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.

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices 41681

TABLE 1

Workshop Address Date and Local Time

Long Beach Convention Center,

300 East Ocean Blvd.,

Long Beach, CA 90802.

Tuesday, September 26, 2000,

9 a.m. to 4:30 p.m.

Pacific time.

Embassy Suites, 150 Anza Blvd.,

Burlingame, CA 94010,

650–340–0327.

Friday, December 8, 2000,

9 a.m. to 4:30 p.m.

Pacific time.

Contact: Marcia Madrigal, Industry

and Small Business Representative,

Food and Drug Administration, Oakland

Federal Bldg., 1301 Clay St., suite

1180N, Oakland, CA 94612, 510–637–

3980; FAX 510–637–3977 or via e-mail:

mmadriga@ora.fda.gov.

Registration: The registration fee is

$295 for ISPE members and $450 for

nonmembers (which will cover

refreshments, lunch, and materials). The

ISPE tax number is FEI 59–2009272.

Contact ISPE for registration forms, and

other registration details at ISPE 3816

W. Linebaugh Ave, suite 412, Tampa,

FL 33624, 813–960–2105; FAX 813–

264–2816, or visit the ISPE website at

http://www.ispe.org. Registrations are

due 1 week prior to the start of each

course. Space is limited, therefore,

interested parties are encouraged to

register early. Limited onsite registration

may be available. Please arrive early to

ensure prompt registration. Persons

needing hotel rooms for the Embassy

Suites location on December 8, 2000,

should mention that they are attending

the FDA/SUPAC workshop. A special

rate is available until November 16,

2000, or until the room block is

exhausted, whichever comes first.

If you need special accommodations

due to a disability, please contact ISPE

at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The

workshops are designed to help achieve

objectives set forth in section 406 of the

FDA Modernization Act of 1997 (21

U.S.C 393) and discussed in the FDA

Plan for Statutory Compliance, which

include working more closely with

stakeholders; maximizing the

availability of, and clarifying

information about the process for review

and submissions; and ensuring access to

needed scientific and technical

expertise.

The workshops also are consistent

with the Small Business Regulatory

Enforcement Fairness Act (Public Law

104–121), as outreach activities by

Government agencies directed to small

businesses.

The topics to be discussed include the

following: (1) The history of SUPAC

development; (2) the impact of scale-up

postapproval change guidances and of

the regulation rewrite of 21 CFR 314.70

(Supplements and other changes to an

approved application); (3) comparison

of SUPAC immediate-release solid

dosage forms, modified-release oral

dosage forms, and semisolid-topical

dosage forms; (4) postapproval changes

sterile aqueous solutions; (5) FDA field

staff’s involvement in SUPAC; (6)

description and use of the equipment

addenda to SUPAC; and (7) facts,

figures, and future directions.

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16979 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources And Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA)

publishes periodic summaries of

proposed projects being developed for

submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Scholarships for

Disadvantaged Students Program—New

The Scholarships for Disadvantaged

Students (SDS) Program has as its

purpose the provision of funds to

eligible schools to provide scholarships

to full-time, financially needy students

from disadvantaged backgrounds

enrolled in health professions and

nursing programs.

To qualify for participation in the SDS

program, a school must be carrying out

a program for recruiting and retaining

students from disadvantaged

backgrounds, including students who

are members of racial and ethnic

minority groups (section 737(d)(1)(B) of

the PHS Act). A school must meet the

eligibility criteria to demonstrate that

the program has achieved success based

on the number and/or percentage of

disadvantaged students who graduate

from the school. In awarding SDS funds

to eligible schools, funding priorities

must be given to schools based on the

proportion of graduating students going

into primary care, the proportion of

underrepresented minority students,

and the proportion of graduates working

in medically underserved communities

(section 737(c) of the PHS Act).

The estimated response burden is as

follows: