Attachment-Statement of Work.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Journal of Gerontology Series A: Biologic Sciences and Medical Sciences, Special Issue on “Development of Function Promoting Therapies – Public Health Need, Molecular Targets, and Drug Development”

Statement of Need and Purpose:

The National Institute on Aging (NIA) Division of Geriatrics and Clinical Gerontology (DGCG) conducted a virtual workshop entitled, “Development of Function Promoting Therapies – Public Health Need, Molecular Targets, and Drug Development, on March 20-22, 2022. The unprecedented need for function-promoting therapies in geriatric populations is more urgent than after research revealed that infection with COVID-19 was significantly associate with worsening mobility and function outcomes in people 50 years and older who had been infected with COVID-19, even without hospitalization.

Therefore a major priority and goal is to publish the results of the scientific presentations, discussions and recommendations originated from the workshop in a special issue of the Journal of Gerontology Series A: Biologic Sciences and Medical Sciences (to be available in both print and electronic formats), to ensure this valuable information is available to health care professionals and investigators worldwide, so that efforts to prevent aging-related loss of muscle mass, strength and function are pursued.

Also, see information under Background.

Background Information and Objective:

The National Institute on Aging (NIA) Division of Geriatrics and Clinical Gerontology (DGCG) conducted a virtual workshop entitled, “Development of Function Promoting Therapies – Public Health Need, Molecular Targets, and Drug Development, on March 20-22, 2022. The workshop explored critical topic areas in the following sessions:

Epidemiology and Societal Impact of Aging-related Functional Limitations: A Looming Public Health Crisis.

Pathobiology of Functional Limitations Associated with Aging and Chronic Disease.

Pharmacologic Interventions to Prevent and Treat Age-Related Functional Limitations.

Drugs Targeting Mechanisms of Aging.

Physical Exercise Interventions.

Nutritional Interventions.

Optimizing the Design of Clinical Trials of Function-Promoting Therapies.

Translating 20 Years of Extraordinary Advances in Muscle Biology into

Approvable Drugs: The Next Leap Forward.

Recognizing the public health importance of the development and implementation of effective interventions to overcome or delay age-related skeletal muscle function deficit (SMFD), this workshop involved academic investigators, the Government, the industry, professional societies and patient advocacy organizations to discuss the current status of interventions, with a major intent of:

Serving as a forum for cross disciplinary scientific discussion, networking, and collaboration

Facilitating the identification of biological targets for therapeutic development Fostering optimization of the design and expeditious implementation of clinical trials of function promoting therapies Ultimately improving older adults’ health, quality of life, and independent living

The unprecedented need for function-promoting therapies in geriatric populations is more urgent than after research revealed that infection with COVID-19 was significantly associate with worsening mobility and function outcomes in people 50 years and older who had been infected with COVID-19, even without hospitalization. Therefore, a major goal is to publish the results of the scientific presentation, discussions and recommendations originated by the workshop to ensure information is available to health care professionals and investigators worldwide.

Period of Performance:

Starting Date targeted for September 5, 2022 or when the Journal receives submission of all 16 manuscripts currently under development by workshop speakers/presenters/discussants to compose the special issue. Delivery or release of the product/publication is ideally targeted for

November 2022 during the Annual Meeting of the Gerontological Society of America to be held in Indianapolis, IN (November 2-6).

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:

A. Sixteen scientific articles that describe results from presentatons, discussions and recommendations originated from knowledge/experience/literature review by experts during the Workshop “Development of Function Promoting Therapies:

Public Health Need, Molecular Targets and Drug Development” held March 20- 22, 2022. These manuscripts will be submitted first to the National Institute on

Aging (NIA) to undergo internal review process to assemble all articles for submission to the journal (target submission schedule to NIA: August 1, 2022).

B. All 16 manuscripts will then be submitted to the Journal of Gerontology Series A:

Biological Sciences and Medical Sciences. These manuscripts will undergo the journal’s production process for publication of the special issue.

C. Manuscripts will be peer reviewed as determined by the journal. Comments from reviewers will be presented by the journal to authors and revisions to manuscripts, if necessary, will be conducted in the timeframe to be established by the journal. Revised manuscripts should be re-submitted to the journal at a schedule also to be determined by the journal at a later time.

D. The journal will finalize all production steps including review of language and format for consistency with guidelines or submission requirements established by the journal and available at:

For manuscripts that are Biological:

https://academic.oup.com/biomedgerontology/pages/General_Instructions_1 For manuscripts that are Medical:

https://academic.oup.com/biomedgerontology/pages/General_Instructions_2

Specific Requirements:

The Journal will coordinate the release of the special issue or the announcement of its release ideally to take place during the November 2022 Annual Meeting of the Gerontological Society of America (GSA), creating great exposure. Disseminations efforst will be coordinated with Public Affairs staff at NIA.

GOVERNMENT RESPONSIBILITIES

The Government will submit to the Journal all 16 manuscripts written by speakers/presenters/discussants at the workshop. Prior to submission to the journal, the Government will review all manuscripts internally, as indicated above.

The Goverment will also review and approve the final product/publication (special issue) prior to publication by the journal.

The Government will not provide workspace, desktop computers and telephones for contractor personnel. Contractor will not require access to Government facilities.

DELIVERY OR DELIVERABLES

Deliverable include the Journal of Gerontology Series A: Biologic Sciences and Medical Sciences special issue with 16 sicientifis articles (both biologic and medical sciences) in electronic and print copies. Completion of review by the Government is schedule for within one week upon receipt of the final product. Delivery of the ‘final product is ideally https://academic.oup.com/biomedgerontology/pages/General_Instructions_1 https://academic.oup.com/biomedgerontology/pages/General_Instructions_2 expected for November 2022 or a few weeks thereafter pending outcomes of the journal’s peer review process.

REPORTING REQUIREMENTS

Contractor will report to NIA COR on a weekly base as the work begins until the end.

Reporting will be accomplished via phone or video-conference calls or in writing to ensure progress is informed, issues are resolved and timelines are kept to the extent possible.

OTHER CONSIDERATIONS

Key Personnel:

Vice President, Publishing and Professional Resources Managing Editor, Journals of Gerontology Staff responsible for steps involved in the publication process

Data Rights:

Data provided by the Government. The NIH Public Access Policy will be followed (https://www.nih.gov/health-information/nih-clinical-research-trials-you/what-is-nih-public-access-policy)

Section 508—Electronic and Information Technology Standards:

The special issue to be published will be made available electronic through PubMed and the journal website. All steps are in place by the journal and NLM’s PubMed to make publications accessible.

Publications and Publicity:

Contractor will not write and publish articles. The Contractor will receive article written by speakers/presenters/discussants at the NIA workshop previously described.

Confidentiality of Information:

The Government will not provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential. The contract is not expected to generate information or data which is confidential. Data (scientific manuscripts) submitted to the journal by NIA will be kept confidential until the release of the product/publication (special issue); this is current policy of scientific journals.

https://www.nih.gov/health-information/nih-clinical-research-trials-you/what-is-nih-public-access-policy https://www.nih.gov/health-information/nih-clinical-research-trials-you/what-is-nih-public-access-policy