Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 / Notices 28391

TABLE 2.—Estimated Annual Recordkeeping Burden1

Item No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

510(k) reviews 35 4 140 60 8,400

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

The burdens are explained as follows:

1. Reporting

a. Requests for accreditation: Under

the agency’s third-party review pilot

program, the agency received 37

applications for recognition as third

party reviewers, of which the agency

recognized 7. Under this expanded

program, the agency anticipates that it

will not see a significant increase in the

number of applicants. Therefore, the

agency is estimating that it will receive

40 applications. The agency anticipates

that it will accredit 35 of the applicants

to conduct third-party reviews.

b. 510(k) reviews conducted by

accredited third-parties: In 18 months

under the Third Party Review Pilot

Program, FDA received only 22 510(k)’s

that requested and were eligible for

review by third parties. Because the new

program is not as limited in time, and

is expanded in scope, the agency

anticipates that the number of 510(k)’s

submitted for third-party review will

increase. The agency anticipates that it

will receive approximately 140 third

party review submissions annually, i.e.,

approximately 4 annual reviews per

each of the estimated 35 accredited

reviewers.

2. Recordkeeping

Third party reviewers are required to

keep records of their review of each

submission. The agency anticipates

approximately 140 annual submissions

of 510(k)’s for third party review.

Prior to the implementation of the

program, FDA will publish in the

Federal Register a notice of OMB’s

decision to approve, modify, or

disapprove the information collection

provisions. An agency may not conduct

or sponsor, and a person is not required

to respond to, a collection of

information unless it displays a

currently valid OMB control number.

Dated: May 19, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–13799 Filed 5–20–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0438]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘User Fee Cover Sheet’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 13, 1998

(63 FR 7420), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0297. The

approval expires on April 30, 2001.

Dated: May 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13648 Filed 5–21–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0327]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Petition for Administrative Stay of

Action’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 12, 1998

(63 FR 7173 and 7174), the agency

announced that the proposed

information collection had been

submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0194. The

approval expires on April 30, 2001.

Dated: May 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13649 Filed 5–21–98; 8:45 am]

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