Provision of Routine HIV Testing, Counseling, Basic Care and Antiretroviral Therapy at Teaching Hospitals in the Republic of Uganda

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Federal RegisterJul 2, 2004
69 Fed. Reg. 40377 (Jul. 2, 2004)

Announcement Type: New.

Funding Opportunity Number: 04227.

Catalog of Federal Domestic Assistance Number: 93.941.

DATES:

Application Deadline: August 2, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under Sections 301 and 307 of the Public Health Service Act, [42 U.S.C. 241 and 242l], as amended, and section 104 of the Foreign Assistance Act of 1961, [22 U.S.C. 2151b].

Purpose: The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2004 funds for a cooperative agreement program for Provision of Routine HIV Testing, Counseling, Basic Care and Antiretroviral Therapy (ART) in Teaching Hospitals in the Republic of Uganda.

The overall aim of this program is to develop national models of routine HIV testing in clinical settings, which also provide for the full continuum of post-test counseling and care, including ART.

The United States Government seeks to reduce the impact of HIV/AIDS in specific countries within sub-Saharan Africa, Asia and the Americas. The President's Emergency Plan for AIDS Relief (PEPFAR) encompasses HIV/AIDS activities in more than 75 countries, and focuses on 14 countries, including Uganda, to develop comprehensive and integrated prevention, care, and treatment programs. CDC has initiated its Global AIDS Program (GAP) to strengthen capacity and expand activities in the areas of: (1) HIV primary prevention; (2) HIV care, support and treatment; and (3) capacity and infrastructure development, including surveillance. Targeted countries represent those with the most severe epidemics and the highest number of new infections. They also represent countries where the potential impact is greatest and where the United States government agencies are already active. Uganda is one of those countries.

CDC's mission in Uganda is to work with Ugandan and international partners to develop, evaluate, and support effective implementation of interventions to prevent HIV and related illnesses, and improve care and support of persons with HIV/AIDS.

Mulago and Mbarara Hospitals are Uganda's only university teaching hospitals. The majority of the nation's doctors and nurses are trained within their facilities. The next tier of clinical provision is the regional referral hospitals, which also have an in-service training and supervisory function for the clinicians within their region. Voluntary counseling and testing (VCT) services are only available at 11 percent of health facilities (Uganda Health Facilities Survey 2002), and currently there is no routine counseling and testing (RCT) within hospitals. Where testing services are available in a hospital setting, only selected patients (about 28 percent, according to a recent study) are referred for testing, and pre- and post-test counseling support is generally poor or absent. In the same study, 55 percent of those not tested said they would have wanted to be tested. The most recent Demographic and Health Survey in Uganda indicated that 70 percent of people living in Uganda would like to receive HIV testing, but only ten percent reported that they had ever been tested. An estimated 20-70 percent of patients in hospital wards, TB clinics, and sexually transmitted infection (STI) clinics are HIV infected, but HIV testing is not currently part of routine care. Improved basic preventative care, as well as ART, is about to become more widely available in Uganda as a result of various activities, including this one. ART will be launched within the public hospital system at those facilities where staffing, laboratory service, and the potential for training are maximal.

The purpose of this program are: to provide assistance to Uganda's two university teaching hospitals, Mulago and Mbarara Hospitals; to establish and manage routine counseling and testing services for all patients; to provide comprehensive clinical care for persons with HIV, including staff; to incorporate cotrimoxazole prophylaxis, other basic care interventions, and ART; and to deliver training to clinicians and other staff in these activities.

In addition, the provision at their homes of HIV counseling and testing to the household members of persons receiving ART, and subsequent inclusion in the HIV care program as appropriate, would be encouraged.

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 two million HIV-infected persons with effective combination ART; care for seven million HIV-infected and affected persons, including those orphaned by HIV/AIDS; and prevent ten million new infections. Some of the specific measurable outputs from this program will be: The number of clients receiving counseling and testing; the percentage of hospital patients receiving counseling and testing; the number of clients receiving basic care packages; the number of new clients served with ART, and those current ART clients receiving continuous service for more than 12 months; and the number of persons trained to provide all the forgoing services.

Activities

Awardee activities for this program are as follows:

a. Establish or expand a project office(s), as required by the activities.

b. Identify project staffing needs; hire and train staff.

c. Identify furnishings, fittings, equipment, computers, and other fixed assets procurement needs of the project and implementing partners, and acquire from normal sources.

d. Establish suitable administrative and financial management structures.

e. Work with Ministry of Health and other stakeholders to develop RCT and care operational guidelines.

f. Support the teaching hospitals to implement RCT in all hospital units, including the outpatient departments.

g. Train hospital staff, residents, and students in provision of HIV/AIDS basic preventive care package and ART management, with the expectation of having at least 1,000 patients receiving regular ART by March 2005.

h. Support the partner hospitals to implement a basic preventive care and ART program for patients and staff.

i. In collaboration with the Ministry of Health train appropriate personnel in conducting the ART accreditation process for potential ART centers.

j. Support the hospitals to develop a simple data collection system, integrated with the general Health Management Information System (HMIS), but collecting specific information related to this program that is not routinely collected by the HMIS.

k. Ensure that the commodities supply and management system is operational with respect to test kits, cotrimoxazole, anti-retrovirals (ARVs), TB diagnostic materials and drugs, and other necessary commodities. Use existing hospital and public sector systems as far as possible and project emergency re-supply only as necessary.

l. Develop a simple quality assurance system for RCT in clinical settings.

m. Publish reports, guidelines and training manuals relating to RCT testing in clinical settings.

n. Ensure that the above activities are undertaken in a manner consistent with the national HIV/AIDS strategy, and ARV policy and implementation guidelines.

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:

a. Provide technical assistance, as needed, in the development of training curricula, materials, and diagnostic therapeutic guidelines.

b. Collaborate with the recipient, as needed, in the development of an information technology system for medical record keeping, information access, and in the analysis of data derived from those records.

c. Assist, as needed, in monitoring and evaluation of the program, and in development of further appropriate initiatives.

d. Assist, as needed, in appropriate analysis and interpretation of data collected during training sessions.

e. Provide input, as needed, into the criteria for selection of staff and training candidates, and the regional hospital to be included in the RCT program.

f. Provide input into the overall program strategy.

g. Collaborate, as needed, with the recipient in the selection of key personnel to be involved in the activities to be performed under this agreement, including approval of the overall manager of the program.

Technical assistance and training may be provided directly by CDC staff, or through organizations that have successfully competed for funding under a separate CDC contract.

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: $9,170,000.

(This amount is the approximate total funding amount for the entire five-year project period.)

Approximate Number of Awards: One.

Approximate Average Award: $1,834,000.

(This amount is for the first 12-month budget period, and includes direct costs.)

Floor of Award Range: None.

Ceiling of Award Range: $1,834,000.

Anticipated Award Date: September 1, 2004.

Budget Period Length: 12 months.

Project Period Length: Five 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

Eligible Applicants

Applications may be submitted by public nonprofit organizations, private nonprofit organizations, universities, colleges, research institutions, hospitals, and faith-based organizations that meet the following criteria:

1. Have at least two years of documented HIV/AIDS related clinical training experience in Uganda.

2. Have existing activities with Mulago Hospital because it is critical that this activity commences quickly and that the applicant is not delayed by procedures required to obtain acceptance from the Mulago Hospital authorities.

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.

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 below, it will not be entered into the review process. You will be notified that your application did not meet the submission requirements.

IV. Application and Submission Information

IV.1. Address to Request Application Package

To apply for this funding opportunity use application form CDC 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 submit a project narrative with your application forms. Your narrative must be submitted in the following format:

  • Maximum number of pages: 25. 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.
  • Must be 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 stated above. Guidance for completing your budget can be found on the United States government Web site 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. This additional information could include but is not limited to: organizational charts, curriculum vitae, 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.

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 “VI.2 Administrative and National Policy Requirements.”

IV.3. Submission Dates and Times

Application Deadline Date: August 2, 2004.

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 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

Funds may be used for:

1. RCT at the facilities targeted by the project including required training, test kit purchase, and staffing.

2. Covering the costs of and procuring elements of the basic preventive care package, including but not necessarily limited to daily cotrimoxazole prophylaxis, TB screening, diagnosis and treatment, as well as possible INH prophylaxis, prevention with positives education, household water treatment and bednets.

3. ART at the facilities targeted by the project, including required ARV purchase, training, additional staffing, laboratory rehabilitation and equipment, and office and information technology equipment to facilitate enhancement of the hospitals' data management systems to include ART and necessary program indicators.

4. Evaluation and management of the activities.

Restrictions, which must be taken into account while writing your budget, are as follows:

  • Funds may not be used for any new construction.
  • Antiretroviral Drugs—The purchase of ARVs, reagents, and laboratory equipment for antiretroviral treatment projects require pre-approval from HHS/CDC officials.
  • 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 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, including program management and operations, and delivery of prevention and care services for which funds are requested.
  • You must obtain an annual audit of these CDC funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by 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.

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 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 (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. Guidance for completing your budget can be found on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

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 Section—PA# 04227, 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. Understanding the issues, principles and systems requirements involved in delivering RCT, basic preventive care, and ART in a clinical context in Uganda (25 points)

Does the applicant demonstrate an understanding of the clinical, social, managerial, ethical and other practical issues involved in delivering RCT, basic preventive care, and ART effectively in the setting of Mulago and Mbarara hospitals?

2. Ability to carry out the proposal (25 points)

Does the applicant demonstrate the capability to achieve the purpose of this proposal?

3. Work Plan (20 points)

Does the applicant describe activities which are realistic, achievable, time-framed and appropriate to complete this program?

4. Personnel (15 points)

Are the personnel, based on qualifications, training, availability, and experience, adequate to carry out the proposed activities?

5. Administrative and Accounting Plan (15 points)

Is there a plan to account for, prepare reports on, monitor, and audit expenditures under this agreement; manage the resources of the program; and produce, collect, and analyze performance data?

6. Budget (not scored)

Is the budget itemized and well justified for conducting the activities; and is it consistent with stated activities and planned program activities?

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)/GAP. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above.

V.3. Anticipated Announcement and Award Dates

September 1, 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 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: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html . The following additional requirements apply to this project:

VI.3. Reporting Requirements

You must provide CDC with an original, plus two hard copies, of the following reports:

1. Interim progress report, 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. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

f. Measures of Effectiveness.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

4. Semi annual progress reports, 30 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: Jonathan Mermin, MD, MPH, Global Aids Program [GAP], Uganda Country Team, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention [CDC], PO Box 49, Entebbe, Uganda, Telephone: +256-41320776, E-mail: jhm@cdc.gov.

For financial, grants management, or budget assistance, contact: Shirley Wynn, Contract Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-1515, E-mail address: zbx6@cdc.gov.

Dated: June 28, 2004.

Alan Kotch,

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

[FR Doc. 04-15065 Filed 7-1-04; 8:45 am]

BILLING CODE 4163-18-P