83 FR 6030 - Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 29 (February 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 29 (February 12, 2018)
| Page Range | 6030-6031 | |
| FR Document | 2018-02803 |
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)] [Notices] [Pages 6030-6031] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02803] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5897] Packaging, Storage, and Disposal Options To Enhance Opioid Safety--Exploring the Path Forward; Public Workshop; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice announcing the public workshop entitled ``Packaging, Storage, and Disposal Options To Enhance Opioid Safety--Exploring the Path Forward'' that appeared in the Federal Register on October 31, 2017, and was held on December 11-12, 2017. That notice requested comments by February 12, 2018; FDA is extending the comment period until March 16, 2018, 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 workshop ``Packaging, Storage, and Disposal Options To Enhance Opioid Safety-- Exploring the Path Forward'' published October 31, 2017 (82 FR 50429). Submit either electronic or written comments by March 16, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 16, 2018. 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. 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-5897 for ``Packaging, Storage, and Disposal Options To Enhance Opioid Safety--Exploring the Path Forward; Public Workshop; Request for Comments.'' 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 Dockets Management Staff 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 [[Page 6031]] 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Irene Z. Chan, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD, 20993-0002, 301-796-3962, [email protected]; or Michelle Eby, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4422, Silver Spring, MD, 20993-0002, 301-796-4714, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of October 31, 2017 (82 FR 50429), FDA published a notice announcing a public workshop entitled ``Packaging, Storage, and Disposal Options to Enhance Opioid Safety--Exploring the Path Forward,'' which was held on December 11-12, 2017. That notice requested comments on the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems; data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings; and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety. The notice requested comments by February 12, 2018; FDA is extending the comment period until March 16, 2018. The Agency believes this extension allows adequate time for interested persons to submit comments. Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02803 Filed 2-9-18; 8:45 am] BILLING CODE 4164-01-P
![6030 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
U.S.C. 355(i)) became effective: October Dated: February 7, 2018. instructions for submitting comments.
7, 2008. The applicant claims Leslie Kux, Comments submitted electronically,
September 8, 2008, as the date the Associate Commissioner for Policy. including attachments, to https://
investigational new drug application [FR Doc. 2018–02791 Filed 2–9–18; 8:45 am] www.regulations.gov will be posted to
(IND) became effective. However, FDA BILLING CODE 4164–01–P the docket unchanged. Because your
records indicate that the IND effective comment will be made public, you are
date was October 7, 2008, which was 30 solely responsible for ensuring that your
days after FDA receipt of the IND. DEPARTMENT OF HEALTH AND comment does not include any
HUMAN SERVICES confidential information that you or a
2. The date the application was third party may not wish to be posted,
initially submitted with respect to the Food and Drug Administration such as medical information, your or
human drug product under section anyone else’s Social Security number, or
[Docket No. FDA–2017–N–5897]
505(b) of the FD&C Act: June 28, 2013. confidential business information, such
FDA has verified the applicant’s claim Packaging, Storage, and Disposal as a manufacturing process. Please note
that the new drug application (NDA) for Options To Enhance Opioid Safety— that if you include your name, contact
IMBRUVICA (NDA 205552) was Exploring the Path Forward; Public information, or other information that
initially submitted on June 28, 2013. Workshop; Extension of Comment identifies you in the body of your
3. The date the application was Period comments, that information will be
approved: November 13, 2013. FDA has posted on https://www.regulations.gov.
AGENCY: Food and Drug Administration, • If you want to submit a comment
verified the applicant’s claim that NDA HHS. with confidential information that you
205552 was approved on November 13, ACTION: Notice of public workshop; do not wish to be made available to the
2013. extension of comment period. public, submit the comment as a
This determination of the regulatory written/paper submission and in the
SUMMARY: The Food and Drug
review period establishes the maximum manner detailed (see ‘‘Written/Paper
Administration (FDA or Agency) is
potential length of a patent extension. Submissions’’ and ‘‘Instructions’’).
extending the comment period for the
However, the USPTO applies several notice announcing the public workshop Written/Paper Submissions
statutory limitations in its calculations entitled ‘‘Packaging, Storage, and
of the actual period for patent extension. Submit written/paper submissions as
Disposal Options To Enhance Opioid follows:
In its application for patent extension, Safety—Exploring the Path Forward’’ • Mail/Hand delivery/Courier (for
this applicant seeks 320 days of patent that appeared in the Federal Register on written/paper submissions): Dockets
term extension. October 31, 2017, and was held on Management Staff (HFA–305), Food and
III. Petitions December 11–12, 2017. That notice Drug Administration, 5630 Fishers
requested comments by February 12, Lane, Rm. 1061, Rockville, MD 20852.
Anyone with knowledge that any of 2018; FDA is extending the comment • For written/paper comments
the dates as published are incorrect may period until March 16, 2018, in submitted to the Dockets Management
submit either electronic or written response to requests for an extension to Staff, FDA will post your comment, as
comments and, under 21 CFR 60.24, ask allow interested persons additional time well as any attachments, except for
for a redetermination (see DATES). to submit comments. information submitted, marked and
Furthermore, as specified in § 60.30 (21 DATES: FDA is extending the comment identified, as confidential, if submitted
CFR 60.30), any interested person may period on the public workshop as detailed in ‘‘Instructions.’’
petition FDA for a determination ‘‘Packaging, Storage, and Disposal Instructions: All submissions received
regarding whether the applicant for Options To Enhance Opioid Safety— must include the Docket No. FDA–
extension acted with due diligence Exploring the Path Forward’’ published 2017–N–5897 for ‘‘Packaging, Storage,
during the regulatory review period. To October 31, 2017 (82 FR 50429). Submit and Disposal Options To Enhance
either electronic or written comments Opioid Safety—Exploring the Path
meet its burden, the petition must
by March 16, 2018. Forward; Public Workshop; Request for
comply with all the requirements of
ADDRESSES: You may submit comments Comments.’’ Received comments will be
§ 60.30, including but not limited to:
as follows. Please note that late, placed in the docket and, except for
Must be timely (see DATES), must be those submitted as ‘‘Confidential
filed in accordance with § 10.20, must untimely filed comments will not be
considered. Electronic comments must Submissions,’’ publicly viewable at
contain sufficient facts to merit an FDA https://www.regulations.gov or at the
be submitted on or before March 16,
investigation, and must certify that a Dockets Management Staff between 9
2018. The https://www.regulations.gov
true and complete copy of the petition a.m. and 4 p.m., Monday through
electronic filing system will accept
has been served upon the patent comments until midnight Eastern Time Friday.
applicant. (See H. Rept. 857, part 1, 98th at the end of March 16, 2018. Comments • Confidential Submissions—To
Cong., 2d sess., pp. 41–42, 1984.) received by mail/hand delivery/courier submit a comment with confidential
Petitions should be in the format (for written/paper submissions) will be information that you do not wish to be
specified in 21 CFR 10.30. considered timely if they are made publicly available, submit your
Submit petitions electronically to postmarked or the delivery service comments only as a written/paper
https://www.regulations.gov at Docket acceptance receipt is on or before that submission. You should submit two
daltland on DSKBBV9HB2PROD with NOTICES
No. FDA–2013–S–0610. Submit written date. copies total. One copy will include the
information you claim to be confidential
petitions (two copies are required) to the Electronic Submissions with a heading or cover note that states
Dockets Management Staff (HFA–305),
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration, 5630 CONFIDENTIAL INFORMATION.’’ The
following way:
Fishers Lane, Rm. 1061, Rockville, MD • Federal eRulemaking Portal: Agency will review this copy, including
20852. https://www.regulations.gov. Follow the the claimed confidential information, in
VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1](https://thefederalregister.org/doc/83_FR_6059/page/1.svg)
![Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices 6031
its consideration of comments. The assessing the impact of packaging, considered timely if they are
second copy, which will have the storage, and disposal options in both the postmarked or the delivery service
claimed confidential information premarket and postmarket settings; and acceptance receipt is on or before that
redacted/blacked out, will be available ways in which FDA could encourage the date. Furthermore, any interested
for public viewing and posted on development and assessment of person may petition FDA for a
https://www.regulations.gov. Submit packaging, storage, and disposal options determination regarding whether the
both copies to the Dockets Management for opioids that have the potential to applicant for extension acted with due
Staff. If you do not wish your name and enhance opioid safety. The notice diligence during the regulatory review
contact information to be made publicly requested comments by February 12, period by August 13, 2018. See
available, you can provide this 2018; FDA is extending the comment ‘‘Petitions’’ in the SUPPLEMENTARY
information on the cover sheet and not period until March 16, 2018. The INFORMATION section for more
in the body of your comments and you Agency believes this extension allows information.
must identify this information as adequate time for interested persons to
‘‘confidential.’’ Any information marked submit comments. Electronic Submissions
as ‘‘confidential’’ will not be disclosed Dated: February 7, 2018. Submit electronic comments in the
except in accordance with 21 CFR 10.20 Leslie Kux,
following way:
and other applicable disclosure law. For • Federal eRulemaking Portal:
Associate Commissioner for Policy.
more information about FDA’s posting https://www.regulations.gov. Follow the
[FR Doc. 2018–02803 Filed 2–9–18; 8:45 am] instructions for submitting comments.
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access BILLING CODE 4164–01–P Comments submitted electronically,
the information at: https://www.gpo.gov/ including attachments, to https://
fdsys/pkg/FR-2015-09-18/pdf/2015- www.regulations.gov will be posted to
DEPARTMENT OF HEALTH AND the docket unchanged. Because your
23389.pdf. HUMAN SERVICES
Docket: For access to the docket to comment will be made public, you are
read background documents or the Food and Drug Administration solely responsible for ensuring that your
electronic and written/paper comments comment does not include any
received, go to https:// [Docket No. FDA–2015–E–1685] confidential information that you or a
www.regulations.gov and insert the third party may not wish to be posted,
Determination of Regulatory Review such as medical information, your or
docket number, found in brackets in the
Period for Purposes of Patent anyone else’s Social Security number, or
heading of this document, into the
Extension; DALVANCE confidential business information, such
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management AGENCY: Food and Drug Administration, as a manufacturing process. Please note
Staff, 5630 Fishers Lane, Rm. 1061, HHS. that if you include your name, contact
Rockville, MD 20852. ACTION: Notice. information, or other information that
FOR FURTHER INFORMATION CONTACT: identifies you in the body of your
Irene Z. Chan, Food and Drug SUMMARY: The Food and Drug comments, that information will be
Administration, 10903 New Hampshire Administration (FDA or the Agency) has posted on https://www.regulations.gov.
Ave., Bldg. 22, Rm. 4420, Silver Spring, determined the regulatory review period • If you want to submit a comment
MD, 20993–0002, 301–796–3962, for DALVANCE and is publishing this with confidential information that you
Irene.Chan2@fda.hhs.gov; or Michelle notice of that determination as required do not wish to be made available to the
Eby, Food and Drug Administration, by law. FDA has made the public, submit the comment as a
10903 New Hampshire Ave., Bldg. 22, determination because of the written/paper submission and in the
Rm. 4422, Silver Spring, MD, 20993– submission of an application to the manner detailed (see ‘‘Written/Paper
0002, 301–796–4714, Michelle.Eby@ Director of the U.S. Patent and Submissions’’ and ‘‘Instructions’’).
fda.hhs.gov. Trademark Office (USPTO), Department
of Commerce, for the extension of a Written/Paper Submissions
SUPPLEMENTARY INFORMATION: patent which claims that human drug Submit written/paper submissions as
In the Federal Register of October 31, product. follows:
2017 (82 FR 50429), FDA published a • Mail/Hand delivery/Courier (for
notice announcing a public workshop DATES: Anyone with knowledge that any
written/paper submissions): Dockets
entitled ‘‘Packaging, Storage, and of the dates as published (in the
Management Staff (HFA–305), Food and
Disposal Options to Enhance Opioid SUPPLEMENTARY INFORMATION section) are
Drug Administration, 5630 Fishers
Safety—Exploring the Path Forward,’’ incorrect may submit either electronic
Lane, Rm. 1061, Rockville, MD 20852.
which was held on December 11–12, or written comments and ask for a • For written/paper comments
2017. That notice requested comments redetermination by April 13, 2018. See submitted to the Dockets Management
on the role of packaging, storage, and ‘‘Petitions’’ in the SUPPLEMENTARY Staff, FDA will post your comment, as
disposal options within the larger INFORMATION section for more
well as any attachments, except for
landscape of activities aimed at information. information submitted, marked and
addressing abuse, misuse, or ADDRESSES: You may submit comments identified, as confidential, if submitted
inappropriate access of prescription as follows. Please note that late, as detailed in ‘‘Instructions.’’
opioid drug products (opioids); guiding untimely filed comments will not be Instructions: All submissions received
principles and considerations for the considered. Electronic comments must must include the Docket No. FDA–
daltland on DSKBBV9HB2PROD with NOTICES
design of packaging, storage, and be submitted on or before April 13, 2015–E–1685 for ’’Determination of
disposal options for opioids; integrating 2018. The https://www.regulations.gov Regulatory Review Period for Purposes
packaging, storage, and disposal options electronic filing system will accept of Patent Extension; DALVANCE.’’
into existing health care and pharmacy comments until midnight Eastern Time Received comments, those filed in a
systems, including both open and at the end of April 13, 2018. Comments timely manner (see ADDRESSES), will be
closed health care systems; data needs received by mail/hand delivery/courier placed in the docket and, except for
and how to address challenges in (for written/paper submissions) will be those submitted as ‘‘Confidential
VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1](https://thefederalregister.org/doc/83_FR_6059/page/2.svg)
Document Created: 2018-11-01 08:43:03
Document Modified: 2018-11-01 08:43:03
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period on the public workshop ``Packaging, Storage, and Disposal Options To Enhance Opioid Safety-- Exploring the Path Forward'' published October 31, 2017 (82 FR 50429). Submit either electronic or written comments by March 16, 2018. | |
| Contact | Irene Z. Chan, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD, 20993-0002, 301-796-3962, [email protected]; or Michelle Eby, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4422, Silver Spring, MD, 20993-0002, 301-796-4714, [email protected] | |
| FR Citation | 83 FR 6030 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR