82 FR 26492 - Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 108 (June 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 108 (June 7, 2017)
| Page Range | 26492-26494 | |
| FR Document | 2017-11818 |
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)] [Notices] [Pages 26492-26494] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11818] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2734] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The public meeting will be held on July 12, 2017, from 8 a.m. to 5 p.m. 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-2734. The docket will close on July 10, 2017. Submit either electronic or written comments on this public meeting by July 10, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 10, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight eastern time, July 10, 2017. Comments received by mail/hand delivery/courier for written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before June 26, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. You may submit comments as follows: 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 [[Page 26493]] 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-2734 for ``Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss biologics license application (BLA) 125646, for tisagenlecleucel-T suspension for intravenous use. The application was submitted by Novartis Pharmaceuticals Corp. The proposed indication (use) for this product is for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/ refractory B-cell acute lymphoblastic leukemia (ALL). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before June 26, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 16, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 19, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Jennifer Shepherd at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on [[Page 26494]] public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-11818 Filed 6-6-17; 8:45 am] BILLING CODE 4164-01-P
![26492 Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
reports annually from 200 to 1,200 immediate previous source(s) and/or burden will not affect voluntary
mandatory and voluntary users of the immediate subsequent recipient(s). The reporters of reportable food events.
electronic reporting system. We utilized Agency bases its estimate on its Therefore, we estimate that the total
the upper-bound estimate of 1,200 for experience with mandatory and burden of notifying the immediate
these calculations. voluntary reports submitted to FDA. previous source(s) and immediate
We estimate that notifying the Although it is not mandatory under subsequent recipient(s) under section
immediate previous source(s) will take FDAAA, section 1005 that responsible 417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and
0.6 hours per reportable food and persons notify the sources and (ii) of the FD&C Act for 1,200 reportable
notifying the immediate subsequent recipients of instances of reportable
foods will be 2,880 hours annually
recipient(s) will take 0.6 hours per food, for purposes of the burden
(1,200 × 0.6 hours) + (1,200 × 0.6 hours)
reportable food. We also estimate that it estimate we are assuming FDA would
will take 0.6 hours for the immediate exercise its authority and require such + (1,200 × 0.6 hours) + (1,200 × 0.6
previous source and/or the immediate notifications in all such instances for hours). This annual burden is shown in
subsequent recipient to also notify their mandatory reporters. This notification table 1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Maintenance of reportable food records under 1,200 1 1,200 0.25 (15 minutes) ......... 300
section 417(g) of the FD&C Act—mandatory
reports.
Maintenance of reportable food records under 4 1 4 0.25 (15 minutes) ......... 1
section 417(g) of the FD&C Act—voluntary re-
ports.
Total ............................................................... ........................ ........................ ........................ ....................................... 301
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping: As noted previously, DEPARTMENT OF HEALTH AND AdvisoryCommittees/
section 417(g) of the FD&C Act requires HUMAN SERVICES AboutAdvisoryCommittees/
that responsible persons maintain ucm408555.htm.
records related to reportable foods Food and Drug Administration FDA is establishing a docket for
reports and notifications under section [Docket No. FDA–2017–N–2734] public comment on this meeting. The
417 of the FD&C Act for a period of 2 docket number is FDA–2017–N–2734.
years. Based on past FDA experiences, Oncologic Drugs Advisory Committee; The docket will close on July 10, 2017.
we estimate that each mandatory report Notice of Meeting; Establishment of a Submit either electronic or written
and its associated notifications will Public Docket; Request for Comments comments on this public meeting by
require 30 minutes of recordkeeping for July 10, 2017. Late, untimely filed
AGENCY: Food and Drug Administration, comments will not be considered.
the 2-year period, or 15 minutes per HHS.
record per year. The annual Electronic comments must be submitted
recordkeeping burden for mandatory ACTION: Notice; establishment of a on or before July 10, 2017. The https://
public docket; request for comments. www.regulations.gov electronic filing
reportable food reports and their
associated notifications is thus system will accept comments until
SUMMARY: The Food and Drug midnight eastern time, July 10, 2017.
estimated to be 300 hours (1,200 × 0.25 Administration (FDA or Agency)
hours). Comments received by mail/hand
announces a forthcoming public delivery/courier for written/paper
We do not expect that records will advisory committee meeting of the submissions will be considered timely if
always be kept in relation to voluntary Oncologic Drugs Advisory Committee. they are postmarked or the delivery
reportable food reports. Therefore, we The general function of the committee is service acceptance receipt is on or
estimate that records will be kept for to provide advice and recommendations before that date.
four voluntary reports we expect to to the Agency on FDA’s regulatory Comments received on or before June
receive annually. The recordkeeping issues. The meeting will be open to the 26, 2017, will be provided to the
burden associated with voluntary public. FDA is establishing a docket for committee. Comments received after
reports is thus estimated to be 1 hour public comment on this document. that date will be taken into
annually (4 × 0.25 hours). The estimated DATES: The public meeting will be held consideration by the Agency.
total annual recordkeeping burden will on July 12, 2017, from 8 a.m. to 5 p.m. You may submit comments as
be 301 hours annually (1,200 × 0.25 ADDRESSES: FDA White Oak Campus, follows:
hours) + (4 × 0.25 hours). This annual 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room Electronic Submissions
sradovich on DSK3GMQ082PROD with NOTICES
burden is shown in table 2.
Dated: June 1, 2017.
(Rm. 1503), Silver Spring, MD 20993– Submit electronic comments in the
0002. Answers to commonly asked following way:
Anna K. Abram, questions including information • Federal eRulemaking Portal:
Deputy Commissioner for Policy, Planning, regarding special accommodations due https://www.regulations.gov. Follow the
Legislation, and Analysis. to a disability, visitor parking, and instructions for submitting comments.
[FR Doc. 2017–11821 Filed 6–6–17; 8:45 am] transportation may be accessed at: Comments submitted electronically,
BILLING CODE 4164–01–P https://www.fda.gov/ including attachments, to
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![26494 Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
public conduct during advisory information, please refer to https:// Instructions: All submissions received
committee meetings. www.fda.gov/AboutFDA/ must include the Docket No. FDA–
Notice of this meeting is given under WorkingatFDA/BuildingsandFacilities/ 2017–N–2094 for ‘‘Developing Rabies
the Federal Advisory Committee Act (5 WhiteOakCampusInformation/ Monoclonal Antibody Products as a
U.S.C. app. 2). ucm241740.htm. Component of Rabies Post-Exposure
Dated: June 1, 2017. You may submit comments as Prophylaxis.’’ Received comments,
Anna K. Abram, follows. Please note that late, untimely those filed in a timely manner (see
filed comments will not be considered. ADDRESSES), will be placed in the docket
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. Electronic comments must be submitted and, except for those submitted as
on or before July 31, 2017. The https:// ‘‘Confidential Submissions,’’ publicly
[FR Doc. 2017–11818 Filed 6–6–17; 8:45 am]
www.regulations.gov electronic filing viewable at https://www.regulations.gov
BILLING CODE 4164–01–P
system will accept comments until or at the Division of Dockets
midnight Eastern Time at the end of July Management between 9 a.m. and 4 p.m.,
DEPARTMENT OF HEALTH AND 31, 2017. Comments received by mail/ Monday through Friday.
HUMAN SERVICES hand delivery/courier (for written paper • Confidential Submissions—To
submissions) will be considered timely submit a comment with confidential
Food and Drug Administration if they are postmarked or the delivery information that you do not wish to be
service acceptance receipt is on or made publicly available, submit your
[Docket No. FDA–2017–N–2094] comments only as a written/paper
before that date.
Developing Rabies Monoclonal submission. You should submit two
Electronic Submissions copies total. One copy will include the
Antibody Products as a Component of
Rabies Post-Exposure Prophylaxis; Submit electronic comments in the information you claim to be confidential
Public Workshop; Request for following way: with a heading or cover note that states
Comments • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
AGENCY: Food and Drug Administration, instructions for submitting comments. Agency will review this copy, including
HHS. Comments submitted electronically, the claimed confidential information, in
ACTION: Notice of public workshop; including attachments, to https:// its consideration of comments. The
request for comments. www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
SUMMARY: The Food and Drug comment will be made public, you are redacted/blacked out, will be available
Administration (FDA, the Agency, or solely responsible for ensuring that your for public viewing and posted on
we) is announcing a public workshop comment does not include any https://www.regulations.gov. Submit
regarding development of rabies confidential information that you or a both copies to the Division of Dockets
monoclonal antibody products to be third party may not wish to be posted, Management. If you do not wish your
used in conjunction with licensed rabies such as medical information, your or name and contact information to be
vaccine as part of a rabies post-exposure anyone else’s Social Security number, or made publicly available, you can
prophylaxis (PEP) regimen. This public confidential business information, such provide this information on the cover
workshop is intended to provide as a manufacturing process. Please note sheet and not in the body of your
information for, and gain perspective that if you include your name, contact comments and you must identify this
from, health care providers, other U.S. information, or other information that information as ‘‘confidential.’’ Any
Government Agencies, academic identifies you in the body of your information marked as ‘‘confidential’’
experts, industry, and other comments, that information will be will not be disclosed except in
stakeholders on various aspects of posted on https://www.regulations.gov. accordance with 21 CFR 10.20 and other
development efforts pertaining to • If you want to submit a comment applicable disclosure law. For more
animal models, laboratory assays, and with confidential information that you information about FDA’s posting of
clinical trials. do not wish to be made available to the comments to public dockets, see 80 FR
DATES: The public workshop will be public, submit the comment as a 56469, September 18, 2015, or access
held on July 17, 2017, from 8:30 a.m. to written/paper submission and in the the information at: https://www.gpo.gov/
5 p.m. Submit either electronic or manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
written comments on this public Submissions’’ and ‘‘Instructions’’). 23389.pdf.
workshop on or before July 31, 2017. Docket: For access to the docket to
See the SUPPLEMENTARY INFORMATION Written/Paper Submissions read the electronic and written/paper
section for registration date and Submit written/paper submissions as comments received, go to https://
information. The workshop draft follows: www.regulations.gov and insert the
Agenda will be made available at: • Mail/Hand delivery/Courier (for docket number, found in brackets in the
http://www.fda.gov/Drugs/NewsEvents/ written/paper submissions): Division of heading of this document, into the
ucm540832.htm prior to the meeting. Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
ADDRESSES: The public workshop will and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
be held at FDA’s White Oak Campus, Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
10903 New Hampshire Ave., Bldg. 31 • For written/paper comments 1061, Rockville, MD 20852.
sradovich on DSK3GMQ082PROD with NOTICES
Conference Center, the Great Room (Rm. submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Lori
1503), Silver Spring, MD 20993. Management, FDA will post your Benner and/or Jessica Barnes, Center for
Entrance for the public workshop comment, as well as any attachments, Drug Evaluation and Research, Food
participants (non-FDA employees) is except for information submitted, and Drug Administration, 10903 New
through Building 1 where routine marked and identified, as confidential, Hampshire Ave., Bldg. 22, Rm. 6221,
security check procedures will be if submitted as detailed in Silver Spring, MD 20993–0002, 301–
performed. For parking and security ‘‘Instructions.’’ 796–1300.
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Document Created: 2017-06-07 02:00:57
Document Modified: 2017-06-07 02:00:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; establishment of a public docket; request for comments. | |
| Dates | The public meeting will be held on July 12, 2017, from 8 a.m. to 5 p.m. | |
| Contact | Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 82 FR 26492 |
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