U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
Characterizing Alveolar Capillary Dysplasia (ACD) in Well-Defined Populations to Increase Awareness among Health Care Providers
Announcement Type: New – Type 1
Funding Opportunity Number: CDC-RFA-DD08-809
Catalog of Federal Domestic Assistance Number: 93.283 - Centers for Disease Control and Prevention Investigations and Technical Assistance
Key Dates:
Letter of Intent Deadline: June 30, 2008
Application Deadline: July 11, 2008
Authority: This program is authorized under Sections 301(a) and 317 (C) of the Public Health Service Act [42 U.S.C. Sections 241(a) and 247b-4] as amended.
Background: Alveolar capillary dysplasia (ACD), with or without misalignment of the pulmonary veins, is a developmental anomaly of the pulmonary vasculature and generally described as the failure of formation of the normal air-blood diffusion barrier in the newborn lung. ACD causes severe and irreversible persistent pulmonary hypertension in the neonate. The etiology of this condition and inheritance pattern is unknown. Life expectancy for infants with ACD is short, and anecdotal evidence indicates ACD is often misdiagnosed.
This rare and lethal neonatal condition usually presents as acute onset of respiratory failure with the first 48 hours of life. Clinically, the initial presentation in the newborn is identical to severe idiopathic pulmonary hypertension. Infants with ACD are unresponsive to various modes of standard therapies or extracorporeal membrane oxygenation (ECMO) and the majority expire within one month of life. ACD may be accompanied by other associated anomalies of the cardiovascular, gastroinstestinal, urogenital, or musculoskeletal systems.
Fewer than 150 cases of ACD have been described in the literature. However, the true incidence is unknown because the diagnostic histological features can be easily overlooked in autopsies. Final diagnosis of the majority of these cases is usually confirmed by examination of the lung on autopsy, or less commonly, through open lung biopsy. Milder, nonfatal forms of this condition may exist with undiagnosed survivors. Because of the uncertainty for the existence of milder cases of ACD, establishing diagnosis of this anomaly during life might enable survival.
Proper recognition and timely diagnosis of ACD are essential first steps to obtaining accurate prevalence data. Increased awareness of this condition is necessary for early diagnosis, will aid in parent counseling, and may help facilitate management of milder forms of the condition.
Purpose: The purpose of this program is for the development and distribution of awareness materials on alveolar capillary dysplasia (ACD) to neonatologists and intensive care pediatricians to assist in the proper diagnosis of ACD. Activities will focus on a plan to determine criteria to characterize and distinguish ACD phenotypes and strategies to target appropriate audiences with awareness materials. These planning components will be used to guide the development and dissemination of ACD awareness materials.
This program addresses the “Healthy People 2010” focus area of Maternal, Infant, and Child Health. Additionally, this program addresses the “Healthy People in Every Stage of Life” focus area(s) of: 1) Infants and Toddlers, ages 0-3: Start Strong; and 2) Children, ages 4-11: Grow Safe and Strong.
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
Activities:
Awardee activities for this program are as follows:
a. Identify recognized experts in pediatric pathology, neonatology, and other fields of clinical research on the subject of ACD, as well as recognized experts in the field of population-based surveillance of rare disorders, to serve on an ad hoc committee related to these activities.
b. Organize and lead a scientific workshop and/or conference on ACD to which these recognized experts, experts in communication science, parent support groups, and national professional organizations are invited. At a minimum, this workshop/conference should focus on:
1) Defining and describing the current state of knowledge as it relates to ACD and associated conditions.
2) Developing a case definition for ACD for use in the educational materials.
3) Developing strategies to raise awareness of and educate healthcare providers on ACD.
c. Compile the minutes and recommendations of the ad hoc meeting of experts.
d. Prepare and disseminate the guidance in a peer-reviewed publication with readership consisting of physicians and health care personnel.
e. Conduct target group evaluations to determine the most appropriate strategies to target and educate specific healthcare providers, such as neonatologists, pediatric pathologists, pediatric intensivists, and neonatal critical care personnel on ACD.
f. The grantee will develop and pretest concepts, messages and materials utilizing generally accepted scientific methods.
g. Conduct exploratory target group evaluation of the ACD awareness information to identify the messages, format, and preferred dissemination channels that resonate with the target audience and are most likely to be successful.
h. Produce a Materials Development and Dissemination Plan for ACD awareness materials. The content within the materials should provide guidelines for considering and diagnosing this condition.
In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program are as follows:
a. Provide advisory technical assistance such as the identification of national experts on ACD, review of preliminary needs assessment, collaboration on the development of the agenda for the expert meeting, participation in the expert meeting, and other guidance throughout the project period.
b. Assist in designing, developing, and evaluating the educational materials and modules.
c. Assist in the dissemination of the guidelines to the public.
d. Assist in the dissemination of the educational materials and modules to the public.
e. Provide a reference point for sharing state, regional, and national data and contact information pertinent to birth defects surveillance programs.
