49248 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices

Document Mail Center (DMC).

Modifications which affect the intended

use or alter the basic fundamental

scientific technology of the device are

not appropriate for review under this

type of application, but rather they

should continue to be subject to routine

510(k) procedures or may be subject to

an ‘‘Abbreviated 510(k)’’ as described in

section I.B of this document.

B. Abbreviated 510(k)

The SMDA introduced the concept of

special controls as the means by which

the safety and effectiveness of Class II

devices can be ensured. Special controls

are defined by statute as those controls

that provide reasonable assurance of the

device’s safety and effectiveness.

Recently, considerable effort has been

expended to develop the concept of a

‘‘special control guidance document’’

(SCGD). Under this initiative,

reasonably foreseeable risks that are

associated with a type of Class II device

would be identified in a SCGD. For each

risk, the agency would also identify a

special control(s) such as a consensus

standard, labeling content, or

postmarket surveillance that would

address the risk.

In addition to SCGD’s that would be

developed for generic Class II devices,

CDRH is committed to recognizing

individual consensus standards. The

consensus standards could be cited in

SCGD’s, recognized in individual policy

statements, or identified as ‘‘special

controls’’ that address specific risks

associated with multiple device types.

IEC 60601 is an example of such a

consensus standard. It has broad

applicability to many electromedical

devices. FDA’s recognition of this

standard, combined with modified

review procedures, could streamline the

review of many 510(k)’s for devices

covered by the standard. Finally, by

using the accompanying particular

standards to adapt the general standard

to specific devices, the 510(k) review

process may be further expedited.

Under the draft paradigm, device

manufacturers could choose to submit

‘‘Abbreviated 510(k)’s’’ for Class II

devices when a SCGD exists or when

FDA has recognized an individual

special control such as a relevant

standard. The incentive for

manufacturers to elect to use special

controls or to declare conformance to

recognized standards would be a more

expedient review of their submissions.

II. Electronic Access

In order to receive ‘‘A New 510(k)

Paradigm—Alternate Approaches to

Demonstrating Substantial Equivalence

in Premarket Notifications’’ document

via your fax machine, call the CDRH

Facts-On-Demand (FOD) system at 800–

899–0381 or 301–827–0111 from a

touch-tone telephone. At the first voice

prompt press 1 to access DSMA Facts,

at second voice prompt press 2, and

then enter the document number (905)

followed by the pound sign (#). Then

follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of the paradigm may also do so by using

the World Wide Web (WWW). CDRH

maintains an entry on the WWW for

easy access to information including

text, graphics, and files that may be

downloaded to a personal computer

with access to the Web. The CDRH

home page, which is updated on a

regular basis, includes: The draft

document entitled ‘‘A New 510(k)

Paradigm—Alternate Approaches to

Demonstrating Substantial Equivalence

in Premarket Notifications,’’ device

safety alerts, Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

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

paradigm will be available at http://

www.fda.gov/cdrh/ode/parad510.html.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

III. Comments

Interested persons may, submit to the

Dockets Management Branch (address

above) written comments regarding this

paradigm by November 18, 1997. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments and

requests for copies are to be identified

with the docket number found in

brackets in the heading of this

document. The paradigm and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: September 9, 1997.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 97–24955 Filed 9–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney 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

National Institute of Diabetes and

Digestive and Kidney Diseases Special

Emphasis Panel meeting:

Name of SEP: HLA Genotyping.

Date: October 8, 1997.

Time: 3:00 p.m.

Contact Person: William Elzinga, Ph.D.,

Scientific Review Administrator, Review

Branch, NIDDK, Natcher Building, Room

6as–37A, National Institutes of Health,

Bethesda, Maryland 20892–6600, Phone:

(301) 594–8895.

Purpose/Agenda: To review and evaluate

grant applications.

This meeting will be closed in accordance

with the provisions set forth in secs.

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. 93.847–849, Diabetes, Endocrine

and Metabolic Diseases; Digestive Diseases

and Nutrition; and Kidney Diseases, Urology

and Hematology Research, National Institutes

of Health)

Dated: September 12, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–24884 Filed 9–18–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Division of Research Grants; Notice of

Closed Meetings

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
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices 49249

meetings that are being held to review

grant applications:

BIOBEHAVIORAL AND SOCIAL SCIENCES INITIAL REVIEW GROUP

Study section/contact

person

October–November 1997

meetings

Time Location

Human Development and Aging-1, Dr. Anita Miller

Sostek, 301–435–1260.

Oct. 23–24 ........ 9:00 a.m. .......... Embassy Suites Hotel, Chevy Chase Pavilion,

Washington, DC.

Human Development and Aging-3, Dr. Anita Miller

Sostek, 301–435–1260.

Nov. 6–7 ........... 9:00 a.m. .......... Embassy Suites Hotel, Chevy Chase Pavilion,

Washington, DC.

The meetings 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 Nos. 93.306, 93.333, 93.337, 93.393–

93.396, 93.837–93.844, 93.846–93.878,

93.892, 93.893, National Institutes of Health,

HHS)

Dated: September 12, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–24883 Filed 9–18–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Limited Exclusive

License: Monoclonal Antibodies to

Thymidylate Synthase

AGENCY: National Institutes of Health,

Public Health Service, HHS.

ACTION: Notice.

SUMMARY: This notice in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(I) that the National Institutes

of Health, Department of Health and

Human Services, is contemplating the

grant of an exclusive worldwide license

to practice the inventions embodied in

the U.S. Patent Application SN 07/

690,841 filed 04/24/91, entitled

‘‘Monoclonal Antibodies to

Thymidylate Synthase’’ to Oncotech,

Inc. of Irvine, CA. The patent rights in

this invention have been assigned to the

United States of America.

The prospective exclusive license

field of use may be limited to the in

vitro diagnosis of elevated Thymidylate

Synthase for the treatment of cancer in

humans.

DATES: Only written comments and/or

applications for a license which are

received by NIH on or before November

18, 1997 will be considered.

ADDRESSES: Requests for copies of the

patent application, inquiries, comments

and other materials relating to the

contemplated licenses should be

directed to: Joseph G. Contrera, M.S.,

J.D., Technology Licensing Specialist,

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; Telephone: (301)

496–7056 ext. 244; Facsimile: (301)

402–0220. A signed Confidentiality

Agreement will be required to receive

copies of the patent application.

SUPPLEMENTARY INFORMATION: The

invention relates to monoclonal

antibody (MoAb) technology. The

technology provides improved

sensitivity and specificity that is

necessary to overcome the problems of

traditional biochemical assays. The

present invention provides for the

immunological detection and

quantitation of thymidylate synthase

(TS) through a series of hybridoma cell

lines that produce MoAbs specific for

antigenic determinants on TS. TS plays

a critical role in DNA nucleotide

precursor synthesis, and thus, an

important therapeutic target for the

fluoropyrimidine class of antineoplastic

agents.

In sum, this invention allows for the

immunological detection and

quantitation of TS in human cells and

enables the immuno-histochemical

localization of TS in human colon

carcinomas.

The prospective exclusive license will

be royalty-bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. The prospective

exclusive license may be granted unless

within sixty (60) days from the date of

this published notice, NIH receives

written evidence and argument that

establishes that the grant of the license

would not be consistent with the

requirements of 35 U.S.C. 209 and 37

CFR 404.7.

Applications for a license in the field

of use filed in response to this notice

will be treated as objections to the grant

of the contemplated license. Comments

and objections submitted to this notice

will not be made available for public

inspection and, to the extent permitted

by law, will not be released under the

Freedom of Information Act, 5 U.S.C.

552.

Dated: September 10, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–24882 Filed 9–18–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4235–N–21]

Federal Property Suitable as Facilities

To Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

FOR FURTHER INFORMATION CONTACT:

Mark Johnston, room 7256, Department

of Housing and Urban Development,

451 Seventh Street SW, Washington, DC

20410; telephone (202) 708–1226; TDD

number for the hearing- and speechimpaired (202) 708–2565 (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with 24 CFR part 581 and

section 501 of the Stewart B. McKinney

Homeless Assistance Act (42 U.S.C.

11411), as amended, HUD is publishing

this notice to identify Federal buildings