32116 Federal Register / Vol. 74, No. 128 / Tuesday, July 7, 2009 / Notices 

recipient to submit additional 

environmental compliance information 

sufficient to enable NOAA to make an 

assessment on any impacts that a project 

may have on the environment. 

THE DEPARTMENT OF COMMERCE 

PRE–AWARD NOTIFICATION 

REQUIREMENTS FOR GRANTS AND 

COOPERATIVE AGREEMENTS: 

The Department of Commerce Pre– 

Award Notification Requirements for 

Grants and Cooperative Agreements 

contained in the Federal Register notice 

of February 11, 2008 (73 FR 7696), are 

applicable to this solicitation. 

PAPERWORK REDUCTION ACT: 

This document contains collection– 

of–information requirements subject to 

the Paperwork Reduction Act (PRA). 

The use of Standard Forms 424, 424A, 

424B, and SF–LLL and CD–346 has been 

approved by the Office of Management 

and Budget (OMB) under the respective 

control numbers 0348–0043, 0348–0044, 

0348–0040, 0348–0046, and 0605–0001. 

Notwithstanding any other provision of 

law, no person is required to, nor shall 

a person be subject to a penalty for 

failure to comply with, a collection of 

information subject to the requirements 

of the PRA unless that collection of 

information displays a currently valid 

OMB control number. 

EXECUTIVE ORDER 12866: 

This notice has been determined to be 

not significant for purposes of Executive 

Order 12866. 

EXECUTIVE ORDER 13132 

(FEDERALISM): 

It has been determined that this notice 

does not contain policies with 

Federalism implications as that term is 

defined in Executive Order 13132. 

ADMINISTRATIVE PROCEDURE ACT/ 

REGULATORY FLEXIBILITY ACT: 

Prior notice and an opportunity for 

public comment are not required by the 

Administrative Procedure Act or any 

other law for rules concerning public 

property, loans, grants, benefits, and 

contracts (5 U.S.C. 553(a)(2)). Because 

notice and opportunity for comment are 

not required pursuant to 5 U.S.C. 553 or 

any other law, the analytical 

requirements for the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) are 

inapplicable. Therefore, a regulatory 

flexibility analysis has not been 

prepared. 

Dated: June 29, 2009. 

Steven A. Murawski, Ph.D. 

NOAA Fisheries, Chief Scientific Advisor, 

Director of Scientific Programs. 

Dated: June 30, 2009. 

Phillip R. Taylor 

Section Head, Ocean Section, Division of 

Ocean Sciences, National Science 

Foundation. 

[FR Doc. E9–15960 Filed 7–6–09; 8:45 am] 

BILLING CODE 3510–22–S 

DEPARTMENT OF COMMERCE 

United States Patent and Trademark 

Office 

[Docket No. PTO–P–2009–0027] 

Grant of Interim Extension of the Term 

of U.S. Patent No. 4,977,138; 

ISTODAXTM

AGENCY: United States Patent and 

Trademark Office. 

ACTION: Notice of Interim Patent Term 

Extension. 

SUMMARY: The United States Patent and 

Trademark Office has issued an order 

granting interim extension under 35 

U.S.C. 156(d)(5) for a one-year interim 

extension of the term of U.S. Patent No. 

4,977,138. 

FOR FURTHER INFORMATION CONTACT: 

Mary C. Till by telephone at (571) 272– 

7755; by mail marked to her attention 

and addressed to the Commissioner for 

Patents, Mail Stop Hatch-Waxman PTE, 

P.O. Box 1450, Alexandria, VA 22313– 

1450; by fax marked to her attention at 

(571) 273–7755, or by e-mail to 

Mary.Till@uspto.gov. 

SUPPLEMENTARY INFORMATION: Section 

156 of Title 35, United States Code, 

generally provides that the term of a 

patent may be extended for a period of 

up to five years if the patent claims a 

product, or a method of making or using 

a product, that has been subject to 

certain defined regulatory review, and 

that the patent may be extended for 

interim periods of up to a year if the 

regulatory review is anticipated to 

extend beyond the expiration date of the 

patent. 

On June 12, 2009, Gloucester 

Pharmaceuticals, Inc., a licensee of 

Astellas Pharma Inc., the patent owner, 

timely filed an application under 35 

U.S.C. 156(d)(5) for an interim extension 

of the term of U.S. Patent No. 4,977,138. 

The patent claims the human drug 

product ISTODAXTM (romidepsin). The 

application indicates that a New Drug 

Application (NDA No. 22–393) for the 

human drug product ISTODAXTM

(romidepsin) has been filed and is 

currently undergoing regulatory review 

before the Food and Drug 

Administration for permission to market 

or use the product commercially. 

Review of the application indicates 

that except for permission to market or 

use the product commercially, the 

subject patent would be eligible for an 

extension of the patent term under 35 

U.S.C. 156, and that the patent should 

be extended for an additional one year 

as required by 35 U.S.C. 156(d)(5)(B). 

Because it is apparent that the 

regulatory review period will continue 

beyond the original expiration date of 

the patent (July 6, 2009), an interim 

extension of the patent term under 35 

U.S.C. 156(d)(5) is appropriate. 

An interim extension under 35 U.S.C. 

156(d)(5) of the term of U.S. Patent No. 

4,977,138 is granted for a period of one 

year from the original expiration date of 

the patent, i.e., until July 6, 2010. 

June 30, 2009. 

John J. Doll, 

Acting Under Secretary of Commerce for 

Intellectual Property and Acting Director of 

the United States Patent and Trademark 

Office. 

[FR Doc. E9–15863 Filed 7–6–09; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

RIN 0648–XQ12 

Marine Mammals; File No. 540–1811 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notice; Issuance of permit 

amendment. 

SUMMARY: Notice is hereby given that 

Mr. John Calambokidis, Cascadia 

Research Collective, Waterstreet 

Building, 218 1/2 West Fourth Avenue, 

Olympia, WA 89501, has been issued an 

amendment to scientific research Permit 

No. 540–1811. 

ADDRESSES: The permit and related 

documents are available for review 

upon written request or by appointment 

(See SUPPLEMENTARY INFORMATION). 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Skidmore or Carrie Hubard, 

(301)713–2289. 

SUPPLEMENTARY INFORMATION: On May 7, 

2008, notice was published in the 

Federal Register (73 FR 25668) that a 

request for a scientific research permit 

amendment to take cetacean species had 

been submitted by the above-named