NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)

PA-16-335
NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)
Department of Health and Human Services
National Institutes of Health

Medical Equipment
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Section I. Funding Opportunity Description

The National Heart, Lung, and Blood Institute (NHLBI) announces a pilot program to encourage Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awardees that are developing and testing technologically innovative or substantial risk medical devices (diagnostics or therapeutics) to engage in early face to face interactions with the FDA Center for Devices and Radiological Health.

Medical device companies spend significant amounts of time, money, and resources developing new technologies based upon a best-guess approach regarding regulatory requirements. For new types of technologies and for high risk devices, even a development plan that is based upon information from public sources – such as Food and Drug Administration (FDA) databases of approvals and clearances, and from professionals with relevant experience – has the potential for generating delays in product development if it is created in the absence of feedback from the FDA.  An early meeting with FDA to validate their development plans can ensure that companies do the appropriate work at the appropriate time and can minimize or eliminate the need to repeat expensive and time consuming studies which can exhaust their limited resources. Although the FDA is noted for saying “come early, come often,” some medical device developers are wary of interacting with the Center for Devices and Radiological Health (CDRH) too early in their development program due to concerns that the CDRH may impose regulatory requirements early in development that are more stringent than those they would need to meet if their technology were more fully developed. CDRH has recently issued guidance documents describing changes to their regulatory approach, including the Expedited Access Pathway Program, the Early Feasibility Studies program, and Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval. CDRH has also worked collaboratively with early stage technology developers to understand the nuances of developing regulatory strategies that fit small business development budgets and timelines (http://medcitynews.com/2015/09/fogarty-institute-hey-medtech-startups-fda-is-your-friend/). These announcements and activities are evidence of a commitment by CDRH to openly engage with the newest types of technologies – such as those represented in their small business portfolios – and wish to encourage their portfolio companies to take advantage of CDRH’s new programs. Furthermore, due to the unique three dimensional aspects of medical devices, NHLBI perceives great value for their portfolio companies to meet in-person with CDRH so that prototypes or components of their technologies can be handled, manipulated, and examined by all attendees.

Companies selected for supplement awards can anticipate an NHLBI-facilitated introduction to a CDRH Coordinator in the appropriate CDRH review division where their technology will be regulated. The CDRH Coordinator will:

  • Introduce the company to the US regulations relevant to the selected technology
  • Talk with the company to more fully understand the technology under development
  • Describe the process of CDRH regulation for the technology type
  • Frame the conversation for a face-to-face meeting
  • Engage appropriate CDRH Senior managers and review staff members with technology-relevant expertise to participate in a face-to-face meeting

The primary outcomes of the face-to-face meeting will be collaborative drafting of a least-burdensome development plan to guide the technology toward submission for first in human or first in US use under an Investigational Device Exemption (IDE), and the development of a relationship between the development team and the CDRH review team. Final guidance on the Least Burdensome approach can be accessed at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf .

It is anticipated that participation in this pilot program will encourage and enable:

  • Increased awareness of CDRH regulatory requirements by SBIR/STTR awardees
  • Increased collaboration between NIH and FDA related to the development of new biomedical therapeutic and diagnostic devices
  • Phase II and Phase IIB SBIR/STTR applications with Research and Commercialization plans that are aligned with regulatory milestones
  • Reduced total time to FDA regulatory clearance or approval for innovative devices as compared to technologies that do not receive early input from the FDA
  • Increased U.S.-based clinical development of highly innovative medical devices (diagnostics and therapeutics)

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-16-335
Funding Opportunity Title: NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.233 — National Center on Sleep Disorders Research
93.837 — Cardiovascular Diseases Research
93.838 — Lung Diseases Research
93.839 — Blood Diseases and Resources Research
93.840 — Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Cost Sharing or Matching Requirement: No
Posted Date: Jun 15, 2016
Last Updated Date: Jun 15, 2016
Original Closing Date for Applications: Aug 15, 2016  
Current Closing Date for Applications: Aug 15, 2016  
Archive Date: Sep 15, 2016
Estimated Total Program Funding:
Award Ceiling: $5,000

Eligibility

Eligible Applicants:
Small businesses
Additional Information on Eligibility: Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this administrative supplement is to provide support to current SBIR and STTR awardees interested in working collaboratively with the FDA’s Center for Devices and Radiological Health (CDRH) to develop strategies for early stage development so that they may bring innovative products to the marketplace more efficiently.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-16-335.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Administrative Supplements for Complementary Health Practitioner Research Experience (Admin Supp)

PA-16-013

Administrative Supplements for Complementary Health Practitioner Research Experience (Admin Supp)
Department of Health and Human Services
National Institutes of Health

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Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

Administrative supplement requests must be submitted on paper for the following activity codes:

P01 Research Program Projects
P50 Specialized Center
U19 Research Program – Cooperative Agreements

Administrative supplement requests may be submitted electronically for the following activity codes:

R01 Research Project Grant
R21/R33 Phased Innovation Award
R34 Clinical Trial Planning Grant Program

R61/R33 Phased Innovation Award
U01 Research Project – Cooperative Agreements

U34 Clinical Planning Grant Cooperative Agreement

Section I. Funding Opportunity Description

The National Center for Complementary and Integrative Health (NCCIH) hereby notify all Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding any of the NIH research grants listed in “Activity Code” above that funds are available for administrative supplements to support and recruit Complementary health practitioners seeking to develop a clinical research career. Administrative supplements must support work within the scope of the original project.

This program is designed to provide support for research experiences for complementary health practitioners.

NCCIH recognizes a compelling need to develop clinician scientists to conduct complementary and integrative health research.  The goal of this initiative, therefore, is to provide hands-on research experience to complementary health practitioners so they can gain experience and acquire skills to enhance their understanding, and appreciation of research in complementary and integrative health domains.  It is hoped that the research opportunity supported under this FOA will encourage and thus increase the participation of clinicians trained in complementary health care to pursue additional complementary and integrative health-related research opportunities, which could include NIH supported research and additional research training (e.g., Mentored Patient-Oriented Research Career Development Award; Parent K23).  In turn, providing a vehicle for complementary health practitioners to obtain research skills will benefit the complementary health research community, since these individuals bring an in depth knowledge of the complementary health practices to the research enterprise.

An individual complementary health practitioner may  be supported once in his or her career under this administrative supplement and cannot be currently supported on an NIH-funded research grant.  The complementary health practitioner candidate must devote at least 75% effort to research related activities supported by this administrative supplement.  Depending on the level of experience, a candidate may have their own research project  that is within the scope of the  parent grant  or at minimum, should be sufficiently immersed  and actively involved  in an ongoing research project(s) such that the candidate has an in depth research experience.  In addition, it is expected that the candidate will take part in regular research group meetings and appropriate seminars.  It is also expected that the candidate will have regular meetings and mentoring sessions with the PD/PI of the parent grant.  Complementary health practitioners may seek out eligible NCCIH grantees for potential research opportunities and support under this FOA using the NIH RePORTER system (https://nccih.nih.gov/research/extramural/awards) with the understanding prospective NCCIH-funded grantees must determine whether a mentoring arrangement is appropriate and feasible before submitting a supplement request.  The supplement awarded under this FOA is intended to provide support to practitioners for 1 year with the option to renew for a second year.

Applications for this award must propose a comprehensive research plan that has: (1) intrinsic research importance in the area of complementary and integrative health, (2) is within the mission of NCCIH, (3) is within the scope of the of the parent research grant, (4) will serve as a suitable vehicle for learning methodology, theories, and concepts needed for to conduct research in the area of complementary and integrative health; and (5) will ensure a high level productivity.  .

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-16-013
Funding Opportunity Title: Administrative Supplements for Complementary Health Practitioner Research Experience (Admin Supp)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.213 — Research and Training in Complementary and Integrative Health
Cost Sharing or Matching Requirement: No

Posted Date:Oct 26, 2015

Creation Date:Oct 26, 2015

Original Closing Date for Applications:Sep 1, 2018 

 Current Closing Date for Applications:Sep 1, 2018 

 Archive Date:Oct 2, 2018

Estimated Total Program Funding: NA

Award Ceiling:$100,000

Award Floor: NA
Eligibility

Eligible Applicants:
Small businesses
Special district governments
Native American tribal governments (Federally recognized)
Private institutions of higher education
County governments
Independent school districts
State governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
City or township governments
Native American tribal organizations (other than Federally recognized tribal governments)
Public and State controlled institutions of higher education
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Additional Information

Agency Name: National Institutes of Health
Description: NCCIH encourages applications for administrative supplements to NCCIH-supported awards (see relevant Activity Codes above) to support complementary health practitioners in an intensive supervised clinical research experience that will lead to a better understanding of and practical experience in complementary and integrative health research. For this FOA, clinicians may include (but are not limited to) licensed acupuncturists, chiropractors, naturopathic medicine practitioners, and massage therapists. Funding is available for one year with an option to renew for a second year. to conduct clinical research associated with the parent program. This initiative is focused on providing a research experience for complementary health practitioners and is not intended to support clinical residency training or other clinical practitioner training.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-16-013.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)

PA-15-322research
Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
Department of Health and Human Services
National Institutes of Health

Funding Opportunity Purpose

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to improve the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project.  Administrative supplements must support work within the scope of the original project.

General Information

Document Type: Grants Notice
Funding Opportunity Number: PA-15-322
Funding Opportunity Title: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Education
Environment
Food and Nutrition
Health
Category Explanation:
Expected Number of Awards:
CFDA Number(s): 93.113 — Environmental Health
93.121 — Oral Diseases and Disorders Research
93.172 — Human Genome Research
93.173 — Research Related to Deafness and Communication Disorders
93.213 — Research and Training in Complementary and Integrative Health
93.233 — National Center on Sleep Disorders Research
93.242 — Mental Health Research Grants
93.273 — Alcohol Research Programs
93.279 — Drug Abuse and Addiction Research Programs
93.286 — Discovery and Applied Research for Technological Innovations to Improve Human Health
93.307 — Minority Health and Health Disparities Research
93.310 — Trans-NIH Research Support
93.350 — National Center for Advancing Translational Sciences
93.351 — Research Infrastructure Programs
93.361 — Nursing Research
93.398 — Cancer Research Manpower
93.837 — Cardiovascular Diseases Research
93.838 — Lung Diseases Research
93.839 — Blood Diseases and Resources Research
93.846 — Arthritis, Musculoskeletal and Skin Diseases Research
93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research
93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders
93.855 — Allergy and Infectious Diseases Research
93.856 — Microbiology and Infectious Diseases Research
93.859 — Biomedical Research and Research Training
93.866 — Aging Research
93.867 — Vision Research
93.879 — Medical Library Assistance
93.989 — International Research and Research Training
Cost Sharing or Matching Requirement: No
Posted Date: Aug 7, 2015
Creation Date: Aug 7, 2015
Original Closing Date for Applications: Sep 29, 2018  
Current Closing Date for Applications: Sep 29, 2018  
Archive Date: Oct 30, 2018
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
Small businesses
Private institutions of higher education
Public and State controlled institutions of higher education
For profit organizations other than small businesses
State governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs) ; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description: The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to improve the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project.Administrative supplements must support work within the scope of the original project.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PA-15-322.html