E6-16436. Guidance for Industry on Bar Code Label Requirements-Questions and Answers; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of additional questions and answers that are being incorporated into the final guidance document entitled “Guidance for Industry: Bar Code Label Requirements—Questions and Answers.” This final guidance is dated October 2006. The additional questions and answers relate to blood and blood components intended for transfusion and requirements that their container labels bear certain machine-readable information. These requirements were part of the final rule on bar code label requirements for human drugs published on February 26, 2004.

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, 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 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:

For products regulated by the Center for Drug Evaluation and Research: Valerie L. Whipp, Center for Drug Evaluation and Research (HFD-310), Food and Drug Administration,11919 Rockville Pike, Rockville, MD 20852, 301-827-8957.

For products regulated by the Center for Biologics Evaluation and Research: Kathleen E. Swisher, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February 26, 2004 (69 FR 9120), FDA published a final rule (the February 2004 final rule) requiring certain human drug and biological products to have on their labels a linear bar code that contains, at a minimum, the drug's NDC number (21 CFR 201.25). The February 2004 final rule requires also that the container label of blood and blood components intended for transfusion bear encoded information in a machine-readable format that must be approved for use by the Director, Center for Biologics Evaluation and Research (21 CFR 606.121(c)(13)).

In the Federal Register of April 27, 2006 (71 FR 24856), FDA announced the availability of a final guidance “Guidance for Industry: Bar Code Label Requirements—Questions and Answers.” The purpose of the April 2006 guidance was to respond to questions about how the requirements in the February 2004 final rule applied to specific products or circumstances. The questions and answers in the April 2006 guidance focused on bar codes, not machine-readable information on container labels of blood and blood components, because most of the questions we received at that time focused on bar codes. In the April 2006 guidance, we stated that the guidance may be revised as we receive additional questions.

Following publication of the February 2004 final rule and issuance of the April 2006 guidance, FDA received several additional questions concerning blood and blood components and the use of machine-readable information. The answers to these additional questions were provided in the preamble to the February 2004 final rule. We have updated the April 2006 guidance with this additional information to make the information more accessible and convenient. We consider the changes to the April 2006 guidance to be level 2 changes because they set forth existing practices (21 CFR 10.115(c)(2)).

Therefore, FDA is announcing the availability of additional questions and answers incorporated in the document entitled “Guidance for Industry: Bar Code Label Requirements—Questions and Answers,” and we are revising the date of the guidance to October 2006.

The guidance is issued consistent with FDA's good guidance practices regulation (21 CFR 10.115), particularly 21 CFR 10.115(g)(4)(i). The guidance represents the 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. 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 http://www.fda.gov/​cber/​guidelines.htm, http://www.fda.gov/​cder/​guidance/​index.htm, or http://www.fda.gov/​ohrms/​dockets/​default.htm.

Dated: September 26, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.