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2016 Annual Report on FDA-Held Conferences

2016 Annual Report on FDA-Held Conferences

FDA-Held Conferences With Expenses Totaling Over 100k

Office of Regulatory Affairs (ORA)

The Food and Drug Administration’s (FDA), Office of Regulatory Affairs (ORA) hosted the following:


2016 Regional Milk Seminars

2016 PAR/SWR Milk Seminar
5/2/2016 – 5/6/2016
DoubleTree by Hilton Denver
3203 Quebec St.
Denver, CO 80207

2016 Central Region Milk Seminar
6/13/2016 – 6/16/2016
Best Western Plus Bloomington Hotel by the Mall of America
1901 Killebrew Dr.
Bloomington, MN 55425

How did these 2016 Regional Milk Seminars advance the mission of the agency?

FDA’s Office of Regulatory Affairs Compliance Program: 18003 mandates annual or biennial Regional Milk Seminars to be held for State Milk Officials. In 2016, FDA held their Regional Milk Seminars for the Pacific, Southwest and Central Region's State regulatory and industry officials. Regional seminars provide an opportunity for FDA and the region’s State National Conference on Interstate Milk Shipments (NCIMS) Program Directors, regulatory and rating officials, Significantly Regulated Organizations (SRO), State Laboratory Officers (LEO), and State Standardization Officers (SSO) to participate in meetings that focus on valuable information exchange, public health safety controls, new developments, problem solving, industry code interpretation, FDA policies concerning the Grade A Pasteurized Milk Ordinance and related documents. Additionally, by hosting these seminars FDA ensures that the States remain in adherence with the following NCIMS Procedures:

“… to be re-standardized, a certified SRO/LEO must attend at least one regional milk seminar during the three year period the individual is certified”.

Attendance to the Regional Milk Seminars is critical in fulfilling this standardization requirement for the SRO’s and LEO’s in the Milk Safety Program. If SRO’s and LEO’s do not attend FDA’s Regional Milk Seminars, as required, their certifications will lapse and the State Programs will be in non-conformance with the U.S. Department of Health and Human Services, Public Health Service, Food And Drug Administration and the National Conference on Interstate Milk Shipment’s Policy:

“Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments”
 2016 CENTRAL Region Milk Seminar2016 PAR/SWR Milk Seminar
Total Costs$106,041.82$136,511.00
Total Attendees72114
Total Feds on Travel1517
Total Non-Feds on Travel5797

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2016 ORA Senior Management Team (SMT) Meeting

8/16/2016 – 8/19/2016
Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD, 20878

 

How did the 2016 ORA Senior Management Team (SMT) Meeting Advance the Mission of the Agency?

The 2016 ORA’s Senior Management Team Meeting involved 174 ORA senior managers in active working sessions specifically aimed at developing plans to meet the FDA Commissioner’s Directive of becoming more aligned with agency programs and to enhance collaboration with FDA Center counterparts. The primary meeting focus was to bring ORA senior leadership together to discuss program alignment, transition planning and to ensure appropriate levels of preparation and input on issues that concern ORA as a whole. The upcoming transition discussed will directly impact the staff managers in attendance as well as their employees. It was critical that ORA managers were in attendance and given the opportunity to be present to give advice, input, and to remain involved with the planning of program alignment and necessary steps in the process. ORA senior managers engaged in ‘values setting’ exercises that assisted in establishing a strong foundation of organizational culture with principles based on quality, respect, public health protection, at the same time helping ORA achieve FDA's strategic goal of organizational excellence. Input from ORA's senior managers continues to be critical in ensuring a transparent, open process while charting the course of its future.

Other topics discussed were vital to ORA’s core responsibilities that included inspectional process, compliance workflows, decision making, workforce composition, training, and security. ORA is now at a critical juncture for evaluating current operations, planning for the future, and engaging stakeholders. Program alignment is one of the Commissioner's critical objectives for FDA and will transition ORA into distinct commodity-based, vertically integrated regulatory programs to include pharmaceutical quality, food and feeds, medical devices, radiological health, tobacco, imports and products regulated by FDA.

2016 continues to be a planning year for ORA to develop transition plans for its organization of more than 4,900 employees to be realigned by program, enhance technical specialization in their investigative workforce, and tracking to appropriation lines.

 2016 ORA Senior Management Team (SMT) Meeting
Total Costs$240,478.43
Total Attendees174
Total Feds on Travel118 and 56 local employees
Total Non-Feds on Travel0

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