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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0385]

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

October 1, 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.

Supplements to Premarket Approval Applications for Medical Devices

The Food and Drug Administration Modernization Act of 1997 (FDAMA)

(Pub. L. 105-115) added section 515(d)(6) to the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C. 360e(d)(6)), modifying FDA's

statutory authority regarding premarket approval of medical devices.

This new section provides for an alternate form of notice to the agency

for certain types of changes to a device for which the manufacturer has

an approved premarket approval application (PMA). Under section

515(d)(6) of the act, PMA supplements are required for all changes that

affect safety and effectiveness, unless such changes involve

modifications to manufacturing procedures or the method of manufacture.

For those types of manufacturing changes, the manufacturer may submit

to the agency an alternate form of notice in the form of a 30-day

notice, or where FDA finds such notice inadequate, a 135-day PMA

supplement. The 30-day notice must: (1) Describe the change the

manufacturer intends to make, (2) summarize the data or information

supporting the change, and (3) state that the change has been made in

accordance with the requirements of 21 CFR part 820.

The manufacturer may distribute the device 30 days after FDA

receives the notice, unless FDA notifies the applicant, within that 30-

day period, that the notice is inadequate. If the notice is inadequate,

FDA will inform the manufacturer that a 135-day supplement is required

and will describe what additional information or action is necessary

for FDA to approve the change. The rule would incorporate the

provisions for a 30-day notice and 135-day supplements into FDA's

regulations in Sec. 814.39 (21 CFR 814.39) to reflect the changes made

by FDAMA.

Description of Respondents: Businesses or other for profit

organizations.

The information collection for Sec. 814.39 has been approved by OMB

until September 30, 1998, under Premarket Approval of Medical Devices

(OMB control number 0910-0231) for a total of 36,063 hours. FDA

believes that the submission of 30-day notices in lieu of PMA

supplements will result in approximately a 10 percent reduction in the

total number of hours needed to comply with Sec. 814.39. As a result,

FDA estimates that the new total number of hours needed to comply with

the information collection requirements in Sec. 814.39 is 32,612 for a

reduction of 3,451 hours.

FDA estimates the burden for this collection of information as

follows:

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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814.39 493 1 493 66.15 32,612

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

[[Page 46465]]

Dated: July 31, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-23404 Filed 8-31-98; 8:45 am]

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