46430 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 

FEDERAL MARITIME COMMISSION 

Ocean Transportation Intermediary 

License; Rescission of Order of 

Revocation 

Notice is hereby given that the Order 

revoking the following license is being 

rescinded by the Federal Maritime 

Commission pursuant to section 19 of 

the Shipping Act of 1984 (46 U.S.C. 

Chapter 409) and the regulations of the 

Commission pertaining to the licensing 

of Ocean Transportation Intermediaries, 

46 CFR part 515. 

License Number: 019597N. 

Name: United Cargo International, 

Inc. 

Address: 30998 Huntwood Ave., #106 

Hayward, CA 94544. 

Order Published: FR: 07/29/09 

(Volume 74, No. 144, Pg. 37711). 

Sandra L. Kusumoto, 

Director, Bureau of Certification and 

Licensing. 

[FR Doc. E9–21680 Filed 9–8–09; 8:45 am] 

BILLING CODE 6730–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0372] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Environmental 

Impact Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection contained in 

FDA regulations entitled 

‘‘Environmental Impact 

Considerations.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by November 9, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Environmental Impact 

Considerations—21 CFR Part 25 (OMB 

Control Number 0910–0322)—Extension 

FDA is requesting OMB approval for 

the reporting requirements contained in 

the FDA regulation ‘‘Environmental 

Impact Considerations.’’ The National 

Environmental Policy Act (NEPA) (42 

U.S.C. 4321–4347) states national 

environmental objectives and imposes 

upon each Federal agency the duty to 

consider the environmental effects of its 

actions. Section 102(2)(C) of NEPA 

requires the preparation of an 

environmental impact statement (EIS) 

for every major Federal action that will 

significantly affect the quality of the 

human environment. The FDA NEPA 

regulations are in part 25 (21 CFR part 

25). All applications or petitions 

requesting agency action require the 

submission of a claim for a categorical 

exclusion or an environmental 

assessment (EA). A categorical 

exclusion applies to certain classes of 

FDA-regulated actions that usually have 

little or no potential to cause significant 

environmental effects and are excluded 

from the requirements to prepare an EA 

or EIS. Section 25.15(a) and (d) specifies 

the procedures for submitting to FDA a 

claim for a categorical exclusion. 

Extraordinary circumstances (§ 25.21), 

which may result in significant 

environmental impacts, may exist for 

some actions that are usually 

categorically excluded. An EA provides 

information that is used to determine 

whether an FDA action could result in 

a significant environmental impact. 

Section 25.40(a) and (c) specifies the 

content requirements for EAs for 

nonexcluded actions. 

This collection of information is used 

by FDA to assess the environmental 

impact of agency actions and to ensure 

that the public is informed of 

environmental analyses. Firms wishing 

to manufacture and market substances 

regulated under statutes for which FDA 

is responsible must, in most instances, 

submit applications requesting 

approval. Environmental information 

must be included in such applications 

for the purpose of determining whether 

the proposed action may have a 

significant impact on the environment. 

Where significant adverse effects cannot 

be avoided, the agency uses the 

submitted information as the basis for 

preparing and circulating to the public 

an EIS, made available through a 

Federal Register document also filed for 

comment at the Environmental 

Protection Agency. The final EIS, 

including the comments received, is 

reviewed by the agency to weigh 

environmental costs and benefits in 

determining whether to pursue the 

proposed action or some alternative that 

would reduce expected environmental 

impact. 

Any final EIS would contain 

additional information gathered by the 

agency’s after the publication of the 

draft EIS, a copy of or a summary of the 

comments received on the draft EIS, and 


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