29142 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

Form No. 21 CFR Section No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours

Form FDA 1932a

(voluntary) 510.302(b) 100 1.0 100 1.0 100

Total burden

hours 19,350

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Response per

Recordkeeper

Hours per

Recordkeeper Total Hours

510.300(a) and 510.301(a) 190 13.16 2,500 10.35 25,875

510.300(b) and 510.301(b) 190 94.74 2,900 0.50 9,000

Total burden hours 34,875

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

The estimate of the times required for

record preparation and maintenance is

based on agency communication with

industry. Other information needed to

calculate the total burden hours (i.e.,

adverse drug reaction, lack of

effectiveness, and product defect

reports) are derived from agency records

and experience.

Dated: May 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13298 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0222]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Medical Devices;

Third-Party Review Under FDAMA

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

information collection requirements for

medical devices; third-party review

under the Food and Drug

Administration Modernization Act of

1997 (FDAMA).

DATES: Submit written or electronic

comments on the collection of

information by July 30, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. 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:

Peggy 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 in this document.

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

Under FDAMA (OMB Control No.

0910–0375)—Extension

Section 210 of FDAMA established 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

pilot program conducted previously by

FDA, participation in this third-party

review program by accredited persons is

entirely voluntary. A third party

wishing to participate will submit a

request for accreditation. Accredited

third-party reviewers have the ability to

review a manufacturer’s 510(k)

Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29143

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

reviews 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 continue to implement the accredited

person review program established by

FDAMA and improve the efficiency of

510(k) review for low to moderate risk

devices.

Respondents to this information

collection are businesses or other forprofit organizations.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Item No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response 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 ....................................................................... 6,560

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Item No. of

Recordkeepers

Annual Frequency

per Recordkeeper

Total Annual

Records

Hours per

Recordkeeper Total Hours

510(k) reviews ................... 35 4 140 10 1,400

Total ............................... 1,400

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 thirdparty 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 the 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

third-party review program is not as

limited in time, and is expanded in

scope, the agency anticipates that the

number of 510(k)s submitted for thirdparty review will remain the same as

they were during the last OMB approval

in 1998. The agency anticipates that it

will receive approximately 140 thirdparty 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 estimate of the times required for

record preparation and maintenance is

based on agency communication with

industry. Other information needed to

calculate the total burden hours (i.e.,

adverse drug reaction, lack of

effectiveness, and product defect

reports) are derived from agency records

and experience.

Dated: May 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13301 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0205]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Applications for

FDA Approval to Market a New Drug

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

requirements governing applications for

FDA approval to market a new drug.

DATES: Submit written or electronic

comments on the collection of

information by July 30, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the 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:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: Under the

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

agencies must obtain approval from the

Office of Management and Budget