41676 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

21 CFR Section2 No. of Recordkeepers

Annual Frequency per

Recordkeeping

Total Annual

Records

Hours per Recordkeeper Total Hours

606.165 1524 3,553 540,000 0.083 44,820

606.170(a) 3223 12 3,864 1 3,864

Total 330,903

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

2The recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOP’s, are included in the estimate for § 606.100(b); the recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for

plateletpheresis, are included in the estimate for § 606.110(a); and the recordkeeping requirements in §§ 640.2(f), 640.3(a)(2), 640.3(f),

640.4(a)(2), 640.25(b)(4) and (c)(1), 640.31(b), 640.33(b), 640.51(b), 640.53(c), 640.56(b) and (d), 640.61, 640.63(b)(3), (e)(1), and (e)(3),

640.65(b)(2), 640.71(b)(1), 640.72, and 640.76(a) and (b), which address the maintenance of various records, are included in the estimate for

§ 606.160. 3 5 percent of HCFA and FDA-registered blood establishments (0.05 X (3,400 + 3,032))

4 5 percent of FDA-registered establishments (3,032)

5 5 percent of pheresis establishments (1,349)

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16978 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1226]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Investigational Device Exemptions,

Reports, and Records

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 August 7,

2000.

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.

Investigational Device Exemptions,

Reports, and Records—21 CFR Part 812

(OMB Control No. 0910–0078)—

Extension

Section 520(g) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360j(g)) establishes the statutory

authority to collect information

regarding investigational devices and

establishes rules under which new

medical devices may be tested using

human subjects in a clinical setting. The

FDA Modernization Act of 1997 added

section 520(g)(6) to the act and

permitted changes to be made to either

the investigational device or to the

clinical protocol without FDA approval

of an investigational device exemption

(IDE) supplement.

An IDE allows a device, which would

otherwise be subject to provisions of the

act, such as premarket notification or

premarket approval, to be used in

investigations involving human subjects

in which the safety and effectiveness of

the device is being studied. The purpose

of part 812 (21 CFR part 812) is to

encourage, to the extent consistent with

the protection of public health and

safety and with ethical standards, the

discovery and development of useful

devices intended for human use. The

IDE regulation is designed to encourage

the development of useful medical

devices and allow investigators the

maximum freedom possible, without

jeopardizing the health and safety of the

public or violating ethical standards.

To do this, the regulation provides for

different levels of regulatory control

depending on the level of potential risk

the investigational device presents to

human subjects. Investigations of

significant risk devices, those that

present a potential for serious harm to

the rights, safety, or welfare of human

subjects, are subject to the full

requirements of the IDE regulation.

Nonsignificant risk device

investigations, those that do not present

a potential for serious harm, are subject

to the reduced burden of the abbreviated

requirements.

The regulation also includes

provisions for treatment IDE’s. The

purpose of these provisions is to

facilitate the availability, as early in the

device development process as possible,

of promising new devices to patients

with life-threatening or serious

conditions for which no comparable or

satisfactory alternative therapy is

available.

Section 812.10 allows the sponsor of

the IDE to request a waiver to all of the

requirements of part 812. This

information is needed for FDA to

determine if waiver of the requirements

of part 812 will impact the public’s

health and safety.

Sections 812.20, 812.25, and 812.27,

consist of the information necessary to

file an IDE application with FDA. The

submission of an IDE application to

FDA is required only for significant risk

device investigations. Section 812.20

lists the data requirements for the

original IDE application, § 812.25 lists

the contents of the investigational plan,

and § 812.27 lists the data relating to

previous investigations or testing. The

information in this original IDE

application is evaluated by the Center

for Devices and Radiological Health to

determine whether the proposed

investigation will reasonably protect the

public health and safety, and for FDA to

make a determination to approve the

IDE.

Once FDA approves an IDE

application, a sponsor must submit

certain requests and reports. Under

§ 812.35, a sponsor who wishes to make

a change in the investigation which

affects the scientific soundness of the

study or the rights, safety, or welfare of

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices 41677

the subjects is required to submit a

request for the change to FDA. Under

§ 812.150, a sponsor is required to

submit reports to FDA. These requests

and reports are submitted to FDA as

supplemental applications. This

information is needed for FDA to ensure

protection of human subjects and to

allow review of the study’s progress.

Section 812.36(c) identifies the

information necessary to file a treatment

IDE application. FDA uses this

information to determine if wider

distribution of the device is in the

interests of the public health. Section

812.36(f) identifies the reports required

to allow FDA to monitor the size and

scope of the treatment IDE, to assess the

sponsor’s due diligence in obtaining

marketing clearance of the device and to

ensure the integrity of the controlled

clinical trials.

Section 812.140 lists the

recordkeeping requirements for

investigators and sponsors. FDA

requires this information for tracking

and oversight purposes. Investigators

are required to maintain records,

including correspondence and reports

concerning the study; records of receipt,

use, or disposition of devices; records of

each subject’s case history and exposure

to the device; informed consent

documentation; study protocol and

documentation of any deviation from

the protocol. Sponsors are required to

maintain records, including

correspondence and reports concerning

the study; records of shipment and

disposition; signed investigator

agreements; adverse device effects

information; and, for a nonsignificant

risk device study, an explanation of the

nonsignificant risk determination,

records on device name and intended

use, study objectives, investigator

information, institutional review board

(IRB) information, and a statement on

the extent that good manufacturing

practices will be followed.

The most likely respondents to this

information collection will primarily be

medical device manufacturers,

investigators, hospitals, health

maintenance organizations, and

businesses.

In the Federal Register of April 13,

2000 (65 FR 19912), the agency

requested comments on the proposed

collection of information. No significant

comments were received.

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

812.10 1 1 1 1 1

812.20,812.25, and 812.27 600 0.5 300 80 24,000

812.35 and 812.150 (Significant) 600 7 4,200 6 25,200

812.150 (Nonsignificant) 600 0.017 10 6 60

812.36(c) 6 1 6 120 720

812.36(f) 6 2 12 20 240

Total 50.221

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

Records

Hours per Recordkeeper Total Hours

812.40 600 0.5 300 10 3,000

Original Supplemental 600 7 4,200 1 4,200

Nonsignificant 600 1 600 6 3,600

Total 10,800

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

I. Reporting

Section 812.10 estimates are based on

the fact that FDA has received very few,

if any, waiver requests in the past, and

estimates that very few will be

submitted in the future. Therefore, FDA

estimates a minimal burden to account

for waiver requests.

Sections 812.20, 812.25, and 812.27

estimates are based on the average of

IDE’s submitted from fiscal years 1995

through 1999. FDA estimates the annual

reporting burden for one IDE original

application to be approximately 80

hours, and the annual reporting burden

for one IDE supplement to be

approximately 6 hours.

Sections 812.35 and 812.150 estimates

are based on the average of IDE

supplements submitted from fiscal years

1995 through 1999 for significant risk

device studies. FDA estimates the

annual reporting burden for one IDE

supplement to be approximately 6

hours.

The reporting burden for

nonsignificant risk device studies

(§ 812.150) is negligible. Nonsignificant

risk device studies are not reported to

FDA unless a problem is reported such

as an unanticipated adverse device

reaction, failure to obtain informed

consent, withdrawal of IRB approval, or

a recall of a device. In the past, an

average of 10 incidences or less

annually have been reported to FDA.

Section 812.36(c) and (f) estimates are

based on FDA’s experience with the

treatment use of drugs and knowledge of

the types of devices that may meet the

treatment use criteria. FDA estimates

that an average of six treatment use

applications will be submitted each

year. FDA estimates that it will take

approximately 120 hours to prepare a

treatment IDE and the total annual

burden for preparing applications will

be 720 hours. FDA also estimates that it

will take approximately 20 hours to

prepare a semiannual report, resulting

in a total annual burden of 240 hours for

annual reports.

II. Recordkeeping

Section 812.40 estimates are based on

conversations with manufacturers,

industry trade association groups, and

41678 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices

businesses over the last 3 years. For

significant risk device investigations,

FDA has estimated that the

recordkeeping burden for preparing an

original IDE submission averages 10

hours for each original IDE submission.

Similarly, through the same

conversations mentioned above, FDA

has estimated recordkeeping for each

supplement requires 1 hour. The

recordkeeping burden for nonsignificant

risk device investigations is difficult to

estimate because nonsignificant risk

device investigations are not required to

be submitted to FDA. The IDE staff

estimates that the number of

recordkeepers for nonsignificant risk

device investigations is equal to the

number for active significant risk device

investigations. The recordkeeping

burden, however, is reduced for

nonsignificant risk device studies. It is

estimated that 600 recordkeepers will

spend 6 hours each in maintaining these

records.

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16974 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0928]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Request

for Samples and Protocols

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 August 7,

2000.

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:

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

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

has submitted the following proposed

collection of information to OMB for

review and clearance.

Request for Samples and Protocols

(OMB Control Number 0910–0206)—

Extension

Under section 351 of the Public

Health Service Act (42 U.S.C. 262), FDA

has the responsibility to issue

regulations that prescribe standards

designed to ensure the safety, purity,

and potency of biological products and

to ensure that licenses for such products

are only issued when a product meets

the prescribed standards. Under § 610.2

(21 CFR 610.2), FDA may at any time

require manufacturers of licensed

biological products to submit to FDA

samples of any lot along with the

protocols showing the results of

applicable tests prior to marketing the

lot of the product. In addition to § 610.2,

there are other regulations that require

the submission of samples and protocols

for specific licensed biological products

as follows: Sections 640.101(f) (21 CFR

640.101(f)) (Immune Globulin (Human)),

660.6 (21 CFR 660.6) (Antibody to

Hepatitis B Surface Antigen), 660.36 (21

CFR 660.36) (Reagent Red Blood Cells),

and 660.46 (21 CFR 660.46) (Hepatitis B

Surface Antigen).

Section 640.101(f)(2) requires for each

lot of Immune Globulin (Human)

product, the submission of all protocols

relating to the history of the product and

all results of all tests prescribed in the

additional standards for the product.

Section 660.6(a) provides

requirements for the frequency of

submission of samples from each lot of

Antibody to Hepatitis B Surface Antigen

product, and § 660.6(b) provides the

requirements for the submission of a

protocol containing specific information

along with each required sample. For

§ 660.6 products subject to official

release by FDA, one sample from each

filling of each lot is required to be

submitted along with a protocol

consisting of a summary of the history

or manufacture of the product,

including all results of each test for

which test results are requested by the

Center for Biologics Evaluation and

Research (CBER). After official release is

no longer required, one sample along

with a protocol is required to be

submitted at an interval of 90 days. In

addition, samples, which must be

accompanied by a protocol, may at any

time be required to be submitted to FDA

if continued evaluation is deemed

necessary.

Section 660.36(a) requires, after each

routine establishment inspection by

FDA, the submission of samples from a

lot of final Reagent Red Blood Cell

product along with a protocol

containing specific information. Section

660.36(a)(2) requires a protocol

containing information including, but

not limited to, manufacturing records,

test records, and test results. Section

660.36(b) requires a copy of the

antigenic constitution matrix specifying

the antigens present or absent to be

submitted to FDA at the time of initial

distribution of each lot.

Section 660.46(a) provides

requirements for the frequency of

submission of samples from each lot of

Hepatitis B Surface Antigen product,

and § 660.46(b) provides the

requirements for the submission of a

protocol containing specific information

along with each required sample. For

§ 660.46 products subject to official

release by FDA, one sample from each

filling of each lot is required to be

submitted along with a protocol

consisting of a summary of the history

or manufacture of the product,

including all results of each test for

which test results are requested by

CBER. After notification of official

release is received, one sample along

with a protocol is required to be

submitted at an interval of 90 days. In

addition, samples, which must be

accompanied by a protocol, may at any

time be required to be submitted to FDA

if continued evaluation is deemed

necessary.

Samples and protocols are required by

FDA to help ensure the safety, purity, or

potency of the product because of the

potential lot-to-lot variability of a

product produced from living

organisms. In cases of certain biological

products (e.g., Albumin, Plasma Protein

Fraction, and specified biotechnology

and specified synthetic biological

products) that are known to have lot-tolot consistency, official lot release is not

normally required. However,

submissions of samples and protocols of

these products may still be required for

surveillance, licensing, and export

purposes, or in the event that FDA

obtains information that the

manufacturing process may not result in

consistent quality of the product.

The following burden estimate is for

protocols required to be submitted with

each sample. The collection of samples

is not a collection of information under

5 CFR 1320.3(h)(2). Respondents to the

collection of information under § 610.2

are manufacturers of any licensed

biological product. Respondents to the