Enhancement of Laboratory Quality System Approach in Building the Capacity of Health Laboratories To Support HIV/AIDS Prevention, Care and Treatment Services in the United Republic of Tanzania, 53224-53229 [05-17679]
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Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices
V.3. Anticipated Announcement and
Award Dates
October 30, 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 as Appropriate
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–12 Lobbying Restrictions
• AR–14 Accounting System
Requirements
• AR–15 Proof of Non-Profit Status
• AR–23 States and Faith Based
Organization
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/
PHS5161–11Certificates.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:
1. In year one, quarterly progress
reports, due 30 days after the end of
each quarter. In subsequent years, a
semi-annual progress report is required
no later than 30 days after the reporting
period.
2. Interim progress report, no less
than 90 days before the end of the
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budget period. The progress report will
serve as the 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,
including progress against the
numerical goals of the President’s
Emergency Plan for AIDS Relief for
Southern Sudan.
f. Additional Requested Information.
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.
5. 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 Southern Sudan.
Recipients must mail these reports to
the Grants Management or Contract
Specialist listed in the ‘‘Agency
Contacts’’ section of this announcement.
Web site of the HHS Office of Global
Health Affairs, Internet address:
www.globalhealth.gov.
VII. Agency Contacts
I. Funding Opportunity Description
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: Thomas Boo, Medical Officer,
GAP, CDC-Kenya, Centers for Disease
Control and Prevention, HHS/CDC
Global AIDS Program, P.O. Box 606
Village Market, 00621 Nairobi, Kenya.
Telephone: 254–20–271–3008, ext. 149
or Mobile: +254–722–200–189. E-mail:
tboo@ke.cdc.gov.
For financial, grants management, or
budget assistance, contact: Diane
Flournoy, Grants Management
Specialist, CDC Procurement and Grants
Office, U.S. Department of Health and
Human Services, 2920 Brandywine
Road, Atlanta, GA 30341. Telephone:
770–488–2072. E-mail: dmf6@cdc.gov.
Authority: This program is authorized
under Sections 301(a) and 307 of the Public
Health Service Act [42 U.S.C. 241 and 242l],
as amended, and under Public Law 108–25
(United States Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003)
[U.S.C. 7601].
VIII. Other Information
Applicants can find this and other
HHS funding opportunity
announcements on the HHS/CDC Web
site, Internet address: www.cdc.gov
(Click on ‘‘Funding’’ then ‘‘Grants and
Cooperative Agreements’’), and on the
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Dated: August 31, 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. 05–17678 Filed 9–6–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Enhancement of Laboratory Quality
System Approach in Building the
Capacity of Health Laboratories To
Support HIV/AIDS Prevention, Care
and Treatment Services in the United
Republic of Tanzania
Announcement Type: New.
Funding Opportunity Number: CDC–
RFA–AA086.
Catalog of Federal Domestic
Assistance Number: 93.067.
Key Date: Application Deadline:
October 3, 2005.
Background: President Bush’s
Emergency Plan for AIDS Relief has
called for immediate, comprehensive
and evidence-based action to turn the
tide of global HIV/AIDS.
The initiative aims to treat more than
two million HIV-infected people with
effective combination anti-retroviral
therapy by 2008; care for ten million
HIV-infected and affected persons,
including those orphaned by HIV/AIDS,
by 2008; and prevent seven million
infections by 2010, with a focus on 15
priority countries, including 12 in subSaharan Africa. 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.
Over the same time period, as part of
a collective national response, the
Emergency Plan goals specific to
Tanzania are to treat at least 150,000
HIV-infected individuals, and care for
750,000 HIV-affected individuals,
including orphans.
Purpose: The purpose of this
cooperative agreement is to collaborate
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with the National Institute for Medical
Research (NIMR), and the Tanzanian
Ministry of Health (MOH) to establish
the National Laboratory Quality
Assurance and Training Center that
will: (1) Provide leadership in HIV/
AIDS related laboratory training; and (2)
provide technical assistance and
leadership in assuring highly functional
and operational testing systems, and
assuring quality systems integration, in
building the capacity of health
laboratories to support HIV/AIDS
prevention, care and treatment in the
United Republic of Tanzania.
Measurable outcomes of the program
will be in alignment with the
performance goals of the President’s
Emergency Plan and with 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): By 2010, work
with other countries, international
organizations, the Department of State,
United States Agency for International
Development (USAID), and other
partners to achieve the United Nations
General Assembly Special Session on
HIV/AIDS goal of reducing prevalence
among young persons 15 to 24 years of
age, reducing HIV transmission, and
improving care of persons living with
HIV/AIDS (PLWHA).
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.
The grantee will produce an annual
operational plan in the context of this
four-year plan, which the U.S.
Government Emergency Plan team on
the ground in Tanzania will review as
part of the annual Emergency Plan for
AIDS Relief Country Operational Plan
review and approval process managed
by the Office of the U.S. Global AIDS
Coordinator. HHS/CDC, under the
guidance of the U.S. Global AIDS
Coordinator, will approve funds for
activities 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.
Awardee activities for this program
are as follows:
1. Provide leadership in HIV/AIDSrelated laboratory training:
a. Develop training materials
(including doing educational design) for
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local training and at the peripheral
levels.
b. Deliver training in HIV/AIDSrelated testing and testing-specific
quality assurance.
c. Train trainers in a laboratoryquality systems approach.
d. Serve as a central area for receiving
and delivering distance-based training
(e.g., satellite- and Internet-based
training).
e. Serve as liaison with international
training efforts with the goal of
producing standardized, harmonized
curricula.
2. Provide technical assistance and
leadership in assuring highly functional
and operational testing systems, and
assuring quality systems integration, in
building the capacity of health
laboratories to support HIV/AIDS
prevention, care and treatment:
a. Provide assistance and leadership
in the development of standard
operating procedures for quality system
components (for example: Sample
management; process control; and
information management).
b. Serve as the primary resource for
receipt of, and knowledge transfer of,
international standards and guidelines
for quality systems, such as those from
the International Organization for
Standardization (IOS) and the U.S.
National Committee for Clinical
Laboratory Standards (NCCLS).
c. Provide technical assistance and
coordination support for external
quality-assessment (proficiency testing)
programs.
3. Serve as a supra-reference
laboratory for HIV-related Testing in
Tanzania:
a. Evaluate, provide and assist, when
needed, with technology transfer for
new diagnostic tests, diagnostic testing
algorithms, tests to stage disease and
monitor immune function, and tests for
anti-retroviral resistance.
b. Serve as the ultimate referral
laboratory in Tanzania for samples that
present unusual or unique testing.
In a cooperative agreement, HHS staff
is substantially involved in the program
activities, above and beyond routine
grant monitoring.
CDC Activities for this program are as
follows:
1. Collaborate with the applicant, the
Tanzania MOH and other in-country
and international partners, in the
development of plans for program
assistance based on the country needs,
the HHS technical assistance portfolio,
and HIV laboratory activities conducted
by other partners.
2. Provide consultation and scientific
and technical assistance based on the
‘‘CDC Global AIDS Program (GAP)
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Technical Strategies’’ document to
promote the use of best practices known
at the time.
3. Facilitate in-country planning and
review meetings for the purpose of
ensuring coordination of country-based
program technical assistance activities.
HHS will act as liaison and assist in
coordinating activities, as required,
between the applicant and other nongovernmental organizations (NGOs), the
Government of the United Republic of
Tanzania, and other Emergency Plan
partners.
Either HHS staff or staff from
organizations that have successfully
competed for funding under a separate
HHS contract, cooperative agreement or
grant will provide technical assistance
and training.
This announcement is only for nonresearch activities supported by HHS/
CDC. If an applicant proposes research
activities, HHS 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.
II. Award Information
Type of Award: Cooperative
Agreement.
HHS involvement in this program is
listed in the Activities Section above.
Fiscal Year Funds: 2006.
Approximate Total Funding:
$3,600,000. (This amount is an estimate
for the entire project period, and is
subject to availability of funds.)
Approximate Number of Awards:
Two.
Approximate Average Award:
$450,000. (This amount is for the first
12-month budget period, and includes
indirect costs.)
Floor of Award Range: None.
Ceiling of Award Range: $600,000.
(This ceiling is for the first 12-month
budget period.)
Anticipated Award Date: October 30,
2005.
Budget Period Length: 12 months.
Project Period Length: Four years.
Throughout the project period, HHS’
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.
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III. Eligibility Information
III.1. Eligible Applicants
Applications may be submitted by:
• Public nonprofit organizations.
• Private nonprofit organizations.
• Universities.
• Colleges.
• For profit organizations.
• Small, minority, women-owned
businesses.
• Community-based organizations.
• Research institutions.
• Hospitals.
• Faith-based organizations.
• Federally recognized Indian tribal
governments.
• Indian tribes.
• Indian tribal organizations.
• State and local governments or their
Bona Fide Agents (this includes the
District of Columbia, the
Commonwealth of Puerto Rico, the
Virgin Islands, the Commonwealth of
the Northern Mariana Islands, American
Samoa, Guam, the Federated States of
Micronesia, the Republic of the
Marshall Islands, and the Republic of
Palau).
• Political subdivisions of States (in
consultation with States).
In addition, applicants must meet the
criteria listed below:
• Be local indigenous to Tanzania.
• Have at least three years of
documented HIV/AIDS related program
implementation experience in Tanzania
particularly related laboratory training
and lab quality assurance.
• Provide letters of support from the
Tanzania Ministry of Health and the
National Institute for Medical Research
as evidence of having established
working relationships that can build
upon an existing framework.
III.2. Cost Sharing or Matching Funds
Matching funds are not required for
this program. Although matching funds
are not required, preference will go to
organizations that can leverage
additional funds to contribute to
program goals.
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.
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• 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 a grant, loan, or an award.
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 you to submit your
application electronically by using the
forms and instructions posted for this
announcement on 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: 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, 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
forms. You must submit the narrative in
the following format:
• Maximum number of pages: 35. If
your narrative exceeds the page limit,
we will only review the first pages
within the page limit.
• Font size: 12 point unreduced.
• Double-spaced.
• 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.
• You MUST submit your application
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
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of program goals, the amount of funding
requested for budget year one of this
cooperative agreement, and the project’s
contribution to the Goals and Objectives
of the Emergency Plan for AIDS Relief.
• Needs Assessment and Capacity
Describe the documented need for the
proposed activities; current activities
that provide relevant experience and
expertise to perform the proposed
activities; and collaborative
relationships with other agencies and
organizations that will be involved in
the proposed activities.
• Year One Operational and
Evaluation Plan
Provide specific, measurable, and
time-phased year one objectives for each
proposed project; the specific activities
proposed to achieve the year one
objectives; and a projected timetable for
completion that displays dates for the
accomplishment of tasks and identifies
responsible parties. For each year one
objective, specify how achievement will
be measured and documented.
• Four-Year Plan
Describe realistic four-year goals and
measurable, time-phased objectives for
each proposed project; the major
activities to achieve each objective;
plans for collaboration with partners,
including the CDC; and the evaluation
process that will be used to determine
effectiveness and initiate modifications,
as needed.
• Management and Staffing Plan
Describe how the program will be
effectively managed. Include the
following:
a. Management structure, including
the lines of authority and plans for fiscal
control.
b. The staff positions responsible for
implementation of the program.
c. Qualifications and experience of
the designated staff.
• Budget and Justification
Provide a detailed 12-month budget
request and line item justification that is
consistent with the purpose of the
program and the proposed objectives
and activities. The budget must be
included within the 35 pages.
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:
• Curriculum Vitas.
• Resumes.
• 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
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nine-digit identification number, which
uniquely identifies business entities.
Obtaining a DUNS number is easy, and
there is no charge. To obtain a DUNS
number, access
www.dunandbradstreet.com or call 1–
866–705–5711.
