Federal Register / Vol. 62, No. 200 / Thursday, October 16, 1997 / Notices 53787

Corporate Blvd., Rockville, MD 20850,

301– 594–5072, FAX 301–480–4224.

SUPPLEMENTARY INFORMATION: FDA, in

cooperation with HIMA, is holding a

public workshop to discuss the

implementation of a different process

for the premarket approval of class III

devices by means of a PDP. Section

515(f) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360e (f)) (the

act) provides for a product development

protocol as an alternate means of

premarket approval of class III medical

devices. Although the PDP has existed

as a means of approval of a medical

device since the Medical Device

Amendments of 1976 (Pub. L. 94–295)

to the act, the PDP has never been

completely implemented. As part of it’s

reengineering initiative, the Center for

Devices and Radiological Health (CDRH)

of FDA established the PDP

Reengineering Team, comprised of FDA

staff, in consultation with industry

representatives, to develop an efficient,

practical PDP process.

The intent of the PDP process is to

substitute the conventional device

approval model, the sequential process

of clinical investigation followed by a

premarket approval application, with an

early interaction between the sponsor

and FDA to produce a focused product

development plan that merges the two

steps. A PDP team has developed

guidelines for creating this focused

development protocol that will be

described at the public workshop.

Workshop participants will have ample

opportunity to ask questions as the new

PDP process is described and case

studies on particular examples of class

III devices are presented. Background

information, a detailed flow chart, and

a descriptive narrative regarding the

proposed PDP process can be found at

the FDA/CDRH Web site at the address

below.

Additional information is available on

the FDA Web page (www.fda.gov/cdrh/

pdp/pdp.html) or the HIMA Web page

(www.himanet.com).

Dated: September 30, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–27433 Filed 10–15–97; 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) will

publish 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 Projects

1. Project To Assess Bi/Multilingual

Services Offered at Selected Community

and Migrant Health Centers—NEW

Recognizing the importance of

language-appropriate services to full

and effective health care provision, the

Office of Minority and Women’s Health

in the Bureau of Primary Health Care

[BPHC], Health Resources and Services

Administration [HRSA], proposes to

conduct a voluntary telephone survey to

assess the composition and provision of

bi/multilingual services at a sample of

40 Community and Migrant Health

Centers [C/MHCs] selected from those

C/MHCs indentified as likely to be

serving high percentages of people who

speak languages other than English.

This effort was developed so that

information could be gathered to assist

the field, funding agency staff, and

policymakers in better understanding

what methods are being used to provide

services to these populations, what

works, what does not, and barriers and

facilitators to effective health service

provision for speakers of languages

other than English.

The information gathered will provide

HRSA with an information base upon

which to build in making future

program decisions regarding C/MHC

resource and staffing needs in order to

reduce or eliminate the barriers to

health care often faced by non-or

limited-English-speaking populations.

The end result of the program will be to

assist the funding agency to help C/

MHCs and by extension, other providers

of health care for non-or limited-English

speaking populations to provide

appropriate services. An estimate of the

hour burden for the 40 C/MHC Directors

selected for the survey is shown below.

Form Number of respondents

Responses

per respondent

Hours per

response

Total hour

burden

Bi/Multilingual Services Survey ............................. 40 C/MHC Directors ............................................. 1 2 80

Send comments to Patricia Royston,

HRSA Reports Clearance Officer, Room

14–36, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857. Written

comments should be received within 60

days of this notice.

Dated: October 9, 1997.

Jane Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 97–27429 Filed 10–15–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is