[Federal Register Volume 67, Number 131 (Tuesday, July 9, 2002)]
[Notices]
[Pages 45520-45523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02184]


Monitoring Trends in Prevalence of Sexually Transmitted Disease 
(STD), Tuberculosis (TB), and Humans Immunodeficiency Virus (HIV) Risk 
Behaviors Among Men Who Have Sex With Men (MSM); Notice of Availability 
of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a competitive 
cooperative agreement for Monitoring Trends in Prevalence of STDs, TB, 
and HIV Risk Behaviors among (MSM) in facilities providing health 
services to this population. This program addresses the ``Healthy 
People 2010'' focus area(s) of STD, HIV, and Immunization and 
Infectious Diseases.

Objectives

    The objectives for this program are:
    (1) To assess the prevalence of, and monitor trends in STDs, TB, 
and HIV risk behaviors among MSM in clinics serving a substantial 
number of HIV positive MSM, and;
    (2) To enhance local prevention services for these populations.
    Recent outbreaks of STDs and TB among MSM, many of whom are HIV 
positive, have identified substantial weaknesses in STD and TB 
surveillance and control efforts and the need for preventive efforts 
among this population. Prevention of STDs and HIV in this population is 
critical to preventing STD, TB, and HIV transmission.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goals for the National Center for 
HIV, STD and TB Prevention: (1) Improve STD and TB surveillance and 
control efforts among the MSM population; and (2) Improve HIV and STD 
prevention programs and continuity of care in the MSM population.

B. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 317 and 317E of the PHS 
Act, 42 U.S.C. 247b and 247b-6. The Catalog of Federal Domestic 
Assistance number 93.977.

C. Eligible Applicants

    Limited Competition: Funding is limited to state and local 
governments that received funding under prior announcements.
    Assistance will be provided only to project areas which received FY 
1999, 2000, or 2001 Competitive Supplemental Funds For Comprehensive 
STD Prevention Systems for ``Monitoring Trends in Prevalence of STDs, 
TB, and HIV Risk Behaviors among MSM,'' Program Announcement 99000. 
Prior supplemental award recipients are uniquely qualified because they 
have an established prevalence monitoring project currently in place 
for STDs, TB, and HIV risk behaviors among MSM. Applicants should 
review section J. ``Where to Obtain Additional Information'' on page 21 
of this program announcement.

D. Availability of Funds

    Approximately $200,000 is available in FY 2002 to fund up to six 
awards. It is expected that the average award will be $45,000, ranging 
from $30,000 to $60,000. The awards will begin on or before September 
30, 2002. Awards will be made for a 12-month budget period within a 
project period of up to three

[[Page 45521]]

years (funding estimates may change). Project areas are expected to 
sustain these projects beyond the period for which funding is provided.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by quality of 
quarterly data submitted and availability of funds.
    Funding is viewed as money for an activity that is expected to 
continue, in full or in part, beyond the project period using other 
local or CDC funds.

1. Use of Funds

    Funds are awarded for a specifically defined purpose and may not be 
used for any other purpose or program. Funds may be used to support 
personnel and to purchase equipment, supplies, and services directly 
related to project activities. Funds must be used to improve the 
collection, management, and reporting of data and, if needed, to 
supplement prevention activities at participating facilities. Funds may 
not be used to provide medical care or for pharmaceuticals.

2. Recipient Financial Participation

    Recipient financial participation is required for this program in 
accordance with this program announcement. Recipients will be required 
to provide 1:3 matching funds (i.e., $1 of new state or local, public 
or private resources for each $3 of federal resources awarded). New 
resources may include newly identified funds or newly identified in-
kind resources. Matching funds may be used to support laboratory 
testing or personnel but may not be used for pharmaceuticals.

3. Funding Preferences

    Funds may be awarded as to achieve geographical diversity.

E. 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. Assess which HIV-care facilities in the project area perform 
routine STD screening. Preferably, facilities will be chosen where 
routine screening is conducted.
    b. Collaborate with one or more facilities serving a total of 
approximately 25 different HIV-positive MSM per month. These may be 
primary care clinics, HIV clinics, managed care organizations, or other 
sites providing primary care services.
    c. Provide STD testing data (optimally for chlamydia, gonorrhea, 
and syphilis) for at least 25 consecutive HIV-positive MSM per month. 
If a single facility does not have this many entrants or clinic visits 
per month, the recipient may identify additional facilities that would 
participate in providing the required sample size.
    d. Each participating facility must conduct tuberculin skin tests 
(TSTs), placed using the Mantoux method, for MSM with HIV infection. 
For HIV-positive MSM tested for TB, information on history of prior TB 
disease, prior TST status, TST results, follow-up for TST-positive 
patients (chest X-ray results, therapy) is required.
    e. For each person examined or tested, participating facilities 
must collect the following core data elements in a standardized format: 
date of visit, unique patient identification number, sex, age or date 
of birth, race/ethnicity, zip code or census tract of residence, gender 
of sex partners, STD symptoms, exam findings, and STD laboratory 
results (chlamydia, gonorrhea, and syphilis).
    f. In addition, collecting the following HIV risk behavior and 
clinical data (for the last 30 days) is preferable, but not required: 
Self-identified sexual orientation; number of male and female sex 
partners; type of sex (oral/anal/vaginal); condom use with various 
types of sex; whether the person has anonymous sex; number of new sex 
partners; sex with a known HIV-infected partner; CD4 count; viral load; 
if currently on HAART therapy; and illicit drug use.
    g. Data management: Data should be computerized, in line-listed 
format to facilitate local analyses and reported quarterly to CDC. 
Demonstrated capacity to organize, manage, and clean data.
    h. Data analysis and dissemination: Demonstrated capacity to 
analyze data and disseminate findings to public health officials and 
community planning groups.
    i. Commitment to and plan for long-term sustainability of the 
project.
    j. Integrated involvement in this project by local STD, TB, and 
HIV/AIDS communicable disease surveillance units.
    k. Electronically transmit data to CDC on a quarterly basis.
    l. Applicants are required to provide Measures of Effectiveness 
that will demonstrate the accomplishment of the various identified 
objectives of the grant. Measures must be objective/quantitative and 
must measure the intended outcome. These Measures of Effectiveness 
shall be submitted with the application and shall be an element of the 
evaluation.

2. CDC Activities

    a. Conduct one site visit to each funded project for technical 
assistance.
    b. Provide technical assistance, if requested, in the design and 
conduct of the project.
    c. As needed, assist in designing a data management system and as 
needed assist in designing data analyses to help guide STD and TB 
prevention and intervention activities.

F. Content

Letter of Intent (LOI)

    An LOI is required for this program. The program announcement title 
and number must appear in the LOI. The narrative should be no more than 
two double-spaced pages, printed on one side, with one-inch margins, 
and unreduced fonts. Your letter of intent will be used only as an 
indicator of the number of applications CDC will receive and will 
assist CDC staff in preparing and coordinating the review process. 
Therefore, your letter of intent should state your plans to submit an 
application.
    Use the information in the Program Requirements, Other 
Requirements, Evaluation Criteria, and this section to develop the 
application content. Describe your project plan, and budget as outlined 
below. Then review the evaluation criteria listed below. Your 
application will be evaluated on the criteria listed, so it is 
important to organize your application by these criteria. Applicants 
may submit more than one proposal, but the average award will be 
$45,000.
    The narrative should be no more than ten double-spaced pages, and 
printed on one side with one-inch margins, unreduced fonts, and a 
number on each page. Applications with more than ten double-spaced 
pages will be returned and not reviewed. Please attach a budget with 
narrative and calculations to support all proposed amounts. Please 
provide only attachments or appendices that are directly relevant to 
this request for funding. The table, budget and attachments/appendices 
are not included in the count for the ten page limit.

Project Plan

    Describe your project plan and include a time frame for 
implementation. Indicate what services will be provided and what 
medical and risk behavior data will be collected and provided to the 
local health department and to CDC. Describe the difficulties, if

[[Page 45522]]

any, in putting data in the standardized format Describe what changes, 
if any, would be made to the current system, with respect to collection 
and management of data and provision of medical services. If you cannot 
examine or test all HIV-positive MSM at participating facilities, 
describe to whom services would be offered, and explain how you would 
quantify acceptance of services. Briefly mention how you will 
disseminate the findings from this project and how this project will 
contribute to local planning for prevention of STDs, HIV infection, and 
tuberculosis.

Budget

    Provide a justified budget for use of CDC funds. Describe any other 
STD-related projects funded by CDC that are currently in place or which 
will be implemented in the same facilities; describe any overlap with 
this project.
    The budget will be reviewed to determine the extent to which it is 
reasonable, clearly justified, consistent with the intended use of 
funds.
    a. Submit a line-item itemized budget with narrative justification 
and any other information to demonstrate that the request for CDC 
assistance is consistent with the purpose and objectives of this 
cooperative agreement program;
    b. Describe any other STD-related projects funded by CDC that are 
currently in place or which will be implemented in the same facilities; 
describe any overlap with this project.
    c. For contracts, include the name of the person or firm to receive 
the contract, itemized budget with narrative justification, the method 
of selection, the period of performance, method of accountability, and 
a description of the contracted service requested.

G. Submission and Deadline

Letter of Intent (LOI)

    On or before July 12,2002 submit the original and two copies of 
your 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 two copies of PHS 5161-1 (OMB Number 0920-
0428) and, if applicable, the Optional Form 310, ``Protection of Human 
Subjects Assurance Identification/Certification/ Declaration''. Forms 
are available in the application kit and at the following Internet 
address: http://www.cdc.gov/od/pgo/forminfo.htm.
    Application forms must be submitted in the following order:

Cover Letter
Table of Contents
Application
Budget Information Form
Budget Justification
Checklist
Assurances
Certifications
Disclosure Form
HIV Assurance Form (if applicable)
Human Subjects Certification (if applicable)
Indirect Cost Rate Agreement (if applicable)
Narrative
    The application must be received on or before August 5, 2002. 
Submit your application to the: Technical Information Management 
Section, 2920 Brandywine Road, Suite 3000, Atlanta, Georgia 30341.
    Deadline: Letters of intent and applications shall be considered as 
meeting the deadline if they are received before 5 P.M. Eastern Time on 
the deadline date. Applicants sending applications by the United States 
Postal Services or commercial delivery services must ensure that the 
carrier will be able to guarantee delivery of the application by the 
closing date and time. If an application is received after closing due 
to (1) carrier error, when the carrier accepted the package with a 
guarantee for delivery by the closing date and time, or (2) significant 
weather delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Applications which do not meet the above criteria will not be 
eligible for competition and will be discarded. Applicants will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

    Applicants are required to provide Measures of Effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the grant or cooperative agreement. Measures of 
Effectiveness must relate to the performance goal (or goals) as stated 
in section ``A. Purpose'' of this announcement. Measures must be 
objective and quantitative and must measure the intended outcome. These 
Measures of Effectiveness shall be submitted with the application and 
shall be an element of evaluation.
    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.
1. Adequacy of Study Participants (20 Points)
    The extent to which the number of HIV positive MSM who will be 
routinely examined and tested and among whom data will be collected at 
the participating facilities meets or exceeds the requirement of 25 per 
month. (Provide letters of support from each participating facility 
documenting the ability to do this); and Does the application 
adequately address 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.
2. Data Interpretation and Management (15 Points)
    Demonstrated ability to manage, clean, and submit data in a timely 
way as demonstrated by previous involvement in similar projects.
3. Adequacy of Facility Data Collection Activities (15 Points)
    The extent to which STD testing is provided at the facility(ies) 
and the standard data elements are routinely collected [ie. date of 
visit, sex, date of birth, race/ethnicity, zip code or census tract of 
residence, gender of sex partners, STD symptoms, exam findings, and STD 
laboratory results (chlamydia, gonorrhea, and syphilis).
4. Routine Data Collection (10 Points)
    Extent to which the suggested data elements are routinely 
collected, including previous HIV test results, CD4 count, viral load, 
and behavioral risk variables (e.g., number of sex partners, type of 
sex [oral/anal].
5. Program Capacity (10 Points)
    Evidence that TB testing is routinely provided for HIV-positive MSM 
at the facility(ies) and that the data elements for HIV-positive MSM 
(ie. history of prior TB, prior TST status, TST results, and follow-up 
chest X-ray results, and therapy) are routinely collected.

[[Page 45523]]

6. Project Assessment and Support (10 Points)
    Provide letters of support from each participating facility. 
Describe how an assessment of STD testing in HIV-care facilities in the 
project area was performed, and provide evidence that facilities are 
chosen where routine STD screening is conducted.
7. Project Sustainability (10 Points)
    Potential sustainability of project, as determined by the extent to 
which current project activities have been integrated with existing 
program activities, and local program support for the proposed project 
so that it may be continued Without federal funding beyond the project 
period.
8. Data Analysis and Dissemination (5 Points)
    Demonstrated ability to analyze data and disseminate findings to 
public health officials and community planning groups.
9. Collaboration (5 Points)
    Extent of participation by STD, TB, and HIV/AIDS communicable 
disease surveillance units, as indicated by letters of support.
10. Budget (Reviewed, But Not Scored)
    The extent to which the itemized budget for conducting the project 
is reasonable and well justified.
11. Human Subjects (Not 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). Does the application adequately address the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects?

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original plus two copies of:
    1. Annual progress reports (The progress report will include a data 
requirement that demonstrates measures of effectiveness).
    2. Financial status report, no more than 90 days after the end of 
the budget period, and
    3. Final financial 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-4  HIV/AIDS Confidentiality Provisions
AR-5  HIV Program Review Panel Requirements
AR-7  Executive Order 12372 Review
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-22  Research Integrity

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    To obtain business management technical assistance, contact: Gladys 
T. Gissentanna, Grants Management Specialist, Procurement and Grants 
Office, Grants Management Branch, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 
30341-4146, Telephone: (770)488-2753, Email address: [email protected].
    For program technical assistance, contact: Catherine McLean, MD, 
Division of STD Prevention, Centers for Disease Control and Prevention 
(CDC), 1600 Clifton Road, MS E02, Atlanta, GA 30333, Telephone: 
(404)639-8467, Email: [email protected].

    Dated: July 2, 2002.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-17160 Filed 7-8-02; 8:45 am]
BILLING CODE 4163-18-P