82_FR_19135 82 FR 19057 - Joint Meeting of the Pediatric Advisory Committee and the Pediatric Ethics Subcommittee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

82 FR 19057 - Joint Meeting of the Pediatric Advisory Committee and the Pediatric Ethics Subcommittee; 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 78 (April 25, 2017)

Page Range19057-19058
FR Document2017-08299

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Pediatric Ethics Subcommittee (PES). The general function of the committees is to provide advice and make recommendations to the Agency on pediatric ethical issues. The meeting will be open to the public. FDA is establishing a docket for public comments on this document.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017) 
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19057-19058]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2017-N-1780]


Joint Meeting of the Pediatric Advisory Committee and the 
Pediatric Ethics Subcommittee; Notice of Meeting; Establishment of a 
Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting; establishment of a public docket, request 
for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Pediatric Advisory 
Committee (PAC) and the Pediatric Ethics Subcommittee (PES). The 
general function of the committees is to provide advice and make 
recommendations to the Agency on pediatric ethical issues. The meeting 
will be open to the public. FDA is establishing a docket for public 
comments on this document.

DATES: The meeting will be held on May 18, 2017, from 8:30 a.m. to 5:30 
p.m. The docket number is FDA 2017-N-1780. The docket will close on May 
19, 2017. Comments received on or before May 5, 2017 will be provided 
to the committee. Comments received after the date will be taken into 
consideration by the Agency.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 
Conference Center, the Great Room (Rm. 1503, section A), Silver Spring, 
MD 20993-0002. For those unable to attend in person, the meeting will 
also be webcast. The link for the webcast is available at https://collaboration.fda.gov/pacm051817. Answers to commonly asked questions 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at 
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    You may submit your 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 submission as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-1780 for the ``Joint Meeting of the Pediatric Advisory 
Committee and the Pediatric Ethics Subcommittee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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

[[Page 19058]]

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 Division of Dockets Management, 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: 
[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 http://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: On May 18, 2017, the PAC and the PES will meet to discuss a 
referral by an Institutional Review Board (IRB) of a clinical 
investigation that involves children and FDA regulated products. The 
clinical investigation is entitled ``A Double-Blind, Placebo-
Controlled, Multi-Center Study with an Open-Label Extension to Evaluate 
the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with 
Duchenne Muscular Dystrophy.'' Comments about the upcoming joint 
meeting should be submitted to Docket No. FDA 2017-N-1780.
    After presentation of an overview of the IRB referral process under 
21 CFR 50.54, an overview of the protocol and the issues raised by the 
IRB referral, other relevant presentations about the request to modify 
the protocol, and a summary of the public comments received concerning 
whether the protocol should proceed as modified, the committee will 
discuss the protocol modification and develop a recommendation 
regarding whether the protocol should proceed as modified. The 
committee's recommendation will then be presented to the Commissioner 
of Food and Drugs.
    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 will be 
available at: http://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. 
Written submissions may be made to the contact person on or before May 
11, 2017. Oral presentations from the public will be scheduled on May 
18, 2017 between approximately 11 a.m. and 12:30 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 3, 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 May 4, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency 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 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 Web site at http://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 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08299 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19057 estimated burden. This burden estimate per meeting are required to meet the this collection of information. No assumes that there are approximately requirements of the regulation. comments were received in response to 2,520 IRBs, that each IRB meets on an In the Federal Register of November the notice. average of 14.6 times annually, and that 1, 2016 (81 FR 75826), we published a FDA estimates the burden of this approximately 100 hours of person-time 60-day notice requesting public collection as follows: comment on the proposed extension of TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Average Number of Total annual 21 CFR part 56; subpart D; records and reports records per burden per Total hours recordkeepers records recordkeeper recordkeeping 56.115 .................................................................................. 2,520 14.6 36,792 100 3,679,200 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 19, 2017. MD 20993–0002. For those unable to Dockets Management (HFA–305), Food Anna K. Abram, attend in person, the meeting will also and Drug Administration, 5630 Fishers Deputy Commissioner for Policy, Planning, be webcast. The link for the webcast is Lane, Rm. 1061, Rockville, MD 20852. Legislation, and Analysis. available at https:// • For written/paper comments [FR Doc. 2017–08327 Filed 4–24–17; 8:45 am] collaboration.fda.gov/pacm051817. submitted to the Division of Dockets BILLING CODE 4164–01–P Answers to commonly asked questions Management, FDA will post your including information regarding special comment, as well as any attachments, accommodations due to a disability, except for information submitted, DEPARTMENT OF HEALTH AND visitor parking, and transportation may marked and identified, as confidential, HUMAN SERVICES be accessed at http://www.fda.gov/ if submitted as detailed in AdvisoryCommittees/ ‘‘Instructions.’’ Food and Drug Administration AboutAdvisoryCommittees/ Instructions: All submissions received [Docket No. FDA 2017–N–1780] ucm408555.htm. must include the Docket No. FDA 2017– You may submit your comments as N–1780 for the ‘‘Joint Meeting of the Joint Meeting of the Pediatric Advisory follows: Pediatric Advisory Committee and the Committee and the Pediatric Ethics Electronic Submissions Pediatric Ethics Subcommittee; Notice Subcommittee; Notice of Meeting; of Meeting; Establishment of a Public Submit electronic comments in the Docket; Request for Comments.’’ Establishment of a Public Docket; following way: Request for Comments Received comments will be placed in • Federal eRulemaking Portal: the docket and, except for those AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the instructions for submitting comments. submitted as ‘‘Confidential HHS. Submissions,’’ publicly viewable at Comments submitted electronically, ACTION: Notice of meeting; https://www.regulations.gov or at the including attachments, to https:// establishment of a public docket, Division of Dockets Management www.regulations.gov will be posted to request for comments. between 9 a.m. and 4 p.m., Monday the docket unchanged. Because your comment will be made public, you are through Friday. SUMMARY: The Food and Drug • Confidential Submissions—To Administration (FDA or Agency) solely responsible for ensuring that your comment does not include any submit a comment with confidential announces a forthcoming public information that you do not wish to be advisory committee meeting of the confidential information that you or a third party may not wish to be posted, made publicly available, submit your Pediatric Advisory Committee (PAC) comments only as a written/paper and the Pediatric Ethics Subcommittee such as medical information, your or anyone else’s Social Security number, or submission. You should submit two (PES). The general function of the copies total. One copy will include the committees is to provide advice and confidential business information, such as a manufacturing process. Please note information you claim to be confidential make recommendations to the Agency with a heading or cover note that states on pediatric ethical issues. The meeting that if you include your name, contact information, or other information that ‘‘THIS DOCUMENT CONTAINS will be open to the public. FDA is CONFIDENTIAL INFORMATION.’’ The establishing a docket for public identifies you in the body of your comments, that information will be Agency will review this copy, including comments on this document. the claimed confidential information, in DATES: The meeting will be held on May posted on https://www.regulations.gov. • If you want to submit a comment its consideration of comments. The 18, 2017, from 8:30 a.m. to 5:30 p.m. second copy, which will have the with confidential information that you The docket number is FDA 2017–N– claimed confidential information do not wish to make available to the 1780. The docket will close on May 19, redacted/blacked out, will be available public, submit the comment as a 2017. Comments received on or before for public viewing and posted on asabaliauskas on DSK3SPTVN1PROD with NOTICES written/paper submission and in the May 5, 2017 will be provided to the https://www.regulations.gov. Submit manner detailed (see ‘‘Written/Paper committee. Comments received after the both copies to the Division of Dockets Submissions’’ and ‘‘Instructions’’). date will be taken into consideration by Management. If you do not wish your the Agency. Written/Paper Submissions name and contact information to be ADDRESSES: FDA White Oak Campus, Submit written/paper submission as made publicly available, you can 10903 New Hampshire Ave., Building follows: provide this information on the cover 31 Conference Center, the Great Room • Mail/Hand delivery/Courier (for sheet and not in the body of your (Rm. 1503, section A), Silver Spring, written/paper submissions): Division of comments and you must identify this VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

19058 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices information as ‘‘confidential.’’ Any summary of the public comments at least 7 days in advance of the information marked as ‘‘confidential’’ received concerning whether the meeting. will not be disclosed except in protocol should proceed as modified, FDA is committed to the orderly accordance with 21 CFR 10.20 and other the committee will discuss the protocol conduct of its advisory committee applicable disclosure law. For more modification and develop a meetings. Please visit our Web site at information about FDA’s posting of recommendation regarding whether the http://www.fda.gov/ comments to public dockets, see 80 FR protocol should proceed as modified. AdvisoryCommittees/ 56469, September 18, 2015, or access The committee’s recommendation will AboutAdvisoryCommittees/ the information at: https://www.gpo.gov/ then be presented to the Commissioner ucm111462.htm for procedures on fdsys/pkg/FR-2015-09-18/pdf/2015- of Food and Drugs. public conduct during advisory 23389.pdf. FDA intends to make background committee meetings. Docket: For access to the docket to material available to the public no later Notice of this meeting is given under read background documents or the than 2 business days before the meeting. the Federal Advisory Committee Act (5 electronic and written/paper comments If FDA is unable to post the background U.S.C. app. 2). received, go to https:// material on its Web site prior to the Dated: April 19, 2017. www.regulations.gov and insert the meeting, the background material will Anna K. Abram, docket number, found in brackets in the be made publicly available at the Deputy Commissioner for Policy, Planning, heading of this document, into the location of the advisory committee Legislation, and Analysis. ‘‘Search’’ box and follow the prompts meeting, and the background material [FR Doc. 2017–08299 Filed 4–24–17; 8:45 am] and/or go to the Division of Dockets will be posted on FDA’s Web site after BILLING CODE 4164–01–P Management, 5630 Fishers Lane, Rm. the meeting. Background material will 1061, Rockville, MD 20852. be available at: http://www.fda.gov/ FOR FURTHER INFORMATION CONTACT: AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND Marieann Brill, Office of the default.htm. Scroll down to the HUMAN SERVICES Commissioner, Food and Drug appropriate advisory committee meeting Administration, 10903 New Hampshire link. Food and Drug Administration Ave., Bldg. 32, Rm. 5154, Silver Spring, Procedure: Interested persons may [Docket No. FDA–2005–N–0464 (Formerly MD 20993, 240–402–3838, email: present data, information, or views, Docket No. 2005N–0403)] marieann.brill@fda.hhs.gov, or FDA orally or in writing, on issues pending Advisory Committee Information Line, before the committee. Written Agency Information Collection 1–800–741–8138 (301–443–0572 in the submissions may be made to the contact Activities; Announcement of Office of Washington, DC area). A notice in the person on or before May 11, 2017. Oral Management and Budget Approval; Federal Register about last minute presentations from the public will be Establishment Registration of modifications that impact a previously scheduled on May 18, 2017 between Producers of Drugs and Listing of announced advisory committee meeting approximately 11 a.m. and 12:30 p.m. Drugs in Commercial Distribution and cannot always be published quickly Those individuals interested in making Blood Establishment Registration and enough to provide timely notice. formal oral presentations should notify Product Listing Therefore, you should always check the the contact person and submit a brief Agency’s Web site at http:// statement of the general nature of the AGENCY: Food and Drug Administration, www.fda.gov/AdvisoryCommittees/ evidence or arguments they wish to HHS. default.htm. Scroll down to the present, the names and addresses of ACTION: Notice. appropriate advisory committee meeting proposed participants, and an link, or call the advisory committee indication of the approximate time SUMMARY: The Food and Drug information line to learn about possible requested to make their presentation on Administration (FDA) is announcing modifications before coming to the or before May 3, 2017. Time allotted for that two collections of information: meeting. each presentation may be limited. If the ‘‘Establishment Registration of number of registrants requesting to Producers of Drugs and Listing of Drugs SUPPLEMENTARY INFORMATION: in Commercial Distribution’’ and Agenda: On May 18, 2017, the PAC speak is greater than can be reasonably accommodated during the scheduled ‘‘Blood Establishment Registration and and the PES will meet to discuss a Product Listing’’ have been approved by referral by an Institutional Review open public hearing session, FDA may conduct a lottery to determine the the Office of Management and Budget Board (IRB) of a clinical investigation (OMB) under the Paperwork Reduction that involves children and FDA speakers for the scheduled open public hearing session. The contact person will Act of 1995. regulated products. The clinical notify interested persons regarding their FOR FURTHER INFORMATION CONTACT: investigation is entitled ‘‘A Double- Blind, Placebo-Controlled, Multi-Center request to speak by May 4, 2017. JonnaLynn Capezzuto, Office of Study with an Open-Label Extension to Persons attending FDA’s advisory Operations, Food and Drug Evaluate the Efficacy and Safety of SRP– committee meetings are advised that the Administration, Three White Flint 4045 and SRP–4053 in Patients with Agency is not responsible for providing North 10A–12M, 11601 Landsdown St., Duchenne Muscular Dystrophy.’’ access to electrical outlets. North Bethesda, MD 20852, 301–796– Comments about the upcoming joint For press inquiries, please contact the 3794. asabaliauskas on DSK3SPTVN1PROD with NOTICES meeting should be submitted to Docket Office of Media Affairs at fdaoma@ SUPPLEMENTARY INFORMATION: On No. FDA 2017–N–1780. fda.hhs.gov or 301–796–4540. December 16, 2016, the Agency After presentation of an overview of FDA welcomes the attendance of the submitted proposed collections of the IRB referral process under 21 CFR public at its advisory committee information entitled ‘‘Establishment 50.54, an overview of the protocol and meetings and will make every effort to Registration of Producers of Drugs and the issues raised by the IRB referral, accommodate persons with disabilities. Listing of Drugs in Commercial other relevant presentations about the If you require accommodations due to a Distribution’’ and ‘‘Blood Establishment request to modify the protocol, and a disability, please contact Marieann Brill Registration and Product Listing’’ to VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1


Document Created: 2017-04-25 02:18:51
Document Modified: 2017-04-25 02:18:51
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 of meeting; establishment of a public docket, request for comments.
DatesThe meeting will be held on May 18, 2017, from 8:30 a.m. to 5:30 p.m. The docket number is FDA 2017-N-1780. The docket will close on May 19, 2017. Comments received on or before May 5, 2017 will be provided to the committee. Comments received after the date will be taken into consideration by the Agency.
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 Web site at http://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 Citation82 FR 19057 
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