Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease; Extension of Comment Period, 71045-71046 [2011-29483]
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Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Notices
in the Federal Register of Thursday,
October 20, 2011, the following
correction is made:
1. On page 65199, in the first column,
in the DATES section, the date ‘‘January
18, 2011’’ is corrected to read ‘‘January
18, 2012.’’
Dated: November 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29485 Filed 11–15–11; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: Neurological
Devices Panel of the Medical Devices
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 February 10, 2012, from 8 a.m.
to 6 p.m.
Location: Hilton Washington, DC
North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel telephone number is
(301) 977–8900.
Contact Person: Avena Russell, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1535, Silver Spring, MD 20993–0002,
Avena.Russell@fda.hhs.gov, (301) 796–
3805, or FDA Advisory Committee
Information Line, 1–(800) 741–8138,
(301) 443–0572 in the Washington, DC
area), and follow the prompts to the
desired center or product area. Please
call the Information Line for up-to-date
information on this meeting. 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 and call the
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appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On February 10, 2012, the
committee will discuss and make
recommendations regarding the possible
reclassification of cranial electrotherapy
stimulator (CES) devices. On August 8,
2011 (76 FR 48062), FDA issued a
proposed rule which, if made final,
would make CES devices Class III
requiring premarket approval. In
response to the proposed rule, FDA
received petitions under section
515(b)(2)(B) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
360e(b)(2)(B)) requesting a change in
classification. The reclassification
petitions are available for public review
and comment at https://
www.regulations.gov under docket
number FDA–2011–N–0504. The
committee discussion will include the
existing data to support CES safety and
effectiveness and whether the data are
sufficient to develop special controls to
support regulation of these devices
under Class II.
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 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 6, 2012.
Oral presentations from the public will
be scheduled between approximately
10 a.m. and 11 a.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 January
27, 2012. 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
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71045
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by January 30, 2012.
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 James Clark
at James.Clark@fda.hhs.gov or (301)
796–5293, 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: November 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29528 Filed 11–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0599]
Center for Biologics Evaluation and
Research Report of Scientific and
Medical Literature and Information on
Non-Standardized Allergenic Extracts
in the Diagnosis and Treatment of
Allergic Disease; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA) is extending to
April 25, 2012, the comment period for
the notice on its report of scientific and
medical literature and information
concerning the use of non-standardized
allergenic extracts in the diagnosis and
treatment of allergic disease that
appeared in the Federal Register of
September 26, 2011 (76 FR 59407). In
the notice, FDA requested comments
from public and private stakeholders on
SUMMARY:
E:\FR\FM\16NON1.SGM
16NON1
71046
Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
the report it provided in a data file
entitled ‘‘Center for Biologics Evaluation
and Research Report of Scientific and
Medical Literature and Information on
Non-Standardized Allergenic Extracts in
the Diagnosis and Treatment of Allergic
Disease.’’ The Agency is taking this
action in response to input it received
from the Allergenic Products Advisory
Committee (APAC) at a meeting held on
October 25, 2011, to allow interested
persons additional time to submit
comments.
DATES: Submit either electronic or
written comments on the report by April
25, 2012.
ADDRESSES: Submit written requests for
single copies of the report to the Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The data file may also be obtained by
mail by calling CBER at 1–(800) 835–
4709 or (301) 827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the data file
document.
Submit electronic comments on the
report to https://www.regulations.gov.
Submit written comments on the report
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
E. Levine, Jr., Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, (301) 827–6210.
SUPPLEMENTARY INFORMATION:
the notice on FDA’s report of scientific
and medical literature and information
concerning the use of non-standardized
allergenic extracts in the diagnosis and
treatment of allergic disease. Materials
related to the report were discussed at
this meeting and are available at: https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/
AllergenicProductsAdvisoryCommittee/
ucm247212.htm. When it is completed,
a transcript of the meeting will also be
available at this Web page.
FDA has considered the comments
from the APAC meeting and is
extending the comment period for the
notice until April 25, 2012. The Agency
believes that an extension until April
25, 2012, allows adequate time for
interested persons to submit comments
without significantly delaying the
evaluation of these important issues.
FDA welcomes comments regarding
its report of scientific and medical
literature and information concerning
the use of non-standardized allergenic
extracts in the diagnosis and treatment
of allergic disease. In particular, FDA is
interested in additional data regarding
the use of these extracts that had been
previously published in the medical or
scientific literature. Unpublished data
should include the following
information, if available: Date(s) of
collection; extract(s) studied and
method of preparation; dose and route
of administration; patient demography;
and additional clinical information
(including confirmatory testing, such as
challenges or serum specific IgE
determinations).
I. Background
In the Federal Register of September
26, 2011 (76 FR 59407), FDA published
a notice with a 60-day comment period
to request comments on its report of
scientific and medical literature and
information concerning the use of nonstandardized allergenic extracts in the
diagnosis and treatment of allergic
disease. Comments on the report will
allow FDA to fully evaluate the
information contained in the report.
The Agency received comments in the
APAC meeting held on October 25,
2011, that FDA should consider
extending the comment period for the
notice for several months. Members of
the APAC expressed concern that the
current 60-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
VerDate Mar<15>2010
17:45 Nov 15, 2011
Jkt 226001
II. Request for Comments
Dated: November 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29483 Filed 11–15–11; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Interagency Breast Cancer and
Environmental Research Coordinating
Committee.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of the Committee: Interagency Breast
Cancer and Environmental Research
Coordinating Committee (IBCERC).
Date: December 14, 2011.
Time: 11 a.m. to 2 p.m.
Agenda: The purpose of the meeting is to
review the consensus study (https://
www.iom.edu/Activities/Environment/Breast
CancerEnvironment.aspx) focused on breast
cancer and the environment that is scheduled
to be released by Institute of Medicine (IOM)
December 7, 2011. In advance of the meeting,
the detailed meeting agenda will be available
on the web at https://www.niehs.nih.gov/
about/orgstructure/boards/ibcercc/.
Place: NIEHS/National Institutes of Health,
Building 4401, East Campus, 79 T.W.
Alexander Drive, Research Triangle Park, NC
27709, (This meeting will be conducted
remotely. To attend the meeting, please RSVP
via email to ibcercc@niehs.nih.gov at least 10
days in advance and instructions for joining
the meeting will be provided.).
Contact Person: Gwen Collman, Ph.D.,
Director, Division of Extramural Research
and Training, Nat. Inst. of Environmental
Health Sciences, National Institutes of
Health, 615 Davis Dr., KEY615/3112,
Research Triangle Park, NC 27709, (919) 541–
4980, collman@niehs.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
E:\FR\FM\16NON1.SGM
16NON1
]]>Agencies
[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71045-71046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29483]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0599]
Center for Biologics Evaluation and Research Report of Scientific
and Medical Literature and Information on Non-Standardized Allergenic
Extracts in the Diagnosis and Treatment of Allergic Disease; Extension
of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to April
25, 2012, the comment period for the notice on its report of scientific
and medical literature and information concerning the use of non-
standardized allergenic extracts in the diagnosis and treatment of
allergic disease that appeared in the Federal Register of September 26,
2011 (76 FR 59407). In the notice, FDA requested comments from public
and private stakeholders on
[[Page 71046]]
the report it provided in a data file entitled ``Center for Biologics
Evaluation and Research Report of Scientific and Medical Literature and
Information on Non-Standardized Allergenic Extracts in the Diagnosis
and Treatment of Allergic Disease.'' The Agency is taking this action
in response to input it received from the Allergenic Products Advisory
Committee (APAC) at a meeting held on October 25, 2011, to allow
interested persons additional time to submit comments.
DATES: Submit either electronic or written comments on the report by
April 25, 2012.
ADDRESSES: Submit written requests for single copies of the report to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The data file may also be obtained by mail by
calling CBER at 1-(800) 835-4709 or (301) 827-1800. See the
SUPPLEMENTARY INFORMATION section for electronic access to the data
file document.
Submit electronic comments on the report to https://www.regulations.gov. Submit written comments on the report to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, (301) 827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 26, 2011 (76 FR 59407), FDA
published a notice with a 60-day comment period to request comments on
its report of scientific and medical literature and information
concerning the use of non-standardized allergenic extracts in the
diagnosis and treatment of allergic disease. Comments on the report
will allow FDA to fully evaluate the information contained in the
report.
The Agency received comments in the APAC meeting held on October
25, 2011, that FDA should consider extending the comment period for the
notice for several months. Members of the APAC expressed concern that
the current 60-day comment period does not allow sufficient time to
develop a meaningful or thoughtful response to the notice on FDA's
report of scientific and medical literature and information concerning
the use of non-standardized allergenic extracts in the diagnosis and
treatment of allergic disease. Materials related to the report were
discussed at this meeting and are available at: https:// www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm247212.htm. When it is completed, a transcript of the meeting will
also be available at this Web page.
FDA has considered the comments from the APAC meeting and is
extending the comment period for the notice until April 25, 2012. The
Agency believes that an extension until April 25, 2012, allows adequate
time for interested persons to submit comments without significantly
delaying the evaluation of these important issues.
FDA welcomes comments regarding its report of scientific and
medical literature and information concerning the use of non-
standardized allergenic extracts in the diagnosis and treatment of
allergic disease. In particular, FDA is interested in additional data
regarding the use of these extracts that had been previously published
in the medical or scientific literature. Unpublished data should
include the following information, if available: Date(s) of collection;
extract(s) studied and method of preparation; dose and route of
administration; patient demography; and additional clinical information
(including confirmatory testing, such as challenges or serum specific
IgE determinations).
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
Dated: November 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29483 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P
