82 FR 26495 - 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 82, Issue 108 (June 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 108 (June 7, 2017)
| Page Range | 26495-26497 | |
| FR Document | 2017-11817 |
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)] [Notices] [Pages 26495-26497] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11817] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2730] 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 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 document. DATES: The public meeting will be held on July 11, 2017, from 12:30 p.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-2730. 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: [[Page 26496]] 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-2730 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.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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, 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 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. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss biologics license application (BLA) 761060, MYLOTARG (gemtuzumab ozogamicin) for intravenous use, submitted by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. The proposed indication (use) for this product is in combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML). 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 3 p.m. and 4 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 [[Page 26497]] due to a disability, please contact Jennifer Shepherd 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. 2017-11817 Filed 6-6-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices 26495
SUPPLEMENTARY INFORMATION: let registrants know if registration closes DEPARTMENT OF HEALTH AND
before the day of the public workshop. HUMAN SERVICES
I. Background If you need special accommodations
FDA is announcing a public due to a disability, please contact Jessica Food and Drug Administration
workshop regarding development of Barnes or Lori Benner (see FOR FURTHER
rabies monoclonal antibody products to INFORMATION CONTACT) no later than July [Docket No. FDA–2017–N–2730]
be used in conjunction with a licensed 12, 2017.
rabies vaccine as part of rabies PEP. Requests for Oral Presentations: Oncologic Drugs Advisory Committee;
Rabies immunoglobulin, in combination During online registration you may Notice of Meeting; Establishment of a
with rabies vaccine, is currently indicate if you wish to present during a Public Docket; Request for Comments
recommended for rabies PEP following public comment session and which
suspected or proven rabies exposure. topic(s) you wish to address. We will do AGENCY: Food and Drug Administration,
Rabies monoclonal antibody products our best to accommodate requests to HHS.
may offer a potential alternative to make public comments. Individuals and ACTION: Notice; establishment of a
rabies immunoglobulin as a component organizations with common interests are public docket; request for comments.
of rabies PEP. urged to consolidate or coordinate their
presentations, and request time for a SUMMARY: The Food and Drug
II. Topics for Discussion at the Public joint presentation. Following the close Administration (FDA or Agency)
Workshop of registration, we will determine the announces a forthcoming public
FDA is conducting this workshop to amount of time allotted to each advisory committee meeting of the
discuss the scientific work needed to presenter and the approximate time Oncologic Drugs Advisory Committee.
advance the development of rabies each oral presentation is to begin, and The general function of the committee is
monoclonal antibodies targeting rabies will select and notify participants by to provide advice and recommendations
viruses for use in a PEP regimen. July 11, 2017. All requests to make oral to the Agency on FDA’s regulatory
Discussions are planned around the presentations must be received by July issues. The meeting will be open to the
following topics: 10, 2017, midnight Eastern Time. If public. FDA is establishing a docket for
selected for presentation, any public comment on this document.
• Rabies epidemiology and vectors
• Current rabies PEP standard of care presentation materials must be emailed DATES: The public meeting will be held
• Scientific challenges of assessing the to RabiesWorkshop2017@fda.hhs.gov no on July 11, 2017, from 12:30 p.m. to 5
likely effects of rabies monoclonal later than July 13, 2017. No commercial p.m.
antibodies or promotional material will be ADDRESSES: FDA White Oak Campus,
• Potential utility of animal models and permitted to be presented or distributed 10903 New Hampshire Ave., Bldg. 31
laboratory assays in rabies at the public workshop. Conference Center, the Great Room (Rm.
monoclonal antibody development Streaming Webcast of the public 1503), Silver Spring, MD 20993–0002.
workshop: This public workshop will
• Clinical trial design challenges related Answers to commonly asked questions
also be Webcast at the following Web including information regarding special
to the scientific evaluation of rabies
site: https://collaboration.fda.gov/ accommodations due to a disability,
monoclonal antibody efficacy as a
r6811zievzz/. visitor parking, and transportation may
component of rabies PEP
If you have never attended a Connect
• Ethical considerations regarding Pro event before, please test your
be accessed at: https://www.fda.gov/
potential clinical trial designs AdvisoryCommittees/
connection at https:// AboutAdvisoryCommittees/
The Agency encourages health care collaboration.fda.gov/common/help/en/
providers, other U.S. Government ucm408555.htm.
support/meeting_test.htm. To get a FDA is establishing a docket for
Agencies, academic experts, industry, quick overview of the Connect Pro
and other stakeholders to attend this public comment on this meeting. The
program, visit https://www.adobe.com/ docket number is FDA–2017–N–2730.
public workshop. go/connectpro_overview. FDA has The docket will close on July 10, 2017.
III. Participating in the Public verified the Web site addresses in this Submit either electronic or written
Workshop document, as of the date this document comments on this public meeting by
publishes in the Federal Register, but July 10, 2017. Late, untimely filed
Registration: Registration is free and
Web sites are subject to change over comments will not be considered.
based on space availability, with
time. Electronic comments must be submitted
priority given to early registrants. Transcripts: Please be advised that as
Persons interested in attending this on or before July 10, 2017. The https://
soon as a transcript of the public
public workshop must register by July www.regulations.gov electronic filing
workshop is available, it will be
12, 2017, midnight Eastern Time. To system will accept comments until
accessible at https://
register, please provide complete midnight Eastern Time at the end of July
www.regulations.gov. It may be viewed
contact information for each attendee, 10, 2017. Comments received by mail/
at the Division of Dockets Management
including name, title, affiliation, hand delivery/courier (for written/paper
(see ADDRESSES). A link to the transcript
address, email, and telephone to submissions) will be considered timely
will also be available on the Internet at
RabiesWorkshop2017@fda.hhs.gov. if they are postmarked or the delivery
http://www.fda.gov/Drugs/NewsEvents/
Early registration is recommended service acceptance receipt is on or
ucm540832.htm approximately 45 days
because seating is limited; therefore, before that date.
sradovich on DSK3GMQ082PROD with NOTICES
after the workshop.
FDA may limit the number of Comments received on or before June
participants from each organization. Dated: May 31, 2017. 26, 2017, will be provided to the
Registrants will receive confirmation Anna K. Abram, committee. Comments received after
when they have been accepted. If time Deputy Commissioner for Policy, Planning, that date will be taken into
and space permit, onsite registration on Legislation, and Analysis. consideration by the Agency.
the day of the public workshop will be [FR Doc. 2017–11820 Filed 6–6–17; 8:45 am] You may submit comments as
provided beginning at 7:30 a.m. We will BILLING CODE 4164–01–P follows:
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![Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices 26497
due to a disability, please contact considered timely if they are comments only as a written/paper
Jennifer Shepherd at least 7 days in postmarked or the delivery service submission. You should submit two
advance of the meeting. acceptance receipt is on or before that copies total. One copy will include the
FDA is committed to the orderly date. information you claim to be confidential
conduct of its advisory committee with a heading or cover note that states
Electronic Submissions
meetings. Please visit our Web site at ‘‘THIS DOCUMENT CONTAINS
https://www.fda.gov/Advisory Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Committees/AboutAdvisoryCommittees/ following way: Agency will review this copy, including
ucm111462.htm for procedures on • Federal eRulemaking Portal: the claimed confidential information, in
public conduct during advisory https://www.regulations.gov. Follow the its consideration of comments. The
committee meetings. instructions for submitting comments. second copy, which will have the
Notice of this meeting is given under Comments submitted electronically, claimed confidential information
the Federal Advisory Committee Act (5 including attachments, to https:// redacted/blacked out, will be available
U.S.C. app. 2). www.regulations.gov will be posted to for public viewing and posted on
the docket unchanged. Because your https://www.regulations.gov. Submit
Dated: June 1, 2017.
comment will be made public, you are both copies to the Division of Dockets
Anna K. Abram, solely responsible for ensuring that your
Deputy Commissioner for Policy, Planning,
Management. If you do not wish your
comment does not include any name and contact information to be
Legislation, and Analysis. confidential information that you or a
[FR Doc. 2017–11817 Filed 6–6–17; 8:45 am]
made publicly available, you can
third party may not wish to be posted, provide this information on the cover
BILLING CODE 4164–01–P such as medical information, your or sheet and not in the body of your
anyone else’s Social Security number, or comments and you must identify this
confidential business information, such information as ‘‘confidential.’’ Any
DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
HUMAN SERVICES information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
Food and Drug Administration information, or other information that accordance with 21 CFR 10.20 and other
identifies you in the body of your applicable disclosure law. For more
[Docket No. FDA–2011–N–0019] comments, that information will be information about FDA’s posting of
posted on https://www.regulations.gov. comments to public dockets, see 80 FR
Agency Information Collection • If you want to submit a comment 56469, September 18, 2015, or access
Activities; Proposed Collection; with confidential information that you
Comment Request; Customer/Partner the information at: https://www.gpo.gov/
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
Service Surveys public, submit the comment as a 23389.pdf.
AGENCY: Food and Drug Administration, written/paper submission and in the Docket: For access to the docket to
HHS. manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
ACTION: Notice.
Written/Paper Submissions received, go to https://
SUMMARY: The Food and Drug www.regulations.gov and insert the
Administration (FDA or Agency) is Submit written/paper submissions as docket number, found in brackets in the
announcing an opportunity for public follows: heading of this document, into the
comment on the proposed collection of • Mail/Hand delivery/Courier (for
‘‘Search’’ box and follow the prompts
certain information by the Agency. written/paper submissions): Division of
and/or go to the Division of Dockets
Under the Paperwork Reduction Act of Dockets Management (HFA–305), Food
Management, 5630 Fishers Lane, Rm.
1995 (PRA), Federal Agencies are and Drug Administration, 5630 Fishers
1061, Rockville, MD 20852.
required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT:
Federal Register concerning each JonnaLynn Capezzuto, Office of
submitted to the Division of Dockets
proposed collection of information, Operations, Food and Drug
Management, FDA will post your
including each proposed extension of an Administration, Three White Flint
comment, as well as any attachments,
existing collection of information, and North, 10A63, 11601 Landsdown St.,
except for information submitted,
to allow 60 days for public comment in North Bethesda, MD 20852, 301–796–
marked and identified, as confidential,
response to the notice. This notice 3794, PRAStaff@fda.hhs.gov.
if submitted as detailed in
solicits comments on voluntary SUPPLEMENTARY INFORMATION: Under the
‘‘Instructions.’’
customer satisfaction service surveys to Instructions: All submissions received PRA (44 U.S.C. 3501–3520), Federal
implement Executive Order 12862. must include the Docket No. FDA– Agencies must obtain approval from the
DATES: Submit either electronic or 2011–N–0019 for ‘‘Customer/Partner Office of Management and Budget
written comments on the collection of Service Surveys.’’ Received comments, (OMB) for each collection of
information by August 7, 2017. those filed in a timely manner (see information they conduct or sponsor.
ADDRESSES: You may submit comments ADDRESSES), will be placed in the docket ‘‘Collection of information’’ is defined
as follows. Please note that late, and, except for those submitted as in 44 U.S.C. 3502(3) and 5 CFR
untimely filed comments will not be ‘‘Confidential Submissions,’’ publicly 1320.3(c) and includes Agency requests
considered. Electronic comments must or requirements that members of the
sradovich on DSK3GMQ082PROD with NOTICES
viewable at https://www.regulations.gov
be submitted on or before August 7, or at the Division of Dockets public submit reports, keep records, or
2017. The https://www.regulations.gov Management between 9 a.m. and 4 p.m., provide information to a third party.
electronic filing system will accept Monday through Friday. Section 3506(c)(2)(A) of the PRA (44
comments until midnight Eastern Time • Confidential Submissions—To U.S.C. 3506(c)(2)(A)) requires Federal
at the end of August 7, 2017. Comments submit a comment with confidential Agencies to provide a 60-day notice in
received by mail/hand delivery/courier information that you do not wish to be the Federal Register concerning each
(for written/paper submissions) will be made publicly available, submit your proposed collection of information,
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Document Created: 2017-06-07 02:00:56
Document Modified: 2017-06-07 02:00:56
| 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 public meeting will be held on July 11, 2017, from 12:30 p.m. to 5 p.m. | |
| Contact | Jennifer Shepherd, 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 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. | |
| FR Citation | 82 FR 26495 |
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