PKG00249106-instructions.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

AGENCY: Office of the Assistant Secretary for Health, Office of Population Affairs

FUNDING OPPORTUNITY TITLE: Announcement of Availability of Funds for Embryo

Adoption/Donation Services and Public Awareness Grants.

ACTION: Notice

ANNOUNCEMENT TYPE: Initial Competitive Grant

FUNDING OPPORTUNITY NUMBER: PA-EAA-19-001

CFDA NUMBER: 93.007

CFDA PROGRAM: Public Awareness Campaigns on Embryo Adoption

DATES:

Technical Assistance:

A technical assistance webinar for potential applicants will be held between two and four weeks from the release of the announcement on Grants.gov. Please check HHS.gov/opa for more information.

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.

Applications: Your application is due May 20, 2019 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) Office of Grants

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

HHS/OASH OGM, 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 ogm.oash@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. Failure to follow Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

The HHS/OASH OGM 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 mailto:ogm.oash@hhs.gov approved written exemption will be accepted. See Section D.7 (“Other Submission

Requirements”) for information on application submission mechanisms.

Executive Order 12372 comment due date: The State Single Point of Contact (SPOC) has 60 days from the application due date to submit any comments. For more information on the

SPOC see section D.4 Intergovernmental Review.

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 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.

EXECUTIVE SUMMARY: The Office of Population Affairs (OPA) announces the availability of funds for Fiscal Year (FY) 2019 grant awards under the authority of Division B, Title II of the Department of Defense and Labor, Health and Human Services, and Education

Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (Public Law No. 115-245) and Section 1704 of the Public Health Service Act (42 U.S.C. § 300 u-3). This notice solicits applications for projects which propose interventions that improve upon and/or expand services related to embryo adoption/donation, and/or which increase public awareness of embryo http://www.grants.gov/ mailto:support@grants.gov adoption/donation as a method of family building. OPA anticipates funding 3-5 grants in the range of $100,000-$300,000 per grant per year. Approximately $700,000 will be awarded through this funding opportunity in fiscal year 2019 and a similar amount in fiscal year 2020

(dependent on the availability of funding). Non-profit as well as for-profit organizations are eligible for this funding. Organizations, but not individuals, are eligible for this funding. Cost-sharing is not required.

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.

A. PROGRAM DESCRIPTION:

The Embryo Adoption Public Awareness Campaign was first funded by Congress in fiscal year

2002. The original purpose of the program was to increase public awareness of the existence of a large number of human embryos remaining after in vitro fertilization procedures, some of which might be available for adoption by infertile couples. In fiscal year 2008, Congress expanded the scope of the program to include interventions that provided “medical and administrative services” to individuals and couples in order to facilitate the adoption and donation of embryos for the purpose of family formation.

The National Survey of Family Growth (NSFG) has collected information over the past several years regarding the behaviors and access to health services of females and males within the

United States of America related to family formation and reproductive health. Data from the

2012 NSFG release (which received partial support from the Embryo Adoption Awareness program) suggested that nearly two-thirds of U.S. women of reproductive age knew of embryo adoption/donation as a method of family formation. Preliminary analysis from more recent studies indicate that awareness continues to increase. Building upon the public’s awareness, in

2016, OPA supported a small but in-depth study of obstetrician/gynecologists’ knowledge and practices regarding embryo adoption/donation. Though awareness of embryo adoption/donation was nearly universal among the study participants, none of them had ever offered education and counseling on embryo adoption/donation nor suggested it to a patient.

This funding opportunity will build upon previous efforts and focus on interventions that develop and/or provide innovative services (including education and counseling) that facilitate the use of embryo adoption/donation as a method of family formation. Recipients of the services, undertaken as part of the proposed projects, should be individuals that are currently involved, soon may be involved, or are interested in adopting or donating remaining embryos. This may include individuals that are infertile, experiencing difficulty achieving a pregnancy, interested in having more children through frozen embryo transfer, or have surplus embryos. Applications may propose new ideas or they may identify existing projects to modify, augment or attempt to bring to scale interventions which have a high likelihood of improving access to, facilitating, or reducing barriers to embryo adoption/donation. For this reason, applicant organizations are permitted to apply for up to a two-year project period. The expectation is that successful applications will have a plan and strategy to continue the project beyond the project period.

HHS/OASH and OPA are interested in projects which address a variety of “medical” and

“administrative services” that facilitate the use of embryo adoption/donation as a method of family formation. For the purposes of this announcement, education and counseling are considered “medical services.” “Administrative services” are those that address and help embryo adoption/donation patients to negotiate the process of embryo adoption/donation, and to overcome the financial, legal and other non-biologic obstacles that may occur in the process of embryo adoption/donation. Training of professionals to enable them to provide administrative and/or medical services to facilitate embryo adoption and donation is also included within this aspect of the program. Applicants may also propose projects that improve the knowledge and awareness of embryo adoption and donation for individuals that are interested or may be interested in this method of family formation, in the form of targeted public awareness campaigns. Additionally, projects may propose to include a combination of the medical services, administrative services and/or public awareness aspects described above in a single application.

Successful applications will provide detailed descriptions of innovative approaches to improve, at a minimum, the likelihood of individuals and couples to consider adopting embryos and/or donating their unused embryos. In the narrative section of the application, applicants should clearly describe the strategies and processes that they will use to design, implement, and assess their proposed project. It is critical that applicants clearly describe how they will measure success, including but not limited to establishing quantifiable targets and attainable goals.

Applicants should clearly identify the process and reason for identifying the individuals that will receive the services (i.e., medical and/or administrative) and/or the target audience(s) of the campaign(s) that focus on increasing the knowledge, awareness, and ability to access embryo adoption and/or donation services. It is highly recommended that the proposed project incorporate current, evidence-based information in all phases of the design, delivery, and evaluation. Applicant organizations should demonstrate competency in the design, development, implementation; the ability to successfully complete the proposed project; and capacity to assess the outcomes of all activities. The successful applicant will provide evidence of familiarity with embryo donation and/or adoption and the ability to translate evidence-based information into the proposed activities. A detailed plan and strategy for how the outcomes of the project will be used beyond the requested funding period should also be included.

Applicants are also encouraged to devise strategies to identify the various professional audiences associated with embryo donation and/or adoption and to develop interventions that involve professionals (e.g., gynecologists and other reproductive medicine physicians, nurses, embryologists, family practice lawyers, adoption counselors, ethicists, social workers, IVF clinic staff, embryo storage facility staff, etc.) associated with the legal, medical, psycho-social, ethical and practical issues associated with both embryo donors and embryo recipients.

For applications that are proposing projects to address medical and/or administrative services that facilitate the use of embryo adoption/donation as a method of family formation:

Successful applicants will clearly and fully explain their strategies on how they will deliver services that increase the ability of individuals or couples to donate or adopt frozen embryos.

Strategies aimed at increasing the percentage of currently frozen embryos that are made available for donation/adoption are acceptable under this program. Additionally, projects that propose services to assist individuals in determining the number of embryos to be created, as well as, education and counseling and education around options to consider if surplus embryos remain once it is determined that the use in one’s own family formation has been completed, are also acceptable under this program.

If proposing projects to provide education and counseling and education and related medical services, applicants should consider including approaches that inform individuals that are infertile or experiencing difficulty achieving a pregnancy about the option of considering embryo donation/adoption at the same time they are receiving education and counseling on other options including, but not limited to infertility treatments and other assisted reproductive technologies

(ART).

Training professionals to offer medical or administrative services to individuals and couples who are involved in embryo donation/adoption is included in the “services” aspect of the program.

Applicants may conduct training activities for professionals that offer individuals or couples help with the medical, legal, psycho-social, ethical, and practical issues surrounding embryo donation and/or adoption. These types of trainings should be designed to enhance the ability of multiple levels of providers to share information and to assist potential donors with embryo donation and/or adoption. Training design and content should be adjusted to the skill and practice role of the target audience. Appropriate continuing education credits may be made available for professional training activities provided under this announcement. The content and number of offerings should be based on an assessment of the need. These offerings should be designed and delivered in a manner appropriate to the content of the course as well as professional preparation of the participants.

For applications that are proposing projects to increase the knowledge and awareness of embryo adoption and donation for individuals that are interested or may be interested in this method of family formation, in the form of targeted public awareness campaigns:

Successful applicants will clearly document their capacity to undertake a campaign focused on the specific audience(s) they are directing their project toward. The narrative should address why the need to target the audience(s) exists and how the campaign will bring greater awareness, understanding, and potentially increase the likelihood of receiving donated embryos for family formation or making more embryos available for adoption/donation. Campaigns should be directed at specific populations, including, but not limited to individuals likely to donate and/or accept donated embryos for family formation or medical and other professionals that provide medical or administrative services related to the treatment of infertility, ART, and related fields.

Services provided by applicant organizations must be offered consistent with 42 CFR 59.5(a)(4), which requires that services be provided “without regard to religion, race, color, national origin, handicapping condition, age, sex, number of pregnancies, or marital status.” Project funds cannot be used to pay for human tissues, nor for any approach that may be construed as involving compensation for the donation of human tissues. Reimbursement of an embryo donor's already accrued costs, including but not limited to storage fees, is not considered an acceptable practice in this program.

AUTHORITY: This program is authorized by Division B, Title II of the Department of

Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and

Continuing Appropriations Act, 2019 (Public Law No. 115-245) and Section 1704 of the Public

Health Service Act (42 U.S.C. §300 u-3).

B. FEDERAL AWARD INFORMATION

OPA intends to make funds available for competing grants.

We will fund awards in annual increments (budget periods) and generally for a project period up to two 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: $700,000

Anticipated Number of Awards: 3-5

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

Award Floor (Federal Funds including indirect costs): $100,000 per budget period

Anticipated Start Date: 07/01/2019

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

C. ELIGIBILITY INFORMATION

1. Eligible Applicants. Only agencies and organizations, not individuals, are eligible to apply.

Eligible applicants include public agencies, non-profit organizations, or for-profit organizations.

Educational institutions—including colleges, universities, academic medical centers and/or their affiliated clinics—are eligible to apply for this grant. Faith-based organizations and American

Indian/Alaskan Native/Native American (AI/AN/NA) organizations are also eligible to apply.

Multiple organizations may apply together, however, one agency must be identified as the applicant organization and this agency will have legal responsibility for the project. These additional agencies and organizations can be included as co-participants, subgrantees, subcontractors, or collaborators if they assist in providing expertise and in helping to meet the needs of the recipients.

2. Cost Sharing or Matching You are not required to provide cost sharing or matching in your proposed budget.

3. Other Eligibility Information

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 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/OGM deems your application eligible according to section C.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 40 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 65 pages. NOTE: items listed in “e” 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.

D. 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 1 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

Office of Grants Management

Phone: 240-453-8822

Email: ogm.oash@hhs.gov

2. Content and Form of Application Submission mailto:ogm.oash@hhs.gov

i. 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 C. 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/OGM, 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.

Appendices Format

Your Appendices should include any specific documents outlined in Section D.2.iii., 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.

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.

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.

ii. Application Content

Successful applications will contain the following information:

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) Project Summary: Provide a summary of the project not to exceed one page. Care should be taken to produce a summary that accurately and concisely reflects the proposed project, especially in regard to the project’s major goals and objectives. This summary will be used to provide reviewers with an overview of the application. The summary should describe the objectives of the project, the approach to be used and the results or benefits expected. This project summary may be posted on the OPA website if the project is awarded a grant.

2) Need for Assistance: Demonstrate a clear understanding of the program goals and explain how the particular approach will contribute to achieving these goals. Clearly identify the clinical/healthcare, physical, economic, social, legal, financial, institutional, and/or other problem(s) requiring a solution. Clearly describe and provide a justification for selecting the specific populations and/or groups to participate in the activities proposed within the application.

Note that grant funds may only be used for domestic purposes and activities. Describe the rationale for use of the proposed approach based upon previous practice, review of the literature, and evaluation findings. Any relevant data based on studies should be included or referred to in the proposed approach and referred to in the endnotes/footnotes.

3) Approach and Objectives: The applicant should provide a detailed work plan and timetable as well as goals and objectives that are specific, measurable, achievable, realistic and time-framed (SMART) for the proposed project. Outline a plan of action which describes the scope and detail of how the proposed work will be accomplished. Account for all functions and activities identified in the application. Cite factors that might accelerate or decelerate the work, and state reasons for taking the proposed approach rather than others. Describe any unusual features of the project such as design or technological innovations, reductions in cost or time, or extraordinary social and/or community involvement. Provide quantitative monthly or quarterly projections of the accomplishments to be achieved for each function or activity in such terms as the number of program activities to be held, or appropriate measurable outcomes. When accomplishments cannot be quantified by activity or function, list them in chronological order to show the schedule of the accomplishments and their target dates.

4) Evaluation: Provide a detailed narrative addressing how results of the project and conduct of the project will be evaluated. In addressing the evaluation of results, the successful applicant will determine the extent to which the project has achieved its stated objectives and the extent to which this accomplishment of objectives can be attributed to the action of the project.

The evaluation should be based on a model or approach that links the program interventions to the program's objectives. The applicant should discuss the criteria used to evaluate results, and explain the methodology that will be used to decide if the identified needs are being met and if the project results are being achieved. Applicants that do not have the in-house capacity to conduct an evaluation are advised to propose contracting with a third-party evaluator to conduct the evaluation.

With respect to the conduct of the project, the applicant should define the procedures to be employed and should discuss the impact of the project's various activities on the project's effectiveness.

5) Organizational Profiles: Provide information on the applicant organization and cooperating partners such as organizational charts, documentation of professional accreditation, documentation of experience in the program area, and other pertinent information. Applicants should demonstrate an understanding of the intended audience as well as the information and skills needed by the designated staff. Applicants are advised to show that they have the organizational capacity and resources to carry out the project on time and to a high standard of quality, including the capacity to resolve a variety of technical and management problems that may occur. Capacity includes, but is not limited to: 1. Previous experience with similar projects;

2. Experience with the target audience; 3. Qualifications and experience of the project leadership, including those who are consultants or subcontractors; and, 4. Suitability of the organizational structure for the proposed project. Applicants are expected to present a feasible management plan for implementing the proposed program. This section should detail how the program will be structured and managed, how timeliness of activities will be ensured, how quality will be maintained, and how costs will be controlled. If applicable, the role and responsibilities of the lead agency should be clearly defined and applicants should describe the management and coordination of activities carried out by any partners, subcontractors, or consultants.

Budget Narrative

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 D.6 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.

Object Class Descriptions and Required Justifications

Personnel Description: Costs of staff salaries and wages, excluding benefits.

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

Fringe Benefits Description: Costs of employee fringe benefits unless treated as part of an approved indirect cost rate.

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.

Travel Description: Costs of travel by staff of the applicant organization only.

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.

Equipment Description: "Equipment" means an article of nonexpendable, tangible personal property having a useful life of more than one year per unit and an acquisition cost that equals or exceeds the lesser of: (a) the capitalization level established by the organization for the financial statement purposes, or (b) $5,000. (Note: Acquisition cost means the net invoice unit price of an item of 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.

Ancillary charges, such as taxes, duty, protective in-transit insurance, freight, and installation, shall be included in or excluded from acquisition cost in accordance with your organization's regular written accounting practices.)

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).

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.

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

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.

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 CFR § 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, as described in 2 CFR §

200.88, 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, the applicant 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, the applicant must provide information on the nature of the work to be delegated, the estimated costs, and the process for selecting the delegate agency.

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.

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

Indirect Costs Description: Total amount of indirect costs. This category has one of two methods that an applicant may select. You may only select one.

1) 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.

2) Per 45 CFR § 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. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs to the award.

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.

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 CFR §

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 CFR

§§ 75.307, 75.407 and 35 U.S.C. §§ 200-212 (applies to inventions made under Federal awards).

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.

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 CFR § 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 awards, exceeds the amount required. Your failure to provide the required matching amount may result in the disallowance of federal funds. If you are funded, you will be required to report these funds on your Federal Financial Reports. For awards that do not require matching or cost sharing by statute or regulation, where “cost sharing” refers to costs of a project in addition to Federal funds requested that you voluntarily propose in your budget, if your application is successful, we will include this non-federal cost sharing in the approved project budget and you will be held accountable for the non-federal cost-sharing funds as shown in the

Notice of Award (NOA). Your failure to provide voluntary cost sharing of non-federal resources that have been accepted by HHS/OASH as part of the approved project costs and that are shown as part of the approved project budget in the NOA may result in the disallowance of federal funds. If you are funded, you will be required to report these funds on your Federal Financial

Reports. Note, you will not receive any preference, priority, or special consideration in the funding process for voluntarily including non-Federal cost sharing in your proposed budget.

Non-federal Resources Justification: You must provide detailed budget information for every funding source identified in box 18. "Estimated Funding ($)" on the SF-424. Provide this documentation as part of your Budget Narrative file, not your Appendices.

You must fully identify and document in your application the specific costs or contributions you propose in order to meet a matching requirement. You must provide documentation in your application on the sources of funding or contribution(s). In-kind contributions must be accompanied by a justification of how the stated valuation was determined. Matching or cost sharing must be documented by budget period (or by project period for fully-funded awards).

If your application does not include the required supporting documentation, it will not be disqualified from competitive review; however, it may impact your score under the evaluation criteria in Section V.1 of this announcement.

Plan for Oversight of Federal Award Funds

You must include a plan for oversight of federal award funds which describes:

o how your organization will provide oversight of federal funds and how award activities and partner(s) will adhere to applicable federal award and programmatic regulations.

Include identification of risks specific to your project as proposed and how your oversight plan addresses these risks.

o the organizational systems that demonstrate effective control over and accountability for federal funds and program income, compare outlays with budget amounts, and provide accounting records supported by source documentation.

o for any program incentives proposed, the specific internal controls that will be used to ensure only qualified participants will receive them and how they will be tracked.

o organizational controls that will ensure timely and accurate submission of Federal

Financial Reports to the OASH Office of Grants Management and Payment Management

Services as well as timely and appropriate withdrawal of cash from the Payment

Management System.

Appendices

All items described in this section will count toward the total page limit of your application.

You must submit them as a single electronic file uploaded to the Attachments section of your Grants.gov application.

Work Plan

Your Work Plan should reflect, and be consistent with, the Project Narrative and Budget

Narrative, and must cover all years of the project period. You may propose multi-year activities, as well as activities that build upon each other. Your Work Plan should include a statement of the project’s overall goal, anticipated outcome(s), key objectives, and the major tasks, action steps, or products that will be pursued or developed to achieve the goal and outcome(s). For each major task of each year, action step, or product, your work plan should identify the timeframes involved (including start- and end-dates), and the lead person responsible for completing the task.

Letters of Commitment from Subrecipient Organizations and Agencies

You should include signed Letters of Commitment for all organizations and entities that have been specifically named as a subrecipient to carry out any aspect of the project. The signed letters of commitment must detail the specific role and resources that will be provided, or activities that will be undertaken, in support of the applicant. The organization’s expertise, experience, and access to the targeted population(s) should also be described in the letter of commitment.

Letters of commitment are not the same as letters of support. Letters of support are letters that are general in nature that speak to the writer’s belief in the capability of an applicant to accomplish a task. Letters of support also may indicate an intent or interest to work together in the future, but they lack specificity. You should NOT provide letters of support, and letters of support such as this will not be considered during the review.

Curriculum Vitae/Résumé for Key Project Personnel

You must submit with your application curriculum vitae and/or résumés of the Project

Director/Principal Investigator and all other Key Personnel. Key Personnel includes those individuals who will oversee the technical, professional, managerial, and support functions and/or assume responsibility for assuring the validity and quality of your organization’s program. This includes at a minimum Program Manager/Program Coordinator. We encourage individuals to use their full name (first, middle, last) on these documents to distinguish them for verification in the System for Award Management exclusion records.

3. Unique Entity Identifier and System for Award Management (SAM)

• You are required to provide a Dun and Bradstreet (D&B) Data Universal

Numbering System (DUNS) number when applying for Federal awards through

Grants.gov. It is a unique, nine-digit identification number, which provides unique identifiers of single business entities. The DUNS number is free and easy to obtain.

• You will find instructions on the Grants.Gov web site as part of the organization registration process at http://www.grants.gov/web/grants/applicants/organization-registration.html.

• Your organization must register online in the System for Award Management

(SAM). Grants.gov will reject submissions from applicants with nonexistent or expired SAM Registrations.

• If you are registering a new entity or renewing your registration, you must submit a notarized letter formally appointing an Entity Administrator to SAM.GOV For detailed instructions on the content of the letter and process for domestic entities see: https://www.fsd.gov/fsd-gov/answer.do?sysparm_kbid=d2e67885db0d5f00b3257d321f96194b&sysparm_ search=kb0013183 http://www.grants.gov/web/grants/applicants/organization-registration.html http://www.grants.gov/web/grants/applicants/organization-registration.html https://www.sam.gov/ https://www.fsd.gov/fsd-gov/answer.do?sysparm_kbid=d2e67885db0d5f00b3257d321f96194b&sysparm_search=kb0013183 https://www.fsd.gov/fsd-gov/answer.do?sysparm_kbid=d2e67885db0d5f00b3257d321f96194b&sysparm_search=kb0013183 https://www.fsd.gov/fsd-gov/answer.do?sysparm_kbid=d2e67885db0d5f00b3257d321f96194b&sysparm_search=kb0013183

• A quick start guide for registrants is available at https://www.sam.gov/sam/transcript/Quick_Guide_for_Grants_Registrations.pdf.

You should allow a minimum of five days to complete an initial SAM registration.

Allow up to 10 business days after you submit your registration for it to be active in SAM. This timeframe may be longer if SAM flags the information you provide for manual validation.