81 FR 87569 - Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 233 (December 5, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 233 (December 5, 2016)
| Page Range | 87569-87570 | |
| FR Document | 2016-29097 |
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)] [Notices] [Pages 87569-87570] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29097] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2896] Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the public meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products that was announced in the Federal Register on October 6, 2016. In that Federal Register notice, FDA requested comments on the approach to testing FDA recommended in its draft guidance ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products'' and FDA's efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products published October 6, 2016 (81 FR 69532). Submit either electronic or written comments by January 3, 2017. ADDRESSES: 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 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.'' [[Page 87570]] Instructions: All submissions received must include the Docket No. FDA-2016-N-2896 for ``Public Meeting on Pre-Market Evaluation of Abuse- Deterrent Properties of Opioid Drug Products; Extension of Comment Period.'' Received comments 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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: Michelle Eby, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6184, Silver Spring, MD 20993, 301-796- 4714, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of October 6, 2016 (81 FR 69532), FDA published a notice announcing a public meeting and requesting comments on the approach to testing FDA recommended in its draft guidance ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products'' \1\ and FDA's efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. The comment period ends on December 1, 2016. Because the Agency has received requests for an extension to allow interested persons additional time to submit comments, FDA is extending the comment period until January 3, 2017. --------------------------------------------------------------------------- \1\ http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm492172.pdf. --------------------------------------------------------------------------- Additional comments specific to the draft guidance ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products'' should be submitted to the docket for the draft guidance (FDA-2016-D-0785) in lieu of, or in addition to, the docket for the public meeting. 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 December 1, 2016. Other comments should be submitted to this docket by January 3, 2016. FDA has committed to taking steps to address the epidemic of opioid abuse transparently and in close cooperation with stakeholders and will provide other opportunities to comment, as appropriate. For example, FDA intends to issue a general guidance for public comment describing the Agency's recommendations for standardized in vitro testing to evaluate purported abuse-deterrent properties and considerations for a potential applicant as it develops an abuse-deterrent formulation of an opioid drug product. Dated: November 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29097 Filed 12-2-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices 87569
(for example, half the testing phase must This determination of the regulatory ‘‘General Principles for Evaluating the
be subtracted as well as any time that review period establishes the maximum Abuse Deterrence of Generic Solid Oral
may have occurred before the patent potential length of a patent extension. Opioid Drug Products’’ and FDA’s
was issued), FDA’s determination of the However, the USPTO applies several efforts to develop standardized in vitro
length of a regulatory review period for statutory limitations in its calculations testing methodologies for evaluating the
a human biological product will include of the actual period for patent extension. abuse deterrence of opioid drug
all of the testing phase and approval In its applications for patent extension, products. We are taking this action in
phase as specified in 35 U.S.C. this applicant seeks 518 days or 255 response to requests for an extension to
156(g)(1)(B). days of patent term extension. allow interested persons additional time
FDA has approved for marketing the III. Petitions to submit comments.
human biologic product BEXSERO DATES: FDA is extending the comment
(Meningococcal Group B vaccine). Anyone with knowledge that any of
period on the Public Meeting on Pre-
BEXSERO is indicated for active the dates as published are incorrect may
Market Evaluation of Abuse-Deterrent
immunization to prevent invasive submit either electronic or written
Properties of Opioid Drug Products
disease caused by Neisseria comments and ask for a redetermination
published October 6, 2016 (81 FR
meningitidis serogroup B and is (see DATES). Furthermore, any interested
69532). Submit either electronic or
approved for use in individuals 10 person may petition FDA for a
written comments by January 3, 2017.
through 25 years of age. Subsequent to determination regarding whether the
applicant for extension acted with due ADDRESSES: You may submit comments
this approval, the USPTO received as follows:
patent term restoration applications for diligence during the regulatory review
BEXSERO (U.S. Patent Nos. 8,273,360 period. To meet its burden, the petition Electronic Submissions
and 8,663,656) from GlaxoSmithKline must be timely (see DATES) and contain
sufficient facts to merit an FDA Submit electronic comments in the
Biologicals SA, and the USPTO following way:
investigation. (See H. Rept. 857, part 1,
requested FDA’s assistance in • Federal eRulemaking Portal:
98th Cong., 2d sess., pp. 41–42, 1984.)
determining the patents’ eligibility for https://www.regulations.gov. Follow the
Petitions should be in the format
patent term restoration. In a letter dated instructions for submitting comments.
specified in 21 CFR 10.30.
April 20, 2016, FDA advised the USPTO Submit petitions electronically to Comments submitted electronically,
that this human biological product had https://www.regulations.gov at Docket including attachments, to https://
undergone a regulatory review period No. FDA–2013–S–0610. Submit written www.regulations.gov will be posted to
and that the approval of BEXSERO petitions (two copies are required) to the the docket unchanged. Because your
represented the first permitted Division of Dockets Management (HFA– comment will be made public, you are
commercial marketing or use of the 305), Food and Drug Administration, solely responsible for ensuring that your
product. Thereafter, the USPTO 5630 Fishers Lane, Rm. 1061, Rockville, comment does not include any
requested that FDA determine the MD 20852. confidential information that you or a
product’s regulatory review period. third party may not wish to be posted,
Dated: November 28, 2016.
II. Determination of Regulatory Review such as medical information, your or
Leslie Kux,
Period anyone else’s Social Security number, or
Associate Commissioner for Policy. confidential business information, such
FDA has determined that the [FR Doc. 2016–29025 Filed 12–2–16; 8:45 am] as a manufacturing process. Please note
applicable regulatory review period for BILLING CODE 4164–01–P that if you include your name, contact
BEXSERO is 3,963 days. Of this time, information, or other information that
3,779 days occurred during the testing identifies you in the body of your
phase of the regulatory review period, DEPARTMENT OF HEALTH AND comments, that information will be
while 184 days occurred during the HUMAN SERVICES posted on https://www.regulations.gov.
approval phase. These periods of time • If you want to submit a comment
were derived from the following dates: Food and Drug Administration
with confidential information that you
1. The date an exemption under [Docket No. FDA–2016–N–2896] do not wish to be made available to the
section 505(i) of the Federal Food, Drug, public, submit the comment as a
and Cosmetic Act (21 U.S.C. 355(i)) Public Meeting on Pre-Market written/paper submission and in the
became effective: March 20, 2004. FDA Evaluation of Abuse-Deterrent manner detailed (see ‘‘Written/Paper
has verified the applicant’s claim that Properties of Opioid Drug Products; Submissions’’ and ‘‘Instructions’’).
the date the investigational new drug Extension of Comment Period
application became effective was on Written/Paper Submissions
AGENCY: Food and Drug Administration,
March 20, 2004. HHS. Submit written/paper submissions as
2. The date the application was ACTION: Notice of public meeting; follows:
initially submitted with respect to the extension of comment period. • Mail/Hand delivery/Courier (for
human biological product under section written/paper submissions): Division of
351 of the Public Health Service Act (42 SUMMARY: The Food and Drug Dockets Management (HFA–305), Food
U.S.C. 262): July 24, 2014. FDA has Administration (FDA or we) is and Drug Administration, 5630 Fishers
verified the applicant’s claim that the extending the comment period for the Lane, Rm. 1061, Rockville, MD 20852.
biologics license application (BLA) for public meeting on Pre-Market • For written/paper comments
sradovich on DSK3GMQ082PROD with NOTICES
BEXSERO (BLA 125546/0) was initially Evaluation of Abuse-Deterrent submitted to the Division of Dockets
submitted on July 24, 2014. Properties of Opioid Drug Products that Management, FDA will post your
3. The date the application was was announced in the Federal Register comment, as well as any attachments,
approved: January 23, 2015. FDA has on October 6, 2016. In that Federal except for information submitted,
verified the applicant’s claim that BLA Register notice, FDA requested marked and identified, as confidential,
125546/0 was approved on January 23, comments on the approach to testing if submitted as detailed in
2015. FDA recommended in its draft guidance ‘‘Instructions.’’
VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1](https://thefederalregister.org/doc/81_FR_87802/page/1.svg)
![87570 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
Instructions: All submissions received Silver Spring, MD 20993, 301–796– DEPARTMENT OF HEALTH AND
must include the Docket No. FDA– 4714, Michelle.Eby@fda.hhs.gov. HUMAN SERVICES
2016–N–2896 for ‘‘Public Meeting on
SUPPLEMENTARY INFORMATION: In the Food and Drug Administration
Pre-Market Evaluation of Abuse-
Deterrent Properties of Opioid Drug Federal Register of October 6, 2016 (81
FR 69532), FDA published a notice [Docket No. FDA–2013–N–1089]
Products; Extension of Comment
Period.’’ Received comments will be announcing a public meeting and Agency Information Collection
placed in the docket and, except for requesting comments on the approach to Activities; Proposed Collection;
those submitted as ‘‘Confidential testing FDA recommended in its draft Comment Request; Recommended
Submissions,’’ publicly viewable at guidance ‘‘General Principles for Glossary and Educational Outreach To
https://www.regulations.gov or at the Evaluating the Abuse Deterrence of Support Use of Symbols on Labels and
Division of Dockets Management Generic Solid Oral Opioid Drug in Labeling of In Vitro Diagnostic
between 9 a.m. and 4 p.m., Monday Products’’ 1 and FDA’s efforts to develop Devices Intended for Professional Use
through Friday. standardized in vitro testing
methodologies for evaluating the abuse AGENCY: Food and Drug Administration,
• Confidential Submissions—To HHS.
submit a comment with confidential deterrence of opioid drug products. The
comment period ends on December 1, ACTION: Notice.
information that you do not wish to be
made publicly available, submit your 2016. Because the Agency has received SUMMARY: The Food and Drug
comments only as a written/paper requests for an extension to allow Administration (FDA) is announcing an
submission. You should submit two interested persons additional time to opportunity for public comment on the
copies total. One copy will include the submit comments, FDA is extending the proposed collection of certain
information you claim to be confidential comment period until January 3, 2017. information by the Agency. Under the
with a heading or cover note that states Additional comments specific to the Paperwork Reduction Act of 1995 (the
‘‘THIS DOCUMENT CONTAINS draft guidance ‘‘General Principles for PRA), Federal Agencies are required to
CONFIDENTIAL INFORMATION.’’ The Evaluating the Abuse Deterrence of publish notice in the Federal Register
Agency will review this copy, including Generic Solid Oral Opioid Drug concerning each proposed collection of
the claimed confidential information, in Products’’ should be submitted to the information, including each proposed
its consideration of comments. The extension of an existing collection of
docket for the draft guidance (FDA–
second copy, which will have the information, and to allow 60 days for
2016–D–0785) in lieu of, or in addition
claimed confidential information public comment in response to the
to, the docket for the public meeting. notice. This notice solicits comments on
redacted/blacked out, will be available
for public viewing and posted on Although you can comment on any recommended glossary and educational
https://www.regulations.gov. Submit guidance at any time (see 21 CFR outreach to support use of symbols on
both copies to the Division of Dockets 10.115(g)(5)), to ensure that the Agency labels and in labeling of in vitro
Management. If you do not wish your considers your comment on this draft diagnostic devices intended for
name and contact information to be guidance before it begins work on the professional use.
made publicly available, you can final version of the guidance, submit DATES: Submit either electronic or
provide this information on the cover either electronic or written comments written comments on the collection of
sheet and not in the body of your on the draft guidance by December 1, information by February 3, 2017.
comments and you must identify this 2016. Other comments should be ADDRESSES: You may submit comments
information as ‘‘confidential.’’ Any submitted to this docket by January 3, as follows:
information marked as ‘‘confidential’’ 2016. FDA has committed to taking
will not be disclosed except in steps to address the epidemic of opioid Electronic Submissions
accordance with 21 CFR 10.20 and other abuse transparently and in close Submit electronic comments in the
applicable disclosure law. For more cooperation with stakeholders and will following way:
information about FDA’s posting of provide other opportunities to • Federal eRulemaking Portal:
comments to public dockets, see 80 FR comment, as appropriate. For example, https://www.regulations.gov. Follow the
56469, September 18, 2015, or access FDA intends to issue a general guidance instructions for submitting comments.
the information at: http://www.fda.gov/ for public comment describing the Comments submitted electronically,
regulatoryinformation/dockets/ Agency’s recommendations for including attachments, to https://
default.htm. standardized in vitro testing to evaluate www.regulations.gov will be posted to
Docket: For access to the docket to purported abuse-deterrent properties the docket unchanged. Because your
read background documents or the comment will be made public, you are
and considerations for a potential
electronic and written/paper comments solely responsible for ensuring that your
applicant as it develops an abuse-
received, go to https:// comment does not include any
deterrent formulation of an opioid drug confidential information that you or a
www.regulations.gov and insert the product.
docket number, found in brackets in the third party may not wish to be posted,
heading of this document, into the Dated: November 29, 2016. such as medical information, your or
‘‘Search’’ box and follow the prompts Leslie Kux, anyone else’s Social Security number, or
and/or go to the Division of Dockets Associate Commissioner for Policy. confidential business information, such
sradovich on DSK3GMQ082PROD with NOTICES
Management, 5630 Fishers Lane, Rm. [FR Doc. 2016–29097 Filed 12–2–16; 8:45 am]
as a manufacturing process. Please note
1061, Rockville, MD 20852. that if you include your name, contact
BILLING CODE 4164–01–P
information, or other information that
FOR FURTHER INFORMATION CONTACT: identifies you in the body of your
Michelle Eby, Center for Drug comments, that information will be
Evaluation and Research, Food and 1 http://www.fda.gov/ucm/groups/fdagov-public/ posted on https://www.regulations.gov.
Drug Administration, 10903 New @fdagov-drugs-gen/documents/document/ • If you want to submit a comment
Hampshire Ave., Bldg. 51, Rm. 6184, ucm492172.pdf. with confidential information that you
VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1](https://thefederalregister.org/doc/81_FR_87802/page/2.svg)
Document Created: 2016-12-03 00:26:05
Document Modified: 2016-12-03 00:26:05
| 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 meeting; extension of comment period. | |
| Dates | FDA is extending the comment period on the Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products published October 6, 2016 (81 FR 69532). Submit either electronic or written comments by January 3, 2017. | |
| Contact | Michelle Eby, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6184, Silver Spring, MD 20993, 301-796- 4714, [email protected] | |
| FR Citation | 81 FR 87569 |
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