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Notice

Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests; Availability

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a document entitled “Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests” dated January 2007. The guidance document provides establishments that make HCT/P donor eligibility determinations with recommendations concerning the donor eligibility requirements contained in 21 CFR part 1271, subpart C, which became effective on May 25, 2005. The guidance applies only to certain HCT/Ps that were not regulated as HCT/Ps before May 25, 2005, and that were recovered from donors beginning on or after the May 25, 2005, and within 30 days of the date of publication of this document in the Federal Register. This guidance has an immediate implementation date because FDA has determined that prior public participation is not feasible or appropriate. In certain cases, donor retesting needs to be initiated quickly, and the availability of certain HCT/Ps may be critical to their intended recipients.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments.

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FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled “Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Start Printed Page 3150Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests” dated January 2007. The guidance document provides establishments that make HCT/P donor eligibility determinations with recommendations concerning the donor eligibility requirements under part 1271 (21 CFR part 1271), subpart C, when donors of certain HCT/Ps were tested for communicable diseases using pooled specimens or diagnostic tests. The effective date of the regulations contained in part 1271, subpart C, was May 25, 2005 (69 FR 29785, May 25, 2004). The guidance is applicable to certain HCT/Ps that were not regulated as HCT/Ps before May 25, 2005, and that were recovered from donors on or after May 25, 2005, and within 30 days of the date of publication of this document in the Federal Register. FDA has determined that donor retesting, in certain cases, needs to be conducted in a timely manner in order to be feasible, and the availability of certain HCT/Ps may be critical to their intended recipients.

The guidance is being issued consistent with FDA's good guidance practices regulation § 10.115 (21 CFR 10.115). The guidance represents FDA'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. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 1271, subpart C, have been approved under OMB control number 0910-0543; the collections of information in part 1271, subpart D, and Form FDA-3486 have been approved under OMB control number 0910-0559.

III. Comments

FDA is soliciting public comment, but is implementing this guidance immediately in accordance with § 10.115(g)(2) and (3) without initially seeking prior comment because the agency has determined that prior public participation is not feasible or appropriate. In certain cases, donor retesting needs to be initiated quickly, and the availability of certain HCT/Ps may be critical to their intended recipients. Interested persons may, at any time, submit to the Division of Dockets Management (See ADDRESSES) written or electronic comments regarding the guidance. 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 the brackets in the heading of this document. A copy of 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.

IV. Electronic Access

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/​cber/​guidelines.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.

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Dated: January 17, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-978 Filed 1-23-07; 8:45 am]

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