80 FR 23797 - Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 82 (April 29, 2015)

Page Range		23797-23798
FR Document		2015-10026

Federal Register, Volume 80 Issue 82 (Wednesday, April 29, 2015)

[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23797-23798]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Transmissible Spongiform Encephalopathies Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Transmissible Spongiform Encephalopathies 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 1, 2015, from 8 
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm.1503), Silver Spring, MD 20993-
0002. For those unable to attend in person, the meeting will also be 
available via Webcast. The Webcast will be available at the following 
link: https://collaboration.fda.gov/cbertseac/. When accessing the 
Webcast please enter as a guest. 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: Bryan Emery or Rosanna Harvey, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, 240-
402-8054 or 240-402-8072; 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 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: On June 1, 2015, the Transmissible Spongiform 
Encephalopathies Advisory Committee will meet in open session to hear 
update presentations on the following topics: (1) The variant 
Creutzfeldt-Jakob Disease (vCJD) situation worldwide and an update on 
the United Kingdom's Transfusion Medicine Epidemiological Review; (2) 
vCJD in the United States; and, (3) the bovine spongiform 
encephalopathy (BSE) situation worldwide and the United States 
Department of Agriculture's regulatory approaches to reduce the risk of 
food-borne exposure of BSE. Following the update presentations, in open 
session, the committee will hear presentations from FDA on current 
measures to reduce risk of vCJD from transfusion in the U.S., and a 
mathematical model of the risk reduction achievable under the current 
and alternative geographically based donor deferral policies when 
implemented in conjunction with the use of leukocyte reduction of blood 
components. The committee will then discuss FDA's geographically based 
donor deferral policies and other strategies, including leukocyte 
reduction of blood components, to reduce the risk of transfusion-
transmitted vCJD. FDA will seek advice from the committee in developing 
future recommendations to reduce this risk.
    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 May 
25, 2015. Oral presentations from the public will be

[[Page 23798]]

scheduled between approximately 2:30 p.m. and 3:30 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 
15, 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 May 18, 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 Bryan Emery 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 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10026 Filed 4-28-15; 8:45 am]
 BILLING CODE 4164-01-P

23798 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices

scheduled between approximately 2:30 SUMMARY: The Food and Drug Ave., Bldg. 66, Rm. 5454, Silver Spring,
p.m. and 3:30 p.m. Those individuals Administration (FDA) is announcing the MD 20993–0002, 301–796–5676.
interested in making formal oral progress of the Center for Devices and
SUPPLEMENTARY INFORMATION:
presentations should notify the contact Radiological Health (CDRH) on its
person and submit a brief statement of 2014–2015 Strategic Priority ‘‘Strike the I. Background
the general nature of the evidence or Right Balance Between Premarket and
arguments they wish to present, the Postmarket Data Collection.’’ To achieve One of three Strategic Priorities for
names and addresses of proposed this priority, CDRH established a goal to 2014–2015 in CDRH is to ‘‘Strike the
participants, and an indication of the assure the appropriate balance between Right Balance Between Premarket and
approximate time requested to make premarket and postmarket data Postmarket Data Collection’’ (Ref. 1).1
their presentation on or before May 15, collection to facilitate and expedite the CDRH’s vision is for patients in the
2015. Time allotted for each development and review of medical United States to have first in the world
presentation may be limited. If the devices, in particular high-risk devices access to high-quality, safe, and
number of registrants requesting to of public health importance, and effective medical devices of public
speak is greater than can be reasonably established a target date of December 31, health importance. A key determinant of
accommodated during the scheduled 2014, by which to review 50 percent of early U.S. patient access to high-quality,
open public hearing session, FDA may product codes subject to a premarket safe, and effective devices is the extent
conduct a lottery to determine the approval application (PMA) that are of premarket data that device developers
speakers for the scheduled open public legally marketed to determine whether provide to FDA. Once a device
hearing session. The contact person will or not, based on our current developer decides to seek U.S.
notify interested persons regarding their understanding of the technology, to rely marketing approval or clearance, the
request to speak by May 18, 2015. on postmarket controls to reduce extent of data that is collected
Persons attending FDA’s advisory premarket data collection, to shift some premarket has an impact upon the
committee meetings are advised that the premarket data collection to the length of time needed to complete a
Agency is not responsible for providing postmarket setting, or to pursue down- premarket submission—the more data to
access to electrical outlets. classification. CDRH has taken such be collected premarket, the longer it
FDA welcomes the attendance of the actions periodically in the past may take to acquire the data and make
public at its advisory committee consistent with the medical device the submission. Consequently, such
meetings and will make every effort to statutory framework but typically has data collection issues affect when U.S.
accommodate persons with physical done so on an ad hoc basis. CDRH also patients have access to a medical
disabilities or special needs. If you will require more data or up-classify a device. On the other hand, it is also
require special accommodations due to device, if warranted, based on the important that there is sufficient data to
a disability, please contact Bryan Emery current state of the science; however, demonstrate a reasonable assurance of
at least 7 days in advance of the up-classification is not warranted for the safety and effectiveness before a device
meeting. devices subject to this retrospective subject to a premarket approval
FDA is committed to the orderly review because they are already in the application (PMA) is approved for
conduct of its advisory committee highest risk classification. In this marketing in the United States. For this
meetings. Please visit our Web site at document, CDRH is providing its reason, it is important that CDRH strike
http://www.fda.gov/Advisory current thinking on reviewed product the right balance between premarket
Committees/AboutAdvisoryCommittees/ types to solicit comments on the and postmarket data collection. If CDRH
ucm111462.htm for procedures on product codes that have been identified can shift—when appropriate—some
public conduct during advisory as candidates for reclassification, for premarket data collection to the
committee meetings. reliance on postmarket controls to postmarket setting, CDRH could
Notice of this meeting is given under reduce premarket data collection, or a improve patient access to high-quality,
the Federal Advisory Committee Act (5 shift in premarket data collection to the safe, and effective medical devices of
U.S.C. app. 2). postmarket setting. public health importance. However,
Dated: April 24, 2015. patient safety could be undermined if
DATES: Submit either electronic or
Peter Lurie, CDRH shifted some data collection from
written comments by June 29, 2015. See
Associate Commissioner for Public Health the premarket to the postmarket setting
section IV for more information on how
Strategy and Analysis. without adequate assurances that
to submit comments to this document
[FR Doc. 2015–10026 Filed 4–28–15; 8:45 am] necessary and timely data collection
and properly identify the device(s) the
will occur. For this reason, CDRH
BILLING CODE 4164–01–P comment concerns.
strives to balance the premarket data
ADDRESSES: Submit electronic and postmarket collection, in
DEPARTMENT OF HEALTH AND comments to http:// accordance with section 513(a)(3)(C) (21
HUMAN SERVICES www.regulations.gov. Submit written U.S.C. 360c(a)(3)(C)) of the Federal
comments to the Division of Dockets Food, Drug, and Cosmetic Act (the
Food and Drug Administration Management (HFA–305), Food and Drug FD&C Act), which directs CDRH to
Administration, 5630 Fishers Lane, Rm. consider whether the extent of data that
[Docket No. FDA–2014–D–0090]
1061, Rockville, MD 20852. Identify otherwise would be required for
Retrospective Review of Premarket comments with the docket number approval of a PMA with respect to
mstockstill on DSK4VPTVN1PROD with NOTICES

Approval Application Devices; Striking found in brackets in the heading of this effectiveness can be reduced through
the Balance Between Premarket and document and with the product code(s) reliance on postmarket controls.
Postmarket Data Collection for the device(s) the comment concerns.
1 CDRH’s 2014–2015 Strategic Priorities include
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
‘‘Strengthen the Clinical Trial Enterprise’’ and
HHS. Nancy Braier, Center for Devices and ‘‘Provide Excellent Customer Service,’’ in addition
Radiological Health, Food and Drug to ‘‘Strike the Right Balance Between Premarket and
ACTION: Notice; request for comments.
Administration, 10903 New Hampshire Postmarket Data Collection’’ (Ref. 1).

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Document Created: 2015-12-16 08:26:06
Document Modified: 2015-12-16 08:26:06

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 23797

80 FR 23797 - Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 82 (April 29, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration