Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children; Cancellation: Change of Meeting Date, 62597 [E6-17931]
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62597
Federal Register / Vol. 71, No. 207 / Thursday, October 26, 2006 / Notices
(FDA Form 483), this draft guidance
recommends that the applicant do the
following: (1) Describe their
investigation of the cause or source of
the problem; and (2) explain their
decision to change the device design,
labeling, or manufacturing process by
describing how the actions taken have
corrected the problem and mitigated the
harm.
This draft guidance also recommends
including a discussion of how the
results and conclusions in clinical
investigations or nonclinical laboratory
studies or reports in scientific literature
could impact the known safety and
effectiveness profile of the device. If
changes to the device or its labeling are
based on clinical investigations or
nonclinical laboratory studies or reports
in scientific literature, this draft
guidance recommends informing FDA
of a plan for submitting a PMA
Supplement or 30-day notice for these
changes; or in the alternative,
explaining why such a submission is
not appropriate.
To help FDA assess the public health
impact of the information provided in
annual reports, this draft guidance also
asks applicants to provide data about
the number of devices shipped or sold
during the reporting period. For device
implants, data regarding the number of
devices actually implanted should be
provided, if it is available.
Finally, this draft guidance suggests
that a redacted copy of the annual report
may be provided in order to be publicly
posted on FDA’s Web site.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in
§§ 814.82(a)(7) and 814.84(b) have been
approved under OMB Control No. 0910–
0231.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Respondents
Information Collection Activity
Annual Frequency per
Response
Total Annual Responses
Hours per Response
Total Hours
Annual Report Cover Letter
434
1
434
0.5
217
Rationale for Changes
434
1
434
3
1,302
Summary of Risk Analysis
434
1
434
4
1,736
Evaluation of Clinical Investigations, Non-Clinical Laboratory
Studies, or Scientific Literature
434
1
434
7
3,038
Information on Devices Shipped,
Sold, or Implanted
434
1
434
5
2,170
Redacted Copy of Annual Report
434
1
434
4
1,736
Total
434
1
434
29.5
10,199
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
The industry-wide burden estimate is
based on an FDA actual average fiscal
year (FY) annual rate of receipt of 434
annual reports, using FY 2003 through
2005 data. The burden data for annual
reports is based on FDA estimates.
V. Comments
ycherry on PROD1PC64 with NOTICES
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this 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: October 17, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–17908 Filed 10–25–06; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:21 Oct 25, 2006
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders and Genetic Diseases in
Newborns and Children; Cancellation:
Change of Meeting Date
Health Resources and Services
Administration; HHS.
AGENCY:
Meeting notice: cancellation and
change of meeting date.
ACTION:
SUMMARY: The Health Resources and
Services Administration published a
document in the Federal Register of
September 22, 2006, regarding a meeting
date for the Advisory Committee on
Heritable Disorders and Genetic
Diseases in Newborns and Children.
The meeting scheduled for November 2–
3, 2006, has been cancelled.
Correction
In the Federal Register of September
22, 2006, in FR Doc. 06–8018, on page
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
55494, correct the ‘‘Dates and Times’’
section to read:
Dates and Times: December 18, 2006,
9 a.m. to 5 p.m., December 19, 2006,
8:30 a.m. to 3 p.m.
Place: Hilton Washington Hotel,
Monroe Room, 1919 Connecticut
Avenue, NW., Washington, DC 20009.
Dated: October 20, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–17931 Filed 10–25–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Health Information National
Trends Survey 2007 (HINTS 2007)
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
E:\FR\FM\26OCN1.SGM
26OCN1
]]>Agencies
[Federal Register Volume 71, Number 207 (Thursday, October 26, 2006)]
[Notices]
[Page 62597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17931]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Heritable Disorders and Genetic Diseases in
Newborns and Children; Cancellation: Change of Meeting Date
AGENCY: Health Resources and Services Administration; HHS.
ACTION: Meeting notice: cancellation and change of meeting date.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration published a
document in the Federal Register of September 22, 2006, regarding a
meeting date for the Advisory Committee on Heritable Disorders and
Genetic Diseases in Newborns and Children. The meeting scheduled for
November 2-3, 2006, has been cancelled.
Correction
In the Federal Register of September 22, 2006, in FR Doc. 06-8018,
on page 55494, correct the ``Dates and Times'' section to read:
Dates and Times: December 18, 2006, 9 a.m. to 5 p.m., December 19,
2006, 8:30 a.m. to 3 p.m.
Place: Hilton Washington Hotel, Monroe Room, 1919 Connecticut
Avenue, NW., Washington, DC 20009.
Dated: October 20, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-17931 Filed 10-25-06; 8:45 am]
BILLING CODE 4165-15-P
