
[Federal Register Volume 79, Number 130 (Tuesday, July 8, 2014)]
[Notices]
[Pages 38541-38542]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0233]


Center for Drug Evaluation and Research; Use of Innovative 
Packaging, Storage, and/or Disposal Systems To Address the Misuse and 
Abuse of Opioid Analgesics; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice entitled ``Center for Drug Evaluation and 
Research; Use of Innovative Packaging, Storage, and/or Disposal Systems 
to Address the Misuse and Abuse of Opioid Analgesics,'' which published 
in the Federal Register of April 9, 2014. FDA is reopening the comment 
period to allow interested persons additional time to submit comments.

DATES: Submit either electronic or written comments by August 7, 2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Colleen Brennan, Center for Drug 
Evaluation and Research, Food and Drug Administration, Office of 
Surveillance and Epidemiology, 10903 New Hampshire Ave., Bldg. 22, Rm. 
4410, Silver Spring, MD 20993-0002, 301-796-2316, email: 
Colleen.Brennan@fda.hhs.gov, with the subject line identified as 
``Packaging Abuse Deterrence Strategies.''

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of April 9, 2014 (79 FR 19619), FDA 
announced the establishment of a docket to receive suggestions, 
recommendations, and comments on innovative packaging, storage and 
disposal systems, technologies or designs that could be used to prevent 
or deter misuse and abuse of opioid analgesics by patients and others. 
In the notice, FDA stated that comments about specific system or 
technology designs should include a description of the following: (1) 
Design features and functionality; (2) results of any formative or 
summative human factors assessments conducted; (3) applications to 
date, including information on the effectiveness and acceptability of 
those applications (with literature references or other documentation); 
(4) recommendations for how the system/technology design could be 
applied or adapted (either alone and/or in combination with other 
systems/technologies) to help prevent or deter misuse and abuse, and 
any limitations of that application; (5) specific problems that could 
be addressed (e.g., serious complications such as addiction or overdose 
due to improper dosage and/or administration, improper disposal, 
accidental use by someone for whom the medication was not prescribed); 
and (6) to the extent possible, considerations for implementation into 
routine dispensing and clinical use (e.g., how the solution would 
impact the workflow in a retail pharmacy).
    To help FDA prioritize among proposed approaches, the Agency is 
also interested in receiving feedback about methods that could be used 
to assess a system or technology's potential abuse-deterrent 
characteristics and real-world impact (e.g., actual ability to prevent 
or deter misuse and abuse, effect on access for appropriate patients, 
patient confidentiality, burden on the healthcare system, feasibility 
of implementation, whether the design could create unintended 
medication errors). Finally, FDA is interested in receiving feedback on 
methods for encouraging further research and development in this area, 
and, if promising technologies are identified, incentivizing the 
pharmaceutical industry (e.g. via patent extensions) to adopt such 
technologies.
    Interested persons were given until June 9, 2014, to submit 
comments. On our own initiative, the Agency is reopening the comment 
period until August 7, 2014 to allow interested persons additional time 
to submit comments. The Agency believes that an additional 30 days 
allows adequate time for interested persons to submit comments without 
significantly delaying the Agency's consideration of these important 
issues.

II. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division

[[Page 38542]]

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.

    Dated: July 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15809 Filed 7-7-14; 8:45 am]
BILLING CODE 4164-01-P


