3400.4—How to apply for a grant.
Code of Federal Regulations
Footnote(s): 6 See footnote 5 in § 340.3 .
(a) Application for permit.
Two copies of a written application for a permit to introduce a regulated article, which may be obtained from APHIS, shall be submitted by the responsible person to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Biotechnology and Scientific Services, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Maryland 20737-1237. If there are portions of the application deemed to contain trade secret or confidential business information (CBI), each page of the application containing such information should be marked “CBI Copy”. In addition, those portions of the application which are deemed “CBI” shall be so designated. The second copy shall have all such CBI deleted and shall be marked on each page of the application where CBI was deleted, “CBI Deleted”. If an application does not contain CBI then the first page of both copies shall be marked “No CBI”.
(b) Permit for release into the environment.
An application for the release into the environment of a regulated article shall be submitted at least 120 days in advance of the proposed release into the environment. An initial review shall be completed by APHIS within 30 days of the receipt of the application. If the application is complete, the responsible individual shall be notified of the date of receipt of the application for purposes of advising the applicant when the 120 day review period commenced. 7 If the application is not complete, the responsible individual will be advised what additional information must be submitted. APHIS shall commence the 120 day review period upon receipt of the additional information, assuming the additional information submitted is adequate. When it is determined that an application is complete, APHIS shall submit to the State department of agriculture of the State where the release is planned, a copy of the initial review and a copy of the application marked, “CBI Deleted”, or “No CBI” for State notification and review. The application shall include the following information: 8
Code of Federal Regulations
Footnote(s): 7 The 120 day review period would be extended if preparation of an environmental impact statement in addition to an environmental assessment was necessary.
Code of Federal Regulations
Footnote(s): 8 Application forms are available without charge from the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Biotechnology and Scientific Services, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Maryland 20737-1237, or from local offices which are listed in telephone directories. A person should specify in requesting the application that the permit is for the introduction of a regulated article subject to regulation under part 340 .
(1)
Name, title, address, telephone number, signature of the responsible person and type of permit requested (for importation, interstate movement, or release into the environment);
(2)
All scientific, common, and trade names, and all designations necessary to identify the: Donor organism(s); recipient organism(s); vector or vector agent(s); constituent of each regulated article which is a product; and, regulated article;
(3)
Names, addresses, and telephone numbers of the persons who developed and/or supplied the regulated article;
(4)
A description of the means of movement (e.g., mail, common carrier, baggage, or handcarried (and by whom));
(5)
A description of the anticipated or actual expression of the altered genetic material in the regulated article and how that expression differs from the expression in the non-modified parental organism (e.g., morphological or structural characteristics, physiological activities and processes, number of copies of inserted genetic material and the physical state of this material inside the recipient organism (integrated or extrachromosomal), products and secretions, growth characteristics);
(6)
A detailed description of the molecular biology of the system (e.g., donor-recipient-vector) which is or will be used to produce the regulated article;
(7)
Country and locality where the donor organism, recipient organism, vector or vector agent, and regulated article were collected, developed, and produced;
(8)
A detailed description of the purpose for the introduction of the regulated article including a detailed description of the proposed experimental and/or production design;
(9)
The quantity of the regulated article to be introduced and proposed schedule and number of introductions;
(10)
A detailed description of the processes, procedures, and safeguards which have been used or will be used in the country of origin and in the United States to prevent contamination, release, and dissemination in the production of the: Donor organism; recipient organism; vector or vector agent; constituent of each regulated article which is a product; and regulated article;
(11)
A detailed description of the intended destination (including final and all intermediate destinations), uses, and/or distribution of the regulated article (e.g., greenhouses, laboratory, or growth chamber location; field trial location; pilot project location; production, propagation, and manufacture location; proposed sale and distribution location);
(12)
A detailed description of the proposed procedures, processes, and safeguards which will be used to prevent escape and dissemination of the regulated article at each of the intended destinations;
(13)
A detailed description of any biological material (e.g., culture medium, or host material) accompanying the regulated article during movement; and
(c) Limited permits for interstate movement or importation of a regulated article.
An application for the interstate movement or importation of a regulated article shall be submitted at least 60 days in advance of the first proposed interstate movement and at least 60 days prior to each importation. An initial review shall be completed by APHIS within 15 days of the receipt of the application. If the application is complete, the responsible person shall be notified of the date of receipt of the application for purposes of advising the applicant when the 60 day review period commenced. If the application is not complete, the responsible person will be advised what additional information must be submitted. APHIS shall commence the 60 day review period upon receipt of the additional information, assuming the additional information submitted is adequate. When it is determined that an application is complete, APHIS shall submit to the State department of agriculture of the State of destination of the regulated article a copy of the initial review and the application marked, “CBI Deleted”, or “No CBI” for State notification and review.
(1) Limited permit for interstate movement.
The responsible person may apply for a single limited permit for the interstate movement of multiple regulated articles in lieu of submitting an application for each individual interstate movement. Each limited permit issued shall be numbered and shall be valid for one year from the date of issuance. If a permit is sought for multiple interstate movements between contained facilities the responsible individual shall specify in the permit application all the regulated articles to be moved interstate; the origins and destinations of all proposed shipments; a detailed description of all the contained facilities where regulated articles will be utilized at destination; and a description of the containers that will be used to transport the regulated articles. A limited permit for interstate movement of a regulated article shall only be valid for the movement of those regulated articles moving between those locations specified in the application. If a person seeks to move regulated articles other than those specified in the application, or to a location other than those listed in the application, a supplemental application shall be submitted to APHIS. No person shall move a regulated article interstate unless the number of the limited permit appears on the outside of the shipping container. The responsible person shipping a regulated article interstate shall keep records for one year demonstrating that the regulated article arrived at its intended destination. The responsible person seeking a limited permit for interstate movement shall submit on an application form obtained from APHIS, the data required by paragraphs (b) (1), (2), (4), (6), (7), (9), and (11) through (14) of this section.
(2) Limited permit for importation.
The responsible person seeking a permit for the importation of a regulated article shall submit an application for a permit prior to the importation of each shipment of regulated articles. The responsible person importing a regulated article shall keep records for one year demonstrating that the regulated article arrived at its intended destination. The responsible person seeking a limited permit for importation shall submit on an application form obtained from APHIS data required by paragraphs (b) (1), (2), (4), (6), (7), (9), and (11) through (14) of this section. 9
Code of Federal Regulations
Footnote(s): 9 Renewals may receive shorter review. In the case of a renewal for a limited permit for importation that has been issued less than one year earlier, APHIS will notify the responsible person within 15 days that either: (1) The renewal permit is approved or (2) that a 60 day review period is necessary because the conditions of the original permit have changed.
(d) Premises inspection.
An inspector may inspect the site or facility where regulated articles are proposed, pursuant to a permit, to be released into the environment or contained after their interstate movement or importation. Failure to allow the inspection of a premises prior to the issuance of a permit or limited permit shall be grounds for the denial of the permit.
(e) Administrative action on applications.
After receipt and review by APHIS of the application and the data submitted pursuant to paragraph (a) of this section, including any additional information requested by APHIS, a permit shall be granted or denied. If a permit is denied, the applicant shall be promptly informed of the reasons why the permit was denied and given the opportunity to appeal the denial in accordance with the provisions of paragraph (g) of this section. If a permit is granted, the permit will specify the applicable conditions for introduction of the regulated article under this part.
(f) Permit conditions.
A person who is issued a permit and his/her employees or agents shall comply with the following conditions, and any supplemental conditions which shall be listed on the permit, as deemed by the Administrator to be necessary to prevent the dissemination and establishment of plant pests:
(1)
The regulated article shall be maintained and disposed of (when necessary) in a manner so as to prevent the dissemination and establishment of plant pests.
(2)
All packing material, shipping containers, and any other material accompanying the regulated article shall be treated or disposed of in such a manner so as to prevent the dissemination and establishment of plant pests.
(3)
The regulated article shall be kept separate from other organisms, except as specifically allowed in the permit;
(5)
An inspector shall be allowed access, during regular business hours, to the place where the regulated article is located and to any records relating to the introduction of a regulated article;
(6)
The regulated article shall, when possible, be kept identified with a label showing the name of the regulated article, and the date of importation;
(7)
The regulated article shall be subject to the application of measures determined by the Administrator to be necessary to prevent the accidental or unauthorized release of the regulated article;
(8)
The regulated article shall be subject to the application of remedial measures (including disposal) determined by the Administrator to be necessary to prevent the spread of plant pests;
(9)
A person who has been issued a permit shall submit to APHIS a field test report within 6 months after the termination of the field test. A field test report shall include the APHIS reference number, methods of observation, resulting data, and analysis regarding all deleterious effects on plants, nontarget organisms, or the environment.
