[Federal Register: June 3, 2005 (Volume 70, Number 106)]
[Notices]
[Page 32620-32624]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn05-85]
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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: 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
[[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: 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
[[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: 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.
[[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: 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-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: 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