NOT-EB-09-006: Notice of Availability of Administrative Supplements for Participation in Standards Development Process

Notice of Availability of Administrative Supplements for Participation in Standards Development Process

Notice Number: NOT-EB-09-006

Key Dates
Release Date: September 30, 2009
Receipt Date: December 1, 2009; April 1, 2010; August 2, 2010; December 1, 2010; April 1, 2011; August 1, 2011
Earliest Anticipated Start Date: February 15, 2010

Issued by
National Institute of Biomedical Imaging & Bioengineering (NIBIB) (http://www.nibib.nih.gov)

Purpose

This notice announces the availability of supplemental funding to NIBIB awards for standards development work. The purpose of these supplements is to encourage NIBIB-funded investigators to focus on translation of their technologies by ensuring interoperability with other technologies. Furthermore, participation of NIBIB-funded investigators in standards development work will ensure that their expertise and experience in bioengineering and biomedical imaging contribute to community-adopted standards.
The funds provided by the supplement are expected to support attendance and travel to standards development meetings as well as time and effort spent on drafting and reviewing standards documents, participating in phone or email discussions, and laboratory testing where appropriate. Applicants may propose to contribute to an existing standard development effort or to initiate a new standard if a need has been identified in the course of research.

Some bioengineering endeavors that would benefit from standards development are biomaterials testing, tissue engineering, nanomedicine, point-of-care testing, biosensors, and neuroengineering. The standards developed in these bioengineering fields are usually characterization, testing, reporting, assay, or material standards. Examples of standards committees that may be of particular interest to NIBIB grantees are: technical subcommittees under ASTM Committee F04 on Medical and Surgical Materials and Devices; the CLSI Area Committee on Point-of-Care Testing; IEEE Technical Committee 1073 on Standard for Medical Device Communications; the ISO Technical Committee 150 on Implants for Surgery; and the ISAC Data Standards Task Force. This list is intended to provide examples and is by no means comprehensive. Interested investigators should please contact us if they would like more information on the best way to get involved in standards development work in their research and development areas.

Background

Across the spectrum of NIBIB’s bioengineering and biomedical imaging program areas, there exists a need for consensus standards. NIBIB’s mission includes a charge to support “studies to assess the effectiveness and outcomes of new biologics, materials, processes, devices, and procedures.” Standards play a critical role in achieving this mission.

In an effort to maximize the impact of the technologies developed with NIBIB funding, we intend to support participation in standards development organizations (SDO’s) that are widely recognized. These SDO’s may be those listed by ANSI as Standards Developing Organizations or may be organizations working in more nascent areas of technology that have not yet received formal recognition. An example of a non-accredited standards group is a panel established to investigate the state of standardization in a particular field. Another example is a consortium with representatives from industry, academia, and government that is focused on a particular technology. In the case of a non-accredited voluntary consensus standards bodies, the standards group should adhere to the criteria laid out by OMB circular A-119 (http://standards.gov/standards_gov/a119.cfm#4); that is it should: be open, represent a balance of interests, and operate by consensus. Consensus is defined as general agreement, not necessarily unanimity, and includes fair consideration of all comments and a process for attempting to resolve objections by interested parties.

Useful sites for background materials and information about the use of standards are:
http://www.nist.gov/public_affairs/standards.htm
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
http://standards.gov

Eligibility

Eligible parent grants should have at least 24 months remaining at the time the request is made (R03 and R21 grants are ineligible).
The individuals chosen for participation should have sufficient breadth and depth of knowledge in the field to ensure meaningful participation in the standards efforts. Furthermore, investigators should be committed to the project for a sufficient period of time to guarantee continuity of the standards work.

The current initiative is a pilot to support standards development work in bioengineering. The scope of this program may be expanded in the future.
IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. 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 they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

Submitting an Administrative Supplement Request

To be considered for an administrative supplement, submit a request in writing to NIBIB, not to the Division of Receipt and Referral, Center for Scientific Review. The request must be signed by the authorized Business Official and describe the need for additional funding and the categorical costs.

Requests under this notice should use the PHS 398 forms (rev. 11/2007; available at https://grants.nih.gov/grants/funding/phs398/phs398.html) and include the following elements in the request packet. Font size restrictions apply as designated within the PHS398 (rev. 4/2006) instructions.)

1) Cover Letter - Citing this Notice (NOT-EB-09-006), a request for an Administrative Supplement, and the following information:

Project Director/Principal Investigator (PD/PI) name
Parent grant number and title
Amount of the requested supplement
Name and title of the institutional official, and
Phone, email, and address information for both the PD/PI and institutional official.

The cover letter must be signed by the authorized organizational representative/institutional official.

2) PHS 398 Form Page 1 (Face page)

The title of the project (Box 1) should be the title of the parent award.
This Notice (number and title, “Notice of Availability of Administrative Supplements for Participation in Standards Development Process”) should be cited in Box 2, and the “yes” box should be checked.
The Principal Investigator (PI) must be the same as the PI on the parent award. For Multiple PI parent awards, the Contact PI must be the PI listed on the supplement request, and the supplement cannot change the Multiple PI team.
The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.

3) PHS 398 Form page 2

Note: The project “summary” is that of the administrative supplement, not the parent grant.

4) A brief proposal describing the project, including:

a) Scope of the overall project and the anticipated contribution of the requested supplement (not to exceed seven pages), including the following:

a short synopsis of the specific aims of the parent grant;
an overview of existing standards efforts in the relevant domain (e.g., names of panels, working groups, committees along with current status of standards development effort);
a discussion of the need for and significance of standards with the respect to the grantee’s research;
a plan for the standards work to be conducted with the supplemental funds (including a concept paper for a draft standard, if appropriate);
an explanation of how the supplemental request falls within the scope of the parent grant; and
a discussion of the broader potential impact of this work.

b) Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs. See Budget and Funding Information below.

c) Biographical Sketch for all new key personnel (those who are additions on the supplemental project)

d) Human Subjects/ Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made. Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted. When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions.

e) PHS 398 Checklist Form

Selection Factors

Administrative supplement requests will be reviewed administratively by NIBIB Program and Grants Management Staff. Selection factors will include the following:

the relevance to the parent grant project and to NIBIB’s mission;
progress of the parent grant appropriate to the current stage of the project;
the impact of the proposed standards works on the development and application of biomedical technologies for the improvement of human health;
the perceived gaps in the current standards or guidance efforts;
the soundness of the proposed plan; and
the qualifications of the investigators to participate in the standards work.

Budget and Funding Information

Budget amounts for these supplements are expected to vary; applicants must justify their budget requests. Some expected budget items are SDO participation fees, travel expenses for attending SDO meetings, and effort of involved investigators. Requests should not be greater than $30,000 (direct costs) for a given year. Supplements may be requested for up to two years but may extend no longer than the parent grant. It is anticipated that supplemental funding will begin in early calendar year 2010.

How to Apply

Requests will be accepted on an ongoing basis and administratively reviewed three times per year by a panel of NIH program staff. Requests will also be reviewed by NIH grants management. Applicants should send an electronic copy of the supplement request as an e-mail attachment in PDF format to the program and grants management contacts listed below under “Inquiries.”

If a request is made for multiple years of funding, a detailed plan should be provided describing the goals and budget for each year. Following each budget year, a one-page progress report summarizing the accomplishments and progress made with the supplemental funds will be required along with the progress report of the parent grant.

Inquiries

You are encouraged to contact the program officer named below to discuss your request before submitting it.

Program Contact:

Zohara Cohen, Ph.D.
Program Director
National Institute of Biomedical Imaging & Bioengineering
Democracy II, Suite 200
6707 Democracy Blvd
Bethesda, MD 20892
Telephone: 301-402-1127
Email: zcohen@mail.nih.gov
Grants Management Contact:

Katie Ellis
Grants Management Specialist
National Institute of Biomedical Imaging
and Bioengineering, NIH
6707 Democracy Blvd., MSC 5469
Suite 900, Democracy II
Bethesda, MD 20892-5469*
Phone: 301-496-8521
Fax: 301-451-5735
Email: kellis@mail.nih.gov

* For Express Courier Services use - Bethesda, MD 20817

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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