NWX-FDA OC

Moderator: Susan Chittooran

April 21, 2016

1:30 pm CT

Coordinator:	Welcome and thank you for standing by. At this time, all
participants are in a listen-only mode until the question and answer
session of today's conference. At that time, you may press star and then
one to ask a question. I would like to inform all parties that today's
conference is being recorded. And if you have any objections, you may
disconnect at this time. Now I would like to turn the conference over to
your host, Mr. Brian Kehoe. Thank you, sir. You may begin.

Brian Kehoe:	Thank you. Thank you for joining today's call to discuss
the recently released draft FDA travel consultation policy. I'm Brian
Kehoe. I'm the Acting Director of Intergovernmental Affairs here at FDA.
Our main speaker today will be Leslie Kux who's our Associate
Commissioner for Policy. We will start with a presentation and then
we'll have time at the end for questions and answers. So I will turn it
over to Ms. Kux.

Leslie Kux:	Good afternoon everyone. Thank you for joining us. I want to
start just by confirming - reaffirming that we're committed to honoring
the special relationship that we have, the American Indian and Alaskan
native tribal governments and our government, the U.S. government. We
thank you all for participating. I think it will be most helpful if I
start with a brief overview of FDA and our mission.

	FDA's primary function is regulatory. So our mission is to protect the
public health by assuring the safety, efficacy and security of products
such as human and veterinary drugs, biological products which includes
blood and vaccines, medical devices, our nation's food supply, cosmetics
and products that emit radiation. The FDA also has responsibility for
regulating the manufacturing, marketing and distribution of tobacco
products to protect the public health and to reduce tobacco use by
minors.

	As a function of our regulatory oversight activities, we are dedicated
to developing and maintaining relationships with state and tribal
partners for enforcement, education and training on our regulations. But
as an agency - a regulatory agency I should say we are a bit different
from other HHS divisions that are primarily grant making agencies or the
agencies that have large public health programmatic activities with the
Indian tribes.

	So today we are consulting on the draft Tribal Consultation Policy that
FDA recently issued and it's based on the HHS Tribal Consultation Policy
and that includes agency specific consultation guidelines that
complement the department wide effort. So we're - the comment period is
open on the draft consultation policy and we're specifically seeking
your comments and feedback and recommendations on the draft policy. And
these will help guide us as we issue a final tribal policy.

	The draft FDA policy, which we sent out to the tribes on February 29,
provides background on FDA's organizational structure and sets out
principles and guidelines for the tribal consultation process. To date,
we followed the HHS Tribal Consultation Policy. Our intent is for the
FDA Tribal Consultation Policy once final to serve as the platform for
the agency to create more consistent and meaningful tribal consultations
across all of the FDA centers and offices.

	We do have a docket to receive written comments on the tribal policy,
the draft policy. And the deadline for comments is May 31, 2016. And the
transcript of this consultation will be also placed in the docket. Our
tribal web page, which is available at www.fda.gov\tribal, includes a
link to the docket as well as instructions on how to submit comments
electronically. You're also welcome to contact Brian Kehoe who's the
Acting Director of Intergovernmental Affairs and his number is
301-796-8913.

	So we're interested in any tribal comments or concerns that would help
us improve our policy as well as suggestions about how we can improve
our communication and outreach with the Indian tribes. So with that, I
will open up this dialogue to your - to any comments and questions about
the draft consultation policy. Thank you.

Brian Kehoe:	And we can move to the question and answer portion.

Coordinator:	Thank you sir. We'll now begin the question and answer
session. To ask a question, please press star followed by the number
one, unmute your phone and record your name and affiliation clearly at
the prompt. To cancel your request, you may press star and then two.
Again if you'd like to ask a question, please press star and then one.
One moment please for questions to queue.

Leslie Kux:	While we're waiting for questions I - maybe it would be
helpful for folks to understand that we do have a number of in addition
to our tribal Web site and the your tribal letters that we send out with
regulations that if people might be interested to know we do have a
number of email listservs that you can sign up for that will - that
cover different aspects of products we regulate. We have a patient
network newsletter. We have a cardio beat newsletter, a diabetes monitor
newsletter or an email listserv. I'm sorry.

	And then we also have a hepatitis B and C update, HIV and AIDS update,
FDA Office of Minority Health email update and then you can also
subscribe to our MedWatch Safety Alerts which are product safety alerts.
They're also the Center for Tobacco has news and updates and other
social media stuff, sorry. I'm not sure what the technical term is,
other social media that you - links that you can sign up for. And then
also on the FDA Web site, we have a FSMA, Food Safety Modernization Act,
page where we post regular updates as well.

	So there are a lot of ways on our in addition to the formal mechanisms
we have for communicating with the tribes. There are also lots of great
ways for anyone who's interested to find out about activities in
specific areas or specific programs that might be of interest to the
tribes as well.

Coordinator:	Speakers we're currently showing no questions over the
phones. But again as a reminder if you'd like to ask a question, please
press star followed by the number one and record your name and
affiliation clearly at the prompt. We're showing no questions at this
time ma'am.

Leslie Kux:	So again while we're waiting for questions or if - to give
people a little bit more time to figure out if they have questions, I
can provide a little bit more information about how in addition to the
social media and email reports that I just discussed where tribes can
find specific information related to FDA issues.

	So we do have a number of other resources. I think you already are
aware that there's our Office of Intergovernmental Affairs led by Brian
Kehoe whose name - who opened the call for us and whose name I
mentioned. Again his phone number is 301-796-8913. We also have five
regional offices and 20 district offices across the country. And if you
want to know how to - where the regional offices and district offices
are located, you can find that information on our Web site or you can
contact Brian.

	We also have a number of training resources. Our Office of Regulatory
Affairs offers ORA University which provides free training and online
courses for state, local and tribal regulatory partners. And for the
Food Safety Modernization Act we announced a funding opportunity for
tribal training that was notified to the tribes through a Dear Tribal
letter on February 12, 2016. The Center for Tobacco Products has offered
tribal webinars on the retail inspection program. And so - and we also
separately offer a variety of webinars with FDA basics for industry and
FDA basics for consumers that are very helpful across our program areas.

	On the - we also as I mentioned have established a tribal web page at
www.fda.gov\tribal. This Web site has information about the draft
consultation policy that this phone call is about and instructions on
how to comment. We're also - our goal is to make this site a central
location where tribes can find all of the Dear Tribal leader letters
that have been sent out in one central place and I think actually we -
they're all up there now. The tribal web page is maintained by our
Intergovernmental Affairs staff.

	It also has links to the web pages of all of the offices and centers
around the agency like the Center for Tobacco Products and the Office of
Foods and Veterinary Medicine and the Center for Food Safety and Applied
Nutrition. And there you can find explanatory background materials that
might be of particular interest for tribal manufacturers and retailers
of related products. And so it's also if you check out this web page if
you have suggestions for how to improve it and other information that we
might include, please contact Brian at the Intergovernmental Affairs
staff and we'll be very interested in working to make the Web site as
helpful as possible.

Coordinator:	Again…

Brian Kehoe:	Do we have a…

Coordinator:	Go ahead sir.

Brian Kehoe:	I was just going to ask if we have any questions.

Coordinator:	We're showing no questions at this time.

Brian Kehoe:	Okay. I guess we can adjourn the call. Thank you everybody
for joining us. A replay of this call will be available in an hour and a
transcript will be placed in the docket. And we look forward to hearing
comments and, you know, hopefully we'll get a comments docket as well.
Thank you very much.

Leslie Kux:	Yes this is Leslie Kux. Thank you very much for your time
and we do encourage comments on the Tribal Consultation Policy. Comments
that we receive on our documents really do help us improve them and make
them as useful as possible. So we - when we encourage people to comment,
we really, really mean it. So thank you very much.

Coordinator:	That does conclude today's conference. Thank you for
participating and you may disconnect at this time.

END

NWX-FDA OC

Moderator: Susan Chittooran

04-21-16/1:30 pm CT

Confirmation # 7206617

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