Monitoring Atypical HIV Strains Among Persons Newly Diagnosed With HIV Using Dried Blood Spots vs. Diagnostic Sera

Federal RegisterApr 20, 2004

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Monitoring Atypical HIV Strains Among Persons Newly Diagnosed

With HIV Using Dried Blood Spots vs. Diagnostic Sera

Announcement Type: New.

Funding Opportunity Number: 04118.

Catalog of Federal Domestic Assistance Number: 93.944.

Key Dates: Letter of Intent Deadline: May 20, 2004. Application

Deadline: June 21, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under the Public Health

Service Act sections 301 and 318(b) (42 U.S.C. 241 and 247c), as

amended.

Purpose: The purpose of the program is to expand the ability of

health departments to perform surveillance of the prevalence of

atypical strains of HIV, including drug resistant strains and non-B

subtypes, by piloting the use of dried blood spots as an additional

specimen type for this purpose. The use of serum from an HIV diagnostic

blood draw for surveillance of atypical strains is the methodology used

in several HIV resistance surveillance projects in various stages of

implementation with different health departments. Some diagnostic sites

and clinical centers cannot currently be included in these projects,

due to logistical problems with specimen availability, processing or

volume. The purpose of CDC funding for this activity is to allow state

and local health departments, including both those already

participating in atypical HIV strain surveillance and those not yet

participating, to:

(1) Evaluate the feasibility and efficiency of routine use of dried

blood spots (DBS) for surveillance of atypical strains of HIV,

including drug resistant strains and non-B subtypes, in persons newly

diagnosed with HIV.

(2) Monitor the prevalence of atypical HIV strains, including

antiretroviral drug resistant strains and non-B subtypes, among persons

newly diagnosed with HIV, including those for whom sera from a

diagnostic blood draw are not available for surveillance purposes, and

those for whom diagnostic sera are used for surveillance of atypical

strains.

Compare the prevalence among the two groups.

This project will fulfill the purpose of monitoring prevalence of

atypical strains by extending surveillance to sites that would

currently be unable to provide sera for genotyping. DBS may also be

collected for atypical strain surveillance in other sites where the

collection of DBS may be more acceptable or require fewer resources

than the collection of diagnostic sera. A comparison of resource

requirements for the two methods in a variety of site types will be an

important part of the evaluation. This program addresses the ``Healthy

People 2010'' focus area(s) of HIV.

Measurable outcomes of the program will be in alignment with one

(or more) of the following performance goal(s) 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.

The expected outcome is an enhanced ability to collect data on

atypical HIV strains in persons newly diagnosed with HIV. Data from

surveillance of atypical strains of HIV are used 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.

Research Objectives: (1) To monitor the prevalence of HIV drug

resistant strains and non-B HIV-1 subtypes in persons newly diagnosed

with HIV in public or private settings, including those in which sera

are not available for HIV genotyping and those in which sera are used.

(2) To compare the results of HIV genotyping for atypical strain

surveillance purposes from both a serum or plasma specimen and a dried

blood spot collected not more than three months after diagnosis for at

least 20 newly diagnosed persons per area.

(3) To compare the prevalence of atypical strains of HIV among

persons diagnosed at sites where HIV diagnostic specimens are used for

HIV drug resistance and subtype surveillance, and sites where HIV

diagnostic specimens cannot be used, such as:

a. Sites where blood draws are not used for HIV diagnosis.

b. Sites where blood draw volumes are consistently too low for 1 ml

of serum to be set aside for HIV genotyping for the purpose of atypical

strain surveillance.

c. Sites where the use of sera from the diagnostic blood draw for

HIV genotyping is not practical because the time between blood draw and

processing is consistently greater than 96 hours, rendering the

amplification of virus for HIV drug resistance genotyping problematic.

d. Sites where the use of DBS for atypical HIV strain surveillance

is more acceptable than the use of sera to staff or participants, or

where fewer resources may be required to collect DBS than sera.

(4) To evaluate the resources needed and the logistics involved in

collecting and transporting specimens and amplifying HIV for genotyping

from DBS, compared with using HIV diagnostic sera, for routine atypical

HIV strain surveillance.

Activities: Awardee activities for this program are as follows:

1. Identify HIV diagnostic sites, Counseling, Testing and Referral

Centers, and/or clinical sites where HIV drug resistance surveillance

in newly diagnosed persons cannot take place using the serum/plasma

based methodology funded under PA 01194, PA 04017, and PA 00005 because

of one of the following conditions:

a. Blood draws are not used for HIV diagnosis.

b. Blood draw volumes are consistently too low for 1 ml of serum to

be set aside for HIV drug resistance genotyping.

c. The use of sera from the diagnostic blood draw for HIV

genotyping is not practical because the time between blood draw and

processing is consistently greater than 96 hours, rendering the

amplification of virus for HIV drug resistance genotyping problematic.

d. DBS are more acceptable to staff or participants, or their

collection, processing, and transport may require fewer resources than

sera.

2. Identify the subset of those sites from which DBS could be

obtained for equal to or greater than 90 percent of persons newly

diagnosed with HIV in each site, either at the time of HIV diagnosis or

no more than three months after diagnosis.

3. Identify comparison sites from which HIV diagnostic sera are

being used, or can be used, for routine surveillance of atypical

strains of HIV, in which logistics, resources, and staff time needed to

collect and process specimens can be compared to those in sites where

DBS will be collected. These sites may include, but are not limited to,

sites already participating in atypical

[[Page 21118]]

HIV strain surveillance under PA 00005, PA 01194, or PA 04017.

4. Identify one or more sites in which paired specimens (sera or

plasma + DBS) can be collected no more than three months after

diagnosis from at least 20 persons newly diagnosed with HIV annually.

(Note that the paired specimens may be collected from a blood draw

required for routine surveillance or clinical purposes no more than

three months following diagnosis, but need not necessarily be collected

as part of a diagnostic blood draw.)

5. Develop and implement (after appropriate ethics review) a

protocol to obtain and transfer DBS from selected sites identified in

(2), sera from sites identified in (3), and at least 20 paired

specimens consisting of sera or plasma + DBS from any atypical strain

surveillance site, to a laboratory collaborating with CDC and local

health department staff on surveillance of HIV drug resistance in newly

diagnosed persons through HIV drug resistance genotyping under PA

00005, PA 01194, or PA 04017.

6. Record or download minimum specimen tracking and non-identifying

demographic and clinical information, in formats currently used in HIV

drug resistance surveillance funded under 00005, 01194, and 04017, to

be transferred to CDC.

7. Make available the option for each participant to designate a

provider to receive a clinician-friendly hard copy report of HIV drug

resistance and subtype results from the genotyping laboratory, similar

to that currently produced in current HIV drug resistance surveillance

protocols.

8. Store HIV drug resistance genotyping data electronically and

analyze them along with risk factor information for use in HIV

prevention and public health programs.

9. Record minimum data to evaluate labor and resources used to

collect and process DBS, and to collect and process diagnostic sera,

for surveillance of atypical strains of HIV.

10. Collaborate with CDC in analyzing the data.

11. Provide results and share data with network participants, other

collaborators in the field, and with CDC.

12. Attend an annual meeting to discuss project activities and

methods for data and specimen collection to facilitate representative

surveillance.

13. Collaborate with CDC in evaluating the feasibility and

efficiency of using DBS to supplement or replace serum-based

surveillance to monitor prevalence of HIV drug resistance and non-B HIV

subtypes in persons newly infected or newly diagnosed with HIV. Further

collaborate with CDC in planning the extension of the method as part of

routine surveillance of atypical HIV strains, if the method proves

successful and if funds are available.

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:

1. Assist in the development of a protocol or project description

for Institutional Review Board (IRB) review at all cooperating

institutions participating in the project to request a non-research

determination. The IRB review at each cooperating institution will be

done by an Office of Human Research Protection (OHRP)-approved IRB with

either a single, multiple, or Federal-wide project assurance. The CDC

IRB will review and approve the protocol initially and on at least an

annual basis until the project is completed, or until a non-research

determination is received.

2. Provide assistance in the design and conduct of the project and

statistical analysis.

3. Provide assistance in training, if requested.

4. Provide assistance in locating or contracting with a laboratory

participating in CDC-funded HIV drug resistance surveillance genotyping

to provide HIV genotypic testing of the DBS and sera (or plasma). Work

with participating laboratories to develop laboratory procedures to

extend and validate current HIV genotyping methods for use with DBS.

5. Assist in the analysis of the data and the presentation and

publication of results.

6. Collaborate with participants in evaluating the feasibility and

cost effectiveness of using DBS to supplement or replace collection of

diagnostic sera to monitor prevalence of atypical strains in persons

newly infected or newly diagnosed with HIV. Further collaborate in

planning the extension of the project as a long-term network, if the

pilot is successful and if funds are available.

II. Award Information

Type of Award: Cooperative agreement.

CDC involvement in this program is listed in the Activities Section

above.

Fiscal Year Funds: 2004.

Approximate Total Funding: $500,000.

Approximate Number of Awards: Six.

Approximate Average Award: $83,000 (This amount is for the first

12-month budget period, and includes both direct and indirect costs).

Floor of Award Range: None.

Ceiling of Award Range: $200,000 (This ceiling is for the first 12-

month budget period.)

Anticipated Award Date: September 1, 2004.

Budget Period Length: 12 months.

Project Period Length: Five 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 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.

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.

Areas conducting these activities must have a sufficient volume of

newly diagnosed HIV cases in order to assess the correlation in results

between DBS and sera or plasma with adequate statistical precision.

Eligible applicants are limited to areas that have a HIV case

reporting system in place as of April 1, 2004.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other

CDC will accept and review applications with budgets greater than

the ceiling of the award range.

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.

Individuals Eligible to Become Principal Investigators: Any

individual

[[Page 21119]]

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 underrepresented racial

and ethnic groups as well as 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 that at least 40 cases of HIV were

diagnosed in the area in the latest 12 months for which data are

available, accompanied by a brief description of the method by which

the figures were obtained (including the elimination of duplicates).

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 five-year project period. Your detailed line-item budget

narrative should cover the costs of activities for first one-year

budget 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.

This PA uses just-in-time concepts.

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: May 20, 2004.

CDC requests that you send a 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: June 21, 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

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.

IV.5. Funding Restrictions

Restrictions, which must be taken into account while writing your

budget, are as follows:

Funding cannot be used for purchase of major laboratory equipment

for the performance of HIV genotyping. (Laboratory supplies and labor

for specimen processing may be included.)

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: Andrew Vernon,

[[Page 21120]]

Scientific Review Administrator, CDC, National Center for HIV, STD and

TB Prevention, Office of the Associate Director for Science, 1600

Clifton Road, Mail-Stop E-07, Atlanta, Georgia, 30333; telephone

number: 404-639-8000, 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 04118, CDC Procurement and

Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.

Applications may not be submitted electronically at this time.

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 application

does not need to be strong in all categories to be judged likely to

have major scientific impact and thus deserve a high priority score.

For example, an investigator may propose to carry out important work

that by its nature is not innovative, but is essential to move a field

forward.

The criteria are as follows:

Significance: Does this study address an important problem? If the

aims of the application are achieved, how will scientific knowledge be

advanced? What will be the effect of these studies on the concepts or

methods that drive this field?

Approach: Applicants should demonstrate the ability to collect

adequate numbers of DBS and sera specimens.

1. Areas having at least 100 newly diagnosed cases of HIV annually

should demonstrate that they are able to provide all of the following:

a. At least 80 specimens (sera, plasma, or DBS) annually for

atypical strain surveillance.

b. At least 30 dried blood spot specimens annually.

c. At least 20 paired sera or plasma + DBS annually.

2. Areas having 40-99 cases of HIV diagnosed annually should

demonstrate that they are able to provide ALL of the following:

a. Specimens (sera, plasma, or DBS) from at least 80 percent of

newly diagnosed cases annually for atypical strain surveillance.

b. DBS specimens from at least 20 HIV cases reported in the state

or local area annually.

c. At least 20 paired sera or plasma /DBS specimens (these may

include specimens in categories 2b and 2c).

Other issues to be examined in applicant's approach include:

Are the conceptual framework, design, methods,

and analyses adequately developed, well-integrated, and appropriate to

the aims of the project?

Does the applicant acknowledge potential problem

areas and consider alternative tactics?

Is there evidence that the health department has

an agreement to collaborate with one or more sites in the area to

collect DBS at the diagnostic blood draw or another routine blood draw

from at least 90 percent of persons newly diagnosed with HIV at that

site/those sites annually?

Innovation: Does the project employ novel concepts, approaches or

methods? Are the aims original and innovative? Does the project

challenge existing paradigms or develop new methodologies or

technologies?

Investigator: Is the investigator appropriately trained and well

suited to carry out this work? Is the work proposed appropriate to the

experience level of the principal investigator and other researchers

(if any)?

Environment: Does the scientific environment in which the work will

be done contribute to the probability of success? Do the proposed

experiments take advantage of unique features of the scientific

environment or employ useful collaborative arrangements? Is there

evidence of institutional support? Has the applicant demonstrated

collaborative planning by the State and local health department, the

State or local HIV diagnostic laboratory, and one or more HIV

diagnostic or clinical sites from which DBS can be obtained?

Protection of Human Subjects from Research Risks: Does the

application adequately address the requirements of 45 CFR part 46 for

the protection of human subjects? This will not be 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.

Inclusion of Women and Minorities in Research: Does the application

adequately address the CDC Policy requirements regarding the inclusion

of women, ethnic, and racial groups in the proposed research? This

includes: (1) The proposed plan for the inclusion of both sexes and

racial and ethnic minority populations for appropriate representation;

(2) the proposed justification when representation is limited or

absent; (3) a statement as to whether the design of the study is

adequate to measure differences when warranted; and (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.

Budget: The reasonableness of the proposed budget and the requested

period of support in relation to the proposed research.

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement

and Grants Office (PGO) and for responsiveness by NCHSTP. 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.

Applications that are complete and responsive to the PA will be

evaluated for scientific and technical merit by an appropriate peer

review group or charter study section convened by NCHSTP in accordance

with the review criteria listed above. As part of the initial merit

review, all applications may:

Undergo a process in which only those

applications deemed to have the highest scientific merit, generally the

top half of the applications under review, will be discussed and

assigned a priority score.

Receive a written critique.

Receive a second level review by the CDC,

NCHSTP, Division of HIV/AIDS Prevention (DHAP) Senior Staff.

Award Criteria: Criteria that will be used to make award decisions

include:

Scientific merit (as determined by peer review).

Availability of funds.

[[Page 21121]]

Programmatic priorities.

V.3. Anticipated Announcement and Award Dates

September 17, 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.

AR-4 HIV/AIDS Confidentiality Provisions.

AR-5 HIV Program Review Panel Requirements.

AR-7 Executive Order 12372.

AR-9 Paperwork Reduction Act Requirements.

AR-10 Smoke-Free Workplace Requirements.

AR-11 Healthy People 2010.

AR-12 Lobbying Restrictions.

AR-14 Accounting System Requirements.

AR-22 Research Integrity.

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 Web site) no less than 90 days

before the end of the 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 and annual progress 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, CDC Procurement and Grants Office, 2920

Brandywine Road, Atlanta, GA 30341; telephone: (770) 488-2700.

For scientific/research issues, contact: Diane Bennett, M.D.,

Extramural Project Officer, CDC, National Center for HIV, STD and TB

Prevention, Division of HIV/AIDS Prevention, 1600 Clifton Road, Mail-

Stop E-47, Atlanta, Georgia 30333; telephone: (404) 639-5349, e-mail:

[email protected].

For questions about peer review, contact: Andrew Vernon, Scientific

Review Administrator, CDC, National Center for HIV, STD and TB

Prevention, Office of the Director, Associate Director for Science,

1600 Clifton Road, Mail-S top E-07, Atlanta, Georgia 30333; telephone:

(404) 639-8000, e-mail: [email protected].

For financial, grants management, or budget assistance, contact:

Brenda 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: April 14, 2004.

William P. Nichols,

Acting Director, Procurement and Grants Office, Centers for Disease

Control and Prevention.

[FR Doc. 04-8875 Filed 4-19-04; 8:45 am]

BILLING CODE 4163-18-P

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