Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability; Reopening of Comment Period, 52861-52862 [E8-21197]
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52861
Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
2009 ...............................................................................................................
Follow-up Survey.
2010 Follow-up Survey ..................................................................................
Estimated Total Annual Burden
Hours: 455.25
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447.
Attn: ACF Reports Clearance Officer. Email address:
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents. Consideration will be
given to comments and suggestions
submitted within 60 days of this
publication.
Dated: September 4, 2008.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. E8–21007 Filed 9–10–08; 8:45 am]
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Total burden
hours
1
45
348
143
1
45
107.25
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2008–N–0132]
[Docket No. FDA–2006–N–0178] (formerly
Docket No. 2006N–0362)
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
State Petitions for Exemption from
Preemption
AGENCY:
Food and Drug Administration,
ACTION:
Notice.
ACTION:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
In the
Federal Register of June 16, 2008 (73 FR
34024), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0277. The
approval expires on August 31, 2011. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Frm 00053
Fmt 4703
Food and Drug Administration,
HHS.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘State Petitions for Exemption from
Preemption’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
PO 00000
Draft Guidance for Industry and Food
and Drug Administration Staff; Class II
Special Controls Guidance Document:
Absorbable Hemostatic Device;
Availability; Reopening of Comment
Period
AGENCY:
HHS.
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14:21 Sep 10, 2008
Average
burden
hours per
response
(minutes)
464
Dated: September 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21020 Filed 9–9–08; 8:45 am]
VerDate Aug<31>2005
Number of
responses per
respondent
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Notice; reopening of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is reopening until
October 14, 2008, the comment period
for a draft guidance entitled ‘‘Class II
Special Controls Guidance Document:
Absorbable Hemostatic Device.’’ The
draft guidance describes a means by
which the absorbable hemostatic device
may comply with the requirements of
special controls if it is reclassified. FDA
is reopening the comment period to
update comments and to receive any
new information. Elsewhere in this
issue of the Federal Register, FDA is
reopening the comment period on a
proposed rule to reclassify the
absorbable hemostatic device from class
III (premarket approval) into class II
(special controls).
DATES Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance October 14, 2008.
ADDRESS: Submit written comments 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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
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52862
Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Notices
FOR FURTHER INFORMATION CONTACT:
David Krause, Center for Devices and
Radiological Health (HFZ–410), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3638.
SUPPLEMENTARY INFORMATION:
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I. Background
In the Federal Register of October 31,
2006 (71 FR 63728), FDA published a
proposed rule to reclassify the
absorbable hemostatic device intended
to produce hemostasis from class III
(premarket) into class II (special
controls). In the same issue of the
Federal Register (71 FR 63774), FDA
published a notice of availability of a
draft guidance document entitled ‘‘Class
II Special Controls Guidance Document:
Absorbable Hemostatic Device.’’ FDA
invited interested persons to comment
on the draft guidance document by
January 29, 2007. In the Federal
Register of May 8, 2007 (72 FR 26134),
FDA published a notice reopening the
comment period for 30 days.
On July 2, 2007, FDA received a
petition under 21 CFR 10.30 and 10.35
requesting that the agency refrain from
issuing a final regulation for the
proposed reclassification and the draft
special controls guidance for the
absorbable hemostatic device until an
updated and complete administrative
record is made available to the public.
The petitioner also requested that FDA
reopen the rulemaking for the proposed
reclassification to allow submission of
comments based on the administrative
record. Elsewhere in this issue of the
Federal Register, FDA is reopening the
comment period on the proposed rule
for 30 days. Because the issues
presented by the guidance document are
intertwined with those presented by the
proposed rule, FDA is reopening the
comment period on the guidance
document for the same period.
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive the draft
guidance document entitled ‘‘Class II
Specials Controls Document:
Absorbable Hemostatic Device,’’ you
may either send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document, or
send a fax request to 240–276–3151 to
receive a hard copy. Please use the
document number 1558 to identify the
guidance you are requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
VerDate Aug<31>2005
14:21 Sep 10, 2008
Jkt 214001
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’’ addresses), small
manufacturer’’ assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
at https://www.regulations.gov.
III. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance
document. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments submissions will be accepted
by FDA through FDMS only.
Dated: September 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21197 Filed 9–10–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0475]
Request for Notification From Industry
Organizations Interested in
Participating in Selection Process for
Nonvoting Industry Representatives on
Public Advisory Panels or Committees
and Request for Nonvoting Industry
Representatives on Public Advisory
Panels or Committees
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting that
any industry organization interested in
participating in the selection of
nonvoting industry representatives to
serve on the Devices Good
Manufacturing Practice Advisory
Committee (DGMPAC) and certain
device panels of the Medical Devices
Advisory Committee in the Center for
Devices and Radiological Health notify
FDA in writing. A nominee may either
be self nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
Any industry organizations
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by October 14, 2008, for the
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by October 14, 2008.
DATES:
All letters of interest and
nominations should be sent to Kathleen
L. Walker (see FOR FURTHER INFORMATION
CONTACT).
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ–17), Food
and Drug Administration, 7520 Standish
Pl. (MPN1), Rockville, MD 20855, 240–
276–8938, e-mail:
kathleen.walker@fda.hhs.gov.
The
agency intends to add nonvoting
industry representatives to the following
advisory committees:
SUPPLEMENTARY INFORMATION:
I. CDRH—Various Committees and
Panels
A. Devices Good Manufacturing Practice
Advisory Committee (DGMPAC)
Section 520 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360(j)), as amended, provides that the
DGMPAC shall be composed of two
representatives of interests of the device
manufacturing industry.
B. Medical Devices Advisory Committee
Section 520(f)(3) of the act, as
amended by the Medical Device
Amendments of 1976, provides that
each medical device panel include one
nonvoting member to represent the
interests of the medical device
manufacturing industry.
E:\FR\FM\11SEN1.SGM
11SEN1
]]>Agencies
[Federal Register Volume 73, Number 177 (Thursday, September 11, 2008)]
[Notices]
[Pages 52861-52862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-N-0178] (formerly Docket No. 2006N-0362)
Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Absorbable
Hemostatic Device; Availability; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening until
October 14, 2008, the comment period for a draft guidance entitled
``Class II Special Controls Guidance Document: Absorbable Hemostatic
Device.'' The draft guidance describes a means by which the absorbable
hemostatic device may comply with the requirements of special controls
if it is reclassified. FDA is reopening the comment period to update
comments and to receive any new information. Elsewhere in this issue of
the Federal Register, FDA is reopening the comment period on a proposed
rule to reclassify the absorbable hemostatic device from class III
(premarket approval) into class II (special controls).
DATES Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
October 14, 2008.
ADDRESS: Submit written comments 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. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
[[Page 52862]]
FOR FURTHER INFORMATION CONTACT: David Krause, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3638.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 31, 2006 (71 FR 63728), FDA
published a proposed rule to reclassify the absorbable hemostatic
device intended to produce hemostasis from class III (premarket) into
class II (special controls). In the same issue of the Federal Register
(71 FR 63774), FDA published a notice of availability of a draft
guidance document entitled ``Class II Special Controls Guidance
Document: Absorbable Hemostatic Device.'' FDA invited interested
persons to comment on the draft guidance document by January 29, 2007.
In the Federal Register of May 8, 2007 (72 FR 26134), FDA published a
notice reopening the comment period for 30 days.
On July 2, 2007, FDA received a petition under 21 CFR 10.30 and
10.35 requesting that the agency refrain from issuing a final
regulation for the proposed reclassification and the draft special
controls guidance for the absorbable hemostatic device until an updated
and complete administrative record is made available to the public. The
petitioner also requested that FDA reopen the rulemaking for the
proposed reclassification to allow submission of comments based on the
administrative record. Elsewhere in this issue of the Federal Register,
FDA is reopening the comment period on the proposed rule for 30 days.
Because the issues presented by the guidance document are intertwined
with those presented by the proposed rule, FDA is reopening the comment
period on the guidance document for the same period.
II. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive the draft guidance document
entitled ``Class II Specials Controls Document: Absorbable Hemostatic
Device,'' you may either send an e-mail request to dsmica@fda.hhs.gov
to receive an electronic copy of the document, or send a fax request to
240-276-3151 to receive a hard copy. Please use the document number
1558 to identify the guidance you are requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers'' addresses), small
manufacturer'' assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at https://www.regulations.gov.
III. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments submissions will be accepted by FDA through
FDMS only.
Dated: September 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21197 Filed 9-10-08; 8:45 am]
BILLING CODE 4160-01-S
