Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability, 22906-22907 [2011-9898]
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22906
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm or https://
www.regulations.gov.
Dated: April 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9938 Filed 4–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–D–0094]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Topical Oxygen Chamber for
Extremities; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled,
‘‘Class II Special Controls Guidance
Document: Topical Oxygen Chamber for
Extremities.’’ This guidance document
was developed as a special control to
support the reclassification of the
topical oxygen chamber for extremities
(TOCE) from class III (premarket
approval) into class II (special controls).
This guidance document describes a
means by which manufacturers of TOCE
may comply with the requirement of
special controls for class II devices.
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
reclassifying these devices from class III
into class II (special controls).
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled, ‘‘Class II Special Controls
Guidance Document: Topical Oxygen
Chamber for Extremities,’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
jdjones on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:21 Apr 22, 2011
Jkt 223001
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 240–276–3151. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Charles N. Durfor, Center for Devices
and Radiological Health (HFZ–410),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3555.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 6,
2006 (71 FR 17390), FDA’s Center for
Devices and Radiological Health (CDRH)
published a proposed rule to reclassify
the TOCE device type from class III
(premarket approval) into class II
(special controls) after reviewing current
technological and scientific
developments. To support the
reclassification, CDRH issued a draft
class II special controls guidance
document entitled ‘‘Class II Special
Controls Guidance Document: Topical
Oxygen Chamber for Extremities’’ (71 FR
17476). Interested persons were invited
to comment on the proposed rule and
guidance by July 5, 2006. FDA received
11 comments on the proposed rule. The
comments received discussed academic
literature, clinical experiences, and
patient outcomes that support the
proposed reclassification’s
determinations of the safety and
effectiveness of the TOCE device. The
comments did not recommend any
changes to the proposed regulation.
FDA is now identifying the guidance
document entitled ‘‘Class II Special
Controls Guidance Document: Topical
Oxygen Chamber for Extremities’’ as the
special control for these devices. This
guidance document provides a means
by which manufacturers of TOCE
devices may comply with the
requirement of special controls for class
II devices. Following the effective date
of the final reclassification rule, any
manufacturer submitting a premarket
notification submission under section
510(k) of the Federal Food, Drug, and
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Cosmetic Act (the FD&C act) (21 U.S.C.
360(k)) for a TOCE device will need to
address the issues covered in the special
controls guidance document. However,
the manufacturer need only show that
its device meets the recommendations
in the guidance document or in some
other way provides equivalent
assurances of safety and effectiveness.
II. Significance of Special Controls
Guidance
FDA believes that adherence to the
recommendations described in this
guidance document, in addition to the
general controls, will provide
reasonable assurance of the safety and
effectiveness of TOCE classified under
§ 878.5650 (21 CFR 878.5650). The final
rule establishing this guidance
document as a special control will be
effective May 25, 2011. Following the
effective date of the final rule, TOCE
classified under § 878.5650 must
comply with the requirement of special
controls; manufacturers must address
the issues requiring special controls as
identified in the guidance, either by
following the recommendations in the
guidance or by some other means that
provides equivalent assurances of safety
and effectiveness.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulation.gov. Always access an
FDA guidance document by using
FDA’s Web site listed previously to find
the most current version of the
guidance.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information were subject
to review by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3520).
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 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; and the collections
of information in 21 CFR parts 50 and
E:\FR\FM\25APN1.SGM
25APN1
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices
56 have been approved under OMB
control number 0910–0130.
V. 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: April 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9898 Filed 4–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
jdjones on DSKHWCL6B1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Auditory
System Study Section.
Date: June 1–2, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy
Chase Pavilion, 4300 Military Road,
NW., Washington, DC 20015.
Contact Person: Lynn E Luethke, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room
5166, MSC 7844, Bethesda, MD 20892,
(301) 806–3323, luethkel@csr.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
VerDate Mar<15>2010
15:21 Apr 22, 2011
Jkt 223001
Sciences; Integrated Review Group.
Molecular and Cellular Endocrinology
Study Section.
Date: June 1, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda,
8120 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: John Bleasdale, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room
6170 MSC 7892, Bethesda, MD 20892,
301–435–4514, bleasdaleje@csr.nih.gov.
Name of Committee: Genes, Genomes,
and Genetics Integrated Review Group;
Molecular Genetics B Study Section.
Date: June 1–2, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Avenue Crowne Plaza Hotel
and Suites, 160 E. Huron Street,
Chicago, IL 60611.
Contact Person: Richard A Currie,
PhD, Scientific Review Officer, Center
for Scientific Review, National Institutes
of Health, 6701 Rockledge Drive, Room
5128, MSC 7840, Bethesda, MD 20892,
(301) 435–1219, currieri@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Cognitive
Neuroscience Study Section.
Date: June 1, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: One Washington Circle Hotel,
One Washington Circle, NW.,
Washington, DC 20037.
Contact Person: Kirk Thompson, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room
5184, MSC 7844, Bethesda, MD 20892,
301–435–1242, kgt@mail.nih.gov.
Name of Committee: Biological
Chemistry and Macromolecular
Biophysics Integrated Review Group;
Macromolecular Structure and Function
E Study Section.
Date: June 1, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Monticello, 1075 Thomas
Jefferson Street, NW., Washington, DC
20007.
Contact Person: Nitsa Rosenzweig,
PhD, Scientific Review Officer, Center
for Scientific Review, National Institutes
of Health, 6701 Rockledge Drive, Room
1102, MSC 7760, Bethesda, MD 20892,
(301) 435–1747,
rosenzweign@csr.nih.gov.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
22907
Name of Committee: Biological
Chemistry and Macromolecular
Biophysics Integrated Review Group;
Synthetic and Biological Chemistry B
Study Section.
Date: June 1–2, 2011.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Dupont Hotel, 1500 New
Hampshire Avenue, NW., Washington,
DC 20036.
Contact Person: Kathryn M Koeller,
PhD, Scientific Review Officer, Center
for Scientific Review, National Institutes
of Health, 6701 Rockledge Drive, Room
4166, MSC 7806, Bethesda, MD 20892,
301–435–2681, koellerk@csr.nih.gov.
Name of Committee: Surgical
Sciences, Biomedical Imaging and
Bioengineering Integrated Review
Group; Surgery, Anesthesiology and
Trauma Study Section.
Date: June 1–2, 2011.
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Agenda: To review and evaluate grant
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Contact Person: Weihua Luo, MD,
PhD, Scientific Review Officer, Center
for Scientific Review, National Institutes
of Health, 6701 Rockledge Drive, Room
5114, MSC 7854, Bethesda, MD 20892,
(301) 435–1170, luow@csr.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group;
Cellular, Molecular and Integrative
Reproduction Study Section.
Date: June 2, 2011.
Time: 7 a.m. to 7 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Allerton Hotel, 701 North
Michigan Avenue, Chicago, IL 60611.
Contact Person: Gary Hunnicutt, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room
6164, MSC 7892, Bethesda, MD 20892,
301–435–0229, gary.hunnicutt@nih.gov.
Name of Committee: Oncology 1–
Basic Translational Integrated Review
Group; Cancer Molecular Pathobiology
Study Section.
Date: June 2–3, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
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Place: The Fairmont Washington, DC,
2401 M Street, NW., Washington, DC
20037.
Contact Person: Manzoor Zarger, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room
6208, MSC 7804, Bethesda, MD 20892,
(301) 435–2477, zargerma@csr.nih.gov.
E:\FR\FM\25APN1.SGM
25APN1
Agencies
[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Notices]
[Pages 22906-22907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9898]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-D-0094]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Topical Oxygen Chamber for
Extremities; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled, ``Class II Special Controls
Guidance Document: Topical Oxygen Chamber for Extremities.'' This
guidance document was developed as a special control to support the
reclassification of the topical oxygen chamber for extremities (TOCE)
from class III (premarket approval) into class II (special controls).
This guidance document describes a means by which manufacturers of TOCE
may comply with the requirement of special controls for class II
devices. Elsewhere in this issue of the Federal Register, FDA is
publishing a final rule reclassifying these devices from class III into
class II (special controls).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled, ``Class II Special Controls Guidance Document:
Topical Oxygen Chamber for Extremities,'' to the Division of Small
Manufacturers, International, and Consumer Assistance (HFZ-220), Center
for Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3555.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 6, 2006 (71 FR 17390), FDA's
Center for Devices and Radiological Health (CDRH) published a proposed
rule to reclassify the TOCE device type from class III (premarket
approval) into class II (special controls) after reviewing current
technological and scientific developments. To support the
reclassification, CDRH issued a draft class II special controls
guidance document entitled ``Class II Special Controls Guidance
Document: Topical Oxygen Chamber for Extremities'' (71 FR 17476).
Interested persons were invited to comment on the proposed rule and
guidance by July 5, 2006. FDA received 11 comments on the proposed
rule. The comments received discussed academic literature, clinical
experiences, and patient outcomes that support the proposed
reclassification's determinations of the safety and effectiveness of
the TOCE device. The comments did not recommend any changes to the
proposed regulation.
FDA is now identifying the guidance document entitled ``Class II
Special Controls Guidance Document: Topical Oxygen Chamber for
Extremities'' as the special control for these devices. This guidance
document provides a means by which manufacturers of TOCE devices may
comply with the requirement of special controls for class II devices.
Following the effective date of the final reclassification rule, any
manufacturer submitting a premarket notification submission under
section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C
act) (21 U.S.C. 360(k)) for a TOCE device will need to address the
issues covered in the special controls guidance document. However, the
manufacturer need only show that its device meets the recommendations
in the guidance document or in some other way provides equivalent
assurances of safety and effectiveness.
II. Significance of Special Controls Guidance
FDA believes that adherence to the recommendations described in
this guidance document, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of TOCE
classified under Sec. 878.5650 (21 CFR 878.5650). The final rule
establishing this guidance document as a special control will be
effective May 25, 2011. Following the effective date of the final rule,
TOCE classified under Sec. 878.5650 must comply with the requirement
of special controls; manufacturers must address the issues requiring
special controls as identified in the guidance, either by following the
recommendations in the guidance or by some other means that provides
equivalent assurances of safety and effectiveness.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or https://www.regulation.gov. Always access an FDA guidance document by
using FDA's Web site listed previously to find the most current version
of the guidance.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
were subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
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 801 have been approved under OMB control
number 0910-0485; the collections of information in 21 CFR part 820
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; and the collections of information in 21 CFR parts 50
and
[[Page 22907]]
56 have been approved under OMB control number 0910-0130.
V. 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: April 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9898 Filed 4-22-11; 8:45 am]
BILLING CODE 4160-01-P