[Federal Register Volume 69, Number 47 (Wednesday, March 10, 2004)]
[Notices]
[Pages 11438-11444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5330]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Varicella and Viral Vaccine Preventable Disease Surveillance and 
Epidemiologic Studies

    Announcement Type: New.
    Funding Opportunity Number: PA 04116.
    Catalog of Federal Domestic Assistance Number: 93.185.
    Key Dates:
    Letter of Intent Deadline: March 22, 2004.
    Application Deadline: May 12, 2004.

I. Funding Opportunity Description

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

    Purpose: The purpose of the program is to support population-based 
active surveillance for varicella, herpes zoster, and other viral 
Vaccine Preventable Diseases (VPD), to assess vaccination coverage by 
age group and to conduct applied epidemiological research on the above 
mentioned viral VPD. This program addresses the ``Healthy People 2010'' 
focus area(s) of priority 20.
    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 varicella and other viral 
VPDs.
    Research Objectives: 1.To evaluate the impact of varicella 
vaccination program on varicella disease and herpes zoster, including 
the impact of disease control and prevention activities.
    2. To conduct applied epidemiological research related to 
varicella, herpes zoster, varicella vaccine policy and/or other viral 
VPD.
    3. To conduct a study to assess immunity against varicella among 
vaccinated health care workers. For those who lack detectable 
antibodies, measure anamnestic response after receiving a third dose.
    4. To evaluate the burden of disease of one or more current VPD, 
like influenza, or that may be vaccine preventable in the future like 
rotavirus, human papillomavirus (HPV), herpes simplex virus type 2 
(HSV2), respiratory syncytial virus (RSV), or CMV cytomegalovirus 
(CMV).
    Applicants may apply for objective 1, 2, 3, and 4 alone, or any or 
all combination of the four components. Separate budgets are required 
for each program component.
    Activities: Awardee activities for this program are as follows: 
Under objective 1:
     Implement, conduct, maintain, and evaluate 
active population based surveillance systems with the capacity to 
monitor varicella and/or herpes zoster disease. To ensure statistical 
validity, these surveillance areas must have populations of at least 
300,000 for varicella and at least 500,000 for herpes zoster to provide 
a sufficient number of varicella and herpes zoster cases each year.
     Perform case investigations for varicella and/or 
herpes zoster, for all ages, and collect, analyze, and disseminate 
information using these data.

[[Page 11439]]

     Collect and report information on vaccine 
coverage by age group. For varicella age group: less than 1 year, 1 
year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8-9 years, 
10-12 years, 13-14 years, 15-19 years and greater than 20 years.
     Develop, implement and evaluate varicella 
prevention and control strategies including outbreak control.
     Provide laboratory specimens such as disease-
causing isolates to appropriate organizations (which may include CDC) 
for laboratory evaluation needed for varicella and/or herpes zoster 
surveillance or as part of epidemiological studies on varicella and/or 
herpes zoster, e.g. virus strain identification, confirmation of 
breakthrough disease, and molecular epidemiological studies.
     Function as part of a network of surveillance 
sites. Submit data to CDC according to project procedures.
    Under Objective 2:
     Conduct applied epidemiological research for 
varicella and/or herpes zoster. Examples of such projects include but 
are not limited to the following: evaluation of risk factors for 
varicella vaccine failure; evaluation of completeness of reporting by 
age group; risk factors for severe varicella disease and 
hospitalization; evaluation of vaccine effectiveness; measurement of 
reliability of physician diagnosis of breakthrough disease; assessment 
of duration of immunity to varicella among vaccinees in low-varicella 
incidence settings; virus strain identification for herpes zoster in 
vaccinees; assessment of herpes zoster hospitalizations and trend of 
herpes zoster over time.

And/or

     Conduct applied epidemiological research for 
other viral VPD. Examples of such projects include but are not limited 
to the following: risk factors for severe influenza disease and 
hospitalization; studies of vaccine effectiveness; planning and 
implementation of community based demonstration/interventions to 
increase vaccination; impact evaluation of implemented demonstration/
interventions on disease incidence and prevalence; evaluation of cost 
effectiveness of suggested demonstration/interventions as well as 
illness and severity.
    Under objective 3:
     The study is going to assess the need for a 
third dose of varicella vaccine among health care workers (HCW) who are 
seronegative after having received two doses. To ensure statistical 
power, the study site should demonstrate ability to enroll at least 200 
HCW who have previously received two doses of varicella vaccine (based 
on assumption of 15 percent susceptibility among vaccinated HCW).
     Identify HCW who have previously received two 
doses of varicella vaccine. Obtain blood samples and send them to CDC 
for serologic and cellular immunity testing. Through interviews and 
using standardized forms, collect data on potential risk factors 
(demographics, varicella vaccination and disease history, time since 
vaccination, work place/type (pediatrics, infectious disease, etc), 
children at home, underlying disease, and exposure to varicella cases 
since vaccination) for susceptibility following two doses. Administer a 
third dose of varicella vaccine to HCW who are seronegative as measured 
by IgG gpELISA and collect blood samples seven to ten days and four to 
six weeks after vaccination for testing humoral and cellular immunity. 
Calculate the proportion of HCW who are protected by showing an 
anamnestic response as measured by antibody levels and correlate it to 
their cell mediated immunity (CMI) response prior to third dose. 
Examine risk factors for not having antibodies following two doses.
    Under Objective 4:
     Implement, maintain, and evaluate a surveillance 
system with the capacity to monitor one or more viral VPD (other than 
varicella and herpes zoster) like influenza, rotavirus, HPV, HSV2, RSV, 
or CMV. To ensure statistical validity, these surveillance areas must 
have populations of at least 500,000 to provide a sufficient number of 
cases each year and include child care centers and schools among the 
sites under surveillance.
     Develop, implement and evaluate influenza and/or 
other viral VPD prevention and control strategies among children.
     Provide laboratory specimens such as disease-
causing isolates to appropriate organizations (which may include CDC) 
for laboratory evaluation needed for influenza and/or other viral VPD 
surveillance or as part of epidemiological studies on influenza and/or 
other viral VPD, e.g. virus strain identification and molecular 
epidemiological studies.

For those choosing influenza, activities may consider:

     Collect and report information on vaccine 
coverage by age group. For influenza age groups: 6-23 months and their 
household contacts; at risk children 2-7 years, 8-19 years and their 
household contacts.
     Evaluate the feasibility of pediatric hospital-
based influenza virologic data for following trends in the impact of 
influenza in children 6-23 months old.
     Conduct applied epidemiological research for 
influenza. Examples of such projects include but are not limited to the 
following: risk factors for severe influenza disease and 
hospitalization; studies of vaccine effectiveness; planning and 
implementation of community based demonstration/interventions to 
increase influenza vaccination; measure impact and monitor 
implementation of the Advisory Committee on Immunization Practices 
(ACIP) recommendations for influenza vaccination of 6-23 month old 
children, at-risk children, and their household contacts: offering 
influenza vaccination at obstetrics and gynecology clinics, public 
health clinics, private providers, day care facilities, school based 
vaccination, and others; evaluation of cost effectiveness of suggested 
demonstration/interventions.
    General Activities (for all objectives):
     Manage, analyze and interpret data and present 
and publish important public health findings.
     Participate in planning meetings to coordinate 
varicella, herpes zoster, other viral VPD, and influenza project 
activities.
     Provide surveillance data on a quarterly basis 
and provide semiannual progress reports for varicella, herpes zoster, 
and other viral VPD and provide timely progress reports for influenza 
during influenza season and the recommended influenza vaccination 
period (September-May).
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
     Provide consultation, scientific and technical 
assistance in general operation of the project and in the design and 
conduct of applied research projects.
     Provide assistance to recipients regarding 
development and implementation of all surveillance activities, data 
collection methods including a standard case investigation form, and 
analysis of data.
     Assist in the development and implementation of 
a standard data management process, including development of computer 
programs for data entry and interim analyses.
     Assist in monitoring and evaluating scientific 
and operational accomplishments of the varicella, herpes zoster, other 
viral VPD, and influenza projects and progress in achieving the purpose 
and overall goals of this program.

[[Page 11440]]

     Participate in analysis and interpretation of 
data and in presentation and publication of findings.
     In addition, for Objective 3, conduct serologic 
and CMI testing on the samples collected.

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: $932,600.
    Approximate Number of Awards: Two to five.
    Approximate Average Award: $460,000 (This amount is for the first 
12-month budget period, and includes both direct and indirect costs).
    Floor of Award Range: $100,000.
    Ceiling of Award Range: $603,000.
    1. Varicella and/or herpes zoster surveillance (objective 1): 
Varicella/herpes zoster surveillance: $200,000; varicella surveillance 
alone: $150,000; herpes zoster surveillance alone: $100,000
    2. Varicella-herpes zoster, other viral VPD epidemiological 
research (objective 2): $150,000
    3. Varicella HCW study (objective 3): $102,600
    4. Influenza and/or other viral VPD surveillance (objective 4): 
$150,000
    Anticipated Award Date: August, 2004.
    Budget Period Length: 12 Months.
    Project Period Length: Five Years. For Objective 3, project period 
is 12 months.
    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
     Indian tribes
     Indian tribal organizations
     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)
     Political subdivisions of States (in 
consultation with States)
    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.

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.
    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 0925-0001 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 instructions 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].
    You must submit a research plan narrative with your application 
forms. The narrative must be submitted in the following format:
     Maximum number of pages: 30. If your narrative 
exceeds the page limit, only the first pages which are within the page 
limit will be reviewed.
     Font size: 12 point unreduced
     Double spaced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Single spaced, printed only on one side of page
     Held together only by rubber bands or metal 
clips; not bound in any other way.
    Your research plan narrative should address the activities listed 
for the objectives/program components you are responding to, and which 
will be conducted over the entire project period, and must include the 
following items in the order listed: Background, Objectives, Methods, 
Plan of Operation, Plan of Evaluation and a separate Budget for each 
submitted program component. The Budget will not be counted as part of 
the stated page limit.

[[Page 11441]]

    For each one of the program components you are responding to, the 
narrative should describe (where pertinent):
     The demographic characteristics of the general 
population which the surveillance system will cover.
     The epidemiology of varicella, herpes zoster, 
other viral VPD, and influenza. For varicella baseline epidemiological 
data, the time period in the surveillance population should be 1995-
2003 and varicella vaccine coverage among specified age groups during 
the period 1995-2003. The availability of historical data for baseline 
disease trends for varicella by age group prior to, and following, 
implementation of a varicella vaccination program is required. These 
data should be comparable to that proposed for collection through this 
project in order to monitor trends. For other viral VPD and influenza, 
the time period would be two to three years of baseline data in 2000-
2003. If available, for other viral VPD and influenza, vaccine coverage 
among specified age groups during the same period should be presented.
     The sources of reporting within the reporting 
area under study: Appropriate reporting and sources for surveillance 
should be identified and described in detail. If sampling is proposed, 
it must be described in detail including how it will be performed and 
how validity will be assured.
     The operation of the varicella, herpes zoster, 
and other viral VPD surveillance system and monitoring of influenza 
impact in children: This should include details of reporting, type and 
format of data to be obtained, mechanism for monitoring the system, and 
personnel requirements for obtaining, managing and analyzing data. The 
proposed systems should provide the basis for epidemiological studies 
of the impact of varicella, other viral VPD, and influenza vaccine, 
identify cases occurring in vaccinated individuals, document the 
severity of disease and facilitate public health action.
     A brief proposal for implementing and evaluating 
a disease prevention and/or control strategy for varicella, other viral 
VPD, and influenza.
     A brief proposal for applied epidemiological 
research studies (addressing issues other than disease prevention and 
control strategies) for varicella, herpes zoster, other viral VPD, and 
influenza. It would be advantageous to indicate the existence or the 
proposed establishment of collaboration with a state/city health 
department for outbreak response/prevention/control activities under 
applied epidemiological research.
     Background information and other data to 
demonstrate that the applicant has the appropriate organizational 
structure, administrative support, and ability to access appropriate 
target populations or study subjects.
    Additional information may be included in the application 
appendices. The appendices will not be counted toward the narrative 
page limit. This additional information includes:
     The qualifications, including training and 
experience, of project personnel, and projected level of effort by each 
toward accomplishment of the proposed activities.
     Letters of support.
     Documentation of bona fide agent status.
     Curricular vitas.
    Budget--Budget section should have separate line items for (1) 
Varicella and/or herpes zoster surveillance; (2) epidemiologic studies 
of varicella, herpes zoster, and/or other viral VPD; (3) Varicella HCW 
study; (4) Other viral VPD surveillance. For each line item show both 
Federal and non-Federal (e.g., State funding) shares of total cost. A 
budget justification is required for all budget items, consistent with 
the purpose and objectives of the program. Letters of support should be 
included if applicants anticipate the participation of other 
organizations in conducting proposed activities.
    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 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 22, 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 Deadlines: 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, first 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
    Awards will not allow reimbursement of pre-award costs. 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

[[Page 11442]]

