[Federal Register: June 24, 2004 (Volume 69, Number 121)]
[Notices]
[Page 35356-35360]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn04-76]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
HIV Treatment for Research Subjects or by Researchers in Kenya
Announcement Type: New.
Funding Opportunity Number: PA 04264.
Catalog of Federal Domestic Assistance Number: 93.941.
Key Dates:
Letter of Intent Deadline: Not required.
Application Deadline: July 26, 2004.
I. Funding Opportunity Description
Authority: This program is authorized under sections 307 and
317(k)(2)of the Public Health Service Act, [42 U.S.C. 242l and
247b(k)(2)] 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].
Purpose: The Centers for Disease Control and Prevention (CDC)
announces the availability of Fiscal Year (FY) 2004 funds for a
cooperative agreement program to provide support for organizations
conducting bio-medical research related to HIV in Kenya in order to
provide treatment to HIV-infected research subjects.
The Global AIDS Program (GAP) has established field operations to
support national HIV/AIDS control programs in 25 countries. The CDC's
GAP exists to help prevent HIV infection, improve care and support, and
build capacity to address the global AIDS pandemic. GAP provides
financial and technical assistance through partnerships with
governments, community- and faith-based organizations, the private
sector, and national and international entities working in the 25
resource-constrained countries. CDC/GAP works with the Health Resources
and Services Administration (HRSA), the National Institutes of Health
(NIH), the U.S. Agency for International Development (USAID), the Peace
Corps, the Departments of State, Labor and Defense, and other agencies
and organizations. These efforts complement multilateral efforts,
including UNAIDS, the Global Fund to Combat HIV, TB and Malaria, World
Bank funding, and other private sector donation programs.
The U.S. Government seeks to reduce the impact of HIV/AIDS in
specific countries within sub-Saharan Africa, Asia, and the Americas
through the Presidential Emergency Plan for AIDS Relief (PEPFAR).
Through this new initiative, CDC's GAP will continue to work with host
countries to strengthen capacity and expand activities in the areas of:
(1) Primary HIV prevention; (2) HIV care, support, and treatment; and
(3) capacity and infrastructure development, especially for
surveillance and training. Targeted countries represent those with the
most severe epidemics where the potential for impact is greatest and
where U.S. government agencies are already active. Kenya is one of
these targeted countries. A specific mandate of this initiative is to
provide treatment to HIV-infected participants identified through U.S.
government funded research agencies. In addition, the ambitious targets
for treatment under this initiative make it imperative to capitalize on
any existing technical expertise related to the administration of
medical treatment for HIV.
To carry out its activities in these countries, CDC is working in a
collaborative manner with national governments and other agencies to
develop programs of assistance to address the HIV/AIDS epidemic. CDC's
program of assistance to Kenya focuses on several areas of national
priority including scaling up activities and funding for HIV
prevention, care, and treatment, improvement of the national blood
safety program, and support for the National AIDS and STD Control
Program.
A number of research scientists, working independently or in
collaboration with Kenyan institutions such as the University of
Nairobi or the Kenya Medical Research Institute have, or will, identify
research participants with HIV as part of their research work. Many of
these scientists have technical capacity related to the treatment of
HIV. Under PEPFAR, CDC Kenya plans to support treatment of HIV-infected
individuals by providing funds and additional technical assistance as
needed to allow the research groups to implement or expand HIV
treatment programs.
The measurable outcomes of the program will be in alignment with
goals of the GAP to reduce HIV transmission and improve care of persons
living with HIV. They also will contribute to the goals of the PEPFAR
which are: within five years treat more than 2 million HIV-infected
persons with effective combination anti-retroviral therapy (ART); care
for 10 million HIV-infected and affected persons including those
orphaned by HIV/AIDS; and prevent 7 million infections in 14 countries
throughout the world.
The key specific measurable outcomes from this program will be: (1)
The numbers of individuals receiving basic care packages; (2) The
number of pregnant women receiving a comprehensive package of PMCT and
PMCT+ services; (3) the number of new patients served with ART; and (4)
those current ART patients receiving continuous service for more than
12 months.
Activities
Awardee activities for this program are as follows:
Develop programs to provide care and treatment for people
with HIV infection, including, but not limited to, participants in
research programs. The individuals to whom services are provided may
include both participants in research programs and individuals who are
not participating in research (family members, other individuals seen
at the same site, individuals seen at other sites). The care should
include testing and ongoing counseling, prevention services (for
example efforts to reduce risk that an HIV infected individual will
transmit HIV to an uninfected partner), diagnosis and management of
opportunistic infections, and treatment with antiretroviral (ARV) drugs
in accordance with U.S.
[[Page 35357]]
Government and Kenya national guidelines.
Through these programs, provide basic treatment and/or ART
to a minimum of 50 people per year for each program.
Evaluate approaches to the provision of HIV treatment that
are in accordance with both Kenya national guidelines, and the
requirements of the emergency plan so as to guide implementation of
other treatment programs.
Collect and analyze standardized data on all of these
services.
Awardee should ensure that all of the above activities integrate
into the national HIV/AIDS strategy and are in line with national
guidelines and the guidelines for the implementation of the emergency
plan.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
Provide technical assistance in clinical, counseling and
laboratory issues, training, data management, and program monitoring
and evaluation.
Provide additional commodities that are not provided
through this program. For example, antiretroviral drugs may be provided
outside of the scope of this cooperative agreement.
Monitor project and budget performance to ensure
satisfactory progress toward the goals of the project.
II. Award Information
Type of Award: Cooperative Agreement. CDC involvement in this
program is listed in the Activities Section above.
Fiscal Year Funds: 2004.
Approximate Total Funding: $7,500,000 (This amount is for the
entire project period.)
Approximate Number of Awards: Eight to twelve individual
organizations, or one or more consortia.
Approximate Average Award: $150,000. (This amount is for the first
12-month budget period, and includes both direct and indirect costs.
This is the anticipated average award for individual organization
applicants; the award for consortia would be expected to be higher
depending upon the numbers of projects/patients represented.)
Floor of Award Range: $20,000.
Ceiling of Award Range: $1,500,000.
Anticipated Award Date: August 15, 2004.
Budget Period Length: 12 months.
Project Period Length: 5 years.
Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal Government.
III. Eligibility Information
III.1. Eligible Applicants
Applications may be submitted by U.S.-based or Kenya-based
universities or other research organizations that meet the following
criteria:
1. Have or will identify HIV-infected individuals through ongoing
research work in Kenya.
2. Have technical expertise related to provision of treatment for
individuals with HIV as evidenced by relevant training and/or
experience.
3. Are able to provide treatment to HIV-infected individuals either
through provision of services at the research site or an appropriate
nearby site.
1. Propose activities that are consistent with the Kenya Country
Operational Plan approved by the PEPFAR coordinator, and contribute to
the achievement of PEPFAR targets for Kenya.
Applications may be submitted by individual organization research
projects or consortia consisting of one or more research projects.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
If your application is incomplete or non-responsive to the
requirements listed in this section, it will not be entered into the
review process. You will be notified that your application did not meet
submission requirements.
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. Application forms and instructions are available on the CDC web
site, at the following Internet address: http://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 CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Submission
Application: You must include a project narrative with your
application forms. The narrative must be submitted in the following
format:
Maximum number of pages: 15. 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.
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.
All pages should be numbered, and a complete index to the
application and any appendices must be included.
Submitted in English.
Your narrative should address activities to be conducted over the
entire project period, and should consist of, as a minimum, a plan,
objectives, activities, methods, an evaluation framework, a budget
highlighting any supplies mentioned in the Program Requirements and any
proposed capital expenditure. The budget justification will not be
counted in the page limit state above. Guidance for completing your
budget can be found on the United States government website at the
following address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.
Additional information is optional and may be included in the
application appendices. The appendices will not be counted toward the
narrative page limit. Additional information could include but is not
limited to: Organizational charts, curriculum vitas, letters of
support, etc.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711.
[[Page 35358]]
For more information, see the CDC web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.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 may require you to submit additional
documentation with your application are listed in section
``Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
Application Deadline Date: July 26, 2004.
Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline
date. If you send your application by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery of the application by the closing date
and time. If CDC receives your application after closing due to: (1)
Carrier error, when the carrier accepted the package with a guarantee
for delivery by the closing date and time, or (2) significant weather
delays or natural disasters, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the application as having
been received by the deadline.
This announcement is the definitive guide on application submission
address and deadline. It supersedes information provided in the
application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your application. If you
have a question about the receipt of your application, first contact
your courier. If you still have a question, contact the PGO-TIM staff
at: 770-488-2700. Before calling, please wait two to three days after
the application deadline. This will allow time for applications to be
processed and logged.
IV.4. Intergovernmental Review of Applications
Executive Order 12372 does not apply to this program.
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows:
Funds may be used for: Training and infrastructure
improvements required to establish HIV treatment services; procurement
of required equipment and supplies and other commodities; procurement
of drugs in line with U.S. Government and Kenyan national guidelines
and regulations; payment of salaries, benefits, and travel costs for
personnel providing health care or supportive technical or
administrative services such as program or data management; and payment
of costs for program evaluation that are in line with PEPFAR goals and
needs.
Antiretroviral Drugs--The purchase of antiretrovirals,
reagents, and laboratory equipment for antiretroviral treatment
projects require pre-approval from the GAP headquarters.
Needle Exchange--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.
Funds may be spent for reasonable program purposes,
including personnel, training, travel, supplies and services. Equipment
may be purchased and renovations completed if deemed necessary to
accomplish program objectives; however, prior written approval by 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, 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 organization 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 relating to the implementation of HIV treatment
programs.
An annual audit of these funds is required 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 CDC. The audit should
specify the use of funds and the appropriateness and reasonableness of
expenditures.
A fiscal Recipient Capability Assessment may be required
with the potential awardee, pre or post award, in order to review their
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.
In addition, any foreign recipient must have a policy explicitly
opposing, in its activities outside the United States, prostitution and
sex trafficking, except that this requirement shall not apply to the
Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Health
Organization, the International AIDS Vaccine Initiative or to any
United Nations agency, if such entity is a recipient of U.S. government
funds in connection with this document.
The following definitions apply for purposes of this clause:
Sex trafficking means the recruitment, harboring,
transportation, provision, or obtaining of a person for
[[Page 35359]]
the purpose of a commercial sex act. 22 U.S.C. 7102(9).
A foreign recipient includes an entity that is not
organized under the laws of any State of the United States, the
District of Columbia or the Commonwealth of Puerto Rico. Restoration of
the Mexico City Policy, 66 FR 17303, 17303 (March 28, 2001).
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, acknowledge that each certification
to compliance with this section, ``Prostitution and Related
Activities,'' are a prerequisite to receipt 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. In addition, all recipients
must ensure, through contract, certification, audit, and/or any other
necessary means, all the applicable requirements in this section,
``Prostitution and Related Activities,'' are met by any other entities
receiving U.S. government funds from the recipient in connection with
this document, including without limitation, the recipients' sub-
grantees, sub-contractors, parents, subsidiaries, and affiliates.
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 primary grantees receiving U.S. Government funds in connection
with this document must certify compliance prior to actual receipt of
such funds in a written statement referencing this document (e.g.,
``[Recipient's name] certifies compliance with the section,
`Prostitution and Related Activities.' '') addressed to the agency's
grants officer. Such certifications 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 it is
determined by HHS that the recipient has not complied with this
section, ``Prostitution and Related Activities.''
Awards will not allow reimbursement of pre-award costs.
IV.6. Other Submission Requirements
Application Submission Address: Submit the original and two hard
copies of your application by mail or express delivery service to:
Technical Information Management--PA 04264, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
You are required to provide measures of effectiveness that will
demonstrate the accomplishment of the various identified objectives of
the cooperative agreement. Measures of effectiveness must relate to the
performance goals stated in the ``Purpose'' section of this
announcement. Measures must be objective and quantitative, and must
measure the intended outcome. These measures of effectiveness must be
submitted with the application and will be an element of evaluation.
Your application will be evaluated against the following criteria:
1. Ability To Carry Out the Project. (25 Points)
Is the applicant specifically familiar with national guidelines for
treatment of HIV in Kenya? Does the applicant document appropriate
technical capacity to implement the program?
2. Ability To Identify Appropriate Recipients for These Program
Services (20 Points)
Is the applicant identifying HIV-infected subjects through an
existing research project? Is the applicant conducting a program that
identifies or will identify HIV-infected individuals? Preference will
be given to programs currently conducting research projects using U.S.
government funds; however, organizations are eligible for funding
regardless of the source of the research funding.
Identification of HIV-infected persons through research is a
requirement for this funding; however, preference will be given to
programs that can provide treatment to large numbers of individuals.
The individuals to whom services are provided may include both
participants in research programs and individuals who are not
participating in research (family members, other individuals seen at
the same site, individuals seen at other sites).
3. Plans for Administration and Management of the Project (20 Points)
Are there adequate plans for administering the project? Does the
applicant have the capacity to provide treatment to at least 50 people
by March 31, 2005? Does the applicant have the capacity to collect and
report data related to the measurable outcomes that will contribute to
PEPFAR targets? Does the applicant describe activities which are
realistic, achievable, time-framed and appropriate to complete this
program?
4. Personnel (20 Points)
Are the professional personnel involved in this project qualified,
including evidence of technical expertise in providing treatment for
HIV, evaluating and reporting on program experience, and reporting data
in a timely manner? Do the personnel have appropriate technical
qualifications?
4. Administrative and Accounting Plan (15 Points)
Is there a plan to account for, prepare reports, monitor and audit
expenditures under this agreement, manage the resources of the program
and produce, collect and analyze performance data?
5. Budget (Not Scored, but Evaluated)
Is the itemized budget for conducting the project, along with
justification, reasonable and consistent with stated objectives and
planned program activities? Does the budget reflect a commitment to
ensure that per patient costs are reasonable in the context of
providing treatment for large numbers of people in Kenya? For example,
is the number of proposed health care providers appropriate for the
number of individuals receiving treatment? Is the percentage of funds
designated for administrative overhead reasonable?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) staff, and for responsiveness by the National
Center for HIV, STD and TB Prevention (NCHSTP). Incomplete applications
and applications that are non-responsive to the eligibility criteria
will not advance through the review process. Applicants will be
notified that their application did not meet submission requirements.
An objective review panel will evaluate complete and responsive
applications according to the criteria listed in the ``Criteria''
section above.
[[Page 35360]]
No award will be made without the concurrence of the U.S. Embassy
and the CDC representative in Kenya.
V.3. Anticipated Announcement and Award Date
August 15, 2004.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
VI.2. Administrative and National Policy Requirements
45 CFR Parts 74 and Part 92
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html
The following additional requirements apply to this project:
AR-1 Human Subjects Requirements.
AR-4 HIV/AIDS Confidentiality Provisions.
AR-6 Patient Care.
AR-8 Public Health System Reporting Requirements.
AR-10 Smoke-Free Workplace Requirements.
AR-14 Accounting System Requirements.
Additional information on these requirements can be found on the
CDC web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting Requirements
You must provide 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, due 30 days after the end of the budget period.
2. 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. Additional Requested Information.
f. Measures of Effectiveness.
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.
These reports must be mailed to the Grants Management or Contract
Specialist listed in the ``Agency Contacts'' section of this
announcement.
VII. Agency Contacts
For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For program technical assistance, contact: Barbara Marston, M.D.,
Project Officer, Global Aids Program [GAP], Kenya Country Team,
National Center for HIV, STD and TB Prevention, Centers for Disease
Control and Prevention [CDC], PO Box 606 Village Market, Nairobi,
Kenya, Telephone: 254-20-271-3008, e-mail: bmarston@kisian.mimcom.net.
For budget assistance, contact: Diane Flournoy, Grants Management
Specialist, CDC Procurement and Grants Office 2920 Brandywine Road,
Atlanta, GA 30341, Telephone: 770-488-2072, e-mail: dmf6@cdc.gov.
VIII. Other Information
None.
Dated: June 18, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-14305 Filed 6-23-04; 8:45 am]
BILLING CODE 4163-18-U