Document ID: FDA-2009-N-0506-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
Posted Date: 2009-11-06T05:00Z

[Federal Register: November 6, 2009 (Volume 74, Number 214)]
[Notices]               
[Page 57495-57496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no09-58]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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.

-----------------------------------------------------------------------

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 January 5, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, Elizabeth.Berbakos@fda.hhs.gov, 301-
796-3792.

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.

[[Page 57496]]

Bar Code Label Requirement for Human Drug and Biological Products (21 
CFR Part 314) (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 pursuant to 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 pursuant to 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.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        No. of Responses     Total Annual        Hours per
  21 CFR Section      Respondents       per Respodent        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
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: November 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26850 Filed 11-5-09; 8:45 am]

BILLING CODE 4160-01-S