a provisional rate, the agreement should be less than 12 months of age.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Beth Gardner, National Immunization 
Program, Centers for Disease Control and Prevention (CDC), 1600 Clifton 
Road, MS E-05, Atlanta, GA 30333, Telephone: 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. 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:
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?
     Adequacy of baseline data and availability of 
trend data for the diseases under surveillance and the proposed viral 
VPD as indicated under activities; and comparability of these data to 
the proposed surveillance system where adequate.
     Clear definition of the geographic area and 
population base in which the surveillance and proposed activities site 
will operate.
     Detailed description of the demographics of the 
proposed population base including the extent to which the population 
base is diverse in terms of demographics and special populations.
     Understanding the objectives of the cooperative 
agreement by demonstrating a clear understanding of the background and 
objectives and the feasibility of accomplishing the outcomes described.
     Quality of the proposed activities under program 
objectives regarding consistency with public health needs, intent of 
this program, feasibility, methodology/approach, and collaboration/
participation of partner organizations.
    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?
    For objective 1:
     Description of existing capacity to perform 
surveillance for varicella and/or herpes zoster and to assess vaccine 
impact.
     Adequacy of plan for performing and maintaining 
varicella and/or herpes zoster surveillance and the extent to which the 
proposed sources of case report will ensure adequate sample size and 
representativeness of populations under surveillance.
     Adequacy of plan for monitoring varicella 
vaccine coverage.
     Description of plan for obtaining information on 
varicella vaccine coverage by age group on an ongoing basis.
     Adequacy of plans for data management and 
analysis.
     Methodology for conducting population-based 
surveillance.
    Under objectives 2 and 3:
     Description of existing capacity to perform 
applied epidemiological research on varicella, herpes zoster, and/or 
other viral VPD.
     Methodology for conducting applied 
epidemiological research on varicella, herpes zoster, and/or other 
viral VPD.
     Methodology for conducting vaccine effectiveness 
studies (Objective 2).
     Quality of the proposed applied epidemiological 
research projects, as requested under the Activities section above, 
regarding objectives, methodology/design, feasibility, and 
collaboration and participation with partner organizations like local 
and state health departments.
    Under Objective 4:
     Description of existing capacity to perform 
surveillance for other viral VPD and to assess vaccine impact.
     Adequacy of plan for performing and maintaining 
other viral VPD surveillance and the extent to which the proposed 
sources of case report will ensure adequate sample size and 
representativeness of populations under surveillance.
     Description of plan for obtaining information on 
vaccine coverage by age group on an ongoing basis.
     Adequacy of plans for data management and 
analysis.
     Methodology for conducting population-based 
surveillance.
    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    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)?
     Identification of applicant's key professional 
personnel to be assigned to manage/perform/implement activities under 
objectives 1-2-3-4 of the program (provide curriculum vitae for each in 
an appendix). Clear identification of their respective roles and 
responsibilities as well as management and operational plan.
     Descriptions of their experience in conducting 
work similar to that proposed in this announcement.
     Description of all support staff and services to 
be assigned to the different activities under program objectives.
     Proven record/publications of surveillance/
research experience of key

[[Page 11443]]

investigator(s) (PI and main researchers) on the disease subjects 
considered under the applicant's response.
    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?
     Operational Plan: The plan should identify the 
proposed organizational and operating structure/procedures including 
the roles and responsibilities of all participating agencies, 
organizations, institutions, and individuals.
     Description of applicant's partnerships with 
necessary and appropriate organizations for establishing and operating 
the proposed varicella, herpes zoster, and/or other viral VPD 
surveillance as well as applied epidemiological research including 
appropriate public health action in response to outbreaks.
     Ability to function as part of a surveillance 
network. The extent to which the applicant describes plans for 
collaboration with other varicella and/or herpes zoster surveillance 
sites in the establishment and operation of the varicella and/or herpes 
zoster surveillance, including project design/development (e.g., 
protocols) and synthesis and dissemination of findings.
     The degree to which the applicant has met the 
CDC Policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research. This includes: (1) The proposed 
plan for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation; (2) the proposed 
justification when representation is limited or absent; (3) a statement 
as to whether the design of the study is adequate to measure 
differences when warranted; and (4) a statement as to whether the plans 
for recruitment and outreach for study participants include the process 
of establishing partnerships with community(ies) and recognition of 
mutual benefits.
     Demonstration of support for non-applicant 
participating agencies, institutions, organizations, etc. indicated in 
applicant's operational plan. Applicant should provide (in an appendix) 
letters of support which clearly indicate collaborators' willingness to 
be participants in surveillance and applied epidemiological research 
activities. Do not include letters of support from CDC personnel.
    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. 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 each objective you are 
applying for, 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 National Immunization 
Program. 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 the National 
Immunization Program 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.
     Programmatic priorities receive a programmatic 
second level review by the National Immunization Program.
    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 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 Women and 
Racial and Ethnic Minorities in Research
     AR-6 Patient Care
     AR-7 Executive Order 12372
     AR-8 Public Health System Reporting Requirements
     AR-9 Paperwork Reduction Act Requirements

[[Page 11444]]

     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
     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 after 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: Dalya Guris, Extramural 
Project Officer, National Immunization Program, Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road, MS E-61, Atlanta, GA 
30333, Telephone: 404-639-6205, E-mail: [email protected].
    For questions about peer review, contact: Beth Gardner, Scientific 
Review Administrator, National Immunization Program, Centers for 
Disease Control and Prevention (CDC), 1600 Clifton Road, MS E-05, 
Atlanta, GA 30333, Telephone: 404-639-6101, FAX: 404-639-0108, 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.

    Dated: March 4, 2004.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-5330 Filed 3-9-04; 8:45 am]
BILLING CODE 4163-18-P