Federal Register / Vol. 66, No. 36 / Thursday, February 22, 2001 / Notices 11175

Labeling in ANDA’s.’’ This is one of

several guidances the agency is

developing to help manufacturers,

packers, and distributors implement the

recently issued final rule establishing

standardized content and format

requirements for the labeling of all OTC

drug products. Once finalized, these

guidances will supersede all other

statements, feedback, and

correspondence provided by the agency

on these matters since the issuance of

the final rule.

In the Federal Register of March 17,

1999 (64 FR 13254), FDA published a

final rule establishing standardized

content and format requirements for the

labeling of OTC drug products. This rule

is intended to standardize labeling for

all OTC drug products so consumers can

easily read and understand OTC drug

product labeling and use these products

safely and effectively.

The regulation for this new

standardized labeling requires

manufacturers to present OTC drug

labeling information in a prescribed

order and format. This new format will

require revision of all existing labeling.

Following issuance of the final rule,

the agency received several inquiries

from manufacturers of generic OTC drug

products seeking guidance on whether

they may convert products to the new

labeling format before the applicable

innovator (or RLD) product revises its

labeling. This guidance addresses those

inquiries.

Generally, the agency believes

manufacturers of generic OTC drug

products (i.e., products marketed under

ANDA’s) need not wait to implement

the new labeling format until after the

RLD holder has submitted its labeling.

This guidance is intended to facilitate

the updating of labeling in ANDA’s to

meet the new OTC drug products format

requirement. Accordingly, the agency

has developed labeling examples as

guidance for manufacturers to follow.

Two such labeling examples are

attached to the draft guidance. The

additional labeling examples that the

agency proposes to develop will be

made available for review in this docket

and at the Internet site referenced in this

draft guidance before the close of the

comment period.

This draft guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

draft guidance represents the agency’s

current thinking on updating labeling in

ANDA’s consistent with the new OTC

drug products standardized labeling

content and format. 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, on or before

April 23, 2001, submit written

comments on the draft 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 draft 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: February 8, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4312 Filed 2–21–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0059]

Draft Guidance for Industry on

Separate Marketing Applications and

Definition of Clinical Data for Purposes

of Assessing User Fees; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Separate Marketing

Applications and Clinical Data for

Purposes of Assessing User Fees.’’ This

draft guidance revises a procedural

guidance entitled ‘‘Attachment E—

Interim Guidance: Separate Marketing

Applications and Clinical Data for

Purposes of Assessing User Fees Under

the User Fee Act of 1992’’ issued in July

1993 (the July 1993 interim guidance),

which provided guidance on the

agency’s policy on ‘‘bundling’’

applications and a definition of

‘‘clinical data’’ for user fee purposes.

This draft guidance deletes two

appendices in the July 1993 interim

guidance and directs readers to the

agency publication entitled ‘‘Approved

Drug Products with Therapeutic

Equivalence Evaluations’’ (the Orange

Book) for a listing of routes of

administration and dosage forms.

DATES: Submit written comments on

this draft guidance by March 26, 2001.

General comments are welcome at any

time.

ADDRESSES: Copies of this draft

guidance for industry are available on

the Internet at http:/www.fda.gov/cder/

guidance and http:/www.fda.gov/cder/

pdufa/default.htm. Submit written

requests for single copies of the draft

guidance entitled ‘‘Separate Marketing

Applications and Clinical Data for

Purposes of Assessing User Fees’’ to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. The

document may also be obtained by fax

by calling the FAX Information System

at 1–888–CBER–FAX or 301–827–3844.

Send one self-addressed adhesive label

to assist the office in processing your

request. Submit written comments on

the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Michael D. Jones, Center for Drug

Evaluation and Research (HFD–5),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–594–2041, FAX 301–

827–5562, or

Carla A. Vincent, Center for Biologics

Evaluation and Research (HFM–

110), 1401 Rockville Pike,

Rockville, MD 20852, 301–827–

3503, FAX 301–827–2875.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Separate

Marketing Applications and Clinical

Data for Purposes of Assessing User

Fees.’’ This draft guidance revises the

July 1993 interim guidance.

The agency is deleting from the 1993

interim guidance the list of routes of

administration in appendix A and

dosage forms in appendix B.

FDA is deleting appendices A and B

so that the guidance reflects current

agency policy, as developed over the

past few years (see Docket Nos. 93P–

0421, 95P–0262, 96P–0317, and 96P–

0459). Among other things, in the

review of abbreviated new drug

applications, the Center for Drug

Evaluation and Research generally has

not considered different mechanisms of

release, particularly for suppository,

delayed, and controlled release

products, as different dosage forms.

11176 Federal Register / Vol. 66, No. 36 / Thursday, February 22, 2001 / Notices

Instead, the draft guidance refers

readers to the Orange Book appendix C,

‘‘Uniform Terms.’’ Although the Orange

Book appendix C is not binding on the

agency or industry, it does serve as

informal guidance on what the ‘‘same’’

or ‘‘identical’’ dosage form or route of

administration would be.

The draft guidance also updates the

July 1993 interim guidance for

consistency with the agency’s good

guidance practices (GGP’s) regulation

(21 CFR 10.115; 65 FR 56468,

September 19, 2000). The agency

anticipates making additional revisions

to this procedural guidance in the

future.

This Level 1 draft guidance is being

issued consistent with FDA’s GGP’s.

The draft guidance represents the

agency’s current thinking on this topic.

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 statutes

and regulations. The draft guidance will

be updated as appropriate.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance at any time. 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 draft

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: February 13, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4311 Filed 2–21–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4655–N–03]

Notice of Proposed Information

Collection: Comment Request;

Management Reviews of Multifamily

Projects

AGENCY: Office of the Assistance

Secretary for Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be 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: April 23,

2001.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Wayne Eddins, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street,

SW., L’Enfant Building, Room 8202,

Washington, DC 20410, telephone (202)

708–5221 (this is not a toll-free number)

for copies of the proposed forms and

other available information.

FOR FURTHER INFORMATION CONTACT:

Beverly J. Miller, Director, Policy and

Participation Standards Division, U.S.

Department of Housing and Urban

Development, 451 7th Street, SW.,

Washington, DC 20410, telephone

number (202) 708–3000, (this is not a

toll-free number) for copies of the

proposed forms and other available

information.

SUPPLEMENTARY INFORMATION: The

Department is submitting the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1955 (44 U.S.C.

Chapter 35, as amended).

This Notice is soliciting comments

from members of the public and affected

agencies concerning the proposed

collection of information to: (1) Evaluate

whether the proposed collection is

necessary for the proper performance of

the functions of the agency, including

whether the information will have

practical utility; (2) evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) enhance the quality,

utility, and clarity of the information to

be collected; and (4) minimize the

burden of the collection of information

on those who are to respond; including

the use of appropriate automated

collection techniques or other forms of

information technology, e.g., permitting

electronic submission of responses.

This Notice also lists the following

information:

Title of Proposal: Management

Reviews of Multifamily Projects.

OMB Control Number, if applicable:

2502–0178.

Description of the need for the

information and proposed use: The form

is completed by HUD staff and

Contractor Administrators gathering and

recording information during an on-site

review of the project operations.

Agency form numbers, if applicable:

Form HUD–9834.

Estimation of the total numbers of

hours needed to prepare the information

collection including number of

respondents, frequency of response, and

hours of response: The estimated

number of respondents for HUD staff

and Contract Administrators is 1,120;

the frequency of response is 1, estimated

time to prepare form is approximately 4

hours; and the estimated total annual

burden hours are 4,480.

Status of the proposed information

collection: Reinstatement with change of

previously approved collection for

which approval has expired.

Authority: The Paperwork Reduction Act

of 1995, 44 U.S.C., Chapter 35, as amended.

Dated: February 13, 2001.

Wayne Eddins,

Reports Management Officer, Office of the

Chief Information Officer.

[FR Doc. 01–4384 Filed 2–21–01; 8:45 am]

BILLING CODE 4210–27–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4655–N–04]

Notice of Proposed Information

Collection: Comment Request;

Minimum Property Standards for

Housing

AGENCY: Office of the Assistant

Secretary for Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be 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: April 23,

2001.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Wayne Eddins, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street,

SW., L’Enfant Plaza Building, Room

8001, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Elizabeth A. Cocke, Acting Director,

Office of Consumer and Regulatory

Affairs, Department of Housing and

Urban Development, 451 7th Street SW.,

Washington, DC 20410, telephone (202)

708–6409 (this is not a toll free number)

for copies of the proposed forms and

other available information.