[Federal Register: May 24, 2004 (Volume 69, Number 100)]
[Notices]
[Page 29546-29551]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my04-69]
-----------------------------------------------------------------------
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:
GrantsInfo@nih.gov.
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 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.
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: nqualls@cdc.gov.
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: SLyss@cdc.gov.
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: nqualls@cdc.gov.
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: bkh4@cdc.gov.
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: vcf6@cdc.gov.
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