(10)
APHIS shall be notified within the time periods and manner specified below, in the event of the following occurrences:
(i)
Orally notified immediately upon discovery and notify in writing within 24 hours in the event of any accidental or unauthorized release of the regulated article;
(ii)
In writing as soon as possible but not later than within 5 working days if the regulated article or associated host organism is found to have characteristics substantially different from those listed in the application for a permit or suffers any unusual occurrence (excessive mortality or morbidity, or unanticipated effect on non-target organisms);
(11)
A permittee or his/her agent and any person who seeks to import a regulated article into the United States shall:
(i)
Import or offer the regulated article for entry only through any USDA plant inspection station listed in § 319.37-14 of this chapter ;
(ii)
Notify APHIS promptly upon arrival of any regulated article at a port of entry, of its arrival by such means as a manifest, customs entry document, commercial invoice, waybill, a broker's document, or a notice form provided for such purpose; and
(g) Withdrawal or denial of a permit.
Any permit which has been issued may be withdrawn by an inspector or the Administrator if he/she determines that the holder thereof has not complied with one or more of the conditions listed on the permit. APHIS will confirm the reasons for the withdrawal of the permit in writing within ten (10) days. Any person whose permit has been withdrawn or any person who has been denied a permit may appeal the decision in writing to the Administrator within ten (10) days after receiving the written notification of the withdrawal or denial. The appeal shall state all of the facts and reasons upon which the person relies to show that the permit was wrongfully withdrawn or denied. The Administrator shall grant or deny the appeal, in writing, stating the reasons for the decision as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing shall be held to resolve such conflict. Rules of practice concerning such a hearing will be adopted by the Administrator.
(h) Courtesy permit—
(1) Issuance.
The Administrator may issue a courtesy permit for the introduction of organisms modified through genetic engineering which are not subject to regulation under this part to facilitate movement when the movement might otherwise be impeded because of the similarity of the organism to other organisms regulated under this part.
(2) Application.
A person seeking a courtesy permit shall submit on an application form obtained from APHIS data required by paragraphs (b) (1), (2), and (5) of this section and shall indicate such data is being submitted as a request for a courtesy permit. A person should also include a statement explaining why he or she believes the organism or product does not come within the definition of a regulated article. The application shall be submitted at least 60 days prior to the time the courtesy permit is sought.
(3) Administrative action.
APHIS shall complete an initial review within 15 days of the date of receipt of the application. If the application is complete, the responsible individual shall be notified of the date of receipt of the application for purposes of advising the applicant when the 60 day review period commenced. If the application is not complete, the responsible individual will be advised what additional information must be submitted, and shall commence the 60 day review period upon receipt of the additional information, assuming the additional information submitted is adequate. Within 60 days from the date of receipt of a complete application, APHIS will either issue a courtesy permit or advise the responsible individual that a permit is required under paragraph (b) or (c) of this section.
(Approved by the Office of Management and Budget under control number 0579-0216)
Code of Federal Regulations
(a)
A request for proposals 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 of solicitation, as early as practicable each fiscal year. It will contain information sufficient to enable all eligible applicants to prepare special research grant proposals and will be as complete as possible with respect to:
(1)
Descriptions of specific research program areas which the Department proposes to support during the fiscal year involved, including anticipated funds to be awarded;
(b) Grant Application Kit.
A Grant 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 proposals.
(c) Format for research grant proposals.
Unless otherwise stated in the specific program solicitation, the following applies:
(1) Grant Application.
All research grant proposals submitted by eligible applicants should contain a Grant Application form, 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.
(2) Title of Project.
The title of the project must be brief (80-character maximum), yet represent the major thrust of the research. This title will be used to provide information to the Congress and other interested parties who may be unfamiliar with scientific terms; therefore, highly technical words or phraseology should be avoided where possible. In addition, phrases such as “investigation of” or “research on” should not be used.
(3) Objectives.
Clear, concise, complete, enumerated, and logically arranged statement(s) of the specific aims of the research must be included in all proposals.
(4) Procedures.
The procedures or methodology to be applied to the proposed research plan should be explicitly stated. This section should include but not necessarily be limited to:
(i)
A description of the proposed investigations and/or experiments in the sequence in which it is planned to carry them out;
(i)
The importance of the problem to the needs of the Department and to the Nation, including estimates of the magnitude of the problem.
(6) Literature review.
A summary of pertinent publications with emphasis on their relationship to the research should be provided and should include all important and recent publications. The citations should be accurate, complete, written in acceptable journal format, and be appended to the proposal.
(7) Current research.
The relevancy of the proposed research to ongoing and, as yet, unpublished research of both the applicant and any other institutions should be described.
(8) Facilities and equipment.
All facilities, including laboratories, which are available for use or assignment to the proposed research project during the requested period of support, should be reported and described. Any materials, procedures, situations, or activities, whether or not directly related to a particular phase of the proposed research, and which may be hazardous to personnel, must be fully explained, along with an outline of precautions to be exercised. All items of major instrumentation available for use or assignment to the proposed research project during the requested period of support should be itemized. In addition, items of nonexpendable equipment needed to conduct and bring the proposed project to a successful conclusion should be listed.
(9) Collaborative arrangements.
If the proposed project requires collaboration with other research scientists, corporations, organizations, agencies, or entities, such collaboration must be fully explained and justified. Evidence should be provided to assure peer reviewers that the collaborators involved agree with the arrangements. It should be specifically indicated whether or not such collaborative arrangements have the potential for any conflict(s) of interest. Proposals which indicate collaborative involvement must state which proposer is to receive any resulting grant award, since only one eligible applicant, as provided in § 3400.3 of this part, may be the recipient of a research project grant under one proposal.
(10) Research timetable.
The applicant should outline all important research phases as a function of time, year by year.
(11) Personnel support.
All personnel who will be involved in the research effort must be clearly identified. For each scientist involved, the following should be included:
(ii)
Vitae of the principal investigator(s), senior associate(s), and other professional personnel to assist reviewers in evaluating the competence and experience of the project staff. This section should include curricula vitae of all key persons who will work on the proposed research project, whether or not Federal funds are sought for their support. The vitae are to be no more than two pages each in length, excluding publications listings; and
(iii)
A chronological listing of the most representative publications during the past five years shall be provided for each professional project member for whom a curriculum vitae appears under this section. Authors should be listed in the same order as they appear on each paper cited, along with the title and complete reference as these usually appear in journals.
(12) 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, along with instructions for completion, is included in the Grant Application Kit identified under § 3400.4(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 is allowable under applicable Federal cost principles and can be identified as necessary for successful conduct of the proposed research project. No funds will be awarded for the renovation or refurbishment of research spaces; purchases or installation of fixed equipment in such spaces; or for the planning, repair, rehabilitation, acquisition, or construction of a building or facility. All research project grants awarded under this part shall be issued without regard to matching funds or cost sharing.
(13) 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 such situations are anticipated, the proposal must so indicate. It is expected that a significant number of special research grant proposals will involve the following:
(i) Recombinant DNA 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 Grant Application Kit, identified above in § 3400.4(b), contains forms which are suitable for such certification of compliance.
(ii) Human subjects at risk.
Responsibility for safeguarding the rights and welfare of human subjects used in any research 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 research plan has been reviewed and approved by the Institutional Review Board at the proposing organization or institution. The Grant Application Kit, identified above in § 3400.4(b), contains forms which are suitable for such certification.
(iii) Laboratory animal care.
The responsibility for the humane care and treatment of any laboratory 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 research project supported with Special Research Grants Program funds rests with the performing organization. In this regard, all key personnel identified in a proposal and all endorsing officials of the proposed performing entity are required to comply with applicable provisions of the Animal Welfare Act of 1966, as amended (7 U.S.C. 2131
et. seq.) and the regulation promulgated thereunder by the Secretary of Agriculture in 9 CFR parts 1, 2, 3, and 4. In the event that a project involving the use of a laboratory animal is recommended for award, the applicant will be required to submit a statement certifying such compliance. The Grant Application Kit, identified above in § 3400.4(b), contains forms which are suitable of such certification.
(14) Current and pending support.
All proposals must list any other current public or private research support, in addition to the proposed project, to which key personnel listed in the proposal under consideration have committed portions of their time, whether or not salary support for the person(s) involved is included in the budgets of the various projects. This section must also contain analogous information for all projects underway and for pending research proposals which are currently being considered by, or which will be submitted in the near future to, other possible sponsors, including other Departmental programs or agencies. Concurrent submission of identical or similar projects to other possible sponsors will not prejudice its review or evaluation by the Administrator or experts or consultants engaged by the Administrator for this purpose. The Grant Application Kit, identified above in § 3400.4(b), contains a form which is suitable for listing current and pending support.
(15) Additions to project description.
Each project description is expected by the Administrator, members of peer review groups, and the relevant program staff to be complete in itself. However, in those instances in which the inclusion of additional information is necessary, the number of copies submitted should match the number of copies of the application requested in the annual solicitation of proposals as indicated in § 3400.4(a)(4). Each set of such materials must be identified with the title of the research project as it appears in the Grant Application and the name(s) of the principal investigator(s). Examples of additional materials may include photographs which do not reproduce well, reprints, and other pertinent materials which are deemed to be unsuitable for inclusion in the proposal.
(16) Organizational management information.
Specific management information relating to an applicant shall be submitted on a one-time basis prior to the award of a research project 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. Copies of forms recommended for use in fulfilling the requirements contained in this section will be provided by the agency specified in this part once a research project grant has been recommended for funding.