80 FR 10123 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 37 (February 25, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 37 (February 25, 2015)
| Page Range | 10123-10124 | |
| FR Document | 2015-03900 |
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)] [Notices] [Pages 10123-10124] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03900] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency regarding ethical protections for children in FDA-regulated clinical trials. Date and Time: The meeting will be held on Monday, March 23, 2015 from 8:30 a.m. to 4:30 p.m. Location: Doubletree by Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD 20910. 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. Contact Person: Walter Ellenberg, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154, Silver Spring, MD 20993, 301-796-0885, email [email protected], or FDA Advisory Committee Information Line, 1-800- [[Page 10124]] 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 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. Agenda: The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart D. A brief summary of the subcommittee's discussion will then be presented to the FDA Pediatric Advisory Committee on Tuesday, March 24, 2015. 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 is 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 March 9, 2014. Oral presentations from the public will be scheduled between 11:30 a.m. and 12:30 p.m. on March 23, 2015. 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 February 26, 2015. 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 March 2, 2015. Persons attending FDA's advisory committee meetings are advised that the Agency 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Walter Ellenberg 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: February 20, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-03900 Filed 2-24-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10123
download from the Internet. See the guidance provides our suggestions on or written comments to the Division of
SUPPLEMENTARY INFORMATION section for how to best characterize the technical Dockets Management (see ADDRESSES). It
information on electronic access to the aspects that are relevant to WSI is only necessary to send one set of
guidance. Submit written requests for a performance for their intended use and comments. Identify comments with the
single hard copy of the draft guidance determine any possible limitations that docket number found in brackets in the
document entitled ‘‘Technical might affect their safety and heading of this document. Received
Performance Assessment of Digital effectiveness. comments may be seen in the Division
Pathology Whole Slide Imaging of Dockets Management between 9 a.m.
II. Significance of Guidance
Devices’’ to the Office of the Center and 4 p.m., Monday through Friday, and
Director, Guidance and Policy This draft guidance is being issued will be posted to the docket at http://
Development, Center for Devices and consistent with FDA’s good guidance www.regulations.gov.
Radiological Health, Food and Drug practices regulation (21 CFR 10.115).
Dated: February 19, 2015.
Administration, 10903 New Hampshire The draft guidance, when finalized, will
represent the Agency’s current thinking Leslie Kux,
Ave., Bldg. 66, Rm. 5431, Silver Spring,
on technical performance assessment of Associate Commissioner for Policy.
MD 20993–0002. Send one self-
digital pathology WSI devices. It does [FR Doc. 2015–03843 Filed 2–24–15; 8:45 am]
addressed adhesive label to assist that
office in processing your request. not create or confer any rights for or on BILLING CODE 4164–01–P
Submit electronic comments on the any person and does not operate to bind
draft guidance to http:// FDA or the public. An alternative
www.regulations.gov. Submit written approach may be used if such approach DEPARTMENT OF HEALTH AND
comments to the Division of Dockets satisfies the requirements of the HUMAN SERVICES
Management (HFA–305), Food and Drug applicable statute and regulations.
Food and Drug Administration
Administration, 5630 Fishers Lane, Rm. III. Electronic Access
1061, Rockville, MD 20852. Identify [Docket No. FDA–2015–N–0001]
comments with the docket number Persons interested in obtaining a copy
found in brackets in the heading of this of the draft guidance may do so by Pediatric Ethics Subcommittee of the
document. downloading an electronic copy from Pediatric Advisory Committee; Notice
the Internet. A search capability for all of Meeting
FOR FURTHER INFORMATION CONTACT:
Center for Devices and Radiological
Nicholas Anderson, Center for Devices Health guidance documents is available AGENCY: Food and Drug Administration,
and Radiological Health, Food and Drug at http://www.fda.gov/MedicalDevices/ HHS.
Administration, 10903 New Hampshire DeviceRegulationandGuidance/ ACTION: Notice.
Ave., Bldg. 66, Rm. 5570, Silver Spring, GuidanceDocuments/default.htm.
MD 20993–0002, 301–796–4310; or Guidance documents are also available This notice announces a forthcoming
Aldo Badano, Center for Devices and at http://www.regulations.gov. Persons meeting of a public advisory committee
Radiological Health, Food and Drug unable to download an electronic copy of the Food and Drug Administration
Administration, 10903 New Hampshire of ‘‘Technical Performance Assessment (FDA). The meeting will be open to the
Ave., Bldg. 62, Rm. 3116, Silver Spring, of Digital Pathology Whole Slide public.
MD 20993–0002, 301–796–2534. Imaging Devices’’ may send an email Name of Committee: Pediatric Ethics
SUPPLEMENTARY INFORMATION: request to CDRH-Guidance@fda.hhs.gov Subcommittee of the Pediatric Advisory
to receive an electronic copy of the Committee.
I. Background General Function of the Committee:
document. Please use the document
Recent technological advances in number 1400053 to identify the To provide advice and
digital microscopy, in particular the guidance you are requesting. recommendations to the Agency
development of whole slide scanning regarding ethical protections for
systems, have accelerated the adoption IV. Paperwork Reduction Act of 1995 children in FDA-regulated clinical
of digital imaging in pathology, similar This draft guidance refers to trials.
to the digital transformation that previously approved collections of Date and Time: The meeting will be
radiology departments have experienced information found in FDA regulations. held on Monday, March 23, 2015 from
over the last decade. FDA regulates WSI These collections of information are 8:30 a.m. to 4:30 p.m.
systems manufacturers to ensure that subject to review by the Office of Location: Doubletree by Hilton Hotel,
the images produced for clinical Management and Budget (OMB) under 8727 Colesville Rd., Silver Spring, MD
intended uses are safe and effective for the Paperwork Reduction Act of 1995 20910. Answers to commonly asked
such purposes. Essential to the (the PRA) (44 U.S.C. 3501–3520). The questions, including information
regulation of these systems is the collections of information in 21 CFR regarding special accommodations due
understanding of the technical part 807, subpart E have been approved to a disability, visitor parking, and
performance of the components in the under OMB control number 0910–0120, transportation, may be accessed at:
imaging chain, from image acquisition the collections of information in 21 CFR http://www.fda.gov/
to image display and their effect on part 814 have been approved under AdvisoryCommittees/
pathologist’s diagnostic performance OMB control number 0910–0231, and AboutAdvisoryCommittees/
and workflow. ucm408555.htm.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
the collections of information in 21 CFR
This draft guidance provides industry part 801 and 21 CFR 809.10 have been Contact Person: Walter Ellenberg,
and Agency staff with recommendations approved under OMB control number Office of the Commissioner, Food and
regarding the technical performance 0910–0485. Drug Administration, 10903 New
assessment data that should be included Hampshire Ave., Bldg. 32, rm. 5154,
for regulatory evaluation of a WSI. This V. Comments Silver Spring, MD 20993, 301–796–
document does not cover the clinical Interested persons may submit either 0885, email walter.ellenberg@
submission data that may be necessary electronic comments regarding this fda.hhs.gov, or FDA Advisory
to support approval or clearance. The document to http://www.regulations.gov Committee Information Line, 1–800–
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![10124 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices
741–8138 (301–443–0572 in the scheduled open public hearing session, devices. Comments and suggestions
Washington, DC area). A notice in the FDA may conduct a lottery to determine generated through this workshop will
Federal Register about last minute the speakers for the scheduled open facilitate further development of
modifications that impact a previously public hearing session. The contact regulatory science for RAS technologies.
announced advisory committee meeting person will notify interested persons Dates and Times: The public
cannot always be published quickly regarding their request to speak by workshop will be held on July 27 and
enough to provide timely notice. March 2, 2015. July 28, 2015, from 8 a.m. to 5 p.m.
Therefore, you should always check the Persons attending FDA’s advisory Location: The public workshop will
Agency’s Web site at http:// committee meetings are advised that the be held at FDA’s White Oak Campus,
www.fda.gov/AdvisoryCommittees/ Agency is not responsible for providing 10903 New Hampshire Ave., Bldg. 31
default.htm and scroll down to the access to electrical outlets. Conference Center, the Great Room (Rm.
appropriate advisory committee meeting FDA welcomes the attendance of the 1503A), Silver Spring, MD 20993.
link, or call the advisory committee public at its advisory committee Entrance for the public meeting
information line to learn about possible meetings and will make every effort to participants (non-FDA employees) is
modifications before coming to the accommodate persons with physical through Building 1 where routine
meeting. disabilities or special needs. If you security check procedures will be
Agenda: The Pediatric Ethics require special accommodations due to performed. For parking and security
Subcommittee of the Pediatric Advisory a disability, please contact Walter information, please refer to http://
Committee will meet to discuss the Ellenberg at least 7 days in advance of www.fda.gov/AboutFDA/
general topic of how procedural the meeting. WorkingatFDA/BuildingsandFacilities/
sedation for nontherapeutic (research) FDA is committed to the orderly WhiteOakCampusInformation/
interventions or procedures in the conduct of its advisory committee ucm241740.htm.
pediatric population should be meetings. Please visit our Web site at Contact Person: Mark Trumbore,
considered under the Additional http://www.fda.gov/ Center for Devices and Radiological
Safeguards for Children in Clinical AdvisoryCommittees/ Health, Food and Drug Administration,
Investigations at 21 CFR 50 subpart D. AboutAdvisoryCommittees/ 10903 New Hampshire Ave., Bldg. 66,
A brief summary of the subcommittee’s ucm111462.htm for procedures on Rm. 5402, Silver Spring, MD 20993,
discussion will then be presented to the public conduct during advisory 301–796–5436, Mark.Trumbore@
FDA Pediatric Advisory Committee on committee meetings. fda.hhs.gov.
Tuesday, March 24, 2015. Notice of this meeting is given under
FDA intends to make background Registration: Registration is free and
the Federal Advisory Committee Act (5 available on a first-come, first-served
material available to the public no later U.S.C. app. 2).
than 2 business days before the meeting. basis. Persons interested in attending
If FDA is unable to post the background Dated: February 20, 2015. this public workshop must register
material on its Web site prior to the Leslie Kux, online by July 17, 2015, at 4 p.m. Early
meeting, the background material will Associate Commissioner for Policy. registration is recommended because
be made publicly available at the facilities are limited and, therefore, FDA
[FR Doc. 2015–03900 Filed 2–24–15; 8:45 am]
location of the advisory committee may limit the number of participants
BILLING CODE 4164–01–P
meeting, and the background material from each organization. If time and
will be posted on FDA’s Web site after space permits, onsite registration on the
the meeting. Background material is DEPARTMENT OF HEALTH AND day of the meeting/public workshop
available at http://www.fda.gov/ HUMAN SERVICES will be provided beginning at 7 a.m.
AdvisoryCommittees/Calendar/ If you need special accommodations
default.htm. Scroll down to the Food and Drug Administration due to a disability, please contact Susan
appropriate advisory committee meeting Monahan, Center for Devices and
[Docket No. FDA–2015–N–0303] Radiological Health, Food and Drug
link.
Procedure: Interested persons may Administration, 10903 New Hampshire
Robotically-Assisted Surgical Devices:
present data, information, or views, Ave., Bldg. 66, Rm. 4321, Silver Spring,
Challenges and Opportunities; Public
orally or in writing, on issues pending MD 20993–0002, 301–796–5661, email:
Workshop; Request for Comments
before the committee. Written susan.monahan@fda.hhs.gov no later
submissions may be made to the contact AGENCY: Food and Drug Administration, than July 14, 2015.
person on or before March 9, 2014. Oral HHS. To register for the public workshop,
presentations from the public will be ACTION: Notice of public workshop; please visit FDA’s Medical Devices
scheduled between 11:30 a.m. and 12:30 request for comments. News & Events—Workshops &
p.m. on March 23, 2015. Those Conferences calendar at http://
individuals interested in making formal The Food and Drug Administration www.fda.gov/MedicalDevices/
oral presentations should notify the (FDA) is announcing the public NewsEvents/WorkshopsConferences/
contact person and submit a brief workshop entitled ‘‘Robotically-Assisted default.htm. (Select this meeting/public
statement of the general nature of the Surgical (RAS) Devices: Challenges and workshop from the posted events list.)
evidence or arguments they wish to Opportunities.’’ FDA is holding this Please provide complete contact
present, the names and addresses of public workshop to obtain information information for each attendee, including
asabaliauskas on DSK5VPTVN1PROD with NOTICES
proposed participants, and an on the current challenges and name, title, affiliation, address, email,
indication of the approximate time opportunities related to robotically- and telephone number. Those without
requested to make their presentation on assisted surgical medical devices, which Internet access should contact Mark
or before February 26, 2015. Time are classified as Class II medical Trumbore to register (see Contact
allotted for each presentation may be devices. The purpose of this workshop Person). Registrants will receive
limited. If the number of registrants is to obtain public feedback on confirmation after they have been
requesting to speak is greater than can scientific, clinical, and regulatory accepted. You will be notified if you are
be reasonably accommodated during the considerations associated with RAS on a waiting list.
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Document Created: 2015-12-18 13:09:39
Document Modified: 2015-12-18 13:09:39
| 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. | |
| FR Citation | 80 FR 10123 |
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