dd11-1104 foa final 3.22.11.doc

PART 1. OVERVIEW INFORMATION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Agency Name: Federal Centers for Disease Control and Prevention (CDC) Funding Opportunity Title: Surveillance of Birth Defects in Low and Middle Income Countries Announcement Type: New – Type 1 Agency Funding Opportunity Number: CDC-RFA-DD11-1104 Catalog of Federal Domestic Assistance Number: 93.073: Birth Defects and Developmental Disabilities – Prevention and Surveillance Key Dates:

Letter of Intent Deadline Date: April 18, 2011 Application Deadline Date: May 31, 2011, 5:00pm Eastern Standard Time.

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/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

This program is authorized under sections 301, 307, 311, and 317C of the Public Health Service Act [42 U.S.C. 241, 242l, 243, 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) efforts to develop and implement population-based programs to prevent birth defects. This program addresses the “Healthy People 2020” focus area(s) of Maternal, Infant and Child Health.

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 external/observable major structural birth defects (i.e. congenital anomalies that require surgical or medical treatment or have a significant impact on health and development). CDC recommends that the catchment birth population should be between 50,000 and 100,000 births per year. If the applicant country has more than 100,000 births per year, the surveillance program must specify a region of the country with a birth population within the above-mentioned range. If the applicant country has fewer than 50,000 births per year, the applicant may collaborate with another country in the region to reach the above-mentioned birth population threshold. If the applicant chooses to collaborate with a non-contiguous country outside the region, a rationale for this should be provided.

1) Applicants with no existing birth defects surveillance system are strongly encouraged to develop a population-based surveillance system. These applicants should not rely on clinical or hospital-based selection of cases unless evidence is presented that this approach would result in a population representative of the area population of children with NTDs and other major structural birth defects with respect to race-ethnicity, maternal age, infant sex, a culturally relevant measure of socio-economic status, and other available demographic characteristics.

2) Applicants with already existing hospital-based surveillance systems are strongly encouraged to broaden their methodologies and approaches to improve their capacity to ascertain cases and generate population-based data of major birth defects.

3) Applicants are strongly encouraged to conduct verification of the specific NTD and other birth defect diagnoses through medical record review, autopsy, and/or cytogenetic studies and not rely exclusively on the passive reporting of cases from hospitals or other health care providers.

4) 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 surveillance data (overall prevalence, prevalence by available socio-demographic characteristics, and prevalence trends over time) for NTDs and other major birth defects to relevant partner organizations (e.g. CDC, non-governmental organizations, governmental organizations, hospitals and other health providers, universities) in a timely fashion (e.g., publish and disseminate an annual report on the surveillance data which does not include personally identifiable information).

c. Identify and engage the above partners within the country to plan and develop birth defects prevention activities (e.g., NTD occurrence and recurrence prevention, targeting prevention messages and activities to various race/ethnic populations). Share the results of these development efforts (e.g., culturally-relevant prevention materials) with other organizations and stakeholders that may not have participated in their development.

d. If collaborations with other countries in the region are essential to the success of the program, describe these proposed or existing collaborations. If not necessary for the surveillance program to succeed, collaboration with other countries is not a requirement.

e. 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.

f. Given the importance of understanding the prevalence of modifiable risk factors for birth defects, document the availability of this information for the surveillance population using existing data sources including medical records, birth certificates, death certificates, laboratory reports, published articles and survey reports, and other databases. The potential risk factors for which prevalence information among women of childbearing age is of interest 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 and toxoplasmosis infections.

5) Tobacco exposure.

6) Alcohol consumption.

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

8) Environmental exposures of concern.

g. 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 for activities that compromise the confidentiality or trust of the families affected by birth defects whose data will be collected under this cooperative agreement. This funding cannot be used to conduct research.

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. Provide guidance in designing, developing, enhancing, and evaluating methodologies and approaches used in each specific grantee’s population-based birth defects surveillance program.

c. Provide epidemiologic and other assistance in analyzing surveillance data related to birth defects.

d. Assist in designing, developing, and implementing an evaluation plan for the grantee’s birth defects surveillance program. 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.

f. Compare characteristics of differing prevention programs and provide technical guidance in designing, developing, and implementing a grantee specific program for the prevention of birth defects.

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

II. AWARD INFORMATION

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: 2011 Approximate Current Fiscal Year Funding: Up To $300,000 Approximate Total Project Period Funding: Up To $900,000 (This amount is an estimate and is subject to availability of funds.) This amount includes direct and indirect costs.

Approximate Number of Awards: 1 - 3 Approximate Average Award: Up To $150,000 (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 direct and indirect costs.)

Anticipated Award Date: September 15, 2011 Budget Period Length: 1 year; 9/15/2011 – 9/14/2012 Project Period Length: 3 years; 9/15/2011 – 9/14/2014 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

Eligible Applicants 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-U.S.) 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, the applicant shall include a letter from the appropriate authority (e.g. Ministry of Health) documenting permission to conduct the proposed birth defects surveillance activities (including the methods of data collection, analysis and dissemination) as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

Required Registrations

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). The CCR registration can require an additional one to two days to complete. You are required to maintain a current registration in CCR.

Central Contractor Registration and Universal Identifier Requirements

All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the Central Contractor Registry (CCR) and maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. CCR is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the CCR internet site at www.ccr.gov.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

Cost Sharing or Matching Cost sharing or matching funds are 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.

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 between 50,000 and 100,000 annual births. Using 2008 annual birth data from UNICEF, we have listed the eligible countries with over 50,000 annual births in Attachment I. Any country listed as ineligible due to less than 50,000 births in 2008 may be reclassified as eligible if the country can document they had over 50,000 annual births in 2009 or 2010, or they partner with another country to achieve the minimum 50,000 annual birth coverage area.

Low or Middle-Income Countries

Using the September 2010 World Bank Income Classification, we have listed the eligible countries that were classified as low- or middle-income in Attachment I.

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. Application and Submission Information” 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.

IV. Application and Submission Information Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from 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. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

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, with the exception of all Federal Holidays. 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.

Content and Form of Application Submission 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 Letter of Intent (LOI):

Prospective applicants are requested 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 Part 1 entitled “Overview Information” and also listed below. 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; principal investigator’s name, phone number, and e-mail address.

· 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: +1-404.498.3919

Fax: +1-404.498.3040

E-mail address: Wparadies@cdc.gov 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 items in the order listed:

1. Goals and Objectives (30 points)

a) Does the applicant clearly and concisely describe the overall and specific goals of the surveillance system and are the goals adequate to carry out the proposed objectives?

b) Are the goals and objectives complete and comprehensive for the entire project period? Does the applicant describe specific, measurable, reasonable, achievable, relevant, and time-phased objectives?

c) Does the applicant describe activities relevant to each objective including a reasonable and achievable timeline for the completion of each activity?

2. Methods for Birth Defects Surveillance (30 points)

a) Does the applicant describe the source (birth) population for the surveillance system including an estimate of annual births and the demographics of these births?

b) Does the applicant describe planned methods for case ascertainment (e.g. passive ascertainment relying on administrative data or active case ascertainment involving seeking information on potential cases from available sources)?

c) Does the applicant detail the technical infrastructure and organization of the surveillance system (e.g. database platform, variables collected, quality control and quality assurance protocols)?

d) At a minimum, does the applicant include a description of the case definition for NTDs, oral clefts, and limb reduction defects?

e) Does the applicant describe current collaborations within the country and/or region with the governmental authorities, non-governmental organizations, universities, hospitals, cytogenetic laboratories, genetic clinics, or other organizations with an interest in birth defects surveillance or prevention activities?

f) Does the applicant describe new collaboration with partners within the country and the region that this funding opportunity announcement may facilitate?

g) Does the applicant detail a plan to analyze and report surveillance data to appropriate health authorities, and disseminate surveillance data more widely to the relevant organizations described above?

h) Does the applicant describe a plan to evaluate the surveillance methodology and quality of the surveillance data?

