19094 Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices 

Part III of the proposed order 

prohibits Respondent from making 

misrepresentations in advertising for 

any morning food or snack food about 

the existence, contents, validity, results, 

conclusions, or interpretations of any 

test, study or research. 

Part IV of the proposed order states 

that the order does not prohibit 

Respondent from making 

representations for any product that are 

specifically permitted in labeling for 

that product by regulations issues by the 

FDA under the Nutrition Labeling and 

Education Act of 1990. 

Parts V through VIII of the proposed 

order require Respondent to keep copies 

of relevant advertisements and materials 

substantiating claims made in the 

advertisements; to provide copies of the 

order to certain of their personnel; to 

notify the Commission of changes in 

corporate structure that might affect 

compliance obligations under the order; 

and to file compliance reports with the 

Commission. Part IX provides that the 

order will terminate after twenty (20) 

years, with certain exceptions. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed order, and it is not intended 

to constitute an official interpretation of 

the agreement and proposed order or to 

modify in any way their terms. 

By direction of the Commission. 

Donald S. Clark 

Secretary. 

[FR Doc. E9–9484 Filed 4–24–09: 8:45 am] 

BILLING CODE 6750–01–S 

GENERAL SERVICES 

ADMINISTRATION 

[OMB Control No. 3090–0044] 

Public Buildings Service; Information 

Collection; GSA Form 3453, 

Application/Permit for Use of Space in 

Public Buildings and Grounds 

AGENCY: Public Buildings Service, GSA. 

ACTION: Notice of request for comments 

regarding a renewal to an existing OMB 

clearance. 

SUMMARY: Under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35), the General Services 

Administration will be submitting to the 

Office of Management and Budget 

(OMB) a request to review and approve 

a renewal of a currently approved 

information collection requirement 

regarding GSA Form 3453, Application/ 

Permit for Use of Space in Public 

Buildings and Grounds. The clearance 

currently expires on April 30, 2009. 

Public comments are particularly 

invited on: Whether this collection of 

information is necessary and whether it 

will have practical utility; whether our 

estimate of the public burden of this 

collection of information is accurate, 

and based on valid assumptions and 

methodology; ways to enhance the 

quality, utility, and clarity of the 

information to be collected. 

DATES: Submit comments on or before: 

June 26, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Frank Giblin, Public Buildings Service, 

at telephone (202) 501–1856, or via 

e-mail to frank.giblin@gsa.gov. 

ADDRESSES: Submit comments regarding 

this burden estimate or any other aspect 

of this collection of information, 

including suggestions for reducing this 

burden, to the Regulatory Secretariat 

(VPR), General Services Administration, 

Room 4041, 1800 F Street, NW., 

Washington, DC 20405. Please cite OMB 

Control No. 3090–0044, GSA Form 

3453, Application/Permit for Use of 

Space in Public Buildings and Grounds, 

in all correspondence. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

The general public uses GSA Form 

3453, Application/Permit for Use of 

Space in Public Buildings and Grounds, 

to request the use of public space in 

Federal buildings and on Federal 

grounds for cultural, educational, or 

recreational activities. A copy, sample, 

or description of any material or item 

proposed for distribution or display 

must also accompany this request. 

B. Annual Reporting Burden 

Respondents: 8,000. 

Responses per Respondent: 1. 

Hours per Response: 0.05. 

Total Burden Hours: 400. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (VPR), 1800 F 

Street, NW., Room 4041, Washington, 

DC 20405, telephone (202) 501–4755. 

Please cite OMB Control No. 3090–0044, 

GSA Form 3453, Application/Permit for 

Use of Space in Public Buildings and 

Grounds, in all correspondence. 

Dated: April 21, 2009. 

Philip E. Klokis, 

Acting Chief Information Officer. 

[FR Doc. E9–9490 Filed 4–24–09; 8:45 am] 

BILLING CODE 6820–YT–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0179] 

Draft Guidance for Industry and Food 

and Drug Administration Staff: 

Technical Considerations for Pen, Jet, 

and Related Injectors Intended for Use 

With Drugs and Biological Products; 

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 ‘‘Technical 

Considerations for Pen, Jet, and Related 

Injectors Intended for Use with Drugs 

and Biological Products.’’ The draft 

guidance document provides technical 

and scientific information for sponsors 

to consider in developing information to 

support a marketing application for a 

pen, jet, or related injector device 

intended for use with drugs or 

biological products. The marketing 

application would typically be a 

premarket notification submission 

(510(k)) or a premarket approval (PMA) 

application for the injector alone. For a 

combination product that includes the 

injector, the marketing application 

would typically be a new drug 

application (NDA) or a biological 

licensing application (BLA). 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by July 27, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Combination Products, 15800 

Crabbs Branch Way, Rockville, MD 

20855. Send one self-addressed 

adhesive label to assist the office in 

processing your requests. The draft 

guidance may also be obtained by mail 

by calling the Office of Combination 

Products at 301–427–1934 or by e-mail 

to combination@fda.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 


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