97-26257. Agency Information Collection Activities; Submission for OMB Review; Comment Request

[Federal Register Volume 62, Number 192 (Friday, October 3, 1997)]
[Notices]
[Pages 51872-51873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26257]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0401]


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 
November 3, 1997.

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. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.


[[Page 51873]]


SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance:

Export of Medical Devices--Foreign Letters of Approval--21 U.S.C. 
381(e)(2) (OMB Control No. 0910-0264--Reinstatement)

    Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 381(e)(2)) provides for the exportation of an 
unapproved device under certain circumstances if the exportation is not 
contrary to the public health and safety and it has the approval of the 
foreign country to which it is intended for export.
    Requesters communicate (either directly or through a business 
associate in the foreign country) with a representative of the foreign 
government to which they seek exportation, and written authorization 
must be obtained from the appropriate office within the foreign 
government approving the importation of the medical device. FDA uses 
the written authorization from the foreign country to determine whether 
the foreign country has any objection to the importation of the device.
    The respondents to this collection of information are companies 
that seek to export medical devices.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                        Annual Frequency per       Total Annual                                                 
  No. of Respondents          Response              Responses          Hours per Response        Total Hours    
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20...................            1                     20                      0.5                  10          
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    These estimates are based on the experience of FDA's medical device 
program personnel. In fiscal year 1995, FDA received approximately 800 
requests from U.S. firms to export medical devices under section 
801(e)(2) of the act. However, the enactment of the Food and Drug 
Export Reform and Enhancement Act of 1996 has greatly reduced the 
number of export permit requests made under section 801(e)(2) to an 
estimated 20 per year.

    Dated: September 26, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-26257 Filed 10-2-97; 8:45 am]
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