3. Evidence of the Need for Birth Defects Surveillance (15 points)

a) Does the applicant describe an understanding of the public health impact of major birth defects in their country?

b) Does the applicant describe the current birth defects surveillance activities already occurring within their country or region?

c) Does the applicant describe the need for the development and implementation (or enhancement) of a birth defects surveillance system for NTDs and other major birth defects?

d) Does the applicant describe their understanding of the public health impact of risk factors for birth defects, such as micronutrient deficiencies; pregestational obesity; pre-existing diabetes; infection with rubella virus and other infectious diseases during pregnancy?

4. Organizational and Program Personnel Capability (15 points)

a) Does the applicant 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? Do the staff members have appropriate expertise, skills, and ability necessary to complete the planned activities?

b) Does the applicant fully describe the management structure of the surveillance program?

c) Does the applicant clearly define the staff roles?

d) As described, will the staff be sufficient to accomplish the program goals?

e) Does the applicant describe 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?

5. Plan for Birth Defects Prevention (10 points)

a) Does the plan describe how the surveillance data will be used to plan for and eventually develop birth defects prevention activities within the country or the region?

b) Does the plan for prevention activities address potentially modifiable risk factors and include clearly stated goals?

c) Does the plan for prevention activities describe specific, measurable, reasonable, achievable, relevant, and time-phased objectives?

6. Budget Justification and Adequacy of Facilities (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? The applicant shall describe and indicate the availability of facilities and equipment necessary to carry out this project.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named ATTACHMENT I, ATTACHMENT II, and so forth and could include such information as:

· 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

· Evidence of applicant’s ability to publish and widely disseminate surveillance data

· 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 or resumes

· Organizational chart

· Letters of Support

· Letters of Commitment

· Subcontractor/Subawardee budget justification

· Proof of Non-Profit Status (if applicable)

· 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 25 attachments should be uploaded per application.

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

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.

Letter of Intent (LOI) Deadline Date: April 18, 2011 Application Deadline Date: May 31, 2011, 5:00pm Eastern Standard Time.

Intergovernmental Review Executive Order 12372 does not apply to this program.

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, 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 regional or annual meetings.

Other Submission Requirements Application Submission 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.

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 made available to CDC for processing from Grants.gov on the deadline date. 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 Grants.gov receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

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, with the exception of all Federal Holidays. 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.

Organizations that encounter technical difficulties in using www.Grants.gov to submit their application must attempt to overcome those difficulties by contacting the Grants.gov Support Center (1-800-518-4726, support@grants.gov). After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to GMO/GMS for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the GMO/GMS at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered.

If a paper application is authorized, the applicant will receive instructions from PGO TIMS to submit the original and two hard copies of the application by mail or express delivery service.

V. 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-DD11-1104. 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. Goals and Objectives (30 points)

a) Does the applicant clearly and concisely describe the overall and specific goals of the surveillance system?

b) Are the goals adequate to carry out the proposed objectives?

c) Are the goals and objectives complete and comprehensive for the entire project period?

d) Does the applicant describe specific, measurable, reasonable, achievable, relevant, and time-phased objectives?

e) Does the applicant describe activities relevant to each objective including a reasonable and achievable timeline for the completion of each activity?

f) Does the applicant include quantitative process and outcome measures for the proposed activities?

2. Methods for Birth Defects Surveillance (30 points)

a) Does the applicant describe the source (birth) population for the surveillance system? A complete description will include the number of births per year overall, and by relevant demographic characteristics such as maternal age, race-ethnicity, a culturally-relevant measure of socio-economic status, 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 that proposes to largely rely on hospital-based case ascertainment. This information should also be presented in tabular form in an Appendix.

b) Does the applicant describe methods for case ascertainment (e.g. passive ascertainment relying on administrative data or active case ascertainment involving seeking information on potential cases from available sources)? If passive, the applicant must provide a description of case validation procedures.

c) Does the applicant detail the technical infrastructure and organization of the surveillance system (e.g. database platform, variables collected, quality control and quality assurance protocols)?

d) At a minimum, does the applicant include a description of the case definition and ascertainment process for NTDs, oral clefts, and limb reduction defects? Other major birth defects detectable up to six weeks after delivery, including congenital heart defects, other central nervous system defects, gastrointestinal defects, genitourinary defects, and genetic or chromosomal disorders, may be ascertained as well. The applicant should specify all major birth defects which will be under surveillance and include the International Classification of Diseases codes used for case identification.

