Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Notices 50619

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the order may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: September 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25588 Filed 9–25–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0398]

Guidance for Industry on Extended

Release Oral Dosage Forms:

Development, Evaluation, and

Application of In Vitro/In Vivo

Correlations; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document for

industry entitled ‘‘Extended Release

Oral Dosage Forms: Development,

Evaluation, and Application of In Vitro/

In Vivo Correlations.’’ This guidance

document is intended to provide

recommendations to pharmaceutical

sponsors who intend to develop

documentation in support of an in vitro/

in vivo correlation (IVIVC) for an oral

extended release (ER) drug product for

submission in a new drug application

(NDA), abbreviated new drug

application (ANDA), or antibiotic drug

application (ANDA/AADA).

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Extended Release Oral

Dosage Forms: Development,

Evaluation, and Application of In Vitro/

In Vivo Correlations’’ to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Ramana Uppoor, Center for Drug

Evaluation and Research, HFD–860,

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5305.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance document for industry entitled

‘‘Extended Release Oral Dosage Forms:

Development, Evaluation, and

Application of In Vitro/In Vivo

Correlations.’’ This guidance document

provides recommendations to

pharmaceutical sponsors who intend to

develop documentation in support of an

IVIVC for an oral ER drug product for

submission in an NDA, ANDA, or

AADA. The guidance presents a

comprehensive perspective on: (1)

Methods of developing an IVIVC and

evaluating its predictability; (2) using an

IVIVC to set dissolution specifications;

and (3) applying an IVIVC as a surrogate

for in vivo bioequivalence when it is

necessary to document bioequivalence

during the initial approval process or

because of certain preapproval or

postapproval changes, e.g., formulation,

equipment, process, and manufacturing

site changes.

This guidance document represents

the agency’s current thinking on the

development, evaluation, and

application of in vitro/in vivo

correlations for an oral ER drug product

for submission in an NDA, ANDA, or

AADA. It does not create or confer any

rights for or on any person and does not

operate to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). 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. The guidance and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

An electronic version of this guidance

is also available on the Internet at http:/

/www.fda.gov/cder/guidance/

index.htm.

Dated: September 18, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25514 Filed 9–25–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4235–N–22]

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.

EFFECTIVE DATE: September 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Mark Johnston, Department of Housing

and Urban Development, Room 7256,

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 the December 12, 1988

court order in National Coalition for the

Homeless v. Veterans Administration,

No. 88–2503–OG (D.D.C.), HUD

publishes a Notice, on a weekly basis,

identifying unutilized, underutilized,

excess and surplus Federal buildings

and real property that HUD has

reviewed for suitability for use to assist

the homeless. Today’s Notice is for the

purpose of announcing that no

additional properties have been

determined suitable or unsuitable this

week.

Dated: September 18, 1997.

Fred Karnas, Jr.,

Deputy Assistant Secretary for Economic

Development.

[FR Doc. 97–25183 Filed 9–25–97; 8:45 am]

BILLING CODE 4210–29–M