Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics; Public Meeting; Request for Comments, 22499-22501 [2014-09123]

Download as PDF 22499 Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices we expect that about 5% of participants taking the pre-choice survey will not return to participate in the experiment one week later, the number of respondents initially required is 5% higher (1,575) than the full sample of 1,500 required for the experiment. We estimate based on our previous experience with the SelectMD 1.0 experiment that participants will require about 10 minutes to review the information on the Web site and select their preferred physician from the set of doctors available. The average time required to complete the post-choice survey is estimated to be 20 minutes. Consequently, respondents will average about 40 minutes completing all three phases of the study. Exhibit 2 shows the respondents’ cost burden for their time to participate in this experiment. The total cost burden is estimated to be $22,297. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Pre-Choice Survey ........................................................................................... Time on Website (Choosing MD) .................................................................... Post-Choice Survey ......................................................................................... Total Hours ............................................................................................... Number of responses per respondent 1575 1500 1500 4,575 1 1 1 na Hour per response (min/60) 10/60 10/60 20/60 na Total burden hours 263 250 500 1,013 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Form name Number of respondents Total burden hours Average hourly wage rate * Pre-Choice Survey ........................................................................................... Time on Website (Choosing MD) .................................................................... Post-Choice Survey ......................................................................................... Total Cost ................................................................................................. 1575 1500 1500 ........................ 263 250 500 ........................ $22.01 22.01 22.01 ........................ Total cost burden $5,789 5,503 11,005 22,297 * Based upon the national mean hourly wage for all occupations from the ‘‘May 2012 Occupational Employment and Wage Estimates’’, U.S. Department of Labor, Bureau of Labor Statistics. tkelley on DSK3SPTVN1PROD with NOTICES Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: April 9, 2014. Richard Kronick, AHRQ Director. [FR Doc. 2014–09168 Filed 4–21–14; 8:45 am] BILLING CODE 4160–90–P VerDate Mar<15>2010 16:26 Apr 21, 2014 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0374] Postmarketing Requirements for the Class-Wide Extended-Release/LongActing Opioid Analgesics; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public meeting to obtain stakeholder input on the design and conduct of the postmarketing requirements (PMRs) for the class-wide extended-release/longacting (ER/LA) opioid analgesic drug products to further assess the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with their long-term use. FDA is seeking input on these issues from stakeholders, including patients, academia, researchers, State and other Federal regulators, health care organizations, health care providers, the pharmaceutical industry, and others from the general public. DATES: The public meeting will be held on May 19 and 20, 2014, from 8 a.m. to SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 5 p.m. Individuals who wish to present at the meeting must register by May 9, 2014. See section III under the SUPPLEMENTARY INFORMATION section for information on how to register to speak at the meeting. ADDRESSES: The public meeting will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Participants must enter through Building 1 and undergo security screening. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Submit either electronic or written comments by June 19, 2014. Submit electronic comments to https:// 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. Identify all comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Janelle Derbis, Center for Drug Evaluation and Research, Food and Drug Administration, 20 North Michigan Ave., Suite 510, Chicago, IL 60602, 312–596–6516, FAX: 312–886– E:\FR\FM\22APN1.SGM 22APN1 22500 Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices 1682, email: ERLAOpioidPMRMeeting@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES I. Background FDA is committed to improving the safe and appropriate use of ER/LA opioid analgesics and preserving appropriate access for those patients who rely on these medications to manage their pain. In May 2012, FDA hosted a scientific workshop to discuss the assessment of analgesic treatment of chronic pain, during which presenters raised concerns about the safe and appropriate use of opioid analgesics.1 Over the past 2 years, FDA has reviewed numerous submissions to Agency dockets, including citizen petitions and comments to petitions, and relevant literature about the benefits and risks associated with opioid drug products, including the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with the long-term use of ER/LA opioid analgesics. FDA has concluded that more data are needed regarding these serious risks. FDA described these data requirements in its September 10, 2013, letter to all new drug application (NDA) applicants for ER/LA opioid analgesics. Data are needed to address the following issues: • The incidence of and risk factors for misuse, abuse, addiction, overdose, and death associated with long-term use of opioids for chronic pain. • Validated measures of misuse, abuse, addiction, overdose, and death. • Validated coded medical terminologies used to identify misuse, abuse, addiction, overdose, and death. • Validated definitions of ‘‘doctor/ pharmacy shopping’’ as outcomes suggestive of misuse, abuse, and addiction. • The serious risk of developing hyperalgesia following use of ER/LA opioid analgesics for at least 1 year to treat chronic pain. In the September 10, 2013, letter, FDA informed the ER/LA opioid analgesic NDA application holders of the requirement to conduct postapproval studies (also referred to as postmarketing requirements or PMRs) and established milestone dates for completion of those studies, which include observational studies and a clinical trial (see section II for more 1 Assessment of Analgesic Treatment of Chronic Pain: A Scientific Workshop (see https:// www.fda.gov/Drugs/NewsEvents/ucm283979.htm). Information and comments from that workshop are available at www.regulations.gov, Docket No. FDA– 2012–N–0067. VerDate Mar<15>2010 16:26 Apr 21, 2014 Jkt 232001 details). The deadline for the applicants’ final protocol submissions is August 2014. II. Purpose and Scope of Meeting The purpose of this public meeting is to obtain stakeholder input on the design and conduct of the PMRs (described in the following paragraph) for the ER/LA opioid analgesic drug products to assess the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with their long-term use. FDA and NDA applicants will consider stakeholder input when preparing final protocols to be submitted by August 2014. The PMRs described in FDA’s September 10, 2013, letter to NDA applicants of ER/LA opioid analgesics are as follows: (1) PMR # 2065–1: Conduct one or more studies to provide quantitative estimates of the serious risks of misuse, abuse, addiction, overdose, and death associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed ER/LA opioid products. Include an assessment of risk relative to efficacy. These studies should address at a minimum the following specific aims: a. Estimate the incidence of misuse, abuse, addiction, overdose, and death associated with long-term use of opioids for chronic pain. Stratify misuse and overdose by intentionality wherever possible. Examine the effect of product/ formulation, dose and duration of opioid use, prescriber specialty, indication, and other clinical factors (e.g., concomitant psychotropic medications, personal or family history of substance abuse, and history of psychiatric illness) on the risk of misuse, abuse, addiction, overdose, and death. b. Evaluate and quantify other risk factors for misuse, abuse, addiction, overdose, and death associated with long-term use of opioids for chronic pain, including, but not limited to, the following: Demographic factors, psychosocial/behavioral factors, medical factors, and genetic factors. Identify confounders and effect modifiers of individual risk factor/ outcome relationships. Stratify misuse and overdose by intentionality wherever possible. (2) PMR # 2065–2: Develop and validate measures of the following opioid-related adverse events: Misuse, abuse, addiction, overdose, and death (based on the Department of Health and Human Services’ definition, or any agreed upon definition), which will be used to inform the design and analysis for PMR # 2065–1 and any future PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 postmarketing safety studies and clinical trials to assess these risks. This can be achieved by conducting an instrument development study or a validation study of an algorithm based on secondary data sources. (3) PMR # 2065–3: Conduct a study to validate coded medical terminologies (e.g., ICD9, ICD10, and SNOMED) used to identify the following opioid-related adverse events: Misuse, abuse, addiction, overdose, and death in any existing postmarketing databases to be employed in the studies. Stratify misuse and overdose by intentionality wherever possible. These validated codes will be used to inform the design and analysis for PMR # 2065–1. (4) PMR # 2065–4: Conduct a study to define and validate ‘‘doctor/pharmacy shopping’’ as outcomes suggestive of misuse, abuse, and addiction. These validated codes will be used to inform the design and analysis for PMR # 2065– 1. (5) PMR # 2065–5: Conduct a clinical trial to estimate the serious risk for the development of hyperalgesia following use of ER/LA opioid analgesics for at least 1 year to treat chronic pain. We strongly encourage you to use the same trial to assess the development of tolerance following use of ER/LA opioid analgesics. Include an assessment of risk relative to efficacy. III. Attendance and Registration Attendance is free and will be on a first-come, first-served basis. Individuals who wish to present at the public meeting must register on or before May 9, 2014, at https:// erlaopioidpmrmeeting.eventbrite.com. In section II, FDA has listed the PMRs. You should identify which PMR(s) you wish to address in your presentation, or whether your comments apply to all PMRs, so FDA can consider that in organizing the presentations. FDA will do its best to accommodate requests to speak and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. An agenda and additional meeting background material will be available approximately 2 weeks before the meeting at https://www.fda.gov/Drugs/ NewsEvents/ucm384489.htm. Individuals who wish to attend the meeting but do not wish to make a presentation should register by May 12, 2014. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations due to a disability, please contact Janelle Derbis (see FOR FURTHER E:\FR\FM\22APN1.SGM 22APN1 Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices INFORMATION CONTACT) at least 7 days in advance. A live Web cast of this meeting will be viewable at https:// collaboration.fda.gov/opmr/ on the day of the meeting. A video record of the meeting will be available at the same Web address for 1 year. IV. Comments Interested persons may submit either electronic comments regarding this document to https://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. To ensure consideration, submit comments by June 19, 2014. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. V. Transcripts As soon as possible after a transcript of the public meeting is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Dated: April 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09123 Filed 4–21–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0398] Eli Lilly and Company, et al.; Withdrawal of Approval of 3 New Drug Applications and 41 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing SUMMARY: 22501 approval of 3 new drug applications and 41 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Effective May 22, 2014. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993–0002, 301– 796–3601. The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: TABLE 1—REQUESTS TO WITHDRAW APPROVAL OF APPLICATIONS Application No. Drug Applicant NDA 050440 ...... Keflet (cephalexin) Tablets ...................................................... NDA 050614 ...... NDA 050673 ...... ANDA 075457 .... Keftab (cephalexin hydrochloride) Tablets .............................. Ceclor CD (cefaclor) Tablets ................................................... Famotidine Tablets USP, 20 milligrams (mg) and 40 mg ....... ANDA 075559 .... Butorphanol Tartrate Injection USP, 1 mg/milliliter (mL) and 2 mg/mL. Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg .......... Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285. Do. Do. Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26505–4310. Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045. ANDA 075572 .... ANDA 075594 .... ANDA 075609 .... ANDA 075613 .... ANDA ANDA ANDA ANDA ANDA ANDA 075627 075730 075793 075847 075905 075943 .... .... .... .... .... .... tkelley on DSK3SPTVN1PROD with NOTICES ANDA 075950 .... ANDA 076018 .... ANDA 076042 .... ANDA 076044 .... Pamidronate Disodium for Injection, 30 mg/vial and 90 mg/ vial. Doxazosin Mesylate Tablets, 1 mg, 2 mg, 4 mg, and 8 mg ... Bupropion HCl Tablets, 75 mg and 100 mg ............................ Acyclovir Injection, 50 mg/mL .................................................. Thiotepa for Injection USP, 15 mg/vial and 30 mg/vial ........... Famotidine Tablets USP, 20 mg and 40 mg ........................... Oxaprozin Tablets USP, 600 mg ............................................. Famotidine Injection, 10 mg/mL ............................................... Etodolac Extended-Release Tablets, 400 mg, 500 mg, and 600 mg. Fluvoxamine Maleate Tablets, 50 mg and 100 mg ................. Amiodarone HCl Injection, 50 mg/mL ...................................... ANDA 076088 .... ANDA 076193 .... ANDA 076259 .... Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg .. Potassium Chloride Extended-Release Tablets USP, 20 milliequivalents. Amiodarone HCl Injection, 50 mg/mL ...................................... Propafenone HCl Tablets, 150 mg, 225 mg, and 300 mg ...... Milrinone Lacate in 5% Dextrose Injection .............................. ANDA 076299 .... Amiodarone HCl Injection, 50 mg/mL ...................................... VerDate Mar<15>2010 16:26 Apr 21, 2014 Jkt 232001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Nesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock Rd., Bridgeton, MO 63044. Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618. Nesher Pharmacueticals (USA) LLC. Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038– 0446. Teva Parenteral Medicines, Inc. Do. Sandoz Inc. Mylan Pharmaceuticals, Inc. Hospira, Inc. Sandoz Inc. Mylan Pharmaceuticals, Inc. Bedford Laboratories, 300 Northfield Rd., Bedford, OH 44146. Mylan Pharmaceuticals, Inc. Nesher Pharmaceuticals (USA) LLC. Bedford Laboratories. Nesher Pharmaceuticals (USA) LLC. Baxter Healthcare Corp., 25212 W. Illinois Route 120, Round Lake, IL 60073. Bedford Laboratories. E:\FR\FM\22APN1.SGM 22APN1

