Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices 57617

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section Number of

respondents

Annual frequency

per response

Total annual

responses Hours per response Total hours

170.35(c)(1) 1 1 1 2,614 (average) 2,614

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

FDA estimates that it may receive one

GRAS petition annually. Although the

burden varies with the type, size, and

complexity of the petition submitted,

GRAS petitions may involve analytical

work, analysis of appropriate

toxicological studies, and the work of

drafting the petition itself. Since 1980,

FDA has not received any petitions for

affirmation of GRAS status under 21

CFR part 186—Indirect Food Substances

Affirmed As Generally Recognized As

Safe. Section 184.1(a) (21 CFR 184.1(a))

affirms the use of those substances

affirmed as GRAS in 21 CFR part 184—

Direct Food Substances Affirmed As

Generally Recognized As Safe, for use as

indirect food ingredients.

Dated: September 19, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24479 Filed 9–22–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1328]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Latex

Condoms; User Labeling; Expiration

Dating

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.

DATES: Submit written comments on the

collection of information by October 25,

2000.

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: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Latex Condoms; User Labeling;

Expiration Dating—21 CFR 801.435

(OMB Control No. 0910–0352)—

Extension

Sections 502(a), 519, 701, and 704 of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 352(a), 360(i),

371, and 374) establish the statutory

authority to collect information under

this regulation. Section 519 of the act

describes recordkeeping, section 502(a)

describes misbranding, section 704

describes authority for inspections, and

section 701 describes general

administrative procedures and

regulations and hearings.

To protect the public health and

minimize the risk of device failure, latex

condoms are required to be labeled with

an expiration date, which must be

supported by data from quality control

tests demonstrating physical and

mechanical integrity of three random

lots of the same product that were

stored under accelerated and real time

conditions (§ 801.435 (21 CFR 801.435)).

The recording of shelf life testing by

condom manufacturers is used to

support the expiration dating on the

labeling of latex condoms. Information

concerning latex shelf life is necessary

to allow lay users to use these products

safely by avoiding use of products that

may have degraded. Degradation of latex

film products like latex condoms occurs

when latex is exposed to various types

of environmental conditions normally

experienced in product use, shipment,

or storage situations. The effectiveness

of latex condoms as a barrier to the

transmission of infectious agents is

dependent upon the integrity of the

latex material. The information and

records generated by condom

manufacturers under this regulation will

be used to establish an expiration date

that will inform consumers when the

product should no longer be used.

Section 510(h) of the act (21 U.S.C.

360(h)) requires that condom

manufacturers as device manufacturers

be inspected at least once in a 2-year

period. During that inspection, FDA

inspectors will review the test records

used to support the expiration date in

order to ensure that the expiration date

is accurate. The respondents to this

collection of information are domestic

and foreign condom manufacturers.

In the Federal Register of June 23,

2000 (65 FR 39150), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of respondents

Annual frequency per

response

Total annual

responses Hours per response Total hours

801.435 45 1 45 96 4,320

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

The number of domestic

establishments was estimated by

reviewing the FDA data base of

registered medical device manufacturers

to arrive at 5 domestic and 40 foreign

condom manufacturers. Based upon

conversations with condom

manufacturers, FDA field personnel,

and comments received from the public

57618 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices

during this collections initial approval,

FDA determined the number hours to

complete labeling and testing of

condoms to be 96 hours per respondent.

Dated: September 19, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24480 Filed 9–22–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Receipt of Application for Endangered

Species Permit

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of Receipt of Application

for Endangered Species Permit.

SUMMARY: The following applicants have

applied for permits to conduct certain

activities with endangered species. This

notice is provided pursuant to Section

10(c) of the Endangered Species Act of

1973, as amended (16 U.S.C. 1531 et

seq.).

If you wish to comment, you may

submit comments by any one of several

methods. You may mail comments to

the Service’s Regional Office (see

ADDRESSES). You may also comment via

the internet to

‘‘victoria_davis@fws.gov’’. Please

submit comments over the internet as an

ASCII file avoiding the use of special

characters and any form of encryption.

Please also include your name and

return address in your internet message.

If you do not receive a confirmation

from the Service that we have received

your internet message, contact us

directly at either telephone number

listed below (see FURTHER INFORMATION).

Finally, you may hand deliver

comments to either Service office listed

below (see ADDRESSES). Our practice is

to make comments, including names

and home addresses of respondents,

available for public review during

regular business hours. Individual

respondents may request that we

withhold their home address from the

administrative record. We will honor

such requests to the extent allowable by

law. There may also be other

circumstances in which we would

withhold from the administrative record

a respondent’s identity, as allowable by

law. If you wish us to withhold your

name and address, you must state this

prominently at the beginning of your

comments. We will not; however,

consider anonymous comments. We

will make all submissions from

organizations or businesses, and from

individuals identifying themselves as

representatives or officials of

organizations or businesses, available

for public inspection in their entirety.

DATES: Written data or comments on

these applications must be received, at

the address given below, by October 25,

2000.

ADDRESSES: Documents and other

information submitted with these

applications are available for review,

subject to the requirements of the

Privacy Act and Freedom of Information

Act, by any party who submits a written

request for a copy of such documents to

the following office within 30 days of

the date of publication of this notice:

U.S. Fish and Wildlife Service, 1875

Century Boulevard, Suite 200, Atlanta,

Georgia 30345 (Attn: Victoria Davis,

Permit Biologist). Telephone: 404/679–

4176; Facsimile: 404/679–7081.

FOR FURTHER INFORMATION CONTACT:

Victoria Davis, Telephone: 404/679–

4176; Facsimile: 404/679–7081.

SUPPLEMENTARY INFORMATION:

Applicant: Brian R. Roh, Burns &

McDonnell, Kansas City, Missouri,

TE033460–0.

The applicant requests authorization

to take (capture, identify, and release)

the endangered American Burying

Beetle, Nicrophorus americanus, around

Lake Fort Smith and Lake Shepherd

Springs in Crawford County, Arkansas

for the purpose of enhancement of

survival of the species.

Applicant: Felicia J. Sanders, Tucker,

Georgia, TE033469–0.

The applicant requests authorization

to take (capture, band, install inserts,

and harass during nest monitoring and

construction of artificial cavities) the

endangered red-cockaded woodpecker,

Picoides borealis, throughout the

species range, for the purpose of

enhancement of survival of the species.

Dated: September 18, 2000.

Sam D. Hamilton,

Regional Director.

[FR Doc. 00–24533 Filed 9–22–00; 8:45 am]

BILLING CODE 4310–55–P

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[MT–925–2810–XU–241E]

Notice of Rescindment of Special Fire

Restrictions and Closures in the

Billings, Miles City, Malta and

Lewistown Field Offices; MT

AGENCY: Bureau of Land Management,

Interior.

ACTION: Notice.

SUMMARY: Pursuant to 43 Code of

Federal Regulations 9212.2, the

prohibitions listed in Order No. MT–00–

12, MT–00–09 (Stillwater, Carbon and

Sweetgrass counties), MT–00–05

applicable to Bureau of Land

Management lands administered by the

Billings, Miles City, Malta, and

Lewistown Field Offices, dated

September 12, 2000, September 5, 2000

and August 11, 2000, will be terminated

at 12:01 a.m. Friday, September 22,

2000.

DATES: Restrictions are terminated at

12:01 a.m. on Friday, September 22,

2000.

ADDRESSES: Comments should be sent to

BLM Montana State Director, Attention:

Pat Mullaney, P.O. Box 36800, Billings,

Montana 59107–6800.

FOR FURTHER INFORMATION CONTACT: Pat

Mullaney, Fire Management Specialist,

406–896–2915.

Dated: September 20, 2000.

Mat Millenbach,

State Director.

[FR Doc. 00–24623 Filed 9–21–00; 2:08 pm]

BILLING CODE 4310–$$–P

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[UT–930–07–1320–00]

Release of Coal Exploration License

Data, UTU–48608

ACTION: Notice of determination to allow

public access to data from coal

exploration license UTU–48608.

SUMMARY: BLM regulations at 43 CFR

2.22 and 3410.4(b) provide that data

obtained under an exploration license

will be kept confidential until the lands

have been leased or BLM determines

that public access to the data would not

damage the competitive position of the

licensee, whichever comes first. Coal

exploration License UTU–48068 was

issued to Royal Land Company on

August 4, 1981. Exploration on this

license included drilling 15 holes in the

vicinity of North Horn Mountain, Emery

County, Utah. The lands covered by this

license were offered for lease on May

29, 1982, and no bids were received.

Since May 29, 1982, no application has

been made for a lease on these lands in

accordance with 43 CFR 3425. The coal

interests in part of the lands contained

within UTU–48068 were transferred to

the State of Utah pursuant to the

provisions of the Utah Schools and

Lands Exchange Act of 1998.