Federal Register / Vol. 62, No. 245 / Monday, December 22, 1997 / Notices 66869

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

The Office of the Secretary

Information Collection Activity Under

Emergency Review by the Office of

Management and Budget (OMB)

Title: Survey of Biomedical Equipment

Manufacturers for Year 2000

Compliance

Paperwork Reduction Act

Requirements

We are required to solicit public

comments under section 3506(c)(2)(A)

of the Paperwork Reduction Act of 1995.

Specifically, comments are invited on

(1) whether the proposed collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

(2) the accuracy of the estimate of the

burden of the proposed collection of

information; (3) ways to enhance the

quality, utility, and clarity of the

information collected; (4) ways to

minimize the burden of the collection of

information on respondents, including

the use of automated collection

techniques or other forms of information

technology. We are seeking emergency

OMB approval for this collection of

information.

Description

The Deputy Secretary of the

Department of Health and Human

Services, on behalf of the governmentwide Biomedical Equipment Subgroup

of the CIO Council’s Year 2000

Subcommittee, is surveying

manufacturers of biomedical equipment

about the Year 2000 compliance of their

products. The existence of a Year 2000

date problem in biomedical equipment

could pose potentially serious health

and safety consequences.

Manufacturers are requested to post

information about noncompliance

products on a web site and link this to

a government web site on biomedical

equipment. If all of a manufacturer’s

products are compliant, they are

requested to provide notice of total

product compliance. Manufacturers

have the option to mail the information

to the Department of Health and Human

Services for posting on the government

web site. All information collected will

be available to the public through the

government web site.

To be Year 2000 compliant, a product

must be able to accurately process date

information in the Year 2000 and

between the twentieth and twenty-first

centuries, including leap year

calculations. Medical devices and

scientific laboratory equipment may

experience problems beginning January

1, 2000 if the computer systems,

software applications, or embedded

chips used in these devices and

equipment contain two-digit fields for

year representation.

The Food and Drug Administration

(FDA) regulates medical devices and

needs information regarding the Year

2000 compliance of these products.

Under a previous Good Manufacturing

Practices regulation and the current

Quality System Regulation, effective

June 1, 1997, manufacturers must

investigate and correct problems with

medical devices that present a

significant risk to public health. This

includes devices that fail to operate

according to their specifications because

of inaccurate date recording and/or

calculations. Also, section 518 of the

Food, Drug and Cosmetic Act requires

notification of users or purchasers when

a device presents a reasonable risk of

substantial harm to public health. These

regulations, however, do not apply to all

biomedical equipment, such as

scientific laboratory equipment, but

only to medical devices. Therefore, a

proactive collection of Year 2000

compliance information of all

biomedical equipment is necessary to

prevent a Year 2000 date problem from

causing any public health risk in the

patient care services and health research

initiatives of the next century.

Burden Information

Respondents: Biomedical Equipment

Manufacturers.

Estimated Number of Potentially

Noncompliant Products: 20,500.

Estimated Percentage of Responses

Collected Electronically: 75%.

Estimated Response Time to Post One

Noncompliant Product: 5 minutes.

Estimated Percentage of Written

Responses: 25%.

Estimated Written Response Time for

One Noncompliant Product: 20 minutes.

Estimated Total Annual Burden: 2989

hours.

Additional Information

HHS is requesting that OMB grant a

seven day approval under procedures

for emergency processing.

Questions about this information

collection can be directed to the Project

Coordinator, Gayle Finch, Director,

Office of Information Technology

Planning and Investment, Humphrey

Building, 200 Independent Avenue,

S.W., Washington, D.C. 20201, phone

202–690–5515 or fax 202–690–8715.

Written comments about the

information collection described above

can be directed to Wendy Taylor, OMB

Desk Officer, Office of Management and

Budget, 725 17th Street, N.W., Room

10235, Washington, D.C. 20503, or fax

202–395–6974.

Dated: December 15, 1997.

Tom Joyce,

Reports Clearance Officer.

[FR Doc. 97–33310 Filed 12–19–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Committee on Vital and Health

Statistics: Meeting

Pursuant to the Federal Advisory

Committee Act, the Department of

Health and Human Services announces

the following advisory committee

meeting.

Name: National Committee on Vital and

Health Statistics (NCVHS), Subcommittee on

Population-Specific Issues.

Times and Dates: 10:00 a.m.–5:00 p.m.,

January 12, 1998; 10:00 a.m.–4:00 p.m.,

January 13, 1998.

Place: Room 303A, Hubert H. Humphrey

Building, 200 Independence Avenue S.W.,

Washington D.C. 20201.

Status: Open.

Purpose: The Subcommittee will discuss

data needs and issues associated with

Medicaid managed care. Presentations will

be made by representatives of federal, State

and local agencies, providers, plans, and

patient advocacy groups who will describe

their data needs and issues relating to

Medicaid managed care. The Subcommittee

also will plan site visits to selected States to

assess data issues in Medicaid managed care.

Contact Person for More Information:

Substantive program information as well as

a roster of committee members may be

obtained from James Scanlon, NCVHS

Executive Staff Director, Office of the

Assistant Secretary for Planning and

Evaluation, DHHS, Room 440–D, Humphrey

Building, 200 Independence Avenue S.W.,

Washington D.C. 20201, telephone (202) 690–

7100, or Marjorie S. Greenberg, Executive

Secretary, NCVHS, NCHS, CDC, Room 1100,

Presidential Building, 6525 Belcrest Road,

Hyattsville, Maryland 20782, telephone 301/

436–7050. Additional information about the

full Committee is available on the NCVHS

website, where the tentative agenda for the

Subcommittee meeting will also be posted

when available: http://aspe.os.dhhs.gov/

ncvhs

Dated: December 17, 1997.

James Scanlon,

Director, Division of Data Policy.

[FR Doc. 97–33354 Filed 12–19–97; 8:45 am]

BILLING CODE 4151–04–M