70 FR 105 pgs. 32620-32624 - Sentinel Network for Detecting Emerging Infections Among Allograft Donors and Recipients
Type: NOTICEVolume: 70Number: 105Pages: 32620 - 32624
FR document: [FR Doc. 05-11044 Filed 6-2-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Sentinel Network for Detecting Emerging Infections Among Allograft Donors and Recipients
Announcement Type: New.
Funding Opportunity Number: AA081.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Letter of Intent Deadline: July 5, 2005.
Application Deadline: August 2, 2005.
Executive Summary: Over the last decade, there has been a large increase in the number of allografts ( e.g. , solid organs and other tissues) recovered from donors for use in transplants. Each year in the United States, over 25,000 solid organs are recovered, and over a million tissue allografts are distributed for life-saving transplantations, including bone, musculoskeletal, vascular, and corneal tissues. Organs and tissues are distributed to different settings: Organs are distributed to transplant services in hospitals, and tissues are distributed to tissue banks, biotechnology companies, and healthcare consignees, including hospitals, outpatient centers, and individual surgeons. A single donor with undetected infection potentially can infect over a hundred organ and tissue recipients located around the world. In addition, tissues may be stored for up to ten years; thus, infections may be transmitted to recipients many years after the death of the donor. Recent investigations have demonstrated severe infections and death from transmission of various agents from donors to recipients, including: Clostridia spp. (e.g., C. sordellii, C. perfringens, C. septicum), West Nile virus, Group A Streptococcus, Trypanosoma cruzi, Lymphocytic choriomeningitis virus, rabies virus, and others. A recent Institute of Medicine report highlighted the urgent need to detect infectious diseases among organ and tissue donor and transplant recipients. Recently, additional regulatory mechanisms have been put in place. For solid organs, through the Organ Procurement and Transplantation Network (OPTN), new standards have been put in place to detect and report adverse events among organ transplant recipients; for other tissues, there will be new FDA rules for organ and tissue procurement organizations (OPOs) and tissue banks, implemented May 1, 2005. Despite these new regulatory standards, challenges remain. A surveillance network for surveillance of allograft-associated infections that would enhance communication between public health officials and organizations responsible for recovering and processing tissues would have high potential as a tool for risk assessment and response, in collaboration with regulatory efforts.
I. Funding Opportunity Description
Authority:
42 U.S.C. 247b(k)(2)
Purpose: The purpose of the program is to develop a national sentinel network of organizations that recover, process, and distribute tissues from organ/tissue donors. The participants in this activity can include OPOs, tissue processors, tissue distributors, and others. This collection of participants has been termed the tissue community. At present, many procurement organizations provide regional tissue recovery services. This program addresses the "Healthy People 2010" focus area(s) of Immunization and Infectious Diseases.
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 death and serious harm caused by medical errors and preventable complications of healthcare.
This announcement is only for non-research activities supported by CDC/ATSDR. If research is proposed, that portion of any application will not be reviewed or considered for funding. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/ads/opspoll1.htm.
Objectives
The objective of the network will be to detect and prevent emerging infectious diseases through:
• Improved communication among those in the tissue community (e.g., tissue recovery organizations, OPOs that recover tissues, tissue processors, tissue distributors), healthcare facilities, and public health officials, concerning potential risks for transmission of infection.
• Improved identification and tracking of tissues to facilitate interventions following recognition of infections among recipients.
• Improved pathologic and microbiologic capabilities on cadaveric donor specimen samples through shared resources and collaborations to identify improvements in donor screening, donor eligibility laboratory testing, critical control points for improved tissue safety, and detection of novel pathogens.
• Development of recommendations to improve the safety of organ and tissue transplantation. Any recommendations regarding activities of OPOs or tissue establishments will be congruent with regulatory requirements and other oversight.
The data from this project will be directly applicable to improvements in blood safety and patient safety.
Activities
Awardee activities for this program are as follows:
A. Develop and maintain a national sentinel network of organizations that recover, process, and distribute tissues from organ/tissue donors and other members of the tissue community. Specifically, conduct the following activities:
1. Develop an electronic communication forum accessible only to network members:
? To discuss possible infectious complications in transplant recipients potentially originating from organ/tissue donors or associated with tissue processing or handling.
? To be rapidly informed of important public health and infectious disease issues.
