[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Pages 28856-28857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11630]



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.


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 June 
17, 2013.

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 [email protected]. 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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, [email protected].

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), 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 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 28857]]

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.
    In the Federal Register of August 17, 2012 (77 FR 49818), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden for this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
Sec.   201.25(d)...................................................               2                1                2               24               48
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11630 Filed 5-15-13; 8:45 am]