28388 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 / Notices

Dated: May 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13650 Filed 5–21–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Medical Devices; Implementation of

Third Party Review Under the Food

and Drug Administration

Modernization Act of 1997; Emergency

Processing Request Under OMB

Review

[Docket No. 98N–0331]

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

program under which persons may be

accredited to review premarket

notifications and recommend initial

classification of certain medical devices.

At the same time, FDA is announcing

the termination of the Third Party

Review Pilot Program. This notice

announces the criteria to accredit or

deny accreditation to persons

(Accredited Persons) who request to

conduct premarket notification reviews

consistent with provisions of the FDA

Modernization Act of 1997 (FDAMA).

FDA is also announcing that this

proposed collection of information has

been submitted to the Office of

Management and Budget (OMB) for

emergency processing under the

Paperwork Reduction Act of 1995 (the

PRA). FDA is requesting OMB approval

within 45 days of receipt of this

submission. FDA is taking this action to

implement section 210 of FDAMA. The

availability of guidance detailing the

review of submissions, training for third

party reviewers, and basic document

processing by FDA is announced

elsewhere in this issue of the Federal

Register.

DATES: Submit written comments on

the collection of information by June 22,

1998. FDA will begin accepting

applications for accreditation of

Accredited Persons on July 20, 1998,

and intends to make a list of Accredited

Persons available on or about September

23, 1998. Beginning November 21, 1998,

the agency will accept reviews and

recommendations from Accredited

Persons. On that same date, FDA plans

to terminate the Third Party Review

Pilot Program that began on August 1,

1996. FDA is currently planning to

provide periodic training sessions for

Accredited Persons, with the first such

session scheduled for October 14-16,

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. All comments should

be identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT: John

F. Stigi, Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850,

301–443–6597, FAX 301–443–8818.

SUPPLEMENTARY INFORMATION:

I. Background

A. Third Party Review Pilot Program

In the Federal Register of April 3,

1996 (61 FR 14789), FDA announced

that it would begin a 2-year voluntary

pilot program to test the feasibility of

using third party reviewers to improve

the efficiency of the agency’s review of

510(k)’s for selected low-and-moderate

risk medical devices. FDA had

previously solicited public comments

on its plans for the pilot program in a

notice issued in the Federal Register of

June 1, 1995 (60 FR 28618), and at a

public workshop held June 19, 1995.

The comments received by the agency

were addressed in the Federal Register

notice (61 FR 14789).

The program announced in the April

3, 1996, notice provided for third party

review for 251 types of devices that

were included in the pilot program.

These included all class I devices that

were not exempt from 510(k) at that

time (221 devices), and 30 class II

devices, 24 of which were to be phased

into the program over time.

Under the pilot program, persons

required to submit 510(k)’s for the

eligible devices were permitted to

contract with an FDA Recognized Third

Party and submit a 510(k) directly to the

third party for review. Persons who did

not wish to participate in the pilot

continued to submit 510(k)’s directly to

FDA. The third party applied FDA’s

510(k) review criteria and submitted its

documented review and

recommendation on the substantial

equivalence of the device to FDA. FDA

then checked the review and issued a

decision letter. FDA established a 30-

day performance goal for its issuance of

final decisions based on third party

reviews.

The purpose of the pilot program was

to: (1) Provide manufacturers of eligible

devices with an alternative review

process that could yield more rapid

marketing clearance decisions, and (2)

enable FDA to target its scientific review

resources at higher-risk devices while

maintaining confidence in the review by

third parties of low-to-moderate risk

devices. The pilot program was

intended to determine the feasibility of

these outcomes.

The agency received applications for

recognition as third party reviewers

from 37 prospective third parties. These

applications were reviewed by a Third

Party Recognition Board established by

FDA. On July 11, 1996, FDA made

publicly available a list of seven

Recognized Third Parties, and

immediately began a training program

for third party review.

The pilot program began August 1,

1996, as scheduled. During the first 18

months of the pilot program, FDA

received 22 510(k)’s that were reviewed

by Recognized Third Parties. In contrast,

during the same period, FDA received

more than 1,300 510(k)’s for third partyeligible devices that were not reviewed

by third parties.

B. FDA Modernization Act of 1997

The President signed FDAMA into

law on November 21, 1997. Section 210

of FDAMA codifies and expands the

ongoing Third Party Review Pilot

Program by establishing a new section

523 of Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360m),

directing FDA to accredit persons in the

private sector to conduct the initial

review of 510(k)’s for selected low-tomoderate risk devices. This section

specifies that an Accredited Person may

not review class III devices or class II

devices that are permanently

implantable, life-supporting, lifesustaining, or for which clinical data are

required. This section also sets limits on

the number of class II devices requiring

clinical data that may be ineligible for

Accredited Person review.

II. FDAMA Third Party Review

Program

Under the provisions of FDAMA, FDA

is establishing the criteria it will use to

determine whether it will accredit or

deny accreditation of persons for the

purpose of reviewing reports submitted

under section 510(k) of the act (21

U.S.C. 360(k)) and making

recommendations to FDA regarding the

initial classification of devices under

section 513(f)(1) of the act (21 U.S.C.

360c(f)(1)). As intended by Congress,
Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 / Notices 28389

this process is an expansion of FDA’s

Third Party Review Pilot Program. This

expanded program is applicable to a

greater number and variety of devices.

To ensure accurate and timely review,

Accredited Persons will be expected to

consult review guidance or national

and/or international standards

recognized by FDA. FDA is making

available on the CDRH home page on

the World Wide Web a list of devices for

which there are recognized standards or

review guidance and which will be

eligible for review by Accredited

Persons. FDA will update the list

regularly.

To be accredited by FDA, applicants

must demonstrate that they have the

appropriate qualifications and facilities

to conduct competent 510(k) reviews

and have instituted effective controls to

prevent any conflict of interest or

appearance of conflict of interest that

might affect the review process.

In accordance with FDAMA, to be

accredited by FDA an applicant must, at

a minimum, have the following

qualifications:

(1) An Accredited Person may not be

a Federal Government employee;

(2) An Accredited Person shall be an

independent organization not owned or

controlled by a manufacturer, supplier,

or vendor of devices and have no

organizational, material, or financial

affiliation with such a manufacturer,

supplier, or vendor;

(3) An Accredited Person shall be a

legally constituted entity permitted to

conduct the activities for which it seeks

accreditation;

(4) An Accredited Person shall not

engage in the design, manufacture,

promotion, or sale of devices;

(5) An Accredited Person shall

operate in accordance with generally

accepted professional and ethical

business practices and agree in writing

that, at a minimum, it will:

(a) Certify that reported information

accurately reflects data reviewed;

(b) Limit work to that for which

competence and capacity are available;

(c) Treat information received,

records, reports, and recommendations

as proprietary information;

(d) Promptly respond and attempt to

resolve complaints regarding its

activities for which it is accredited; and

(e) Protect against the use of any

officer or employee of the Accredited

Person who has a financial conflict of

interest regarding the device, and

annually make available to the public

disclosures of the extent to which the

Accredited Person, and the officers and

employees of the Accredited Person,

have maintained compliance with

requirements relating to financial

conflicts of interest.

In accordance with FDAMA, an

Accredited Person also must, at a

minimum, maintain records that

support its initial and continuing

qualifications to be an Accredited

Person. These records include:

(1) Documenting the training

qualifications of the Accredited Person

and the employees of the Accredited

Person;

(2) The procedures used by the

Accredited Person for handling

confidential information;

(3) The compensation arrangements

made by the Accredited Person; and

(4) The procedures used by the

Accredited Person to identify and avoid

conflicts of interest.

In addition to the above minimum

requirements for Accredited Persons,

FDA is establishing the following:

1. Personnel Qualifications

FDA expects to consider several

factors with respect to personnel

qualifications when it considers

accrediting applicants. These include:

(1) Whether the applicant’s personnel

have demonstrated knowledge of:

• The Federal Food, Drug, and

Cosmetic Act (21 U.S.C., 301 et seq.);

• The Public Health Service Act (42

U.S.C., 201 et seq.); and

• The regulations implementing these

statutes, particularly 21 CFR parts 800

through 1299.

(2) Whether the applicant:

• Has established, documented, and

executed policies and procedures to

ensure that 510(k)’s are reviewed by

qualified personnel, and will maintain

records on the relevant education,

training, skills, and experience of all

personnel who contribute to the

technical review of a 510(k);

• Has clear written instructions for

duties and responsibilities with respect

to 510(k) reviews available to its

personnel;

• Has employed personnel who, as a

whole, are qualified in all of the

scientific disciplines addressed by the

510(k)’s that the Accredited Person

accepts for review;

• Has identified at least one

individual who is responsible for

providing supervision over 510(k)

reviews and who has sufficient

authority and competence to assess the

quality and acceptability of these

reviews; and

• Is prepared to conduct technically

competent reviews at the time of

requesting accreditation by FDA.

(3) For appropriate review of a

particular class II device, FDA will

expect specialized education or

experience to assure a technically

competent review. In addition,

Accredited Persons will be expected to

consult national and/or international

standards recognized by FDA or review

guidance.

2. Facilities

FDA expects to accredit persons that

have the capability to interface with

FDA’s electronic data systems,

including FDA home page, CDRH home

page, and CDRH Facts-On-Demand. At a

minimum, this would include a

computer system with a modem and an

independent facsimile machine. FDA

will rely extensively on the use of FDA’s

electronic data systems for timely public

dissemination of guidance documents to

Accredited Persons.

3. Prevention of Conflicts of Interest

FDA expects Accredited Persons to be

impartial and free from any commercial,

financial, and other pressures that might

present a conflict of interest or an

appearance of conflict of interest. To

that end, when deciding whether to

accredit a person, FDA will consider

whether the person has established,

documented, and executed policies and

procedures to prevent any individual or

organizational conflict of interest,

including conflicts of contractors or

individual contract employees.

4. Training

Accredited Persons must certify in

their application that they will have

designated employees attend FDA

training for Accredited Persons. FDA

plans to provide such training on a

periodic basis for persons newly

accredited. FDA encourages applicants

who wish to begin submitting reviews

on November 21, 1998, to apply at least

60 days before the scheduled October 14

through 16, 1998 training session. FDA

will not accept 510(k) reviews and

recommendations from Accredited

Persons that have failed to have at least

one designated employee attend a

training session for Accredited Persons.

C. Safeguards

The Third Party Review Program

established by FDAMA includes

safeguards to maintain a high level of

quality in 510(k)’s reviewed by

Accredited Persons and to minimize

risk to public health. To ensure that

persons accredited under section 523 of

the act will continue to meet the

standards of accreditation, the statute

requires FDA to: (1) Make onsite visits

on a periodic basis to each Accredited

Person to audit the performance of such

person, and (2) take such additional
28390 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 / Notices

measures as the agency determines to be

appropriate.

In addition, the statute permits FDA

to suspend or withdraw accreditation of

any person accredited under section 523

of the act, after providing notice and an

opportunity for an informal hearing,

when such person is substantially not in

compliance with the requirements of

this section or poses a threat to public

health or fails to act in a manner

consistent with the purposes of this

section.

The act also has been amended to

establish a new prohibited act section to

protect the integrity of the Accredited

Person Program established by section

523 of the act. It is a prohibited act

under new section 301(y)(1) of the act

(21 U.S.C. 331(y)(1)) for an Accredited

Person to:

(1) Submit a report that is false or

misleading in any material respect;

(2) Disclose confidential information

or trade secrets without the express

written consent of the person who

submitted such information or secrets to

the Accredited Person; or

(3) Receive a bribe in any form or do

a corrupt act associated with a

responsibility delegated to the

Accredited Person under the act.

FDA also is requiring applicants who

wish to become an Accredited Person to

establish policies designed to identify,

prevent, and ensure reporting to FDA, of

instances of forum shopping by

submitters of 510(k)’s. Submitters of

510(k)’s who consult with more than

one party in order to find the Accredited

Person who is most likely to

recommend clearance of the 510(k) will

undermine the independence and

integrity of the Accredited Person

Review Program. FDA, therefore,

expects Accredited Persons to ensure

that the submitters of the 510(k)’s they

are reviewing have not previously

presented the submission to another

Accredited Person.

It is not feasible to identify or state

categorically all of the criteria for

evaluating whether a submitter has

forum shopped. However, if FDA

determines that a submitter has

obtained reviews of the same 510(k)

from more than one Accredited Person,

there will be a presumption of forum

shopping and FDA may refuse to

provide special processing of a

submitter’s 510(k) unless the submitter

can explain to FDA’s satisfaction why

the circumstances do not indicate forum

shopping.

III. Environmental Impact

The agency has determined under 21

CFR 25.30(k) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Paperwork Reduction Act of 1995

This voluntary third party review

program contains information collection

provisions which are subject to review

by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). FDA has submitted this proposed

collection of information to OMB and

has requested emergency processing

under section 3507(j) of the Paperwork

Reduction Act of 1995 and 5 CFR

1320.13. The information is essential to

the agency’s mission and is needed

immediately to meet the statutory

deadline for implementation of the

voluntary third party review program as

required by FDAMA. The use of normal

clearance procedures would be likely to

result in the prevention or disruption of

this collection of information. The title,

description, and respondent description

of the information collection provisions

are shown below with an estimate of the

annual recordkeeping and periodic

reporting burden. Included in the

estimate is the time for reviewing

instructions, gathering and maintaining

the data needed, and completing and

reviewing each collection of

information.

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.

Description: Section 210 of FDAMA

establishes a new section 523 of 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 previously conducted 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 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

Item No. of

Respondents

No. of Responses per

Respondents

Total Annual

Responses

Hours per

Respondents Total Hours

Request for accreditation 40 1 40 24 960

510(k) reviews conducted by accredited 3rd 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.
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]

BILLING CODE 4160–01–F

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]

BILLING CODE 4160–01–F

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]

BILLING CODE 4160–01–F