Augmenting Laboratory Outcomes in HIV Assessment (ALOHA), 38939-38944 [05-13223]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38939-38944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13223]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Augmenting Laboratory Outcomes in HIV Assessment (ALOHA)

    Announcement Type: Supplemental (04017).
    Funding Opportunity Number: AA120.
    Catalog of Federal Domestic Assistance Number: 93.944.
    Key Dates:
    Application Deadline: August 5, 2005.

I. Funding Opportunity Description

    Authority: This program is authorized under sections 317(k)(2) and 
318b of the Public Health Service Act (42 U.S.C. Sections 247b(k)(2) 
and 247c), as amended.
    Purpose: CD4+ T-lymphocyte (CD4) and viral load (VL) tests are used 
to stage disease and, when opportunistic infections (OI) are present, 
to guide therapeutic decisions. Because CD4 and VL testing should be 
performed throughout the course of HIV disease, reporting of these lab 
tests has been used as a marker for whether HIV-infected persons are 
receiving healthcare. Augmenting Laboratory Outcomes in HIV Assessment 
(ALOHA) will augment routine HIV/AIDS surveillance data collection for 
the purpose of assessing the completeness and validity of laboratory 
(i.e., CD4 count and VL) and OI information. This will be accomplished 
by the following:
    1. Assessing the stage of HIV disease at initial diagnosis among a 
cohort of newly diagnosed HIV-infected persons, over the age of 13, 
using routine and augmented laboratory and clinical information.
    2. Better characterizing CD4 count and VL, and correlating this 
laboratory information with available data on OIs. If, after complete 
enumeration of lab and OI information, OIs add little to nothing to 
help stage HIV disease, then future surveillance practices may be 
streamlined.
    3. Identifying surveillance practices (e.g., laboratory reporting 
requirements, electronic lab reporting, and program policies or 
organization) that affect the completeness and accuracy of surveillance 
laboratory data.
    4. Assessing lab reporting as a marker for access and adherence to 
care following HIV diagnosis.
    5. Identifying correlates for not being in care, as indicated by 
the presence or absence of laboratory reports.
    6. Systematically evaluating the availability of clinical and 
laboratory data on the prevalence of common co-morbid conditions (e.g., 
hepatitis B, hepatitis C, tuberculosis, and cancer) that are associated 
with risk factors for HIV infection and influence the clinical course 
of HIV disease. Data on these conditions will be compared to levels of 
CD4 and VL to assess the effects of co-morbid conditions on levels of 
immunosuppression at the time of HIV diagnosis.
    A variety of HIV/AIDS reporting areas with different surveillance 
practices and procedures will be sought for ALOHA. This project will 
attempt to include an area that currently warehouses lab results, 
specifically CD4, in a separate lab results database, and does not 
report this information to the national HIV/AIDS surveillance system. 
The completeness of reporting for CD4 results will be assessed to 
determine if these reports truly indicate access to care. This 
proportion has not been reliably estimated by national surveillance 
data. Some reporting areas report a high proportion (greater than 75 
percent) of newly diagnosed cases with CD4 and/or VL results within 12 
months of diagnosis.
    The factors that contribute to the ability of lower morbidity areas 
to report completely has not been fully examined, but may be due to 
their ability to conduct active case finding and medical record 
abstraction. These practices may have national surveillance policy 
implications. Since lab reporting data is critical to the expectations 
of the Morbidity Monitoring Project (MMP), an area will be sought to 
provide validation of lab reporting as a marker for receiving health 
care, and to collect information about reasons for no lab testing and 
the inability to link a person to care.
    Lastly, ALOHA will include at least one area that will match its 
HIV/AIDS case registry to infectious disease databases to identify, 
apart from medical record review, OIs that occurred six months before 
and after HIV diagnosis. Examples of these databases include the 
National Electronic Disease Surveillance System (NEDSS); cancer, 
hepatitis or tuberculosis registries; or prescription medication 
databases (e.g., Medicaid or AIDS Drug Assistance Program).
    As part of this project, participating areas will conduct their 
usual surveillance activities for information on CD4 and VL lab results 
and OIs. These activities include active case surveillance, medical 
record review and data extraction for newly diagnosed cases (over the 
age of 13). When no lab result is received by the HIV/AIDS surveillance 
program, ongoing active case follow-up will be needed to determine case 
disposition and record specific categorical information, such as

[[Page 38940]]

the source of CD4 and OI results and, alternatively, reasons for no CD4 
testing (e.g., lost to follow-up, did not return for HIV test results, 
etc). Surveillance information will be entered into the national HIV/
AIDS surveillance system and uploaded monthly to CDC; ancillary data 
will be sent to CDC without personal identifiers.
    Annual reported cases to CDC will be used as an eligibility 
criterion. Eligible areas are restricted to those submitting HIV data 
to CDC because this project is an evaluation of data included in the 
national HIV/AIDS reporting system, which includes only those 
surveillance data collected in confidential name-based systems, and 
because HIV (not AIDS) cases are currently more likely to be missing 
CD4 information. Because a limited number of sites (approximately five 
to seven sites) will be funded, racial and ethnic diversity of cases 
among each of the participating sites will be required to ensure a 
measure of representation of national data.
    This program addresses the ``Health People 2010'' focus area 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.
    Activities: Awardee activities for this program are as follows:
    1. Accurately linking incoming lab results to all HIV and AIDS 
cases or an agreed upon sample, over the age of 13, in the local HIV/
AIDS registry, and transmitting that information to the national HIV/
AIDS surveillance system for the duration of ALOHA.
    2. Conducting active surveillance and medical record abstraction, 
following a protocol developed in collaboration with CDC, of all cases 
or the agreed upon sampled cases. A minimum of 500 diagnosed HIV/AIDS 
cases annually, of which 300 cases were initially diagnosed with HIV 
(not AIDS), will be prospectively followed for a period of time (to be 
determined through collaborative development of a protocol). This 
protocol will include the collection of CD4 and VL results, OIs, and 
ancillary information on data collection forms.
    3. Conducting active, ongoing follow-up of cases without any CD4 or 
VL results following diagnosis. Identifiable reasons for lack of 
linkage or failure to access health care will be sought from medical 
records and recorded on project data collection forms. No interview of 
cases will occur as part of this follow-up.
    4. Documenting methods of linking lab results to registry cases, 
including methods of reconciling possible matches.
    5. Participating in a conference call (within one month of the 
award) with CDC and other awardees to begin to develop a project plan 
and 16-month timeline.
    6. Collaborating with CDC staff members to develop data collection 
forms for ancillary information about co-morbidities and barriers to 
reporting lab results, as well as whether samples for CD4/VL testing 
are drawn at post test counseling, possible reasons for no CD4/VL 
testing, and the inability to link newly diagnosed persons to care.
    7. Meeting with CDC. The area project collaborator will travel to 
Atlanta for one meeting and participate in monthly conference calls 
related to planning, coordinating, and conducting this project.
    8. Transferring collected data to CDC monthly.
    CDC Activities for this program are as follows:
    1. Conduct a conference call, within one month of award, to develop 
a project plan and time line for the collection and reporting of data 
to CDC.
    2. Support and assist training needed to conduct project including 
monthly conference calls with awardees.
    3. Collaborate with awardees to develop strategies for enhancing 
surveillance activities that address barriers to reporting of 
opportunistic infections, CD4, and viral load test results.
    4. Receive data monthly, assess data quality, and store data in 
secure environment.
    5. Provide quarterly analytic progress reports to participating 
areas.
    6. Analyze data and write reports in collaboration with awardees.

II. Award Information

    Type of Award: Cooperative agreement.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $500,000 (This amount is an estimate, 
and is subject to availability of funds.)
    Approximate Number of Awards: Five to Seven.
    Approximate Average Award: $100,000 (This amount is for the first 
12-month budget period, and includes both direct and indirect costs.)
    Floor of Award Range: $75,000.
    Ceiling of Award Range: $125,000.
    Anticipated Award Date: August 31, 2005.
    Budget Period Length: Four months.
    Project Period Length: 16 months. 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

    1. Eligible applicants are state or territorial health departments 
or directly funded city health departments currently engaged in HIV/
AIDS surveillance funded through Program Announcement 04017. Eligible 
applicants must have reported a minimum of 500 HIV and AIDS cases in 
2003, of which at least 300 are HIV cases, as reflected in Volume 15 
(Tables 14 and 16) of the CDC HIV/AIDS Surveillance Report. Single 
reporting areas that do not have sufficient cases may form a consortium 
with an adjoining area or areas so that the combined total number of 
HIV and AIDS cases is at least 500, of which at least 300 are HIV cases 
reported in 2003. Areas wishing to collaborate must designate a lead 
grantee for protocol implementation, data collection, communication, 
and coordination of financial remuneration.
    2. Eligible applicants must be located in areas where persons of 
color (Asian, Pacific Islanders, Black, American Indian/Alaskan Native, 
Hispanic and Multiracial) comprise more than 30 percent of new HIV/AIDS 
cases with known race/ethnicity.
    Known eligible areas include: Alabama, Arizona, Colorado, Florida, 
Houston, Indiana, Louisiana, Michigan, Mississippi, Missouri, New 
Jersey, New York, New York City, North Carolina, Ohio, Pennsylvania, 
Puerto Rico, South Carolina, Tennessee, Texas, and Virginia.
    Eligible areas are restricted to those with confidential, name-
based HIV (with or without AIDS at the time of diagnosis) reporting 
(those submitting HIV data to CDC) because this project will augment 
surveillance data with complete laboratory data and other sources of 
surveillance data where the use of name is the most accurate method to 
link HIV surveillance data to supplemental data. Furthermore, to most 
efficiently use available resources, the standard surveillance software 
will be used and only those areas with confidential, name-based 
reporting currently submit both HIV and AIDS data to CDC.

[[Page 38941]]

    In each area, HIV morbidity must be sufficient to allow for 
adequate sample sizes therefore, annual reported cases to CDC will be 
used as a criterion for eligibility. The sizes of the samples must be 
large enough to be able to detect HIV opportunistic infections which 
are uncommon.
    Eligible applicants must have reported to the CDC HIV/AIDS 
reporting system a minimum of 500 HIV and AIDS cases in 2003, of which 
at least 300 are HIV cases, as reflected in Volume 15 (Tables 14 and 
16) of the CDC HIV/AIDS Surveillance Report. Single reporting areas 
that do not have sufficient cases may form a consortium with an 
adjoining area or areas so that the combined total number of HIV and 
AIDS cases is at least 500, of which at least 300 are HIV cases 
reported in 2003.
    Eligible applicants are areas where persons of color (Asian, 
Pacific Islanders, Black, American Indian/Alaskan Native, Hispanic and 
Multiracial) comprise >=30% of new HIV/AIDS cases with known race/
ethnicity. Because a limited number of sites will be funded, racial and 
ethnic diversity of cases among each of the participating sites will be 
required to ensure a measure of representation of national data.

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.
    Special Requirements: If the application is incomplete or non-
responsive to the special requirements listed in this section, it will 
not be entered into the review process. The applicant will be notified 
the application did not meet submission requirements.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     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.
    The following are general considerations that will affect decisions 
on funding levels. At least one unique reporting area for each of the 
following categories should be funded:
     Separate laboratory results database that complements the 
national HIV/AIDS surveillance system data. Areas have received, 
entered, and maintained CD4 counts, with or without VL values, for HIV/
AIDS registry cases, in a separate laboratory database for a period of 
not less than one year from application date. This activity should be 
ongoing, with plans to further expand capacity, including VL reporting 
if this is not already being conducted. Areas that have not routinely 
uploaded CD4 counts to the national HIV/AIDS surveillance system will 
be required to do so. Source of lab results (e.g., electronic lab 
reporting, results received on paper, medical record extraction, etc.) 
will be recorded.
     More than 55 percent of the area's combined HIV and AIDS 
cases have at least one CD4 count within 12 months of initial HIV 
diagnosis. At least one CD4 count, obtained within 12 months following 
the initial diagnosis, was reported for most (greater than 55 percent) 
of the combined HIV and AIDS cases diagnosed in 2002 and 2003. This 
information should have been transmitted to CDC as part of the national 
HIV/AIDS surveillance system. Areas may average two years of diagnostic 
data to reach the 55 percent prevalence estimate, if each year's cases 
do not exceed 55 percent.
     Current participant in the Morbidity Monitoring Project. 
Not all cases enrolled in the Morbidity Monitoring Project (MMP), 
formerly announced as the Morbidity and Risk Behavior Surveillance 
Project, will be eligible for this project. Systematic sampling of 
newly diagnosed cases will be used to identify the population for 
ALOHA. At a minimum, include 500 HIV/AIDS cases annually, of which no 
less than 300 cases were initially diagnosed with HIV only. All cases 
included in ALOHA will require medical record abstraction and possible 
case follow-up. Cases enrolled in both the MMP and ALOHA will be 
identified as such.
     Experience conducting large electronic database matching 
to HIV/AIDS case registry. Areas will be required to match to another 
database to add comprehensive OI and co-morbidity information to their 
HIV/AIDS case registry. OIs will be limited to those diagnosed six 
months before and after initial HIV diagnosis. Database areas may match 
to include infectious disease (e.g., NEDSS; hepatitis, cancer or 
tuberculosis registries), prescription medication databases (e.g., 
Medicaid; AIDS Drug Assistance Program; etc.), or other databases with 
similar information. It may be necessary to match to multiple databases 
to provide a comprehensive review of OIs for a newly diagnosed case. 
The participating HIV/AIDS surveillance program will need a memorandum 
of understanding or similar written agreement with the program that 
manages the matched-to database. Case follow-up that examines periods 
of antibiotic/antiviral use should provide information about 
opportunistic infections being treated, if this is not obvious from the 
class of medication.

IV. Application and Submission Information

IV.1. Address to Request Application Package

    To apply for this funding opportunity, use application form CDC 
5161-1.
    Electronic Submission: CDC strongly encourages the applicant to 
submit the application electronically by utilizing the forms and 
instructions posted for this announcement on https://www.Grants.gov, the 
official Federal agency wide E-grant Web site. Only applicants who 
apply on-line are permitted to forego paper copy submission of all 
application forms.
    Paper Submission: Application forms and instructions are available 
on the CDC Web site, at the following Internet address: https://
www.cdc.gov/od/pgo/forminfo.htm.
    If access to the Internet is not available, or if there is 
difficulty accessing the forms on-line, contact the CDC Procurement and 
Grants Office Technical Information Management Section (PGO-TIM) staff 
at 770-488-2700 and the application forms can be mailed.

IV.2. Content and Form of Submission

    Application: A project narrative must be submitted with the 
application forms. The narrative must be submitted in the following 
format:
     Maximum number of pages: 15 pages. If the narrative 
exceeds the page limit, only the first pages that are within the page 
limit will be reviewed.
     Font size: 12 point unreduced
     Line spacing: Double-spaced
     Paper size: 8.5 by 11 inches
     Page margin: One inch
     Printing: Only on one side of page
     Binding: Hold document together only by rubber bands or 
metal clips; do not bind document in any other way.
    The narrative should address activities that will be conducted over 
the entire project period, and must include the following items in the 
order listed:
     Program Plan
     Objectives
     Understanding
     Methods
     Performance Measures
     Budget Justification (not included in the narrative page 
limitation)

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    Additional information may be included in the application 
appendices. The appendices will not count toward the narrative page 
limit. This additional information includes:
     State laboratory reporting laws
     Evidence of legal authority to follow-up, and abstract 
medical records
     State specific statistics to support application
     Curriculum Vitas or Resumes
    The agency or organization is required to have a Dun and Bradstreet 
Data Universal Numbering System (DUNS) number to apply for a grant or 
cooperative agreement from the Federal government. The DUNS number is a 
nine-digit identification number, which uniquely identifies business 
entities. Obtaining a DUNS number is easy and there is no charge. To 
obtain a DUNS number, go to https://www.dunandbradstreet.com or call 1-
866-705-5711.
    For more information, see the CDC Web site at: https://www.cdc.gov/
od/pgo/funding/pubcommt.htm.
    If the application form does not have a DUNS number field, please 
write the DUNS number at the top of the first page of the application, 
and/or include the DUNS number in the application cover letter.
    Additional requirements that may require submittal of additional 
documentation with the application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    Application Deadline Date: August 5, 2005.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline 
date.
    Applications may be submitted electronically at https://
www.grants.gov. Applications completed on-line through Grants.gov are 
considered formally submitted when the applicant organization's 
Authorizing Official electronically submits the application to https://
www.grants.gov.
    Electronic applications will be considered as having met the 
deadline if the application has been submitted electronically by the 
applicant organization's Authorizing Official to Grants.gov on or 
before the deadline date and time.
    If submittal of the application is done electronically through 
Grants.gov (https://www.grants.gov), the application will be 
electronically time/date stamped, which will serve as receipt of 
submission. Applicants will receive an e-mail notice of receipt when 
CDC receives the application.
    If submittal of the application is by the United States Postal 
Service or commercial delivery service, the applicant must ensure that 
the carrier will be able to guarantee delivery by the closing date and 
time. If CDC receives the submission after the closing date 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, the applicant will be given the 
opportunity to submit documentation of the carrier's guarantee. If the 
documentation verifies a carrier problem, CDC will consider the 
submission as having been received by the deadline.
    If a hard copy application is submitted, CDC will not notify the 
applicant upon receipt of the submission. If questions arise on the 
receipt of the application, the applicant should first contact the 
carrier. If the applicant still has questions, contact the PGO-TIM 
staff at (770) 488-2700. The applicant should wait two to three days 
after the submission deadline before calling. This will allow time for 
submissions to be processed and logged.
    This announcement is the definitive guide on application content, 
submission address, and deadline. It supersedes information provided in 
the application instructions. If the submission does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. The applicant will be notified the application did not meet 
the submission requirements.

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. To 
get the current SPOC list, go to https://www.whitehouse.gov/omb/grants/
spoc.html.

IV.5. Funding Restrictions

    The following restrictions must be taken into account while writing 
your budget:
     Funds may not be used for research.
     Reimbursement of pre-award costs is not allowed.
    If requesting indirect costs in the budget, a copy of the indirect 
cost rate agreement is required. If the indirect cost rate is a 
provisional rate, the agreement should be less than 12 months of age.
    Guidance for completing the budget can be found on the CDC Web 
site, at the following Internet address: https://www.cdc.gov/od/pgo/
funding/budgetguide.htm.

IV.6. Other Submission Requirements

    Application Submission Address: Electronic Submission: CDC strongly 
encourages applicants to submit applications electronically at https://
www.Grants.gov. The application package can be downloaded from https://
www.Grants.gov. Applicants are able to complete it off-line, and then 
upload and submit the application via the Grants.gov Web site. E-mail 
submissions will not be accepted. If the applicant has technical 
difficulties in Grants.gov, customer service can be reached by e-mail 
at https://www.grants.gov/CustomerSupport or by phone at 1-800-518-4726 
(1-800-518-GRANTS). The Customer Support Center is open from 7 a.m. to 
9 p.m. Eastern Time, Monday through Friday.
    CDC recommends that submittal of the application to Grants.gov 
should be early to resolve any unanticipated difficulties prior to the 
deadline. Applicants may also submit a back-up paper submission of the 
application. Any such paper submission must be received in accordance 
with the requirements for timely submission detailed in Section IV.3. 
of the grant announcement. The paper submission must be clearly marked: 
``BACK-UP FOR ELECTRONIC SUBMISSION.'' The paper submission must 
conform to all requirements for non-electronic submissions. If both 
electronic and back-up paper submissions are received by the deadline, 
the electronic version will be considered the official submission.
    It is strongly recommended that the applicant submit the grant 
application using Microsoft Office products (e.g., Microsoft Word, 
Microsoft Excel, etc.). If the applicant does not have access to 
Microsoft Office products, a PDF file may be submitted. Directions for 
creating PDF files can be found on the Grants.gov Web site. Use of file 
formats other than Microsoft Office or PDF may result in the file being 
unreadable by staff.
 or
    Paper Submission: Applicants should submit the original and two 
hard copies of the application by mail or express delivery service to: 
Technical Information Management--RFA AA120, CDC Procurement 
and Grants

[[Page 38943]]

Office, 2920 Brandywine Road, Atlanta, GA 30341.

V. Application Review Information

V.1. Criteria

    Applicants 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 application will be evaluated against the following criteria:
    1. Methods (30 points)
    The extent to which the applicant demonstrates the technical 
capability to conduct the project using appropriate data collection and 
analytic methods for the following:
    a. Accurately linking incoming lab results to all HIV and AIDS 
cases.
    b. Transmitting that information to the national HIV/AIDS 
surveillance system for the duration of ALOHA.
    c. Conducting active surveillance and medical record abstraction, 
including CD4 and VL results, OIs, and ancillary information, following 
a protocol developed in collaboration with CDC.
    d. Conducting active, ongoing follow-up of cases.
    e. Documenting methods for linking lab results to registry cases, 
including methods of reconciling possible matches.
    f. Describing specific activities in support of the general funding 
considerations (Section III.3., bullets 1-4).
    2. Understanding of Project Objectives (25 points)
    The applicant's understanding of ALOHA objectives and the 
applicant's specific role in achieving those objectives.
    3. Performance Measures (20 points)
    The applicant's ability to evaluate progress, including:
    a. Measures of success in improving CD4, VL, and OI ascertainment 
and their impact on overall reporting, compared with cases diagnosed in 
calendar year 2004.
    b. Documenting collaboration with CDC staff to develop data 
collection forms for ancillary information about co-morbidities, 
barriers to reporting lab results, whether samples for CD4/VL testing 
are drawn at post test counseling, possible reasons for no CD4/VL 
testing, and the inability to link newly diagnosed persons to care.
    c. Transfer data collected to CDC on a monthly basis.
    4. Program Plan (15 points)
    Applicants must demonstrate that they meet the eligibility 
criteria. Applicants must indicate the general consideration (Section 
III.3., bullets 1-4) under which they want to be evaluated (choose only 
one) and provide supporting documentation, as needed. Is the plan 
adequate to carry out the proposed objectives? How complete and 
comprehensive is the plan for the entire project period? Does the plan 
include quantitative process and outcome measures?
    5. Objectives (10 points)
    The extent to which the objectives are specific (with time frames), 
realistic, and address the required recipient activities.
    6. Budget Justification (Reviewed, but not scored).
    The extent to which the budget is reasonable, clearly justified, 
and consistent with the intended use of funds. All budget categories 
should be itemized.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff, 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.
    An objective review panel will evaluate complete and responsive 
applications according to the criteria listed in the ``V.1. Criteria'' 
section above. The objective review process will follow the policy 
requirements as stated in the GPD 2.04 [https://198.102.218.46/doc/
gpd204.doc].
    Applications will be funded according to their score and rank, 
which will be determined by the review panel. All persons serving on 
the panel will be external to the funding division of NCHSTP. In 
addition, the following factor may affect the funding decision: At 
least one applicant should be funded in each of the four general 
consideration areas (See Section III.3., bullets 1-4).
    CDC will provide justification for any decision to fund out of rank 
order.

V.3. Anticipated Award Date

    August 31, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Award (NoA) from the 
CDC Procurement and Grants Office. The NoA shall be the only binding, 
authorizing document between the recipient and CDC. The NoA 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

    Successful applicants must comply with the administrative 
requirements outlined in 45 CFR Part 74 and Part 92 as Appropriate. The 
following additional requirements apply to this project:
     AR-4 HIV/AIDS Confidentiality Provisions
     AR-5 HIV Program Review Panel Requirements
     AR-7 Executive Order 12372
     AR-8 Public Health System Reporting Requirements
     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-25 Release and Sharing of Data
    Additional information on these requirements can be found on the 
CDC web site at the following Internet address: https://www.cdc.gov/od/
pgo/funding/ARs.htm.
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: https://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    An additional Certifications form from the PHS5161-1 application 
needs to be included in the Grants.gov electronic submission only. 
Applicants should refer to https://www.cdc.gov/od/pgo/funding/PHS5161-1-
Certificates.pdf. Once the applicant has filled out the form, it should 
be attached to the Grants.gov submission as Other Attachments Form.

VI.3. Reporting Requirements

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, due no less than 90 days before the end 
of the

[[Page 38944]]

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. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Annual progress report, due 90 days after the end of the budget 
period.
    3. Financial status report, no more than 90 days after the end of 
the budget period.
    4. Final financial and performance reports, no more than 90 days 
after the end of the project period.

VII. Agency Contacts

    We encourage inquiries concerning this announcement. For general 
questions, contact: Technical Information Management Section, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, 
Telephone: 770-488-2700.
    For program technical assistance, contact: Debra Hayes-Hughes, 
Project Officer, Centers for Disease Control and Prevention, 1600 
Clifton Road, NE., MS E-47, Atlanta, GA 30333, Telephone: 404-639-4493, 
E-mail: DHayes-Hughes@cdc.gov.
    For financial, grants management, or budget assistance, contact: 
Kang Lee, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 404-498-
1917, E-mail: kil8@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
at https://www.cdc.gov. Click on ``Funding,'' then ``Grants and 
Cooperative Agreements.''

    Dated: June 28, 2005.
Alan A. Kotch,
Acting Deputy Director, Procurement and Grants Office, Centers for 
Disease Control and Prevention.
[FR Doc. 05-13223 Filed 7-5-05; 8:45 am]
BILLING CODE 4163-18-P