Document ID: FDA-2012-N-0873-0006
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: 2016-07-19T04:00Z

[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46940-46941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17044]

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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 
18, 2016.

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 
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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown Street, North Bethesda, MD 20852, 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 Products and Blood; OMB 
Control No. 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 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 health care facilities. The rule 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 health care facilities, the bar code must contain the 
NDC number for the product. For blood and blood components, the 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 the rule helps to 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.
    While most of the information collection burdens created by the 
final rule have now been incorporated into currently 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 2 exemption 
requests will be submitted annually and that each exemption request 
will require 24 hours to complete. This results in an annual reporting 
burden of 48 hours, as reflected below in Table 1.
    In the Federal Register of December 15, 2015 (80 FR 77637) FDA 
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:

[[Page 46941]]

                                                     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: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17044 Filed 7-18-16; 8:45 am]
 BILLING CODE 4164-01-P