83_FR_6885 83 FR 6853 - Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

83 FR 6853 - 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 32 (February 15, 2018)

Page Range6853-6854
FR Document2018-03174

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.

Federal Register, Volume 83 Issue 32 (Thursday, February 15, 2018) 
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6853-6854]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0408]


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) 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 March 7, 2018, from 8 a.m. to 12:30 
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-0408. The docket will close on March 6, 
2018. Submit either electronic or written comments on this public 
meeting by March 6, 2018. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before March 6, 2018. The https://www.regulations.gov electronic 
filing system will accept comments until midnight Eastern Time at the 
end of March 6, 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 February 26, 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.

[[Page 6854]]

     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-0408 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 ADDRESSSES), 
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. 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: 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 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 supplemental biologic license 
application (sBLA) 125557/S-013, for BLINCYTO (blinatumomab) injection 
for intravenous use, application submitted by Amgen, Inc. The proposed 
indication (use) for this product is for the treatment of minimal 
residual disease-positive B-cell precursor acute lymphoblastic 
leukemia.
    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 February 26, 2018. Oral presentations from the 
public will be scheduled between approximately 10:30 a.m. to 11:30 a.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 
February 21, 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 February 22, 
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 
fdaoma@fda.hhs.gov 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 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: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03174 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6853 Emergency Assistance Act (Stafford President 13589 and the memorandum be used to support ACF/OHSEPR’s goal Act), as amended, 42 U.S.C. 5189d to the Heads of Executive Departments to quickly identify critical gaps, authorizes the Federal Emergency and Agencies M–12–12 from the Office resources, needs, and services to Management Agency (FEMA) and the of Management and Budget to ‘‘Promote support State, local and non-profit U.S. Department of Health Services’ Efficient Spending to Support Agency capacity for disaster case management Administration for Children and Operations.’’ and to augment and build capacity Families (ACF) to provide Immediate The primary purpose of the where none exists. All information Disaster Case Management (IDCM) information collection pertains to ACF/ gathered will be exclusively used to services under the federal Disaster Case OHSEPR’s initiative to improve the inform the delivery of disaster case Management Program (DCMP). intake process and delivery of case management services and programmatic The use of the Electronic Case management services to individuals and strategies and improvements. Management Record System (ECMRS) is households impacted by a disaster. Respondents: Individuals impacted by aligned with Executive Order of the Further, the information collection will a disaster. ANNUAL BURDEN ESTIMATES Number of Number of Burden hours Total burden Instrument responses per respondents per response hours respondent IDCM Intake Assessment ................................................................................ 3,500 1 40 minutes 2,333 Estimated Total Annual Burden DEPARTMENT OF HEALTH AND untimely filed comments will not be Hours: 2,333 hours or 140,000 minutes. HUMAN SERVICES considered. Electronic comments must In compliance with the requirements be submitted on or before March 6, of Section 506(c)(2)(A) of the Paperwork Food and Drug Administration 2018. The https://www.regulations.gov Reduction Act of 1995, the [Docket No. FDA–2018–N–0408] electronic filing system will accept Administration for Children and comments until midnight Eastern Time Families is soliciting public comment Oncologic Drugs Advisory Committee; at the end of March 6, 2018. Comments on the specific aspects of the Notice of Meeting; Establishment of a received by mail/hand delivery/courier information collection described above. Public Docket; Request for Comments (for written/paper submissions) will be Copies of the proposed collection of considered timely if they are AGENCY: Food and Drug Administration, postmarked or the delivery service information can be obtained and HHS. comments may be forwarded by writing acceptance receipt is on or before that ACTION: Notice; establishment of a date. to the Administration for Children and public docket; request for comments. Families, Office of Planning, Research Comments received on or before and Evaluation, 370 L’Enfant SUMMARY: The Food and Drug February 26, 2018, will be provided to Promenade SW, Washington, DC 20447, Administration (FDA) announces a the committee. Comments received after Attn: ACF Reports Clearance Officer. forthcoming public advisory committee that date will be taken into Email address: infocollection@ meeting of the Oncologic Drugs consideration by FDA. acf.hhs.gov. All requests should be Advisory Committee. The general You may submit comments as identified by the title of the information function of the committee is to provide follows: collection. advice and recommendations to FDA on Electronic Submissions The Department specifically requests regulatory issues. The meeting will be comments on: (a) Whether the proposed open to the public. FDA is establishing Submit electronic comments in the collection of information is necessary a docket for public comment on this following way: for the proper performance of the document. • Federal eRulemaking Portal: functions of the agency, including DATES: The meeting will be held on https://www.regulations.gov. Follow the whether the information shall have March 7, 2018, from 8 a.m. to 12:30 p.m. instructions for submitting comments. practical utility; (b) the accuracy of the ADDRESSES: FDA White Oak Campus, Comments submitted electronically, agency’s estimate of the burden of the 10903 New Hampshire Ave., Bldg. 31 including attachments, to https:// proposed collection of information; (c) Conference Center, the Great Room (Rm. www.regulations.gov will be posted to the quality, utility, and clarity of the 1503), Silver Spring, MD 20993–0002. the docket unchanged. Because your information to be collected; and (d) Answers to commonly asked questions comment will be made public, you are ways to minimize the burden of the including information regarding special solely responsible for ensuring that your collection of information on accommodations due to a disability, comment does not include any respondents, including through the use visitor parking, and transportation may confidential information that you or a of automated collection techniques or be accessed at: https://www.fda.gov/ third party may not wish to be posted, other forms of information technology. AdvisoryCommittees/AboutAdvisory such as medical information, your or Consideration will be given to anyone else’s Social Security number, or sradovich on DSK3GMQ082PROD with NOTICES Committees/ucm408555.htm. comments and suggestions submitted FDA is establishing a docket for confidential business information, such within 60 days of this publication. public comment on this meeting. The as a manufacturing process. Please note docket number is FDA–2018–N–0408. that if you include your name, contact Robert Sargis, The docket will close on March 6, 2018. information, or other information that Reports Clearance Officer. Submit either electronic or written identifies you in the body of your [FR Doc. 2018–03105 Filed 2–14–18; 8:45 am] comments on this public meeting by comments, that information will be BILLING CODE 4184–01–P March 6, 2018. Please note that late, posted on https://www.regulations.gov. VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1

6854 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices • If you want to submit a comment of comments to public dockets, see 80 Procedure: Interested persons may with confidential information that you FR 56469, September 18, 2015, or access present data, information, or views, do not wish to be made available to the the information at: https://www.gpo.gov/ orally or in writing, on issues pending public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- before the committee. All electronic and written/paper submission and in the 23389.pdf. written submissions submitted to the manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Docket (see ADDRESSES) on or before Submissions’’ and ‘‘Instructions’’). read background documents or the February 26, 2018. Oral presentations Written/Paper Submissions electronic and written/paper comments from the public will be scheduled received, go to https:// between approximately 10:30 a.m. to Submit written/paper submissions as www.regulations.gov and insert the follows: 11:30 a.m. Those individuals interested docket number, found in brackets in the in making formal oral presentations • Mail/Hand delivery/Courier (for heading of this document, into the should notify the contact person and written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts submit a brief statement of the general Management Staff (HFA–305), Food and and/or go to the Dockets Management nature of the evidence or arguments Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, they wish to present, the names and Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments Rockville, MD 20852. addresses of proposed participants, and submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: an indication of the approximate time Staff, FDA will post your comment, as Lauren D. Tesh, Center for Drug requested to make their presentation on well as any attachments, except for Evaluation and Research, Food and or before February 21, 2018. Time information submitted, marked and Drug Administration, 10903 New allotted for each presentation may be identified, as confidential, if submitted Hampshire Ave., Bldg. 31, Rm. 2417, limited. If the number of registrants as detailed in ‘‘Instructions.’’ Silver Spring, MD 20993–0002, 301– requesting to speak is greater than can Instructions: All submissions received 796–9001, Fax: 301–847–8533, email: be reasonably accommodated during the must include the Docket No. FDA– ODAC@fda.hhs.gov, or FDA Advisory scheduled open public hearing session, 2018–N–0408 for ‘‘Oncologic Drugs Committee Information Line, 1–800– Advisory Committee; Notice of Meeting; FDA may conduct a lottery to determine 741–8138 (301–443–0572 in the Establishment of a Public Docket; the speakers for the scheduled open Washington, DC area). A notice in the Request for Comments.’’ Received public hearing session. The contact Federal Register about last minute comments, those filed in a timely modifications that impact a previously person will notify interested persons manner (see ADDRESSSES), will be announced advisory committee meeting regarding their request to speak by placed in the docket and, except for cannot always be published quickly February 22, 2018. those submitted as ‘‘Confidential enough to provide timely notice. Persons attending FDA’s advisory Submissions,’’ publicly viewable at Therefore, you should always check the committee meetings are advised that https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ FDA is not responsible for providing Dockets Management Staff between 9 AdvisoryCommittees/default.htm and access to electrical outlets. a.m. and 4 p.m., Monday through scroll down to the appropriate advisory Friday. For press inquiries, please contact the committee meeting link, or call the Office of Media Affairs at fdaoma@ • Confidential Submissions—To advisory committee information line to submit a comment with confidential fda.hhs.gov or 301–796–4540. learn about possible modifications information that you do not wish to be before coming to the meeting. FDA welcomes the attendance of the made publicly available, submit your public at its advisory committee comments only as a written/paper SUPPLEMENTARY INFORMATION: meetings and will make every effort to submission. You should submit two Agenda: The committee will discuss accommodate persons with disabilities. copies total. One copy will include the supplemental biologic license If you require accommodations due to a information you claim to be confidential application (sBLA) 125557/S–013, for disability, please contact Lauren D. Tesh with a heading or cover note that states BLINCYTO (blinatumomab) injection at least 7 days in advance of the ‘‘THIS DOCUMENT CONTAINS for intravenous use, application submitted by Amgen, Inc. The proposed meeting. CONFIDENTIAL INFORMATION.’’ FDA will review this copy, including the indication (use) for this product is for FDA is committed to the orderly claimed confidential information, in its the treatment of minimal residual conduct of its advisory committee consideration of comments. The second disease-positive B-cell precursor acute meetings. Please visit our website at copy, which will have the claimed lymphoblastic leukemia. https://www.fda.gov/Advisory confidential information redacted/ FDA intends to make background Committees/AboutAdvisoryCommittees/ blacked out, will be available for public material available to the public no later ucm111462.htm for procedures on viewing and posted on https:// than 2 business days before the meeting. public conduct during advisory www.regulations.gov. Submit both If FDA is unable to post the background committee meetings. copies to the Dockets Management Staff. material on its website prior to the Notice of this meeting is given under If you do not wish your name and meeting, the background material will the Federal Advisory Committee Act (5 contact information be made publicly be made publicly available at the U.S.C. app. 2). available, you can provide this location of the advisory committee information on the cover sheet and not meeting, and the background material Dated: February 9, 2018. sradovich on DSK3GMQ082PROD with NOTICES in the body of your comments and you will be posted on FDA’s website after Leslie Kux, must identify the information as the meeting. Background material is Associate Commissioner for Policy. ‘‘confidential.’’ Any information marked available at https://www.fda.gov/ [FR Doc. 2018–03174 Filed 2–14–18; 8:45 am] as ‘‘confidential’’ will not be disclosed AdvisoryCommittees/Calendar/ BILLING CODE 4164–01–P except in accordance with 21 CFR 10.20 default.htm. Scroll down to the and other applicable disclosure law. For appropriate advisory committee meeting more information about FDA’s posting link. VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00021 Fmt 4703 Sfmt 9990 E:\FR\FM\15FEN1.SGM 15FEN1


Document Created: 2018-02-15 00:21:02
Document Modified: 2018-02-15 00:21:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of a public docket; request for comments.
DatesThe meeting will be held on March 7, 2018, from 8 a.m. to 12:30 p.m.
ContactLauren 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 Citation83 FR 6853 
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