Revised GH18-1829 Epi Language.pdf

Centers for Disease Control and Prevention

Center for Global Health

Infrastructure Support to the Mozambican Health System to Scale-Up HIV/AIDS and TB

Services on Behalf of the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH18-1829

Application Due Date: 11/14/2017

Infrastructure Support to the Mozambican Health System to Scale-Up HIV/AIDS and TB

Services on Behalf of the President's Emergency Plan for AIDS Relief (PEPFAR)

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- GH18-1829. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR)

B. Notice of Funding Opportunity (NOFO) Title:

Infrastructure Support to the Mozambican Health System to Scale-Up HIV/AIDS and TB Services on Behalf of the President's Emergency Plan for AIDS Relief (PEPFAR)

C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

Amendment II:

This amendment is for informational purposes only. CDC is not accepting new applications for award. The purpose of this amendment is to include language regarding HIV epidemic control under d. Other National Public Health Priorities and Strategies.

D. Agency Notice of Funding Opportunity Number:

E. Assistance Listings (CFDA) Number:

93.067 Additional CFDA Number: 93.338 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A

2. Due Date for Applications: 11/14/2017, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

An informational conference call/ pre-application workshop will be held for this NOFO within 10 days of the NOFO posting. Applicants should contact the Project Officer listed in Agency Contacts for further information regarding the pre-application workshop.

G. Executive Summary:

1. Summary Paragraph:

This NOFO seeks to provide infrastructure support and technical assistance to Mozambican Ministry of Health (MOH) health clinics and facilities in order to scale-up HIV and TB services through PEPFAR. This NOFO will provide technical assistance to help address MOH https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html infrastructure needs as well as providing overall alternative solutions to improving the health infrastructure either through renovations, pre-fabricated (pre-fab) structures, or equipment necessary for the improvement of HIV/AIDS and TB services across the clinical cascade. Sites for infrastructure support will be selected based on MOH and PEPFAR priorities. Health centers may require different infrastructure solutions which may include pre-fab structures for warehouses, pharmacies, laboratories, and medium-sized health units. Supported health facilities may be geographically dispersed throughout Mozambique and involve rural and urban areas. The accomplishment of these objectives will support the Government of Mozambique’s goal of promoting epidemic control through an increased facility maximum HIV patient capacity and will in turn facilitate the country’s HIV strategic goals.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 2 The expected number of awards is 1-2.

d. Total Period of Performance Funding: $0 The Approximate Project Period Funding/Estimated Total Funding for the Total 5 year Project Period is None. Award ceilings for years 2-5 will be set at continuation.

e. Average One Year Award Amount: $5,000,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 04/01/2018

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although there is no statutory match requirement for this NOFO, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Mozambique’s health infrastructure was devastated by decades of war. Despite significant rebuilding, the network of 1,591 health facilities remains inadequate for the estimated 27 million Mozambicans who are widely distributed across a vast area. In 2015, there were 17,585 inhabitants per health facility with lower than expected staff to patient ratios. Compounding this, health facilities constructed before the HIV epidemic era are now over-burdened with limited reorganization of workflow given resource constraints faced. Over the past 5-10 years, the number of HIV patients currently enrolled on treatment has increased by almost two-fold.

Mozambique has yet to reach epidemic control, despite significant PEPFAR financial investment. For many health care facilities, whether high, medium, or low volume, the expectation is for a continued increase in patient volumes given PEPFAR’s focus on test and start, retention, and linkages into care.

PEPFAR’s response involves a highly complex health systems approach, distributed across multiple partners, and geographically dispersed by region. As HIV health service delivery models move to standard practice, challenging infrastructure constraints persist. To mitigate, integrative health service delivery models were introduced to some health facilities resulting in one-stop services at the point of care and the elimination of patient workflows across health units within a facility. Some partners have successfully introduced pre-fab structures to health facilities with noted change in workflows and staff/provider morale. Minor renovations, such as building shelves or improving equipment placement in health services areas, have resulted in safety and workflow improvements. Even then, for other health facilities, solutions are exhausted due to a lacking footprint for needed renovation or there is an urgent need for additional space to meet high volume demands. Pharmacy, laboratory, and HIV health services units are particularly challenged, resulting in high volume bottlenecks, long waiting times, inappropriate storage, and general erosion of the physical plant over time. For HIV health services, patient confidentiality is often compromised due to two or more patient encounters at the point of care and by differing health care providers. Many pharmacy units are constrained by workspaces now managing an increase in HIV essential drugs, resulting in unsafe and unsecure workspaces or inappropriate drug storage. Laboratories require unique accreditation specifications, and constraints in physical plan options result in compromised services. For many facilities, the ability to reorganize the workflow is no longer feasible without alternative solutions such as the addition of pre-fab units or other alternatives.

