oppCDC-RFA-PS18-1812-cfda93.939-cidCDC-RFA-PS18-1812-instructions.pdf

Centers for Disease Control

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention

Sustainable Healthcenter Implementation Pre-Exposure Prophylaxis (PrEP) Pilot (SHIPP)

CDC-RFA-PS18-1812

Application Due Date: 04/09/2018

Sustainable Healthcenter Implementation Pre-Exposure Prophylaxis (PrEP) Pilot (SHIPP)

CDC-RFA-PS18-1812

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Catalog of Federal Domestic Assistance (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 "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-PS18-1812. 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:

Sustainable Healthcenter Implementation Pre-Exposure Prophylaxis (PrEP) Pilot (SHIPP) 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)).

Pursuant to the statutory authority cited in CDC-RFA-PS18-1812, CDC is authorized to provide funds to the CDC Foundation through a grant for the activities described; however, the grant award shall not be used to fund administrative support and services.

The amount of the annual grant CDC provides to the CDC Foundation for administrative support and services is statutorily set (42 USC 280e-11 (i)(2)(A)), and shall not be increased without a change to the statutory authority set by Congress.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS18-1812

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.939 F. Dates:

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

2. Due Date for Applications: 04/09/2018, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

Due Date for Applications: April 09, 2018 , 11:59 p.m. U.S. Eastern Standard Time, at www .grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances prelude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

The Centers for Disease Control and Prevention announces the availability of fiscal year 2018 funds for a cooperative agreement program for one community based organization (CBO) to https://www.grants.gov 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 https://www.grants.gov http://www.grants.gov/ http://www.grants.gov/ conduct a project: Core Health Services Demonstration project Observational Cohort Project.

The objective of this project is to assess the socioeconomic, demographic, and behavioral HIV acquisition risk characteristics of persons who initiate, continue, or discontinue PrEP medication use, and the costs and clinic reimbursements for PrEP medications and clinical services. The applicant must possess the ability to contract with clinics that will coordinate project assessments of clinical and behavioral safety while persons are prescribed PrEP, evaluate the levels and determinants of medication adherence by persons prescribed PrEP, including those who receive basic or supplementary adherence support interventions, and evaluate clinician compliance/variation with PHS PrEP guidelines and their relationship to patient outcomes. These goals will be achieved by capturing information about PrEP services provided in community health centers to understand patient outcomes associated with documented fidelity or variance in actual practice to guidelines-recommended clinical services and patient behaviors. Standard performance measures for HIV prevention programs that are consistent with the focus of accountability are included in this NOFO.

a. Eligible Applicants:

b. NOFO Type:

c. Approximate Number of Awards:

d. Total Period of Performance Funding:

e. Average One Year Award Amount:

f. Total Period of Performance Length:

g. Estimated Award Date:

Single Cooperative Agreement

$833,025

$833,025

1.5 04/16/2018

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, 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 HIV infections in the United States continue to be a major public health crisis. An estimated 1.2 million Americans are living with HIV, and 1 out of 8 people with HIV do not know they have

it. The highest rates of new HIV infections are occurring in African American and Hispanic MSM, African American women, and persons living in the southern U.S., however, initial use of Pre-Exposure Prophylaxis (PrEP) has been highest in urban, white, middle-aged gay and bisexual MSM.

The project aims to encourage adoption of evidence-based healthcare delivery models to reach populations that will benefit from PrEP use – particularly currently underserved populations in highly impacted communities – in order to decrease HIV infection rates. The recipient should use tools that capture information about PrEP services provided in community health centers to understand patient outcomes associated with documented fidelity or variance in actual practice to guidelines-recommended clinical services.

b. Statutory Authorities Sections 301 and 318 of the PHS Act [42 U.S.C. 241 and 247(c)], as amended.

c. Healthy People 2020 This NOFO addresses the “Healthy People 2020” focus area of HIV: https://www.healthypeople .gov/2020/topics-objectives/topic/hiv.

d. Other National Public Health Priorities and Strategies The National HIV/AIDS Strategy for the United States: Updated to 2020 and CDC Division of HIV/AIDS Prevention (DHAP) Strategic Plan: https://www.cdc.gov/nchhstp/docs/NCHHSTP- Strategic-Plan-through-2020-508.pdf Minority AIDS Initiative (MAI): https://www.hhs.gov/ohaidp/initiatives/index.html# CDC Winnable Battles: https://www.cdc.gov/WinnableBattles/index.html HIV/AIDS Care Continuum: https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care -continuum Additional information about the goals and strategies of NCHHSTP is available: http://www .cdc.gov/nchhstp

e. Relevant Work CDC-RFA-PS11-1113: https://www.grants.gov/web/grants/view-opportunity.html?oppId =80913 CDC-RFA-PS15-1502: https://www.grants.gov/web/grants/view-opportunity.html?oppId =263908 CDC-RFA-PS13-1308: https://www.grants.gov/web/grants/view-opportunity.html?oppId =218715 CDC-RFA-PS12-1201: https://www.grants.gov/web/grants/view-opportunity.html?oppId =102574 CDC-RFA-PS15-1510: https://www.grants.gov/web/grants/view-opportunity.html?oppId =275553 CDC-RFA-PS15-1509: https://www.grants.gov/web/grants/view-opportunity.html?oppId =275526 CDC-RFA-PS15-1506: https://www.grants.gov/web/grants/view-opportunity.html?oppId =275551 CDC-RFA-PS17-1704: https://www.grants.gov/web/grants/view-opportunity.html?oppId https://www.healthypeople.gov/2020/topics-objectives/topic/hiv https://www.healthypeople.gov/2020/topics-objectives/topic/hiv https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.hhs.gov/ohaidp/initiatives/index.html https://www.cdc.gov/WinnableBattles/index.html https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum http://www.cdc.gov/nchhstp http://www.cdc.gov/nchhstp https://www.grants.gov/web/grants/view-opportunity.html?oppId=80913 https://www.grants.gov/web/grants/view-opportunity.html?oppId=80913 https://www.grants.gov/web/grants/view-opportunity.html?oppId=263908 https://www.grants.gov/web/grants/view-opportunity.html?oppId=263908 https://www.grants.gov/web/grants/view-opportunity.html?oppId=218715 https://www.grants.gov/web/grants/view-opportunity.html?oppId=218715 https://www.grants.gov/web/grants/view-opportunity.html?oppId=102574 https://www.grants.gov/web/grants/view-opportunity.html?oppId=102574 https://www.grants.gov/web/grants/view-opportunity.html?oppId=275553 https://www.grants.gov/web/grants/view-opportunity.html?oppId=275553 https://www.grants.gov/web/grants/view-opportunity.html?oppId=275526 https://www.grants.gov/web/grants/view-opportunity.html?oppId=275526 https://www.grants.gov/web/grants/view-opportunity.html?oppId=275551 https://www.grants.gov/web/grants/view-opportunity.html?oppId=275551 https://www.grants.gov/web/grants/view-opportunity.html?oppId=286101

=286101

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities Short Term

Outcomes Intermediate Outcomes

Long Term Outcomes

Coordinate implementation of health services demonstration project to capture information about PrEP services provided in community health centers

Contract with clinics that will coordinate project assessments of clinical and behavioral safety while persons are prescribed PrEP, evaluate the levels and determinants of medication adherence by persons prescribed PrEP, including those who receive basic or supplementary adherence support interventions, and evaluate clinician compliance/variation with PHS PrEP guidelines and their relationship to patient outcomes

Assess the socioeconomic, demographic, and behavioral HIV acquisition risk characteristics of persons who initiate, continue, or discontinue PrEP medication use, and the costs and clinic reimbursements for PrEP medications and clinical services

Analyze data collected from the

Improved understanding of patient outcomes associated with documented fidelity or variance in actual practice to guidelines, recommended clinical services and patient behaviors

Increased evidence base for decision-making around PrEP delivery in the U.S

Increased adoption of evidence-based healthcare delivery models to reach underserved populations that will benefit from PrEP use

Increased knowledge among providers in the use of PrEP and patient outcomes

Increase use of PrEP among high risk populations

Decrease HIV transmission

Decrease HIV Incidence https://www.grants.gov/web/grants/view-opportunity.html?oppId=286101 clinics in order to develop a written report on the subject matter

Write report using the analyzed data that was collected from the clinics for educational purposes and to make informed health decisions

i. Purpose The purpose of the SHIPP Project is to answer important questions about the delivery, outcomes, cost and sustainability of PrEP when provided as a clinical prevention service in community settings. SHIPP is unique in engaging United States (U.S.) populations at highest risk for HIV infection, and providing them with PrEP care in settings with providers and procedures representative of “real world” use.

ii. Outcomes Improved understanding of patient outcomes associated with documented fidelity or variance in actual practice to guidelines, recommended clinical services and patient behaviors Increased evidence base for decision-making around PrEP delivery in the U.S Increased adoption of evidence-based healthcare delivery models to reach underserved populations that will benefit from PrEP use

iii. Strategies and Activities Coordinate implementation of health services demonstration project to capture information about PrEP services provided in community health centers Contract with clinics that will coordinate project assessments of clinical and behavioral safety while persons are prescribed PrEP, evaluate the levels and determinants of medication adherence by persons prescribed PrEP, including those who receive basic or supplementary adherence support interventions, and evaluate clinician compliance/variation with PHS PrEP guidelines and their relationship to patient outcomes Assess the socioeconomic, demographic, and behavioral HIV acquisition risk characteristics of persons who initiate, continue, or discontinue PrEP medication use, and the costs and clinic reimbursements for PrEP medications and clinical services Analyze data collected from the clinics in order to develop a written report on the subject matter Write report using the analyzed data that was collected from the clinics for educational purposes and to make informed health decisions

1. Collaborations

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

N/A

b. With organizations not funded by CDC:

The recipient must collaborate with the following clinics:

Access Community Health Center, Grand Boulevard in Chicago, Illinois Howard Brown Health Center in Chicago, Illinois Open Arms Health Center in Jackson, Mississippi Strawberry Mansion in Philadelphia, Pennsylvania Whitman Walker Health in Washington, DC

2. Target Populations All persons at risk for HIV infection, to include gay and bisexual men, communities of color, women, injection drug users (IDUs) and transgender persons.

a. Health Disparities The NOFO will reduce health disparities among populations at greatest risk by understanding the adoption of evidence-based healthcare delivery models for populations that will benefit from PrEP use- particularly currently underserved populations in highly impacted communities.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

The observational cohort assessment (non-research) retrieves de-identified data from the electronic medical records and billing records of all patients who received PrEP at the 5 clinics during the period of performance (2018 to 2019); >5000 patients are in the observational cohort:

o Through late 2017, costs for non-research and project coordination activities have been provided by external funders to the CDC Foundation who, in turn sub-contracts with the sites.

o These costs (which will continue for the remaining months of the project and its close-out activities) include:

site investigator salary to oversee project activities, participate in investigator calls and face-to-face meetings, conduct analyses of local and project-wide data for publication and presentation site staff to coordinate project activities, resolve questions arising during cleaning of project data for analysis, assign SHIPP IDs for record extraction, conduct or assist with medical record and billing record abstraction computer programmer and EMR vendor costs in obtaining medical record abstraction

DHAP will prepare datasets for each analysis approved by the SHIPP investigators to insure uniform definition of critical variables. Some of these analyses are done at DHAP in consultation with site investigators. In some cases, datasets are sent to site investigators for analysis with participation of DHAP scientists, statisticians, and SHIPP investigators from other sites.

NOFO activities will support current and future CDC HIV prevention programs and initiatives.

SHIPP Project Outcome Measures

Among persons who initiate, continue, or discontinue PrEP use:

o Age, race/ethnicity, sex, sexual orientation o HIV acquisition risk level o Partnership status (HIV discordant or not)

Among all persons who are being prescribed PrEP medication:

o Rates of renal adverse events o Rates of atraumatic bone fractures o Rates of PrEP discontinuation of adverse events related to safety o Trends in HIV acquisition risk behaviors over time

Among persons being prescribed PrEP medications:

o Proportion who have documented screening of acute HIV infection, HIV-negative test results, hepatitis B infection/vaccination status, pregnancy (women) prior to first prescription;

o Proportion of persons who have documented HIV test results at three month intervals while receiving PrEP

Costs for PrEP medications and clinical services:

o Costs-billed, reimbursed, and unreimbursed o Source of payment for PrEP medication

Among persons who acquire HIV infection while taking PrEP medication:

o Proportion with detected viral mutations associated with resistance PrEP medication

Level of self-report adherence measure at the visit where HIV infection detected and the immediately prior visit

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, 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 All applicant organizations must demonstrate their existing or forthcoming capacity to successfully execute all proposed strategies and activities to meet the program requirements.

Applicants must have demonstrable expertise, experience, and/or capacity to develop, implement, and evaluate the required program strategies and activities. Working with community health centers, and other community providers who serve the selected target population(s) are integral to program implementation. Applicants should describe their mission;

organizational structure; overall organizational budget and funding sources; staff size and expertise; the nature and scope of their work and capabilities; long-term sustainability plan; and other information that would help CDC assess the organization’s infrastructure and capacity to implement the proposed program. Applicant organizations should address the physical infrastructure as it relates to equipment, electronic information and data systems, and communication systems to implement the award.

Workforce Capacity https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Additionally, applicants must provide details on their workforce capacity and competence, expertise and experience serving and/or working with the target population(s) selected as it relates to all category-specific program strategies and activities. Applicants must have a strategy to ensure that the development and delivery of the Sustainable Healthcenter Implementation Pre-Exposure Prophylaxis (PrEP) Pilot (SHIPP) is culturally, linguistically, and educationally appropriate to meet the needs of the selected target population(s). This includes experience and expertise related to the implementation of the required strategies and activities, recent examples of HIV prevention program development and implementation, specifically for the target population(s), and demonstrated outcomes or benefits related to the HIV prevention services provided. If applicable, the applicant will be expected to provide a description of their current CDC funded HIV prevention projects.

Staffing Applicants must provide evidence of adequate program management/staffing plans, performance measurement, evaluation, financial reporting, management of travel requirements, and workforce development and training. Applicants must have a plan to ensure program has competent staff (e.g., accessing capacity building assistance to support workforce development), inclusive of subcontractors and consultants if applicable, throughout the duration of the 18-month project. The plan should be designed to promote and sustain peer leadership from within the target population(s). Staff must have the breadth of subject matter expertise and experience required to conduct all proposed work. When feasible, applicants must hire direct service staff who have 12 months minimum experience working with and who are reflective of the target population(s). Applicants should describe how they will assess staff competencies and develop a plan to address gaps through organizational and individual training and development opportunities. Additionally, a curriculum vitae or resume must be submitted for each existing staff person who will be affiliated with this program. Applicant organizations are also required to provide an agency-wide organizational chart and an organizational chart for the proposed program.

d. Work Plan Applicants are required to provide a work plan that provides both a high-level overview of the entire 18-month period of performance and a detailed description of the award. The work plan should incorporate all NOFO-related program strategies and activities. Applicants should propose specific, measurable, achievable, realistic, and time-based (SMART) process and/or outcome objectives for each activity aligned with the related NOFO performance objectives.

Also included should be the training, capacity building, and technical assistance (TA) needs to support the implementation of the proposed program. Included in the work plan should be a concise description on how the recipient plans to implement and monitor each program activity.

Note: Post-award, proposed work plan activities may be adjusted in collaboration with CDC to better address the overarching goals of the project.

The applicant should address the following outline in their work plan:

1. One-Year Overview of Project (include narrative)

Intended outcomes for the entire one-year project period

1. Detailed Work Plan

Program strategies and activities Outcomes aligned with program strategies and activities SMART objectives aligned with performance targets (including quantitative baselines and targets, based on the proposed program, that lead to an increase, decrease, or maintenance over time)

Activities aligned with program objectives Timeline for implementation (including staffing of the proposed program, CBA/TA and training, etc.)

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 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)

In a cooperative agreement, CDC staff will be substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program are as follows:

1. Collaborate to ensure coordination and implementation of strategies to arrange for availability of HIV prevention providers in healthcare organizations.

2. Work with recipient to identify and address CBA/TA needs that are essential to the success of the project.

Within the first three (3) months of funding, recipient must work with the assigned PPB Project Officer to establish a CBA Request Information System (CRIS) user account to facilitate receipt of capacity building assistance.

Within the first six (6) months of funding, CDC will work with recipient to finalize data collection, use, and submission requirements.

3. Provide guidance and coordination to funded organizations to improve the quality and effectiveness of work plans, evaluation strategies, products and services, and collaborative activities with other organizations.

4. Collaborate to compile and publish accomplishments, best practices, performance criteria, and lessons learned during the project period.

5. Collaborate, as appropriate, in assessing progress toward meeting strategic and operational goals/objectives and in establishing measurement and accountability systems for documenting outcomes, such as increased performance improvements and best or promising practices.

6. Collaborate on strategies to ensure the provision of appropriate and effective HIV prevention services to target populations, as deemed appropriate and as requested.

7. Convene, plan, and facilitate a joint recipient meeting during the project period.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: U01

3. Fiscal Year: 2018

4. Approximate Total Fiscal Year Funding: $833,025

5. Approximate Period of Performance Funding: $833,025

This amount is subject to the availability of funds.

Estimated Total Funding: $833,025

6. Approximate Period of Performance Length: 1.50 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $833,025 Per Budget Period

9. Award Ceiling:

This amount is subject to the availability of funds.

10. Award Floor:

11. Estimated Award Date:

12. Budget Period Length:

$833,025 Per Budget Period

$833,025 Per Budget Period

04/16/2018

18 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the 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. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this FOA.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Additional Information on Eligibility Eligibility is limited to the CDC Foundation.

The award ceiling for Part 1 is $833,025. CDC will not consider any application requesting an award higher than the specified amount.

3. Justification for Less than Maximum Competition As the incumbent organization currently implementing the SHIPP study, the CDC Foundation is uniquely qualified to perform the work proposed in this NOFO. The CDC foundation launched the SHIPP Study in 2013 to answer questions about the delivery, outcomes, cost and sustainability of Pre-Exposure Prophylaxis (PrEP) when provided as a clinical prevention service in community settings. SHIPP is unique in engaging U.S. populations at highest risk for HIV infection and providing them with PrEP care in settings with providers and procedures representative of “real world” use. Study findings will be a significant and much needed contribution to the evidence base for future decision-making around PrEP delivery in the U.S.

The CDC Foundation is requesting funding to conduct the following non-research activities which are crucial to completing the Project: The de-identify, transfer analysis, compilation and publication of data that has already been collected over the course of the study.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number.

A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the “Get Registered” option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/portal/public/SAM/ https://grants.gov/ https://www.grants.gov/ https://www.grants.gov/ https://www.grants.gov/ usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

Step System Requirements Duration Follow Up 1 Data

Universal Number System

(DUNS)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-5711

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to www.sam.gov and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/ fsd-gov/ home.do Calls:

866-606-8220

3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the password the E- BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the organization

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants

MUST

obtain a

DUNS

number and

SAM

account before applying on grants.gov)

Register early!

Log into grants.gov and check AOR status until it shows you have been approved http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://www.sam.gov https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC OGS staff at 770-488- 2700 or e-mail OGS ogstims@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by

OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: N/A

b. Application Deadline Due Date for Applications: 04/09/2018 , 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Date for Information Conference Call N/A

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC https://www.grants.gov https://www.grants.gov mailto:ogstims@cdc.gov https://www.grants.gov http://www.grants.gov/ http://www.grants.gov/ http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent LOI is not requested or required as part of the application for this NOFO.

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary (Maximum 1 page) A project abstract is included on the mandatory documents list and must be submitted http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Unless specified in the "H. Other Information" section, maximum of 20 pages, single spaced, 12 point font, 1-inch margins, number all pages. This includes the work plan. Content beyond the specified page number will not be reviewed.)

Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov. The Project Narrative must include all of the following headings (including subheadings): Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire period of performance as identified in the CDC Project Description section. Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Notice of Funding Opportunity. Note that recipients should also use these tools when creating public communication materials supported by this NOFO. Failure to follow the guidance and format may negatively impact scoring of the application.

a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDC Background).

b. Approach

i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the public health problem as described in the CDC Background section.

ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period, as identified in the logic model in the Approach section of the CDC Project Description.

Outcomes are the results that the program intends to achieve and usually indicate the intended direction of change (e.g., increase, decrease).

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the period of performance outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan how these strategies will be evaluated over the course of the project period.

https://www.grants.gov

See the Strategies and Activities section of the CDC Project Description.

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC. Applicants must address the Collaboration requirements as described in the CDC Project Description.

2. Target Populations and Health Disparities Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. The applicants must also address how they will include specific populations that can benefit from the program that is described in the Approach section. Applicants must address the Target Populations and Health Disparities requirements as described in the CDC Project Description.

c. 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. The Paperwork Reduction Act of 1995 (PRA): Applicants are advised that any activities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and local governmental agencies, and funded or sponsored by the Federal Government are subject to review and approval by the Office of Management and Budget. For further information about CDC’s requirements under PRA see http://www.hhs.gov/ ocio/policy/collection/.

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, data management plan (DMP), and other relevant data information (e.g., performance measures proposed by the applicant).

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 http://www.hhs.gov/ocio/policy/collection/ plan (including the DMP elements) within the first 6 months of award, as described in the Reporting Section of this NOFO.

d. Organizational Capacity of Applicants to Implement the Approach Applicants must address the organizational capacity requirements as described in the CDC Project Description.

11. Work Plan (Included in the Project Narrative’s page limit) Applicants must prepare a work plan consistent with the CDC Project Description Work Plan section. The work plan integrates and delineates more specifically how the recipient plans to carry out achieving the period of performance outcomes, strategies and activities, evaluation and performance measurement.

12. Budget Narrative Applicants must submit an itemized budget narrative. When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget must include:

Salaries and wages Fringe benefits Consultant costs Equipment Supplies Travel Other categories Contractual costs Total Direct costs Total Indirect costs

Indirect costs could include the cost of collecting, managing, sharing and preserving data.

Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements at a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activities as they relate to the intent of this NOFO to meet national standards or seek health department accreditation through the Public Health Accreditation

Board (see: http://www.phaboard.org). Applicant entities to whom this provision applies include state, local, territorial governments (including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau), or their bona fide agents, political subdivisions of states (in consultation with states), federally recognized or state-recognized American Indian or Alaska Native tribal governments, and American Indian or Alaska Native tribally designated organizations. Activities include those that enable a public health organization to deliver public health services such as activities that ensure a capable and qualified workforce, up-to-date information systems, and the capability to assess and respond to public health needs. Use of these funds must focus on achieving a minimum of one national standard that supports the intent of the NOFO. Proposed activities must be included in the budget narrative and must indicate which standards will be addressed.

Applicants must name this file “Budget Narrative” and upload it as a PDF file at www.grants.gov. If requesting indirect costs in the budget, a copy of the indirect cost-rate agreement is required. If the indirect costs are requested, include a copy of the current negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Recipients under such a plan. Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.

13. Funds Tracking Proper fiscal oversight is critical to maintaining public trust in the stewardship of federal funds.

Effective October 1, 2013, a new HHS policy on subaccounts requires the CDC to set up payment subaccounts within the Payment Management System (PMS) for all new grant awards.

Funds awarded in support of approved activities and drawdown instructions will be identified on the Notice of Award in a newly established PMS subaccount (P subaccount). Recipients will be required to draw down funds from award-specific accounts in the PMS. Ultimately, the subaccounts will provide recipients and CDC a more detailed and precise understanding of financial transactions. The successful applicant will be required to track funds by P-accounts/sub accounts for each project/cooperative agreement awarded. Applicants are encouraged to demonstrate a record of fiscal responsibility and the ability to provide sufficient and effective oversight. Financial management systems must meet the requirements as described 2 CFR 200 which include, but are not limited to, the following:

Records that…