General

Modular applications and awards employ a simplified process for developing and reviewing application budgets, documenting approved budgets, and making post-award budgetary changes.

Applicability

Modular procedures are required to be used for new and competing continuation and revised applications as well as for competing supplements for individual research project grants (R01), small grants (R03), exploratory/development grants (R21), and Academic Research Enhancement Awards (R15) that request up to a total of $250,000 of direct costs per year, regardless of whether the application is an unsolicited investigator-initiated application or is one submitted in response to a PA/RFA. Modular procedures also apply to SBIR and STTR Phase I grants (R43 and R41) that request up to $100,000 (exclusive of fee).

Instructions for specific grant mechanisms other than the R01 and guidelines for IC programs may indicate a particular number or range of modules allowed. In addition, an IC may, at its discretion, specify in an RFA that the modular application requirements apply to applications for amounts in excess of the modular ceiling (currently $250,000).

Modular applications and awards also are subject to other simplified procedures, specifically just-in-time requirements and SNAP.

Application Requirements

Except as indicated in this subsection, the following instructions apply to use of the PHS-398. Instructions for modular submission under the SBIR/STTR programs are included in those solicitations.

Budget

Modular applications request direct cost funding in modules of $25,000, up to a maximum of $250,000, for each year of support. Total costs requested are comprised of modular direct costs plus applicable F&A costs. Standard application budget forms are not used. Instead, total direct costs requested for each year should be presented.

The total direct costs request is accompanied by a narrative for all personnel by position, role, and level of effort. This includes consultants and any "to be appointed" positions. No individual salary information should be provided. Since the modules should be a reasonable estimate of allowable, allocable, and reasonable costs for the proposed project, applicants must use the current salary cap when determining the number of modules (see "Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Salaries and Wages"). Given the ability to rebudget and to carry forward unobligated balances, funds generally should be available to cover any modest increase in the statutorily imposed salary cap.

As appropriate, the narrative also must address consortium/contractual costs (including applicable F&A costs) rounded to the nearest $1,000. The narrative should list the individuals/organizations with whom consortium or contractual arrangements have been (or will be) made, the percent of effort of key personnel and their role on the project, and indicate whether the collaborating organization is foreign or domestic. If a contract/consortium arrangement is proposed, a letter of commitment or intent should be included. Sample modular application budget pages are available at http://grants.nih.gov/grants/funding/modular/modular.htm.

A typical modular application will request the same number of modules for each year; however, well-justified modular increments (up to the specified modular ceiling) or decrements in the total direct costs for any year of the project that reflect substantial changes in expected future activities may be requested at the outset. For example, purchase of major equipment in the first year may justify a higher overall budget in that year, but not necessarily in succeeding years. There is no provision for escalation in future years. NIH requires additional narrative budget justification if there is a variation in the number of modules requested from year to year.

Biographical Sketch

The "Other Support" pages of the PHS-398 are not submitted with the application. Information on other research activities of the PI and key personnel will be provided as part of the "Biographical Sketch." This information must include the specific aims of ongoing research projects or research projects completed during the previous 3 years. A biographical sketch is required for the PI and for all key personnel. The Biographical Sketch is limited to three pages per person. A sample biographical sketch is available at http://grants.nih.gov/grants/funding/modular/modular.htm

Checklist

The application checklist must be completed and submitted with the application. The checklist should include F&A costs calculated at the current negotiated rate, less exclusions, for the initial budget period and all future budget periods covered by the application.

Non-compliant Applications

The modular application instructions require limited budgetary information. Therefore, applications not complying with those instructions will not be accepted for review and will be returned to the applicant by CSR as non-compliant applications.

An application will be considered non-compliant if one or more of the following occurs:

• The requested direct cost budget is not in modules of $25,000 for all years of support for requests up to $250,000 (total direct costs) per year.
• A detailed itemized categorical budget is provided.
• The budget narrative justification includes an itemized justification for one or more of the following: equipment, travel, supplies, other expenses, etc., but the number of modules requested for each year is the same, or the information is not intended to explain the request for a different number of modules for one or more years.

A returned application, if revised and resubmitted to NIH in a timely manner, may remain in the review cycle for which it was originally submitted.

Evaluation and Award

Scientific Review Groups (SRGs) evaluate the budget on the basis of a general, expert estimate of the total effort and resources required to carry out the proposed research. If the SRG recommends an adjustment in the project budget, the recommended adjustment will be in terms of an entire module.

