Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices 77877 

disability, please contact Penelope 

Beattie on 202–452–3982. For the 

hearing impaired only, please use the 

Telecommunication Device for the Deaf 

(TDD) on 202–263–4869. 

Privacy Act Notice: Providing the 

information requested is voluntary; 

however, failure to provide your name, 

date of birth, and social security number 

or passport number may result in denial 

of entry to the Federal Reserve Board. 

This information is solicited pursuant to 

Sections 10 and 11 of the Federal 

Reserve Act and will be used to 

facilitate a search of law enforcement 

databases to confirm that no threat is 

posed to Board employees or property. 

It may be disclosed to other persons to 

evaluate a potential threat. The 

information also may be provided to law 

enforcement agencies, courts and others, 

but only to the extent necessary to 

investigate or prosecute a violation of 

law. 

MATTERS TO BE CONSIDERED: 

Discussion Agenda 

1. Proposed Rule Governing Debit 

Card Interchange Fees and Routing. 

Note: 1. The staff memo to the Board will 

be made available to the public in paper and 

the background material will be made 

available on a computer disc in Word format. 

If you require a paper copy of the document, 

please call Penelope Beattie on 202–452– 

3982. 

2. This meeting will be recorded for 

the benefit of those unable to attend. 

Computer discs (CDs) will then be 

available for listening in the Board’s 

Freedom of Information Office, and 

copies can be ordered for $4 per disc by 

calling 202–452–3684 or by writing to: 

Freedom of Information Office, Board of 

Governors of the Federal Reserve 

System, Washington, DC 20551. 

FOR MORE INFORMATION PLEASE CONTACT: 

Michelle Smith, Director, or Dave 

Skidmore, Assistant to the Board, Office 

of Board Members at 202–452–2955. 

SUPPLEMENTARY INFORMATION: You may 

call 202–452–3206 for a recorded 

announcement of this meeting; or you 

may contact the Board’s Web site at 

http://www.federalreserve.gov for an 

electronic announcement. (The Web 

page also includes procedural and other 

information about the open meeting.) 

Dated: December 9, 2010. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2010–31410 Filed 12–10–10; 11:15 am] 

BILLING CODE 6210–01–P 

FEDERAL RESERVE SYSTEM 

Notice of Proposals To Engage in 

Permissible Nonbanking Activities or 

To Acquire Companies That Are 

Engaged in Permissible Nonbanking 

Activities 

The companies listed in this notice 

have given notice under section 4 of the 

Bank Holding Company Act (12 U.S.C. 

1843) (BHC Act) and Regulation Y, (12 

CFR part 225) to engage de novo, or to 

acquire or control voting securities or 

assets of a company, including the 

companies listed below, that engages 

either directly or through a subsidiary or 

other company, in a nonbanking activity 

that is listed in § 225.28 of Regulation Y 

(12 CFR 225.28) or that the Board has 

determined by Order to be closely 

related to banking and permissible for 

bank holding companies. Unless 

otherwise noted, these activities will be 

conducted throughout the United States. 

Each notice is available for inspection 

at the Federal Reserve Bank indicated. 

The notice also will be available for 

inspection at the offices of the Board of 

Governors. Interested persons may 

express their views in writing on the 

question whether the proposal complies 

with the standards of section 4 of the 

BHC Act. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors 

not later than December 28, 2010. 

A. Federal Reserve Bank of 

Minneapolis (Jacqueline G. King, 

Community Affairs Officer) 90 

Hennepin Avenue, Minneapolis, 

Minnesota 55480–0291: 

1. Bigfork Bancshares, Inc., Bigfork, 

Minnesota; to engage, de novo, in 

extending credit and servicing loans, 

pursuant to section 225.28(b)(1) of 

Regulation Y. 

Board of Governors of the Federal Reserve 

System, December 8, 2010. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2010–31241 Filed 12–13–10; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–E–0022; FDA– 

2010–E–0023; FDA–2010–E–0024] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; VIBATIV 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

VIBATIV and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of 

applications to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of patents 

which claim that human drug product. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 


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