Document ID: FDA-2009-N-0506-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Bar Code Label Requirement for Human Drug and Biological Products
Posted Date: 2010-04-29T04:00Z

[Federal Register: April 29, 2010 (Volume 75, Number 82)]
[Notices]               
[Page 22597-22598]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap10-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. Docket No. FDA-2009-N-0506]

 
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 June 1, 
2010.

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 e-mailed 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: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@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), we 
issued new 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 Director, Center for Biologics Evaluation and 
Research 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 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 two 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 November 6, 2009 FR 74 57495, FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    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          Hours per          Total Hours
                                                          Respondents          Respodent           Responses           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.

[[Page 22598]]

    Dated: April 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9902 Filed 4-28-10; 8:45 am]
BILLING CODE 4160-01-S