Creutzfeldt-Jakob Disease-Nationwide Education and Communication, 34483-34487 [05-11693]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 113 (Tuesday, June 14, 2005)]
[Notices]
[Pages 34483-34487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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.

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    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: https://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: https://www.cdc.gov/od/pgo/
forminfo.htm.
    To submit your application electronically, please utilize the forms 
and instructions posted for this announcement at https://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.

[[Page 34485]]

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: https://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: https://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: 404-639-4655; Fax: 404-639-3838, E-mail: 
EBelay@cdc.gov.
Application Submission Address
    You may submit your application electronically at: https://
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

[[Page 34486]]

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: https://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: https://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.

[[Page 34487]]

    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: 770-488-2700.
    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: 404-639-4655; Fax: 404-639-3838, E-mail: 
EBelay@cdc.gov.
    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: 770-
488-2716, E-mail: SOrum@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address: https://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.
[FR Doc. 05-11693 Filed 6-13-05; 8:45 am]
BILLING CODE 4163-18-P