Sentinel Network for Detecting Emerging Infections Among Allograft Donors and Recipients, 32620-32624 [05-11044]

Agencies

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

[Federal Register Volume 70, Number 106 (Friday, June 3, 2005)]
[Notices]
[Pages 32620-32624]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11044]


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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: https://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

[[Page 32621]]

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:
    [cir] To discuss possible infectious complications in transplant 
recipients potentially originating from organ/tissue donors or 
associated with tissue processing or handling.
    [cir] To be rapidly informed of important public health and 
infectious disease issues.
    [cir] To improve communication between participating members of the 
tissue community and public health officials, transplant clinicians, 
surgeons, and blood banks.
    [cir] 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:
    [cir] A method for linkage to allow for subsequent investigation 
without the use of personal identifiers.

    [cir] A mechanism to share use of diagnostic methods for unusual or 
emerging pathogens.
    [cir] 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:
    [cir] Assist recipient as needed on network design:
    [cir] 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.
    [cir] Assist recipient as needed to ensure that appropriate public 
health agencies are represented and participating in the network.
    [cir] Assist recipient and healthcare partners as needed in 
defining adverse events for monitoring and appropriate interventions 
for suspectedallograft-associated infections.
    [cir] Provide scientific and technical assistance:
    [cir] 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.
    [cir] Serve as subject matter resource on laboratory detection of 
pathogens causing allograft-associated infections.
    [cir] Provide technical assistance to ensure that design of 
algorithms for diagnostic testing will fulfill the objectives of the 
network.
    [cir] Participate as needed with other federal and state public 
health agencies to provide scientific resources and policy guidance.
     Evaluate performance of the network:
    [cir] Monitor progress to determine if network objectives are being 
met.
    [cir] Assist recipient as needed in modification of network 
activities to address problems that are encountered.
     Assist recipient as needed in communication of network 
findings:
    [cir] Facilitate presentations at national meetings.
    [cir] Facilitate reports to peer-reviewed journals.
    [cir] 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

[[Page 32622]]

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: 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.

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  https://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: 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

[[Page 32623]]

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: https://
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: 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: 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: 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--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.

[[Page 32624]]

     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: 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-21 Small, Minority, and Women-Owned Business
     AR-23 States and Faith-Based Organizations
     AR-24 Health Insurance Portability and Accountability Act 
Requirements
     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 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: 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. 05-11044 Filed 6-2-05; 8:45 am]
BILLING CODE 4163-18-P