81 FR 13375 - Advancing the Development of Pediatric Therapeutics: Successes and Challenges of Performing Long-Term Pediatric Safety Studies; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 49 (March 14, 2016)

Page Range		13375-13376
FR Document		2016-05621

The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT) and Center for Drug Evaluation and Research are announcing a 2-day public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies.'' The purpose of this 2- day public workshop is for FDA to have an open discussion with experts in the field examining the need and path forward for long-term pediatric safety studies. Day 1 of the public workshop will focus on an exposition of the successes and challenges of long-term safety studies in children. Day 2 of the public workshop will focus on suggestions for the future on study design and implementation of long-term safety studies in children. Viewpoints of patient representatives of children with chronic conditions and industry will be included.

Federal Register, Volume 81 Issue 49 (Monday, March 14, 2016)

[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13375-13376]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advancing the Development of Pediatric Therapeutics: Successes 
and Challenges of Performing Long-Term Pediatric Safety Studies; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration's (FDA) Office of Pediatric 
Therapeutics (OPT) and Center for Drug Evaluation and Research are 
announcing a 2-day public workshop entitled ``Advancing the Development 
of Pediatric Therapeutics (ADEPT): Successes and Challenges of 
Performing Long-Term Pediatric Safety Studies.'' The purpose of this 2-
day public workshop is for FDA to have an open discussion with experts 
in the field examining the need and path forward for long-term 
pediatric safety studies. Day 1 of the public workshop will focus on an 
exposition of the successes and challenges of long-term safety studies 
in children. Day 2 of the public workshop will focus on suggestions for 
the future on study design and implementation of long-term safety 
studies in children. Viewpoints of patient representatives of children 
with chronic conditions and industry will be included.

DATES: The public workshop will be held on April 13 and 14, 2016, from 
8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at The DoubleTree by Hilton 
Hotel--Bethesda, 8120 Wisconsin Ave., Bethesda, MD 20814.

FOR FURTHER INFORMATION CONTACT: Renan A. Bonnel, Office of Pediatric 
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-8654, FAX: 301-847-8640, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Medical product safety studies in children are usually performed 
for 6 months or less. In children, measurement of long-term outcomes is 
particularly challenging since, compared to adults, children are 
undergoing dramatic growth and developmental changes. This 2-day public 
workshop will focus on the challenges of long-term follow-up in 
children receiving medical products. The first day of the public 
workshop will focus on the problems or barriers, including; challenges 
with study design, data capture, infrastructure, and endpoints. 
Viewpoints of parents and industry will be represented. The second day 
of the public workshop will include panel discussions to propose 
solutions to the problems posed on day one and to discuss the 
epidemiological challenges posed by the collection of data on different 
types of adverse events. On both days of the public workshop there will 
be a certain amount of time on the agenda for attendee questions or 
comments.

II. Participation in the Public Workshop

    Registration: There is no fee to attend the public workshop, but 
attendees should register in advance. Space is limited, and 
registration will be on a first-come, first-served basis. Persons 
interested in attending this workshop must register online at: http://pediatricsafety.eventbrite.com before April 7, 2016. For those without 
Internet access, please contact Renan A. Bonnel (see FOR FURTHER 
INFORMATION CONTACT) to register. In the event that a minimum number of 
participants have not registered, the workshop will be postponed. 
Registered participants will be notified of any change. Onsite 
registration will be available if seating permits it. Registration 
information, the agenda, and additional background materials can be 
found at http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm477639.htm.
    If you need special accommodations due to a disability, please 
contact Renan A. Bonnel (see FOR FURTHER INFORMATION CONTACT) at least 
7 days in advance. Persons attending the meeting are advised that FDA 
is not responsible for providing access to electrical outlets.
    Web cast: The live Web cast on April 13, 2016, will be available 
at: https://event.webcasts.com/starthere.jsp?ei=1093258. After the 
morning session, users will be automatically redirected to the 
afternoon link. Should you lose connection over lunch, please use the 
following link for the afternoon session (note that it is different 
from the morning's session): https://event.webcasts.com/starthere.jsp?ei=1093259. On April 14, 2016, the live Web cast will be 
available at: https://event.webcasts.com/starthere.jsp?ei=1093263. 
After the morning session, users will be automatically redirected to 
the afternoon link. Should you lose connection over lunch, please use 
the following link for the afternoon session (note that it is different 
from the morning's session): https://event.webcasts.com/starthere.jsp?ei=1093265. The Web cast will only be for listening and 
there will not be an opportunity for Web cast participants to speak.
    The videocast will be posted after the workshop at http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm477639.htm.
    Transcripts: Transcripts of the workshop will be available for 
review at the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
at http://www.regulations.gov approximately 30 days after the workshop. 
A transcript will also be available in either hard copy or on CD-ROM, 
after submission of a Freedom of Information request. Send written 
requests to the Division of Freedom of Information. The Freedom of 
Information address is available on the Agency's Web site at

[[Page 13376]]

http://www.fda.gov. Send faxed requests to 301-827-9267.

    Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05621 Filed 3-11-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices 13375

the Office of Management and Budget discussion with experts in the field must register online at: http://pediatric
(OMB) under the Paperwork Reduction examining the need and path forward safety.eventbrite.com before April 7,
Act of 1995 (44 U.S.C. 3501–3520). The for long-term pediatric safety studies. 2016. For those without Internet access,
collection of information in 21 CFR part Day 1 of the public workshop will focus please contact Renan A. Bonnel (see FOR
312 has been approved under 0910– on an exposition of the successes and FURTHER INFORMATION CONTACT) to
0014; the collection of information in 21 challenges of long-term safety studies in register. In the event that a minimum
CFR part 314 has been approved under children. Day 2 of the public workshop number of participants have not
0910–0001; the collection of will focus on suggestions for the future registered, the workshop will be
information in 21 CFR part 601 has been on study design and implementation of postponed. Registered participants will
approved under 0910–0338; and the long-term safety studies in children. be notified of any change. Onsite
collection of information for Viewpoints of patient representatives of registration will be available if seating
applications submitted under section children with chronic conditions and permits it. Registration information, the
351(k) of the PHS Act has been industry will be included. agenda, and additional background
approved under 0910–0719. In DATES: The public workshop will be materials can be found at http://www.
accordance with the PRA, before held on April 13 and 14, 2016, from 8 fda.gov/NewsEvents/Meetings
publication of the final guidance a.m. to 5 p.m. See the SUPPLEMENTARY ConferencesWorkshops/
document, FDA intends to solicit public INFORMATION section for registration date ucm477639.htm.
comment and obtain OMB approval for and information. If you need special accommodations
any information collections due to a disability, please contact Renan
ADDRESSES: The public workshop will
recommended in this guidance that are A. Bonnel (see FOR FURTHER INFORMATION
be held at The DoubleTree by Hilton
new or that would represent material CONTACT) at least 7 days in advance.
Hotel—Bethesda, 8120 Wisconsin Ave.,
modifications to previously approved Persons attending the meeting are
Bethesda, MD 20814.
collections of information found in FDA advised that FDA is not responsible for
FOR FURTHER INFORMATION CONTACT: providing access to electrical outlets.
regulations or guidances.
Renan A. Bonnel, Office of Pediatric Web cast: The live Web cast on April
III. Electronic Access Therapeutics, Food and Drug 13, 2016, will be available at: https://
Persons with access to the Internet Administration, 10903 New Hampshire event.webcasts.com/starthere.jsp
may obtain the document at http:// Ave., Silver Spring, MD 20993–0002, ?ei=1093258. After the morning session,
www.fda.gov/Drugs/Guidance 301–796–8654, FAX: 301–847–8640, users will be automatically redirected to
ComplianceRegulatoryInformation/ email: renan.bonnel@fda.hhs.gov. the afternoon link. Should you lose
Guidances/default.htm, http:// SUPPLEMENTARY INFORMATION: connection over lunch, please use the
www.fda.gov/BiologicsBloodVaccines/ following link for the afternoon session
I. Background
GuidanceComplianceRegulatory (note that it is different from the
Information/default.htm or http:// Medical product safety studies in morning’s session): https://event.
www.regulations.gov. children are usually performed for 6 webcasts.com/starthere.jsp?ei=1093259.
Dated: March 8, 2016.
months or less. In children, On April 14, 2016, the live Web cast
measurement of long-term outcomes is will be available at: https://event.
Leslie Kux,
particularly challenging since, webcasts.com/starthere.jsp?ei=1093263.
Associate Commissioner for Policy.
compared to adults, children are After the morning session, users will be
[FR Doc. 2016–05626 Filed 3–11–16; 8:45 am] undergoing dramatic growth and automatically redirected to the
BILLING CODE 4164–01–P developmental changes. This 2-day afternoon link. Should you lose
public workshop will focus on the connection over lunch, please use the
challenges of long-term follow-up in following link for the afternoon session
DEPARTMENT OF HEALTH AND children receiving medical products. (note that it is different from the
HUMAN SERVICES The first day of the public workshop morning’s session): https://event.
Food and Drug Administration will focus on the problems or barriers, webcasts.com/starthere.jsp?ei=1093265.
including; challenges with study design, The Web cast will only be for listening
[Docket No. FDA–2016–N–0001] data capture, infrastructure, and and there will not be an opportunity for
endpoints. Viewpoints of parents and Web cast participants to speak.
Advancing the Development of industry will be represented. The The videocast will be posted after the
Pediatric Therapeutics: Successes and second day of the public workshop will workshop at http://www.fda.gov/News
Challenges of Performing Long-Term include panel discussions to propose Events/MeetingsConferencesWorkshops/
Pediatric Safety Studies; Public solutions to the problems posed on day ucm477639.htm.
Workshop one and to discuss the epidemiological Transcripts: Transcripts of the
AGENCY: Food and Drug Administration, challenges posed by the collection of workshop will be available for review at
HHS. data on different types of adverse the Division of Dockets Management
ACTION: Notice of public workshop. events. On both days of the public (HFA–305), Food and Drug
workshop there will be a certain amount Administration, 5630 Fishers Lane, Rm.
SUMMARY: The Food and Drug of time on the agenda for attendee 1061, Rockville, MD 20852, and at
Administration’s (FDA) Office of questions or comments. http://www.regulations.gov
Pediatric Therapeutics (OPT) and Center approximately 30 days after the
for Drug Evaluation and Research are II. Participation in the Public workshop. A transcript will also be
jstallworth on DSK7TPTVN1PROD with NOTICES

announcing a 2-day public workshop Workshop available in either hard copy or on CD–
entitled ‘‘Advancing the Development of Registration: There is no fee to attend ROM, after submission of a Freedom of
Pediatric Therapeutics (ADEPT): the public workshop, but attendees Information request. Send written
Successes and Challenges of Performing should register in advance. Space is requests to the Division of Freedom of
Long-Term Pediatric Safety Studies.’’ limited, and registration will be on a Information. The Freedom of
The purpose of this 2-day public first-come, first-served basis. Persons Information address is available on the
workshop is for FDA to have an open interested in attending this workshop Agency’s Web site at

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13376 Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices

http://www.fda.gov. Send faxed requests Evaluation and Research, in co- SUPPLEMENTARY INFORMATION: ISPE is an
to 301–827–9267. sponsorship with the International association of engineers, scientists,
Dated: March 8, 2016. Society for Pharmaceutical Engineering manufacturing, quality, and industrial
Leslie Kux,
(ISPE), is announcing a meeting entitled professionals involved in the
‘‘Fifth Annual FDA–ISPE Quality development, manufacture, quality
Associate Commissioner for Policy.
Conference.’’ The purpose of the control, and regulation of
[FR Doc. 2016–05621 Filed 3–11–16; 8:45 am]
meeting is to discuss manufacturing, pharmaceuticals and related products.
BILLING CODE 4164–01–P compliance, and management practices This co-sponsored meeting facilitates
that create, implement, and sustain a discussion and problem solving around
culture of high quality and result in technical, quality, compliance, and
DEPARTMENT OF HEALTH AND
reliable pharmaceutical and biologic other manufacturing issues.
HUMAN SERVICES
products that support patient health. Registration: There is a registration fee
Food and Drug Administration DATES: The meeting will be held on June to attend this meeting. The registration
6, 7, and 8, 2016, from 8:30 a.m. to 4 fee is charged to help defray the costs
[Docket No. FDA–2016–N–0001] of programming and facilities. Seats are
p.m.
limited, and registration will be on a
The Fifth Annual Food and Drug ADDRESSES: The meeting will be held at first-come, first-served basis.
Administration-International Society the Bethesda North Marriott Hotel & To register, please complete
for Pharmaceutical Engineering Conference Center, 5701 Marinelli Rd., registration online at http://
Quality Conference Bethesda, MD 20852. www.ispe.org/events. FDA has verified
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: the Web address, but FDA is not
HHS. Susan Krys, ISPE, 7200 Wisconsin Ave., responsible for subsequent changes to
ACTION: Notice of meeting. Suite 305, Bethesda, MD 20814, 301– the Web site after this document
364–9202, FAX: 240–204–6024, email: publishes in the Federal Register. The
SUMMARY: The Food and Drug skrys@ispe.org, or Sau (Larry) Lee, 301– costs of registration for the different
Administration’s (FDA) Center for Drug 796–2905, email: Sau.Lee@fda.hhs.gov. categories of attendees are as follows:

Category Cost

Industry Representatives:
ISPE Members ........................................................................................................................................ $1,895 (early-bird); $2,095 (onsite).
Non-members .......................................................................................................................................... $2,275 (early-bird); $2,475 (onsite).
Academic ........................................................................................................................................................ $1,425 (early-bird); $1,575 (onsite).
Government .................................................................................................................................................... $700 (early-bird); $700 (onsite).

Accommodations: Attendees are DEPARTMENT OF HEALTH AND Location: College Park Marriott Hotel
responsible for their own hotel HUMAN SERVICES and Conference Center, Chesapeake
accommodations. Attendees making Ballroom, 3501 University Blvd. East,
reservations at the Bethesda North Food and Drug Administration Hyattsville, MD 20783. The conference
Marriott Hotel & Conference Center in [Docket No. FDA–2016–N–0001] center’s telephone number is 301–985–
Bethesda, MD are eligible for a reduced 7300.
rate of $209 USD, not including Peripheral and Central Nervous Contact Person: Moon Hee V. Choi,
applicable taxes. To receive the reduced System Drugs Advisory Committee; Center for Drug Evaluation and
rate, contact the Bethesda North Notice of Meeting Research, Food and Drug
Marriott Hotel (1–301–822–9200 or 1– Administration, 10903 New Hampshire
800–859–8003) and identify yourself as AGENCY: Food and Drug Administration, Ave., Bldg. 31, Rm. 2417, Silver Spring,
an attendee of the meeting. If you need HHS. MD 20993–0002, 301–796–9001, FAX:
special accommodations due to a ACTION: Notice. 301–847–8533, email: PCNS@
disability, please contact Susan Krys at fda.hhs.gov, or FDA Advisory
This notice announces a forthcoming Committee Information Line, 1–800–
least 7 days in advance.
meeting of a public advisory committee 741–8138 (301–443–0572 in the
Transcripts: We expect that of the Food and Drug Administration Washington, DC area). A notice in the
transcripts will be available (FDA). The meeting will be open to the Federal Register about last minute
approximately 30 days after the public. modifications that impact a previously
meeting. A transcript will be available Name of Committee: Peripheral and announced advisory committee meeting
in either hard copy or on CD–ROM, after Central Nervous System Drugs Advisory cannot always be published quickly
submission of a Freedom of Information Committee. enough to provide timely notice.
request. The Freedom of Information General Function of the Committee: Therefore, you should always check the
office address is available on the To provide advice and Agency’s Web site at http://
Agency’s Web site at http:// recommendations to the Agency on www.fda.gov/AdvisoryCommittees/
www.fda.gov. Send faxed requests to FDA’s regulatory issues.
jstallworth on DSK7TPTVN1PROD with NOTICES

default.htm and scroll down to the
301–827–9267. Date and Time: The meeting will be appropriate advisory committee meeting
Dated: March 8, 2016. held on April 25, 2016, from 8 a.m. to link, or call the advisory committee
5:30 p.m. This meeting is a reschedule information line to learn about possible
Leslie Kux,
of a postponed meeting announced in modifications before coming to the
Associate Commissioner for Policy. the Federal Register of December 18, meeting.
[FR Doc. 2016–05627 Filed 3–11–16; 8:45 am] 2015 (80 FR 79047), originally Agenda: The committee will discuss
BILLING CODE 4164–01–P scheduled for January 22, 2016. new drug application (NDA) 206488,

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Document Created: 2016-03-12 01:00:42
Document Modified: 2016-03-12 01:00:42

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 of public workshop.
Dates		The public workshop will be held on April 13 and 14, 2016, from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Contact		Renan A. Bonnel, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8654, FAX: 301-847-8640, email: [email protected]
FR Citation		81 FR 13375

81 FR 13375 - Advancing the Development of Pediatric Therapeutics: Successes and Challenges of Performing Long-Term Pediatric Safety Studies; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 49 (March 14, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration