51114 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices

records to trace patients, and the

organization and indexing of records

into identifiable files to ensure the

device’s continued safety and

effectiveness. These requirements are to

be performed only by those

manufacturers who have an approved

PMA and who had original clinical

research in support of that PMA. For a

typical year’s submissions, 70 percent of

the PMA’s are eventually approved and

75 percent of those have original

clinical trial data. Therefore, about 27

PMA’s a year would be subject to these

requirements. Also, because the

requirements apply to all active PMA’s,

all holders of active PMA applications

must maintain these records. PMA’s

have been required since 1976, so there

are around 567 active PMA’s that could

be subject to these requirements (21

years x 27 per year). Each study has

about approximately 200 subjects, and,

at an average of 5 minutes per subject,

there is a total burden per study of 1,000

minutes, or 16.7 hours. The aggregate

burden for all 567 holders of approved

original PMA’s, therefore, is 9,469 hours

(567 approved PMA’s with clinical data

x 16.7 hours per PMA).

The applicant determines what

records should be maintained during

product development to document and/

or substantiate the device’s safety and

effectiveness. Records required by the

Current Good Manufacturing Practices

for medical devices regulation part 820

may be relevant to a PMA review and

may be submitted as part of an

application. In individual instances,

records may be required as conditions to

approval to ensure the device’s

continuing safety and effectiveness.

With the additional 9,469 hours or

recordkeeping, the total annual burden

is 104,020 hours.

Dated: September 23, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25938 Filed 9-29-97; 8:45 am]

BILLING CODE 4160-01-F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Statement of Organization, Functions,

and Delegations of Authority

Part D, Chapter DE, Office of External

Affairs (Food and Drug Administration)

of the Statement of Organization,

Functions, and Delegations of Authority

for the Department of Health and

Human Services (35 FR 3685, February

25, 1970, and 60 FR 56605, November,

9, 1995, and in pertinent part at 56 FR

29484, June 27, 1991) is amended to

reflect the title change of the Industry

and Small Business Liaison Staff. The

title is being changed to more accurately

reflect the expanding concerns and

community issues in the jurisdictions

containing various FDA headquarter

facilities. The Industry and Small

Business Liaison Staff will be retitled as

the Industry, Small Business and

Community Affairs Staff. The current

functions remain the same with the

addition of two new functions.

Delete the Industry and Small

Business Liaison Staff (DE–1) in its

entirety and insert the following:

Industry, Small Business and

Community Affairs Staff (DE–1).

Advises and assists the Commissioner

and other Agency officials on industryrelated issues which have an impact on

policy, directions, and goals.

Serves as the Agency focal point for

overall industry liaison and

communication activities within FDA,

including FDA Centers, and between

FDA and FDA-regulated industry,

industry trade associations, and

scientific associations.

Serves as liaison with other Agency

components to provide advice and

assistance to small manufacturers and

scientific associations to promote their

understandings of and compliance with

FDA regulations.

Develops and maintains effective

channels of communication with

regulated industry, professional

societies, and trade and scientific

associations.

Serves as liaison with local civic

organizations in jurisdictions containing

or contiguous to the various FDA

headquarters facilities.

Provides official contact point within

the Agency for discussion and

resolution of community issues and

concerns arising in connection with the

construction, renovation, or ongoing

operation of FDA’s widely dispersed

physical point.

Prior Delegations of Authority.

Pending further delegations, directives,

or orders by the Commissioner of Food

and Drugs, all delegations of authority

to positions of the affected organizations

in effect prior to this date shall continue

in effect in them or their successors.

Dated: September 2, 1997.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

[FR Doc. 97–25782 Filed 9–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–211]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) the

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: State Child

Health Plan and Supporting Information

Collection Requirements Referenced in

Title XXI of the Social Security Act;

Form No.: HCFA–R–211, OMB # 0938–

0707; Use: This Model template will

enable states to apply for funds under

Title XXI of the Social Security Act, to

initiate and expand the provision of

child health insurance to uninsured,

low income children in a effective and

efficient manner that is coordinated

with other sources of health coverage for

children; Affected Public: State, Local or

Tribal Government; Number of

Respondents: 56; Total Annual

Responses: 56; Total Annual Hours:

8,960.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address: