[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Notices]
[Pages 49818-49819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20205]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0873]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Bar Code Label Requirement for Human Drug and
Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the bar code label
requirements for human drug and biological products.
DATES: Submit either electronic or written comments on the collection
of information by October 16, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Bar Code Label Requirement for Human Drug and Biological Products--(OMB
Control Number 0910-0537)--Extension
In the Federal Register of February 26, 2004 (69 FR 9120), we
issued regulations that required human drug product and biological
product labels to have bar codes. The rule required bar codes on most
human prescription drug products and on over-the-counter (OTC) drug
products that are dispensed under an order and commonly used in health
care facilities. The rule also required machine-readable information on
blood and blood components. For human prescription drug products and
OTC drug products that are dispensed under an order and commonly used
in health care facilities, the bar code must contain the National Drug
Code number for the product. For blood and blood components, the rule
specifies the minimum contents of the machine-readable information in a
format approved by the Center for Biologics Evaluation and Research
Director as blood centers have generally agreed upon the information to
be encoded on the label. The rule is intended to help reduce the number
of medication errors in hospitals and other health care settings by
allowing health care professionals to use bar code scanning equipment
to verify that the right drug (in the right dose and right route of
administration) is being given to the right patient at the right time.
Most of the information collection burden resulting from the final
rule, as calculated in table 1 of the final rule (69 FR at 9149), was a
one-time burden that does not occur after the rule's compliance date of
April 26, 2006. In addition, some of the information collection burden
estimated in the final rule is now covered in other OMB-approved
information collection packages for FDA. However, parties may continue
to seek an exemption from the bar code requirement under certain,
limited circumstances. Section 201.25(d) (21 CFR 201.25(d)) requires
submission of a written request for an exemption and describes the
contents of such requests. Based on the number of exemption requests we
have received, we estimate that approximately 2 exemption requests may
be submitted annually, and that each exemption request will require 24
hours to complete. This would result in an annual reporting burden of
48 hours.
[[Page 49819]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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201.25(d) 2 1 2 24 48
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: August 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20205 Filed 8-16-12; 8:45 am]
BILLING CODE 4160-01-P