Regulatory Site Visit Training Program; Correction, 23924 [E6-6120]
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23924
Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual Frequency
per Response
No. of Respondents
Total Annual
Responses
Hours per
Response
1,800 (content study: screener)
1
1,800
900 (content study: questionnaire)
1
600 (format study: screener)
300 (format study: questionnaire)
Total Hours
.017
31
900
.33
297
1
600
.017
10
1
300
.33
99
Total
437
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6142 Filed 4–24–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Industry Exchange Workshop on Food
and Drug Administration Clinical Trial
Requirements; Public Workshop;
Correction
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
[Docket No. 2004N–0408]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
April 11, 2006. The document
reannounced the invitation for
participation in its Regulatory Site Visit
Training Program. The document was
published with an incorrect e-mail
address. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Joyce A. Strong, Office of Policy (HF–
27), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–827–7010.
SUPPLEMENTARY INFORMATION: In FR Doc.
E6–5221, appearing on page 18340 in
the Federal Register of Tuesday, April
11, 2006, the following correction is
made:
1. On page 18340, in the third
column, in the last sentence under the
‘‘ADDRESSES’’ caption and under the
‘‘FOR FURTHER INFORMATION CONTACT’’
caption, the e-mail address is corrected
to read matt@cber.fda.gov.
wwhite on PROD1PC65 with NOTICES
Notice of public workshop;
correction.
ACTION:
Regulatory Site Visit Training Program;
Correction
Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6120 Filed 4–24–06; 8:45 am]
16:59 Apr 24, 2006
Jkt 208001
Guidance for Sponsors, Institutional
Review Boards, Clinical Investigators,
and Food and Drug Administration
Staff; Guidance on Informed Consent
for In Vitro Diagnostic Device Studies
Using Leftover Human Specimens That
Are Not Individually Identifiable;
Availability
AGENCY:
The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
March 7, 2006. The document
announced a workshop on FDA clinical
trial statutory and regulatory
requirements. The document was
published with an incorrect Internet
address. This document corrects that
error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Joyce A. Strong, Office of Policy (HF–
27), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–827–7010.
In FR Doc.
E6–3229, appearing on page 11434 in
the Federal Register of Tuesday, March
7, 2006, the following correction is
made:
1. On page 11434, in the second
column, under the ‘‘Registration’’
caption, the Internet address is
corrected to read https://www.socra.org/
html/FDA_Conference.htm.
SUPPLEMENTARY INFORMATION:
Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6119 Filed 4–24–06; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
VerDate Aug<31>2005
[Docket No. 2006D–0150]
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable.’’ This
guidance is intended to inform
sponsors, institutional review boards,
clinical investigators, and agency staff
that under circumstances described in
the guidance, that FDA does not intend
to object to the use in device
investigations, without informed
consent, of leftover human specimens
that are not individually identifiable.
FDA intends to include in this policy
leftover specimens that are remnants of
specimens collected for routine clinical
care or analysis that would otherwise
have been discarded, specimens
obtained from specimen repositories,
and specimens that are leftover from
specimens previously collected for other
unrelated research. This guidance
document will be implemented
immediately, but it remains subject to
comment in accordance with the
agency’s good guidance practices
(GGPs).
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 71, Number 79 (Tuesday, April 25, 2006)]
[Notices]
[Page 23924]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6120]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0408]
Regulatory Site Visit Training Program; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice that
appeared in the Federal Register of April 11, 2006. The document
reannounced the invitation for participation in its Regulatory Site
Visit Training Program. The document was published with an incorrect e-
mail address. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy (HF-
27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-7010.
SUPPLEMENTARY INFORMATION: In FR Doc. E6-5221, appearing on page 18340
in the Federal Register of Tuesday, April 11, 2006, the following
correction is made:
1. On page 18340, in the third column, in the last sentence under
the ``ADDRESSES'' caption and under the ``FOR FURTHER INFORMATION
CONTACT'' caption, the e-mail address is corrected to read
matt@cber.fda.gov.
Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6120 Filed 4-24-06; 8:45 am]
BILLING CODE 4160-01-S
