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

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]

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