This NOFO will provide assistance to the Mozambican MOH through technical assistance in guiding U.S. Government (USG) infrastructure investment in Mozambique as well as providing overall alternative solutions for improving the health infrastructure either through renovations, pre-fab structures, or equipment necessary for the improvement of HIV/AIDS and TB services across the clinical cascade. Sites for infrastructure support will be selected sites based on MOH and PEPFAR priorities. Differing options are required and may include pre-fab structures for warehouses, pharmacies, and medium-sized health units. Targeted health facilities may be geographically dispersed throughout Mozambique and involve rural and urban areas.

b. Statutory Authorities This program is authorized under Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601, et seq.] and Public Law 110-293 (the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008), and Public Law 113-56 (PEPFAR Stewardship and Oversight Act of 2013).

The President’s Emergency Plan for AIDS Relief (PEPFAR) has called for immediate, comprehensive and evidence based action to turn the tide of global HIV/AIDS. The overarching purpose of this NOFO is to fund activities to prevent or control disease or injury and improve health, or to improve a public health program or service.

On July 30, 2008, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 amended Public Health Service Act, Section 307, International Cooperation. The amendments gave CDC authority to award assistance agreements for Construction and Modernization projects in foreign countries.

Public Health Service Act, Section 307(b)(10) [42 U.S.C. § 242l(b)(10), as amended], which states: "...through grant or cooperative agreement, make funds available to public or nonprofit private institutions or agencies in foreign countries in which the Secretary is participating in activities described under subsection (a) to acquire, lease, construct, alter, or renovate facilities in those countries."

c. Healthy People 2030 N/A

d. Other National Public Health Priorities and Strategies Under the leadership of the U.S. Global AIDS Coordinator, as part of the President's Emergency Plan, the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works with host countries and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation's strategic plan and partnership framework.

HHS/CDC focuses primarily on two or three major program areas in each country. Goals and priorities include the following:

Achieving primary prevention of HIV infection through activities such as expanding confidential counseling and testing programs linked with evidence based behavioral change and building programs to reduce mother-to-child transmission;

Improving the care and treatment of HIV/AIDS, sexually transmitted infections (STIs) and related opportunistic infections by improving STI management; enhancing laboratory diagnostic capacity and the care and treatment of opportunistic infections;

interventions for intercurrent diseases impacting HIV infected patients including tuberculosis (TB); and initiating programs to provide anti-retroviral therapy (ART);

Strengthening the capacity of countries to collect and use surveillance data and manage national HIV/AIDS programs by expanding HIV/STI/TB surveillance programs and strengthening laboratory support for surveillance, diagnosis, treatment, disease monitoring and HIV screening for blood safety; and

Developing, validating and/or evaluating public health programs to inform, improve and target appropriate interventions, as related to the prevention, care and treatment of HIV/AIDS, TB and opportunistic infections.

In an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC also supports coordination with and among partners and integration of activities that promote Global Health Initiative principles. As such, recipients may be requested to participate in programmatic activities that include the following activities:

Implement a woman- and girl-centered approach;

Increase impact through strategic coordination and integration;

Strengthen and leverage key multilateral organizations, global health partnerships and private sector engagement;

Encourage country ownership and invest in country-led plans;

Build sustainability through investments in health systems;

Improve metrics, monitoring and evaluation; and Promote research, development and innovation (research is not supported by this

NOFO).

PEPFAR defines national HIV epidemic control as the point at which the total number of new infections falls below the total number of deaths from all causes among HIV-infected individuals (the classic R0 to Ri approach to infectious diseases), with both declining. This definition of epidemic control does not suggest near-term elimination or eradication of HIV as may be possible with other infectious diseases, but rather suggests a decline of HIV-infected persons in a population, achieved through the reduction of new HIV infections when mortality among people living with HIV (PLHIV) is steady or declining, consistent with natural aging.

Critically, however, a country will not be able to maintain epidemic control if program efforts are not sufficiently sustained and new infections are allowed to rebound or death rates to increase.

Effective December 1, 2018, in addition to the specific activities listed in the Strategies and Activities section of this NOFO, all CDC PEPFAR cooperative agreements resulting from this NOFO may address the following activities, where and when appropriate, that focus U.S.

government resources and activities toward achieving and sustaining the HIV/AIDS epidemic:

Optimize HIV testing and treatment strategies to reach undiagnosed populations living with HIV, especially young adults, men, and key populations. These strategies may include or build upon traditional methods and activities related to outbreak detection, investigation, and response. Responding to recent infections or ongoing patterns of transmission will be prioritized.

Focus on prevention among children, adolescents, young adults, and members of vulnerable and key populations.

Support surveillance activities and programs, along with information systems, that improve understanding of HIV epidemiology, remaining gaps, and informed future programming.

Support efforts to maintain quality for laboratory systems and activities, including diagnostics and viral load measurement.

Actively use epidemiologic, program, and financial/cost data to ensure implementation of high quality, cost-effective programs to improve partner performance and increase epidemiologic impact.

Support country-led, sustainable programming by working with and implementing activities through indigenous partners, including faith communities and faith-based organizations (FBOs), HIV network organizations and community-based organizations directly servicing communities and populations at-risk and most affected by HIV to build local capacity.

Strengthen policy and financial contributions by partner governments in the HIV/AIDS response.

Support activities, interventions, and programs to find, treat, and prevent Tuberculosis (TB) among PLHIV and to identify and treat HIV among people infected with TB.

Support efforts to prevent, detect, respond, and treat infectious and non-infectious diseases that impact PLHIV and populations affected by HIV.

The Epidemic Control language immediately listed above is in effect under this NOFO from December 1, 2018 through the remainder of the project period.

This announcement is only for non-research activities supported by CDC. Recipients may not use funds for research. Certain activities that may require human subjects review due to institutional requirements but that are generally considered not to constitute research (e.g., formative assessments, surveys, disease surveillance, program monitoring and evaluation, field evaluation of diagnostic tests, etc.) may be funded through this mechanism. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/integrity/docs /cdc-policy-distinguishing-public-health-research-nonresearch.pdf

e. Relevant Work N/A

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

i. Purpose The purpose of this NOFO is to announce CDC’s intentions to provide USG assistance funds for the construction of clinics, laboratories, and related health facilities in several Mozambique provinces to contend with large patient volumes, improve access to services, and decrease wait-times, leading to increased retention and patient satisfaction. These structures will expand health services in existing units and workflows and create opportunities to expand services to new areas. Renovations can also more appropriately refinish crowded health services areas for better organization.

ii. Outcomes Short-Term Outcomes:

Increased knowledge of barriers and facilitators to improved patient management with limited infrastructure

Improved understanding of existing best practices Improved knowledge of patient demand and space requirements

Improved immediate patient capacity

Intermediate Outcomes:

Decreased wait times and bottlenecks at targeted facilities Improved use of health facility space at targeted facilities

Long-Term Outcome:

Increased and/or improved physical capacity of health facilities for patient visits

iii. Strategies and Activities Project Information: Applicants should include the following project-specific information in the application:

Description of project.

General physical location of project.

Description of the intended usage of the completed project.

Description of the intended occupancy of the completed project.

Estimated useful life of the project in years.

Time schedule for the overall project and major components thereof with estimated start and completion dates.

Description of work-to-date on the project.

List and description of anticipated contracts (e.g. design, builder) to be awarded for the project.

Applicable building codes.

Applicable safety and security needs.

Description of methods for assessing site and needed site work.

Methods for assessing existing and needed on-site utility systems.

Special design or construction considerations.

Facility accessibility by individuals with physical disabilities.

Example of a site map for project, to be produced for each specific site.

Example of a floor plan for project to be produced for each specific site.

Example of drawings and specifications for the project.

Example of list of fixed equipment to be installed in the completed facility, to be assessed for each site.

Method for obtaining and evaluating legal opinion on property title.

Description of how the Notice of Federal Interest will be filed.

Anticipated project signage.

How the project will be insured.

List of Technical Assistance needed from CDC.

List of project requirements that are thought to conflict with host country or international law or bilateral agreements.

Recipient Activities: Recipient activities will include the following:

(1) Objective: The objective of the award is for the Recipient(s) to construct clinics, laboratories, and related health facilities in several provinces in Mozambique.

(2) Outcomes: Measurable outcomes of this project will align with the following performance goals for CDC/Mozambique: Achievement of PEPFAR targets through improved efficiency of HIV/AIDS and TB services; and allocation of health system infrastructure through an evidence based process in alignment with MOH and PEPFAR policies and priorities.

(3) Authority to Act: The Recipient(s) must hold the proper legal authority and necessary approvals to apply for and receive USG assistance for the project.

(4) Intended Use: The Recipient(s) will use the constructed/renovated facilities for housing and directly supporting HIV/AIDS and TB health activities of the Government of Mozambique.

(5) Useful Life: The anticipated useful life of the constructed/renovated facilities will be 15 years.

(6) Project Design: The Recipient(s) must design the project in accordance with the following or comparable Mozambican design standards: Regulamento Geral de Edificacoes urbanas;

Regulamento de Estruturas de Betao Armado; Regulamento de Aco para Edificios;

Regulamento de Seguranca de Pessoas e Higiene no Trabalho; Regulamento Geral das Canalizacoes de Agua e de esgotos; and Regulamento de Sistemas de Instalacao de U. E.

Electrico. The Recipient(s) will not advertise for builder bids or negotiate a builder contract until the project design has been approved by CDC.

(7) Prohibited Space: The facility space that is constructed or modernized must not include any space that is constructed or modernized for the direct benefit of the USG, any space for USG occupancy, or any build-to-lease space.

(8) Project Phases:

Procurement Planning phase:

o Actions: Definition of terms of reference for the selection of a Consultant firm for a design and built contract type and/or vendors for materials and pre-fabs o Submissions/deliverables: Submission of a procurement plan and budget

Assessment phase:

o Actions:

Confirmation of health facilities with critical HIV/AIDS needs in line with both MOH expansion plans and CDC PEPFAR goals Assessment of site conditions o Submissions/deliverables:

List of selected sites Land availability and site assessment report Definition and approval of project scope (renovation works, prefab installation, and equipment supply) per proposed site Design phase:

o Actions: Prepare design plans and specification details in line with Mozambican design procedures o Submissions/deliverables:

Detailed design per site Logistics plan for transport and delivery per site

Implementation phase:

o Actions:

Project presentation to beneficiaries and relevant stakeholders Ensure that all permits, licenses, and fees are in place Project execution o Submissions/deliverables:

Periodic progress report Project completion reports and site handover

(9) Insurance: In addition to maintaining for the project the equivalent of insurance coverage maintained for other real property owned or controlled by the Recipient(s), the Recipient(s) must also obtain builder's risk insurance, title insurance, and physical destruction insurance in accordance with and as required by the applicable, normal, and customary practices for the local jurisdiction. Evidence of such insurance or their preclusion, must be submitted to CDC, and CDC must be notified of any changes in insurance coverage. The Recipient(s) must remit insurance payouts to CDC unless CDC authorizes an alternate use. CDC may elect to waive these insurance requirements if the Recipient(s) is a self-insured governmental agency.

(10) Control of Project: The Recipient(s) must exercise appropriate institutional, managerial, and financial controls to ensure proper planning, management, and completion of the project.

Sub-awards to sub-recipients are not authorized.

(11) Use of Contractors: The Recipient(s), to the extent possible, will not self-perform the project, but will engage qualified contractors to perform the project. The Recipient(s) must ensure that their contractors provide the architectural, engineering, construction, trade, legal, and any other goods and services necessary to complete the project, to include all fees, licenses, bonds, warrants, assurances, permits, and approvals required by law or regulation. The Recipient(s) must ensure that their contractors comply with any award requirements regarding the preparation, review, and approval of project design, phases, and contracts. The Recipient(s) must ensure that their contractors initiate work after the receipt of any required prior approvals from CDC, and complete the project within the required timeframes, budget, and allowable cost rules. The Recipient(s) must ensure that their contractors provide and maintain competent and adequate supervision and provide appropriate technical engineering oversight to ensure that the completed work conforms to the approved design, complies with applicable construction codes, and that progress reports and other technical information is submitted to CDC in a timely manner. Although the Recipient(s) may contract with other organizations to accomplish the project, the Recipient(s) retains overall responsibility for the project, to include oversight of any selected contractors.

(12) Assurances: The Recipient(s) must accomplish the project in accordance with the assurances shown on form "SF-424D Assurances for Construction Programs," except for these eight assurances: #8, #10, #11, #13, #14, #15, #16, and #17.

(13) Final Inspection, Cost Analysis, Closeout: The Recipient(s) will submit the completed project to a final inspection, cost analysis, and closeout by CDC. The project is complete at the point at which the builder turns over to the Recipient(s) a facility or portion of a facility that: (a) conforms to the design and specifications approved by CDC; and (b) is available for occupancy.

This date is either the final acceptance of the building or portion of a building or the date of beneficial occupancy, whichever comes first. The date of beneficial occupancy is the date that a facility or portion of a facility conforming to the design and specifications approved by the CDC is available for occupancy. The completion date establishes the beginning date for the facility usage requirement under the Notice of Federal Interest.

(14) Technical Assistance: Technical Assistance may be provided by CDC to the Recipient(s) for purposes of increasing the likelihood of successful performance and compliance with financial management system standards. The Recipient(s) may request post-award Technical Assistance from CDC both in the application and at any time during the project. Such Technical Assistance will be at CDC's discretion as there is no guarantee that requested Technical Assistance can or will be provided. CDC may self-initiate post-award Technical Assistance without a Recipient request if in the best interests of CDC. CDC may provide Technical Assistance on a grant or a cooperative agreement.

(15) Conflicts: CDC will collaborate with Recipient(s) to resolve U.S. legal and policy requirements that conflict with the laws and customs of the host country or international laws or bilateral agreements. The Applicant or Recipient(s) must notify CDC of any objections to the requirements in this NOFO or the Award that create such a conflict. Upon notification, to the extent allowed by applicable U.S. federal laws, regulations, and policies, CDC will consider and respond to such objections. The requirements imposed remain in effect unless modified or waived by appropriate HHS or CDC officials. Conflicts may arise, for example, due to differences between NOFO and Award requirements and foreign building codes, foreign public policy requirements, foreign property ownership systems, and foreign construction-industry practices. CDC cannot waive U.S. legal requirements.

(16) Legal Disclaimer: The Recipient(s), by accepting USG funds, agrees to this legal disclaimer. Under this Award, CDC may review and approve certain Recipient-submitted project documents, reports, and architectural and engineering drawings. CDC approval of such items is advisory in nature only and is intended to ensure compliance with the scope, terms, and conditions of the NOFO and the underlying project's purpose, and does not constitute or imply any CDC representation or architectural and engineering certification or permit by CDC of activities by the Recipient to any local authority, to the Recipient’s contractors, or to any other interested party. Resolution of any disputes between CDC and Recipient regarding CDC reviews and approvals will be undertaken in accordance with applicable U.S. federal laws and regulations.

(17) Project Director: The Recipient(s) must name a Project Director, who will oversee and manage the project, serve as the primary point of contact for interaction with CDC, ensure compliance with project requirements, and control the project budget.

(18) Other required Recipient Activities:

Conduct readiness assessment to determine appropriate changes for pre-fab units or renovations:

o Working drawings and specifications of the proposed space and alterations.

o A narrative description of the proposed functional utilization, specifications, and equipment requirements for the proposed space.

o A space schedule (detailed description of floor space).

o A list of fixed equipment proposed for the facility.

o A detailed project cost estimate.

o Identification of special design problems.

o Description of the existing workflow and utility systems and those proposed for the modified facility.

o Plans for accessibility by individuals with physical disabilities.

o Description of safety criteria incorporated in the existing building and in the facility as modified.

o If property is leased, a statement, and documentation of, the length of lease.

o Time schedule for each major activity in the project.

o A detailed narrative justification of the need to perform the work before the building is completed.

o A cost comparison between doing the work before and after the building is completed.

o A description of other specific benefits to be gained by doing the work before the building is completed.

Conduct a literature review to establish minimum requirements for health facility physical space needs and best practices in adapting space to optimize patient flow.

Introduce pre-fab units or renovations to at least 36 medium health facilities, 39 pharmacies, and 16 laboratories:

o Deliver and assemble pre-fab structure according to needs assessment findings.

o Renovate structure according to needs assessment findings

Train local health facility staff to optimize and maintain usage of renovations and pre-fab units:

o Deliver training for maintaining pre-fab structure.

o Introduce maintenance metrics for health facility monitoring and evaluation.

In furtherance of the underlying purpose of this announcement, Recipient is expected to provide copies and/or access to all data, software, tools, training materials, guidelines, and systems developed under this NOFO to Ministry of Health and other relevant stakeholders for appropriate use. CDC should be provided access consistent with applicable grants regulations.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

It is expected that the recipient(s) will collaborate with other CDC programs and activities, especially those who currently support health facilities where the recipient(s) will be working.

b. With organizations not funded by CDC:

The recipient(s) will be expected to collaborate with other organizations not funded by CDC, including but not limited to:

United States Agency for International Development (USAID): Mozambique PEPFAR partner with program representing approximately 50% national coverage of people living with HIV (PLHIV), https://www.usaid.gov/

Department of Defense: Mozambique PEFPAR partner with program representing less than 5% National coverage of PLHIV, https://www.defense.gov/

Mozambique health sector and other government sectors responsible for assuring public works

Mozambique civil society organizations and other organizations directly working in HIV programmatic areas

2. Target Populations The target population of this NOFO is both health care workers, including the MOH and the various CDC clinical and programmatic partners, and PLHIV. Targeting these populations though increased and improved facility capacity will increase their ability and focus on sustainable epidemic control, which will directly affect the population of Mozambique and support the achievement of epidemic control.

a. Health Disparities N/A

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Partners receiving HHS/CDC funding must place a clear emphasis on developing local indigenous capacity to deliver HIV/AIDS related services to the Mozambican population and must also coordinate with activities supported by Mozambican, international, or USG agencies to avoid duplication. Partners receiving HHS/CDC funding must collaborate across program areas whenever appropriate or necessary to improve service delivery.

It is expected that the recipient(s) should allocate 3% of their budget for internal monitoring activities and 3% of the budget for internal evaluation activities.

Performance Measurement: (Please Note: The targets included in this Evaluation and Performance Measurement Plan (EPMP) are expected to be achieved by the recipient(s) at the end of the project period.)

Monitoring Questions: Are NOFO outputs and outcomes being achieved?

Target Outputs:

o Health Facility Readiness Assessment conducted at 100% of the pre-identified priority sites, with 100% of the results reviewed and disseminated by 6 months after the last assessment o Findings from the Health Facility Readiness Assessment are used to inform implementation and the prioritization of healthy facility need https://www.usaid.gov/ https://www.defense.gov/ o 100% of health facilities selected for renovation and/or pre-fabs with documentation of decision-making by end of project o Clear documentation of a consistent process implemented across multiple partners to improve efficiencies and program impact o Bi-weekly communication with relevant stakeholders in targeted facilities to assess the need and impact of renovations/pre-fabs

Data Source: Monthly partner meetings, quarterly Monitoring, Evaluation, and Reporting (MER) and Narrative results reporting

Frequency of Collection: Recipient(s) will manage and analyze performance measure data and will report to CDC Mozambique (CDC MZ) every quarter. CDC will review data submitted by partners on a quarterly, semi-annual, and annual basis and will submit data to the Office of the Global AIDS Coordinator (OGAC).

Evaluation Question:

How did recipient activities impact (increase, decrease) patient capacity and utilization - as measured by patient load per day, patient wait times, and overall number of patients - at selected health facilities?

Type of Evaluation: Outcome Evaluation (to be conducted in year 4) Data Source and Variable: Monthly partner meetings, project officers, facility records, patient registries, program managers to determine at minimum:

o Space available at selected health facilities before and after renovation or pre-fab installation o Layout of space before and after o Patient flow in facilities before and after o Patient load by selected facility before and after o Patient wait times and satisfaction before and after

Collection Method: Literature review, key informant interviews, strategic meetings, and other methods as appropriate

Dissemination: Recipient(s) are expected to report on evaluation results and on performance measures at least annually or as specified by the CDC MZ project officer.

The findings of any additional evaluation or study will be disseminated to the CDC MZ project officer through the Annual Progress Report.

Evaluations are expected to align with national, PEPFAR, and agency priorities and programmatic gaps, and will be reviewed and approved as part of the Country Operating Plan (COP). As such, the evaluation questions listed in this announcement may be amended based on feedback from the Office of the U.S. Global AIDS Coordinator and Health Diplomacy during the annual COP review process.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans.

For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach Applicants should provide the following materials in the appendix:

Curricula Vitae (CVs)/Resumes of key positions, including but not limited to: Project Manager, Construction Supervisor, Logistics Advisor, Key Implementation Staff

Job Descriptions for key positions, including but not limited to those listed above Organizational Chart Experience Statement (maximum 3 pages total). Each example should include:

o Title of program/project o Organizational role (prime or sub-recipient) o Collaborations o Approximate duration of program/project (years or months) o Project budget (in US dollars) and funding source(s) o Geographic and population focus o Main achievements/accomplishments of the work

Financial management statement (maximum 4 pages) that describes the following:

o Systems and procedures used to manage funds https://www.cdc.gov/grants/additionalrequirements/ar-25.html o Procurement procedures o Human resource management model o Office based in Mozambique o Approach to manage program performance, evaluation, performance monitoring, financial reporting o Previous experience managing budgets greater than $1,000,000 total project funding

These materials should demonstrate organizational capacity to address the requirements of the NOFO and specifically in the following areas:

Capacity in sub-Saharan Africa / Mozambique Expertise in managing health services renovations or setting up pre-fab units Appropriate attribution of Senior-level, given the complexity described Experience in convening multi-stakeholders via participatory approaches Experience in working with USG donors Experience in working with the Government of Mozambique Fluency in English and Portuguese

Applicants must title these documents in their appendix as follows: "CVs/Resumes," "Job Descriptions," "Organizational Chart," "Experience," or "Financial Management" and upload it at www.grants.gov.

d. Work Plan Applicant must include a work plan that demonstrates how the outcomes, strategies, activities, timelines, and staffing will take place over the course of the award. Applicants must submit a detailed work plan for the first year of the project and a high level plan for the subsequent years.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of http://www.grants.gov/ outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

CDC Activities

(1) Recipient Monitoring: CDC will conduct post-award monitoring of Recipient performance to ensure: (a) The Recipient’s progress in achieving the objectives of the award; (b) The adequacy of the Recipient's systems that underlie and generate reports, such as accounting systems and systems that collect and report project data; (c) Accountability for USG resources to include the property acquired or generated under the award; and (d) An environment that fosters integrity in program performance and results.

(2) Substantial Involvement: In addition to monitoring, CDC anticipates substantial involvement in the project. In a cooperative agreement, CDC staff is substantially involved in program activities, above and beyond routine grant monitoring. CDC activities for this program include, but are not limited to, the following:

1. Organize an orientation meeting with the recipient for a briefing on applicable USG, HHS/CDC, and PEPFAR expectations, regulations and key management requirements, as well as report formats and contents. The orientation could include meetings with staff from HHS agencies and OGAC.

2. Review and make recommendations as necessary to the process used by the recipient to select key personnel and/or post-award sub-contractors and/or sub-recipients to be involved in the activities performed under this agreement, as part of PEPFAR Country Operational Plan (COP) review and approval process, managed by the OGAC.

3. Review and approve recipient’s annual work plan and detailed budget, as part of the Emergency Plan for AIDS Relief Country Operational Plan review-and-approval process, managed by OGAC.

4. Review and approve the recipient’s monitoring and evaluation plan, including for compliance with the strategic information guidance established by the OGAC.

5. Meet on a regular basis with the recipient to assess expenditures in relation to approved work plan and modify plans as necessary.

6. Meet on a quarterly basis with the recipient to assess quarterly technical and financial progress reports and modify plans as necessary.

7. Meet on an annual basis with the recipient to review annual progress report for each USG Fiscal Year, and to review annual work plans and budgets for the subsequent year, as part of the PEPFAR review and approval process for COPs, managed by OGAC.

8. Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans. It could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, and confidential counseling and testing.

9. Provide in-country administrative support to help the recipient meet USG financial and reporting requirements approved by the Office of Management and Budget (OMB).

10. Collaborate with the recipient on designing and implementing the activities listed above, including, but not limited to: assistance in prioritization and selection of the final location of construction projects as well as the final design requirements for structures, the provision of technical assistance to develop program activities, data management and analysis, quality assurance, the presentation and possibly publication of information related to the program, and the management and tracking of finances.

11. Provide technical assistance or advice on any data collections on 10 or more people that are planned or conducted by the recipient. All such data collections-- where CDC staff will be or are approving, directing, conducting, managing, or owning data-- must undergo OMB project determinations by CDC and may require OMB PRA clearance prior to the start of the project.

12. Provide consultation and scientific and technical assistance based on appropriate HHS/CDC and OGAC documents to promote the use of best practices known at the time.

13. Assist the recipient in developing and implementing quality-assurance criteria and procedures.

14. Facilitate in-country planning and review meetings for technical assistance activities.

15. Provide technical oversight for all activities under this award.

16. Conduct site visits through the Site Improvement through Monitoring System (SIMS), in compliance with PEPFAR requirements, to monitor and evaluate clinical and community service delivery site capacity to provide high-quality HIV/AIDS services in all program areas and 'above-site' capacity to perform supportive or systemic functions, by assessing and scoring key program area elements of site performance and work with the recipient on identified gaps and continuous quality improvement, which might include more thorough data quality or service quality assessments as indicated.

17. Ensure the recipient’s Evaluation and Performance Measurement Plan is aligned with the strategic information guidance established by OGAC and other HHS/CDC requirements, including PEPFAR’s Monitoring Reporting and Evaluation (MER) strategy, PEPFAR’s Evaluation Standards of Practice, and CDC’s Data for Partner Monitoring Program (DFPM).

18. Provide ethical reviews, as necessary, for evaluation activities, including from HHS/CDC headquarters. Evaluations can be process, outcome or impact.

1. Process Evaluation: measures how the intervention was delivered, what worked/did not, differences between the intended population and the population served, and access to the intervention

2. Outcome Evaluation: determines effects of intervention in target population(s) (e.g., change in knowledge, attitudes, behavior, capacity, etc.).

3. Impact Evaluation: measures net effects of program and prove of causality.

19. Supply the recipient with protocols for related evaluations.

(3) Technical Assistance: Technical Assistance may be provided by CDC to the Recipient for purposes of increasing the likelihood of successful performance and compliance with financial management system standards. The Recipient may request post-award Technical Assistance from CDC both in the application and at any time during the project. Such Technical Assistance will be at CDC's discretion as there is no guarantee that requested Technical Assistance can or will be provided. CDC may self-initiate post-award Technical Assistance without a Recipient request if in the best interests of CDC. CDC may provide Technical Assistance on a grant or a cooperative agreement.

(4) Pre-Completion Inspections: As part of Recipient Monitoring and if BFO determines them to be necessary, CDC will conduct pre-completion inspections of the project. Such inspections may be triggered by calendar dates, by specific events, or by percentages of completion.

Inspections should be sufficient in quantity to ensure the quality of the project. Inspections may be conducted by a capable, independent inspector, to include CDC field staff, or they may be performed by other PEPFAR implementing partners that support health services at the site of the project on behalf of CDC. A Final Inspection of the project is always required (see below) and is not listed here.

(5) Final Inspection, Cost Analysis, and Closeout: After the completion date of the project, CDC or a designated implementing partner will perform a final inspection to ensure that the project conforms to the approved design documents. The final inspection may be conducted as a site visit, Recipient-submitted photographs of space, or other appropriate means, as determined by CDC. After the final inspection, CDC will perform a cost analysis to determine the final allowable costs for the project. The final allowable costs will be used for project closeout, and to quantify the USG interests in the project.

(6) Project Officer and Technical Advisor(s): CDC's Project Officer and Technical Advisors will monitor technical performance by the Recipient. The Technical Advisor(s) named in the award will review and provide technical assistance on technical aspects of the project such as drawings and specifications, applicable design standards and building codes, and building contractual documents.

(7) CDC Approval of Project Documents and Phases: As noted above, this project will be broken into four major phases: Procurement Planning, Assessment, Design, and Implementation.