NSF 03-525: NSF/FDA Scholar-in-Residence at FDA
Program Solicitation
NSF/FDA SCHOLAR-IN-RESIDENCE AT FDA
Program Solicitation
NSF
03-525
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Food and Drug Administration Center for Devices and Radiological Health | ||
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There is no fixed deadline date
Summary Of Program Requirements
General Information
Program Title:
NSF/FDA SCHOLAR-IN-RESIDENCE AT FDA
Synopsis of Program:
The National Science Foundation (NSF), through the Directorate for Engineering's Division of Bioengineering and Environmental Systems (BES), and the U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH) are establishing the NSF/FDA Scholar-in-Residence Program at FDA. This program comprises an interagency partnership for the investigation of scientific and engineering issues concerning emerging trends in medical device technology. This partnership is designed to enable investigators in science, engineering, and mathematics to develop research collaborations within the intramural research environment at the FDA. This solicitation features four flexible mechanisms for support of research at the FDA: 1) Faculty at FDA; 2) Graduate Student Fellowships; 3) Postdoctoral Fellowships; and, 4) Undergraduate Student Research Experiences. Undergraduate student participants supported with NSF funds must be citizens or permanent residents of the United States.
Cognizant Program Officer(s):
D. Helen Gill, Program Director, Directorate for Computer & Information Science & Engineering, Division of Computer-Communications Research, 1145 S, telephone: (703) 292-8910, fax: (703) 292-9059, email: hgill@nsf.gov
Gilbert Devey, Program Director, Directorate for Engineering, Division of Bioengineering & Environmental Systems, 565 S, telephone: (703) 292-7943, fax: (703) 292-9098, email: gdevey@nsf.gov
William A Herman, Director. Division of Physical Sciences, Center for Devices and Radiological Health, Food and Drug Administration, 12725 Twinbrook Parkway, Rockville, MD, 20852, telephone: 301-827-5599, email: wah@cdrh.fda.gov
Applicable Catalog of Federal Domestic Assistance (CFDA) Number(s):
- 47.070 --- Computer and Information Science and Engineering
- 47.041 --- Engineering
Eligibility Information
- Organization Limit: None Specified.
- PI Eligibility Limit: None Specified.
- Limit on Number of Proposals: None Specified.
Award Information
- Anticipated Type of Award: Other - Standard grant or supplement.
- Estimated Number of Awards: 3 to 10
- Anticipated Funding Amount: $500,000 in FY 2003 pending the availability of funds.
Proposal Preparation and Submission Instructions
A. Proposal Preparation Instructions
- Full Proposal Preparation Instructions: This solicitation contains information that supplements the standard Grant Proposal Guide (GPG) proposal preparation guidelines. Please see the full text of this solicitation for further information.
B. Budgetary Information
- Cost Sharing Requirements: Cost Sharing is Specialized. Please see the full text of this solicitation for further information.
- Indirect Cost (F&A) Limitations: Limitations may vary depending on the funding opportunity. See Section II. Program Description for detailed information.
- Other Budgetary Limitations: Other budgetary limitations apply. Please see the full text of this solicitation for further information.
C. Due Dates
- There is no fixed deadline date
Proposal Review Information
- Merit Review Criteria: National Science Board approved criteria apply.
Award Administration Information
- Award Conditions: Standard NSF award conditions apply.
- Reporting Requirements: Standard NSF reporting requirements apply.
I. Introduction
The objectives of the program are to promote progress in science and engineering through investigations that develop new knowledge in service to society by contributing to improved public health and health care, and to provide educational research experiences in science, engineering, and mathematics. The program objectives include promoting research into the fundamental scientific and engineering processes necessary for: (a) the innovation and development of safe and effective new medical devices and technologies; (b) expanding the knowledge pool of scientific techniques and tools needed to identify basic mechanisms by which medical devices interact with the body from the molecular to the physiological level; and (c) preparing the knowledge base that will be needed to shepherd emerging medical device technologies efficiently and responsibly from the early research stage to societal adoption.
II. Program Description
This activity encompasses an eclectic mix of research and collaborations with investigators in the intramural FDA laboratory research program including opportunities for faculty, postdoctoral fellows, and students to conduct engineering and scientific research on topics contributing to public health and to gain experience related to emerging medical device technologies in a research setting, both individually and in collaborative teams.
The following opportunities are options to be considered, and may be combined or modified in alternative arrangements to meet the objectives of the program. Such alternate proposals should represent comparable levels of commitment and interaction.
1. Faculty at FDA - For science, engineering, and mathematics faculty to conduct research for three to twelve months at FDA. Budget: Awards from NSF will range from $25,000 to $150,000 for up to one year and may include 85 percent of faculty salary and fringe benefits during the FDA residency period. Faculty-at-FDA proposals must include a commitment of funds from the applicant's home institution to support the remaining 15 percent of the salary and fringe benefits during the FDA residency. For awards greater than three months it is generally expected that the applicant's home academic institution will share costs through sabbatical salary or other resources. Up to 20 percent of the total requested amount may be used for travel and research expenses for the faculty member and his/her students at the FDA, including materials; and up to 15 percent of the total cost may be allocated for administrative expenses in lieu of indirect costs for the home institution.
2. Graduate Student Fellowship -- For science, engineering, and mathematics graduate students for one to four semesters of full- or part-time work at FDA in an area related to his/her research under the guidance of an academic advisor and an FDA mentor. Budget: Awards will be for up to one year with award amounts typically up to $30,000, and may include the following: a stipend of $1,500 to $1,800 per month for one to four semesters (3 to 24 months); transportation expenses for the graduate student; a 10 percent allowance for the faculty advisor for research-related expenses; and an additional allowance up to 15 percent of the total direct cost for the sponsoring academic institution for administrative costs, in lieu of indirect costs.
3. Postdoctoral Fellowship -- For engineering, science, and mathematics fellows for full-time work at FDA under the guidance of an FDA mentor. Budget: Awards from NSF will be for amounts up to $55,000 per year for one to two years and may include the following: 85 percent of the stipend including fringe benefits for the postdoctoral fellow. Proposals must include a commitment of funds from the applicant's home institution to support the other 15 percent of the salary and fringe benefits during the FDA residency. The award may also include transportation and moving expenses (limited to $3,000); up to 10 percent of the total budget allowance may be used by a faculty advisor for research-related expenses; and an allowance of up to 15 percent of the total direct cost for a sponsoring academic institution for administrative expenses, in lieu of indirect costs.
4. Undergraduate Student Research Experiences -- For engineering, science, and mathematics undergraduate students for summer projects, or one to two semesters of part-time or full-time work at FDA in an area related to his/her academic program under the guidance of an academic advisor and an FDA mentor. Budget: Awards include stipends in amounts typically $300 per week, and some assistance with housing and/or travel expenses. Total project cost per student may be about $6,000 for summer projects.
FDA will provide office space, research facilities, research costs in the form of expendable and minor equipment purchases to the host CDRH laboratory, and the time of its research staff. NSF will, as appropriate, assist with funds for transporting specialized equipment between the applicant's home institution and FDA for use in the collaborative research.
Applicants may request support for this activity as a new proposal, or as a supplement to an eligible existing NSF grant of the participating Directorates. The length of support requested should be appropriate to the purpose and can vary, for example from two months for a summer visit to FDA to three or more years for a full research proposal. Proposals will be evaluated in accordance with NSF merit review criteria and the program objectives (see above).
Topics addressed in awards under this activity need not focus on fundamental issues only, but should be oriented toward generic research within an intellectual envelope shared by FDA. Typically, FDA scientists and researchers will participate in the merit review of proposals submitted under this so. Investigators are expected to integrate research objectives with educational and human resources goals and FDA scientific priorities.
Proposals to NSF must be accompanied with a letter of invitation from FDA, following procedures described more fully below. FDA will host up to 10 NSF scholars and awardees to be in residence at any one time under this activity. Interested applicants should contact the designated NSF Directorate coordinator to learn more about the procedures for proposal preparation, submission, and evaluation.
III. Eligibility Information
The categories of proposers identified in the Grant Proposal Guide are eligible to submit proposals under this program announcement/solicitation.
