[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Notices]
[Pages 63182-63183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31063]


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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

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 
December 26, 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. 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.

Reports of Corrections and Removals for Manufacturers, Importers, 
and Distributors of Medical Devices (21 CFR 806.10 and 806.20).

    In a final rule published in the Federal Register of May 19, 1997 
(62 FR 27183), FDA issued regulations requiring that manufacturers, 
importers, and distributors of medical devices report promptly to FDA 
any corrections or removals of a device undertaken to reduce a risk to 
health posed by the device or to remedy a violation of the Federal 
Food, Drug, and Cosmetic Act (the act) that could present a risk to 
health. The collection of this information is required by section 
519(f) of the act (21 U.S.C. 360i(f)). These regulations will help FDA 
to protect the public health by ensuring that the agency has current 
and complete information regarding those actions taken to reduce risks 
to health caused by devices. Reports of such actions will improve the 
agency's ability to evaluate device-related problems and to take prompt 
action against potentially dangerous devices.

                                   Table 1.--Estimated Annual Reporting Burden                                  
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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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                                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.                                                                                                  


[[Page 63183]]

    In the final rule (62 FR 27183), the agency requested comments on 
the information collection provision of the new regulation. The 60-day 
comment period closed July 18, 1997. The agency received four comments. 
Comments received in response to the information collection provisions 
stated that: (1) The U.S. designated agent provisions should be 
reinstated; (2) the definition of risk to health is confusing and 
contradictory, and it raises the threshold of reports of corrective and 
removal actions to that of a voluntary recall, and as such will de 
facto result in the automatic classification of these reports as 
recalls; (3) FDA has underestimated the reporting burden; and (4) the 
recordkeeping requirements place undue burden on industry.
    FDA disagrees with these comments. As discussed in the May 1997 
final rule requiring reports of corrections and removals, FDA published 
a final rule staying the U.S. designated agent provisions of the 
medical device reporting (MDR) rule in the Federal Register of July 23, 
1996 (61 FR 38346). FDA stayed those provisions in response to serious 
concerns on the part of regulated industry that the agency had not 
adequately considered the costs to and administrative burden on foreign 
firms. The same concerns apply to the U.S. designated agent provision 
included in the proposed rule to require reports of corrections and 
removals (59 FR 13828, March 23, 1994). FDA omitted that provision in 
the final rule (62 FR 27183) to allow the agency to continue to 
consider industry's concerns. The agency has not announced its decision 
on whether it will reinstate U.S. designated agent provisions in MDR or 
the corrections and removals rule, but intends to do so in the future.
    FDA does not believe that the definition of ``risk to health'' in 
the corrections and removals rule is confusing or contradictory. The 
agency and manufacturers have used this same definition successfully 
under part 7 (21 CFR part 7), the voluntary recall rule, for over 20 
years. Moreover, by using the definition of ``risk to health'' that 
appears in the voluntary recall rule, the agency believes that it has 
established an appropriate threshold for requiring reports of removals 
and corrections. The definition the agency adopted in the final rule is 
narrower than the one that appeared in the proposed rule and eliminates 
the burden on manufacturers of having to report corrections of minor or 
very remote health risks. Adoption of this definition does not affect 
recall procedures under part 7, which remain voluntary.
    The agency does not believe that the reporting burden for reports 
of corrections and removals has been underestimated. The agency revised 
the reporting and recordkeeping burden estimate in the final rule 
upward based on a review of voluntary reporting data and industry 
complaint files. The comments did not submit any specific data as to 
what they believe to be the true costs of the rule.
    The agency disagrees with the comment that recordkeeping 
requirements place an undue burden on industry. The statute requires 
manufacturers to keep records of corrections and removals that do not 
meet the requirements for reporting. The regulation implements this 
statutory requirement. FDA believes that the recordkeeping requirement 
of the corrections and removals rule carries out the statutory mandate 
and is appropriately tailored to the agency's mission of protecting the 
public health. The statute and the regulation require reporting only of 
events, corrections, and removals that are initiated to address a 
public-health risk. FDA believes that it has limited reporting 
requirements to information necessary to carry out its mission of 
protecting the public health.

    Dated: November 19, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-31063 Filed 11-25-97; 8:45 am]
BILLING CODE 4160-01-F