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

41680 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices

before a seizure is accomplished or

injunctive relief is obtained.

FDA also has the statutory authority

under section 516 of the act (21 U.S.C.

360f) to ban devices that present

substantial deception or an

unreasonable and substantial risk of

illness or injury. The final regulation for

banned devices contains certain

reporting requirements (§§ 895.21(d)

and 895.22(a) (21 CFR 895.21(d) and

895.22(a))). Section 895.21(d) states that

if the Commissioner of Food and Drugs

(the Commissioner) decides to initiate a

proceeding to make a device a banned

device, a notice of proposed rulemaking

will be published in the Federal

Register, and this notice will contain

the finding that the device presents a

substantial deception or an

unreasonable and substantial risk of

illness or injury. The notice will also

contain the reasons why the proceeding

was initiated, an evaluation of data and

information obtained under other

provisions of the act, any consultations

with the panel, and a determination as

to whether the device could be

corrected by labeling or change of

labeling, or change of advertising, and if

that labeling or change of advertising

has been made. Under § 895.21(d), any

interested person may request an

informal hearing and submit written

comments. Under § 895.22, a

manufacturer, distributor, or importer of

a device may be required to submit to

FDA all relevant and available data and

information to enable the Commissioner

to determine whether the device

presents substantial deception,

unreasonable and substantial risk of

illness or injury, or unreasonable, direct,

and substantial danger to the health of

individuals.

Respondents to this collection of

information are those manufacturers,

distributors, or importers whose

products FDA seeks to detain or ban.

In the Federal Register of March 31,

2000 (65 FR 17282), the agency

requested comments on the proposed

collection of information. No significant

comments were received. Also, in the

notice published in the Federal Register

of March 31, 2000 (65 FR 17282 at

17283), Table 1 contained several errors.

Table 1 of this document corrects those

errors.

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

800.55(g)(1) and (g)(2) 1 1 1 1 1

895.22(a) 26 1 26 16 416

Total 441

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

800.55(k) 1 1 1 20 20

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

Over the past 3 years, there has been

an average of one new administrative

detention action per year. Each

administrative detention will have

varying amounts of data and

information that must be maintained.

Historically, FDA’s Center for Devices

and Radiological Health (CDRH) has had

very few or no annual responses for this

information collection and normally

reports one response per year. CDRH is

anticipating a banning action in fiscal

year 2000 that will involve 26 firms.

Dated: June 28, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–17021 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Food and Drug Administration/Industry

Exchange Workshop on Scale-Up and

Postapproval Changes (SUPAC),

Supplements, and Other Postapproval

Changes; Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of workshop.

SUMMARY: The Food and Drug

Administration (FDA), Office of the

Commissioner, Office of Regulatory

Affairs, Center for Drug Evaluation and

Research, and the Central Region Small

Business Assistance Office, and the

Pacific Region Small Business Office, in

cooperation with the International

Society for Pharmaceutical Engineering

(ISPE) is announcing two workshops

entitled FDA/Industry Exchange

Workshops on Scale-Up and

Postapproval Changes (SUPAC),

Supplements, and Other Postapproval

Changes. The workshops are intended to

review the scientific, regulatory, and

quality basis of SUPAC; discuss current

issues; and provide attendees with

information on the impact of the SUPAC

guidances that have been finalized, as

well as future agency efforts in this area.

Date and Time: See Table 1 following

the Location section of this document.

Location: See Table 1 below.