Document ID: FDA-2012-N-0873-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
Posted Date: 2019-07-22T04:00Z

[Federal Register Volume 84, Number 140 (Monday, July 22, 2019)]
[Notices]
[Pages 35118-35119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15488]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0873]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
21, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All

[[Page 35119]]

comments should be identified with the OMB control number 0910-0537. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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), FDA 
issued a final rule that requires human drug product and biological 
product labels to have bar codes. Specifically, the final rule requires 
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 healthcare facilities. It also requires 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 healthcare facilities, the bar code 
must contain the national drug code number for the product. For blood 
and blood components, the final rule specifies the minimum contents of 
the label in a format that is machine readable and approved for use by 
the Director, Center for Biologics Evaluation and Research. We believe 
that the final rule helps reduce the number of medication errors in 
hospitals and other healthcare settings by allowing healthcare 
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.
    Although most of the information collections created by the final 
rule have now been incorporated in OMB approved information collections 
supporting the applicable regulations, respondents to the collection 
may continue to seek an exemption from the bar code label requirement 
under Sec.  201.25(d) (21 CFR 201.25(d)). Section 201.25(d) requires 
submission of a written request for an exemption and describes the 
information that must be included in such a request. Based on the 
number of exemption requests we have received previously, we estimate 
that approximately two exemption requests will be submitted annually 
and each exemption request will require 24 hours to complete. This 
results in an annual reporting burden of 48 hours, as reflected in 
table 1.
    In the Federal Register of November 1, 2018 (83 FR 54930), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate 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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21 CFR 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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15488 Filed 7-19-19; 8:45 am]
 BILLING CODE 4164-01-P