42508 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2904] 

Expanding Access to Effective 

Treatment for Opioid Use Disorder: 

Provider Perspectives on Reducing 

Barriers to Evidence-Based Care; 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the following public 

meeting entitled ‘‘Expanding Access to 

Effective Treatment for Opioid Use 

Disorder: Provider Perspectives on 

Reducing Barriers to Evidence-Based 

Care.’’ Convened by the Duke-Robert J. 

Margolis, MD, Center for Health Policy 

at Duke University and supported by a 

cooperative agreement with FDA, the 

public meeting is intended to generate 

a discussion with providers and health 

system stakeholders on the 

armamentarium of medications to treat 

opioid use disorder (OUD), current 

barriers to appropriate use of these 

medications, opportunities to further 

reduce stigma, and methods to expand 

access to effective pharmacotherapies as 

part of an evidence-based approach to 

OUD treatment. 

DATES: The public meeting will be held 

on September 20, 2018, from 9 a.m. to 

4 p.m. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public meeting will be 

held at the National Press Club, 529 

14th St. NW, Washington, DC 20045. 

For additional travel and hotel 

information, please refer to the 

following web page: https://

healthpolicy.duke.edu/events/ 

expanding-access-to-treatment-for-OUD. 

There will also be a live webcast for 

those unable to attend the meeting in 

person (see Streaming Webcast of the 

Public Meeting). 

FOR FURTHER INFORMATION CONTACT: 

Mitra Ahadpour, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, Rm. 4546, 

Silver Spring, MD 20993–0002, 301– 

796–8469, Mitra.Ahadpour@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The opioid epidemic remains a 

growing public health crisis. FDA efforts 

to address the opioid crisis have 

included, among other things, revision 

of the document entitled ‘‘FDA 

Education Blueprint for Health Care 

Providers Involved in the Management 

or Support of Patients with Pain’’ 

(https://www.fda.gov/Drugs/ 

NewsEvents/ucm553931.htm), to 

support rational prescribing, packaging, 

storage, and disposal of opioids; 

stemming illegal opioid sales; 

expanding the Risk Evaluation and 

Mitigation Strategy to cover immediaterelease opioid formulations; monitoring 

the abuse potential of marketed opioids 

and taking regulatory action as needed; 

and addressing barriers to new drug 

development for non-opioid alternative 

treatment of pain. Despite these efforts 

and those of others, opioid misuse, 

OUD, and overdose remain major public 

health challenges (Refs. 1 and 2). 

Over 2.1 million persons aged 12 or 

older suffer from opioid use disorders 

related to prescription opioid analgesics 

or heroin (Ref. 2), and the majority of 

those suffering from OUD still lack 

access to evidence-based treatment. 

Although there is no one-size-fits-all 

approach to OUD treatment, there is 

strong evidence demonstrating the 

effectiveness of FDA-approved 

medications, combined with counseling 

and behavioral therapies, for these 

patients. Promoting the wider use of 

these safe and effective therapies is a 

key priority of FDA. However, 

substantial challenges remain in patient 

access and provider use of medications 

for OUD treatment. 

This public meeting is intended to 

serve as a platform to engage in and 

generate an active discussion with 

provider communities and health 

system stakeholders on the 

armamentarium of medications to treat 

OUD, barriers to appropriate use of 

these medications, opportunities to 

further reduce stigma, and methods to 

expand access to effective OUD 

treatment. 

II. Topics for Discussion at the Public 

Meeting 

During the public meeting, speakers 

and participants will cover issues 

related to expanding access to effective 

treatment for OUD, specifically in 

regard to provider perspectives on 

reducing barriers to evidence-based 

care. Topics will include, but are not 

limited to, the following: 

• The role of FDA and the 

Department of Health and Human 

Services in confronting and combatting 

the opioid epidemic; 

• The current state of knowledge on 

addiction, clinical approaches for 

identifying and assessing OUD, and use 

of medication-assisted treatment; 

• Gaps in the pharmacological 

armamentarium for treating OUD, 

including shortfalls or unmet needs that 

should be considered in developing new 

therapies; 

• Innovative and evidence-based 

approaches to OUD treatment delivery, 

lessons learned, and challenges to 

broader implementation; 

• Legal, regulatory, and cultural 

barriers to access for treatment for OUD 

and potential opportunities to reduce 

stigma and expand access to effective 

OUD treatment; 

• Care models and challenges for 

increasing access to OUD treatment for 

vulnerable and medically underserved 

populations; and 

• Clinical, health system, and 

economic perspectives on defining 

successful outcomes for OUD treatment, 

including how establishing outcome 

measures may facilitate quality 

improvement, innovative payment 

approaches, and access to effective care. 

During meeting sessions, audience 

and webcast participants will be invited 

to actively participate in the discussion 

regarding provider and clinical expert 

perspectives on treatment for OUD and 

barriers to care. 

III. Participating in the Public Meeting 

Registration: Persons interested in 

attending this public meeting must 

register online at https://

healthpolicy.duke.edu/expandingaccess-to-treatment-for-OUD by 

September 19, 2018, by 5 p.m. Eastern 

Time. Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email 

address, and telephone number. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when the registration has 

been accepted. If time and space permit, 

onsite registration on the day of the 

public meeting will be provided 

beginning at 8 a.m. We will let 

registrants know if registration closes 

before the day of the public meeting. 

If you need special accommodations 

due to a disability, please contact Sarah 

Supsiri at the Duke-Margolis Center for 

Health Policy (202–791–9561, 

sarah.supsiri@duke.edu) no later than 

September 13, 2018. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast, and archived video footage 

will be available at the Duke-Margolis 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42509 

Center’s website following the meeting: 

https://healthpolicy.duke.edu/events/ 

expanding-access-to-treatment-for-OUD. 

Webcast participants will be able to 

submit questions and comments via the 

webcast portal. Persons interested in 

participating in the live webcast must 

register online by September 19, 2018, 

by 5 p.m. Eastern Time (see Registration 

section above). Early registration is 

recommended because webcast 

connections are limited. Organizations 

are required to register all participants; 

however, we request that organizations 

view the meeting using one connection 

per location whenever possible. 

Other Issues for Consideration: All 

event materials will be provided to 

registered attendees via email prior to 

the meeting and will be made publicly 

available at the Duke-Margolis Center’s 

website: https://healthpolicy.duke.edu/ 

events/expanding-access-to-treatmentfor-OUD. A 1-hour lunch break is 

scheduled, but food will not be 

provided. There are multiple restaurants 

within walking distance of the 

Conference Center. 

IV. References 

The following references are on 

display in the Dockets Management 

Staff (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, and are 

available for viewing by interested 

persons between 9 a.m. and 4 p.m., 

Monday through Friday; they are also 

available electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Hedegaard, H., M. Warner, and A.M. 

Minin ̃ o, ‘‘Drug Overdose Deaths in the 

United States, 1999–2016,’’ NCHS Data 

Brief, no. 294, Hyattsville, MD: National 

Center for Health Statistics. 2017 

(available at https://www.cdc.gov/nchs/ 

products/databriefs/db294.htm), 

accessed June 27, 2018. 

2. Substance Abuse and Mental Health 

Services Administration, Center for 

Behavioral Health Statistics and Quality, 

‘‘Results from the 2016 National Survey 

on Drug Use and Health: Detailed 

Tables.’’ September 8, 2016 (available at 

https://www.samhsa.gov/data/sites/ 

default/files/NSDUH-DetTabs-2016/ 

NSDUH-DetTabs-2016.htm), accessed 

June 27, 2018. 

Dated: August 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18071 Filed 8–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0449] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Sun Protection 

Factor Labeling and Testing 

Requirements for Over-the-Counter 

Sunscreen Drug Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on sun protection 

factor (SPF) labeling and testing 

requirements for over-the-counter (OTC) 

sunscreen products containing specified 

ingredients and marketed without 

approved applications, and comments 

on compliance with Drug Facts labeling 

requirements for all OTC sunscreen 

products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 22, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 22, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 22, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2011–N–0449 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Sun 

Protection Factor Labeling and Testing 

Requirements and Drug Facts Labeling 

for Over-the-Counter Sunscreen Drug 

Products.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 


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