For more information, see the 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: October 7,
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.
You may submit your applications
electronically at 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
www.grants.gov. Electronic applications
will be considered 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 you submit your application
electronically through Grants.gov, your
application will be electronically time/
date stamped, which will serve as
receipt of submission. You 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 that the carrier will be able to
guarantee delivery by the closing date
and time. If HHS/CDC receives your
submission after the closing date
because: (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 having been
received by the deadline.
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If you submit a hard copy application,
HHS/CDC will not notify you upon
receipt of the 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 the 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 not be used for any new
construction.
• Antiretroviral drugs—the purchase
of ARVs, reagents, and laboratory
equipment for antiretroviral treatment
projects requires pre-approval in writing
from HHS/CDC officials.
• Needle exchange—No funds
appropriated under this solicitation
shall be used to carry out any program
of distributing sterile needles or
syringes for the hypodermic injection of
any illegal drug.
• 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
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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 an 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 Standard(s) or equivalent
standards approved in writing by HHS/
CDC.
• A Fiscal Recipient Capability
Assessment may be required, prior to or
post award, in order to review the
applicant’s business management and
fiscal capabilities regarding the
handling of U.S. Federal funds.
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.
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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
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15:05 Sep 06, 2005
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section, ‘‘Prostitution and Related
Activities.’’
You may 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 you to submit
electronically at www.Grants.gov. The
application package can be downloaded
from www.Grants.gov. You will be 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 you are having
technical difficulties in Grants.gov,
customer service can be reached by email at support@grants.gov 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 you
submit your application to Grants.gov
early enough to resolve any
unanticipated difficulties prior to the
deadline. You may also submit a backup paper submission of your
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
with all requirements for non-electronic
submissions. If we receive both
electronic and back-up paper
submissions by the deadline, the
electronic version will be considered
the official submission.
We strongly recommend that you
submit the grant application by using
Microsoft Office products (e.g.,
Microsoft Word, Microsoft Excel, etc.). If
you do not have access to Microsoft
Office products, a PDF file may be
submitted. You may find directions for
creating PDF files on the Grants.gov
Web site. Use of file formats other than
Microsoft Office or PDF could make
your 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 ManagementAA086, CDC Procurement and Grants
Office, U.S. Department of Health and
Human Services, 2920 Brandywine
Road, Atlanta, GA 30341.
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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
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. Technical Approach (25 Points)
Does the applicant describe strategies
that are pertinent and match those
identified in the five-year strategy of the
President’s Emergency Plan and
activities that are evidence-based,
realistic, achievable, measurable and
appropriate to achieve the goals of the
Emergency Plan? Does the applicant’s
proposal include an overall design
strategy, including measurable time
lines? Does the proposal address regular
monitoring and evaluation, and the
potential effectiveness of the proposed
activities in meeting objectives?
2. Understanding of the Problem (20
Points)
Does the applicant demonstrate a
clear and concise understanding of the
nature of the problem described in the
Purpose section of this announcement?
Does the proposal specifically include a
description of the public health
importance of the planned activities to
be undertaken, and a realistic
presentation of proposed objectives and
projects?
3. Ability To Carry Out the Project (20
Points)
Does the applicant document
demonstrated capability to achieve the
purpose of the project?
4. Personnel (20 Points)
Are the professional personnel
involved in this project qualified, with
evidence of experience in working with
HIV/AIDS, opportunistic infections, and
HIV/STD surveillance?
5. Plans for Administration and
Management of Projects (15 Points)
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. Budget (Not Scored)
Is the itemized budget for conducting
the project, along with justification,
reasonable and consistent with stated
objectives, the five-year strategy and
goals of the President’s Emergency Plan
and Emergency Plan, and planned
program activities?
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.
In addition, the following factors
could affect the funding decision:
While U.S.-based organizations are
eligible to apply, we will give
preference to existing national/
Tanzanian organizations. It is possible
for one organization to apply as lead
grantee with a plan that includes
partnering with other organizations,
preferably local. Although matching
funds are not required, preference will
be go to organizations that can leverage
additional funds to contribute to
program goals.
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 may
affect the funding decision:
• Maintaining geographic diversity
V.3. Anticipated Announcement and
Award Dates
October 30, 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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15:05 Sep 06, 2005
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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–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 PHS5161–
1 application in the 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
Objectives.
b. Current Budget Period Financial
Progress.
c. New Budget Period Program
Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness,
including progress against the
numerical goals of the President’s
Emergency Plan for AIDS Relief for
Tanzania.
f. Additional Requested Information.
2. Annual progress report, due no
later than 90 days after the end of the
budget period.
3. Financial status report, due no later
than 90 days after the end of the budget
period.
4. Final financial and performance
reports, due no later than 90 days after
the end of the project period.
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53229
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: Cecil Threat, Project Officer,
Global AIDS Program, c/o American
Embassy, 2140 Dar es Salaam Place,
Washington, DC 20521–2140.
Telephone: 255 22 212 1407. Cell: 255
744 222986. Fax: 255 22 212 1462. Email: Cthreat@cdc.gov.
For financial, grants management, or
budget assistance, contact: Diane
Flournoy, Grants Management
Specialist, CDC Procurement and Grants
Office, U.S. Department of Health and
Human Services, 2920 Brandywine
Road, Atlanta, GA 30341. Telephone:
770–488–2072. E-mail: dmf6@cdc.gov.
VIII. Other Information
Applicants can find this and other
HHS funding opportunity
announcements on the HHS/CDC Web
site, Internet address: 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:
www.globalhealth.gov.
Dated: August 31, 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. 05–17679 Filed 9–6–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[ATSDR 213]
Fees for Sanitation Inspections of
Cruise Ships
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces fees
for vessel sanitation inspections for
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[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Notices]
[Pages 53224-53229]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17679]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Enhancement of Laboratory Quality System Approach in Building the
Capacity of Health Laboratories To Support HIV/AIDS Prevention, Care
and Treatment Services in the United Republic of Tanzania
Announcement Type: New.
Funding Opportunity Number: CDC-RFA-AA086.
Catalog of Federal Domestic Assistance Number: 93.067.
Key Date: Application Deadline: October 3, 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. 241 and 242l], as
amended, and under Public Law 108-25 (United States Leadership
Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [U.S.C.
7601].
Background: President Bush's Emergency Plan for AIDS Relief has
called for immediate, comprehensive and evidence-based action to turn
the tide of global HIV/AIDS.
The initiative aims to treat more than two million HIV-infected
people with effective combination anti-retroviral therapy by 2008; care
for ten million HIV-infected and affected persons, including those
orphaned by HIV/AIDS, by 2008; and prevent seven million infections by
2010, with a focus on 15 priority countries, including 12 in sub-
Saharan Africa. 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.
Over the same time period, as part of a collective national
response, the Emergency Plan goals specific to Tanzania are to treat at
least 150,000 HIV-infected individuals, and care for 750,000 HIV-
affected individuals, including orphans.
Purpose: The purpose of this cooperative agreement is to
collaborate
[[Page 53225]]
with the National Institute for Medical Research (NIMR), and the
Tanzanian Ministry of Health (MOH) to establish the National Laboratory
Quality Assurance and Training Center that will: (1) Provide leadership
in HIV/AIDS related laboratory training; and (2) provide technical
assistance and leadership in assuring highly functional and operational
testing systems, and assuring quality systems integration, in building
the capacity of health laboratories to support HIV/AIDS prevention,
care and treatment in the United Republic of Tanzania.
Measurable outcomes of the program will be in alignment with the
performance goals of the President's Emergency Plan and with 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): By 2010, work with other
countries, international organizations, the Department of State, United
States Agency for International Development (USAID), and other partners
to achieve the United Nations General Assembly Special Session on HIV/
AIDS goal of reducing prevalence among young persons 15 to 24 years of
age, reducing HIV transmission, and improving care of persons living
with HIV/AIDS (PLWHA).
