Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0331]

Agency Information Collection Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an

opportunity for public comment on the proposed collection of certain

information by the agency. Under the Paperwork Reduction Act of 1995

(the PRA), Federal agencies are required to publish notice in the

Federal Register concerning each proposed collection of information,

including each proposed extension of an existing collection of

information, and to allow 60 days for public comment in response to the

notice. This notice solicits comments on the Third-Party Review Pilot

Program established by FDA's Center for Devices and Radiological Health

(CDRH) under the FDA Modernization Act of 1997 (FDAMA). Elsewhere in

this issue of the Federal Register, FDA is publishing a notice

announcing OMB's approval of this collection of information (OMB

control number 0910-0375). Since this was an emergency approval that

expires on November 30, 1998, FDA is following the normal PRA clearance

procedures by isuing this notice.

DATES: Submit written comments on the collection of information by

October 5, 1998.

ADDRESSES: Submit written comments on the collection of information to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should

be identified with the docket number found in brackets in the heading

of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal

agencies must obtain approval from the Office of Management and Budget

(OMB) for each collection of information they conduct or sponsor.

``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests or requirements that members of

the public submit reports, keep records, or provide information to a

third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506

(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the

Federal Register concerning each proposed collection of information,

including each proposed extension of an existing collection of

information, before submitting the collection to OMB for approval. To

comply with this requirement, FDA is publishing notice of the proposed

collection of information set forth below.

With respect to the following collection of information, FDA

invites comments on: (1) Whether the proposed collection of information

is necessary for the proper performance of FDA's functions, including

whether the information will have practical utility; (2) the accuracy

of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

Title: Medical Devices; FDAMA Third-Party Review (OMB Control

Number 0910-0375--Extension)

Description: Section 210 of FDAMA establishes a new section 523 of

the Federal Food, Drug, and Cosmetic Act (the act), directing FDA to

accredit persons in the private sector to review certain premarket

applications and notifications. As with the Third-Party Review Pilot

Program previously conducted by FDA, participation in this Third-Party

Review Pilot Program by accredited persons is entirely voluntary. A

third party wishing to participate will submit a request for

accreditation. Accredited third-party reviewers will have the ability

to review a manufacturer's 510(k) submission for selected devices.

After reviewing a submission, the reviewer will forward a copy of the

510(k) submission, along with the reviewer's documented review and

recommendation, to FDA. Third-party reviewers should maintain records

of their 510(k) reviews and a copy of the 510(k) for a reasonable

period of time. This information collection will allow FDA to implement

the Accredited Person Review Program established by FDAMA and improve

the efficiency of 510(k) review for low to moderate-risk devices.

Description of Respondents: Businesses or other for profit

organizations.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden1

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No. of

Item No. of Responses Per Total Annual Hours per Total Hours

Respondents Respondent Responses Respondent

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Requests for accreditation 40 1 40 24 960

510(k) reviews conducted by

accredited third parties 35 4 140 40 5,600

Total hours 6,560

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

[[Page 41576]]

Table 2.--Estimated Annual Recordkeeping Burden1

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Annual

Item No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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510(k) reviews 35 4 140 102 3502

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

information.

\2\ Due to clerical error, the recordkeeping burden hours for 510(k) reviews that appeared in a notice issued in

the Federal Register of May 22, 1998 (63 FR 28388) were incorrect. Table 2 of this document contains the

correct estimates.

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 were 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. The agency estimates

that each third-party reviewer will require approximately 10 annual

hours to maintain records of their reviews and reports.

Dated: July 24, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-20705 Filed 8-3-98; 8:45 am]

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