[Federal Register Volume 69, Number 54 (Friday, March 19, 2004)]
[Notices]
[Pages 13039-13044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6168]



[[Page 13039]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Enhanced Surveillance for New Vaccine Preventable Diseases

    Announcement Type: New.
    Funding Opportunity Number: 04117.
    Catalog of Federal Domestic Assistance Number: 93.185.
    Key Dates:
    Letter of Intent Deadline: March 29, 2004.
    Application Deadline: May 12, 2004.
    Executive Summary: The program will provide funding for 
approximately two grantees for five years (initially $550,000 per award 
in year one) to establish surveillance and evaluation sites that will 
collaborate with a larger network (the New Vaccine Surveillance Network 
(NVSN)) to conduct multi-site and individual projects to assess the 
impact of new vaccines and vaccine policies for diseases that are 
currently vaccine-preventable and those that are potentially vaccine 
preventable in the future. The current network consists of a total of 
three sites, one located in each New York, Tennessee, and Ohio. Two 
sites are in year five of a five-year project period, and one site is 
in year two of a five year project period. Currently, these sites 
conduct population-based surveillance of hospitalizations for ferbrile 
and acute viral respiratory illness (ARI) among children aged less than 
five years, surveillance for medically attended outpatient visits in 
community practices and emergency departments for ARIs among children 
aged less than five years, health service evaluation and research 
projects of knowledge, attitudes, and practices regarding vaccine use 
(including provider surveys, chart abstraction for vaccine use in 
community-wide provider practices, evaluation of vaccine effectiveness, 
and other projects.) The activities have included data collection on 
vaccine use, disease burden, and other variables in order to assess the 
impact of vaccines and related policies in populations. Although the 
current focus is on young children, the program is not restricted to 
the younger age group.

I. Funding Opportunity Description

    Authority: Public Health Service Act, Section 317(1), 42 U.S.C. 
247b(k)(1), as amended.

    Purpose: 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 the new vaccines, and new vaccine policies through 
enhanced inpatient and outpatient surveillance, applied epidemiologic 
research, and investigator-initiated investigations. This program 
addresses the ``Healthy People 2010'' focus area(s) of Immunization and 
Infectious Diseases.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Immunization Program (NIP): 
Reduce the number of indigenous cases of vaccine-preventable diseases 
(VPD).
    Research Objectives: 1. To evaluate the impact of new vaccines or 
new vaccine policies on disease in site populations. 2. To evaluate the 
impact of new vaccines or new vaccine policies on administration of 
other vaccines. 3. To understand the burden of VPD in the population.
    Activities: Awardee activities for this program are as follows:
    A. Establish and operate an NVSN site. The site must be able to 
conduct the following activities:
    (1) Establish a site with a defined catchment population, which 
could include either an entire state or a geographically defined area 
(or areas) within a state, e.g., counties, in order to conduct 
population-based surveillance. A minimum population base of 
approximately 500,000 persons of all ages will be necessary to 
accomplish the objectives of certain NVSN activities (e.g., obtaining 
population-based estimates of influenza and respiratory syncytial virus 
(RSV) in children less than five years of age.)
    (2) Simultaneously conduct multiple surveillance activities and 
other studies e.g., population-based inpatient surveillance for ARI 
among children less than five years old, outpatient ARI surveillance in 
a representative sample of children, other joint projects with one or 
more of the other NVSN sites (current or past projects include 
influenza vaccine effectiveness studies among inpatients and 
outpatients using case-cohort or screening method, and 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 (including timeliness in 
administering other vaccines, number of injections per vaccination 
visit, etc.)).
    (3) 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.
    (4) Develop projects and protocols collaboratively as part of a 
multi-site network with investigators at other NVSN sites and CDC. Site 
data will have to be integrated with data from the other sites for most 
projects. 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 together in joint publications. 
This requires that variables be available and defined in a way that is 
compatible with data from other sites. Sites must make every effort to 
ensure that data can be integrated with those of other NVSN sites.
    (5) Conduct surveillance and other studies (e.g., influenza vaccine 
effectiveness) with pediatric care providers in both inpatient and 
outpatient facilities during the first year of participation. 
Activities include promoting vaccination following ACIP recommendations 
and accurately estimating vaccination coverage in the surveillance area 
by conducting chart reviews in providers practices, as well as other 
methods deemed appropriate for particular study designs (e.g., vaccine 
effectiveness using case-cohort or screening method).
    B. Have plans for obtaining additional programmatic support to 
supplement assistance from CDC.
    C. Utilize existing relationships with state and local health 
departments, and other public and private organizations to facilitate 
the ability to interact with health care providers and others in 
addressing study needs and public health issues relating to new 
vaccines and vaccine policies.
    D. Conduct activities addressing (1) through (7) below. 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 in advance by CDC.
    (1) Conduct year-round enhanced surveillance consistent with NVSN 
protocol (applicants can refer to NVSN publications, conference 
proceedings/abstracts, etc., that can be found in the literature or on 
websites), 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 ARI; 
collect information on demographics, insurance

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coverage, medical history, influenza vaccination, 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; demonstrate ability to perform 
timely, sensitive and specific viral culture and polymerase chain 
reaction (PCR) testing for influenza, RSV, and parainfluenza on a large 
volume of collected samples; conduct quality assurance checks of the 
data including laboratory assays in accordance with NVSN procedures; 
and enter data and send it to CDC using the NVSN web-based data 
collection system. Site must be able to begin inpatient surveillance in 
the first year of participation. Have the flexibility and capability of 
extending surveillance to other vaccine-preventable diseases, which may 
require the conduct of other laboratory tests. Collect influenza 
vaccination data on inpatients enrolled during surveillance, including 
accurate vaccination data from the primary care providers and other 
settings where vaccine is administered. Access hospital databases for 
hospital admission data for periodic enrollment audits.
    (2) Depending on funding and priorities, conduct surveillance 
similar to that described in (1) above among a population-based or 
representative sample of children less than five years old seen at 
outpatient practices in the surveillance area. Viral culture and/or PCR 
would be used to test specimens from outpatients. Collect influenza 
vaccination data on outpatients enrolled during surveillance, including 
accurate vaccination data from the primary care providers and other 
settings where vaccine is administered.
    (3) As needed, and depending on funding and priorities, study the 
impact of incorporating new vaccines on provider policies, practices, 
and utilization. Collect data from pediatric outpatient care providers 
to document the impact of new vaccines recommended for routine use 
among children, potentially including combination vaccines. 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.
    (4) As needed, and depending on priorities, access hospital, clinic 
and other databases that will provide important administrative and 
patient level data for surveillance and other studies.
    (5) Depending on funding and priorities, in addition and as a 
related or separate effort to influenza vaccination data collection 
under D(1) and D(2) activities, immunization data should be collected 
using methods that enable the NVSN to estimate accurately vaccine 
coverage and uptake for the defined site population, overall and for 
important subgroups. Applicants must have sufficiently extensive and 
established collaboration with pediatric provider practices in the 
catchment area in order to be able to estimate coverage in the first 
year of site's participation.
    (6) As needed, possibly on an annual basis (including the first 
year of participation), and depending of funding and priorities, 
evaluate influenza vaccine effectiveness/efficacy. Examples of current 
ongoing evaluation of vaccine effectiveness using NVSN inpatient and 
outpatient surveillance cases include case-cohort (screening method) 
studies that obtain vaccination coverage by conducting chart reviews in 
provider practices throughout the catchment counties, and also by 
county-wide random digit dial telephone household surveys with provider 
validation of vaccination. In order to obtain accurate estimates, 
applicants must have sufficiently extensive and established 
collaboration with pediatric provider practices in the catchment area 
such that all could be considered for inclusion in chart reviews. Other 
childhood vaccinations would also be collected during the chart 
reviews.
    (7) Depending on funding and priorities, develop and conduct other 
applied epidemiologic and/or health services research projects related 
to new vaccine introduction. Examples of completed or current projects 
include: cost effectiveness of influenza vaccination; 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; a feasibility study of 
implementing a recommendation for universal influenza vaccination of 
young children 6-35 months old through focus groups, national provider 
survey, time and motion study in seven provider 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.
    In a cooperative agreement, CDC staff are substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC activities for this program are as follows:

     Provide CDC investigator(s) to monitor the NVSN 
cooperative agreement as protocol investigators and project officer(s). 
At least one CDC investigator will be assigned to each NVSN project.
     Provide consultation, scientific, and technical 
assistance in designing and conducting individual NVSN projects.
     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.
     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 integrate results with data from other NVSN sites.
     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. Merged datasets will be shared among sites for approved 
analyses that require multi-site data.
     Analyze and interpret data from NVSN projects, 
and publish and disseminate findings in collaboration with NVSN site 
investigators.
     Participate as co-investigators on project 
activities including research design, methods, obtaining CDC IRB 
approval of protocols, data collection, data analysis, and co-authoring 
manuscripts.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $1,100,000.
    Approximate Number of Awards: Two.

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    Approximate Average Award: $550,000 (This amount is for the first 
12-month budget period, and includes both direct and indirect costs).
    Floor of Award Range: None.
    Ceiling of Award Range: $575,000 (This ceiling is for the first 12-
month budget period.)
    Anticipated Award Date: August, 2004.
    Budget Period Length: 12 Months.
    Project Period Length: Five years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies, such as:

     Public nonprofit organizations
     Private nonprofit organizations
     Universities
     Colleges
     Research institutions
     Hospitals
     Community-based organizations
     Faith-based organizations
     Federally recognized Indian tribal governments
     State and local governments or their Bona Fide 
Agents (this includes the District of Columbia, the Commonwealth of 
Puerto Rico, the Virgin Islands, the Commonwealth of the Northern 
Marianna Islands, American Samoa, Guam, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau)

    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.
    The existing site in Ohio, which is in Year 2 of 5, is based in 
Cincinnati with a Hamilton County catchment area. Applicants with 
catchment populations from this Cincinnati area will not be considered 
eligible to apply. New York and Tennessee sites are eligible.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    CDC will accept and review applications with budgets greater than 
the ceiling of the award range.
    If your application is incomplete or non-responsive to the 
requirements listed in this section, it will not be entered into the 
review process. You will be notified that your application did not meet 
submission requirements.
    Applicants must demonstrate their capability and organizational 
ability to perform functions under Activities. In addition to 
describing inpatient and outpatient surveillance, applicants must 
describe activities listed under D(1) through D(4), describe proposed 
methods to accurately estimate vaccination coverage as listed in D(5), 
and propose at least one specific project from each of D(6) and D(7) 
under Activities. Each specific proposal for D(5)-D(7) activities must 
be clearly identified in a distinct portion of the Operational Plan and 
cannot exceed four pages.
    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support. Individuals from underrepresented 
racial and ethnic groups as well as individuals with disabilities are 
always encouraged to apply for CDC programs.

    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, grant, or loan.

IV. Application and Submission Information

IV.1. Address to Request Application Package

    To apply for this funding opportunity, use application form PHS 398 
(OMB number 925-0001 rev. 5/2001). Forms and instructions are available 
in an interactive format on the CDC Web site, at the following Internet 
address: http://www.cdc.gov/od/pgo/forminfo.htm.
    Forms and instruction are also available in an interactive format 
on the National Institutes of Health (NIH) Web site at the following 
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Application Submission

    Letter of Intent (LOI): Your LOI must be written in the following 
format:

     Maximum number of pages: two
     Font size: 12-point unreduced
     Single spaced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Written in plain language, avoid jargon
    Your LOI must contain the following information:
     Descriptive title of the proposed research
     Name, address, E-mail address, telephone number 
and fax phone number of the Principal Investigator
     Names of other key personnel
     Participating institutions
     Number and title of this Program Announcement 
(PA)

    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. For further assistance with 
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or 
contact GrantsInfo, Telephone (301) 435-0714, e-mail: 
[email protected].
    Your research plan should be single spaced and address activities 
to be conducted over the entire project period. Also refer to III.3 
Other, for description of required application content.
    Descriptions of D(5)-D(7) activities must include objectives, 
methods, analytic approach, and illustrative sample size calculations 
and/or confidence intervals 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 interests, needs, and resources.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. Your DUNS number must be entered 
on line 11 of

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the face page of the PHS 398 application form. The DUNS number is a 
nine-digit identification number, which uniquely identifies business 
entities. Obtaining a DUNS number is easy and there is no charge. To 
obtain a DUNS number, access www.dunandbradstreet.com or call 1-866-
705-5711. For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    This PA uses just-in-time concepts.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    LOI Deadline Date: March 29, 2004.
    A Letter of Intent (LOI) is required for this Program Announcement. 
The LOI will not be evaluated or scored. Your LOI will be used to 
estimate the potential reviewer workload and to avoid conflicts of 
interest during the review. If you do not submit a LOI, you will not be 
allowed to submit an application.
    Application Deadline Date: May 12, 2004.
    Explanation of Deadline: Applications must be received in the: 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 1040, MSC 7710, Bethesda, MD 20892-7710. 
Bethesda, MD 20817 (for express/courier service) by 4 p.m. eastern time 
on the deadline date. If you send your application by the United States 
Postal Service or commercial delivery service, you must ensure that the 
carrier will be able to guarantee delivery of the application by the 
closing date and time.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your application, contact your 
courier.

IV.4. Intergovernmental Review of Applications

    Your application is subject to Intergovernmental Review of Federal 
Programs, as governed by Executive Order (EO) 12372. This order sets up 
a system for state and local governmental review of proposed federal 
assistance applications. You should contact your state single point of 
contact (SPOC) as early as possible to alert the SPOC to prospective 
applications, and to receive instructions on your state's process. 
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Construction.
     Real estate lease or purchase.
     Vehicle purchase.
     Vehicle lease, other than rental associated with 
travel for this project.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.
    Awards will not allow reimbursement of pre-award costs.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or e-mail to: Beth Gardner, Centers for Disease Control 
and Prevention, National Immunization Program, 1600 Clifton Road, MS E-
05, Atlanta, GA 30333, Telephone Number: 404-639-6101, FAX: 404-639-
0108, E-mail: [email protected].
     Application Submission Address: Submit the original and three hard 
copies of your application by mail or express delivery service to: 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 1040, MSC 7710, Bethesda, MD 20892-7710, 
Bethesda, MD 20817 (for express/courier service).
     At the time of submission, two additional copies of the 
application must be sent to: Scientific Review Administrator Beth 
Gardner, Centers for Disease Control and Prevention, National 
Immunization Program, 1600 Clifton Road, MS E-05, Atlanta, GA 30333, 
Telephone Number: 404-639-6101, FAX: 404-639-0108, E-mail: 
[email protected].
     Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

     You 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 stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative, and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
     The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and enhance health. In the written comments, 
reviewers will be asked to evaluate the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.
     The scientific review group will address and consider each of the 
following criteria in assigning the application's overall score, 
weighting them as appropriate for each application. The application 
does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score. 
For example, an investigator may propose to carry out important work 
that by its nature is not innovative, but is essential to move a field 
forward.
     The criteria are as follows:
     Capability demonstration: The application will be evaluated based 
on response to all lettered and numbered items listed under Activities, 
and demonstration of capability of conducting these activities.
     Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics? The application will be 
evaluated based on:

     Methodology for conducting population-based 
surveillance among patients at all surveillance area hospitals. 
Applicant must provide supporting evidence that surveillance would be 
population-based.
     Methodology for conducting surveillance among 
outpatients at a representative sample of outpatient practices.
     Methodology for conducting collection of 
influenza vaccination data and data for other vaccines that will enable 
accurate estimation of vaccine coverage in the population and for 
important subgroups.
     Methodology for conducting influenza vaccine 
effectiveness studies.
     Quality of the proposed additional research 
projects, as requested in IV.2 above, regarding objectives, 
methodology/design, feasibility, and collaboration and participation of 
partner organizations and CDC.

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    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?
     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.
     Past experience of key professional staff in 
conducting work similar to that proposed in this announcement.
     Identifying key professional personnel from 
other collaborating organizations, agencies, etc. outside of the 
applicant's agency who will participate in NVSN activities, with roles 
described.
     Description of support staff and services to be 
assigned to the NVSN.
     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.
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support.
     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.
     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.
     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.
     Clear definition of the geographic area and 
population base in which the NVSN site will operate.
     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.
     Description of vaccination providers within the 
NVSN site, and availability of or participation in a vaccination 
registry.
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score: The extent to which the applicant 
demonstrates:
     A clear understanding of the background and 
objectives of this cooperative agreement program.
     A clear understanding of the requirements, 
responsibilities, problems, constraints, and complexities that may be 
encountered in establishing and operating the NVSN site.
     A clear understanding of the roles and 
responsibilities of participation in the NVSN network.
     Knowledge and understanding of current research 
and activities performed in this area, past studies, and existing 
literature.
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 CFR Part 46 
for the protection of human subjects? This will not be 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.
    Inclusion of Women and Minorities in Research: Does the application 
adequately 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; 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.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research. In addition 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). 
Provide a separate detailed budget for inpatient surveillance and 
outpatient surveillance and epidemiological and/or health services 
research studies, with accompanying justification of all operating 
expenses that is consistent with the stated objectives and planned 
activities of the project.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Center for 
Scientific Review, and for responsiveness by the NIP. Incomplete 
applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified that their application did not meet 
submission requirements.
    Applications that are complete and responsive to the PA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group or charter study section convened by NIP in accordance 
with the review criteria listed above. As part of the initial merit 
review, all applications may:

     Undergo a process in which only those 
applications deemed to have the highest scientific merit, generally the 
top half of the applications under review, will be discussed and 
assigned a priority score.
     Receive a written critique.
     Receive a programmatic second level review by 
the NIP.

    Award Criteria: Criteria that will be used to make award decisions 
include:

     Scientific merit (as determined by peer review)
     Availability of funds
     Programmatic priorities

V.3. Anticipated Announcement and Award Dates

    Announcement date: March 2004.
    Award date: August 2004.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the

[[Page 13044]]

recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

    45 CFR Part 74 and Part 92.
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements
     AR-2 Requirements for Inclusion of Woman and 
Racial and Ethnic Minorities in Research
     AR-6 Patient Care
     AR-7 Executive Order 12372
     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, if applicable
     AR-22 Research Integrity
     AR-23 States and Faith-Based Organizations
     AR-24 Health Insurance Portability and 
Accountability Act Requirements

Additional information on these requirements can be found on the CDC 
Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Semi annual progress report, (use form PHS 2590, OMB Number 
0925-0001, rev. 5/2001 as posted on the CDC Web site) no less than 30 
days before the end of the first half of the budget period. The 
progress report will serve as your non-competing continuation 
application, and must contain the following elements:

    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Additional Requested Information.
    f. Measures of Effectiveness.

    2. Financial status report and annual progress 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.
    These reports must be mailed to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    For general questions about this announcement, contact:

    Technical Information Management Section, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2700.

    For scientific/research issues, contact: Carolyn Bridges, Centers 
for Disease Control and Prevention, National Immunization Program, ESD, 
1600 Clifton Road, MS E-61, Atlanta, GA 30333, Telephone: 404-639-8689, 
E-mail: [email protected].
    Marika Iwane, Extramural Project Officer, Centers for Disease 
Control and Prevention, National Immunization Program, ESD, 1600 
Clifton Road, MS E-61, Atlanta, GA 30333, Telephone: 404-639-8769, E-
mail: [email protected].

    For questions about peer review, contact: Beth Gardner, Scientific 
Review Administrator, Centers for Disease Control and Prevention, 
National Immunization Program, OD, 1600 Clifton Road, MS E-05, Atlanta, 
GA 30333, Telephone: 404-639-6101, E-mail: [email protected].

    For financial, grants management, or budget assistance, contact: 
Peaches Brown, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2738, E-mail: [email protected].

VIII. Other Information

    http://www.cdc.gov/nip.

Sandra R. Manning, CGFM,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 04-6168 Filed 3-18-04; 8:45 am]
BILLING CODE 4163-18-M