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Office on Women's Health

Notice of Funding Opportunity:

Addressing Eating Disorders in Adolescent Girls and the COVID-19 Pandemic

Opportunity Number: WH-AST-22-005

Application Due Date:

July 15, 2022 at 6:00 PM Eastern

OVERVIEW

FEDERAL AGENCY NAME

Office of the Assistant Secretary for Health, Office on Women’s Health

FUNDING OPPORTUNITY TITLE

Addressing Eating Disorders in Adolescent Girls and the COVID-19 Pandemic

ACTION

Notice

ANNOUNCEMENT TYPE

Initial Competitive Grant

FUNDING OPPORTUNITY NUMBER

WH-AST-22-005

ASSISTANCE LISTING NUMBER AND PROGRAM:

93.088 Advancing System Improvements for Key Issues in Women's Health

DATES

Application Deadline: July 15, 2022 by 6:00 PM Eastern.

Technical Assistance: Webinar, May 25,2022 at 1:00 PM Eastern.

EXECUTIVE SUMMARY

The Office on Women’s Health (OWH) announces the availability of funds for Fiscal Year

(FY) 2022 Grants under the authority of section 1703(a) of the Public Health Service (PHS) Act

(42 U.S.C. § 300u-2(a)), and section 229 of the PHS Act (42 U.S.C. § 237a).

This notice solicits applications to fund up to three (3) projects focusing on adolescent girls at risk for eating disorders exacerbated by the COVID-19 pandemic. Each project will identify, develop, and implement an evidence-based intervention(s) aimed at detecting and preventing eating disorders.

Each project must:

• Develop and implement an evidence-based intervention(s) to address modifiable risk factors, encourage behavior change, and improve health outcomes in response to challenges posed by the COVID-19 pandemic;

• Create partnerships that integrate physical and mental health aspects of eating disorders among care providers, nutritionists, and/or community organizations to address gaps in care exacerbated by the COVID-19 pandemic;

• Create developmentally appropriate education and outreach for adolescent girls at risk for eating disorders; and

• Plan for transition of a successful project to sustainability.

OWH intends to fund projects focusing on eating disorders. Each funded project will focus on at least one of the following: anorexia nervosa, bulimia, binge-eating disorder, and/or avoidant restrictive food intake disorder (ARFID). The target population for projects is adolescent girls.

The projects will be expected to track and evaluate outcomes to assess success.

Applicants may be a public or private (profit or non-profit) entity. Examples are found in

Section E.1.

OWH anticipates making up to 3 grant awards of up to $500,000 each for the first year for a total of $1,500,000 in FY2022. OWH anticipates project periods of up to three years awarded in annual budget periods. Recipients will be required to submit a non-competing continuation application for each budget period for the second and third years. OWH anticipates offering a competing continuation for a fourth year for the purpose of providing funding to support selected recipients as they transition projects to sustainability. Funding for the budget periods after the first year will be contingent upon availability of funding, satisfactory performance (including recipient progress towards meeting stated project milestones and goals, timely submission of required reports, and compliance with all grant terms and conditions), and the best interests of the government.

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 their application complies with all requirements and instructions.

TABLE OF CONTENTS

A. DATES

1. Application Deadline _________________________________________________ 5

2. Technical Assistance __________________________________________________ 6

B. PROGRAM DESCRIPTION

1. Background _________________________________________________________ 6

2. Expectations for Funded Projects _______________________________________ 8

C. AUTHORITY

D. FEDERAL AWARD INFORMATION

E. ELIGIBILITY INFORMATION

1. Eligible Applicants __________________________________________________ 11

2. Cost Sharing or Matching ____________________________________________ 12

3. Other – Application Responsiveness Criteria ____________________________ 12

4. Application Disqualification Criteria ___________________________________ 13

F. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package ________________________________ 14

2. Content and Form of Application Submission ____________________________ 14

3. Application Content _________________________________________________ 15

4. Unique Entity Identifier (UEI) and System for Award Management (SAM) ___ 28

5. Submission Dates and Times __________________________________________ 29

6. Intergovernmental Review____________________________________________ 29

7. Funding Restrictions ________________________________________________ 30

8. Other Submission Requirements ______________________________________ 31

G. APPLICATION REVIEW INFORMATION

1. Criteria ___________________________________________________________ 33

2. Review and Selection Process _________________________________________ 36

3. Review of Risk Posed by Applicant _____________________________________ 37

4. Final Award Decisions, Anticipated Announcement, and Federal Award Dates 38

H. FEDERAL AWARD ADMINISTRATION INFORMATION

1. Federal Award Notices _______________________________________________ 38

2. Administrative and National Policy Requirements ________________________ 39

3. Program Specific Terms and Conditions ________________________________ 39

4. Closeout of Award __________________________________________________ 40

5. Lobbying Prohibitions _______________________________________________ 40

6. Non-Discrimination Requirements _____________________________________ 41

7. Smoke- and Tobacco-free Workplace ___________________________________ 42

8. Acknowledgement of Funding _________________________________________ 42

9. HHS Rights to Materials and Data _____________________________________ 42

10. Trafficking in Persons _______________________________________________ 43

11. Efficient Spending __________________________________________________ 43

12. Whistleblower Protection ____________________________________________ 43

13. Prohibition on certain telecommunications and video surveillance services or equipment. ________________________________________________________ 43

14. Human Subjects Protection ___________________________________________ 44

15. Research Integrity __________________________________________________ 44

16. Reporting __________________________________________________________ 45

I. CONTACTS

1. Administrative and Budgetary Requirements: ___________________________ 47

2. Program Requirements ______________________________________________ 48

3. Electronic Submission Requirements ___________________________________ 48

J. OTHER INFORMATION

1. Awards under this Announcement _____________________________________ 48

2. Application Elements ________________________________________________ 49

K. SUPPLEMENTARY MATERIALS

1. Considerations in Recipient Plans for Oversight of Federal Funds ___________ 50

2. Suggested Work Plan Template _______________________________________ 51

3. National Standards for Culturally and Linguistically Appropriate Services in

Health and Health Care (National CLAS Standards) _____________________ 52

4. Disparity Impact Statement (DIS) _____________________________________ 57

5. References _________________________________________________________ 58

FUNDING OPPORTUNITY DETAILS

A. DATES

1. Application Deadline

Your application is due July 15, 2022 by 6:00 PM 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, Grants and

Acquisitions Management (GAM) Division, Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services (HHS). To obtain an exemption, you must request one via email from 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 unique entity identifier (UEI) number; your organization’s name, address and telephone number; the name and telephone number of your

Authorizing Official; the Grants.gov Tracking Number (e.g., 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.

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. Failure to follow Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

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, OASH recommends that you register as early as possible in Grants.gov because the registration process can take up to one month. You must register an authorizing official for your organization. OASH does not determine your organization’s authorizing official; your organization makes that designation. For mailto:OASH_Grants@hhs.gov information on registering for Grants.gov, refer to https://grants.gov or contact the 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

We will provide a technical assistance webinar for potential applicants on May 25, 2022 at

1:00 PM Eastern Time. Registration details will be posted at https://womenshealth.gov.

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 on Women's Health

(OWH) announces the availability of funds for Fiscal Year (FY) 2022 under the authority of section 1703(a) of the PHS Act (42 U.S.C. § 300u-2(a)), and section 229 of the PHS Act (42 U.S.C.

§ 237a). 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, OWH provides national leadership and coordination to improve the health of women and girls through policy, education, and innovative programs. OWH advances and coordinates a comprehensive women’s health agenda across HHS and works to develop and expand innovative approaches to advance the field of women’s and girls’ health.

1. Background

The COVID-19 pandemic has impacted individuals living with or at risk of eating disorders. Eating disorders are serious and often fatal illnesses associated with severe disturbances in people’s eating behaviors and related thoughts and emotions (National Institute of Mental

Health, 2021). Projects funded through this initiative will focus on one or more of the following eating disorders:

(a) anorexia nervosa, a condition where people avoid food, severely restrict food, or eat very small quantities of only certain foods;

(b) bulimia, a condition where people have recurrent and frequent episodes of eating unusually large amounts of food and feeling a lack of control over these episodes followed by a type of behavior that compensates for the binge, such as purging;

https://grants.gov/ mailto:support@grants.gov https://womenshealth.gov/

(c) binge-eating disorder, a condition where people lose control over their eating and have reoccurring episodes of eating unusually large amounts of food; and/or

(d) avoidant restrictive food intake disorder (ARFID), previously known as selective eating disorder, a condition where people limit the amount or type of food eaten resulting in not eating enough calories to grow or to maintain basic body function

(National Institute of Mental Health, 2021).

Eating disorders became the fifth most prominent mental health condition as of August

2020 (Katzman, 2021). In addition, a recent review of 70 research articles revealed eating disorder symptom severity and incidence of probable diagnoses appear to be elevated during the COVID-

19 pandemic (Linardon, Messer, Rodgers, & Fuller-Tyszkiewicz, 2022). The upswing comes at a time when barriers to treatment have increased during the pandemic, making access to care difficult (Reed & Ort, 2021). Additionally, researchers have noted that many young people with eating disorders dismiss the significance of their symptoms or do not seek professional help for their symptoms or concerns (Schlegl, Maier, Meule, & Voderholzer, 2020).

The average age of onset is between 12 and 25 years, making adolescence a high-risk time for developing an eating disorder (Volpe, et al., 2016). However, less than 20% of college students with eating disorders report receiving treatment (Eisenberg, Nicklett, Roeder, & Kirz, 2011).

Collaborative touchpoints with members of multidisciplinary healthcare teams and innovative modes of outreach to individuals with eating disorders may help to reach individuals currently not receiving any treatment (Heafala, Ball , Rayner, & Mitchell, 2021) (Kazdin, Fitzsimmons-Craft, & Wilfley, 2017). Moreover, those who receive care may benefit from collaboration among care providers across specialties, yet care is not often integrated, which may hinder successful interventions (Da Luz, Hay, Touyz, & Sainsbury, 2018).

The COVID-19 pandemic has increased the risk of and barriers to care for eating disorders

(Vuillier, May, Greville-Harris, Surman, & Moseley, 2021). Patient referrals to eating disorder treatment centers increased 30-40% (Katzman, 2021). The demand for treatment may be greater than has been reported (Otto, et al., 2021). According to a recent study, nearly 80% of those identified with an existing eating disorder had concerns that their condition may regress due to a lack of structure during the pandemic (Spigel, et al., 2021). Researchers found disrupted routines, requirements for physical and social distancing, greater exposure to environmental triggers, and difficulties regulating emotion as possible reasons for worsening symptoms. Some researchers have noted anxiety and depression are on the rise for many teens because of the pandemic, which can also impact symptoms (Konstantinovsky, 2020).

In addition, during the pandemic, time spent on and engagement with social media sites increased for many adolescents. Social media has been associated with body dissatisfaction, drive for thinness, and low self-esteem (Saunders & Eaton, 2018) (Zemlyanskaya, Valente, & Syurina, 2021). Young women who are already suffering from or in treatment for an eating disorder are much more susceptible to the influence and pressures of social media (Zhang, Liu, Li, & Chung, 2021).

This funding opportunity seeks projects with evidence-based intervention(s) to address these conditions exacerbated by the COVID-19 pandemic. Targeted efforts will require an understanding of pandemic-related stressors and potential barriers to early diagnosis. Fostering partnerships among key stakeholders will be critical to support the development of evidence-based intervention(s).

2. Expectations for Funded Projects

Award recipients under this announcement should meet each of the below expectations in the execution of their funded project.

a. Develop and implement evidence-based intervention(s)

To improve detection and prevention of eating disorders, we expect recipients to develop and implement evidence-based intervention(s) to address modifiable risk factors, encourage behavior change, and improve health outcomes in response to challenges posed by the COVID-19 pandemic. Intervention(s) should focus on detecting and preventing eating disorders in adolescent girls at risk of developing an eating disorder. Evidence-based intervention(s) should address the contributing factors of social isolation, loneliness, or social restrictions. These contributing factors were uniquely heightened during the COVID-19 pandemic among adolescent girls.

We encourage recipients to include approaches and evidence-based intervention(s) that address health equity related to eating disorders. Recipients should identify and track outcomes to demonstrate improvements in early detection and prevention of eating disorders among at-risk adolescent girls. We expect recipients to both quantitatively and qualitatively evaluate their projects in improving detection and prevention of eating disorders. Recipients should demonstrate how their intervention(s) has improved the early detection and prevention of eating disorders and methods used for assessment of the eating disorder(s). Additionally, recipients should disseminate outcomes of the intervention(s) both quantitatively and qualitatively.

b. Create partnerships to address gaps in care

We expect recipients to evaluate the gaps in care for adolescent girls with eating disorders and develop partnerships that integrate physical and mental health aspects of eating disorders among care providers, nutritionists, and/or community organizations. Recipients should engage these partners and stakeholders to participate in the development and implementation of intervention(s) to address the identified gaps in care. We expect recipients to engage partners throughout the intervention(s) to address modifiable risk factors, encourage behavior change, improve health outcomes, and create developmentally appropriate education and outreach for adolescent girls at risk for eating disorders. We expect partnership(s) to be documented as described in Section F.3.c.2.

c. Create developmentally appropriate education and outreach

OWH expects recipients to engage adolescent girls at risk for developing or who currently experience an eating disorder through developmentally appropriate innovative education and outreach. For example, recipients may consider content specifically tailored to post-pandemic adolescents for social media platforms where there is an increased risk of developing eating disorders or through curricula, manuals, videos, apps, or other evidence-based approaches.

We expect recipients to incorporate the National Standards for Culturally and

Linguistically Appropriate Services in Health and Health Care (National CLAS Standards).

Recipients should, as appropriate to the intervention(s), provide effective, equitable, understandable, and respectful quality care and services responsive to diverse cultural health beliefs and practices, preferred languages, health literacy, and other communication needs.

Recipients should offer language assistance to individuals who have limited English proficiency and/or other communication needs, at no cost to them, to facilitate timely access to all health care and services; inform all individuals of the availability of language assistance services clearly and in their preferred language, verbally and in writing; ensure the competence of individuals providing language assistance, recognizing that the use of untrained individuals and/or minors as interpreters should be avoided; and provide easy-to-understand print and multimedia materials and signage in the languages commonly used by the populations in the service area.

d. Disparity Impact Statement

Recipients are expected to develop a disparity impact statement (DIS) during the project period using local data to identify populations at highest risk for health disparities relative to this initiative. 1 A DIS refers to the demographic, cultural, and linguistic data that identify the population(s) in which health disparities exist and the quality improvement plan designed to address the noted disparities. The DIS will provide the measurement framework for ongoing monitoring and determining the impact of the project activities on outcomes and overarching goal of advancing health equity. Project activities must comply with the non-discrimination requirements described in Section H.6.

Below are available HHS resources:

• CMS.gov: Quality Improvement & Interventions: Disparity Impact Statement

(https://www.cms.gov/About-CMS/Agency-Information/OMH/resource-center/hcps-and-researchers/quality-improvements-and-interventions)

1 Applicants may choose to use the Centers for Disease Control (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR) Social Vulnerability Index (SVI) [https://www.atsdr.cdc.gov/placeandhealth/svi/index.html], or other local data tools, in developing disparity impact statements.

https://www.cms.gov/About-CMS/Agency-Information/OMH/resource-center/hcps-and-researchers/quality-improvements-and-interventions https://www.cms.gov/About-CMS/Agency-Information/OMH/resource-center/hcps-and-researchers/quality-improvements-and-interventions

• SAMHSA.gov: Disparity Impact Statement

(https://www.samhsa.gov/grants/grants-management/disparity-impact-statement)

• OMH Disparity Impact Strategy https://www.minorityhealth.hhs.gov/omh/content.aspx?ID=22540

Additional information and links to resources are available in Section K.4.

e. Plan for transition of a successful project to sustainability

We expect recipients to plan for and work toward sustainability of successful evidence-based intervention(s) beyond the end of the funded project. Recipients should begin to develop a plan for sustainability by the end of the second year. We expect the plan to identify key individuals and/or organization(s) whose support will be required to sustain activities; financial and staff resources needed; and existing collaborative partnerships with organizations that might support continuation of the project after the final budget period expires. In the third year, successful projects will have the option to compete for one more year of funding to aid in the transition to sustainability.

C. AUTHORITY

Section 1703(a) of the PHS Act (42 U.S.C. § 300u-2(a)), and section 229 of the PHS Act

(42 U.S.C. § 237a)

D. FEDERAL AWARD INFORMATION

The Office on Women's Health intends to make funds available for competing grant awards. We will fund awards in annual increments (budget periods) and generally for a period of performance up to three (3) years with an optional competitive fourth year, although we may approve shorter periods of performance. Recipients will be required to submit a non-competing continuation application for each budget period for the second and third years. We anticipate offering a competing continuation for a fourth year for the purpose of providing funding to support selected recipients as they transition projects to sustainability.

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.

https://www.samhsa.gov/grants/grants-management/disparity-impact-statement https://www.samhsa.gov/grants/grants-management/disparity-impact-statement https://www.minorityhealth.hhs.gov/omh/content.aspx?ID=22540

Award Information

Estimated Federal Funds Available: $ 1,500,000

Anticipated Number of Awards: 3

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

Award Floor (Federal Funds including indirect costs): $ 300,000 per budget period

Anticipated Start Date: September 15, 2022

Estimated Period of Performance: Not to exceed 3 year(s) with an optional competitive fourth year for transition to sustainability

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 (profit or nonprofit) entity located in a State (which includes one of the 50 United States, District of Columbia, Commonwealth of Puerto Rico, U.S. Virgin Islands, Commonwealth of the Northern Mariana Islands, American Samoa, Guam, Republic of Palau, Federated States of Micronesia, and the Republic of the Marshall Islands) is eligible to apply for an award under this announcement. Community-based organizations, faith-based organizations and American Indian/Alaska Native/Native American (AI/AN/NA) organizations are eligible to apply. Examples of eligible Organizations include:

• State Governments

• U.S. territories

• County Governments

• City or township governments

• Special district governments

• Independent school districts

• Public and State controlled institutions of higher education

• Native American tribal governments (Federally recognized)

• Public Housing authorities/Indian housing authorities

• Native American tribal organizations (other than federally recognized tribal governments)

• Nonprofits having 501(c)(3) status with the IRS, other than institutions of higher education

• Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education

• Private institutions of higher education

• For profit organizations, including small businesses.

2. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget. If you voluntarily include cost sharing in your application, you must include in your budget narrative a non-federal sources justification as described in Section F.3.b.1.t. Voluntary cost sharing is not expected for research applications. During the merit review of an application, cost sharing will only be considered in the overall review of the adequacy of the total proposed budget (Federal and non-Federal share) to support the project proposed. Applications including cost sharing or matching, whether required or voluntary, that result in an award will include the cost sharing or matching commitment on the notice of award at the level proposed in the application. See

Section F.3.b.1.s. Any change in the responsibility to provide cost sharing or matching at that level will require prior approval of the grants management officer.

3. Other – 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:

• You must identify in the first paragraph of your project narrative at least one of the conditions (i.e., anorexia nervosa, bulimia, binge-eating disorder, and/or

ARFID) that is the focus of your project. You may select up to all four of the conditions, but you must identify at least one of the four conditions to be responsive.

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 https://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 application must be submitted in the English language and must be in the terms of U.S. dollars (45 C.F.R. § 75.111(a)).

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

(g) 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).

(h) Your total application, including the Project Narrative plus Appendices, must not exceed 55 pages. NOTE: items listed in “(g)” immediately above do not count toward total page limit.

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

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

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

(l) If your application includes cost sharing (voluntary or required), you must include in your budget narrative a non-federal sources justification.

https://grants.gov/

F. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

You may obtain an application package electronically by accessing Grants.gov at https://www.grants.gov/. You can find it by searching on the Assistance Listing (formerly CFDA) number shown on page 1 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

OASH Grants and Acquisitions Management Division

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. This includes but is not limited to: SF-424 Application for Federal

Assistance; SF-424A Budget Information for Non-Construction Programs; SF-424B Assurances for Non-Construction Programs.; SF-LLL Disclosure of Lobbying Activities; and Project Abstract

Summary.

We encourage individuals to use their full name (first, middle, last) on the Standard Forms and other documents such as resumes and curriculum vitae to distinguish them for verification in the System for Award Management exclusion records. Delays may result in award processing if full names are not provided. NOTE: only one Project Director/Principal Investigator will be named on any resulting award. You should clearly identify the individual in that role in your application.

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, 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.

https://www.grants.gov/ mailto:OASH_Grants@hhs.gov

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/biosketches, 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.

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 and its proposed intervention(s). HHS/OASH recommends that your project narrative include the following components:

NOTE: You must identify in the first paragraph of your project narrative at least one of the conditions (anorexia nervosa, bulimia, binge-eating disorder, and/or ARFID) that is the focus of your project. You may select up to all four of the conditions, but you must identify at least one of the four conditions to be responsive.

1) Statement of Need

You should describe in this section, in both quantitative and qualitative terms, the nature and scope of the of the specific and particular need the project is designed to address, and the condition(s) of focus. You should include in your description the impact of the COVID-19 pandemic on your target population. Also describe any unique circumstances the pandemic created for adolescent girls at risk or diagnosed with the condition(s) of focus.

Describe the population(s) of focus, including demographic characteristics, and the geographic location. You should detail how the project will potentially affect the populations served, specific subgroups within those populations, and other interested stakeholders as identified.

You should describe how your proposed intervention(s) will engage underserved and disadvantaged populations, including racial/ethnic minorities, limited-English speaking populations, and persons with disabilities. Note, your project activities may not involve the selection or exclusion of participants based on race/ethnicity. Additionally, this section should outline who you consider vested stakeholders in the project (for example community-based organizations and/or hospitals), how they were or will be identified, and how they will be meaningfully engaged in the project. You should provide memoranda of agreement and/or letters of commitment as described below in the appendices section.

We recommend that you focus your statement of need on the specific aspects of the history and policy considerations bearing on the program area and existing literature with a focus on high quality evidence including randomized controlled trials, cohort studies, case control studies, and if necessary, case series from the primary literature. Avoid providing a broad or sweeping historical overview that is not directly related to the proposed intervention(s) and activities.

2) Goals, Objectives, and Outcomes

This section should start with the specific question or hypothesis you will address, the rationale for the question or hypothesis, and how your project’s proposed goal(s) and major objectives will address this question. You should provide a realistic and clear timetable for the project and intervention(s) and a rationale that these timelines are achievable. Describe your objectives in the SMART format (Specific, Measurable, Achievable, Relevant and Time-

Oriented). For example, “By the end of month one, create a plan for developing the evidence-based intervention.”

You should clearly state the expected outcome(s) that will result from your project after you: (1) Develop and implement evidence-based intervention(s) to address modifiable risk factors, encourage behavior change, and improve health outcomes in response to challenges posed by the

COVID-19 pandemic; (2) Create partnerships that integrate physical and mental health aspects of eating disorders among care providers, nutritionists, and/or community organizations to address gaps in care exacerbated by the COVID-19 pandemic; (3) Create developmentally appropriate education and outreach for adolescent girls at risk for eating disorders; and (4) Plan for transition of a successful project to sustainability.

HHS/OASH will not fund any project that does not include measurable outcomes. In addition, you should describe how you envision the project will benefit the field at large.

A measurable outcome is an observable end-result that describes how a particular intervention(s) benefits project participants. It demonstrates the “impact” of the intervention(s).

For example, a change in a client’s financial, health, and/or functional status; mental well-being;

knowledge; skill; attitude; awareness; or behavior. It can also describe a change in the degree to which participants exercise choice over the types of services they receive, or whether they are satisfied with the way a service is delivered. Additional examples include: a change in the responsiveness or cost-effectiveness of a service delivery system; a new model of support or care that can be replicated; new knowledge; a measurable increase in community awareness; or a measurable increase in persons receiving services. A measurable outcome is not a measurable output, such as: the number of clients served; the number of training sessions held; or the number of service units provided without demonstration that this improved a measurable clinical outcome.

3) Proposed Approach

You should provide a clear and concise description of the intervention(s) you are proposing to use to address the need you identified in your statement of need. You should explain the rationale for using a particular intervention(s) and to present a clear connection between identified system gaps and needs and your proposed activities. Your proposal should detail the nature of the activities to be undertaken, how they address identified issues, how they will account for post-pandemic risk factors, and how they will assist in achieving the overall project goals and objectives. You should clarify why these specific activities were selected (e.g., has this approach been successful in other settings or does the research suggest this direction). You should describe how your intervention(s) is evidence-based. For an intervention(s) to be evidence-based, it must be informed by research and utilize effective methodology.

Your proposal should demonstrate how technology will be incorporated to advance programs and services, provide training and/or technical assistance, and/or disseminate information and products. You should provide specifics about the intervention(s), expected outcomes, and barriers for all anticipated years of the award.

Your proposed project should incorporate the National CLAS Standards (See Section K.3).

In particular, you should demonstrate how you will provide effective, equitable, understandable, and respectful quality care and services that are responsive to diverse cultural health beliefs and practices, preferred languages, health literacy, and other communication needs. You should also demonstrate how you will: offer language assistance to individuals who have limited English proficiency and/or other communication needs, at no cost to them, to facilitate timely access to all health care and services; inform all individuals of the availability of language assistance services clearly and in their preferred language, verbally and in writing; ensure the competence of individuals providing language assistance, recognizing that the use of untrained individuals and/or minors as interpreters should be avoided; and provide easy-to-understand print and multimedia materials and signage in the languages commonly used by the populations in the service area.

In reference to the Work Plan that you will separately submit as a table or chart in your

Appendices (Section F.3.c), describe your implementation of the above approach over the three-year project. Your proposed approach must include, at a minimum, a description of how you will:

• Develop and implement evidence-based intervention(s) to address modifiable risk factors, encourage behavior change, and improve health outcomes in response to challenges posed by the COVID-19 pandemic; (See Section B.2.a)

• Create partnerships that integrate physical and mental health aspects of eating disorders among care providers, nutritionists, and/or community organizations to address gaps in care exacerbated by the COVID-19 pandemic; (see Section

B.2.b)

• Create developmentally appropriate education and outreach for adolescent girls at risk for eating disorders; (see Section B.2.c) and

• Plan for transition of a successful project to sustainability (see Section B.2.e).

4) Evaluation

You should describe the methods you will use to evaluate if the proposed intervention(s) achieves its measurable outcome(s) and assess and evaluate the impact of the activities you propose, including challenges posed by the COVID-19 pandemic. You should describe how you will measure and report on the outcomes of the project, including how the expectation for independence of the evaluator will be met. You should describe both the quantitative and qualitative tools and techniques that you will employ to measure the outcome(s) and how you will identify and document the lessons learned. Your evaluation plan should describe your approach for a robust statistical analysis.

Suggested resources for developing an Evaluation Plan include:

https://www.cdc.gov/dhdsp/evaluation_resources/tips-training.htm and https://www.cdc.gov/std/program/pupestd/types%20of%20evaluation.pdf

5) Organizational Capability

You should describe your organization’s capability to successfully implement the proposed project. You should describe how your organization (or the particular division of a larger organization which will have responsibility for this project) is organized, the nature and scope of its work, and the capabilities it possesses. Your description should cover your capabilities not included elsewhere in the project narrative, including demonstrated capacity and capability to work with the population of focus, any current or previous relevant experience, and/or the record of the https://www.cdc.gov/dhdsp/evaluation_resources/tips-training.htm https://www.cdc.gov/std/program/pupestd/types%20of%20evaluation.pdf project team in preparing cogent and useful reports, publications, and other products. You should demonstrate relevant, appropriate experience and educational background for proposed positions on the project, as supported by the curricula vitae, résumés, or bio sketches for key personnel. If appropriate, include an organizational chart in your Appendices showing the relationship of the project to the current organization (See Section F.3.c).

You should clearly delineate the roles and responsibilities of project staff and subrecipients and how they will contribute to achieving the project’s objectives and outcomes. You should specify who would have day-to-day responsibility for key tasks such as: leadership of project;

monitoring the project’s on-going progress; preparation of reports; and communications with other partners and HHS/OASH. You should also describe the approach that will be used to monitor and track progress on the project’s tasks and objectives. You should clearly identify the individual who will serve as the Principal Investigator/Project Director (PI/PD) and that individual’s qualifications, competing time commitments, and related ongoing projects. HHS/OASH expects that, throughout the award period, the PI/PD will have involvement in, and substantial knowledge about, all aspects of the project.

You should describe the collaborative partnership(s) which will support project activities.

You should describe the role and makeup of partners intended to be involved in completing specific tasks. Describe the anticipated level of effort and responsibilities of each partner in completing programmatic activities.

Also include information about any contractual and/or supportive staff/organization(s) that will have a secondary role(s) in implementing the project and achieving project goals.

6) Dissemination

You should describe the method you will use to disseminate the project’s results and findings in a timely manner and in easily understandable formats to the population served, the general public, and other parties who might be interested in using the results of the project. This may include but is not limited to peer reviewed journals. HHS/OASH may publish (including on a website), all appropriate findings and products (See Section H.9). You should propose other, innovative approaches to informing parties who might be interested in using the results of your project to inform practice, service delivery, program development, and/or policy-making, especially to those parties who would be interested in replicating the project.

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 period 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 period.

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.

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