Confidentiality Arrangement Between the United States Food and Drug Administration and the French Health Products Safety Agency, 13606-13608 [06-2539]

Download as PDF 13606 Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices facilitating the use of a centralized IRB review process. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Nancy Stanisic, Center for Drug Evaluation and Research (HFD–1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1660, or Steve Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration,1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301– 827–6210, or David Lepay, Good Clinical Practice Program, Office of Science and Health Coordination (HF–34), 5600 Fishers Lane, Rockville, MD 20857, 301–827–3340. SUPPLEMENTARY INFORMATION: wwhite on PROD1PC61 with NOTICES I. Background In the Federal Register of March 28, 2005 (70 FR 15635), FDA published a notice announcing the availability of a draft guidance entitled ‘‘Using a Centralized IRB Process in Multicenter Clinical Trials.’’ The notice gave interested persons an opportunity to submit comments by May 27, 2005. The agency received only a small number of comments, and we carefully considered the received comments as we finalized the draft guidance. Other than minor editorial changes and some clarifications, no substantive changes were made to the draft guidance. VerDate Aug<31>2005 15:48 Mar 15, 2006 Jkt 208001 This guidance is intended to assist sponsors, institutions, IRBs, and clinical investigators involved in multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review process. The guidance does the following: (1) Describes the roles of the participants in a centralized IRB review process, (2) offers guidance on how a centralized IRB review process might consider the concerns and attitudes of the various communities participating in a multicenter clinical trial, (3) makes recommendations about documenting agreements between a central IRB and the IRBs at institutions involved in the centralized IRB review process concerning the responsibilities of a central IRB and each institution’s IRB, and (4) discusses IRB procedures for implementing a centralized review process. Finally, the guidance recommends how to ensure effective IRB review for clinical trial sites not already affiliated with an IRB. This guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application or IND regulations). This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the guidance. Submit a single copy of electronic comments or two paper copies, 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. The guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the guidance at https:// PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 www.fda.gov/cder/guidance/index.htm. https://www.fda.gov/cber/ guidelines.htm, or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: March 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–3785 Filed 3–15–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225–06–8000] Confidentiality Arrangement Between the United States Food and Drug Administration and the French Health Products Safety Agency AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is providing notice of a confidentiality arrangement between the United States Food and Drug Administration and the French Health Products Safety Agency. The purpose of this confidentiality arrangement is to establish mutual commitments to retain the confidentiality of non-public information shared between the agencies. The agreement became effective February 8, 2006. DATES: FOR FURTHER INFORMATION CONTACT: Matthew E. Eckel, Office of International Programs (HFG–1), Food and Drug Administration, 5600 Fishers Lane, Rockville MD, 20857, 301–827– 4480, FAX: 301–480–0716. In accordance with 21 CFR 20.108(c), which states that all written agreements and understandings between FDA and others shall be published in the Federal Register, the agency is publishing notice of this confidentiality arrangement. SUPPLEMENTARY INFORMATION: Dated: March 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S E:\FR\FM\16MRN1.SGM 16MRN1 VerDate Aug<31>2005 15:48 Mar 15, 2006 Jkt 208001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\16MRN1.SGM 16MRN1 13607 EN16MR06.001</GPH> wwhite on PROD1PC61 with NOTICES Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices 13608 Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices [FR Doc. 06–2539 Filed 3–15–06; 8:45 am] VerDate Aug<31>2005 15:48 Mar 15, 2006 Jkt 208001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1 EN16MR06.002</GPH> wwhite on PROD1PC61 with NOTICES BILLING CODE 4160–01–C

Agencies

[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Notices]
[Pages 13606-13608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-06-8000]


Confidentiality Arrangement Between the United States Food and 
Drug Administration and the French Health Products Safety Agency

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a confidentiality arrangement between the United States Food and Drug 
Administration and the French Health Products Safety Agency. The 
purpose of this confidentiality arrangement is to establish mutual 
commitments to retain the confidentiality of non-public information 
shared between the agencies.

DATES: The agreement became effective February 8, 2006.

FOR FURTHER INFORMATION CONTACT: Matthew E. Eckel, Office of 
International Programs (HFG-1), Food and Drug Administration, 5600 
Fishers Lane, Rockville MD, 20857, 301-827-4480, FAX: 301-480-0716.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and understandings between FDA and 
others shall be published in the Federal Register, the agency is 
publishing notice of this confidentiality arrangement.

    Dated: March 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160-01-S

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[[Page 13608]]


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[FR Doc. 06-2539 Filed 3-15-06; 8:45 am]
BILLING CODE 4160-01-C

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