[Federal Register Volume 68, Number 207 (Monday, October 27, 2003)]
[Notices]
[Pages 61282-61300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26837]



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Part III





Department of Health and Human Services





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Center for Disease Control and Prevention



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HIV/AIDS Surveillance; Notice

  Federal Register / Vol. 68, No. 207 / Monday, October 27, 2003 / 
Notices  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


HIV/AIDS Surveillance

    Announcement Type: New.
    Funding Opportunity Number: Program Announcement 04017
    Catalog of Federal Domestic Assistance Number: 93.944
    Key Dates: Letter of Intent Deadline: None. Application Deadline: 
January 16, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under the Public Health 
Service Act sections 301 (42 U.S.C. 241); 318b (42 U.S.C. 247c-2), 
as amended.

    Purpose: The purpose of the program is to monitor the HIV epidemic 
through core surveillance of HIV/AIDS cases; HIV incidence; HIV 
behavioral surveillance; capacity building for epidemiologic and 
program evaluation activities; enhanced surveillance for perinatal 
prevention; for special evaluations of these HIV Surveillance programs; 
and supplemental projects to assess surveillance of transmission of 
atypical strains of HIV, including antiretroviral drug resistant virus; 
unusual modes of transmission of HIV; and assessments of HIV 
prevalence. FY 2004 is the first year of a three-year project period. 
Recipients may implement certain required or supplemental activities in 
years one, two or three, depending on eligibility criteria and when HIV 
case surveillance activities have been, or will be implemented. 
Recipients will need to submit a competitive application for each 
supplemental project described in Parts IV and V of this announcement 
in the year in which funds are requested. See further discussion on 
this subject in Parts IV and V. This program addresses the ``Healthy 
People 2010'' focus area for HIV.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for HIV/STD/TB 
Prevention (NCHSTP): Strengthen the capacity nationwide to monitor the 
epidemic, develop and implement effective HIV prevention interventions 
and evaluate prevention programs.

Part I. Core Surveillance

    AIDS case surveillance is conducted in all States and U.S. 
Territories, and the cities of Chicago, Houston, Los Angeles, New York, 
Philadelphia, and San Francisco. HIV infection case surveillance is not 
yet conducted in all States or territories, but CDC recommends that all 
areas should conduct HIV infection case surveillance as an integrated 
component of their HIV/AIDS surveillance activities. The National HIV/
AIDS Surveillance System is the primary source of population-based 
information on persons with HIV/AIDS in the United States.
    The primary purpose of providing cooperative agreement funds for 
the core HIV/AIDS Surveillance program is to assist all State and 
territorial health departments to conduct the following activities:
    1. Monitor the number of annual cases of HIV diagnosed, the 
prevalence of persons living with HIV infection, and HIV-related 
morbidity (including AIDS) and mortality in adults, adolescents and 
children.
    2. Monitor perinatal exposure to HIV and HIV infection in infants.
    3. Monitor behaviors related to HIV testing, risks/exposure to HIV 
infection, and access to care in HIV-infected populations.
    4. Identify changes in trends of HIV transmission.
    5. Assist State and local health departments to use these data as a 
guide for allocation of many federal resources for HIV treatment, care, 
and other services provided to HIV-infected persons and affected 
communities, and for prevention and treatment services planning and 
evaluation.
    6. Evaluate the performance of HIV/AIDS surveillance systems.
    7. Implement projects to supplement the information available 
through HIV and AIDS case reporting to enhance and extend the ability 
of States and local areas to plan for public health programs.

Part II. HIV Incidence Surveillance

    The purpose of HIV Incidence Surveillance is to provide reliable 
and scientifically valid estimates of the number of newly acquired 
infections at the local, State, territorial, and national level. The 
purpose of CDC funding for this activity is to provide support to 
State, territorial and local health departments for development of the 
infrastructure in newly funded areas, and expansion of activities in 
areas previously funded for this activity, to incorporate HIV incidence 
estimation into HIV Surveillance. The ultimate goal is for States, 
territories, and the separately funded cities to be able to:
    1. Collect and test the diagnostic blood specimens from all newly 
diagnosed HIV infections reported from public and private laboratories 
and providers to HIV Surveillance.
    2. Collect the HIV testing information needed for the statistical 
estimates of incidence.
    3. Calculate population-based estimates of HIV incidence.
    4. Use these to identify emerging epidemics, monitor trends in 
transmission, target prevention resources and interventions to areas 
and populations most heavily affected, and evaluate programs designed 
to prevent the transmission of HIV.

Part III. Capacity Building for Epidemiologic and Program Evaluation 
Activities

    There are multiple sources of data available to health departments 
that can be analyzed to guide program planning and assess the impact of 
HIV prevention programs in a health department's jurisdiction. These 
include surveillance, program evaluation and data from special 
projects. There are systems and guidances in place for various data 
sets. Opportunities to use these data are often not exploited to better 
assess HIV status and prevention efforts in a jurisdiction because of 
the limited availability of trained and dedicated personnel with the 
capacity to collectively or comprehensively analyze and synthesize 
these types of information.
    The purpose of providing funds for this activity is to improve the 
epidemiologic, evaluative, analytic, and dissemination capabilities of 
health departments that currently have limited resources. The specific 
purpose of this support is to allow health departments to hire 
dedicated, professional staff. Staff employed through this funding will 
assist health departments to develop and implement a more integrated 
use of these independent, but related data sets by:
    1. Analyzing and interpreting HIV/AIDS surveillance and other 
health-related data to describe the HIV/AIDS epidemic within their 
jurisdiction in terms of person, place and time for various 
populations.
    2. Producing consolidated epidemiologic profiles that meet the 
needs of both CDC-supported HIV prevention planning programs and HRSA-
supported HIV care planning programs.
    3. Collecting, analyzing, interpreting, and disseminating 
surveillance, program, and other health-related data to assess the 
effectiveness of HIV prevention efforts.
    4. Providing technical assistance to community planning groups on 
the use of HIV and other public health data for program planning and 
evaluation.
    5. Collaborating with CDC to develop the systematic collection and 
analysis of

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community-related and program data which can be used with HIV/AIDS 
surveillance data to track progress towards goals identified in CDC's 
HIV Prevention Strategic Plan (http://www.cdc.gov/nchstp/od/hiv_plan/default.htm).

Part IV. Enhanced Surveillance for Perinatal Prevention

    The purpose of providing funds for this activity is to target and 
follow the progress toward maximal reduction of perinatal HIV 
transmission. Specifically, this support is to allow State and local 
health departments to evaluate (1) the impact of implementation of 
efforts to maximally reduce perinatal HIV transmission; (2) prevention 
failures for perinatal HIV transmission; (3) the efficacy of zidovudine 
(ZDV) and other antiretroviral medications in preventing perinatal HIV 
transmission; (4) potential adverse outcomes of perinatal and postnatal 
antiretroviral therapy; and (5) the Public Health Service 
recommendations for opportunistic infection prophylaxis by:
    1. Conducting medical record reviews of mother/infant pairs and 
longitudinal follow-up of all HIV exposed children to ascertain 
knowledge of maternal HIV infection status before birth, HIV incidence, 
AIDS incidence, and death, the use of maternal and neonatal ZDV and its 
efficacy in preventing HIV transmission, and the use of other 
antiretroviral medications.
    2. Conducting medical record reviews to evaluate recommendations 
for opportunistic infection prophylaxis and initiation of HIV 
evaluation and treatment in children.
    3. Assessing potential adverse outcomes of exposure to 
antiretroviral medications among infected and uninfected children in 
the short term (e.g., birth defects, ascertained through record reviews 
and registry matches) and in the long term (e.g., by matching to tumor 
registries).
    4. Matching HIV/AIDS registries to birth registries to ensure 
complete ascertainment of mother/infant pairs.
    5. Collaborating with CDC to track progress towards the maximal 
reduction of perinatal HIV transmission.

Part V. Laboratory Testing for Recent HIV Infection

    The Serologic Testing Algorithm for Recent HIV Seroconversion 
(STARHS) is the currently accepted method used for estimation of HIV 
incidence. With STARHS, confirmed HIV-positive samples are analyzed 
with a Less Sensitive HIV Enzyme-Linked Immunosorbent Assay (LS-EIA) 
which identifies antibodies at a point later in the course of infection 
than the routine test. In performance of STARHS, the standard testing 
methodology for a commercially available HIV Enzyme-Linked 
Immunosorbent Assay (EIA) is altered by reducing the incubation time 
and increasing the dilution of the sample according to extremely 
precise criteria. Quantitative values from these tests are evaluated 
against control values and cut-off points to estimate the likelihood 
that that sample was collected from an individual who was infected with 
HIV within a finite period of time before the sample was collected. 
Because the testing procedures must be conducted with extreme 
precision, multiple control samples are run in tandem with each sample 
run. Other tests to identify recent HIV infection are currently being 
developed. In order to adopt those for more widespread use, new tests 
will need to be run on samples tested with the existing method to 
validate the new methodology.
    STARHS has not been approved by the Food and Drug Administration 
(FDA) for routine use. STARHS is conducted under an Investigational New 
Drug/Device (IND) authorization from the FDA which allows for testing 
in controlled settings in which performance is closely monitored and 
data with regard to unforeseen adverse events and aggregate results are 
reported through CDC. All IND laboratories are required to participate 
in a quarterly proficiency testing program administered by CDC. A 
limited number of laboratories participate in the CDC-sponsored IND.
    Since 1999, CDC has supported six health department laboratories to 
conduct the STARHS on stored, un-linked HIV-positive samples from HIV 
testing programs and research projects. This testing was for research 
purposes, therefore, it was not necessary to complete testing and 
return test results quickly. Laboratories were allowed to hold 
specimens, run them in batches, and schedule testing to accommodate the 
time requirements for their other work. For HIV Incidence Surveillance, 
laboratories will be required to return results to submitting health 
departments quickly. The current laboratory protocol allows for either 
manual or automated dilution and processing. For this activity, only 
laboratories that agree to use automated methods will be supported in 
order to maximize the number of tests they will be able to process and 
to optimize the accuracy and consistency of STARHS results. 
Laboratories will be selected to maximize efficiency, ensure timely 
availability of test results for all geographic areas and to 
standardize methodology.

Part VI. Behavioral Surveillance

    CDC's HIV/AIDS Strategic Plan has identified that monitoring 
behaviors that place people at risk for HIV infection is a key element 
of an integrated surveillance system. Measures of behavior are 
necessary to quantify progress in the plan's objectives. In addition, 
the plan identifies that studies of HIV incidence in special 
populations, including populations at high risk for infection, are an 
important strategy to provide locally relevant data for prevention 
resource allocation. The objectives of this program are to develop an 
ongoing surveillance system to ascertain the prevalence of HIV risk 
behaviors among groups at high risk for HIV infection for use in 
developing and directing national prevention services and programs; and 
to evaluate the impact of a variety of prevention efforts.
    This announcement provides an opportunity to capitalize on 
experience recruiting at-risk individuals from non-healthcare community 
settings using a scientifically sound methodology to develop an ongoing 
system for surveillance of behaviors related to HIV acquisition. This 
system will assess risk behaviors and trends in behaviors over time 
among adults 18 years old and older at high risk for HIV infection 
through sexual behavior between men and injection drug use. These 
studies may be expanded to include high risk heterosexuals. In 
addition, access to and utilization of HIV prevention programs, 
including HIV testing, will be assessed. Each funded site will be 
expected to enroll at least 500 Men Who Have Sex with Men (MSM) and 500 
Injection Drug Users (IDUs). Funded sites will also be expected to 
collaborate with CDC directly funded community-based organizations 
(CBOs) and CBOs funded by States/cites through the community planning 
process for allocating Federal HIV prevention funds, schools of public 
health, universities, ethnographers and behavioral scientists.

Part VII. Core Surveillance in the Pacific Island Jurisdictions

    AIDS case surveillance is conducted in all U.S. dependencies, 
possessions, and independent nations that make up the six Pacific 
Island jurisdictions referred to as the Pacific Island Jurisdiction 
AIDS Advisory Group (PIJAAG). These islands and island groups are 
American Samoa, Guam, Marshall Islands, Palau, the Commonwealth of the 
Northern Mariana Islands and the Federated States of

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Micronesia. HIV infection case surveillance is not yet conducted in all 
these areas, but CDC recommends that all areas should conduct HIV case 
surveillance as an integrated component of their HIV/AIDS surveillance 
activities. However, there are substantial public health, logistical 
and medical infrastructure challenges to conducting core surveillance 
in these island jurisdictions.
    The objective of this proposal is to support the infrastructure and 
activities necessary to enable newly identified HIV/AIDS cases to be 
reported to the Centers for Disease Control and Prevention's Statistics 
and Data Management Branch. Preparatory to this end, each island 
jurisdiction must be authorized by local public health law, rule or 
regulation to collect and report the necessary medical and socio-
demographic information to the CDC. A letter, signed by the 
jurisdiction's senior public health official, must be sent to Dr. 
Matthew McKenna, Chief for Informatics, HIV Incidence and Case 
Surveillance Branch (HICSB) declaring the jurisdiction's intent to 
report previously unidentified HIV/AIDS cases to the CDC. Also a copy 
of the jurisdiction's legal authority to report HIV/AIDS cases to the 
CDC will be needed.
    The primary purpose of providing cooperative agreement funds for 
the core HIV/AIDS Surveillance program is to assist all State and 
territorial health departments to conduct the following activities:
    1. Monitor the number of annual cases of HIV diagnosed, the 
prevalence of persons living with HIV infection, and HIV-related 
morbidity (including AIDS) and mortality in adults, adolescents and 
children.
    2. Monitor perinatal exposure to HIV and HIV infection in infants.
    3. Monitor behaviors related to HIV testing, risks/exposure to HIV 
infection, and access to care in HIV-infected populations.
    4. Identify changes in trends of HIV transmission.
    5. Assist territorial and local health departments to use these 
data as a guide for allocation of many federal resources for HIV 
treatment, care, and other services provided to HIV-infected persons 
and affected communities, and for prevention and treatment services 
planning and evaluation.
    6. Conduct basic evaluation and quality control assessment of the 
surveillance data collected.

