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

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices 41679

collection of information under

§§ 640.101(f)(2), 660.6(b), 660.36(a)(2)

and (b), and 660.46(b) are manufacturers

of the specific products referenced

previously. The estimated number of

respondents for each regulation is based

on the annual number of manufacturers

that submitted samples and protocols

for biological products, including

submissions for lot release, surveillance,

licensing, or export. There are an

estimated 350 manufacturers of licensed

biological products, however, based on

information obtained from FDA’s data

base system, approximately 100

manufacturers submitted samples and

protocols in 1998, under the regulations

cited previously. FDA estimates that

approximately 86 manufacturers

submitted protocols under § 610.2, and

14 manufacturers submitted protocols

under the regulations for the specific

products. FDA had previously estimated

80, instead of 90, manufacturers would

submit samples and protocols annually

under all the regulations cited

previously to account for biotechnology

firms that are exempt from lot release

requirements. Because biotechnology

firms may still be required to submit

samples and protocols for purposes

other than lot release, as explained

previously, the number of respondents

for § 610.2 in this estimate includes

them. The slight increase in the total

estimated number of respondents (100)

is due to a normal variation in annual

submissions.

The total annual responses are based

on FDA’s final actions completed in

fiscal year 1998, which totaled 7,221, for

the various submission requirements of

samples and protocols for biological

products. The rate of final actions is not

expected to change significantly in the

next few years. The hours per response

are based on information provided by

industry. The burden estimates

provided by industry ranged from 1 to

5.5 hours. Under § 610.2, the hours per

response are based on the average of

these estimates and rounded to 3 hours.

Under the remaining regulations, the

hours per response are based on the

higher end of the estimate (rounded to

5 or 6 hours) since more information is

generally required to be submitted in

the protocol than under § 610.2.

In the Federal Register of March 22,

2000 (65 FR 15341), 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

610.2 86 82.72 7,114 3 21,342

640.101(f)(2) 5 4.40 22 5 110

660.6(b) 6 11.33 68 5 340

660.36(a)(2) and (b) 1 1 1 6 6

660.46(b) 2 8 16 5 80

Total 100 7,221 21,878

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

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16975 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–1072]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Administrative Detention and Banned

Medical Devices; Correction

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. This document

also corrects several errors that

appeared in Table 1 of a notice

published in the Federal Register of

March 31, 2000 (65 FR 17282).

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.

Administrative Detention and Banned

Medical Devices—21 CFR 800.55(g),

800.55(k), 895.21, and 895.22 (OMB No.

0910–0114)—Extension

FDA has the statutory authority under

section 304(g) of the Federal Food, Drug,

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

334(g)), to detain during establishment

inspections devices that are believed to

be adulterated or misbranded. On March

9, 1979, FDA issued a final regulation

on administrative detention procedures,

which includes, among other things,

certain reporting requirements

(§ 800.55(g) (21 CFR 800.55(g))) and

recordkeeping requirements

(§ 800.55(k)). Under § 800.55(g), an

applicant of a detention order must

show documentation of ownership if

devices are detained at a place other

than that of the appellant. Under

§ 800.55(k), the owner or other

responsible person must supply records

about how the devices may have

become adulterated or misbranded, as

well as records of distribution of the

detained devices. These recordkeeping

requirements for administrative

detentions allow FDA to trace devices

for which the detention period expired