FDA Tribal Consultation Webinar 6.16.2014

FDA Tribal Consultation Webinar 6.16.2014


– Good day,
and welcome to the FDA Virtual Tribal
Consultation Conference Call. At this time, I would like
to turn the conference over to Evonne Bennett-Barnes. Please go ahead. – Thank you, Melissa. Welcome to today’s webinar
with FDA and the Center
for Tobacco Products. My name
is Evonne Bennett-Barnes, Naasht’ezhi Dine’e
and Numunu. This is how I am Navajo
and Comanche. My role today is the moderator
for today’s session. I am also
the Tribal Policy Analyst in the Office of Compliance
and Center for Tobacco Products. Today we will begin providing
a webinar as a follow-up to a Dear Tribal Leader Letter that discusses
the Center for Tobacco Products Office of Compliance
and Enforcement, or CTP. As we begin working with Tribes,
we recognize that this process will allow us to better
understand your concerns, your needs,
and your circumstances. My hope for today
is that Creator can guide us through an open
and meaningful discussion. Before we begin, I would like to
ask everyone in the room with me to quickly introduce themselves. Then I will turn the program
over to our center director, Mr. Mitch Zeller, to provide an opening remark
and affirm CTP’s commitment to interact with Tribes on a
government-to-government basis. – Hi, I’m Mitch Zeller, director of the Center
for Tobacco Products with FDA. – I’m Ann Simoneau, the director of the Office
of Compliance and Enforcement at the Center
for Tobacco Products. – Good morning,
this is Paul Allis from the Pool Tribe. Yoho.
Welcome. I am the Tribal Policy Analyst in the Office
of the Center Director. – Hi,
this is Heather Althouse. I’m in the Office of Compliance
and Enforcement. – Thank you all. And now I present to you
Mr. Mitch Zeller. – Thanks, Evonne. Good afternoon,
or good morning if you’re in
the western time zone. And I’d like to open
this consultation today by wishing you
a warm welcome and thanking you
for your participation. It is important for
the Center for Tobacco Products to have a strong
working relationship with Tribes and Tribal leaders. We are here today to discuss our compliance
and enforcement activities under
the Family Smoking Prevention and Tobacco Control Act. We understand that you
are facing unique challenges in your communities
regarding tobacco use. Tobacco-related heart disease,
cancer, and diabetes are major causes of deaths
among American Indian and Alaska Native adults. We also know that tobacco
is sacred amongst some Tribes and there are traditional uses
of tobacco that are important
to American Indian and Alaska Native communities. And we recognize
that certain Tribes may have commercial interest
in tobacco products. Given these various
complexities, the Center for Tobacco Products
looks forward to collaborating with Tribes and Tribal leaders. It’s important for us
to understand the traditional roles
tobacco can play. We also want to make sure
you understand how to comply with relevant provisions
of the law. And we are committed
to working together to build healthier communities and improve public health for American Indians
and Alaska Natives. Today we will talk
about the Tobacco Control Act and some of its specific
provisions that are in effect. We’ve been busy developing
the regulatory science base to best evaluate
the products we regulate. We’ve also been hard at work
reviewing product submissions and launching
a national ad campaign designed to decrease
youth tobacco use. And we’ve been developing
guidance documents to help regulated industry
comply with the law. And it’s compliance that
we’re here to talk about today. To help ensure compliance, the Center’s Office
of Compliance and Enforcement uses a three-pronged approach. First, developing and providing compliance training
and education. Second, monitoring compliance
with the law through surveillance,
inspections, and investigations. And third, initiating advisory
and enforcement actions such as warning letters, seeking civil money penalties
against noncompliant companies as appropriate. Ensuring compliance
with the provisions of this important
public health law and taking enforcement actions
when needed is a critical part
of an overall strategy to reduce the number of young
people who use tobacco products and to help reduce the overall
death and disease toll related to tobacco use. We hope this consultation today will better acquaint you with
the Center for Tobacco Products and provide an understanding of the compliance
and enforcement efforts that support the public health
goals of this law. I know we share
the mutual goal of keeping tobacco products
away from our kids. I am enthusiastic
about continuing the consultation activities
we’ve begun and am committed
to a meaningful consultation with Tribal nations. So on behalf of everyone at CTP, I look forward to continuing
to build a strong government-to-government
relationship with you. It is a unique relationship and important
that we work with you to positively impact
the health status of American Indian
and Alaska Native people. Thank you. – Thank you, Mr. Zeller. I’d now like to present to you the director of the Office
of Compliance and Enforcement, Ann Simoneau. Ann will provide an overview
of the Tobacco Control Act and compliance and enforcement
activities and opportunities to also highlight
any potential impact to Tribes. At the conclusion
of Ann’s remarks, we will begin our open forum
for discussion of CTP’s Office of Compliance
and Enforcement activities. Ann. – Thanks, Evonne. As Evonne said,
my name is Ann Simoneau. I’m the director of the Office
of Compliance and Enforcement here at the Center
for Tobacco Products. Mitch briefly described to you
the importance of our participation today and your involvement
in the activities of CTP. I plan to go through the Family Smoking Prevention
and Tobacco Control Act and the public health code
behind the law. It is our job in the Office
of Compliance and Enforcement to make sure that regulated
industry follows the law so that we can make a positive
impact on public health. The Family Smoking Prevention
and Tobacco Control Act was signed into law
on June 22, 2009. We’re coming up on our
five-year anniversary shortly. And it provides FDA with a broad
set of regulatory tools. The law gives FDA authority as a public health
regulatory agency to regulate the manufacture,
distribution, and promotion of tobacco products
among other things. This authority
and our regulations impact retailers
and manufacturers and others of tobacco products, and that includes Tribes. Our current jurisdiction,
however, includes cigarettes,
cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco. It restricts reduce–
excuse me. These restrictions
to reduce youth access and attractiveness of cigarettes
and smokeless tobacco. It establishes product–
excuse me– public health and population
health regulatory standards for tobacco products. And it gives FDA
enforcement authority and enforcement tools
in which come– in which we do
surveillance and inspections to ensure that companies
are in compliance. Now, I mentioned the four
categories of tobacco products that we currently regulate. On April 24, 2014,
FDA proposed a new rule that would extend
the agency’s authority to cover other additional
tobacco products. Now, that would include
some other categories that are on the slide here– electronic cigarettes,
cigars, pipe tobacco,
nicotine gels, and other types
of regulated tobacco products. We recommend that you submit
any comments that you have to that proposed regulation to the docket. On May 29th, the Center
sent a Dear Tribal Leader Letter to notify Tribes
of this proposed rule. Now, we held
the Tribal Consultation webinar on that date. Under the current authority
in the Tobacco Control Act, there’s many requirements
that are currently in effect, and many of these requirements apply to tobacco product
manufacturers. Some of these requirements
include: manufacturers and importers
are required to pay user fees. Manufacturers have to register
and list their products with the agency. They have to report levels
of harmful and potentially harmful
constituents. It also gives us authority to establish tobacco product
standards of products, requires us to review
premarket review of applications on modified risk
and new tobacco products. It also provides restrictions on tobacco product retailers. Some of these restrictions
include prohibiting the sale of cigarettes and smokeless
tobacco product to anyone under the age of 18, and it requires
that cigarettes be sold in pack–
in packages with– or prohibits that cigarettes
be sold in packages of less than 20 cigarettes. It prohibits the sale
of flavored cigarettes and flavored cigarette tobacco. And it prohibits the use
of descriptors like “light,” “low,” and “mild” in the label, labeling,
or advertising of regulated tobacco products
without an order from FDA. In addition, it prohibits
the distribution of free samples
of cigarettes. And it provides certain
restrictions on the distribution of free samples
of smokeless tobacco products. Now, in order to ensure
compliance of tobacco retailers, the Office of Compliance
and Enforcement has worked closely
with our colleagues in states and territories. We’re doing inspections
of tobacco product manufacturers who utilize FDA’s
Office of Regulatory Affairs. Those are the folks who do traditional manufacturing
inspections on drug facilities, medical devices,
and food facilities. But for tobacco product
retailers, FDA currently contracts
with states and territories and uses our FDA-commissioned
officials to conduct compliance check
inspections at tobacco retail
establishments. We’re here today to request your collaboration
with us to conduct these retail
compliance check inspections on Indian country. Now, this map that you see
on your screen currently shows
where we are today with our compliance check
inspection of retailers. The blue–
the darker blue area are those states
in which we currently have compliance check inspection
contracts with states and territories. The lighter blue area is where we have
third-party contracts, so the contracts
with other entities to inspect in these areas. Finally, in the gray areas
on the states are areas in which staff of the Office of Compliance
and Enforcement within the Center
for Tobacco Products are currently out
doing retailer inspections in those states. Now the program continues
to expand. We continue to go out
with new request for proposals for the remaining states
and territories as well as other
third-party organizations who want to contract with us. And we’re here today
pleased to announce to you that today a request
for proposal has been issued to request that Tribes
apply for these contracts to work with us to do these
compliance check inspections on Tribal lands. And as the slide has indicated, there’s about–there’s more than
500,000 tobacco retailers across the country, and we’ve contracted
with 48 jurisdictions to date. And we plan to issue
these contracts to any other states,
and under the law, the states that are
under contract with FDA do not yet inspect
on these Tribal lands, and under the law,
they will not without the consent
of the Tribe. Now, there are ways for us, and we plan to collaborate
with these tribes. How do we do that? Well, there’s provisions
of the Tobacco Control Act, including those related to the retail sale
of tobacco products, that also apply
to Indian Tribes. We plan to collaborate
with Indian Tribes and Tribal entities
to ensure that there is
compliance education to these representatives,
manufacturers, importers, and retailers
to ensure that they understand the legal requirements
of the law as it pertains to them
and their Tribal lands. FDA plans to contract with these federally recognized
Indian Tribes, where feasible, to conduct retail
compliance check inspections. And FDA announced its plan
to offer contract opportunities
to Tribes and the request for proposal,
as I mentioned, posted today. And in that proposal, it details
all of the requirements to file an application
with FDA. Now, the next section
I want to talk about is Tribal–
excuse me– tobacco manufacturing
inspections. As I mentioned, these
inspections are conducted by FDA’s
Office of Regulatory Affairs. Now, these manufacturers
could be owned by Tribes or privately owned facilities that are located
on Tribal lands. What happens
during these inspections? Well, FDA conducts
these inspections every other year, and we do these inspections
to determine compliance with the provisions of the law
that are currently in effect. And the investigators inspect
the manufacturing facilities, they observe operations,
and they collect information. They review the operations
and the procedures, and they evaluate the processes and document
any potential violations. The agency has a book that’s available online. It’s called the Investigations
Operations Manual, and in that manual,
it talks about the processes and procedures
that FDA investigators do in conducting inspection of
tobacco product manufacturers. Also, we have
a compliance training webinar that’s archived on our website and available for anyone
to watch. In that webinar, it talks about how you can
prepare for an inspection, when we conduct
these inspections, and what a firm can expect
during an inspection. It tells you all the areas
that are covered during the inspection
and how it will conclude. I recommend that any
Tribally owned manufacturers or independent owners of tobacco product
manufacturing facilities, that you provide
that information to them to educate them
on what they can expect from these inspections. Now, other types of compliance
and enforcement activities that are conducted in the Office
of Compliance and Enforcement include surveillance
of tobacco product advertising, packaging, and labeling. These include
internet retailers, publications
in which tobacco products are advertised and promoted, smokeless free sampling events
at festivals and sporting events to ensure that they’re
in compliance with providing free samples
of smokeless tobacco products, and also at sponsorship events in which tobacco products
may be advertised and promoted. Another area is at our borders
across the United States. We have issued the following
Import Alerts. When a product’s
entering our borders, we determine whether or not
they’re in violation of the law. Four of these Import Alerts
include labels, advertising,
and labeling that would include the “light,”
“low,” and “mild” descriptors on the products’ labels that might not have to date
a marketing order issued by
the Office of Science. Another one is to see
if someone’s trying to import flavored cigarettes
into the United States that are currently banned
under Section 907 of the law. Next is, we look to make sure that the smokeless tobacco
products have the required warnings
on their labels. And finally, we detain
the physical examination of certain regulated
tobacco products that are not found
substantially equivalent. So if our colleagues
in the Office of Science issued a non-substantial
equivalent order, we ensure that those products are not being imported
into the United States. Now, as I previously mentioned, the law gives us
many enforcement tools to ensure that companies
are in compliance with the law. These tools include
a warning letter. A warning letter is issued by the Office of Compliance
and Enforcement after an inspection or a potential violation
is identified during an investigation
or a surveillance. This is essentially
a warning to the company to alert them that they’re currently
in violation of the law. It warns them that failure
to change their practices and failure
to change the labeling or whatever the violation is may result
in further enforcement action. What could be some of those
further enforcement actions that we could bring? One of which
is a civil money penalty. That’s a penalty of fines that could be levied
on the company. We also have the authority to
pursue No Tobacco Sale Orders, and I’ll talk about that
a little further in a later slide. We also have the authority
to issue seizure actions. Now, that’s an action
in which we can seize the actual violative
tobacco product. We have the authority
to issue injunctions, which is a court action,
a judicial action, in which companies
are enjoined from further violating
the law. And finally,
we can refer the case for criminal prosecution for certain circumstances. Now, to talk a little bit more
about civil money penalty and fines. For the tobacco product
retailers, the Tobacco Control Act
has a schedule of these fines, and there’s two different
schedules. One is a more serious schedule, and one is just as serious, however, the amount of money
that we pursue is less. Because tobacco product
retailers had not been regulated
previously by FDA, the agency determined that for the first time
a violation was identified during the inspection of a tobacco product
retailing facility that we would pursue
a warning letter for the first violation. As you can see, the more violations that are
observed during an inspection of a tobacco product retailer, we can pursue
civil money penalties on an increased level over a certain period of time. And ultimately, we can get
to a No Tobacco Sale Order. We may imposed
a No Tobacco Sale Order against any person found to have
committed repeated violations of the restrictions
at any particular outlet, and that means that there’s
at least five violations of the particular requirements
over a 36-month period at a particular retail outlet that constitutes
a repeat violation. Next, my office handles
all small business assistance. It is contained within the Office of Compliance
and Enforcement. It serves as the primary
point of contact for small businesses. We provide technical assistance and subject matter expertise
to small businesses. And we provide resources
and training to enable small
tobacco businesses to comply with the requirements
of the law. The reference here
is on our web page. It has a wealth of information for people to access
for small businesses in how to comply with the law. We also conduct
several webinars throughout the year that are specifically targeted
to small businesses. Now, these small businesses primarily could be
small manufacturers, or they can also be retailers
also. We encourage anyone
to sign up for our webinars to learn about the requirements
of the law and how they can comply. Some of the examples of topics
that we’ve covered during recent webinars
are listed on your slide. All of these webinars
are archived on our website. So even though you’ve missed
a previous webinar, you can log on and watch and determine
whether that is an area that’s covered
under your question. We can also tailor
our webinars to meet topics that you need
for the future. There’s a mechanism
on our website for which you can request
a topic that is pertaining
to your issue. Or we have references in which you can reach out to
the Center for Tobacco Products to ask any specific questions
that you have on how to comply
with the law. Now, as I previously mentioned, we look forward
to collaborating, and there’s several
opportunities for you to collaborate with
the Center for Tobacco Products. The reason why we’re here today is to announce
our request for proposal to encourage you to apply for our compliance check
inspections and to work with us
to ensure that we keep cigarettes,
smokeless tobacco out of the hands of children. We also encourage you
to comment on our proposed rules
and guidance documents. And finally,
we can work together if you can report potential
violations that you see to the Center
for Tobacco Products. The center has developed a potential tobacco product
report form, and it’s listed
right on our website, and you can download
the information to us. We also have contact email
and phone number information. Once we get potential
violation information, we review everything
that is sent to us and determine what, if any,
follow-up action is needed. And oftentimes, you will see
enforcement actions that are posted
to our website that were the result
of a complaint that came in and originated
from multiple sources. So I encourage you to report any potential violations
to the agency. And next,
I want to point out a wealth of resources
that you can use– our CTP website. Any kind of questions
that you have for the agency, there’s [email protected] The link is also there for our Office
of Small Business Assistance, and again, any questions
that you have on how to comply with the law. Also, any questions
that you have for us on how to get your information to our Office of Acquisitions to apply for our contracts, we can put you
with the right people to answer any
of your specific questions to meet your needs. And finally,
we have an ombudsman at the Center
for Tobacco Products. That is his contact information, and he can help resolve
any conflicts that you may or may not have
with the center or facilitate any kind
of discussion that you might need. And the last contact sheet
is my senior officials in the Office of Compliance
and Enforcement– my two deputy directors, Swati Kabaria
and Terry McDonald, and also,
my Tribal Affairs Policy Analyst who’s speaking today,
Evonne Bennett-Barnes, can also assist you if you have
any specific questions about today’s webinar. So I’m so grateful
that you’ve decided to join us, and I’m gonna turn it back over
to Evonne now. – Thank you, Ann. It’s now time to open
the open forum of the consultation. Before we begin, we will begin
with comments and questions from Tribally elected officials and their delegates first. We will also open comment
to the public if there is time remaining. If you do send us questions
in your chat box, we will also have
the same process. So, Melissa, we can go from the line
for questions. Our operator, Melissa,
we’re ready for your questions if there are any on the phone
at this time. – If you would like to ask
a question, please press star 1
on your telephone keypad. A voice prompt
on the phone line will indicate when your line
is open. Please state your name
before posing your question. Again, press star 1
if you have a question. That’s star 1,
and we’ll pause just a moment to allow everyone
the opportunity to signal for questions. Again, that’s star 1
if you have a question. And currently,
we have no questions. We do have a question
on the phone from Ben Fenner. – Hi.
