[Federal Register: October 5, 2006 (Volume 71, Number 193)]
[Rules and Regulations]
[Page 58739-58740]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc06-5]
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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.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
ets/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