Agencies

[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Pages 22499-22501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09123]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0374]


Postmarketing Requirements for the Class-Wide Extended-Release/
Long-Acting Opioid Analgesics; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to obtain stakeholder input on the design and conduct of the 
postmarketing requirements (PMRs) for the class-wide extended-release/
long-acting (ER/LA) opioid analgesic drug products to further assess 
the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, 
and death associated with their long-term use.
    FDA is seeking input on these issues from stakeholders, including 
patients, academia, researchers, State and other Federal regulators, 
health care organizations, health care providers, the pharmaceutical 
industry, and others from the general public.

DATES: The public meeting will be held on May 19 and 20, 2014, from 8 
a.m. to 5 p.m. Individuals who wish to present at the meeting must 
register by May 9, 2014. See section III under the SUPPLEMENTARY 
INFORMATION section for information on how to register to speak at the 
meeting.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Participants must enter 
through Building 1 and undergo security screening. For parking and 
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit either electronic or written comments by June 19, 2014. 
Submit electronic comments to https://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. Identify all comments with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Janelle Derbis, Center for Drug 
Evaluation and Research, Food and Drug Administration, 20 North 
Michigan Ave., Suite 510, Chicago, IL 60602, 312-596-6516, FAX: 312-
886-

[[Page 22500]]

1682, email: ERLAOpioidPMRMeeting@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to improving the safe and appropriate use of ER/LA 
opioid analgesics and preserving appropriate access for those patients 
who rely on these medications to manage their pain. In May 2012, FDA 
hosted a scientific workshop to discuss the assessment of analgesic 
treatment of chronic pain, during which presenters raised concerns 
about the safe and appropriate use of opioid analgesics.\1\ Over the 
past 2 years, FDA has reviewed numerous submissions to Agency dockets, 
including citizen petitions and comments to petitions, and relevant 
literature about the benefits and risks associated with opioid drug 
products, including the serious risks of misuse, abuse, hyperalgesia, 
addiction, overdose, and death associated with the long-term use of ER/
LA opioid analgesics. FDA has concluded that more data are needed 
regarding these serious risks.
---------------------------------------------------------------------------

    \1\ Assessment of Analgesic Treatment of Chronic Pain: A 
Scientific Workshop (see https://www.fda.gov/Drugs/NewsEvents/ucm283979.htm). Information and comments from that workshop are 
available at www.regulations.gov, Docket No. FDA-2012-N-0067.
---------------------------------------------------------------------------

    FDA described these data requirements in its September 10, 2013, 
letter to all new drug application (NDA) applicants for ER/LA opioid 
analgesics. Data are needed to address the following issues:
     The incidence of and risk factors for misuse, abuse, 
addiction, overdose, and death associated with long-term use of opioids 
for chronic pain.
     Validated measures of misuse, abuse, addiction, overdose, 
and death.
     Validated coded medical terminologies used to identify 
misuse, abuse, addiction, overdose, and death.
     Validated definitions of ``doctor/pharmacy shopping'' as 
outcomes suggestive of misuse, abuse, and addiction.
     The serious risk of developing hyperalgesia following use 
of ER/LA opioid analgesics for at least 1 year to treat chronic pain.
    In the September 10, 2013, letter, FDA informed the ER/LA opioid 
analgesic NDA application holders of the requirement to conduct 
postapproval studies (also referred to as postmarketing requirements or 
PMRs) and established milestone dates for completion of those studies, 
which include observational studies and a clinical trial (see section 
II for more details). The deadline for the applicants' final protocol 
submissions is August 2014.

II. Purpose and Scope of Meeting

    The purpose of this public meeting is to obtain stakeholder input 
on the design and conduct of the PMRs (described in the following 
paragraph) for the ER/LA opioid analgesic drug products to assess the 
serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and 
death associated with their long-term use. FDA and NDA applicants will 
consider stakeholder input when preparing final protocols to be 
submitted by August 2014.
    The PMRs described in FDA's September 10, 2013, letter to NDA 
applicants of ER/LA opioid analgesics are as follows:
    (1) PMR  2065-1: Conduct one or more studies to provide 
quantitative estimates of the serious risks of misuse, abuse, 
addiction, overdose, and death associated with long-term use of opioid 
analgesics for management of chronic pain among patients prescribed ER/
LA opioid products. Include an assessment of risk relative to efficacy.
    These studies should address at a minimum the following specific 
aims:
    a. Estimate the incidence of misuse, abuse, addiction, overdose, 
and death associated with long-term use of opioids for chronic pain. 
Stratify misuse and overdose by intentionality wherever possible. 
Examine the effect of product/formulation, dose and duration of opioid 
use, prescriber specialty, indication, and other clinical factors 
(e.g., concomitant psychotropic medications, personal or family history 
of substance abuse, and history of psychiatric illness) on the risk of 
misuse, abuse, addiction, overdose, and death.
    b. Evaluate and quantify other risk factors for misuse, abuse, 
addiction, overdose, and death associated with long-term use of opioids 
for chronic pain, including, but not limited to, the following: 
Demographic factors, psychosocial/behavioral factors, medical factors, 
and genetic factors. Identify confounders and effect modifiers of 
individual risk factor/outcome relationships. Stratify misuse and 
overdose by intentionality wherever possible.
    (2) PMR  2065-2: Develop and validate measures of the 
following opioid-related adverse events: Misuse, abuse, addiction, 
overdose, and death (based on the Department of Health and Human 
Services' definition, or any agreed upon definition), which will be 
used to inform the design and analysis for PMR  2065-1 and any 
future postmarketing safety studies and clinical trials to assess these 
risks. This can be achieved by conducting an instrument development 
study or a validation study of an algorithm based on secondary data 
sources.
    (3) PMR  2065-3: Conduct a study to validate coded medical 
terminologies (e.g., ICD9, ICD10, and SNOMED) used to identify the 
following opioid-related adverse events: Misuse, abuse, addiction, 
overdose, and death in any existing postmarketing databases to be 
employed in the studies. Stratify misuse and overdose by intentionality 
wherever possible. These validated codes will be used to inform the 
design and analysis for PMR  2065-1.
    (4) PMR  2065-4: Conduct a study to define and validate 
``doctor/pharmacy shopping'' as outcomes suggestive of misuse, abuse, 
and addiction. These validated codes will be used to inform the design 
and analysis for PMR  2065-1.
    (5) PMR  2065-5: Conduct a clinical trial to estimate the 
serious risk for the development of hyperalgesia following use of ER/LA 
opioid analgesics for at least 1 year to treat chronic pain. We 
strongly encourage you to use the same trial to assess the development 
of tolerance following use of ER/LA opioid analgesics. Include an 
assessment of risk relative to efficacy.

III. Attendance and Registration

    Attendance is free and will be on a first-come, first-served basis. 
Individuals who wish to present at the public meeting must register on 
or before May 9, 2014, at https://erlaopioidpmrmeeting.eventbrite.com. 
In section II, FDA has listed the PMRs. You should identify which 
PMR(s) you wish to address in your presentation, or whether your 
comments apply to all PMRs, so FDA can consider that in organizing the 
presentations. FDA will do its best to accommodate requests to speak 
and will determine the amount of time allotted to each presenter and 
the approximate time that each oral presentation is scheduled to begin. 
An agenda and additional meeting background material will be available 
approximately 2 weeks before the meeting at https://www.fda.gov/Drugs/NewsEvents/ucm384489.htm.
    Individuals who wish to attend the meeting but do not wish to make 
a presentation should register by May 12, 2014. Onsite registration on 
the day of the meeting will be based on space availability.
    If you need special accommodations due to a disability, please 
contact Janelle Derbis (see FOR FURTHER

[[Page 22501]]

INFORMATION CONTACT) at least 7 days in advance.
    A live Web cast of this meeting will be viewable at https://collaboration.fda.gov/opmr/ on the day of the meeting. A video record 
of the meeting will be available at the same Web address for 1 year.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://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. To ensure 
consideration, submit comments by June 19, 2014. Received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

V. Transcripts

    As soon as possible after a transcript of the public meeting is 
available, it will be accessible at https://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see ADDRESSES). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09123 Filed 4-21-14; 8:45 am]
BILLING CODE 4160-01-P
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