[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)]
[Notices]
[Pages 33091-33093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15652]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99155]


Non-Invasive Diagnosis of Viral and Bacterial Sexually 
Transmitted Diseases (STDs) in Sexually Assaulted Female Adolescents 
and Children; 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 
program for non-invasive diagnosis of viral and bacterial sexually 
transmitted diseases (STDs) in sexually assaulted female adolescents 
and children. This program addresses the ``Healthy People 2000'' 
priority area of Immunization and Infectious Diseases. The purpose of 
the program is to assist Child Protection and Child Abuse and Assault 
Intervention Centers (CPCs) in conducting investigations to achieve the 
project goals to (1) evaluate use of non-invasive specimens with less 
discomfort for the patient, and greater ease of storage, transport and 
sensitivity, for diagnosis of STDs; (2) study the epidemiology of viral 
STDs among sexually abused and non-abused children and adolescents, 
specifically exploring the significance of infection with various human 
papilloma virus (HPV) types and herpes simplex virus (HSV-2), and; (3) 
determine usefulness, if any, of non-invasive assays for viral STDs in 
increasing certainty of abuse assessment. These funds would enable CPCs 
to evaluate, in real world settings, the modalities in the diagnosis of 
STDs and their role in the determination, in children, that sexual 
abuse has taken place.

B. Eligible Applicants

    Assistance will be provided only to recognized CPCs or their bona 
fide agents. For the purpose of this announcement, CPCs are limited to 
facilities, including emergency rooms, urgent care facilities, and 
child protection services that examine at least 300 patients, female 
children (aged 3-13 years of age) and adolescents (13 years 1 day to 20 
years of age), for possible sexual abuse or assault. Applicants need to 
be facilities that obtain laboratory diagnostic testing for STDs as 
part of these examinations.

    Note: Pub. L. 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 $80,000 is available in FY 1999, to fund one award. 
It is expected that the average award will be $80,000. It is expected 
that the award 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 five 
years. The funding estimate may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under 2. (CDC Activities).

1. Recipient Activities

    a. Design a protocol to:
    1. Evaluate the sensitivity and specificity of urine nucleic acid 
amplification tests for C. trachomatis and N. gonorrhoeae relative to 
the ``gold standard'' of cultures performed at the laboratory(ies) at 
which the applicant normally has its diagnostic tests performed. A 
``gold standard'' is the test to which experimental tests will be 
compared;
    2. Perform routine diagnostic tests on children and adolescents in 
whom sexual abuse or assault is suspected, including vaginal or 
cervical cultures for C. trachomatis and N. gonorrhoeae; HSV cultures 
and/or other tests as judged appropriate by applicant in a Clinical 
Laboratory Improvement Act (CLIA) approved laboratory;
    3. Evaluate the significance relative to certainty of sexual abuse, 
of finding antibody to HSV 2 or HPV by serologic tests.
    4. Evaluate the significance, by HPV type, of genital warts, 
relative to certainty of sexual abuse.
    b. Conduct epidemiologic studies to assess certainty of abuse in 
children, by whether they present with each of a variety of common 
complaints related to sexual abuse, including genital lesions, 
witnessed or reported abuse, etc.
    c. Analyze and summarize data from these studies in collaboration 
with CDC and other funded applicants for presentation, publication, and 
revision of current child sexual abuse and adolescent sexual assault 
guidelines.

2. CDC Activities

    a. Provide consultation and scientific and technical assistance in 
designing the protocol, collecting study specimens, and conducting the 
studies.
    b. Assist in the development of a research protocol for IRB review 
by all cooperating institutions participating in the research project. 
The CDC IRB will review and approve the protocol initially and on at 
least an annual basis until the research project is completed.
    c. Conduct experimental tests not performed by applicant (including 
HPV and HSV 2 serologic tests, C. trachomatis and N. gonorrhoeae urine 
nucleic acid amplification tests, and type-specific HPV tests for 
genital warts), blinded to the certainty of abuse.
    d. Assist in analysis and interpretation of data and participate in 
the timely dissemination of findings and information stemming from 
these studies.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than [12] double-spaced pages, 
printed on one side, with one-inch margins, and unreduced font.

F. Submission and Deadline

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are available in the application kit. On or before August 
15, 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 prior to the 
submission to the review panel. (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.

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G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Background

    The extent to which the applicant in the Background section 
demonstrates a clear understanding of this program and its main goals. 
The extent to which applicant demonstrates a clear understanding of the 
requirements, responsibilities, problems, constraints and complexities 
that may be encountered in conducting this study. (10 points).

2. Technical Approach

    The extent to which the applicant defined clearly the population 
base from which the participants will be enrolled. The extent to which 
the applicant defines a population base for the study that is 
appropriate in size and diversity, with high enough number of children 
and adolescents presenting with possible, probable or certain abuse or 
assault, and with high enough prevalence of the infections of interest 
for the accomplishment of proposed activities. The extent to which the 
applicant clearly describes a population served in 1998, how they came 
to the attention of the CPC, how the decision was made to test or not 
test for STDs, the outcome of these laboratory tests and how the 
determination of certainty of abuse was made. (20 points).

3. Capacity

    The extent to which the applicant demonstrates its capacity and 
ability to maintain a sufficient number of female children possibly, 
probably or definitely abused by demonstrating referral sources, and 
collaboration in past or on-going studies. The extent to which the 
applicant demonstrates its ability to develop and maintain strong 
cooperative relationships with various public and private local and 
regional medical, public health, community-based and academic 
organizations. The extent to which applicant demonstrates its ability 
to collaborate with other public and private organizations for 
conducting public health research projects and/or activities related to 
sexual abuse and/or STDs in children and adolescents. The extent to 
which applicant provides letters of support from non-applicant 
participating agencies, institutions, organizations, individuals, 
consultants, etc., indicating their willingness to participate, as 
represented in applicant's operational plan, in conducting the study. 
(25 points).

4. Operational Plan

    a. The extent to which the applicant's proposed plan for conducting 
the study and the protocol is detailed and clearly describes the 
proposed organizational and operating structure/procedures and clearly 
identifies the roles and responsibilities of all participating 
agencies, organizations, institutions, and individuals. The extent to 
which the applicant describes plans for conducting the project. The 
extent to which the applicant's plan addresses all Recipient Activities 
listed in this announcement and appears feasible and capable of 
accomplishing the purpose of the program. The extent to which the 
applicant covers Recipients Activities explained in this announcement 
(15 points).
    b. The extent to which the applicant proposal demonstrates support 
from applicant's institution and consistency with the intent of the 
RFA, its feasibility, quality of methodology and documentation of plans 
for recruitment and enrollment of study participants (10 points).
    c. 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.
    (4) A statement as to whether the plans for recruitment and 
outreach for study participants include the process for study 
establishing partnerships with community(ies) and recognition of mutual 
benefits. (5 points).

5. Personnel Qualification and Management Plan

    The extent to which the applicant identifies its own professional 
and support staff, and professional and support staff from other 
agencies, institutions, and organizations, that have the experience, 
authority and willingness to carry out recipient activities as 
evidenced by job descriptions, curriculum vitae, organizational charts, 
etc. The extent to which the applicant describes an approach to 
maintain a sufficiently flexible staffing pattern. (10 points).

6. Evaluation Plan

    The extent to which applicant provides an adequate evaluation plan, 
which includes time-based and outcome-based criteria. The quality of 
the proposed plan for monitoring accomplishments. The quality of the 
proposed evaluation plan for monitoring progress in achieving the 
purpose and overall goals of this program. (5 points).

7. Budget

    The extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of the awarded funds. 
The extent to which both Federal and non-Federal (e.g., state funding) 
contributions are presented. (Not scored).

8. Human Subjects

    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects? (Not scored).

H. Other Requirements

Technical Reporting Requirements

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

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2000
AR-12  Lobbying Restrictions
AR-15  Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Public Health Service Act, 
sections 301(a) (42 U.S.C. 241(a)) and 317(k)(2) (42 U.S.C. 
247b(k)(2)), as amended. The Catalog of Federal Domestic Assistance 
number is 93.283.

J. Where To Obtain Additional Information

    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4

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(1-888-472-6874). You will be asked to leave your name and address and 
will be instructed to identify the Announcement number of interest, 
99155.
    See also the CDC home page on the Internet web site at http://
www.cdc.gov and the program and grants office web site for additional 
funding opportunities and electronic versions of all necessary forms 
(www.cdc.gov/od/pgo/forminfo.htm).
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Gladys T. Gissentanna, 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 Number: 770-488-2753, Email Address: 
[email protected].
    For program technical assistance, contact: Dr. Consuelo Beck-Sague, 
Office of Minority Health, National Center for Infectious Diseases, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., 
Atlanta, GA 30333, Telephone Number: 404-639-3467, Email Address: 
[email protected].

    Dated: June 15, 1999.
Henry S. Cassell,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 99-15652 Filed 6-18-99; 8:45 am]
BILLING CODE 4163-18-P