Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices 41573

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology. Send comments to Seleda

Perryman, CDC Assistant Reports

Clearance Officer, 1600 Clifton Road,

MS-D24, Atlanta, GA 30333. Written

comments should be received within 60

days of this notice. Comments regarding

this information collection are best

assured of having their full effect if

received within 60 days of the date of

this publication.

Proposed Projects

1. Requirement for a Special Permit to

Import Cynomolgus-African Green or

Rhesus Monkeys—(0920–0263)—

Extension—National Center for

Infectious Disease (NCID) Division of

Quarantine—A registered importer

nonhuman primates must submit to the

Director, CDC, a written plan which

specifies the steps that will be taken to

prevent exposure of persons and

animals during the entire importation

and quarantine process for the arriving

nonhuman primates. Under the special

permit arrangement, registered

importers must submit a plan to CDC for

the importation and quarantine if they

wish to import the specific monkeys

covered. The plan must address disease

prevention procedures to be carried out

in every step of the chain of custody of

such monkeys, from embarkation in the

country of origin to release from

quarantine. Information such as species,

origin and intended use for monkeys,

transit information, isolation and

quarantine procedures, and procedures

for testing of quarantined animals is

necessary for CDC to make public health

decisions. This information enables

CDC to evaluate compliance with the

standards and determine whether the

measures being taken to prevent

exposure of persons and animals during

importation are adequate. Once CDC is

assured, through the monitoring of

shipments (normally no more than 2),

that the provisions of a special permit

plan are being followed by a new permit

holder, and that the use of adequate

disease control practices is being

demonstrated, the special permit is

extended to cover the receipt of

additional shipments under the same

plan for a period of 180 days, and may

be renewed upon request. This

eliminates the burden on importers to

repeatedly report identical information,

requiring only that specific shipment

itineraries and information on changes

to the plan which require approval be

submitted.

The respondents are commercial or

not-for-profit importers of nonhuman

primates. We are requesting clearance

for 3 years. Total cost to Respondents:

$350 (14 x $25)

Respondents Number of respondents

Number of responses/respondentsAvg. burden/

responses

(in hrs.)

Total burden

(in hrs.)

Businesses ....................................................................................................... 5 5 2@0.5; 3@0.1 6.5

Organizations .................................................................................................... 15 5 0.1 7.5

Total ....................................................................................................... ........................ ........................ ........................ 14

Dated: July 29, 1998.

Charles W. Gollmar,

Acting Associate Director for Policy, Planning

and Evaluation Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–20719 Filed 8–3–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0453]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

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 and

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the submission of applications to

recognized accreditation bodies that

will assess potential U.S. Conformity

Assessment Bodies (CAB’s) seeking to

be designated under the United States

(U.S.)/European Community (EC)

Mutual Recognition Agreement (MRA)

to assess medical devices produced for

the EC market. 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

0910–0378). Since this was an

emergency approval that expires on

January 31, 1999, FDA is following the

normal PRA clearance procedures by

issuing 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 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.
41574 Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices

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.

Medical Devices: Third-Party Review

Program Under U.S./EC MRA (OMB

Control Number 0910–0378—Extension)

The third-party program under U.S./

EC MRA is intended to implement that

part of U.S./EC MRA that covers the

exchange of quality system evaluation

reports for all medical devices and

premarket evaluation reports for

selected low-to-moderate risk devices.

Under MRA, firms may apply to become

designated as a U.S. CAB. Firms who

are designated will be qualified to

conduct quality system evaluations for

all classes of devices and product-type

examinations and verifications for

selected devices based on EC

requirements under the voluntary thirdparty program authorized by MRA.

Firms designated as EC CAB’s could, in

turn, conduct quality system

evaluations for all classes of devices and

premarket 510(k) evaluations for

selected devices based on FDA

requirements. Under the voluntary

third-party program, reports of these

evaluations would be submitted by EC

CAB’s to FDA. EC CAB’s would also be

required to maintain copies of their

evaluation reports.

FDA estimates the burden of this

collection as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Item No. of

Respondents

Number of Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

Requests for Designation as U.S. CAB 12 1 12 24 288

Premarket Reports by EC CAB’s 20 5 100 40 4,000

Quality System Reports by EC CAB’s 20 5 100 32 3,200

Total 7,488

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Item No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Records of Evaluation of Premarket Submissions by

EC CAB’s 20 5 100 10 1,000

Records of Evaluation of Quality Systems 20 5 100 10 1,000

Total 2,000

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

The burdens are explained as follows:

I. Reporting

A. Requests for Designation as U.S. CAB

Under this program, U.S. firms may

apply for designation as a U.S. CAB.

Such designation will enable that firm

to perform third-party evaluations of

U.S. products for export to EC.

Likewise, European firms may apply to

be designated as EC CAB’s, which will

enable them to perform third-party

evaluations of products to be exported

to the United States. The application for

nomination as an EC CAB does not

represent a paperwork burden subject to

the PRA because the designation

procedure is an internal process which

is required by, and administered by,

European authorities. Only the

application for designation as a U.S.

CAB represents a paperwork burden

under the PRA. The agency anticipates,

based on discussions with the National

Institute of Science and Technology of

the U.S. Department of Commerce and

officials of other standards

organizations, that approximately 12

applications for designation as U.S.

CAB’s will be received.

B. Premarket Reports

Under this program, EC CAB’s will be

able to perform third-party evaluations

for certain products produced in Europe

for export to the United States. EC

CAB’s would be required to submit

reports of their evaluations to FDA.

Based upon information gathered during

the negotiation of U.S./EC MRA, the

agency anticipates that European

manufacturers will request third-party

evaluation for approximately 100

medical device products annually. The

agency further estimates, based on

dialogue with EC officials, that 20 firms

will be designated to act as EC CAB’s.

C. Quality System Reports

Under this program, EC CAB’s will be

able to perform third-party evaluations

of the quality systems established by

manufacturers of European products

produced for export to the United

States. EC CAB’s would be required to

submit reports of their evaluations to

FDA. Based upon information gathered

during the negotiation of U.S./EC MRA,

the agency anticipates that European

manufacturers will request third-party

evaluations for approximately 100

medical device products annually. The

agency estimates that 20 EC CAB’s will

perform these evaluations.

II. Recordkeeping

As stated previously, firms designated

as EC CAB’s will be able to perform

third-party evaluations of quality

systems and premarket submissions for

certain products produced for export to

the United States. Such evaluation will

be conducted consistent with FDA’s

regulatory requirements, and FDA will

require the reviewers to keep, in their

records, a copy of the report that they

submit to FDA for each evaluation. The

agency anticipates that 100 premarket
Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices 41575

reports and 100 quality system reports

will be generated and required to be

maintained by EC CAB’s annually.

Thus, the agency estimates that 100

records of evaluations of quality systems

and premarket submissions will be

retained by the designated EC CAB’s.

Based on experience with the ThirdParty Review Pilot Program, which was

announced in the Federal Register of

April 3, 1996 (61 FR 14789), the agency

anticipates that each recordkeeper will

require no more than 2 hours of

recordkeeping per review. The agency is

estimating 5 reviews per respondent and

a total of 10 hours per recordkeeper.

Dated: July 24, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20702 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

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.

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. Thirdparty 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

Item No. of

Respondents

No. of Responses Per

Respondent

Total Annual

Responses

Hours per

Respondent Total Hours

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

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