03-16790. Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires; Availability

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: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires” dated July 2003. The guidance document provides guidance to blood and plasma establishments on the recommendations of FDA for implementing self-administered donor questionnaires at the predonation donor screening interview. The guidance document also describes the information to be included in a biologics license application supplement or annual report for the implemented changes. The guidance supersedes section I.A of FDA's memorandum dated April 23, 1992, entitled “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products,” and finalizes the draft guidance of the same title dated April 2002.

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, 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 the CBER Voice Information System 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.

FOR FURTHER INFORMATION CONTACT:

Michael D. Anderson, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled “Guidance for industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires,” dated July 2003. The guidance is intended to provide recommendations to the blood and plasma establishments on the changes from the current predonation donor screening interview procedure to a self-administered format. The guidance also describes the information to be included in a biologics license application supplement or annual report for the implemented changes. The guidance does not address the informed consent process or specific screening questions, a specific questionnaire, or how to submit changes to the questions on a currently approved questionnaire. The guidance supersedes section I.A of FDA's memorandum dated April 23, 1992, entitled “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products,” and finalizes the draft guidance of the same title dated April 2002.

The 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 requirement of the applicable statutes and regulations.

II. Comments

Interested persons may, at any time, submit written or electronic comments to the Division of Dockets Management (see ADDRESSES) regarding this 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.

III. 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.

Dated: June 24, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.