82 FR 40003 - 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 82, Issue 162 (August 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 162 (August 23, 2017)
| Page Range | 40003-40005 | |
| FR Document | 2017-17856 |
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)] [Notices] [Pages 40003-40005] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17856] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4835] 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 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 September 28, 2017, from 9 a.m. to 4:30 p.m. ADDRESSES: Tommy Douglas Conference Center, The Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information about the Tommy Douglas Conference Center may be accessed at: http://www.tommydouglascenter.com/. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4835. The docket will close on September 27, 2017. Submit either electronic or written comments on this public meeting by September 27, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 27, 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 September 14, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. [[Page 40004]] 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-2017-N-4835 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.'' 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 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 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 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 new drug application (NDA) 200896, ataluren for oral suspension, sponsored by PTC Therapeutics, Inc., for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. 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 ADDRESSES) on or before September 14, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1:15 p.m. and 2:15 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 September 6, 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 September 7, 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 Moon [[Page 40005]] Hee V. Choi 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: August 18, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17856 Filed 8-22-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 40003
Burden Information Collection Reports, cdc.gov), National Institute for DEPARTMENT OF HEALTH AND
in all correspondence. Occupational Safety and Health, Centers HUMAN SERVICES
Jeffrey A. Koses,
for Disease Control and Prevention,
Mailstop E–20, 1600 Clifton Road NE., Food and Drug Administration
Director, Office of Acquisition Policy, Office
of Government-wide Policy. Atlanta, GA 30329. [Docket No. FDA–2017–N–4835]
[FR Doc. 2017–17831 Filed 8–22–17; 8:45 am] SUPPLEMENTARY INFORMATION: The Peripheral and Central Nervous
BILLING CODE 6820–61–P National Occupational Research Agenda System Drugs Advisory Committee;
(NORA) is a partnership program Notice of Meeting; Establishment of a
created to stimulate innovative research Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND and improved workplace practices. The
HUMAN SERVICES national agenda is developed and AGENCY: Food and Drug Administration,
implemented through the NORA sector HHS.
Centers for Disease Control and and cross-sector councils. Each council ACTION: Notice; establishment of a
Prevention develops and maintains an agenda for public docket; request for comments.
[Docket No. CDC–2017–0072, NIOSH–300] its sector or cross-sector. SUMMARY: The Food and Drug
The National Occupational Research Administration (FDA) announces a
Draft—National Occupational Research Agenda for Manufacturing is intended forthcoming public advisory committee
Agenda for Manufacturing to identify the research, information, meeting of the Peripheral and Central
AGENCY: National Institute for and actions most urgently needed to Nervous System Drugs Advisory
Occupational Safety and Health prevent occupational injuries and Committee. The general function of the
(NIOSH), Centers for Disease Control illnesses in the manufacturing sector. committee is to provide advice and
and Prevention (CDC), Department of The National Occupational Research recommendations to the Agency on
Health and Human Services (HHS). Agenda for Manufacturing provides a FDA’s regulatory issues. The meeting
will be open to the public. FDA is
ACTION: Request for comments. vehicle for industry stakeholders to
establishing a docket for public
describe the most relevant issues, gaps,
SUMMARY: As steward of the National comment on this document.
and safety and health needs for the
Occupational Research Agenda (NORA), DATES: The public meeting will be held
sector. Each NORA research agenda is
the National Institute for Occupational on September 28, 2017, from 9 a.m. to
meant to guide or promote high priority
Safety and Health of the Centers for 4:30 p.m.
research efforts on a national level,
Disease Control and Prevention ADDRESSES: Tommy Douglas Conference
conducted by various entities,
announces the availability of the draft Center, The Ballroom, 10000 New
including: Government, higher Hampshire Ave., Silver Spring, MD
National Occupational Research Agenda education, and the private sector. The
for Manufacturing for public comment. 20903. Answers to commonly asked
first National Occupational Research questions about FDA Advisory
Written by the NORA Manufacturing
Agenda for Manufacturing was Committee meetings may be accessed at:
Sector Council, the Agenda identifies
published in 2010 for the second decade https://www.fda.gov/
the most important occupational safety
and health research needs for the next of NORA (2006–2016). This draft is an AdvisoryCommittees/
decade, 2016–2026. A copy of the draft updated agenda for the third decade of AboutAdvisoryCommittees/
Agenda is available at http:// NORA (2016–2026). The revised agenda ucm408555.htm. Information about the
www.regulations.gov (search Docket was developed considering new Tommy Douglas Conference Center may
Number CDC–2017–0072). information about injuries and illnesses, be accessed at: http://
DATES: Electronic or written comments
the state of the science, and the www.tommydouglascenter.com/.
probability that new information and FDA is establishing a docket for
must be received by October 23, 2017.
approaches will make a difference. public comment on this meeting. The
ADDRESSES: You may submit comments, docket number is FDA–2017–N–4835.
identified by Docket No. CDC–2017– As the steward of the NORA process,
The docket will close on September 27,
0072 and docket number NIOSH–300, NIOSH invites comments on the draft
2017. Submit either electronic or
by any of the following methods: National Occupational Research Agenda written comments on this public
• Federal eRulemaking Portal: http:// for Manufacturing. A copy of the draft meeting by September 27, 2017. Late,
www.regulations.gov. Follow the Agenda is available at http:// untimely filed comments will not be
instructions for submitting comments. www.regulations.gov (see Docket considered. Electronic comments must
• Mail: National Institute for Number CDC–2017–0072, NIOSH–300). be submitted on or before September 27,
Occupational Safety and Health, NIOSH Dated: August 17, 2017. 2017. The https://www.regulations.gov
Docket Office, 1090 Tusculum Avenue, electronic filing system will accept
Frank Hearl,
MS C–34, Cincinnati, Ohio 45226–1998. comments until midnight Eastern Time
Instructions: All submissions received Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
at the end of September 27, 2017.
must include the agency name and Comments received by mail/hand
Docket Number [CDC–2017–0072; Disease Control and Prevention.
[FR Doc. 2017–17786 Filed 8–22–17; 8:45 am]
delivery/courier (for written/paper
NIOSH–300]. All relevant comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
submissions) will be considered timely
received will be posted without change BILLING CODE 4163–18–P
if they are postmarked or the delivery
to http://www.regulations.gov, including service acceptance receipt is on or
any personal information provided. For before that date.
access to the docket to read background Comments received on or before
documents or comments received, go to September 14, 2017, will be provided to
http://www.regulations.gov. the committee. Comments received after
FOR FURTHER INFORMATION CONTACT: that date will be taken into
Emily Novicki (NORACoordinator@ consideration by the Agency.
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![Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 40005
Hee V. Choi at least 7 days in advance I. Background A. Bonnel (see FOR FURTHER INFORMATION
of the meeting. Large volumes of data in the context CONTACT) at least 7 days in advance.
FDA is committed to the orderly Persons attending the meeting are
of the health care industry have the
conduct of its advisory committee advised that FDA is not responsible for
potential to provide additional
meetings. Please visit our Web site at providing access to electrical outlets.
information related to medication use,
https://www.fda.gov/ Streaming Webcast of the Public
which may affect the benefit-risk
AdvisoryCommittees/ Workshop: This public workshop will
assessment of medicines in general and
AboutAdvisoryCommittees/ also be webcast.
pediatric medicines in particular. Since
ucm111462.htm for procedures on September 18: Login URL: https://
pediatric pharmacoepidemiologic
public conduct during advisory event.webcasts.com/
studies tend to enroll fewer patients
committee meetings. starthere.jsp?ei=1144352 (morning
Notice of this meeting is given under than adult studies, additional
information may be needed to better session).
the Federal Advisory Committee Act (5 After the morning session, users will
U.S.C. app. 2). understand the safety and efficacy of
use of these drugs in children. ‘‘Big be automatically redirected to the
Dated: August 18, 2017. Data’’, including forms of real world afternoon link. Should you lose
Leslie Kux, evidence that may involve large and connection over lunch, please use the
Associate Commissioner for Policy. complex data sets, may be particularly following link for the afternoon session
[FR Doc. 2017–17856 Filed 8–22–17; 8:45 am] useful as a supplement to traditional (Note: the link for the afternoon session
BILLING CODE 4164–01–P studies. Supplementary information is different from the morning session):
may include additional clinical trial Login URL: https://event.webcasts.com/
data, registry data, and electronic health starthere.jsp?ei=1144354 (afternoon
DEPARTMENT OF HEALTH AND record information. session).
HUMAN SERVICES September 19: Login URL: https://
II. Topics for Discussion at the Public event.webcasts.com/
Food and Drug Administration Workshop starthere.jsp?ei=1144356 (morning
[Docket No. FDA–2017–N–2464] In this workshop, FDA will gather session).
information on the latest developments After the morning session, users will
Advancing the Development of in ‘‘Big Data’’ from the perspective of a be automatically redirected to the
Pediatric Therapeutics: Application of number of stakeholders and expand the afternoon link. Should you lose
‘‘Big Data’’ to Pediatric Safety Studies; conversation to include the utility and connection over lunch, please use the
Public Workshop challenges associated with the use of following link for the afternoon session
‘‘Big Data’’ in the pediatric setting. Day (Note: the link for the afternoon session
AGENCY: Food and Drug Administration,
1 will focus on national and is different from the morning session):
HHS.
international uses of ‘‘Big Data’’ in Login URL: https://event.webcasts.com/
ACTION: Notice of public workshop. health care. Day 2 will focus on ‘‘Big starthere.jsp?ei=1144357 (afternoon
SUMMARY: The Office of Pediatric Data’’ utility in the pediatric setting, session).
Therapeutics, Food and Drug including specific challenges associated If you have never attended a Connect
Administration (FDA), is announcing a with pediatric data. Pro event before, test your connection at
public workshop entitled ‘‘Advancing III. Participation in the Public https://collaboration.fda.gov/common/
the Development of Pediatric Workshop help/en/support/meeting_test.htm. To
Therapeutics (ADEPT): Application of get a quick overview of the Connect Pro
‘‘Big Data’’ to Pediatric Safety Studies.’’ Registration: Persons interested in program, visit https://www.adobe.com/
The purpose of this 2-day workshop is attending this workshop must register go/connectpro_overview. FDA has
to understand how to access and online at: https://www.eventbrite.com/e/ verified the Web site addresses in this
analyze ‘‘Big Data’’ associated with public-workshop-advancing-the- document, as of the date this document
safety information in the health care development-of-pediatric-therapeutics- publishes in the Federal Register, but
setting, and the utility and challenges adept-application-of-big-data-tickets- Web sites are subject to change over
associated with the use of ‘‘Big Data’’ to 32470264435 by August 22, 2017. For time.
study the safety of therapeutics in those without internet access, please Transcripts: Please be advised that as
children. contact Renan A. Bonnel (see FOR soon as a transcript of the public
FURTHER INFORMATION CONTACT) to workshop is available, it will be
DATES: The public workshop will be register.
held on September 18 and 19, 2017, accessible at https://
Registration is free and based on www.regulations.gov. It may be viewed
from 8:30 a.m. to 5 p.m. See the space availability, with priority given to
SUPPLEMENTARY INFORMATION section for at the Dockets Management Staff office
early registrants. Persons interested in (HFA–305), Food and Drug
registration date and information. attending this public workshop must Administration, 5630 Fishers Lane, Rm.
ADDRESSES: The public workshop will register by August 22, 2017. Early 1061, Rockville, MD 20852. A link to
be held at the DoubleTree by Hilton registration is recommended because the transcript will be available on the
Hotel, 8727 Colesville Rd. (Route 29), seating is limited; therefore, FDA may internet at https://www.fda.gov/
Silver Spring, MD 20910.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
limit the number of participants. NewsEvents/
FOR FURTHER INFORMATION CONTACT: Registration information, the agenda, MeetingsConferencesWorkshops/
Renan A. Bonnel, Office of Pediatric and additional background materials ucm545847.htm.
Therapeutics, Food and Drug can be found at https://www.fda.gov/
Administration, 10903 New Hampshire NewsEvents/ Dated: August 17, 2017.
Ave., Silver Spring, MD 20993–0002, MeetingsConferencesWorkshops/ Leslie Kux,
301–796–8654, Fax: 301–847–8640, ucm545847.htm. Associate Commissioner for Policy.
renan.bonnel@fda.hhs.gov. If you need special accommodations [FR Doc. 2017–17783 Filed 8–22–17; 8:45 am]
SUPPLEMENTARY INFORMATION: due to a disability, please contact Renan BILLING CODE 4164–01–P
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Document Created: 2017-08-22 23:51:23
Document Modified: 2017-08-22 23:51:23
| 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 September 28, 2017, from 9 a.m. to 4:30 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 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 40003 |
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