Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 18296-18297 [2017-07771]

Download as PDF 18296 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices test results are reported to the subject’s health care provider and public health authorities, as applicable. Under § 50.23(e)(4), the investigator provides the IRB with the information required by § 50.25 (21 CFR 50.25) (except for the information described in § 50.25(a)(8)) and the procedures that will be used to provide this information to each subject or the subject’s legally authorized representative. FDA estimates that there are approximately 150 laboratories that could perform testing that uses investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents. FDA estimates that in the United States each year there are approximately 450 naturally occurring cases of diseases or conditions that are identified in the Centers for Disease Control and Prevention’s list of category ‘‘A’’ biological threat agents. The number of cases that would result from a terrorist event or other public health emergency is uncertain. Based on its knowledge of similar types of submissions, FDA estimates that it will take about 2 hours to prepare each certification. We estimate the operating and maintenance cost of $200 for copying and mailing the information to FDA. Based on its knowledge of similar types of submissions, FDA estimates that it will take about 1 hour to prepare a report disclosing the investigational status of the in vitro diagnostic device and what is known about the performance characteristics of the device and submit it to the health care provider and, where appropriate, to public health authorities. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR Section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Total operating and maintenance costs Written certification (sent to FDA)— 50.23(e)(3) ............................................ 150 3 450 0.25 113 $200 Average burden per disclosure Total hours 1 There are no capital costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents 21 CFR Part Number of disclosures per respondent Total annual disclosures Written certification (sent to IRB)—50.23(e)(1) and (e)(2) .. Informed consent information—50.23(e)(4) ......................... 150 150 3 3 450 450 2 1 900 450 Total .............................................................................. ........................ ........................ ........................ ........................ 1,350 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. 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. [FR Doc. 2017–07768 Filed 4–17–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–2093] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, sradovich on DSK3GMQ082PROD with NOTICES HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (ODAC). The general function of the committee is to SUMMARY: VerDate Sep<11>2014 16:55 Apr 17, 2017 The meeting will be held on May 24, 2017, from 8 a.m. to 5 p.m. The docket number is FDA–2017–N–1063. The docket will close on May 23, 2017. Comments received on or before May 10, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. DATES: Jkt 241001 FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. 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. You may submit comments as follows: ADDRESSES: PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 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 E:\FR\FM\18APN1.SGM 18APN1 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices Docket: For access to the docket to read background documents or the electronic and written/paper comments Written/Paper Submissions received, go to https:// Submit written/paper submissions as www.regulations.gov and insert the follows: docket number, found in brackets in the • Mail/Hand delivery/Courier (for heading of this document, into the written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food and/or go to the Division of Dockets and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. • For written/paper comments FOR FURTHER INFORMATION CONTACT: submitted to the Division of Dockets Lauren D. Tesh, Center for Drug Management, FDA will post your Evaluation and Research, Food and comment, as well as any attachments, Drug Administration, 10903 New except for information submitted, Hampshire Ave., Building 31, Rm. 2417, marked and identified, as confidential, Silver Spring, MD 20993–0002, 301– if submitted as detailed in 796–9001, FAX: 301–847–8533, email: ‘‘Instructions.’’ Instructions: All submissions received ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– must include the Docket No. FDA– 741–8138 (301–443–0572 in the 2017–N–2093 for ‘‘Oncologic Drugs Advisory Committee; Notice of Meeting; Washington, DC area). A notice in the Federal Register about last minute Establishment of a Public Docket; modifications that impact a previously Request for Comments.’’ Received announced advisory committee meeting comments will be placed in the docket cannot always be published quickly and, except for those submitted as enough to provide timely notice. ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov Therefore, you should always check the Agency’s Web site at https:// or at the Division of Dockets Management between 9 a.m. and 4 p.m., www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the Monday through Friday. appropriate advisory committee meeting • Confidential Submissions—To link, or call the advisory committee submit a comment with confidential information line to learn about possible information that you do not wish to be modifications before coming to the made publicly available, submit your meeting. comments only as a written/paper submission. You should submit two SUPPLEMENTARY INFORMATION: copies total. One copy will include the Agenda: During the morning session, information you claim to be confidential the committee will discuss new drug with a heading or cover note that states application (NDA) 208051, for neratinib ‘‘THIS DOCUMENT CONTAINS maleate, an application submitted by CONFIDENTIAL INFORMATION.’’ The Puma Biotechnology. The proposed Agency will review this copy, including indication (use) for this product is as a the claimed confidential information, in single agent for the extended adjuvant its consideration of comments. The treatment of adult patients with earlysecond copy, which will have the stage HER2-overexpressed/amplified claimed confidential information breast cancer who have received prior redacted/blacked out, will be available adjuvant traustuzumab-based therapy. for public viewing and posted on During the afternoon session, the https://www.regulations.gov. Submit committee will discuss NDA 208587, for both copies to the Division of Dockets L-glutamine powder (oral solution), Management. If you do not wish your submitted by Emmaus Medical, Inc. The name and contact information to be proposed indication (use) for this made publicly available, you can product is for the treatment of sickle cell provide this information on the cover disease. sheet and not in the body of your FDA intends to make background comments and you must identify this material available to the public no later information as ‘‘confidential.’’ Any than 2 business days before the meeting. information marked as ‘‘confidential’’ If FDA is unable to post the background will not be disclosed except in material on its Web site prior to the accordance with 21 CFR 10.20 and other meeting, the background material will applicable disclosure law. For more be made publicly available at the information about FDA’s posting of location of the advisory committee comments to public dockets, see 80 FR meeting, and the background material 56469, September 18, 2015, or access will be posted on FDA’s Web site after the information at: https://www.gpo.gov/ the meeting. Background material is fdsys/pkg/FR-2015-09-18/pdf/2015available at https://www.fda.gov/ 23389.pdf. AdvisoryCommittees/Calendar/ sradovich on DSK3GMQ082PROD with NOTICES manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). VerDate Sep<11>2014 16:55 Apr 17, 2017 Jkt 241001 PO 00000 Frm 00021 Fmt 4703 Sfmt 9990 18297 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 must be submitted on or before May 23, 2017. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11 a.m. and 3:30 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 May 2, 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 May 3, 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 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 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: April 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–07771 Filed 4–17–17; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\18APN1.SGM 18APN1

Agencies

[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18296-18297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2093]


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 (ODAC). 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 meeting will be held on May 24, 2017, from 8 a.m. to 5 p.m. 
The docket number is FDA-2017-N-1063. The docket will close on May 23, 
2017. Comments received on or before May 10, 2017, will be provided to 
the committee. Comments received after that date will be taken into 
consideration by the Agency.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. 
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. 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

[[Page 18297]]

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-2093 for ``Oncologic Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; 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 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: Lauren D. Tesh, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Building 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: During the morning session, the committee will discuss new 
drug application (NDA) 208051, for neratinib maleate, an application 
submitted by Puma Biotechnology. The proposed indication (use) for this 
product is as a single agent for the extended adjuvant treatment of 
adult patients with early-stage HER2-overexpressed/amplified breast 
cancer who have received prior adjuvant traustuzumab-based therapy. 
During the afternoon session, the committee will discuss NDA 208587, 
for L-glutamine powder (oral solution), submitted by Emmaus Medical, 
Inc. The proposed indication (use) for this product is for the 
treatment of sickle cell disease.
    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 must be submitted on or before 
May 23, 2017. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11 a.m. and 3:30 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 May 
2, 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 May 3, 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 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 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: April 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07771 Filed 4-17-17; 8:45 am]
 BILLING CODE 4164-01-P

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