81_FR_39387 81 FR 39271 - Pediatric Clinical Investigator Training; Public Workshop

81 FR 39271 - Pediatric Clinical Investigator Training; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 116 (June 16, 2016)

Page Range39271-39272
FR Document2016-14230

The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development are announcing a 2-day public workshop entitled ``Pediatric Clinical Investigator Training.'' The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. Although we have learned a lot about conducting pediatric trials over the past two decades, there are still challenges that need to be addressed. The training course is intended to provide investigators with: (1) A clear understanding of some of the challenges of studying products in the pediatric population, including: Pediatric study design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial design, formulations; (2) an overview of extrapolation as it relates to the pediatric population; and (3) an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.

Federal Register, Volume 81 Issue 116 (Thursday, June 16, 2016) 
[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39271-39272]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Pediatric Clinical Investigator Training; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA) Office of Pediatric 
Therapeutics, and the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development are announcing a 2-day public 
workshop entitled ``Pediatric Clinical Investigator Training.'' The 
purpose of this workshop is to provide investigators with training and 
expertise in designing and conducting clinical trials in pediatric 
patients that will lead to appropriate labeling. Although we have 
learned a lot about conducting pediatric trials over the past two 
decades, there are still challenges that need to be addressed. The 
training course is intended to provide investigators with: (1) A clear 
understanding of some of the challenges of studying products in the 
pediatric population, including: Pediatric study design, neonates, 
biomarkers, endpoints, orphan drugs and rare disease trial design, 
formulations; (2) an overview of extrapolation as it relates to the 
pediatric population; and (3) an overview of ethically appropriate 
methods related to the design of clinical trials in the pediatric 
population.

DATES: The public workshop will be held on September 12 and 13, 2016, 
from 8 a.m. to 4 p.m. Registration to attend the workshop should be 
completed by September 6, 2016. (See the SUPPLEMENTARY INFORMATION 
section for instructions).

ADDRESSES: This public workshop will be held at the DoubleTree 
Bethesda, 8120 Wisconsin Ave., Bethesda, MD 20814.

FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of 
Pediatric Therapeutics, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 
[email protected]; or Betsy Sanford, Office of Pediatric 
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In July 2012, the Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-144) made permanent the pediatric 
initiatives, Best Pharmaceuticals for Children Act (BPCA) and Pediatric 
Research Equity Act, which have stimulated pediatric research over the 
past two decades. The National Institutes of Health section of BPCA 
legislation, however, is due for reauthorization in 2017. Though much 
progress has been made, pediatric trials for the purpose of developing 
product use information are still performed less frequently than adult 
trials. As such, current standards for trials are much more oriented to 
adult scientific, ethical, and clinical processes. This situation is 
due, in part, to the fact that pediatric trials have both scientific 
challenges and unique attributes and requirements which must be met if 
the data are to be accepted or used by FDA.
    The development of safe and effective products in the pediatric 
population presents many challenges. These challenges include trial 
design, appropriate endpoints, extrapolation of data from adults, and 
ethical issues. It is extremely important that pediatric

[[Page 39272]]

researchers recognize and understand the challenges and differences 
between the standards for adult trials and pediatric trials. 
Researchers are responsible for ensuring the safe and ethical treatment 
of pediatric patients and obtaining adequate and reliable data to 
support regulatory decisions. There is a critical need for further 
pediatric research on medical products to obtain additional data which 
will help ensure that these products are safe and effective in the 
pediatric population. Much of the progress which has been made in 
obtaining proper therapeutic information in pediatrics has occurred in 
the older and more populous pediatric populations. The challenge of 
obtaining data from non-verbal children, neonates, and for conditions 
existing in limited populations is much more difficult. This need 
reinforces our responsibility to educate clinical investigators to 
assure that children are only enrolled in research that is 
scientifically necessary, ethically sound, and designed to meet the 
challenges of review by FDA.

II. Workshop Attendance and Participation

    If you wish to attend this workshop, visit http://pedsinvesttrain.eventbrite.com. Please register by September 6, 2016. 
Those who are unable to attend the workshop in person can register to 
view a live Webcast of the workshop. You will be asked to indicate in 
your registration if you plan to attend in person or via the Webcast. 
Your registration will also require your complete contact information, 
including name, title, affiliation, address, email address, and phone 
number. Seating will be limited so early registration is recommended. 
Registration is free and will be on a first-come, first-served basis. 
Onsite registration on the day of the workshop will be based on space 
availability. Persons attending the workshop are advised that FDA is 
not responsible for providing access to electrical outlets.
    Registration information, the agenda, and additional background 
materials can be found at http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm392506.htm.
    Webcast: The workshop will be Webcast live and available on the 
Internet.
    The live Webcast on September 12, 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 
September 13, 2016, the live Webcast 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 
Webcast will only be for listening and there will not be an opportunity 
for Webcast participants to speak. The Webcast will be posted after the 
workshop at: http://wcms.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm392506.htm?ssSourceSiteId=null&SSContributor=true, approximately 30 
days after the workshop.
    If you need special accommodations due to a disability, please 
contact Betsy Sanford (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.

    Dated: June 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14230 Filed 6-15-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices 39271 April 23, 2013, and the comment period the collections of information in 21 CFR course is intended to provide closed on July 22, 2013. The final parts 801 and 809 have been approved investigators with: (1) A clear guidance was revised in response to the under OMB control number 0910–0485; understanding of some of the challenges comments to emphasize use of risk the collections of information in 21 CFR of studying products in the pediatric assessment and leveraging of prior part 807, subpart E, have been approved population, including: Pediatric study information within a submission to under OMB control number 0910–0120; design, neonates, biomarkers, potentially reduce the need for new the collections of information in 21 CFR endpoints, orphan drugs and rare biocompatibility testing. part 812 have been approved under disease trial design, formulations; (2) an Commenters also requested additional OMB control number 0910–0078; the overview of extrapolation as it relates to details regarding biocompatibility collections of information in 21 CFR the pediatric population; and (3) an testing of devices in contact with gas part 814, subparts A through E, have overview of ethically appropriate pathways and color additives used in been approved under OMB control methods related to the design of clinical medical devices. FDA has determined number 0910–0231; the collections of trials in the pediatric population. that these concepts would be information in 21 CFR part 814, subpart DATES: The public workshop will be appropriately addressed in separate H, have been approved under OMB held on September 12 and 13, 2016, guidance documents and have therefore control number 0910–0332; the from 8 a.m. to 4 p.m. Registration to been removed from this final guidance. collections of information in 21 CFR attend the workshop should be II. Significance of Guidance part 820 have been approved under completed by September 6, 2016. (See OMB control number 0910–0073; and the SUPPLEMENTARY INFORMATION section This guidance is being issued the collections of information in the for instructions). consistent with FDA’s good guidance guidance document ‘‘Requests for ADDRESSES: This public workshop will practices regulation (21 CFR 10.115). Feedback on Medical Device be held at the DoubleTree Bethesda, The guidance represents the current Submissions: The Pre-Submission 8120 Wisconsin Ave., Bethesda, MD thinking of FDA on Use of International Program and Meetings with Food and 20814. Standard ISO 10993–1, ‘‘Biological Drug Administration Staff Requests for evaluation of medical devices—Part 1: FOR FURTHER INFORMATION CONTACT: Feedback on Medical Device Terrie L. Crescenzi, Office of Pediatric Evaluation and testing within a risk Submissions: The Pre-Submission management process.’’ It does not Therapeutics, Food and Drug Program and Meetings with Food and Administration, 10903 New Hampshire establish any rights for any person and Drug Administration Staff’’ have been is not binding on FDA or the public. Ave., Silver Spring, MD 20993–0002, approved under OMB control number terrie.crescenzi@fda.hhs.gov; or Betsy You can use an alternative approach if 0910–0756. it satisfies the requirements of the Sanford, Office of Pediatric applicable statutes and regulations. Dated: June 8, 2016. Therapeutics, Food and Drug Leslie Kux, Administration, 10903 New Hampshire III. Electronic Access Associate Commissioner for Policy. Ave., Silver Spring, MD 20993–0002, Persons interested in obtaining a copy [FR Doc. 2016–14190 Filed 6–15–16; 8:45 am] elizabeth.sanford@fda.hhs.gov. of the guidance may do so by BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: downloading an electronic copy from the Internet. A search capability for all I. Background Center for Devices and Radiological DEPARTMENT OF HEALTH AND In July 2012, the Food and Drug Health guidance documents is available HUMAN SERVICES Administration Safety and Innovation at http://www.fda.gov/MedicalDevices/ Act (Pub. L. 112–144) made permanent DeviceRegulationandGuidance/ Food and Drug Administration the pediatric initiatives, Best GuidanceDocuments/default.htm. Pharmaceuticals for Children Act [Docket No. FDA–2016–N–0001] Guidance documents are also available (BPCA) and Pediatric Research Equity at http://www.regulations.gov. Persons Pediatric Clinical Investigator Training; Act, which have stimulated pediatric unable to download an electronic copy Public Workshop research over the past two decades. The of ‘‘Use of International Standard ISO National Institutes of Health section of 10993–1, ‘Biological evaluation of AGENCY: Food and Drug Administration, BPCA legislation, however, is due for medical devices—Part 1: Evaluation and HHS. reauthorization in 2017. Though much testing within a risk management ACTION: Notice of public workshop. progress has been made, pediatric trials process’ ’’ may send an email request to for the purpose of developing product CDRH-Guidance@fda.hhs.gov to receive SUMMARY: The Food and Drug use information are still performed less an electronic copy of the document. Administration’s (FDA) Office of frequently than adult trials. As such, Please use the document number 1811 Pediatric Therapeutics, and the Eunice current standards for trials are much to identify the guidance you are Kennedy Shriver National Institute of more oriented to adult scientific, requesting. Child Health and Human Development ethical, and clinical processes. This are announcing a 2-day public situation is due, in part, to the fact that IV. Paperwork Reduction Act of 1995 workshop entitled ‘‘Pediatric Clinical pediatric trials have both scientific This guidance refers to previously Investigator Training.’’ The purpose of challenges and unique attributes and approved collections of information this workshop is to provide requirements which must be met if the asabaliauskas on DSK3SPTVN1PROD with NOTICES found in FDA regulations. These investigators with training and expertise data are to be accepted or used by FDA. collections of information are subject to in designing and conducting clinical The development of safe and effective review by the Office of Management and trials in pediatric patients that will lead products in the pediatric population Budget (OMB) under the Paperwork to appropriate labeling. Although we presents many challenges. These Reduction Act of 1995 (44 U.S.C. 3501– have learned a lot about conducting challenges include trial design, 3520). The collections of information in pediatric trials over the past two appropriate endpoints, extrapolation of 21 CFR part 58 have been approved decades, there are still challenges that data from adults, and ethical issues. It under OMB control number 0910–0119; need to be addressed. The training is extremely important that pediatric VerDate Sep<11>2014 18:04 Jun 15, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\16JNN1.SGM 16JNN1

39272 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices researchers recognize and understand session (note that it is different from the availability and other medical device the challenges and differences between morning’s session): https:// compliance and enforcement decisions the standards for adult trials and event.webcasts.com/start are generally fact-specific, FDA believes pediatric trials. Researchers are here.jsp?ei=1093259. On September 13, that consideration of the factors listed in responsible for ensuring the safe and 2016, the live Webcast will be available the draft guidance, when relevant, will ethical treatment of pediatric patients at: https://event.webcasts.com/start improve the consistency and and obtaining adequate and reliable data here.jsp?ei=1093263. After the morning transparency of those decisions and that to support regulatory decisions. There is session, users will be automatically a shared understanding of benefit and a critical need for further pediatric redirected to the afternoon link. Should risk will better align industry’s and research on medical products to obtain you lose connection over lunch, please FDA’s focus on actions that maximize additional data which will help ensure use the following link for the afternoon benefit to patients, improve medical that these products are safe and effective session (note that it is different from the device quality, and reduce risk to in the pediatric population. Much of the morning’s session): https:// patients. This draft guidance is not final progress which has been made in event.webcasts.com/starthere.jsp?ei= nor is it in effect at this time. obtaining proper therapeutic 1093265. The Webcast will only be for DATES: Although you can comment on information in pediatrics has occurred listening and there will not be an any guidance at any time (see 21 CFR in the older and more populous opportunity for Webcast participants to 10.115(g)(5)), to ensure that the Agency pediatric populations. The challenge of speak. The Webcast will be posted after considers your comment on this draft obtaining data from non-verbal children, the workshop at: http://wcms.fda.gov/ guidance before it begins work on the neonates, and for conditions existing in FDAgov/NewsEvents/Meetings final version of the guidance, submit limited populations is much more ConferencesWorkshops/ either electronic or written comments difficult. This need reinforces our ucm392506.htm?ssSourceSiteId= on the draft guidance by September 14, responsibility to educate clinical null&SSContributor=true, 2016. investigators to assure that children are approximately 30 days after the only enrolled in research that is ADDRESSES: You may submit comments workshop. as follows: scientifically necessary, ethically sound, If you need special accommodations and designed to meet the challenges of due to a disability, please contact Betsy Electronic Submissions review by FDA. Sanford (see FOR FURTHER INFORMATION Submit electronic comments in the II. Workshop Attendance and CONTACT) at least 7 days in advance. following way: Participation Dated: June 10, 2016. • Federal eRulemaking Portal: http:// If you wish to attend this workshop, Leslie Kux, www.regulations.gov. Follow the visit http://pedsinvesttrain.event Associate Commissioner for Policy. instructions for submitting comments. brite.com. Please register by September [FR Doc. 2016–14230 Filed 6–15–16; 8:45 am] Comments submitted electronically, 6, 2016. Those who are unable to attend BILLING CODE 4164–01–P including attachments, to http:// the workshop in person can register to www.regulations.gov will be posted to view a live Webcast of the workshop. the docket unchanged. Because your You will be asked to indicate in your DEPARTMENT OF HEALTH AND comment will be made public, you are registration if you plan to attend in HUMAN SERVICES solely responsible for ensuring that your person or via the Webcast. Your comment does not include any registration will also require your Food and Drug Administration confidential information that you or a complete contact information, including third party may not wish to be posted, [Docket No. FDA–2016–D–1495] name, title, affiliation, address, email such as medical information, your or address, and phone number. Seating Factors To Consider Regarding anyone else’s Social Security number, or will be limited so early registration is Benefit-Risk in Medical Device Product confidential business information, such recommended. Registration is free and Availability, Compliance, and as a manufacturing process. Please note will be on a first-come, first-served Enforcement Decisions; Draft that if you include your name, contact basis. Onsite registration on the day of Guidance for Industry and Food and information, or other information that the workshop will be based on space Drug Administration Staff; Availability identifies you in the body of your availability. Persons attending the comments, that information will be workshop are advised that FDA is not AGENCY: Food and Drug Administration, posted on http://www.regulations.gov. responsible for providing access to HHS. • If you want to submit a comment electrical outlets. ACTION: Notice. with confidential information that you Registration information, the agenda, do not wish to be made available to the and additional background materials SUMMARY: The Food and Drug public, submit the comment as a can be found at http://www.fda.gov/ Administration (FDA or Agency) is written/paper submission and in the NewsEvents/MeetingsConferences announcing the availability of the draft manner detailed (see ‘‘Written/Paper Workshops/ucm392506.htm. guidance entitled ‘‘Factors to Consider Submissions’’ and ‘‘Instructions’’). Webcast: The workshop will be Regarding Benefit-Risk in Medical Device Product Availability, Written/Paper Submissions Webcast live and available on the Internet. Compliance, and Enforcement Submit written/paper submissions as asabaliauskas on DSK3SPTVN1PROD with NOTICES The live Webcast on September 12, Decisions.’’ This draft guidance, when follows: 2016, will be available at: https:// finalized, is intended to provide clarity • Mail/Hand delivery/Courier (for event.webcasts.com/start for FDA staff and industry regarding the written/paper submissions): Division of here.jsp?ei=1093258. After the morning benefit and risk factors FDA may Dockets Management (HFA–305), Food session, users will be automatically consider in prioritizing resources for and Drug Administration, 5630 Fishers redirected to the afternoon link. Should compliance and enforcement efforts to Lane, Rm. 1061, Rockville, MD 20852. you lose connection over lunch, please maximize medical device quality and • For written/paper comments use the following link for the afternoon patient safety. Although product submitted to the Division of Dockets VerDate Sep<11>2014 18:04 Jun 15, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\16JNN1.SGM 16JNN1


Document Created: 2016-06-16 00:37:26
Document Modified: 2016-06-16 00:37:26
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 public workshop.
DatesThe public workshop will be held on September 12 and 13, 2016, from 8 a.m. to 4 p.m. Registration to attend the workshop should be completed by September 6, 2016. (See the SUPPLEMENTARY INFORMATION section for instructions).
ContactTerrie L. Crescenzi, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, [email protected]; or Betsy Sanford, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 39271 
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