PKG00262095-instructions.pdf

DEPARTMENT OF

HEALTH AND HUMAN SERVICES

OFFICE OF THE

ASSISTANT SECRETARY FOR HEALTH

Office of Population Affairs

Funding Opportunity: Pregnancy Prevention Research Grants

Opportunity Number: PA-PHE-20-002

Application Due Date:

Tuesday, August 4, 2020 at 6:00 PM Eastern

OVERVIEW

FEDERAL AGENCY NAME

Office of the Assistant Secretary for Health / Office of Population Affairs

FUNDING OPPORTUNITY TITLE

Pregnancy Prevention Research Grants

ACTION

Notice

ANNOUNCEMENT TYPE

Initial Competitive Grant

FUNDING OPPORTUNITY NUMBER

PA-TPE-20-002

CFDA NUMBER AND PROGRAM:

93.343

DATES

Application Deadline: Tuesday, August 4, 2020 by 6:00 PM Eastern.

Technical Assistance: Webinar Wednesday June 24, 2020 at 4:00 PM Eastern.

EXECUTIVE SUMMARY

The Office of Population Affairs (OPA) announces the availability of funds for Fiscal Year

(FY) 2020 initial competitive grant awards under the authority of Section 241 of the Public Health

Service Act.

This notice solicits applications for projects that will conduct research that would make significant contributions to the mission of the Office of Population Affairs and to the pregnancy prevention and family planning fields.

Under this announcement, research and evaluation projects that encourage healthy behavior choices to delay the onset of sexual activity, reduce number of sexual partners, and if sexually active, encourage the use of preventative measures for STIs and pregnancy will be considered. These grants are for research that can be conducted within 1-2 years, such as secondary data analyses using existing program and evaluation data or administrative data.

Potential areas of investigation include, but are not limited to:

• Identify factors that improve the efficiency, effectiveness, and quality of pregnancy prevention programs for adolescents or young adults, or reduce disparities, by age, gender, race/ethnicity, or setting.

• Identify and/or validate core program components or “active ingredients” essential for programs and practices to produce the desired outcomes.

• Identify specific characteristics of program models, participants, or program implementation associated with program impacts.

• Apply innovative methods or techniques from other disciplines that are novel to pregnancy prevention research such as network analysis, matching and distillation techniques, system dynamics modeling or geographic information systems, to address questions beyond the general effectiveness of pregnancy prevention programs.

HHS/OASH encourages applicants to review all program requirements, eligibility information, application format and submission information, evaluation criteria, and other information in this funding announcement to ensure that its application complies with all requirements and instructions.

FUNDING OPPORTUNITY DETAILS

A. DATES

1. Application Deadline

Your application is due Tuesday, August 4, 2020 by 6 p.m. Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this due date and time. If you do not submit your application by the specified deadline, we will return it to you unread. You must submit electronically via Grants.gov unless you obtain a written exemption from this requirement 2 business days in advance of the deadline from the Director, HHS/Office of the Assistant Secretary for Health (OASH) Grants and Acquisitions Management

(GAM) Division. To obtain an exemption, you must request one via email from the

HHS/OASH/GAM, and provide details as to why you are technologically unable to submit electronically through Grants.gov. Your request should be submitted at least 4 business days prior to the application deadline to ensure your request can be considered prior to 2 business days in advance of the deadline. If you request an exemption, include the following in your e-mail request:

the HHS/OASH announcement number; your organization's DUNS number; your organization’s name, address and telephone number; the name and telephone number of your Authorizing

Official; the Grants.gov Tracking Number (for example, GRANT####) assigned to your submission; and a copy of the "Rejected with Errors" notification from Grants.gov. Send the request with supporting documentation to OASH_Grants@hhs.gov. Note: failure to have an active

System for Account Management (SAM) registration prior to the application due date will not be grounds for receiving an exemption to the electronic submission requirement. As a result of the public health emergency for COVID-19, the requirement for an active SAM registration at the time of application submission has been waived (see Section F.4). However, if you do not have a

DUNS number at this time, you should contact the Grants.gov to establish a temporary DUNS number. Your application will not be accepted through Grants.gov without this number. Failure to follow Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

HHS/OASH/GAM will only accept applications via alternate methods (hardcopy paper via

U.S. mail or other provider or PDF via email) from applicants obtaining prior written approval. If you receive an exemption, you must still submit your application by the deadline. Only applications submitted through the Grants.gov portal or alternate format (hardcopy paper via U.S.

mail or other service or PDF via email) with an approved written exemption will be accepted. See

Section F.8 (“Other Submission Requirements”) for information on application submission mechanisms.

To ensure adequate time to submit your application successfully, HHS/OASH recommends that you register as early as possible in Grants.gov since the registration process can take up to one month. You must register an authorizing official for your organization. HHS/OASH does not determine your organization’s authorizing official; your organization makes that designation. For information on registering for Grants.gov, refer to http://www.grants.gov or contact the Grants.gov http://www.grants.gov/

Contact Center 24 hours a day, 7 days a week (excluding Federal holidays) at 1-800-518-4726 or support@grants.gov.

Your organization is strongly encouraged to register multiple authorized organization representatives in Grants.gov to ensure someone is available to submit your application.

2. Technical Assistance

A technical assistance webinar for potential applicants will be held on Wednesday, June

24, 2020 at 4:00 PM Eastern. Log-in information and additional details will be posted on the OPA website at https://www.hhs.gov/opa/grants-and-funding/index.html.

We recommend you review the entire announcement promptly so you can have any questions answered well in advance of the application due date. We also recommend you subscribe to this announcement in Grants.gov so you receive any amendments, question and answer documents, or other updates.

B. PROGRAM DESCRIPTION:

The Office of the Assistant Secretary for Health (OASH), Office of Population Affairs

(OPA) announces the availability of funds for Fiscal Year (FY) 2020 grant awards under the authority of Section 241 of the Public Health Service Act.

The primary focus of OASH is leading America to healthier lives, especially for those who are most vulnerable, including those who have suffered historic disparities. In support of this vision, the OPA promotes health across the reproductive lifespan through innovative, evidence-based adolescent health and family planning programs, services, strategic partnerships, evaluation, and research. Research supporting the Teen Pregnancy Prevention (TPP) Program is designed to give youth the information and skills to promote optimal health and prevent teen pregnancy across mailto:support@grants.gov https://www.hhs.gov/opa/grants-and-funding/index.html the United States, especially among those who are most vulnerable, including those who have suffered historic disparities.

1. Background

There has been much progress in reducing teen pregnancy and teen birth. However, the current teen birth rate in 2017 of 18.8 per 1,000 females aged 15-19 [3] is still much higher than other western industrialized nations [1], young people ages 15 to 24 account for nearly one-half of all new cases of sexually transmitted diseases [1], and we continue to see disparities by race [3], ethnicity [3], and among our most vulnerable populations, including youth who are homeless, living in foster care, or involved with the juvenile justice system [4, 6].

This purpose of this FOA is to solicit applications for projects that will allow the exploration of new questions in the area of promotion of healthy behaviors to prevent teen pregnancy. The funding for this FOA comes from authority in Section 241 of the Public Health

Service Act and is subject to annual appropriations “to carry out evaluations (including longitudinal evaluations) of teenage pregnancy prevention approaches.” P.L. 116-94. With this

FOA, OPA is interested in analyses of existing rigorous evaluation data, including new or advanced methods of analyses, or novel combination and integration of datasets to allow the exploration of new questions in the area of teen pregnancy prevention.

OPA expects awardees to conduct investigations in relation to key pregnancy prevention outcomes including, but not limited to: 1) delay of the onset of sexual activity; 2) number of sexual partners; 3) use of effective contraceptive methods; 4) pregnancies and births; and/or 5) incidence of STIs. Awardees may focus on one or more of these outcomes, or focus on outcomes not listed in here but pertinent to preventing teenage pregnancy as described in their application.

Proposed grant projects are not limited to publications and datasets from OPA’s prior

Federal evaluations but may also include large, nationally representative data sets; data from other sources; and data from Federal, State, or local governmental agencies. If quantitative data is not publically available, the applicant will need to describe their possession of or ability to obtain and utilize private datasets.

Awards under this announcement are intended to synthesize and translate existing research.

Awards under this announcement are not intended as a means to carry out data collection, ongoing data analysis or for the maintenance and distribution of data sets. Proposed secondary data analyses must be distinct from the aims and methods of the primary research under which the data were collected, i.e., effects or outcomes previously examined in the original scope of research, and avoid duplication with existing projects in the field. Secondary data analyses using extant data obtained from rigorous program evaluations that analyze program components, populations, or settings that were not previously examined in the original scope of research, and particularly analyses that combine data from multiple rigorous evaluations of a particular effective TPP program, are a priority for this announcement.

2. OPA’s Pregnancy Prevention Efforts

The Office of Population Affairs’ (OPA)’s mission is to promote health across the reproductive lifespan through innovative, evidence-based adolescent health and family planning programs, services, strategic partnerships, evaluation and research. OPA currently administers multiple large assistance programs and several large national evaluation contracts that aim to reduce teenage pregnancy rates, and promote optimal health for adolescents.

OPA’s Teen Pregnancy Prevention (TPP) Program was initiated in FY 2010 as one of six major evidence-based policy initiatives across the Federal government. From FY2010 – FY2020, OPA has provided funding to over 200 organizations across the country to either 1) support replication of evidence-based programs proven effective through rigorous evaluation to prevent teen pregnancy and/or other associated risk behaviors; or 2) to support research and demonstration projects to develop and test additional models and innovative strategies. OPA also administers the

Title X Family Planning program, the only federal grant program dedicated to solely providing individuals with comprehensive family planning and related preventative health services. The

Title X program is designed to provide access to contraceptive services, supplies, and information to all who want and need them. By law, priority is given to persons from low-income families.

For more information about the Title X program and grantees see https://www.hhs.gov/opa/title-x-family-planning/about-title-x-grants/index.html.

Between FY2010-FY2019 OPA also funded the Pregnancy Assistance Fund, providing funding to states and tribes for programs that support expectant and parenting teens, women, fathers, and their families. In addition to these grant programs, OPA has several contracts to support and conduct rigorous Federal evaluations of interventions in these grant programs. For a description of program evaluations and research ongoing or previously conducted as part of

Federal evaluations, please refer to https://www.hhs.gov/ash/oah/evaluation-and-research/federal-led-evaluation/index.html and https://www.hhs.gov/ash/oah/evaluation-and-research/teen-pregnancy-prevention-program-evaluations/ .

Finally, Adolescent Health: Think, Act, Grow® (TAG) is a national call to action to improve health, to reduce risky behavior and to promote engagement and healthy development among young people. TAG sought the input of professionals who, through their work in after-https://www.hhs.gov/opa/title-x-family-planning/about-title-x-grants/index.html https://www.hhs.gov/opa/title-x-family-planning/about-title-x-grants/index.html https://www.hhs.gov/ash/oah/evaluation-and-research/federal-led-evaluation/index.html https://www.hhs.gov/ash/oah/evaluation-and-research/federal-led-evaluation/index.html https://www.hhs.gov/ash/oah/evaluation-and-research/teen-pregnancy-prevention-program-evaluations/ https://www.hhs.gov/ash/oah/evaluation-and-research/teen-pregnancy-prevention-program-evaluations/ school or community-based programs, education, faith-based organizations, health care, public health, and social services settings, reach a large number of adolescents. Together these national leaders identified five essential components of adolescent health, including positive connections with supportive people; safe and secure places to live, to learn and to play, access to high-quality, teen-friendly health care; opportunities for teens to engage as learners, leaders, team members and workers; and coordinated, adolescent and family-centered services. For more information about

TAG, please refer to: https://youth.gov/youth-topics/TAG.

It is important to note that OPA does not possess in-house the data from any of the grantee-led evaluations. Therefore, applicants will need to coordinate and or collaborate with current or former TPP grantees to obtain the data if they opt to utilize those data for analysis. OPA may assist with requests to obtain requested data and make it available. All TPP grantees are required to produce impact evaluation reports as part of their grants and these reports will either be made available to the public through the OPA website as they are completed and approved by OPA or available from OPA upon request. TPP grantees are also encouraged to publish their findings and impact reports may be published in academic journals. For more information on OPA’s grantee evaluations please refer to https://www.hhs.gov/ash/oah/grant-programs/teen-pregnancy-prevention-program-tpp/current-grantees/index.html

3. Program Components

The Federal government has placed great emphasis on utilizing interventions that are evidence-based. However, when evidence-based programs are replicated or scaled up, it is critical to know which program elements are essential in making the program successful. Unfortunately, there is little evidence to date about which program features are critical “core components” and https://youth.gov/youth-topics/TAG https://www.hhs.gov/ash/oah/grant-programs/teen-pregnancy-prevention-program-tpp/current-grantees/index.html https://www.hhs.gov/ash/oah/grant-programs/teen-pregnancy-prevention-program-tpp/current-grantees/index.html which features can be adapted without jeopardizing outcomes in these evidence-based interventions.

Core components are directly related to a program’s theory of change. To identify and validate core components through measures of fidelity is a difficult task, requiring research over time and across multiple replications. Additionally, with a strict focus on implementing evidence-based interventions with fidelity, few program evaluations have been able to research which components of the program are most strongly related to positive outcomes, because natural variation in implementation is often eliminated. While TPP grantees implement with fidelity, there are natural variations in population, setting, duration, etc. across the same program model or type of program that may provide ripe opportunity for examination.

According to Blase and Fixsen [5], “‘Core components’ include the functions or principles and related activities necessary to achieve outcomes. Strategies for a well-operationalized program include a clear description of: the context of the program; the core components; the active ingredients to operationally define the core components so they can be taught and learned and can be implemented in typical settings; and a practical strategy for assessing the behaviors and practices that reflect the program’s values and principles, as well as the program’s active ingredients and activities.” If a replication or an evaluation of an evidence-based program is unable to demonstrate outcomes, then it is critical to understand whether the core components were implemented correctly. This will allow us to disentangle whether the program was not effective due to the demographic or whether it was not implemented well.

By identifying and defining core components of evidence-based interventions, we are better able to:

• Focus resources and supports related to implementation (e.g., resources for staff recruitment and selection, training, coaching, fidelity monitoring).

• Interpret outcomes and engage in effective program improvement strategies.

• Make adaptations that improve fit and community acceptance, without jeopardizing the effectiveness of the intervention.

• Replicate and scale-up while avoiding program ‘drift’ that can lead to poor outcomes.

• Build coherent theory and practice related to diverse settings and/or programs.

4. Mediator/moderator analyses

Not all evidenced-based interventions are equally effective for all participants. There may be certain subgroups for which interventions demonstrate a greater level of effectiveness—these subgroups can be within populations, e.g., ethnicity or age or may include the program delivery setting and various lengths of program exposure. Understanding which subgroups an intervention will produce the desired outcomes of interest for is important when choosing an intervention for a particular need, as well as for developing future research priorities.

Moderators are variables that are present among the population before an intervention is implemented. Moderators have an effect on the outcome of interest by either positively or negatively intensifying it, thereby creating subgroups for which the intervention is more or less effective [7]. Alternatively, mediators show the steps through which change progresses from the intervention to the outcome [7]. If something is a mediator, then part of the intervention’s effect should move through the mediator before reaching the outcome. Therefore, if the mediator were removed, the total effect of the intervention should be decreased [7].

Identifying moderators and mediators of an intervention’s effect can lend support or clarify the theory of change for an intervention, inform optimization of an intervention’s effectiveness, and impart information that could lead to better efficiency in implementing the intervention [8].

5. New Outcome Measures

OPA’s TPP evaluations FY10-FY14 were required to address at least one outcome from the HHS Pregnancy Prevention Evidence Review (https://tppevidencereview.youth.gov/) including pregnancies, births, STIs, condom or contraceptive use, number of sexual partners, sexual initiation and frequency of sexual activity. In a time where the rate of pregnancies and births has dropped dramatically and the rates of sexual activity among adolescents is very low, along with limited time to conduct program evaluations, OPA is interested in new outcome measures, behavioral or otherwise, to capture the effectiveness of programs designed to prevent teen pregnancy, especially among younger teens. Identifying these “pre-sex” or more proximal measures related to later behavior changes and assessing their reliability, validity and variability would be an important contribution to the field.

C. AUTHORITY

Section 241 of the Public Health Service Act.

D. FEDERAL AWARD INFORMATION

https://tppevidencereview.youth.gov/

The Office of Population Affairs intends to make funds available for initial competitive grants. OPA will fund awards in annual increments (budget periods) and generally for a project period up to 2 years, although we may approve shorter project periods. Budget periods may also vary from the estimate indicated below due to timing of award issuance or other administrative factors. Funding for all approved budget periods beyond the first is generally level with the initial award amount and is contingent upon the availability of funds, satisfactory progress of the project, adequate stewardship of Federal funds, and the best interests of the Government.

Award Information

Estimated Federal Funds Available: $1,500,000

Anticipated Number of Awards: 2-3

Award Ceiling (Federal Funds including indirect costs): $1,500,000 per budget period

Award Floor (Federal Funds including indirect costs): $500,000 per budget period

Anticipated Start Date: September 30, 2020

Estimated Period of Performance: Not to exceed 2 years

Anticipated Initial Budget Period Length: 12 months

Type of Award: Grant

Type of Application Accepted: Electronic via Grants.gov ONLY unless an exemption is granted

E. ELIGIBILITY INFORMATION

1. Eligible Applicants.

Any public or private entity is eligible to apply for a grant under this announcement.

2. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget.

3. Application Responsiveness Criteria

We will review your application to determine whether it meets the responsiveness criteria below. If your application does not meet the responsiveness criteria, we will disqualify it from the competition; we will not review it beyond the initial screening. The responsiveness criteria are as follows:

The proposed investigations relate to key pregnancy prevention outcomes clearly identified in the Project Abstract including, but not limited to: 1) delay of the onset of sexual activity; 2) number of sexual partners; 3) use of effective contraceptive methods; 4) pregnancies and births;

and/or 5) incidence of STIs.

4. Application Disqualification Criteria

If you successfully submit an application, we will screen it to ensure it meets the below requirements. If we determine your application fails to meet the criteria described below we will disqualify it, that is, we will not review it and will give it no further consideration.

(a) You must submit your application electronically via www.grants.gov

(unless an exemption was granted 2 business days prior to the deadline) by the date and time indicated in the DATES Section (A.1) of this announcement.

(b) If you successfully submit multiple applications from the same organization for the same project, we will only review the last application received by the deadline.

(c) HHS/OASH/GAM deems your application eligible according to

Section E.1 Eligible Applicants.

(d) You must complete the required forms in the application package: SF-424, SF-424A, SF-424B, SF-LLL, and Project Abstract Summary.

(e) Your Project Narrative section of the application must be double-spaced, on the equivalent of 8 ½ ” x 11” inch page size, with 1” margins on all sides (top, bottom, left and right) and font size not less than 12 points.

(f) Your Project Narrative must not exceed 25 pages. NOTE: The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF-424B, SF-LLL, Project Abstract Summary, and

Budget Narrative (including budget tables).

(g) Your total application, including the Project Narrative plus Appendices, must not exceed 50 pages. NOTE: items listed in “(f)” immediately above do not count toward total page limit.

(h) Your Federal funds request including indirect costs must not exceed the maximum indicated in Award Ceiling.

(i) Your Federal funds request including indirect costs must not be below the minimum indicated in Award Floor.

(j) Your application must meet the Application Responsiveness Criteria outlined above.

F. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

You may obtain an application package electronically by accessing Grants.gov at http://www.grants.gov/. You can find it by searching on the CFDA number shown on page 2 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

OASH Grants and Acquisitions Management

Phone: 240-453-8822

Email: OASH_Grants@hhs.gov

2. Content and Form of Application Submission

a. Application Format

Your application must be prepared using the forms and information provided in the online application package.

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section E.4. The page limit does not include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application Disqualification Criteria. Please do not number pages or include a table of contents. Our grants management system will generate page numbers once your application is complete. If your application exceeds the specified page limits for the Project

Narrative or Project Narrative plus Appendices when printed on 8.5” X 11” paper by

HHS/OASH/GAM, we will not review it. We recommend you print out your application before submitting electronically to ensure that it is within the page limits and is easy to read.

You must double-space the Project Narrative pages.

You should use an easily readable typeface, such as Times New Roman or Arial. You must use 12-point font. You may single-space tables or use alternate fonts but you must ensure the tables are easy to read.

b. Appendices Format

Your Appendices should include any specific documents outlined in Section F.3.c, under the heading “Appendices” in the Application Content Section of this funding opportunity announcement. Your documents should be easy to read. You should use the same formatting specified for the Project Narrative. However, documents such as résumés/CVs, organizational charts, tables, or letters of commitment may use formatting common to those documents, but the pages must be easy to read. All of your appendices must be uploaded as a single, consolidated file in the Attachments Section of your Grants.gov application.

c. Project Abstract Summary Format

You must complete the Project Abstract Summary form provided in the application package. The abstract will be used to provide reviewers with an overview of the application and will form the basis for the application summary in grants management and program summary documents. If your project is funded, HHS may publish information from your form; therefore, do not include sensitive or proprietary information.

You must complete the Project Abstract Summary form provided in the application package. The abstract will be used to provide reviewers with an overview of the application and will form the basis for the application summary in grants management and program summary documents. HHS/OASH may publish your abstract if your project is funded; therefore, it should not include sensitive or proprietary information.

d. Budget Narrative Format

The Budget Narrative should use the formatting required of the Project Narrative for the explanatory text. Budget tables may be single-spaced but should be laid out in an easily-readable format and within the printable margins of the page.

3. Application Content

Successful applications will contain the following information:

a. Project Narrative Content

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether your project meets the minimum requirements for an award under this announcement. The Project Narrative should provide a clear and concise description of your project. HHS/OASH recommends that your project narrative include the following components: (1) Introduction/Background; (2) Goal and Objectives; (3) Significance; (4) Research

Design and Methods; (5) Capacity and Experience; and (6) Project Management.

The application should address activities that will be conducted over the entire project period and must include the following items:

1) Introduction/Background

• Explain the importance of the proposed analysis in teen pregnancy prevention efforts and how it will add to the knowledge base of understanding disparities in effectiveness.

• Describe the proposed intervention(s), population(s), setting(s), that will be studied. Include a description of prior similar research, methods and findings and how the proposed project will build upon or expand that prior research or otherwise contribute to the field.

2) Goals and Objectives

• Specify overall aims or objectives of the proposed analysis.

• The application should have focused research questions and hypotheses that are relevant to the proposed intervention, population or setting to be analyzed.

• Significance

• Describe how the results of the analysis will improve efforts to prevent teen pregnancy.

• Describe how the findings will contribute to decreasing teen pregnancy and contribute to improvements in the design, delivery or evaluation of evidence-based TPP programs.

• Describe how the project includes innovative approaches to analyzing pregnancy prevention programs to further the knowledge base including but not limited to improving intervention delivery methods, identifying fit for target populations, selecting the most relevant settings, appropriate duration, or key components.

3) Research Design and Methods

• State the research questions and hypotheses that are relevant to the proposed analysis and aligned with the analysis method proposed.

Include an analysis plan with a fully developed design, processes, and procedures to conduct the proposed project.

• The applicant should describe the evidence-based teen pregnancy prevention program(s) proposed for the analysis. The analysis, population, evidence-based program(s) selected for analysis, and implementation settings should clearly align with the proposed research questions for the project.

• Describe the analysis design, including the appropriate statistical methods to be utilized. Applicants should provide a justification for using this analysis method.

• Describe the reports/data to be utilized for the analysis. If using multiple datasets, include a description of the process for obtaining those datasets and combining them for analysis. Include a description of the measures in the dataset and the quality of the data and item response rates.

• Describe key outcomes to be assessed, including but not limited to: 1) delay of the onset of sexual activity; 2) number of sexual partners; 3) use of effective contraceptive methods; 4) pregnancies and births;

and/or 5) incidence of STIs.

• Describe any potential obstacles to the research project and how they plan to overcome the potential obstacles.

• References to the researcher’s prior similar work, conducted with similar data should be provided.

4) Capacity and Experience

• Describe experience and expertise of key staff and Study Team in the evaluation of evidence-based interventions particularly interventions aimed at improving teen pregnancy outcomes among teens. The applicant should describe the experience and expertise of all proposed staff, including staff experience implementing similar research projects and conducting analyses similar to the proposed project, collaborating with and monitoring partners to complete research projects, and conducting implementation and outcome evaluation. The application should include (in the appendices) resumes or CVs for proposed key staff along with a staff organizational chart. It is preferred for key staff to already be onboard, but if the funded applicant needs to hire additional research assistants or analysts, the applicant should describe its process and timeline for recruiting and hiring staff.

• Demonstrate sufficient staffing, such as but not limited to, research assistants, statisticians, technical writers/editors, to complete all aspects of the project.

• Describe how well the proposed project aligns with the organization’s mission and the capacity of the organization’s leadership team to support the project.

• Describe the organization’s previous and relevant work supporting and managing a project of this size, combining and analyzing datasets to address research questions of the kind proposed, and ability to protect the data of human subjects.

• Describe the organization’s ability to establish partnerships and leverage existing systems and networks needed to complete the project.

Describe how the organization effectively and efficiently manages financial resources, staff performance and strategic relationships with partner organizations.

• Describe the fiscal controls and accounting procedures used by its organization, and how these would ensure prudent use, proper and timely disbursement (if appropriate), and accurate accounting of funds received under this funding opportunity announcement.

• Describe anticipated challenges or risks to the project and the organization’s capacity to address the challenges and/or risks.

5) Project Management

• Describe how it will manage, implement, and monitor the overall project. The project management plan should describe an understanding of the complexity of the overall project and potential challenges. The applicant should describe the approach that will be used to monitor and track progress, completion, and quality of all project objectives and activities.

• The applicant should provide a description of the project team, including the Principal Investigator/Project Director and other key staff.

The applicant should describe the roles and responsibilities of all staff and how they will contribute to achieving the project’s objectives and outcomes. The applicant should describe who will have day-to-day responsibility for key tasks including, but not limited to, leadership of the overall project and of specific tasks, monitoring the progress of the research, monitoring implementation partners, conducting the analysis, and disseminating findings.

• MOUs should be included for any partners outside of the applicant organization.

• The applicant should describe its plans for ensuring that all staff responsible for implementing the project, including partner staff, are well trained and prepared to successfully fulfill their roles and responsibilities.

• Applicants will include a detailed analysis plan and work plan (as an appendix) for their project and disseminating results through informal and formal methods, including but not limited to peer reviewed publications, presentations at professional conferences, and policy briefings. The application should include a plan to disseminate and publish findings. Applicants should expect to prepare for publishing throughout the life of the cooperative agreement, and that the final six to eight months of the cooperative agreement will be focused on preparing a final report that summarizes the study results.

b. Budget Narrative Content

You must complete the required budget forms and submit a budget narrative with detailed justification as part of your application. You must enter the project budget on the Budget

Information Non-construction Programs standard form (SF 424A) according to the directions provided with this standard form. The budget narrative consists of a detailed line-item budget that includes calculations for all costs and activities by "object class categories" identified on the SF-

424A and justification of the costs. You must indicate the method you are selecting for your indirect cost rate. See Indirect Costs below for further information.

Project budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. If matching or cost sharing is required, you must include a detailed listing of any funding sources identified in box 18 of the SF-

424 (Application for Federal Assistance).

Please be sure to carefully review section F.7 Funding Restrictions for specific information regarding allowable, unallowable, and restricted costs.

You must provide an object class category budget using Section B, box 6 of the SF 424A for the first year of the proposed project. Provide a budget justification, which includes explanatory text and line-item detail, for the first year of the proposed project. The budget narrative should describe how the categorical costs are derived. Discuss the necessity, reasonableness, and allocation of the proposed costs.

For subsequent budget years, provide a summary narrative and line item budget. For categories or items that differ significantly from the first budget year, provide a detailed justification explaining these changes. Note, do not include costs beyond the first budget year in the object class budget in box 6 of the SF- 424A or box 18 of the SF-424; the amounts entered in these sections should only reflect the first budget year.

Your budget narrative should justify the overall cost of the project as well as the proposed cost per activity, service delivered, and/or product. For example, the budget narrative should define the amount of work you have planned and expect to perform, what it will cost, and an explanation of how the result is cost effective. For example, if you are proposing to provide services to clients, you should describe how many clients are you expecting to serve, the unit cost of serving each client, and how this is cost effective.

Use the following guidelines for preparing the detailed object class budget required by box

6 of the SF-424A. The object class budget organizes your proposed costs into a set of defined categories outlined below. Both federal and non-federal resources (when required) must be detailed and justified in the budget narrative. "Federal resources" refers only to the HHS/OASH funds for which you are applying. "Non-federal resources" are all other non-HHS/OASH federal and non-federal resources. We recommend you present budget amounts and computations in a columnar format: first column, object class categories; second column, federal funds requested;

third column, non-federal resources; and last column, total budget.

Sample Budget Table

Object Class Federal Funds Requested

Non-federal Resources

Total Budget

Personnel $100,000 $25,000 $125,000

Note, subrecipient/contract and consultant detailed costs should all be included in those specific line items, not in the overall project object class line items, i.e., subrecipient travel should be included in the Contractual line item not in Travel.

1) Object Class Descriptions and Required Justifications

(a) Personnel Description

Costs of staff salaries and wages, excluding benefits.

(b) Personnel Justification

Clearly identify the project director or principal investigator, if known at the time of application. Provide a separate table for personnel costs detailing for each proposed staff person:

the title; full name (if known at time of application), time commitment to the project as a percentage or full-time equivalent: annual salary and/or annual wage rate; federally funded award salary; non-federal award salary, if applicable; and total salary. No salary rate may exceed the statutory limitation in effect at the time you submit your application (see D.6 Funding Restrictions, Salary Rate Limitation for details). Do not include the costs of consultants, personnel costs of delegate agencies, or of specific project(s) and/or businesses to be financed by the applicant.

Contractors and consultants should not be placed under this category.

Sample Personnel Table

Position Title and Full Name

Percent Time

Annual Salary

Federally-funded Salary

Non-federal Salary

Total Project Salary

Project Director, John K. Doe

50% $100,000 $50,000 $0 $50,000

Data Assistant, Susan R.

Smith

10% $30,000 $3,000 $3,000

(c) Fringe Benefits Description

Costs of employee fringe benefits unless treated as part of an approved indirect cost rate.

(d) Fringe Benefits Justification:

Provide a breakdown of the amounts and percentages that comprise fringe benefit costs such as health insurance, Federal Insurance Contributions Act (FICA) taxes, retirement insurance, and taxes.

(e) Travel Description

Costs of travel by staff of the applicant organization only.

(f) Travel Justification

For each trip proposed for applicant organization staff only, show the date of the proposed travel, total number of traveler(s); travel destination; duration of trip; per diem; mileage allowances, if privately owned vehicles will be used; and other transportation costs and subsistence allowances. Do not include travel costs for subrecipients or contractors.

(g) Equipment Description

Equipment means tangible personal property (including information technology systems) having a useful life of more than one year and a per-unit acquisition cost which equals or exceeds the lesser of the capitalization level established by the non-Federal entity for financial statement purposes, or $5,000. (Note: Acquisition cost means the cost of the asset including the cost to ready the asset for its intended use. Acquisition cost for equipment, for example, means the net invoice price of the equipment, including the cost of any modifications, attachments, accessories, or auxiliary apparatus necessary to make it usable for the purpose for which it is acquired. Acquisition costs for software includes those development costs capitalized in accordance with generally accepted accounting principles (GAAP). Ancillary charges, such as taxes, duty, protective in transit insurance, freight, and installation may be included in or excluded from the acquisition cost in accordance with the non- Federal entity’s regular accounting practices.) See 45 C.F.R. § 75.2 for additional information.

(h) Equipment Justification

For each type of equipment requested you must provide a description of the equipment; the cost per unit; the number of units; the total cost; and a plan for use of the equipment in the project;

as well as a plan for the use, and/or disposal of, the equipment after the project ends. An applicant organization that uses its own definition for equipment should provide a copy of its policy, or section of its policy, that includes the equipment definition; include this with your Budget

Narrative file. Reference the policy in this justification and include the policy copy in your Budget

Narrative file (not your appendices).

(i) Supplies Description

Costs of all tangible personal property other than those included under the Equipment category. This includes office and other consumable supplies with a per-unit cost of less than

$5,000.

(j) Supplies Justification

Specify general categories of supplies and their costs. Show computations and provide other information that supports the amount requested.

(k) Contractual Description

Costs of all contracts or subawards for services and goods except for those that belong under other categories such as equipment, supplies, construction, etc. Include third-party evaluation contracts, if applicable, and contracts or subawards with subrecipient organizations

(with budget detail), including delegate agencies and specific project(s) and/or businesses to be financed by the applicant. This line item is not for individual consultants.

(l) Contractual Justification

Demonstrate that all procurement transactions will be conducted in a manner to provide, to the maximum extent practical, open, and free competition. Recipients and subrecipients are required to use 45 C.F.R. § 75.329 procedures and must justify any anticipated procurement action that is expected to be awarded without competition and exceeds the simplified acquisition threshold fixed by 41 U.S.C. § 134 and currently set at $250,000. Recipients may be required to make pre-award review and procurement documents, such as requests for proposals or invitations for bids, independent cost estimates, etc., available to HHS/OASH.

Note: Whenever you intend to delegate part of the project to another agency, you must provide a detailed budget and budget narrative for each subrecipient/contractor, by agency title, along with the same supporting information referred to in these instructions. If you plan to select the subrecipients/contractors post-award and a detailed budget is not available at the time of application, you must provide information on the nature of the work to be delegated, the estimated costs, and the process for selecting the delegate agency.

(m) Other Description

Enter the total of all other costs. Such costs, where applicable and appropriate, may include but are not limited to: consultants; insurance; professional services (including audit charges); space and equipment rent; printing and publication; training, such as tuition and stipends; participant support costs including incentives, staff development costs; and any other costs not addressed elsewhere in the budget.

(n) Other Justification

Provide computations, a narrative description, and a justification for each cost under this category.

(o) Indirect Costs Description

Total amount of indirect costs. This category has one of two methods that you may select.

You may only select one.

• Your organization currently has an indirect cost rate approved by the

Department of Health and Human Services (HHS) or another cognizant federal agency. You should enclose a copy of the current approved rate agreement in your Budget Narrative file. If you request a rate that is less than allowed, your authorized representative must submit a signed acknowledgement that the organization is accepting a lower rate than allowed.

• Per 45 C.F.R. § 75.414(f) Indirect (F&A) costs, “any non-Federal entity

[i.e., applicant] that has never received a negotiated indirect cost rate, … may elect to charge a de minimis rate of 10% of modified total direct costs (MTDC) which may be used indefinitely. As described in §

75.403, costs must be consistently charged as either indirect or direct costs, but may not be double charged or inconsistently charged as both.

If chosen, this methodology once elected must be used consistently for all Federal awards until such time as a non-Federal entity chooses to negotiate for a rate, which the non-Federal entity may apply to do at any time.”

This method only applies if you have never received an approved negotiated indirect cost rate from HHS or another cognizant federal agency. If you are waiting for approval of an indirect cost rate, you may request the 10% de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs to the award.

(p) Indirect Costs Justification

Provide the calculation for your indirect costs total, i.e., show each line item included in the base, the total of these lines, and the application of the indirect rate. If you have multiple approved rates, indicate which rate as described in your approved agreement is being applied and why that rate is being used. For example, if you have both on-campus and off-campus rates, identify which is being used and why.

(q) Program Income Description

Program income means gross income earned by your organization that is directly generated by this project if funded except as provided in 45 C.F.R. § 75.307(f). Program income includes but is not limited to income from fees for services performed or the use or rental of real or personal property acquired under the award. Interest earned on advances of Federal funds is not program income. Except as otherwise provided in Federal statutes, regulations, or the terms and conditions of the Federal award, program income does not include rebates, credits, discounts, and interest earned on any of them. See also 45 C.F.R. §§ 75.307, 75.407 and 35 U.S.C. §§ 200-212 (applies to inventions made under Federal awards).

(r) Program Income Justification

Describe and estimate the sources and amounts of program income that this project may generate if funded. Unless being used for cost sharing, if applicable, these funds should not be added to your budget. This amount should be reflected in box 7 of the SF-424A.

(s) Non-Federal Resources Description

Amounts of non-federal resources that will be used to support the project as identified in box 18 of the SF-424. For all federal awards, any shared costs or matching funds and all contributions, including cash and third-party in-kind contributions, must be accepted as part of the recipient’s cost sharing or matching when such contributions meet all of the criteria listed in 45

C.F.R. § 75.306. For awards that require matching by statute, you will be held accountable for projected commitments of non-federal resources in your application budgets and budget justifications by budget period or by project period for fully-funded awards, even if the justification by budget period, or by project period for fully-funded…