Transforming the Future of Self-Care Challenge

https://ninesights.ninesigma.com/servlet/hype/IMT?userAction=Browse&documentId=0aae3c4064a479fcf65a2a7b9615a85e&templateName=&documentTableId=3422744953560066495&utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Ignite%2011-16-18%20(2)&utm_content=&spMailingID=37361687&spUserID=ODA4Nzg5ODQ1NTgxS0&spJobID=1401753270&spReportId=MTQwMTc1MzI3MAS2

Contest Number:

IC_2018_0172

About the Challenge

GlaxoSmithKline (GSK) Consumer Healthcare is on a mission to “Transform the Future of Self-Care” to enable consumers to do more, feel better and live longer.  We are actively seeking to establish strategic partnerships with start-ups and entrepreneurs who are equally passionate about delivering against this mission.  The way consumers treat, diagnose and engage with their health is dramatically shifting and we want to partner with breakthrough thinkers so that we can jointly improve lives.

To drive this mission to enhance our current key, over-the-counter and consumer product brands, we are currently seeking new opportunities in the following three Challenge Topics:  Digital Health, At-Home Diagnostics, and Formulation Technologies.

Click links below to view detailed descriptions about each topic:

Topic 1:  Digital Health Technologies >>

Topic 2:  At-Home Diagnostics >>

Topic 3:  Formulation Technologies >>

Award

There is a maximum of US$50,000 available for cash prizes.  The Competition will award up to five (5) US$10,000 prizes to the winners across the three Topics.  The Challenge sponsor may also explore funding or other support of an Entry for further development and/or commercialization.

 

Timeline

Launch: October 22, 2018

Webinar: 10:00 am EST on November 27, 2018

Submission Deadline: January 31, 2019 by 5:00 pm EST

Winners Announcement: March 2019

 

Eligibility

The following types of approaches are not eligible:

  • Approaches that are only at concept level of technology readiness
  • Technologies that do not align with product categories above
  • Business to Business (B2B) service models
  • Ways of running clinical trials or scientific studies to allow for product claims
  • Approaches that require a prescription or visit to a medical doctor

Additional ineligible approaches are documented in each Challenge Topic Summary document.

 

Success Criteria

The Challenge sponsor will judge each submission against the following criteria:

  • How thorough and concise is the description of problem, solution approach, and business model
  • Effectiveness of the approach to address Topic
  • Extent to which approach addresses a consumer need
  • Creativity and originality (more than a “me-too” offering, clear differentiation to other products already on the market)
  • Technology maturity (a solution in a later stage of maturity receives a better score)
  • Ease of implementation (clear and tractable path to manufacturability or supply and deployment to market)
  • Potential to transfer the solution to other scenarios
  • Likelihood to be economical at consumer product price point

Minimum Requirements that apply to all Challenge Topics:

  • You must already be working on your approach. (Preferably the technology readiness of your approach is at the prototype phase (proof-of-concept stage), or later)
  • Your approach has a clear business model and value proposition
  • You have protected intellectual property (either by patent or as proprietary information)

Submissions

You must complete and submit the online response form by January 31, 2019 at 5:00 PM ET.  You will be able to upload supplemental documents with your response.

In your concise, non-confidential response you should:

  • Describe your technology innovation and:

o    its working principle

o    its alignment with Topic Key Attributes and with Challenge Evaluation Criteria

o    its unique benefits compared to existing solutions already in the market

o    your business model and value proposition

  • Discuss the results of any testing you have done (safety, consumer, efficacy, etc.)
  • Describe steps, activity, estimated budget, and timeline to reach commercial scale
  • Discuss the status of the intellectual property related to your approach

o    Who owns the related IP

o    Your assessment of freedom to practice

o    Upload a copy of your patent and detailed illustrations and photos, if applicable

  • Describe your (or your team’s) background and related experience
  • (Optional) Provide a private link to a short (2-5 minute) video presentation in which you pitch your approach and capabilities

Challenge Moderator

Kevin Andrews

  • Senior Program Manager
  • NineSigma Inc.

Meet the GSK Consumer Healthcare Sponsors

Contact our Help Desk

phd@ninesigma.com

Background

GlaxoSmithKline (GSK) Consumer Healthcare develops and markets consumer-preferred and expert-recommended brands in the Pain Relief, Oral Health, Respiratory Health, Digestive Health, and Skin Health product categories.

 

GSK Consumer Healthcare is one of the leading over-the-counter healthcare companies.  We hold number one positions in Wellness across 36 markets and are market leaders in specialist oral care.

