Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Notices 65277

There are also an estimated 4,500 Health

Care Financing Administration

registered transfusion services. The

recordkeeping chart reflects the estimate

that 95 percent of the recordkeepers

which collect 98 percent of the blood

supply had developed SOP’s as part of

their normal business practice.

Establishments may minimize burdens

associated with the CGMP and related

regulations by using model SOP’s

developed by blood organizations.

These blood organizations represent

almost all of the registered

establishments.

FDA estimates the burden of this

information collection as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

606.170(b) 42 1 42 8 336

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

606.100(b) 151 1 151 24 3,624

606.100(c) 151 3.6 550 3.6 550

606.110(a) 90 5 450 2.5 225

606.151(e) 239 12 2,868 1 239

606.160 151 3,112 470,000 1,556 234,956

606.165 151 3,112 470,000 258 38,958

606.170(a) 376 12 4,512 12 4,512

1There 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. 97–32458 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N–0453]

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 January 12,

1998.

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:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

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.

Human Tissue Intended for

Transplantation (OMB Control Number

0910–0302)—Reinstatement

FDA issued final regulations in the

Federal Register of July 29, 1997 (62 FR

40429) to prevent the transmission of

human immunodeficiency virus (HIV),

hepatitis B, and hepatitis C through the

use of human tissue for transplantation.

The final regulations closely parallel

those contained in the interim rule on

human tissue intended for

transplantation. Both the interim and

final rule provide for inspection by FDA

of persons and tissue establishments

engaged in the recovery, screening,

testing, processing, storage, or

distribution of human tissue. These

facilities are required to meet standards

intended to ensure appropriate

screening and testing of human tissue

donors and ensure that records are kept

documenting that the appropriate

screening and testing have been

completed.

There are approximately 60 tissue

establishments with 300 employees that

are members of the American

Association of Tissue Banks. There are

an additional 600 individual members

of which 50 percent are performing a

tissue banking activity. The Eye Bank

Association of America’s membership

consists of 120 eye banks of which 110

are in the continental United States.

With the rare exceptions noted in the

preamble of the rule, FDA believes that

all respondents perform donor testing

and screening for HIV and hepatitis and

these regulations add no additional

requirements. 21 CFR 1270.31(c) and (d)

require written procedures for the

designation and identification of

quarantined tissue and to prevent the

contamination or cross-contamination of

tissue during processing. 21 CFR

1270.35(c) requires documentation of

the distribution and receipt of human

tissue, completing the accounting of

tissue between determination of

suitability, and the destruction or

disposition of the tissue.

When the interim rule was issued in

the Federal Register of December 14,

1993 (58 FR 65514), accredited members

of the American Association of Tissue

Banks and the Eye Bank Association of

America were already in compliance

with the regulations by adhering to the

standards established by these

organizations. The requirements in the
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: