D.1. SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Wound-healing assay in mice for the National Center for Advancing Translational Sciences

(NCATS)

Statement of Need and Purpose:

The purpose of this procurement is to perform full thickness, excisional wound-healing assays in mice, to evaluate the regenerative potential of drugs (2 compounds, each tested at 2 different doses in parallel) for NCATS.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, to ultimately translate basic science into real products and services that help improve people’s lives. Included in this process is the development of unique chemical material as a probe to investigate the mechanisms of tissue regeneration and to potentially assist in the development of new methods of treating human disease.

NCATS is interested in performing full thickness, excisional would-healing assays in mice, to evaluate the regenerative potential of novel drugs that are being developed at NCATS. The data from these assays is of key interest into determining the biological effects of these molecules in-vivo.

Period of Performance:

The period of performance is 4-months from the time of award.

Place of Performance:

Services shall be performed on-site at the Contractor facility.

Place of Delivery:

The results of the testing services shall be delived to NCATS upon completion:

9800 Medical Center Dr

Bldg B / Room 1222

Rockville, MD 20850

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

1. The Contractor shall perform full-thickness, excisional wound-healing assays in normal mice as follows.

a. Two compounds will be tested at two doses for each compound, with an n=8 for each compound and dose.

b. Additionally a control group of 8 wounds dosed with placebo will be included.

c. A total of 40 wounds will be utilized (8 placebo, 32 dosed with compound)

2. Compounds will be formulated in 30% F127 Pluronic gel, or alternate formulation as needed

3. Treatment regimen: treatments will start immediately after wound-induction at day zero, and will proceed for at least 2 weeks, or until healing of the control treated wounds is completed.

Compounds will be topically administered directly into the wound beds once every two days, for the entire duration of the experiment. A Tegaderm cover dressing will be place over the wounds after each treatment.

4. Animal-monitoring: all mice will be check daily for mortality, behavior and general condition.

All mice will be weighted 3 times per week throughout the experiment. 800-552-9951

5. Wound-monitoring: all wounds will be observed and imaged every other day throughout the experiment. The wound area will be determined from photos taken every other day and the time required for complete healing of each wound will be determined accordingly. A statement on the tolerance to treatments with reporting of all observations made during the experiment

(inflammation, redness, infection, maceration etc.) will be generated.

6. A comprehensive report will be issued a the end of the study. The report will include the protocol, all methods used for the study, all photographs taken during the study, and a quantitative comprehensive analysis, which may include digital planimetry, in order to definitively compare the relative speed of wound healing between the doses. This analysis will include proper statistical analysis for comparison, and give significance (in p values) for differences observed between groups.

LEVEL OF EFFORT:

The Contractor shall use best efforts in providing the requested results as described in the “specific requirements” above.

GOVERNMENT RESPONSIBILITIES

Government will provide the chemical samples to the contractor to accomplish the above requirements.

DELIVERY OR DELIVERABLES

Bi-weekly progress report

Final Report

As noted in the Requirements section above, the Contractor shall provide a comprehensive final report for the contents of this statement of work and shall be submitted electronically to (To be specified prior to award).

REPORTING REQUIREMENTS

Every two weeks, or more often as required by e-mail, with an update on the progress of the project.

POC:

(To be specified prior to award).

Final report due at the completion of the work will be provided to NCATS. Report will cover the results of excisional wound-healing assays in mice, to evaluate the regenerative potential of drugs (2 compounds, each tested at 2 different doses in parallel). The lead scientist at mailto:michele.ceribelli@nih.gov

Contractor’s facility will report on the status of the ongoing work via phone, e-mail, meetings, or presentations.

OTHER CONSIDERATIONS

Travel:

Not applicable.

Key Personnel:

Not applicable.

Information System Security Plan:

Not applicable.

Data Rights:

The NCATS shall have unlimited rights to and ownership of all deliverables provided under this acquisition, including reports, analyses, recommendations, and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of

“unlimited rights” is contained in FAR 27.401, “Definitions.” FAR clause 52.227-14, “Rights in

Data-General,” (MAY 2014) is incorporated into any resulting contract by reference.

Under 52.227-14(c)(1), the contractor must obtain approval from the contracting officer to assert copyright in any data first produced in performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. Under 52.227-

14(d)(2), the contractor must obtain approval from the contracting officer to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the contractor in the performance of this contract.

In addition, the contractor will keep the results of the acquisition confidential.

Section 508—Electronic and Information Technology Standards:

Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The FAR Final Rule for

Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s

Web site at https://www.access-board.gov/508.htm. The contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Publications and Publicity:

The Contractor may not publish the results of its work under this contract without informing

NCATS which will determine the date for publication.

Confidentiality of Information:

Confidential Information means information or data of a personal nature about an individual or proprietary information or data submitted by or pertaining to an institution or organization.

Confidential Information or records shall not be disclosed by the Contractor without written authorization from the CO. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the CO prior to any release, disclosure, dissemination, or publication.

Non-Personal Service Statement:

Contract employee performing services will be controlled, directed, and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the FAR.