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.
The grantee will produce an annual operational plan in the context
of this four-year plan, which the U.S. Government Emergency Plan team
on the ground in Tanzania will review as part of the annual Emergency
Plan for AIDS Relief Country Operational Plan review and approval
process managed by the Office of the U.S. Global AIDS Coordinator. HHS/
CDC, under the guidance of the U.S. Global AIDS Coordinator, will
approve funds for activities 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.
Awardee activities for this program are as follows:
1. Provide leadership in HIV/AIDS-related laboratory training:
a. Develop training materials (including doing educational design)
for local training and at the peripheral levels.
b. Deliver training in HIV/AIDS-related testing and testing-
specific quality assurance.
c. Train trainers in a laboratory-quality systems approach.
d. Serve as a central area for receiving and delivering distance-
based training (e.g., satellite- and Internet-based training).
e. Serve as liaison with international training efforts with the
goal of producing standardized, harmonized curricula.
2. Provide technical assistance and leadership in assuring highly
functional and operational testing systems, and assuring quality
systems integration, in building the capacity of health laboratories to
support HIV/AIDS prevention, care and treatment:
a. Provide assistance and leadership in the development of standard
operating procedures for quality system components (for example: Sample
management; process control; and information management).
b. Serve as the primary resource for receipt of, and knowledge
transfer of, international standards and guidelines for quality
systems, such as those from the International Organization for
Standardization (IOS) and the U.S. National Committee for Clinical
Laboratory Standards (NCCLS).
c. Provide technical assistance and coordination support for
external quality-assessment (proficiency testing) programs.
3. Serve as a supra-reference laboratory for HIV-related Testing in
Tanzania:
a. Evaluate, provide and assist, when needed, with technology
transfer for new diagnostic tests, diagnostic testing algorithms, tests
to stage disease and monitor immune function, and tests for anti-
retroviral resistance.
b. Serve as the ultimate referral laboratory in Tanzania for
samples that present unusual or unique testing.
In a cooperative agreement, HHS staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
1. Collaborate with the applicant, the Tanzania MOH and other in-
country and international partners, in the development of plans for
program assistance based on the country needs, the HHS technical
assistance portfolio, and HIV laboratory activities conducted by other
partners.
2. Provide consultation and scientific and technical assistance
based on the ``CDC Global AIDS Program (GAP) Technical Strategies''
document to promote the use of best practices known at the time.
3. Facilitate in-country planning and review meetings for the
purpose of ensuring coordination of country-based program technical
assistance activities. HHS will act as liaison and assist in
coordinating activities, as required, between the applicant and other
non-governmental organizations (NGOs), the Government of the United
Republic of Tanzania, and other Emergency Plan partners.
Either HHS staff or staff from organizations that have successfully
competed for funding under a separate HHS contract, cooperative
agreement or grant will provide technical assistance and training.
This announcement is only for non-research activities supported by
HHS/CDC. If an applicant proposes research activities, HHS 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.
II. Award Information
Type of Award: Cooperative Agreement.
HHS involvement in this program is listed in the Activities Section
above.
Fiscal Year Funds: 2006.
Approximate Total Funding: $3,600,000. (This amount is an estimate
for the entire project period, and is subject to availability of
funds.)
Approximate Number of Awards: Two.
Approximate Average Award: $450,000. (This amount is for the first
12-month budget period, and includes indirect costs.)
Floor of Award Range: None.
Ceiling of Award Range: $600,000. (This ceiling is for the first
12-month budget period.)
Anticipated Award Date: October 30, 2005.
Budget Period Length: 12 months.
Project Period Length: Four years.
Throughout the project period, HHS' 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.
[[Page 53226]]
III. Eligibility Information
III.1. Eligible Applicants
Applications may be submitted by:
Public nonprofit organizations.
Private nonprofit organizations.
Universities.
Colleges.
For profit organizations.
Small, minority, women-owned businesses.
Community-based organizations.
Research institutions.
Hospitals.
Faith-based organizations.
Federally recognized Indian tribal governments.
Indian tribes.
Indian tribal organizations.
State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Mariana
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the Marshall Islands, and the Republic of Palau).
Political subdivisions of States (in consultation with
States).
In addition, applicants must meet the criteria listed below:
Be local indigenous to Tanzania.
Have at least three years of documented HIV/AIDS related
program implementation experience in Tanzania particularly related
laboratory training and lab quality assurance.
Provide letters of support from the Tanzania Ministry of
Health and the National Institute for Medical Research as evidence of
having established working relationships that can build upon an
existing framework.
III.2. Cost Sharing or Matching Funds
Matching funds are not required for this program. Although matching
funds are not required, preference will go to organizations that can
leverage additional funds to contribute to program goals.
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 a grant, loan, or an
award.
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 you to submit your
application electronically by using the forms and instructions posted
for this announcement on 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:
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, 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 forms. You must submit the narrative in the following
format:
Maximum number of pages: 35. If your narrative exceeds the
page limit, we will only review the first pages within the page limit.
Font size: 12 point unreduced.
Double-spaced.
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.
You MUST submit your application 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,
the amount of funding requested for budget year one of this cooperative
agreement, and the project's contribution to the Goals and Objectives
of the Emergency Plan for AIDS Relief.
Needs Assessment and Capacity
Describe the documented need for the proposed activities; current
activities that provide relevant experience and expertise to perform
the proposed activities; and collaborative relationships with other
agencies and organizations that will be involved in the proposed
activities.
Year One Operational and Evaluation Plan
Provide specific, measurable, and time-phased year one objectives
for each proposed project; the specific activities proposed to achieve
the year one objectives; and a projected timetable for completion that
displays dates for the accomplishment of tasks and identifies
responsible parties. For each year one objective, specify how
achievement will be measured and documented.
Four-Year Plan
Describe realistic four-year goals and measurable, time-phased
objectives for each proposed project; the major activities to achieve
each objective; plans for collaboration with partners, including the
CDC; and the evaluation process that will be used to determine
effectiveness and initiate modifications, as needed.
Management and Staffing Plan
Describe how the program will be effectively managed. Include the
following:
a. Management structure, including the lines of authority and plans
for fiscal control.
b. The staff positions responsible for implementation of the
program.
c. Qualifications and experience of the designated staff.
Budget and Justification
Provide a detailed 12-month budget request and line item
justification that is consistent with the purpose of the program and
the proposed objectives and activities. The budget must be included
within the 35 pages.
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:
Curriculum Vitas.
Resumes.
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
[[Page 53227]]
nine-digit identification number, which uniquely identifies business
entities. Obtaining a DUNS number is easy, and there is no charge. To
obtain a DUNS number, access www.dunandbradstreet.com or call 1-866-
705-5711.
For more information, see the 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: October 7, 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.
You may submit your applications electronically at 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 www.grants.gov.
Electronic applications will be considered 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 you submit your application electronically through Grants.gov,
your application will be electronically time/date stamped, which will
serve as receipt of submission. You 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 that the carrier will
be able to guarantee delivery by the closing date and time. If HHS/CDC
receives your submission after the closing date because: (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 having been
received by the deadline.
If you submit a hard copy application, HHS/CDC will not notify you
upon receipt of the 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 the 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 not be used for any new construction.
Antiretroviral drugs--the purchase of ARVs, reagents, and
laboratory equipment for antiretroviral treatment projects requires
pre-approval in writing from HHS/CDC officials.
Needle exchange--No funds appropriated under this
solicitation shall be used to carry out any program of distributing
sterile needles or syringes for the hypodermic injection of any illegal
drug.
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 an 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 Standard(s) or equivalent standards
approved in writing by HHS/CDC.
A Fiscal Recipient Capability Assessment may be required,
prior to or post award, in order to review the applicant's business
management and fiscal capabilities regarding the handling of U.S.
Federal funds.
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.
[[Page 53228]]
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 may 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 you to submit
electronically at www.Grants.gov. The application package can be
downloaded from www.Grants.gov. You will be 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 you are having
technical difficulties in Grants.gov, customer service can be reached
by e-mail at support@grants.gov 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 you submit your application to Grants.gov
early enough to resolve any unanticipated difficulties prior to the
deadline. You may also submit a back-up paper submission of your
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 with all requirements for non-
electronic submissions. If we receive both electronic and back-up paper
submissions by the deadline, the electronic version will be considered
the official submission.
We strongly recommend that you submit the grant application by
using Microsoft Office products (e.g., Microsoft Word, Microsoft Excel,
etc.). If you do not have access to Microsoft Office products, a PDF
file may be submitted. You may find directions for creating PDF files
on the Grants.gov Web site. Use of file formats other than Microsoft
Office or PDF could make your 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-AA086, 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 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. Technical Approach (25 Points)
Does the applicant describe strategies that are pertinent and match
those identified in the five-year strategy of the President's Emergency
Plan and activities that are evidence-based, realistic, achievable,
measurable and appropriate to achieve the goals of the Emergency Plan?
Does the applicant's proposal include an overall design strategy,
including measurable time lines? Does the proposal address regular
monitoring and evaluation, and the potential effectiveness of the
proposed activities in meeting objectives?
2. Understanding of the Problem (20 Points)
Does the applicant demonstrate a clear and concise understanding of
the nature of the problem described in the Purpose section of this
announcement? Does the proposal specifically include a description of
the public health importance of the planned activities to be
undertaken, and a realistic presentation of proposed objectives and
projects?
3. Ability To Carry Out the Project (20 Points)
Does the applicant document demonstrated capability to achieve the
purpose of the project?
4. Personnel (20 Points)
Are the professional personnel involved in this project qualified,
with evidence of experience in working with HIV/AIDS, opportunistic
infections, and HIV/STD surveillance?
5. Plans for Administration and Management of Projects (15 Points)
Is there a plan to manage the resources of the program, prepare
reports, monitor and evaluate activities and audit expenditures?
[[Page 53229]]
6. Budget (Not Scored)
Is the itemized budget for conducting the project, along with
justification, reasonable and consistent with stated objectives, the
five-year strategy and goals of the President's Emergency Plan and
Emergency Plan, and planned program activities?
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.
In addition, the following factors could affect the funding
decision:
While U.S.-based organizations are eligible to apply, we will give
preference to existing national/Tanzanian organizations. It is possible
for one organization to apply as lead grantee with a plan that includes
partnering with other organizations, preferably local. Although
matching funds are not required, preference will be go to organizations
that can leverage additional funds to contribute to program goals.
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 may affect the funding decision:
Maintaining geographic diversity
V.3. Anticipated Announcement and Award Dates
October 30, 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-6 Patient Care.
AR-8 Public Health System Reporting 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
PHS5161-1 application in the 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 Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness, including progress against the
numerical goals of the President's Emergency Plan for AIDS Relief for
Tanzania.
f. Additional Requested Information.
2. Annual progress report, due no later than 90 days after the end
of the budget period.
3. Financial status report, due no later than 90 days after the end
of the budget period.
4. Final financial and performance reports, due no later 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: Cecil Threat, Project
Officer, Global AIDS Program, c/o American Embassy, 2140 Dar es Salaam
Place, Washington, DC 20521-2140. Telephone: 255 22 212 1407. Cell: 255
744 222986. Fax: 255 22 212 1462. E-mail: Cthreat@cdc.gov.
For financial, grants management, or budget assistance, contact:
Diane Flournoy, Grants Management Specialist, CDC Procurement and
Grants Office, U.S. Department of Health and Human Services, 2920
Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-2072. E-mail:
dmf6@cdc.gov.
VIII. Other Information
Applicants can find this and other HHS funding opportunity
announcements on the HHS/CDC Web site, Internet address: 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: www.globalhealth.gov.
Dated: August 31, 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. 05-17679 Filed 9-6-05; 8:45 am]
BILLING CODE 4163-18-P