Type of Award: Cooperative Agreement.
CDC’s involvement in this program is listed in the Activities Section above.
Award Mechanism: U50 - Special Cooperative Health Investigations and Assessments of Control and Prevention Methods
Fiscal Year Funds: 2008
Approximate Current Fiscal Year Funding: $200,000
Approximate Total Project Period Funding: $200,000 (This amount is an estimate of the total direct and indirect cost, and is subject to availability of funds.)
Approximate Number of Awards: 1
Approximate Average Award: $200,000 (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: $225,000 (This ceiling is for the first 12-month budget period and includes direct and indirect costs.)
Anticipated Award Date: 9/30/2008
Budget Period Length: 1 year; 9/30/2008 – 9/29/2009
Project Period Length: 1 year; 9/30/2008 – 9/29/2009
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.1. 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)
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.
III.2. Cost Sharing or Matching
Cost sharing or matching funds are not required for this program.
III.3. 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 submission 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.
IV.1. Address to Request Application Package
To apply for this funding opportunity use the application forms package posted in Grants.gov.
Electronic Submission:
CDC strongly encourages the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide E-grant Web site. Only applicants who apply on-line are permitted to forego paper copy submission of all application forms.
Registering your organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Registered” screen of www.Grants.gov. While application submission through www.Grants.gov is optional, we strongly encourage you to use this online tool.
Please visit www.Grants.gov at least 30 days prior to filing your application to familiarize yourself with the registration and submission processes. Under “Get Registered,” the one-time registration process will take three to five days to complete; however, as part of the Grants.gov registration process, registering your organization with the Central Contractor Registry (CCR) annually, could take an additional one to two days to complete. We suggest submitting electronic applications prior to the closing date so if difficulties are encountered, you can submit a hard copy of the application prior to the deadline.
IV.2. Content and Form of Submission
Letter of Intent (LOI):
Prospective applicants are asked to submit a LOI. The LOI will not be scored or used to eliminate potential applicants, but it will enable CDC to determine the level of interest and plan the review more efficiently. The LOI should include the following information:
· This FOA title and number.
· The applicant’s name and address; Principal Investigator/Project Director’s name, phone number, and e-mail.
· A brief description of the current status of ACD activities in the community and overview of proposed activities. 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.
Application:
A Project Abstract must be submitted with the application forms. All electronic project abstracts must be uploaded in a PDF file format when submitting via www.grants.gov. The abstract must be submitted in the following format:
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 Project Abstract must not include any proprietary/confidential information.
A project narrative must be submitted with the application forms. All electronic narratives must be uploaded in a PDF file format when submitting via www.grants.gov. The narrative must be submitted in the following format:
The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:
1. Need
· Understanding of need for planned activities.
· A brief description of the most current annual number of state-wide births, current birth defects surveillance system, and current newborn screening system.
2. Plan
· Adequate for planned objectives.
· Complete and comprehensive for project period.
· Quantitative process and outcome measures.
· Reasonable and achievable timeline.
· Evaluation methods.
3. Methods
· Feasible and accomplish program goals.
· Involve parent support groups and national professional organizations.
4. Personnel
· Appropriate expertise and skills.
· Ability to identify and hire needed staff and consultants.
· Staff roles defined and sufficient to accomplish program goals.
Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:
Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:
No more than 20 appendices should be uploaded per application.
The agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access the Dun and Bradstreet website or call 1-866-705-5711.
Additional requirements that may request submission of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”
Letter of Intent (LOI) Deadline Date: June 30, 2008
Application Deadline Date: July 11, 2008
Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date.
Applications must be submitted electronically at www.Grants.gov. Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Organization Representative (AOR) electronically submits the application to 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 AOR to Grants.gov on or before the deadline date and time.
When submission of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped and a tracking number will be assigned, which will serve as receipt of submission. The AOR will receive an e-mail notice of receipt when HHS/CDC receives the application.
This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline above, it will not be eligible for review. The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance. The applicant will be notified the application did not meet the submission requirements.
IV.4. Intergovernmental Review of Applications
The application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contact the state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State’s process. Visit the following Web address to get the current SPOC list:
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing the budget, are as follows:
If requesting 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 recommended guidance for completing a detailed justified budget can be found on the CDC Web site, at the following Internet address:
http://www.cdc.gov/od/pgo/funding/budgetguide.htm.
IV.6. Other Submission Requirements
LOI Submission Address: Submit the LOI by express mail, delivery service, fax, or E-mail to:
Bill Paradies, Project Officer Wes Duke, Project Officer
Telephone: 404.498.3919 Telephone: 404.498.3922
E-mail: wep2@cdc.gov E-mail: cji7@cdc.gov
National Center on Birth Defects and Developmental Disabilities
4770 Buford Hwy., NE, M/S E-86
Atlanta, GA 30341
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 the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
Application Submission Address:
Electronic Submission:
HHS/CDC strongly encourages applicants to submit applications electronically at www.Grants.gov. The application package can be downloaded from www.Grants.gov. Applicants are able to complete it off-line, and then upload and submit the application via the Grants.gov Web site. E-mail submissions will not be accepted. If the applicant has technical difficulties in Grants.gov, customer service can be reached by E-mail at support@grants.gov or by phone at 1-800-518-4726 (1-800-518-GRANTS). The Customer Support Center is open from 7:00a.m. to 9:00p.m. Eastern Time, Monday through Friday.
HHS/CDC recommends that submittal of the application to Grants.gov should be prior to the closing date to resolve any unanticipated difficulties prior to the deadline. Applicants may also submit a back-up paper submission of the application. Any such paper submission must be received in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. The paper submission must be clearly marked: “BACK-UP FOR ELECTRONIC SUBMISSION.” The paper submission must conform to all requirements for non-electronic submissions. If both electronic and back-up paper submissions are received by the deadline, the electronic version will be considered the official submission.
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.
V.1. Criteria
Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. The measures of effectiveness must be submitted with the application and will be an element of evaluation.
The application will be evaluated against the following criteria:
1. Need (20 Points)
To what extent does the applicant demonstrate understanding of the need for this program and the planned activities within the target community?
2. Plan (30 Points)
Is the plan adequate to carry out the proposed objectives? How complete and comprehensive is the plan for the entire project period? Does the plan include quantitative process and outcome measures? Does the applicant include a reasonable and achievable timeline to complete the activities in the specified project period? Does the applicant include appropriate evaluation methods to assess the guidelines and educational materials and modules?
3. Methods (30 Points)
Are the proposed methods feasible? To what extent will they accomplish the program goals? Does the applicant document plans to involve parent support groups and national professional organizations to assist them in coordinating a meeting that will develop guidelines that will be widely accepted among health care providers who care for infants with ACD? Does the applicant document plans to involve parent support groups and national professional organizations as focus group participants to assist them in the development, testing and dissemination of the materials?
4. Personnel (20 Points)
Do the staff members have appropriate expertise and skills necessary to complete the planned activities? If additional staff or consultants are needed, does the applicant have the capacity to identify additional staff and consultants? Are the staff roles clearly defined? As described, will the staff be sufficient to accomplish the program goals?
5. Budget (SF 424A) and Budget Narrative (Reviewed, but not scored)
Is the proposed budget accurate and reasonable for the planned activities?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness jointly 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 submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above. Applications will be funded in order by score and rank determined by the review panel.
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and emailed to the program director and a hard copy mailed to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
VI.2. Administrative and National Policy Requirements
Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92, as appropriate. The following additional requirements apply to this project:
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.
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
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
VI.3. Reporting Requirements
The applicant must provide CDC with an annual interim progress report via www.grants.gov:
1. The interim progress report is due no less than 90 days before the end of the budget period. The 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.
Additionally, the applicant must provide CDC with an original, plus two hard copies of the following reports:
2. Financial status report and annual progress report, no more than 90 days after the end of the budget period.
These reports must be submitted to the attention of the Grants Management Specialist listed in the “VII. Agency Contacts” section of this announcement.
CDC encourages inquiries concerning this announcement.
For general questions, contact:
CDC Procurement and Grants Office
2920 Brandywine Road, MS E-14
Atlanta, GA 30341
Telephone: 770.488.2700
For program technical assistance, contact:
Bill Paradies, Project Officer Wes Duke, Project Officer
Telephone: 404.498.3919 Telephone: 404.498.3922
E-mail: wep2@cdc.gov E-mail: cji7@cdc.gov
National Center on Birth Defects and Developmental Disabilities
4770 Buford Hwy., NE, M/S E-86
Atlanta, GA 30341
For financial, grants management, or budget assistance, contact:
Hector Buitrago, Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Road, MS E-14
Telephone: 770-488-2921
E-mail: gmf2@cdc.gov
CDC Telecommunications for the hearing impaired or disabled is available at: TTY 770-488-2783.
VIII. 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.
Applicants may access the application process and other awarding documents using the Electronic Research Administration System (eRA Commons). A one-time registration is required for interested institutions/organizations at http://era.nih.gov/ElectronicReceipt/preparing.htm
Program Directors/Principal Investigators (PD/PIs) should work with their institutions/organizations to make sure they are registered in the eRA Commons.
1. Organizational/Institutional Registration in the eRA Commons
2. Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should check with their business official to determine whether their organization/institution is already registered in the eRA Commons. HHS/CDC strongly encourages applicants to register to utilize these helpful on-line tools when applying for funding opportunities.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:
http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm