Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Notices 33687

(revised Form FDA 356h) for vaccines or

related products. This action is part of

FDA’s continuing effort to achieve the

objectives of the President’s

‘‘Reinventing Government’’ initiatives

and the FDA Modernization Act of

1997, and is intended to reduce

unnecessary burdens for industry

without diminishing public health

protection.

DATES: Written comments may be

submitted at any time, however,

comments should be submitted by

August 18, 1998, to ensure their

adequate consideration in preparation of

the final document.

ADDRESSES: Submit written requests for

single copies of the draft guidance

document entitled ‘‘Guidance for

Industry: Content and Format of

Chemistry, Manufacturing and Controls

Information and Establishment

Description Information for a Vaccine or

Related Product’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The draft guidance document may also

be obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: Content and

Format of Chemistry, Manufacturing

and Controls Information and

Establishment Description Information

for a Vaccine or Related Product.’’ This

draft guidance document, when

finalized, is intended to provide

guidance to applicants in completing

the CMC section and the establishment

description information of revised Form

FDA 356h. As announced in the Federal

Register of July 8, 1997 (62 FR 36558),

this form will be used as a single

harmonized application form for all

drug and licensed biological products.

Use of the new harmonized Form FDA

356h, when fully implemented, will

allow a biologic product manufacturer

to submit one biologics license

application instead of two separate

applications (product license

application and establishment license

application).

This draft guidance document

represents FDA’s current thinking on

the content and format of the CMC and

Establishment Description sections of a

license application for a vaccine or

related product. 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

requirement of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this draft guidance document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. The draft guidance document

is intended to provide information and

does not set forth requirements.

II. Request for Comments

This draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding the draft guidance

document. Written comments may be

submitted at any time, however,

comments should be submitted by

August 18, 1998, to ensure adequate

consideration in preparation of the final

document. Two copies of any comments

are to be submitted, except individuals

may submit one copy. Comments

should be identified with the docket

number found in brackets in the

heading of this document. A copy of the

draft guidance document and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the draft guidance document

by using the World Wide Web (WWW).

For WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’.

Dated: June 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16291 Filed 6–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4349–N–24]

Submission for OMB Review:

Comment Request

AGENCY: Office of the Assistant

Secretary for Administration, 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: July 20,

1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within thirty (30) days from the

date of this Notice. 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, Department of Housing and

Urban Development, 451 7th Street,

Southwest, Washington, DC 20410,

telephone (202) 708–1305. 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
33688 Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Notices

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 names and telephone

numbers of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

Authority: Section 3507 of the Paperwork

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

amended.

Dated: June 12, 1998.

David S. Cristy,

Director, IRM Policy and Management

Division.

Title of Proposal: Manufactured Home

Construction and Safety Standards.

Office: Housing.

OMB Approval Number: 2502–0253.

Description of the Need for the

Information and Its Proposed Use: The

National Manufactured Housing

Construction and Safety Standards Act

authorized HUD to establish

construction and safety standards for

manufactured (mobile) homes and to

enforce these standards. The standards

require pertinent information in the

form of labels and notices to be placed

in each manufactured home. HUD needs

this information to make sure

manufacturers are complying with the

standards.

Form number: None.

Respondents: State, Local or Tribal

Governments, and businesses or other

for-profit.

Frequency of submission: Monthly

and recordkeeping.

Reporting burden:

Number of

respondents × Frequency ofresponse × Hours per response = Burden hours

SAA Reports .............................................................................. 432 1 .64 276

IPIA Reports ............................................................................... 1,056 1 .60 633

Manufacturer Records ................................................................ 360,000 1 .16 57,600

Consumer Information Cards ..................................................... 360,000 1 .48 172,800

State Plans ................................................................................. 12 40 1.00 480

Consumer Manuals .................................................................... 360,000 1 .08 28,800

Labels and Notices .................................................................... 360,000 1 .22 79,200

Total Estimated Burden Hours:

339,789.

Status: Reinstatement with changes.

Contacts: Stuart Margulies, HUD,

(202) 708–6409; Joseph F. Lackey, Jr.,

OMB, (202) 395–7316.

Dated: June 12, 1998.

[FR Doc. 98–16329 Filed 6–18–98; 8:45 am]

BILLING CODE 4210–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4349–N–25]

Submission for OMB Review:

Comment Request

AGENCY: Office of the Assistant

Secretary for Administration, 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: July 20,

1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within thirty (30) days from the

date of this Notice. 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, Department of Housing and

Urban Development, 451 7th Street,

Southwest, Washington, DC 20410,

telephone (202) 708–1305. 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 names and telephone

numbers of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

Authority: Section 3507 of the Paperwork

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

amended.

Dated: June 12, 1998.

David S. Cristy,

Director, IRM Policy and Management

Division.

Title of Proposal: Lead-Based Paint

Hazard Control Grant Program Data

Collection for Rounds Two and Three

Grantees.

Office: Lead Hazard Control.

OMB Approval Number: 2539–0008.

Description of the Need for the

Information and its Proposed Use: This

data collection is designed to provide

timely information to HUN regarding

the implementation progress of the

grantees on carrying out the Lead-Based

Paint Hazard Control Grant Program.

The information collection will also be

used to provide Congress with status

reports as required by Title X of the

Housing and Community Development

Act of 1992.

Form Number: 96005.

Respondents: State, Local, or Tribal

Government.

Frequency of Submission: Quarterly.

Reporting Burden: