[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Pages 54347-54348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0426]


Draft Guidance for Industry: Bar Code Label Requirements--
Questions and Answers (Question 12 Update); Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: Bar 
Code Label Requirements--Questions and Answers (Question 12 Update)'' 
dated August 2010. This draft guidance provides you, manufacturers of a 
licensed vaccine, with advice concerning compliance with the bar code 
label requirements. In this guidance, FDA is proposing to amend our 
response to question 12 (Q12) in the ``Bar Code Label Requirements--
Questions and Answers'' guidance dated October 2006 (Bar Code 
Guidance), to provide recommendations to manufacturers of licensed 
vaccines in connection with the use of alternative coding technologies. 
When this guidance is finalized, we intend to incorporate the revised 
response to Q12 into the Bar Code Guidance, but otherwise continue with 
our recommendations for bar code label requirements as currently 
provided in the Bar Code Guidance.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments

[[Page 54348]]

on the draft guidance by November 8, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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 The draft guidance may also be obtained by 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, 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

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Bar Code Label Requirements--Questions and 
Answers (Question 12 Update)'' dated August 2010. FDA regulations 
require that certain human drug and biological product labels contain a 
bar code (Sec.  201.25 (21 CFR 201.25)). This draft guidance provides 
you, manufacturers of a licensed vaccine, with advice concerning 
compliance with the bar code label requirements. Previously, FDA issued 
questions and answers regarding how the bar code label requirements 
apply to specific products or circumstances in the Bar Code Guidance 
(October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to 
amend our response to question 12 (Q12) in the Bar Code Guidance to 
provide recommendations to manufacturers of licensed vaccines in 
connection with the use of alternative coding technologies. We are 
revising our response because we believe that an alternative regulatory 
program, comprised of alternative technology such as two dimensional 
symbology, could render the use of linear bar codes unnecessary for 
patient safety and could enhance health care providers' ability to 
comply with the National Childhood Vaccine Injury Act of 1986 (Public 
Law 99-660) (42 U.S.C. 300aa-25(a))). We would consider granting a 
request for exemption to the bar code requirement under Sec.  
201.25(d)(ii) in connection with such use.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of 
information found in FDA regulations. The collection of information in 
21 CFR part 201 has been approved under OMB control number 0910-0537.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) either 
electronic or written comments regarding this document. It is only 
necessary to send one set of comments. It is no longer necessary to 
send two copies of mailed comments. Identify comments with the docket 
number found in brackets in the heading of this document. Received 
comments may be seen 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 draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22169 Filed 9-3-10; 8:45 am]
BILLING CODE 4160-01-S