82 FR 27271 - Data and Methods for Evaluating the Impact of Opioid Formulations With Properties Designed To Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 113 (June 14, 2017)

Page Range		27271-27273
FR Document		2017-12299

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled ``Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities.'' The purpose of the public workshop is to host a scientific discussion with expert panel members and interested stakeholders about the challenges in using the currently available data and methods for assessing the impact of opioid formulations with properties designed to deter abuse on opioid misuse, abuse, addiction, overdose, and death in the postmarket setting. The goal of this meeting is to discuss ways to improve the analysis and interpretation of existing data, as well as to discuss opportunities and challenges for collecting and/or linking additional data to improve national surveillance and research capabilities in this area. To assist in the workshop discussion, FDA is making available an issues paper that provides a brief overview of the currently available data resources used for evaluating the impact of opioid formulations with properties designed to deter abuse; summarizes some of the key methodological issues in this area; and outlines the issues that we would like to discuss during the upcoming workshop, including enhancing existing resources, applying new methodology, and creating new resources.

Federal Register, Volume 82 Issue 113 (Wednesday, June 14, 2017)

[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27271-27273]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2903]


Data and Methods for Evaluating the Impact of Opioid Formulations 
With Properties Designed To Deter Abuse in the Postmarket Setting: A 
Scientific Discussion of Present and Future Capabilities; Public 
Workshop; Issues Paper; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a public workshop entitled ``Data and Methods for Evaluating 
the Impact of Opioid Formulations with Properties Designed to Deter 
Abuse in the Postmarket Setting: A Scientific Discussion of Present and 
Future Capabilities.'' The purpose of the public workshop is to host a 
scientific discussion with expert panel members and interested 
stakeholders about the challenges in using the currently available data 
and methods for assessing the impact of opioid formulations with 
properties designed to deter abuse on opioid misuse, abuse, addiction, 
overdose, and death in the postmarket setting. The goal of this meeting 
is to discuss ways to improve the analysis and interpretation of 
existing data, as well as to discuss opportunities and challenges for 
collecting and/or linking additional data to improve national 
surveillance and research capabilities in this area. To assist in the 
workshop discussion, FDA is making available an issues paper that 
provides a brief overview of the currently available data resources 
used for evaluating the impact of opioid formulations with properties 
designed to deter abuse; summarizes some of the key methodological 
issues in this area; and outlines the issues that we would like to 
discuss during the upcoming workshop, including enhancing existing 
resources, applying new methodology, and creating new resources.

DATES: The public workshop will be held on July 10 and 11, 2017, from 
8:30 a.m. to 5 p.m. Submit either electronic or written comments on 
this public workshop by September 11, 2017. Late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before September 11, 2017. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of September 11, 2017. 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. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public workshop will be held at the Sheraton Silver 
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's 
phone number is 301-589-0800.
    You may submit comments as follows:

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

[[Page 27272]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2017-N-2093 for ``Data and Methods for Evaluating the Impact of 
Opioid Formulations with Properties Designed to Deter Abuse Properties 
in the Postmarket Setting: A Scientific Discussion of Present and 
Future Capabilities; Public Workshop; Issues Paper; Request for 
Comments.'' Received comments, those filed in a timely manner (see 
DATES), will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cynthia Kornegay, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2456, Silver 
Spring, MD, 20993-0002, 301-796-0187, [email protected]; or 
Cherice Holloway, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 22, Rm. 4466, Silver Spring, MD, 20993-0002, 301-796-4909, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In this 2-day public workshop, FDA plans to host a scientific 
discussion with expert panel members and interested stakeholders about 
the challenges in using the currently available data and methods for 
assessing the impact of opioid formulations with properties designed to 
deter abuse on opioid misuse, abuse, addiction, overdose, and death in 
the postmarket setting. The goal of this meeting is to discuss ways to 
improve the analysis and interpretation of existing data, as well as to 
discuss opportunities and challenges for collecting and/or linking 
additional data to improve national surveillance and research 
capabilities in this area.

II. Topics for Discussion at the Public Workshop

    FDA has developed an issues paper entitled ``Data and Methods for 
Evaluating the Impact of Opioid Formulations with Properties Designed 
to Deter Abuse in the Postmarket Setting.'' This issues paper (1) 
provides a brief overview of the currently available data resources 
used for evaluating opioid formulations with properties designed to 
deter abuse; (2) summarizes some of the key methodological issues in 
this area; and (3) outlines the issues we would like to discuss during 
the upcoming workshop, including modifying existing resources, applying 
new methodology, and creating new resources. The issues paper can be 
found on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm540845.htm.

III. Participating in the Public Workshop

    Registration: To register to attend the public workshop, ``Data and 
Methods for Evaluating the Impact of Opioid Formulations with 
Properties Designed to Deter Abuse in the Postmarket Setting: A 
Scientific Discussion of Present and Future Capabilities,'' in person 
or virtually via Webcast, please contact Cherice Holloway at 
[email protected] by June 26, 2017. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by June 26, 2017. Early registration is 
recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. Registrants will receive 
confirmation when they have been accepted. If time and space permit, 
onsite registration on the day of the public meeting/public workshop 
will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Cherice Holloway at [email protected] no later than 
Friday, June 30, 2017.
    Public Participation in Scientific Workshop: Time will be provided 
during the discussion of each agenda topic for audience participants to 
provide comments if desired. Comments should be specific to the 
discussion topic, and the time provided will be at the discretion of 
the session chair.
    Streaming Webcast of the Public Workshop: This public workshop will

[[Page 27273]]

also be Webcast. Additional information about accessing the Webcast 
will be made available at least 2 days prior to the public workshop at: 
https://www.fda.gov/Drugs/NewsEvents/ucm540845.htm.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets 
Management (see ADDRESSES). A link to the transcript will also be 
available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm540845.htm.

    Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12299 Filed 6-13-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 27271

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden per
Activity 1 responses per Total hours 2
respondents responses response
respondent

Pretest ....................................................................... 500 1 500 0.33 (20 min.) ........... 165
Eye-Tracking Screener ............................................. 80 1 80 .08 (5 min.) ............... 7
Eye-Tracking Study .................................................. 20 1 20 1 ................................ 20
Main Study Screener ................................................ 2,206 1 2,206 .03 (2 min.) ............... 67
Main Study ................................................................ 1,500 1 1,500 0.33 (20 min.) ........... 495

Total ................................................................... ........................ ........................ ........................ ................................... 1,563
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the next full hour.

References Dated: June 9, 2017. assist in the workshop discussion, FDA
Anna K. Abram, is making available an issues paper that
1. Dodge, T. and A. Kaufman. ‘‘What Makes
Deputy Commissioner for Policy, Planning, provides a brief overview of the
Consumers Think Dietary Supplements
Are Safe and Effective? The Role of
Legislation, and Analysis. currently available data resources used
Disclaimers and FDA Approval.’’ Health [FR Doc. 2017–12329 Filed 6–13–17; 8:45 am] for evaluating the impact of opioid
Psychology, 26(4), 513–517. (2007). BILLING CODE 4164–01–P formulations with properties designed
2. Dodge, T., D. Litt, and A. Kaufman. to deter abuse; summarizes some of the
‘‘Influence of the Dietary Supplement key methodological issues in this area;
Health and Education Act on Consumer DEPARTMENT OF HEALTH AND and outlines the issues that we would
Beliefs About the Safety and HUMAN SERVICES like to discuss during the upcoming
Effectiveness of Dietary Supplements.’’ workshop, including enhancing existing
Journal of Health Communication: Food and Drug Administration resources, applying new methodology,
International Perspectives. 16(3), 230– [Docket No. FDA–2017–N–2903] and creating new resources.
244. (2011). DATES: The public workshop will be
3. Mason, M.J., D.L. Scammon, and X. Feng. Data and Methods for Evaluating the held on July 10 and 11, 2017, from 8:30
‘‘The Impact of Warnings, Disclaimers Impact of Opioid Formulations With a.m. to 5 p.m. Submit either electronic
and Product Experience on Consumers’ Properties Designed To Deter Abuse in or written comments on this public
Perceptions of Dietary Supplements.’’ the Postmarket Setting: A Scientific workshop by September 11, 2017. Late,
Journal of Consumer Affairs, 41(1), 74– Discussion of Present and Future untimely filed comments will not be
99. (2007). Capabilities; Public Workshop; Issues considered. Electronic comments must
4. France, K.R. and P.F. Bone. ‘‘Policy Paper; Request for Comments be submitted on or before September 11,
Makers’ Paradigms and Evidence from 2017. The https://www.regulations.gov
Consumer Interpretations of Dietary AGENCY: Food and Drug Administration, electronic filing system will accept
Supplement Labels.’’ Journal of HHS. comments until midnight Eastern Time
Consumer Affairs, 39(1), 27–51. (2005). ACTION: Notice of public workshop; at the end of September 11, 2017.
5. FTC. ‘‘Full Disclosure.’’ Accessed at: request for comments. Comments received by mail/hand
https://www.ftc.gov/news-events/blogs/ delivery/courier (for written/paper
business-blog/2014/09/full-disclosure SUMMARY: The Food and Drug submissions) will be considered timely
(September 23, 2014). Administration (FDA, the Agency, or if they are postmarked or the delivery
6. Higgins, E., M. Leinenger, and K. Rayner. we) is announcing a public workshop service acceptance receipt is on or
‘‘Eye Movements When Viewing entitled ‘‘Data and Methods for before that date. See the SUPPLEMENTARY
Advertisements.’’ Frontiers in Evaluating the Impact of Opioid INFORMATION section for registration date
Psychology, 5, 210. (2014). Formulations with Properties Designed and information.
7. Pieters, R., M. Wedel, and R. Batra. ‘‘The to Deter Abuse in the Postmarket
Stopping Power of Advertising: ADDRESSES: The public workshop will
Setting: A Scientific Discussion of be held at the Sheraton Silver Spring
Measures and Effects of Visual Present and Future Capabilities.’’ The
Complexity.’’ Journal of Marketing, Hotel, 8777 Georgia Ave., Silver Spring,
purpose of the public workshop is to MD 20910. The hotel’s phone number is
74(5), 48–60. (2010). host a scientific discussion with expert
8. Thomsen, S. and K. Fulton. ‘‘Adolescents’ 301–589–0800.
panel members and interested You may submit comments as
Attention to Responsibility Messages in
stakeholders about the challenges in follows:
Magazine Alcohol Advertisements: An
using the currently available data and
Eye-Tracking Approach.’’ Journal of Electronic Submissions
Adolescent Health, 41, 27–34. (2007).
methods for assessing the impact of
9. Simola, J., J. Kuisma, A. Öörni, L. Uusitalo, opioid formulations with properties Submit electronic comments in the
et al. ‘‘The Impact of Salient designed to deter abuse on opioid following way:
Advertisements on Reading and misuse, abuse, addiction, overdose, and • Federal eRulemaking Portal:
death in the postmarket setting. The https://www.regulations.gov. Follow the
mstockstill on DSK30JT082PROD with NOTICES

Attention on Web pages.’’ Journal of
Experimental Psychology: Applied, goal of this meeting is to discuss ways instructions for submitting comments.
17(2), 174–190. (2011). to improve the analysis and Comments submitted electronically,
10. Wedel, M. and R. Pieters. ‘‘A Review of interpretation of existing data, as well as including attachments, to https://
Eye-Tracking Research in Marketing.’’ In to discuss opportunities and challenges www.regulations.gov will be posted to
Review of Marketing Research, Vol. 4 for collecting and/or linking additional the docket unchanged. Because your
(pp. 123–147), N.K. Malhotra (Ed.). data to improve national surveillance comment will be made public, you are
Armonk, New York: M.E. Sharpe. (2008). and research capabilities in this area. To solely responsible for ensuring that your

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Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 27273

also be Webcast. Additional information Time: 8:00 a.m. to 5:00 p.m. Date: June 29–30, 2017.
about accessing the Webcast will be Agenda: To review and evaluate grant Time: 8:00 a.m. to 5:00 p.m.
made available at least 2 days prior to applications. Agenda: To review and evaluate grant
Place: Crystal City Marriott, 1999 Jefferson applications.
the public workshop at: https:// Davis Highway, Arlington, VA 22202. Place: Bethesda North Marriott Hotel &
www.fda.gov/Drugs/NewsEvents/ Contact Person: William J. Johnson, Ph.D., Conference Center, 5701 Marinelli Road,
ucm540845.htm. Scientific Review Officer, Office of Scientific Bethesda, MD 20852.
Transcripts: Please be advised that as Review/DERA, National Heart, Lung, and Contact Person: Kan Ma, Ph.D., Scientific
soon as a transcript of the public Blood Institute, 6701 Rockledge Drive, Room Review Officer, Scientific Review Branch,
workshop is available, it will be 7178, Bethesda, MD 20892–7924, 301–827– National Institute of Arthritis,
accessible at https:// 7938, johnsonwj@nhlbi.nih.gov. Musculoskeletal and Skin Diseases, NIH,
www.regulations.gov. It may be viewed Name of Committee: National Heart, Lung, 6701 Democracy Boulevard, Suite 814,
and Blood Institute Special Emphasis Panel; Bethesda, MD 20892, 301–451–4838, mak2@
at the Division of Dockets Management mail.nih.gov.
(see ADDRESSES). A link to the transcript Short-Term Research Education to Increase
Diversity. (Catalogue of Federal Domestic Assistance
will also be available on the Internet at Date: July 7, 2017. Program Nos. 93.846, Arthritis,
https://www.fda.gov/Drugs/NewsEvents/ Time: 8:30 a.m. to 4:00 p.m. Musculoskeletal and Skin Diseases Research,
ucm540845.htm. Agenda: To review and evaluate grant National Institutes of Health, HHS)
Dated: June 9, 2017. applications.
Place: The William F. Bolger Center, 9600 Dated: June 8, 2017.
Anna K. Abram, Sylvia L. Neal,
Newbridge Drive, Potomac, MD 20854.
Deputy Commissioner for Policy, Planning, Contact Person: Lindsay Marie Garvin, Program Analyst, Office of Federal Advisory
Legislation, and Analysis. Ph.D., Scientific Review Officer, National Committee Policy.
[FR Doc. 2017–12299 Filed 6–13–17; 8:45 am] Heart, Lung, and Blood Institute, 6701 [FR Doc. 2017–12240 Filed 6–13–17; 8:45 am]
BILLING CODE 4164–01–P Rockledge Drive, Suite 7189, Bethesda, MD
BILLING CODE 4140–01–P
20892, 301–827–7911, lindsay.garvin@
nih.gov.
DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND
HUMAN SERVICES Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
HUMAN SERVICES
National Institutes of Health Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
National Institutes of Health
National Heart, Lung, and Blood and Resources Research, National Institutes
of Health, HHS) National Institute of Arthritis and
Institute; Notice of Closed Meetings Musculoskeletal and Skin Diseases;
Pursuant to section 10(d) of the Dated: June 8, 2017. Notice of Closed Meeting
Federal Advisory Committee Act, as Michelle Trout, Pursuant to section 10(d) of the
amended (5 U.S.C. App.), notice is Program Analyst, Office of Federal Advisory Federal Advisory Committee Act, as
hereby given of the following meetings. Committee Policy. amended (5 U.S.C. App.), notice is
The meetings will be closed to the [FR Doc. 2017–12239 Filed 6–13–17; 8:45 am] hereby given of the following meeting.
public in accordance with the BILLING CODE 4140–01–P The meeting will be closed to the
provisions set forth in sections public in accordance with the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., provisions set forth in sections
as amended. The grant applications and DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
the discussions could disclose HUMAN SERVICES as amended. The grant applications and
confidential trade secrets or commercial the discussions could disclose
property such as patentable material, National Institutes of Health
confidential trade secrets or commercial
and personal information concerning property such as patentable material,
individuals associated with the grant National Institute of Arthritis and
Musculoskeletal and Skin Diseases; and personal information concerning
applications, the disclosure of which individuals associated with the grant
would constitute a clearly unwarranted Notice of Closed Meeting
applications, the disclosure of which
invasion of personal privacy. Pursuant to section 10(d) of the would constitute a clearly unwarranted
Name of Committee: National Heart, Lung, Federal Advisory Committee Act, as invasion of personal privacy.
and Blood Institute Special Emphasis Panel; amended (5 U.S.C. App.), notice is
Name of Committee: National Institute of
Career Development Program to Promote hereby given of the following meeting. Arthritis and Musculoskeletal and Skin
Diversity in Health Research. The meeting will be closed to the
Date: July 6, 2017. Diseases Special Emphasis Panel; Training
public in accordance with the Grants Review.
Time: 8:30 a.m. to 4:00 p.m. provisions set forth in sections
Agenda: To review and evaluate grant Date: June 20, 2017.
applications.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 2:00 p.m. to 3:30 p.m.
Place: The William F. Bolger Center, 9600 as amended. The grant applications and Agenda: To review and evaluate grant
Newbridge Drive, Potomac, MD 20854. the discussions could disclose applications.
Contact Person: Lindsay Marie Garvin, confidential trade secrets or commercial Place: National Institute of Arthritis and
Ph.D., Scientific Review Officer, National property such as patentable material, Musculoskeletal and Skin Diseases, 6701
Heart, Lung, and Blood Institute, 6701 Democracy Blvd., Suite 824, Bethesda, MD
and personal information concerning 20892 (Telephone Conference Call).
Rockledge Drive, Suite 7189, Bethesda, MD individuals associated with the grant
mstockstill on DSK30JT082PROD with NOTICES

20892, 301–827–7911, lindsay.garvin@ Contact Person: Yin Liu, Ph.D., MD,
applications, the disclosure of which Scientific Review Officer, Scientific Review
nih.gov.
would constitute a clearly unwarranted Branch, National Institute of Health/NIAMS,
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
invasion of personal privacy. 6701 Democracy Blvd., Suite 824, Bethesda,
MD 20892, 301–594–4952, liuy@
NHLBI Biorepository: Scientific Name of Committee: National Institute of
exchange.nih.gov.
Opportunities for Exploratory Research Arthritis and Musculoskeletal and Skin
(R21). Diseases Special Emphasis Panel; P30 Core (Catalogue of Federal Domestic Assistance
Date: July 7, 2017. Centers for Clinical Research. Program Nos. 93.846, Arthritis,

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Document Created: 2017-06-14 01:23:37
Document Modified: 2017-06-14 01:23:37

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop; request for comments.
Dates		The public workshop will be held on July 10 and 11, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by September 11, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 11, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 11, 2017. 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. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Contact		Cynthia Kornegay, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2456, Silver Spring, MD, 20993-0002, 301-796-0187, [email protected]; or Cherice Holloway, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4466, Silver Spring, MD, 20993-0002, 301-796-4909, [email protected]
FR Citation		82 FR 27271

82 FR 27271 - Data and Methods for Evaluating the Impact of Opioid Formulations With Properties Designed To Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 113 (June 14, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration