83_FR_18392 83 FR 18311 - Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

83 FR 18311 - Pediatric Advisory Committee and the Endocrinologic and Metabolic 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 81 (April 26, 2018)

Page Range18311-18312
FR Document2018-08766

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). At least one portion of the meeting will be closed to the public. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comments on this document.

Federal Register, Volume 83 Issue 81 (Thursday, April 26, 2018) 
[Federal Register Volume 83, Number 81 (Thursday, April 26, 2018)]
[Notices]
[Pages 18311-18312]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-08766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1439]


Pediatric Advisory Committee and the Endocrinologic and Metabolic 
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.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Pediatric Advisory Committee 
(PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee 
(EMDAC). At least one portion of the meeting will be closed to the 
public. The general function of the committees is to provide advice and 
recommendations to FDA on regulatory issues. FDA is establishing a 
docket for public comments on this document.

DATES: The meeting will be held on May 11, 2018, from 8 a.m. to 6 p.m. 
This is a reschedule of a postponed meeting announced in the Federal 
Register of January 23, 2018 (83 FR 3156), originally scheduled for 
March 22, 2018. An amendment to the Federal Register notice was 
published on March 16, 2018 (83 FR 11755).

ADDRESSES: Tommy Douglas Conference Center, 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 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-1439. The docket will close on May 10, 
2018. Submit either electronic or written comments on this public 
meeting by that date. Please note that late, untimely filed comments 
will not be considered. Electronic comments must be submitted on or 
before May 10, 2018. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
May 10, 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 May 4, 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 Docket No. FDA-
2018-N-1439 for ``Pediatric Advisory Committee and the Endocrinologic 
and Metabolic 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 
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

[[Page 18312]]

Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver 
Spring, MD 20993, 240-402-3838, 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 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: On Friday, May 11, 2018, the PAC and EMDAC will meet to 
discuss drug development for the treatment of children with 
achondroplasia. The following topics should be considered for 
discussion: Evidence required to establish dose-response, study design, 
study duration, intended population, and endpoints. In the open 
session, the committee does not intend to discuss any individual 
research programs.
    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: On May 11, 2018, from 12 p.m. to 6 p.m., the meeting is 
open to the public. Interested persons may present data, information, 
or views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
4, 2018. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2:30 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 May 4, 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 May 7, 2018.
    Closed Committee Deliberations: On May 11, 2018, from 8 a.m. to 11 
a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)). During this session, the committees will discuss the 
premarketing drug development program of an investigational product.
    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 (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: April 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08766 Filed 4-25-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 81 / Thursday, April 26, 2018 / Notices 18311 procedures on public conduct during Submit either electronic or written identified, as confidential, if submitted advisory committee meetings. comments on this public meeting by as detailed in ‘‘Instructions.’’ Notice of this meeting is given under that date. Please note that late, untimely Instructions: All submissions received the Federal Advisory Committee Act (5 filed comments will not be considered. must include Docket No. FDA–2018–N– U.S.C. app. 2). Electronic comments must be submitted 1439 for ‘‘Pediatric Advisory Committee Dated: April 20, 2018. on or before May 10, 2018. The https:// and the Endocrinologic and Metabolic Leslie Kux, www.regulations.gov electronic filing Drugs Advisory Committee; Notice of Associate Commissioner for Policy. system will accept comments until Meeting; Establishment of a Public midnight Eastern Time at the end of Docket; Request for Comments.’’ [FR Doc. 2018–08711 Filed 4–25–18; 8:45 am] May 10, 2018. Comments received by Received comments, those filed in a BILLING CODE 4164–01–P mail/hand delivery/courier (for written/ timely manner (see ADDRESSES), will be paper submissions) will be considered placed in the docket and, except for timely if they are postmarked or the those submitted as ‘‘Confidential DEPARTMENT OF HEALTH AND delivery service acceptance receipt is on Submissions,’’ publicly viewable at HUMAN SERVICES or before that date. https://www.regulations.gov or at the Food and Drug Administration Comments received on or before May Dockets Management Staff between 9 4, 2018, will be provided to the a.m. and 4 p.m., Monday through [Docket No. FDA–2018–N–1439] committee. Comments received after Friday. that date will be taken into • Confidential Submissions—To Pediatric Advisory Committee and the consideration by FDA. submit a comment with confidential Endocrinologic and Metabolic Drugs You may submit comments as information that you do not wish to be Advisory Committee; Notice of follows: made publicly available, submit your Meeting; Establishment of a Public comments only as a written/paper Docket; Request for Comments Electronic Submissions submission. You should submit two AGENCY: Food and Drug Administration, Submit electronic comments in the copies total. One copy will include the HHS. following way: information you claim to be confidential ACTION: Notice; establishment of a • Federal eRulemaking Portal: with a heading or cover note that states public docket; request for comments. https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ FDA SUMMARY: The Food and Drug Comments submitted electronically, will review this copy, including the Administration (FDA) announces a including attachments, to https:// claimed confidential information, in its forthcoming public advisory committee www.regulations.gov will be posted to consideration of comments. The second meeting of the Pediatric Advisory the docket unchanged. Because your copy, which will have the claimed Committee (PAC) and the comment will be made public, you are confidential information redacted/ Endocrinologic and Metabolic Drugs solely responsible for ensuring that your blacked out, will be available for public Advisory Committee (EMDAC). At least comment does not include any viewing and posted on https:// one portion of the meeting will be confidential information that you or a www.regulations.gov. Submit both closed to the public. The general third party may not wish to be posted, copies to the Dockets Management Staff. function of the committees is to provide such as medical information, your or If you do not wish your name and advice and recommendations to FDA on anyone else’s Social Security number, or contact information be made publicly regulatory issues. FDA is establishing a confidential business information, such available, you can provide this docket for public comments on this as a manufacturing process. Please note information on the cover sheet and not document. that if you include your name, contact in the body of your comments and you DATES: The meeting will be held on May information, or other information that must identify the information as 11, 2018, from 8 a.m. to 6 p.m. This is identifies you in the body of your ‘‘confidential.’’ Any information marked a reschedule of a postponed meeting comments, that information will be as ‘‘confidential’’ will not be disclosed announced in the Federal Register of posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20 January 23, 2018 (83 FR 3156), • If you want to submit a comment and other applicable disclosure law. For originally scheduled for March 22, 2018. with confidential information that you more information about FDA’s posting An amendment to the Federal Register do not wish to be made available to the of comments to public dockets, see 80 notice was published on March 16, 2018 public, submit the comment as a FR 56469, September 18, 2015, or access (83 FR 11755). written/paper submission and in the the information at: https://www.gpo.gov/ ADDRESSES: Tommy Douglas Conference manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015- Center, 10000 New Hampshire Ave., Submissions’’ and ‘‘Instructions’’). 23389.pdf. Silver Spring, MD 20903. Answers to Docket: For access to the docket to Written/Paper Submissions read background documents or the commonly asked questions about FDA Advisory Committee meetings may be Submit written/paper submissions as electronic and written/paper comments accessed at: https://www.fda.gov/ follows: received, go to https:// AdvisoryCommittees/ • Mail/Hand delivery/Courier (for www.regulations.gov and insert the AboutAdvisoryCommittees/ written/paper submissions): Dockets docket number, found in brackets in the ucm408555.htm. Information about the Management Staff (HFA–305), Food and heading of this document, into the amozie on DSK30RV082PROD with NOTICES Tommy Douglas Conference Center can Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts be accessed at https:// Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management www.tommydouglascenter.com. • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061, FDA is establishing a docket for submitted to the Dockets Management Rockville, MD 20852. public comment on this meeting. The Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT: docket number is FDA–2018–N–1439. well as any attachments, except for Marieann Brill, Office of the The docket will close on May 10, 2018. information submitted, marked and Commissioner, Food and Drug VerDate Sep<11>2014 16:58 Apr 25, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\26APN1.SGM 26APN1

