[Federal Register Volume 71, Number 193 (Thursday, October 5, 2006)]
[Rules and Regulations]
[Pages 58739-58740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16436]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 606, and 610

[Docket No. 2005D-0202]


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

[[Page 58740]]

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.
[FR Doc. E6-16436 Filed 10-4-06; 8:45 am]
BILLING CODE 4160-01-S