83 FR 8283 - Psychopharmacologic 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 38 (February 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 38 (February 26, 2018)
| Page Range | 8283-8284 | |
| FR Document | 2018-03808 |
[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)] [Notices] [Pages 8283-8284] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03808] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0650] Psychopharmacologic 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 Psychopharmacologic 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 March 27, 2018, from 8 a.m. to 5 p.m. ADDRESSES: Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center's telephone number is 240-645-4000. 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. Information about the Tommy Douglas Conference Center can be accessed at: https://www.tommydouglascenter.com/. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0650. The docket will close on March 23, 2018. Submit either electronic or written comments on this public meeting by March 23, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 23, 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 March 13, 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-0650 for ``Psychopharmacologic 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 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 [[Page 8284]] and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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) 209229, lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment. 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 March 13, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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 March 5, 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 6, 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 Kalyani Bhatt (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 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03808 Filed 2-23-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices 8283
If you have never attended a Connect Information about the Tommy Douglas Drug Administration, 5630 Fishers
Pro event before, test your connection at Conference Center can be accessed at: Lane, Rm. 1061, Rockville, MD 20852.
https://collaboration.fda.gov/common/ https://www.tommydouglascenter.com/. • For written/paper comments
help/en/support/meeting_test.htm. To FDA is establishing a docket for submitted to the Dockets Management
get a quick overview of the Connect Pro public comment on this meeting. The Staff, FDA will post your comment, as
program, visit https://www.adobe.com/ docket number is FDA–2018–N–0650. well as any attachments, except for
go/connectpro_overview. FDA has The docket will close on March 23, information submitted, marked and
verified the website addresses in this 2018. Submit either electronic or identified, as confidential, if submitted
document, as of the date this document written comments on this public as detailed in ‘‘Instructions.’’
publishes in the Federal Register, but meeting by March 23, 2018. Please note Instructions: All submissions received
websites are subject to change over time. that late, untimely filed comments will must include the Docket No. FDA–
Transcripts: Please be advised that as not be considered. Electronic comments 2018–N–0650 for
soon as a transcript of the public must be submitted on or before March ‘‘Psychopharmacologic Drugs Advisory
meeting is available, it will be accessible 23, 2018. The https:// Committee; Notice of Meeting;
at https://www.regulations.gov. It may www.regulations.gov electronic filing Establishment of a Public Docket;
be viewed at the Dockets Management system will accept comments until Request for Comments.’’ Received
Staff (see ADDRESSES). A link to the midnight Eastern Time at the end of comments, those filed in a timely
transcript will also be available on the March 23, 2018. Comments received by manner (see ADDRESSES), will be placed
internet at https://www.fda.gov/Drugs/ mail/hand delivery/courier (for written/ in the docket and, except for those
NewsEvents/ucm587344.htm. paper submissions) will be considered submitted as ‘‘Confidential
timely if they are postmarked or the Submissions,’’ publicly viewable at
Dated: February 20, 2018.
delivery service acceptance receipt is on https://www.regulations.gov or at the
Leslie Kux, Dockets Management Staff between 9
or before that date.
Associate Commissioner for Policy. a.m. and 4 p.m., Monday through
Comments received on or before
[FR Doc. 2018–03804 Filed 2–23–18; 8:45 am] March 13, 2018, will be provided to the Friday.
BILLING CODE 4164–01–P committee. Comments received after • Confidential Submissions—To
that date will be taken into submit a comment with confidential
consideration by FDA. information that you do not wish to be
DEPARTMENT OF HEALTH AND You may submit comments as made publicly available, submit your
HUMAN SERVICES follows: comments only as a written/paper
submission. You should submit two
Food and Drug Administration Electronic Submissions copies total. One copy will include the
[Docket No. FDA–2018–N–0650] Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
Psychopharmacologic Drugs Advisory • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Committee; Notice of Meeting; https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ FDA
Establishment of a Public Docket; instructions for submitting comments. will review this copy, including the
Request for Comments Comments submitted electronically, claimed confidential information, in its
including attachments, to https:// consideration of comments. The second
AGENCY: Food and Drug Administration, copy, which will have the claimed
www.regulations.gov will be posted to
HHS. confidential information redacted/
the docket unchanged. Because your
ACTION: Notice; establishment of a comment will be made public, you are blacked out, will be available for public
public docket; request for comments. solely responsible for ensuring that your viewing and posted on https://
SUMMARY: The Food and Drug comment does not include any www.regulations.gov. Submit both
Administration (FDA) announces a confidential information that you or a copies to the Dockets Management Staff.
forthcoming public advisory committee third party may not wish to be posted, If you do not wish your name and
meeting of the Psychopharmacologic such as medical information, your or contact information to be made publicly
Drugs Advisory Committee. The general anyone else’s Social Security number, or available, you can provide this
function of the committee is to provide confidential business information, such information on the cover sheet and not
as a manufacturing process. Please note in the body of your comments and you
advice and recommendations to FDA on
that if you include your name, contact must identify this information as
regulatory issues. The meeting will be
information, or other information that ‘‘confidential.’’ Any information marked
open to the public. FDA is establishing
identifies you in the body of your as ‘‘confidential’’ will not be disclosed
a docket for public comment on this
comments, that information will be except in accordance with 21 CFR 10.20
document.
posted on https://www.regulations.gov. and other applicable disclosure law. For
DATES: The meeting will be held on • If you want to submit a comment more information about FDA’s posting
March 27, 2018, from 8 a.m. to 5 p.m. with confidential information that you of comments to public dockets, see 80
ADDRESSES: Tommy Douglas Conference do not wish to be made available to the FR 56469, September 18, 2015, or access
Center, the Ballroom, 10000 New public, submit the comment as a the information at: https://www.gpo.gov/
Hampshire Ave., Silver Spring, MD written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
20903. The conference center’s manner detailed (see ‘‘Written/Paper 23389.pdf.
telephone number is 240–645–4000. Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
daltland on DSKBBV9HB2PROD with NOTICES
Answers to commonly asked questions read background documents or the
including information regarding special Written/Paper Submissions electronic and written/paper comments
accommodations due to a disability, Submit written/paper submissions as received, go to https://
visitor parking, and transportation may follows: www.regulations.gov and insert the
be accessed at: https://www.fda.gov/ • Mail/Hand delivery/Courier (for docket number, found in brackets in the
AdvisoryCommittees/AboutAdvisory written/paper submissions): Dockets heading of this document, into the
Committees/ucm408555.htm. Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
VerDate Sep<11>2014 17:58 Feb 23, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\26FEN1.SGM 26FEN1](https://thefederalregister.org/doc/83_FR_8321/page/1.svg)
![8284 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices
and/or go to the Dockets Management proposed participants, and an Office of Management and Budget
Staff, 5630 Fishers Lane, Rm. 1061, indication of the approximate time (OMB) for review and clearance under
Rockville, MD 20852. requested to make their presentation on the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: or before March 5, 2018. Time allotted DATES: Fax written comments on the
Kalyani Bhatt, Center for Drug for each presentation may be limited. If collection of information by March 28,
Evaluation and Research, Food and the number of registrants requesting to 2018.
Drug Administration, 10903 New speak is greater than can be reasonably ADDRESSES: To ensure that comments on
Hampshire Ave., Bldg. 31, Rm. 2417, accommodated during the scheduled the information collection are received,
Silver Spring, MD 20993–0002, 301– open public hearing session, FDA may OMB recommends that written
796–9001, Fax: 301–847–8533, email: conduct a lottery to determine the comments be faxed to the Office of
PDAC@fda.hhs.gov, or FDA Advisory speakers for the scheduled open public Information and Regulatory Affairs,
Committee Information Line, 1–800– hearing session. The contact person will OMB, Attn: FDA Desk Officer, Fax: 202–
741–8138 (301–443–0572 in the notify interested persons regarding their 395–7285, or emailed to oira_
Washington, DC area). A notice in the request to speak by March 6, 2018. submission@omb.eop.gov. All
Federal Register about last minute Persons attending FDA’s advisory comments should be identified with the
modifications that impact a previously committee meetings are advised that OMB control number 0910–0249. Also
announced advisory committee meeting FDA is not responsible for providing include the FDA docket number found
cannot always be published quickly access to electrical outlets. in brackets in the heading of this
enough to provide timely notice. For press inquiries, please contact the document.
Therefore, you should always check the Office of Media Affairs at fdaoma@
FOR FURTHER INFORMATION CONTACT:
FDA’s website at https://www.fda.gov/ fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the Jonna Capezzuto, Office of Operations,
AdvisoryCommittees/default.htm and Food and Drug Administration, Three
scroll down to the appropriate advisory public at its advisory committee
meetings and will make every effort to White Flint North, 10A–12M, 11601
committee meeting link, or call the Landsdown St., North Bethesda, MD
advisory committee information line to accommodate persons with disabilities.
If you require accommodations due to a 20852, 301–796–3794, PRAStaff@
learn about possible modifications fda.hhs.gov.
before coming to the meeting. disability, please contact Kalyani Bhatt
(see FOR FURTHER INFORMATION CONTACT) SUPPLEMENTARY INFORMATION: In
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss at least 7 days in advance of the compliance with 44 U.S.C. 3507, FDA
new drug application (NDA) 209229, meeting. has submitted the following proposed
lofexidine hydrochloride, submitted by FDA is committed to the orderly collection of information to OMB for
US WorldMeds, LLC, for mitigation of conduct of its advisory committee review and clearance.
symptoms associated with opioid meetings. Please visit our website at FDA Recall Regulations—21 CFR Part 7
withdrawal and facilitation of https://www.fda.gov/
completion of opioid discontinuation AdvisoryCommittees/About OMB Control Number 0910–0249—
treatment. AdvisoryCommittees/ucm111462.htm Extension
FDA intends to make background for procedures on public conduct during Section 701 of the Federal Food, Drug,
material available to the public no later advisory committee meetings. and Cosmetic Act charges the Secretary
than 2 business days before the meeting. Notice of this meeting is given under of Health and Human Services, through
If FDA is unable to post the background the Federal Advisory Committee Act (5 FDA, with the responsibility of assuring
material on its website prior to the U.S.C. app. 2). recalls (21 U.S.C. 371, Regulations and
meeting, the background material will Dated: February 20, 2018. Hearings, and 21 CFR part 7,
be made publicly available at the Leslie Kux, Enforcement Policy, Subpart C, Recalls
location of the advisory committee Associate Commissioner for Policy. (Including Product Corrections)—
meeting, and the background material [FR Doc. 2018–03808 Filed 2–23–18; 8:45 am] Guidance on Policy, Procedures, and
will be posted on FDA’s website after Industry Responsibilities which pertain
BILLING CODE 4164–01–P
the meeting. Background material is to the recall regulations and provide
available at https://www.fda.gov/ guidance to manufacturers on recall
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND responsibilities). The regulations and
default.htm. Scroll down to the HUMAN SERVICES guidance apply to all FDA-regulated
appropriate advisory committee meeting products (i.e., food, including animal
link. Food and Drug Administration feed; drugs, including animal drugs;
Procedure: Interested persons may medical devices, including in vitro
present data, information, or views, [Docket No. FDA–2017–N–6175] diagnostic products; cosmetics;
orally or in writing, on issues pending biological products intended for human
Agency Information Collection
before the committee. All electronic and use; and tobacco).
Activities; Submission for Office of
written submissions submitted to the These responsibilities of companies
Management and Budget Review;
docket (see ADDRESSES) on or before conducting recalls include providing
Comment Request; Food and Drug
March 13, 2018, will be provided to the FDA with complete details of the recall
Administration Recall Regulations
committee. Oral presentations from the including: (1) Reason(s) for the removal
public will be scheduled between AGENCY: Food and Drug Administration, or correction, risk evaluation, quantity
daltland on DSKBBV9HB2PROD with NOTICES
approximately 1 p.m. and 2 p.m. Those HHS. produced, distribution information,
individuals interested in making formal ACTION: Notice. firm’s recall strategy, a copy of any
oral presentations should notify the recall communication(s), and a contact
contact person and submit a brief SUMMARY: The Food and Drug official (§ 7.46); (2) notifying direct
statement of the general nature of the Administration (FDA) is announcing accounts of the recall, providing
evidence or arguments they wish to that a proposed collection of guidance regarding further distribution,
present, the names and addresses of information has been submitted to the giving instructions as to what to do with
VerDate Sep<11>2014 17:58 Feb 23, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\26FEN1.SGM 26FEN1](https://thefederalregister.org/doc/83_FR_8321/page/2.svg)
Document Created: 2018-02-24 01:00:26
Document Modified: 2018-02-24 01:00:26
| 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 March 27, 2018, from 8 a.m. to 5 p.m. | |
| Contact | Kalyani Bhatt, 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 8283 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR