05-11693. Creutzfeldt-Jakob Disease-Nationwide Education and Communication

Announcement Type: New.

Funding Opportunity Number: AA109.

Catalog of Federal Domestic Assistance Number: 93.283.

Key Dates: Letter of Intent Deadline: June 24, 2005.

Application Deadline: July 14, 2005.

I. Funding Opportunity Description

Authority: 42 U.S.C. 247b(k)(2).

Background: Creutzfeldt-Jakob disease (CJD) is an incurable brain disorder that occurs with an incidence of one case per million annually. The majority of patients die within six months of illness onset. The disease causes damage to the brain leaving patients completely dependent on their caregivers for the most basic needs of daily living. In 1996, a variant form of CJD emerged in the United Kingdom, which was causally linked to bovine spongiform encephalopathy (BSE). Over 170 variant CJD cases have been identified worldwide, including one case in the United States.

Purpose: The purpose of this program is to enhance national surveillance for CJD and its emerging variants by (1) facilitating interaction of researchers with family members of CJD patients (2) increasing awareness about CJD and (3) increasing the number of autopsies of suspected CJD cases. This program addresses the “Healthy People 2010” focus area of Infectious Diseases.

Increasing awareness about CJD can be achieved by facilitating dialogue among CJD researchers, family members, and health care professionals. Increasing awareness empowers CJD families to make the appropriate decisions about the care of their loved ones. Learning more about prion diseases through autopsy study of CJD cases would assist in the surveillance of potentially emerging forms of the disease and would facilitate the development of a pre-mortem diagnostic test or treatment for CJD. Increasing autopsy rates is critical because CJD can only be confirmed after an autopsy. Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Infectious Diseases (NCID): Protect Americans from infectious diseases.

This announcement is only for non-research activities supported by CDC/ATSDR. 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/​ads/​opspoll1.htm.

Activities

Awardee activities for this program are as follows:

• Educate family members of CJD patients nationwide by maintaining a toll-free helpline and preparing necessary fact sheets through which family members of CJD patients can obtain guidance and advice from experienced and trained persons about the disease, related infection control issues, the need for autopsy, and necessary care for patients. Assure that personnel managing the helpline have first-hand experience with the disease, its impacts on surviving family members, and sensitivity regarding post-mortem care.
• Sponsor a national conference annually during the project period that would bring together family members and professionals working on CJD. Design the conference to educate families regarding surveillance and treatment of CJD and to facilitate dialogue between researchers working on CJD and family members. These discussions help researchers to gain more knowledge about the social impacts of the disease and exchange ideas on potential areas of research.
• Through the nationwide helpline, fact sheets, national conference, and other educational efforts, increase awareness about the state-of-the art CJD diagnostic services provided free of charge by the National Prion Disease Pathology Surveillance Center, provide guidance on home and post-mortem care for CJD patients, and communicate the importance of the need to conduct autopsy of suspected CJD cases to facilitate surveillance of the disease.

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:

• Monitor the implementation of program activities.
• Provide input in and support the development of education materials as necessary.
• Monitor the provision of guidance and information support by the applicant.
• Participate in the national conference as needed.

II. Award Information

Type of Award: Cooperative Agreement.

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

Fiscal Year Funds: 2005.

Approximate Total Funding: $50,000 (This amount is an estimate, and is subject to availability of funds.)

Approximate Number of Awards: 1.

Approximate Average Award: $50,000 per year (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Floor of Award Range: None.

Ceiling of Award Range: $50,000 (This ceiling is for the first 12-month budget period.)

Anticipated Start Date: August 1, 2005.

Budget Period Length: 12 months.

Project Period Length: 5 years.

Throughout the project period, CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

III. Eligibility Information

III.1. Eligible Applicants

Applications may be submitted by public and private non-profit organizations and by governments and their agencies, such as:

• Public non-profit organizations
• Private non-profit organizations
• Universities
• Colleges
• Research institutions
• Hospitals
• Community-based organizations
• Faith-based organizations
• Federally recognized Indian tribal governments
• Indian tribes
• Indian tribal organizations
• 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)

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 you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Place this documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other

CDC will accept and review applications with budgets greater than the ceiling of the award range.

Special Requirements

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.

• Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
• Applicants must document eligibility by providing proof of 501(c)(3) status or letters of support in an application appendix.
• This program is not designed or intended to support research, therefore no research will be supported under this cooperative agreement. Any applications proposing research will be considered non-responsive.

Note:

Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1. Address To Request Application Package

To apply for this funding opportunity use application form PHS 5161. Application forms and instructions are available on the CDC Web site, at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

To submit your application electronically, please utilize the forms and instructions posted for this announcement at http://www.grants.gov.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.

IV.2. Content and Form of Submission

Letter of Intent (LOI): Your LOI must be written in the following format:

• Maximum number of pages: 1
• Font size: 12-point unreduced
• Single spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Written in plain language, avoid jargon

Your LOI must contain the following information:

• Name of the organization
• Previous experience related to the announcement
• Name and contact information for point of contact

Application: You must submit a project narrative with your application forms. 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
• Single spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Held together only by rubber bands or metal clips; not bound in any other way.

Your narrative should address activities to be conducted over the entire project period, should clearly address the Evaluation Criteria in Section V.1., below, and must include the following items in the order listed: Background and Need, Capacity, Objectives, Operational Plan, Evaluation Plan, Collaborations, Budget and budget justification (budget not included in page limit).

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

• Curriculum Vitaes, Resumes, Organizational Charts, Letters of Support, etc.

You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711.

For more information, see the CDC Web site at: http://www.cdc.gov/​od/​pgo/​funding/​pubcommt.htm. If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter.

Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”

IV.3. Submission Dates and Times

LOI Deadline Date: June 24, 2005.

CDC requests that you submit an LOI if you intend to apply for this program. Although the LOI will not be evaluated, and does not enter into review of your subsequent application, the LOI will be used to gauge the level of interest in this program, and to allow CDC to plan the application review.

Application Deadline Date: July 14, 2005.

Explanation of Deadlines: LOIs and Applications must be received in the CDC Procurement and Grants Office by 4 p.m. eastern time on the deadline date. If you submit your LOI or application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If CDC receives your submission after closing due to: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carriers guarantee. If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline.

This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application form instructions. If your submission does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements.

CDC will not notify you upon receipt of your submission. If you have a question about the receipt of your LOI or application, first contact your courier. If you still have a question, contact the PGO-TIMS staff at: 770-488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for submissions to be processed and logged.

IV.4. Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

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

• Funds may not be used for research.
• Reimbursement of pre-award costs is not allowed.
• Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives.
• Funding provided for conference support may not be used for purchasing meals.

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.

Guidance for completing your 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 your LOI by express mail, delivery service, fax, or E-mail to: Ermias Belay, M.D., Project Officer, Centers for Disease Control and Prevention, National Center for Infectious Diseases, 1600 Clifton Road, NE., Mailstop A-39, Atlanta, GA 30333, Telephone: [phone]; Fax: [phone], E-mail: [e-mail].

Application Submission Address

You may submit your application electronically at: http://www.grants.gov,, OR submit the original and two hard copies of your application by mail or express delivery service to:

Technical Information Management—AA109, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.

V. Application Review Information

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. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

Your application will be evaluated against the following criteria:

Applicant's Operational Plan for This Cooperative Agreement (40 Points)

Is the plan adequate to carry out the proposed objectives? Does the plan thoroughly address all project goals and awardee activities for the entire project period? Is an adequate timeline in place? Does the applicant demonstrate they have working knowledge of or have collaborative experience with the National Prion Disease Pathology Surveillance Center to be able to educate others about the diagnostic services provided by the center? Does the applicant demonstrate ability to organize a successful national conference with a high attendance of family members and CJD researchers?

Applicant Organizational History, Description of Capacity (30 Points)

Does the organization's mission and values emphasize CJD support services for families? Does the applicant demonstrate that the needs of CJD families have been and will remain at the forefront of the organization's priorities? Does the applicant demonstrate a history of implementing programs for CJD families? Does the applicant demonstrate ability to advocate among family members of CJD patients for the need for the more sensitive issue of autopsy and post-mortem care of CJD patients to facilitate surveillance of the disease? Does the applicant provide evidence that suggests they possess the necessary experience, required level of sensitivity, and trust by family members to be able to confidentially advise, educate, and provide support to family members of CJD patients? Does the applicant demonstrate the capacity to create a five-year plan for the services outlined in this program announcement? Does the organization possess the appropriate community relationships needed to effectively render CJD support services?

Methods (15 Points)

Are the proposed methods feasible for dealing with CJD families? Does the methodology include a family centered approach? Are these methods sensitive to the emotional state of CJD families? To what extent will these methods accomplish the program goals?

Applicant's Staffing and Management (10 Points)

Can the organization demonstrate that its front line/help line staff has the appropriate understanding of CJD family needs to speak with families on a regular basis? Do the staff members have previous experience working with CJD families? As described, will the staff have enough experience in communicating with the general public such as family members of CJD patients to be able to accomplish the program goals?

Evaluation Plan and Measures of Effectiveness (5 Points)

Does the applicant provide measures of effectiveness as described in the opening paragraph of this Section V.1., above such that effective “outcome” evaluation can be accomplished? Does the applicant propose a plan to effectively evaluate the following measures?

• Success in creating clear and effective educational materials.
• Success in the organization of a national conference with the participation of CJD researchers and family members.
• The number of family members successfully counseled using the toll-free helpline.

Budget and Justification (Reviewed, but not scored)

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness by NCID. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above. The objective review panel will consist of CDC employees from outside the funding center who will evaluate the technical merit of applications for the purpose of advising the awarding official. As part of the review process, all applications will:

• Undergo review by a primary, secondary and tertiary reviewer using only the Evaluation Criteria included in this Program Announcement, above.
• Receive a vote of approval or disapproval and if approved, a score based on the points for the Evaluation Criteria, above.
• Receive a second programmatic level review by Division senior staff based on rank order of scores.

VI. Award Administration Information

Anticipated Award Date: August 1, 2005.

VI.1. Award Notices

Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer, and mailed to the recipient's fiscal officer identified in the application.

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

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/​nara/​cfr/​cfr-table-search.html.

The following additional requirements apply to this project:

• AR-9 Paperwork Reduction Act Requirements
• AR-10 Smoke-Free Workplace Requirements
• AR-11 Healthy People 2010
• AR-12 Lobbying Restrictions
• AR-15 Proof of Non-Profit Status
• AR-20 Conference Support
• AR-23 States and Faith-Based Organizations
• AR-25 Release and Sharing of Data

Additional information on these requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/​od/​pgo/​funding/​ARs.htm.

VI.3. Reporting Requirements

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

1. Interim progress report, due no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Budget.

e. Measures of Effectiveness.

f. Additional Requested Information.

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

3. Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be mailed to the Grants Management or Contract Specialist listed in the “Agency Contacts” section of this announcement.

VII. Agency Contacts

We encourage inquiries concerning this announcement.

For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: [phone].

For program technical assistance, contact: Ermias Belay, M.D., Project Officer, Centers for Disease Control and Prevention, National Center for Infectious Diseases, 1600 Clifton Road, NE., Mailstop A-39, Atlanta, GA 30333, Telephone: [phone]; Fax: [phone], E-mail: [e-mail].

For financial, grants management, or budget assistance, contact: Sharron P. Orum, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: [phone], E-mail: [e-mail].

VIII. Other Information

This and other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

Dated: May 27, 2005

William P. Nichols,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.