Science Board to the Food and Drug Administration; Notice of Meeting, 78449-78450 [2014-30516]
Download as PDF
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jennifer Dickey, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5262, Silver Spring,
MD 20993–0002, 301–796–5028.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background
This draft guidance provides
recommendations to assist industry in
designing studies to establish the
analytical and clinical performance
characteristics of radiation biodosimetry
medical countermeasure devices.
Radiation biodosimetry
countermeasure devices are devices
used for the purpose of reconstructing
the ionizing radiation dose received by
individuals or populations using
physiological, chemical or biological
markers of exposure found in humans.
Radiation biodosimetry technologies
may be used at various stages during
triage and treatment after the exposure
of a population to ionizing radiation as
a result of intentional harm or as an
unintended consequence of a disaster.
Devices may be designed to give
quantitative outputs or qualitative
information around a clinical decision
making cut-point. Likewise, devices
may be designed for use in field triage
settings, at patient bedsides, or in
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) (Pub. L.
100–578) certified clinical laboratories.
FDA considered both high-throughput
and single-use devices in developing
this draft guidance document.
This draft guidance only applies to
validation of biodosimetry devices
intended to be used to assess exposure
in non-therapeutic or accidental
scenarios (e.g. a deliberate attack, such
as use of an improvised nuclear device,
or a natural disaster). This draft
guidance neither applies to devices that
assess deliberate radiation dosing that
may occur in the course of medical
treatment nor to devices that measure
effects from long term exposure. In
VerDate Sep<11>2014
21:42 Dec 29, 2014
Jkt 235001
addition, dosimeters, which are devices
that detect radiation exposure on a
physical substrate rather than through a
biological response and are worn by
people who might be exposed to
radiation during the course of their
normal work (such as film badges), are
not addressed in this guidance
document. Finally, biological assays
that might be used to detect the
presence of ingested radioisotopes in
sputum or urine are not considered in
this draft guidance document.
This draft guidance document does
not provide specific study designs; it
describes design principles for studies
that may be used to establish the safety
and effectiveness of radiation
biodosimetry devices.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on evaluating the performance
characteristics of radiation biodosimetry
devices. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Radiation Biodosimetry Devices’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1400045 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 58 have
been approved under OMB control
number 0910–0119; the collections of
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
78449
information in 21 CFR parts 801 and
809 have been approved under OMB
control number 0910–0485; the
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 814 have been approved under
OMB control number 0910–0231; the
collections of information in the
guidance document entitled ‘‘Informed
Consent For In Vitro Diagnostic Device
Studies Using Leftover Human
Specimens That Are Not Individually
Identifiable’’ have been approved under
OMB control number 0910–0582; and
the collections of information in the
guidance document entitled ‘‘Guidance
for Industry and FDA Staff:
Administrative Procedures for CLIA
Categorization’’ have been approved
under OMB control number 0910–0607.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30453 Filed 12–29–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Science Board to the Food and Drug
Administration; 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: Science Board to
the Food and Drug Administration
(Science Board).
E:\FR\FM\30DEN1.SGM
30DEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
78450
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
General Function of the Committee:
The Science Board provides advice
primarily to the Commissioner of Food
and Drugs and other appropriate
officials on specific complex scientific
and technical issues important to the
FDA and its mission, including
emerging issues within the scientific
community. Additionally, the Science
Board provides advice to the Agency on
keeping pace with technical and
scientific developments including in
regulatory science, input into the
Agency’s research agenda, on upgrading
its scientific and research facilities, and
training opportunities. It will also
provide, where requested, expert review
of Agency-sponsored intramural and
extramural scientific research programs.
