82 FR 18296 - 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 73 (April 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 73 (April 18, 2017)
| Page Range | 18296-18297 | |
| FR Document | 2017-07771 |
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)] [Notices] [Pages 18296-18297] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07771] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.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: 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: [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: 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
![18296 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
test results are reported to the subject’s devices to identify chemical, biological, estimate the operating and maintenance
health care provider and public health radiological, or nuclear agents. FDA cost of $200 for copying and mailing the
authorities, as applicable. Under estimates that in the United States each information to FDA.
§ 50.23(e)(4), the investigator provides year there are approximately 450 Based on its knowledge of similar
the IRB with the information required naturally occurring cases of diseases or types of submissions, FDA estimates
by § 50.25 (21 CFR 50.25) (except for the conditions that are identified in the that it will take about 1 hour to prepare
information described in § 50.25(a)(8)) Centers for Disease Control and a report disclosing the investigational
and the procedures that will be used to Prevention’s list of category ‘‘A’’ status of the in vitro diagnostic device
provide this information to each subject biological threat agents. The number of and what is known about the
or the subject’s legally authorized cases that would result from a terrorist performance characteristics of the
representative. event or other public health emergency device and submit it to the health care
FDA estimates that there are is uncertain. Based on its knowledge of provider and, where appropriate, to
approximately 150 laboratories that similar types of submissions, FDA public health authorities.
could perform testing that uses estimates that it will take about 2 hours FDA estimates the burden of this
investigational in vitro diagnostic to prepare each certification. We collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total operating
Number of Average
Number of Total annual and
21 CFR Section responses per burden per Total hours
respondents responses maintenance
respondent response costs
Written certification (sent to FDA)—
50.23(e)(3) ............................................ 150 3 450 0.25 113 $200
1 There are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR Part burden per Total hours
respondents per disclosures disclosure
respondent
Written certification (sent to IRB)—50.23(e)(1) and (e)(2) .. 150 3 450 2 900
Informed consent information—50.23(e)(4) ......................... 150 3 450 1 450
Total .............................................................................. ........................ ........................ ........................ ........................ 1,350
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 11, 2017. provide advice and recommendations to Electronic Submissions
Anna K. Abram, the Agency on FDA’s regulatory issues. Submit electronic comments in the
Deputy Commissioner for Policy, Planning, The meeting will be open to the public. following way:
Legislation, and Analysis. FDA is establishing a docket for public • Federal eRulemaking Portal:
[FR Doc. 2017–07768 Filed 4–17–17; 8:45 am] comment on this document. https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P instructions for submitting comments.
DATES: The meeting will be held on May
Comments submitted electronically,
24, 2017, from 8 a.m. to 5 p.m. The
including attachments, to https://
DEPARTMENT OF HEALTH AND docket number is FDA–2017–N–1063. www.regulations.gov will be posted to
HUMAN SERVICES The docket will close on May 23, 2017. the docket unchanged. Because your
Comments received on or before May comment will be made public, you are
Food and Drug Administration 10, 2017, will be provided to the solely responsible for ensuring that your
committee. Comments received after comment does not include any
[Docket No. FDA–2017–N–2093] that date will be taken into confidential information that you or a
consideration by the Agency. third party may not wish to be posted,
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a ADDRESSES: FDA White Oak Campus, such as medical information, your or
Public Docket; Request for Comments 10903 New Hampshire Ave., Building anyone else’s Social Security number, or
31 Conference Center, the Great Room confidential business information, such
AGENCY: Food and Drug Administration, as a manufacturing process. Please note
(Rm. 1503), Silver Spring, MD 20993.
HHS. that if you include your name, contact
Answers to commonly asked questions
ACTION: Notice; establishment of a information, or other information that
including information regarding special
sradovich on DSK3GMQ082PROD with NOTICES
public docket; request for comments. identifies you in the body of your
accommodations due to a disability, comments, that information will be
SUMMARY: The Food and Drug visitor parking, and transportation may posted on https://www.regulations.gov.
Administration (FDA) announces a be accessed at: https://www.fda.gov/ • If you want to submit a comment
forthcoming public advisory committee AdvisoryCommittees/ with confidential information that you
meeting of the Oncologic Drugs AboutAdvisoryCommittees/ do not wish to be made available to the
Advisory Committee (ODAC). The ucm408555.htm. You may submit public, submit the comment as a
general function of the committee is to comments as follows: written/paper submission and in the
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![Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices 18297
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to default.htm. Scroll down to the
Submissions’’ and ‘‘Instructions’’). read background documents or the appropriate advisory committee meeting
electronic and written/paper comments link.
Written/Paper Submissions
received, go to https:// Procedure: Interested persons may
Submit written/paper submissions as www.regulations.gov and insert the
follows: present data, information, or views,
docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
orally or in writing, on issues pending
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts before the committee. All electronic and
Dockets Management (HFA–305), Food and/or go to the Division of Dockets written submissions must be submitted
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. on or before May 23, 2017. Oral
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. presentations from the public will be
• For written/paper comments scheduled between approximately 10:30
FOR FURTHER INFORMATION CONTACT:
submitted to the Division of Dockets a.m. and 11 a.m. and 3:30 p.m. and 4
Lauren D. Tesh, Center for Drug
Management, FDA will post your p.m. Those individuals interested in
Evaluation and Research, Food and
comment, as well as any attachments, making formal oral presentations should
Drug Administration, 10903 New
except for information submitted, notify the contact person and submit a
Hampshire Ave., Building 31, Rm. 2417,
marked and identified, as confidential, brief statement of the general nature of
Silver Spring, MD 20993–0002, 301–
if submitted as detailed in the evidence or arguments they wish to
796–9001, FAX: 301–847–8533, email:
‘‘Instructions.’’
present, the names and addresses of
Instructions: All submissions received ODAC@fda.hhs.gov, or FDA Advisory
must include the Docket No. FDA– Committee Information Line, 1–800– proposed participants, and an
2017–N–2093 for ‘‘Oncologic Drugs 741–8138 (301–443–0572 in the indication of the approximate time
Advisory Committee; Notice of Meeting; Washington, DC area). A notice in the requested to make their presentation on
Establishment of a Public Docket; Federal Register about last minute or before May 2, 2017. Time allotted for
Request for Comments.’’ Received modifications that impact a previously each presentation may be limited. If the
comments will be placed in the docket announced advisory committee meeting number of registrants requesting to
and, except for those submitted as cannot always be published quickly speak is greater than can be reasonably
‘‘Confidential Submissions,’’ publicly enough to provide timely notice. accommodated during the scheduled
viewable at https://www.regulations.gov Therefore, you should always check the open public hearing session, FDA may
or at the Division of Dockets Agency’s Web site at https:// conduct a lottery to determine the
Management between 9 a.m. and 4 p.m., www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public
Monday through Friday. default.htm and scroll down to the hearing session. The contact person will
• Confidential Submissions—To appropriate advisory committee meeting
notify interested persons regarding their
submit a comment with confidential link, or call the advisory committee
request to speak by May 3, 2017.
information that you do not wish to be information line to learn about possible
made publicly available, submit your modifications before coming to the Persons attending FDA’s advisory
comments only as a written/paper meeting. committee meetings are advised that the
submission. You should submit two SUPPLEMENTARY INFORMATION:
Agency is not responsible for providing
copies total. One copy will include the Agenda: During the morning session, access to electrical outlets.
information you claim to be confidential the committee will discuss new drug FDA welcomes the attendance of the
with a heading or cover note that states application (NDA) 208051, for neratinib public at its advisory committee
‘‘THIS DOCUMENT CONTAINS maleate, an application submitted by meetings and will make every effort to
CONFIDENTIAL INFORMATION.’’ The Puma Biotechnology. The proposed accommodate persons with disabilities.
Agency will review this copy, including indication (use) for this product is as a If you require special accommodations
the claimed confidential information, in single agent for the extended adjuvant due to a disability, please contact
its consideration of comments. The treatment of adult patients with early- Lauren D. Tesh at least 7 days in
second copy, which will have the stage HER2-overexpressed/amplified advance of the meeting.
claimed confidential information breast cancer who have received prior
redacted/blacked out, will be available adjuvant traustuzumab-based therapy. FDA is committed to the orderly
for public viewing and posted on During the afternoon session, the conduct of its advisory committee
https://www.regulations.gov. Submit committee will discuss NDA 208587, for meetings. Please visit our Web site at
both copies to the Division of Dockets L-glutamine powder (oral solution), https://www.fda.gov/
Management. If you do not wish your submitted by Emmaus Medical, Inc. The AdvisoryCommittees/
name and contact information to be proposed indication (use) for this AboutAdvisoryCommittees/
made publicly available, you can product is for the treatment of sickle cell ucm111462.htm for procedures on
provide this information on the cover disease. public conduct during advisory
sheet and not in the body of your FDA intends to make background committee meetings.
comments and you must identify this material available to the public no later Notice of this meeting is given under
information as ‘‘confidential.’’ Any than 2 business days before the meeting. the Federal Advisory Committee Act (5
information marked as ‘‘confidential’’ If FDA is unable to post the background U.S.C. app. 2).
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 Dated: April 12, 2017.
sradovich on DSK3GMQ082PROD with NOTICES
applicable disclosure law. For more be made publicly available at the Anna K. Abram,
information about FDA’s posting of location of the advisory committee Deputy Commissioner for Policy, Planning,
comments to public dockets, see 80 FR meeting, and the background material Legislation, and Analysis.
56469, September 18, 2015, or access will be posted on FDA’s Web site after [FR Doc. 2017–07771 Filed 4–17–17; 8:45 am]
the information at: https://www.gpo.gov/ the meeting. Background material is BILLING CODE 4164–01–P
fdsys/pkg/FR-2015-09-18/pdf/2015- available at https://www.fda.gov/
23389.pdf. AdvisoryCommittees/Calendar/
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Document Created: 2017-04-18 00:00:04
Document Modified: 2017-04-18 00:00:04
| 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 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. | |
| 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: [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 18296 |
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