Blood Products Advisory Committee; Notice of Meeting, 56899-56900 [2013-22423]
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Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / Notices
DC 20503, Fax Number: (202) 395–
6974.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0607. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Dated: September 12, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–22517 Filed 9–13–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2013–N–0514]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requests for
Clinical Laboratory Improvement
Amendments Categorization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. Requests for
Clinical Laboratory Improvement
Amendments of 1988 (CLIA)
Categorization—42 CFR 493.17 (OMB
Control Number 0910–0607)—
Extension.
A guidance document entitled
‘‘Guidance for Administrative
Procedures for CLIA Categorization’’
was released on May 7, 2008. The
document describes procedures FDA
uses to assign the complexity category
to a device. Typically, FDA assigns
complexity categorizations to devices at
the time of clearance or approval of the
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 16,
2013.
SUMMARY:
56899
device. In this way, no additional
burden is incurred by the manufacturer
because the labeling (including
operating instructions) is included in
the premarket notification (510(k)) or
premarket approval application (PMA).
In some cases, however, a manufacturer
may request CLIA categorization even if
FDA is not simultaneously reviewing a
510(k) or PMA. One example is when a
manufacturer requests that FDA assign
CLIA categorization to a previously
cleared device that has changed names
since the original CLIA categorization.
Another example is when a device is
exempt from premarket review. In such
cases, the guidance recommends that
manufacturers provide FDA with a copy
of the package insert for the device and
a cover letter indicating why the
manufacturer is requesting a
categorization (e.g. name change,
exempt from 510(k) review). The
guidance recommends that in the
correspondence to FDA the
manufacturer should identify the
product code and classification as well
as reference to the original 510(k) when
this is available. In the Federal Register
of May 22, 2013 (78 FR 30312), FDA
published a 60-day notice requesting
public comment on the proposed
collection of information. No comments
were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN ACTIVITY 1
Activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Operating and
maintenance
costs
Request for CLIA categorization ..............
60
15
900
1
900
$46,800
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
are no capital costs associated with this collection of information.
The number of respondents is
approximately 60. On average, each
respondent will request categorizations
(independent of a 510(k) or PMA) 15
times per year. The cost, not including
personnel, is estimated at $52 per hour
(52 × 900), totaling $46,800. This
includes the cost of copying and mailing
copies of package inserts and a cover
letter, which includes a statement of the
reason for the request and reference to
the original 510(k) numbers, including
regulation numbers and product codes.
The burden hours are based on FDA
familiarity with the types of
documentation typically included in a
sponsor’s categorization requests, and
costs for basic office supplies (e.g.
paper).
VerDate Mar<15>2010
17:46 Sep 13, 2013
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Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22443 Filed 9–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00044
Fmt 4703
Sfmt 4703
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Blood Products
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 November 1, 2013, from 8 a.m. to 4:30
p.m.
Location: FDA Fishers Lane Building, 5630
Fishers Lane, rm. 1066, Rockville, MD 20857.
For those unable to attend in person, the
meeting will also be Web cast. The Web cast
will be available at the following link: https://
fda.yorkcast.com/webcast/Viewer/?peid=
18390c01dfff405681afa644b1837e5a1d.
Contact Person: Bryan Emery or Pearline
Muckelvene, Center for Biologics Evaluation
E:\FR\FM\16SEN1.SGM
16SEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
56900
Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / Notices
and Research (HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–1277 or 301–
827–1281, 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/Advisory
Committees/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 the morning of November 1,
2013, the committee will meet in open
session to discuss MP Biomedicals’ biologic
license application for the MP Diagnostics
HTLV Blot 2.4, a Western Blot intended for
use as a confirmatory test for blood donors.
In the afternoon, the committee will hear
update presentations on the following topics:
(1) The April 2013 FDA public workshop on
multiplex detection of transfusion
transmissible agents and blood cell antigens
in blood donations and (2) FDA safety
communications on new boxed warnings for
immune globulin products and hydroxyethyl
starch solutions. Following the update
presentations, the committee will meet in
open session to hear presentations on the
research programs of the Laboratory of
Biochemistry and Vascular Biology, Division
of Hematology, Office of Blood Research and
Review, Center for Biologics Evaluation and
Research, FDA.
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: On November 1, 2013, from 8
a.m. to approximately 4 p.m., the meeting is
open to the public. 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
October 24, 2013. Oral presentations from the
public will be scheduled between
approximately 11 a.m. and 11:30 a.m.
Afternoon presentations will be scheduled
between approximately 3:30 p.m. and 4 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 October 16, 2013. Time allotted for
each presentation may be limited. If the
number of registrants requesting to speak is
VerDate Mar<15>2010
18:30 Sep 13, 2013
Jkt 229001
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 October
17, 2013.
Closed Committee Deliberations: On
November 1, 2013, from approximately 4
p.m. to 4:30 p.m., the meeting will be closed
to permit discussion where disclosure would
constitute a clearly unwarranted invasion of
personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the site visit report of
the intramural research programs and make
recommendations regarding personnel
staffing decisions.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets. Seating for this
meeting may be limited, so the public is
encouraged to watch the free Web cast if you
are unable to attend. The Web cast will be
available at 8 a.m. on November 1, 2013, at
the link provided.
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 https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/ucm111462.htm
for procedures on public conduct during
advisory committee meeting.
Notice of this meeting is given under the
Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: September 9, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–22423 Filed 9–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Antiviral Drugs 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: Antiviral Drugs
Advisory Committee.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 October 25, 2013, from 8 a.m. to 5 p.m.
Location: Sheraton Silver Spring Hotel,
Cypress Ballroom, 8777 Georgia Ave., Silver
Spring, MD. The hotel phone number is 301–
589–0800.
Contact Person: Karen Abraham-Burrell,
Food and Drug Administration, Center for
Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, email: AVAC@
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 committee will discuss new
drug application (NDA) 204671, sofosbuvir
(an NS5B polymerase inhibitor),
manufactured by Gilead Sciences, Inc., with
a proposed indication for the treatment of
chronic hepatitis C infection, in combination
with other agents in adult patients with
genotypes 1 to 6 and/or adult patients
awaiting liver transplantation.
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
October 9, 2013. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 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
October 1, 2013. 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
E:\FR\FM\16SEN1.SGM
16SEN1
]]>Agencies
[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Pages 56899-56900]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22423]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Blood Products 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Blood Products 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 November 1, 2013,
from 8 a.m. to 4:30 p.m.
Location: FDA Fishers Lane Building, 5630 Fishers Lane, rm.
1066, Rockville, MD 20857. For those unable to attend in person, the
meeting will also be Web cast. The Web cast will be available at the
following link: https://fda.yorkcast.com/webcast/Viewer/?peid=18390c01dfff405681afa644b1837e5a1d.
Contact Person: Bryan Emery or Pearline Muckelvene, Center for
Biologics Evaluation
[[Page 56900]]
and Research (HFM-71), Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301-827-1277 or 301-827-1281, 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: On the morning of November 1, 2013, the committee will
meet in open session to discuss MP Biomedicals' biologic license
application for the MP Diagnostics HTLV Blot 2.4, a Western Blot
intended for use as a confirmatory test for blood donors. In the
afternoon, the committee will hear update presentations on the
following topics: (1) The April 2013 FDA public workshop on
multiplex detection of transfusion transmissible agents and blood
cell antigens in blood donations and (2) FDA safety communications
on new boxed warnings for immune globulin products and hydroxyethyl
starch solutions. Following the update presentations, the committee
will meet in open session to hear presentations on the research
programs of the Laboratory of Biochemistry and Vascular Biology,
Division of Hematology, Office of Blood Research and Review, Center
for Biologics Evaluation and Research, FDA.
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: On November 1, 2013, from 8 a.m. to approximately 4
p.m., the meeting is open to the public. 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 October 24, 2013. Oral presentations
from the public will be scheduled between approximately 11 a.m. and
11:30 a.m. Afternoon presentations will be scheduled between
approximately 3:30 p.m. and 4 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 October 16, 2013.
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 October 17,
2013.
Closed Committee Deliberations: On November 1, 2013, from
approximately 4 p.m. to 4:30 p.m., the meeting will be closed to
permit discussion where disclosure would constitute a clearly
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the site visit report of the intramural
research programs and make recommendations regarding personnel
staffing decisions.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to
electrical outlets. Seating for this meeting may be limited, so the
public is encouraged to watch the free Web cast if you are unable to
attend. The Web cast will be available at 8 a.m. on November 1,
2013, at the link provided.
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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 9, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-22423 Filed 9-13-13; 8:45 am]
BILLING CODE 4160-01-P
