83_FR_126 83 FR 125 - Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

83 FR 125 - Pediatric 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 1 (January 2, 2018)

Page Range125-127
FR Document2017-28259

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). 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 comments.

Federal Register, Volume 83 Issue 1 (Tuesday, January 2, 2018) 
[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 125-127]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28259]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6928]


Pediatric 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.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Pediatric Advisory Committee 
(PAC). 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 comments.

DATES: The meeting will be held on March 23, 2018, from 8:30 a.m. to 
3:05 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

[[Page 126]]

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 document. 
The docket number is Docket No. FDA-2017-N-6928. The docket will close 
on March 26, 2018. Submit either electronic or written comments on this 
public meeting by that date. Please note that late, untimely comments 
will not be considered. The https://www.regulations.gov electronic 
filing system will accept comments until midnight Eastern Time at the 
end of March 26, 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 9, 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 make 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-6928 for ``Pediatric 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 and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, 
[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. 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 PAC will meet to discuss pediatric-focused safety 
reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. 
L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-
155). Comments about the upcoming advisory committee meeting should be 
submitted to Docket No. FDA-2017-N-6928.
    The PAC will meet to discuss the following products (listed by FDA 
Center):

(1) Center for Drug Evaluation and Research
    a. BANZEL
    b. INTUNIV
    c. LEXAPRO
(2) Center for Devices and Radiological Health
    a. FLOURISH (Humanitarian Device Exemption (HDE))
    b. ACTIVA (HDE)
    c. LIPOSORBER (HDE)
    d. IMPELLA RP SYSTEM

    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,

[[Page 127]]

orally or in writing, on issues pending before the committee. Written 
submissions may be made to the contact person on or before March 16, 
2018. Oral presentations from the public will be scheduled between 
approximately 9 a.m. and 10 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 8, 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 9, 2018.
    Persons attending FDA's advisory committee meetings are advised 
that FDA 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 accommodations due to a disability, please 
contact Marieann Brill 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: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28259 Filed 12-29-17; 8:45 am]
 BILLING CODE 4164-01-P

Vol. 83 Friday, No. 126 June 29, 2018 Pages 30525–30830 OFFICE OF THE FEDERAL REGISTER sradovich on DSK3GMQ082PROD with FRONT MATTER WS VerDate Sep 11 2014 20:00 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00001 Fmt 4710 Sfmt 4710 E:\FR\FM\29JNWS.LOC 29JNWS

II Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 The FEDERAL REGISTER (ISSN 0097–6326) is published daily, SUBSCRIPTIONS AND COPIES Monday through Friday, except official holidays, by the Office PUBLIC of the Federal Register, National Archives and Records Administration, Washington, DC 20408, under the Federal Register Subscriptions: Act (44 U.S.C. Ch. 15) and the regulations of the Administrative Paper or fiche 202–512–1800 Committee of the Federal Register (1 CFR Ch. I). The Assistance with public subscriptions 202–512–1806 Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402 is the exclusive distributor of the official General online information 202–512–1530; 1–888–293–6498 edition. Periodicals postage is paid at Washington, DC. Single copies/back copies: The FEDERAL REGISTER provides a uniform system for making Paper or fiche 202–512–1800 available to the public regulations and legal notices issued by Assistance with public single copies 1–866–512–1800 Federal agencies. These include Presidential proclamations and (Toll-Free) Executive Orders, Federal agency documents having general FEDERAL AGENCIES applicability and legal effect, documents required to be published Subscriptions: by act of Congress, and other Federal agency documents of public interest. Assistance with Federal agency subscriptions: Documents are on file for public inspection in the Office of the Email FRSubscriptions@nara.gov Federal Register the day before they are published, unless the Phone 202–741–6000 issuing agency requests earlier filing. For a list of documents currently on file for public inspection, see www.ofr.gov. The seal of the National Archives and Records Administration authenticates the Federal Register as the official serial publication established under the Federal Register Act. Under 44 U.S.C. 1507, the contents of the Federal Register shall be judicially noticed. The Federal Register is published in paper and on 24x microfiche. It is also available online at no charge at www.fdsys.gov, a service of the U.S. Government Publishing Office. The online edition of the Federal Register is issued under the authority of the Administrative Committee of the Federal Register as the official legal equivalent of the paper and microfiche editions (44 U.S.C. 4101 and 1 CFR 5.10). It is updated by 6:00 a.m. each day the Federal Register is published and includes both text and graphics from Volume 59, 1 (January 2, 1994) forward. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing Office. Phone 202-512-1800 or 866-512- 1800 (toll free). E-mail, gpocusthelp.com. The annual subscription price for the Federal Register paper edition is $749 plus postage, or $808, plus postage, for a combined Federal Register, Federal Register Index and List of CFR Sections Affected (LSA) subscription; the microfiche edition of the Federal Register including the Federal Register Index and LSA is $165, plus postage. Six month subscriptions are available for one-half the annual rate. The prevailing postal rates will be applied to orders according to the delivery method requested. The price of a single copy of the daily Federal Register, including postage, is based on the number of pages: $11 for an issue containing less than 200 pages; $22 for an issue containing 200 to 400 pages; and $33 for an issue containing more than 400 pages. Single issues of the microfiche edition may be purchased for $3 per copy, including postage. Remit check or money order, made payable to the Superintendent of Documents, or charge to your GPO Deposit Account, VISA, MasterCard, American Express, or Discover. Mail to: U.S. Government Publishing Office—New Orders, P.O. Box 979050, St. Louis, MO 63197-9000; or call toll free 1-866-512-1800, DC area 202-512-1800; or go to the U.S. Government Online Bookstore site, see bookstore.gpo.gov. There are no restrictions on the republication of material appearing in the Federal Register. How To Cite This Publication: Use the volume number and the page number. Example: 83 FR 12345. Postmaster: Send address changes to the Superintendent of sradovich on DSK3GMQ082PROD with FRONT MATTER WS Documents, Federal Register, U.S. Government Publishing Office, Washington, DC 20402, along with the entire mailing label from the last issue received. . VerDate Sep 11 2014 20:00 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4710 Sfmt 4710 E:\FR\FM\29JNWS.LOC 29JNWS

III Contents Federal Register Vol. 83, No. 126 Friday, June 29, 2018 Administrative Conference of the United States Coast Guard NOTICES RULES Adoptions of Recommendations, 30683–30687 Safety Zones: Recurring Events in Captain of the Port Duluth Zone— Agricultural Marketing Service LaPointe Fireworks, 30551 PROPOSED RULES Tennessee River, Gilbertsville, KY, 30551–30553 United States Standards: Special Local Regulations: Canola, 30590–30591 Corpus Christi Bay, Corpus Christi, TX, 30548–30551 Corn, 30591–30592 Soybeans, 30592 Commerce Department Agriculture Department See Foreign-Trade Zones Board See Agricultural Marketing Service See International Trade Administration See Animal and Plant Health Inspection Service See National Institute of Standards and Technology NOTICES See National Oceanic and Atmospheric Administration Total Amounts of Fiscal Year 2019 WTO Tariff-Rate Quotas: Committee for Purchase From People Who Are Blind or Raw Cane Sugar and Certain Sugars, Syrups and Severely Disabled Molasses, 30687–30688 NOTICES Procurement List; Additions and Deletions, 30702–30703 Alcohol and Tobacco Tax and Trade Bureau RULES Establishment of Dahlonega Plateau Viticultural Area, Commodity Futures Trading Commission 30535–30538 RULES Adaptation of Regulations to Incorporate Swaps; Correction, Animal and Plant Health Inspection Service 30533–30534 NOTICES Environmental Impact Statements; Availability, etc.: Movement and Outdoor Use of Certain Genetically Defense Acquisition Regulations System RULES Engineered Organisms, 30688–30689 Defense Federal Acquisition Regulation Supplement: Centers for Disease Control and Prevention Offset Costs, 30825–30829 NOTICES Repeal of Defense Federal Acquisition Regulation Charter Amendments: Supplement Clause Pricing Adjustments, 30824– Healthcare Infection Control Practices Advisory 30825 Committee, 30731 Repeal of Defense Federal Acquisition Regulation Charter Renewals: Supplement Clause Requirements, 30587–30588 Board of Scientific Counselors, National Center for Undefinitized Contract Action Definitization, 30584– Environmental Health/Agency for Toxic Substances 30587 PROPOSED RULES and Disease Registry, 30730–30731 Defense Federal Acquis Regulation Supplement: National Institute for Occupational Safety and Health, Safety and Occupational Health Study Section, 30731 Electronic Submission and Processing of Payment Requests for Nominations: Requests and Receiving Reports, 30661–30666 Healthcare Infection Control Practices Advisory Defense Federal Acquisition Regulation Supplement: Committee, 30731–30732 Inapplicability of Certain Laws and Regulations to Commercial Items, 30646–30656 Modification of DFARS Clause Surge Option, 30659– Centers for Medicare & Medicaid Services 30661 NOTICES Only One Offer, 30656–30659 Agency Information Collection Activities; Proposals, Submission of Summary Subcontract Reports, 30666– Submissions, and Approvals, 30732–30733 30668 Use of Commercial or Non-Government Standards, sradovich on DSK3GMQ082PROD with FRONT MATTER CN Children and Families Administration 30644–30645 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 30734–30736 Defense Department See Defense Acquisition Regulations System Civil Rights Commission See Engineers Corps NOTICES See Navy Department Meetings: NOTICES Michigan Advisory Committee, 30690 Agency Information Collection Activities; Proposals, Tennessee Advisory Committee, 30689–30690 Submissions, and Approvals, 30703–30705 VerDate Sep<11>2014 19:39 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00001 Fmt 4748 Sfmt 4748 E:\FR\FM\29JNCN.SGM 29JNCN


Document Created: 2017-12-29 23:38:37
Document Modified: 2017-12-29 23:38:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of a public docket; request for comments.
DatesThe meeting will be held on March 23, 2018, from 8:30 a.m. to 3:05 p.m.
ContactMarieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, [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. 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 Citation83 FR 125 
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