[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: 
[email protected]. 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: [email protected].
    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