of the applicant’s description of the requirements, objectives, and purpose of the cooperative agreement. The applicant should:

a) Clearly and concisely describe their understanding of the public health impact of NTDs and other major birth defects in their country and complexities of their already existing or proposed birth defects surveillance program.

b) For applicants without a current birth defects surveillance program, the need for the development and implementation of a surveillance program for NTDs and other major birth defects should be clearly described.

c) For applicants with an existing birth defects surveillance program, the need for enhancement and improvement of the NTD surveillance program should be clearly described. Applicants with an existing birth defects surveillance program should provide current estimates for the prevalence of NTDs and other major birth defects by the relevant demographic characteristics listed in the Recipient Activities. This information should be presented in tabular form in an appendix.

d) Clearly and concisely describe their understanding of the public health impact of potential contextual or risk factors for birth defects, such as micronutrient deficiencies (e.g. folate, vitamin B12); pregestational overweight and obesity; pre-existing diabetes; infection with rubella virus and other infectious diseases during pregnancy.

4. Current and Potential Future Collaborations (10 points)

a) For single country applicants, the applicant’s description of any current collaborations with the Ministry of Health, universities, hospitals, cytogenetic laboratories, genetic clinics, or other partnering organizations focused on birth defects surveillance or prevention activities.

b) For multiple country applicants, the applicant’s description of any current collaborations on birth defects surveillance or prevention activities with other countries’ Ministries of Health, universities, hospitals, cytogenetic laboratories, genetic clinics, or other partnering organizations focused on birth defects surveillance or prevention activities.

c) The accuracy and completeness of the applicant’s description of potential collaborations this funding opportunity announcement may facilitate.

d) Letters of Support from Ministries of Health and other organizations referring to specific collaborative efforts from current and future partner organizations should be included as appendices.

5. Organizational and Program Personnel Capability (10 points)

a) Whether the applicant has the appropriate experience, skills, and ability to develop and improve birth defects surveillance and use surveillance data to develop prevention programs.

b) The adequacy of the present staff and/or the capability to assemble competent staff to either implement or improve upon a birth defects surveillance system and develop programs for prevention. If it is necessary to hire staff to conduct program activities, the applicant should provide plans for identifying and hiring qualified applicants on a timely basis. The applicant should provide plans for how program activities will be conducted prior to hiring necessary staff. The applicant’s staff are encouraged to complete the National Institutes of Health Ethics Training (http://ethics.od.nih.gov/training.htm).

c) The applicant shall identify all current and potential personnel who will work on this cooperative agreement including qualifications and specific experience as it relates to the requirements set forth in this announcement.

d) The applicant shall include a letter from the Ministry of Health (or Ministries of Health if the applicant is a collaboration between multiple countries) indicating the government’s support for these activities and the methods of data collection, analysis and dissemination proposed by the applicant.

6. Budget Justification and Adequacy of Facilities (not scored) The budget will be evaluated for the extent to which it is reasonable, clearly justified, and consistent with the intended use of the cooperative agreement funds. The applicant shall describe and indicate the availability of facilities and equipment necessary to carry out this project.

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 only expend funds for reasonable program purposes, including personnel, fringe benefits, travel, supplies, services (such as contractual), and indirect.

· 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.

· Project funds may not be used to supplant funds available for birth defects surveillance or prevention, health care services, patient care, nor construction.

· Award recipients agree to use cooperative agreement funds for travel by project staff agreed-upon by CDC to participate in CDC-sponsored workshops, or other called meetings such as annual meetings.

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 the 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 if 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 from outside the funding division who will evaluate the technical merit of the application for the purpose of advising the awarding official. The panel shall numerically score each application using only the criteria listed in the announcement.

Applications Selection Process

Applications will be funded in order by score and rank determined by the review panel. In addition, the following factors may affect the funding decision: number of annual births, race/ethnic populations, geographical coverage, existing birth defects surveillance systems, collaborations with other countries.

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-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-14

Accounting System Requirements

· AR-15

Proof of Non-Profit Status

· 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

· 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 90 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. Budget Narrative

d. Indirect Cost Rate Agreement

e. Project Narrative

f. Current Budget Period Activities Objectives

g. Current Budget Period Financial Progress

h. 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.

i. New Budget Period Program Proposed Activity Objectives

j. Budget

k. Measures of Effectiveness

l. Additional Requested Information

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

2. Financial Status Report (SF 269) and annual progress report, due no more than 90 days after the end of the budget period. The annual progress report must contain all activities that have been conducted within the 12 month budget period.

3. Final performance report and final Financial Status Report, 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:

William Paradies, Project Officer Department of Health and Human Services

Centers for Disease Control and Prevention

National Center on Birth Defects and Developmental Disabilities Division of Birth Defects and Developmental Disabilities

1600 Clifton Road NE, MS E-86

Atlanta, GA 30333

Telephone: (404) 498-3919

E-mail: WParadies@cdc.gov For financial, grants management, or budget assistance, contact:

Tracey Sims, Grants Management Specialist

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-09

Atlanta, GA 30341

Telephone: (770) 488-2739

E-mail: tsims@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 CDC Web site, Internet address: http://www.cdc.gov/od/pgo/funding/FOAs.htm.

ATTACHMENT I

LIST OF ELIGIBLE COUNTRIES

Highlighted = ineligible due to <100,000 births or classified as high income

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