PART 3415—BIOTECHNOLOGY RISK ASSESSMENT RESEARCH GRANTS PROGRAM Authority: 5 U.S.C. 301 and 7 U.S.C. 5921. Source: 58 FR 65647, Dec. 15, 1993, unless otherwise noted. Editorial Note: Nomenclature changes to part 3415 appear at 76 FR 4811, Jan. 27, 2011. Subpart A—General § 3415.1 Applicability of regulations. (a) The regulations of this part apply to research grants awarded under the authority of section 1668 of the Food, Agriculture, Conservation, and Trade Act of 1990, (7 U.S.C. 5921). Grants awarded under this section will support biotechnology risk assessment research to help address concerns about the effects of introducing certain biotechnology products into the environment and to help regulators develop policies concerning the introduction of such products. Taking into consideration any determinations made through consultations with such entities as the Animal and Plant Health Inspection Service, the Forest Service, the Environmental Protection Agency, the Office of Agricultural Biotechnology, and the Agricultural Biotechnology Research Advisory Committee, the Director of NIFA and Administrator of ARS shall determine and announce, through publication of a Notice in such publications as the Federal Register, (b) The regulations of this part do not apply to grants awarded by the Department of Agriculture under any other authority. § 3415.2 Definitions. As used in this part: (a) Ad hoc reviewers (b) Administrator (c) Awarding official (d) Biotechnology (e) Budget period (f) Department (g) Director (h) Grant (i) Grantee (j) Peer review group (k) Principal investigator (l) Project (m) Project period (n) Research (o) Methodology [58 FR 65647, Dec. 15, 1993, as amended at 76 FR 4811, Jan. 27, 2011] § 3415.3 Eligibility requirements. (a) Except where otherwise prohibited by law, any public or private research or educational institution or organization shall be eligible to apply for and to receive a grant award under this part, provided that the applicant qualifies as a responsible grantee under the criteria set forth in paragraph (b) of this section. (b) To qualify as responsible, an applicant must meet the following standards as they relate to a particular project: (1) Adequate financial resources for performance, the necessary experience, organizational and technical qualifications, and facilities, or a firm commitment, arrangement, or ability to obtain same (including by proposed subagreements); (2) Ability to comply with the proposed or required completion schedule for the project; (3) Satisfactory record of integrity, judgment, and performance, including, in particular, any prior performance under grants or contracts from the Federal government; (4) Adequate financial management system and audit procedures that provide efficient and effective accountability and control of all funds, property, and other assets; and (5) Otherwise be qualified and eligible to receive a grant under the applicable laws and regulations. (c) Any applicant who is determined to be not responsible will be notified in writing of such finding and the basis therefor. § 3415.4 How to apply for a grant. (a) A program solicitation will be prepared and announced through publications such as the Federal Register, The Department may elect to solicit preproposals each fiscal year in order to eliminate from consideration proposed research that does not address narrowly focused program objectives. A preproposal will be limited in length (in comparison to a full proposal) to alleviate waste of time and effort by applicants in the preparation of proposals and USDA staff in the review of proposals. If the Department solicits preproposals through publication of the annual program solicitation, the Department does not anticipate publishing a subsequent solicitation for full proposals. Applicants submitting preproposals deemed appropriate to the objectives of this program as set out in the annual solicitation will be requested to submit full proposals; the full proposals will then be evaluated in accordance with § 3415.5 through § 3415.15 of this part. The annual program solicitation will contain information sufficient to enable applicants to prepare preproposals or full proposals under this program and will be as complete as possible with respect to: (1) Descriptions of the specific research areas that the Department proposes to support during the fiscal year involved, including anticipated funds to be awarded; (2) Eligibility requirements; (3) Obtaining application kits; (4) Deadline dates for submission of preproposal or proposal packages; (5) Name and mailing address to send preproposals or proposals; (6) Number of copies to submit; and (7) Special requirements. (b) Application Kit. (c) Format for preproposals. (1) “Application for Funding (Form NIFA-661)”. (2) Project summary. (i) Overall project goal(s) and supporting objectives; (ii) Plans to accomplish project goal(s); and (iii) Relevance or significance of the project to United States agriculture. (3) Budget. (4) Special requirements. (ii) By signing the “Application for Funding” identified under § 3415.4(c)(1) in its submission of a preproposal, the applicant is certifying compliance with the restrictions on the use of appropriated funds for lobbying set out in 7 CFR part 3018. (5) Evaluation of preproposals. (d) Format for full proposals. (1) “Application for Funding” (Form NIFA-661). (2) Project summary. (i) Overall project goal(s) and supporting objectives; (ii) Plans to accomplish project goal(s); and (iii) Relevance or significance of the project to United States agriculture. (3) Project description. (i) Introduction. (ii) Progress report. (A) A comparison of actual accomplishments with the goals established for the previous award; (B) The reasons established goals were not met, if applicable; and (C) A listing of any publications resulting from the award. Copies of reprints or preprints may be appended to the proposal if desired. (4) Rationale and significance. (5) Experimental plan. (i) A description of the investigations and/or experiments proposed and the sequence in which the investigations or experiments are to be performed; (ii) Techniques to be used in carrying out the proposed project, including the feasibility of the techniques; (iii) Results expected; (iv) Means by which experimental data will be analyzed or interpreted; (v) Pitfalls that may be encountered; (vi) Limitations to proposed procedures; and (vii) Tentative schedule for conducting major steps involved in these investigations and/or experiments. In describing the experimental plan, the applicant must explain fully any materials, procedures, situations, or activities that may be hazardous to personnel (whether or not they are directly related to a particular phase of the proposed project), along with an outline of precautions to be exercised to avoid or mitigate the effects of such hazards. (6) Facilities and equipment. (7) Collaborative arrangements. i.e. (8) Personnel support. (i) An estimate of the time commitments necessary; (ii) Curriculum vitae. The curriculum vitae should be limited to a presentation of academic and research credentials, e.g., educational, employment and professional history, and honors and awards. Unless pertinent to the project, to personal status, or to the status of the organization, meetings attended, seminars given, or personal data such as birth date, marital status, or community activities should not be included. The vitae shall be no more than two pages each in length, excluding the publication lists. The Department reserves the option of not forwarding for further consideration a proposal in which each vitae exceeds the two-page limit; and (iii) Publication List(s). A chronological list of all publications in referred journals during the past five years, including those in press, must be provided for each professional project member for whom a curriculum vitae is provided. Authors should be listed in the same order as they appear on each paper cited, along with the title and complete reference as these items usually appear in journals. (9) Budget. (10) Research involving special considerations. (i) Recombinant DNA and RNA molecules. (ii) Human subjects at risk. (iii) Experimental vertebrate animal care. et seq. (11) Current and pending support. (12) Additions to project description. (13) Organizational management information. § 3415.5 Evaluation and disposition of applications. (a) Evaluation. ad hoc (b) Disposition. [58 FR 65647, Dec. 15, 1993, as amended at 80 FR 81738, Dec. 31, 2015] § 3415.6 Grant awards. (a) General. (b) Grant award document and notice of grant award Grant award document. (i) Legal name and address of performing organization or institution to whom the Director or Administrator has awarded a grant under the terms of this Part; (ii) Title of project; (iii) Name(s) and address(es) of principal investigator(s) chosen to direct and control approved activities; (iv) Identifying grant number assigned by the Department; (v) Project period, specifying the amount of time the Department intends to support the project without requiring recompetition for funds; (vi) Total amount of Departmental financial assistance approved by the Director or Administrator during the project period; (vii) Legal authority(ies) under which the grant is awarded; (viii) Approved budget plan for categorizing allocable project funds to accomplish the stated purpose of the grant award; and (ix) Other information or provisions deemed necessary by NIFA or ARS to carry out their respective granting activities or to accomplish the purpose of a particular grant. (2) Notice of grant award. (c) Types of grant instruments. (1) New grant. (2) Renewal grant. de novo (3) Supplemental grant. (d) Funding mechanisms. (1) Standard grant. (2) Continuation grant. (e) Obligation of the Federal Government. [58 FR 65647, Dec. 15, 1993, as amended at 79 FR 76000, Dec. 19, 2014] § 3415.7 Use of funds; changes. (a) Delegation of fiscal responsibility. (b) Change in project plans. (2) Changes in approved goals, or objectives, shall be requested by the grantee and approved in writing by the awarding official of NIFA or ARS, as appropriate, prior to effecting such changes. Normally, no requests for such changes that are outside the scope of the original approved project will be approved. (3) Changes in approved project leadership or the replacement or reassignment of other key project personnel shall be requested by the grantee and approved in writing by the awarding official of NIFA or ARS, as appropriate, prior to effecting such changes. (4) Transfers of actual performance of the substantive programmatic work in whole or in part and provisions for payment of funds, whether or not Federal funds are involved, shall be requested by the grantee and approved in writing by the awarding official of NIFA or ARS, as appropriate, prior to effecting such changes, unless prescribed otherwise in the terms and conditions of a grant. (c) Changes in project period. (d) Changes in approved budget. § 3415.8 Other Federal statutes and regulations that apply. (a) The Office of Management and Budget (“OMB”) issued guidance on Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards at 2 CFR part 200 on December 26, 2013. In 2 CFR 400.1, the Department adopted OMB's guidance in subparts A through F of 2 CFR part 200, as supplemented by 2 CFR part 400, as the Department's policies and procedures for uniform administrative requirements, cost principles, and audit requirements for federal awards. As a result, this regulation contains references to 2 CFR part 200 as it has regulatory effect for the Department's programs and activities.” (b) Several other Federal statutes and/or regulations apply to grant proposals considered for review or to research project grants awarded under this part. These include but are not limited to: 2 CFR part 200—Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. 2 CFR part 180 and Part 417—OMB Guidelines to Agencies on Government-Wide Debarment And Suspension (Nonprocurement) and USDA Nonprocurement Debarment And Suspension 7 CFR part 1c—USDA Implementation of the Federal Policy for the Protection of Human Subjects. 7 CFR 1.1—USDA Implementation of Freedom of Information Act. 7 CFR part 3—USDA Implementation of OMB Circular A-129 Regarding Debt Collection. 7 CFR part 15, subpart A—USDA Implementation of Title VI of the Civil Rights Act of 1964. 7 CFR part 3407—NIFA Procedures To Implement the National Environmental Policy Act; 29 U.S.C. 794 (section 504, Rehabilitation Act of 1973) and 7 CFR part 15B (USDA implementation of statute)—prohibiting discrimination based upon physical or mental handicap in Federally assisted programs; and 35 U.S.C. 200 et seq. [79 FR 76000, Dec. 19, 2014] § 3415.9 Other conditions. The Director or Administrator may elect to use a portion of available funding each fiscal year to support an Annual Conference, the purpose of which will be to bring together scientists and regulatory officials relevant to this program. At the Annual Conference, the participants may offer individual opinions regarding research needs, update information and discuss progress, or may offer individual opinions on areas of risk assessment research appropriate to agricultural biotechnology. The annual program solicitation will indicate whether funds are available to support an Annual Conference and, if so, will include instructions on the preparation and submission of proposals requesting funds from the Department for support of an Annual Conference. The Department may also elect to require principal investigators whose research is funded under this program to attend an Annual Conference and to present data on the results of their research efforts. Should attendance at an Annual Conference be required, the annual program solicitation will so indicate, and principal investigators may include attendance costs in their proposed budgets. The Director or Administrator may, with respect to any grant or to any class of awards, impose additional conditions prior to or at the time of any award when, in the Director's or Administrator's judgment, such conditions are necessary to ensure or protect advancement of the approved project, the interests of the public, or the conservation of grant funds. Subpart B—Scientific Peer Review of Research Grant Applications § 3415.10 Establishment and operation of peer review groups. Subject to § 3415.5, the Director or Administrator shall adopt procedures for the conduct of peer reviews and the formulation of recommendations under § 3415.14. § 3415.11 Composition of peer review groups. (a) Peer review group members and ad hoc (1) The level of formal scientific or technical education by the individual and the extent to which an individual is engaged in relevant research activities; (2) The need to include as peer reviewers experts from various areas of specialization within relevant scientific or technical fields; (3) The need to include as peer reviewers experts from a variety of organizational types (e.g., universities, Federal laboratories, industry, private consultant(s), Federal and State regulatory agencies, environmental organizations) and geographic locations; and (4) The need to maintain a balanced composition of peer review groups related to minority and female representation and an equitable age distribution. (b) [Reserved] § 3415.12 Conflicts of interest. Members of peer review groups covered by this part are subject to relevant provisions contained in title 18 of the United States Code relating to criminal activity, Departmental regulations governing employee responsibilities and conduct (part O of this title), and Executive Order No. 11222, as amended. § 3415.13 Availability of information. Information regarding the peer review process will be made available to the extent permitted under the Freedom of Information Act (5 U.S.C. 552), the Privacy Act (5 U.S.C. 552a.), and implementing Departmental regulations (part 1 of this title). § 3415.14 Proposal review. (a) All grant applications will be acknowledged. Prior to technical examination, a preliminary review will be made for responsiveness to the program solicitation (e.g., relationship of application to announced program area). Proposals that do not fall within the guidelines as stated in the program solicitation will be eliminated from competition and will be returned to the applicant. (b) All applications will be carefully reviewed by the Director or Administrator, qualified officers or employees of the Department, the respective peer review group, and ad hoc ad hoc (c) No awarding official will make a grant based upon an application covered by this part unless the application has been reviewed in accordance with the provisions of this part and unless said reviewers have made recommendations concerning the scientific merit and relevance to the program of such application. (d) Except to the extent otherwise provided by law, such recommendations are advisory only and are not binding on program officers or on the awarding officials of NIFA and ARS. § 3415.15 Evaluation factors. In carrying out its review under § 3415.14, the peer review group will take into account the following factors unless, pursuant to § 3415.5(a), different evaluation criteria are specified in the annual program solicitation: (a) Scientific merit of the proposal. (1) Conceptual adequacy of hypothesis; (2) Clarity and delineation of objectives; (3) Adequacy of the description of the undertaking and suitability and feasibility of methodology; (4) Demonstration of feasibility through preliminary data; (5) Probability of success of project; (6) Novelty, uniqueness and originality; and (7) Appropriateness to regulation of biotechnology and risk assessment. (b) Qualifications of proposed project personnel and adequacy of facilities. (1) Training and demonstrated awareness of previous and alternative approaches to the problem identified in the proposal, and performance record and/or potential for future accomplishments; (2) Time allocated for systematic attainment of objectives; (3) Institutional experience and competence in subject area; and (4) Adequacy of available or obtainable support personnel, facilities, and instrumentation. (c) Relevance of project to solving biotechnology regulatory uncertainty for United States agriculture. (1) Scientific contribution of research in leading to important discoveries or significant breakthroughs in announced program areas; and (2) Relevance of the risk assessment research to agriculture and environmental regulations.