18312 Federal Register / Vol. 83, No. 81 / Thursday, April 26, 2018 / Notices Administration, 10903 New Hampshire their presentation on or before May 4, National Vaccine Injury Compensation Ave., Bldg. 32, Rm. 5154, Silver Spring, 2018. Time allotted for each Program (the program), as required by MD 20993, 240–402–3838, email: presentation may be limited. If the the Public Health Service (PHS) Act, as marieann.brill@fda.hhs.gov, or FDA number of registrants requesting to amended. While the Secretary of HHS is Advisory Committee Information Line, speak is greater than can be reasonably named as the respondent in all 1–800–741–8138 (301–443–0572 in the accommodated during the scheduled proceedings brought by the filing of Washington, DC area). A notice in the open public hearing session, FDA may petitions for compensation under the Federal Register about last minute conduct a lottery to determine the program, the United States Court of modifications that impact a previously speakers for the scheduled open public Federal Claims is charged by statute announced advisory committee meeting hearing session. The contact person will with responsibility for considering and cannot always be published quickly notify interested persons regarding their acting upon the petitions. enough to provide timely notice. request to speak by May 7, 2018. FOR FURTHER INFORMATION CONTACT: For Therefore, you should always check the Closed Committee Deliberations: On information about requirements for Agency’s website at https:// May 11, 2018, from 8 a.m. to 11 a.m., filing petitions and the program in www.fda.gov/AdvisoryCommittees/ the meeting will be closed to permit general, contact Lisa L. Reyes, Clerk of default.htm and scroll down to the discussion and review of trade secret Court, United States Court of Federal appropriate advisory committee meeting and/or confidential commercial Claims, 717 Madison Place NW, link, or call the advisory committee information (5 U.S.C. 552b(c)(4)). Washington, DC 20005, (202) 357–6400. information line to learn about possible During this session, the committees will For information on HRSA’s role in the modifications before coming to the discuss the premarketing drug Program, contact the Director, National meeting. development program of an Vaccine Injury Compensation Program, SUPPLEMENTARY INFORMATION: investigational product. 5600 Fishers Lane, Room 08N146B, Agenda: On Friday, May 11, 2018, the Persons attending FDA’s advisory Rockville, MD 20857; (301) 443–6593, PAC and EMDAC will meet to discuss committee meetings are advised that or visit our website at: http:// drug development for the treatment of FDA is not responsible for providing www.hrsa.gov/vaccinecompensation/ children with achondroplasia. The access to electrical outlets. index.html. FDA welcomes the attendance of the following topics should be considered SUPPLEMENTARY INFORMATION: The public at its advisory committee for discussion: Evidence required to program provides a system of no-fault meetings and will make every effort to establish dose-response, study design, compensation for certain individuals accommodate persons with disabilities. study duration, intended population, who have been injured by specified If you require accommodations due to a and endpoints. In the open session, the childhood vaccines. Subtitle 2 of Title disability, please contact Marieann Brill committee does not intend to discuss XXI of the PHS Act, 42 U.S.C. 300aa– (see FOR FURTHER INFORMATION CONTACT) any individual research programs. 10 et seq., provides that those seeking FDA intends to make background at least 7 days in advance of the compensation are to file a petition with material available to the public no later meeting. FDA is committed to the orderly the United States Court of Federal than 2 business days before the meeting. Claims and to serve a copy of the conduct of its advisory committee If FDA is unable to post the background petition on the Secretary of HHS, who meetings. Please visit our website at material on its website prior to the is named as the respondent in each https://www.fda.gov/ meeting, the background material will proceeding. The Secretary has delegated AdvisoryCommittees/AboutAdvisory be made publicly available at the this responsibility under the program to Committees/ucm111462.htm for location of the advisory committee HRSA. The Court is directed by statute procedures on public conduct during meeting, and the background material to appoint special masters who take advisory committee meetings. will be posted on FDA’s website after Notice of this meeting is given under evidence, conduct hearings as the meeting. Background material is the Federal Advisory Committee Act appropriate, and make initial decisions available at https://www.fda.gov/ (5 U.S.C. app. 2). as to eligibility for, and amount of, AdvisoryCommittees/Calendar/ compensation. default.htm. Scroll down to the Dated: April 20, 2018. A petition may be filed with respect appropriate advisory committee meeting Leslie Kux, to injuries, disabilities, illnesses, link. Associate Commissioner for Policy. conditions, and deaths resulting from Procedure: On May 11, 2018, from [FR Doc. 2018–08766 Filed 4–25–18; 8:45 am] vaccines described in the Vaccine Injury 12 p.m. to 6 p.m., the meeting is open BILLING CODE 4164–01–P Table (the table) set forth at 42 CFR to the public. Interested persons may 100.3. This table lists for each covered present data, information, or views, childhood vaccine the conditions that orally or in writing, on issues pending DEPARTMENT OF HEALTH AND may lead to compensation and, for each before the committee. Written HUMAN SERVICES condition, the time period for submissions may be made to the contact occurrence of the first symptom or person on or before May 4, 2018. Oral Health Resources and Services manifestation of onset or of significant presentations from the public will be Administration aggravation after vaccine scheduled between approximately administration. Compensation may also 1 p.m. and 2:30 p.m. Those individuals National Vaccine Injury Compensation be awarded for conditions not listed in interested in making formal oral Program; List of Petitions Received the Table and for conditions that are amozie on DSK30RV082PROD with NOTICES presentations should notify the contact AGENCY: Health Resources and Services manifested outside the time periods person and submit a brief statement of Administration (HRSA), Department of specified in the table, but only if the the general nature of the evidence or Health and Human Services (HHS). petitioner shows that the condition was arguments they wish to present, the ACTION: Notice. caused by one of the listed vaccines. names and addresses of proposed Section 2112(b)(2) of the PHS Act, 42 participants, and an indication of the SUMMARY: HRSA is publishing this U.S.C. 300aa–12(b)(2), requires that approximate time requested to make notice of petitions received under the ‘‘[w]ithin 30 days after the Secretary VerDate Sep<11>2014 16:58 Apr 25, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\26APN1.SGM 26APN1


Document Created: 2018-11-02 08:20:16
Document Modified: 2018-11-02 08:20:16
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 May 11, 2018, from 8 a.m. to 6 p.m. This is a reschedule of a postponed meeting announced in the Federal Register of January 23, 2018 (83 FR 3156), originally scheduled for March 22, 2018. An amendment to the Federal Register notice was published on March 16, 2018 (83 FR 11755).
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: [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 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 Citation83 FR 18311 
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