[Federal Register Volume 66, Number 113 (Tuesday, June 12, 2001)]
[Notices]
[Pages 31649-31652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01112]


Clinical Immunization Safety Assessment Centers (CISA); Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 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 following ``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 initiate the establishment of a 
national network of CISA Centers (hereforth called Centers) to improve 
the scientific understanding of Immunization Safety issues at the 
individual patient level. Because 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 essentially creating a new medical specialty of 
Immunization Safety.
    The Centers will develop and disseminate standardized clinical 
evaluation protocols to clinicians who may be required to apply them to 
a patient; 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

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educational interventions in the area of Immunization Safety.
    The goals are to enhance our understanding of known serious or 
unusual vaccines reactions, including the pathophysiology and risk 
factors (including genetics) for such reactions, as well as evaluate 
and gain an understanding for 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.
    This program will only be accomplished if there is strong and 
continual collaboration among the parties involved in the network and 
if each Center will be staffed by a group of clinical specialists in 
Immunization Safety. Collaboration will need to take place in the areas 
of expertise-sharing and clinical evaluation and assessment workload.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit 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.

    Note: Title 2 United States Code, Chapter 26, Section 1611 
states that an organization described in section 501(c)(4) of the 
Internal Revenue Code of 1986 that engages in lobbying activities is 
not eligible to receive Federal funds constituting an award, grant, 
cooperative agreement, contract, loan, or any other form.

C. Availability of Funds

    Approximately $1,700,000 is available in FY 2001 to fund at least 
three awards. It is expected that the average award will be $500,000, 
ranging from $400,000 to $600,000. It is expected that the awards will 
begin on or before September 30, 2001, and will be made for a 12-month 
budget period within a project period of up to five 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.

B. 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 its 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, 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 identified from the routine and enhanced 
assessment of case reports from the VAERS, as necessary to clarify the 
potential relationship with immunizations (for examples see Addendum 
A.)
    c. Establish the protocols and the capacity to immunize under 
medical supervision, for patients who have had an adverse reaction that 
may not contraindicate further vaccination but where there is concern. 
These will aid in the development of valid contraindications.
    d. Serve as referral centers for clinical Immunization Safety 
inquiries.
    e. Establish the development of 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 linkages with clinical experts both regionally and 
nationally, 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 would manage the routine follow-up activities that would 
be 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 activities:
    1. Clinical consultation service capacity for health care 
providers.
    2. Outreach and education activities.

2. CDC Activities

    a. Provide technical assistance.
    b. Arrange first coordinating meeting.
    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. 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.

E. Content

Letter of Intent (LOI)

    A non-binding LOI should be submitted for this program. It should 
be no more than one page. The LOI will be used to determine the number 
of

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reviewers needed and evaluate public interest in the CISA Program. The 
LOI should include the name of the institution and name, title and 
affiliation of the principal investigator who will lead the Center. And 
if available, the name(s) and address(s) of the participating 
institution(s) that will form the infrastructure of the proposed CISA 
Center.

Applications

    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.

F. Submission and Deadline

Letter Of Intent

    The letter of intent should be submitted on or before July 9, 2001, 
to the Grants Management Specialist identified in the ``Where to Obtain 
Additional Information'' section of this announcement.

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are available in the application kit and at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm
    On or before August 8, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    1. Received on or before the deadline date; or
    2. Sent on or before the deadline date and received in time for 
submission to the independent 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 shall not be acceptable as proof of timely mailing.)
    Late Applications: Applications which do not meet the criteria in 
1. or 2. above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated against the following criteria 
by an objective review panel appointed by CDC.

1. Understanding of the Project (10 points)

    The extent to which the applicant possesses an understanding of the 
needs and purpose of the project will be evaluated, as demonstrated 
through knowledge and understanding of current research and activities 
being performed in this area, past studies, existing literature and 
both 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 and practical, including recognition of potential 
difficulties in performance and appropriateness and soundness of 
proposed solutions.

2. 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.
    Additional paragraphs should address the CDC Policy requirements 
regarding the inclusion of women, ethnic, and racial groups in the 
proposed research. This includes:
    1. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    2. The proposed justification when representation is limited or 
absent.
    3. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    4. 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.

3. Management Plan (20 points)

    The soundness and feasibility of the applicant's proposed 
management plan for accomplishing the work expectations outlined in 
``Section D'' 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. 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.

5. Human Subjects (not scored)

    The application should also adequately address the requirements of 
Title 45 CFR part 46 for the protection of human subjects (specific 
research studies may be undertaken by a Center or the Network--each 
will be undertaken as the need is identified through the ongoing 
experience of reviewing vaccine safety issues by the functioning 
Network (and if funding is available), 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 D''. This shall include a description of the Center 
organization, including proposed person hours for each key individual.

H. Reporting Requirements

    Provide CDC with original plus two copies of
    1. semi-annual progress reports;
    2. financial status report, no more than 90 days after the end of 
the budget period; and
    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

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Information'' section of this announcement.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in the 
application kit.

AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-6 Patient Care
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

I. 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 Federal 
Domestic Assistance number is 93.185.

J. Where to Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from:
    Mike Smiley, 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: 770-488-2718, Email: [email protected].
    For program technical assistance, contact:
    Dr. Robert Pless, Vaccine Safety and Development Activity, National 
Immunization Program, Centers for Disease Control and Prevention, 1600 
Clifton Road, MS-E61, Atlanta, GA 30333, Telephone: 404-321-0248, 
Email: [email protected].
    Sharon Holmes, Program Analyst, Vaccine Safety and Development 
Activity, National Immunization Program, Centers for Disease Control 
and Prevention, 1600 Clifton Road, MS-E61, Atlanta, GA 30333, 
Telephone: 404-639-8582, Email: [email protected].

    Dated: June 6, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-14720 Filed 6-11-01; 8:45 am]
BILLING CODE 4163-18-P