[Federal Register Volume 69, Number 100 (Monday, May 24, 2004)]
[Notices]
[Pages 29546-29551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11643]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Testing for Primary HIV Infection in Seronegative Patients

    Announcement Type: New.
    Funding Opportunity Number: 04119.
    Catalog of Federal Domestic Assistance Number: 93.943.
    Key Dates:
    Letter of Intent Deadline: June 23, 2004.
    Application Deadline: July 23, 2004.
    Summary: The technology for human immunodeficiency virus (HIV) 
screening tests has progressively improved over the first generation 
HIV-1 enzyme-linked immunoassay (EIA) tests licensed in 1985. Newer 
testing technology can identify infected individuals earlier in the 
course of their infection. Identifying individuals earlier in the 
course of infection holds the potential for reducing transmission, 
increasing diagnosis of infected persons, and improving health outcomes 
for infected individuals. Because of the high viral load during acute 
infection, the risk of HIV transmission through sexual and needle 
contact may be particularly high during this time period.
    In both domestic (US) and international settings, methods have been 
piloted to demonstrate detection of HIV infection early in the course 
of infection. In these approaches, individuals were tested with 
standard antibody tests. Individual specimens from patients testing 
negative on initial screening tests were grouped into pools, which were 
tested by ribonucleic acid (RNA) amplification. Such pooling strategies 
have been demonstrated to identify persons with early HIV infection, or 
primary HIV infection (PHI), before they would have otherwise been 
identified with early generation, less sensitive EIAs.
    Based on experiences reported in the medical literature, RNA 
screening for PHI appears to be feasible in a setting with moderate HIV 
prevalence, without anonymous testing, and with sufficient staff to 
contact those identified with PHI who do not return for their results. 
However, the utility and costs of screening for acute infection among 
other populations needs study. Issues include: (1) Whether testing for 
acute infection can be accomplished in real-time; (2) whether patients 
return for their test results, particularly those with non-reactive 
rapid HIV tests; (3) whether patients with PHI who do not return for 
test results can be contacted for followup; (4) whether identifying PHI 
increases the yield from partner contact and referral services (PCRS); 
and (5) whether the utility of the strategy differs in the context of 
anonymous testing.
    Furthermore, pooled RNA testing must be compared not only to 
insensitive EIAs, but also to other methods that may identify HIV 
infection earlier than the insensitive EIAs, such as p24 antigen 
testing (positive approximately 5 days after RNA); third generation 
EIAs (positive approximately 10 days after RNA); or OraQuick testing 
(similar to third-generation EIAs). Laboratory results from multiple 
testing technologies can also be compared to determine potential 
laboratory criteria for identifying certain specimens which would 
warrant further testing for PHI (e.g., supplemental testing if a single 
EIA is positive or if the Western blot is negative or indeterminate, or 
an EIA is in the ``grey zone'' as defined by signal/cutoff ratios less 
than 1.0, but greater than a specified threshold). The marginal utility 
of pooled RNA screening needs to be compared to these other methods of 
identifying earlier HIV infection.
    Identifying persons with acute HIV infection can also serve as the 
basis for collecting longitudinal follow-up specimens from recently 
infected individuals, essential for developing, validating, and 
comparing potential HIV incidence assays.
    In this program, specimens from all patients presenting for 
voluntary HIV testing will be tested with standard antibody tests (EIA 
or rapid test). Specimens that test antibody-negative on screening 
tests and those that test antibody-positive on screening tests but 
negative or indeterminate by confirmatory Western blot or 
immunofluorescence will be tested with multiple other testing 
technologies, including pooled nucleic acid testing, p24 antigen 
testing, a third generation EIA (if not already performed), and (for 
some specimens) OraQuick and Western blot (if not previously 
performed). (Please note that patients testing negative with tests 
performed on finger stick or oral specimens will only be able to 
participate in this project if venous blood samples are drawn.) Nucleic 
acid testing and p24 antigen testing must be performed in real-time so 
that results would be available as soon as usual confirmatory test 
results (typically two weeks). Demographic data, testing history, and 
information about self-perceived risk, recent exposures, and PHI 
symptoms would be collected on all patients who had preliminary 
evidence

[[Page 29547]]

of PHI, but were antibody negative by standard screening. RNA-positive, 
antibody-negative patients would be followed with antibody tests to 
confirm seroconversion. All persons with preliminary evidence of PHI 
would be offered enrollment in a follow-up study to collect additional 
information by interview and to collect longitudinal (seroconversion 
and post-seroconversion) specimens in larger quantities.
    This activity will be funded in 2 parts. Part 1 applicants will 
propose collaboration with testing sites to identify and secure 
appropriate specimens from a variety of setting types with various 
prevalences within their jurisdiction; they will conduct client follow-
up activities and assimilate study data. Part 2 applicants will be 
laboratories that propose to perform laboratory testing for specimens 
collected by Part 1 sites and refine pooling strategies for screening 
antibody negative specimens by nucleic acid testing.

I. Funding Opportunity Description

    Authority: This program is authorized under the Public Health 
Service Act sections 301 and 317 (42 U.S.C. 241 and 247b), as amended.
    Purpose: The purpose of the program is to determine the 
feasibility, effectiveness, and costs of screening for acute infection 
among seronegative individuals tested for HIV. This program addresses 
the ``Healthy People 2010'' focus area of HIV.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for HIV/STD and TB 
Prevention (NCHSTP): Strengthen the capacity nationwide to monitor the 
epidemic, develop and implement effective HIV prevention interventions 
and evaluate prevention programs. In addition, this program addresses 
the Division of HIV/AIDS Prevention priorities: Develop new methods for 
diagnosing HIV infection, and institute integrated surveillance with 
emphasis on incidence, behavioral surveillance, and evaluation.

Research Objectives

    1. To compare different tests and testing algorithms that could be 
used to detect acute infection (nucleic acid testing, p24 antigen 
testing, third-generation EIA, OraQuick, alterations in current 
diagnostic algorithm) where possible with regard to feasibility, 
sensitivity, specificity, predictive value, and cost.
    2. To determine optimal settings/venues and/or individuals to be 
screened with a test sensitive for PHI.
    3. To collect a panel of longitudinal specimens from a cohort of 
recently infected individuals.
    4. To obtain preliminary information on alternative pooling 
strategies for nucleic acid testing to optimize cost and predictive 
value of test results.

Activities

    Awardee activities for this program are as follows:
    Part 1:
     Develop a protocol in collaboration with other funded 
sites (including the laboratory funded through part 2 of this 
announcement) and the CDC. The protocol must be reviewed by the CDC and 
local IRBs. (Project timeline and budget must allow for sufficient 
time--approximately 6 months--for the development of the protocol and 
determination of human subjects status and consent procedures.)
     Identify approximately 50,000 seronegative and 
indeterminate specimens through customary HIV testing procedures from a 
variety of setting types with various prevalence within their 
jurisdiction. Prepare and ship specimens according to applicable 
regulations within a mutually agreed upon time period to the laboratory 
funded through Part 2 of this announcement for additional testing. 
(Please note that patients testing negative with tests performed on 
finger stick or oral specimens will only be able to participate in this 
project if venous blood samples are drawn.)
     Collect and maintain database of information linked to 
initial and follow-up tests, including data routinely collected by the 
Counseling and Testing System on characteristics of the patient, the 
testing site, and the HIV test(s) performed. Obtain additional 
information from the routine HIV diagnostic tests performed, including 
EIA or rapid test kit manufacturer, EIA signal to cut-off ratio, and, 
if performed, Western blot manufacturer and banding patterns; maintain 
this information in an electronic database.
     Work with the CDC to develop and implement post-test 
counseling messages that incorporate the findings of additional tests 
performed for identification of PHI as part of this announcement.
     Contact clients who test positive for PHI and who do not 
return as scheduled 2 weeks following initial testing. Document time 
and effort required for follow-up activities.
     To patients who test positive for PHI, offer enrollment in 
a research study to obtain additional data by interview and to collect 
longitudinal specimens:
    [ctrcir] Obtain human subjects clearance from CDC and local IRB and 
consent for participation. (This may require a second protocol.)
    [ctrcir] Conduct interview to collect demographic data, testing 
history, and information about self-perceived risk, recent exposures, 
and PHI symptoms.
    [ctrcir] Collect follow-up specimens at 2-week intervals until the 
initial positive test for PHI can be determined to be a true positive 
or a false positive test result according to the combination of tests 
performed at the original testing site and at the funded laboratory. 
These samples should be tested by the laboratory routinely used by the 
original testing site and according to routine HIV testing protocols. 
Specimens should also be prepared and sent to the laboratory funded in 
Part 2 for further testing for PHI.
    [ctrcir] Obtain a total of 10 longitudinal samples (large volume) 
on all patients testing positive for PHI at appropriate intervals over 
a 9-12 month period (as permitted by the project period), with at least 
6 of these samples obtained during the first 6 months of follow-up. 
Utilize DIS services as necessary. Prepare and ship specimens to the 
funded testing laboratory.
     Participate in periodic conference calls and grantee 
meetings with other funded sites and the CDC.
     Disseminate findings jointly with CDC and other 
participating sites.
    Part 2:
     Participate with CDC and the health departments funded 
through Part 1 of this application in the development of testing 
protocols for the identification of PHI among approximately 100,000 
specimens supplied by the Part 1 grantees. Identification of PHI should 
include pooled, automated HIV nucleic acid, p24 antigen, and 3rd 
generation EIA testing (if not performed at field site) on all 
specimens submitted. Other tests, including OraQuick and Western blot 
testing, should be performed on up to 150 specimens with preliminary 
evidence of PHI that were not previously tested with these tests in 
order to evaluate potential laboratory criteria for identification of 
PHI.
     Secure IRB review and approval by the local IRB. (Project 
timeline and budget must allow for sufficient time--approximately 6 
months--for the development of the protocol and determination of human 
subjects status.)
     Conduct pooled, automated nucleic acid testing on initial 
seronegative specimens in real time. All test results must be 
transmitted to the designated

[[Page 29548]]

contact at testing facility within 7 calendar days of receipt of 
specimens.
     Individually test follow-up specimens of patients who 
tested positive for PHI at baseline with HIV nucleic acid and p24 
antigen tests. Follow-up nucleic acid and p24 antigen testing will be 
conducted at 2-week intervals until the initial positive test for PHI 
can be determined to be a true positive or a false positive according 
to the combination of tests performed at the original testing site and 
at the funded laboratory.
     Aliquot and store longitudinal specimens from patients who 
test positive for PHI at baseline (approximately 10 samples per patient 
collected periodically over a 9-12 month period, see Part I above). 
Note that no testing will be performed upon longitudinal samples 
collected after a patient who initially tested positive for PHI has 
been determined to be infected or not.
     Maintain a database containing all test results and 
specimen numbers.
     Store frozen samples at -70 [deg]C until the end of the 
project. Ship all samples to CDC-designated laboratory or permanent 
storage site.
     In the second year of the project, conduct additional 
automated, pooled nucleic acid testing (not in real time) to determine 
alternative pooling strategies to optimize cost and predictive value of 
pooled, RNA screening.
     Obtain human subjects clearance from local IRB and consent 
for participation, if required.
     Participate in periodic conference calls and grantee 
meetings with other funded sites and the CDC.
     Disseminate findings jointly with CDC and other 
participating sites.
    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:
     Assist in the development and review of the required 
protocols.
     Provide guidance and assistance in the development of 
forms and data collection instruments as well as data management 
systems and procedures.
     Work with Part I grantees to develop post-test counseling 
messages that incorporate the findings of the additional tests 
performed as part of this announcement for the identification of PHI.
     Facilitate conference calls, grantee meetings, and site 
visits.
     Assist in the analysis and dissemination of findings.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2004, 2005.
    Approximate Total Funding: $2,000,000/2 years.
    Approximate Number of Awards: 3 awards: Part 1: 2 awards; Part 2: 1 
award.
    Approximate Average Award: Part 1: $500,000; Part 2: $1,000,000 
(This amount is to be divided over the two-year project period, and 
includes both direct and indirect costs. Applications should include a 
budget indicating separately how the funds will be used in Year 1 and 
Year 2. The award need not be equal for the 2 funding years.)
    Floor of Award Range: None.
    Ceiling of Award Range: None.
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: 2 years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies, such as:

     Universities.
     Colleges.
     Research institutions.
     Hospitals.
     Community-based organizations.
     Federally recognized Indian tribal governments.
     Indian tribes.
     Indian tribal organizations.
     State and local governments or their Bona Fide Agents 
(this includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna 
Islands, American Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, and the Republic of Palau).
     Political subdivisions of States (in consultation with 
States).

    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If your application is incomplete or non-responsive to the 
requirements listed in this section, it will not be entered into the 
review process. You will be notified that your application did not meet 
submission requirements.
    Applicants for Part 1 must demonstrate their ability to provide, in 
a 12 month period, samples from 50,000 seronegative individuals (the 
required sample size) tested by serologic methods as part of the CDC-
funded Counseling and Testing System in the proposed jurisdiction. In 
addition, areas must demonstrate that the seropositivity rate of HIV 
tests in the CDC-funded Counseling and Testing System which will be the 
source of the specimens is at least 1.5 percent. A sufficiently high 
level of HIV morbidity is required of the participating sites in order 
to evaluate the feasibility of this activity at higher morbidity areas 
and in order to complete this research within the required timeframe.
    Applicants for Part 2 must demonstrate experience using automated 
methods for conducting pooled nucleic acid testing, the ability to 
return results within 7 calendar days of specimen receipt, and the 
ability to process 8,000-10,000 specimens per month for the required 
testing. It is critical that the grantee be able to conduct the pooled 
nucleic acid testing with automated methods, because nucleic acid 
testing is vulnerable to contamination and false positive results. 
Automated methods minimize this problem. Also, because it is expected 
that results must be available before the client returns to retrieve 
test results at the testing point, it is required that the grantee be 
able to accommodate the expected specimen volume and be able to 
complete test results in a timely manner.
    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support. Individuals from racial and ethnic 
groups underrepresented in the field as well as

[[Page 29549]]

individuals with disabilities are always encouraged to apply for CDC 
programs.


    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity, use application form PHS 398 
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) Web site at the following 
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Application Submission Letter of Intent (LOI)

    Your LOI must be written in the following format:

     Maximum number of pages: Three.
     Font size: 12-point unreduced.
     Single spaced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Written in plain language, avoid jargon.
    Your LOI must contain the following information:

     Descriptive title of the proposed research.
     Evidence, as listed under ``III.3. Eligibility 
Information--Other,'' that:
    [cir] For Part 1: The applicant can provide the required sample 
size of 50,000 seronegative individuals with an HIV seropositivity rate 
of at least 1.5 percent.
    [cir] For Part 2: The applicant has experience using automated 
methods for conducting pooled nucleic acid testing, the ability to 
return results within 7 calendar days of specimen receipt, and the 
ability to process 8,000 to 10,000 specimens per month.

     Name, address, e-mail address, and telephone number of the 
Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Program Announcement (PA).

    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. For further assistance with 
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or 
contact GrantsInfo, Telephone (301) 435-0714, E-mail: 
[email protected].
    Your research plan should address activities to be conducted over 
the entire project period.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. Your DUNS number must be entered 
on line 11 of the face page of the PHS 398 application form. The DUNS 
number is a nine-digit identification number, which uniquely identifies 
business entities. Obtaining a DUNS number is easy and there is no 
charge. To obtain a DUNS number, access 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.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    LOI Deadline Date: June 23, 2004.
    CDC requests that you send an LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review.
    Application Deadline Date: July 23, 2004.
    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 announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your application, first contact 
your courier. 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.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     None
    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 should be less than 12 
months of age.
    Awards will not allow reimbursement of pre-award costs.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or e-mail to: Noreen Qualls, Dr., P.H., Scientific Review 
Administrator, CDC, National Center for HIV, STD, and TB Prevention, 
Office of the Associate Director for Science, 1600 Clifton Road, NE., 
Mailstop E-07, Atlanta, GA 30333, telephone Number: (404) 639-8006, 
fax: (404) 639-8600, e-mail address: [email protected].
    Application Submission Address: Submit the original and five hard 
copies of your application by mail or express delivery service to: 
Technical Information Management-PA 04119, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

[[Page 29550]]

V. Application Review Information

V.1. Criteria

    You are required to provide measures of effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the cooperative agreement. Measures of effectiveness must relate to the 
performance goals stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative, and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and enhance health. In the written comments, 
reviewers will be asked to evaluate the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.
    The scientific review group will address and consider each of the 
following criteria in assigning the application's overall score, 
weighting them as appropriate for each application.
    The criteria are as follows:
    Part 1:
    1. Capacity (40 points): Does the applicant have the appropriate 
facilities and staff to conduct this research? Is adequate and 
objective information provided to demonstrate the availability of 
sufficient numbers of clients tested and sufficient seropositivity 
rates? Is the primary investigator well qualified, by education and 
experience, to lead the project team, hire and train appropriate staff, 
and provide scientific oversight? Does the applicant currently 
demonstrate effort, willingness, and success in contacting HIV-
infecting clients tested confidentially who do not return for their 
test results?
    2. Methods (30 points): Are the proposed methods feasible? Will 
they accomplish program goals? Does the applicant address required 
follow-up activities and methods to complete them in a timely manner? 
Does the applicant address changes to their HIV testing program 
required to return all results within 2 weeks, to schedule clients to 
return and to find clients with evidence of PHI who do not return for 
scheduled post test counseling? Does the applicant provide a reasonable 
timeline for the completion of the awardee activities?
    3. Objectives (30 points): Are the objectives reasonable, time-
phased and measurable? Does the applicant provide reasonable methods to 
evaluate their progress toward the timely accomplishment of objectives?
    4. Does the application adequately address the requirements of 45 
CFR part 46 for the protection of human subjects? (Not scored; however, 
an application can be disapproved if the research risks are 
sufficiently serious and protection against risks is so inadequate as 
to make the entire application unacceptable.)
    5. Does the applicant adequately address the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits.
    6. Budget (not scored): Is the budget reasonable for the proposed 
activities?
    Part 2:
    1. Capacity (50 points): Does the applicant have the appropriate 
facilities and staff to conduct this research including equipment 
required to conduct automated sample processing and testing and the 
ability to hire and train appropriate staff? Does the applicant 
demonstrate their ability to process the required number of specimens 
within the required timeframe? Does the applicant have specific 
experience conducting the tests required for this activity and have the 
required knowledge to provide scientific oversight for the conduct of 
the research?
    2. Methods (25 points): Are the proposed methods feasible? Will 
they accomplish program goals? Are the proposed methods scientifically 
sound and do they demonstrate understanding of the problem to be 
evaluated? Is a specific proposed pooling strategy articulated and 
justified? Does the applicant provide a reasonable timeline for the 
completion of awardee activities?
    3. Objectives (25 points): Are the objectives reasonable, time-
phased and measurable? Does the applicant provide reasonable methods to 
evaluate their progress toward the timely accomplishment of objectives?
    4. Budget (not scored): Is the budget reasonable for the proposed 
activities?

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff and for responsiveness by the National 
Center for HIV/STD/TB Prevention, Division of HIV/AIDS Prevention. 
Incomplete applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified that their application did not meet 
submission requirements.
    Applicants may apply for Parts 1 or 2 or both. A separate 
application should be submitted for each Part proposed. Each Part will 
be evaluated independently by the objective review panel.
    In addition, the following factors may affect the funding decision:
    Preference will be given to applicants for Part 1 that have larger 
numbers of clients tested through publicly funded HIV testing programs 
and higher historical HIV seropositivity rates. For Part 2, 
laboratories that have demonstrated experience in using automated 
methods for conducting pooled nucleic acid screening studies will be 
given preference.

V.3. Anticipated Announcement and Award Dates

    September 1, 2004.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

    45 CFR part 74 and part 92.
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:

 AR-1-- Human Subjects Requirements
 AR-2--Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research

[[Page 29551]]

 AR-4--HIV/AIDS Confidentiality Provisions
 AR-5--HIV Program Review Panel Requirements
 AR-6--Patient Care
 AR-8--Public Health System Reporting Requirements
 AR-10--Smoke-Free Workplace Requirements
 AR-11--Healthy People 2010
 AR-12--Lobbying Restrictions
 AR-14--Accounting System Requirements
 AR-15--Proof of Non-Profit Status
 AR-21--Small, Minority, and Women-Owned Business
 AR-22--Research Integrity
 AR-23--States and Faith-Based Organizations
 AR-24--Health Insurance Portability and Accountability Act 
Requirements
 AR-25--Release and Sharing of Data

    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC website) no less than 90 days 
before the end of the first 12 month budget period. The progress report 
will serve as your non-competing continuation application, and must 
contain the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Additional Requested Information.
    f. Measures of Effectiveness.
    2. Financial status report no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section--PA 04119, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, telephone: 770-
488-2700.
    For scientific/research issues, contact:
    Sheryl Lyss, MD, Extramural Project Officer, CDC, National Center 
for HIV, STD, and TB Prevention, 1600 Clifton Road, MS E-46, Atlanta, 
Georgia 30333, telephone: 404-639-2093, e-mail: [email protected].
    For questions about peer review, contact: Noreen Qualls, Dr.P.H., 
Scientific Review Administrator, CDC, National Center for HIV, STD, and 
TB Prevention, Office of the Associate Director for Science, 1600 
Clifton Road, NE., Mailstop E-07, Atlanta, GA 30333, telephone number: 
404-639-8006, fax: 404-639-8600, e-mail address: [email protected].
    For financial, grants management, or budget assistance, contact: 
Brenda D. Hayes, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, telephone: 770-
488-2741, e-mail: [email protected].
    For financial, grants management, or budget assistance in the 
territories, contact: Vincent Falzone, Contract Specialist, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, 
telephone: 770-488-2763, e-mail: [email protected].

    Dated: May 18, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-11643 Filed 5-21-04; 8:45 am]
BILLING CODE 4163-18-P