4842 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Notices

maintenance costs in table 1 of this

document are, therefore, $1,781,400.

When determining the annual

recordkeeping burden (table 2 of this

document), we estimated that the

number of firms that would maintain

records to substantiate labeling that

their products were not developed using

bioengineering is the same as the

number of respondents with the

reporting burden minus the number of

firms marketing organic products (i.e.,

68). We did not include products that

are labeled ‘‘organic’’ in the estimated

annual recordkeeeping burden because

according to a proposal in the Federal

Register of March 13, 2000 (65 FR

13512), issued by the Agriculture

Marketing Service of the U.S.

Department of Agriculture, a food

labeled as ‘‘organic’’ would not be

permitted to contain bioengineered

materials. Therefore, the 16,985 organic

products available today would be able

to bear a voluntary labeling statement

that the food was not developed using

bioengineering. Thus, there is no

additional paperwork burden to

substantiate a claim that a product is not

developed using bioengineering for

these products. Because most of the

non-organic products whose producers

have stated they will not use

bioengineered ingredients are made by

large firms for whom the verification

process is not likely to impose a

significant burden relative to the size of

their operation, we assume that the

paperwork processing time associated

with testing or source verification for

these products is approximately 1 hour

for a total of 1,768 hours per year.

Therefore, FDA estimated that the total

recordkeeping burden would be 1,768

hours per year. Based on our

experience, we have estimated that the

overhead and maintenance cost are $30

per hour. The estimated total operating

and maintenance cost in table 2 of this

document are, therefore, $53,040 total.

III. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance by March 19, 2001, to ensure

adequate consideration in the

preparation of a revised guidance, if

warranted. However, interested persons

may submit written comments at any

time. Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. Submit to the Dockets

Management Branch written comments

concerning this collection of

information by March 19, 2001. The

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

IV. Electronic Access

An electronic version of the draft

guidance also is available on the

Internet at http://www.cfsan.fda.gov/

dms/.

Dated: November 15, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–1047 Filed 1–17–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA)

publishes periodic summaries of

proposed projects being developed for

submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Organ Procurement

and Transplantation Network (42 CFR

Part 121, OMB No. 0915–0184):

Extension

The operation of the Organ

Procurement and Transplantation

Network (OPTN) necessitates certain

recordkeeping and reporting

requirements in order to perform the

functions related to organ

transplantation under contract to HHS.

This is a request for an extension of the

current recordkeeping and reporting

requirements associated with the OPTN.

These data will be used by HRSA in

monitoring the contracts for the OPTN

and the Scientific Registry and in

carrying out other statutory

responsibilities. Information is needed

to match donor organs with recipients,

to monitor compliance of member

organizations with OPTN rules and

requirements, and to ensure that all

qualified entities are accepted for

membership in the OPTN.

The estimated annual response

burden is as follows:

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN

Section and activity Number of

respondents

Responses

per

respondent

Total

responses

Hours

per response

Total

burden hours

121.3(b)(2)—OPTN membership and application requirements for OPOs, hospitals, histocompatibility laboratories ................................................................................. 30 1 30 40 1,200

121.6(c)—Submitting criteria for organ acceptance ............ 900 1 900 0.1 90

121.6(c)—Sending criteria to OPOs .................................... 900 1 900 0.1 90

121.7(b)(4)—Reasons for Refusal ....................................... 900 0.5 34,200 0.1 3,420

121.7(e)—Transplant to prevent organ wastage ................. 900 0.5 420 0.1 42

121.9(b)—Designated Transplant Program Requirements 10 1 10 2 20

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Notices 4843

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN—Continued

Section and activity Number of

respondents

Responses

per

respondent

Total

responses

Hours

per response

Total

burden hours

Total .................................................................................. 940 38.8 36,460 .1 4,862

Send comments to Susan G. Queen,

Ph.D., HRSA Reports Clearance Officer,

Room 14–33, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: January 10, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–1390 Filed 1–17–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center For Research

Resources; 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.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Center for

Research Resources, Special Emphasis Panel,

Research Centers in Minority Institutions.

Date: February 22, 2001.

Time: 6 p.m. to 7 p.m.

Agenda: To review and evaluate grant

applications.

Place: Residence Inn, 7335 Wisconsin

Avenue, Bethesda, MD 20814.

Contact Person: C. William Angus, PhD,

Scientific Review Administrator, Office of

Review, National Center for Research

Resources, 6705 Rockledge Drive, MSC 7965,

Room 6018, Bethesda, MD 20892—7965,

301–435–0812.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.306, Comparative Medicine,

93.306; 93.333, Clinical Research, 93.333;

93.371, Biomedical Technology; 93.389,

Research Infrastructure, National Institutes of

Health, HHS)

Dated: January 9, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–1459 Filed 1–17–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of General Medical

Sciences; Notice of Closed Meeting

Pursuant to section 10(b) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

General Medical Sciences Special Emphasis

Panel.

Date: January 10, 2001.

Time: 3 PM to 4:30 PM.

Agenda: To review and evaluate grant

applications.

Place: Natcher Building, Room 1AS–13,

Bethesda, MD 20892, (Telephone Conference

Call).

Contact Person: Laura Moen, PhD,

Scientific Review Administrator, Office of

Scientific Review, National Institute of

General Medical Sciences, National Institutes

of Health, Natcher Building, Room 1AS–13H,

Bethesda, MD 20892, 301–594–3998.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.375, Minority Biomedical

Research Support; 93.821, Cell Biology and

Biophysics Research; 93.859, Pharmacology,

Physiology, and Biological Chemistry

Research; 93.862, Genetics and

Developmental Biology Research; 93.88,

Minority Access to Research Careers; 93.96,

Special Minority Initiatives, National

Institutes of Health, HHS)

Dated: January 8, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–1451 Filed 1–17–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Arthritis and

Musculoskeletal and Skin Diseases;

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.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personnel information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: Arthritis and

Musculoskeletal and Skin Diseases Special

Grants Review Committee.

Date: February 20, 2001.

Time: 8:30 AM to 3:30 PM.

Agenda: To review and evaluate grant

applications.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: John R. Lymangrover, PhD,

Scientific Review Administrator, National

Institutes of Health, NIAMS, Natcher Bldg.,

Room 5As25N, Bethesda, MD 20892, 301–

594–4952.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.846, Arthritis,

Musculoskeletal and Skin Diseases Research,

National Institutes of Health, HHS)

Dated: January 9, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–1452 Filed 1–12–01; 8:45 am]

BILLING CODE 4140–01–M