[Federal Register Volume 71, Number 141 (Monday, July 24, 2006)]
[Notices]
[Pages 41817-41818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0279]


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 written or electronic comments on the collection of 
information by September 22, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Elizabeth Berbakos, Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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

    In the Federal Register of February 26, 2004 (69 FR 9120), we 
issued a new rule 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 9120 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

[[Page 41818]]

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 submitted 
during 2004 and 2005, we estimate that approximately 2 waiver 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.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                     No. of Responses Per      Total Annual
                21 CFR Section                  No. of Respondents        Respondent             Responses        Hours per Response      Total Hours
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201.25(d)                                                         2                     1                     2                    24                 48
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Total                                          ....................  ....................  ....................  ....................                 48
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11641 Filed 7-21-06; 8:45 am]
BILLING CODE 4160-01-S