2019-15488. 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 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: [phone], or emailed to [e-mail]. 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:

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, [e-mail].

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 § 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

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
21 CFR 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.

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.