Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 26488-26489 [2017-11819]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Pages 26488-26489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11819]



[[Page 26488]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2732]


Oncologic Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Oncologic Drugs 
Advisory Committee. The general function of the committee is to provide 
advice and recommendations to the Agency on FDA's regulatory issues. 
The meeting will be open to the public. FDA is establishing a docket 
for public comment on this meeting.

DATES: The public meeting will be held on July 13, 2017, from 8 a.m. to 
5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions, including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2017-N-2732. The docket will close on July 10, 
2017. Submit either electronic or written comments on this public 
meeting by July 10, 2017. Late, untimely filed comments will not be 
considered. Electronic comments must be submitted on or before July 10, 
2017. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time at the end of July 10, 
2017. 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.
    Comments received on or before June 26, 2017, will be provided to 
the committee. Comments received after that date will be taken into 
consideration by the Agency.
    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.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-2732 for ``Oncologic Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments.'' 
Received comments, those filed in a timely manner (see ADDRESSES), 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: 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jay R. Fajiculay, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: ODAC@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area). A notice in the Federal Register about last 
minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the Agency's Web site 
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down 
to the appropriate advisory committee meeting link, or call the 
advisory committee information line to learn about possible 
modifications before coming to the meeting.

[[Page 26489]]


SUPPLEMENTARY INFORMATION: 
    Agenda: During the morning session, the committee will discuss 
biologics license application (BLA) 761028 for ABP 215, a proposed 
biosimilar to Genentech/Roche's AVASTIN (bevacizumab), submitted by 
Amgen Inc. The proposed indications/uses for this product are: (1) For 
the first- or second-line treatment of patients with metastatic 
carcinoma of the colon or rectum in combination with intravenous 5-
fluorouracil-based chemotherapy; (2) in combination with 
fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based 
chemotherapy, for the second-line treatment of patients with metastatic 
colorectal cancer who have progressed on a first-line ABP 215-
containing regimen; (3) for the first-line treatment of unresectable, 
locally advanced, recurrent or metastatic non-squamous, non-small cell 
lung cancer in combination with carboplatin and paclitaxel; (4) for the 
treatment of glioblastoma with progressive disease in adult patients 
following prior therapy as a single agent; (5) for the treatment of 
metastatic renal cell carcinoma in combination with interferon alfa; 
and (6) in combination with paclitaxel and cisplatin or paclitaxel and 
topotecan for the treatment of persistent, recurrent, or metastatic 
carcinoma of the cervix.
    During the afternoon session, the committee will discuss BLA 761074 
for MYL-1401O, a proposed biosimilar to Genentech Inc.'s HERCEPTIN 
(trastuzumab), submitted by Mylan GmbH. The proposed indications/uses 
for this product are: (1) For adjuvant treatment of HER2 overexpressing 
node positive or node negative (ER/PR negative or with one high risk 
feature) breast cancer; (a) as part of a treatment regimen consisting 
of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; 
(b) with docetaxel and carboplatin; or (c) as a single agent following 
multimodality anthracycline based therapy; (2) in combination with 
paclitaxel for first-line treatment of HER2-overexpressing metastatic 
breast cancer; (3) as a single agent for treatment of HER2-
overexpressing breast cancer in patients who have received one or more 
chemotherapy regimens for metastatic disease; and (4) in combination 
with cisplatin and capecitabine or 5-fluorouracil, for the treatment of 
patients with HER2 overexpressing metastatic gastric or 
gastroesophageal junction adenocarcinoma who have not received prior 
treatment for metastatic disease.\1\
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    \1\ This indication is protected by orphan drug exclusivity 
expiring on October 20, 2017. See the Orphan Drug Designations and 
Approvals database at https://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm.
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    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All electronic and written submissions submitted to the docket (see the 
ADDRESSES section) on or before June 26, 2017, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 10:45 a.m. to 11:15 a.m., and 3:45 p.m. to 4:15 p.m. 
Those individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before June 
16, 2017. Time allotted for each presentation may be limited. If the 
number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by June 19, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require special accommodations due to a 
disability, please contact Jay R. Fajiculay at least 7 days in advance 
of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11819 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P