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[Federal Register: June 12, 2001 (Volume 66, Number 113)]
[Notices]
[Page 31649-31652]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn01-98]
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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
[[Page 31650]]
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
[[Page 31651]]
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
[[Page 31652]]
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: znr6@cdc.gov.
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: rpless@cdc.gov.
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: sholmes@cdc.gov.
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]
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