OMJSA Educational Grant
Submission Process
Rev. 5/2010
Objectives
 Provide an overview of the OMJSA Medical Education
Department and scientific areas of interest
 Review the required elements for educational grant applications
 Provide an overview of our submission process and required
documents for the following companies:
 Janssen®
McNeil Pediatrics™
Ortho-McNeil®
Ortho-McNeil Neurologics®
PRICARA™
Ortho Women's Health & Urology®
 Eligibility Requirements
 Requirements and New Updates
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Our Mission
To support educational programs with qualified organizations,
that:
 are clinically relevant
 within scientific and medical areas of interest
 meet the needs of our customers
 comply with industry standards, regulatory and corporate
guidelines
 improve patient care and outcomes
To recognize the need for education at all levels, including
national, regional and local activities.
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Scientific Areas of Interest
 Janssen – www.janssen.com
 Schizophrenia
 Schizoaffective Disorder
 Bipolar Disorder
 McNeil Pediatrics – www.mcneilpediatrics.net
 ADHD
 Ortho-McNeil Neurologics – www.ortho-mcneilneurologics.com
 Epilepsy
 Ortho Women’s Health and Urology
www.ortho-mcneilpharmaceutical.com
 Hormonal Contraception
 Interstitial Cystitis
p. 4
Scientific Areas of Interest (Con’t)
 PRICARA – www.pricara.com
 Infectious Diseases
• Multi-drug Resistance Organisms
• Antimicrobial Stewardship
• Antimicrobial Resistance
 Pain
• Acute and Chronic
 Gastroenterology
• Acid Reflux/GERD
 ORTHO-MCNEIL – www.ortho-mcneil.com
 Cardiovascular
• VTE Prevention (Orthopedics)
• Stroke Prevention in Atrial Fibrillation
• Thromboembolic Disease (Other)
p. 5
Scientific Areas of Interest (Con’t)
 ORTHO-MCNEIL – www.ortho-mcneil.com
 Infectious Diseases
• Multi-drug Resistance Organisms
• Antimicrobial Stewardship
• Antimicrobial Resistance
p. 6
Medical Education Scope
Activities we CAN Support
 Certified Continuing Education (CME/CPE/CEU)
 Non-certified educational activities
 Development of materials for patient or provider education
 Fellowships
 Travel Scholarships
Activities we CANNOT Support
 Education outside our therapeutic areas of interest
 Programs that have already occurred
 Promotional activities related to products of Operating
Companies supported by OMJSA
 Charitable contributions (Send Request to: contributions@its.jnj.com)
 Advisory boards
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Things to Consider When Requesting an
Educational Grant
Examples of Line Items We Cannot Support
Normal organizational overhead, e.g., purchase of computer
equipment, staff training
Reimbursement for the cost of obtaining CME credits incurred by
attendees/learners
Funds used to pay for travel, lodging, conference expenses or
honorarium for a customer presenting a poster or paper
Food and beverage expenses at non-accredited programs
(exception for grand rounds “modest” food/beverage)
Applicant’s business expenses
Commercial display fees
Corporate sponsorship/membership fees
p. 8
Required Documents
(see Forms link on company websites)
 Letter of Request (LOR)
 Budget Template
 Agenda
New in 2009
 A signed Eligibility Questionnaire from the
Accredited Provider and Educational Partner (if
applicable)
 A signed Payee’s W-9 Form from the requested
Payee
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Required Document
(see Forms link on company websites)
Eligibility Questionnaire
Required application component for all proposed
educational activities that will have credit/contact hours
 NEW in 2009!
 Effective immediately, this document replaces the CE
Provider Questionnaire and Certification of Separation
templates and is required for CME activities
 Must be completed and signed by the Accredited Provider
and uploaded within the “CE Provider Questionnaire” field
of the application form
 If an Educational Partner is involved, an Eligibility
Questionnaire must also be completed and signed by this
party and uploaded within the “Educational Partner
Questionnaire” field of the application form
p. 10
Required Document
(see Forms link on company websites)
Eligibility Questionnaire (Con’t)
 Electronic signature is accepted
 Assures OMJSA that accredited provider/educational
sponsor meets the standards set forth by J&J and abides
by acceptable standards (e.g., ACCME, ANCC, ACPE,
FDA, and OIG)
 To be completed by the accredited provider and
educational partner and included as part of the
submission packet.
