83 FR 46172 - Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 177 (September 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 177 (September 12, 2018)
| Page Range | 46172-46173 | |
| FR Document | 2018-19741 |
[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)] [Notices] [Pages 46172-46173] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19741] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3308] 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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) 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 FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on October 10, 2018, from 8 a.m. to 1 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-2018-N-3308. The docket will close on October 9, 2018. Submit either electronic or written comments on this public meeting by October 9, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 9, 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. Comments received on or before October 1, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. 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): 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-2018-N-3308 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 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.'' FDA 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 Dockets Management Staff. [[Page 46173]] If you do not wish your name and contact information 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 the 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: Lauren D. Tesh, 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: [email protected]; 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 FDA's website 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. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss biologics license application 761088 for CT-P10, a proposed biosimilar to Genentech, Inc.'s RITUXAN (rituximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are for the treatment of adult patients with (1) relapsed or refractory, low-grade or follicular, CD20-positive, B- cell Non-Hodgkin's Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to CT-P10 in combination with chemotherapy, as single- agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone. 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 website 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 website 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 ADDRESSES) on or before October 1, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. 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 September 24, 2018. 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 September 25, 2018. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540. 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 accommodations due to a disability, please contact Lauren D. Tesh (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website 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: September 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19741 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
![46172 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
organizations with common interests are ACTION: Notice; establishment of a confidential information that you or a
urged to consolidate or coordinate their public docket; request for comments. third party may not wish to be posted,
presentations, and request time for a such as medical information, your or
joint presentation, or submit requests for SUMMARY: The Food and Drug anyone else’s Social Security number, or
designated representatives to participate Administration (FDA) announces a confidential business information, such
in the focused sessions. Following the forthcoming public advisory committee as a manufacturing process. Please note
close of registration, we will determine meeting of the Oncologic Drugs that if you include your name, contact
the amount of time allotted to each Advisory Committee. The general information, or other information that
presenter and the approximate time function of the committee is to provide identifies you in the body of your
each oral presentation is to begin, and advice and recommendations to FDA on comments, that information will be
will select and notify participants by regulatory issues. The meeting will be posted on https://www.regulations.gov.
September 14, 2018. All requests to open to the public. FDA is establishing • If you want to submit a comment
make oral presentations must be a docket for public comment on this with confidential information that you
received by September 10, 2018. If document. do not wish to be made available to the
selected for presentation, any DATES: The meeting will be held on public, submit the comment as a
presentation materials must be emailed October 10, 2018, from 8 a.m. to 1 p.m. written/paper submission and in the
to TransplantationWorkshop2018@ manner detailed (see ‘‘Written/Paper
ADDRESSES: FDA White Oak Campus,
fda.hhs.gov (see FOR FURTHER Submissions’’ and ‘‘Instructions’’).
10903 New Hampshire Ave., Bldg. 31
INFORMATION CONTACT) no later than Conference Center, the Great Room (Rm. Written/Paper Submissions
September 19, 2018. No commercial or 1503), Silver Spring, MD 20993–0002.
promotional material will be permitted Submit written/paper submissions as
Answers to commonly asked questions follows:
to be presented or distributed at the including information regarding special • Mail/Hand delivery/Courier (for
public workshop. accommodations due to a disability, written/paper submissions): Dockets
Streaming Webcast of the Public visitor parking, and transportation may Management Staff (HFA–305), Food and
Workshop: This public workshop will be accessed at: https://www.fda.gov/ Drug Administration, 5630 Fishers
also be webcast at https:// AdvisoryCommittees/AboutAdvisory Lane, Rm. 1061, Rockville, MD 20852.
collaboration.fda.gov/ebtd092018/. Committees/ucm408555.htm. • For written/paper comments
If you have never attended a Connect FDA is establishing a docket for submitted to the Dockets Management
Pro event before, test your connection at public comment on this meeting. The Staff, FDA will post your comment, as
https://collaboration.fda.gov/common/ docket number is FDA–2018–N–3308. well as any attachments, except for
help/en/support/meeting_test.htm. To The docket will close on October 9, information submitted, marked and
get a quick overview of the Connect Pro 2018. Submit either electronic or identified, as confidential, if submitted
program, visit https://www.adobe.com/ written comments on this public as detailed in ‘‘Instructions.’’
go/connectpro_overview. FDA has meeting by October 9, 2018. Please note Instructions: All submissions received
verified the website addresses in this that late, untimely filed comments will must include the Docket No. FDA–
document, as of the date this document not be considered. Electronic comments 2018–N–3308 for ‘‘Oncologic Drugs
publishes in the Federal Register, but must be submitted on or before October Advisory Committee; Notice of Meeting;
websites are subject to change over time. 9, 2018. The https://www.regulations. Establishment of a Public Docket;
Transcripts: Please be advised that as gov electronic filing system will accept Request for Comments.’’ Received
soon as a transcript of the public comments until midnight Eastern Time comments, those filed in a timely
workshop is available, it will be at the end of October 9, 2018. Comments manner (see ADDRESSES), will be placed
accessible at https:// received by mail/hand delivery/courier in the docket and, except for those
www.regulations.gov. It may be viewed (for written/paper submissions) will be submitted as ‘‘Confidential
at the Dockets Management Staff (see considered timely if they are Submissions,’’ publicly viewable at
ADDRESSES). A link to the transcript will postmarked or the delivery service https://www.regulations.gov or at the
also be available on the internet at acceptance receipt is on or before that Dockets Management Staff between 9
https://www.fda.gov/Drugs/NewsEvents/ date. a.m. and 4 p.m., Monday through
ucm605761.htm. Comments received on or before Friday.
Dated: September 6, 2018. October 1, 2018, will be provided to the • Confidential Submissions—To
Leslie Kux, committee. Comments received after submit a comment with confidential
that date will be taken into information that you do not wish to be
Associate Commissioner for Policy.
consideration by FDA. made publicly available, submit your
[FR Doc. 2018–19816 Filed 9–11–18; 8:45 am]
You may submit comments as comments only as a written/paper
BILLING CODE 4164–01–P
follows: submission. You should submit two
copies total. One copy will include the
Electronic Submissions information you claim to be confidential
DEPARTMENT OF HEALTH AND
Submit electronic comments in the with a heading or cover note that states
HUMAN SERVICES
following way: ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ FDA
https://www.regulations.gov. Follow the will review this copy, including the
instructions for submitting comments. claimed confidential information, in its
daltland on DSKBBV9HB2PROD with NOTICES
[Docket No. FDA–2018–N–3308]
Comments submitted electronically, consideration of comments. The second
Oncologic Drugs Advisory Committee; including attachments, to https:// copy, which will have the claimed
Notice of Meeting; Establishment of a www.regulations.gov will be posted to confidential information redacted/
Public Docket; Request for Comments the docket unchanged. Because your blacked out, will be available for public
comment will be made public, you are viewing and posted on https://
AGENCY: Food and Drug Administration, solely responsible for ensuring that your www.regulations.gov. Submit both
HHS. comment does not include any copies to the Dockets Management Staff.
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![Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46173
If you do not wish your name and chemotherapy, as single-agent at least 7 days in advance of the
contact information be made publicly maintenance therapy; and (3) non- meeting.
available, you can provide this progressing (including stable disease), FDA is committed to the orderly
information on the cover sheet and not low-grade, CD20-positive, B-cell NHL as conduct of its advisory committee
in the body of your comments and you a single agent after first-line meetings. Please visit our website at
must identify the information as cyclophosphamide, vincristine, and https://www.fda.gov/Advisory
‘‘confidential.’’ Any information marked prednisone. Committees/AboutAdvisoryCommittees/
as ‘‘confidential’’ will not be disclosed FDA intends to make background ucm111462.htm for procedures on
except in accordance with 21 CFR 10.20 material available to the public no later public conduct during advisory
and other applicable disclosure law. For than 2 business days before the meeting. committee meetings.
more information about FDA’s posting If FDA is unable to post the background Notice of this meeting is given under
of comments to public dockets, see 80 material on its website prior to the the Federal Advisory Committee Act (5
FR 56469, September 18, 2015, or access meeting, the background material will U.S.C. app. 2).
the information at: https://www.gpo.gov/ be made publicly available at the Dated: September 6, 2018.
fdsys/pkg/FR-2015-09-18/pdf/2015- location of the advisory committee Leslie Kux,
23389.pdf. meeting, and the background material Associate Commissioner for Policy.
Docket: For access to the docket to will be posted on FDA’s website after
[FR Doc. 2018–19741 Filed 9–11–18; 8:45 am]
read background documents or the the meeting. Background material is
BILLING CODE 4164–01–P
electronic and written/paper comments available at https://www.fda.gov/
received, go to https:// AdvisoryCommittees/Calendar/
www.regulations.gov and insert the default.htm. Scroll down to the DEPARTMENT OF HEALTH AND
docket number, found in brackets in the appropriate advisory committee meeting HUMAN SERVICES
heading of this document, into the link.
‘‘Search’’ box and follow the prompts Procedure: Interested persons may Food and Drug Administration
and/or go to the Dockets Management present data, information, or views,
Staff, 5630 Fishers Lane, Rm. 1061, [Docket No. FDA–2017–N–4853]
orally or in writing, on issues pending
Rockville, MD 20852. before the committee. All electronic and Receipt of Notice That a Patent
FOR FURTHER INFORMATION CONTACT: written submissions submitted to the Infringement Complaint Was Filed
Lauren D. Tesh, Center for Drug Docket (see ADDRESSES) on or before Against a Biosimilar Applicant
Evaluation and Research, Food and October 1, 2018, will be provided to the
Drug Administration, 10903 New committee. Oral presentations from the AGENCY: Food and Drug Administration,
Hampshire Ave., Bldg. 31, Rm. 2417, public will be scheduled between HHS.
Silver Spring, MD 20993–0002, 301– approximately 11 a.m. and 12 noon. ACTION: Notice.
796–9001, Fax: 301–847–8533, email: Those individuals interested in making
ODAC@fda.hhs.gov; or FDA Advisory formal oral presentations should notify SUMMARY: The Food and Drug
Committee Information Line, 1–800– the contact person and submit a brief Administration (FDA) is publishing
741–8138 (301–443–0572 in the statement of the general nature of the notice that an applicant for a proposed
Washington, DC area). A notice in the evidence or arguments they wish to biosimilar product notified FDA that a
Federal Register about last minute present, the names and addresses of patent infringement action was filed in
modifications that impact a previously proposed participants, and an connection with the applicant’s
announced advisory committee meeting indication of the approximate time biologics license application (BLA).
cannot always be published quickly requested to make their presentation on Under the Public Health Service Act
enough to provide timely notice. or before September 24, 2018. Time (PHS Act), an applicant for a proposed
Therefore, you should always check the allotted for each presentation may be biosimilar product or interchangeable
FDA’s website at https://www.fda.gov/ limited. If the number of registrants product must notify FDA within 30 days
AdvisoryCommittees/default.htm and requesting to speak is greater than can after the applicant was served with a
scroll down to the appropriate advisory be reasonably accommodated during the complaint in a patent infringement
committee meeting link, or call the scheduled open public hearing session, action described under the PHS Act.
advisory committee information line to FDA may conduct a lottery to determine FDA is required to publish notice of the
learn about possible modifications the speakers for the scheduled open complaint in the Federal Register.
before coming to the meeting. public hearing session. The contact FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION: person will notify interested persons Angela Hoague, Center for Drug
Agenda: The committee will discuss regarding their request to speak by Evaluation and Research, Food and
biologics license application 761088 for September 25, 2018. Drug Administration, 10903 New
CT–P10, a proposed biosimilar to Persons attending FDA’s advisory Hampshire Ave., Bldg. 51, Rm. 6257,
Genentech, Inc.’s RITUXAN (rituximab), committee meetings are advised that Silver Spring, MD 20993–0002, 301–
submitted by Celltrion, Inc. The FDA is not responsible for providing 348–3915, angela.hoague@fda.hhs.gov.
proposed indications (uses) for this access to electrical outlets. SUPPLEMENTARY INFORMATION: The
product are for the treatment of adult For press inquiries, please contact the Biologics Price Competition and
patients with (1) relapsed or refractory, Office of Media Affairs at fdaoma@ Innovation Act of 2009 (BPCI Act) was
low-grade or follicular, CD20-positive, fda.hhs.gov or 301–796–4540. enacted as part of the Patient Protection
daltland on DSKBBV9HB2PROD with NOTICES
B-cell Non-Hodgkin’s Lymphoma (NHL) FDA welcomes the attendance of the and Affordable Care Act (Pub. L. 111–
as a single agent; (2) previously public at its advisory committee 148) on March 23, 2010. The BPCI Act
untreated follicular, CD20-positive, B- meetings and will make every effort to amended the PHS Act and created an
cell NHL in combination with first-line accommodate persons with disabilities. abbreviated licensure pathway for
chemotherapy and, in patients If you require accommodations due to a biological products shown to be
achieving a complete or partial response disability, please contact Lauren D. Tesh biosimilar to, or interchangeable with,
to CT–P10 in combination with (see FOR FURTHER INFORMATION CONTACT) an FDA-licensed biological reference
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Document Created: 2018-09-12 02:06:18
Document Modified: 2018-09-12 02:06:18
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on October 10, 2018, from 8 a.m. to 1 p.m. | |
| Contact | Lauren D. Tesh, 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: [email protected]; 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 FDA's website 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. | |
| FR Citation | 83 FR 46172 |
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