The "Biographical Sketch" information will be used by the SRG in assessing each key individual's qualifications for a specific role in the proposed project as well as to evaluate the overall qualifications of the research team.

Following peer review, for applications being considered for award, the IC will request from the applicant information about "Other Research Support." Additional budget information will be requested prior to award only under special circumstances.

NIH will attempt to make awards at or close to the level of total direct costs recommended by the SRG, taking other support into account. In unusual situations, an IC may have to reduce the funding amount to accommodate the IC's cost management plan.

The award budget will be a non-categorical budget specifying approved total direct costs and F&A costs, if applicable.

Post-Award Administration

In accordance with the applicable cost principles and other cost policies included in Subpart A of this part, grantees are required to allocate and account for costs related to their awards by category within their organizational accounting system.

As indicated in this section, modular awards are subject to SNAP.

Grantees may request administrative supplements as under non-modular awards.

NIH supports scientific meetings, conferences, and workshops (hereafter "conferences") that are relevant to its scientific mission and to public health under the R13 and U13 activity codes. NIH's support of conferences is contingent on the interests and priorities of the individual ICs. Some ICs do not provide conference support. For those that do, the preaward process and budget guidelines may vary. For example, some ICs require submission of a letter of intent prior to submission of the application. Therefore, potential applicants are encouraged to contact the funding IC for specific information as well as to ensure compliance with presubmission requirements. All applications for conference support must be submitted at least 6 months prior to the scheduled start of the conference. Further, awards must be issued prior to the start date of the conference.

Applicability

This section applies to domestic and international conferences. Some of these policies differ from the coverage in Subpart A, while others are in addition to that coverage. The following subsections indicate how they relate to Subpart A. If an area is not addressed in this section, the Subpart A coverage applies, e.g., program income.

Questions concerning the allowability of conference activity under research grants should be directed to the designated GMO.

Definitions

Scientific Meeting (Conference): A gathering, symposium, seminar, workshop, or any other organized, formal event where persons assemble to coordinate, exchange and disseminate information or to explore or clarify a defined subject, problem, or area of knowledge.

International Conference: A scientific meeting so designated by its sponsor or one to which open invitations are issued on an equal basis to potential participants in two or more countries other than the U.S. or Canada. The meeting may be held in any country, including the U.S.

Domestic Conference: A scientific meeting held in the U.S. or Canada primarily for U.S. or U.S.-Canadian participation (even if foreign speakers are invited).

Eligibility

Any domestic organization eligible to receive grants from NIH, including a scientific or professional society, is eligible for a conference grant. Both domestic and international conferences may be supported; however, an international conference can be supported only through the U.S. representative organization of an established international scientific or professional society. In exceptional cases, when there is no U.S. representative organization, a grant to support a specific aspect of an international conference may be awarded directly to a foreign institution or international organization. An individual is not eligible to receive a grant in support of a conference.

Application

The PHS-398 is to be completed by an organization seeking NIH conference support. Supplemental instructions are available in the NIH Guide for Grants and Contracts notice on support of scientific meetings (Vol. 26, No. 15, May 9, 1997) at http://www.nih.gov/grants/guide.

Public Policy Requirements and Objectives

In addition to any applicable public policy requirements and objectives specified in Subpart A, conference grant applicants must comply with the "Guidelines on the Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Sponsored and/or-Supported Intramural and Extramural Meetings and Conferences" (available through the NIH/OER Home Page at http://www.nih.gov/grants/oer.htm. Appropriate representation of women, individuals who are members of racial/ethnic minority groups, persons with disabilities, and other individuals who have been traditionally underrepresented in science must be included in all aspects of planning, organization, and implementation of NIH-sponsored or -supported meetings. "Appropriate representation" is that based on the availability of scientists from these groups known to be working in a particular field of biomedical or behavioral research. If appropriate representation is not apparent, NIH will not make an award until the applicant has submitted acceptable documentation regarding its compliance.

Review

Applications for conference grants will be reviewed for programmatic relevance and for merit using the following criteria:

• The need for, and timeliness of, the conference;
• Its format and agenda;
• Qualifications of the organizers and proposed participants;
• Past performance, where applicable;
• Appropriateness of the meeting site;
• Plans for the appropriate involvement of women, individuals who are members of racial/ethnic minority groups, and persons with disabilities, in the planning, organization, and implementation of the proposed conference (see "Public Policy Requirements and Objectives" in this section); and
• Appropriateness of the proposed budget, in accordance with IC guidelines.

Depending on IC policy, applications for conference grants also may be reviewed by the IC's National Advisory Council or Board.

Funding

Grants or cooperative agreements may be used to provide conference support. A cooperative agreement may be awarded if the IC determines that it needs to have substantial involvement in the planning and conduct of a conference. Awards in support of a single conference will be made for a project period commensurate with the time involved in planning and conducting the conference and post-conference follow-up, usually 1 year. A conference grant made to a permanently sponsoring organization for conferences held annually or biennially on a recurring topic may be awarded for up to 5 years in total and will be funded annually. Continued funding beyond the first year will be contingent on a report of satisfactory progress submitted as part of a streamlined noncompeting award process. A shift in conference focus after the first year requires IC prior approval.

Allowability of Costs/Activities

The following specifies the types of costs that are generally allowable under conference grants. Although some of these reiterate coverage in Subpart A, no costs other than those specified in this subsection are allowable under conference grants. The following also highlights certain unallowable costs.

General Support: Grant funds may not be used to provide general support for international conferences held in the U.S. or Canada. In those cases, grant funds may be awarded to support only specific aspects of a conference. An example would be a selected symposium, panel, or workshop, including the costs of planning and travel of U.S. participants.

Alterations and Renovations: Grant funds may not be used to support A&R of any kind.

Conference Services: Grant funds may be used for necessary recording of proceedings, simultaneous translation, etc., and subsequent transcriptions.

Consultant Services: Grant funds may be used to pay consultant fees, including travel and supporting costs (per diem or, where applicable, subsistence).

Entertainment and Personal Expenses: Costs of amusement, diversion, social activities, ceremonials, and related incidental costs, such as bar charges, tips, personal telephone calls, and laundry charges of participants or guests, are unallowable. (Also see "Meals" in this subsection.)

Equipment: Grant funds may be used for the rental of necessary equipment but may not be used for the purchase of equipment.

Facilities and Administrative Costs: F&A costs will not be allowed on grants in support of conferences.

Federal Employees: See "Grants to Federal Institutions and Payments to (or on Behalf of) Federal Employees under Grants."

Honoraria: Honoraria or other payments given for the purpose of conferring distinction or to symbolize respect, esteem, or admiration may not be paid from grant funds. However, speakers' fees for services rendered are allowable.

Meals: When certain meals are an integral and necessary part of a conference (i.e., a working meal where business is transacted), grant funds may be used for such meals, as qualified under "Travel" in this subsection.

Membership Dues: Not allowable.

Publication Costs: When grant funds are awarded to pay for either the entire or partial cost of publication of proceedings or a book or pamphlet, these costs are considered to cover special plates, charts, diagrams, printing, distribution, mailing, postage, and general handling, unless otherwise specified at the time the grant is awarded.

Registration Fees: Registration fees, when paid by the grantee to other organizations on behalf of attendees, may be paid from grant funds, provided such fees cover only those allowable costs properly chargeable to the grant.

Research Patient Care: Not allowable.

Salaries: In accordance with the policy of the grantee organization, grant funds may be used for salaries, in whole or in part, of professional personnel, clerical assistants, editorial assistants, and other nonprofessional staff in proportion to the time or effort spent directly related to the conference.

Supplies: Grant funds may be used for the purchase of supplies for the conference, provided the supplies are received and used during the budget period.

Travel: Funds may be used for the travel of staff, speakers, participants, and attendees, if identified in the application and approved at the time of award. Travel expenses for employees of the grantee organization are governed by the grantee's travel policies, consistently applied regardless of the source of funds.

Any U.S. foreign travel restrictions that are in effect at the time of the award will be followed, such as:

• Limitations or restrictions on countries to which travel will be supported.
• Budgetary or other limitations on availability of funds for foreign travel.

Proposed per diem or subsistence allowances must be reasonable and limited to the days of attendance at the conference plus the actual travel time to reach the conference location by the most direct route. Where meals and/or lodgings are furnished without charge or at a nominal cost (e.g., as part of the registration fee), the proposed per diem or subsistence allowance must take this into consideration.

Transportation costs for attendees and participants at the conference may not exceed coach class fares. In all cases, U.S. flag carriers will be used where possible (see "Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Travel").

With the exception of local mileage, grant funds may not be used to pay per diem or expenses for local participants in the conference.

Costs associated with obtaining visas and passports are not allowable charges to the grant.

Administrative Requirements

If the grantee organization wishes to publish material developed in whole or in part with NIH funds, the material may be distributed free of charge. If the grantee organization charges for the material, the sales proceeds are considered program income, and must be accounted for as specified in the NGA and reported on the Financial Status Report (see "Reporting and Record Retention" in this subsection).

Unless otherwise provided in the terms and conditions of the award, the grantee is free to arrange for copyright of any publication resulting from an NIH-supported conference. However, any such copyrighted publication shall be subject to a nonexclusive, irrevocable, royalty-free license to the Government to reproduce, translate, publish, and dispose of the material and to authorize others to use the work for Government purposes. Copyright does not extend to any materials prepared by Federal employees as part of their official duties.

Reporting and Record Retention

Grantees are responsible for submitting the following reports to the IC upon completion or termination of a grant in support of a conference:

Progress/Final Report

For single conferences, a final report of the conference must be submitted to the awarding IC within 90 days after the end of the project period (competitive segment). The report should include the following:

• Grant number;
• Title, date, and place of the conference;
• Name of the person shown on the application as the conference director, principal investigator, or program director;
• Name of the organization that conducted the conference;
• A list of the individuals, and their institutional affiliations, who participated as speakers or discussants in the formally planned sessions of the meeting; and
• A summary of topics discussed/conclusions.

Under multiple-year awards, i.e., ones that support more than one conference, NIH requires an annual progress report that contains a description of specific plans for the next award period, in similar detail and format as a single conference. The annual progress report must be at least 6 months before the next scheduled conference. The final progress report should be submitted within 90 days after the end of the project period.

With the approval of the IC, copies of proceedings or publications resulting from the conference(s) may be substituted for the final report, provided that they contain the information specified for inclusion in the final report.

Expenditure Report

A Financial Status Report is required from the grantee within 90 days after the end of the project period. Records of expenditures must be maintained in accordance with the provisions of 45 CFR 74.53 or 92.42 (see "Administrative Requirements—Monitoring—Record Retention and Access").

The grantee, as the direct and primary recipient of NIH grant funds, is accountable to NIH for the performance of the project, the appropriate expenditure of grant funds by all parties, and all other obligations of the grantee, as specified in this policy statement. This section includes the requirements for an applicant/grantee under "consortium agreements" in which the grantee collaborates with one or more other organizations in carrying out the grant-supported research. In general, the requirements that apply to the grantee also apply to the consortium participant(s) with the exceptions noted in this section. Recipients of Small Business Technology Transfer (STTR) grants should follow the specific requirements for research collaboration established for that program (see "Grants to For-Profit Organizations").

Under consortium agreements:

• The award will be made to a single grantee with a single PI, even though one or more organizations other than the grantee will carry out portions of the planned programmatic activity.
• The grantee must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties.

Applicants are expected to detail their proposed collaborations as part of the grant application. If the application is approved as submitted, no further approval is required unless, during performance, the grantee plans to undertake additional or alternative collaborations that would constitute a change in the scope of the approved project (see "Administrative Requirements—Changes in Project and Budget").

The following information must be provided to NIH as part of a competing application:

• A list of all proposed performance sites both at the applicant/grantee organization and at the consortium participant(s);
• Complete application budget pages (for the first year and each future year of support requested) for each consortium participant, unless the application is for a modular award (see "Modular Applications and Awards" in this Subpart); and

The signature of the authorized organizational official on the application signifies that the applicant organization and all proposed consortium participants understand and agree with the following statement:

NIH may request additional information prior to award and may place a special condition(s) on the award.

Administrative and Other Requirements

The following highlights several areas within the consortium relationship that the grantee needs to address with the consortium participant to ensure compliance with NIH requirements. The requirement for a written agreement addressing these and other areas is specified in this section.

Public Policy Requirements and Objectives

The grantee is responsible for determining whether a consortium participant has filed assurances with NIH that would cover its activities within the consortium and, if not, for ensuring that any required assurances or certifications are submitted to NIH. See "Public Policy Requirements and Objectives" for the full statement of these requirements and their applicability to consortium participants.

It is the grantee organization's responsibility to ensure that all sites engaged in research involving human subjects have an appropriate OHRP-approved assurance and IRB approval of the research consistent with 45 CFR Part 46, and to comply with NIH prior approval requirements related to the addition of sites not included in the approved application (see "Administrative Requirements—Changes in Project and Budget—Prior Approval Requirements"). The list of organizations with approved assurances is available at the OHRP web site http://www.hhs.gov/ohrp.

Application of Cost Principles

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