Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability; Reopening of Comment Period, 26134-26135 [E7-8780]
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26134
Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Activity
No. of
Respondents
Annual Frequency
per Response
Completed survey
44,500
Total domestic
Total Annual
Responses
1
61,500
Hours per
Response
44,500
Total Hours
.75
61,500
33,375
34,514
Foreign Facilities
Screening questions only
14,000
1
14,000
.067
Completed survey
26,000
1
26,000
.75
Total foreign
40,000
1
40,000
Grand total
101,500
1There
19,500
20,438
54,952
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates of the number of
respondents and the burden hours per
response are based on FDA’s registration
database and FDA and the contractor’s
experience with previous surveys. The
respondents are divided into two
groups: Domestic and foreign. We
estimate the number of domestic
facilities at 126,000 based on
information in the registration database.
However, we do not expect that all of
these firms will participate in the
survey. We anticipate that
approximately 61,500 facilities will
participate, which takes into account
typical response rates to these types of
surveys and inaccurate contact
information that facilities have entered
into the registration database (see https://
www.cfsan.fda.gov/~furls/
ffregacc.html). Similarly, among the
81,000 foreign facilities in the
registration database, we expect that
40,000 foreign facilities will respond.
We estimate that it will take a
respondent 4 minutes (.067 hours) to
complete the screening questions and 45
minutes (0.75 hours) to complete the
entire survey. Prior to the
administration of the survey, the agency
plans to conduct a pretest of the final
survey to identify and resolve potential
problems. The pretest will be conducted
with nine participants.
Dated: May 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–8783 Filed 5–7–07; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0363]
Draft Guidance for Industry and Food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
June 7, 2007, the comment period for a
draft guidance entitled ‘‘Class II Special
Controls Guidance Document:
Absorbable Hemostatic Device.’’ FDA
published a notice of availability of the
draft guidance in the Federal Register of
October 31, 2006 (71 FR 63774). The
draft guidance describes a means by
which the absorbable hemostatic device
may comply with the requirement of
special controls for class II devices, if
the device is reclassified. 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: Submit written or electronic
comments on the draft guidance by June
7, 2007. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Class II Special
Controls Guidance Document:
Absorbable Hemostatic Device’’ to the
Division of Small Manufacturers,
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
International, and Consumer Assistance
(HFZ–220), Center for Devices and
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 draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
David Krause, Center for Devices and
Radiological Health (HFZ–410), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–3090, ext. 141.
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 approval) 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.’’ The
draft guidance describes a means by
which the absorbable hemostatic device
may comply with the requirement of
special controls if they were
reclassified. FDA invited interested
persons to comment on the proposed
E:\FR\FM\08MYN1.SGM
08MYN1
Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices
rule and on the draft guidance
document by January 29, 2007.
Two companies requested FDA to
extend the comment period on the
proposed rule by 90 days because the
proposal presented complex medical
and scientific issues that required the
company to assemble a team of many
different specialties in order to prepare
their comments. 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.
cprice-sewell on PROD1PC66 with NOTICES
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
Special 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 submissions,
approved applications, and
manufacturers’ addresses), small
manufacturer’s 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 are also available on the
Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
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
VerDate Aug<31>2005
15:36 May 07, 2007
Jkt 211001
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 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–8780 Filed 5–7–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0027]
Voluntary Self-Inspection of Medicated
Feed Manufacturing Facilities; Draft
Compliance Policy Guide; 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 to
June 8, 2007, the comment period for
the notice of availability that appeared
in the Federal Register of February 12,
2007 (72 FR 6572). In the notice, FDA
requested comments on the draft
compliance policy guide on voluntary
self-inspection of medicated feed
manufacturing facilities. The agency is
taking this action in response to
requests for an extension to allow
interested persons additional time to
submit comments.
DATES: Submit written and electronic
comments by June 8, 2007.
ADDRESSES: Submit written comments
on the draft compliance policy guide 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.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the documents.
FOR FURTHER INFORMATION CONTACT: Paul
Bachman, Center for Veterinary
Medicine (HFV–230), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9225, email: Paul.Bachman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February
12, 2007 (72 FR 6572), FDA published
a notice of availability with a 75-day
comment period to request comments
on a draft compliance policy guide
(CPG) on voluntary self inspection of
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
26135
medicated feed manufacturing facilities.
The purpose of this CPG is intended to
provide guidance to FDA field offices on
considering, among other factors, the
conduct of self-inspections when
prioritizing inspections of medicated
feed manufacturing facilities for
compliance with Current Good
Manufacturing Practices for Medicated
Feeds regulations.
The agency has received a request for
an extension of the comment period for
the draft compliance policy guide. This
request conveyed concern that the
current 75-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the compliance policy guide.
FDA has considered the request and
is reopening the comment period for the
draft compliance policy guide until June
8, 2007. The agency believes this
reopening allows adequate time for
interested persons to submit comments.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on these documents. 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.
Dated: May 1, 2007.
David Horowitz,
Assistant Commissioner for Regulatory
Affairs.
[FR Doc. E7–8781 Filed 5–7–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review—Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 72, Number 88 (Tuesday, May 8, 2007)]
[Notices]
[Pages 26134-26135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8780]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0363]
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 June
7, 2007, the comment period for a draft guidance entitled ``Class II
Special Controls Guidance Document: Absorbable Hemostatic Device.'' FDA
published a notice of availability of the draft guidance in the Federal
Register of October 31, 2006 (71 FR 63774). The draft guidance
describes a means by which the absorbable hemostatic device may comply
with the requirement of special controls for class II devices, if the
device is reclassified. 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: Submit written or electronic comments on the draft guidance by
June 7, 2007. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Absorbable Hemostatic Device'' 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 draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments https://www.fda.gov/dockets/ecomments. Identify comments with
the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: David Krause, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141.
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
approval) 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.'' The draft guidance
describes a means by which the absorbable hemostatic device may comply
with the requirement of special controls if they were reclassified. FDA
invited interested persons to comment on the proposed
[[Page 26135]]
rule and on the draft guidance document by January 29, 2007.
Two companies requested FDA to extend the comment period on the
proposed rule by 90 days because the proposal presented complex medical
and scientific issues that required the company to assemble a team of
many different specialties in order to prepare their comments.
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 Special 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 submissions, approved applications, and
manufacturers' addresses), small manufacturer's 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 are also available on the Division of Dockets
Management Internet site at https://www.fda.gov/ohrms/dockets.
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.
Dated: April 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8780 Filed 5-7-07; 8:45 am]
BILLING CODE 4160-01-S
