Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
| Published date | 22 July 2019 |
| Citation | 84 FR 35118 |
| Record Number | 2019-15488 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
Federal Register, Volume 84 Issue 140 (Monday, July 22, 2019)
[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 [email protected]. 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,
[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), 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
