Division of Pulmonary, Allergy &

Critical Care Medicine

CONTENTS

GRANTS AND CONTRACTS 101: A Reference Guide for Pulmonary Division Researchers

Last updated on November 28, 2006

Dear Pulmonary Division Researchers:

This Grants and Contracts 101 page has been created to supplement and summarize existing Columbia University research resources and information in effort to clarify the grant application and submission process, assist in budget preparation, provide information on funding opportunities, and post announcements and policy changes.

Please contact your grants manager for further assistance with any and all matters related to grants, consortiums, contract negotiations, agreements (i.e. MTA’s) as well as information regarding Columbia University and sponsor agency policy and guidelines.

■ Announcements- “NIH Electronic submissions” and “NIH revised forms”

■ Useful Links

■ Useful Forms

■ Useful CU Contacts (Administrative Officials and Signatories)

■ Types of Grants and Sponsored Projects

■ Grant Preparation and Submission Process

■ Budget Preparation and Excel Budget Template (revised 11/20/06)

■ Funding Opportunities

Useful Links:

Columbia University Links:

§ CU Research Administration – MEDICAL CENTER

§ CUMC Institutional Review Board

§ CUMC IACUC Office

§ CUMC Office of Clinical Trials

§ CU Rascal System

§ CU- InfoEd TRAINING Site

§ USING eSNAP at CU, a tutorial

§ ****CU- Institutional Information for Applications

§ CU- Application Preparation Forms and Tools

§ Research Administration Glossary

§ CU Training (i.e. NIH paylines and NIH scoring system explained)

§ CUBHIS (Columbia University Biomedical and Health Information Services)

§ CU SOFTWARE AVAILABLE (some software available for free download, i.e. ENDNOTE)

§ CU Statistical Consulting Services Available

§ ABOUT CUMC

§ Administrative Policy Library

National Institutes of Health Links:

§ NIH.gov - Office of Extramural Affairs

§ NIH Types of Grant Programs (Mechanisms)

§ NIH Request for Applications (RFA’s)

§ NIH Forms

§ NIH Grant Review Process Video

§ NIH’s Scoring System explained

§ NIH Regional Seminars on Program Funding and Grants Administration

§ National Heart, Lung, and Blood Institute - Model K08 Application

§ National Heart, Lung, and Blood Institute - K23 Model Applications

§ NIH-Grant Writing Tips Sheets

§ NIH Issued Notice of Grant Awards (NGA’s) IPF#1833205

§ NIH Award Data - Trends

§ NIH Extramural Awards By State and Foreign Site

§ NIH eRA Commons

§ NIH PROGRESS REPORT Listed by due date IPF#1833205

Other Links:

§ RAMS- Proposal Central

§ InfoEd– Scheduled to go live Oct 1^st,2006

§ Grants.gov

§ “The elements of Style” by William Strunk, Jr.

§ Computer Retrieval of Information on Scientific Projects

Useful Forms:

Institutional Tobacco Disclosure Statement Appendix (i.e., for FAMRI)

CU Face page w/ institutional signature required (use this when none are provided by the agency)

Many more...Forms

ANNOUNCEMENTS:

This just in....

via the AAMC:

"The Washington Post reported on Wednesday that Northrup Grumman has lost the contract to develop and manage grants.gov, the government-wide grant application IT platform. The contract has been awarded to General Dynamic Information Technology, which "will create a new system by March 31..." The contract changes hands on November 1. The Post article notes that the change puts into question the ability of the system to correct a major impediment - its inability to seamlessly manage Mac-generated applications. The change is also calling into question NIH's February 1, 2007 deadline for the electronic submission of all R01 applications. The article reports the NIH is considering whether to push back the deadline."

<http://tinyurl.com/jx2ku>

NIH ELECTRONIC SUBMISSIONS:

For details on how to apply electronically, refer to http://era.nih.gov/ElectronicReceipt/process.htm

A word on the NIH’s current transition from Paper to On-line submissions. The NIH is gradually requiring certain grant types at a time to be submitted electronically through grants.gov. As per the Electronic Submission Timeline (NIH’s planned timeline for transitioning all competing grant programs/mechanisms by September 2007), R03’s and R21’s for example are currently ONLY ACCEPTED ELECTRONICALLY. R01’s are slated to go electronically by Feb. 2007. And K awards will be submitted electronically by June 2007. These dates may change as technical adjustments are made but we should be prepared.

Grants.gov submissions require the download of the PURE EDGE software (not yet available for MAC’s). This software allows you to create a file that is saved off-line (on your hard-drive) to which you would upload pieces of your application and complete form questions as directed. This file would be submitted via e-mail attachment to your project officer for approval and final submission. Always “validate” any electronic proposal whenever possible before submitting.

ALTERNATIVELY, the university is planning to establish the InfoEd system, slated to go live by 2006! This program, once in place, will become our university wide, Research Administration System and will not only replace the grants and contracts module of Rascal, but will also help us put together all grants (both Private and Government), help us create a budget, and will submit NIH grants to grants.gov for us. If you wish to preview a beta copy of the system to get your feet wet, goto: CU- InfoEd TRAINING Site. PLEASE KEEP IN MIND THIS IS A BETA VERSION. For those of you familiar with the Rams proposal central system for non-gov applications, it is very similar.

NIH NEW Forms:

For those NIH grant types/mechanisms still being accepted as PAPER SUBMISSIONS, I have gathered the required forms for you here below (rev 04/06):

PHS398 INSTRUCTIONS

PHS 398 combined forms.doc

PHS 398 Face and Budget Pages (with automatic calculations embedded)

PHS 398 Bio sketch.doc

PHS 398 Continuation form.doc (for scientific section)

For JIT requests: PHS 398 Other Support.doc

For Progress Reports via mail: PHS 2590 Instructions; PHS2590 combined forms.doc

For Progress Reports via eRA common, use a continuation form for the Science. ALL other necessary information is entered directly on the on-line forms. See also USING eSNAP at CU, a tutorial.

For those of you pro’s familiar with the previous NIH application forms, I’ve summarized here the major changes to be aware of that you will find on the new PHS 398 forms effective May 1^st 2006. Notable changes include:

1. Ability to identify multiple PI’s

2. the change from % effort to months (conversion calculator)

3. some changes in terminology:

“Competing Continuation” is now termed “Renewal”

“Revision” or “Amendment” is now termed “Resubmission”

“Competing Supplement” is now termed “Revision”

4. and the addition of section G. which is now called “Select Agent Research”. Here is the list of Select Agents and Toxins. You would simply identify and detail your uses of any of these agents as per page 39 & 40 of the instructions (also below), otherwise, simply write:

G. Select Agent Research: N/A

[item X] currently excluded as per HHS 42 CFR 73.4(f)(5)

application pending for exclusion of [item X] from HHS 42 CFR 73.4(f)(5).

G. Select Agent Research

Select Agents are hazardous biological agents and toxins that have been identified by HHS or USDA as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. CDC maintains a list of these agents. See http://www.cdc.gov/od/sap/docs/salist/pdf.

Create a section heading entitled “Select Agent Research” and place it immediately following the Vertebrate Animal section (Section F) of the application.

If the activities proposed in your application involve only the use of a strain(s) of Select Agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.4(f)(5), the Select Agent requirements do not apply. Use Section G to identify the strain(s) of the Select Agent that will be used and note that it has been excluded from this list. The CDC maintains a list of exclusions at http://www.cdc.gov/od/sap/sap/exclusion.htm.

If the strain(s) is not currently excluded from the list of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from the list, use Section G to indicate the status of your request or your intent to apply for an exclusion and provide a brief justification for the exclusion.

If any of the activities proposed in your application involve the use of Select Agents at any time during the proposed project period, either at the applicant organization or at any other performance site, address the following three points for each site at which Select Agent research will take place. Although no specific page limitation applies to this section, be succinct.

1. Identify the Select Agent(s) to be used in the proposed research.

2. Provide the registration status of all entities* where Select Agent(s) will be used.

· If the performance site(s) is a foreign institution, provide the name(s) of the country or countries where Select Agent research will be performed.

*An “entity” is defined in 42 CFR 73.1 as “any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.”

3. Provide a description of all facilities where the Select Agent(s) will be used.

· Describe the procedures that will be used to monitor possession, use and transfer of Select Agent(s).

· Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

If you are responding to a specific funding opportunity announcement (e.g., PA or RFA), address any requirements specified by the solicitation.

Reviewers will assess the information provided in this Section, and any questions associated with Select Agent research will need to be addressed prior to award.

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Types of Sponsored Projects:

I. GRANTS

a. Research

b. Training

1. Individual Fellowships,

2. Training Grants,

3. Career Development Awards

c. Service

d. Other

II. CONTRACTS AND AGREEMENTS

(i.e. MTA’s)

III. RESEARCH SUBCONTRACTS/ CONSORTIUM AGREEMENTS

Terms between PI and 2^nd cooperating institution.

IV. SERVICE CONTRACTS

V. COOPERATIVE AGREEMENTS

(i.e. Multi-center, Clinical Trials funded by Federal Government only.)

To determine if a sponsored project is a clinical trial, refer to the definition of a clinical trial.

Types of Grant Applications:

I. NEW APPLICATIONS PA’s compete with general pool of applicants w/special consideration.

a. Grant or Cooperative Agreement

b. Response to Special Announcement: RFA-grants (Request for Application) or PA (ongoing Program Announcement)

c. Unsolicited Contract

d. Response to Special Announcement: RFP-contracts (Request for Proposal)

II. COMPETING CONTINUATION (RENEWAL)

Application to obtain funds to continue a project beyond the currently funded project period. Competes with general pool of applicants.

III. RESUBMISSION/AMMENDED APPLICATIONS

Modified resubmissions for previously denied Grants or Renewals. For Renewal resubmissions, a request can be made for no-cost extensions or funded extensions to allow PI time to resubmit Renewal.

IV. NON-COMPETING CONTINUATION

Funding agency is committed or “obligated” to support the project for several years but awarded its funds on a yearly basis through a non-competing continuation application or renewal.

V. SUPPLEMENTAL APPLICATIONS

Request for an increase in support for the expansion of a project or meet unforeseen costs.

VI. EXTENSION/NO FUND EXTENSIONS

Request to fund the research for an additional period. Under the Federal Demonstration Project, a one-time no-fund extension up to 12 months can be approved by the Office of Grants and Contracts without approval of the funding agency—only for Federal Grants.

VII. TRANSFER of Sponsored Project to the HEALTH SCIENCES

Allows a new PI to bring their on-going sponsored projects to the institution. Requires relinquishment form or letter from the original awarded institution and acceptance of the grant from Columbia University.

--Excerpts from CU Grants and Contracts Manual of Policy and Procedures, 1998

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Useful CU Contacts:

1. General Research Grants (non-clinical trials)

Signing Official

Cheryl Mapou, Senior Project Officer

Office of Research Administration

2. General Research MTA’s, Contracts/Agreements

Reviewer

Victoria Malia, J.D., Assoc Director

Office of Science and Technology Ventures (STV)

Signing Official