[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Pages 3141-3142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0531]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
February 20, 1998.
ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed

[[Page 3142]]

collection of information to OMB for review and clearance.

Exemptions and Variances from the Performance Standard for 
Electrode Lead Wires and Patient Cables

    FDA regulations in part 898 (21 CFR part 898) mandate a performance 
standard for electrode lead wires and patient cables. The purpose of 
the performance standard is to prevent electrocution from the use of 
unprotected electrode lead wires and patient cables with medical 
devices. To provide maximum flexibility in situations where the 
electrical accidents can be prevented in other ways, Sec. 898.14 
provides that any person subject to the performance standard may submit 
a petition under 21 CFR 10.30 requesting an exemption or variance from 
the standard. The petition must demonstrate why compliance with the 
standard is unnecessary or unfeasible and what alternate means will be 
used to protect the public health. FDA will use this information to 
determine whether granting an exemption is in the best interests of the 
public health. Allowing for exemptions and variances will provide for 
flexibility while assuring public health protection. Section 898.14 is 
stayed pending OMB clearance. FDA will announce the effective date of 
Sec. 898.14 in the Federal Register. Anticipated respondents to this 
collection of information are medical device manufacturers and 
distributors, and health care facilities.

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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10.30                                  50               1              50              10             500       
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\1\ There are no capital costs or operating maintenance costs associated with this collection of information.   


    Dated: January 8, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-1294 Filed 1-20-98; 8:45 am]
BILLING CODE 4160-01-F