 

We have a portfolio of loved and trusted brands, underpinned by science, that includes: Sensodyne, Parodontax, Poligrip, Voltaren, Panadol, Otrivin, and Theraflu.

Official Rules

Topic 1 Challenge Summary

Topic 2 Challenge Summary

Topic 3 Challenge Summary

·         Challenge Summary-Topic 3 Formulation Technologies.pdf

National Science Foundation Update All NSF Upcoming Due Dates Update

Division of Physics: Investigator-Initiated Research Projects (PHY)

Full Proposal Deadline Date: December 11, 2018
Elementary Particle Physics – Theory; Particle Astrophysics and Cosmology – Theory; Physics of Living Systems; Quantum Information Science

Program Guidelines: NSF 18-564

The Division of Physics (PHY) supports physics research and the preparation of future scientists in the nation’s colleges and universities across a broad range of physics disciplines that span scales of space and time from the largest to the smallest and the oldest to the youngest.  The Division is comprised of disciplinary programs covering experimental and theoretical research in the following major subfields of physics: Atomic, Molecular and Optical …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=505058&WT.mc_id=USNSF_39&WT.mc_ev=click

 

Improving Undergraduate STEM Education: Education and Human Resources (IUSE: EHR)

 

Full Proposal Deadline Date: December 11, 2018
Development and Implementation Tier for Engaged Student Learning & Institution and Community Transformation

Program Guidelines: NSF 17-590

The fields of science, technology, engineering, and mathematics (STEM) hold much promise as sectors of the economy where we can expect to see continuous vigorous growth in the coming decades. STEM job creation is expected to outpace non-STEM job creation significantly, according to the Commerce Department, reflecting the importance of STEM knowledge to the US economy.

The National Science Foundation (NSF) plays a leadership role in development and implementation of efforts to …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=505082&WT.mc_id=USNSF_39&WT.mc_ev=click

 

Smart and Connected Health (SCH)

Full Proposal Deadline Date: December 11, 2018

Program Guidelines: NSF 18-541

The goal of the interagency Smart and Connected Health (SCH): Connecting Data, People and Systems program is to accelerate the development and integration of innovative computer and information science and engineering approaches to support the transformation of health and medicine. Approaches that partner technology-based solutions with biomedical and biobehavioral research are supported by multiple agencies of the federal government including the National Science Foundation (NSF) …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504739&WT.mc_id=USNSF_39&WT.mc_ev=click

 

WINDOWS ON THE UNIVERSE: THE ERA OF MULTI-MESSENGER ASTROPHYSICS (WoU-MMA)

Full Proposal Deadline Date: December 11, 2018
Particle Astrophysics and Cosmology – Theory

Program Guidelines: PD 18-5115

The universe is the ultimate laboratory, and we can now probe it as never before through several powerful and diverse windows – electromagnetic waves, high-energy particles, and gravitational waves.  Each of these windows provides a different view.  Together they reveal a detailed picture of the Universe that will allow us to study matter, energy, and the cosmos in fundamentally new ways.

The NSF’s Big Idea “Windows on the Universe” is implemented through …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=505593&WT.mc_id=USNSF_39&WT.mc_ev=click

 

Alliances for Graduate Education and the Professoriate (AGEP)

Full Proposal Deadline Date: December 14, 2018

Program Guidelines: NSF 16-552

The Alliances for Graduate Education and the Professoriate (AGEP) program seeks to advance knowledge about models to improve pathways to the professoriate and success for historically underrepresented minority doctoral students, postdoctoral fellows and faculty, particularly African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and Native Pacific Islanders, in specific STEM disciplines and/or STEM education research fields.  New and …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=5474&WT.mc_id=USNSF_39&WT.mc_ev=click

 

Mathematical Sciences Research Institutes

 

Letter of Intent Deadline Date: December 14, 2018

Program Guidelines: NSF 17-553

Mathematical Sciences Research Institutes are national resources that aim to advance research in the mathematical sciences through programs supporting discovery and dissemination of knowledge in mathematics and statistics and enhancing connections to related fields in which the mathematical sciences can play important roles. Institute activities help focus the attention of some of the best mathematical minds on problems of particular importance and timeliness. Institutes are also community …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=5302&WT.mc_id=USNSF_39&WT.mc_ev=click

 

Oceanographic Facilities and Equipment Support

Full Proposal Target Date: December 14, 2018
Oceanographic Instrumentation

Program Guidelines: NSF 13-589

Oceanographic facilities and equipment are supported by the Integrative Programs Section (IPS) of the Division of Ocean Sciences Division (OCE), Directorate for Geosciences (GEO).  These awards are made for the procurement, conversion and/or up-grade, enhancement or annual operation of platforms in the ocean, coastal, near-shore and Great Lakes. Awards are generally directed specifically to support facilities that lend themselves to shared use within the broad range of …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504848&WT.mc_id=USNSF_39&WT.mc_ev=click

 

Oceanographic Facilities and Equipment Support

Full Proposal Target Date: December 14, 2018
Shipboard Scientific Support Equipment

Program Guidelines: NSF 13-589

Oceanographic facilities and equipment are supported by the Integrative Programs Section (IPS) of the Division of Ocean Sciences Division (OCE), Directorate for Geosciences (GEO).  These awards are made for the procurement, conversion and/or up-grade, enhancement or annual operation of platforms in the ocean, coastal, near-shore and Great Lakes. Awards are generally directed specifically to support facilities that lend themselves to shared use within the broad range of …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504848&WT.mc_id=USNSF_39&WT.mc_ev=click

 

CNH2: Dynamics of Integrated Socio-Environmental Systems (CNH2)

Letter of Intent Deadline Date: December 17, 2018

Program Guidelines: NSF 19-528

The CNH2 Program supports research projects that advance basic scientific understanding of integrated socio-environmental systems and the complex interactions (dynamics, processes, and feedbacks) within and among the environmental (biological, physical and chemical) and human (“socio”) (economic, social, political, or behavioral) components of such a system.  The program seeks proposals that emphasize the truly integrated nature of a socio-environmental system versus two discrete …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=13681&WT.mc_id=USNSF_39&WT.mc_ev=click

 

Mathematical Sciences Infrastructure Program

Full Proposal Deadline Date: December 17, 2018

Program Guidelines: PD 18-1260

The major aim of the DMS Infrastructure Program is to foster the continuing health of the mathematical sciences research community as a whole. Hence, the program supports projects that positively influence the entire community, most often those cutting across multiple sub-disciplines.  Activities funded include working research sessions, such as conferences and symposia, as well as larger initiatives focused on enhancing and developing the mathematical sciences at the national …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=12756&WT.mc_id=USNSF_39&WT.mc_ev=click

 

NSF Quantum Computing & Information Science Faculty Fellows (QCIS-FF)

Preliminary Proposal Deadline Date: December 17, 2018

Program Guidelines: NSF 19-507

In 2016, the National Science Foundation (NSF) unveiled a set of “Big Ideas,” 10 bold, long-term research and process ideas that identify areas for future investment at the frontiers of science and engineering (see https://www.nsf.gov/news/special_reports/big_ideas/index.jsp). One of these ideas, “The Quantum Leap: Leading the Next Quantum Revolution,” advances quantum …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=505535&WT.mc_id=USNSF_39&WT.mc_ev=click

 

Statistics

Full Proposal Window: December 17, 2018

Program Guidelines: PD 18-1269

The Statistics Program supports research in statistical theory and methods, including research in statistical methods for applications to any domain of science and engineering. The theory forms the base for statistical science. The methods are used for stochastic modeling, and the collection, analysis and interpretation of data. The methods characterize uncertainty in the data and facilitate advancement in science and engineering. The Program encourages proposals ranging from …
More at https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=5556&WT.mc_id=USNSF_39&WT.mc_ev=click

NIH Update: Protecting the Integrity of Research, Inclusion Policy, Updated Grants Policy Statement

Working Together to Protect the Integrity of NIH-funded Research

By Mike Lauer

When research findings are made up from thin air, misrepresented in some way, or blatantly and without credit copied from others, we risk eroding the public’s trust, damaging institutional reputation, harming careers, incurring skepticism, misleading future research, and, arguably most importantly, hurting patients. NIH takes research misconduct seriously. We are being proactive.
Continue reading →

Understanding Age in the NIH Portfolio: Implementation of the NIH Inclusion Across the Lifespan Policy

By Dawn Corbett and Michael Lauer

Last December, NIH announced a revision to its Inclusion of Children Policy to expand the policy to individuals of all ages. The revised policy, now called the Inclusion Across the Lifespan policy, requires individuals of all ages (including children and older adults) be included in clinical research studies unless there are scientific or ethical reasons to exclude them.
A recent Viewpoint Essay published in the Journal of the American Medical Association (JAMA), co-authored by Drs. Marie Bernard (National Institute on Aging), Janine Clayton (NIH Office of Research on Women’s Health), and Michael Lauer, highlights the need for such a policy. The essay summarizes efforts by NIH to implement 21st Century Cures requirements to publish data on the age of research participants, to convene a workshop on age grouping and exclusions, and to make a determination on whether to revise inclusion guidelines on age.
Continue reading →

What Contributes to the Success of Early Career Scientists? – A NIAID Look

By Mike Lauer

At NIH, we are heavily invested in our workforce and in understanding the barriers they face. What characteristics do they share? How do they compete in the current hypercompetitive environment? When do they stop applying to NIH (drop out), even after receiving their first award? Staff from the National Institute of Allergy and Infectious Diseases (NIAID) delve into these questions in a paper published recently in PLOS ONE , whose findings I’d like to highlight today. Here, Drs. Patricia Haggerty and Matthew Fenton looked at factors that may contribute to the success of early-career investigators and if these factors affect all junior researchers equally. Continue reading →

Protecting Participants, Empowering Researchers: Providing Access to Genomic Summary Results

Guest post by Carrie Wolinetz and Eric Green

Today, we are updating the way we manage data related to the NIH Genomic Data Sharing Policy to again allow unrestricted access to genomic summary results for most of the studies we support in order to advance health or further research purposes. These summary results are importantly distinct from other genomic research data, most notably in that they do not include individual-level information. Instead, these results come from analyzing pooled genomic data from multiple individuals together to generate a statistical result for the entire dataset. Such information can be a powerful tool for helping researchers determine which genomic variants potentially contribute to a disease or disorder. Continue reading →

Top Stories

 

Revised NIH Grants Policy Statement for Fiscal Year 2019

NIH has released a revised Grants Policy Statement that applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2018. This revised version does not introduce new policies, but it does incorporate all policy changes or updates made throughout the previous year and includes significant enhancements to improve the user interface, navigation, and search. Continue reading →

 

Legislative Mandates for Fiscal Year 2019

NIH issued a notice detailing statutory provisions that limit or condition the use of funds on NIH grant, cooperative agreement, and contract awards for FY 2019. Continue reading →

 

New Application Requirements for Institutional Training Grants:

Letter of Institutional Commitment to Harassment and Discrimination Protections

NIH takes the issue of sexual harassment and discrimination very seriously. As such, beginning with applications submitted for due dates on or after January 25, 2019, institutional training grant applications (T15, T32, T34, T35, T36, T37, T90/R90, TL1, TL4) must include a letter that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices. Continue reading →

Spring Into Action and Register for the 2019 NIH Regional Seminar in Baltimore Today!

Each year, the NIH Regional Seminar on Program Funding and Grants Administration continues to draw participants from all over the globe.  If you are new to working with NIH grants and would like the opportunity to learn more directly from NIH & HHS experts, then make plans now to participate in the next NIH Regional Seminar on Program Funding and Grants Administration, Spring 2019 in Baltimore, MD.  Continue reading →

 

Resources

New “All About Grants” Podcast on Preparing for Private Investment

Wondering how to knock that investor pitch out of the park? In this next installment of the “All About Grants” podcast series, small business innovators will get a front row seat to hear how to prepare for private investment. Dr. Ethel Ruben, NIH’s Entrepreneur-In-Residence, steps up to the plate and shares insights on who these investors are, how they decide on what innovations to invest in the biomedical commercial space, and some valuable tips and tricks to improve the accuracy of your investor pitch. Continue reading →

 

Multi-project Application Resources

Submitting a multi-project application for the January 25 standard due date? If so, you’ll want to check out these handy resources. Continue reading →

 

Decoding NIH Grant Numbers

Have you ever wondered what each part of an NIH grant number means? Decode that string of letters and numbers with this helpful cheat sheet. Continue reading →

NSF Career Compass Challenge

https://challenge.gov/a/buzz/challenge/86/ideas/top

 

ABOUT THE COMPETITION

NSF has a hypothesis.

Technology is changing the way we do our work, and the work itself.  To keep up, the National Science Foundation (NSF) plans to invest in its most critical resource – the workforce.  And it’s not just NSF.  The need for an adaptable and ready workforce extends to other Federal agencies and beyond.  No industry will be immune to the way advances in technology change the nature of work.  As a pressing example, we are facing critical gaps in matching people with data science and cybersecurity skills with the right mission needs.  NSF believes that, along with other agencies and organizations, the best way to maintain a workforce ready to carry out its mission is to encourage a culture of continuous learning, and to empower each person to refresh and modernize their skills toward future work.  We want to spark the thinking of the best and brightest to co-create a solution that can enable individual skill-matching and tailored training for the Workforce for the 21st Century.

 

COMPETITION OVERVIEW

The different types of roles and opportunities the Government offers the Federal workforce are more diverse than they have ever been, and the way federal staff work is changing.  Federal employees no longer stay on a linear career path in the same field for most of their careers.  Instead, many employees are branching out by making lateral moves into different fields.  In addition, the pace of changes to the types of work that employees do, largely because of the ever-changing pace of technology, has increased dramatically over the past few years.  It is difficult for agencies to identify and provide training for the workforce at the same rate of those changes.  And it’s likely that the Federal Government is not alone. The winning solution will:

  • Describe the proposed solution, explain how it works, and clearly identify how it will solve the problems articulated in the challenge description
  • Address individuals as the end user for the solution, starting with NSF employees
  • Explain the competitive advantage of the approach
  • Include a comprehensive workflow for the proposed solution
  • Provide an example use case (“Part 1”) or working prototype (“Part 2”)
  • Include a visual representation of the solution, such as a drawing, architecture diagram, or framework

Part 1 (November 9, 2018 – December 31, 2018)

In Part 1 of this challenge, solvers are asked to submit a concept white paper that describe a solution to the challenge of continuous workforce reskilling and the desire for increased mobility within and between NSF and other Federal agencies (and perhaps even the private sector), as an example.  Solvers are asked to think creatively about methods that go beyond the traditional “career path” thinking and “strategic workforce planning” methodology when exposing future skill needs or opportunities for an individual’s consideration when choosing a development path.  Solvers are also asked to consider relevant research on adult cognition and reskilling, particularly for those that must “work” and “learn” simultaneously.  A panel of judges will evaluate the concept paper submissions, and up to five may be selected as Part 1 prize winners.  The winning concepts will then be made available for solvers interested in participating in Part 2 of this challenge.

Based on the quality of submissions received, between one and five white papers will be selected to win the award purse for “Part 1”.  Each winner or winning team will receive a one-time prize of $5,000.00 to be issued in the form of an electronic direct deposit payment.  Winners will be responsible for providing the NSF Division of Financial Management with banking information (must be a U.S. bank account) in order to facilitate the electronic payment (i.e. direct deposit).

For a participant’s concept submission to be eligible to win “Part 1” prize monies, the submitter must agree to have their winning concept materials posted on Challenge.gov and for the “Part 2” solver community to be able to leverage the concept materials for prototype development.

 

Part 2 (February 25, 2019 – June 28, 2019)

In Part 2, solvers are encouraged to leverage and build upon winning concepts to develop a working prototype for Government testing and evaluation.  Solvers will have approximately one month to register to participate in Part 2 of the challenge, either as individuals or as teams.  NSF will host an entrance conference with Part 2 registered solvers to:

  1. Understand the solver community’s ideal needs for data, NSF staff subject matter expertise, etc.
  2. Set a cadence for regular interaction with the Part 2 solver community for the duration of the Part 2 competition timeframe.
  3. Answer questions the Part 2 solver community may have related to winning concept papers.

The intent of the Government is to hold webinars and/or teleconferences with all Part 2 potential solvers simultaneously, to the extent that the solvers are interested in participating.  All engagement between the Government and the Part 2 solver community will be open to all registered solvers who wish to participate, and any information shared during these times will be made available to all Part 2 registered solvers.

 

Based on the quality of submissions received, up to one successful prototype will be selected to win the award purse for “Part 2”.  The winner or winning team will receive a one-time prize of $75,000.00 to be issued in the form of an electronic direct deposit payment.  Winners will be responsible for providing the NSF Division of Financial Management with banking information (must be a U.S. bank account) in order to facilitate the electronic payment (i.e. direct deposit).

For a participant’s prototype submission to be eligible to win “Part 2” prize money, the submitter must make the prototype available for live testing and evaluation by the Federal government.

 

 

From: NSF ERA Forum <nsferaforum@nsf.gov>
Sent: Thursday, November 15, 2018 10:47 AM
To: NSF ERA Forum <nsferaforum@nsf.gov>
Subject: Help the National Science Foundation Shape the Future Workforce!

 

Dear Colleagues,

The ERA Forum Team wanted to share this exciting opportunity with you. The National Science Foundation (NSF) has just launched a cash prize competition, totaling $100,000, called the NSF Career Compass Challenge. Entries are being accepted now at https://challenge.gov/a/buzz/challenge/86/ideas/top

 

NSF is looking to spark the thinking of the best and brightest to co-create a tool that can be tested on a small scale, for NSF, but is intended to be useful to a broad range of employers in both the public and private sectors. Join this opportunity for the general public, research communities, private sector and other interested stakeholders to assist with creating a solution that will invest in the future of the U.S. workforce!

 

For questions regarding the challenge please contact the NSF Career Compass Challenge team: CareerCompassChallenge@nsf.gov

 

Best,

NSF ERA Forum Team

National Science Foundation

nsferaforum@nsf.gov

NIH Grants Policy Statement – Oct. 2018

The revised NIH Grants Policy Statement (NIHGPS, rev. 10/01/2018) represents an update to the October 2017 version and is applicable to all NIH grants and cooperative agreements beginning on or after October 1, 2018. While the update does not introduce any new material for the first time, it incorporates new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes since the previous version of the NIHGPS dated October 2017. The 10/01/2018 revision supersedes, in its entirety, the NIH Grants Policy Statement (October 2017) as a standard term and condition of the award.

 

Notable Policy Changes: Implements new policies and clarification of existing policies announced in the NIH Guide since October 2017, and listed at Grants Policy & Guidance.

 

  1. Part 1: NIH Grants – General Information:
    1. Chapter 1 – Glossary: Micro-purchase Threshold definition – updated micro-purchase threshold to $10,000
  2. Part II: Terms and Conditions of NIH Grant Awards
    1. Chapter 4 – Public Policy Requirements, Objectives and Other Appropriation Mandates
      1. Section 4.1.15.11, NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research, added. (per NOT-OD-18-003)
      2. Section 4.1.15.7 Inclusion of Individuals Across the Lifespan as participants in Research Involving Human Subjects. Policy has been updated to state that individuals of all ages, including children (i.e. individuals under the age of 18) and older adults, must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. (per NOT-OD-18-116)
      3. 4.1.15.8 Inclusion of Women and Minorities as Subjects in Clinical Research and Reporting Sex/Gender, Racial and Ethnic Participation. Updated to include a requirement that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analyses by sex/gender, race, and/or ethnicity are submitted to Clinicaltrials.gov.
      4. 4.1.34 Federal Awardee Performance and Integrity Information System (FAPIIS), and 4.1.35 Mandatory Disclosures. Updated to more clearly state the requirements of 45 CFR 75.113 for disclosing data to the HHS Office of Inspector General
  1. Chapter 7 – Cost Consideration
    1. 7.4 Reimbursement of Facilities and Administrative Costs. Updated to more clearly state the existing requirement that if a consortium is with a for-profit entity, such as a small business, the organization must have an established F&A cost rate before they can charge F&A costs.
  2. Chapter 8 – Administrative Requirements
    1. 8.1.2.11 Provide Subawards Based on Fixed Price Amounts. Updated to note the distinction between dixed amount Subawards and fixed rate agreements.
    2. 8.2.4 Inventions and Patents. Updates language to implement the new regulatory requirements (changes to 37 CFR 401, per NOT-OD-18-233)
    3. 8.3.4.2 Approval Requirements. Update Simplified Acquisition Threshold to $250,000. (per NOT-OD-18-219)
    4. 8.4.1.1 Non-Competition Continuation Progress Reports. Updated previous references to the Inclusion Management System to reflect use of new Human Subjects System (HSS), effective June 9, 2018 (per NOT-OD-18-179)
    5. 8.6.4 Submission of Closeout Documents. Updated to online current requirements for electronic submission
  3. Chapter 11 – Ruth L. Kirschstein National Service Awards
    1. 11.3.3.4 Recruitment Plan to Enhance Diversity. Updated to reflect updated Diversity Statement
    2. 11.3.6.2 Trainees. Updated to state the request for part-time training must be signed by the trainee, the AOR and the training grant PD/PI. The request for part-time training must provide a justification of the need for a reduced level of effort and the expected duration of the period of part-time training.

REVISED OCTOBER 2018. This document applies to all NIH grants and cooperative agreements for budget periods beginning on or after October 1, 2018

PDF version available at: https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf

Summary of Significant Changes to the NIH GPS for October 2018 Version (https://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2018.pdf)