[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Notices]
[Pages 22952-22955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10829]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 733]
Year-Long Estimation of the Frequency of Bacterial Contamination
of Blood Products in the United States
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of funds in fiscal year (FY) 1997 for a cooperative
agreement program to conduct a year-long study to estimate the
frequency of bacterial contamination of blood and blood products in the
United States (U.S.).
CDC is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2000, a national activity to
reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority areas of Immunization and
Infectious Diseases and HIV Infection. (For ordering a copy of Healthy
People 2000, see the section Where to Obtain Additional Information.)
In addition, the Public Health Service (PHS) in Addressing Emerging
Infectious Disease Threats: A Prevention Strategy for the United
States, emphasizes the need for identification and prevention of new
and emerging infections. Some of these newly identified infections have
been associated with the transfusion of blood and blood products. This
announcement is related to the national identification of bacterially
contaminated blood products in the U.S. blood supply and to ensuring
the safety of the U.S. blood supply.
Authority
This program is authorized by Section 301(a) of the Public Health
Service Act, as amended [42 U.S.C. 241(a)]. Applicable program
regulations are found in 42 CFR Part 52, Grants for Research Projects.
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which education,
library, day care, health care, and early childhood development
services are provided to children.
Eligible Applicants
Assistance will be provided only to national nonprofit
organizations that coordinate multiple blood collection sites for the
purpose of collecting and distributing blood and blood products
nationwide. Status as a national organization will be determined if the
organization coordinates blood collection sites in a majority of the
States in the U.S. The applicant must indicate the number of States in
which they coordinate blood collection sites. For nonprofit
organizations, 501(c)(3) status is required. For-profit organizations
are not eligible for this program.
Only national nonprofit organizations that coordinate the
collection and distribution blood and blood products nationwide will be
considered eligible applicants because of the need to generalize data
to the entire nation and to ensure that no duplication of data occur.
Only these organizations have the capability to initiate a nationwide
study to develop standardized definitions of adverse transfusion
reactions, to increase clinical nursing and medical staff awareness of
these reactions and of bacterial contamination as a mechanism for these
reactions, and to prospectively determine the rates of bacterial
contamination of blood products (RBC, whole blood, and platelets) in
the U.S.
Note: Effective January 1, 1996, Public Law 104-65 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code of 1986 which engages in Lobbying activities shall not
be eligible for the receipt of Federal funds constituting an award,
grant (cooperative agreement), contract, loan, or any other form.
Availability of Funds
Approximately $150,000 will be available in FY 1997 to fund
approximately two to three awards. It is expected that awards will
range from $40,000 to $75,000 with an average award of $50,000. It is
expected that awards will begin on or about August 1, 1997, and will be
made for a 12-month budget period within a one year project period.
Funding estimates may vary and are subject to change. No specific
matching funds are required.
Use of Funds
Cooperative agreement funds shall not be used for the collection or
delivery of blood or blood products. They will be used for developing:
(1) educational materials, and (2) data collection materials and
systems.
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352 (which has been in effect since
December 23, 1989), recipients (and their subtier contractors) are
prohibited from using appropriated Federal funds (other than profits
from a Federal contract) for lobbying Congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that,
in whole or in part, involve conferences for which Federal funds cannot
be used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.
In addition, the FY 1997 HHS Appropriations Act, which became
effective October 1, 1996, expressly prohibits the use of 1997
appropriated funds for indirect or ``grass roots'' lobbying efforts
that are designed to support or defeat legislation pending before State
legislatures. This new law, Section 503 of Pub. L. No. 104-208,
provides as follows:
Sec. 503(a) No part of any appropriation contained in this Act
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for
the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to
support or defeat legislation pending before the Congress, * * *
except in presentation to the Congress or any State legislative body
itself.
(b) No part of any appropriation contained in this Act shall be
used to pay the salary or expenses of any grant or contract
recipient, or agent acting for such recipient, related to any
activity designed to influence legislation or appropriations pending
before the Congress or any State legislature.
Department of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus
Consolidated Appropriations Act, 1997, Division A, Title I, Section
101(e), Pub. L. No. 104-208 (September 30, 1996).
Background
Each year over 20 million units of blood products are transfused in
the United States. Although safety has improved through improved donor
screening and testing by the blood product industry in response to the
human immunodeficiency virus (HIV)
[[Page 22953]]
epidemic, residual risk remains for the transmission of HIV and other
emerging infectious pathogens. Some of these transfusion-associated
pathogens and affected blood products include the transmission of
Trypanosoma cruzi, the cause of Chagas' disease, by red blood cell
(RBC) transfusion and hepatitis C virus by intravenous immunoglobulin
product. Other emerging infectious pathogens, i.e., bacteria, also have
been associated with transfusions and adverse reactions.
Approximately one death per million units transfused occurs due to
transfusion-associated sepsis, a newly recognized and emerging problem
(CDC, unpublished data). From 1986 through 1991, 16 percent (29/182) of
transfusion-associated fatalities reported to the FDA were associated
with bacterial contamination of blood products, including red blood
cells (RBCs), whole blood, and platelets. Reports of sepsis and death
after transfusion of blood products, platelets, and RBCs contaminated
by bacteria have been increasing over the past decade. Since 1987, CDC
has received anecdotal reports, from community sources and
conversations with transfusion service personnel and clinical nursing
and medical staff, regarding the bacterial contamination of blood
products. These reports include 20 episodes of Yersinia enterocolitica-
contaminated red blood cells (RBCs), including 12 deaths.
The Code of Federal Regulations (Title 21, Section 606.170[b])
requires only that fatal complications of blood collection or
transfusion be reported to the Food and Drug Administration (FDA);
thus, when non-fatal events are considered, the true incidence of
infectious complications associated with the receipt of blood and blood
products may be substantially underestimated. Lack of knowledge
concerning the mechanisms of adverse transfusion reactions and
transfusion-associated bacterial infection may be another reason for
under-reporting. If blood products are not cultured after an adverse
reaction, bacterial contamination of the product as a cause of the
reaction cannot be definitely established. After a cluster of bacterial
contamination of platelets occurred at one university hospital, medical
staff were educated about adverse transfusion reactions and active
surveillance for bacterial contamination of platelets was initiated;
subsequently the number of platelet transfusion reactions reported
monthly and the reported rate of bacterial contamination of platelets
increased 31 (2.3/1000 to 72.4/1000 platelet pools) and 23 (0.3% to
7.7%) fold, respectively, in the following 22 month period.
A recent study from Germany estimated RBC bacterial contamination
at approximately 0.5 percent and random donor platelet contamination at
approximately 2.5 percent. Since the rates of bacterial contamination
of different blood products in the U.S. is unknown, how the German
rates compare with the bacterial contamination rates of blood products
in the U.S. is unclear.
The existence of a significant number of transfusion-associated
bacterial infectious events reported to CDC, the lack of known
incidence of bacterial contamination of blood products in the U.S., and
likely current underestimation of morbidity and mortality from these
events, demonstrate the need to determine the incidence of transfusion-
associated bacterial contamination of blood and blood products in the
U.S. Therefore, this cooperative agreement is being established to
initiate a study to develop standardized definitions of adverse
transfusion reactions, to increase clinical nursing and medical staff
awareness of these reactions and of bacterial contamination as a
mechanism for these reactions, and to prospectively determine the rates
of bacterial contamination of blood products (RBC, whole blood, and
platelets) in the U.S. These results will aid in the study of the
etiologic agents, risk factors, and outcomes associated with
transfusion-associated bacterial contamination.
Purpose
The purpose of this cooperative agreement is to develop a pilot
study with the national non-profit organizations that coordinate
multiple blood collection sites to: (1) Determine the bacterial
contamination rate of blood products; (2) identify donor risk factors
for bacterial contamination of these blood products; and (3) determine
the impact of transfusion of these bacterially contaminated blood
products on the recipients.
The objectives of the cooperative agreement are:
1. To determine the rates of bacterial contamination of blood
products, i.e., RBCs, pooled and apheresis platelets, and whole blood.
2. To describe risk factors of donors of bacterially contaminated
blood products, i.e., prior or past medical history and prior exposures
significantly associated with bacteremia at time of donation.
3. To determine health outcomes in recipients receiving bacterially
contaminated blood products.
4. To describe underlying medical conditions of recipients that are
significantly associated with death following receipt of bacterially
contaminated blood products.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipients will be responsible for the activities under A., below,
and CDC will be responsible for conducting activities under B., below:
A. Recipient Activities
1. Coordinate the collection of denominator data to include the
number and types of blood products collected by the transfusion
services, the number and types of blood products distributed by
transfusion services, the number and types of blood products
subsequently transfused.
2. Develop standardized definitions to include a microbiologic
description of bacterially contaminated blood products and the clinical
indicators to differentiate significant and insignificant transfusion
reactions.