e) Does the applicant describe current collaboration with the governmental authorities, non-governmental organizations, universities, hospitals, cytogenetic laboratories, genetic clinics, or other organizations with an interest in birth defects surveillance or prevention activities?

f) Does the applicant describe new collaboration with partners within the country and the region that this funding opportunity announcement may facilitate?

g) Does the applicant detail a plan to analyze and report surveillance data to appropriate health authorities, and disseminate surveillance data more widely to the relevant organizations described above?

h) Does the applicant describe a plan to evaluate the surveillance methodology and quality of the surveillance data?

i) Does the applicant describe or document policies and procedures for maintaining confidentiality of data collected by the surveillance program?

j) Are the proposed methods feasible and to what extent will the methods accomplish the program goals?

3. Evidence of the Need for Birth Defects Surveillance (15 points)

a) Does the applicant describe an understanding of the public health impact of major birth defects in their country? This description should include any available estimates of the prevalence of NTDs and other major birth defects in the country or proposed geographic region for surveillance (e.g. multiple countries or a region within the country are eligible applicants). Prevalence data, if available, should also be presented in tabular form in an Appendix, with relevant demographic characteristics including race-ethnicity, maternal age, infant sex, and a culturally relevant measure of socio-economic status.

b) Does the applicant describe the current birth defects surveillance activities already occurring within their country or region?

c) Does the applicant describe the need for the development and implementation (or enhancement) of a birth defects surveillance system for NTDs and other major birth defects.

d) Does the applicant describe their understanding of the public health impact of risk factors for birth defects, such as micronutrient deficiencies; pregestational obesity; pre-existing diabetes; infection with rubella virus and other infectious diseases during pregnancy?

4. Organizational and Program Personnel Capability (15 points)

a) Does the applicant 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? Do the staff members have appropriate expertise, skills, and ability necessary to complete the planned activities?

b) Does the applicant fully describe the management structure of the surveillance program?

c) Does the applicant clearly define the staff roles?

d) As described, will the staff be sufficient to accomplish the program goals?

e) Does the applicant describe 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 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 members are encouraged to complete the National Institutes of Health Ethics Training (http://ethics.od.nih.gov/training.htm).

5. Plan for Birth Defects Prevention (10 points)

a) Does the plan describe how the surveillance data will be used to plan for and eventually develop birth defects prevention activities within the country or the region?

b) Does the plan for prevention activities address potentially modifiable risk factors and include clearly stated goals?

c) Does the plan for prevention activities describe specific, measurable, reasonable, achievable, relevant, and time-phased objectives?

6. Budget Justification and Adequacy of Facilities (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 applicants 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. The applicant shall describe and indicate the availability of facilities and equipment necessary to carry out this project.

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 Review and Selection Process Review

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 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 V. “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.

Selection

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/ethnicity of the birth population proposed for surveillance (inclusion of large, under-studied racial/ethnic group), geographical coverage, existence of a birth defects surveillance system that can be enhanced by this funding opportunity, collaborations with other countries.

VI. 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.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration and Transparency Act requirements.

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 2020

· 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

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

· AR-27

Conference Disclaimer and Use of Logos

· AR-29

Compliance with E.O. 13513 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 Reporting Federal Funding Accountability And Transparency Act Of 2006 (FFATA): Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:

1. The name of the entity receiving the award

2. The amount of the award

3. Information on the award including transaction type, funding agency, etc.

4. The location of the entity receiving the award

5. A unique identifier of the entity receiving the award; and

6. Names and compensation of highly-compensated officers (as applicable)

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the Federal Funding Accountability and Transparency Act of 2006, please review the following website:

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf 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.

*Disclaimer: As of February 1, 2011, current Financial Status Report (FSR) requirements will be obsolete. Existing practices will be updated to reflect changes for implementation of the new Federal Financial Reporting (FFR) requirements.

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

VII. Agency Contacts CDC encourages inquiries concerning this announcement.

For programmatic technical assistance, contact:

William Paradies, Project Officer Department of Health…