[Code of Federal Regulations]
[Title 7, Volume 15]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 7CFR3415.4]

[Page 405-409]
 
                          TITLE 7--AGRICULTURE
 
  CHAPTER XXXIV--COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION 
                   SERVICE, DEPARTMENT OF AGRICULTURE
 
PART 3415_BIOTECHNOLOGY RISK ASSESSMENT RESEARCH GRANTS PROGRAM
--Table of Contents
 
                            Subpart A_General
 
Sec. 3415.4  How to apply for a grant.

    (a) A program solicitation will be prepared and announced through 
publications such as the Federal Register, professional trade journals, 
agency or program handbooks, the Catalog of Federal Domestic Assistance, 
or any other appropriate means, as early as practicable each fiscal 
year.

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 Sec. 3415.5 through Sec. 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. An Application Kit will be made available to 
any potential grant applicant who requests a copy. This kit contains 
required forms, certifications, and instructions applicable to the 
submission of grant preproposals or proposals.

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    (c) Format for preproposals. As stated above, the Department may 
elect to solicit preproposals under this program. Unless otherwise 
indicated by the Department in the annual program solicitation, the 
following general format applies for the preparation of preproposals:
    (1) ``Application for Funding (Form CSREES-661)''. All preproposals 
submitted by eligible applicants should contain an ``Application for 
Funding'', Form CSREES-661, which must be signed by the proposing 
principal investigator(s) and endorsed by the cognizant authorized 
organizational representative who possesses the necessary authority to 
commit the applicant's time and other relevant resources. The title of 
the proposal must be brief (80-character maximum), yet represent the 
major thrust of the project. Because this title will be used to provide 
information to those who may not be familiar with the proposed project, 
highly technical words or phraseology should be avoided where possible. 
In addition, phrases such as ``investigation of'' and ``research on'' 
should not be used.
    (2) Project summary. Each preproposal must contain a project 
summary, the text of which may not exceed three (3) single- or double-
spaced pages. The Department reserves the option of not forwarding for 
further consideration a preproposal in which the project summary page 
limit is exceeded. The project summary is not intended for the general 
reader; consequently, it may contain technical language comprehensible 
primarily by persons in disciplines relating to the food and 
agricultural sciences. The project summary should be a self-contained 
specific description of the activity to be undertaken and should focus 
on:
    (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. A budget detailing requested support for the proposed 
project period must be included in each preproposal. A copy of the form 
which must be used for this purpose, along with instructions for 
completion, is included in the Application Kit identified under Sec. 
3415.4(b) of this part and may be reproduced as needed by applicants. 
Funds may be requested under any of the categories listed on the budget 
form, provided that the item or service for which support is requested 
may be identified as necessary for successful conduct of the proposed 
project, is allowable under applicable Federal cost principles, and is 
not prohibited under any applicable Federal statute.
    (4) Special requirements. (i) The annual program solicitation will 
describe any special preproposal submission requirements, such as paper 
size or type pitch to be used in the preparation of preproposals. The 
solicitation will also describe special program requirements, such as 
conference attendance or electronic project reporting, for which 
applicants may allocate funds when preparing proposed budgets.
    (ii) By signing the ``Application for Funding'' identified under 
Sec. 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. Preproposals shall be evaluated to 
determine whether the substance of the proposed project is appropriate 
to the objectives of this program as set out in the annual program 
solicitation. Subsequently, the Administrator shall request full 
proposals from those applicants proposing projects deemed appropriate to 
the objectives of this program as set out in the annual program 
solicitation. Such proposals shall conform to the format for full 
proposals set out below and shall be evaluated in accordance with Sec. 
3415.5 through Sec. 3415.15 of this part.
    (d) Format for full proposals. Unless otherwise indicated by the 
Department in the annual program solicitation, the following general 
format applies for the preparation of full proposals under this program:
    (1) ``Application for Funding'' (Form CSREES-661). All full 
proposals submitted by eligible applicants should contain an Application 
for Funding'', Form CSREES-661, which must be

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signed by the proposed principal investigator(s) and endorsed by the 
cognizant authorized organizational representative who possesses the 
necessary authority to commit the applicant's time and other relevant 
resources. Investigators who do not sign the full proposal cover sheet 
will not be listed on the grant document in the event an award is made. 
The title of the proposal must be brief (80-character maximum), yet 
represent The major emphasis of the project. Because this title will be 
used to provide information to those who may not be familiar with the 
proposed project, highly technical words or phraseology should be 
avoided where possible. In addition, phrases such as ``investigation 
of'' or ``research on'' should not be used.
    (2) Project summary. Each full proposal must contain a project 
summary, the length of which may not exceed three (3) single- or double-
spaced pages. This summary is not intended for the general reader; 
consequently, it may contain technical language comprehensible primarily 
by persons in disciplines relating to the food and agricultural 
sciences. The project summary should be a self-contained, specific 
description of the activity to be undertaken and should focus on:
    (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. The specific aims of the project must be 
included in all proposals. The text of the project description may not 
exceed 15 single- or double-spaced pages. The Department reserves the 
option of not forwarding for further consideration proposals in which 
the project description exceeds this page limit. The project description 
must contain the following components:
    (i) Introduction. A clear statement of the long-term goal(s) and 
supporting objectives of the proposed project should preface the project 
description. The most significant published work in the field under 
consideration, including the work of key project personnel on the 
current application, should be reviewed. The current status of research 
in the particular scientific field also should be described. All work 
cited, including that of key personnel, should be referenced.
    (ii) Progress report. If the proposal is a renewal of an existing 
project supported under this program, include a clearly marked 
performance report describing results to date from the previous award. 
This section should contain the following information:
    (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. Present concisely the rationale 
behind the proposed project. The objectives' specific relationship and 
relevance to the area in which an application is submitted and the 
objectives' specific relationship and relevance to potential regulatory 
issues of United States biotechnology research should be shown clearly. 
Any novel ideas or contributions that the proposed project offers also 
should be discussed in this section.
    (5) Experimental plan. The hypotheses or questions being asked and 
the methodology to be applied to the proposed project should be stated 
explicitly. Specifically, this section must include:
    (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

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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. All facilities and major items of 
equipment that are available for use or assignment to the proposed 
research project during the requested period of support should be 
described. In addition, items of nonexpendable equipment necessary to 
conduct and successfully conclude the proposed project should be listed.
    (7) Collaborative arrangements. If the nature of the proposed 
project requires collaboration or subcontractual arrangements with other 
research scientists, corporations, organizations, agencies, or entities, 
the applicant must identify the collaborator(s) and provide a full 
explanation of the nature of the collaboration. Evidence (i.e., letters 
of intent) should be provided to assure peer reviewers that the 
collaborators involved have agreed to render this service. In addition, 
the proposal must indicate whether or not such a collaborative 
arrangement(s) has the potential for conflict(s) of interest.
    (8) Personnel support. To assist peer reviewers in assessing the 
competence and experience of the proposed project staff, key personnel 
who will be involved in the proposed project must be identified clearly. 
For each principal investigator involved, and for all senior associates 
and other professional personnel who expect to work on the project, 
whether or not funds are sought for their support, the following should 
be included:
    (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. A detailed budget is required for each year of requested 
support. In addition, a summary budget is required detailing requested 
support for the overall project period. A copy of the form which must be 
used for this purpose, Form CSREES-55, along with instructions for 
completion, is included in the Application Kit identified under Sec. 
3415.4(b) of this part and may be reproduced as needed by applicants. 
Funds may be requested under any of the categories listed, provided that 
the item or service for which support is requested may be identified as 
necessary for successful conduct of the proposed project, is allowable 
under applicable Federal cost principles, and is not prohibited under 
any applicable Federal statute.
    (10) Research involving special considerations. A number of 
situations encountered in the conduct of research require special 
information and supporting documentation before funding can be approved 
for the project. If any such situation is anticipated, the proposal must 
so indicate. It is expected that a significant number of proposals will 
involve the following:
    (i) Recombinant DNA and RNA molecules. All key personnel identified 
in a proposal and all endorsing officials of a proposed performing 
entity are required to comply with the guidelines established by the 
National Institutes of Health entitled, ``Guidelines for Research 
Involving Recombinant DNA Molecules,'' as revised. The Application Kit, 
identified above in Sec. 3415.4(b), contains a form which is suitable 
for such certification of compliance (Form CSREES-662).
    (ii) Human subjects at risk. Responsibility for safeguarding the 
rights and welfare of human subjects used in any

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proposed project supported with grant funds provided by the Department 
rests with the performing entity. Regulations have been issued by the 
Department under 7 CFR Part 1c, Protection of Human Subjects. In the 
event that a project involving human subjects at risk is recommended for 
award, the applicant will be required to submit a statement certifying 
that the project plan has been reviewed and approved by the 
Institutional Review Board at the proposing organization or institution. 
The Application Kit, identified above in Sec. 3415.4(b), contains a 
form which is suitable for such certification (Form CSREES-662).
    (iii) Experimental vertebrate animal care. The responsibility for 
the humane care and treatment of any experimental vertebrate animal, 
which has the same meaning as ``animal'' in section 2(g) of the Animal 
Welfare Act of 1966, as amended (7 U.S.C. 2132(g)), used in any project 
supported with grant funds rests with the performing organization. In 
this regard, all key personnel associated with any supported project and 
all endorsing officials of the proposed performing entity are required 
to comply with the applicable provisions of the Animal Welfare Act of 
1966, as amended (7 U.S.C. 2131 et seq.) and the regulations promulgated 
thereunder by the Secretary of Agriculture in 9 CFR parts 1, 2, 3, and 
4. The applicant must submit a statement certifying that the proposed 
project is in compliance with the aforementioned regulations, and that 
the proposed project is either under review by or has been reviewed and 
approved by an Institutional Animal Care and Use Committee. The 
Application Kit, identified above in Sec. 3415.4(b), contains a form 
which is suitable for such certification (Form CSREES-662).
    (11) Current and pending support. All proposals must list any other 
current public or private research support (including in-house support) 
to which key personnel identified in the proposal have committed 
portions of their time, whether or not salary support for the person(s) 
involved is included in the budget. Analogous information must be 
provided for any pending proposals that are being considered by, or that 
will be submitted in the near future to, other possible sponsors, 
including other USDA programs or agencies. Concurrent submission of 
identical or similar proposals to other possible sponsors will not 
prejudice proposal review or evaluation by the Administrator or experts 
or consultants engaged by the Administrator for this purpose. However, a 
proposal that duplicates or overlaps substantially with a proposal 
already reviewed and funded (or that will be funded) by another 
organization or agency will not be funded under this program. The 
Application Kit, identified above in Sec. 3415.4(b), contains a form 
which is suitable for listing current and pending support (Form CSREES-
663).
    (12) Additions to project description. Each project description is 
expected by the Administrator, the members of peer review groups, and 
the relevant program staff to be complete while meeting the page limit 
established in Sec. 3415.4(d)(3). However, if the inclusion of 
additional information is necessary to ensure the equitable evaluation 
of the proposal (e.g., photographs that do not reproduce well, reprints, 
and other pertinent materials that are deemed to be unsuitable for 
inclusion in the text of the proposal), the number of copies submitted 
should match the number of copies of the application requested in the 
program solicitation. Each set of such materials must be identified with 
the name of the submitting organization, and the name(s) of the 
principal investigator(s). Information may not be appended to a proposal 
to circumvent page limitations prescribed for the project description. 
Extraneous materials will not be used during the peer review process.
    (13) Organizational management information. Specific management 
information relating to an applicant shall be submitted on a one-time 
basis prior to the award of a grant identified under this Part if such 
information has not been provided previously under this or another 
program for which the sponsoring agency is responsible. The Department 
will contact an applicant to request organizational management 
information once a proposal has been recommended for funding.

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