Stem Cell Research Project

2018 Request for Applications (RFA)

Issue Date:

February 16, 2018

Application Due Date March 30, 2018; by 4:00 pm CST

Main Contact: Maya Chilese

Community Health & Performance Management Division of Public Health

Department of Health & Human Services Box 95026

Lincoln, NE 68509-5026 (402) 471-7779

maya.chilese@nebraska.gov

Application Instructions for the 2018 Stem Cell Research Project

Description In the 2008 legislative session, the Stem Cell Research Act (Neb.Rev.Stat. § 71-8801 et seq) was passed. This Act established the Stem Cell Research Advisory Committee. The Committee is responsible for developing a grant process and making grants to Nebraska institutions or researchers to conduct stem cell research that does not use human embryonic stem cells. The Act defines the types of research projects that are acceptable. The Act states that:

No state facilities, no state funds, fees, or charges, and no investment income on state funds shall be used to destroy human embryos for the purpose of research. In no case shall state facilities, state funds, fees, or charges, or investment income on state funds be used to create a human embryo by somatic cell nuclear transfer for any purpose.

For purposes of the Act, human embryo means the developing human organism from the time of fertilization until the end of the eighth week of gestation and includes an embryo or developing human organism created by somatic cell nuclear transfer; somatic cell nuclear transfer means a technique in which the nucleus of an oocyte is replaced with the nucleus of a somatic cell.

Eligibility

Grants will be awarded to Nebraska institutions or researchers as defined below:

Sponsoring Institution. Preference will be given to funding proposals submitted by an institution in Nebraska that has an ongoing, large-scale research program that is conducive to the completion of a complex project in stem cell research that does not use human embryonic stem cells.

Principal Investigator. The leader of a project is the “principal investigator”. Researchers with a doctoral degree in science (PhD or equivalent), or a professional degree in a medical field (MD, DMD, DVM, or similar), are eligible to submit a proposal to the Stem Cell Research Advisory Committee as a Principal Investigator (PI). The PI must be employed at an institution in Nebraska that meets the criteria for “Sponsoring Institution” (see above). Researchers that are classified as Post-doctorates or Fellows are not eligible.

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Availability of Funds and Matching Requirements The amount of money available for new grants is approximately $425,000. The maximum grant is $110,000 for twelve months. As provided in Neb.Rev.Stat. § 71-8805: No single institution or researcher shall receive more than seventy percent of the funds available for distribution under this section on an annual basis. Per Neb.Rev.Stat. § 71-8805, each Sponsoring Institution or researcher must provide a dollar-for-dollar match. The matching funds must be obtained from sources other than funds provided by the Stem Cell Research Act (e.g., principal investigator’s salary provided by the sponsoring institution, other research grants from federal sources, stipends for students and post-doctorates).

Prior to Submission

Each proposal must be vetted and approved by a local committee appointed by the Sponsoring Institution, or its equivalent, before it is accepted by the Stem Cell Research Advisory Committee for full review. The composition of the committee is at the discretion of the institution.

Approval of the application by the Sponsoring Institution should be based upon the degree to which the proposal appears to meet the selection criteria outlined below.

Submission

Proposals that have been vetted and approved by local committee or its equivalent, must be submitted to the Division of Public Health of the Nebraska Department of Health and Human Services.

Each Sponsoring Institution may submit a maximum of five (5) proposals in a given funding cycle.

No Principal Investigator may hold more than a single grant at a given time.

Application Format Although there is no page limit for the total application, some sections have page limitations. Grant applications that exceed the specified page limits will not be reviewed. The application will consist of the following components:

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1. Face Page: one page maximum 2. Table of Contents: one page maximum 3. Abstract and Specific Aims of the Project: maximum of 30 lines of text 4. Description of Key Personnel: two page maximum 5. Biographical Sketches: four page maximum per researcher (may use NIH 398 form) 6. Previous and Current Related Projects Funded 7. Research Plan Description: five page maximum 8. References: the citations should be single-spaced with no page limit 9. Budget and Budget Justification: the applicant may request a one year grant for up to

$110,000 Professional salaries for the Principal Investigator and doctoral level co-investigators as well as clerical or administrative assistance are NOT allowed (but may be included in the matching funds). Allowable budget items include non-professional salaries (e.g., laboratory assistants, post-doctorates, and graduate assistants), equipment, travel, and other expenses such as consultant costs. There is a two page maximum on the budget justification.

10. General Terms and Assurances (Attachment A)

Selection Criteria

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternatives?

Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Principal Investigator: Is the PI appropriately trained and well suited to carry out this work? Is the work proposal appropriate to the experience level of the PI and other researchers (if any)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?

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Proposal Evaluations

Proposals are evaluated by the Stem Cell Research Advisory Committee using the current NIH scoring system from 1 to 9 where the lowest scores indicate the highest level of merit (http://grants.nih.gov/grants/peer_review_process.htm).

The Committee may seek outside expertise and assistance in providing the most knowledgeable and fair evaluations of the grant proposals.

Each applicant that submits an application will receive strengths and weaknesses of their proposal from the Committee.

Submission Instructions 1. The completed application must include all of the items listed on the checklist shown on

page 7 of this document, plus the completed General Terms and Assurances (Attachment A).

2. If any portion of the application is received after the due date and time, that portion of

the application will not be reviewed. 3. The narrative sections must be typed on 8 ½” x 11” size pages that are single-spaced

with one-inch margins and font no smaller than 12 point. 4. Do not exceed page limits identified on page 4 of this document and repeated on the

checklist, page 7. The pages must be numbered consecutively from the face page to the last page of the application.

5. The applicant is required to submit the application electronically as a PDF or Word

document no later than 4:00 pm CST on March 30, 2018 to both Maya Chilese (maya.chilese@nebraska.gov) and Pat DeLancey (patti.delancey@nebraska.gov). Applications received after 4:00 pm CST on this date will not be acknowledged or reviewed.

6. Once applications are in the review process, there will be no further discussion regarding

an applicant’s submission.

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Timeline February 16, 2018 Notice of availability of funds is distributed to the appropriate

institutions March 30, 2018 Deadline for submission of applications; must be received by

4:00 pm CST Mid-June, 2018 Selection of awards July 1, 2018 Grant period begins

Contact Person RFA material requests or questions about the program should be directed to: Maya Chilese Community Health & Performance Management

Division of Public Health Department of Health & Human Services Box 95026 Lincoln, NE 68509-5026 (402) 471-7779 maya.chilese@nebraska.gov This RFA, including all templates, is also available in Microsoft Word/Excel format by contacting Pat DeLancey at (402) 471-2353 or patti.delancey@nebraska.gov

Notification When the evaluation process is complete, Committee recommendations are forwarded to the Division of Public Health’s Chief Medical Officer for final approval. The Office of Community Health & Performance Management will notify applicants as to their award status. The start date for the 2018 grants will be July 1st.

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Checklist for the 2018 Stem Cell Research Project

Do not include this form in your application. It is for your use only to be sure you have included the required information in the required manner. The information must be in your application in the following order: ____ Face Page (page 9 of RFA) ____ Table of Contents: one page maximum (page 10 of RFA) ____ Abstract and Specific Aims of the Project: maximum of 30 lines of text (page 11 of

RFA) ____ Description of Key Personnel: two page maximum (page 12 of RFA) ____ Biographical Sketches: four page maximum per researcher (may use NIH 398 form);

(page 14 of RFA) ____ Previous and Current Related Projects Funded: (page 15 of RFA) ____ Research Plan Description: five page maximum (page 16 of RFA) ____ References: single-spaced but no page limit (page 19 of RFA) ____ Budget (page 20 of RFA) ____ Budget Justification: two page maximum (page 23 of RFA) ____ General Terms and Assurances (page 25 of RFA; Attachment A: Sponsored

Programs must complete “For Grantee” section on last page) Applications are due by 4:00 pm CST on March 30, 2018. Applications received after this date and time will not be acknowledged or reviewed.

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Application and Instructions

The application and selected instructions are on the following pages. Applicants should use this format and follow all instructions.

Nebraska Department of Health and Human Services Stem Cell Research Grant Application

Follow Instructions Carefully

Leave Blank for Department of Health and Human Services

1. Title of Project (Do not exceed 50 characters, including spaces and punctuation.)

2. Principal Investigator Name (Last, first, middle)

2a. Degree(s)

2b. Position Title

2c. Mailing Address of PI (Organization, street, city, state, zip) Organization Street Address City, State, Zip

2d. Department, Service, Laboratory or Equivalent

2e. Major Subdivision

2f. PI Contact Numbers (Area code, number and extension) Telephone Fax E-mail Address

2g. New Application

Revised Application (This application replaces a prior Unfunded version of the new competing application # _____________________).

3. Human Subjects If Yes, IRB approval or exemption date (attach copy)

No Yes _____________________

4. Vertebrate Animals (IACUC) If Yes, Review Board approval date (attach copy)

No Yes _____________________

5. Recombinant DNA (IBC) If Yes, Review Board approval date (attach copy)

No Yes ___________________________

6. Proposed Project Period: July 1, 2018 – June 30, 2019 Total Direct Costs Requested:

7. Administrative official to be notified if award is made Name Title Address Telephone Fax E-mail Address

8. Name of Official Signing for Applicant Organization Name Title Address Telephone Fax E-mail Address

9. Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports, if a grant is awarded as a result of this application.

Signature of person named in 2. (In ink. "Per" signature not acceptable.) Date ________________________

10. Application Organization, Certification and Acceptance: I certify that the above statements herein are true, complete and accurate to the best of my knowledge and accept the obligation to comply with Department regulations and conditions if a grant is awarded as a result of this application.

Signature of person named in 8. (In ink. "Per" signature not acceptable.) Date ________________________

Face Page - 1 Date: March 30, 2018

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title:

Table of Contents

Please number each page and indicate on table of contents

Section 1. General Guidelines Face Page .............................................................................................................................................. 1 Table of Contents ................................................................................................................................ 2 Abstract and Specific Aims of the Project ....................................................................................... 3 Description of Key Personnel ........................................................................................................... 4 Biographical Sketch: Principal Investigator and Others ................................................................ 6 Previous and Current Related Projects Funded .............................................................................. 7 Research Plan Description ................................................................................................................. 8 References .......................................................................................................................................... 11 Detailed Budget for Proposed Project Period ............................................................................... 12 Budget Justification ........................................................................................................................... 15 Attachment A (Terms and Assurance) Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b.

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title: Abstract: List the application's specific aims, and make a clear statement of the project's relevancy to stem cell research. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This abstract is meant to serve as a succinct and accurate description of the proposed work when separated from the application. There is a maximum of 30 lines of text.

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Instructions for the Description of Key Personnel Section Key personnel are defined as, and should be limited to, individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested. The PI must be an independent investigator with an appropriate faculty appointment, adequately assigned laboratory space, and the ability to apply for federal grants as a PI. Junior applicants may apply if they provide a statement or letter from their Chairperson specifically confirming their faculty level appointment, the amount of independent research space available to them and that they are considered eligible to apply for federal grants as a PI. Consultants should be included only when their level of involvement meets the definition. Individuals providing technical services are not considered key personnel. For each individual, provide: name, organization, and role on the project. Under role on the project, indicate how the individual will function with regard to the proposed project, for example, principal investigator, graduate research assistance, etc. (two page maximum and use format on the next page).

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title: Key Personnel. See specific instructions on previous page. Use another page as needed to provide the required information in the format shown below. Name Organization Role on Project

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title:

Biographical Sketch Give the following information for the key personnel and consultants and collaborators. Begin with the principal Investigator/program director. Photocopy this page for each person.

Name Position Title

Education (begin with baccalaureate or other initial professional education, such as nursing, and include post-doctoral training)

Institution and Location

Degree

Year Conferred

Field of Study

Research and professional experience: Concluding with present position, list, in chronological order, previous employment, experience, and honors. List, in chronological order, the titles, all authors, and complete references of recent peer reviewed publications and to representative earlier publications pertinent to this application only. This section should not exceed three additional pages (applicants may use the NIH 398 form). There is a maximum of four pages for each individual, even if the NIH 398 form is used.

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title:

Previous and Current Related Projects

Please list all active and pending extramural sources of funding, as well as previously funded projects from the past three years. For each project, list: (1) the project title; (2) budget amount and PI percent effort; (3) source and period of funding; and (4) project abstract including Specific Aims. Identify any potential overlap with the proposed research.

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Specific Instructions for the Research Plan

The research plan should include sufficient information to facilitate an effective review. Be specific and informative and avoid redundancies. Reviewers often consider brevity and clarity in the presentation to be indicative of a principal investigator’s focused approach to a research objective and ability to achieve the specific aims of the project. Organize Sections A-D of the Research Plan to answer these questions: (A) What do you intend to do? (B) Why is the work important? (C) What has already been done? (D) How are you going to do the work? Do not exceed five pages, including all tables and graphs. A five page absolute maximum will be strictly enforced. Applications that exceed this limit, or that exceed the type size limitations, will be returned without review. You may use any page distribution within this overall limitation adhering to the following format: A. Specific Aims. State the broad, long-term objectives and describe concisely and realistically

what the specific research described in this application is intended to accomplish and any hypotheses to be tested.

B. Background and Significance. Briefly sketch the background to the present proposal,

critically evaluate existing knowledge, and specifically identify the gaps in which the project is intended to fill. State concisely the importance of the research described in this application by relating the specific aims to the broad, long-term objectives.

C. Preliminary Studies. Provide an account of the principal investigator’s preliminary studies

pertinent to the application and/or any other information that will help to establish the experience and competence of the investigator to pursue the proposed project.

D. Research Design and Methods. Outline the research design and the procedures to be used

to accomplish the specific aims of the project. Include the means by which the data will be collected, analyzed, and interpreted. Describe any new methodology and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. Provide a tentative sequence or timetable for the investigation. Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.

Gender and Minority Inclusion: According to the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (2001), applications for grants that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions in which disproportionately affect them. IRB, IACUC, and IBC Approval: If this proposal employs the use of human subjects or materials (IRB), use of animals (IACUC), or use of recombinant DNA (IBC), the necessary

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approval(s) by the appropriate IRB, IACUC, or IBC at the institutions must be obtained prior to the actual expenditure of any awarded funds. IRB, IACUC and IBC applications should be submitted through campus approval channels in a timely way to allow "just-in-time” processing and funding of possible awards. No research employing human subjects, animal subjects, or recombinant DNA may be initiated prior to full approval of related protocol applications. Although no specific page limitation applies to the following sections (E-G) of the application, it is important to be succinct. E. Consultants/Collaborators. Include biographical sketch pages for each consultant and

collaborator and place them with those of the other participants on the project.

F. Contractual Arrangements. Provide a detailed explanation of the programmatic, fiscal, and administrative arrangements made between the applicant organization and the collaborating organizations and individuals. Attach confirming letters countersigned by an authorized official of the collaborating institutions and principal investigator or copies of written agreements.

G. Literature Cited. Do not scatter literature citations throughout the text. List them on a

separate page at the end of the Research Plan. Each literature citation must include the title of the article, the names of all authors, the name of the book or journal, volume number, page numbers, and year of publication. Make every attempt to be judicious in compiling a relevant and current list of literature citations.

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title:

Research Plan

The research plan should describe specific aims, background and significance, preliminary studies, and research and design methods – five page maximum (see instructions on previous pages).

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title:

References

References should be single-spaced with no page limit.

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Instructions for the Budget

Detailed Budget for Project Period. List only the direct costs requested in this application. Direct costs are those that can be identified specifically within a particular cost objective. Indirect costs or overhead costs are unallowable. The budget sheet following these instructions must be completed for funding proposed for Year 2018. The budget justification has a two page limit. Applications which fail to present itemized budgets and justification will be judged incomplete and will not be considered for funding. Personnel: Personnel costs should include salaries, wages, and associated fringe benefits paid for services rendered to the research project. Personnel costs should be budgeted in relation to the amount of time and effort expected to be devoted to the project by each individual involved. Salary support for the Principal Investigator or other faculty will not be permitted on these grants. Personnel costs should be itemized by position title. Percent of Effort on Project. Indicate the percent of each appointment at the applicant organization to be devoted to this project. Institutional Base Salary. Institutional base salary is defined as the annual compensation that the applicant organization pays for the individual’s appointment, whether that individual’s time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual may be permitted to earn outside of duties to the applicant organization. Base salary may not be increased as a result of replacing institutional salary funds with grant funds. Dollar Amount Requested Salary Requested. Enter the dollar amounts for each position for which funds are requested. The maximum salary that may be requested is calculated by multiplying the individual’s base salary, defined above, by the percent of effort on this project. Professional salaries for the Principal Investigator and doctoral level co-investigators as well as clerical or administrative assistance are NOT allowed. The applicant must designate the percent of FTE for the Principal Investigator and indicate any matching funds. Fringe Benefits. Fringe benefits may be requested in accordance with the existing rate established by the applicant organization. The applicant must provide information of the benefits for each position being funded. Totals. Calculate the totals for each position and enter the subtotal in each column where indicated.

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Supplies. Supplies, both laboratory and office, that are expected to be consumed in the conduct of the project should be budgeted. Itemize supplies in separate categories such as glassware, chemicals, radioisotopes, office supplies, etc. Travel. Travel expenses are allowable only when incurred for the purposes of collecting, receiving, or delivering samples. State the purpose of any travel, giving the number of trips involved, the destinations, and the number of individuals for whom funds are requested. Travel expenses to attend national, international, professional research, or educational conferences are not allowed. Other Consultant Costs. Whether or not costs are involved, provide the names and organizational affiliations of any consultants, including physicians in connection with patient care, who have agreed to serve in that capacity. Consultants are usually individuals organizationally separate from the Principal Investigator. Consultant fees are not allowed for full-time faculty or researchers in other departments of the same institution of the Principal Investigator. Briefly describe the services to be performed, including the number of days of consultation, the expected rate of compensation, travel, per diem, and other related costs. Equipment. No office equipment will be allowed. Other Expenses. Other expenses include postage, data processing, and other types of operating expenses not classified elsewhere in these instructions. These costs will only be allowable to the extent that they are incurred for the direct benefit of an approved grant (e.g., postage, copy and printing costs for forms, correspondence, and reports required or generated by an approved grant). The cost of publishing the findings in a scientific journal will be allowed up to $2,500. Each item in this cost category must be identified with its associated costs. In general, telephone costs are not allowable except long distance calls required by the nature of the project. Indirect or overhead costs, such as rent and utilities, are not allowable. Matching Funds. A dollar-for dollar match must be provided by the institutions or researchers from sources other than state funds provided through this grant. Federal funds can be considered as the match. In the line-item budget shown on page 22 of this RFA, there is a column for matching funds. If the matching funds are being supported by the institution and can not be shown in the specific line item categories, applicants must list the match under the total column and detail the sources of the match in the budget narrative (i.e., list awards from federal and non-federal sources that are being used to support the match). Of course, if the matching funds are included as line items, they must also be explained in the budget narrative.

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title:

Line-Item Budget

Line Item Grant Funds Requested

Matching Funds: Cash and Source

Total Project Cost

Personnel

PI ___% FTE $0

Laboratory Asst __% FTE

Others/Specify

SUBTOTAL

Benefits

SUBTOTAL

Operating Expenses

Supplies

Other (specify):

SUBTOTAL

Travel

(reimbursed at .545/mile)

SUBTOTAL

Other (specify)

Equipment

Consultants

SUBTOTAL

TOTAL

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Instructions for Budget Justification Applicants must explain the budget in detail noting how estimated expenditures support the project aims. Describe the components of each line item and how the final figure was calculated. For example, explain the specific functions of the personnel and consultants. Describe what personnel benefits are being requested through this grant. Also, justify the purchase of major equipment, usual supplies, and travel. The amounts in the budget justification total must equal the amounts in the line-item budget. There is a two page limit on the budget justification.

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Principal Investigator/Program Director (Last, first, middle): Applicant Organization: Abstract Title:

Budget Justification (two page limit)

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Attachment A

GENERAL TERMS AND ASSURANCES A. ACCESS TO RECORDS AND AUDIT RESPONSIBILITIES.

1. All Grantee books, records, and documents regardless of physical form, including data maintained in computer files or on magnetic, optical or other media, relating to work performed or monies received under this grant shall be subject to audit at any reasonable time upon the provision of reasonable notice by DHHS. Grantee shall maintain all records for three (3) years from the date of final payment, except records that fall under the provisions of the Health Insurance Portability and Accountability Act (HIPAA) shall be maintained for six (6) full years from the date of final payment. In addition to the foregoing retention periods, all records shall be maintained until all issues related to an audit, litigation or other action are resolved to the satisfaction of DHHS. The Grantee shall maintain its accounting records in accordance with generally accepted accounting principles. DHHS reserves and hereby exercises the right to require the Grantee to submit required financial reports on the accrual basis of accounting. If the Grantee’s records are not normally kept on the accrual basis, the Grantee is not required to convert its accounting system but shall develop and submit in a timely manner such accrual information through an analysis of the documentation on hand (such as accounts payable).

2. The Grantee shall provide DHHS any and all written communications received by the

Grantee from an auditor related to Grantee’s internal control over financial reporting requirements and communication with those charged with governance including those in compliance with or related to Statement of Auditing Standards (SAS) 122. The Grantee agrees to provide DHHS with a copy of all such written communications immediately upon receipt or instruct any auditor it employs to deliver copies of such written communications to DHHS at the same time copies are delivered to the Grantee, in which case the Grantee agrees to verify that DHHS has received a copy.

3. The Grantee shall immediately commence follow-up action on findings arising from audits

or other forms of review. Follow-up action includes responding to those conducting such examinations with clear, complete views concerning the accuracy and appropriateness of the findings. If the finding is accepted, corrective action, such as repaying disallowed costs, making financial adjustments, or taking other actions should proceed and be completed as rapidly as possible. If the Grantee disagrees, it should provide an explanation and specific reasons that demonstrate that the finding is not valid.

4. In addition to, and in no way in limitation of any obligation in this grant, the Grantee shall

be liable for audit exceptions, and shall return to DHHS all payments made under this grant for which an exception has been taken or which has been disallowed because of such an exception, upon demand from DHHS.

B. ANTI-DISCRIMINATION. The Grantee shall comply with all applicable local, state and

federal statutes and regulations regarding civil rights and equal opportunity employment,

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including Title VI of the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq.; the Rehabilitation Act of 1973, 29 U.S.C. §§ 794 et seq.; the Americans with Disabilities Act of 1990, 42 U.S.C. §§ 12101 et seq.; and the Nebraska Fair Employment Practice Act, Neb. Rev. Stat. §§ 48-1101 to 48-1125. Violation of said statutes and regulations will constitute a material breach of this grant. The Grantee shall insert a similar provision into all grants and subcontracts.

C. ASSIGNMENT. The Grantee shall not assign or transfer any interest, rights, or duties under

this grant to any person, firm, or corporation without prior written consent of DHHS. In the absence of such written consent, any assignment or attempt to assign shall constitute a breach of this grant.

D. ASSURANCE. If DHHS, in good faith, has reason to believe that the Grantee does not intend

to, is unable to, has refused to, or discontinues performing material obligations under this grant, DHHS may demand in writing that the Grantee give a written assurance of intent to perform. Failure by the Grantee to provide written assurance within the number of days specified in the demand may, at DHHS’s option, be the basis for terminating this grant.

E. BREACH OF GRANT. DHHS may immediately terminate this grant and agreement, in whole or in part, if the Grantee fails to perform its obligations under the grant in a timely and proper manner. DHHS may withhold payments and provide a written notice of default to the Grantee, allow the Grantee to correct a failure or breach of grant within a period of thirty (30) days or longer at DHHS’s discretion considering the gravity and nature of the default. Said notice shall be delivered by Certified Mail, Return Receipt Requested or in person with proof of delivery. Allowing the Grantee time to correct a failure or breach of this grant does not waive DHHS’s right to immediately terminate the grant for the same or different grant breach which may occur at a different time. DHHS may, at its discretion, obtain any services required to complete this grant and hold the Grantee liable for any excess cost caused by Grantee’s default. This provision shall not preclude the pursuit of other remedies for breach of grant as allowed by law.

F. CONFIDENTIALITY. Any and all confidential or proprietary information gathered in the

performance of this grant, either independently or through DHHS, shall be held in the strictest confidence and shall be released to no one other than DHHS without the prior written authorization of DHHS, provided that contrary grant provisions set forth herein shall be deemed to be authorized exceptions to this general confidentiality provision. This provision shall survive termination of this grant.

G. CONFLICTS OF INTEREST. In the performance of this grant, the Grantee shall avoid all

conflicts of interest and all appearances of conflicts of interest. The Grantee shall not acquire an interest either directly or indirectly which will conflict in any manner or degree with performance and shall immediately notify DHHS in writing of any such instances encountered.

H. DATA OWNERSHIP AND COPYRIGHT. DHHS shall own the rights in data resulting from this project or program. The Grantee may copyright any of the copyrightable material

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and may patent any of the patentable products produced in conjunction with the performance required under this grant without written consent from DHHS. DHHS hereby reserves a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use, and to authorize others to use the copyrightable material for state government purposes. This provision shall survive termination of this grant.

I. DEBARMENT, SUSPENSION OR DECLARED INELIGIBLE. The Grantee certifies that neither it nor its principals are debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency. Failure to comply with this section may result in withholding of payments or immediate termination of the grant.

J. DOCUMENTS INCORPORATED BY REFERENCE. All references in this grant to laws, rules, regulations, guidelines, directives, and attachments which set forth standards and procedures to be followed by the Grantee in discharging its obligations under this grant shall be deemed incorporated by reference and made a part of this grant with the same force and effect as if set forth in full text, herein.

K. DRUG-FREE WORKPLACE. Grantee certifies that it maintains a drug-free workplace environment to ensure worker safety and workplace integrity. Grantee shall provide a copy of its drug-free workplace policy at any time upon request by DHHS.

L. FORCE MAJEURE. Neither party shall be liable for any costs or damages resulting from its

inability to perform any of its obligations under this grant due to a natural disaster, or other similar event outside the control and not the fault of the affected party (“Force Majeure Event”). A Force Majeure Event shall not constitute a breach of this grant. The party so affected shall immediately give notice to the other party of the Force Majeure Event. Upon such notice, all obligations of the affected party under this grant which are reasonably related to the Force Majeure Event shall be suspended, and the affected party shall do everything reasonably necessary to resume performance as soon as possible. Labor disputes with the impacted party’s own employees will not be considered a Force Majeure Event and will not suspend performance requirements under this grant.

M. FRAUD OR MALFEASANCE. DHHS may immediately terminate this grant for fraud,

misappropriation, embezzlement, malfeasance, misfeasance, or illegal conduct pertaining to performance under the grant by Grantee, its employees, officers, directors, volunteers, shareholders, or subcontractors.

N. FUNDING AVAILABILITY. DHHS may terminate the grant, in whole or in part, in the

event funding is no longer available. Should funds not be appropriated, DHHS may terminate the award with respect to those payments for the fiscal years for which such funds are not appropriated. DHHS shall give the Grantee written notice thirty (30) days prior to the effective date of any termination. The Grantee shall be entitled to receive just and equitable

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compensation for any authorized work which has been satisfactorily completed as of the termination date. In no event, shall the Grantee be paid for a loss of anticipated profit.

O. GRANT CLOSE-OUT. Upon completion or notice of termination of this grant, the following procedures shall apply for close-out of the grant: 1. The Grantee will not incur new obligations after the termination or completion of the

grant, and shall cancel as many outstanding obligations as possible. DHHS shall give full credit to Grantee for non-cancelable obligations properly incurred by Grantee prior to termination, and costs incurred on, or prior to, the termination or completion date.

2. Grantee shall immediately return to DHHS any unobligated balance of cash advanced or

shall manage such balance in accordance with DHHS instructions.

3. Within a maximum of 90 days following the date of expiration or completion, Grantee shall submit all financial, performance, and related reports required by the Grantee Reporting Requirements. DHHS reserves the right to extend the due date for any report and may waive, in writing, any report it considers to be unnecessary.

4. The Grantee shall assist and cooperate in the orderly transition and transfer of grant

activities and operations with the objective of preventing disruption of services.

5. Close-out of this grant shall not affect the retention period for, or state rights of access to, Grantee records, or Grantee’s responsibilities regarding property or with respect to any program income for which Grantee is still accountable under this grant. If no final audit is conducted prior to close-out, DHHS reserves the right to disallow and recover an appropriate amount after fully considering any recommended disallowances resulting from an audit which may be conducted at a later time.

P. GOVERNING LAW. The award shall be governed in all respects by the laws and statutes of

the United States and the State of Nebraska. Any legal proceedings against DHHS or the State of Nebraska regarding this award shall be brought in Nebraska administrative or judicial forums as defined by Nebraska State law. The Grantee shall comply with all Nebraska statutory and regulatory law.

Q. HOLD HARMLESS.

1. The Grantee shall defend, indemnify, hold, and save harmless the State of Nebraska and its employees, volunteers, agents, and its elected and appointed officials (“the indemnified parties”) from and against any and all claims, liens, demands, damages, liability, actions, causes of action, losses, judgments, costs, and expenses of every nature, including investigation costs and expenses, settlement costs, and attorney fees and expenses (“the claims”), sustained or asserted against the State of Nebraska, arising out of, resulting from, or attributable to the willful misconduct, negligence, error, or omission of the Grantee, its employees, consultants, representatives, and agents, except to the extent such Grantee’s liability is attenuated by any action of the State of Nebraska which directly and proximately contributed to the claims.

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2. DHHS’s liability is limited to the extent provided by the Nebraska Tort Claims Act, the Nebraska Contract Claims Act, the Nebraska Miscellaneous Claims Act, and any other applicable provisions of law. DHHS does not assume liability for the action of its Grantees.

R. INDEPENDENT ENTITY. The Grantee is an Independent Entity and neither it nor any of

its employees shall, for any purpose, be deemed employees of DHHS. The Grantee shall employ and direct such personnel, as it requires, to perform its obligations under this grant, exercise full authority over its personnel, and comply with all workers’ compensation, employer’s liability and other federal, state, county, and municipal laws, ordinances, rules and regulations required of an employer providing services as contemplated by this grant.

S. REIMBURSEMENT REQUEST. Requests for payments submitted by the Grantee shall

contain sufficient detail to support payment. Any terms and conditions included in the Grantee’s request shall be deemed to be solely for the convenience of the parties.

T. NEBRASKA NONRESIDENT INCOME TAX WITHHOLDING. Grantee acknowledges that Nebraska law requires DHHS to withhold Nebraska income tax if payments for personal services are made in excess of six hundred dollars ($600) to any Grantee who is not domiciled in Nebraska or has not maintained a permanent place of business or residence in Nebraska for a period of at least six months. This provision applies to: individuals; to a corporation, if 80% or more of the voting stock of the corporation is held by the shareholders who are performing personal services, and to a partnership or limited liability company, if 80% or more of the capital interest or profits interest of the partnership or limited liability company is held by the partners or members who are performing personal services. The parties agree, when applicable, to properly complete the Nebraska Department of Revenue Nebraska Withholding Certificate for Nonresident Individuals Form W-4NA or its successor. The form is available at: http://www.revenue.ne.gov/tax/current/f_w-4na.pdf or http://www.revenue.ne.gov/tax/current/fill-in/f_w-4na.pdf

U. NEBRASKA TECHNOLOGY ACCESS STANDARDS. The Grantee shall review the Nebraska Technology Access Standards, found at http://www.nitc.nebraska.gov/standards/2-201.html and ensure that products and/or services provided under the grant comply with the applicable standards. In the event such standards change during the Grantee’s performance, the State may create an amendment to the grant to request that Grantee comply with the changed standard at a cost mutually acceptable to the parties.

V. NEW EMPLOYEE WORK ELIGIBILITY STATUS. The Grantee shall use a federal

immigration verification system to determine the work eligibility status of new employees physically performing services within the State of Nebraska. A federal immigration verification system means the electronic verification of the work authorization program authorized by the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, 8 U.S.C. § 1324a,

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known as the E-Verify Program, or an equivalent federal program designated by the United States Department of Homeland Security or other federal agency authorized to verify the work eligibility status of a newly hired employee.

If the Grantee is an individual or sole proprietorship, the following applies:

1. The Grantee must complete the United States Citizenship Attestation Form, available on the Department of Administrative Services website at www.das.state.ne.us.

2. If the Grantee indicates on such attestation form that he or she is a qualified alien, the Grantee agrees to provide the U.S. Citizenship and Immigration Services documentation required to verify the Grantee’s lawful presence in the United States using the Systematic Alien Verification for Entitlements (SAVE) Program.

3. The Grantee understands and agrees that lawful presence in the United States is required and the Grantee may be disqualified or the grant terminated if such lawful presence cannot be verified as required by NEB. REV. STAT. § 4-108.

W. PUBLICATIONS. Grantee shall acknowledge the project was supported DHHS in all

publications that result from work under this grant. X. PROGRAMMATIC CHANGES. The Grantee shall request in writing to DHHS for approval

of programmatic changes. DHHS shall approve or disapprove in whole or in part in writing within thirty (30) days of receipt of such request.

Y. PROMPT PAYMENT. Payment shall be made in conjunction with the State of Nebraska

Prompt Payment Act, NEB. REV. STAT. §§ 81-2401 through 81-2408. Unless otherwise provided herein, payment shall be made by electronic means. Automated Clearing House (ACH) Enrollment Form Requirements for Payment. The Grantee shall complete and sign the State of Nebraska ACH Enrollment Form and obtain the necessary information and signatures from their financial institution. The completed form must be submitted before payments to the Grantee can be made. Download ACH Form: http://www.das.state.ne.us/accounting/nis/address_book_info.htm

Z. PUBLIC COUNSEL. In the event Grantee provides health and human services to individuals

on behalf of DHHS under the terms of this award, Grantee shall submit to the jurisdiction of the Public Counsel under NEB. REV. STAT. §§ 81-8,240 through 81-8,254 with respect to the provision of services under this grant. This clause shall not apply to grants between DHHS and long-term care facilities subject to the jurisdiction of the state long-term care ombudsman pursuant to the Long-Term Care Ombudsman Act.

AA. RESEARCH. The Grantee shall not engage in research utilizing the information obtained through the performance of this grant without the express written consent of DHHS. The term "research" shall mean the investigation, analysis, or review of information, other than aggregate statistical information, which is used for purposes unconnected with this grant.

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BB. SEVERABILITY. If any term or condition of this grant is declared by a court of competent jurisdiction to be illegal or in conflict with any law, the validity of the remaining terms and conditions shall not be affected, and the rights and obligations of the parties shall be construed and enforced as if this grant did not contain the particular provision held to be invalid.

CC. SUBGRANTEES OR SUBCONTRACTORS. The Grantee shall not grant or subcontract any portion of this award without prior written consent of DHHS. The Grantee shall ensure that all subcontractors and sub-grantees comply with all requirements of this grant and applicable federal, state, county and municipal laws, ordinances, rules and regulations.

DD. TIME IS OF THE ESSENCE. Time is of the essence in this grant. The acceptance of late performance with or without objection or reservation by DHHS shall not waive any rights of DHHS nor constitute a waiver of the requirement of timely performance of any obligations on the part of the Grantee remaining.

FOR DHHS: FOR GRANTEE: Maya Chilese Name Community Health & Performance Mgmt Title Division of Public Health Entity NE Department of Health & Human Services Address Box 95026 Address Lincoln, NE 68509-5026 City, State, Zip + 4 (402) 471-7779 Phone