3. Collect numerator data to determine the bacterial contamination
rate of blood products, to identify donor risk factors for bacterial
contamination of these products; and, to determine the impact of
transfusion of these bacterially contaminated blood products on the
recipients.
4. Develop educational materials to increase clinical nursing and
medical staff awareness of transfusion reactions.
5. Publish the study outcomes.
B. CDC Activities
1. Assist in the conduct of the study, including:
a. Collaboration in the development of study design.
b. Support recipients as a reference laboratory in confirmation of
contaminating organisms, endotoxin and antibody testing.
2. Assist in the development of data management systems.
3. Collaborate in the coordination of data analysis, dissemination,
and presentation of aggregated data from all recipients.
4. Collaborate in the publication of the study outcomes.
Technical Reporting Requirements
A narrative progress report is required semiannually. An original
and two copies of all progress reports are due within 30 days after
each semiannual reporting period. Progress reports should address the
status of projects and progress toward project objectives and the goals
of this cooperative agreement
[[Page 22954]]
as represented in the Purpose and Recipient Activities sections of this
announcement.
An original and two copies of the financial status report (FSR) are
required no later than 90 days after the end of the budget period. A
final FSR is due no later than 90 days after the end of the project
period. All reports are submitted to the Grants Management Branch,
Procurement and Grants Office, CDC. Please address all reports or other
correspondence to: Sharron P. Orum, Grants Management Officer, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop
E-18, Room 300, Atlanta, Georgia 30305.
Application Content
Format
Pages must be clearly numbered, and a complete index to the
application and its appendices must be included. Please begin each
separate section on a new page. The original and each copy of the
application set must be submitted unstapled and unbound. All material
must be typewritten, single-spaced, with unreduced type on 8\1/2\'' by
11'' paper, with at least 1'' margins, headings and footers, and
printed on one side only.
Application Narrative
All applicants must develop their applications in accordance with
the PHS Form 5161-1 (revised 7/92, OMB Number 0937-0189), information
contained in this announcement, and the instructions outlined below.
Also, the narrative must be limited to 10 pages excluding appendices
and should include the following:
1. The background and feasibility, need for funding, and
willingness to collaborate with CDC in the conduct of the study.
2. The objectives of the proposed study which are consistent with
the purposes of the cooperative agreement and are measurable and time-
phased. The applicant should establish a specific and realistic plan of
operation and timetable for all activities including development of
methodology, development and dissemination of educational material,
development and implementation of data collection instruments,
collection of potentially contaminated blood products, laboratory
identification of bacterial contamination of blood products, and data
analysis.
3. The methods which will be used to accomplish the objectives of
the study. Describe activities and methods already in place or planned,
including capacity and experience to coordinate study efforts; assess
quality of the project coordinators, facilities, and supporting
resources; plan, coordinate, and maintain data collection and analysis;
and disseminate information.
4. A budget which is reasonable and consistent with the purpose and
objectives of the cooperative agreement funds. Please use standard form
424A, ``Budget Information'', provided with the PHS 5161-1 application.
All budget categories should be itemized and individually justified.
5. A description of the project's principal investigator's role and
responsibilities.
6. Documentation of eligibility status including: the number of
States in which blood collection sites are coordinated; and, 501(c)(3)
documentation of nonprofit status.
7. Establish a specific and realistic plan of operation and
timetable for all activities.
8. Any other information that will support the request for
technical and funding assistance.
9. Human Subjects: Whether or not exempt from the Department of
Health and Human Services (DHHS) regulations, if the proposed project
involves human subjects, describe adequate procedures for the
protection of human subjects. Also, ensure that women, racial and
ethnic minority populations are appropriately represented in
applications for research involving human subjects.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria: (Total 100 points)
1. The applicant's understanding of the purpose and objectives of
the cooperative agreement and willingness to cooperate with CDC in the
design, implementation, and analysis of the project. (20 Points)
2. The quality of the plans to coordinate and conduct the project
with multiple blood collection sites, including a description of
techniques for educational material, data collection, and data
management. (20 Points)
3. The quality and feasibility of methods to accomplish objectives
and required activities, including the provision of numerator and
denominator data for the generalization of results nationally. The
degree to which the applicant has met CDC requirements regarding the
inclusion of women, ethnic, and racial groups in the proposed research.
This includes: (a) The proposed plan for inclusion of both sexes and
racial and ethnic minority populations for appropriate representation.
