[Federal Register Volume 64, Number 124 (Tuesday, June 29, 1999)]
[Notices]
[Pages 34813-34816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16473]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99131]


Active Sentinel Hospital Surveillance and Epidemiologic Studies 
for Rotavirus Gastroenteritis; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
for Active Sentinel Hospital Surveillance and Epidemiologic Studies for 
Rotavirus Gastroenteritis. This program addresses the ``Healthy People 
2000'', Immunization and Infectious Diseases.
    The purpose of the program is to provide assistance to recipients 
to develop, maintain, and evaluate surveillance for hospitalizations 
among children <5 years of age due to rotavirus gastroenteritis and to 
conduct case-control studies (enrolling patients hospitalized with 
rotavirus gastroenteritis and appropriate control subjects) to evaluate 
vaccine effectiveness and risk factors for severe rotavirus disease and 
hospitalization due to rotavirus gastroenteritis.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, and federally recognized Indian tribal 
governments, Indian tribes, or Indian Tribal Organizations.

    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible to receive Federal funds 
constituting an award, grant, cooperative agreement, contract, loan, 
or any other form.

C. Availability of Funds

    Approximately $250,000 is available in FY 1999 to fund four 
cooperative agreement awards. It is expected that there will be two 
awards at an average of $105,000 (direct and indirect costs) for sites 
which conduct active surveillance and epidemiologic studies and two 
awards at an average of $20,000 (direct and indirect costs) for sites 
which only conduct active surveillance. It is expected that the awards 
will begin on or about September 30, 1999, and will be made for a 12-
month budget period within a project period of up to 2 years. Funding 
estimates may change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.
    Applicants may request Federal personnel, equipment, or supplies 
(such as rapid antigen EIA test kits for testing hospitalized patients 
with gastroenteritis) as direct assistance, in lieu of a portion of 
financial assistance.

D. Program Requirements

    In conducting the activities to achieve the purpose of this 
program, the recipient will be responsible for the activities listed 
under A. (Recipient Activities) and CDC will be responsible for the 
activities listed under B. (CDC Activities).

A. Recipient Activities

    1. Meet three or four times each year with other funded sites to 
develop standardized research protocols (surveillance and epidemiologic 
studies).
    2. Establish, maintain, and evaluate a surveillance system for 
hospitalizations due to rotavirus gastroenteritis among children <5 
years of age in the hospital(s) affiliated with recipient institution.
    3. Collect and analyze data.
    4. Collaborate with a clinical laboratory to ensure: (1) Cases of 
pediatric gastroenteritis in the surveillance population are examined 
for rotavirus; and (2) cases of rotavirus gastroenteritis are strain 
typed.
    5. Summarize the data and disseminate findings in peer-reviewed 
journals and at professional meetings.
    6. For sites conducting both active surveillance and epidemiologic 
studies only: Conduct case-control studies. Enroll and interview 
hospitalized case-patients and age-matched control subjects from 
appropriate groups of children in order to examine vaccine 
effectiveness and identify risk factors for severe rotavirus disease 
and hospitalization due to rotavirus disease.

B. CDC Activities

    1. Provide scientific and technical assistance and coordination, as 
requested, for all phases of the study.
    2. As needed, participate in the analysis of data gathered from 
research projects and the reporting of results.
    3. Facilitate group meetings with the sites to allow for the 
exchange of information and for input into the development and 
refinement of the research and intervention protocol.
    4. Assist in the development of a research protocol for IRB review 
by each institution participating in the research project as well as 
the CDC IRB. CDC IRB will review the projects on at least an annual 
basis until the research is complete.
    5. As needed, provide clinical laboratory services, at no charge, 
to ensure cases of rotavirus gastroenteritis are strain typed.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application. Your application will be evaluated on the criteria listed, 
so it is important to follow them in preparing your research plan.
    Applicants must indicate whether they are applying to be a site 
where active surveillance will be performed (``surveillance site''), or 
to be a site where active surveillance and case-control studies will be 
performed (``combined study site''). Applicants may apply to be 
considered for either one or both study sites, but must submit separate 
applications for each type--one for funding to conduct active 
surveillance only and one to conduct surveillance and case-control 
studies only.
    The research plan for each application should include the sections 
listed in the table of contents on page CC of form PHS 398:
    1. Specific aims of the proposed rotavirus sentinel hospital 
surveillance system.
    2. Background and Significance. This section should include the 
following:

--the demographic characteristics of the population served by the 
pediatric hospital including race, ethnicity, and socio-economic data,
--detailed characteristics of the hospital including size, number of 
admissions, academic affiliation, previous experience with pediatric 
research,
--information to demonstrate that the applicant has the appropriate 
organizational structure, administrative and laboratory support, and 
ability to access appropriate target populations, current hospital 
guidelines (if any) and information about hospital practice regarding 
testing for rotavirus in cases of gastroenteritis, and current 
laboratory testing procedures for rotavirus.
    3. Preliminary studies. This section should include the following:

--number of admissions for gastroenteritis in children <5 years of age 
(by year of age)
--data on the number of admissions for laboratory confirmed rotavirus 
gastroenteritis for the target age group,

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--other available data or previous studies on rotavirus gastroenteritis 
in the surveillance population,
--information on coverage with the current routine infant 
immunizations, including rotavirus vaccine, in this population.

    4. Research Design and Methods. This section should include the 
following:

--the proposed operation of surveillance for rotavirus gastroenteritis 
in the hospital, to include details of how cases of gastroenteritis 
will be detected, how routine testing of each case for rotavirus will 
be organized, how the immunization status of case-patients will be 
verified, the type and format of data to be collected, mechanism for 
monitoring the system, and type of personnel required for obtaining and 
managing data.
--The proposed operation of case-control studies of cases of rotavirus 
gastroenteritis (if applying to perform epidemiologic studies). This 
should include a description of the populations from which control 
subjects will be selected, details of how case and control subjects 
will be selected and enrolled, possible sources of bias in selection of 
control subjects, how the immunization status of case-patients and 
control subjects will be verified, the type and format of data to be 
collected, and type of personnel required for obtaining, managing, and 
analyzing data.

    5. Current letters of support should be included if applicant 
anticipates the participation of other organizations in conducting 
proposed activities.

F. Submission and Deadline

Letter of Intent

    In order to assist CDC in planning and executing the evaluation of 
applications submitted under this announcement, all parties intending 
to submit an application are requested to submit a letter of intent. 
Your letter of intent should include the following information. (1) 
Name and address of institution, and (2) name, address, and telephone 
number of contact person, (3) identification of type site(s). On or 
before July 16, 1999, submit the letter of intent to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.

Application

    Submit the original and five copies of PHS 398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet). 
Forms are in the application kit. On or before August 18, 1999, submit 
the application to the Grants Management Specialist identified in the 
``Where to Obtain Additional Information'' section of this 
announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
orderly processing. (Applicants must request a legibly dated U.S. 
Postal Service postmark or obtain a legibly dated receipt from a 
commercial carrier or U.S. Postal Service. Private metered postmarks 
shall not be acceptable as proof of timely mailing.)
    Late Applications: Applications which do not meet the criteria in 
(a) or (b) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC. 
Applications for ``Surveillance Sites'' will be evaluated against 
Criteria A., and applications for ``Combined Sites'' will be Evaluated 
against Criteria B.

A. Surveillance sites

11. Specific aims: (5 percent)
    The extent to which the applicant demonstrates an understanding of 
the purpose of the proposed rotavirus sentinel hospital surveillance 
system activity and the feasibility of accomplishing the outcomes 
described.
2. Background and Significance: (15 percent)
    The extent to which background information and other data 
demonstrate that the applicant (a) has the appropriate organizational 
structure, administrative and laboratory support, and the ability to 
access and test cases of gastroenteritis admitted to the hospital and 
affiliated emergency department and (b) has experience with conducting 
pediatric research.
3. Preliminary Studies: ( 30 percent)
    (a) The extent to which the applicant demonstrates that the 
participating hospital(s) will have sufficient rotavirus admissions 
among children <5 years of age to provide adequate statistical power 
for surveillance studies (i.e. >150 admissions per year due to 
gastroenteritis or >75 admissions per year due to rotavirus 
gastroenteritis),
    (b) The extent to which background information and other data 
demonstrate that uptake of rotavirus vaccine is likely to be 
substantial in the population served by the hospital in the first 2 
years of surveillance, and the extent to which the applicant 
demonstrates capacity for estimation of rotavirus immunization coverage 
rates during the study period,
    (c) The extent to which previous studies demonstrate experience and 
expertise in conducting studies on rotavirus in this population.
4. Research Design and Methods: (35 percent)
    The adequacy of the plan for detecting, testing for rotavirus, and 
obtaining and reporting information, including verified immunization 
histories on cases of childhood gastroenteritis, and the extent to 
which these proposed methods of testing will ensure complete monitoring 
for rotavirus of all cases of gastroenteritis admitted.
    5. Qualifications of Key Personnel: (15 percent)
    Qualifications, including training and experience, of key project 
personnel and the projected level of effort by each toward 
accomplishment of the proposed activities.
6. Budget (not scored)
    Extent to which the line-item budget is detailed, clearly 
justified, and consistent with the purpose and objectives of this 
program.
7. Human Subjects (not scored)
    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects?
8. Inclusion of Women and Racial and Ethnic Minorities in Research (not 
scored)
    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:
    A. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    B. The proposed justification when representation is limited or 
absent.
    C. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    D. 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.

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B. Combined Study Sites

1. Specific Aims: (5 percent)
    The extent to which the applicant demonstrates an understanding of 
the purpose of the proposed rotavirus sentinel hospital surveillance 
system activity and the feasibility of accomplishing the outcomes 
described.
2. Background and Significance: (10 percent)
    The extent to which background information and other data 
demonstrate that the applicant (a) Has the appropriate organizational 
structure, administrative and laboratory support, and the ability to 
access and test cases of gastroenteritis admitted to the hospital and 
affiliated emergency department and (b) has experience with conducting 
pediatric research.
3. Preliminary studies: (25 percent)
    (a) The extent to which the applicant demonstrates that the 
participating hospital(s) will have sufficient rotavirus admissions 
among children <5 years of age to provide adequate statistical power 
for surveillance studies (i.e., >150 admissions per year due to 
gastroenteritis or >75 admissions per year due to rotavirus 
gastroenteritis),
    (b) The extent to which background information and other data 
demonstrate that uptake of rotavirus vaccine is likely to be 
substantial in the population served by the hospital in the first 2 
years of surveillance, and the extent to which the applicant 
demonstrates capacity for estimation of rotavirus immunization coverage 
rates during the study period,
    (c) The extent to which previous studies demonstrate experience and 
expertise in conducting studies on rotavirus in this population.
4. Research design and methods: (45 percent)
    (a) The adequacy of the plan for detecting, testing for rotavirus, 
and obtaining and reporting information, including verified 
immunization histories on cases of childhood gastroenteritis, and the 
extent to which these proposed methods of testing will ensure complete 
monitoring for rotavirus of all cases of gastroenteritis admitted.
    (b) Ability to enroll and interview an adequate (>50 per year) 
number of hospitalized children with cases of rotavirus 
gastroenteritis.
    (c) Adequacy of the plan for selecting, enrolling, and interviewing 
suitable controls, including the plan for obtaining a suitable number 
of controls per case to obtain a study with adequate power to assess 
vaccine effectiveness and risk factors; adequacy of the plan to 
minimize potential sources of bias in the selection of control 
populations.
5. Qualifications of key personnel: (15 percent)
    Qualifications, including training and experience, of key project 
personnel and the projected level of effort by each toward 
accomplishment of the proposed activities.
6. Budget (not scored)
    Extent to which the line-item budget is detailed, clearly 
justified, and consistent with the purpose and objectives of this 
program.
7. Human Subjects (not scored)
    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects?
8. Inclusion of Women and Racial and Ethnic Minorities in Research (not 
scored)
    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:
    A. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    B. The proposed justification when representation is limited or 
absent.
    C. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    D. 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.

H. Other Requirements

    Technical Reporting Requirements
    Provide CDC with original plus two copies of:
    1. Semiannual progress reports.
    2. Financial Status Report (FSR), no more than 90 days after the 
end of the budget period
    3. Final FSR and performance report, no more than 90 days after the 
end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Addendum I in the 
application kit.

AR 98-1  Human Subjects Requirements
AR 98-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR 98-7  Executive Order 12372 Review
AR 98-9  Paperwork Reduction Act Requirements
AR 98-10  Smoke-Free Workplace Requirements
AR 98-11  Healthy People 2000
AR 98-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a) and 317(k)(1) and 
(K)(2) of the Public Health Service Act [42 U.S.C. 241(a), 247b(K)(1) 
and (k)(2)].

The Catalog of Federal Domestic Assistance Number is 93.185.

J. Where To Obtain Additional Information

    This and other CDC announcements may be viewed and downloaded from 
the CDC homepage on the Internet, at: http://www.cdc.gov. Click on 
``funding opportunities.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and you will be instructed to identify 
the Announcement number of interest. If you have questions after 
reviewing the contents of all documents, business management technical 
assistance may be obtained from: Sharron Orum, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, 
Room 3000, Atlanta, GA 30341-4146, Telephone: (770) 488-2716, E-Mail: 
[email protected].
    Programmatic technical assistance may be obtained from:

Charles Vitek, M.D., Medical Epidemiologist, Epidemiology and 
Surveillance Division, National Immunization Program, Mailstop E-61, 
Centers for Disease Control and Prevention (CDC), Telephone: (404) 639-
8715, E-Mail: [email protected]
    OR
Rebecca Prevots, Ph.D., Epidemiologist, Epidemiology and Surveillance 
Division, National Immunization Program, Mailstop E-61, Centers for 
Disease Control and Prevention (CDC), Telephone (404) 639-8255, E-Mail: 
[email protected]
    OR
Joseph Bresee, M.D., Medical Epidemiologist, Viral and Rickettsial 
Diseases, Natl. Center for Infectious

[[Page 34816]]

Diseases, Mailstop A-34, Centers for Disease Control and Prevention 
(CDC), Atlanta, GA 30333, Telephone: (404) 639-4651, E-Mail: 
[email protected]

    Dated: June 23, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-16473 Filed 6-28-99; 8:45 am]
BILLING CODE 4163-18-P