[Federal Register Volume 64, Number 124 (Tuesday, June 29, 1999)]
[Notices]
[Pages 34809-34812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16475]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99129]


Enhanced Surveillance for Newly Vaccine Preventable Diseases; 
Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program for a New Vaccine Surveillance Network (NVSN). This program 
will compliment existing local, State, and national surveillance 
efforts and will facilitate research on issues related to new vaccine 
introduction and impact. This program addresses the ``Healthy People 
2000'' priority area, Immunization and Infectious Diseases. The purpose 
of the program is to create a surveillance network that can provide 
surveillance and data collection on new vaccine use and impact through 
enhanced surveillance, applied epidemiologic research, and investigator 
initiated studies to investigate the impact of new vaccines on the 
overall vaccination program.

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, and federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations.

    Note: Pub. L. 104-65 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 $900,000 is available in FY 1999 to fund two awards 
of approximately $450,000 each. It is expected that the awards will 
begin on or about September 30, 1999, 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.

[[Page 34810]]

D. Programmatic Interest

    As new vaccines are licensed and recommended for use in children, 
new strategies are needed for surveillance and monitoring. CDC has 
identified several areas that are considered programmatic priorities: 
(1) Improving identification of cases, for some conditions using 
enhanced diagnostic testing; (2) monitoring outpatient reports of 
clinical diagnoses (such as otitis media) or inpatient conditions (such 
as lobar pneumonia or diarrhea and dehydration); (3) evaluating 
immunological responses to new vaccines and laboratory testing of 
isolates from patients with vaccine preventable diseases; and (4) 
assessing the impact of new vaccines on clinical practices. CDC also 
values the flexibility to respond to emerging issues as new vaccines 
are introduced and new questions arise.

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) and CDC will be responsible for the activities 
listed under 2. (CDC Activities).

1. Recipient Activities

    A. Establish and operate a NVSN site. The site should have the 
following characteristics:
    1. Be established in a defined population, which could include 
either an entire State or a geographically defined area (or areas) 
within a State. (A minimum population base of approximately 500,000 may 
be necessary to accomplish the objectives of certain NVSN activities.)
    2. Have the capacity to conduct up to four concurrent projects; 
accommodate changes in specific projects and priorities as the public 
health system's need for information changes or new vaccines are 
licensed and implemented into the vaccination program; and function 
effectively as part of a network to further local, State, and national 
efforts to monitor introduction of new vaccines.
    3. Maintain participation of pediatric care providers and all 
facilities providing inpatient pediatric care. This provider network 
should participate in required surveillance activities (see D.1.-D.3. 
below), enroll patients in studies and participate in health services 
research (D.4. and D.5. below).
    B. Develop plans for obtaining additional support to supplement 
assistance from CDC.
    C. Establish collaboration in accomplishing program activities 
between public and private organizations that have an interest in 
addressing public health issues relating to new vaccines.
    D. Conduct activities addressing sections D.1.-D.3. below, and 
either D.4 or D.5 below. Specific protocols for the activities to be 
conducted at all surveillance sites will be developed jointly by 
investigators at those sites and CDC.
    1. Impact of incorporation of new vaccines on provider policies, 
practices, and utilization. Collect data from the network of pediatric 
care providers to document the impact of rotavirus and other new 
vaccines recommended for routine use among children (including 
combination vaccines).
    2. Enhance surveillance for vaccine preventable diseases, including 
reporting of specific clinical diagnoses from the network of pediatric 
care providers, improving diagnosis through enhanced etiological 
diagnostic testing, and reporting of all hospitalizations for vaccine 
preventable diseases at inpatient facilities in the surveillance area.
    3. Conduct serologic surveillance of 2-year-old children who 
received recommended childhood vaccines as part of routine pediatric 
care in an ongoing evaluation of the immunogenicity of vaccines 
administered as part of the recommended childhood immunization series.
    4. Develop and conduct other applied epidemiologic research 
projects. See Appendix II for examples of potential projects.
    5. Develop and conduct health services research. See Appendix II 
for examples of potential projects.
    E. Routinely evaluate progress in achieving the purpose of this 
program.
    F. Analyze and interpret data from NVSN projects, and publish and 
disseminate findings.

2. CDC Activities

    A. Assist in the development of a research protocol for 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.
    B. Provide consultation, scientific, and technical assistance in 
designing and conducting individual NVSN projects.
    C. Assist with analysis and interpretation of data, dissemination 
of findings.
    D. As needed and arranged with investigators, perform laboratory 
evaluation of specimens or isolates (e.g., molecular epidemiologic 
studies, evaluation of diagnostic tools) obtained in NVSN projects; and 
assist with integrating results with data from other NVSN site.
    E. As needed, store serum specimens at the CDC specimen bank, 
arrange for routine serological testing of a sample of isolates, and 
bank specimens for later evaluations, as appropriate.

F. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application. Your application will be evaluated on the criteria listed, 
so it is important to follow them in preparing your program plan. The 
narrative (excluding budget, appendices, and required forms) should be 
no more than 30 double-spaced pages, printed on one side, with one inch 
margins, and unreduced font. Only the following information should be 
presented in appendices: Letters of support, documentation of bona fide 
agent status, curricula vitae of key project personnel, and budget. 
Letters of support should clearly indicate collaborators' willingness 
to be participants in the NVSN activities. All other materials or 
information that should be included in the narrative will not be 
accepted if placed in the appendices.
    Applicants should propose a total of 4 projects from the list of 
activities provided in Program Requirements, 1. Recipient Activities, 
paragraphs D.1. through D.5. Projects described in paragraphs D.1. 
through D.3., above, must be proposed along with one project as 
described in D.4. and D.5. Each specific project proposal should be 
clearly identified in a distinct portion of the Operational Plan and 
should not exceed 5 pages. Although the specific activities described 
address distinct issues and needs, they may be implemented in an 
integrated manner such that staff members work on more than one 
activity and supplies and equipment are shared, etc.
    Since enhanced surveillance will be done in collaboration with the 
other NVSN site, the project should be designed so that data can be 
integrated with data from the other site.
    Applicants should detail a plan for establishing collaboration 
between public and private organizations that have an interest in 
addressing public health issues relating to new vaccines. Such a plan 
should document meaningful collaboration in accomplishing project 
objectives including developing inpatient and outpatient surveillance 
networks, collecting data, and analyzing results.

[[Page 34811]]

    In describing the impact of incorporation of new vaccines on 
provider policies, practices, and utilization (Recipient activities, 
D.1.), applicants may include but need not be limited to description of 
the number of vaccines and injections offered at visits during the 
first two years of life; vaccine-specific coverage rates of all 
recommended vaccines at specified ages, before and after incorporating 
new vaccines; the number of visits used to complete administration of 
all recommended vaccines by ages 1 and 2; and revenues and costs 
associated with incorporating new vaccines in practice.
    In describing plans to enhance surveillance for newly vaccine 
preventable diseases (Recipient activities, D.2.), applicants may 
include but need not be limited to a description of approaches to 
collecting outpatient data from the network of pediatric care providers 
who can report specified clinical diagnoses, therapy, and outcome, and 
enhance etiological diagnosis of infections such as rotavirus, 
pertussis, and/or influenza; enhancing laboratory diagnosis which could 
be conducted as an ongoing or periodic activity (e.g., one day per 
week) depending on the needed sample size; and estimating the 
completeness of case detection using an appropriate method such as 
focused chart reviews. Detection and reporting of inpatient conditions 
may include but need not be limited to data on all children in the 
surveillance area hospitalized for varicella, gastroenteritis, 
pneumonia, and documented pneumococcal or influenza infections. In 
addition, applicants should describe approaches to obtaining additional 
data on etiological diagnosis (where available), demographic data, and 
clinical course (for example, through chart reviews), and data on 
vaccination status.
    In describing plans for serological testing (Recipient activity 
D.3.), applicants description may include but need not be limited to an 
approach to recruiting through the provider network; age group of 
children tested (e.g., 20-28 months); plans for phlebotomy, storage and 
shipping of serum samples to CDC; and plans for providing additional 
doses of vaccine to children who are found to have less than protective 
levels of antibody for one or more vaccines (where good correlates of 
protection exist). An illustrative sample size calculation should be 
included recognizing that data from 2 sites will be aggregated for 
analysis.

Budget Instructions

    For each line-item (as identified on the Form 424a of the 
application), show both Federal and non-Federal (e.g., State or other 
funding) shares of total cost for the NVSN. For each staff member 
listed under the Personnel line item, indicate their specific 
responsibilities relative to each of the proposed projects. Include 
provisions for travel of the principal investigator and one NVSN 
participant to two meetings at CDC in Atlanta during the first year of 
the program.

G. Submission and Deadline

Letter of Intent (LOI)

    In order to assist CDC with planning, your letter of intent should 
include: (1) Name and address of institution, and (2) name, address, 
and telephone number of contact person. The letter of intent must be 
submitted on or before July 16, 1999, 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 5161-1. Forms are 
available in the application kit. On or before August 18, 1999, 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:
    (a) Received on or before the deadline; or
    (b) Sent on or before the deadline date and received in time for 
submission to the review panel. (Applicants must request a legibly 
dated U.S. Postal Service postmark or obtain a legibly dated receipt 
from a commercial carrier of 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 (a) 
or (b) above a considered late applications, will not be considered, 
and will be returned to the applicant.

H. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.
    1. Understanding the objectives of the NVSN (5 points)
    a. Demonstration of a clear understanding of the background and 
objectives of this cooperative program.
    b. Demonstration of a clear understanding of the requirements, 
responsibilities, problems, constraints, and complexities that may be 
encountered in establishing and operating the NVSN site.
    c. Demonstration of a clear understanding of the roles and 
responsibilities of participation in the NVSN network.
    2. Description of the population base and the vaccine providers in 
the NVSN site. (10 points)
    a. Clear definition of the geographic area and population base in 
which the NVSN site will operate. Detailed description of the 
demographics of the proposed population base.
    b. Clear description of various special populations within the 
defined population base as they relate to the proposed activities of 
the NVSN site. Extent to which the population base is diverse in terms 
of demographics and special populations.
    c. Description of vaccination providers within the NVSN site and 
the representativeness of the providers and patient populations 
included in the study network.
    3. Description of existing capacity to implement new vaccines and 
assess their impact: (15 points)
    a. Description of applicant's past experience in conducting studies 
of vaccines including monitoring coverage, disease, and impact; and in 
applied epidemiologic research and health services research, in 
general.
    b. Demonstration of applicant's ability to develop and maintain 
strong cooperative relationships with both public and private vaccine 
providers at the NVSN site, public health agencies, academic centers, 
managed care organizations, and community organizations. Evidence of 
applicant's ability to solicit and secure programmatic collaboration, 
and financial and technical support from such organizations.
    c. Demonstration of support from non-applicant participating 
agencies, institutions, organizations, laboratories, individuals, 
consultants, etc., indicated in applicant's operational plan.
    4. Operational plan (30 points)
    a. The extent to which the applicant's plan for establishing and 
operating the NVSN site clearly describes the proposed organizational 
and operating structure/procedures and clearly identifies the roles and 
responsibilities of all participating agencies, organizations, 
institutions, and individuals. The extent to which the applicant 
describes plans for collaboration with the other NVSN site and CDC in 
the establishment and operation of the NVSN and individual NVSN 
projects, including project design/development (e.g., protocols), 
management and analysis of data, and synthesis and dissemination of 
findings.

[[Page 34812]]

    b. Description of a plan to solicit and secure financial and 
technical assistance from other public and private organizations (e.g., 
schools of public health, university medical schools, public health 
laboratories, community-based organizations, other Federal and State 
government agencies, research organizations, foundations, etc.) to 
supplement the proposed funding from CDC.
    c. Quality of the proposed projects regarding consistency with 
public health needs, intent of this program, feasibility, methodology/
approach, and collaboration/participation of partner organizations. The 
degree to which the applicant has met 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; 
and (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.
    5. Collaborative relationships (15 points) 
    If applicant is a state or local health department, description of 
applicant's partnerships with necessary and appropriate non-
governmental organizations for establishing and operating the proposed 
NVSN and for conducting individual NVSN projects. If applicant is a 
non-governmental organization, description of applicant's plans for 
collaboration with State public health officials for establishing and 
operating the proposed NVSN and for conducting individual NVSN 
projects.
    6. Personnel qualifications and management plan (15 points) 
    a. Identification of applicant's key professional personnel to be 
assigned to the NVSN site and NVSN projects. Clear identification of 
their respective roles in the management and operation of the NVSN 
site. Descriptions of their experience in conducting work similar to 
that proposed in this announcement.
    b. Identification of key professional personnel from other 
participating or collaborating institutions, agencies, organizations 
outside of the applicant's agency that will be assigned to NVSN 
activities. Clear identification of their respective roles.
    c. Description of all support staff and services to be assigned to 
the NVSN.
    d. Description of approach to maintaining sufficiently flexible 
NVSN staffing to accommodate the likelihood that the requirements of 
NVSN projects will change from time to time due to changes in the 
public health system's need for information or licensure of new 
vaccines.
    7. Evaluation (10 points)
    a. Quality of plan for monitoring and evaluating the quality of 
vaccine coverage data, the completeness of case ascertainment, and the 
scientific and operational accomplishments of the NVSN site and of 
individual NVSN projects
    b. Quality of plan for monitoring and evaluating progress in 
achieving the purpose and overall goals of this cooperative program.
    8. Budget (not scored)
    If requesting funds for any contracts, provide the following 
information for each proposed contract: (1) Name of proposed 
contractor, (2) breakdown and justification for estimated costs, (3) 
description and scope of activities to be performed by contractor, (4) 
period of performance, and (5) method of contractor selection (e.g., 
sole-source or competitive solicitation).
    9. Human Subjects (not scored)
    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects?

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semiannual progress reports. The first semiannual report is 
required with each year's continuation application and should cover 
program activities from beginning of the current budget period to date 
of report/application preparation. The second semiannual report is due 
90 days after the end of each budget period and should cover activities 
for the entire budget period.
    2. Financial Status Report (FSR), no more than 90 days after the 
end of the budget period; and
    3. Final FSR 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. 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-7  Executive Order 12372 Review
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2000
AR-12  Lobbying Restrictions

J. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a) and 317(k)(1),(2) 
of the Public Health Service Act (42 U.S.C. sections 241(a) and 
247b(k)(1),(2)), as amended. The Catalog of Federal Domestic Assistance 
number is 93.185.

K. Where To Obtain Additional Information

    Copies of this and other announcements and application forms may be 
downloaded from the CDC homepage address on the Internet:
http://www.cdc.gov. Click on ``funding''.
    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 you 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: Sharron Orum, Grants 
Management Specialist, Grants Management Branch, Procurement & Grants 
Office, Announcement 99129, Centers for Disease Control and Prevention 
(CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, 
Telephone: (770) 488-2716, Fax: (770) 488-2716, E-mail: [email protected]
    For program technical assistance, contact: Benjamin Schwartz, M.D., 
or Melinda Wharton, M.D., Epidemiology and Surveillance Division, 
National Immunization Program, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE, Mailstop E-61, Atlanta, GA 
30333, Telephone: (404) 639-8254 and (404) 639-8253, E-mail: 
[email protected] and [email protected]

    Dated: June 23, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-16475 Filed 6-28-99; 8:45 am]
BILLING CODE 4163-18-P