82 FR 24720 - Pediatric Oncology Subcommittee of the 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 102 (May 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 102 (May 30, 2017)
| Page Range | 24720-24722 | |
| FR Document | 2017-11030 |
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)] [Notices] [Pages 24720-24722] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11030] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2731] Pediatric Oncology Subcommittee of the 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 Pediatric Oncology Subcommittee 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 June 21, 2017, from 8 a.m. to 3:15 p.m. and June 22, 2017, from 8 a.m. to 12 noon. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 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-2731. The docket will close on June 20, 2017. Submit either electronic or written comments on this public meeting by June 20, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight eastern time, June 20, 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 7, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. [[Page 24721]] You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): 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-2731 for ``Pediatric Oncology Subcommittee of the 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: Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the 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: On June 21, 2017, information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) APX- 005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; and (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. On June 22, 2017, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) Prexasertib, presentation by Dista Products/Eli Lilly and Company and (2) olaratumab, presentation by Eli Lilly and Company. 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 subcommittee. All electronic [[Page 24722]] and written submissions submitted to the Docket (see the ADDRESSES section) on or before June 7, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 8:50 a.m. to 9:10 a.m., 11 a.m. to 11:20 a.m., and 1:55 p.m. to 2:15 p.m. on June 21, 2017. Oral presentations from the public will also be scheduled between approximately 8:50 a.m. to 9:10 a.m. and 11 a.m. to 11:20 a.m. on June 22, 2017. 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 30, 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 31, 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: May 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-11030 Filed 5-26-17; 8:45 am] BILLING CODE 4164-01-P
![24720 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Total
Number of Average
Number of Total annual operating and
21 CFR section/FDA form responses per burden per Total hours
respondents responses maintenance
respondent response costs
Food Additive Petitions
171.1 ........................................................ 3 1 3 7,093 21,279 0
FDA Form 3503 ....................................... 6 1 6 1 6 0
Total .................................................. ........................ ........................ ........................ ........................ 23,959 $5,600
1 There are no capital costs associated with this collection of information.
The estimate of burden for food minimum information needed for SUMMARY: The Food and Drug
additive or color additive petitions is labeling in order that food and color Administration (FDA or Agency)
based on FDA’s experience with the manufacturers may comply with all announces a forthcoming public
petition process. The burden for this applicable provisions of the FD&C Act advisory committee meeting of the
information collection has changed and other specific labeling acts Pediatric Oncology Subcommittee of the
since the last OMB approval because the administered by FDA. Label information Oncologic Drugs Advisory Committee.
Generally Recognized as Safe does not require any additional The general function of the committee is
affirmations have been removed information gathering beyond what is to provide advice and recommendations
pursuant to the implementation of already required to assure conformance to the Agency on FDA’s regulatory
‘‘Substances Generally Recognized as with all specifications and limitations in issues. The meeting will be open to the
Safe; Final Rule,’’ August 17, 2016 (81 any given food or color additive public. FDA is establishing a docket for
FR 54960), 21 CFR parts 20, 25, 170, regulation. Label information does not public comment on this document.
184, 186, and 570. FDA is retaining its have any specific recordkeeping
prior estimate of the number of petitions DATES: The public meeting will be held
requirements unique to preparing the
received because the average number of on June 21, 2017, from 8 a.m. to 3:15
label. Therefore, because labeling
petitions received annually has varied p.m. and June 22, 2017, from 8 a.m. to
requirements under § 70.25 for a
little over the past 10 years. The figures 12 noon.
particular color additive involve
for hours per response are based on information required as part of the CAP ADDRESSES: FDA White Oak Campus,
estimates from experienced persons in safety review process, the estimate for 10903 New Hampshire Ave., Building
the Agency and in industry. Although number of respondents is the same for 31 Conference Center, the Great Room
the estimated hour burden varies with § 70.25 and § 71.1, and the burden hours (Rm. 1503), Silver Spring, MD 20993–
the type of petition submitted, an for labeling are included in the estimate 0002. Answers to commonly asked
average petition involves analytical for § 71.1. Also, because labeling questions including information
work and appropriate toxicological requirements under parts 172, 173, 179, regarding special accommodations due
studies, as well as the work of drafting and 180 for particular food additives to a disability, visitor parking, and
the petition itself. The burden varies involve information required as part of transportation may be accessed at:
depending on the complexity of the the FAP safety review process under https://www.fda.gov/
petition, including the amount and § 171.1, the burden hours for labeling AdvisoryCommittees/AboutAdvisory
types of data needed for scientific are included in the estimate for § 171.1. Committees/ucm408555.htm.
analysis.
Color additives are subjected to Dated: May 23, 2017. FDA is establishing a docket for
payment of fees for the petitioning Anna K. Abram, public comment on this meeting. The
process. The listing fee for a color Deputy Commissioner for Policy, Planning, docket number is FDA–2017–N–2731.
additive petition ranges from $1,600 to Legislation, and Analysis. The docket will close on June 20, 2017.
$3,000, depending on the intended use [FR Doc. 2017–11009 Filed 5–26–17; 8:45 am] Submit either electronic or written
of the color additive and the scope of BILLING CODE 4164–01–P
comments on this public meeting by
the requested amendment. A complete June 20, 2017. Late, untimely filed
schedule of fees is set forth in § 70.19. comments will not be considered.
An average of one Category A and one DEPARTMENT OF HEALTH AND Electronic comments must be submitted
Category B color additive petition is HUMAN SERVICES on or before June 20, 2017. The https://
expected per year. The maximum color www.regulations.gov electronic filing
additive petition fee for a Category A Food and Drug Administration system will accept comments until
petition is $2,600 and the maximum [Docket No. FDA–2017–N–2731] midnight eastern time, June 20, 2017.
color additive petition fee for a Category Comments received by mail/hand
B petition is $3,000. Because an average Pediatric Oncology Subcommittee of delivery/courier for written/paper
of 2 CAPs are expected per calendar the Oncologic Drugs Advisory submissions will be considered timely if
year, the estimated total annual cost Committee; Notice of Meeting; they are postmarked or the delivery
sradovich on DSK3GMQ082PROD with NOTICES
burden to petitioners for this startup Establishment of a Public Docket; service acceptance receipt is on or
cost would be less than or equal to Request for Comments before that date.
$5,600 ((1 × $2,600) + (1 × $3,000) AGENCY: Food and Drug Administration, Comments received on or before June
listing fees = $5,600). There are no HHS. 7, 2017, will be provided to the
capital costs associated with CAPs. The committee. Comments received after
ACTION: Notice; establishment of a
labeling requirements for food and color that date will be taken into
public docket; request for comments.
additives were designed to specify the consideration by the Agency.
VerDate Sep<11>2014 19:59 May 26, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\30MYN1.SGM 30MYN1](https://thefederalregister.org/doc/82_FR_24822/page/1.svg)
![24722 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
and written submissions submitted to If you require special accommodations ACTION: Notice.
the Docket (see the ADDRESSES section) due to a disability, please contact
on or before June 7, 2017, will be Lauren D. Tesh at least 7 days in SUMMARY: The Food and Drug
provided to the committee. Oral advance of the meeting. Administration (FDA) is publishing a
presentations from the public will be FDA is committed to the orderly list of information collections that have
scheduled between approximately 8:50 conduct of its advisory committee been approved by the Office of
a.m. to 9:10 a.m., 11 a.m. to 11:20 a.m., meetings. Please visit our Web site at Management and Budget (OMB) under
and 1:55 p.m. to 2:15 p.m. on June 21, https://www.fda.gov/ the Paperwork Reduction Act of 1995.
2017. Oral presentations from the public AdvisoryCommittees/AboutAdvisory
will also be scheduled between Committees/ucm111462.htm for FOR FURTHER INFORMATION CONTACT: Ila
approximately 8:50 a.m. to 9:10 a.m. procedures on public conduct during S. Mizrachi, Office of Operations, Food
and 11 a.m. to 11:20 a.m. on June 22, advisory committee meetings. and Drug Administration, Three White
2017. Those individuals interested in Notice of this meeting is given under Flint North, 11601 Landsdown St.,
making formal oral presentations should the Federal Advisory Committee Act (5 North Bethesda, MD 20852,
notify the contact person and submit a U.S.C. app. 2). 301–796–7726, PRAStaff@fda.hhs.gov.
brief statement of the general nature of Dated: May 23, 2017.
the evidence or arguments they wish to SUPPLEMENTARY INFORMATION: The
Anna K. Abram, following is a list of FDA information
present, the names and addresses of
proposed participants, and an Deputy Commissioner for Policy, Planning, collections recently approved by OMB
Legislation, and Analysis. under § 3507 of the Paperwork
indication of the approximate time
[FR Doc. 2017–11030 Filed 5–26–17; 8:45 am] Reduction Act of 1995 (44 U.S.C. 3507).
requested to make their presentation on
or before May 30, 2017. Time allotted BILLING CODE 4164–01–P The OMB control number and
for each presentation may be limited. If expiration date of OMB approval for
the number of registrants requesting to each information collection are shown
speak is greater than can be reasonably DEPARTMENT OF HEALTH AND
in table 1. Copies of the supporting
accommodated during the scheduled HUMAN SERVICES
statements for the information
open public hearing session, FDA may Food and Drug Administration collections are available on the Internet
conduct a lottery to determine the at http://www.reginfo.gov/public/do/
speakers for the scheduled open public [Docket Nos. FDA–2016–N–2544; FDA–
2013–N–0823; FDA–2013–N–0795; FDA–
PRAMain. An Agency may not conduct
hearing session. The contact person will or sponsor, and a person is not required
notify interested persons regarding their 2013–N–1147; FDA–2013–N–1064; FDA–
2008–D–0150; FDA–2013–N–0663; FDA– to respond to, a collection of
request to speak by May 31, 2017.
Persons attending FDA’s advisory 2010–D–0319; FDA–2013–N–0403; FDA– information unless it displays a
2012–D–0530; FDA–2016–N–0544] currently valid OMB control number.
committee meetings are advised that the
Agency is not responsible for providing Agency Information Collection
access to electrical outlets. Activities; Announcement of Office of
FDA welcomes the attendance of the Management and Budget Approvals
public at its advisory committee
meetings and will make every effort to AGENCY: Food and Drug Administration,
accommodate persons with disabilities. HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Current Good Manufacturing Practice; Quality System Regulation ........................................................................ 0910–0073 1/31/2020
Format and Content Requirements for Over-the-Counter Drug Product Labeling ................................................. 0910–0340 1/31/2020
Medical Devices; Third Party Review Under FDAMA ............................................................................................. 0910–0375 1/31/2020
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for
Food Safety and Applied Nutrition ....................................................................................................................... 0910–0541 1/31/2020
Application for Participation in the Medical Device Fellowship Program; Form FDA 3608 .................................... 0910–0551 1/31/2020
GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims ................................................ 0910–0670 1/31/2020
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety
Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans ......................................... 0910–0672 1/31/2020
GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information .................. 0910–0754 1/31/2020
Protection of Human Subjects: Informed Consent; Institutional Review Boards .................................................... 0910–0755 1/31/2020
Requests for Feedback on Medical Device Submissions ....................................................................................... 0910–0756 1/31/2020
National Direct-to-Consumer Advertising Survey .................................................................................................... 0910–0828 1/31/2020
Dated: May 23, 2017.
Anna K. Abram,
sradovich on DSK3GMQ082PROD with NOTICES
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11011 Filed 5–26–17; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2018-11-08 08:54:50
Document Modified: 2018-11-08 08:54:50
| 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 June 21, 2017, from 8 a.m. to 3:15 p.m. and June 22, 2017, from 8 a.m. to 12 noon. | |
| Contact | Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the 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 24720 |
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