Eligible Student Participants: Undergraduate student participants supported with NSF funds in either Full Proposals or Supplements to existing awards must be citizens or permanent residents of the United States or its possessions. An undergraduate student is a student who is enrolled in a degree program (part-time or full-time) leading to a baccalaureate or associates degree. Students who are transferring from one institution to another and are enrolled at neither institution during the intervening summer may participate. High school graduates who have not yet enrolled and students who have received their bachelor's degree and are no longer enrolled as undergraduates generally are not eligible.
IV. Award Information
V. Proposal Preparation And Submission Instructions
A. Proposal Preparation Instructions
Full Proposal Instructions:
Proposals submitted in response to this program announcement/solicitation should be prepared and submitted in accordance with the general guidelines contained in the NSF Grant Proposal Guide (GPG). The complete text of the GPG is available electronically on the NSF Website at: https://www.nsf.gov/cgi-bin/getpub?gpg. Paper copies of the GPG may be obtained from the NSF Publications Clearinghouse, telephone (301) 947-2722 or by e-mail from pubs@nsf.gov.
FDA HOST LABORATORY PROCEDURES
Proposals submitted to NSF for this activity require a letter of invitation from one or more Division Directors in the intramural laboratory research program in the FDA's Center for Devices and Radiological Health. Proposals must include an endorsement from the Director of CDRH's Office of Science and Technology (OST) stating that the FDA investigator's laboratory will host the applicant and collaborate in the activity, and outlining the commitments the host laboratory will make to the project. Applicants should submit to the FDA a white paper (800-word maximum, text format) outlining the proposed project to the following e-mail address: wah@cdrh.fda.gov. This paper should be accompanied with a biographical sketch in the standard two-page NSF format, along with a list of current and pending support. The letter of invitation and the letter of endorsement should be scanned and uploaded to the Supplementary Documents section in FastLane.
Proposers are reminded to identify the program announcement/solicitation number ((03-525)) in the program announcement/solicitation block on the proposal Cover Sheet. Compliance with this requirement is critical to determining the relevant proposal processing guidelines. Failure to submit this information may delay processing.
B. Budgetary Information
Cost Sharing:
The proposed cost sharing must be shown on Line M on the proposal budget. Documentation of the availability of cost sharing must be included in the proposal. Only items which would be allowable under the applicable cost principles, if charged to the project, may be included as the awardee's contribution to cost sharing. Contributions may be made from any non-Federal source, including non-Federal grants or contracts, and may be cash or in-kind (see OMB Circular A-110, Section 23). It should be noted that contributions counted as cost-sharing toward projects of another Federal agency may not be counted towards meeting the specific cost-sharing requirements of the NSF award. All cost-sharing amounts are subject to audit. Failure to provide the level of cost-sharing reflected in the approved award budget may result in termination of the NSF award, disallowance of award costs and/or refund of award funds to NSF.
Indirect Cost (F&A) Limitations:
Other Budgetary Limitations:
C. Due Dates
Proposals must be submitted by the following date(s):
Full Proposal Deadline(s) (due by 5 p.m proposer's local time):
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April 14,
2003
- March 15, Annually Thereafter
D. FastLane Requirements
Proposers are required to prepare and submit all proposals for this announcement/solicitation through the FastLane system. Detailed instructions for proposal preparation and submission via FastLane are available at: http://www.fastlane.nsf.gov/a1/newstan.htm. For FastLane user support, call the FastLane Help Desk at 1-800-673-6188 or e-mail fastlane@nsf.gov. The FastLane Help Desk answers general technical questions related to the use of the FastLane system. Specific questions related to this program announcement/solicitation should be referred to the NSF program staff contact(s) listed in Section VIII of this announcement/solicitation.
Submission of Electronically Signed Cover Sheets. The Authorized Organizational Representative (AOR) must electronically sign the proposal Cover Sheet to submit the required proposal certifications (see Chapter II, Section C of the Grant Proposal Guide for a listing of the certifications). The AOR must provide the required electronic certifications within five working days following the electronic submission of the proposal. Proposers are no longer required to provide a paper copy of the signed Proposal Cover Sheet to NSF. Further instructions regarding this process are available on the FastLane Website at: http://www.fastlane.nsf.gov
VI. Proposal Review Information
A. NSF Proposal Review Process
Reviews of proposals submitted to NSF are solicited from peers with expertise in the substantive area of the proposed research or education project. These reviewers are selected by Program Officers charged with the oversight of the review process. NSF invites the proposer to suggest, at the time of submission, the names of appropriate or inappropriate reviewers. Care is taken to ensure that reviewers have no conflicts with the proposer. Special efforts are made to recruit reviewers from non-academic institutions, minority-serving institutions, or adjacent disciplines to that principally addressed in the proposal.
The National Science Board approved revised criteria for evaluating proposals at its meeting on March 28, 1997 (NSB 97-72). All NSF proposals are evaluated through use of the two merit review criteria. In some instances, however, NSF will employ additional criteria as required to highlight the specific objectives of certain programs and activities.
On July 8, 2002, the NSF Director issued Important Notice 127, Implementation of new Grant Proposal Guide Requirements Related to the Broader Impacts Criterion. This Important Notice reinforces the importance of addressing both criteria in the preparation and review of all proposals submitted to NSF. NSF continues to strengthen its internal processes to ensure that both of the merit review criteria are addressed when making funding decisions.
In an effort to increase compliance with these requirements, the January 2002 issuance of the GPG incorporated revised proposal preparation guidelines relating to the development of the Project Summary and Project Description. Chapter II of the GPG specifies that Principal Investigators (PIs) must address both merit review criteria in separate statements within the one-page Project Summary. This chapter also reiterates that broader impacts resulting from the proposed project must be addressed in the Project Description and described as an integral part of the narrative.
Effective October 1, 2002, NSF will return without review proposals that do not separately address both merit review criteria within the Project Summary. It is believed that these changes to NSF proposal preparation and processing guidelines will more clearly articulate the importance of broader impacts to NSF-funded projects.
The two National Science Board approved merit review criteria are listed below (see the Grant Proposal Guide Chapter III.A for further information). The criteria include considerations that help define them. These considerations are suggestions and not all will apply to any given proposal. While proposers must address both merit review criteria, reviewers will be asked to address only those considerations that are relevant to the proposal being considered and for which he/she is qualified to make judgments.
- What is the intellectual merit of the proposed activity?
How important is the proposed activity to advancing knowledge and understanding within its own field or across different fields? How well qualified is the proposer (individual or team) to conduct the project? (If appropriate, the reviewer will comment on the quality of the prior work.) To what extent does the proposed activity suggest and explore creative and original concepts? How well conceived and organized is the proposed activity? Is there sufficient access to resources?
- What are the broader impacts of the proposed activity?
How well does the activity advance discovery and understanding while promoting teaching, training, and learning? How well does the proposed activity broaden the participation of underrepresented groups (e.g., gender, ethnicity, disability, geographic, etc.)? To what extent will it enhance the infrastructure for research and education, such as facilities, instrumentation, networks, and partnerships? Will the results be disseminated broadly to enhance scientific and technological understanding? What may be the benefits of the proposed activity to society?
NSF staff will give careful consideration to the following in making funding decisions:
- Integration of Research and Education
One of the principal strategies in support of NSF's goals is to foster integration of research and education through the programs, projects, and activities it supports at academic and research institutions. These institutions provide abundant opportunities where individuals may concurrently assume responsibilities as researchers, educators, and students and where all can engage in joint efforts that infuse education with the excitement of discovery and enrich research through the diversity of learning perspectives.
- Integrating Diversity into NSF Programs, Projects, and Activities
Broadening opportunities and enabling the participation of all citizens -- women and men, underrepresented minorities, and persons with disabilities -- is essential to the health and vitality of science and engineering. NSF is committed to this principle of diversity and deems it central to the programs, projects, and activities it considers and supports.
B. Review Protocol and Associated Customer Service Standard
All proposals are carefully reviewed by at least three other persons outside NSF who are experts in the particular field represented by the proposal. Proposals submitted in response to this announcement/solicitation will be reviewed by Ad Hoc and/or panel review.
Reviewers will be asked to formulate a recommendation to either support or decline each proposal. The Program Officer assigned to manage the proposal's review will consider the advice of reviewers and will formulate a recommendation.
A summary rating and accompanying narrative will be completed and submitted by each reviewer. In all cases, reviews are treated as confidential documents. Verbatim copies of reviews, excluding the names of the reviewers, are sent to the Principal Investigator/Project Director by the Program Director. In addition, the proposer will receive an explanation of the decision to award or decline funding.
NSF is striving to be able to tell applicants whether their proposals have been declined or recommended for funding within six months. The time interval begins on the date of receipt. The interval ends when the Division Director accepts the Program Officer's recommendation.
In all cases, after programmatic approval has been obtained, the proposals recommended for funding will be forwarded to the Division of Grants and Agreements for review of business, financial, and policy implications and the processing and issuance of a grant or other agreement. Proposers are cautioned that only a Grants and Agreements Officer may make commitments, obligations or awards on behalf of NSF or authorize the expenditure of funds. No commitment on the part of NSF should be inferred from technical or budgetary discussions with a NSF Program Officer. A Principal Investigator or organization that makes financial or personnel commitments in the absence of a grant or cooperative agreement signed by the NSF Grants and Agreements Officer does so at their own risk.
VII. Award Administration Information
A. Notification of the Award
Notification of the award is made to the submitting organization by a Grants Officer in the Division of Grants and Agreements. Organizations whose proposals are declined will be advised as promptly as possible by the cognizant NSF Program Division administering the program. Verbatim copies of reviews, not including the identity of the reviewer, will be provided automatically to the Principal Investigator. (See section VI.A. for additional information on the review process.)
B. Award Conditions
An NSF award consists of: (1) the award letter, which includes any special provisions applicable to the award and any numbered amendments thereto; (2) the budget, which indicates the amounts, by categories of expense, on which NSF has based its support (or otherwise communicates any specific approvals or disapprovals of proposed expenditures); (3) the proposal referenced in the award letter; (4) the applicable award conditions, such as Grant General Conditions (NSF-GC-1); * or Federal Demonstration Partnership (FDP) Terms and Conditions * and (5) any announcement or other NSF issuance that may be incorporated by reference in the award letter. Cooperative agreement awards also are administered in accordance with NSF Cooperative Agreement Terms and Conditions (CA-1). Electronic mail notification is the preferred way to transmit NSF awards to organizations that have electronic mail capabilities and have requested such notification from the Division of Grants and Agreements.
*These documents may be accessed electronically on NSF's Website at https://www.nsf.gov/home/grants/grants_gac.htm. Paper copies may be obtained from the NSF Publications Clearinghouse, telephone (301) 947-2722 or by e-mail from pubs@nsf.gov.
More comprehensive information on NSF Award Conditions is contained in the NSF Grant Policy Manual (GPM) Chapter II, available electronically on the NSF Website at https://www.nsf.gov/cgi-bin/getpub?gpm. The GPM is also for sale through the Superintendent of Documents, Government Printing Office (GPO), Washington, DC 20402. The telephone number at GPO for subscription information is (202) 512-1800. The GPM may be ordered through the GPO Website at http://www.gpo.gov.
C. Reporting Requirements
For all multi-year grants (including both standard and continuing grants), the PI must submit an annual project report to the cognizant Program Officer at least 90 days before the end of the current budget period.
Within 90 days after the expiration of an award, the PI also is required to submit a final project report. Failure to provide final technical reports delays NSF review and processing of pending proposals for the PI and all Co-PIs. PIs should examine the formats of the required reports in advance to assure availability of required data.
PIs are required to use NSF's electronic project reporting system, available through FastLane, for preparation and submission of annual and final project reports. This system permits electronic submission and updating of project reports, including information on project participants (individual and organizational), activities and findings, publications, and other specific products and contributions. PIs will not be required to re-enter information previously provided, either with a proposal or in earlier updates using the electronic system.
VIII. Contacts For Additional Information
General inquiries regarding this program should be made to:
D. Helen Gill, Program Director, Directorate for Computer & Information Science & Engineering, Division of Computer-Communications Research, 1145 S, telephone: (703) 292-8910, fax: (703) 292-9059, email: hgill@nsf.gov
Gilbert Devey, Program Director, Directorate for Engineering, Division of Bioengineering & Environmental Systems, 565 S, telephone: (703) 292-7943, fax: (703) 292-9098, email: gdevey@nsf.gov
William A Herman, Director. Division of Physical Sciences, Center for Devices and Radiological Health, Food and Drug Administration, 12725 Twinbrook Parkway, Rockville, MD, 20852, telephone: 301-827-5599, email: wah@cdrh.fda.gov
For questions related to the use of FastLane, contact:
- None Specified.
IX. Other Programs Of Interest
The NSF Guide to Programs is a compilation of funding for research and education in science, mathematics, and engineering. The NSF Guide to Programs is available electronically at https://www.nsf.gov/cgi-bin/getpub?gp. General descriptions of NSF programs, research areas, and eligibility information for proposal submission are provided in each chapter.
Many NSF programs offer announcements or solicitations concerning specific proposal requirements. To obtain additional information about these requirements, contact the appropriate NSF program offices. Any changes in NSF's fiscal year programs occurring after press time for the Guide to Programs will be announced in the NSF E-Bulletin, which is updated daily on the NSF Website at https://www.nsf.gov/home/ebulletin, and in individual program announcements/solicitations. Subscribers can also sign up for NSF's Custom News Service (https://www.nsf.gov/home/cns/start.htm) to be notified of new funding opportunities that become available.
About The National Science Foundation
The National Science Foundation (NSF) funds research and education in most fields of science and engineering. Awardees are wholly responsible for conducting their project activities and preparing the results for publication. Thus, the Foundation does not assume responsibility for such findings or their interpretation.
NSF welcomes proposals from all qualified scientists, engineers and educators. The Foundation strongly encourages women, minorities and persons with disabilities to compete fully in its programs. In accordance with Federal statutes, regulations and NSF policies, no person on grounds of race, color, age, sex, national origin or disability shall be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving financial assistance from NSF, although some programs may have special requirements that limit eligibility.
Facilitation Awards for Scientists and Engineers with Disabilities (FASED) provide funding for special assistance or equipment to enable persons with disabilities (investigators and other staff, including student research assistants) to work on NSF-supported projects. See the GPG Chapter II, Section D.2 for instructions regarding preparation of these types of proposals.
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The National Science Foundation promotes and advances scientific progress in the United States by competitively awarding grants and cooperative agreements for research and education in the sciences, mathematics, and engineering. To get the latest information about program deadlines, to download copies of NSF publications, and to access abstracts of awards, visit the NSF Website at https://www.nsf.gov
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Privacy Act And Public Burden Statements
The information requested on proposal forms and project reports is solicited under the authority of the National Science Foundation Act of 1950, as amended. The information on proposal forms will be used in connection with the selection of qualified proposals; project reports submitted by awardees will be used for program evaluation and reporting within the Executive Branch and to Congress. The information requested may be disclosed to qualified reviewers and staff assistants as part of the proposal review process; to applicant institutions/grantees to provide or obtain data regarding the proposal review process, award decisions, or the administration of awards; to government contractors, experts, volunteers and researchers and educators as necessary to complete assigned work; to other government agencies needing information as part of the review process or in order to coordinate programs; and to another Federal agency, court or party in a court or Federal administrative proceeding if the government is a party. Information about Principal Investigators may be added to the Reviewer file and used to select potential candidates to serve as peer reviewers or advisory committee members. See Systems of Records, NSF-50, "Principal Investigator/Proposal File and Associated Records," 63 Federal Register 267 (January 5, 1998), and NSF-51, "Reviewer/Proposal File and Associated Records," 63 Federal Register 268 (January 5, 1998). Submission of the information is voluntary. Failure to provide full and complete information, however, may reduce the possibility of receiving an award.
An agency may not conduct or sponsor, and a person is not required to respond to an information collection unless it displays a valid OMB control number. The OMB control number for this collection is 3145-0058. Public reporting burden for this collection of information is estimated to average 120 hours per response, including the time for reviewing instructions. Send comments regarding this burden estimate and any other aspect of this collection of information, including suggestions for reducing this burden, to: Suzanne Plimpton, Reports Clearance Officer, Information Dissemination Branch, Division of Administrative Services, National Science Foundation, Arlington, VA 22230.
OMB control number: 3145-0058.
