Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop; Correction, 23924 [E6-6119]

Download as PDF 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: E6-6119]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Industry Exchange Workshop on Food and Drug Administration 
Clinical Trial Requirements; Public Workshop; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; correction.

-----------------------------------------------------------------------

SUMMARY: 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.

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. E6-3229, 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.

    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

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