[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49772-49773]
[FR Doc No: 2011-20385]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Guidance for Industry: Bar Code Label Requirements--Questions and
Answers; 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 document entitled ``Guidance for Industry: Bar Code
Label Requirements--Questions and Answers'' dated August 2011. The
guidance announced in this notice amends the October 2006 guidance
document of the same title by incorporating a revised response to
question 12 (Q12). The revised response concerns the ability of vaccine
manufacturers to use alternative coding technologies to the linear bar
code requirement. The guidance announced in this notice finalizes the
draft guidance entitled ``Guidance for Industry: Bar Code Label
Requirements--Questions and Answers (Question 12 Update)'' dated August
2010, and is superseding the guidance entitled ``Guidance for Industry:
Bar Code Label Requirements--Questions and Answers'' dated October
2006.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the 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 guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the 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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Guidance for Industry: Bar Code Label Requirements--Questions and
Answers'' dated August 2011. 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
national drug code number (Sec.  201.25 (21 CFR 201.25)). To explain
how the bar code label requirements apply to specific products or
circumstances, in the Federal Register of April 27, 2006 (71 FR 24856),
FDA announced the availability of a guidance entitled ``Guidance for
Industry: Bar Code Label Requirement--Questions and Answers'' that was
revised several months later, as discussed in the Federal Register of
October 5, 2006 (71 FR 58739). Since then, FDA has received additional
information concerning vaccines and the linear bar code requirement. In
light of this information, we are incorporating a new response to
question 12 in the guidance document entitled ''Guidance for Industry:
Bar Code Label Requirements--Questions and Answers''. We are providing
a revised response to manufacturers of licensed vaccines in connection
with the use of alternative coding technologies because it has become
increasingly clear that vaccines present unique concerns in the bar
coding context, particularly with respect to compliance with
recordkeeping and mandatory adverse event reporting requirements that
are specific to the administration of childhood vaccines. These
concerns are particularly important because vaccines are typically
administered in an office or clinic which may have limited
administrative support. For example, health care providers who
administer a vaccine that is subject to the requirements in the
National Childhood Vaccine Injury Act of 1986 (Pub. L. 99-660) (42
U.S.C. 300aa-25(a))) (NCVIA) are required to ensure that there is
recorded in the vaccine recipient's permanent medical record (or in a
permanent office log or file) the date the vaccine was administered,
the manufacturer, lot number of the vaccine, and the name, address, and
title of the person administering the vaccine (42 U.S.C. 300aa-25(a)).
Manual data entry of this information requires rigorous procedures to
ensure accurate records as not all of this information is encoded and
clerical recording errors can diminish the value of information
available for mandatory adverse event reporting. Furthermore,
inaccurate recording of a lot number may delay or misdirect FDA's
investigation of an adverse event. At this time, FDA believes that two
dimensional symbology technology has advanced such that health care
providers may wish to invest in the technology to capture information
from a two dimensional code because, through use of this technology,
they may more effectively be able to address the reporting requirements
reflected in NCVIA.
    FDA also believes that enhanced compliance with NCVIA will in turn
enable compliance with the mandatory reporting of adverse events by
health care providers under the Vaccine Adverse Event Reporting System
(VAERS), administered jointly by the Centers for Disease Control and
Prevention and FDA. For example, complete automatic entry of vaccine
information would facilitate accurate reporting to VAERS, decrease
incorrect VAERS entries, and would facilitate rapid, accurate entry
into immunization registries. Finally, the ready availability of
information in machine readable format will enable more efficient
electronic recordation of information, including lot number and vaccine
expiration dates.
    For these reasons, FDA now will consider requests from vaccine
manufacturers who request to use alternate coding technologies, such as
two dimensional symbology, that encode lot number and expiration date
information, for an exemption under Sec.  201.25(d)(1)(ii) to the
linear bar code requirement. In particular, the Agency will consider
granting such an exemption request under Sec.  201.25(d)(1)(ii) on the
grounds that an alternative regulatory program, comprised of
alternative technology such as two dimensional symbology used to
facilitate compliance with requirements of public health programs
applicable to childhood vaccines, could render the use of linear bar
codes unnecessary for patient safety, and we would consider granting a
request for an exemption to the bar code requirement under Sec.
201.25(d)(1)(ii) in connection with such use. FDA recognizes that it
may be infeasible for a vaccine manufacturer to implement alternate
coding technology only for childhood vaccines that are subject to
NCVIA, while retaining linear bar coding for its

other vaccines due to practical considerations related to manufacturing
and cost. Moreover, the schedule of vaccines subject to NCVIA is not
static and is updated regularly. The Agency therefore will consider a
vaccine manufacturer's request for an exemption to the linear bar code
requirement for any of its other licensed vaccines in addition to
childhood vaccines.
    Note that, as FDA stated in the preamble to the final rule, the
Agency continues to emphasize that the general exemption provision in
Sec.  201.25(d)(1)(ii) is intended to be used in rare cases (69 FR 9120
at 9131). FDA believes that its revised response to Q12 is consistent
with that view because it is narrowly tailored. Further, as alternative
technologies continue to advance, the Agency intends to assess these
technologies in relation to current bar coding practices and other FDA
initiatives, such as efforts to further enhance the security of the
drug supply chain through use of a standardized numerical identifier
for uniquely identifying prescription drug packages, and the
establishment of a unique device identification system for medical
devices.
    In the Federal Register of September 7, 2010 (75 FR 54347), FDA
announced the availability of a draft guidance entitled ``Guidance for
Industry: Bar Code Label Requirements--Questions and Answers (Question
12 Update)'' dated August 2010. FDA received several comments on the
draft guidance and those comments were considered as the guidance was
finalized. The guidance announced in this notice finalizes the draft
guidance dated August 2010 and incorporates a revised response to
question 12 into the guidance entitled ``Guidance for Industry: Bar
Code Label Requirements--Questions and Answers''. In addition,
editorial changes were made to the guidance to improve clarity.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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. Paperwork Reduction Act of 1995

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

III. Comments

    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 guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20385 Filed 8-10-11; 8:45 am]
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[Federal Register: October 15, 2010 (Volume 75, Number 199)]
[Notices]
[Page 63466]
[DOCID:fr15oc10-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-26-000]

Ashtabula Wind III, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

October 7, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Ashtabula Wind III, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 27, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25956 Filed 10-14-10; 8:45 am]
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