Federal Register / Vol. 62, No. 196 / Thursday, October 9, 1997 / Notices 52723

Board of Governors of the Federal Reserve

System, October 3, 1997.

William W. Wiles,

Secretary of the Board.

[FR Doc. 97–26735 Filed 10–8–97; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Notice of Meetings

Notice of two meetings of the National

Bioethics Advisory Commission

(NBAC), one each of its genetics and

human subjects subcommittees, and a

brief joint session of the full

Commission.

SUMMARY: Pursuant to Section 10(d) of

the Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is given of two meetings of the National

Bioethics Advisory Commission and a

brief joint session of the full

Commission. Commission members will

discuss the protection of the rights and

welfare of human subjects in research

including decisionally and/or

cognitively impaired populations and

will address the use of genetic

information involved in tissue storage.

The meetings are open to the public and

opportunities for statements by the

public will be provided.

Dates/times Locations

Human Subjects Subcommittee, October

19, 1997, 7:30 am–

4:30 pm.

National Institutes of

Health, 9000 Rockville Pike, Building

31, 6th Floor, Conference Room 10,

Bethesda, Maryland

20892.

11:30 am–1:30 pm .... Full Commission

Meeting, Conference Room 10.

Genetics Subcommittee, October 19,

1997, 7:30 am–

4:30 pm.

National Institutes of

Health, 9000 Rockville Pike, Building

31, 6th Floor, Conference Room 9,

Bethesda, Maryland

20892.

SUPPLEMENTARY INFORMATION: The

President established the National

Bioethics Advisory Commission (NBAC)

by Executive Order 12975 on October 3,

1995 for an initial two years. An

amendment to Executive Order 12975,

dated May 16, 1997, extended the term

of the Commission for an additional two

years. The mission of the NBAC is to

advise and make recommendations to

the National Science and Technology

Council and other entities on bioethical

issues arising from the research on

human biology and behavior, and in the

applications of that research including

clinical applications.

Public Participation

All meetings are open to the public

with attendance limited by the

availability of space. Members of the

public who wish to present oral

statements should contact Ms. Patricia

Norris by telephone, fax machine, or

mail as shown below prior to the

meeting as soon as possible. Individuals

unable to make oral presentations are

encouraged to mail or fax their

comments to the NBAC staff office for

distribution to the subcommittee or

Commission members and inclusion in

the public record. Persons needing

special assistance, such as sign language

interpretation or other special

accommodations, should contact NBAC

staff at the address or telephone number

listed below as soon as possible.

FOR FURTHER INFORMATION CONTACT: Ms.

Patricia Norris, National Bioethics

Advisory Commission, MSC–7508, 6100

Executive Boulevard, Suite 5B01,

Rockville, Maryland 20892–7508,

telephone 301–402–4242, fax number

301–480–6900.

Henrietta D. Hyatt-Knorr,

Deputy Executive Director, Acting, National

Bioethics Advisory Commission.

[FR Doc. 97–26866 Filed 10–8–97; 8:45 am]

BILLING CODE 4160–17–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Minimizing Medical Product Errors—A

Systems Approach; Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public workshop entitled ‘‘Minimizing

Medical Product Errors—A Systems

Approach.’’ The purpose of this

workshop is to provide a forum for an

open exchange with industry, health

professionals, consumers, and others on

issues relating to minimizing the

potential for medical product errors due

to similarities in drug names, similar

labeling, design and packaging of

human drugs, biologics, blood/blood

products, vaccines, and medical

devices.

DATES: The public workshop will be

held on Thursday, January 8, 1998, 7:30

a.m. to 6 p.m. An open public hearing

to present comments, 4:15 p.m. to 5:45

p.m. Submit written abstracts by

November 7, 1997. Submit written

notices of participation by December 5,

1997. There is no registration fee for this

workshop, however, because seating is

limited interested persons are

encouraged to register by December 15,

1997.