(b) The proposed justification when representation is limited or
absent. (c) A statement as to whether the design of the study is
adequate to measure differences when warranted. (d) A statement as to
whether the plans for recruitment and outreach for study participants
include the process of establishing partnerships with community(ies)
and recognition of mutual benefits will be documented. (30 Points)
4. How the study will be administered, including duties and
responsibilities and time allocation of the proposed staff; and a
schedule for accomplishing the program activities, including time
frames. (15 Points)
5. A statement of the applicant's demonstrated capabilities and
experience in conducting such a project. (15 Points)
6. The extent to which the budget is reasonable, clearly
justifiable, and consistent with the intended use of cooperative
agreement funds. (Not scored)
7. Human Subjects (not scored): If the proposed project involves
human subjects, whether or not exempt from the DHHS regulations, the
extent to which adequate procedures are described for the protection of
human subjects. Recommendations on the adequacy of protections include:
(a) Protections appear adequate and there are no comments to make or
concerns to raise, (b) protections appear adequate, but there are
comments regarding the protocol, (c) protections appear inadequate and
the ORG has concerns related to human subjects, (d) disapproval of the
application is recommended because the research risks are sufficiently
serious and protection against the risks are inadequate as to make the
entire application unacceptable, or (e) protections appear adequate
that women, racial and ethnic minority populations are appropriately
represented in applications involving human research.
Executive Order 12372 Review
This program is not subject to review by Executive Order 12372.
Public Health Systems Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.283,
Centers for
[[Page 22955]]
Disease Control and Prevention (CDC)--Investigations and Technical
Assistance.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by cooperative agreements will be subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act.
Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human Services
Regulations (45 CFR Part 46) regarding the protection of human
subjects. Assurance must be provided to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. The applicant will be responsible for
providing evidence of this assurance in accordance with the appropriate
guidelines and form provided in the application kit.
Women, Racial and Ethnic Minorities
It is the policy of the Centers for Disease Control and Prevention
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)
to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian, Alaskan Native, Asian, Pacific Islander, Black and
Hispanic. Applicants shall ensure that women, racial and ethnic
minority populations are appropriately represented in applications for
research involving human subjects. Where clear and compelling rationale
exist that inclusion is inappropriate or not feasible, this situation
must be explained as part of the application. This policy does not
apply to research studies when the investigator cannot control the
race, ethnicity and/or sex of subjects. Further guidance to this policy
is contained in the Federal Register, Vol. 60, No. 179, pages 47947-
47951, dated Friday, September 15, 1995.
Application Submission and Deadline
The original and two copies of the completed application PHS Form
5161-1 (revised 7/92, OMB Number 0937-0189) must be submitted to
Sharron P. Orum, Grants Management Officer, Grants Management Branch,
Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-18, Room
300, Atlanta, Georgia 30305, on or before May 30, 1997.
1. Deadline
Applications shall be considered as meeting the deadline if they
are either:
a. Received on or before the deadline date, or
b. Sent on or before the deadline date and received in time for
submission to the objective review group. (Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or U.S. Postal Service. Private
metered postmarks will not be acceptable as proof of timely mailings.)
2. Late Applications
Applications which do not meet the criteria in either 1.a. or 1.b.
above are considered late applications. Late applications will not be
considered and will be returned to the applicant.
Where To Obtain Additional Information
A complete program description, information on application
procedures, an application package, and business management technical
assistance may be obtained from Locke Thompson, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Mailstop E-18, Room 300, Atlanta, GA 30305, telephone (404)
842-6595 or through the Internet or CDC WONDER electronic mail at:
lxt1@cdc.gov. Programmatic technical assistance may be obtained from
Matthew J. Kuehnert, M.D. or Marsha A. Jones, Hospital Infections
Program, National Center for Infectious Diseases, Centers for Disease
Control and Prevention (CDC), Mailstop E-69, Atlanta, GA 30333,
telephone (404) 639-6413 or through the Internet or CDC WONDER
electronic mail at: mgk8@cdc.gov.
You may obtain this announcement from one of two Internet sites:
CDC's homepage at: http://www.cdc.gov or the Government Printing Office
homepage (including free on-line access to the Federal Register) at:
http://www.access.gpo.gov.
Please refer to Announcement Number 733 when requesting information
and submitting an application.
Potential applicants may obtain a copy of Healthy People 2000 (Full
Report; Stock No. 017-001-00474-0) or Healthy People 2000 (Summary
Report, Stock No. 017-001-00473-1) referenced in the Introduction
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone (202) 512-1800.
Dated: April 22, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-10829 Filed 4-25-97; 8:45 am]
BILLING CODE 4163-18-P
