9582 Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices

the MERS–TM to track internal events

will be recruited to participate. These

facilities will be asked to fill in the

textual description of the blood-product

related adverse event and to transfer the

two outcome codes from the MERS–TM

concerning problems with blood

products to two additional data fields in

the electronic format that will be

dedicated to collecting this coded

information. FDA will compare the

information obtained in this reporting

system with that obtained under

existing mandatory and voluntary

systems that are in place for transfusionrelated fatalities, product deviations,

and clinical adverse events. FDA will

consider the information that is

voluntarily reported under this pilot

program to design a system that will

assist FDA in gathering the most useful

data, in the least burdensome manner,

for its regulation (including packaging

and labeling provisions) of

establishments and products used in

transfusion medicine.

Participation in this pilot will be

voluntary and will initially include 25

hospitals that will respond to the

medical device questions. At the same

time, an initial nine blood

establishments and transfusion services

sites, which currently use the MERS–

TM, will be recruited to participate. It

is anticipated that during this pilot the

number of participants will increase to

approximately 250 facilities reporting

medical device problems and the

number of blood establishments and

transfusion-services sites is anticipated

to increase to 30. The electronic version

will take approximately 45 minutes, or

less, to complete. For the blood centers

that are participating, the burden of

participation will be approximately 15

minutes.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Medical devices: 83 15 1,245 .75 934

Blood transfusions: 10 150 1,500 .25 375

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

The number of respondents for

medical devices was determined by the

average number of respondents given

that 25 facilities will be enrolled in the

first year, up to 100 the second year, and

up to 250 the third year. Eighty three is

the average of the final complement of

250 facilities. The annual frequency of

response is based on FDA’s experience

with its mandatory and voluntary

reporting systems.

The number of respondents for blood

transfusions was determined by the

average number of respondents given

that a total of 30 blood establishments

will be enrolled at the end of 3 years.

The annual frequency of response was

based on the information that the

American Red Cross submits about 15

reports per establishment per year. The

MERS–TM will yield about a tenfold

higher than the American Red Cross rate

since it will include close-calls as well

as actual adverse events.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3321 Filed 2–7–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0050]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Medical Devices;

Classification/Reclassification;

Restricted Devices: Premarket

Approval of Medical Devices

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 information

collection, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection requirements for

premarket approval of medical devices.

DATES: Submit written or electronic

comments on the collection of

information by April 9, 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:

I. Background

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.

Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices 9583

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.

Premarket Approval of Medical

Devices—21 CFR Part 814 (OMB

Control No. 0910–0231)—Extension

Section 515 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360(e)) sets forth the requirements for

premarket approval of certain class III

medical devices. Class III devices are

either preamendments devices that have

been classified into class III,

postamendments devices which are not

substantially equivalent to a

preamendments device, or transitional

devices. Class III devices are devices

such as implants, life sustaining or life

supporting devices, or devices which

otherwise present a potentially

unreasonable risk of illness or injury, or

for which are of substantial importance

in preventing impairment of human

health. Most premarket approval

applications (PMA’s) are for

postamendments class III devices.

Under section 515 of the act, an

application must contain several pieces

of information including full reports of

all information concerning

investigations showing whether the

device is reasonably safe and effective.

The application should also include a

statement of components, ingredients,

and properties and of the principle or

principles of operation of such a device

and should also include a full

description of the methods used in, and

the facilities and controls used for the

manufacture and processing of the

device; and labeling specimens.

The implementing regulations,

contained in part 814 (21 CFR part 814),

further specify the contents of a PMA

for a class III medical device and the

criteria FDA employs in approving,

denying, or withdrawing approval of a

PMA and supplements to PMA’s. The

regulation’s purpose is to establish an

efficient and thorough procedure for

FDA’s review of PMA’s and

supplements to PMA’s for certain class

III (premarket approval) medical

devices. The regulations contained in

part 814 facilitate the approval of PMA’s

and supplements to PMA’s for devices

that have been shown to be reasonably

safe and effective and otherwise meet

the statutory criteria for approval. The

regulations also ensure the disapproval

of PMA’s and supplements to PMA’s for

devices that have not been show to be

reasonably safe and effective and that do

not otherwise meet the statutory criteria

for approval.

The Food and Drug Modernization

Act of 1997 (FDAMA) (Public Law 105–

115) was enacted on November 21,

1997, to implement revisions to the act

by streamlining the process of bringing

safe and effective drugs, medical

devices, and other therapies to the U.S.

market. Several provisions of this act

affect the PMA process, such as section

515(d)(6) of the act. This section

provided that PMA supplements were

required for all device changes that

affect safety and effectiveness of a

device unless such changes are

modifications to manufacturing

procedures or method of manufacture.

This type of manufacturing change

requires a 30-day notice, or where FDA

finds such notice inadequate, a 135-day

PMA supplement.

To make the PMA process more

efficient, FDA has in the past 3 years

made changes to the PMA program

based on comments received, has

complied with changes to the program

mandated by FDAMA and has worked

towards completion of its PMA

reinvention efforts.

Respondents to this information

collection are persons filing a PMA

application or a PMA supplement with

FDA for approval of certain class III

medical devices. Part 814 defines a

person as any individual, partnership,

corporation, association, scientific or

academic establishment, government

agency or organizational unit, or other

legal entity. These respondents include

entities meeting the definition of

manufacturers such as manufacturers of

commercial medical devices in

distribution prior to May 28, 1976 (the

enactment date of the Medical Device

Amendments). Additionally, hospitals

that re-use single use devices (SUD’s)

are also included in the definition of

manufacturers. For the next 3 years, it

is expected that FDA will receive four

PMA applications from hospitals that

remanufacture SUD’s. This figure has

been included in table 1 of this

document as part of the reporting

burden in § 814.15.

The total estimated reporting and

recordkeeping burden for this

information collection is 107,321 hours.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

814.15, 814.20, and 814.37 62 1 62 837 51,894

814.39(f) 487 1 487 66 32,142

814.82 43 1 43 66 5,805

814.84 43 1 43 10 430

Section 201 (FDAMA) 10 1 10 10 100

Section 202 (FDAMA) 15 1 15 10 150

Section 205 (FDAMA) 8 1 8 50 400

Section 208 (FDAMA) 26 1 26 30 780

Section 209 (FDAMA) 8 1 8 40 320

Totals 92,021

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

9584 Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

814.82(a)(5) and (a)(6) 900 1 900 17 15,300

Totals 15,300

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

The industry-wide burden estimate

for PMA’s is based on an FDA actual

average fiscal year annual rate of receipt

of 62 PMA original applications and 487

PMA supplements, using fiscal year

1996 through 2000 data.

The burden data for PMA’s is based

on data provided by manufacturers by

device type and cost element in an

earlier study. The specific burden

elements for which FDA has data are as

follows: (1) Clinical investigations: 67

percent of total burden estimate; (2)

submission of additional data or

information to FDA during a PMA

review: 12 percent; (3) additional device

development cost (e.g., testing): 10

percent; and (4) PMA and PMA

supplement preparation and

submissions, and development of

manufacturing and controls data: 11

percent.

II. Paperwork Burden Estimate

The burden estimates were derived by

consultation with FDA and industry

personnel. FDA’s estimates are based on

actual data collected from industry over

the past 3 years. An evaluation of the

type and scope of information requested

was also used to derive some time

estimates. For example, disclosure

information primarily requires time

only to update and maintain existing

manuals.

A. Reporting/Disclosure

The reporting burden can be broken

out by certain sections of the PMA

regulation: (1) § 814.15 Research

conducted outside the United States; (2)

§ 814.20 Application; and (3) § 814.37

PMA amendments and resubmitted

PMA’s.

The majority of the burden—51,894

burden hours—is due to the above three

requirements. Included in these three

requirements are the conduct of

laboratory and clinical trials as well as

the analysis, review, and physical

preparation of the PMA application.

FDA estimates that 62 manufacturers

(including hospital re-manufacturers of

single use devices) will be affected by

these requirements based on actual

average FDA receipt of new PMA

applications in years 1996 through

2000. FDA’s estimate of the hours per

response (837) was derived through

FDA’s experience and consultation with

industry and trade associations.

Included in these three requirements are

the conduct of laboratory and clinical

trails as well as the analysis, review,

and physical preparation of the PMA

application. In addition, FDA has based

its estimate on the results of an earlier

study that these requirements account

for the bulk of the burden identified by

manufacturers.

1. § 814.39(f)—PMA Supplements:

32,142 Burden Hours

FDA believes that the amendments

mandated by FDAMA for § 814.39(f),

permitting the submission of the 30-day

notices in lieu of regular PMA

supplements, will result in an

approximate ten percent reduction in

the total number of hours as compared

to regular PMA supplements. As a

result, FDA estimates that 32,142 hours

of burden are needed to complete the

requirements for regular PMA

supplements.

2. § 814.82—Postapproval requirements:

5,805 Burden Hours

Postapproval requirements concern

approved PMA’s that were not

reclassified and require a periodic

report. In the last decade (1991 to 2000),

the range of PMA’s that fit this category

averaged approximately 43 per year (70

percent of the 62 periodic submissions).

Most approved PMA’s have been subject

to some post approval study

requirement. Approximately half of the

average submitted PMA’s (31) require

associated postapproval studies (i.e.,

followup of patients used in clinical

trials to support the PMA or additional

preclinical information) that is laborintensive to compile and complete, and

the other PMA’s require minimal

information. Based on its experience

and on consultation with industry, FDA

estimates that preparation of reports and

information required by this section

require 5,805 hours (135 hours per

respondent).

3. § 814.84—Reports: 430 Burden Hours

Postapproval requirements described

in § 814.82 (above) require a periodic

report. FDA has determined

respondents meeting the criteria of

§ 814.84 will submit reports on a

periodic basis. As stated previously, the

range of PMA’s fitting this category

averaged approximately 43 per year.

These reports have minimal information

requirements. FDA estimates that

respondents will construct their report

and meet their requirements in

approximately 10 hours. This estimate

is based on FDA’s experience and on

consultation with industry. FDA

estimates that the periodic reporting

required by this section take 430 hours.

The total hours for statutory burden is

1,750. This burden estimate was based

on actual real FDA data tracked from

January 1, 1998, to the present, and an

estimate was derived to forecast future

expectations with regard to this

statutory data.

B. Recordkeeping

The recordkeeping burden in this

section involves the maintenance of

records used to trace patients and the

organization and indexing of records

into identifiable files to ensure the

device’s continued safety and

effectiveness. These records would be

required only of those manufacturers

who have an approved PMA and who

had original clinical research in support

of that PMA. For a typical year’s

submissions, 70 percent of the PMA’s

are eventually approved and 75 percent

of those have original clinical trial data.

Therefore, approximately 43 PMA’s a

year (62 annual submissions times 70

percent) would be subject to these

requirements. Also, because the

requirements apply to all active PMA’s,

all holders of active PMA applications

must maintain these records. PMA’s

have been required since 1976, and

there are 900 active PMA’s that could be

subject to these requirements, based on

actual FDA data. Each study has

approximately 200 subjects, and, at an

average of 5 minutes per subject, there

is a total burden per study of 1,000

minutes, or 17 hours. The aggregate

burden for all 900 holders of approved

original PMA’s, therefore, is 15,300

hours (900 approved PMA’s with

clinical data x 17 hours per PMA).

The applicant determines which

records should be maintained during

product development to document and/

or substantiate the device’s safety and

effectiveness. Records required by the

Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices 9585

current good manufacturing practices

for medical devices regulation (21 CFR

part 820) may be relevant to a PMA

review and may be submitted as part of

an application. In individual instances,

records may be required as conditions to

approval to ensure the device’s

continuing safety and effectiveness.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3323 Filed 2–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96M–0311]

Agency Information Collection

Activities; Announcement of OMB

Approval; Public Health Service

Guideline on Infectious Disease Issues

in Xenotransplantation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Public Health Service Guideline on

Infectious Disease Issues in

Xenotransplantation’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995.

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 October 18, 2000 (65

FR 62359), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 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 0910–0456. The

approval expires on January 31, 2004. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3320 Filed 2–7–01; 8:45 am]

BILLING CODE: 3510–22–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–0239]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Request

for Resolution of Scientific Disputes

Concerning the Regulation of Medical

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by March 12,

2001.

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: Wendy

Taylor, Desk Officer for FDA.

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: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Request for Resolution of Scientific

Disputes Concerning the Regulation of

Medical Devices

Section 404 of the Food and Drug

Administration Modernization Act of

1997 (FDAMA) is intended to ensure

that FDA has effective processes to

resolve the scientific disputes that

occasionally arise between FDA and the

regulated industry. Section 404 of

FDAMA added new section 562 to the

Federal Food, Drug, and Cosmetic Act

(the act) which requires FDA to

establish, by regulation, a procedure

under which a person who is a sponsor,

applicant, or manufacturer may request

a review of a scientific controversy,

when no other provision of the act or

regulation provides such review.

In a final rule issued in the Federal

Register of November 18, 1998 (63 FR

63978), FDA amended 21 CFR 10.75 to

reflect the provisions of FDAMA. Each

affected FDA center is responsible for

developing and administering its own

processes for handling requests for

section 404 of FDAMA reviews and is

issuing a guidance document containing

specific information of the type

suggested by the comments. The draft

guidance document outlines the

requirements for persons who are

sponsors, applicants, or manufacturers

of medical devices and who wish to file

a request for a review of a scientific

dispute by the panel as set out in the

guidance. Persons filing a request for

review should provide a Center for

Devices and Radiological Health

ombudsman with a concise summary of

the scientific issue in dispute, including

a summary of the particular FDA action

or decision to which the requesting

party objects, any prior advisory panel

action and the results of all efforts that

have been made to resolve the dispute,

and a clear articulated summary of the

arguments and relevant data and

information. They may also provide

material outside the official

administrative record and not in the

possession of FDA at the time the

decision or action in dispute was made

if it has a significant bearing on the

issue or related public health

considerations. The information that is

collected will form the basis for

resolving the dispute between the

requester and FDA.

The likely respondents to this

collection of information are medical

device sponsors, applicants, or

manufacturers who have a scientific

dispute with FDA and who request a

review of the matter by the Medical

Devices Dispute Resolution Panel.

In the Federal Register of April 27,

1999 (64 FR 22617), the agency

requested comments on the proposed

collection of information. No comments

concerning the information collection

were received.

FDA estimates the burden of this

collection of information as follows: