Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Extension of Comment Period, 6030-6031 [2018-02803]

Download as PDF 6030 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices U.S.C. 355(i)) became effective: October 7, 2008. The applicant claims September 8, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 7, 2008, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: June 28, 2013. FDA has verified the applicant’s claim that the new drug application (NDA) for IMBRUVICA (NDA 205552) was initially submitted on June 28, 2013. 3. The date the application was approved: November 13, 2013. FDA has verified the applicant’s claim that NDA 205552 was approved on November 13, 2013. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 320 days of patent term extension. daltland on DSKBBV9HB2PROD with NOTICES III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–02791 Filed 2–9–18; 8:45 am] BILLING CODE 4164–01–P 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. Notice of public workshop; extension of comment period. ACTION: 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. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 E:\FR\FM\12FEN1.SGM 12FEN1 daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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, Irene.Chan2@fda.hhs.gov; or Michelle Eby, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4422, Silver Spring, MD, 20993– 0002, 301–796–4714, Michelle.Eby@ fda.hhs.gov. 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 VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–E–1685] Determination of Regulatory Review Period for Purposes of Patent Extension; DALVANCE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DALVANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 13, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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 April 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 13, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 6031 considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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– 2015–E–1685 for ’’Determination of Regulatory Review Period for Purposes of Patent Extension; DALVANCE.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6030-6031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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

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