[Federal Register: March 19, 2004 (Volume 69, Number 54)]
[Notices]
[Page 13039-13044]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19mr04-55]
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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
[[Page 13040]]
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:
GrantsInfo@nih.gov.
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
[[Page 13042]]
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 http://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: BGardner@cdc.gov.
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:
BGardner@cdc.gov.
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.
[[Page 13043]]
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: CBridges@cdc.gov.
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: MIwane@cdc.gov.
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: BGardner@cdc.gov.
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: POBrown@cdc.gov.
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