Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products, 2890 [E7-916]

Download as PDF 2890 Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Notices BILLING CODE 4184–01–P Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1482. DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: [FR Doc. E7–808 Filed 1–22–07; 8:45 am] In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Food and Drug Administration [Docket No. 2006N–0279] 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: Bar Code Label Requirement for Human Drug and Biological Products— (OMB Control Number 0910–0537)— Extension 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 February 22, 2007. 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: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief In the Federal Register of February 26, 2004 (69 FR 9120), FDA issued a new rule 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 machinereadable 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 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 submitted during 2004 and 2005, we estimate that approximately 2 waiver 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 July 24, 2006 (71 FR 41817), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 201.25(d) Annual Frequency per Response 2 Total Annual Responses 1 Hours per Response 2 24 Total 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ACTION: BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on PROD1PC70 with NOTICES 48 48 Dated: January 16, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–916 Filed 1–22–07; 8:45 am] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Total Hours Food and Drug Administration, HHS. VerDate Aug<31>2005 19:33 Jan 22, 2007 Jkt 211001 Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on February 22, 2007, from 8 a.m. to 5 p.m. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Location: Hilton Washington DC North/Gaithersburg, Salons A, B and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Ronald P. Jean, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3676, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512521. Please call the Information Line for up-to-date information on this meeting. Agenda: On February 22, 2007, the committee will discuss, make recommendations and vote on a E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 72, Number 14 (Tuesday, January 23, 2007)]
[Notices]
[Page 2890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-916]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0279]


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 
February 22, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 new rule 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 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 
submitted during 2004 and 2005, we estimate that approximately 2 waiver 
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 July 24, 2006 (71 FR 41817), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
201.25(d)                          2                  1                  2                 24                 48
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................                 48
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: January 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-916 Filed 1-22-07; 8:45 am]
BILLING CODE 4160-01-S
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