83 FR 7727 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 36 (February 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 36 (February 22, 2018)
| Page Range | 7727-7728 | |
| FR Document | 2018-03603 |
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)] [Notices] [Pages 7727-7728] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03603] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0140] Peripheral and Central Nervous System 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 Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on April 19, 2018, from 8 a.m. to 12:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0140. The docket will close on April 18, 2018. Submit either electronic or written comments on this public meeting by April 18, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 18, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before April 5, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-0140 for ``Peripheral and Central Nervous System 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 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For [[Page 7728]] more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss new drug application (NDA) 210365, cannabidiol oral solution, sponsored by GW Pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the docket (see ADDRESSES) on or before April 5, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 28, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 29, 2018. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Moon Hee V. Choi (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03603 Filed 2-21-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7727
trained staff to meet those requirements. public. FDA is establishing a docket for • If you want to submit a comment
The expansion of the existing program public comment on this document. with confidential information that you
and its services through this DATES: The meeting will be held on do not wish to be made available to the
supplemental award is a key strategy for April 19, 2018, from 8 a.m. to 12:30 p.m. public, submit the comment as a
ORR to be prepared to meet its ADDRESSES: FDA White Oak Campus,
written/paper submission and in the
responsibility to provide shelter for 10903 New Hampshire Ave., Bldg. 31 manner detailed (see ‘‘Written/Paper
Unaccompanied Children referred to its Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’).
care by DHS and so that the U.S. Border 1503), Silver Spring, MD 20993–0002. Written/Paper Submissions
Patrol can continue its vital national Answers to commonly asked questions
security mission to prevent illegal Submit written/paper submissions as
including information regarding special follows:
migration, trafficking, and protect the accommodations due to a disability,
borders of the United States. • Mail/Hand delivery/Courier (for
visitor parking, and transportation may written/paper submissions): Dockets
Statutory Authority: This program is be accessed at: https://www.fda.gov/
authorized by— Management Staff (HFA–305), Food and
AdvisoryCommittees/ Drug Administration, 5630 Fishers
(A) Section 462 of the Homeland AboutAdvisoryCommittees/
Security Act of 2002, which in March Lane, Rm. 1061, Rockville, MD 20852.
ucm408555.htm. • For written/paper comments
2003, transferred responsibility for the FDA is establishing a docket for submitted to the Dockets Management
care and custody of Unaccompanied public comment on this meeting. The Staff, FDA will post your comment, as
Alien Children from the Commissioner docket number is FDA–2018–N–0140. well as any attachments, except for
of the former Immigration and The docket will close on April 18, 2018. information submitted, marked and
Naturalization Service (INS) to the Submit either electronic or written identified, as confidential, if submitted
Director of ORR of the Department of comments on this public meeting by as detailed in ‘‘Instructions.’’
Health and Human Services (HHS). April 18, 2018. Please note that late, Instructions: All submissions received
(B) The Flores Settlement Agreement, untimely filed comments will not be must include the Docket No. FDA–
Case No. CV85–4544RJK (C. D. Cal. considered. Electronic comments must 2018–N–0140 for ‘‘Peripheral and
1996), as well as the William be submitted on or before April 18, Central Nervous System Drugs Advisory
Wilberforce Trafficking Victims 2018. The https://www.regulations.gov Committee; Notice of Meeting;
Protection Reauthorization Act of 2008 electronic filing system will accept Establishment of a Public Docket;
(Pub.L. 110–457), which authorizes post comments until midnight Eastern Time Request for Comments.’’ Received
release services under certain at the end of April 18, 2018. Comments comments, those filed in a timely
conditions to eligible children. All received by mail/hand delivery/courier manner (see ADDRESSES), will be placed
programs must comply with the Flores (for written/paper submissions) will be in the docket and, except for those
Settlement Agreement, Case No. CV85– considered timely if they are submitted as ‘‘Confidential
4544–RJK (C.D. Cal. 1996), pertinent postmarked or the delivery service Submissions,’’ publicly viewable at
regulations and ORR policies and acceptance receipt is on or before that https://www.regulations.gov or at the
procedures. date. Dockets Management Staff between 9
Elizabeth Leo, Comments received on or before April a.m. and 4 p.m., Monday through
Grants Policy Specialist, Division of Grants 5, 2018, will be provided to the Friday.
Policy, Office of Administration. committee. Comments received after • Confidential Submissions—To
[FR Doc. 2018–03583 Filed 2–21–18; 8:45 am] that date will be taken into submit a comment with confidential
consideration by FDA. information that you do not wish to be
BILLING CODE 4184–45–P
You may submit comments as made publicly available, submit your
follows: comments only as a written/paper
DEPARTMENT OF HEALTH AND submission. You should submit two
Electronic Submissions copies total. One copy will include the
HUMAN SERVICES
Submit electronic comments in the information you claim to be confidential
Food and Drug Administration following way: with a heading or cover note that states
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2018–N–0140] https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ FDA
instructions for submitting comments. will review this copy, including the
Peripheral and Central Nervous
Comments submitted electronically, claimed confidential information, in its
System Drugs Advisory Committee;
including attachments, to https:// consideration of comments. The second
Notice of Meeting; Establishment of a
www.regulations.gov will be posted to copy, which will have the claimed
Public Docket; Request for Comments
the docket unchanged. Because your confidential information redacted/
AGENCY: Food and Drug Administration, comment will be made public, you are blacked out, will be available for public
HHS. solely responsible for ensuring that your viewing and posted on https://
ACTION: Notice, establishment of a comment does not include any www.regulations.gov. Submit both
public docket; request for comments. confidential information that you or a copies to the Dockets Management Staff.
third party may not wish to be posted, If you do not wish your name and
SUMMARY: The Food and Drug such as medical information, your or contact information be made publicly
Administration (FDA) announces a anyone else’s Social Security number, or available, you can provide this
daltland on DSKBBV9HB2PROD with NOTICES
forthcoming public advisory committee confidential business information, such information on the cover sheet and not
meeting of the Peripheral and Central as a manufacturing process. Please note in the body of your comments and you
Nervous System Drugs Advisory that if you include your name, contact must identify the information as
Committee. The general function of the information, or other information that ‘‘confidential.’’ Any information marked
committee is to provide advice and identifies you in the body of your as ‘‘confidential’’ will not be disclosed
recommendations to FDA on regulatory comments, that information will be except in accordance with 21 CFR 10.20
issues. The meeting will be open to the posted on https://www.regulations.gov. and other applicable disclosure law. For
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![7728 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
more information about FDA’s posting orally or in writing, on issues pending DEPARTMENT OF HEALTH AND
of comments to public dockets, see 80 before the committee. All electronic and HUMAN SERVICES
FR 56469, September 18, 2015, or access written submissions submitted to the
the information at: https://www.gpo.gov/ docket (see ADDRESSES) on or before Food and Drug Administration
fdsys/pkg/FR-2015-09-18/pdf/2015- April 5, 2018, will be provided to the [Docket No. FDA–2014–N–1048]
23389.pdf. committee. Oral presentations from the
Docket: For access to the docket to public will be scheduled between Agency Information Collection
read background documents or the approximately 10:30 a.m. and 11:30 a.m. Activities; Proposed Collection;
electronic and written/paper comments Those individuals interested in making Comment Request; Medical Device
received, go to https:// formal oral presentations should notify Labeling Regulations
www.regulations.gov and insert the the contact person and submit a brief
docket number, found in brackets in the AGENCY: Food and Drug Administration,
statement of the general nature of the HHS.
heading of this document, into the
evidence or arguments they wish to ACTION: Notice.
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management present, the names and addresses of
proposed participants, and an SUMMARY: The Food and Drug
Staff, 5630 Fishers Lane, Rm. 1061, Administration (FDA or Agency) is
Rockville, MD 20852. indication of the approximate time
requested to make their presentation on announcing an opportunity for public
FOR FURTHER INFORMATION CONTACT: comment on the proposed collection of
Moon Hee V. Choi, Center for Drug or before March 28, 2018. Time allotted
for each presentation may be limited. If certain information by the Agency.
Evaluation and Research, Food and Under the Paperwork Reduction Act of
Drug Administration, 10903 New the number of registrants requesting to
1995 (PRA), Federal Agencies are
Hampshire Ave., Bldg. 31, Rm. 2417, speak is greater than can be reasonably required to publish notice in the
Silver Spring, MD 20993–0002, 301– accommodated during the scheduled Federal Register concerning each
796–9001, Fax: 301–847–8533, email: open public hearing session, FDA may proposed collection of information,
PCNS@fda.hhs.gov, or FDA Advisory conduct a lottery to determine the including each proposed extension of an
Committee Information Line, 1–800– speakers for the scheduled open public existing collection of information, and
741–8138 (301–443–0572 in the hearing session. The contact person will to allow 60 days for public comment in
Washington, DC area). A notice in the notify interested persons regarding their response to the notice. This notice
Federal Register about last minute request to speak by March 29, 2018. solicits comments on Medical Device
modifications that impact a previously Persons attending FDA’s advisory Labeling Regulations.
announced advisory committee meeting committee meetings are advised that DATES: Submit either electronic or
cannot always be published quickly FDA is not responsible for providing written comments on the collection of
enough to provide timely notice. access to electrical outlets. information by April 23, 2018.
Therefore, you should always check the ADDRESSES: You may submit comments
FDA’s website at https://www.fda.gov/ For press inquiries, please contact the
Office of Media Affairs at fdaoma@ as follows. Please note that late,
AdvisoryCommittees/default.htm and untimely filed comments will not be
scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540.
considered. Electronic comments must
committee meeting link, or call the FDA welcomes the attendance of the be submitted on or before April 23,
advisory committee information line to public at its advisory committee 2018. The https://www.regulations.gov
learn about possible modifications meetings and will make every effort to electronic filing system will accept
before coming to the meeting. accommodate persons with disabilities. comments until midnight Eastern Time
SUPPLEMENTARY INFORMATION: If you require accommodations due to a at the end of April 23, 2018. Comments
Agenda: The committee will discuss disability, please contact Moon Hee V. received by mail/hand delivery/courier
new drug application (NDA) 210365, Choi (see FOR FURTHER INFORMATION (for written/paper submissions) will be
cannabidiol oral solution, sponsored by CONTACT) at least 7 days in advance of considered timely if they are
GW Pharmaceuticals, for the adjunctive the meeting. postmarked or the delivery service
treatment of seizures associated with acceptance receipt is on or before that
Lennox-Gastaut syndrome or Dravet FDA is committed to the orderly
conduct of its advisory committee date.
syndrome in patients 2 years of age and
older. meetings. Please visit our website at Electronic Submissions
FDA intends to make background https://www.fda.gov/ Submit electronic comments in the
material available to the public no later AdvisoryCommittees/ following way:
than 2 business days before the meeting. AboutAdvisoryCommittees/ • Federal eRulemaking Portal:
If FDA is unable to post the background ucm111462.htm for procedures on https://www.regulations.gov. Follow the
material on its website prior to the public conduct during advisory instructions for submitting comments.
meeting, the background material will committee meetings. Comments submitted electronically,
be made publicly available at the Notice of this meeting is given under including attachments, to https://
location of the advisory committee the Federal Advisory Committee Act (5 www.regulations.gov will be posted to
meeting, and the background material U.S.C. app. 2). the docket unchanged. Because your
will be posted on FDA’s website after comment will be made public, you are
the meeting. Background material is Dated: February 15, 2018. solely responsible for ensuring that your
daltland on DSKBBV9HB2PROD with NOTICES
available at https://www.fda.gov/ Leslie Kux, comment does not include any
AdvisoryCommittees/Calendar/ Associate Commissioner for Policy. confidential information that you or a
default.htm. Scroll down to the [FR Doc. 2018–03603 Filed 2–21–18; 8:45 am] third party may not wish to be posted,
appropriate advisory committee meeting BILLING CODE 4164–01–P
such as medical information, your or
link. anyone else’s Social Security number, or
Procedure: Interested persons may confidential business information, such
present data, information, or views, as a manufacturing process. Please note
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Document Created: 2018-02-22 02:51:20
Document Modified: 2018-02-22 02:51:20
| 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 April 19, 2018, from 8 a.m. to 12:30 p.m. | |
| Contact | Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 83 FR 7727 |
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