[Federal Register Volume 67, Number 106 (Monday, June 3, 2002)]
[Notices]
[Pages 38282-38285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02169]


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) 2002 funds to expand the current New 
Vaccine Surveillance Network (NVSN) cooperative agreement program to 
conduct broader-based surveillance and research projects. This program 
complements existing local, State, and national surveillance efforts 
and facilitates research on issues related to new vaccine introduction 
or new vaccine policies and their impact. This program addresses the 
``Healthy People 2010'' focus area, Immunization and Infectious 
Diseases. The purpose of the program is to support a network of sites 
that provide surveillance and data collection on new vaccine use, the 
impact of new vaccines, and new vaccine policies through enhanced 
inpatient and outpatient surveillance, applied epidemiologic research, 
and investigator-initiated investigations. The two current NVSN sites 
are affiliated with the University of Rochester, NY, and Vanderbilt 
University, TN. They are currently in year three of the project.
    As new vaccines are licensed and recommended for use, new 
strategies are needed for surveillance and monitoring. The NVSN 
currently conducts surveillance and studies in children, but future 
NVSN activities could extend to the adult population. CDC has 
identified several areas that are considered programmatic priorities: 
(1) Population-based collection of clinical and etiological data from 
children hospitalized for selected current and prospective vaccine 
preventable diseases such as viral respiratory illnesses caused by 
influenza, respiratory syncytial virus (RSV), and parainfluenza; (2) 
collection of similar data from a representative sample of outpatients 
such that conclusions drawn can be considered population-based; (3) 
collection of data on illnesses and syndromes among outpatients and 
inpatients that may be affected by use of new vaccines (e.g., otitis 
media, lobar pneumonia); and (4) assessment of the impact of new 
vaccines or policies on clinical practices. CDC also values the 
flexibility to respond to emerging issues as new vaccines are 
introduced and new questions arise.

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), and 300aa-2(a)], as amended. The Catalog of 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, research institutions, hospitals, faith-based 
organizations, community-based organizations, other public and private 
nonprofit organizations, health departments of States 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, federally recognized Indian 
tribal governments, the Federated States of Micronesia, the Republic of 
the Marshall Islands, and the Republic of Palau.
    Preference will be given to applicants whose geographic areas are 
not covered by an existing NVSN site.

    Note: Title 2 of the 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 or loan.

D. Availability of Funds

    Approximately $500,000 is available in FY 2002 to fund one award. 
It is expected that the award 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 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.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities shown below under 
item 1. Recipient Activities, and CDC will be responsible for the 
activities listed under item 2. CDC Activities.
    1. Recipient Activities
    a. Establish and operate an NVSN site. To effectively function as 
part of this network, the site should have the following 
characteristics and capabilities:
    (1) Be established in a defined population, which could include 
either an entire state or a geographically defined area (or areas) 
within a state, in order to conduct population-based surveillance. A 
minimum population base of approximately 500,000 persons may be 
necessary to accomplish the objectives of certain NVSN activities 
(e.g., obtaining population-based estimates of influenza and RSV in 
children less than five years of age).
    (2) Have the capacity to simultaneously conduct population-based 
inpatient surveillance for Acute Respiratory Illness (ARI) among 
children less than five years old, outpatient ARI surveillance in a 
representative sample of children, and two other joint projects with 
one or more of the other NVSN sites. As examples, ongoing projects 
include: analysis of an existing database to assess vaccine impact 
among outpatients in the study area, chart reviews from a broad sample 
of pediatric care providers in the community to assess uptake of 
Pneumococcal Conjugate Vaccine (PCV) and its clinical impact and impact 
on vaccination practices (e.g., timeliness in administering other 
vaccines, number of injections per vaccination visit, etc.).
    (3) Have the flexibility to 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. Function effectively as part of a network 
where projects and protocols are developed collaboratively among 
investigators at the NVSN sites and CDC.
    (4) Have an established relationship with pediatric care providers 
in both inpatient and outpatient facilities so that surveillance and 
other studies can be conducted with them during the first year of 
participation.

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    b. Develop plans for obtaining additional support to supplement 
assistance from CDC.
    c. Have a relationship with state and local health departments, and 
other public and private organizations, that have an interest in 
addressing public health issues relating to new vaccines.
    d. Conduct activities addressing section d.(1) through d.(4), 
below. As an option, propose an additional study addressing section 
d.(5) that can be implemented as a network-wide project or that can be 
completed at the recipient's site with or without the participation of 
other NVSN sites. Specific protocols for activities conducted at more 
than one surveillance site must be developed collaboratively by 
investigators at those sites and CDC. Specific protocols for activities 
conducted at a single site must be approved by CDC.
    (1) Conduct year-round enhanced surveillance according to NVSN 
protocol, for selected current and prospective vaccine preventable 
diseases by performing the following activities in all surveillance 
area hospitals that admit children less than five years old: Provide 
staff to screen admissions year-round and enroll children with ARIs; 
collect information on demographics, insurance coverage, medical 
history, risk factors, hospital course, admission and discharge 
diagnoses, and laboratory results from parents and medical records; 
collect nasal and throat swabs from all enrolled children; perform 
viral culture and Polymerase Chain Reaction (PCR) testing for 
influenza, RSV, and parainfluenza on all collected samples (PCR primers 
will be supplied by CDC); conduct quality assurance checks of the data 
in accordance with NVSN procedures; and enter data and send it to CDC 
using the NVSN web-based data collection system. Have the flexibility 
to extend surveillance to other vaccine preventable diseases (e.g., 
pertussis) which may require the conduct of other laboratory tests.
    (2) Conduct surveillance similar to that described in section d.(1) 
among a representative sample of children less than five years old seen 
at outpatient practices in the surveillance area such that results can 
be considered population-based. Only PCR will be used to test specimens 
from outpatients.
    (3) Study the impact of incorporating new vaccines on provider 
policies, practices, and utilization. Collect data from a network of 
pediatric outpatient care providers to document the impact of new 
vaccines recommended for routine use among children, potentially 
including combination vaccines.
    (4) Investigate the impact of new vaccines on disease burden and 
health care utilization through analysis of local databases. Have 
established access, or propose developing one or more data sources that 
are representative of children in the surveillance area. Possible 
sources of data include insurance databases, managed care organization 
data, Medicaid databases, or other sources that would include 
vaccination and disease burden data.
    (5) Develop and conduct other applied epidemiologic and/or health 
services research projects related to new vaccine introduction. 
Examples of completed or current projects include: ARI inpatient 
surveillance of about 1,000 patients recruited during the first 18 
surveillance months; complementary outpatient surveillance of ARIs; 
analyses of Medicaid and private insurance databases to assess the 
impact of PCV on the burden of pneumococcal disease-related outcomes; 
survey of provider attitudes and practices regarding PCV; conduct a 
feasibility study of implementing a recommendation for universal 
influenza vaccination of young children 6-35 months old (focus groups, 
national provider survey, time and motion study in seven practices, and 
a database analysis).
    e. Routinely evaluate progress in achieving the purpose of this 
program.
    f. Analyze and interpret data from NVSN projects, and publish and 
disseminate findings in collaboration with CDC.
    2. CDC Activities
    a. Provide CDC investigator(s) to monitor the NVSN cooperative 
agreement as project officer(s). At least one CDC investigator will be 
assigned to each NVSN project.
    b. Provide consultation, scientific, and technical assistance in 
designing and conducting individual NVSN projects.
    c. Assist in the development of research protocols for 
Institutional Review Boards (IRB) review by all cooperating 
institutions participating in the research projects. For each protocol, 
the CDC IRB will review and approve the protocol initially and on at 
least an annual basis until the research project is completed.
    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; 
provide PCR primers and quality control specimens; and integrate 
results with data from other NVSN sites.
    e. Manage, maintain, and update the secure, encrypted CDC web-based 
system which is used by the NVSN for data entry of ARI surveillance 
data at the sites, transfer of data from sites to CDC, merging of data 
from NVSN sites, and creation of data sets and data summaries which are 
accessible by each site. Each NVSN site will be able to download only 
its own site's raw data through the web-based system.
    f. Analyze and interpret data from NVSN projects, and publish and 
disseminate findings in collaboration with NVSN site investigators.

F. Content

Applications

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Applications will be evaluated based on the 
criteria listed in this program announcement, 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 
single-spaced pages, printed on one side, with one-inch margins, and 12 
point 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. Letter 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 at least one project from the activities 
provided in Program Requirements. Each specific project proposal should 
be clearly identified in a distinct portion of the Operational Plan and 
should not exceed four pages. Descriptions should include objectives, 
methods, analytic approach, and illustrative sample size calculations 
recognizing that data from two or more sites may be aggregated for 
analysis. 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. The specific project proposal(s) will be 
reviewed as a potential project that could be conducted under the 
award, but the NVSN may choose not to conduct the project depending on 
other NVSN competing interests, needs, and resources.

[[Page 38284]]

    Since enhanced surveillance will be done in collaboration with the 
other NVSN sites, most projects will need to be designed so that data 
can be integrated with data from the other sites. The ARI surveillance 
data from hospitals and outpatient clinics must be merged with data 
from other sites. Some local databases of vaccination or disease burden 
(e.g., registries or insurance company data) may be proprietary; 
however, for joint NVSN projects, the data can be analyzed locally and 
presented in joint publications.
    This would require that variables be available and defined in a way 
that is compatible with data from other sites. Sites are expected to 
make every effort to ensure that data can be integrated with those of 
other NVSN sites.
    In describing the impact of incorporation of new vaccines on 
provider policies, practices, and utilization (Recipient activities, 
d.(3)), applicants may include, but are not limited to, a description 
of the number of vaccine and injections offered at visits during the 
first two years of life; vaccine-specific coverage rates of all 
recommended vaccines at specified ages, both before and after 
incorporating new vaccines; the number of visits used to complete 
administration of all recommended vaccine by ages one and two; and 
revenues and costs associated with incorporating new vaccines in 
practice.
    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 the principal investigator and one NVSN participant to 
travel to two meetings at CDC in Atlanta during the first year of 
participation, and one meeting at CDC in Atlanta during subsequent 
years of participation.

G. Submission and Deadline

Application

    Submit the original and two copies of PHS 5161-1. Forms are 
available in the application kit and at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm. On or before July 15, 2002, submit the 
application to: Technical Information Management-PA02169, Procurement 
and Grants Office, Centers for Disease Control and Prevention, 2920 
Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.
    Deadline: Applications shall be considered as meeting the deadline 
if they are received on or before the deadline date.

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 of effectiveness must 
relate to the performance goals as stated in section ``A. Purpose'' of 
this announcement. Measures must be objective and 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 independent review group appointed by CDC:

1. Surveillance and Research Plan (30 points)

    The application will be evaluated based on: (a) Methodology for 
conducting population-based surveillance among inpatients at all 
surveillance area hospitals; (b) methodology for conducting population-
based surveillance among outpatients at a representative sample of 
outpatient practices; and (c) quality of the proposed additional 
research projects, as requested in the Application Content section 
above, regarding objectives, methodology/design, feasibility, and 
collaboration and participation of partner organizations and CDC. The 
applicant also must state the degree to which they have met CDC policy 
requirements regarding representation of women, ethnic, and racial 
groups in the proposed research, including: (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 plans for recruitment and outreach for 
study participants include the process of establishing partnerships 
with community ties and recognition of mutual benefits.

2. Personnel Qualifications and Management Plan (30 points)

    The extent to which the applicant can demonstrate qualifications 
for establishing an NVSN site and managing projects will be evaluated: 
(a) The extent to which the applicant's plan for establishing and 
operating the NVSN site clearly describes the organizational structure 
and procedures and identifies all participating persons and groups 
including identifying key professional staff and their roles and 
responsibilities; (b) past experience of key professional staff in 
conducting work similar to that proposed in this announcement (provide 
curriculum vitae of each in appendix); (c) identifying key professional 
personnel from other collaborating organizations, agencies, etc. 
outside of the applicant's agency who will participate in NVSN 
activities (provide curriculum vitae for each in an appendix), with 
roles described; (d) description of support staff and services to be 
assigned to the NVSN; (e) description of approach to flexible staffing 
to accommodate the changing requirements of NVSN projects that may 
occur due to changing public health needs and new vaccines or vaccine 
policies.

