82 FR 39790 - 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 82, Issue 161 (August 22, 2017)

Page Range		39790-39792
FR Document		2017-17726

The Food and Drug Administration (FDA or the Agency) 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 the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comments.

Federal Register, Volume 82 Issue 161 (Tuesday, August 22, 2017)

[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39790-39792]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4885]


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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) 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 the Agency on FDA's 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 September 11, 2017, from 8:30 a.m. 
to 5:30 p.m. and September 12, 2017, from 8:30 a.m. to 1 p.m.

ADDRESSES: Hilton Washington DC/Rockville Hotel & Executive Meeting 
Center, 1750 Rockville Pike, Rockville, MD 20852. The hotel's telephone 
number is 301-468-1100. Answers to commonly asked questions including 
information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html.
    FDA is establishing a docket for public comment on this document. 
The docket number is FDA-2017-N-4885. The docket will close on 
September 13, 2017. Submit either electronic or written comments on 
this public meeting by that date. Late, untimely comments will not be 
considered. Electronic comments must be submitted on or before 
September 13, 2017. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
September 13, 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 August 28, 2017, will be provided to 
the committee. Comments received after that date will be taken into 
consideration by FDA.

[[Page 39791]]

    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-4885 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.'' 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: 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 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: 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 (Pub. L. 108-155). 
Comments about the upcoming September advisory committee meeting should 
be submitted to Docket No. FDA-2017-N-4885.
    On September 11, 2017, the PAC will discuss the use of prescription 
opioid products containing hydrocodone or codeine for the treatment of 
cough in pediatric patients. The discussion will include current 
practice for the treatment of cough in children and benefit-risk 
considerations regarding the use of prescription opioid products in 
pediatric patients.
    On September 12, 2017, the PAC will meet to discuss the following 
products (listed by FDA Center):

(1) Center for Drug Evaluation and Research
    a. ABILIFY (aripiprazole)
    b. KEPPRA/KEPPRA XR (levetiracetam)
(2) Center for Devices and Radiological Health
    a. CONTEGRA Pulmonary Valved Conduit (humanitarian device exemption 
(HDE)
    b. ENTERRA Therapy System (HDE)
    c. PLEXIMMUNE (HDE)
    d. ELANA Surgical Kit (HDE)

    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 
September 5, 2017. Oral presentations from the public will be scheduled 
on September 11, 2017, between approximately 1 p.m. and 2 p.m. and on 
September 12, 2017, 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

[[Page 39792]]

proposed participants, and an indication of the approximate time 
requested to make their presentation on or before August 25, 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 August 28, 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: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17726 Filed 8-21-17; 8:45 am]
 BILLING CODE 4164-01-P

39792 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices

proposed participants, and an of information has been submitted to the Section 50.23(e)(1) (21 CFR
indication of the approximate time Office of Management and Budget 50.23(e)(1)) provides an exception to the
requested to make their presentation on (OMB) for review and clearance under general rule that informed consent is
or before August 25, 2017. Time allotted the Paperwork Reduction Act of 1995. required for the use of an investigational
for each presentation may be limited. If DATES: Fax written comments on the in vitro diagnostic device. This
the number of registrants requesting to collection of information by September exception applies to those situations in
speak is greater than can be reasonably 21, 2017. which the in vitro investigational
accommodated during the scheduled ADDRESSES: To ensure that comments on diagnostic device is used to prepare for,
open public hearing session, FDA may the information collection are received, and respond to, a chemical, biological,
conduct a lottery to determine the OMB recommends that written radiological, or nuclear terrorism event
speakers for the scheduled open public comments be faxed to the Office of or other public health emergency, if the
hearing session. The contact person will Information and Regulatory Affairs, investigator and an independent
notify interested persons regarding their OMB, Attn: FDA Desk Officer, Fax: 202– licensed physician make the
request to speak by August 28, 2017. 395–7285, or emailed to oira_ determination and later certify in
Persons attending FDA’s advisory submission@omb.eop.gov. All writing that: (1) There is a life-
committee meetings are advised that the comments should be identified with the threatening situation necessitating the
Agency is not responsible for providing OMB control number 0910–0586. Also use of the investigational device, (2)
access to electrical outlets. include the FDA docket number found obtaining informed consent from the
For press inquiries, please contact the in brackets in the heading of this subject is not feasible because there was
Office of Media Affairs at fdaoma@ document. no way to predict the need to use the
fda.hhs.gov or 301–796–4540. investigational device when the
FOR FURTHER INFORMATION CONTACT:
FDA welcomes the attendance of the specimen was collected and there is not
Amber Sanford, Office of Operations, sufficient time to obtain consent from
public at its advisory committee Food and Drug Administration, Three
meetings and will make every effort to the subject or the subject’s legally
White Flint North 10A63, 11601 authorized representative, and (3) no
accommodate persons with disabilities. Landsdown St., North Bethesda, MD
If you require accommodations due to a satisfactory alternative device is
20852, 301–796–8867, PRAStaff@ available. Under the rule, these
disability, please contact Marieann Brill fda.hhs.gov.
at least 7 days in advance of the determinations are made before the
meeting. SUPPLEMENTARY INFORMATION: In device is used, and the written
FDA is committed to the orderly compliance with 44 U.S.C. 3507, FDA certifications are made within 5 working
conduct of its advisory committee has submitted the following proposed days after the use of the device. If use
meetings. Please visit our Web site at collection of information to OMB for of the device is necessary to preserve
http://www.fda.gov/ review and clearance. the life of the subject and there is not
AdvisoryCommittees/ Medical Devices; Exception From sufficient time to obtain the
AboutAdvisoryCommittees/ General Requirements for Informed determination of the independent
ucm111462.htm for procedures on Consent OMB Control Number 0910– licensed physician in advance of using
public conduct during advisory 0586—Extension the investigational device, § 50.23(e)(2)
committee meetings. provides that the certifications must be
In the Federal Register of June 7, 2006 made within 5 working days of use of
Notice of this meeting is given under (71 FR 32827), FDA issued an interim
the Federal Advisory Committee Act (5 the device. In either case, the
final rule to amend its regulations to certifications are submitted to the
U.S.C. app. 2). establish a new exception from the Institutional Review Board (IRB) and,
Dated: August 17, 2017. general requirements for informed under § 50.23(e)(3) (76 FR 36989, June
Leslie Kux, consent, to permit the use of 24, 2011), to FDA within 5 working days
Associate Commissioner for Policy. investigational in vitro diagnostic of the use of the device.
[FR Doc. 2017–17726 Filed 8–21–17; 8:45 am] devices to identify chemical, biological, Section 50.23(e)(4) provides that an
BILLING CODE 4164–01–P
radiological, or nuclear agents without investigator must disclose the
informed consent in certain investigational status of the device and
circumstances. The Agency took this what is known about the performance
DEPARTMENT OF HEALTH AND action because it was concerned that, characteristics of the device at the time
HUMAN SERVICES during a potential terrorism event or test results are reported to the subject’s
other potential public health emergency, health care provider and public health
Food and Drug Administration delaying the testing of specimens to authorities, as applicable. Under
obtain informed consent may threaten § 50.23(e)(4), the investigator provides
[Docket No. FDA–2010–N–0062] the life of the subject. In many the IRB with the information required
instances, there may also be others who by § 50.25 (21 CFR 50.25) (except for the
Agency Information Collection
have been exposed to, or who may be information described in § 50.25(a)(8))
Activities; Submission for Office of
at risk of exposure to, a dangerous and the procedures that will be used to
Management and Budget Review;
chemical, biological, radiological, or provide this information to each subject
Comment Request; Medical Devices;
nuclear agent, thus necessitating or the subject’s legally authorized
Exception From General Requirements
identification of the agent as soon as representative.
for Informed Consent
possible. FDA created this exception to
sradovich on DSK3GMQ082PROD with NOTICES

FDA estimates that there are
AGENCY: Food and Drug Administration, help ensure that individuals who may approximately 150 laboratories that
HHS. have been exposed to a chemical, could perform testing that uses
ACTION: Notice. biological, radiological, or nuclear agent investigational in vitro diagnostic
are able to benefit from the timely use devices to identify chemical, biological,
SUMMARY: The Food and Drug of the most appropriate diagnostic radiological, or nuclear agents. FDA
Administration (FDA or the Agency) is devices, including those that are estimates that in the United States each
announcing that a proposed collection investigational. year there are approximately 450

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Document Created: 2018-10-24 11:54:39
Document Modified: 2018-10-24 11:54:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; establishment of a public docket; request for comments.
Dates		The meeting will be held on September 11, 2017, from 8:30 a.m. to 5:30 p.m. and September 12, 2017, from 8:30 a.m. to 1 p.m.
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 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 Citation		82 FR 39790

82 FR 39790 - Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 161 (August 22, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration