64450 Federal Register / Vol. 65, No. 209 / Friday, October 27, 2000 / Notices

variable drugs is expected to occur

rarely. In these instances, FDA believes

that all relevant statistical issues have

been sufficiently resolved and that no

important public health risk will arise if

the criterion is used to allow market

access.

This guidance replaces the following

guidances: (1) ‘‘Guidelines for the

Evaluation of Controlled Release Drug

Products’’ (April 1984); (2) ‘‘Oral

Extended (Controlled) Release Dosage

Form: In Vivo Bioequivalence and In

Vitro Dissolution Testing’’ (September

1993); (3) ‘‘Statistical Procedures for

Bioequivalence Studies Using a

Standard Two-Treatment Crossover

Design’’ (July 1992); (4) the preliminary

draft guidance on ‘‘In Vivo

Bioequivalence Studies Based on

Population and Individual

Bioequivalence Approaches’’ (October

1997), and (5) the draft guidance on ‘‘BA

and BE Studies for Orally Administered

Drug Products—General

Considerations.’’ This guidance

supersedes any prior guidance, or any

relevant part of a prior guidance issued

to assist sponsors in meeting the

requirements in part 320.

This level 1 guidance is being issued

consistent with FDA’s good guidance

practices (65 FR 56468, September 19,

2000). This guidance document

represents the agency’s current thinking

on BA and BE studies for orally

administered drug products. 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 an

approach satisfies the requirements of

the applicable statutes and regulations.

Interested persons may 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 are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: October 19, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27602 Filed 10–26–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4561–N–67]

Notice of Submission of Proposed

Information Collection to OMB;

Uniform Physical Standards and

Physical Inspection Requirements for

Certain HUD Housing, Administrative

Process for Assessment of Insured

and Assisted Properties

AGENCY: Office of the Chief Information

Officer, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: November

27, 2000.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

approval number (2502–0369) and

should be sent to: Joseph F. Lackey, Jr.,

OMB Desk Officer, Office of

Management and Budget, Room 10235,

New Executive Office Building,

Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Q, Department of Housing and

Urban Development, 451 Seventh Street,

Southwest, Washington, DC 20410; email Wayne_Eddins@HUD.gov;

telephone (202) 708–2374. This is not a

toll-free number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Mr. Eddins.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

Act (44 U.S.C. Chapter 35). The Notice

lists the following information: (1) The

title of the information collection

proposal; (2) the office of the agency to

collect the information; (3) the OMB

approval number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of

response, and hours of response; (9)

whether the proposal is new, an

extension, reinstatement, or revision of

an information collection requirement;

and (10) the name and telephone

number of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

This Notice also lists the following

information:

Title of Proposal: Uniform Physical

Standards and Physical Inspection

Requirements for Certain HUD Housing,

Administrative Process for Assessment

of Insured and Assisted Properties.

OMB Approval Number: 2502–0369.

Form Numbers: None.

Description of the Need for the

Information and its Proposed Use: The

uniform physical condition standards

are intended to ensure that HUD

program participants carry out their

legal obligations to maintain HUD

properties in a condition that is decent,

safe, sanitary, and in good repairs.

Respondents: Business or Other ForProfit.

Frequency of Submission: Annually.

Reporting Burden:

Number of

respondents × Frequency of response × Hours perresponse = Burden hours

7,100 1 9 153,900

Federal Register / Vol. 65, No. 209 / Friday, October 27, 2000 / Notices 64451

Total Estimated Burden Hours:

153,900.

Status: Reinstatement, with change.

Authority: Section 3507 of the Paperwork

Reduction Act of 1995, 44 U.S.C. 35, as

amended.

Dated: October 20, 2000.

Wayne Eddins,

Departmental Reports Management Officer,

Office of the Chief Information Officer.

[FR Doc. 00–27608 Filed 10–26–00; 8:45 am]

BILLING CODE 4210–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4561–N–68]

Notice of Submission of Proposed

Information Collection to OMB; 2000

Survey of Homeless Residential

Service Providers

AGENCY: Office of the Chief Information

Officer, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: November

27, 2000.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

approval number and should be sent to:

Joseph F. Lackey, Jr., OMB Desk Officer,

Office of Management and Budget,

Room 10235, New Executive Office

Building, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Q, Department of Housing and

Urban Development, 451 Seventh Street,

Southwest, Washington, DC 20410; email Wayne_Eddins@HUD.gov;

telephone (202) 708–2374. This is not a

toll-free number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Mr. Eddins.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

Act (44 U.S.C. Chapter 35). The Notice

lists the following information: (1) The

title of the information collection

proposal; (2) the office of the agency to

collect the information; (3) the OMB

approval number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of

response, and hours of response; (9)

whether the proposal is new, an

extension, reinstatement, or revision of

an information collection requirement;

and (10) the name and telephone

number of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

This Notice also lists the following

information:

Title of Proposal: 2000 Survey of

Homeless Residential Service Providers.

OMB Approval Number: 2502–XXXX.

Form Numbers: None.

Description of the Need for the

Information and its Proposed Use: The

2000 Survey of Homeless Residential

Service Providers will provide

information about the current operation

of programs assisting homeless persons

in 16 jurisdictions in order to improve

HUD’s ability to assess the success of

homeless service programs and grantees

Frequency of Submission: One-time.

Reporting Burden:

Number of respondents × Freqency of

response × Hours perresponse =

Reporting Burden ...................................................................... 900 1 1 900

Total Estimated Burden Hours: 900.

Status: New.

Authority: Section 3507 of the Paperwork

Reduction Act of 1995, 44 U.S.C. 35, as

amended.

Dated: October 20, 2000.

Wayne Eddins,

Departmental Reports Management Officer,

Office of the Chief Information Officer.

[FR Doc. 00–27609 Filed 10–26–00; 8:45 am]

BILLING CODE 4210–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4561–N–69]

Notice of Submission of Proposed

Information Collection to OMB;

Multifamily Default Status

AGENCY: Office of the Chief Information

Officer, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: November

27, 2000.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

approval number (2502–0041) and

should be sent to: Joseph F. Lackey, Jr.,

OMB Desk Officer, Office of

Management and Budget, Room 10235,

New Executive Office Building,

Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Q, Department of Housing and

Urban Development, 451 Seventh Street,

Southwest, Washington, DC 20410; email Wayne_Eddins@HUD.gov;

telephone (202) 708–2374. This is not a

toll-free number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Mr. Eddins.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

Act (44 U.S.C. Chapter 35). The Notice

lists the following information: (1) The

title of the information collection

proposal; (2) the office of the agency to

collect the information; (3) the OMB

approval number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of