3. Description of Existing Relationships With Pediatric Vaccination 
Providers in the Surveillance Area and Ability to Obtain Their 
Participation for Surveillance and Research Activities (20 points)

    The extent to which the applicant demonstrates: (a) Past experience 
working with pediatric inpatient facilities and outpatient care 
providers in conducting epidemiologic and health services research of 
vaccines or other health care practices or interventions; (b) the 
ability to develop and maintain strong cooperative relationships 
broadly with both public and private vaccine providers at the NVSN 
site, including public health agencies, academic centers, managed care 
organizations, and community organizations; and (c) support from non-
applicant participating agencies, institutions, organizations, 
laboratories, consultants, etc. indicated in applicant's operational 
plan. Applicant should provide (in an appendix) letters of support 
which clearly indicate collaborators' willingness to contribute to NVSN 
activities. Do not include letters of support from CDC personnel.

4. Description of the Population Base and the Vaccine Providers in the 
NVSN Site (10 points)

    The extent to which the applicant provides a: (a) Clear definition 
of the geographic area and population base in which the NVSN site will 
operate; (b) description of the demographics of the proposed population 
base including a description of various special populations as they 
relate to the proposed activities of the NVSN site; and (c) description 
of vaccination providers within the NVSN site and

[[Page 38285]]

availability of or participation in a vaccination registry.

5. Understanding the Objectives of the NVSN (5 points)

    The extent to which the applicant demonstrates: (a) A clear 
understanding of the background and objectives of this cooperative 
agreement program; (b) a clear understanding of the requirements, 
responsibilities, problems, constraints, and complexities that may be 
encountered in establishing and operating the NVSN site; (c) a clear 
understanding of the roles and responsibilities of participation in the 
NVSN network.; and (d) knowledge and understanding of current research 
and activities performed in this area, past studies, and existing 
literature.

6. Evaluation (5 points)

    The quality of the plan for monitoring and evaluating the quality 
of vaccine coverage data, quality and timeliness of laboratory data, 
completeness of case ascertainment, population representativeness of 
surveillance data, and the scientific and operational accomplishments 
of the NVSN site and individual NVSN projects, including plans to 
monitor and evaluate progress in achieving the goals of the cooperative 
agreement program.

7. Budget (not scored)

    The application will be evaluated on the extent to which the line-
item budget is detailed, clearly justified, consistent with the purpose 
and objectives of the program, and reflects both Federal and non-
Federal (e.g., State funding) shares of total cost for the NVSN site.
    If requesting funds for any contracts, provide the following 
information for each proposed contract: name of proposed contractor, 
breakdown and justification for estimated costs, description and scope 
of activities to be performed by contractor, period of performance, and 
method of contractor selection (e.g., sole-source or competitive 
solicitation).

8. Human Subjects (not scored)

    The application should adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects. (not scored; 
however, an application can be disapproved if the research risks are 
sufficiently serious and protection against risks is so inadequate as 
to make the entire application unacceptable).

I. Other Requirements

Technical Reporting Requirements

    Applicants should submit an original plus two copies of:
    1. Annual progress reports. The results of the Measures of 
Effectiveness shall be a data requirement to be submitted with or 
incorporated into progress report.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial report and performance report, 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 of the 
announcement.

AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
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 20241-4146, Telephone number: 770-488-2738, 
E-mail address: [email protected].
    For program technical assistance, contact:

Ben Schwartz, M.D., Epidemiology and Surveillance Division, National 
Immunization Program, Centers for Disease Control and Prevention, 1600 
Clifton Road, MS E-61, Atlanta GA 30333, Phone: 404-639-8254, E-mail: 
[email protected].
Marika K. Iwane, Ph.D., M.P.H., Epidemiology and Surveillance Division, 
National Immunization Program, Centers for Disease Control and 
Prevention, 1600 Clifton Road, MS E-61, Atlanta GA 30333, Phone: 404-
639-8257, E-mail: [email protected].

    Dated: May 26, 2002.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-13779 Filed 5-31-02; 8:45 am]
BILLING CODE 4163-18-P