Strengthen HIV/AIDS Prevention, Care, and Treatment Services for Infants of HIV Positive Mothers in the Republic of Haiti Through Provision of Improved Pediatric HIV/AIDS Laboratory Diagnosis, 46866-46872 [05-15893]
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46866
Federal Register / Vol. 70, No. 154 / Thursday, August 11, 2005 / Notices
Government Country Program Office.
The panel may include both Federal and
non-Federal participants.
Applications will be funded in order
by score and rank determined by the
review panel. HHS/CDC will provide
justification for any decision to fund out
of rank order.
V.3. Anticipated Announcement and
Award Dates
September 23, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a
Notice of Award (NoA) from the HHS/
CDC Procurement and Grants Office.
The NoA shall be the only binding,
authorizing document between the
recipient and HHS/CDC. An authorized
Grants Management Officer will sign the
NoA, and mail it 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: https://
www.access.gpo.gov/nara/cfr/cfr-tablesearch.html.
The following additional
requirements apply to this project:
• AR–4 HIV/AIDS Confidentiality
Provisions
• AR–6 Patient Care
• AR–8 Public Health System
Reporting Requirements
• AR–10 Smoke-Free Workplace
Requirements
• AR–12 Lobbying Restrictions
• AR–14 Accounting System
Requirements
Applicants can find additional
information on the requirements on the
HHS/CDC Web site at the following
Internet address: https://www.cdc.gov/
od/pgo/funding/ARs.htm.
You need to include an additional
Certifications form from the PHS5161–
1 application needs in your Grants.gov
electronic submission only. Please refer
to https://www.cdc.gov/od/pgo/funding/
PHS5161–1-Certificates.pdf. Once you
have filled out the form, please attach it
to the Grants.gov submission as Other
Attachments Form.
VI.3. Reporting Requirements
You must provide HHS/CDC with an
original, plus two hard copies, of the
following reports:
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1. Interim progress reports (annual): a
brief, comprehensive narrative progress
report should be submitted no less than
90 days after 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. Detailed Line-Item Budget.
e. Measures of Effectiveness,
including progress against the
numerical goals of the President’s
Emergency Plan for AIDS Relief for
Namibia.
f. Additional Requested Information.
2. Financial status report due no more
than 90 days after the end of the budget
period.
3. Final financial and performance
reports, due no more than 90 days after
the end of the project period.
4. Annual progress report, due no
more than 60 days after the end of the
budget period. Reports should include
progress against the numerical goals of
the President’s Emergency Plan for
AIDS Relief for Namibia.
Recipients must mail these reports to
the Grants Management Specialist listed
in the ‘‘Agency Contacts’’ section of this
announcement.
VII. Agency Contacts
We encourage inquiries concerning
this announcement.
For general questions, contact:
Technical Information Management
Section, CDC Procurement and Grants
Office, U.S. Department of Health and
Human Services, 2920 Brandywine
Road, Atlanta, GA 30341, Telephone:
770–488–2700.
For program technical assistance,
contact: Leonard Floyd, Project Officer,
U.S. Department of State, 2540
Windhoek Place, Washington, DC
20521–8320, Telephone: 011 264 61224
149, E-mail: Floydl@nacop.net.
For financial, grants management, or
budget assistance, contact: Shirley
Wynn, Grants Management Specialist,
CDC Procurement and Grants Office,
U.S. Department of Health and Human
Services, 2920 Brandywine Road,
Atlanta, GA 30341, Telephone: (770)
488–1515, E-mail: SWynn@cdc.gov.
VIII. Other Information
Applicants can find this and other
CDC funding opportunity
announcements on the HHS/CDC Web
site, Internet address: https://
www.cdc.gov (Click on ‘‘Funding’’ then
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‘‘Grants and Cooperative Agreements’’),
and on the Web site of the HHS Office
of Global Health Affairs, Internet
address: https://www.globalhealth.gov.
Dated: August 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention,
U.S. Department of Health and Human
Services.
[FR Doc. 05–15892 Filed 8–10–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Strengthen HIV/AIDS Prevention, Care,
and Treatment Services for Infants of
HIV Positive Mothers in the Republic of
Haiti Through Provision of Improved
Pediatric HIV/AIDS Laboratory
Diagnosis
Announcement Type: New.
Funding Opportunity Number: RFA
AA178.
Catalog of Federal Domestic
Assistance Number: 93.067.
Key Dates:
Application Deadline: September 6,
2005.
I. Funding Opportunity Description
Authority: This program is authorized
under Sections 301(a) and 307 of the Public
Health Service Act [42 U.S.C. Sections 241
and 242l], as amended, and under Public
Law 108–25 (United States Leadership
Against HIV/AIDS, Tuberculosis and Malaria
Act of 2003) [22 U.S.C. 7601].
Background: President Bush’s
Emergency Plan for AIDS Relief (The
Emergency Plan) has called for
immediate, comprehensive and
evidence-based action to turn the tide of
global HIV/AIDS. The initiative aims to
prevent at least seven million new HIV
infections by 2010; to treat more than
two million people with effective
combination anti-retroviral therapy by
2008; and to provide care for ten million
HIV-infected and affected persons,
including those orphaned by HIV/AIDS,
by 2008, with a focus on 15 priority
countries. The five-year strategy for the
Emergency Plan is available at the
following Internet address: https://
www.state.gov/s/gac/rl/or/c11652.htm.
Under the leadership of the U.S.
Global AIDS Coordinator, as part of the
President’s Emergency Plan, the U.S.
Department of Health and Human
Services (HHS) works with host
countries and other key partners to
assess the needs of each country and
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design a customized program of
assistance that fits within the host
nation’s strategic plan.
An essential element of preventing
new cases of HIV is to ensure that highrisk groups have adequate access to
screening, treatment, and care facilities.
Haiti’s HIV prevalence rate in adults is
reported to be 5.6 percent, according to
the Joint United Nations Programme on
HIV/AIDS (UNAIDS) 2004 Annual
Report. Access to prevention and
treatment is limited to the Haitian
population because of the
underdeveloped public health
infrastructure and lack of clinical
capacity.
Haiti’s Central Plateau region is a
rural area northeast of the capital, Portau-Prince. Years of neglect and illconceived engineering projects have left
the region’s population largely destitute
and reliant on largely subsistence
farming for survival. Access to this
region is difficult due to the poor
transportation infrastructure. These
social, economic and physical barriers
have prevented significant numbers of
Haitian non-governmental organizations
from emerging and offering services in
the Central Plateau.
Purpose: The purpose of this funding
announcement is to progressively build
an indigenous, sustainable response to
the national HIV epidemic through the
rapid expansion of innovative,
culturally appropriate, high-quality
HIV/AIDS prevention and care
interventions. In Haiti, Emergency Plan
goals include treatment of at least
25,000 HIV-infected individuals and
care for 125,000 HIV-infected and
affected individuals, including orphans.
Measurable outcomes of the program
will be in alignment with the numerical
performance goals of the President’s
Emergency Plan and one (or more) of
the following performance goal(s) for
the National Center for HIV, sexually
transmitted diseases and Tuberculosis
Prevention of the Centers for Disease
Control and Prevention (CDC) within
the U.S. Department of Health and
Human Services (HHS): Increase the
proportion of HIV-infected people who
are linked to appropriate prevention,
care and treatment services; strengthen
the capacity nationwide to monitor the
epidemic; develop and implement
effective HIV prevention interventions;
and evaluate prevention programs.
This announcement is only for nonresearch activities supported by HHS. If
an applicant proposes research, we will
not review the application. For the
definition of research, please see the
HHS/CDC web site at the following
Internet address: https://www.cdc.gov/
od/ads/opspoll1.htm
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Activities: The awardee will either
implement activities directly or will
implement them through its subgrantees
and/or subcontractors; the awardee will
retain overall financial and
programmatic management under the
oversight of HHS/CDC and the strategic
direction of the Office of the Global
AIDS Coordinator. The awardee must
show a measurable progressive
reinforcement of the capacity of
indigenous organizations and local
communities to respond to the national
HIV epidemic, as well as progress
towards the sustainability of activities.
Applicants should describe activities
in detail as part of a four-year action
plan (U.S. Government Fiscal Years
2005–2008 inclusive) that reflects the
policies and goals outlined in the fiveyear strategy for the President’s
Emergency Plan.
HHS/CDC, under the guidance of the
U.S. Global AIDS Coordinator, will
approve funds on an annual basis, based
on documented performance toward
achieving Emergency Plan goals, as part
of the annual Emergency Plan for AIDS
Relief Country Operational Plan review
and approval process.
This program announcement seeks
proposals from Haitian organizations to
strengthen and expand pediatric testing
and diagnosis for infants of HIV-positive
mothers. The funding through this
cooperative agreement will establish
and provide ongoing and effective
pediatric HIV/AIDS testing and
diagnosis and strengthen laboratory
support services and personnel integral
in reducing the incidence of pediatric
HIV/AIDS in Haiti. Program proposals
should include program strategies that
address the following activities:
1. Provide pediatric testing and
diagnosis to infants.
2. Strengthen laboratory services to
support pediatric diagnosis and
treatment, and build capacity in lab
personnel internally and within the
HIV/AIDS service-delivery network.
3. Record and report sample
collection results regularly.
4. Reduce the incidence of pediatric
HIV/AIDS through partnering with
prevention of mother-to-child
transmission (PMTCT) linkages to
ensure access to pediatric HIV/AIDS
information and care.
5. Expand services and transfer
pediatric diagnostic testing technology
to other sites.
6. Administer anti-retroviral (ARV)
treatment in adherence with Department
of Health and Human Services (HHS)
guidelines.
7. Provide basic laboratory services in
support of pediatric HIV/AIDS diagnosis
and treatment.
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1. Perform CD4 counts.
2. Perform complete blood counts.
3. Perform HIV rapid testing.
4. Perform confirmatory HIV/AIDS
testing.
8. Provide post-test counseling, care,
and other social services, as needed by
the newborn.
9. Provide appropriate referrals to
ensure that HIV-infected pregnant
women receive care for their own
health, and to prevent HIV transmission
to their babies.
10. Provide referrals to appropriate
prevention ,1 treatment, care and
support services.
11. Implement monitoring and
evaluation strategies, assessing:
1. Number of infants tested.
2. Number of infants receiving
treatment and follow-up.
3. Number of technical assists
provided to other lab sites.
12. Work to link activities described
here with related HIV care and other
social services in the area, and promote
coordination at all levels, including
through bodies such as village, district,
regional and national HIV coordination
committees and networks of faith-based
organizations.
13. Participate in relevant national
technical coordination committees and
in national process(es) to define,
implement and monitor simplified
small grants program(s)for faith- and
community-based organizations, to
ensure local stakeholders receive
adequate information and assistance to
engage and access effectively funding
opportunities supported by the
President’s Emergency Plan and other
donors.
14. Progressively reinforce the
capacity of faith- and community-based
organizations and village and district
AIDS committees to promote quality,
local ownership, accountability and
sustainability of activities.
1 Prevention interventions directed toward
behavior change should promote the ABC model.
Methods and strategies should emphasize
abstinence for youth and other unmarried persons,
mutual faithfulness and partner reduction for
sexually active adults, and correct and consistent
use of condoms by those populations who are
engaged in high-risk behaviors. Behaviors that
increase risk for HIV transmission include: engaging
in casual sexual encounters, engaging in sex in
exchange for money or favors, having sex with an
HIV-positive partner or one whose status is
unknown, using drugs or abusing alcohol in the
context of sexual interactions, and using
intravenous drugs. Women, even if faithful
themselves, can still be at risk of becoming infected
by their spouse, regular male partner, or someone
using force against them. Other high-risk persons or
groups include men who have sex with men and
workers who are employed away from home.
Awardees may not implement condom social
marketing without also implementing the
abstinence and faithfulness behavior-change
interventions outlined above.
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15. Develop and implement a projectspecific participatory monitoring and
evaluation plan by drawing on national
and U.S. Government requirements and
tools, including the strategic
information guidance provided by the
Office of the U.S. Global AIDS
Coordinator.
Administration: Comply with all HHS
management requirements for meeting
participation and progress and financial
reporting for this cooperative agreement.
(See HHS Activities and Reporting
sections below for details.) Comply with
all policy directives established by the
Office of the U.S. Global AIDS
Coordinator.
In a cooperative agreement, HHS staff
is substantially involved in the program
activities, above and beyond routine
grant monitoring.
HHS Activities for this program are as
follows:
1. Organize an orientation meeting
with the awardee to brief them on
applicable U.S. Government, HHS, and
Emergency Plan expectations,
regulations and key management
requirements, as well as report formats
and contents. The orientation could
include meetings with staff from HHS
agencies and the Office of the U.S.
Global AIDS Coordinator.
2. Review and approve the process
used by the awardee to select key
personnel and/or post-award
subcontractors and/or subgrantees to be
involved in the activities performed
under this agreement, as part of the
Emergency Plan for AIDS Relief Country
Operational Plan review and approval
process, managed by the Office of the
U.S. Global AIDS Coordinator.
3. Review and approve awardee’s
annual work plan and detailed budget,
as part of the Emergency Plan for AIDS
Relief Country Operational Plan review
and approval process, managed by the
Office of the U.S. Global AIDS
Coordinator.
4. Review and approve awardee’s
monitoring and evaluation plan,
including for compliance with the
strategic information guidance
established by the Office of the U.S.
Global AIDS Coordinator.
5. Meet on a monthly basis with
awardee to assess monthly expenditures
in relation to approved work plan and
modify plans as necessary.
6. Meet on a quarterly basis with
awardee to assess quarterly technical
and financial progress reports and
modify plans as necessary.
7. Meet on an annual basis with
awardee to review annual progress
report for each U.S. Government Fiscal
Year, and to review annual work plans
and budgets for subsequent year, as part
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of the Emergency Plan for AIDS Relief
review and approval process for
Country Operational Plans, managed by
the Office of the U.S. Global AIDS
Coordinator.
8. Support an electronic medical
record (EMR) database system; provide
and support a surveillance database
system.
9. Provide and install of hardware
necessary for the use of database
systems.
10. Assist in organizing regional
meetings.
11. Provide technical laboratory
consultations to support all activities
related to pediatric diagnosis.
12. Provision of laboratory
consultations to pediatric diagnosis and
coordination of this project.
II. Award Information
Type of Award: Cooperative
Agreement.
HHS involvement in this program is
listed in the Activities Section above.
Fiscal Year Funds: 2005.
Approximate Total Funding:
$1,000,000 (This amount is an estimate,
and is subject to availability of funds.).
Approximate Number of Awards:
One.
Approximate Average Award:
$200,000 (This amount is for the first
12-month budget period, and includes
direct costs.).
Floor of Award Range: $200,000.
Ceiling of Award Range: $200,000.
Anticipated Award Date: September
15, 2005.
Budget Period Length: 12 months.
Project Period Length: Five years.
Throughout the project period, HHS’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, through the
Emergency Plan for AIDS Relief review
and approval process for Country
Operational Plans, managed by the
Office of the U.S. Global AIDS
Coordinator.
III. Eligibility Information
III.1. Eligible Applicants
Eligible applicants must:
• Be private, non-profit organizations,
indigenous to Haiti, and may be faithbased organizations.
• Have between three to five years of
experience in HIV/AIDS pediatric
diagnosis and testing.
• Currently work in HIV/AIDS care in
the Central Plateau Region of Haiti.
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• Already be integrated into the
Haitian national HIV/AIDS program.
III.2. Cost-Sharing or Matching
Matching funds are not required for
this program.
III.3. Other
If applicants request a funding
amount greater than the ceiling of the
award range, HHS/CDC will consider
the application non-responsive, and it
will not enter into the review process.
We will notify you that your application
did not meet the submission
requirements.
Special Requirements: If your
application is incomplete or nonresponsive to the special requirements
listed in this section, it will not enter
into the review process. We will notify
you that your application did not meet
submission requirements.
• HHS/CDC will consider late
applications 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.
IV. Application and Submission
Information
IV.1. Address to Request Application
Package
To apply for this funding opportunity
use application form PHS 5161–1.
Electronic Submission: HHS strongly
encourages the applicant to submit the
application electronically by using 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
HHS/CDC web site, at the following
Internet address: https://www.cdc.gov/
od/pgo/forminfo.htm.
If you do not have access to the
Internet, or if you have difficulty
accessing the forms on-line, you may
contact the HHS/CDC Procurement and
Grants Office Technical Information
Management Section (PGO–TIM) staff
at: 770–488–2700. We can mail
application forms to you.
IV.2. Content and Form of Submission
Application: You must submit a
project narrative with your application
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forms. You must submit the narrative in
the following format:
• Maximum number of pages: 30. If
your narrative exceeds the page limit,
only the first pages which are within the
page limit will be reviewed.
• Font size: 12 point unreduced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page.
• Held together only by rubber bands
or metal clips; not bound in any other
way.
• Submitted in English.
Your narrative should address
activities to be conducted over the
entire project period, and must include
the following items in the order listed:
• Executive Summary: Provide a clear
and concise summary of the proposed
goals, major objectives and activities
required for achievement of program
goals, and amount of funding requested
for budget year one of this cooperative
agreement.
• Project Context and Background
(Understanding and Need)
• Project Strategy—Description and
Methodologies
• Project Goals
• Project Outputs
• Project Contribution to the Goals
and Objectives of the Emergency Plan
for AIDS Relief
• Work Plan and Description of
Project Components and Activities
• Performance Measures
• Timeline (e.g., GANNT Chart)
• Management of Project Funds and
Reporting.
You may include additional
information in the application
appendices. The appendices will not
count toward the narrative page limit.
This additional information includes
the following:
• Budget Justification (only for Year
01)
• Curricula Vitae
• Organizational Charts
• Letters of Support
You must have a Dun and Bradstreet
Data Universal Numbering System
(DUNS) number to apply for a grant or
cooperative agreement from the Federal
government. The DUNS number is a
nine-digit identification number, which
uniquely identifies business entities.
Obtaining a DUNS number is easy and
there is no charge. To obtain a DUNS
number, access https://
www.dunandbradstreet.com or call 1–
866–705–5711. For more information,
see the HHS/CDC web site at: https://
www.cdc.gov/od/pgo/funding/
grantmain.htm. If your application form
does not have a DUNS number field,
please write your DUNS number at the
top of the first page of your application,
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and/or include your DUNS number in
your application cover letter.
Additional requirements that could
require you to submit additional
documentation with your application
are listed in section ‘‘VI.2.
Administrative and National Policy
Requirements.’’
submission address, and deadline. It
supersedes information provided in the
application instructions. If your
submission does not meet the deadline
above, it will not be eligible for review,
and we will discard it. We will notify
you that you did not meet the
submission requirements.
IV.3. Submission Dates and Times
Application Deadline Date:
September 6, 2005.
Explanation of Deadlines:
Applications must be received in the
HHS/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.
We consider applications completed online through Grants.gov as formally
submitted when the applicant
organization’s Authorizing Official
electronically submits the application to
https://www.grants.gov. We will consider
electronic applications as having met
the deadline if the applicant
organization’s Authorizing Official has
submitted the application electronically
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 HHS/CDC
receives the application.
If you submit your application by the
United States Postal Service or
commercial delivery service, you must
ensure the carrier will be able to
guarantee delivery by the closing date
and time. If HHS/CDC receives your
submission after closing because of: (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 have the opportunity
to submit documentation of the carrier’s
guarantee. If the documentation verifies
a carrier problem, HHS/CDC will
consider the submission as received by
the deadline.
If a hard copy application is
submitted, HHS/CDC will not notify you
upon receipt of your submission. 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 submission
deadline. This will allow time for us to
process and log submissions.
This announcement is the definitive
guide on application content,
IV.4. Intergovernmental Review of
Applications
Executive Order 12372 does not apply
to this program.
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IV.5. Funding Restrictions
Restrictions, which you must take
into account while writing your budget,
are as follows:
• Funds may not be used for research.
• Reimbursement of pre-award costs
is not allowed.
• Funds may be spent for reasonable
program purposes, including personnel,
travel, supplies, and services.
Equipment may be purchased if deemed
necessary to accomplish program
objectives; however, prior approval by
HHS/CDC officials must be requested in
writing.
• All requests for funds contained in
the budget shall be stated in U.S.
dollars. Once an award is made, HHS/
CDC will not compensate foreign
grantees for currency exchange
fluctuations through the issuance of
supplemental awards.
• The costs that are generally
allowable in grants to domestic
organizations are allowable to foreign
institutions and international
organizations, with the following
exception: With the exception of the
American University, Beirut and the
World Health Organization, Indirect
Costs will not be paid (either directly or
through sub-award) to organizations
located outside the territorial limits of
the United States or to international
organizations regardless of their
location.
• The applicant may contract with
other organizations under this program;
however, the applicant must perform a
substantial portion of the activities
(including program management and
operations, and delivery of prevention
services for which funds are required).
• You must obtain annual audit of
these HHS/CDC funds (program-specific
audit) by a U.S.-based audit firm with
international branches and current
licensure/authority in-country, and in
accordance with International
Accounting Standards or equivalent
standard(s) approved in writing by
HHS/CDC.
• A fiscal Recipient Capability
Assessment may be required, prior to or
post award, in order to review the
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applicant’s business management and
fiscal capabilities regarding the
handling of U.S. Federal funds.
• Funds received from this
announcement will not be used for the
purchase of anti-retroviral drugs for
treatment of established HIV infection,
with the exception of nevirapine in
PMTCT cases and with prior written
approval, occupational exposures, and
non-occupational exposures and will
not be used for the purchase of
machines and reagents to conduct the
necessary laboratory monitoring for
patient care.
• No funds appropriated under this
act shall be used to carry out any
program of distributing sterile needles
or syringes for the hypodermic injection
of any illegal drug.
Prostitution and Related Activities
The U.S. Government is opposed to
prostitution and related activities,
which are inherently harmful and
dehumanizing, and contribute to the
phenomenon of trafficking in persons.
Any entity that receives, directly or
indirectly, U.S. Government funds in
connection with this document
(‘‘recipient’’) cannot use such U.S.
Government funds to promote or
advocate the legalization or practice of
prostitution or sex trafficking. Nothing
in the preceding sentence shall be
construed to preclude the provision to
individuals of palliative care, treatment,
or post-exposure pharmaceutical
prophylaxis, and necessary
pharmaceuticals and commodities,
including test kits, condoms, and, when
proven effective, microbicides.
A recipient that is otherwise eligible
to receive funds in connection with this
document to prevent, treat, or monitor
HIV/AIDS shall not be required to
endorse or utilize a multisectoral
approach to combating HIV/AIDS, or to
endorse, utilize, or participate in a
prevention method or treatment
program to which the recipient has a
religious or moral objection. Any
information provided by recipients
about the use of condoms as part of
projects or activities that are funded in
connection with this document shall be
medically accurate and shall include the
public health benefits and failure rates
of such use.
In addition, any recipient must have
a policy explicitly opposing prostitution
and sex trafficking. The preceding
sentence shall not apply to any ‘‘exempt
organizations’’ (defined as the Global
Fund to Fight AIDS, Tuberculosis and
Malaria, the World Health Organization
and its six Regional Offices, the
International AIDS Vaccine Initiative or
to any United Nations agency).
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The following definition applies for
purposes of this clause:
• Sex trafficking means the
recruitment, harboring, transportation,
provision, or obtaining of a person for
the purpose of a commercial sex act. 22
U.S.C. 7102(9).
All recipients must insert provisions
implementing the applicable parts of
this section, ‘‘Prostitution and Related
Activities,’’ in all subagreements under
this award. These provisions must be
express terms and conditions of the
subagreement, must acknowledge that
compliance with this section,
‘‘Prostitution and Related Activities,’’ is
a prerequisite to receipt and
expenditure of U.S. government funds
in connection with this document, and
must acknowledge that any violation of
the provisions shall be grounds for
unilateral termination of the agreement
prior to the end of its term. Recipients
must agree that HHS may, at any
reasonable time, inspect the documents
and materials maintained or prepared
by the recipient in the usual course of
its operations that relate to the
organization’s compliance with this
section, ‘‘Prostitution and Related
Activities.’’
All prime recipients that receive U.S.
Government funds (‘‘prime recipients’’)
in connection with this document must
certify compliance prior to actual
receipt of such funds in a written
statement that makes reference to this
document (e.g., ‘‘[Prime recipient’s
name] certifies compliance with the
section, ‘Prostitution and Related
Activities.’ ’’) addressed to the agency’s
grants officer. Such certifications by
prime recipients are prerequisites to the
payment of any U.S. Government funds
in connection with this document.
Recipients’ compliance with this
section, ‘‘Prostitution and Related
Activities,’’ is an express term and
condition of receiving U.S. Government
funds in connection with this
document, and any violation of it shall
be grounds for unilateral termination by
HHS of the agreement with HHS in
connection with this document prior to
the end of its term. The recipient shall
refund to HHS the entire amount
furnished in connection with this
document in the event HHS determines
the recipient has not complied with this
section, ‘‘Prostitution and Related
Activities.’’
You can find guidance for completing
your budget on the HHS/CDC web site,
at the following Internet address: http:/
/www.cdc.gov/od/pgo/funding/
budgetguide.htm.
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IV.6. Other Submission Requirements
Application Submission Address:
Electronic Submission: HHS/CDC
strongly encourages applicants to
submit applications electronically at
https://www.Grants.gov. The application
package can be downloaded from http:/
/www.Grants.gov. Applicants are able to
complete it off-line, and then upload
and submit the application via the
Grants.gov Web site. We will not accept
e-mail submissions. If the applicant has
technical difficulties in Grants.gov, the
applicant can reach customer service 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.
HHS/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. We
must receive any such paper submission
in accordance with the requirements for
timely submission detailed in Section
IV.3. of the grant announcement. You
must clearly mark the paper submission:
‘‘BACK-UP FOR ELECTRONIC
SUBMISSION.’’
The paper submission must conform
to all requirements for non-electronic
submissions. If we receive both
electronic and back-up paper
submissions by the deadline, we will
consider the electronic version the
official submission.
We strongly recommend that the
applicant submit the grant application
by using Microsoft Word, Microsoft
Excel, etc.). If the applicant does not
have access to Microsoft Office
products, you may submit a PDF file.
Directions for creating PDF files can be
found on the Grants.gov Web site. Use
of file formats other than Microsoft
Office or PDF could make the file
unreadable for our staff.
or
Paper Submission: Submit the
original and two hard copies of your
application by mail or express delivery
service to the following address:
Technical Information ManagementAA178, CDC Procurement and Grants
Office, U.S. Department of Health and
Human Services, 2920 Brandywine
Road, Atlanta, GA 30341.
V. Application Review Information
V.1. Criteria
Applicants must provide measures of
effectiveness that will demonstrate the
accomplishment of the various
identified objectives of the cooperative
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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.
Applicants must submit these measures
of effectiveness with the application and
they will be an element of evaluation.
We will evaluate your application
against the following criteria:
1. Need (20 Points) To what extent
does the applicant justify the need for
this program within the target
community?
2. Plan (20 Points) Does the applicant
display knowledge of the five-year
strategy and goals of the President’s
Emergency Plan, such that it can build
on these to develop a comprehensive,
collaborative project to reach
underserved populations? Does the
applicant describe strategies that are
pertinent and match those identified in
the five-year strategy of the President’s
Emergency Plan and describe activities
that are evidence-based, realistic,
achievable, measurable and culturally
appropriate in Haiti? Is the plan
appropriate to the social, political and
cultural context in Haiti? 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?
3. Monitoring Evaluation and
Reporting (20 points) Does the applicant
have a system for reviewing and
adjusting program activities based on
monitoring information? Applicants
must develop indicators for each
program milestone and incorporate
them into the periodic financial and
programmatic reports. Applicants must
draw all indicators from the President’s
Emergency Plan for AIDS Relief
Indicator Guide, and be consistent with
the guidance established by the Office of
the U.S. Global AIDS Coordinator.
Applicants must generate periodic
financial and program reports to show
disbursement of funds and progress
towards achieving program objectives.
4. Methods (15 Points).
Are the proposed methods feasible?
To what extent will they accomplish the
program goals?
5. Management and Personnel (15
Points).
Do the staff members have
appropriate experience? Are the staff
roles clearly defined? As described, will
the staff be sufficient to accomplish the
program goals? Is there a plan to manage
the resources of the program, prepare
reports, monitor and evaluate activities
and audit expenditures?
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6. Eligibility (10 points).
Organizations indigenous to Haiti
must have between three to five years of
experience in HIV/AIDS pediatric
diagnosis and testing, must currently
work in HIV/AIDS care in the Central
Plateau, and must be integrated into the
Haitian national HIV/AIDS program.
7. Budget and Justification (Reviewed,
but not scored) Is the itemized budget
for conducting the project, along with
justification, reasonable and consistent
with the five-year strategy and goals of
the President’s Emergency Plan,
Emergency Plan activities in Haiti, and
the National Haitian HIV/AIDS
program?
V.2. Review and Selection Process
The HHS/CDC Procurement and
Grants Office (PGO) staff will review
applications for completeness, and HHS
Global AIDS program will review them
for responsiveness. Incomplete
applications and applications that are
non-responsive to the eligibility criteria
will not advance through the review
process. Applicants will receive
notification 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. All persons who serve on the
panel will be external to the U.S.
Government Country Program Office.
The panel may include both Federal and
non-Federal participants.
Applications will be funded in order
by score and rank determined by the
review panel. HHS/CDC will provide
justification for any decision to fund out
of rank order.
In addition, the following factors
could affect the funding decision:
• Maintaining geographic diversity
• Preference to organizations in
certain geographic areas
HHS/CDC will provide justification
for any decision to fund out of rank
order.
V.3. Anticipated Announcement and
Award Dates
September 15, 2005
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a
Notice of Award (NoA) from the HHS/
CDC Procurement and Grants Office.
The NoA shall be the only binding,
authorizing document between the
recipient and HHS/CDC. An authorized
Grants Management Officer will sign the
NoA, and mail it to the recipient fiscal
officer identified in the application.
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46871
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: https://
www.access.gpo.gov/nara/cfr/cfr-tablesearch.html
The following additional
requirements apply to this project:
• AR–4 HIV/AIDS Confidentiality
Provisions
• AR–10 Smoke-Free Workplace
Requirements
• AR–12 Lobbying Restrictions
• AR–14 Accounting System
Requirements
Applicants can find additional
information on these requirements on
the HHS/CDC web site at the following
Internet address: https://www.cdc.gov/
od/pgo/funding/ARs.htm.
You need to include an additional
Certifications form from the PHS 5161–
1 application in your Grants.gov
electronic submission only. Please refer
to https://www.cdc.gov/od/pgo/funding/
PHS5161-1-Certificates.pdf. Once you
have filled out the form, please attach it
to the Grants.gov submission as Other
Attachment Forms.
VI.3. Reporting Requirements
You must provide HHS/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
budget period. The progress report will
serve as your non-competing
continuation application, and must
contain the following elements:
a. Current Budget Period Activities
and Objectives.
b. Current Budget Period Financial
Progress.
c. New Budget Period Program
Proposed Activities and Objectives.
d. Budget and budget narrative with
justification.
e. Measures of Effectiveness,
including progress against the
numerical goals of the President’s
Emergency Plan for AIDS Relief for
Haiti.
f. Additional Information.
2. Annual reports are due within 30
days of the end of the budget period.
The report should detail progress
toward achieving program milestones
and projected next year activities.
Indicators must be developed for each
program milestone and incorporated
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into the annual financial and
programmatic reports. All indicators
need to be drawn from the Emergency
Plan.
3. Financial status report, no more
than 90 days after the end of the budget
period. The financial report must show
obligations, disbursements and funds
remaining by program activity.
Indicators must be developed for each
program milestone and incorporated
into the periodic financial and
programmatic reports. All indicators
need to be drawn from The Emergency
Plan Indicator Guide.
4. Final performance reports, no more
than 90 days after the end of the project
period.
Recipients must mail these reports to
the Grants Management or Contract
Specialist listed in the ‘‘Agency
Contacts’’ section of this announcement.
VII. Agency Contacts
We encourage inquiries concerning
this announcement. For general
questions, contact: Technical
Information Management Section, CDC
Procurement and Grants Office, U.S.
Department of Health and Human
Services, 2920 Brandywine Road,
Atlanta, GA 30341. Telephone: 770–
488–2700.
For program technical assistance,
contact: Kathy Grooms, Project Officer,
Global AIDS Program, HHS/CDC
National Center for HIV, STD, and TB
Prevention, 1600 Clifton Road, Mailstop
E–04, Atlanta, GA 30333. Telephone:
404–639–8394.
For financial, grants management, or
budget assistance, contact: Vivian
Walker, Grants Management Specialist,
CDC Procurement and Grants Office,
U.S. Department of Health and Human
Services, 2920 Brandywine Road,
Atlanta, GA 30341. Telephone: 770–
488–2724. E-mail: vwalker@cdc.gov.
VIII. Other Information
Applicants can find this and other
HHS/CDC funding opportunity
announcements on the HHS/CDC web
site, Internet address: https://
www.cdc.gov (Click on ‘‘Funding,’’ then
‘‘Grants and Cooperative Agreements’’),
and on the web site of the HHS Office
of Global Health Affairs, Internet
address: https://www.globalhealth.gov.
Dated: August 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention,
U.S. Department of Health and Human
Services.
[FR Doc. 05–15893 Filed 8–10–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Program Announcement AA134]
Strengthening HIV/AIDS, TB and STI
Prevention, Control and Treatment
Activities Within the Police Force of
Ethiopia; Notice of Intent To Fund
Single Eligibility Award
A. Purpose
The Centers for Disease Control and
Prevention (CDC) announces the intent
to fund fiscal year (FY) 2005 funds for
a cooperative agreement program to
strengthen the activities in the
prevention, control, and treatment of
HIV/AIDS, Sexually Transmitted
Infections (STI) and Tuberculosis (TB)
within the Police Force of Ethiopia. The
project particularly aims to: (1) Improve
HIV/AIDS, STI and TB prevention
following the Abstinence, Be Faithful,
and Correct and Consistent Condom Use
(ABC) strategies, care and treatment
services within the Police Force of
Ethiopia; (2) strengthen human resource
capacity of the police force for HIV/
AIDS/STI/TB services; and (3)
implement and support targeted
monitoring and evaluation. The Catalog
of Federal Domestic Assistance number
for this program is 93.067.
B. Eligible Applicant
Assistance will be provided only to
the FPC of the Federal Democratic
Republic of Ethiopia for this project.
The FPC of Ethiopia is the most
appropriate and qualified agency to
conduct the activities because:
1. FPC’s HIV Prevention and Control
Office is the only office uniquely
positioned in terms of legal authority,
ability, and credibility to coordinate and
support prevention, care, and treatment
activities among members of the police
force and their dependents.
2. The FPC administers all the police
force health facilities which constitute
the only facilities where members of the
police force and their dependents
receive care.
3. FPC is the umbrella entity that can
access the police force and their
dependents at the national and regional
levels.
4. FPC is mandated by the Federal
Government of Ethiopia to work on
HIV/AIDS in behalf of the police force
and their dependants with international
organizations and civil societies in the
prevention and control of HIV/AIDS.
5. The Police Hospital is the only
referral hospital for the police and their
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dependants in the country playing a
leading role in providing an integrated
and comprehensive HIV/AIDS treatment
and care and serving also as a major
training center for all cadres of health
care professionals deployed at the
police force health facilities in the
country that also integrate training,
service and research.
C. Funding
Approximately $140,000 is available
in FY 2005 to fund this award on
September 15, 2005, and will be made
for a 12-month budget period within a
project period of up to five years.
Funding estimates may change.
D. Where To Obtain Additional
Information
For general comments or questions
about this announcement, contact:
Technical Information Management,
CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA
30341–4146. Telephone: 770–488–2700.
For technical questions about this
program, contact: Tadesse Wuhib, MD,
MPH, Country Director, CDC-Ethiopia,
P.O. Box 1014, Entoto Road, Addis
Ababa. Telephone: (Office) 251–1–66–
95–33; (Cell) 251–9–228543. E-mail
address: wuhibt@etcdc.com.
Dated: August 4, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–15894 Filed 8–10–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Medical Device User Fee Rates for
Fiscal Year 2006
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2006. The Federal Food, Drug, and
Cosmetic Act (the act), as amended by
the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
and the Medical Device User Fee
Stabilization Act of 2005 (MDUFSA),
authorizes FDA to collect user fees for
certain medical device applications. The
FY 2006 fee rates are provided in this
notice. For all applications submitted on
or after October 1, 2005, and through
September 30, 2006, fees must be paid
E:\FR\FM\11AUN1.SGM
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Agencies
[Federal Register Volume 70, Number 154 (Thursday, August 11, 2005)]
[Notices]
[Pages 46866-46872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15893]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Strengthen HIV/AIDS Prevention, Care, and Treatment Services for
Infants of HIV Positive Mothers in the Republic of Haiti Through
Provision of Improved Pediatric HIV/AIDS Laboratory Diagnosis
Announcement Type: New.
Funding Opportunity Number: RFA AA178.
Catalog of Federal Domestic Assistance Number: 93.067.
Key Dates:
Application Deadline: September 6, 2005.
I. Funding Opportunity Description
Authority: This program is authorized under Sections 301(a) and
307 of the Public Health Service Act [42 U.S.C. Sections 241 and
242l], as amended, and under Public Law 108-25 (United States
Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003)
[22 U.S.C. 7601].
Background: President Bush's Emergency Plan for AIDS Relief (The
Emergency Plan) has called for immediate, comprehensive and evidence-
based action to turn the tide of global HIV/AIDS. The initiative aims
to prevent at least seven million new HIV infections by 2010; to treat
more than two million people with effective combination anti-retroviral
therapy by 2008; and to provide care for ten million HIV-infected and
affected persons, including those orphaned by HIV/AIDS, by 2008, with a
focus on 15 priority countries. The five-year strategy for the
Emergency Plan is available at the following Internet address: https://
www.state.gov/s/gac/rl/or/c11652.htm.
Under the leadership of the U.S. Global AIDS Coordinator, as part
of the President's Emergency Plan, the U.S. Department of Health and
Human Services (HHS) works with host countries and other key partners
to assess the needs of each country and
[[Page 46867]]
design a customized program of assistance that fits within the host
nation's strategic plan.
An essential element of preventing new cases of HIV is to ensure
that high-risk groups have adequate access to screening, treatment, and
care facilities. Haiti's HIV prevalence rate in adults is reported to
be 5.6 percent, according to the Joint United Nations Programme on HIV/
AIDS (UNAIDS) 2004 Annual Report. Access to prevention and treatment is
limited to the Haitian population because of the underdeveloped public
health infrastructure and lack of clinical capacity.
Haiti's Central Plateau region is a rural area northeast of the
capital, Port-au-Prince. Years of neglect and ill-conceived engineering
projects have left the region's population largely destitute and
reliant on largely subsistence farming for survival. Access to this
region is difficult due to the poor transportation infrastructure.
These social, economic and physical barriers have prevented significant
numbers of Haitian non-governmental organizations from emerging and
offering services in the Central Plateau.
Purpose: The purpose of this funding announcement is to
progressively build an indigenous, sustainable response to the national
HIV epidemic through the rapid expansion of innovative, culturally
appropriate, high-quality HIV/AIDS prevention and care interventions.
In Haiti, Emergency Plan goals include treatment of at least 25,000
HIV-infected individuals and care for 125,000 HIV-infected and affected
individuals, including orphans.
Measurable outcomes of the program will be in alignment with the
numerical performance goals of the President's Emergency Plan and one
(or more) of the following performance goal(s) for the National Center
for HIV, sexually transmitted diseases and Tuberculosis Prevention of
the Centers for Disease Control and Prevention (CDC) within the U.S.
Department of Health and Human Services (HHS): Increase the proportion
of HIV-infected people who are linked to appropriate prevention, care
and treatment services; strengthen the capacity nationwide to monitor
the epidemic; develop and implement effective HIV prevention
interventions; and evaluate prevention programs.
This announcement is only for non-research activities supported by
HHS. If an applicant proposes research, we will not review the
application. For the definition of research, please see the HHS/CDC web
site at the following Internet address: https://www.cdc.gov/od/ads/
opspoll1.htm
Activities: The awardee will either implement activities directly
or will implement them through its subgrantees and/or subcontractors;
the awardee will retain overall financial and programmatic management
under the oversight of HHS/CDC and the strategic direction of the
Office of the Global AIDS Coordinator. The awardee must show a
measurable progressive reinforcement of the capacity of indigenous
organizations and local communities to respond to the national HIV
epidemic, as well as progress towards the sustainability of activities.
Applicants should describe activities in detail as part of a four-
year action plan (U.S. Government Fiscal Years 2005-2008 inclusive)
that reflects the policies and goals outlined in the five-year strategy
for the President's Emergency Plan.
HHS/CDC, under the guidance of the U.S. Global AIDS Coordinator,
will approve funds on an annual basis, based on documented performance
toward achieving Emergency Plan goals, as part of the annual Emergency
Plan for AIDS Relief Country Operational Plan review and approval
process.
This program announcement seeks proposals from Haitian
organizations to strengthen and expand pediatric testing and diagnosis
for infants of HIV-positive mothers. The funding through this
cooperative agreement will establish and provide ongoing and effective
pediatric HIV/AIDS testing and diagnosis and strengthen laboratory
support services and personnel integral in reducing the incidence of
pediatric HIV/AIDS in Haiti. Program proposals should include program
strategies that address the following activities:
1. Provide pediatric testing and diagnosis to infants.
2. Strengthen laboratory services to support pediatric diagnosis
and treatment, and build capacity in lab personnel internally and
within the HIV/AIDS service-delivery network.
3. Record and report sample collection results regularly.
4. Reduce the incidence of pediatric HIV/AIDS through partnering
with prevention of mother-to-child transmission (PMTCT) linkages to
ensure access to pediatric HIV/AIDS information and care.
5. Expand services and transfer pediatric diagnostic testing
technology to other sites.
6. Administer anti-retroviral (ARV) treatment in adherence with
Department of Health and Human Services (HHS) guidelines.
7. Provide basic laboratory services in support of pediatric HIV/
AIDS diagnosis and treatment.
1. Perform CD4 counts.
2. Perform complete blood counts.
3. Perform HIV rapid testing.
4. Perform confirmatory HIV/AIDS testing.
8. Provide post-test counseling, care, and other social services,
as needed by the newborn.
9. Provide appropriate referrals to ensure that HIV-infected
pregnant women receive care for their own health, and to prevent HIV
transmission to their babies.
10. Provide referrals to appropriate prevention ,\1\ treatment,
care and support services.
---------------------------------------------------------------------------
\1\ Prevention interventions directed toward behavior change
should promote the ABC model. Methods and strategies should
emphasize abstinence for youth and other unmarried persons, mutual
faithfulness and partner reduction for sexually active adults, and
correct and consistent use of condoms by those populations who are
engaged in high-risk behaviors. Behaviors that increase risk for HIV
transmission include: engaging in casual sexual encounters, engaging
in sex in exchange for money or favors, having sex with an HIV-
positive partner or one whose status is unknown, using drugs or
abusing alcohol in the context of sexual interactions, and using
intravenous drugs. Women, even if faithful themselves, can still be
at risk of becoming infected by their spouse, regular male partner,
or someone using force against them. Other high-risk persons or
groups include men who have sex with men and workers who are
employed away from home. Awardees may not implement condom social
marketing without also implementing the abstinence and faithfulness
behavior-change interventions outlined above.
---------------------------------------------------------------------------
11. Implement monitoring and evaluation strategies, assessing:
1. Number of infants tested.
2. Number of infants receiving treatment and follow-up.
3. Number of technical assists provided to other lab sites.
12. Work to link activities described here with related HIV care
and other social services in the area, and promote coordination at all
levels, including through bodies such as village, district, regional
and national HIV coordination committees and networks of faith-based
organizations.
13. Participate in relevant national technical coordination
committees and in national process(es) to define, implement and monitor
simplified small grants program(s)for faith- and community-based
organizations, to ensure local stakeholders receive adequate
information and assistance to engage and access effectively funding
opportunities supported by the President's Emergency Plan and other
donors.
14. Progressively reinforce the capacity of faith- and community-
based organizations and village and district AIDS committees to promote
quality, local ownership, accountability and sustainability of
activities.
[[Page 46868]]
15. Develop and implement a project-specific participatory
monitoring and evaluation plan by drawing on national and U.S.
Government requirements and tools, including the strategic information
guidance provided by the Office of the U.S. Global AIDS Coordinator.
Administration: Comply with all HHS management requirements for
meeting participation and progress and financial reporting for this
cooperative agreement. (See HHS Activities and Reporting sections below
for details.) Comply with all policy directives established by the
Office of the U.S. Global AIDS Coordinator.
In a cooperative agreement, HHS staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
HHS Activities for this program are as follows:
1. Organize an orientation meeting with the awardee to brief them
on applicable U.S. Government, HHS, and Emergency Plan expectations,
regulations and key management requirements, as well as report formats
and contents. The orientation could include meetings with staff from
HHS agencies and the Office of the U.S. Global AIDS Coordinator.
2. Review and approve the process used by the awardee to select key
personnel and/or post-award subcontractors and/or subgrantees to be
involved in the activities performed under this agreement, as part of
the Emergency Plan for AIDS Relief Country Operational Plan review and
approval process, managed by the Office of the U.S. Global AIDS
Coordinator.
3. Review and approve awardee's annual work plan and detailed
budget, as part of the Emergency Plan for AIDS Relief Country
Operational Plan review and approval process, managed by the Office of
the U.S. Global AIDS Coordinator.
4. Review and approve awardee's monitoring and evaluation plan,
including for compliance with the strategic information guidance
established by the Office of the U.S. Global AIDS Coordinator.
5. Meet on a monthly basis with awardee to assess monthly
expenditures in relation to approved work plan and modify plans as
necessary.
6. Meet on a quarterly basis with awardee to assess quarterly
technical and financial progress reports and modify plans as necessary.
7. Meet on an annual basis with awardee to review annual progress
report for each U.S. Government Fiscal Year, and to review annual work
plans and budgets for subsequent year, as part of the Emergency Plan
for AIDS Relief review and approval process for Country Operational
Plans, managed by the Office of the U.S. Global AIDS Coordinator.
8. Support an electronic medical record (EMR) database system;
provide and support a surveillance database system.
9. Provide and install of hardware necessary for the use of
database systems.
10. Assist in organizing regional meetings.
11. Provide technical laboratory consultations to support all
activities related to pediatric diagnosis.
12. Provision of laboratory consultations to pediatric diagnosis
and coordination of this project.
II. Award Information
Type of Award: Cooperative Agreement.
HHS involvement in this program is listed in the Activities Section
above.
Fiscal Year Funds: 2005.
Approximate Total Funding: $1,000,000 (This amount is an estimate,
and is subject to availability of funds.).
Approximate Number of Awards: One.
Approximate Average Award: $200,000 (This amount is for the first
12-month budget period, and includes direct costs.).
Floor of Award Range: $200,000.
Ceiling of Award Range: $200,000.
Anticipated Award Date: September 15, 2005.
Budget Period Length: 12 months.
Project Period Length: Five years.
Throughout the project period, HHS'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, through the Emergency Plan for AIDS
Relief review and approval process for Country Operational Plans,
managed by the Office of the U.S. Global AIDS Coordinator.
III. Eligibility Information
III.1. Eligible Applicants
Eligible applicants must:
Be private, non-profit organizations, indigenous to Haiti,
and may be faith-based organizations.
Have between three to five years of experience in HIV/AIDS
pediatric diagnosis and testing.
Currently work in HIV/AIDS care in the Central Plateau
Region of Haiti.
Already be integrated into the Haitian national HIV/AIDS
program.
III.2. Cost-Sharing or Matching
Matching funds are not required for this program.
III.3. Other
If applicants request a funding amount greater than the ceiling of
the award range, HHS/CDC will consider the application non-responsive,
and it will not enter into the review process. We will notify you that
your application did not meet the submission requirements.
Special Requirements: If your application is incomplete or non-
responsive to the special requirements listed in this section, it will
not enter into the review process. We will notify you that your
application did not meet submission requirements.
HHS/CDC will consider late applications 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.
IV. Application and Submission Information
IV.1. Address to Request Application Package
To apply for this funding opportunity use application form PHS
5161-1.
Electronic Submission: HHS strongly encourages the applicant to
submit the application electronically by using 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 HHS/CDC web site, at the following Internet address: https://
www.cdc.gov/od/pgo/forminfo.htm.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the HHS/CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. We can mail application forms to you.
IV.2. Content and Form of Submission
Application: You must submit a project narrative with your
application
[[Page 46869]]
forms. You must submit the narrative in the following format:
Maximum number of pages: 30. If your narrative exceeds the
page limit, only the first pages which are within the page limit will
be reviewed.
Font size: 12 point unreduced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page.
Held together only by rubber bands or metal clips; not
bound in any other way.
Submitted in English.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
Executive Summary: Provide a clear and concise summary of
the proposed goals, major objectives and activities required for
achievement of program goals, and amount of funding requested for
budget year one of this cooperative agreement.
Project Context and Background (Understanding and Need)
Project Strategy--Description and Methodologies
Project Goals
Project Outputs
Project Contribution to the Goals and Objectives of the
Emergency Plan for AIDS Relief
Work Plan and Description of Project Components and
Activities
Performance Measures
Timeline (e.g., GANNT Chart)
Management of Project Funds and Reporting.
You may include additional information in the application
appendices. The appendices will not count toward the narrative page
limit. This additional information includes the following:
Budget Justification (only for Year 01)
Curricula Vitae
Organizational Charts
Letters of Support
You must have a Dun and Bradstreet Data Universal Numbering System
(DUNS) number to apply for a grant or cooperative agreement from the
Federal government. The DUNS number is a nine-digit identification
number, which uniquely identifies business entities. Obtaining a DUNS
number is easy and there is no charge. To obtain a DUNS number, access
https://www.dunandbradstreet.com or call 1-866-705-5711. For more
information, see the HHS/CDC web site at: https://www.cdc.gov/od/pgo/
funding/grantmain.htm. If your application form does not have a DUNS
number field, please write your DUNS number at the top of the first
page of your application, and/or include your DUNS number in your
application cover letter.
Additional requirements that could 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
Application Deadline Date: September 6, 2005.
Explanation of Deadlines: Applications must be received in the HHS/
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. We consider applications completed on-line through
Grants.gov as formally submitted when the applicant organization's
Authorizing Official electronically submits the application to https://
www.grants.gov. We will consider electronic applications as having met
the deadline if the applicant organization's Authorizing Official has
submitted the application electronically 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
HHS/CDC receives the application.
If you submit your application by the United States Postal Service
or commercial delivery service, you must ensure the carrier will be
able to guarantee delivery by the closing date and time. If HHS/CDC
receives your submission after closing because of: (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 have the opportunity to submit documentation of the
carrier's guarantee. If the documentation verifies a carrier problem,
HHS/CDC will consider the submission as received by the deadline.
If a hard copy application is submitted, HHS/CDC will not notify
you upon receipt of your submission. 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 submission deadline.
This will allow time for us to process and log submissions.
This announcement is the definitive guide on application content,
submission address, and deadline. It supersedes information provided in
the application instructions. If your submission does not meet the
deadline above, it will not be eligible for review, and we will discard
it. We will notify you that you did not meet the submission
requirements.
IV.4. Intergovernmental Review of Applications
Executive Order 12372 does not apply to this program.
IV.5. Funding Restrictions
Restrictions, which you must take into account while writing your
budget, are as follows:
Funds may not be used for research.
Reimbursement of pre-award costs is not allowed.
Funds may be spent for reasonable program purposes,
including personnel, travel, supplies, and services. Equipment may be
purchased if deemed necessary to accomplish program objectives;
however, prior approval by HHS/CDC officials must be requested in
writing.
All requests for funds contained in the budget shall be
stated in U.S. dollars. Once an award is made, HHS/CDC will not
compensate foreign grantees for currency exchange fluctuations through
the issuance of supplemental awards.
The costs that are generally allowable in grants to
domestic organizations are allowable to foreign institutions and
international organizations, with the following exception: With the
exception of the American University, Beirut and the World Health
Organization, Indirect Costs will not be paid (either directly or
through sub-award) to organizations located outside the territorial
limits of the United States or to international organizations
regardless of their location.
The applicant may contract with other organizations under
this program; however, the applicant must perform a substantial portion
of the activities (including program management and operations, and
delivery of prevention services for which funds are required).
You must obtain annual audit of these HHS/CDC funds
(program-specific audit) by a U.S.-based audit firm with international
branches and current licensure/authority in-country, and in accordance
with International Accounting Standards or equivalent standard(s)
approved in writing by HHS/CDC.
A fiscal Recipient Capability Assessment may be required,
prior to or post award, in order to review the
[[Page 46870]]
applicant's business management and fiscal capabilities regarding the
handling of U.S. Federal funds.
Funds received from this announcement will not be used for
the purchase of anti-retroviral drugs for treatment of established HIV
infection, with the exception of nevirapine in PMTCT cases and with
prior written approval, occupational exposures, and non-occupational
exposures and will not be used for the purchase of machines and
reagents to conduct the necessary laboratory monitoring for patient
care.
No funds appropriated under this act shall be used to
carry out any program of distributing sterile needles or syringes for
the hypodermic injection of any illegal drug.
Prostitution and Related Activities
The U.S. Government is opposed to prostitution and related
activities, which are inherently harmful and dehumanizing, and
contribute to the phenomenon of trafficking in persons.
Any entity that receives, directly or indirectly, U.S. Government
funds in connection with this document (``recipient'') cannot use such
U.S. Government funds to promote or advocate the legalization or
practice of prostitution or sex trafficking. Nothing in the preceding
sentence shall be construed to preclude the provision to individuals of
palliative care, treatment, or post-exposure pharmaceutical
prophylaxis, and necessary pharmaceuticals and commodities, including
test kits, condoms, and, when proven effective, microbicides.
A recipient that is otherwise eligible to receive funds in
connection with this document to prevent, treat, or monitor HIV/AIDS
shall not be required to endorse or utilize a multisectoral approach to
combating HIV/AIDS, or to endorse, utilize, or participate in a
prevention method or treatment program to which the recipient has a
religious or moral objection. Any information provided by recipients
about the use of condoms as part of projects or activities that are
funded in connection with this document shall be medically accurate and
shall include the public health benefits and failure rates of such use.
In addition, any recipient must have a policy explicitly opposing
prostitution and sex trafficking. The preceding sentence shall not
apply to any ``exempt organizations'' (defined as the Global Fund to
Fight AIDS, Tuberculosis and Malaria, the World Health Organization and
its six Regional Offices, the International AIDS Vaccine Initiative or
to any United Nations agency).
The following definition applies for purposes of this clause:
Sex trafficking means the recruitment, harboring,
transportation, provision, or obtaining of a person for the purpose of
a commercial sex act. 22 U.S.C. 7102(9).
All recipients must insert provisions implementing the applicable
parts of this section, ``Prostitution and Related Activities,'' in all
subagreements under this award. These provisions must be express terms
and conditions of the subagreement, must acknowledge that compliance
with this section, ``Prostitution and Related Activities,'' is a
prerequisite to receipt and expenditure of U.S. government funds in
connection with this document, and must acknowledge that any violation
of the provisions shall be grounds for unilateral termination of the
agreement prior to the end of its term. Recipients must agree that HHS
may, at any reasonable time, inspect the documents and materials
maintained or prepared by the recipient in the usual course of its
operations that relate to the organization's compliance with this
section, ``Prostitution and Related Activities.''
All prime recipients that receive U.S. Government funds (``prime
recipients'') in connection with this document must certify compliance
prior to actual receipt of such funds in a written statement that makes
reference to this document (e.g., ``[Prime recipient's name] certifies
compliance with the section, `Prostitution and Related Activities.' '')
addressed to the agency's grants officer. Such certifications by prime
recipients are prerequisites to the payment of any U.S. Government
funds in connection with this document.
Recipients' compliance with this section, ``Prostitution and
Related Activities,'' is an express term and condition of receiving
U.S. Government funds in connection with this document, and any
violation of it shall be grounds for unilateral termination by HHS of
the agreement with HHS in connection with this document prior to the
end of its term. The recipient shall refund to HHS the entire amount
furnished in connection with this document in the event HHS determines
the recipient has not complied with this section, ``Prostitution and
Related Activities.''
You can find guidance for completing your budget on the HHS/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: HHS/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. We
will not accept e-mail submissions. If the applicant has technical
difficulties in Grants.gov, the applicant can reach customer service 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.
HHS/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. We must receive any such paper submission in accordance
with the requirements for timely submission detailed in Section IV.3.
of the grant announcement. You must clearly mark the paper submission:
``BACK-UP FOR ELECTRONIC SUBMISSION.''
The paper submission must conform to all requirements for non-
electronic submissions. If we receive both electronic and back-up paper
submissions by the deadline, we will consider the electronic version
the official submission.
We strongly recommend that the applicant submit the grant
application by using Microsoft Word, Microsoft Excel, etc.). If the
applicant does not have access to Microsoft Office products, you may
submit a PDF file. Directions for creating PDF files can be found on
the Grants.gov Web site. Use of file formats other than Microsoft
Office or PDF could make the file unreadable for our staff.
or
Paper Submission: Submit the original and two hard copies of your
application by mail or express delivery service to the following
address: Technical Information Management-AA178, CDC Procurement and
Grants Office, U.S. Department of Health and Human Services, 2920
Brandywine Road, Atlanta, GA 30341.
V. Application Review Information
V.1. Criteria
Applicants must provide measures of effectiveness that will
demonstrate the accomplishment of the various identified objectives of
the cooperative
[[Page 46871]]
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. Applicants must submit these measures of effectiveness with
the application and they will be an element of evaluation.
We will evaluate your application against the following criteria:
1. Need (20 Points) To what extent does the applicant justify the
need for this program within the target community?
2. Plan (20 Points) Does the applicant display knowledge of the
five-year strategy and goals of the President's Emergency Plan, such
that it can build on these to develop a comprehensive, collaborative
project to reach underserved populations? Does the applicant describe
strategies that are pertinent and match those identified in the five-
year strategy of the President's Emergency Plan and describe activities
that are evidence-based, realistic, achievable, measurable and
culturally appropriate in Haiti? Is the plan appropriate to the social,
political and cultural context in Haiti? 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?
3. Monitoring Evaluation and Reporting (20 points) Does the
applicant have a system for reviewing and adjusting program activities
based on monitoring information? Applicants must develop indicators for
each program milestone and incorporate them into the periodic financial
and programmatic reports. Applicants must draw all indicators from the
President's Emergency Plan for AIDS Relief Indicator Guide, and be
consistent with the guidance established by the Office of the U.S.
Global AIDS Coordinator. Applicants must generate periodic financial
and program reports to show disbursement of funds and progress towards
achieving program objectives.
4. Methods (15 Points).
Are the proposed methods feasible? To what extent will they
accomplish the program goals?
5. Management and Personnel (15 Points).
Do the staff members have appropriate experience? Are the staff
roles clearly defined? As described, will the staff be sufficient to
accomplish the program goals? Is there a plan to manage the resources
of the program, prepare reports, monitor and evaluate activities and
audit expenditures?
6. Eligibility (10 points).
Organizations indigenous to Haiti must have between three to five
years of experience in HIV/AIDS pediatric diagnosis and testing, must
currently work in HIV/AIDS care in the Central Plateau, and must be
integrated into the Haitian national HIV/AIDS program.
7. Budget and Justification (Reviewed, but not scored) Is the
itemized budget for conducting the project, along with justification,
reasonable and consistent with the five-year strategy and goals of the
President's Emergency Plan, Emergency Plan activities in Haiti, and the
National Haitian HIV/AIDS program?
V.2. Review and Selection Process
The HHS/CDC Procurement and Grants Office (PGO) staff will review
applications for completeness, and HHS Global AIDS program will review
them for responsiveness. Incomplete applications and applications that
are non-responsive to the eligibility criteria will not advance through
the review process. Applicants will receive notification 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. All persons who serve on the panel will be external to
the U.S. Government Country Program Office. The panel may include both
Federal and non-Federal participants.
Applications will be funded in order by score and rank determined
by the review panel. HHS/CDC will provide justification for any
decision to fund out of rank order.
In addition, the following factors could affect the funding
decision:
Maintaining geographic diversity
Preference to organizations in certain geographic areas
HHS/CDC will provide justification for any decision to fund out of
rank order.
V.3. Anticipated Announcement and Award Dates
September 15, 2005
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the
HHS/CDC Procurement and Grants Office. The NoA shall be the only
binding, authorizing document between the recipient and HHS/CDC. An
authorized Grants Management Officer will sign the NoA, and mail it 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: https://www.access.gpo.gov/nara/cfr/cfr-table-search.html
The following additional requirements apply to this project:
AR-4 HIV/AIDS Confidentiality Provisions
AR-10 Smoke-Free Workplace Requirements
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements
Applicants can find additional information on these requirements on
the HHS/CDC web site at the following Internet address: https://
www.cdc.gov/od/pgo/funding/ARs.htm.
You need to include an additional Certifications form from the PHS
5161-1 application in your Grants.gov electronic submission only.
Please refer to https://www.cdc.gov/od/pgo/funding/PHS5161-1-
Certificates.pdf. Once you have filled out the form, please attach it
to the Grants.gov submission as Other Attachment Forms.
VI.3. Reporting Requirements
You must provide HHS/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 budget period. The progress report will serve as your non-
competing continuation application, and must contain the following
elements:
a. Current Budget Period Activities and Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activities and Objectives.
d. Budget and budget narrative with justification.
e. Measures of Effectiveness, including progress against the
numerical goals of the President's Emergency Plan for AIDS Relief for
Haiti.
f. Additional Information.
2. Annual reports are due within 30 days of the end of the budget
period. The report should detail progress toward achieving program
milestones and projected next year activities. Indicators must be
developed for each program milestone and incorporated
[[Page 46872]]
into the annual financial and programmatic reports. All indicators need
to be drawn from the Emergency Plan.
3. Financial status report, no more than 90 days after the end of
the budget period. The financial report must show obligations,
disbursements and funds remaining by program activity. Indicators must
be developed for each program milestone and incorporated into the
periodic financial and programmatic reports. All indicators need to be
drawn from The Emergency Plan Indicator Guide.
4. Final performance reports, no more than 90 days after the end of
the project period.
Recipients must mail these reports to the Grants Management or
Contract Specialist listed in the ``Agency Contacts'' section of this
announcement.
VII. Agency Contacts
We encourage inquiries concerning this announcement. For general
questions, contact: Technical Information Management Section, CDC
Procurement and Grants Office, U.S. Department of Health and Human
Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-
2700.
For program technical assistance, contact: Kathy Grooms, Project
Officer, Global AIDS Program, HHS/CDC National Center for HIV, STD, and
TB Prevention, 1600 Clifton Road, Mailstop E-04, Atlanta, GA 30333.
Telephone: 404-639-8394.
For financial, grants management, or budget assistance, contact:
Vivian Walker, Grants Management Specialist, CDC Procurement and Grants
Office, U.S. Department of Health and Human Services, 2920 Brandywine
Road, Atlanta, GA 30341. Telephone: 770-488-2724. E-mail:
vwalker@cdc.gov.
VIII. Other Information
Applicants can find this and other HHS/CDC funding opportunity
announcements on the HHS/CDC web site, Internet address: https://
www.cdc.gov (Click on ``Funding,'' then ``Grants and Cooperative
Agreements''), and on the web site of the HHS Office of Global Health
Affairs, Internet address: https://www.globalhealth.gov.
Dated: August 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention, U.S. Department of Health and Human Services.
[FR Doc. 05-15893 Filed 8-10-05; 8:45 am]
BILLING CODE 4163-18-P