33686 Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Notices

VIII. Method of Application

A. Submission Instructions

Applications will be accepted during

normal working hours, 8 a.m. to 4:30

p.m., Monday through Friday, on or

before August 3, 1998.

Applications will be considered

received on time if sent or mailed on or

before the receipt dates as evidenced by

the legible U.S. Postal Service dated

postmark or a legible date receipt from

a commercial carrier, unless they arrive

too late for orderly processing. Private

metered postmarks shall not be

acceptable as proof of timely mailing.

Applications not received on time will

not be considered for review and will be

returned to the applicant.

Note: Applicants should note that the

U.S. Postal Service does not uniformly

provide dated postmarks. Before relying

on this method, applicants should check

with their local post office.

B. Format of Application

Applications must be submitted on

Grant Application Form PHS 398 (Rev.

5/95). All ‘‘General Instructions’’ and

‘‘Specific Instructions’’ in the

application kit should be followed with

the exception of the receipt dates and

the mailing label addresses. Do not send

applications to the Center for Scientific

Review, NIH. This information

collection is approved under OMB

control number 00925–0001.

Applications from State and local

governments may be submitted on Form

PHS 5161 (Rev.7/92) or PHS 398 (Rev.5/

95). The face page of the application

must reflect the request for applications

number RFA–FDA–CDER–99–1. This

information collection is approved

under OMB control number 0937–0189.

C. Legend

Unless disclosure is required by the

Freedom of Information Act as amended

(5 U.S.C. 552) as determined by the

freedom of information officials of the

Department of Health and Human

Services or by a court, data contained in

the portions of the application that have

been specifically identified by page

number, paragraph, etc., by the

applicant as containing confidential

commercial information or other

information that is exempt from public

disclosure will not be used or disclosed

except for evaluation purposes.

Dated: June 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16293 Filed 6–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0192]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Establishment and Product License

Applications’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 8, 1998 (63 FR

17183), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0124. The

approval expires on June 30, 1998.

Dated: June 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16292 Filed 6–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0529]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘National Tobacco Retailer Tracking

Study,’’ has been approved by the Office

of Management and Budget (OMB)

under the Paperwork Reduction Act of

1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of Tuesday, December

30, 1997 (62 FR 67876), the agency

announced that the proposed

information collection had been

submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0369. The

approval expires on May 31, 2001.

Dated: June 11, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16340 Filed 6–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0401]

Draft ‘‘Guidance for Industry: Content

and Format of Chemistry,

Manufacturing and Controls

Information and Establishment

Description Information for a Vaccine

or Related Product’’; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (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.’’ The draft guidance

document would provide guidance to

applicants on the content and format of

the Chemistry, Manufacturing and

Controls (CMC) and Establishment

Description sections of the ‘‘Application

to Market a New Drug, Biologic, or an

Antibiotic Drug for Human Use’’