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  1. Center for Biologics Evaluation and Research (CBER)

ORISE Frequently Asked Questions

1) What does the acronym ORISE mean?

Oak Ridge Institute for Science and Education (ORISE).

2) What is the ORISE program's purpose?

The program's purpose is to provide practical scientific training experiences for domestic and foreign scientists through temporary contractual fellowship appointments, administered by the Oak Ridge Associated Universities (ORAU).

3) What types of appointments are offered?

University faculty
Summer students
Foreign Nationals

Other applicants, including established research scientists interested in new training activities will be considered on a case-by-case basis.

4) What non-immigrant visa statuses are accepted?

Exchange Visitor J-1
Student F-1
Optional Practical Training (OPT)

5) What is the eligibility requirement for an ORISE fellow?

Postgraduate applicants should have received a college degree within five years of the appointment start date or expect to complete all requirements for such a degree prior to the appointment start date. Student applicants must provide proof of current enrollment in an accredited school or university.

6) How long is the ORISE appointment period?

ORISE appointments are limited to a total of five years, inclusive of all ORISE appointments. Qualified exceptions to this limit will be evaluated on a case-by-case basis, but may not exceed a maximum of seven years. All ORISE appointments are temporary.

7) What types of training can an ORISE fellow attend?

Regulations in the Government Training Handbook states that "contractors may be trained in rules, practices, procedures and/or systems that are unique to the employing agency and essential to the performance of the contractor's assigned duties, such as agency computer security procedures." Therefore training must be appropriate to the ORISE fellow's assigned duties. Eligibility of ORISE to participate in CBER supported training is left to the discretion of the Office/Division.

If appropriate to the ORISE fellows assigned duties, the fellow may attend local training (within 50 miles of the fellow's duty station), i.e., Washington, DC or Baltimore, MD (e.g., Fundamental English, offered through Foundation for Advanced Education in the Sciences (FAES)).

If appropriate to the ORISE fellows assigned duties, the fellow may attend centrally funded training (paid by CBER), e.g., CBER Office (OVRR, OCTGT, OBRR, etc.) Seminar Series. Note: To participate in the CBER New Reviewer Training Course or the Medical Device Reviewer Training (non-public/confidential information not discussed) an ORISE fellow must bring an unsigned copy of the "Commitment to Protect Non-Public Information Agreement (FDA form 3398)" to the training, and the OCOD representative overseeing the training must witness the ORISE fellow signing the form prior to the start of the course. Failure to do so may prevent the ORISE fellow from participating in future training opportunities of this nature. Preference is given to CBER full time employees for centrally funded CBER training; however in the case that slots are available ORISE fellows are encouraged to register.

ORISE fellows may not attend any training activities where non-public/confidential information is discussed (e.g., CBER Clinical Oversight meeting).

Please note: It is the ORISE fellow's responsibility to ensure that supervisory approval has been granted PRIOR to registering or attending any training. See Office/Division administrative staff to obtain the FDA form 3398.

8) Can an ORISE fellow travel to scientific meetings for training purposes?

Yes. ORISE fellows may attend up to 1 domestic and 1 foreign scientific meeting per year as part of the training experience, pending supervisory and administrative approval, in addition to the completion of the appropriate paperwork. Domestic travel requests must be submitted to the sponsoring Office at least 45 days prior to the anticipated start date of the meeting. Foreign travel requests must be submitted to the sponsoring Office at least 60 days prior to the anticipated start date of the meeting. Decisions to send fellows to scientific meetings beyond this limit should be balanced with time, available resources, and adequate data to present, as well as pre-approval by the appropriate supervisory and administrative staff. See Office/Division administrative staff for appropriate forms (Travel Authorization Request — TAR) and approval process.

9) If an ORISE fellow is approved to travel to a meeting, can the registration and airfare be pre-paid before the actual meeting?

Yes. ORISE fellows can request on the TAR that ORISE purchase airfare and pay for the registration fee, in advance of the actual meeting. (See Office/Division administrative staff for TAR form)

Yes. When a Travel Authorization Request (TAR) for an ORISE fellow is submitted prior to the travel, the fellow can request that ORISE pays for the airfare and registration fee in advance. To prompt airfare payment in advance, indicate "YES" on the "Airfare to be Reserved by ORAU/ORISE" line of the TAR. To prompt registration fee payment in advance, indicate "YES" on the "Registration Fee Prepaid by ORAU/ORISE" line on the TAR. A Travel/cash advance may also be requested on the TAR for the entire Meals and Incidental Expenses (M&IE). An example of "IE" would be a tip for the waiter or the taxi driver. ORISE does not pay the hotel cost upfront.

The following is a brief description of how to request and calculate the Travel/cash advance:

Depending on your Office/Division's procedure for completing the TAR, you or your administrative staff can request advance for the entire M&IE by indicating "YES" on the "Travel Advance (per diem only)" line on the TAR. This will prompt the cash advance. You can determine the amount for the cash advance based on your total M&IE. Please be reminded that the ORISE Program follows the M&IE structure set by the General Services Administration (GSA). You can find the M&IE for your destination on this site: http://www.gsa.gov/portal/category/21287 The first and last calendar day of travel is calculated at 75% of the M&IE.

For example, if your travel is from May 2-4, 2012 and the Per Diem for your destination is $71, your M&IE will be as follows:

May 2-75% of M&IE of $71 = $53.25
May 3-100% of M&IE = $71
May 4-75% of M&IE of $71 = $53.25

Total M&IE Travel/cash advance for this trip is $177.50.

Note: The Travel/cash advance will be directly deposited into your account approximately 10 business days prior to your departure. If you receive a cash advance and your trip is cancelled or the cost is less than estimated you will be required to return the advance to ORISE.

(See Office/Division administrative staff for TAR form)

10) Can other expenses incurred while on travel be reimbursed (e.g., ground transportation), once the ORISE fellow returns from the meeting?

Yes. When the fellow returns from his/her trip, the fellow submits a Travel Expense Statement (TES) to be reimbursed for actual costs incurred, such as lodging (hotel expense), as well as other costs (e.g., ground transportation). (See Office/Division administrative staff for TES form)

11) What are the regulations for printing or copying services, including printing a scientific poster?

When an ORISE fellow is in need of printing or copying services that are related to the appointment (e.g., scientific poster for a meeting), an ORISE Printing and Copying Request form must be completed and approved by the appropriate Office/Division staff, and then submitted by Office/Division Administrative staff to the Center ADR Office for approval. Once approved by the Center ADR Office, the form is sent to the Office of Management/Division of Acquisition and Budget Resources (OM/DABR) for budget approval. The OM/DABR contact [Daytona Philpotts 301-796-6488] will send the approved form back to the Office/Administrative staff notifying them that the fellow may contact ORAU to obtain next steps to complete the printing or copying request (contact information found on Printing and Copying Request form)

12) Can an ORISE fellow apply for and/or receive outside funding (i.e., grants, fellowships)?

ORISE fellows may apply for fellowships (e.g. American Heart Association Fellowship) to support their salary and training. However, due to CBER policy and administrative restrictions ORISE fellows may not apply for or receive outside grant funding in their own name.

13) Do ORISE fellows need health/medical insurance coverage during their appointment?

Yes. All ORISE fellows must have, and demonstrate proof of health/medical insurance coverage as one of the conditions of the appointment.

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