RFA67-211.pdf

Health and Human Services Building | 625 Forster Street | Harrisburg, PA 171200701 | www.health.pa.gov

October 8, 2026

Dear Potential Applicant:

You are invited to submit an application to the Pennsylvania Department of Health in accordance with the enclosed Request for Applications (“RFA”) #67-211.

All questions regarding this RFA must be directed by e-mail to RA-healthresearch@pa.gov, no later than 12:00 p.m. ET on October 22, 2026. All questions must include the specific section of the RFA about which the potential applicant is requesting clarification. Answers to all questions will be posted at www.emarketplace.state.pa.us. Click on ‘Solicitations’ and search for the above RFA number.

A Letter of Intent (“LOI”) must be submitted by email to RA-HEALTHRESEARCH@pa.gov.

The LOI must be prepared using the LOI form provided in Part Two of this RFA. The LOI must be submitted no later than 1:30 pm ET on November 9, 2026. If the LOI is not received using the form provided on or before this date and time, the application will not be accepted. Type “LOI ENCLOSED RFA #67-211” as the subject line of your e-mail submission.

Upon receipt of the LOI, the applicant will receive a link to a SharePoint site for submission of the application. The application must be submitted through the SharePoint site link no later than 1:30 pm ET on December 10, 2026. As the link will be removed at the submission deadline, applicants are encouraged to not wait until this closing date and time.

LATE APPLICATIONS WILL NOT BE ACCEPTED REGARDLESS OF THE

REASON.

We expect that the evaluation of applications and the selection of Grantees will be completed within six months of the submission due date.

Sincerely, Office of Procurement For Agency Head

Enclosure

Request for Application

Spinal Cord Injury Research Grant

RFA Number 67-211

Date of Issuance October 8, 2026

Issuing Office: Pennsylvania Department of Health Office of Procurement Email: RA-DHHEALTH_DEPT_DOC@pa.gov

RFA Project Officer: Rodeen Lechleitner, Ph.D.

Pennsylvania Department of Health Health Research Office

Email: rlechleitn@pa.gov

RFA 67-211

Spinal Injury Research Grant

CONTENTS

Part One: General Information

A. Information for Applicants ………………………………2

1. Background of Funding Source

2. RFA Information

3. Lead Applicant and Support

4. Requirements of the Collaborative Research Project

5. Use of Funds – Limitations and Additional Requirements

6. Use of Existing Health Data

B. Application Procedures …………….………………………………………………………9

1. General

2. Evaluation of Applications

3. Awards

4. Deliverables and Reporting Requirements

C. Application Instructions and Required Format

1. Application Instructions

2. Application Format

3. Definitions

D. Research Information and Priorities

1. Research Information

2. Research Priorities

Part Two: Title of Application

Application Forms and Attachments I. Cover Page II. BOP-2201 Worker Protection and Investment Certification Form III. Research Proposal (Section One) and Letters of Support (Section Two) is downloadable and is attached for completion IV. Budget Template is downloadable and is attached for completion of the budget request V. Certifications for the Protection of Human Subjects and Regarding the Use of Human Embryonic Stem Cell Research VI. Certifications for the Containment of Recombinant DNA Research and the

Care and Treatment of Vertebrate Laboratory Animals VII. Application to the Pennsylvania Department of Health Institutional Review

Board VIII. Memorandum of Understanding Regarding Ethical Standards as Required by 35 P.S. § 5701.905(f) IX. Letter of Intent Form X. Annual Expenditure Report

Any grant agreement resulting from this RFA will include certain standard terms and conditions that will be attached as appendices and will be part of the agreement, which may either be found at http://www.health.pa.gov/vendors or are attachments to this RFA.

These terms and conditions are not negotiable and are listed below:

� Grant Payment Provisions (Rev. 3/26) � Commonwealth Standard General Terms and Conditions, Grant Version (Rev.

10/24) � Department Standard General Terms and Conditions (Grant) (Rev. 3/26) � Audit Requirements (Rev. 11/25)

PART ONE

General Information

A. Information for Applicants

1. Background of Funding Source

In 1998, Pennsylvania’s Attorney General along with the Attorneys General from 46 states, five territories and Commonwealths, and the District of Columbia, joined the Tobacco Master Settlement Agreement (“MSA”) with five major tobacco manufacturers, which account for almost 99% of the tobacco industry’s revenues. The MSA has no termination date and provides a perpetual reimbursement to states for costs incurred as a result of tobacco use. Pennsylvania’s share of the MSA funds for the first 25 years of the agreement is estimated to be approximately $11 billion. Pennsylvania is slated to receive annual payments of between $344 million and $459 million between 1999 and 2025. Pennsylvania’s annual computed adjustment amount under the agreement will affect the actual amount received.

Adjustments will depend upon levels of inflation and domestic sales of tobacco products.

The Commonwealth of Pennsylvania (“Commonwealth”) established the Spinal Cord Injury Research Grant Program (“Program”) in the Pennsylvania Department of Health (“Department”) through Act 126 of 2018, 35 P.S. §§ 5701.901 – .910, which was an amendment to the Tobacco Settlement Act of 2001. Act 126 directed the Department to establish a grant program for Pennsylvania institutions conducting spinal cord injury research to focus on new and innovative treatments and rehabilitative efforts for the functional improvement of people with spinal cord injuries.

The intent of this RFA is to fund spinal cord injury research grants with the overall objective of fostering and encouraging innovative research for treatment and rehabilitative techniques for spinal cord injuries. The Department is interested in funding three levels or tiers of spinal cord injury research:

a) Pilot Project Grants;

b) Standard Research Grants; and

c) Clinical/Translational Grant (addressing the research priorities established by the

Department in conjunction with the Spinal Cord Research Advisory Board).

Read the entire RFA. Additional information about how to apply, relevant and specific restrictions, evaluation of applications and deliverables are noted and outlined in Section B.

Application Procedures

2. RFA Information

Through this RFA process, the Department is soliciting research applications on Spinal Cord Injury Research. The overall goal of this funding is to promote functional improvement of people with spinal cord injuries. The anticipated initial period of performance under the resulting grant agreement(s) is July 1, 2027 to June 30, 2031, subject to the availability of funding. If the anticipated period of performance start date is changed by the Department for the resulting grant agreement, the initial period of performance is expected to remain a total of 48 months, subject to the availability of funding. The grant agreement term is not to exceed four years, per Section 904 of Act 2001-77 (35 P.S. § 5701.904).

The Department has $1,300,030.08 available for this RFA. The Department expects to award three to six grant agreements and expects awards not to exceed $1,300,030.08.

At the Department’s discretion and by letter notice, the Department may extend the resulting grant agreement as follows:

Extension. Upon written notice to the Grantee, the Department may extend the term for up to 90 days by providing written notice of extension to the Grantee without the need to amend the agreement. Any extension of the term in excess of 90 days must be accomplished through a formal amendment to the agreement.

1. 3-Month. The 3-month extension extends the agreement for up to three months.

Applications are welcomed from eligible applicants, as defined in Section 3, “Lead Applicant and Support” below. Additional information about how to apply, relevant and specific restrictions, and stated preferences regarding applicants are noted and outlined in Section B.

Applicants are encouraged to be innovative and creative in their approach.

This RFA provides interested and eligible parties with information to prepare and submit applications to the Department. Questions about this RFA can be directed to the contact listed in the potential applicant letter (which is the first page of this RFA) by the date and time listed therein. All questions must include the specific section of the RFA about which the potential applicant is requesting clarification. Answers to all questions will be posted under the RFA Solicitation at www.emarketplace.state.pa.us. Each applicant shall be responsible to monitor the website for new or revised RFA information. The Department shall not be bound by any information that is not either contained within the RFA or formally issued as an addendum by the Department.

In order to do business with the Commonwealth of Pennsylvania providers are required to enroll in the SAP system. Applicants may enroll by selecting “Non-Procurement” at:

https://www.budget.pa.gov/Services/ForVendors/Pages/Vendor-Registration.aspx or by calling toll free at 1-877-435-7363. The PDF and MP4 embedded links next to “Non- Procurement” provide guidance on enrolling.

3. Lead Applicant and Support

Eligible applicants shall be located in Pennsylvania and shall be spinal cord injury research institutions within this Commonwealth that are equipped and actively conducting spinal cord injury research designated by the Secretary of Health to be eligible to receive contributions and shall be (1) a nonprofit entity that conducts research, (2) a hospital that conducts research and is established under the Act of July 19, 1979 (P.L. 130, No. 48), known as the Health

Care Facilities Act, or (3) an institution of higher education that conducts research. All applicants shall have their primary location within Pennsylvania. Entities other than general partnerships and sole proprietorships shall be registered with the Pennsylvania Department of State.

If the application involves collaboration among two or more applicants, one applicant shall be designated on the application as the lead agency. The applicant shall be a legal entity that will receive all grant funds and shall be responsible for the fiscal aspects and all other aspects of the resulting grant agreement. Both the applicant and collaborating institutions shall have a significant and meaningful role in the proposed research project. The research role of the applicant and each collaborating institution must be clearly described in the application and demonstrate that each institution is contributing substantially to the overall project. The applicant and all collaborating organizations must be located in Pennsylvania.

Lead applicants and collaborating organizations shall conduct 98 percent of the research proposed in the application at Pennsylvania based facilities.

Subcontractors, beyond the collaborating organization(s), shall have a minor role in the research project and are not considered collaborating partners. Subcontractors may be non- Pennsylvania based institutions which are located outside of Pennsylvania. However, if out of state subcontractors participate on the project team, the application must clearly describe how any barriers to communication and close collaborative research work will be overcome.

The Principal Investigator (“PI”) on the research project may reside outside of Pennsylvania;

however, the applicant or collaborating institution where the PI works shall be located in Pennsylvania. Consultants may have only a minor role in the research project and may be located outside of Pennsylvania.

The total cost of out-of-state subcontractors, consultants, fee-for-service providers and vendors and the cost of research conducted outside of Pennsylvania by the lead applicant and collaborating organizations may not exceed two percent of the total grant agreement costs. If a product or service that is essential for conducting the research is not available in Pennsylvania, the total cost of the out-of-state subcontractor or vendor which will provide the service or product may exceed two percent of the total grant agreement costs, provided that the application contains adequate justification that the service or product is essential to the conduct of the research and evidence that the service or product is not available in Pennsylvania.

There is no limit on the number of applications submitted by an institution. If a single institution is submitting multiple applications in response to this RFA, a different PI shall be identified for each separate application. If multiple applications are submitted under the same PI from one institution, ALL applications submitted from that institution will be deemed ineligible and will not be reviewed.

Funds will be awarded to applicants located within the Commonwealth. By supporting Pennsylvania based researchers with tobacco settlement funds, the Commonwealth’s intent is to attract additional research funds from other sources and to achieve health and economic goals that existing revenues could not underwrite.

This RFA is subject to applicable sections of the Tobacco Settlement Act, 35 P.S. §§

5701.901 – 5701.910, Act 200177 (Act) as amended 2018.

4. Requirements of the Collaborative Research Project The goal of this funding is to discover scientific knowledge that can be applied toward improving the health of Pennsylvanians living with spinal cord injuries.

The Research project must provide the following activities:

Conduct research – Design and conduct only one scientifically meritorious research project consistent with the research priority. One research project may consist of several hypothesis-driven sub aims or studies that are proposed to address each aim of the overall research project or address a different aspect of the overall goal. The studies must be closely related to each other and the overall goal. The proposal must include only studies that will be completed within the grant agreement period. All research applications submitted in response to this RFA must be consistent with the research priority listed in Section D.2. Research Priority of this RFA.

Collaboration is not a requirement of this RFA. If collaboration is chosen, the following is applicable:

For the purposes of this RFA, a collaborative research project is defined as two or more organizations that are committed to working together, as collaborating applicants, to jointly conduct a single research project. Letters of commitment from collaborating organizations are required to be submitted in the application for this RFA to demonstrate this collaborative commitment.

5. Use of Funds

Funds must be used for research projects regarding spinal cord injuries and related infrastructure by eligible applicants. Only the following types of research, as defined by Act 2001-77 below, may be conducted:

a) Biomedical Research - Comprehensive research pertaining to the application of the natural sciences to the study and clinical practice of medicine at an institution, including biobehavioral research related to tobacco use.

b) Clinical Research – Patient-oriented research which involves direct interaction and study of the mechanisms of human disease, including therapeutic interventions, clinical trials, epidemiological and behavioral studies and the development of new technology.

c) Health Services Research - Includes any of the following: (1) research on the promotion and maintenance of health including biobehavioral research, (2) research on the prevention and reduction of disease, and (3) research on the delivery of health care services to reduce health risks and transfer research advances to community use.

At least 50 percent of the funds requested in the application must be used for clinical research or health services research or both clinical research and health services research as defined in the Act; no more than 50 percent of each grant’s funds may be spent on biomedical research, as defined in the Act.

All research projects must be consistent with the research priorities listed in Section D.2. of this RFA, Research Priorities. Funds must be used for one or more of the types of health research described and defined in Section D.1 of this RFA, Research Information;

biomedical, clinical, and health services.

Indirect costs may not be charged against items in Categories II (Consultant Services), III (Subcontract Services) and V (Equipment) of the budget. The indirect costs specified in Attachment VI - Budget may not be greater than 16.1 percent of the sum of total direct costs less the costs of Categories II, III and V. The indirect cost rate may not be increased at any time for the duration of the resulting grant agreement.

Funds are awarded for a specifically defined purpose and must be used for implementation and management of the research project. Funds may not be used for subgrants or pilot studies that are not clearly specified in detail in the application. Research aims, research design and research methodology must be described for every study included in the application.

Funds may not be used to pay costs incurred prior to the effective date of the resulting grant agreement.

Funds may not be used to establish registries, patient databases or tissue banks unless the research project includes at least one specific hypothesis-driven research study that uses the registry, patient database or tissue bank and is completed within the timeframe of the resulting grant agreement.

Funds may support personnel and services directly related to the research project and may be used to purchase computer hardware and software.

Funds may not be used for the purchase or lease of motor vehicles or to supplant federal or other state funds that have been made available for this purpose. Funds may not be used for international travel.

Funds may not be used to indemnify institutions that are performance sites against adverse events associated with the research project.

Funds may be used for tuition, but only for those investigators who are directly involved in carrying out research funded by the resulting grant agreement. Funds may not be used for educational programs designed to interest school children in careers in biomedical, health services or clinical research.

Funds may not be used to pay honoraria to individuals asked to serve on advisory committees.

Funds may be used to reimburse advisory committee members for travel expenses related to attendance at advisory committee meetings.

Funds may be used to pay costs for consultants or speakers related to the research project.

Funds may not be used to develop Continuing Medical Education programs. Funds may not be used to develop or implement patient, professional or community educational programs designed to change patient or health care provider behaviors unless such programs are part of a rigorously designed scientific trial to evaluate the effectiveness of the education intervention on behaviors to improve health outcomes morbidity or mortality.

Grantee shall only use funds for research purposes. Grantee shall not use funds for patient travel or subsistence, consulting physician fees, or any other direct payments related to all classes of individuals, including inpatients, outpatients, subjects, volunteers, and donors, or any other non-research patient care costs. Grantee shall not use funds for costs of ancillary tests performed in facilities outside the hospital on a fee-for-service basis (for example, in an independent privately owned laboratory) or laboratory tests performed at a medical school/university not associated with a hospital routine or ancillary service. Grantee shall not use funds for recruitment or retention fees. Grantee shall not use funds for data management or statistical analysis of clinical research results.

No more than 50 percent of the funds may be used for infrastructure. Infrastructure is defined as:

a) Office equipment;

b) Office supplies;

c) Nonprofessional personnel (secretaries, administrative assistants, and clerks); and

d) Laboratory or building construction or renovations used to conduct research.

All other personnel are professional personnel and are non-infrastructure costs. Research equipment is not infrastructure. Research equipment may be purchased as part of an approved research project funded under the resulting grant agreement or as part of a research infrastructure project involving research facilities construction or renovation. Costs of equipment purchased as part of a research infrastructure project may not exceed 50 percent of the entire project costs. Funds allocated for a research laboratory or building construction project may not be used for personnel.

Applications containing requests for infrastructure funds must describe the location of the facilities and potential users of the facilities both at the host institution and other institutions.

Sharing of infrastructure facilities among universities and public and private research organizations is encouraged. Personnel (technicians) to operate equipment and facilities may not be requested as part of a research facilities construction or renovation project.

The applicant shall adhere to applicable federal, state and local standards and laws for the construction and renovation of research facilities. (See http://grants.nih.gov/grants/policy/policy.htm)

Funds may not be used for licensing or option fees, attorney's fees for preparing or submitting patent applications, and fees paid to the United States Patent and Trademark Office for patent application, patent maintenance, or recordation of patent-related information.

For the duration of the resulting grant agreement, hourly rates and fringe benefit rates for all personnel except union-covered positions may not be increased above the rates specified in the resulting grant agreement. Hourly rates and fringe benefit rates may be increased only for union-covered positions and only when those increases are negotiated as part of an approved collective bargaining unit agreement that was put into place after the resulitng grant agreement was fully executed.

Grant funds may not be used to pay an individual at a rate in excess of the Executive Level II ($228,000/year or $109.61/hour) of the 2026 Federal Executive Schedule, in accordance with the National Institutes of Health (“NIH”) Guide for Grants & Funding.

Grant funds m a y not be used to pay an individual to manage or administer the resulting grant agreement.

Grant funds m a y not be used for research projects focused primarily or exclusively on program planning and evaluation.

No more than 10 percent of the budget may be used for personnel to perform statistical and data analyses.

6. Use of Existing Health Data

Applicants are encouraged to utilize existing health data and resources. Relevant databases such as the Pennsylvania Cancer Registry, hospital discharge, outpatient and ambulatory care, and managed care data already exist. Other state agencies such as the Pennsylvania Health Care Cost Containment Council and health care researchers in Pennsylvania have already undertaken significant work with these resources.

B. Application Procedures

1. General

a) Applications must be received by the Department by the time and date stated in the cover letter. The Department will reject any late applications. The decision of the Department with regard to timeliness of submission is final. No changes, amendments, supplements, alterations or additions of any nature to the application or any additional letters or materials of any kind will be accepted after the application due date as stated in the cover letter.

b) If it becomes necessary to revise any part of the application guidelines, an amendment will be posted under the RFA Solicitation at www.emarketplace.state.pa.us.

c) The decision of the Department with regard to selection of applicants is final. The Department reserves the right, in its sole and complete discretion, to reject any and all applications received as a result of this request and to negotiate separately with competing applicants.

d) The Department is not liable for any costs the applicant incurs in preparation and submission of its application, in participating in the RFA process or in anticipation of award of the resulting grant agreement(s).

e) The Department reserves the right to cancel the RFA at any time up until the full execution of the resulting grant agreement(s).

f) Awarded applicants and non-selected applicants shall not be permitted to issue news releases pertaining to this project prior to official written notification of award by the Department review committee. Any subsequent publication or media release issued by the Grantee throughout the life of the grant using funding from this grant agreement must acknowledge the Department as the granting agency and be approved in writing by the Department.

2. Evaluation of Applications

All applications meeting stated requirements in this RFA and received by the designated date and time, will be reviewed and evaluated by the Department as follows:

Following the requirements of Act 2001-77, applications will be reviewed and evaluated through a two-stage review process. The first stage will be a peer evaluation of the scientific and technical merit of the application by a committee of impartial reviewers with expertise in the proposed research topic. Each application will be evaluated individually against the following criteria: scientific and technical merit based on scientific need, scientific method, research design, adequacy of the facility and qualifications of the research personnel.

The second stage of the review will be conducted by the Department Review Committee (“Committee”) comprised of Department staff. The Committee will review applications that meet the requirements in this RFA. The selection of research projects to be funded will be based on the rankings developed from the peer review process. In making its selection, the Committee will use the rankings, avoid unnecessary duplication, ensure relevance to the research priority, encourage collaboration between applicants and provide for the development of a complementary statewide research program. The Secretary of Health will make the final selection of applications to be funded.

If the Committee determines that additional clarification of an application is needed, the Department will schedule an oral presentation, either in person or via a conference call, or assign a due date for the submission of a written clarification, or both.

3. Awards

Grants will be administered through the Department. Payment will be made in accordance with the Payment Provisions contained in Part Two of the RFA. Awards will be made to the lead agency of the collaborative research project.

All applicants will receive official written notification of the status of their application from the Department. Unsuccessful applicants may request a report containing the peer review panel’s written comments on their application. This request must be in writing and must be received by the Health Research Office within 30 calendar days of the written official notification of the status of the application. Comparison of applications will not be provided. Applicants will not be given any information regarding the evaluation other than the peer review comments on their individual application.

4. Deliverables and Reporting Requirements

See Section XXIV of Research Proposal, which is Attachment IV in Part Two of the

RFA.

C. Application Instructions and Required Format

1. Application Instructions

The following is a list of requirements.

a) A Letter of Intent (“LOI”) must be submitted by email to RA- HEALTHRESEARCH@pa.gov on or before the date and time specified in the cover letter using the form provided in Part Two, Attachment XI of this RFA. The Department cannot accept secure or encrypted emails. Any submission via secure or encrypted email will be immediately discarded.

b) The LOI must be received by the date and time specified in the cover letter, using the form provided, or the application will not be accepted. Applicants should consider that technical difficulties could arise and allow sufficient time to ensure timely email receipt. (Late submissions will be rejected, regardless of the reason). The LOI can be submitted as soon as it is ready for submission; to prevent late submissions, applicants are encouraged to not wait until the date and time in the cover letter.

c) Upon successful submission of a LOI, the Department will provide a link and instructions for uploading to the SharePoint site for submission of the application.

d) The application must be submitted using the format described in subsection 2, below

– Application Format.

e) The application must be submitted via the SharePoint link provided to the applicant on or before the time and date specified in the cover letter. The SharePoint link will be disconnected at that date and time. Late applications will not be accepted regardless of the reason.

Applicants are strongly encouraged to be brief and clear in the presentation of ideas.

2. Application Format

Applicants must follow the format as described below to complete Part Two of this RFA.

All required forms can be found in Part Two. When uploading, the following naming convention must be followed: Keep the file name as is and add the applicant’s name at the end. For example: RFA 67-144 Cover Page, Applicant Name. On all forms, the name of the applicant must be identical to the legal name of the applicant organization exactly as registered with the Department of State. Forms that do not contain the legal name of the applicant organization will be returned.

a) Cover Page – Complete the form. This form must be signed by an official authorized to bind the applicant/organization to the application.

b) Worker Protection and Investment Certification Form (BOP-2201) – BOP-2201 must be completed and signed by an official authorized to execute the certification on behalf of the applicant.

c) Research Proposal – The research proposal consists of the following two sections:

i. Section One – Research Proposal (upload in PDF format; must be a directly created PDF and not the result of scanning)

ii. Section Two – Letters of Support (upload in PDF format, as one separate PDF)

e) Budget Detail – Use the downloadable format to present your budget request.

Instructions regarding completion of the budget can be found in the last worksheet of the downloadable excel budget file. Must be completed for applicant for the entire grant period (upload in Excel format). One budget must be completed by the lead applicant. This budget must list the costs for all subcontractors under subcontract services. It is the awarded applicant’s responsibility to monitor subcontractor budgets and at minimum to hold all subcontractors to the same standard as the fully executed grant agreement. Awarded applicants shall also be responsible for producing subcontractor budgets at the request of the Department. NOTE: Based on the number of applications and the amount of grant funds available, the Department may ask applicants to submit a revised budget prior to the issuance of the grant award.

The anticipated initial period of performance is July 1, 2027 to June 30, 2031. The grant agreement term is not to exceed four years, per Section 904 of the Act (35 P.S.

§ 5701.904). The grant award is provided upfront and is for the entirety of the grant agreement time period and spent based on the budget.

See the Budget Definitions section below for more information.

f) Certification for the Protection of Human Subjects and Regarding the Use of Human Embryonic Stem Cell Research – One per project. Complete and sign the form.

The authorized institutional official must sign this form. Grants involving human subjects do not have to be approved or exempted from review by the applicant’s Institutional Review Board (“IRB”) prior to the submission of the application. All research involving human subjects must be approved by the applicant’s IRB prior to the initiation of the research involving human subjects and prior to the use of grant funds to pay for research involving human subjects. If the research project involves human subjects and approval is pending from the applicant’s IRB, check the third option on the first page of this form. If the research project involves the use of human embryonic stem cells, only human embryonic stem cell lines that are approved by the NIH and derived from outside of Pennsylvania can be used.

g) Certification for the Containment of Research Involving Recombinant or

Synthetic Nucleic Acid Molecules (r/sNA) and the Care and Treatment of Vertebrate Laboratory Animals – One per project. Complete and sign the form.

The authorized institutional official must sign this form. Grants involving recombinant DNA or laboratory animals do not have to be approved or exempted from review by the applicant’s appropriate review committee prior to the submission of the application. All such research must be approved by the applicant’s review committee prior to the initiation of such research and use of grant funds to pay for such research.

h) Application to the Pennsylvania Department of Health Institutional Review

Board – Instructions and an electronic copy of the form may be obtained at https://www.health.pa.gov/topics/Research/Pages/IRB.aspx by selecting IRB Application.

i. If the research project does not involve human subjects, this application form does not need to be completed.

ii. If the research involves human subjects and has not been approved or exempted from review by the applicant’s IRB, this form must not be submitted with the application. However, it must be submitted prior to the initiation of such research and use of grant funds to pay for research involving human subjects. If the research involves human subjects and it has already been approved or exempted from review by the applicant’s IRB, this form must be completed and submitted with the RFA application and include documentation that the applicant’s IRB either approved or exempted the research from review.

iii. Note on the use of human specimens or data: If the applicant checks "No human subjects will be used in any of the proposed research" on the Certification for the Protection of Human Subjects and Regarding the Use of Human Embryonic Stem Cell Research (above), but the application proposes using human specimens or data, this form must be completed and submitted with the RFA application and must include documentation from the applicant’s IRB stating that the research does not constitute human subjects research

i) Memorandum of Understanding Regarding Ethical Standards as Required by

35 P.S. § 5701.905(f): The official who is authorized to bind the organization to its application must sign this form.

j) Letter of Intent Form: Do not submit the LOI with the application; see instructions above in C.1. Application Instructions.

k) Annual Expenditure Report: Do not submit the Annual Expenditure Report with the application; see instructions in Section XXIV of the Research Proposal template.

l) Supplemental Information Required for Applicants Receiving $400,000 or More in Health Research Formula Grant Funds, if applicable (upload in Word format)

3. Definitions

a) Budget Definitions:

Personnel: This budget category shall identify each position by research role on the project, hourly rate, and the number of hours per year allocated to the project, starting with the PI. Fringe benefits are to be shown as a separate line-item by percentage and shall include a detailed listing of the benefits being covered.

Consultant Services: This budget category shall identify the services to be provided by each consultant including hourly rate and number of hours to be utilized under this grant agreement.

Subcontract Services: This budget category shall identify the services to be provided by each subcontractor under this grant agreement.

Patient Services: This budget category shall reflect funding dedicated for patient services.

Equipment: This budget category shall reflect the actual or projected cost of any equipment $5,000 or greater. Justification for the purchase of any equipment must be included. Purchase of equipment is not a priority of the Department.

Supplies: This budget category shall reflect expected costs for general office supplies including personal computers and facsimile machines and other types of supplies valued at less than $5,000, needed to support this project. List types of supplies separately, for example, office supplies, laboratory supplies and so on.

Travel: This budget category shall include anticipated expenditures for travel including mileage, hotels and meals.

Other: This budget category shall be used for anticipated expenditures that do not fit into any of the other budget categories such as telephone, printing, postage, and indirect costs (overhead, general, and administrative). Indirect rates cannot exceed the provider’s federally approved indirect cost rate schedule. In the description area under OTHER COSTS include the % that the rate reflects, identify the budget categories to which the rate was applied, and list the specific items that the indirect is paying for.

Laboratory or Building Construction or Renovations: This budget category shall be used for construction or renovation project(s), if any. Construction and renovation costs are infrastructure costs.

When filling out the budget, refer to the instructions tab within the Excel budget file, as well as the limitations noted above in Part One, A.5. Use of Funds – Limitations and Restrictions.

D. Research Information and Research Priorities

1. Research Information

Applications must include plans for conducting only one research project that must be focused on Spinal Cord Injury Research. The research project m u s t involve an applicant and may involve one or more collaborating organizations that cooperate to identify priorities and conduct research. The research project must provide for the sharing of infrastructure, resources and expertise. The applicant and, if applicable, collaborating organization(s), shall be separate institutions. The application must describe the roles of the applicant and, if applicable, the collaborating organization(s). If collaborative, the application must also demonstrate that the collaborating partners will be playing real and substantive roles in the research project. The research project must have one common goal, and if collaborative, the collaborating organization(s) shall be working together on all phases of the project instead of each collaborating organization working independently on separate phases of the research project.

All responses to this RFA must be consistent with the research priority for spinal cord injury funded research as shown in D.2. Research Priority below.

The ultimate goal of the research must be to improve health status and access. The Department shall encourage, through the application process and accountability requirements, research that:

a) Promotes business and community involvement;

b) Increases infrastructure and research capacity;

c) Increases the number of new investigators, new grants, new discoveries, and new products;

d) Leverages new and existing research funds;

e) Leads to population-based applications that address disparities in health status among various Commonwealth populations and promotes the health of all Pennsylvanians;

and

f) Allows collaboration.

Funds must be used for research projects regarding spinal cord injury research.

Institutions receiving grants under Section 909.1 of Act 2001-77 shall also comply with the requirements of Section 910. Accountability procedures of Act 2001-77 by providing reports as required.

Only the following types of research, as defined by Act 2001-77 below, may be conducted:

a) Biomedical research – comprehensive research pertaining to the application of the natural sciences to the study and clinical practice of medicine at an institution, including biobehavioral research related to tobacco use.

b) Clinical research – patient-oriented research which involves direct interaction and study of the mechanisms of human disease, including therapeutic interventions, clinical trials, epidemiological and behavioral studies and the development of new technology.

c) Health services research – includes any of the following: (1) research on the promotion and maintenance of health including biobehavioral research, (2) research on the prevention and reduction of disease, (3) research on the delivery of health care services to reduce health risks and transfer research advances to community use.

If the research is a collaborative project funded by this RFA, the research must bring together established research scientists with proven records of scientific excellence to work with clinicians, non-traditional partners and other researchers, including junior faculty as members of the research team. The collaborating organization(s) shall share essential facilities, services, knowledge, and other resources to conduct research designed to improve the health of Pennsylvanians.

2. Research Priorities

All Spinal Cord Injury Research projects submitted in response to this RFA must be aligned with the following specific priorities as established by the Department in conjunction with the Spinal Cord Research Advisory Committee.

a) Pharmacologic, biologic, medical device, brain stimulus, and rehabilitative approaches and techniques.

b) Preference will be given to those projects and techniques that seek to change the nature and course of the injury.

c) To address the gap in translation of discovery to human study and proposal, further preference will be given to research that is strategically translational or translatable relative to aims and outcomes.

d) Finally, further preference will be given to research strategies that represent either potential or existing collaboration with industry, whether in the development and trial of biologics, pharmacologics, device, or novel therapeutic rehabilitative treatments in combination with these developments.

e) Research that may benefit persons with SCI across the continuum of care in ways that impact quality of life (that is, focus on medical comorbidities including but not limited to bladder/bowel, reproductive functions, pressure ulcers, kidney stones;

reducing barriers to care; increasing access to care.

This RFA provides three funding options aligned to the research priority described above.

Each of the three Tiers of funding, which are described below, will have specific maximum allowable budget requests, project requirements and a maximum allowable resulting grant agreement period:

Tier 1: Pilot Research Grant:

a) Maximum Budget Request: $200,000.

b) Project Requirements: This tier will fund applications that propose early research investment aligned with the research priority as the institution applicant prepares to seek a larger research grant from a federal program or non-profit organization.

Preliminary data is not required for this Tier.

c) Anticipated grant agreement period: July 1, 2027, to June 30, 2031.

Tier 2: Standard Research Grant:

a) Maximum Budget Request: $300,000.

b) Project Requirements: This tier will primarily fund applications for research aligned with the research priority which include supporting and preliminary data for the research proposed. This tier may also fund pilot research (with no preliminary or supporting detail) if the application justifies the budget for pilot research. Institution applicants are encouraged to attach research papers; in-press, pre-published drafts, and accepted research papers may be cited or submitted separately as an attachment to the application.

c) Anticipated grant agreement period: July 1, 2027, to June 30, 2031.

Tier 3: Clinical/Translational Research Grant:

a) Maximum Budget Request: $500,000.

b) Project Requirements: This tier will fund applications which have a concurrent application to, or funding from, federal or industry sources for projects aligned with the research priority. Preliminary data must be published or in press in a scientific journal and cited or submitted separately as an attachment to the application.

c) Anticipated grant agreement period: July 1, 2027, to June 30, 2031.

The Research Proposal must address the project period and funding requested, show the scope of the overall project, and justify how the proposed research will provide new and innovative treatments and rehabilitative efforts for the functional improvement of people with spinal cord injuries. The Research Proposal must include a justification as to why the project falls within the funding tier selected. The anticipated grant agreement term is July 1, 2027, to June 30, 2031, for all successful applicants for Pilot Project Grant and Standard Research Grant, and for Clinical/Translational Grant applicants, subject to the availability of funding.

The funds are awarded based on the tier level identified. The Department’s decision on the tier level funding is final.

The research should hold the potential for addressing the health needs of underserved segments of the population, including rural, urban, racial/ethnic minorities, and other populations that are at high risk for the health condition addressed by the proposed research project. Research proposals must include clear objectives and targeted outcomes. No more than 50% of the funds may be used for research infrastructure as defined in the Act, as amended. Research infrastructure is defined as including the following items: office equipment, office supplies, nonprofessional personnel, and laboratory or building construction or renovations, used to conduct research.

Research priority must include the identification of critical research areas, disparities in health status among various Commonwealth populations, expected research outcomes and benefits and disease prevention and treatment methodologies.

Funds must be used for one or more of the types of health research described and defined in Section D.1. of this RFA, Research Information; biomedical, clinical, and health services.

Any combination of these research types may be included in an application.

At least 50% of the funds requested m u s t be used for clinical research or health services research or both clinical research and health services research.

PART TWO

Pennsylvania Department of Health

Health Research Office

Request for Applications (RFA) #67-211

RFA #67-211

Attachment I

COVER PAGE

Type of Grant: Health Research Non-Formula Grant

Applicant Name: _________________________________________________________________________ (Legal Name of Organization or Institution, exactly as registered with PA Dept. of State) Type of Legal Entity: ______________________________________________________________________ (Corporation, Partnership, Professional Corporation, Sole Proprietorship, etc.)

Grant Amount: $____________________ Grant Start Date: July 1, 2027

SAP Vendor #: ______________________ Grant End Date: June 30, 2031

Federal ID#: ________________________

Address*: ________________________________________________________________________________

City: _______________________ County: __________________ State: ________ Zip Code: ____________

(Complete billing address that corresponds to the organization or institution’s vendor number; this should be the same as the billing address listed in SAP for the associated vendor number)

*The address provided above shall be the same as the vendor billing address that is listed in the SAP system for the associated vendor number.

In order to do business with the Commonwealth of Pennsylvania, providers are required to enroll in the SAP system.

Research Priority (Check only one box): Spinal Cord Injury Research:

Tier 1: Pilot Research Grant Tier 2: Standard Research Grant Tier 3: Clinical/Translational Research Grant

Principal Investigator-Primary Contact

Name: (First Name, MI, Last Name) ______________________________________________________________

Position Title: ________________________________________________________________________________

Telephone Number: (Area code, number and extension) _______________________________________________

Direct Email Address: __________________________________________________________________________

Degree(s): ___________________________________________________________________________________

Mailing Address: _________________________________________________________________________________

Secondary Contact for the Grant Coordinator

Name: (First Name, MI, Last Name) _______________________________________________________________

RFA #67-211

Attachment I

Position Title: _________________________________________________________________________________

Telephone Number: (Area code, number and extension) _______________________________________________

Direct Email Address: __________________________________________________________________________

Degree(s): ____________________________________________________________________________________ Mailing Address: ______________________________________________________________________________

Administrative Contact (to be notified when funds become available)

Name: (First Name, MI, Last Name) ______________________________________________________________

Position Title: ________________________________________________________________________________

Telephone Number: (Area code, number and extension) _______________________________________________

Direct Email Address: __________________________________________________________________________

Mailing Address: ______________________________________________________________________________

Applications received shall remain valid, unless deemed unresponsive, until such time that final award(s) is or are made.

BY SIGNING BELOW, THE APPLICANT, BY ITS AUTHORIZED SIGNATORY, IS BINDING ITSELF TO

THE…