? To improve communication between participating members of the tissue community and public health officials, transplant clinicians, surgeons, and blood banks.
? To facilitate recognition of donor infection through sharing of knowledge on optimal screening and diagnostic methods.
2. Develop and implement a mechanism for assigning tissue donors with a unique donor identifier to improve tissue tracking. Currently, different donor identifiers are assigned by various tissue recovery, processing, and distribution entities. Developing a common, unique donor identifier will allow members of the tissue community to link their various donor identifiers to a common identifier. This activity will require development of a mechanism for users to acquire and maintain these identifiers and for allowing access to them when needed for tracking tissues from an infected donor. For those donors that are a source of both organs and tissues, this activity also will require collaboration with the United Network for Organ Sharing (UNOS) and affiliated partners to utilize or link to existing UNOS unique donor identifiers.
3. Develop collaborations among members in the tissue community for testing of existing cadaveric donor samples, including serum or plasma samples and tissue, allowing:
? A method for linkage to allow for subsequent investigation without the use of personal identifiers.
? A mechanism to share use of diagnostic methods for unusual or emerging pathogens.
? A mechanism to discuss donor clinical history and interpretation of testing results to facilitate further investigation.
Note that this cooperative agreement is not intended to fund establishment of a tissue bank, collection of specimens, or research on specimens. Therefore, applicants should not include these activities in the application. Although the network may provide the infrastructure for research at a later date, the intent of this cooperative agreement is solely to support network participant activities within the scope of this announcement and to foster collaborations within the organ and tissue community.
B. Develop a series of recommendations, based on network experiences and collaborative investigations with public health, to improve the safety of organ and tissue transplantation and identify emerging infectious diseases in organ and tissue transplant recipients. These recommendations will be made in concert with existing regulatory oversight agencies.
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:
? Assist recipient as needed on network design:
? Provide technical assistance on development of a secure network platform for communication between members of the tissue community using experiences from implementing other CDC-sponsored networks.
? Assist recipient as needed to ensure that appropriate public health agencies are represented and participating in the network.
? Assist recipient and healthcare partners as needed in defining adverse events for monitoring and appropriate interventions for suspectedallograft-associated infections.
? Provide scientific and technical assistance:
? Participate as needed with recipient and representatives from the tissue community in development of mechanisms for assigning, registering, maintaining, and controlling access to donor identifiers in collaboration with other federal agencies.
? Serve as subject matter resource on laboratory detection of pathogens causing allograft-associated infections.
? Provide technical assistance to ensure that design of algorithms for diagnostic testing will fulfill the objectives of the network.
? Participate as needed with other federal and state public health agencies to provide scientific resources and policy guidance.
• Evaluate performance of the network:
? Monitor progress to determine if network objectives are being met.
? Assist recipient as needed in modification of network activities to address problems that are encountered.
• Assist recipient as needed in communication of network findings:
? Facilitate presentations at national meetings.
? Facilitate reports to peer-reviewed journals.
? Facilitate development of new policies for improved allograft tissue safety.
• Facilitate communication of data and results among stakeholders.
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 Current Fiscal Year Funding: $250,000 (This amount is an estimate, and is subject to availability of funds. This amount includes both direct and indirect costs.)
Approximate Number of Awards: One.
Approximate Average Award: $250,000.
This amount is for the first 12-month budget period, and includes both direct and indirect costs. This amount assumes all activities ( i.e. , A.1., A.2., and A.3., above) are funded. See Note in budget instructions under Section IV.2. "Application" below.
Floor of Award Range: None.
Ceiling of Award Range: None.
Anticipated Award Date: August 1, 2005.
Budget Period Length: 12 months.
Project Period Length: Three 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 nonprofit organizations and by governments and their agencies, such as:
• Public nonprofit organizations
• Private nonprofit 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 Mariana 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
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.
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: Five.
• Font size: 12-point unreduced.
• Double 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:
• Descriptive title of the proposed project.
• Name, address, E-mail address, telephone number, and FAX number of the Project Director.
• Description of experience in the scientific, administrative, and policy aspects of organ and tissue procurement or distribution.
• Involvement with establishing standards for the above activities.
• Number and title of this Announcement.
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.
• Double 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, and must include the following items in the order listed:
• Background and Need
• Understanding
• Capacity
• Operational Plan
• Objectives
• Timeline
• Staff
• Performance Measures
• Budget and Justification (will not count toward the page limit).
Note:
Provide three separate budgets-one each for Activities A.1., A.2., and A.3. Activity B should be factored into each budget. Depending on funding availability, CDC will fund A.1., A.2., and A.3., in priority order.
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
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 http://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: July 5, 2005.
CDC requests that you submit a LOI if you intend to apply for this program. Although the LOI is not required, not binding, 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: August 2, 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 carrier's 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 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.
If you submit your application electronically, you will receive an e-mail notice of receipt.
Otherwise, 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-TIM 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
Your 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. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state's process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.
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.
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: Machel Forney, Public Health Analyst, Division of Health Quality Promotion, Centers for Disease Control and Prevention, 1600 Clifton Road, N.E., Mailstop A-07, Atlanta, GA 30329, telephone: (404) 498-1174, Fax: (404) 498-1188; E-mail: MForney@cdc.gov.
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-CI05-078, 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:
1. Background/Need (40 Points)
Does the applicant demonstrate a strong understanding of the need to develop a sentinel network of organizations that recover tissues for transplantation? Does the applicant illustrate the need for this project? Does the applicant present a clear goal for this project?
2. Capacity (30 Points)
Does the applicant demonstrate that it has the expertise, facilities, and other resources necessary to accomplish the program requirements? Does the applicant have experience and success in management of organ/tissue recovery? Has the applicant demonstrated past collaborations with organ/tissue procurement organizations? Has the applicant demonstrated past collaborations with local, State, and Federal public health officials? Does the applicant have an efficient administrative infrastructure to support the requirements of the cooperative agreement?
3. Operational Plan (20 Points)
Does the applicant present clear, time-phased objectives that are consistent with the stated program goal and a detailed operational plan outlining specific activities that are likely to achieve the objective? Does the plan clearly outline the responsibilities of each of the key personnel?
4. Measures of Effectiveness (10 Points)
Does the applicant provide Measures of Effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement? Are the measures objective/quantitative and do they adequately measure the intended outcome?
5. Budget (Not Scored)
Does the applicant present a detailed budget with a line-item justification and any other information to demonstrate that the request for assistance is consistent with the purpose and objectives of this grant program?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness by the Center for Infectious Diseases. 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 division 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:
• Receive a written Summary Statement of the findings of the Objective Review Panel.
• Receive a vote of approval or disapproval and an approval score.
• Receive a second programmatic level review by Division senior staff based on rank order.
Award Criteria: Criteria that will be used to make award decisions during the programmatic review include:
• Technical Merit (as determined by the objective review)
• Availability of funds
• Applicants must possess significant experience in the scientific, administrative, and policy aspects of organ and tissue procurement. Funding preference will be given to: organ/tissue procurement organizations; Associations or professional societies that represent organ/tissue procurement organizations; and organizations involved with establishing standards for the above activities.
CDC will provide justification for any decision to fund out of rank order.
V.3. Anticipated Announcement and Award Dates
August 1, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and 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
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-9Paperwork Reduction Act Requirements
• AR-10Smoke-Free Workplace Requirements
• AR-11Healthy People 2010
• AR-12Lobbying Restrictions
• AR-15Proof of Non-Profit Status
• AR-21Small, Minority, and Women-Owned Business
• AR-23States and Faith-Based Organizations
• AR-24Health Insurance Portability and Accountability Act Requirements
• AR-25Release 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 no more than 90 days after the end of the 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: 770-488-2700.
For program technical assistance, contact: Dan Jernigan, M.D., Division of Healthcare Quality Promotion, National Center for Infectious Diseases,Centers for Disease Control and Prevention,1600 Clifton Road, N.E., Mailstop A-35,Atlanta, GA 30333,Telephone: 404-639-2621; E-mail: DJernigan@cdc.gov.
For financial, grants management, or budget assistance, contact: Mattie B. Jackson, Grants Management Specialist, CDC Procurement and Grants Office,2920 Brandywine Road, MS K14,Atlanta, GA 30341,Telephone: 770-488-2696; E-mail: mij3@cdc.gov.
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.
[FR Doc. 05-11044 Filed 6-2-05; 8:45 am]
BILLING CODE 4163-18-P