Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices 18137

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses per

respondent

Average

burden hours

per

response

Total

burden hours

TANF Tribal Plan .............................................................................................. 18 1 60 1,080

Estimated Total Annual Burden Hours: 1,080.

Additional Information: ACF is

requesting that OMB grant a 180 day

approval for this information collection

under procedures for emergency

processing by April 9, 1997. A copy of

this information collection, with

applicable supporting documentation,

may be obtained by calling the

Administration for Children and

Families, Reports Clearance Officer,

Larry Guerrero at (202) 401–6465.

Comments and questions about the

information collection described above

should be directed to the Office of

Information and Regulatory Affairs,

Attn: OMB Desk Officer for ACF, Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street NW.,

Washington, DC 20503, (202) 395–7316.

Dated: April 8, 1997.

Larry Guerrero,

Reports Clearance Officer.

[FR Doc. 97–9535 Filed 4–11–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of the Committee: Device Good

Manufacturing Practice Advisory

Committee.

General Function of the Commitee: To

provide advice and recommendations to

the agency on FDA regulatory issues.

Date and Time: The meeting will be

held on April 29, 1997, 8:30 a.m. to 5

p.m.

Location: Parklawn Bldg., Conference

room D, 5600 Fishers Lane, Rockville,

MD.

Contact Person: Sharon M.

Kalokerinos, Center for Devices and

Radiological Health (HFZ–331), Food

and Drug Administration, 2094 Gaither

Rd., Rockville, MD 20850, 301–594–

4613, ext. 139, or FDA Advisory

Committee Information line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12398.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will consider

a proposed plan developed by the

Center for Devices and Radiological

Health (CDRH) to introduce a risk-based

planning model for determining where

headquarters and field enforcement

resources should be focused. The model

to be presented calls for greater

emphasis on those products that present

the greatest risk to public health, based

on such factors as device classification

(Class III and Class II/Tier 3 products),

current knowledge of product

performance, and information from the

recall and medical device reporting

(MDR) adverse event data bases. Those

products that present minimal risk

(Class I and some Class II) would

receive less oversight. Areas being

considered for increased coverage

include premarket approval inspections

(Class III products), inspections deemed

necessary to address a risk to public

health (for cause), followup to violative

inspections, and inspections of devices

identified by the risk-based model.

There are two aspects to this planning

model: (1) The identification of top

priority devices which would receive a

more indepth evaluation in terms of

causes associated with failures and

malfunctions reported in the data bases;

and (2) the utilization of risk criteria

such as the classification and tiering of

devices to determine the parameters of

routine good manufacturing practice

(GMP) surveillance, both the frequency

and depth of inspectional coverage.

Data used to identify top priority

devices would undergo a quality control

evaluation to determine the basis for the

large numbers of reports in the data

systems. For example, the recall

information would be evaluated to

assure that inclusion on the list is based

on substantive causes of the recall and

not on isolated events. Likewise, MDR

information would be evaluated for

public health risk versus reporting

artifacts. Scientific implications of

failures/malfunctions would form the

basis of the investigational assignments

issued, and CDRH staff would analyze

the data collected for commonalities

and trends. Resolution of issues noted

may vary depending upon the nature of

the problems. Options include technical

and scientific discussions, training

initiatives by FDA or industry, or

compliance followup activities.

The plan proposes a tiered approach

to conducting routine GMP surveillance

inspections. Devices carrying a higher

risk for the patient such as Class III and

Class II/Tier 3 would be inspected more

frequently. These higher risk devices

will also receive comprehensive

inspectional coverage and limited

inspections will be conducted for the

lower classifications and tiers.

Procedure: The meeting is open to the

public. Interested persons may present

data, information, or views, orally or in

writing, on issues pending before the

committee. Written submissions may be

made to the contact person by April 22,

1997. Those desiring to make formal

presentations should notify the contact

person, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

aproximate time requested to make their

presentation.

Notice of this meeting is given under

the Federal Advisory Committe Act (5

U.S.C. app. 2).

A limited number of overnight

accommodations have been reserved at

the DoubleTree Hotel. Attendees

requiring overnight accommodations

may contact the hotel at 301–468–1100

and reference the FDA Device Good

Manufacturing Practice Advisory

Committee meeting block. Reservations

will be confirmed at the group rate

based on availability. Attendees with a

disability requiring special

accommodations should contact

Christie Wyatt, KRA Corp., 301–495–

1591, ext. 224. The availability of

appropriate accommodations cannot be

assured unless prior written notification

is received.

Dated: April 8, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–9528 Filed 4–11–97; 8:45 am]

BILLING CODE 4160–01–F