I have a question. I’m here on behalf of
the Winnebago Tribe of Nebraska, and I have a question regarding
additional consultation on either enforcement of the Tobacco Control Act in Indian Country
or the deeming regs. And I–my question
is whether there will be additional
consultation opportunities provided by FDA to Tribes. I’ve heard mention
of continuing consultation. I’m just wondering if there’s
anything in the works. Thank you. – If I could ask you
a follow-up question. Is there anything specific
regarding deeming that you’re looking for? Are there any
specific questions? – Just, you know, the– whether–
not specifically. And obviously,
there’s comment opportunity available to all on the regs, but, you know,
I just want to make sure that the full scope of the–
the impact of the deeming regs is considered– the impact on Tribal
manufacturers specifically is taken into account. – Okay. I certainly– Could you hold on
one second? – Certainly. – Okay. All right, I just had
someone–I’m sorry– clarify to me
that the May 29th webinar was considered an official
consultation webinar. So certainly, one of the things
I absolutely encourage you to do is to submit
your written comments to the docket
on the deeming rule, the proposed deeming rule. I can assure you that each
and every comment gets reviewed
and it gets evaluated before there’s any finalization
of any proposed rule. So I–the comment period
has been opened, and it’s still open. And I really encourage you
to submit your comments particularly on your issue, what you said about impact
on Tribal manufacturers. Did you have an opportunity
to see that webinar? Because the other thing
I wanted to mention to you is that the deeming webinar
as well as the slides have both been posted
to our website, and there is a wealth
of information on that too. – We can take the next question
if you’re ready. – Okay. If you have a question,
again, please press star 1. That’s star 1
if you have a question. And we’ll take a question
from Isaiah Brokenleg. – I have several questions–
oops. Hi, this is Isaiah Brokenleg. I have several questions
that I posted on the Q&A, but one are,
does the law allow for coupons for free cigarettes
to be given away? Because some people
don’t give away the packs. They just give away the coupons
that then you take to the bar, which then you get
a free pack. – Okay. I can speak
to your coupon question. If it’s a–if it’s a coupon
for a free sample, that’s prohibited,
’cause you can’t give away free samples of cigarettes. Now, if it’s a coupon
for, like, 10– you know, 10¢ off or $1 off, that’s permitted. The other prohibition is,
you can’t have coupons for the mail of cigarettes. – Okay. And are roll-your-own machines
considered manufacturing? – When it comes to– It all depends
on the circumstances of how things are being sold. – Okay, we have a lot
of these big machines, and you can go
and you could buy– you buy tobacco, you buy
the, like, cigarette things, and then they put ’em
in this machine, and it spits out cigarettes, but they say that people
are rolling their own. And does that count
as manufacturing? – Okay, well,
that would be a situation where I would encourage you
to share that information of the retailer
or the establishment where you’re observing this to us. You could use either
a report a violation form, or you can email us
so that we can take a look and make an assessment
of what’s going on. – Okay. And then, in terms
of violations, it’s– You know,
there’s multiple violations increases the amount of money,
so is it per event? Like, let’s say you went
and you looked at a retailer and they had, like,
four different things that were considered violations. Are those four things
considered four violations, or is it per event,
so all four of those things would be listed
on one violation sheet and they would get a warning
for that one thing, and then if you went again
two weeks later, that would be
a second violation? – Okay, let me recommend
that you take a look on our website. We have something called
a guidance document. Are you familiar with those? – Yes. – Because we have a guidance. It’s a Civil Money Penalties Frequently Asked Question
guidance. And in that guidance,
it specifically describes how we count as we follow
the Tobacco Control Act and the authority
that they’ve given us under the Tobacco Control Act. And it goes through what’s
considered a repeat violation, what’s considered a violation, and how you count. So I recommend
that you take a look, and it’s written
in plain language so that it’s relatively easy
to navigate through those. – Okay, and my last question
is about– – And if you need– Let me let you know. If you need to have a link
to that, if you can’t locate it,
don’t hesitate. Reach out to Evonne
or myself or someone else
that’s on the contact list, and we can email you the link
to the guidance. – Okay. My last question
is about the difference between traditional tobacco,
the Nicotiana Rustica, and the difference
between commercial tobacco, Nicotiana Tabacum. How is Nicotiana Rustica viewed under this Tobacco Control Act? And that’s
the traditional tobacco that Indians used
a long time ago that we still use
in ceremonies. How is that viewed if people
grow it on their own and use it in ceremonies, and how are you gonna navigate
the religious freedom issues that will be involved
in that process? – Well, I’ll let
Heather Althouse answer that question for you. – So hi.
This is Heather Althouse. I work in Ann’s office in the Office of Compliance
and Enforcement. And in the law itself,
there is no definition for traditional tobacco
or ceremonial tobacco. We only have
specific definitions for things like
cigarette tobacco, roll-your-own tobacco,
smokeless tobacco. But with that said, we also only regulate
the manufacturing, distribution, and promotion
of tobacco products. So FDA is not in the business of regulating the use
of tobacco products. So that may be a consideration
as well. And certainly,
we’re always open to learning
from your experience and the experience
of other Tribal members, Tribal communities on how, maybe,
they use these products and any of their concerns. But our focus
is on manufacturers and on the retail distribution and promotion
of tobacco products, but the definitions
that we have to work with are those that are outlined
in the law. – So I guess my concern is, we grow traditional tobacco
for use in ceremonies because our research shows that if people use
traditional tobacco, the Nicotiana Rustica,
in ceremonies, they’re less likely
to use commercial tobacco recreationally. And when we grow it,
our religious rules are that we’re not supposed
to sell it. You just give it to people
when they ask you for it. So how does that fit
under this law, and will we be in trouble for
giving away traditional tobacco? – Well, I think, you know, you’re definitely
in a nuanced area that’s really not
clearly defined in the law. You know,
as Ann has outlined what our compliance
and enforcement activities have included, really have not gone
into going on farms and growers. And also, when it comes
to FDA’s authority in general, there tends– the interstate commerce
component is an important factor
of where our authority lies. So, you know, this definitely
is not a black-and-white issue, but, you know–and I certainly
understand your concern, but I can say that that is not really
where our focus is. Our focus is on the–the retail and manufacturing of products for interstate commerce. – Okay. Thank you. – We’ll take your next question
from Ross Colburn. – Hello? – We can hear you. – Can you hear me?
– Yes. – Sorry,
just a follow-up to– Ross Colburn on behalf
of Big Sandy Rancheria. As a follow up to Ben Fenner’s
questions, is there the due date– Do you know the due date for the
comments on the proposed rule? – Hold–hold on. We’ll research that, and we’ll announce it
once we have it up. – Okay? We’ll take a look.
– Okay. – I can tell you
that the center– I don’t know
if this is public yet, but the center has gotten
requests for extensions. So if a decision is made
on that, that will certainly be posted
on our website too. But what we’ll do
is get ahold of the– the exact deadline currently, as of the date
of this webinar. So hold on, and as soon
as we send a quick email, we’ll get you
the exact deadline date. – Okay. The other question I had was,
do you have any– Has the RFP
regarding the contracts been finalized? – Yes, it has,
and it’s been post– it posted at, I was told, 12:30 today. So it’s available.
– Okay. – And if you need information, feel free to contact
either Heather or Evonne, and they can put you
either in contact with the specialist
from our Office of Acquisitions or get you the link
so that you can open it up and, you know, answer– and they can help you answer
any questions. – Okay. – And that includes anybody
who’s listening today. If you have any concerns
or questions, don’t hesitate. Reach out to Evonne or Heather. That’s what we’re here today,
to answer any of your questions, any of your concerns,
and to encourage you to apply. We really want to work
with you. – Thank you. – It looks like deeming comments
are due by July 9th. – Okay, for everybody
on the phone, so far,
July 9th is the deadline to submit comments
to the docket on the deeming rule,
but as I previously mentioned, the center has gotten a request
for extending that. There hasn’t been a final
decision on those requests yet. And if a decision is made
to extend it, that will be also posted
on our website. – Just a reminder. If you have a question,
please press star 1. We do have a question.
Caller, please state your name. Caller, your line is open. Mr. or Miss Goodwin,
your line is open. – Can you hear me now? – Yes. – Thank you.
Sorry, I had my phone on mute. – No problem. – During today’s presentation, you showed us when we go
through retailer inspections, the state will notify
the Tribe. Can you tell me who is notified
in the Tribe so we’re prepared? – To date, there has been no state that’s been working
under contract with FDA who’s entered any Tribe
to do retailer inspections. Okay?
– Okay. – We are here today
to encourage the Tribes to apply for our contracts so that we can work together so that you all
can do these inspections on your Tribal lands. – And then when it comes
to manufacturer inspections, do–does the CTP
notify the Tribe that they’re coming in to do
a manufacturer inspection? – We have recently sent
a Dear Tribal Leader Letter out to notify
all the Tribal leaders that we’re going to be
inspecting tobacco product manufacturers that are located
on Tribal lands. That’s the notification
that we’re providing. And in addition,
we called them all and let them know too. It’s not like
a preannounced inspection. These are compliance
regulatory inspections that we do for companies that are located in the states– manufacturers that are located
throughout the United States irregardless of whether
they’re on Tribal lands or on states or territories. – Okay, great. And, Ann, I just had one
additional question, if I could. – Sure. – Isaiah mentioned
the machines that manufacture the tobacco–
excuse me– that take the loose tobacco and apply to it the tubes
and/or filters and that’s
potentially considered a manufacturing process. Do those notifications
of those businesses doing that need to go to you, or do those
need to go to the state? – If you’re looking to tell– You know, if you’re looking
to share information with FDA that there could be
a potential violation at these retail establishments, you can share that
with my office, and I gave you the references
on the slides. You can put it on
the report a violation form that we have readily available
on our website, or you can send an email
at CTP and share that information
with us. – Okay, ’cause here– – In addition, though–
this is Heather– you certainly could– If it’s an entity that your
state may have authority over, you certainly could report it
to them, because some states
do have different laws than the federal laws. Some of them may be
more stringent or maybe defined differently. So there may be actions
that the state could take that FDA cannot take
or vice versa. So should there be a potential
violation of concern to you, it certainly couldn’t hurt
to report it to both FDA and, if it’s an entity
that the state may regulate, to the state as well. – Great. That’s the answer
I was looking for. As we’ve notified our state
here in Washington of those violations,
we’ve not seen any follow-up. I was hoping for an additional
amount of muscle behind the CTP to help us
with those situations. – Yeah, and every state– You know, every state
is so different. Their laws are different
and even their resources as to how they can–
how they can prioritize the laws that they have. So we’re in the same boat
to some extent too, but reporting it to both
is probably the best– the best way to do it. – Okay. Thank you very much. – And we’ll now take a–
– Thank you. – We’ll now take a question
from Sarah Dakota. – Hi. Hello. We had a question
about the third party. It looks like the Dakotas
are shaded in light blue, and we had a question about
who the contract is with to do inspections
in the Dakotas and whether that entity might be
subcontracted on the side. – Sure. Hold on a second.
I’m just checking. – The information
is on our website. There is a link to all– It’s not always the easiest
to find, so if you have a hard time,
you can contact us and we can point you to it. But there’s a link of each– that includes a list
of every state and territory and who FDA has contracted with to do the retail inspections. And one point of clarification,
’cause I don’t know that we went into that detail
in the slide, is, although we contract
with private entities to do the inspections
in some states, the inspectors themselves are
either state or local officials that are commissioned–
that are or will be commissioned by FDA before they do
any inspections. So they will operate much like
the state contracts where– where they are
FDA-commissioned officials that they do have– they are employees of the state
or local government or the territorial government, which is one of the requirements
for commissioning. So although a third-party
private contractor may be facilitating and
administering the inspections, they’re actually conducted
by commissioned officials. – Okay. Thank you. – Thank you, Sarah. – And again,
if you have a question, please press star 1. We have a question
from June Maher. – Yes, my question is, if– when you write your proposal, would you be required–
or be restricted to just that one Tribe, like Cherokee Nation,
or can you go outside and work with other Tribes? – Hi, June.
It’s Heather. No, certainly if you could
work out agreements with other Tribes,
that’s certainly fine. You can collaborate, and we certainly
welcome the Tribes working amongst themselves to come up with some amenable
situations for you guys. And it’s actually ideal
to submit one proposal with a lead Tribe
such as the Cherokees or others and having, you know, either
agreements with the other Tribes or subcontracts
with the other Tribes. So that’s ideal,
and also, another thing, we are planning to have what our Office of Acquisitions
and Grant Services calls a pre-solicitation conference. It’s going to be a webinar. They do this
for a lot of different request for proposals
that post, and it basically allows us to walk through the requirements
of the request for proposal and also through
the instructions so that we’re– You know, we try to be
really clear about how– you know, the instructions
you need to follow and how you apply
and when you apply and things like that. And I believe they also allow
questions and answers, and the folks from our office
would be on that call, on that webinar call, and also people
from our contracts office. So they answer
the more technical questions, and we answer more
of the logistical things that pertain
to the work required. So that should be very helpful, and I believe it’s tentatively
scheduled right now for June 26th at 1:00 p.m.
eastern time. So mark that
on your calendars, and we’ll try to get
that information out to folks that are interested. – Thank you. – And don’t hesitate,
after this webinar, if you or anybody else
on this call have further questions
on how to apply, I encourage you to call
either Evonne or Heather to get further information. I can certainly tell you
that Heather’s been with– in my office
for more than four years, and she has helped facilitate
many states and territories on successfully
getting contracts– our contracts with FDA and getting them up and running
and inspecting and making sure that, you know,
it runs very seamless. And she’s got
a wealth of information that she’d be more than happy
to assist you with in developing your RFPs. So again, take advantage
of that opportunity if you’re considering applying
for any of these contracts. – Okay. Thank you very much.
Thanks, Heather, Evonne. – One thing–
one thing to note is that these are not
competitive. Much like with the states
and territories, we want to contract
with everybody that has regulated retailers
on their lands. So we want to do that. It’s something,
you know– Tribes do not need to compete
against each other for funding
or anything like that. So don’t be concerned
about that. The only place
where we can have competition is within one jurisdiction. So for example,
we couldn’t have two potential offers
from the Cherokee Tribe unless they were splitting up
the jurisdiction or something like that. So we’re not gonna do
any sort of competition. – I would like to read
two questions from the chat box, because they’re along the lines
of retail inspection contracts. One is from Nathan Schreiner,
and he asks, “Will Tribal governments
that sell cigarettes be considered for the retail
inspection contracts?” – This is Heather again. Yes, they can be considered for
the retail inspection contracts. One thing that–that may need
to be worked on in the proposal is, the RFP has a conflict
of interest section in it where any potential
conflicts of interest would need to be disclosed. So for example,
if there are Tribal enterprises that would benefit or not benefit
from these inspections, those types of things
would need to be disclosed, and any sort
of mitigation strategy would need to be provided for
in the proposal. So we would expect–
we do expect, given these circumstances, that there will be
potential conflicts, but the key
is that they’re– they’re presented
in the proposal and mitigation strategies
are also presented. – Thank you, Heather. The next question’s
from Gregory Smith, and he asks, “So will
a non-Public Law 280 Tribe contract directly with FDA?” – I don’t know
the ins and outs of that– this is Heather again– but I don’t think that we have
any restrictions on who we contract with. As long as they–
I know as long– with the state and–
the state and territories, as long as they are
a government agency– you know,
that was acceptable and they were
acceptable contractors– I don’t see this
being an issue, but we could certainly
look into it further. But I don’t see it
being an issue. The key is that they would be
employees of the Tribal Government
conducting the inspections because that’s the requirement
for us to commission them as FDA officials for these
retail compliance checks. – Heather. That concludes
our questions in the chat box. We’re still available
for questions on the phone. – If you have a question
on the phone, please press star 1. And there are currently
no questions in the phone queue. – We do have a question
in the chat box. Can you put a link
to the RFP on here? And we will be sending out
the link to everyone that has joined. The link will also be
on our website, and so you’ll see the link
very shortly. We just–it just posted
this afternoon, so it’s not yet up
on our website. – The other thing
I wanted to mention is, I know we have a good group here
participating today, but if you have any friends
or colleagues in other Tribes that you think
might be interested or– I request
that you forward our link and our RFP
or, you know, call ’em up and recommend that they watch
this webinar, which will be recorded
and posted on our website also. – We do have a question
from Ben Fenner. – Hi. Thanks for– Thanks for taking my question. I had one kind of follow-up. You mentioned
that the manufacturers– that the inspection
of the manufacturers, that is conducted
by the CTP itself. Is that correct? – Yeah,
how that works is, FDA has an Office
of Regulatory Affairs, and that’s the field folks. Those are the people
that have district offices all around the United States. They go in and do
food facility inspections, drug inspections,
medical devices, blood inspections. They are the ones
who do the inspections for tobacco product
manufacturers. They go as a part of a team, and staff from my office serve
as subject matter experts to assist them
during these inspections. And those are all conducted
by FDA folks around the United States. The tobacco retailers,
as you can imagine, when we have an estimate
of over 500,000 tobacco product manufacturers–
excuse me–retailers, those are conducted
with the assistance of states, territories,
and, after today, hopefully, Tribal leaders
and Tribal members who apply for our contracts to assist us on these
inspections in Tribal lands. – Thank you. You mentioned there was
a Dear Tribal Leader Letter on the–
in manufacturer inspections. Is that posted online? – Yes, it is.
– Okay. – CTP has a web page that’s titled
State Territorial– State, Tribal, Territorial
and Local web page where we have a lot
of this kind of information, and that includes
the Dear Tribal Leader Letter that we sent out
on May 16th announcing this webinar
and some of these activities. And we also– I was just gonna
include it on the chat with that link to the RFP
I just put. We also hope to post the link to this FedBizOpps RFP so it’s a little easier
for some folks to find. – If you can’t find anything
that we talked about today, again, you can either send
to AskCTP, or you can reach out to Heather
and Evonne directly. We can help you navigate
to our website and find anything
that you need. – Oh, and Evonne just raised
a good point, that currently the way
the RFP is written, the–any interested parties would need to submit a proposal by, I believe it’s 5:00 p.m.
July 18th. – And they can be sent
electronically as well. – Thank you, Heather. We’re still taking questions. – Again, if you have a question,
please press star 1. And there are currently
no questions on the phone. – Okay, great. We don’t have any questions
in the chat box either. Again, please reach out
to folks on the phone, which is Heather Althouse
or myself. If you have any questions
about the RFP, Office of Compliance
and Enforcement, manufacturing inspections, we’ll definitely be able
to assist you. And that brings us to the end
of today’s webinar. Thank you very much
for joining us. The Center for Tobacco Products will respond and follow up
communications to everyone
that has registered. Also, these slides will be
posted to our website very soon. Ann, do you have
any closing remarks? – Just my personal thanks to
everyone for joining us today. We look forward to receiving
your applications to work with us, to assist us
in our compliance activities, in particular as it pertains
to compliance education on Tribal lands as well as inspections
of tobacco product retailers. So thank you again
for joining us. – Thank you all
for your participation in today’s webinar. Also, if you do have
follow-up questions or comments, we can always take those
anytime. This concludes our consultation on CTP’s Office of Compliance
and Enforcement activities. Thank you and ahe’hee.

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