ADDRESSES: The public workshop will

be held at Natcher Auditorium, National

Institutes of Health, 45 Center Dr.,

Bethesda, MD. Submit written abstracts

and notices of participation to Mary C.

Gross (address below).

FOR FURTHER INFORMATION CONTACT:

For general information: Mary C.

Gross, Office of External Affairs

(HF–60), Food and Drug

Administration, 5600 Fishers Lane,

rm. 14C–03, Rockville, MD 20857,

301–827–3440, FAX 301–594–0113,

e-mail

MGROSS@BANGATE.FDA.GOV.

For information regarding the

scientific paper selection process:

Jerry Phillips, Center for Drug

Evaluation and Research, 7500

Standish Pl., rm. N271, Rockville,

MD 20852, 301–827–5840, FAX

301–594–0183, e-mail

PHILLIPSJ@A1@FDACD.

SUPPLEMENTARY INFORMATION:

I. Background

FDA will explore the extent of user

error occurring with FDA-regulated

products; collect data to help FDA

determine what methods, if any, already

exist to assess the potential for medical

product errors; hear discussion from

outside groups about the appropriate

role for FDA in minimizing medical

product errors; and discuss how the

agency can effectively collaborate in

minimizing user errors.

II. Submission of the Abstracts

For purposes of discussion at the

workshop, FDA is requesting abstracts

that discuss how best to minimize the

incidence of user error with FDAregulated products. FDA will select a

limited number of abstracts that contain

information on what methods, if any,

already exist to assess the potential for

user error in relation to labeling,

packaging, and design of FDA-regulated

products for formal presentation at the

workshop.

The abstracts should be printed

(typewritten or computer) within the

confines of an 8 1/2 x 11-inch page of

white paper. All lines should be single

spaced with a three-letter indent for

each paragraph. The title should be brief

and capitalized. The authors name(s)

should then be listed, underlining each,

then list agency, institution, or facility

involved.
52724 Federal Register / Vol. 62, No. 196 / Thursday, October 9, 1997 / Notices

The body of the abstract must be

organized in the following manner:

(1) A brief statement of purpose,

(2) A statement of methods used,

(3) A statement of results obtained,

and

(4) A statement of conclusions

reached.

Each presenter should submit a current

curriculum vitae with the abstract.

Interested persons who wish to speak

should submit a written notice of

participation including a name,

affiliation, address, phone number, and

summary of remarks. FDA will allocate

the time available for the hearing among

the persons who properly file notices of

their intent to make a presentation at the

meeting. If time permits, FDA may

allow additional presentations from

interested persons attending the meeting

who did not submit a written notice of

participation to make a presentation.

Dated: October 2, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–26707 Filed 10–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

National Vaccine Injury Compensation

Program: Excise Tax Revision and

Coverage of New Vaccines

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: On August 5, 1997, the

President signed Pub. L. 105–32, the

‘‘Taxpayer Relief Act of 1997,’’

containing amendments to revise the

excise tax structure to a flat rate of 75

cents per dose for each vaccine covered

under the National Vaccine Injury

Compensation Program (VICP). The

amendments also make effective the

coverage of three new vaccines under

the VICP.

The VICP, established by Subtitle 2 of

Title XXI of the Public Health Service

Act (the Act), provides a system of nofault compensation for certain

individuals who have been injured by

specific childhood vaccines. The

Vaccine Injury Table (the Table),

included in the Act, establishes

presumptions about causation of certain

illnesses and conditions which are used

by the U.S. Court of Federal Claims to

adjudicate petitions. The Act provides

that a revision to the Table, based on the

addition of new vaccines under section

2114(e) of the Act, shall take effect upon

the effective date of a tax enacted to

provide funds for compensation for

injuries from vaccines that are added to

the Table. See section 13632(a)(3) of the

Omnibus Budget Reconciliation Act of

1993, Pub. L. 103–66 enacted August 10,

1993.

EFFECTIVE DATE: August 6, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas E. Balbier, Jr., Director, Division

of Vaccine Injury Compensation, Bureau

of Health Professions, (301) 443–6593.

SUPPLEMENTARY INFORMATION: Section

904(a) of the Taxpayer Relief Act of

1997 provides that the excise tax on all

covered vaccines is 75 cents per dose

and that combinations of vaccines are

subject to an excise tax which is the

sum of the amounts for each vaccine

included in the combination.

On February 20, 1997, a Final rule

was published in the Federal Register

(62 FR 7685) announcing the addition of

hepatitis B, Hib, and varicella vaccines

to the Table. The Final rule states in

§ 100.3(c)(2) that the inclusion of

hepatitis B, Hib, and varicella vaccines

and other new vaccines (Items VIII, IX,

X, XI and XII of the Table) will be

effective on the effective date of a tax

enacted to provide funds for

compensation paid with respect to such

vaccines.

Section 904(b) of the Taxpayer Relief

Act of 1997 provides for an excise tax

for these three new vaccines, effective

August 6, 1997, and this notice serves

as an announcement of such a tax.

Accordingly, petitions for compensation

for injuries or deaths related to hepatitis

B, Hib, and varicella vaccines may now

be filed under the VICP. In accordance

with section 2116(b) of the Act, for

injuries or deaths that occurred before

August 6, 1997, for these three vaccines,

petitions may be filed no later than

August 6, 1999, provided that the injury

or death occurred no earlier than August

6, 1989.

A document will be published in the

Federal Register to amend the CFR to

include a date certain (August 6, 1997)

in § 100.3(c), so that there will be no

uncertainty as to the coverage of these

three vaccines.

Dated: October 2, 1997.

Claude Earl Fox,

Acting Administrator.

[FR Doc. 97–26706 Filed 10–8–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Indian Health Service

Alternate Method of Acquisition for

Health Care Services; Authorized by

the Federal Acquisition Regulations

AGENCY: Indian Health Service, HHS.

ACTION: General notice.

SUMMARY: The Indian Health Service

(IHS) issues this General Notice to

inform the public that IHS has adopted

the Rate Quotation as an alternate

acquisition method to establish

reimbursement rates for health care

services purchased by its Contract

Health Services Program.

EFFECTIVE DATE: October 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Ronald Freeman, Acting Director,

Division of Managed Care, Room 6A–55,

5600 Fishers Lane, Rockville, MD

20857, (301) 443–3024 or Carol

Silverman, Acting Director, Division of

Acquisition and Grants Management,

Suite 450A, 12300 Twinbrook Parkway,

Rockville, MD 20857, (301) 443–5774.

(These are not toll-free numbers).

SUPPLEMENTARY INFORMATION: The IHS

Contract Health Services program is

administered under regulations at 42

CFR 36.21 et seq. and services

purchased are governed by the Federal

Acquisition Regulations (FAR). Under

this program IHS purchases health care

services from hospitals, physicians, and

other health care facilities and providers

to supplement the IHS direct care

delivery system. The IHS last issued a

payment policy in 51 FR 23540 on June

30, 1986. This policy requires the IHS

Area Offices to enter into formal

agreements with providers that they

expect to use for health care services.

With certain specified exceptions in the

IHS Payment Policy, the formal

agreement must provide for

reimbursement of services at rates

which do not exceed prevailing

Medicare reimbursement rates

(including deductibles and coinsurance), and the IHS service units

will make patient referrals and procure

all its routine health care services from

providers with formal agreements.

The IHS issued a general notice in 56

FR 10566 on March 13, 1991 to inform

the public that the IHS was conducting

a pilot project in the IHS Portland Area.

The project was designed to determine

whether an alternative method of

acquisition for contract health services

would result in greater participation by

health care providers and lower costs to

IHS. The project was originally

scheduled to end on March 31, 1992,