[Federal Register Volume 63, Number 227 (Wednesday, November 25, 1998)]
[Notices]
[Pages 65210-65211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 91N-0396]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Medical Devices; Reports of Corrections and 
Removals

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 in this document 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 
December 28, 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 collection 
of information to OMB for review and clearance.
    Title: Medical Devices; Reports of Corrections and Removals.
    Description: FDA issued a direct final rule to amend the reporting 
and recordkeeping requirements for corrections and removals under part 
806 (21 CFR part 806) to eliminate those requirements for distributors 
of medical devices. This amendment implements changes made by the Food 
and Drug Administration Modernization Act of 1997 (FDAMA) to section 
519(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360i(f)). FDAMA did not amend section 519(f) of the act with respect to 
manufacturers and importers. Manufacturers and importers continue to be 
subject to the requirements of part 806.
    Description of Respondents: Business or other for profit 
organizations.
     In the Federal Register of August 7, 1998 (63 FR 42229), the 
agency requested comments on the proposed collections of information. 
No significant comments were received.
     FDA estimates the burden for this collection of information as 
follows:

[[Page 65211]]



                                  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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806.10                                880               1             880              10           8,800
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                Table 2.--Estimated Annual Recordkeeping Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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806.20                                440               1             440              10           4,400
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The information collection requirements in part 806 prior to the 
direct final rule (63 FR 42229) have been approved by OMB and assigned 
control number 0910-0359. When preparing the earlier package for 
approval of the information collection requirements in part 806, FDA 
reviewed the reports of corrections and removals submitted in the 
previous 3 years under 21 CFR part 7 (the agency's recall provisions). 
During that period of time, no reports of corrections or removals were 
submitted by distributors. For that reason, FDA did not include 
distributors among the respondents estimated in the collection burden 
for the requirements previously approved by OMB. Because distributors 
were not included in that earlier estimate and because FDAMA now has 
eliminated requirements for distributor reporting, FDA has determined 
that estimates of the reporting burden for Secs. 806.10 and 806.20 
should remain the same.

    Dated: November 17, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-31411 Filed 11-24-98; 8:45 am]
BILLING CODE 4160-01-F