36816 Federal Register / Vol. 65, No. 113 / Monday, June 12, 2000 / Notices

ACTION: Notice of Supplemental

Funding Award.

SUMMARY: The Administration for

Native Americans announces that a noncompetitive grant award is being made

to the InterTribal Bison Cooperative in

the amount of $140,190 for Grant

#90NA7059. The project period is

September 1, 1998—August 341, 2000.

This supplement will augment Year 2

funding to allow for the hiring of

necessary staff as well as other supports

to facilitate the completion of all

original objectives projected under the

grant. The InterTribal Bison Cooperative

is funded to provide services to fortytwo member tribes, including:

Marketing and sales; land base and

production capacity; research and

development of herd management and a

collaboration with tribal colleges in

developing bison curricula.

FOR FURTHER INFORMATION CONTACT: Lois

Hodge, Grants Officer, Department of

Health and Human Services,

Administration for Children and

Families, Office of Grants

Administration, 370 L’Enfant

Promenade SW., Mail Stop HHH 326F,

Washington, DC 20447, telephone: 202–

401–2344 or Georgeline Sparks, Program

Specialist, Administration for Native

Americans, DHHS./ACF/ANA, 370

L’Enfant Promenade SW., Washington,

DC 20447, telephone: 202–690–6420.

Authority: This award will be made

pursuant to Native Americans Programs Act

of 1974 as amended, 42 U.S.C. 2991 B.

(CFDA 93.612).

Dated: June 5, 2000.

Gary Mounts,

Acting Commissioner, Administration for

Native Americans.

[FR Doc. 00–14750 Filed 6–9–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1303]

Agency Information Collection

Activities: Proposed Collection;

Comment Request; Agreement for

Shipment of Devices for Sterilization

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish a notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

reporting requirements relating to

shipment of nonsterile devices that are

to be sterilized elsewhere or are shipped

to other establishments for further

process labeling or repacking.

DATES: Submit written comments on the

collection of information by August 11,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Agreement for Shipment of Devices for

Sterilization—21 CFR 801.150(e) (OMB

Control No. 0910–0131)—Extension

Under sections 501(c) and 502(a) of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 351(c) and

352(a)), nonsterile devices that are

labeled as sterile but are in interstate

transit to a facility to be sterilized are

adulterated and misbranded. FDA

regulations in § 801.150(e) (21 CFR

801.150(e)) establish a control

mechanism by which firms may

manufacture and label medical devices

as sterile at one establishment and ship

the devices in interstate commerce for

sterilization at another establishment, a

practice that facilitates the processing of

devices and is economically necessary

for some firms. Under § 801.150(e),

manufacturers and sterilizers may sign

an agreement containing the following:

(1) Instructions for maintaining

accountability of the number of units in

each shipment; (2) acknowledgment that

the devices are nonsterile, being

shipped for further processing; and (3)

specifications for sterilization

processing.

This agreement allows the

manufacturer to ship misbranded

products to be sterilized without

initiating regulatory action and provides

FDA with a means to protect consumers

from use of nonsterile products. During

routine plant inspections, FDA normally

reviews agreements that must be kept

for 2 years after final shipment or

delivery of devices.

The respondents to this collection of

information are device manufacturers

and contract sterilizers.

FDA estimates the reporting burden of

this collection of information as follows:

Federal Register / Vol. 65, No. 113 / Monday, June 12, 2000 / Notices 36817

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

801.150(e) 90 20 1,800 4 7,200

Total 7,200

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

FDA’s estimate of the burden is based

on actual data obtained from industry

during the past 3 years where there are

approximately 90 firms subject to this

requirement.

No burden has been estimated for the

recordkeeping requirement in

§ 801.150(a)(2) because these records are

maintained as a usual and customary

part of normal business activities. Under

5 CFR 1320.3(b)(2), the time, effort, and

financial resources necessary to comply

with a collection of information are

excluded from the burden estimate if

the reporting, recordkeeping, or

disclosure activities needed to comply

are usual and customary because they

would occur in the normal course of

activities.

Dated: June 5, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–14701 Filed 6–9–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M–0811, 00M–1215, 00M–

1216, 00M–0915, 99M–4619, 00M–0901,

99M–4763, 00M–0424, 00M–1073, 00M–0577,

00M–0579, 00M–0599, 00M–0445, 00M–0580,

00M–0578, 00M–0810, 00M–0809, 00M–1212]

Medical Devices; Availability of Safety

and Effectiveness Summaries for

Premarket Approval Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

list of premarket approval applications

(PMA’s) that have been approved. This

list is intended to inform the public of

the availability of safety and

effectiveness summaries of approved

PMA’s through the Internet and the

agency’s Dockets Management Branch.

ADDRESSES: Summaries of safety and

effectiveness are available on the

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

pmapage.html. Copies of summaries of

safety and effectiveness are also

available by submitting a written

request to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Please cite

the appropriate docket number as listed

in table 1 in the SUPPLEMENTARY

INFORMATION section of this document

when submitting a written request.

FOR FURTHER INFORMATION CONTACT:

Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ–402),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2186.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 30, 1998 (63

FR 4571), FDA published a final rule to

revise §§ 814.44(d) and 814.45(d) (21

CFR 814.44(d) and 814.45(d)) to

discontinue publication of individual

PMA approvals and denials in the

Federal Register. Instead, revised

§§ 814.44(d) and 814.45(d) state that

FDA will notify the public of PMA

approvals and denials by posting them

on FDA’s Internet home page at http://

www.fda.gov; by placing the summaries

of safety and effectiveness on the

Internet and in FDA’s Dockets

Management Branch; and by publishing

in the Federal Register after each

quarter a list of available safety and

effectiveness summaries of approved

PMA’s and denials announced in that

quarter.

FDA believes that this procedure

expedites public notification of these

actions because announcements can be

placed on the Internet more quickly

than they can be published in the

Federal Register, and FDA believes that

the Internet is accessible to more people

than the Federal Register.

In accordance with section 515(d)(3)

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360e(d)(3)),

notification of an order approving,

denying, or withdrawing approval of a

PMA will continue to include a notice

of opportunity to request review of the

order under section 515(g) of the act.

The 30-day period for requesting

reconsideration of an FDA action under

§ 10.33(b) (21 CFR 10.33(b)) for notices

announcing approval of a PMA begins

on the day the notice is placed on the

Internet. Section 10.33(b) provides that

FDA may, for good cause, extend this

30-day period. Reconsideration of a

denial or withdrawal of approval of a

PMA may be sought only by the

applicant; in these cases, the 30-day

period will begin when the applicant is

notified by FDA in writing of its

decision.

The following is a list of approved

PMA’s for which summaries of safety

and effectiveness were placed on the

Internet in accordance with the

procedure explained previously from

January 1, 2000, through March 31,

2000. There were no denial actions

during this period. The list provides the

manufacturer’s name, the product’s

generic name or the trade name, and the

approval date.

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMA’S MADE AVAILABLE JANUARY 1, 2000,

THROUGH MARCH 31, 2000

PMA Number/Docket No. Applicant Trade Name Approval Date

P970005/00M–0811 Kremer Laser Eye Center Kremer Exciber Laser System (Serial

#KEA940202)

July 30, 1998

P970055/00M–1215 Biotrin International, Ltd. Biotrin Parvovirus IgM EIA (V619IMUS) August 6, 1999

P970054/00M–1216 Biotrin International, Ltd. Biotrin Parvovirus IgG EIA (V519IGUS) August 6, 1999

P980049/00M–0915 ELA Medical, Inc. Defender II Model 9201 Implantable Cardiovascular DefibrillatorSeptember 15, 1999

H990003/99M–4619 American Medical Systems ActiconTM Neosphincter September 20, 1999