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

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