2890 Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Notices 

[FR Doc. E7–808 Filed 1–22–07; 8:45 am] 

BILLING CODE 4184–01–P 

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 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

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

201.25(d) 2 1 2 24 48 

Total 48 

1There 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Orthopaedic and Rehabilitation 

Devices Panel of the Medical Devices 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: 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. 

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 

mstockstill on PROD1PC70 with NOTICES