65278 Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices

final rule do not impose an additional

burden since the members will be

complying with the current

organizations’ standards which are

comparable to the requirements in the

final rule. To account for persons or

establishments that may not be a

member of an industry organization

and, for whom therefore, the extent of

compliance with the requirements of the

final rule is unknown, FDA will be

using 1 percent as an estimation of the

information collection burden on the

tissue industry.

Industry estimates that in 1994 there

were 350,000 bone transplants, 42,000

corneal transplants, 5,000 patellar

tendon transplants, and the

transplantation of 5,000 square feet of

skin. There are approximately 300

persons and 170 tissue banks currently

operating in the Untied States affected

by the regulations.

The total annual estimated burden

imposed by this collection of

information is 32,260 hours annually.

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency of

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

1270.31 (b)–(d) 11 4 44 28 308

1270.35 (a)–(b) 11 420 4,620 290 3,190

1270.35 (c) 11 2,893 31,823 4,782 52,602

1270.35 (d) 11 17 187 17 187

Total .......................... .......................... .......................... .......................... 56,287

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

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32459 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Orthopaedic and Rehabilitation

Devices Panel of the Medical Devices

Advisory Committee; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that published in the Federal

Register of November 25, 1997 (62 FR

62777). The notice announced a meeting

of the Orthopaedics and Rehabilitation

Devices Panel of the Medical Devices

Advisory Committee that is scheduled

for December 11 and 12, 1997. The

notice published with an error. This

document corrects that error.

FOR FURTHER INFORMATION CONTACT:

LaJuana D. Caldwell, Office of Policy

(HF–27), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–2994.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 25, 1997

(62 FR 62777), in FR Doc. 97–30914,

FDA announced that a meeting of the

Orthopaedic and Rehabilitation Devices

Panel of the Medical Devices Advisory

Committee would be held on December

11 and 12, 1997. The notice published

with an error in the first sentence in the

Agenda portion of the meeting.

Beginning on page 62777, in the 2d

column, under the Agenda portion of

the meeting, the first sentence should be

corrected to read ‘‘On December 11,

1997, the committee will discuss, make

recommendations, and vote on one

premarket approval application (PMA)

for a spinal intervertebral fusion device

and a second PMA for a spinal

intervertebral fusion system.’’

Dated: December 9, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–32584 Filed 12–9–97; 3:03 pm]

BILLING CODE 4160–01–F

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

made of the following National

Advisory body scheduled to meet

during the month of February 1998:

Name: National Advisory Committee on

Rural Health.

Dates and Time: February 1–4, 1998.

Place: J.W. Marriott Hotel, 1331

Pennsylvania Avenue, N.W., Washington,

D.C. 20004, Phone: (202) 393–2000, FAX:

(202) 626–6915.

The meeting is open to the public.

Agenda: The plenary session on Monday

morning, February 2, will include a national

legislative update, discussion of quality

issues, universal service provisions of the

Telecommunications Act, definition of rural,

and telemedicine payment issues.

Presentations on graduate medical

education, the rural minority health project,

and long-term care; assisted living housing

will be the bases of discussion for the

Committee of the Whole on Tuesday.

The final plenary session will be convened

on Wednesday, February 4, at 8:00 a.m.

During this session there will be an update

of the Office of Rural Health Policy activities,

a report of the Committee of the Whole

regarding the discussions that took place on

Tuesday, and information regarding the next

agenda and future meeting dates and places

will be discussed. The meeting will be

adjourned at approximately 11:30 a.m.

Anyone requiring information regarding

the subject Committee should contact Dena

S. Puskin, Sc.D., Executive Secretary,

National Advisory Committee on Rural

Health, Health Resources and Services

Administration, Room 9–05, Parklawn

Building, 5600 Fishers Lane, Rockville, MD

20857, telephone (301) 443–0835, FAX (301)

443–2803.

Persons interested in attending any portion

of the meeting should contact Arlene A.

Granderson or Lilly Smetana, Office of Rural

Health Policy, (301) 443–0835.

Agenda items change as priorities dictate.

Dated: December 4, 1997.

Jane M. Harrison,

Committee Management Office, HRSA.

[FR Doc. 97–32409 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Human Genome Research

Institute; Notice of Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

meeting:
Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices 65279

Name of Committee: National Human

Genome Research Institute, Special Emphasis

Panel ZHG1 (W2).

Date: December 18, 1997.

Place: Hyatt Regency Bethesda, One

Bethesda Metro Center, Bethesda, MD 20814.

Open: December 18, 8:30 am to recess.

Agenda/purpose: To discuss a concept

review of a component of NHGRI’s five-year

plan.

Note: Advanced Registration Required for

Open session on December 18.

Closed: December 19, 8:30 am to

adjournment.

Contact Person: Jane L. Peterson, National

Human Genome Research Institute, National

Institutes of Health, Building 38A, Room 614,

Bethesda, Maryland 20892, (301) 496–7531.

The meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C. The

applications and/or contract proposals, and

the discussions could reveal confidential

trade secrets or commercial property such as

patentable material, and personal

information concerning individuals

associated with applications, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than

fifteen days prior to the meeting due to the

urgent need to meet extramural process

requirements.

Individuals who plan to attend these

meetings and need special assistance, such as

sign language interpretation or other

reasonable accommodations, should contact

Dr. Jane Peterson, (301) 496–7531, two weeks

in advance of the meeting.

(Catalog of Federal Domestic Assistance

Program No. 93,172, Human Genome

Research)

Dated: December 4, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–32389 Filed 12–10–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of Closed

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

National Institute of Child Health and

Human Development Special Emphasis

Panel (SE) meeting:

Name of SEP: The Effects of Yoga on Peak

Rates in Pregnant Asthmatics,

(TELECONFERENCE).

Date: December 18, 1997.

Time: 3:30 p.m.–adjournment.

Place:

Contact Person: Norman Chang, Ph. D.,

Scientific Review Administrator, NICHD,

6100 Executive Boulevard, Room 5E01,

Rockville, MD 20852, Telephone: 301–496–

1485.

Purpose/Agenda: To evaluate and review

research grant applications.

This meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C. The

discussion of this application could reveal

confidential trade secrets or commercial

property such as patentable material and

personal information concerning individuals

associated with the application, the

disclosure of which would constitute a

clearly unwarranted invasion of personal

privacy.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Nos. [93.864, Population Research

and No. 93.865, Research for Mothers and

Children], National Institute of Health, HHS)

Dated: December 5, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–32386 Filed 12–10–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Neurological

Disorders and Stroke, Division of

Extramural Activities; Notice of Closed

Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

meeting:

Name of Committee: National Institute of

Neurological Disorders and Stroke Special

Emphasis Panel (Teleconference).

Date: December 16, 1997.

Time: 10:00 a.m.

Place: National Institutes of Health, 7550

Wisconsin Avenue, Room 9C10, Bethesda,

MD 20892.

Contact Person: Dr. Katherine Woodbury,

Scientific Review Administrator, NINDS,

National Institutes of Health, 7550 Wisconsin

Avenue, Room 9C10, Bethesda, MD 20892,

(301) 496–9223.

Purpose/Agenda: To review and evaluate a

grant application.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding office.

The meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.853, Clinical Research

Related to Neurological Disorders; No.

93.854, Biological Basis Research in the

Neurosciences)

Dated: December, 4, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–32387 Filed 12–10–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following meeting

of the National Institute of Mental

Health Special Emphasis Panel:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: December 10, 1997.

Time: 12 p.m.

Place: Parklawn, Room 9C–26, 5600

Fishers Lane, Rockville, MD 20857.

Contact Person: Jean G. Noronha,

Parklawn, Room 9C–26, 5600 Fishers Lane,

Rockville, MD 20857, Telephone: 301, 443–

6470.

The meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than

fifteen days prior to the meeting due to the

urgent need to meet timing limitations

imposed by the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

Dated: December 5, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–32390 Filed 12–10–97; 8:45 am]

BILLING CODE 4140–01–M