81_FR_16244 81 FR 16186 - General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products; Draft Guidance for Industry; Availability

81 FR 16186 - General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 58 (March 25, 2016)

Page Range16186-16187
FR Document2016-06766

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.'' This draft guidance recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug.

Federal Register, Volume 81 Issue 58 (Friday, March 25, 2016) 
[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16186-16187]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0785]


General Principles for Evaluating the Abuse Deterrence of Generic 
Solid Oral Opioid Drugs Products; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``General 
Principles for Evaluating the Abuse Deterrence of Generic Solid Oral 
Opioid Drug Products.'' This draft guidance recommends studies, 
including comparative in vitro studies, which should be conducted to 
demonstrate that a proposed generic solid oral opioid drug product is 
no less abuse-deterrent than its reference listed drug.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 24, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2016-D-0785 for ``General Principles for Evaluating the Abuse-
Deterrence of Generic Solid Oral Opioid Drugs.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

[[Page 16187]]

    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Office of Generic 
Drugs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-9291, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``General Principles for Evaluating the Abuse Deterrence of 
Generic Solid Oral Opioid Drug Products.'' Prescription opioid 
analgesics are an important component of modern pain management. 
However, abuse and misuse of these drug products have created a serious 
and growing public health problem. One important step toward the goal 
of creating safer opioid analgesics has been the development of opioid 
drug products that are formulated to deter abuse. FDA considers the 
development of these products a high public health priority. It is 
important that generic versions of opioids that reference listed drugs 
whose labeling describes abuse-deterrent properties are available to 
help ensure availability of analgesics for patients who need them.
    For FDA to approve an abbreviated new drug application (ANDA), the 
Agency must find, among other things, that the generic drug product has 
the same active ingredient(s), dosage form, route of administration, 
strength, and, with limited exceptions, labeling as the reference 
listed drug (RLD); is bioequivalent to its RLD; that the methods used 
in, or the facilities and controls used for, the manufacture, 
processing, and packing of the drug are adequate to assure and preserve 
its identity, strength, quality, and purity; and that the inactive 
ingredients and composition of the generic drug are not unsafe for use 
under the conditions prescribed, recommended, or suggested in the 
labeling (see, e.g., the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) 505(j)(2)(A) and (j)(4) (21 U.S.C. 355(j)(2)(A) and (j)(4))). FDA 
classifies as ``therapeutically equivalent'' those products that meet 
the following general criteria: (1) They are approved as safe and 
effective; (2) they are pharmaceutical equivalents in that they: (a) 
Contain identical amounts of the same active ingredient in the same 
dosage form and route of administration, and (b) meet compendial or 
other applicable standards of strength, quality, purity, and identity; 
(3) they are bioequivalent; (4) they are adequately labeled; and (5) 
they are manufactured in compliance with current good manufacturing 
practices regulations. (See preface of Approved Drug Products with 
Therapeutic Equivalence Evaluations (commonly referred to as the Orange 
Book).) FDA believes that a product classified as therapeutically 
equivalent can be substituted with the full expectation that the 
substituted product will produce the same clinical effect and safety 
profile as the reference product.
    Accordingly, if the RLD's labeling describes abuse-deterrent 
properties, the ANDA applicant should evaluate its product to show that 
it is no less abuse-deterrent than the RLD with respect to all 
potential routes of abuse. Marketing a generic opioid drug product that 
is less abuse-deterrent than the RLD could lead opioid abusers to 
preferentially seek out and abuse generics.
    This draft guidance describes FDA's current thinking about the 
studies that should be conducted by a potential ANDA applicant and 
submitted to FDA in an ANDA to demonstrate that a generic solid oral 
opioid drug product is no less abuse-deterrent than its RLD with 
respect to all potential routes of abuse.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the principles 
for evaluating the abuse-deterrence of generic solid oral opioid drug 
products. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.
    FDA intends to hold a public meeting following the close of the 
comment period to discuss further the evaluation of the abuse 
deterrence of generic opioid drug products and related issues, as 
appropriate. Further details will follow in a notice of public meeting 
published in the Federal Register.

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06766 Filed 3-24-16; 8:45 am]
 BILLING CODE 4164-01-P

16186 Federal Register / Vol. 81, No. 58 / Friday, March 25, 2016 / Notices approved by the Secretary in accordance DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper with section 1413 and if it meets the HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). standards established by the Secretary. Written/Paper Submissions Food and Drug Administration Section 155.405(a) of the Exchange Submit written/paper submissions as Final Rule (77 FR 18310) provides more [Docket No. FDA–2016–D–0785] follows: detail about the application that must be • Mail/Hand delivery/Courier (for used by the Exchange to determine General Principles for Evaluating the written/paper submissions): Division of eligibility and to collect information Abuse Deterrence of Generic Solid Dockets Management (HFA–305), Food necessary for enrollment. The Oral Opioid Drugs Products; Draft and Drug Administration, 5630 Fishers regulations in § 435.907 and § 457.330 Guidance for Industry; Availability Lane, Rm. 1061, Rockville, MD 20852. establish the requirements for State AGENCY: Food and Drug Administration, • For written/paper comments Medicaid and CHIP agencies related to HHS. submitted to the Division of Dockets the use of the single streamlined Management, FDA will post your ACTION: Notice of availability. comment, as well as any attachments, application. CMS is designing the single streamlined application to be a dynamic SUMMARY: The Food and Drug except for information submitted, electronic application that will tailor the Administration (FDA) is announcing the marked and identified, as confidential, amount of data required from an availability of a draft guidance for if submitted as detailed in industry entitled ‘‘General Principles for ‘‘Instructions.’’ applicant based on the applicant’s Instructions: All submissions received circumstances and responses to Evaluating the Abuse Deterrence of must include the Docket No. FDA– particular questions. The paper version Generic Solid Oral Opioid Drug 2016–D–0785 for ‘‘General Principles of the application will not be able to be Products.’’ This draft guidance for Evaluating the Abuse-Deterrence of tailored in the same way but is being recommends studies, including Generic Solid Oral Opioid Drugs.’’ designed to collect only the data comparative in vitro studies, which Received comments will be placed in required to determine eligibility. should be conducted to demonstrate the docket and, except for those Individuals will be able to submit an that a proposed generic solid oral opioid submitted as ‘‘Confidential application electronically, through the drug product is no less abuse-deterrent Submissions,’’ publicly viewable at mail, over the phone through a call than its reference listed drug. http://www.regulations.gov or at the center, or in person, per § 155.405(c)(2) DATES: Although you can comment on Division of Dockets Management of the Exchange Final Rule, as well as any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday through other commonly available 10.115(g)(5)), to ensure that the Agency through Friday. electronic means as noted in considers your comment on this draft • Confidential Submissions—To § 435.907(a) and § 457.330 of the guidance before it begins work on the submit a comment with confidential final version of the guidance, submit information that you do not wish to be Medicaid Final Rule. The application either electronic or written comments made publicly available, submit your may be submitted to an Exchange, on the draft guidance by May 24, 2016. comments only as a written/paper Medicaid or CHIP agency. The ADDRESSES: You may submit comments submission. You should submit two electronic application process will vary as follows: copies total. One copy will include the depending on each applicant’s information you claim to be confidential circumstances, their experience with Electronic Submissions with a heading or cover note that states health insurance applications and Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS online capabilities. The goal is to solicit following way: CONFIDENTIAL INFORMATION.’’ The sufficient information so that in most • Federal eRulemaking Portal: http:// Agency will review this copy, including cases no further inquiry will be needed. www.regulations.gov. Follow the the claimed confidential information, in Form Number: CMS–10440 (OMB instructions for submitting comments. its consideration of comments. The control number: 0938–1191); Frequency: Comments submitted electronically, second copy, which will have the Annually; Affected Public: Individuals including attachments, to http:// claimed confidential information and Households; Number of www.regulations.gov will be posted to redacted/blacked out, will be available Respondents: 7,200,000; Total Annual the docket unchanged. Because your for public viewing and posted on Responses: 7,200,000; Total Annual comment will be made public, you are http://www.regulations.gov. Submit Hours: 2,410,767. (For policy questions solely responsible for ensuring that your both copies to the Division of Dockets regarding this collection contact Beth comment does not include any Management. If you do not wish your Liu at 301–492–4135.) confidential information that you or a name and contact information to be third party may not wish to be posted, made publicly available, you can Dated: March 22, 2016. such as medical information, your or provide this information on the cover William N. Parham, III, anyone else’s Social Security number, or sheet and not in the body of your Director, Paperwork Reduction Staff, Office confidential business information, such comments and you must identify this of Strategic Operations and Regulatory as a manufacturing process. Please note information as ‘‘confidential.’’ Any Affairs. that if you include your name, contact information marked as ‘‘confidential’’ [FR Doc. 2016–06830 Filed 3–24–16; 8:45 am] information, or other information that will not be disclosed except in asabaliauskas on DSK3SPTVN1PROD with NOTICES BILLING CODE 4120–01–P identifies you in the body of your accordance with 21 CFR 10.20 and other comments, that information will be applicable disclosure law. For more posted on http://www.regulations.gov. information about FDA’s posting of • If you want to submit a comment comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access do not wish to be made available to the the information at: http://www.fda.gov/ public, submit the comment as a regulatoryinformation/dockets/ written/paper submission and in the default.htm. VerDate Sep<11>2014 18:30 Mar 24, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1

Federal Register / Vol. 81, No. 58 / Friday, March 25, 2016 / Notices 16187 Docket: For access to the docket to processing, and packing of the drug are FDA intends to hold a public meeting read background documents or the adequate to assure and preserve its following the close of the comment electronic and written/paper comments identity, strength, quality, and purity; period to discuss further the evaluation received, go to http:// and that the inactive ingredients and of the abuse deterrence of generic opioid www.regulations.gov and insert the composition of the generic drug are not drug products and related issues, as docket number, found in brackets in the unsafe for use under the conditions appropriate. Further details will follow heading of this document, into the prescribed, recommended, or suggested in a notice of public meeting published ‘‘Search’’ box and follow the prompts in the labeling (see, e.g., the Federal in the Federal Register. and/or go to the Division of Dockets Food, Drug, and Cosmetic Act (the FD&C Act) 505(j)(2)(A) and (j)(4) (21 II. Electronic Access Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. U.S.C. 355(j)(2)(A) and (j)(4))). FDA Persons with access to the Internet Submit written requests for single classifies as ‘‘therapeutically may obtain the document at either copies of the draft guidance to the equivalent’’ those products that meet http://www.fda.gov/Drugs/Guidance Division of Drug Information, Center for the following general criteria: (1) They ComplianceRegulatoryInformation/ Drug Evaluation and Research, Food are approved as safe and effective; (2) Guidances/default.htm or http:// and Drug Administration, 10001 New they are pharmaceutical equivalents in www.regulations.gov. Hampshire Ave., Hillandale Building, that they: (a) Contain identical amounts Dated: March 21, 2016. 4th Floor, Silver Spring, MD 20993– of the same active ingredient in the Leslie Kux, 0002. Send one self-addressed adhesive same dosage form and route of Associate Commissioner for Policy. label to assist that office in processing administration, and (b) meet compendial or other applicable [FR Doc. 2016–06766 Filed 3–24–16; 8:45 am] your requests. See the SUPPLEMENTARY INFORMATION section for electronic standards of strength, quality, purity, BILLING CODE 4164–01–P access to the draft guidance document. and identity; (3) they are bioequivalent; FOR FURTHER INFORMATION CONTACT: Gail (4) they are adequately labeled; and (5) they are manufactured in compliance DEPARTMENT OF HEALTH AND Schmerfeld, Office of Generic Drugs, HUMAN SERVICES Center for Drug Evaluation and with current good manufacturing Research, Food and Drug practices regulations. (See preface of Meeting of the President’s Council on Administration, 10903 New Hampshire Approved Drug Products with Fitness, Sports, and Nutrition Ave., Silver Spring, MD 20993–0002, Therapeutic Equivalence Evaluations 301–796–9291, email: gail.schmerfeld@ (commonly referred to as the Orange AGENCY: President’s Council on Fitness, fda.hhs.gov. Book).) FDA believes that a product Sports, and Nutrition, Office of the classified as therapeutically equivalent Assistant Secretary for Health, Office of SUPPLEMENTARY INFORMATION: can be substituted with the full the Secretary, Department of Health and I. Background expectation that the substituted product Human Services. will produce the same clinical effect ACTION: Notice of meeting. FDA is announcing the availability of and safety profile as the reference a draft guidance for industry entitled product. SUMMARY: As stipulated by the Federal ‘‘General Principles for Evaluating the Accordingly, if the RLD’s labeling Advisory Committee Act, the U.S. Abuse Deterrence of Generic Solid Oral describes abuse-deterrent properties, the Department of Health and Human Opioid Drug Products.’’ Prescription ANDA applicant should evaluate its Services (HHS) is hereby giving notice opioid analgesics are an important product to show that it is no less abuse- that the President’s Council on Fitness, component of modern pain deterrent than the RLD with respect to Sports, and Nutrition (PCFSN) will hold management. However, abuse and all potential routes of abuse. Marketing its annual meeting. The meeting will be misuse of these drug products have a generic opioid drug product that is open to the public. created a serious and growing public less abuse-deterrent than the RLD could DATES: The meeting will be held on May health problem. One important step lead opioid abusers to preferentially 16, 2016, from 9:00 a.m. to 12:00 p.m. toward the goal of creating safer opioid seek out and abuse generics. ADDRESSES: Hubert H. Humphrey analgesics has been the development of This draft guidance describes FDA’s opioid drug products that are Building, 200 Independence Avenue current thinking about the studies that formulated to deter abuse. FDA SW., Great Hall, Washington, DC 20201. should be conducted by a potential considers the development of these ANDA applicant and submitted to FDA FOR FURTHER INFORMATION CONTACT: Ms. products a high public health priority. in an ANDA to demonstrate that a Shellie Pfohl, Executive Director, Office It is important that generic versions of generic solid oral opioid drug product is of the President’s Council on Fitness, opioids that reference listed drugs no less abuse-deterrent than its RLD Sports, and Nutrition, Tower Building, whose labeling describes abuse- with respect to all potential routes of 1101 Wootton Parkway, Suite 560, deterrent properties are available to help abuse. Rockville, MD 20852, (240) 276–9567. ensure availability of analgesics for This draft guidance is being issued Information about PCFSN, including patients who need them. consistent with FDA’s good guidance details about the upcoming meeting, can For FDA to approve an abbreviated practices regulation (21 CFR 10.115). be obtained at www.fitness.gov. new drug application (ANDA), the The draft guidance, when finalized, will SUPPLEMENTARY INFORMATION: The Agency must find, among other things, represent the current thinking of FDA primary functions of the PCFSN include asabaliauskas on DSK3SPTVN1PROD with NOTICES that the generic drug product has the on the principles for evaluating the (1) advising the President, through the same active ingredient(s), dosage form, abuse-deterrence of generic solid oral Secretary, concerning progress made in route of administration, strength, and, opioid drug products. It does not carrying out the provisions of Executive with limited exceptions, labeling as the establish any rights for any person and Order 13545 and recommending to the reference listed drug (RLD); is is not binding on FDA or the public. President, through the Secretary, actions bioequivalent to its RLD; that the You can use an alternative approach if to accelerate progress; (2) advising the methods used in, or the facilities and it satisfies the requirements of the Secretary on ways to promote regular controls used for, the manufacture, applicable statutes and regulations. physical activity, fitness, sports VerDate Sep<11>2014 18:30 Mar 24, 2016 Jkt 238001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1


Document Created: 2018-02-02 15:17:44
Document Modified: 2018-02-02 15:17:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 24, 2016.
ContactGail Schmerfeld, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9291, email: [email protected]
FR Citation81 FR 16186 
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