Activities

    Awardee activities for this program are as follows:

Part I. Core Surveillance

Recipient Activities
    1. Plan and conduct HIV/AIDS surveillance activities in 
collaboration and coordination with CDC, and, where appropriate, with 
State and local professional associations; health care providers and 
institutions serving, diagnosing, or providing treatment and care for 
persons with HIV/AIDS, including laboratories providing HIV, CD4+ 
lymphocyte and HIV-1 Ribonucleic Acid Determination (i.e. viral load) 
testing; organizations that serve persons at increased risk of HIV/AIDS 
(e.g., drug treatment facilities, STD clinics, family planning 
agencies, maternal and infant care programs, comprehensive hemophilia 
treatment centers, correctional facilities); community groups and 
organizations, especially those with a racial and ethnic minority 
membership and focus; and HIV/AIDS service organizations.
    a. Active case finding.
    At a minimum, all recipients shall conduct active case finding 
(i.e. soliciting case reports in a timely manner directly from 
potential reporting sources) in large in- and out-patient facilities 
serving HIV-infected persons and in laboratories, where feasible and 
permitted by law, and shall conduct a systematic review of death 
certificates. Other required components of active surveillance programs 
include educating providers on their reporting responsibilities, 
establishing on-going communication with all reporting sites and 
providing them feedback, conducting routine visits to reporting 
sources, and establishing awareness of and support for surveillance 
activities. In particular, in areas where a large volume of reports or 
limited resources preclude timely investigation of new case reports, 
special efforts shall be made to inform providers of their importance 
in promptly notifying the health department of any cases with unusual 
transmission, laboratory or clinical circumstances/characteristics. The 
minimum information required to report a case of HIV infection or AIDS 
to CDC's HIV/AIDS Reporting System (HARS) is the alpha-numeric 
(soundex) code of the patient's name (patient and physician names 
should not be submitted to CDC); state-assigned patient identifier 
number; HIV/AIDS diagnosis information, including date(s) of diagnosis; 
and the patient's date of birth, race/ethnicity, and sex.
    Two additional variables that are critical to ascertain are initial 
CD4 count and mode of HIV exposure. In an effort to better characterize 
the extent of disease at diagnosis, and the impact of targeted testing 
efforts on identifying persons early in the course of their infections, 
information on CD4 count at initial diagnosis shall be collected. This 
information should be submitted to CDC as part of the case record. 
Information on the mode of HIV exposure is also essential in order to 
monitor epidemic trends and target prevention interventions. Therefore, 
timely follow-up to complete risk history shall be conducted. Funding 
limitations may preclude complete investigations of all cases, but at a 
minimum, States are expected to follow-up a representative sample of 
reported cases to ascertain risk according to a protocol developed by 
CDC and the recipient.
    Where pediatric HIV exposure and infection surveillance is 
conducted, recipients shall also collect data on maternal HIV test 
history, prenatal and neonatal antiretroviral therapy, and other 
variables relevant to the evaluation of recommended actions to prevent 
perinatal HIV transmission. For areas with the highest burden of 
perinatal HIV transmission, additional funds are available to conduct 
enhanced surveillance activities for HIV-infected mothers and their 
children (See section D, Funding, above; and Part IV, Enhanced 
Surveillance for Perinatal Prevention, below in this section)
    b. Follow-up investigations of cases/populations of special 
epidemiologic significance.
    Recipients shall develop procedures for promptly notifying CDC of 
unusual occurrences of HIV transmission and for using CDC-developed 
protocols and criteria to conduct epidemiologic and laboratory 
investigations of cases that may have rare or previously unidentified 
modes of HIV transmission, unusual clinical manifestations, or unusual 
laboratory test results. These include transfusion and transplant-
related cases, cases of HIV transmitted in health care or other 
occupational settings, cases of HIV-2 infection, cases transmitted 
through female-to-female sexual contact, cases with potentially unusual 
HIV strain variants, and cases with clinical evidence of HIV infection 
but negative HIV test results.
    Recipients may also propose activities to better describe the 
epidemic in specific populations of epidemiologic significance or 
interest (e.g. for example, persons diagnosed concurrently with HIV and 
TB or HIV and STDs), or in collaboration with prevention and care 
partners to augment the collection of risk behaviors in cases reported 
initially with no reported risk (NRR) or projects to collect risk 
behaviors of cases using

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novel methods of risk assessment such as computer-assisted interviews.
    c. Evaluation of the performance of the surveillance system.
    Recipients shall continue to evaluate the attributes of their HIV/
AIDS surveillance system according to protocols provided by CDC that 
have been developed as part of focused pilot projects. Ongoing 
evaluation will continue regardless of the status of, or procedures 
used, to conduct HIV/AIDS surveillance (e.g. AIDS or HIV reporting, or 
name or code-based reporting).
    All evaluation projects should include critical reviews of 
surveillance methods and redirection of resources to those case-finding 
methods that are the most accurate and productive. Using the 
recommendations published in ``CDC Guidelines for National Human 
Immunodeficiency Virus Case Surveillance, Including Monitoring for 
Human Immunodeficiency Virus Infection and Acquired Immunodeficiency 
Syndrome'' (see Attachment A for summary) these evaluations should 
include routine analysis of surveillance data to discover possible 
sources of under reporting and delays in reporting, monitoring data 
quality, and assessing completeness of reporting by statistical methods 
developed by CDC (e.g. multiple source capture-recapture) or comparing 
surveillance registries with alternate databases that are not routinely 
used for case finding (e.g., Medicaid databases).
    At least once a year, all recipients shall routinely re-abstract 
demographic, risk, laboratory, and clinical data from a representative 
sample of records to assess the quality and validity of information 
collected.
    d. Interstate reciprocal notification of newly identified HIV/AIDS 
cases.
    Recipients should routinely interact with other reporting areas 
using a list of potential inter-State duplicates supplied by CDC to 
ensure that reciprocal notification of newly identified HIV/AIDS cases, 
perinatal exposure cases, and deaths from HIV infection is executed. 
Routine engagement in this activity will minimize the number of 
duplicate case reports in the national data system. This communication 
is supported by the Council of State and Territorial Epidemiologists 
(Position statement 01-ID-04). It should be carried out by 
appropriately trained and authorized surveillance staff, in a 
confidential manner consistent with local security, confidentiality and 
reporting policies and procedures. Recipients will use the same system 
for reciprocal notification of HIV, AIDS, perinatal HIV exposure and 
deaths among persons with HIV infection, including provision of 
appropriate identifying information (e.g., name or other identifier). 
Currently, because of the diversity and limitations of the coded 
identifiers used by reporting areas in States engaged in alternatives 
to confidential, name-based reporting for HIV cases, there is no 
scientifically validated, systematic way for CDC to identify potential 
duplicates for HIV cases in those areas. These areas are encouraged to 
communicate with nearby reporting areas to identify the most accurate 
and efficient methods for minimizing duplication across State reporting 
jurisdictions.
    e. Analysis and dissemination of HIV/AIDS surveillance data and 
promoting their uses of prevention and health services planning and 
evaluation.
    All recipients should routinely disseminate reports of aggregate 
surveillance data for epidemic monitoring and education of the public 
and reporting sources and should promote uses of HIV/AIDS surveillance 
data for prevention and health services planning and evaluation. These 
activities should include: Providing HIV/AIDS surveillance data and 
ongoing epidemiologic assistance to community planning groups; 
disseminating surveillance data through publications and presentations; 
participating in planning and implementation meetings; conducting 
analyses to monitor trends, assess need for health-care resources, and 
project the future impact of the disease; and providing feedback to 
reporting sources on ways in which the surveillance data have been used 
to promote public health.
    f. Conduct activities to improve the quality, efficiency, and 
productivity of the core surveillance program.
    As part of core surveillance (given availability of either 
increased core funding or a redirection of existing core surveillance 
funding) all recipients shall also conduct one or more surveillance 
activities to develop and test new approaches to conducting 
surveillance whose aim is to improve the quality of the data, develop 
more efficient methods of case ascertainment, ensure accurate and valid 
case report information, and maximize the performance of the system. In 
particular, areas should develop technical information systems that 
facilitate electronic reporting of HIV and AIDS surveillance data from 
health care providers and public and private laboratories to health 
departments. Examples of focused analyses and evaluations of 
surveillance data that applicants may conduct include:
    (1) Assessing how priority populations access or receive referrals 
to prevention and treatment services in public and private settings 
(e.g., treatment for HIV infection and prevention of opportunistic 
infections).
    (2) Assessing the association of stage of disease (i.e., HIV or 
AIDS) with interstate migration.
    (3) Better defining trends (through analysis of HARS reports or 
chart reviews or interviews):
    (a) In various populations (e.g., Native Americans, health-care 
workers, substance-abusing pregnant women).
    (b) For various AIDS-defining conditions or opportunistic 
infections (e.g., Tuberculosis, Mycobacterium Avium Complex (MAC).
    (c) In conjunction with other Federal, State, local prevention and 
care programs (e.g., HRSA Ryan White CARE locations).
    g. Reporting of data using CDC standards and software.
    Recipients should ensure that data collection forms and electronic 
data formats used to submit case reports from laboratories, clinical 
records, and patient interviews contain CDC's recommended standard data 
elements/questions on HIV testing behaviors, risk/exposure behaviors, 
and treatment access/adherence behaviors. In addition, during this 
project period, recipients should report HIV/AIDS case surveillance 
data to CDC on at least a monthly basis using either standardized 
software or according to data submission standards established by CDC.
    Data from reporting areas using coded identifiers for HIV 
surveillance will be eligible for inclusion in national surveillance 
reports after these systems are evaluated using published performance 
standards (see Attachment A) through the implementation of protocols 
established by CDC. Areas using coded identifier systems will need to 
use customized data transfer and storage systems (either electronic or 
hardcopy) in order to accommodate the diversity of codes, 
inconsistencies in codes between areas (e.g. inability to generate 
soundex in some areas), and inability of areas using coded reporting to 
reciprocally notify and de-duplicate cases with other areas using 
standardized lists generated by CDC. Specific data management systems 
will be developed by CDC in consultation with the local areas. These 
areas should continue to report AIDS cases and deaths to CDC using HARS 
or its identified equivalent, as is current practice.
    h. Security.

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    Consistent with ``Appendix C'' of CDC's ``Guidelines for HIV/AIDS 
Surveillance,'' applicants must ensure that the program requirements 
detailed in the Security Standards are attained as indicated by the 
signature of the Overall Responsible Party (ORP) on the attached form 
(Attachment B). HIV/AIDS surveillance funds will be restricted unless 
the signed ORP form has been submitted to CDC.
    i. All applicants are required to attend CDC-sponsored conferences 
and workshops consistent with recipient activities in accordance with 
the budget allocated.
    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:
    a. Provide training in surveillance methods, study methods, and 
surveillance program planning and management.
    b. Provide laboratory training that includes current scientific and 
technical information about the practical and the theoretical 
sensitivity and specificity of the different serological tests.
    c. Coordinate and convene conferences, develop routine 
communications, provide guidelines and standards for the conduct of 
surveillance program activities, and communicate with recipients to 
develop, refine, and disseminate HIV/AIDS surveillance program 
information that describes effective methods to carry out program 
activities and monitor progress.
    d. Provide: (1) Criteria for the surveillance definition of 
nationally reported HIV infection/disease (including AIDS); (2) 
prototype (model) case report forms; and (3) assistance in establishing 
and maintaining software for collecting, transferring and evaluating 
HIV/AIDS surveillance data.
    e. Participate in the analysis and dissemination of information and 
data gathered from program activities and facilitate the transfer and 
utilization of information and technology among all States and 
communities.
    f. Provide standardized protocols, data collection forms, data 
entry capability for core surveillance and time-limited studies, and on 
a routine basis generate lists of records of potential inter-State 
duplicate cases to facilitate reciprocal notification and de-
duplication of HIV, AIDS, perinatal exposure cases as well as deaths 
from HIV infection.
    g. Assist in the evaluation of the overall effectiveness of program 
operations, including the impact of surveillance data on the 
development of public policy and on targeting and evaluating HIV 
Prevention Community Planning activities.
    h. Assist States to better use the national HIV/AIDS surveillance 
data provided to CDC by States for public health policy formulation; to 
obtain and allocate federal resources for HIV/AIDS surveillance, 
prevention, and care; and to evaluate national public health 
recommendations. Promote and facilitate coordination of CDC 
surveillance data and activities with other CDC programs and other 
agencies of the federal government.
    i. Provide technical assistance in the area of information 
technology to assure that reporting areas using electronic transfer of 
HIV/AIDS surveillance data: (1) Adhere to appropriate confidentiality 
and security procedures; (2) execute the necessary data management and 
analytic procedures to assure data integrity and accuracy; and (3) 
provide guidance to grantees in obtaining equipment that possesses the 
necessary technologic capabilities to process and transfer data using 
either CDC provided software or according to standards developed by CDC 
for reporting to the national system. Supplemental funds may be 
provided by CDC contingent on the availability of funds and the 
magnitude of the identified requirements for information technology 
improvements in areas that do not currently have adequate 
infrastructure to manage data according to current or emerging CDC 
specifications.
    j. Disseminate national surveillance data for public health 
research purposes through routine reports, articles in books and peer-
reviewed journals, and presentations.
    k. Maintain a secure and confidential national HIV/AIDS 
surveillance database.

Part II. HIV Incidence Surveillance

Recipient Activities
    a. Collaborate with CDC, laboratories, providers and affected 
communities to develop the capacity to conduct population-based HIV 
incidence surveillance.
    b. Collaborate with CDC (and other funded project sites) in project 
design, implementation, and evaluation.
    c. Collaborate with CDC in the development of area specific 
protocols that demonstrate the ability to link HIV case data to 
laboratory specimens, and to HIV testing history information to meet 
the statistical data requirements for HIV incidence estimates.
    d. Collaborate with public and commercial HIV testing laboratories 
(within and outside the state) to secure an aliquot of serum from 
original diagnostic HIV tests and have it shipped to the state public 
health laboratory or an appropriately designated lab that is authorized 
to store specimens for the area health department.
    e. Identify, in a timely fashion, which diagnostic specimens 
represent HIV infection cases new to the State HIV Surveillance system.
    f. Prepare and transport aliquots of serum from the original 
diagnostic HIV test of new HIV infection cases from the state public 
health laboratory to a CDC designated STARHS testing laboratory.
    g. Obtain adequate information on HIV testing history from a 
sufficient number of persons with newly identified, recent HIV 
infections, reported from private and public providers to allow for HIV 
incidence estimation. The sources and methods for acquiring this 
testing history information, and the procedures for linking, or 
unlinking, these data from surveillance records with personal 
identifiers when computing incidence estimates will be developed 
collaboratively with CDC.
    h. In some areas results from investigational tests such as STARHS 
may be linked to identifying information on individual patients. These 
protocols must be approved by a local IRB, and undergo review by CDC 
and the Food and Drug Administration (FDA) before they can be 
implemented.
    i. On at least a monthly basis, report to CDC the data necessary to 
conduct incidence surveillance using either standardized software or 
according to data submission standards provided by CDC.
    j. Areas conducting HIV incidence surveillance have the unique 
capacity to identify active transmission of atypical strains of HIV, 
including antiretroviral drug resistant virus. As part of incidence 
surveillance, areas may collaborate with CDC to develop procedures for 
obtaining the appropriate specimens to monitor transmission of such 
atypical strains.
    k. Maintain a secure environment to protect the security and 
confidentiality of data obtained during this surveillance activity.
    l. All applicants are required to attend CDC-sponsored conferences 
and workshops consistent with recipient activities in accordance with 
the budget allocated.
    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:

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    a. Provide training in HIV incidence surveillance and estimation 
methodology.
    b. Provide laboratory training that includes current scientific and 
technical information required to obtain, ship, and process specimens 
according to existing standards of safety in order to obtain reliable 
results for incidence estimation.
    c. Coordinate and convene conferences, provide guidelines, provide 
technical assistance for development as well as review and approval of 
protocols, develop materials such as model consent forms and procedural 
standards for the conduct of incidence surveillance program activities. 
CDC will communicate regularly with recipients to develop, refine, and 
disseminate HIV information that describes effective methods to carry 
out program activities and monitor progress.
    d. Provide support in the form of technical assistance, and where 
necessary and available, supplemental funding to establish and maintain 
information systems adequate for collecting, transferring and 
evaluating HIV incidence surveillance data.
    e. Provide technical assistance for activities designed to assess 
and monitor the active transmission of atypical strains of HIV, 
including antiretroviral resistant virus.
    f. Participate in the analysis and dissemination of information and 
data from these program activities.
    g. Assist in the evaluation of the overall effectiveness of program 
operations, including the impact of incidence data on the development 
of public policy and on targeting and evaluating HIV Prevention 
Community Planning activities.
    h. Maintain a secure and confidential national data system for HIV 
Incidence Surveillance and estimation.
    i. Coordinate the identification and interaction between areas 
supported to conduct HIV incidence surveillance and designated CDC 
STARHS laboratories.
    j. Conduct at least one site visit during a program announcement 
funding period to each grantee to assess progress toward meeting 
program objectives and provide such technical assistance as is 
necessary as determined by the grantee and CDC.
    k. Provide technical assistance in the area of information 
technology to assure that reporting areas using electronic transfer of 
HIV/AIDS surveillance data: (1) Adhere to appropriate confidentiality 
and security procedures; (2) execute the necessary data management and 
analytic procedures to assure data integrity and accuracy; and (3) 
provide guidance to grantees in obtaining equipment that has the 
necessary technologic capabilities to process and transfer data using 
either CDC provided software or according to standards developed by CDC 
for reporting to the national system. Supplemental funds may be 
provided by CDC contingent on the availability of funds and the 
magnitude of the identified requirements for information technology 
improvements in areas that do not currently have adequate 
infrastructure to manage data according to current or emerging CDC 
specifications.
    1. Coordinate with recipients and private and public health 
laboratories to promote the efficient transport and processing of 
diagnostic specimens for identification of newly diagnosed persons and 
execution of STARHS, or other CDC approved testing for recent HIV 
infections.

Part III. Capacity Building for Epidemiologic and Program Evaluation 
Activities

Recipient Activities
    a. Employ and sufficiently support trained staff who will develop 
or enhance the recipient's capacity to plan and conduct epidemiologic 
and program evaluation activities in collaboration and coordination 
with CDC, and state and local HIV prevention and care community 
planning groups; and
    b. Promote uses of the HIV/AIDS surveillance, program, and other 
health-related data for the planning and evaluation of HIV prevention 
and care services. These uses should address two components:
    (1) Epidemiologic activities. These activities should include 
providing or recommending the use of HIV/AIDS and other public health 
surveillance data. Activities should also include the analysis, 
interpretation, and presentation of these data in describing the HIV/
AIDS epidemic in the recipient's jurisdiction in terms of socio-
demographic, geographic, behavioral, and clinical characteristics for 
use in the epidemiologic profile for HIV prevention and care community 
planning.
    (2) Program evaluation activities. These activities should include 
collecting, analyzing, and reporting process and outcome data that can 
be used:
    (a) To assess the effectiveness of various types of interventions.
    (b) To monitor achievement of the health department's goals and 
objectives.
    (c) To provide program data to CDC in appropriate and useful 
formats so that data may be aggregated by CDC to monitor progress in 
achieving the goals and objectives of its strategic plan.
    (d) To assess the impact of HIV prevention efforts in health 
department jurisdictions.
    c. All applicants are required to attend CDC-sponsored conferences 
and workshops consistent with recipient activities in accordance with 
the budget allocated.
    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:
    a. Develop and promote the use of standard guidelines for 
development of epidemiologic profiles and program evaluation for HIV 
prevention and care community planning.
    b. Assist recipients to better use HIV/AIDS surveillance, program, 
and other health-related data for HIV prevention and care community 
planning and to evaluate HIV prevention program effectiveness.
    c. Collaborate with recipients to facilitate the use of 
surveillance, program, and other health-related data to monitor 
achievement of CDC and HRSA prevention and care planning goals and 
objectives.
    d. Assist recipients to use surveillance, evaluation, and other 
health-related data to assess the impacts of HIV prevention efforts 
(e.g., to inform policy and service delivery issues).
    e. Collaborate with grantees to ensure appropriate transfer of 
data.

Part IV. Enhanced Surveillance for Perinatal Prevention

Recipient Activities
    Implement and continue surveillance for perinatal HIV exposure and 
pediatric HIV infection by performing the following activities:
    a. Conduct medical record review of mother/infant pairs and 
longitudinal follow-up of all HIV exposed children to ascertain 
knowledge of maternal HIV infection status before birth, HIV incidence, 
AIDS incidence, and death, the use of maternal and neonatal ZDV and its 
efficacy in preventing HIV transmission, and the use of other 
antiretroviral medications.
    b. Conduct medical record review to evaluate recommendations for 
opportunistic infection prophylaxis and initiation of HIV evaluation 
and treatment in children.
    c. Assess potential adverse outcomes of antiretroviral exposure 
among infected and uninfected children in the short term (e.g., birth 
defects,

[[Page 61288]]

ascertained through record reviews and registry matches) and in the 
long term (e.g., by matching to tumor registries).
    d. Match HIV/AIDS registries to birth registries to ensure complete 
ascertainment of mother/infant pairs.
    e. Regularly report data to CDC in a secure manner using CDC-
provided forms and software.
    f. All applicants are required to attend CDC-sponsored conferences 
and workshops consistent with recipient activities in accordance with 
the budget allocated.
    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:
    a. Provide training in surveillance methodology, study methodology, 
and in program planning and management.
    b. Provide laboratory training that includes current scientific and 
technical information about the practical and the theoretical 
sensitivity and specificity of the different serological tests.
    c. Develop, refine, and disseminate HIV/AIDS surveillance program 
information that describes effective methods to carry out program 
activities and monitor progress.
    d. Provide: (1) Criteria for the surveillance definition of 
nationally reported HIV infection/ disease; (2) case report forms; and 
(3) assistance in establishing and maintaining the computerized HARS.
    e. Participate in the analysis and dissemination of information and 
data gathered from program activities and facilitate the transfer and 
utilization of information and technology among all States and 
communities.
    f. Provide standardized protocols, data collection forms, and 
computer software.
    g. Assist in the evaluation of the overall effectiveness of program 
operations, including the impact of enhanced perinatal surveillance 
data on the development of public policy and on targeting and 
evaluating HIV Prevention Community Planning activities.
    h. Provide standard data collection forms, questionnaires, and 
computer software for the supplemental surveillance projects.
    i. Disseminate national perinatal surveillance data for public 
health research purposes through routine reports, articles, and 
presentations.
    j. Maintain a secure and confidential national HIV/AIDS 
surveillance database.

Part V. Laboratory Testing for Recent HIV Infection

Recipient Activities
    a. Conduct testing according to the protocols and requirements 
stipulated in the existing CDC IND agreement.
    b. Establish local procedures for specimen testing and processing.
    c. Conduct quality control for each run, and on an ongoing basis, 
participate in CDC's quality assurance program. Establish quality 
criteria for inclusion or exclusion of testing runs.
    d. Establish protocols for collaborating health departments for the 
preparation and shipping of specimens. Laboratories may specify the 
type of vial and conditions for acceptable specimens, designate the 
days of the week that specimens will be received, specify how specimens 
will be labeled (label type, numbering system, barcoding), shipped, and 
the format for packing lists.
    e. Return test results to submitting health department within seven 
days of receipt of specimen.
    f. Develop data management systems for tracking specimens, raw data 
including control values and specimen results consistent with the IND 
protocol.
    g. Ensure the confidentiality of data and specimens.
    h. Obtain, from collaborating health departments, protocols and 
documentation of institutional review board approval (or non-research 
determination) that allowed for the initial specimen collection and for 
incidence testing. Track testing results by protocol for required 
reports.
    i. Conduct testing for other CDC supported research projects.
    j. Establish mechanism for tracking all costs (staff time, project 
resources and reagents) associated with testing for specimens not 
associated with national HIV incidence.
    k. All applicants are required to attend CDC-sponsored conferences 
and workshops consistent with recipient activities in accordance with 
the budget allocated.
    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:
    a. Provide protocols for conducting tests for recent HIV infection.
    b. Facilitate the distribution or designation of assigned 
collaborating health departments to ensure optimal work loads for 
funded laboratories and optimal ability to return results in a timely 
manner.
    c. Provide proficiency testing program.
    d. Provide resources to collaborating health departments for the 
collection, processing and shipping of specimens to funded 
laboratories.
    e. Provide technical assistance to laboratories on testing methods.
    f. Provide computer software for interpretation of testing results, 
quality control and for tracking results for required reports.

VI. Behavioral Surveillance

Recipient Activities
    a. Collaborate with CDC and other funded project sites in the 
design, implementation and evaluation of proposed activities. 
Participate in required planning meetings with other funded sites and 
CDC at an out of state location to be determined by CDC and grantees.
    b. Collaborate with CDC and other funded sites to develop a multi-
site protocol and questionnaire.
    c. Collaborate with CDC in the development of site specific 
operational plans.
    d. Engage Community Based Organizations (CBOs) funded directly by 
CDC or by States/cities through the Community Planning process, 
behavioral scientists, ethnographers, schools of public health, or 
universities in the formative research and questionnaire development.
    e. Collaborate with local HIV/AIDS prevention program to assess 
exposure to and use of HIV prevention programs.
    f. Maintain a secure environment to protect the security and 
confidentiality of data obtained in this activity.
    g. Report project data to CDC in a timely manner according to 
established protocols for data collection, storage and transfer.
    h. Disseminate study data for use in state/local prevention, and in 
treatment services planning and evaluation.
    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:
    a. Lead the development of a standardized multi-site protocol and 
questionnaire.
    b. Facilitate the development of site-specific operational plans.
    c. Provide training in the methodology (including formative 
research), program planning and management.
    d. Provide technical assistance to support implementation of agreed 
upon methods to accomplish project objectives.
    e. Provide assistance in establishing and maintaining the 
computerized

[[Page 61289]]

database to record information collected in this activity.
    f. Participate in the analysis and dissemination of data. Conduct 
and/or coordinate analyses of the multi-site data and distribute 
information to support national HIV prevention efforts.
    g. Lead the development of computer programs to evaluate 
performance indicators and data quality.
    h. Assist in the evaluation of the overall effectiveness of program 
operations. Provide timely feedback on reported data for quality 
assurance purposes.
    i. Maintain a secure and confidential national database.

Part VII. Core Surveillance in the Pacific Island Jurisdictions

Recipient Activities
    Plan and conduct HIV/AIDS surveillance activities in collaboration 
and coordination with CDC, and, where appropriate, with professional 
associations; health care providers and institutions serving, 
diagnosing, or providing treatment and care for persons with HIV/AIDS, 
including facilities or organizations providing HIV, CD4+ lymphocyte 
and HIV-1 Ribonucleic Acid Determination (i.e. viral load) testing; 
organizations that serve persons at increased risk of HIV/AIDS (e.g., 
drug treatment facilities, STD clinics, family planning agencies, 
maternal and infant care programs, correctional facilities); community 
groups and organizations. Specific areas with laboratories capable of 
providing confirmatory testing services (i.e. Western Blot or IFA) 
should indicate a willingness and describe their capacity to serve as 
central data coordination areas by working with other island 
jurisdictions that submit specimens for such confirmatory testing. 
These descriptions should include a process for assuring compliance 
with security and confidentiality requirements.
    Collaboration with CDC includes attendance at meetings and 
workshops that address recipient HIV/AIDS surveillance activities 
described in this announcement. In accordance with available funds, all 
applicants should plan to attend CDC-sponsored conferences and 
workshops consistent with recipient activities.
    a. Active case finding
    At a minimum, all recipients shall conduct active case finding 
(i.e. soliciting case reports in a timely manner directly from 
potential reporting sources) in appropriate in-patient and out-patient 
facilities serving HIV-infected persons and in laboratories, where 
feasible and permitted by law, and shall conduct a systematic review of 
death certificates. Other required components of active surveillance 
programs include educating providers on their reporting 
responsibilities, establishing on-going communication with all 
reporting sites and providing them feedback, conducting routine visits 
to reporting sources, and establishing awareness of and support for 
surveillance activities. The minimum information required to report a 
case of HIV infection or AIDS to CDC's HARS is the alpha-numeric 
(soundex) code of the patient's name (patient and physician names 
should not be submitted to CDC); state-assigned patient identifier 
number; HIV/AIDS diagnosis information, including date(s) of diagnosis; 
and the patient's date of birth, race/ethnicity, and sex.
    An additional variable that is critical to ascertain is the initial 
CD4 count. In an effort to better characterize the extent of disease at 
diagnosis, and the impact of targeted testing efforts on identifying 
persons early in the course of their infections, information on CD4 
count at initial diagnosis shall be collected. This information should 
be submitted to CDC as part of the case record. Information on the mode 
of HIV exposure is also essential in order to monitor epidemic trends 
and target prevention interventions. Therefore, timely follow-up to 
complete risk history shall be conducted.
    b. Follow-up investigations of cases/populations of special 
epidemiologic significance. Recipients shall develop procedures for 
promptly notifying CDC of unusual occurrences of HIV transmission and 
for using CDC-developed protocols and criteria to conduct epidemiologic 
and laboratory investigations of cases that may have rare or previously 
unidentified modes of HIV transmission, unusual clinical 
manifestations, or unusual laboratory test results. These include 
transfusion and transplant-related cases, cases of HIV transmitted in 
health care or other occupational settings, cases of HIV-2 infection, 
cases transmitted through female-to-female sexual contact, cases with 
potentially unusual HIV strain variants, and cases with clinical 
evidence of HIV infection but negative HIV test results.
    c. Evaluation of the performance of the surveillance system.
    Recipients shall continue to assess the quality of their HIV/AIDS 
surveillance system and the data generated from this set of activities. 
Assessment will continue regardless of the status of, or procedures 
used, to conduct HIV/AIDS surveillance (e.g. AIDS or HIV reporting, or 
name or code-based reporting).
    Evaluation activities should include critical reviews of 
surveillance methods and redirection of resources to those case-finding 
methods that are the most accurate and productive. Using the 
recommendations published in ``CDC Guidelines for National Human 
Immunodeficiency Virus Case Surveillance, Including Monitoring for 
Human Immunodeficiency Virus Infection and Acquired Immunodeficiency 
Syndrome'', assessments should include routine analysis of surveillance 
data to discover possible sources of under reporting and delays in 
reporting, monitoring data quality. At least once a year, recipients 
shall routinely re-abstract demographic, risk, laboratory, and clinical 
data from a sample of records to assess the quality and validity of 
information collected.
    d. Inter-island and inter-state reciprocal notification of newly 
identified HIV/AIDS cases.
    Recipients should routinely interact with other reporting areas to 
assure coordinate reporting between the island jurisdictions and ensure 
that reciprocal notification of newly identified HIV/AIDS cases, 
perinatal exposure cases, and deaths from HIV infection is executed. 
Routine engagement in this activity will improve the efficiency in 
reporting to CDC and minimize the number of duplicate case reports in 
the national data system. This communication is supported by the 
Council of State and Territorial Epidemiologists (Position Statement 
01-ID-04). It should be carried out by appropriately trained and 
authorized surveillance staff, in a confidential manner consistent with 
local security, confidentiality and reporting policies and procedures. 
Recipients will use the same system for reciprocal notification of HIV, 
AIDS, perinatal HIV exposure and deaths among persons with HIV 
infection, including provision of appropriate identifying information 
(e.g., name or other identifier).
    e. Analysis and dissemination of HIV/AIDS surveillance data and 
promoting their uses of prevention and health services planning and 
evaluation.
    All recipients should routinely disseminate reports of aggregate 
surveillance data for epidemic monitoring and education of the public 
and reporting sources and should promote uses of HIV/AIDS surveillance 
data for prevention and health services planning and evaluation. These 
activities should include: providing HIV/AIDS surveillance data and 
ongoing epidemiologic assistance to community planning groups; 
disseminating surveillance data through publications and presentations;

[[Page 61290]]

participating in planning and implementation meetings; conducting 
analyses to monitor trends, assess need for health-care resources, and 
project the future impact of the disease; and providing feedback to 
reporting sources on ways in which the surveillance data have been used 
to promote public health.
    f. Reporting of data using CDC standards and software.
    Recipients should ensure that data collection forms used to submit 
case reports from laboratories, clinical records, and patient 
interviews contain CDC's recommended standard data elements/questions 
on HIV testing behaviors, risk/exposure behaviors, and treatment 
access/adherence behaviors.
    g. Security
    Consistent with ``Appendix C'' of CDC's ``Guidelines for HIV/AIDS 
Surveillance,'' recipients must ensure that the program requirements 
detailed in the Security Standards are attained as indicated by the 
signature of the Overall Responsible Party (ORP) on the attached form. 
HIV/AIDS surveillance funds will be restricted unless the signed ORP 
form has been submitted to CDC.
    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:
    a. Provide training in surveillance methods, study methods, and 
surveillance program planning and management.
    b. Provide laboratory training that includes current scientific and 
technical information about the practical and the theoretical 
sensitivity and specificity of the different serological tests.
    c. Coordinate and convene conferences, develop routine 
communications, provide guidelines and standards for the conduct of 
surveillance program activities, and communicate with recipients to 
develop, refine, and disseminate HIV/AIDS surveillance program 
information that describes effective methods to carry out program 
activities and monitor progress.
    d. Provide: (1) Criteria for the surveillance definition of 
nationally reported HIV infection/disease (including AIDS), (2) 
prototype (model) case report forms, and (3) assistance in establishing 
and maintaining software for collecting, transferring and evaluating 
HIV/AIDS surveillance data.
    e. Participate in the analysis and dissemination of information and 
data gathered from program activities and facilitate the transfer and 
utilization of information and technology among all States and 
communities.
    f. Assist in the evaluation of the overall effectiveness of program 
operations, including the impact of surveillance data on the 
development of public policy and on targeting and evaluating HIV 
Prevention Community Planning activities.
    g. Assist areas to better use the national HIV/AIDS surveillance 
data provided to CDC by areas for public health policy formulation; 
obtaining and allocating federal resources for HIV/AIDS surveillance, 
prevention, and care; and evaluation of national public health 
recommendations. Promote and facilitate coordination of CDC 
surveillance data and activities with other CDC programs and other 
agencies of the federal government.
    h. Provide technical assistance in the area of data storage and 
management to assure that reporting areas: (1) Adhere to appropriate 
confidentiality and security procedures; and (2) execute the necessary 
data management and analytic procedures to assure data integrity and 
accuracy.
    i. Disseminate national surveillance data for public health 
research purposes through routine reports, articles in books and peer-
reviewed journals, and presentations.
    j. Maintain a secure and confidential national HIV/AIDS 
surveillance database.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.

Part I. Core Surveillance

    Fiscal Year Funds: 2004.
    Approximate Total Funding: $34,000,000.
    Approximate Number of Awards: 65.
    Approximate Average Award: $500,000.
    Floor of Award Range: $9,000 to $4,000,000.
    Ceiling of Award Range: $4,000,000.
    Anticipated Award Date: April 1, 2004.
    Budget Period Length: 9 months.
    Project Period Length: 2 years and 9 months.
    Considerations for Funding Levels: All technically acceptable 
applications will be funded. The following items are general 
considerations that will affect decisions on funding levels.
    1. Greatest consideration will be given to areas with an HIV case 
reporting system as of the due date of this application.
    2. Areas that do not meet criterion one, but have a written plan 
with established regulations or laws that will enable HIV case 
reporting to be in place as of April 1, 2004 will receive greater 
consideration than areas with no immediate plans for implementation of 
such a reporting system.
    3. The presence of at least one Ryan White Title I Eligible 
Metropolitan Area (EMA) within the jurisdiction of the applicant.
    4. The applicant's description of:
    (a) Surveillance evaluation activities that are in place.
    (b) Information from surveillance evaluation activities 
demonstrating that the HIV case reporting system meets the minimum 
performance standards for HIV case reporting published in ``CDC 
Guidelines for National Human Immunodeficiency Virus Case Surveillance, 
Including Monitoring for Human Immunodeficiency Virus Infection and 
Acquired Immunodeficiency Syndrome''. These standards are summarized in 
Attachment A (as posted with this announcement on the CDC Web site.)
    5. Additional programmatic consideration will be based on increases 
or decreases in the volume of reported cases of HIV or AIDS and their 
implications for HIV/AIDS surveillance program activities.

Part II. HIV Incidence Surveillance

    Fiscal Year Funds: 2004.
    Approximate Total Funding: $15,000,000.
    Approximate Number of Awards: 35.
    Approximate Average Award: $250,000.
    Floor of Award Range: $130,000 to $790,000.
    Ceiling of Award Range: $790,000.
    Anticipated Award Date: April 1, 2004.
    Budget Period Length: 9 months.
    Project Period Length: 2 years and 9 months.
    Consideration for Funding Levels: All technically acceptable 
applications will be funded. Funding levels will be determined by a 
formula using the highest new annual AIDS case count estimated for 
either of the two most recent calendar years available. Additional 
programmatic consideration will be based on trends in reported cases of 
HIV and the implications for HIV Incidence surveillance program 
activities.

Part III. Capacity Building for Epidemiologic and Program Evaluation 
Activities

    Fiscal Year Funds: 2004.
    Approximate Total Funding: $2,100,000.
    Approximate Number of Awards: 21.

[[Page 61291]]

    Approximate Average Award: $100,000.
    Floor of Award Range: None.
    Ceiling of Award Range: $100,000.
    Anticipated Award Date: April 1, 2004.
    Budget Period Length: 9 months.
    Project Period Length: 2 years and 9 months.
    Consideration for Funding Levels: All technically acceptable 
applications will be funded.

Part IV. Enhanced Surveillance for Perinatal Prevention

    Fiscal Year Funds: 2004.
    Approximate Total Funding: $1,800,000.
    Approximate Number of Awards: 20.
    Approximate Average Award: $82,000.
    Floor of Award Range: $30,000 to $200,000.
    Ceiling of Award Range: $200,000.
    Anticipated Award Date: April 1, 2004.
    Budget Period Length: 9 months.
    Project Period Length: 2 years and 9 months.
Funding Preferences
    Because Part IV is competitive, applications for activity under 
this Part will be evaluated by an Objective Review Panel. Some 
applicants may not be funded.
    The following items are general considerations that will affect 
decisions on funding levels:
    1. Greatest preference will be given to areas that receive 
categorical funding from CDC for perinatal prevention program 
activities.
    2. Secondary preference will be given to areas that possess an 
authorized reporting system for pediatric HIV exposure as well as 
adult, adolescent, and pediatric HIV infection.
    3. Additional programmatic funding considerations will be based on 
the estimated number of HIV infected women giving birth (Source: 1994 
Survey of Childbearing Women) and its implications for HIV/AIDS 
surveillance program activities.

Part V. Laboratory Testing for Recent HIV Infection

    Fiscal Year Funds: 2004.
    Approximate Total Funding: $800,000.
    Approximate Number of Awards: 2 to 3.
    Approximate Average Award: $320,000.
    Floor of Award Range: $270,000 to $400,000.
    Ceiling of Award Range: $400,000.
    Anticipated Award Date: April 1, 2004.
    Budget Period Length: 9 months.
    Project Period Length: 2 years and 9 months.
Funding Preferences
    Because Part V is competitive, applications for activity under this 
Part will be evaluated by an independent review panel (formerly 
Objective Review Panel). Some applicants may not be funded.
    Preference will be given to sites that achieve the best 
distribution and representation of geographic regions (e.g., Northeast, 
South, and West).
    Preference will be given to areas that demonstrate the greatest 
degree of automation in sample processing and testing.

Part VI. Behavioral Surveillance

    Fiscal Year Funds: 2004.
    Approximate Total Funding: $10,000,000.
    Approximate Number of Awards: 25.
    Approximate Average Award: $400,000.
    Floor of Award Range: $350,000 to $450,000.
    Ceiling of Award Range: $450,000.
    Anticipated Award Date: April 1, 2004.
    Budget Period Length: 9 months.
    Project Period Length: 2 years and 9 months.
Consideration for Funding
    All technically acceptable applications will be funded.

Part VII. Core Surveillance in the Pacific Island Jurisdictions

    Fiscal Year Funds: 2004.
    Approximate Total Funding: $100,000.
    Approximate Number of Awards: 6.
    Approximate Average Award: $17,500.
    Floor of Award Range: $10,000 to $25,000.
    Ceiling of Award Range: $25,000.
    Anticipated Award Date: April 1, 2004.
    Budget Period Length: 9 months.
    Project Period Length: 2 years and 9 months.
Considerations for Funding Levels
    All technically acceptable applications will be funded. The 
following items are general considerations that will affect decisions 
on funding levels.
    1. Greatest consideration will be given to areas that have a 
functional laboratory physically located on an island within the funded 
island jurisdiction that is either currently able, or could, with a 
reasonable investment in the appropriate equipment, accept, process, 
and distribute results for confirmatory HIV diagnostic tests. This 
laboratory should be able to execute Western Blot or immunofluoresence 
assay (IFA) tests. The health department on an island jurisdiction with 
such a facility should be able to serve as a central data collection 
center that coordinates available clinical information on cases 
confirmed through processing of specimens from other island 
jurisdictions.
    2. The next greatest consideration will be given to areas with an 
HIV case reporting system as of the due date of this application.
    3. Areas that do not meet criterion one, but have a written plan 
with established regulations or laws that will enable HIV case 
reporting to be in place as of April 1, 2004 will receive greater 
consideration than areas with no immediate plans for implementation of 
such a reporting system.
    4. Additional programmatic consideration will be based on increases 
or decreases in the volume of reported cases of HIV or AIDS and their 
implications for HIV/AIDS surveillance program activities.
    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

Eligible Applicants

Part I. Core Surveillance

    Applications may be submitted by health departments of States, U.S. 
territories or their bona fide agents, including the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, and the 
six independently-funded city health departments of Chicago, Houston, 
Los Angeles, New York City, Philadelphia, and San Francisco. All 
eligible applicants for core HIV/AIDS surveillance activities will be 
funded. Funding will include activities that expand the uses and 
improve the quality of HIV/AIDS surveillance data to more effectively 
guide public health policy and provide relevant information necessary 
to direct and evaluate prevention and care activities.

Part II. HIV Incidence Surveillance

    In order to ensure execution of this complex project, and provide 
estimates for incidence that possess adequate

[[Page 61292]]

statistical precision, eligible sites must possess HIV reporting 
systems, and they must have a sufficient number of reports on new, 
annual HIV diagnoses.
    Therefore, eligibility is limited to applicants previously funded 
for this activity as part of the supplemental awards provided through 
Program Announcement 00005. States will be eligible regardless of the 
AIDS case count if there is an independently funded city health 
department within the State that has either been previously funded, or 
will be funded under the criteria described below.
    New applicants eligible for these funds will include those areas 
which will have HIV case reporting as of April 1, 2004, and have, 
according to the National AIDS Reporting System maintained by CDC, at 
least 300 new AIDS cases in either of the calendar years during the 
budget period.
    The known eligible sites are: Alabama, Arizona, California, 
Chicago, Colorado, Connecticut, District of Columbia, Florida, Georgia, 
Houston, Illinois, Indiana, Kentucky, Los Angeles, Louisiana, Maryland, 
Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York 
State, New York City, North Carolina, Ohio, Oklahoma, Pennsylvania, 
Philadelphia, Puerto Rico, San Francisco, South Carolina, Tennessee, 
Texas, Virginia, and Washington.

Part III. Capacity Building for Epidemiologic and Program Evaluation 
Activities

    Recipient health departments must have sufficient disease burden 
for analytic activities to provide information with sufficient 
statistical and epidemiologic precision.
    Therefore, assistance will be provided to moderate morbidity States 
reporting from 240 to 1500 AIDS cases from July 2000 through June 2001, 
(Centers for Disease Control, HIV/AIDS Surveillance Report, 
2000;13(no.1):6) and States or territories previously funded for fewer 
than five of the following supplemental surveillance projects.
    Projects include the following and correspond to the appropriate 
sections of Part II of FY2000's Program Announcement 00005 and 
Activities One through Four of FY2001's Program Announcement 00005B: 
(1) Adult/Adolescent Spectrum of Disease (ASD); (2) Survey of HIV 
Disease and Care (SHDC); (3) Survey of HIV Disease and Care plus 
Interview Supplement (SHDC+); (4) Supplement to HIV/AIDS Surveillance 
(SHAS); (5) New Supplemental Interview Projects; (6) Enhanced 
Surveillance for Perinatal Prevention; (7) Alternate Approaches; (8) 
Regional Technical Assistance Centers; (9) HIV Testing Survey; and (10) 
Estimation of HIV incidence.
    Known eligible applicants are: Alabama, Arizona, Connecticut, 
Delaware, District of Columbia, Georgia, Illinois, Indiana, Kentucky, 
Louisiana, Massachusetts, Mississippi, Missouri, Nevada, North 
Carolina, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, and 
Virginia.

Part IV. Enhanced Surveillance for Perinatal Prevention

    This is a complex activity that requires substantial resources, 
commitment on the part of the affected surveillance program, and a 
sufficient number of events to provide reasonably precise assessments 
of the effectiveness of perinatal prevention efforts.
    Therefore, eligible applicants are limited to the high-morbidity 
areas (estimated 60 or more HIV-positive women giving birth--Source: 
1994 Survey of Childbearing Women) previously funded by CDC for 
Enhanced Perinatal Surveillance, or to areas that have received 
categorical funding from CDC for perinatal HIV prevention program 
activities.
    Eligible applicants should have implemented, or plan to implement, 
HIV surveillance for adults and children (including reporting HIV-
exposed infants) as an extension of their AIDS surveillance activities, 
by April 1, 2004. If this has not occurred, the applicant may propose 
to continue to conduct these activities in selected facilities serving 
large numbers of HIV-infected women and their infants using established 
research (i.e., IRB) procedures for case ascertainment.
    Known eligible applicants are: Alabama, California, Chicago, 
Connecticut, Delaware, District of Columbia, Florida, Georgia, Houston, 
Illinois, Los Angeles, Louisiana, Maryland, Massachusetts, Michigan, 
Mississippi, New Jersey, New York, New York City, North Carolina, 
Pennsylvania, Philadelphia, Puerto Rico, Ohio, Tennessee, Texas, 
Virginia, and South Carolina.

Part V. Laboratory Testing for Recent HIV Infection

    Because this is a technically sophisticated technique, only 
laboratories that are already participating in the IND with prior 
experience conducting large numbers of STARHS tests and documented 
proficiency will be considered.

Part VI. Behavioral Surveillance

    Eligibility will be limited to the State or local health 
departments which include the top 26 Metropolitan Statistical Areas 
(MSA's) by number of people living with AIDS at the end of 2000 as 
reported in ``HIV/AIDS Surveillance Supplemental Report,'' 
(2002;8(No.2:18-19)).
    These are the directly funded city health departments of Los 
Angeles, CA; San Francisco, CA; Chicago, IL; New York City, NY; 
Philadelphia, PA; Houston, TX; and, the State health departments 
containing the following MSAs: Phoenix, AZ; San Diego, CA; Denver, CO; 
New Haven, CT; Washington, DC; Miami, and Ft. Lauderdale, FL; Atlanta, 
GA; New Orleans, LA; Boston, MA; Baltimore, MD; Detroit, MI; St. Louis, 
MO; Las Vegas, NV; Newark, NJ; Nassau-Suffolk, NY; San Juan, PR; 
Dallas, TX; Norfolk, VA; and, Seattle, WA.
    Projects will be supported only within the MSA listed and only 
within the geographic bounds of the funded entity (where MSAs extend 
beyond the jurisdiction of the eligible state or city health 
department). Recruitment venues may be limited to the geographic 
subdivision (e.g., city, county, health district) within the MSA with 
the highest AIDS morbidity where it would be impractical to conduct 
surveillance in the entire area.

Part VII. Core Surveillance in the Pacific Island Jurisdictions

    Applications may be submitted by health departments of American 
Samoa, Guam, Marshall Islands, Palau, the Commonwealth of the Northern 
Mariana Islands and the Federated States of Micronesia.
    All technically acceptable applicants for core HIV/AIDS 
surveillance activities will be funded. Funding will include activities 
that facilitate the development and improvement in the quality of HIV/
AIDS surveillance data to more effectively guide public health policy 
and provide relevant information necessary to direct and evaluate 
prevention and care activities.
    Other Eligibility Requirements: None.
    Cost Sharing or Matching: Matching funds are not required for this 
program.

    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

    How to Obtain Application Forms: To apply for this funding 
opportunity use application form PHS 5161-1. Forms are available on the 
CDC Web site, at the

[[Page 61293]]

following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    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.
    This program announcement is the definitive guide on application 
format, content, and deadlines. It supersedes information provided in 
the application instructions. If there are discrepancies between the 
application form instructions and the program announcement, adhere to 
the guidance in the program announcement.
    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. 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.
    If your application form does not have a DUNS number field, please 
write your DUNS number at the top of the first page of your 
application, and/or include your DUNS number in your application cover 
letter.
Content and Form of Submission
    Application: Applications for activities under Section I, II, III, 
VI, and VII will receive a Technical Acceptability Review. Part IV and 
Part V will be evaluated separately by an independent and separate 
objective review panel. To facilitate this review, submit separate and 
complete applications for each activity under Parts I, II, III, IV, V, 
VI, and VII for which you are applying, including separate budgets and 
narrative justifications, that can stand alone as an application for 
review purposes.
    You must submit a signed original and two copies of your 
application forms. You must include a project narrative with your 
application forms. Your narrative must be submitted in the following 
format:

Part I. Core Surveillance

    [sbull] Maximum number of pages: 30 pages double spaced, including 
up to five pages of program plans and budgets for years 2005 and 2006, 
excluding reports and appendices. Applications with narratives in 
excess of 30 pages will be returned to the applicant and not considered 
for funding.
    [sbull] Font size: 12 point unreduced.
    [sbull] Paper size: 8.5 by 11 inches.
    [sbull] Page margin size: 1 inch.
    [sbull] Printed only on one side of page.
    [sbull] Held together only by rubber bands or metal clips; not 
bound in any other way.
    Format:
    In developing this Part of the application, your narrative must 
follow the format below:
    1. Program Need and Resources.
    2. Collaboration and Use of Data.
    3. Objectives.
    4. Program Plan and Methods for Implementation.
    5. Program Evaluation Plan.
    6. Project Management and Staffing Plan.
    7. Budget.
    8. Attachments.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
    1. Describe proposed active case-finding efforts, follow-up of 
priority cases, and activities that promote uses of HIV and AIDS 
surveillance data for prevention planning.
    2. Describe procedures for critically reviewing surveillance 
methodologies to promote efficient and effective use of resources, 
disseminating data for public health purposes, ensuring that the 
surveillance program contributes to the goals and public health mission 
of the health department, using surveillance data to evaluate the 
effectiveness of State/local prevention efforts, policies, and 
programs, and using surveillance data to target and evaluate proposed 
community-based interventions.
    Also, describe proposed activities that will facilitate the 
efficiency, reliability, completeness of variables and accuracy of HIV/
AIDS surveillance data. Examples of such activities include procedures 
that facilitate the identification and investigations of cases of 
public health importance (e.g. atypical or variant HIV sub-types or 
strains), with specific outcomes and co-morbidities (e.g., persons 
diagnosed concurrently with HIV and TB or HIV and STDs), or 
collaborations with prevention and care partners (e.g., projects to 
assess the availability of data on risk behaviors in Prevention 
Counseling and Referral Systems [PCRS], or assessment of the validity 
of CD4 or viral load reporting as a marker of receiving regular care 
and treatment of HIV).
    3. If HIV case surveillance is, or will soon be implemented, and 
case reports are used to facilitate voluntary prevention referral 
services [e.g. PCRS], or conduct registry matching with other public 
health programs in the health department (e.g., tuberculosis, STD), 
document steps to ensure that such practices are consistent with the 
Security and Confidentiality Standards (as published in ``Appendix C'' 
of the Guidelines for HIV/AIDS Surveillance) and consistent with CDC 
and State or local IRB requirements for secondary uses of surveillance 
data.
    4. PCRS can be conducted without linkage to surveillance 
information. Some areas may elect to link surveillance information to 
PCRS. In areas that link surveillance reporting and PCRS activities, 
CDC recommends that these activities should be evaluated to assure that 
the programmatic objectives of PCRS are attained without unnecessarily 
compromising community and provider support for surveillance program 
activities. These evaluations should be executed in partnership with 
HIV prevention programs. Applicants should document that such 
evaluations are jointly funded and conducted by the surveillance and 
HIV/AIDS prevention program staff.
    5. Describe existing evaluation activities to assess the 
performance attributes of the HIV/AIDS surveillance system according to 
published CDC recommendations (Attachment A). This description should 
include the methods and results associated with efforts to limit the 
number of inter-state duplication of HIV, AIDS, perinatal exposure and 
HIV infection deaths across States, and intra-state reporting areas 
through reciprocal notification of cases. Provide documentation that 
the applicant will collaborate with CDC to conduct evaluations during 
the period of this cooperative agreement according to established and 
validated protocols developed by CDC.
    6. Describe State laws, rules, or regulations pertaining to the 
protection or release of surveillance information; and physical 
security of hard copies and electronic files containing confidential 
surveillance information; any laws, rules, regulations, or health 
department policies that require or permit the release of patient 
identifying information collected under the HIV/AIDS surveillance 
system to entities outside of the public health department and measures 
the health department has taken to ensure that the confidentiality of 
individuals reported to the surveillance system is protected from 
further or unlawful disclosure. As part of the application, you must 
submit a signed copy of the form (Attachment B) designating the ORP and 
attesting that

[[Page 61294]]

all Program Requirements as stipulated in the Security Standards in 
Appendix C of the ``Guidelines for HIV/AIDS Surveillance'' have been 
attained.
    7. Provide a description of the personnel, and the level of support 
provided through CDC funding for each staff person involved with HIV/
AIDS core surveillance activities. A description of the experience, 
training, credentials and activities of these staff members should be 
included. Curriculum vitae should be included as attachments to the 
application for those staff members occupying supervisory, leadership, 
and advanced technical or scientific positions.
    8. Budget
    a. In the travel category, include a total for local travel and a 
total for out-of-state travel.
    b. The following information is required for all proposed 
contracts: name of contractor, period of performance, method of 
selection (e.g., competitive or sole source), description of 
activities, justification for subcontracting, and itemized budget.
    c. Submit a single budget and justification for core surveillance 
Recipient Activities.
    Following receipt of your FY 2004 award, CDC may request additional 
activity- or project-specific budgetary information.

Part II. HIV Incidence Surveillance

    [sbull] Maximum number of pages: 20 double spaced, including up to 
five pages of program plans and budgets for years 2005 and 2006 
excluding reports and appendices. Applications with narratives in 
excess of 20 pages will be returned to the applicant and not considered 
for funding.
    [sbull] Font size: 12 point unreduced.
    [sbull] Paper size: 8.5 by 11 inches.
    [sbull] Page margin size: 1 inch.
    [sbull] Printed only on one side of page.
    [sbull] Held together only by rubber bands or metal clips; not 
bound in any other way.
    Format:
    In developing this Part of the application, your narrative must 
follow the format below:
    1. Program Plan.
    2. Objectives.
    3. Methods for Implementation.
    4. Program Evaluation Plan.
    5. Budget.
    6. Attachments.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
    1. Describe the characteristics of the HIV reporting system 
including regulations or statutes that authorize the collection of HIV 
data, length of time it has been in place, major sources of reports, 
whether laboratory reporting exists, and if so, if electronic 
laboratory reporting is used. This description must also verify that 
diagnosed HIV infections are reported in a timely manner.
    2. Describe the potential ability of the surveillance system to 
coordinate with laboratory partners, including public health 
laboratories and commercial laboratories responsible for HIV testing in 
the state, to obtain aliquots of blood for STARHS testing.
    3. How the recipient will collaborate with CDC to assure 
appropriate and efficient preparation and transport from the lab of 
diagnosis to the public health lab, and then from the public health lab 
to reference laboratories for STARHS testing.
    4. Describe how HIV testing histories will be obtained (either 
before or after STARHS testing) from persons identified as recently 
infected by the STARHS assay, or its equivalent. The strategies for 
acquiring these data should include a diverse sample of persons from 
public and private facilities to assure representative and adequately 
precise population-based estimates for incidence.
    5. Describe how HIV case data will be linked to results from 
laboratory specimens, and to HIV testing history information.
    6. In addition to linking STARHS results to information in the HIV 
reporting system, in some settings a set of specimens will be tested in 
an unlinked fashion. Describe how specimens from such individuals will 
be anonymized, and data for this component of the surveillance system 
will be managed.
    7. Describe the number, activities, level of support and 
qualifications of the personnel who will be involved in the HIV 
Incidence Surveillance program.
    8. Budget
    a. In the travel category, include a total for local travel and a 
total for out-of-state travel.
    b. The following information is required for all proposed 
contracts: name of contractor, period of performance, method of 
selection (e.g., competitive or sole source), description of 
activities, justification for subcontracting, and itemized budget.
    c. Submit a single budget and justification for HIV Incidence 
Surveillance Recipient Activities.
    Following receipt of your FY 2004 award, CDC may request additional 
activity- or project-specific budgetary information.

Part III. Capacity Building for Epidemiologic and Program Evaluation 
Activities

    [sbull] Maximum number of pages: 15 double-spaced pages including 
up to five pages of program plans for years 2005 and 2006, excluding 
reports and appendices. Applications with narratives in excess of 15 
pages will be returned to the applicant and not considered for funding.
    [sbull] Font size: 12 point unreduced.
    [sbull] Paper size: 8.5 by 11 inches.
    [sbull] Page margin size: 1 inch.
    [sbull] Printed only on one side of page.
    [sbull] Held together only by rubber bands or metal clips; not 
bound in any other way.
    Format:
    In developing this Part of the application, your narrative must 
follow the format below:
    1. Program Need and Resources.
    2. Plan and Objectives.
    3. Methods.
    4. Staffing.
    5. Budget.
    6. Attachments.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
    Describe how staff hired for this project will:
    1. Provide on-going assistance in the development and use of the 
epidemiologic profile, program, and other health-related data for HIV 
prevention and care community planning.
    2. Assist HIV prevention and care community planning groups with 
evaluation activities.
    3. Describe the number, and type of activities, the level of 
support and qualifications of the personnel who will be involved in the 
HIV Incidence Surveillance program.
    4. Budget
    a. In the travel category, include a total for local travel and a 
total for out-of-state travel.
    b. The following information is required for all proposed 
contracts: name of contractor, period of performance, method of 
selection (e.g., competitive or sole source), description of 
activities, justification for subcontracting, and itemized budget.
    c. Submit a single budget and justification for Capacity Building 
for Epidemiologic and Program Evaluation Activities Recipient 
Activities. Following receipt of your FY 2004 award, CDC may request 
additional activity- or project-specific budgetary information.

[[Page 61295]]

Part IV. Enhanced Surveillance for Perinatal Prevention

    [sbull] Maximum number of pages: The narrative should be no more 
than 15 double-spaced pages, including up to five pages of program 
plans and budgets for years 2005 and 2006, excluding reports and 
appendices. Applications with narratives in excess of 15 pages will be 
returned to the applicant and not considered for funding.
    [sbull] Font size: 12 point unreduced.
    [sbull] Paper size: 8.5 by 11 inches.
    [sbull] Page margin size: 1 inch.
    [sbull] Printed only on one side of page.
    [sbull] Held together only by rubber bands or metal clips; not 
bound in any other way.
    Format:
    In developing this Part of the application, your narrative must 
follow the format below:
    1. Program Plan.
    2. Objectives.
    3. Methods.
    4. Evaluation.
    5. Proposed Data Uses.
    6. Staffing.
    7. Budget.
    8. Attachments.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
    1. Describe the current ability of surveillance activities to 
collect information on all HIV exposed infants and HIV infected 
mothers. Applicants that will not implement HIV reporting to include 
HIV exposure reporting by April 1, 2004 and apply for a time-limited 
research project must submit evidence that the proposed activity will 
be approved by an IRB as required by CDC.
    2. Describe the methods that will be used in identifying and 
linking data on HIV exposed infants and HIV infected mothers; 
conducting systematic chart reviews to complete abstraction forms and 
HIV/AIDS case report forms; conducting longitudinal follow-up of HIV 
exposed infants to ascertain infection status and initiation of HIV 
related treatment and care; and assessing short-and/or long-term 
outcomes in HIV exposed infants.
    3. Describe the methods that will be used in evaluating the 
Enhanced Surveillance of Perinatal Prevention activities, to include a 
description of the timeliness and completeness of data collection and 
submission of data to CDC.
    4. Describe how the data from Enhanced Surveillance of Perinatal 
Prevention will be coordinated with and used to improve perinatal 
prevention activities.
    5. Describe the number, activities, level of support and 
qualifications of the personnel who will be involved in the Enhanced 
Surveillance of Perinatal Prevention.
    6. Budget
    a. In the travel category, include a total for local travel and a 
total for out-of-state travel.
    b. The following information is required for all proposed 
contracts: name of contractor, period of performance, method of 
selection (e.g., competitive or sole source), description of 
activities, justification for subcontracting, and itemized budget.
    c. Submit a single budget and justification for Enhanced 
Surveillance of Perinatal Prevention Activities. Following receipt of 
your FY 2004 award, CDC may request additional activity-or project-
specific budgetary information.

Part V. Laboratory Testing for Recent HIV Infection

    [sbull] Maximum number of pages: The narrative should be no more 
than 15 double-spaced pages printed on one side, including up to five 
pages of program plans and budgets for years 2005 and 2006 excluding 
reports and appendices. Attachments should not exceed an additional 25 
pages, including budget and budget narrative. Required forms do not 
count toward page limits. Applications with narratives in excess of 15 
pages will be returned to the applicant and not considered for funding.
    [sbull] Font size: 12 point unreduced.
    [sbull] Paper size: 8.5 by 11 inches.
    [sbull] Page margin size: 1 inch.
    [sbull] Printed only on one side of page.
    [sbull] Held together only by rubber bands or metal clips; not 
bound in any other way.
    Format:
    In developing this Part of the application, your narrative must 
follow the format below:
    1. Technical Competence.
    2. Capacity.
    3. Evaluation.
    4. Staffing.
    5. Budget.
    6. Attachments.

VI. Behavioral Surveillance

    [sbull] Maximum number of pages: The program narrative should be no 
more than 15 double-spaced pages. Attachments should not exceed an 
additional 25 pages, including budget and budget narrative. Required 
forms do not count toward page limits. Applications with narratives in 
excess of 15 pages will be returned to the applicant and not considered 
for funding.
    [sbull] Font size: 12 point unreduced.
    [sbull] Paper size: 8.5 by 11 inches.
    [sbull] Page margin size: 1 inch.
    [sbull] Printed only on one side of page.
    [sbull] Held together only by rubber bands or metal clips; not 
bound in any other way.
    Format:
    In developing this Part of the application, your narrative must 
follow the format below:
    1. Program Plan.
    2. Objectives.
    3. Methods.
    4. Evaluation.
    5. Proposed Data Uses.
    6. Staffing.
    7. Budget.
    8. Attachments.

Part VII. Core Surveillance in the Pacific Island Jurisdictions

    [sbull] Maximum number of pages: The narrative should be no more 
than 15 double-spaced pages, including up to five pages of program 
plans and budgets for years 2005 and 2006, excluding reports and 
appendices. Applications with narratives in excess of 30 pages will be 
returned to the applicant and not considered for funding.
    [sbull] Font size: 12 point unreduced.
    [sbull] Paper size: 8.5 by 11 inches.
    [sbull] Page margin size: 1 inch.
    [sbull] Printed only on one side of page.
    [sbull] Held together only by rubber bands or metal clips; not 
bound in any other way.
    Format:
    In developing this Part of the application, your narrative must 
follow the format below:
    1. Program Need and Resources.
    2. Collaboration and Use of Data.
    3. Objectives.
    4. Program Plan and Methods for Implementation.
    5. Program Evaluation Plan.
    6. Project Management and Staffing Plan.
    7. Budget.
    8. Attachments.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
    1. Describe proposed plans for developing active case-finding 
efforts, follow-up of priority cases, and activities that promote uses 
of HIV and AIDS surveillance data for prevention planning.
    2. Describe procedures for critically reviewing surveillance 
methodologies to promote efficient and effective use of resources; 
disseminating data for public health purposes; ensuring that the 
surveillance program contributes to the goals and public health mission 
of the

[[Page 61296]]

health department; using surveillance data to evaluate the 
effectiveness of prevention efforts, policies, and programs; and using 
surveillance data to target and evaluate proposed community-based 
interventions.
    3. Describe existing or proposed assessment activities to improve 
the performance attributes of the HIV/AIDS surveillance system. This 
description should include the methods to improve the completeness of 
reporting, limit the number of inter-island duplicates of HIV, AIDS, 
and promote the accuracy of the data.
    4. In specific areas where there is laboratory capacity to perform 
confirmatory testing (i.e. Western Blot or IFA) describe the capacity 
to serve as central data coordination area through collaboration with 
other island jurisdictions that submit specimens for such confirmatory 
testing. These descriptions should include a process for assuring 
compliance with security and confidentiality requirements.
    5. Describe State laws, rules, or regulations pertaining to the 
protection or release of surveillance information; physical security of 
hard copies and electronic files containing confidential surveillance 
information; any laws, rules, regulations, or health department 
policies that require or permit the release of patient identifying 
information collected under the HIV/AIDS surveillance system to 
entities outside of the public health department and measures the 
health department has taken to ensure that the confidentiality of 
individuals reported to the surveillance system is protected from 
further or unlawful disclosure. As part of the application, you must 
submit a signed copy of the form (Attachment B) designating the ORP and 
attesting that all Program Requirements as stipulated in the Security 
Standards in Appendix C of the ``Guidelines for HIV/AIDS Surveillance'' 
have been attained.
    6. Provide a description of the personnel, and the level of support 
provided through CDC funding for each staff person involved with HIV/
AIDS core surveillance activities. A description of the experience, 
training, credentials and activities of these staff members should be 
included. Curriculum vitae should be included as attachments to the 
application for those staff members occupying supervisory, leadership, 
and advanced technical or scientific positions.
    7. Budget
    a. In the travel category, include a total for local travel and a 
total for out-of-state travel.
    b. The following information is required for all proposed 
contracts: name of contractor, period of performance, method of 
selection (e.g., competitive or sole source), description of 
activities, justification for subcontracting, and itemized budget.
    c. Submit a single budget and justification for core surveillance 
Recipient Activities. Following receipt of your CY 2004 award, CDC may 
request additional activity-or project-specific budgetary information.
    Funding Restrictions:
    Funding restrictions, which must be taken into account while 
writing your budget for parts I-VII are as follows:
    [sbull] Funds are awarded for a specifically defined purpose 
described in this announcement and may not be used for any other 
purpose or program.
    [sbull] Funds may be used to support personnel and to purchase 
equipment, supplies, and services directly related to project 
activities.
    [sbull] Funds may not be used to supplant State or local health 
department funds available for HIV Prevention and Surveillance.
    [sbull] Funds may not be used to provide direct medical care or 
prevention case management.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement must be less than 12 
months of age.
    Guidance for completing your budget can be found on the CDC Web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.
    Submission Date, Time, and Address: Application Deadline Date: 
January 16, 2004.
    Application Submission Address: Submit your application by mail or 
express delivery service to:
    Technical Information Management-PA 04017, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office 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. If CDC receives your application 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, you will be given the opportunity to 
submit documentation of the carriers guarantee. If the documentation 
verifies a carrier problem, CDC will consider the application as having 
been received by the deadline.
    This program announcement is the definitive guide on application 
format, content, and deadlines. 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 you did not meet the submission 
requirements.
    If you have a question about the receipt of your application, first 
contact your courier. If you still have a question, contact the PGO-TIM 
staff at: 770-488-2700. Before calling, please wait two to three days 
after the application deadline. This will allow time for applications 
to be processed and logged. CDC will not be sending post cards 
acknowledging receipt of applications.
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.

V. Application Review Information

    Review 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.
    Your application will be evaluated against the following criteria:
    A Technical Acceptability Review will be conducted by CDC for Parts 
I, II, III, VI, and VII. Parts IV and V will involve Objective Review 
Panels. The individual ``Parts'' are further discussed below.

[[Page 61297]]

Part I. Core Surveillance

    The following criteria will be used to evaluate applications for 
their technical acceptability:
    1. Program Need and Resources: The extent to which the applicant 
describes the requirements for, and activities of, the HIV/AIDS 
surveillance system that includes a presentation of existing strengths 
and limitations. The extent to which this overview includes: the 
program need in terms of HIV/AIDS morbidity (i.e., delineation of the 
annual number of HIV/AIDS cases and case rates); extent and level of 
funding devoted to prevention, treatment, and care programs in the area 
that require HIV/AIDS surveillance data for resource allocation and 
program planning; uses of surveillance data, including linkages to 
public health program activities such as PCRS; ability to analyze data 
that allows for the identification of trends in emerging modes of HIV 
transmission (by various demographic indicators and behaviors); all 
existing and potential sources of HIV/AIDS cases; a description of HIV/
AIDS reporting procedures and resources in the area including a 
presentation of data items currently collected; ongoing quality 
assurance procedures to promote data quality; sources of funding beyond 
federal monies provided by CDC; the flow of data through the reporting 
system; existing policies and procedures that are written and 
implemented for security, confidentiality, data dissemination and 
surveillance procedural activities; educational and training activities 
undertaken to develop and enhance the skills of surveillance staff and 
staff in reporting facilities; a copy of the most recent annual 
surveillance report; State legislation and/or regulations pertaining to 
the reporting, collection, uses and dissemination of HIV/AIDS 
surveillance data.
    2. Collaboration and Use of Data: The extent to which the applicant 
describes past, current, and proposed collaboration with: the relevant 
HIV/AIDS organizations and agencies within the reporting area; CDC, and 
other States or national organizations involved in coordinating and 
assuring the quality, completeness, and accuracy of HIV/AIDS 
surveillance data; locally and Federally-funded prevention, treatment 
and care programs such as the CDC prevention programs or the Ryan White 
Care Act; and the extent HIV/AIDS surveillance data are used to assist 
public and private partners (e.g., community planning groups, AIDS 
Service Organizations) as a guide for allocating HIV prevention and 
care resources, and as a means to evaluate the success of their 
intervention programs.
    3. Proposed Objectives: The extent to which program objectives are: 
specific, measurable, time-phased, and realistic; related to recipient 
activities, program purpose and program activities; derived from needs 
identified in the resources and needs assessment; and consistent with 
national HIV/AIDS surveillance program objectives.
    4. Program Plan and Methods for Implementation: The extent to which 
the applicant adequately describes the procedures and methods to be 
used to accomplish the program objectives for their surveillance 
program; and describes how program plans and procedures will facilitate 
achievement of national objectives for HIV/AIDS surveillance.
    5. Program Evaluation Plan: The applicant provides an evaluation 
plan that is appropriate for measuring progress toward program area and 
national HIV/AIDS surveillance objectives; the plan should include a 
specified time-line and methods for identifying promoters and barriers 
to program success.
    6. Project Management and Staffing Plan: The extent to which 
proposed staffing, organizational structure, staff experience and 
background, identified training needs or plan, and job descriptions and 
curricula vitae for both proposed and current staff indicate ability to 
carry out the purposes of the program.
    7. Budget: The budget is reasonable, clearly justified, consistent 
with the demonstrated need and proposed activities, and likely to lead 
to program success.

Part II. HIV Incidence Surveillance

    1. Program Plan: The degree to which the applicant provides 
evidence of their understanding of the project goals and conceptual 
background through the presentation of a coherent plan that describes 
all the necessary activities and personnel needed to conduct HIV 
Incidence surveillance. Quality of plans for conducting data analysis 
and presentation showing how data have been and will be used to improve 
state and local HIV prevention programs and HIV services and care.
    2. Objectives: The extent to which the objectives are specific 
(with time frames), realistic, and address the required recipient 
activities.
    3. Methods for Implementation: The extent to which the applicant 
demonstrates the technical capability to conduct the project using the 
appropriate data collection and analytic methods. Specific technical 
capabilities to be reviewed for each project include: The ability to 
identify new HIV infections reported to the surveillance system in a 
timely manner; collaboration with laboratory partners, including public 
health laboratories and commercial laboratories responsible for HIV 
testing in the state, to obtain aliquots of blood for STARHS testing; 
preparation and transport of specimens to reference laboratories for 
STARHS testing; obtainment of sufficient HIV testing history 
information; linkage of HIV case data to laboratory specimens, and to 
HIV testing history information; and in areas that execute unlinked 
STARHS, the extent to which the methods are feasible and appropriate.
    4. Program Evaluation Plan: The applicant provides an evaluation 
plan that is appropriate for measuring progress toward program area and 
national HIV Incidence surveillance objectives; the plan should include 
a specified time-line and methods for identifying promoters and 
barriers to program success.
    5. Budget: The budget is reasonable, clearly justified, consistent 
with the demonstrated need and proposed activities, and likely to lead 
to program success.

Part III. Capacity Building for Epidemiologic and Program Evaluation 
Activities

    1. Program Need and Resources: The extent to which the applicant 
describes the need for resources to achieve the purpose. The detail 
should include how awardees will collaborate with public and private 
partners (such as, HIV prevention and care community planning groups 
and AIDS service organizations) to use surveillance, program, and other 
health-related data to enhance community planning, evaluation, and 
monitoring achievement of goals and objectives.
    2. Plan and Objectives: The extent to which the applicant describes 
its plan for achieving the purpose, including presentation of goals, 
objectives, activities, and time frames along with narrative 
discussion. The narrative discussion should include:
    a. Objectives for the collection, use, analysis, interpretation of 
surveillance, program, and other health-related data to enhance 
epidemiologic and program evaluation activities.
    b. Discussion of the ``Recipient Activities'' outlined above.
    3. Methods: The extent to which the applicant describes how 
surveillance and other health-related data will be used to improve 
epidemiologic and program evaluation activities, including,

[[Page 61298]]

but not limited to, prevention and care community planning, assessment 
of prevention program effectiveness, and the monitoring of goals and 
objectives. Requests should include discussion of various data sets and 
specific studies that may be available to assist with assessment of the 
impact of HIV prevention activities in the jurisdiction.
    4. Staffing: The extent to which the qualifications, duties, 
responsibilities, and time allocation of proposed staff (including 
potential contractors) are discussed, and how these attributes are 
justified and appropriate to accomplish the purpose and implement the 
recipient activities. Discussion should include the degree to which 
proposed staff will be able to provide appropriate scientific oversight 
as well as programmatic and administrative support for the proposed 
activities.
    5. Budget: Budgets will be assessed to ensure they are reasonable, 
clearly justified, consistent with the demonstrated need and proposed 
activities, and likely to lead to program success.

Part IV. Enhanced Surveillance for Perinatal Prevention

    Note: Applications submitted for this Part will be reviewed by 
an independent objective review panel appointed by CDC that will 
evaluate each application against the following criteria:

    1. Methods (25 points): The extent to which the applicant 
demonstrates technical capability to conduct the project using the 
appropriate data collection and analytic methods. Specific methods 
for accomplishing the following technical activities should be 
described:
    a. Identifying and linking data on related infected mothers and 
HIV exposed children.
    b. Conducting systematic chart reviews, abstraction forms and 
HIV/AIDS case report forms.
    c. Conducting longitudinal follow-up of HIV-exposed infants to 
ascertain infection status and initiation of HIV related treatment 
and care.
    d. Past ability to conduct the project including a description 
of the timeliness and completeness of data collection and submission 
on mother-infant pairs.
    2. Program Plan (20 points): The extent to which the applicant 
provides a clear and feasible plan for enhancing surveillance 
activities for children and women by expanding core perinatal 
surveillance by collecting data:
    a. On all children born to HIV-infected women (including 
zidovudine (ZDV) and other antiretroviral therapy used during 
pregnancy, at labor or delivery, and to the neonate; opportunistic 
infection prophylaxis; initiation of HIV evaluation and care; HIV 
infection status; and short as well as long-term outcomes in 
antiretroviral exposed and unexposed children).
    b. On HIV-infected women who deliver a live infant, to assess 
the counseling and therapy they received during pregnancy, the date 
of their HIV diagnosis, dates of initiation of prenatal care, dates 
of initiation of ZDV and other antiretroviral therapy, pregnancy 
outcomes, stage of HIV disease, and HIV risk behaviors.
    c. Applicants that will not implement HIV reporting by April 1, 
2004 and apply for a time-limited research project must submit 
evidence that the proposed activity will be approved by an IRB as 
required by CDC.
    3. Objectives (15 points): The extent to which the objectives 
are specific (with time frames), realistic, and address the required 
recipient activities.
    4. Evaluation (15 points): The extent to which realistic plans 
for evaluation of project activities have been developed, and the 
quality of such plans. Includes a description of the timeliness of 
the system and the completeness of ascertainment of mother-infant 
pairs.
    5. Proposed Data Uses (15 points): The extent to which data 
have, or will, assist in HIV prevention and care activities, so that 
these data are used for formulating public health strategies and 
targeting resources. In areas that received categorical CDC funding 
for perinatal prevention activities, the extent to which the 
applicant describes how the data from this system will be 
coordinated with and be used to improve these activities.
    6. Staffing (10 points): The extent to which proposed staffing, 
organizational structure, staff experience and background, 
identified training needs or plan, and job descriptions and 
curricula vitae for both proposed and current staff indicate ability 
to carry out the purposes of the program.
    7. Budget (not scored): The extent to which the budget is 
reasonable, clearly justified, and consistent with the intended use 
of funds. All budget categories should be itemized.

Part V. Laboratory Testing for Recent HIV Infection

    Note: Applications submitted for this Part will be reviewed by 
an independent objective review panel appointed by CDC that will 
evaluate each application against the following criteria:


    1. Technical Competence (40 points): Ability to perform the 
assay for incident HIV infection with an extremely high degree of 
reliability, as evidenced by previous successful proficiency 
conducting this test and demonstrated satisfactory participation in 
the CDC quality assurance program for this test. Applicants should 
include quality control charts from actual testing conducted over 
the most recent three months.
    2. Capacity (40 points): Ability to process and test at least 
6,000 specimens per month, using acceptable automated testing 
equipment and protocols. Ability to track receipt of specimens and 
report results within seven days of receipt of specimen using 
appropriate data and specimen management systems. Availability of 
adequate, dedicated laboratory space and equipment for receipt, 
testing and short-term storage of a large volume of specimens.
    3. Staff capabilities and Project Oversight (20 points): 
Demonstrates inclusion of scientific oversight as appropriate for 
the complexity of the proposed activities, as evidenced by: (a) 
Project administration plans; (b) ability to recruit, hire, and 
train appropriate number and type of personnel to conduct a large 
number of highly complex tests; and (c) qualifications, research and 
laboratory experience of the staff who will participate in this 
project documented in attached CVs of key staff. This includes 
evidence of ability to collaborate and conduct testing for external, 
collaborating organization (e.g., documentation from state health 
departments for which they have conducted testing in the past) 
including attached letters of support from current collaborators and 
a letter from the State or City health department human resources 
office director confirming their ability to recruit and hire 
appropriate staff within three months of the start of the funding.
    4. Budget (Not scored): The extent to which the budget is 
reasonable, clearly justified, and consistent with the intended use 
of funds.

Part VI. Behavioral Surveillance

    The technical acceptability of the application will be evaluated 
based on the following criteria:
    1. The degree to which the applicant provides evidence of their 
understanding of the project protocol and objectives. The extent to 
which plans for evaluation of project activities have been developed 
and are realistic. Quality of plans for data analysis and presentation 
showing how data have been and will be used to improve state and local 
HIV prevention programs and HIV services and care.
    2. The extent to which the applicant provides evidence of their 
ability to implement study methodology. The extent to which the 
applicant provides evidence of their ability to recruit/sample 500 MSM 
and 500 IDUs within the budget period.
    3. The quality of the applicant's plan to develop, implement and 
administer the project operations and the degree to which the 
objectives and time schedules are reasonable, time-phased and 
appropriate for accomplishing project activities. The quality of the 
applicants plan to address Recipient Activities outlined in Section E 
(1). The degree to which the applicant has met the CDC policy 
requirements regarding the inclusion of ethnic, racial groups in the 
proposed research. This includes:
    a. The proposed plan for the inclusion of both sexes' 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.

[[Page 61299]]

    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.
    5. The degree to which the qualifications, duties, 
responsibilities, and time allocation of proposed staff (including 
potential contractors), are justified and appropriate to accomplish 
study objectives. The degree to which the proposed staff will be able 
to provide appropriate scientific oversight, as well as programmatic 
and administrative support for the proposed activities. The extent to 
which collaborating entities (e.g., HIV prevention programs, community 
groups, community gatekeepers, CBOs, behavioral scientists) are 
appropriate (i.e., meet specific needs), sufficient, promote project 
objectives, and document their ability in letters of support.
    6. The extent to which the budget is reasonable, clearly justified, 
and consistent with the intended use of funds.

Part VII. Core Surveillance in the Pacific Island Jurisdictions

    The following criteria will be used to evaluate applications for 
their technical acceptability:
    1. Program Need and Resources: The extent to which the applicant 
describes the requirements for, and activities of, the HIV/AIDS 
surveillance system that includes a presentation of existing strengths 
and limitations. The extent to which this overview includes: The 
program need in terms of HIV/AIDS morbidity; extent and level of 
funding devoted to prevention, treatment, and care programs in the area 
that require HIV/AIDS surveillance data for resource allocation and 
program planning; uses of surveillance data; ability to analyze data 
that allows for the identification of trends in emerging modes of HIV 
transmission (by various demographic indicators and behaviors); 
existing and potential sources of HIV/AIDS cases; a description of HIV/
AIDS reporting procedures if they are in place; ongoing quality 
assurance procedures to promote data quality; sources of funding beyond 
federal monies provided by CDC; existing policies and procedures that 
are written and implemented for security, confidentiality, data 
dissemination and surveillance procedural activities; educational and 
training activities undertaken to develop and enhance the skills of 
surveillance staff and staff in reporting facilities; a copy of the 
most recent annual surveillance report; area legislation and/or 
regulations pertaining to the reporting, collection, uses and 
dissemination of HIV/AIDS surveillance data.
    2. Collaboration and Use of Data: The extent to which the applicant 
describes past, current, and proposed collaboration with: The relevant 
HIV/AIDS organizations and agencies within the reporting area; locally 
and Federally-funded prevention, treatment and care programs such as 
the CDC prevention programs or the Ryan White Care Act; and the extent 
HIV/AIDS surveillance data are used to assist public and private 
partners (e.g., community planning groups, AIDS Service Organizations) 
as a guide for allocating HIV prevention and care resources.
    3. Proposed Objectives: The extent to which program objectives are: 
specific, measurable, time-phased, and realistic; related to recipient 
activities, program purpose and program activities; derived from needs 
identified in the resources and needs assessment; consistent with local 
and national HIV/AIDS surveillance program objectives.
    4. Program Plan and Methods for Implementation: The extent to which 
the applicant: Adequately describes the procedures and methods to be 
used to accomplish the program objectives for their surveillance 
program; describes how program plans and procedures will facilitate 
achievement of national objectives for HIV/AIDS surveillance.
    5. Program Evaluation Plan: The applicant provides an evaluation 
plan that is appropriate for measuring progress toward program area and 
national HIV/AIDS surveillance objectives; the plan should include a 
specified time-line and methods for identifying promoters and barriers 
to program success.
    6. Project Management and Staffing Plan: The extent to which 
proposed staffing, organizational structure, staff experience and 
background, identified training needs or plan, and job descriptions and 
curricula vitae for both proposed and current staff indicate ability to 
carry out the purposes of the program.
    7. Budget: The budget is reasonable, clearly justified, consistent 
with the demonstrated need and proposed activities, and likely to lead 
to program success.
    Review and Selection Process: A Technical Acceptability Review will 
be conducted by CDC for Parts I, II, III, VI, and VII. Parts IV and V 
will involve Objective Review Panels.

VI. Award Administration Information

    Award Notices: If your application is to be funded, you 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.
    Administrative and National Policy Requirements: 45 CFR Part 74 and 
92.
    The following additional requirements apply to this project:

[sbull] AR-1 Human Subjects Requirements
[sbull] AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
[sbull] AR-4 HIV/AIDS Confidentiality Provisions
[sbull] AR-5 HIV Program Review Panel Requirements
[sbull] AR-7 Executive Order 12372
[sbull] AR-9 Paperwork Reduction Act Requirements
[sbull] AR-10 Smoke-Free Workplace Requirements
[sbull] AR-11 Healthy People 2010
[sbull] AR-12 Lobbying Restrictions

    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.
    Additionally, CDC recognizes that HIV/AIDS surveillance data are 
critical to the development and implementation of HIV/AIDS prevention 
programs and that responsiveness to the needs of prevention program 
managers and Community Planning Groups (CPGs) requires the commitment 
of resources and personnel that are funded under the surveillance 
cooperative agreement. These activities include analyzing and 
interpreting surveillance data, preparing reports for use by the CPGs, 
and conducting other related activities that directly improve and 
support HIV prevention activities. HIV Prevention Cooperative Agreement 
funds may be used to support unmet HIV/AIDS surveillance activities 
described above or projects to address data gaps or unmet State or 
local needs for supplemental surveillance or serosurveillance data, 
provided there is concurrence of CPGs and approval by the CDC Grants 
Management Official.
Reporting Requirements
    You must provide CDC with an original, plus two copies of the 
following reports:
    1. Interim Progress Report will be submitted annually and will be 
due on the date (usually in the late summer of the year preceding the 
budget period)

[[Page 61300]]

indicated in your Notice of Grant Award from CDC. The Interim 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. Requested amount for the continuation award, to be submitted in 
accordance with your projected level of funding for the 2005 and 2006 
budget periods.
    e. Detailed line item budget and justification for the amount 
requested.
    f. Modifications/adjustments concerning changes to support proposed 
subcontracts, if any.
    g. A description of any programmatic and staffing changes. Please 
submit a listing of your current staff and an organizational chart in 
support of your CDC program.
    2. Annual Progress Report is due 90 days after the end of each 
budget period. The Annual Progress Report for years 2004, 2005 and 2006 
should cover the entire budget period.
    Annual progress reports will include a data requirement that 
demonstrates measures of effectiveness. (See the beginning of section 
``H. Evaluation Criteria'' for the definition of measures of 
effectiveness.)
    The progress report must include the following for each program, 
function, or activity involved:
    a. A description of the program accomplishments and a comparison of 
actual accomplishments with the objectives established in the work plan 
for the funding period.
    b. Other pertinent information that includes, but is not limited to 
analysis and explanation of unexpected delays or high costs of 
performance.
    c. A listing of presentations and publications produced by, 
supported by, or related to program activities.
    3. Annual Financial Status Report, no more than 90 days after the 
end of the budget period.
    4. Final financial and performance report for the entire project 
period (2004-2006), no more than 90 days after the end of the project 
period.
    Send all reports to the Grants Management and Contracting Officer 
identified 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 business management and budget assistance in the states, 
contact: Carlos Smiley, Grants Management and Contracting Officer, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-
4146, Telephone: 770-488-2722, E-mail address: [email protected].
    For business management and budget assistance in the territories, 
contact: Vincent Falzone, Grants Management Specialist, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, 
Telephone: 770-488-2763, E-mail: [email protected].
    For program technical assistance with Parts I-IV and VII of this 
announcement, contact: Debra Hayes-Hughes, Deputy Chief, Surveillance 
Branch, Division of HIV/AIDS Prevention-Surveillance and Epidemiology, 
National Center for HIV, STD and TB Prevention, Centers for Disease 
Control and Prevention, 1600 Clifton Road, Mailstop E-47, Atlanta, GA 
30333, Telephone Number (404) 639-2050, E-mail address: [email protected].
    For program technical assistance with Parts V and VI of this 
announcement, contact: Ken A. Bell, Deputy Chief, Behavioral and 
Clinical Surveillance Branch, Division of HIV/AIDS Prevention-
Surveillance and Epidemiology, National Center for HIV, STD and TB 
Prevention, Centers for Disease Control and Prevention, 1600 Clifton 
Road, Mailstop E-46, Atlanta, GA 30333, Telephone Number (404) 639-
2970, E-mail address [email protected].

Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-26837 Filed 10-24-03; 8:45 am]
BILLING CODE 4163-18-P