Date and Time: The meeting will be
held on March 4, 2015, from 8:30 a.m.
to 4 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503 B and C) Silver Spring, MD
20993–0002. For those unable to attend
in person, the meeting will also be
Webcast. The link for the Webcast is
available at https://
collaboration.fda.gov/sb315/.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Martha Monser,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 3309,
Silver Spring, MD 20993–0002, 301–
796–4627, martha.monser@fda.hhs.gov,
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 https://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 Science Board will be
provided with a progress report or a
final draft report the Commissioner’s
Fellowship Program Evaluation
subcommittee and will hear a progress
VerDate Sep<11>2014
21:42 Dec 29, 2014
Jkt 235001
report from Science Moving Forward
subcommittee. The Science Board will
be asked to provide feedback on FDA’s
public access policy. FDA will seek the
Science Board’s input regarding
approaches to regulatory science
training coordination. The Science
Board will be provided with a follow up
on FDA’s activities regarding the reintroduction of bovine heparin and will
hear an overview of science-related
activities from one of the centers. A
recipient of one of the Fiscal Year 2014
Scientific Achievement Awards
(selected by the Science Board) will
provide an overview of the activities for
which the award was given.
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 https://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 February 25, 2015.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 1:30 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 February
17, 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 February 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Ms. Martha
Monser 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
https://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: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30516 Filed 12–29–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1936]
Electronic Cigarettes and the Public
Health; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Tobacco Products, is
announcing a public workshop to obtain
information on electronic cigarettes and
the public health. This will be the
second in a series of three workshops.
The workshop will include
presentations and panel discussions
about the current state of the science
and will focus on individual health
impacts. FDA intends to follow this
workshop with an electronic cigarette
workshop on population health effects.
DATES AND TIMES: The public workshop
will be held on March 9, 2015, from 8
a.m. to 5 p.m. and on March 10, 2015,
from 8 a.m. to 5 p.m. Individuals who
wish to attend the public workshop
must register by February 20, 2015.
LOCATION: The public workshop will be
held at the Marriott Inn and Conference
Center, University of Maryland
University College, Potomac Ballroom,
3501 University Blvd. East, Hyattsville,
MD 20783. The conference center’s
telephone number is 301–985–7300.
CONTACT PERSON: Caryn Cohen, Office of
Science, Center for Tobacco Products,
Food and Drug Administration,
Document Control Center, Bldg. 71, Rm.
E:\FR\FM\30DEN1.SGM
30DEN1
Agencies
[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78449-78450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Science Board to the Food and Drug Administration; 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: Science Board to the Food and Drug
Administration (Science Board).
[[Page 78450]]
General Function of the Committee: The Science Board provides
advice primarily to the Commissioner of Food and Drugs and other
appropriate officials on specific complex scientific and technical
issues important to the FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice to the Agency on keeping pace with technical and
scientific developments including in regulatory science, input into the
Agency's research agenda, on upgrading its scientific and research
facilities, and training opportunities. It will also provide, where
requested, expert review of Agency-sponsored intramural and extramural
scientific research programs.
Date and Time: The meeting will be held on March 4, 2015, from 8:30
a.m. to 4 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503 B and C) Silver Spring,
MD 20993-0002. For those unable to attend in person, the meeting will
also be Webcast. The link for the Webcast is available at https://collaboration.fda.gov/sb315/. Information regarding special
accommodations due to a disability, visitor parking, and transportation
may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm;
under the heading ``Resources for You,'' click on ``Public Meetings at
the FDA White Oak Campus.'' Please note that visitors to the White Oak
Campus must enter through Building 1.
Contact Person: Martha Monser, Office of the Commissioner, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309,
Silver Spring, MD 20993-0002, 301-796-4627, martha.monser@fda.hhs.gov,
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 https://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 Science Board will be provided with a progress report
or a final draft report the Commissioner's Fellowship Program
Evaluation subcommittee and will hear a progress report from Science
Moving Forward subcommittee. The Science Board will be asked to provide
feedback on FDA's public access policy. FDA will seek the Science
Board's input regarding approaches to regulatory science training
coordination. The Science Board will be provided with a follow up on
FDA's activities regarding the re-introduction of bovine heparin and
will hear an overview of science-related activities from one of the
centers. A recipient of one of the Fiscal Year 2014 Scientific
Achievement Awards (selected by the Science Board) will provide an
overview of the activities for which the award was given.
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 https://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
February 25, 2015. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 1:30 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 February 17, 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 February 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 Ms. Martha Monser 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 https://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: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30516 Filed 12-29-14; 8:45 am]
BILLING CODE 4164-01-P