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Notice

HIV Treatment for Research Subjects or by Researchers in Kenya

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Information about this document as published in the Federal Register.

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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. Start Printed Page 35357Government 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: 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 www.dunandbradstreet.com or call 1-866-705-5711. Start Printed 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 Start Printed Page 35359the 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. Start Printed 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.

Start Signature

Dated: June 18, 2004.

William P. Nichols,

Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

End Signature End Preamble

[FR Doc. 04-14305 Filed 6-23-04; 8:45 am]

BILLING CODE 4163-18-U