[Federal Register Volume 67, Number 121 (Monday, June 24, 2002)]
[Notices]
[Pages 42564-42567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15826]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02168]


Clinical Immunization Safety Assessment Centers (CISA); Notice of 
Availability of Funds for Fiscal Year 2002

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
program for Clinical Immunization Safety Assessment Centers (CISA). The 
term ``Immunization Safety'' encompasses safety aspects of the vaccine 
administration process as well as the vaccine itself. This program 
addresses the ``Healthy People 2010'' focus areas of Immunization and 
Infectious Diseases, Medical Product Safety, Public Health 
Infrastructure, Maternal, Infant and Child Health, Health Communication 
and Access to Quality Health Services.
    The purpose of the program is to expand the national network of 
CISA Centers (hereforth called Centers) to improve the scientific 
understanding of immunization safety issues at the individual patient 
level. Clinically significant adverse events occur rarely. They are 
infrequently seen in clinical trials and individual clinicians see them 
too infrequently to be able to manage them in a standardized fashion. 
In collaboration with CDC, the Centers will fill this gap by creating a 
new medical specialty of immunization safety. The Centers will develop 
and disseminate standardized evaluation protocols to clinicians; they 
will provide referral and consultation services to health care 
providers on how to evaluate patients who may have had an adverse 
reaction to vaccination, which will include how to manage the adverse 
reaction, as well as advise on continued immunization; and they will 
undertake outreach and educational interventions in the area of 
immunization safety. The first goal is to enhance our understanding of 
known serious or unusual vaccine reactions, including the 
pathophysiology and risk factors (including genetics) for such 
reactions. The second goal is to evaluate and gain an understanding of 
newly hypothesized syndromes or events identified from the routine and 
enhanced assessment of Vaccine Adverse Event Reporting System (VAERS) 
case reports, in order to clarify any potential relationship with 
immunization.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Immunization Program: To 
improve vaccine safety surveillance.

B. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301, 317(k)(1) and 
2102(a) of the Public Health Service Act, (42 U.S.C. sections 241, 
247b(k)(1), and 300aa-2(a)), as amended. The Catalog of

[[Page 42565]]

Federal Domestic Assistance number is 93.185.

C. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations, and by governments and their agencies; that is, 
universities, colleges, technical schools, research institutions, 
hospitals, other public and private nonprofit organizations, community-
based organizations, faith-based organizations, State and local 
governments or their bona fide agents, including 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, federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations. Preference 
will be given to applicants' proposals that would service a geographic 
region not currently covered by an existing CISA center.

    Note: Title 2 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.

D. Availability of Funds

    Approximately $1 million is available in FY 2002 to fund at least 
two awards. It is expected that the average award will be $500,000. It 
is expected that the awards will begin on or before September 30, 2002, 
and will be made for a 12-month budget period within a project period 
of up to four years. Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Use of Funds

    Funds cannot be used for construction or renovation, to purchase or 
lease vehicles or vans, to purchase a facility to house project staff 
or carry out project activities, or to supplant existing support.
    Matching funds are not required for this program.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. Recipient 
Activities, CDC will be responsible for the activities listed under 2. 
CDC Activities, and the Recipient and CDC will both be responsible for 
activities listed under 3. Coordinating activities.

1. Recipient Activities

    The following section describes the expected activities of each 
Center and it's functioning within the CISA network. The recipient 
shall perform all services necessary to establish and operate a Center 
for Clinical Immunization Safety Assessment in accordance with the 
requirements described:
    a. Perform or coordinate the standardized intensive clinical and 
laboratory assessments of patients who may have had a known serious or 
unusual vaccine reaction (e.g. anaphylaxis, idiopathic thrombocytopenia 
purpura (ITP), swollen leg after DtaP vaccine), to improve the 
understanding of the pathophysiology and risk factors (including 
genetics) for the reaction.
    b. Develop the necessary clinical evaluation protocols and conduct 
or coordinate the standardized clinical evaluation and any other 
follow-up studies of appropriate patients (and controls) for newly 
hypothesized syndromes. The syndromes are identified from the routine 
and enhanced assessment of case reports from the VAERS, to clarify the 
potential relationship with immunizations.
    c. For patients who have had an adverse reaction that may not 
contraindicate further vaccination, but where there is concern, 
establish the protocols and the capacity to immunize under medical 
supervision. These will aid in the development of valid 
contraindications.
    d. Serve as referral centers for clinical immunization safety 
inquiries.
    e. Develop clinical evaluation protocols and case definitions of 
adverse events possibly related to immunizations that can be 
disseminated for use by health care providers.
    f. Establish regional and national linkages with clinical experts 
who could participate in the evaluation of patients following an 
adverse event, and can also potentially be called upon to assist as 
needed with the development of clinical evaluation protocols and their 
implementation.
    g. For case reports received by the VAERS program that refer to 
clinical conditions or syndromes under investigation by the Network, 
Center staff will manage the routine follow-up activities conducted to 
complete missing case report information, and solicit additional 
clinical records that may be useful in evaluating the case. The VAERS 
program will assist as needed in these activities to decrease 
administrative workload on the network.
    h. Participation and collaboration in the Network of clinical 
centers to include, but not limited to, participation in weekly 
conference calls, electronic mail discussions, and annual meetings.
    i. Funded institutions may be able to request supplemental funding 
for the following additional activities:
    1. Clinical consultation service capacity for health care 
providers.
    2. Outreach and education activities.

2. CDC Activities

    CDC will participate as an academic partner in the activities of 
the network of CISA Centers, providing technical assistance as well as 
scientific collaboration.
    a. Provide technical assistance.
    b. Arrange coordinating meetings.
    c. Assist in the development of any research protocols that may be 
developed to further investigate selected adverse events, for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.

3. Coordinating Activities

    a. Centers will develop joint network operating protocols/
procedures including, but not limited to, mechanisms for billing of 
clinical assessment costs, patient billing as necessary, arranging 
specialist referrals, and other shared or commonly delegated 
activities.
    b. All protocols/procedures pertaining to patient care costs shall 
be submitted to the CDC for prior approval before implementation. The 
Network will jointly discuss cases, make decisions regarding the need 
to carry out additional case follow-ups, and then select cases for 
detailed clinical evaluation.

F. Content

Letter of Intent (LOI)

    A LOI is required for this program. The program announcement title 
and number must appear in the LOI. The narrative should be no more than 
one page, printed on one side, with one-inch margins, and unreduced 
font. Your letter of intent will be used to determine the number of 
objective reviewers needed and evaluate public interest in the CISA 
Program. The LOI should include the name of the Institution and the 
name, title, and affiliation of the ``principal investigator'' who will 
lead the Center. If available, include the

[[Page 42566]]

name(s) and address(es) of the participating institution(s) that will 
form the infrastructure of the proposed CISA Center.

Applications

    The program announcement title and number must appear in the 
application. Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 25 pages, single-spaced, 
printed on one side with one-inch margins, and unreduced font.
    The narrative should consist of, at a minimum, a Plan, Objectives, 
Methods, Evaluation and Budget.

G. Submission and Deadline

Letter of Intent

    The letter of intent should be submitted on or before July 12, 
2002, to the Grants Management Specialist identified in the ``Where to 
Obtain Additional Information'' section of this announcement.

Application

    Submit the original and two copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are available at the following Internet address: 
http:www.cdc.gov/od/pgo/forminfo.htm
    Application forms must be submitted in the following order:
Cover Letter
Table of Contents
Application
Budget Information Form
Budget Justification
Checklist
Assurances
Certifications
Disclosure Form
Human Subjects Certification
Indirect Cost Rate Agreement
Narrative

    The application must be received on or before 5 p.m. eastern time 
August 1, 2002. Submit the application to: Technical Information 
Management-PA02168, Procurement and Grants Office, Centers for Disease 
Control and Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 
30341-4146.
    Deadline: Letters of intent and applications shall be considered as 
meeting the deadline if they are received before 5 p.m. eastern time on 
the deadline date. Applicants sending applications by the United States 
Postal Service or commercial delivery services must ensure that the 
carrier will be able to guarantee delivery of the application by the 
closing date and time. If an application is received after closing due 
to (a) carrier error, when the carrier accepted the package with a 
guarantee for delivery by the closing date and time, or (b) significant 
weather delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Applications that do not meet the above criteria will not be 
eligible for competition and will be discarded. Applicants will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures must be objective/
quantitative and must measure the intended outcome. These measures of 
effectiveness shall be submitted with the application and shall be an 
element of evaluation.
    Each application will be evaluated against the following criteria 
by an objective review panel appointed by CDC:

1. Methodology and Collaboration Potential (35 points)

    The soundness, practicality and feasibility of the applicant's 
organizational plan and methodology for undertaking the project will be 
evaluated. Since the project will involve collaboration with other 
Centers performing similar work, the value of the project will be 
maximized if: (a) Patients do not need to travel to reach a Center, and 
(b) Centers have well established professional contacts outside their 
immediate geographic or metropolitan boundaries. Thus, Centers should 
describe how they propose to extend their ``virtual'' clinical coverage 
area, and how they intend to measure the effectiveness of this 
expansion. Additional paragraphs should address the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes:
    a. The proposed plan for the 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.

2. Experience and Capabilities (35 points)

    The applicant's (including proposed staff in applicable areas) 
experience, qualifications, and technical ability relevant to (1) the 
content areas of immunizations and adverse drug and vaccine reactions; 
(2) conducting clinical research and publishing in peer-reviewed 
journals; (3) providing clinical services and external consultation 
services; (4) transmission of information in a timely, efficient, 
secure and accurate manner; (5) discussing medical conditions with 
health care providers and the general public; (6) retrieving medical 
records and medical information from within their institution and on 
request from external institutions; (7) receiving and storing 
biological specimens related to this project; (8) taking part in multi-
center projects and clinical trials; and (9) undertaking collaborative 
projects involving geographically separated institutions and 
consultations to health care providers in distant locations.

3. Management Plan (20 points)

    The soundness and feasibility of the applicant's proposed 
management plan for accomplishing the work expectations outlined in 
Section E, to include identification of applicant's key personnel to be 
assigned to the CISA program and clear identification of their 
respective roles in the management and operations of the program.

4. Understanding of the Project (10 points)

    The extent to which the applicant possesses an understanding of the 
needs and purpose of the project, as demonstrated though: knowledge and 
understanding of current research and activities being performed in 
this area, past studies, existing literature, and the clarity, 
practicality, and flexibility of the proposed project plan such that it 
can be networked with others. The application shall demonstrate that 
the applicant's plan to accomplish the effort is clear, feasible, 
practical, and includes recognition of potential difficulties in 
performance and appropriateness and soundness of proposed solutions.

5. Human Subjects (not scored)

    The application should also adequately address the requirements of 
Title 45 CFR part 46 for the protection

[[Page 42567]]

of human subjects. Specific research studies may be undertaken by a 
Center or by the Network. Each will be undertaken as the need is 
identified through the ongoing experience of reviewing vaccine safety 
issues by the functioning Network, if funding is available, and with 
the development of a formal research protocol at that time.

6. Budget (not scored)

    The applicant shall describe their proposed plan for managing the 
resources necessary to comply with the requirements specified in 
Section E. This shall include a description of the Center organization, 
including proposed person hours for each key individual.

I. Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semi-annual progress reports. The progress report will include a 
data requirement that demonstrates measures of effectiveness.
    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.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    The following additional requirements are applicable to this 
program.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7  Executive Order 12372 Review
AR-8  Public Health System Reporting Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-14  Accounting System Requirements
AR-15  Proof of Non-Profit Status
AR-22  Research Integrity

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC home page Internet address--
http://www.cdc.gov Click on ``Funding'' then ``Grants and Cooperative 
Agreements.''
    For business management assistance contact: Peaches Brown, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention, 2920 Brandywine 
Road, Room 3000, Atlanta, GA 30341-4146, Telephone: 770-488-2738, E-
mail: [email protected].
    For program technical and administrative assistance, contact:

Dr. Christine Casey, Vaccine Safety and Development Activity, National 
Immunization Program, Centers for Disease Control and Prevention, 1600 
Clifton Road, NE., Mailstop E-62, Atlanta, GA 30333, Phone: 404-639-
2973, E-mail: [email protected]
or
Sharon Holmes, Program Analyst, Vaccine Safety and Development 
Activity, National Immunization Program, Centers for Disease Control 
and Prevention, 1600 Clifton Road, NE., Mailstop E-62, Atlanta, GA 
30333, Phone: 404-639-8582, E-mail: [email protected].

    Dated: June 18, 2002.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-15826 Filed 6-21-02; 8:45 am]
BILLING CODE 4163-18-P