 If accreditation status is Probationary Status, this will
result in rejection of the grant application.
Note: After January 1, 2010, use of the CE Provider
Questionnaire and Certification of Separation templates
will result in the rejection of the request. – NEW in 2010!
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Required Document - LOR
 Signed Letter of Request (LOR) on Accredited Provider’s /Requesting
Organization’s Letterhead (electronic signatures acceptable)
 LOR Should Include:
• CME/CE Activity – LOR on Accredited Provider’s letterhead
• Name or topic of program/event
• Date of program/event
• Accredited Providers must be Schools of Medicine, Pharmacy, or
Nursing, Hospitals, Medical Societies, Professional
• Accreditation information (if CME activity)
• Program agenda and/or topics
 New in 2009
• Societies, or government agencies
• Criteria for selecting faculty
p. 12
Required Document – LOR (Con’t)
• Funding amount
• Organization’s 9-digit Federal Tax ID number
• Name and address to which the check should be made payable, and mailed
if your request is approved.
 New in 2009:
• Payee must be the accredited provider
• It is preferred that Accredited Providers receive funds from OMJSA.
There may be exceptions to Educational Planners receiving funds from
OMJSA but these exceptions are handled on a case by case basis.
• Exceptions must be addressed in the Accredited Provider’s LOR.
 New in 2010:
• Non-CME/CE Activity – LOR on requestor’s organization’s letterhead.
Discussion of Johnson & Johnson products must be within approved product
labeling and fairly balanced.
• Statement of how disclosure of financial support will be made to program
p. 13
participants (see the Guidelines section for specific language)
Request For Grant Applications – RFGAs
(NEW in 2009)
(see Forms link on company websites)
OMJSA may occasionally issue notifications of funding
availability in the form of RFGAs
RFGAs may be broadly disseminated to potential applicants
and/or posted on the OMJSA Medical Education website
RFGAs do not replace the spontaneous process of grant
submissions (OMJSA has an open submission process)
Questions regarding the RFGA process or regarding specific
RFGAs may be directed to OMJSA-RFGA@its.jnj.com
Organizations may opt-out of receiving RFGAs by following the
link embedded in each RFGA, or by sending an email to
OMJSA-RFGA@its.jnj.com
Note: RFGA responses in review may have a status of
composing as a function of our process
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Totality
Status
/ Customer Status Definitions
Grant Status
Definitions
Status
- Composing
- Withdrawn (RFGAs)
- Review
- Request for More Information
- Declined
- Contracting
- Approved
- Procurement Initiated
- Closed
Applicant Definition
In Process (Processing)
Declined
In Review
Applicant must submit more
information
Not approved/denied
Awaiting signed Educational Grant
Agreement
Approved
Payment being executed or
Pending Reconciliation
Payment mailed and copy of signed
EGA was e-mailed to applicant
p. 15
Grant Submission Process
1 MINIMUM OF 10 WEEKS PRIOR TO PROGRAM
Organization submits complete grant request package on-line through the appropriate operating company website.
A notification will be sent to the primary email address on file upon receipt of the application. OMJSA reserves the
right to deny requests not submitted in this timeframe.
No faxed or mailed requests will be accepted.
2 CHECK GRANT STATUS ON-LINE
Grant status is available on-line. To access the status, you will need to provide the grant identification number and
the email address of the primary contact on file with the grant application.
Go to company website
(Read Guidelines section)
Submit/View Request
Check Grant Status
3 AFTER REVIEW AND APPROVAL
EGA e-mailed to the organization for signature. A written agreement must be executed between OMJSA and the
institution prior to the date of program and disbursement of funds. The agreement must be signed and returned
within 15 days.
Funding in any calendar year does not guarantee funding in subsequent years.
p. 16
Key Information To Consider
Review the “Therapeutic Areas of Interest” page to ensure
funding is available before completing an application
Review the OMJSA Guidelines for areas of interest and
download necessary forms (templates provided)
View Quick Reference Guide and FAQs for assistance
Complete and save attachments before submitting an
application (60 minutes timeout)
Ensure that the Eligibility Questionnaire is signed by the
Accredited Provider and Educational Partner (if applicable)
for CME/CE applications
p. 17
Key Information To Consider (Con’t)
The Requestor Information and Primary Contact
information must both be from the Accredited Provider
Payee will be the Accredited Provider.
Print and save confirmation page. You will need this
information to check the on-line status of your grant.
A grant identification number and primary contact email
address is required to check the submission status
 Grant identification number will facilitate all
communications about your application
p. 18
Key Information To Consider (Con’t)
When OMJSA requests more information
 Needs Assessment - new information should be bolded
and underlined
 Submit additional information within 5-10 business days,
unless otherwise specified
 Indicate Grant Identification # in Subject line of e-mail
 Failure to respond after the above timeline will prompt
system to deny request and a new submission will be
required
For university/teaching institution sponsored activities,
payments can only be directed to the institution or medical
education department, not to a Department
p. 19
Document Submission Consideration
System is compatible with the following document types only:
 Word (.doc)
 Excel (.xls)
 PowerPoint (.ppt)
 PDF (.pdf)
Zip (.zip) files are not accepted
Maximum file size is 20 megabytes
Combine files to condense the number of attachments (e.g.,
use tabs within Excel for multiple budget templates)
Name files appropriately (e.g., LOR, Agenda)
A maximum of 6 documents can only be attached.
p. 20
Disclosure Statement - Required
The recommended language regarding disclosure of
financial support is:
“Supported by an educational grant from (insert company
name), Division of Ortho-McNeil-Janssen Pharmaceuticals,
Inc., administered by Ortho-McNeil Janssen Scientific
Affairs, LLC”.
Company logos will be provided upon request.
p. 21
Budget Adjustment
Applicants may be offered less financial support than
requested
Applicants are required to adjust line items within budget
template to conform to approved grant amount
Revised budget template is to be re-submitted within 10
business days
Request for the signed EGA is contingent upon the receipt
of the adjusted budget
Note: If approved grant amount is same as requested, no
action is needed
p. 22
Reconciliation of Paid Grants
(Effective as of 4Q08)
Applicants are required to reconcile post activity using the
approved budget template that was submitted with the
application (refer to information in the “Requested Funding
from OMJSA” column)
Provide activity materials:
Grants >$25,000 (Completion of Verification of Education
Activity form - New in 2010, Summary of Activity Evaluations,
and Activity Outcomes Measurement, if applicable)
Grants <$25,000 (Completion of Verification of Education
Activity form - New in 2010, Final Agenda, and Summary of
Activity Evaluations)
Financial audits will be conducted based upon selection by
OMJSA
p. 23
Reconciliation of Paid Grants (Con’t)
(Effective as of 4Q08)
Unused/excess funds must be returned within six months
following the completion of all activities supported by this
grant
Accounting Purposes – J&J Tax ID #22-2203696
Program Monitoring – OMJSA reserves the right to
monitor supported activities to ensure appropriate
standards are met
Note: Failure to comply with this reconciliation and return of
unused/excess funds requirement, may risk approval
of future requests.
p. 24
Public Posting: Transparency Process
Release Date: October, 2008
Based on Johnson & Johnson’s policies, actual payments
made to grant recipients will be posted for public
transparency on our operating division websites on a
quarterly basis.
Information reported will include:
 Name and location of the payee
 Name and location of the accredited provider, if different
 The dollar amount paid
 Title of activity
 Program start date
p. 25
Contact Information
 Contact Information
 Requests for funding should be submitted to
www.OMJSAMedEd.jnj.com - NEW in 2010!
 Contacts for Further Information
 General Questions for grant submissions:
» Contact OMJSA @ 1-866-447-2687 or forward an e-mail to
EdGrants@ompus.jnj.com
 Technical Assistance:
» If you are experiencing problems with the web page, please email
the System Administrator at Totalitysitemgr@ompus.jnj.com
p. 26