51112 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices

Management Specialist, CDC, 1600

Clifton Road, NE, M/S D50, Atlanta,

Georgia 30333, telephone 404/639–

7250.

Dated: September 24, 1997.

Nancy C. Hirsch,

Acting Director, Management Analysis and

Services Office Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–25834 Filed 9–29–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Safety and Occupational Health Study

Section; NIOSH Meeting

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

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting:

Name: Safety and Occupational Health

Study Section, National Institute for

Occupational Safety and Health (NIOSH).

Times and Dates: 8 a.m.-5:30 p.m., October

29–30, 1997.

Place: National Institute for Occupational

Safety and Health, 1095 Willowdale Road,

Morgantown, West Virginia, 26505–2888.

Status: Open business session, 8 a.m.-8:30

a.m., October 29, 1997; Closed evaluation

sessions 8:30 a.m.-5:30 p.m., October 29,

1997; and 8 a.m.-5:30 p.m., October 30, 1997.

Purpose: The Safety and Occupational

Health Study Section will review, discuss,

and evaluate grant application(s) in response

to the Institute’s standard grants review and

funding cycles pertaining to research issues

in occupational safety and health and allied

areas. It is the intent of NIOSH to support

broad-based research endeavors in keeping

with the Institute’s program goals which will

lead to improved understanding and

appreciation for the magnitude of the

aggregate health burden associated with

occupational injuries and illnesses, as well as

to support more focused research projects

which will lead to improvements in the

delivery of occupational safety and health

services and the prevention of work-related

injury and illness. It is anticipated that

research funded will promote these program

goals.

Matters To Be Discussed: The meeting will

convene in open session from 8 a.m.-8:30

a.m. on October 29, 1997, to address matters

related to the conduct of Study Section

business. The meeting will proceed in closed

session from 8:30 a.m. until scheduled

adjournment (5:30 p.m.) on October 29, 1997.

The meeting will continue in closed session

from 8 a.m. until scheduled adjournment

(5:30 p.m.) or earlier on October 30, 1997.

The purpose of the closed sessions is for the

Safety and Occupational Health Study

Section to consider safety and occupational

health related grant applications. These

portions of the meeting will be closed to the

public in accordance with provisions set

forth in section 552(c) (4) and (6) title 5

U.S.C., and the Determination of the

Associate Director for Management and

Operations, CDC, pursuant to Pub. L. 92–463.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Pervis C. Major, Ph.D., Scientific Review

Administrator, Office of Extramural

Coordination and Special Projects, Office of

the Director, NIOSH, 1095 Willowdale Road,

Morgantown, West Virginia 26505–2888,

telephone 304/285–5979.

Dated: September 18, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–25948 Filed 9–29–97; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0385]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the

collection of information by October 30,

1997.

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: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, 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 section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance:

Premarket Approval of Medical

Devices—Part 814 (OMB Control

Number 0910–0231—Reinstatement)

Section 515 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360e) sets forth requirements for

premarket approval of certain medical

devices. Under section 515 of the act, an

application must contain several pieces

of information, including: Full reports

of all information concerning

investigations showing whether the

device is safe and effective; a statement

of components; a full description of the

methods used in, and the facilities and

controls used for, the manufacture and

processing of the device; and labeling

specimens. The implementing

regulations, contained in part 814 (21

CFR part 814), further specify the

contents of a premarket approval

application (PMA) for a medical device

and the criteria FDA will employ in

approving, denying, or withdrawing

approval of a PMA. The purpose of

these regulations is to establish an

efficient and thorough procedure for

FDA’s review of PMA’s for class III

(premarket approval) medical devices,

in order to facilitate the approval of

PMA’s for devices that have been shown

to be safe and effective and otherwise

meet the statutory criteria for approval

and to ensure the disapproval of PMA’s

for devices that have not been shown to

be safe and effective and that do not

otherwise meet the statutory criteria for

approval.

Under § 814.15, an applicant may

submit in support of a PMA studies

from research conducted outside the

United States, but an applicant must

explain in detail any differences

between standards used in a study to

support the PMA’s and those standards

found in the Declaration of Helsinki.

Section 814.20 provides a list of

information required in the PMA,

including: A summary of information in

the application, a complete description

of the device, technical and scientific

information, and copies of proposed

labeling. Section 814.37 provides

requirements for an applicant who seeks

to amend a pending PMA. Under

§ 814.39, an applicant must submit a

supplement to the PMA before making

a change affecting the safety or

effectiveness of the device. Section

814.82 sets forth postapproval

requirements FDA may propose,

including periodic reporting on safety,

effectiveness, reliability, and display in

the labeling and advertising of certain

warnings. Section 814.82 requires the

maintenance of records to trace patients

and the organizing and indexing of

records into identifiable files to enable
Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices 51113

FDA to determine whether there is

reasonable assurance of the device’s

continued safety and effectiveness.

Section 814.84 specifies the contents of

periodic reports. 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

(21 CFR 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 to be

maintained as conditions of approval to

ensure the device’s continuing safety

and effectiveness.

Respondents to this information

collection are persons filing an

application for approval of a Class III

medical device. Part 814 defines a

person as any individual, partnership,

corporation, association, scientific or

academic establishment, government

agency or organizational unit, or other

legal entity. These respondents include

manufacturers of commercial medical

devices in distribution prior to May 28,

1976 (the enactment date of the Medical

Device Amendments).

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

814.15, 814.20, and 814.37 52 1 52 837.28 43,539

814.39 493 1 493 73.15 36,063

814.82 545 1 545 9.14 4,983

814.84 545 1 545 18.29 9,966

Total 94,551

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

In March 1997, while completing

work on the CDRH Annual Information

Collection Budget, an error was

discovered on this information

collection’s burden hours by CDRH

program staff. This error was not

discovered until after the publishing of

this information collection’s 60-day

notice in the Federal Register of January

7, 1997 (62 FR 995), Docket No. 96N–

0491. The narrative portion of the

Federal Register notice correctly stated

that 52 original PMA’s and 493 PMA

Supplements were processed each year.

The burden chart, however, incorrectly

stated that 545 original PMA’s and 545

PMA Supplements were processed each

year (the 545 figure was derived by

adding the 52 original and 493 PMA

supplements together). When the correct

number of respondents was plugged

into the burden hour table and the

numbers recalculated, the new total

burden hours equals 104,020 hours, a

savings of 416,583 hours from the

original 1997 figure of 520,603.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

814.82 (a) (5) and (a) (6) 567 1 567 16.7 9,469

Total 9,469

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

FDA estimates that the cost to device

manufacturers to comply with the

requirements for premarket approval of

medical devices is approximately

$34.95 million per year. The industrywide cost estimate for PMA’s is based

on an average fiscal year annual rate of

receipt of 52 PMA original applications

and 493 PMA supplements, using fiscal

years 1991 through 1995 data.

The cost data for PMA’s is based on

data provided by manufacturers in 1985

by device type and cost element. The

specific cost elements for which FDA

has data are as follows:

(1) Clinical investigations: 67 percent

of total cost estimate,

(2) Submitting additional data or

information to FDA during a PMA

review: 12 percent,

(3) Additional device development

cost (e.g., testing): 10 percent and,

(4) PMA and PMA supplement

preparation and submissions, and

development of manufacturing and

controls data: 11 percent.

A weighted average calculation in

1985 produced a total cost of $280,000

for a PMA application. These cost

estimates are considered to be solely

attributable to PMA requirements. FDA

does not have more recent data on the

cost to manufacturers of collecting,

analyzing, and preparing the data

needed for a PMA submission. FDA has

adjusted the 1985 estimate for inflation

(using an average of 7.5 percent per year

for the health care sector) and

multiplied it by 52 (the average number

of PMA’s submitted annually) to yield

an annual cost attributable to PMA’s of

$32,323,200 ($280,000 x index of 2.22 x

52).

FDA estimates that 493 PMA

supplements will be submitted

annually. No recent information on the

cost of PMA supplements has been

collected from medical device

manufacturers. However, the agency has

taken an earlier cost estimate for PMA

supplements ($2,400 per supplement)

and adjusted it for inflation. The annual

cost of PMA supplements is estimated

to be $2,626,704 (493 x $2,400 x 2.22

index factor).

Thus, the cost estimate for PMA’s and

PMA supplements is $34,949,904. This

figure represents the burden on industry

due to the PMA approval requirement.

This cost includes both the effect of the

statutory requirement and the effect of

the agency’s implementation of the

statute.

The recordkeeping burden in this

section requires the maintenance of
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: