# Presentation: 390326

## ORA Small Business Representative

- David Arvelo
- FDA ORA SWR SBR

**Notes:**
About my position: The Small Business Representative or SBR...

## Mission

- Assist industry and entrepreneurs
- Facilitate access to guidance, policies, regulations and laws enforced by FDA
- Provide technical assistance
- Act as liaison

**Notes:**
The objective of the SBR program is to help industry comply with FDA regulations.
We provide industry with the regulations pertinent to their products and with technical assistance.
We also act as liaisons to other resources in the agency.
In other words, if we don’t know the answer, we find someone that does.
We foster education and encourage voluntary compliance which hopefully reduces the workload of our investigators and compliance officers.

## Customers

- Small Businesses
- Entrepreneurs
- Start-ups
- Industry Associations
- Consultants
- Corporations

**Notes:**
Please don’t let my title fool you. While most of my clients are small businesses and entrepreneurs, I will assist industry associations, consultants and even large corporations. It just so happens that small businesses need me the most, so they contact me most often.

## Jurisdiction

- Foods
- Drugs
- Biologics
- Cosmetics
- Medical Devices
- Radiation-Emitting Products
- Veterinary Products

**Notes:**
The SBR offers assistance over the entire jurisdiction of the FDA. We assist with foods, drugs, biologics, cosmetics, devices, products that emit radiation and veterinary products. The key point for this jurisdiction is interstate commerce. This is something easy to achieve in this global economy of ours since even if your product does not enter interstate commerce, chances are that at least one of your ingredients, components, packaging or labeling comes from another state. That’s all we need as evidence of interstate commerce.

## Services

- Inquiries
- Training
- On-Site Visits

**Notes:**
We provide assistance in three major ways...
Inquiries
Training
On-Site Visits
This brochure includes some of the information in the next few slides.

## Inquiries

- Received and responded via
- Telephone
- e-Mail
- Fax
- Snail-Mail
- 10-day deadline
- 2-day average turnaround

**Notes:**
We receive and respond to inquiries via telephone, email, fax and regular mail. In my office in particular, we handle over 1,000 inquiries per year. About 75% of them occur via email.
My duties require I respond within 10 working days of receiving an inquiry. However, our average turnaround time is 2 days.

## SWR SBR Inquiries

**Notes:**
This graph shows the number of inquiries we have handled in my office since before I worked in this office. The dip in 200 happened after the agency eliminated the toll-free number my predecessor had. I started in this position in 2001. Even without the toll-free number, the program has become more popular than ever.

## SWR SBR FY-2004 Inquiries

**Notes:**
I included this chart here just to show you the typical distribution of inquiries. This represents inquiries from last fiscal year. As you can see, most inquiries were related to CFSAN, in other words, foods, dietary supplements and cosmetics. As you can imagine, there are more food establishments than any other kinds.
Drugs and devices are in close second place.

## Training

- Deliver presentations
- To industry and professional associations
- Organize and publicize workshops
- Co-sponsor with industry and professional associations

**Notes:**
The second service the SBR provides is training. We deliver presentations to qualified entities. We also organize and publicize workshops and educational forums we co-sponsor with qualified entities.
This is the logo of the FDA Medical Device Industry Coalition or FMDIC. It is a coalition of medical device associations and the FDA Dallas District geared towards improving cooperation, encouraging communication and offering educational opportunities to the medical device industry in Arkansas, Oklahoma and Texas. FDA has co-sponsored with FMDIC several times to bring medical device workshops to the area. I am also the FDA Co-Chair for FMDIC at this time. For more information, please visit www.fmdic.org.

## Upcoming Training

- Medical Device Educational Forum
- Dallas, TX, April 2006
- Clinical Trials Conference
- Cincinnati, OH, December, 2005
- Baltimore, MD, January, 2006
- Houston, TX, February 2006 (tentative)

**Notes:**
Here are some training opportunities I have planned for the near future:
The FDA will co-sponsor with the FMDIC another Medical Device Educational Forum in Dallas on April 2006. This one will cover a subsystem of the Quality System Regulation (QSR). If you are interested in learning more about this event, please drop me an email and I will keep you posted.
FDA is co-sponsoring with the Society of Clinical Research Associates (SoCRA) to bring a series of Clinical Trial Requirements Regulations, Compliance and GCP Conferences. They already held one last month in Philadelphia. The next one is in December in Cincinnati. Another one will be in San Francisco next January. We are planning to have one in San Antonio sometime next year too. I will let all of you know via email of this one as details firm up.

## On-Site Visits

- Voluntary review
- At industry’s request
- Confidential
- Cursory, brief
- Limited by schedule and budget

**Notes:**
The third way the SBR assists industry is with on-site visits. I visit establishments at industry’s request.
These courtesy “audits” are confidential, cursory and brief.
Unfortunately, my ability to perform on-site visits is limited to available funds and staffing restrictions.

## Confidentiality

- We are prohibited by law from divulging proprietary or confidential information
- We do not discuss industry inquiries with inspectors _unless it is life threatening_

**Notes:**
A note on confidentiality. All FDA employees are prohibited by law from divulging or benefiting from proprietary or confidential information.
In addition to this safeguard, the SBR does not discuss industry inquiries with inspectors. Of course, if the situation is one of life or death, I am morally obligated to report it. After all, my first obligation is to the American consumer.

## Limitations

- Cannot intervene when a current investigation reveals violative conditions that warrant regulatory action
- 483 observations
- Warning letters
- Import detentions

**Notes:**
On the flip side, I cannot step on the toes of the enforcement folks. So I cannot intervene when a current investigation reveals violative conditions that warrant regulatory action. So 483 items, warning letters, import detentions, etc., please discuss them with the person who issued them.

## The Southwest Region

- Arkansas
- Colorado
- Iowa
- Kansas
- Missouri
- Nebraska
- New Mexico
- Oklahoma
- Texas
- Utah
- Wyoming
- US-Mexico Border

**Notes:**
I also have geographical limitations. These are the 11 states I assist, including imports through the entire US-Mexico border.

## Regions

**Notes:**
Don’t despair, each of the other 4 regions has its own SBR program to provide you with assistance.

## http://www.fda.gov/

**Notes:**
For more information on the SBR program, please visit the FDA web site at www.fda.gov. Scroll down...

## Slide 17

**Notes:**
(note where the Code of Federal Regulations and Federal Register are available on this web page)

Click on “Information for” “Industry”...

## Slide 18

**Notes:**
This page is a compilation of online resources useful to our regulated industry.

(highlight some of the links)

Your Small Business Representatives have put together a Small Business Guide to FDA that is available through this web page. Let’s click on that link...

## Slide 19

**Notes:**
Here is the document. As you can see, it contains... (highlight some of the features available)

Let’s scroll down...

## Slide 20

**Notes:**
(highlight more of the features)

We also have the listing of all the Small Business Representatives, let’s click on that link...

## Slide 21

**Notes:**
Here is the contact information for the SBR’s in the 5 regions of FDA. Note that the states are listed in each one to help folks find the most appropriate person.

Besides ORA, most of our other centers offer some form of industry assistance program...

<Next slide: Drugs>

## We Want You

- To Voluntarily Comply!

**Notes:**
FDA prefers voluntary compliance. It is more cost efficient to the American consumer and to our regulated industry. That’s what I am here for...

## My Contact Information

- David Arvelo, SBR
- FDA/ORA/SWRO (HFR-SW2)4040 N. Central ExpresswaySuite 900Dallas, TX 75204
- Telephone 214-253-4952
- Fax 214-253-4970
- Email David.Arvelo@fda.gov

**Notes:**
Please don’t hesitate to contact me if you have any questions. Any questions now? <Pause for questions>

I want to personally thank:
Lesly Forsberg with the Kansas City Health Department for all her help
John Friel from CDER OTCOMM for his support of this event
Ron Wilson, CDER Small Business Assistance for his continuous support
And all the speakers:
Kim Colangelo
Martin Shimer
David Hilfiker
Ram Randad
John Thorsky, and
Thomas Arista

Also thanks to all of you for attending. Have a safe trip home!

## Coming up next...

- Turn in your evaluation sheets
- Have a safe trip home