71016 Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Rules and Regulations 

distinct work, and distributes that work 

to an audience. In this clause, the term 

‘‘news’’ means information that is about 

current events or that would be of 

current interest to the public. Examples 

of news-media entities are television or 

radio stations broadcasting to the public 

at large and publishers of periodicals 

(but only if such entities qualify as 

disseminators of ‘‘news’’) who make 

their products available for purchase by 

or subscription by or free distribution to 

the general public. These examples are 

not all-inclusive. Moreover, as methods 

of news delivery evolve (for example, 

the adoption of the electronic 

dissemination of newspapers through 

telecommunications services), such 

alternative media shall be considered to 

be news-media entities. A freelance 

journalist shall be regarded as working 

for a news-media entity if the journalist 

can demonstrate a solid basis for 

expecting publication through that 

entity, whether or not the journalist is 

actually employed by the entity. A 

publication contract would present a 

solid basis for such an expectation; the 

Council may also consider the past 

publication record of the requester in 

making such a determination. 

* * * * * 

(ii) * * * 

(C) * * * 

(2 ) The fee for documents generated 

by computer is the hourly rate for the 

computer operator (at GS 7, step 5, plus 

16 percent for benefits if clerical staff, 

and GS 13, step 5, plus 16 percent for 

benefits if professional staff) plus the 

cost of materials (computer paper, tapes, 

disks, labels, etc.). 

* * * * * 

(F) Other services. Complying with 

requests for special services such as 

certifying records as true copies or 

mailing records by express mail is 

entirely at the discretion of the Council. 

The Council will recover the full costs 

of providing such services to the extent 

it elects to provide them. 

* * * * * 

(H) Waiving or reducing fees. As part 

of the initial request for records, a 

requester may ask that the Council 

waive or reduce fees if disclosure of the 

records is in the public interest because 

it is likely to contribute significantly to 

public understanding of the operations 

or activities of the Council and is not 

primarily in the commercial interest of 

the requester. The initial request for 

records must also state the justification 

for a waiver or reduction of fees. 

Determinations as to a waiver or 

reduction of fees will be made by the 

Executive Secretary of the Council and 

the requester will be notified in writing 

of his/her determination. A 

determination not to grant a request for 

a waiver or reduction of fees under this 

paragraph may be appealed to the 

Chairman of the Council pursuant to the 

procedure set forth in paragraph 

(b)(3)(vi) of this section. 

(iii) Categories of requesters. (A) 

Commercial use requesters. The Council 

will assess fees for commercial use 

requesters sufficient to recover the full 

direct costs of searching for, reviewing 

for release, the duplicating the records 

sought. 

* * * * * 

(iv) Interest on unpaid fees. The 

Council may begin assessing interest 

charges on an unpaid bill starting on the 

31st day following the day on which the 

bill was sent. Interest will be at the rate 

prescribed in 31 U.S.C. 3717 and will 

accrue from the date of the billing. 

* * * * * 

(vii) * * * 

(B) A requester has previously failed 

to pay a fee charged in a timely fashion. 

The Council may require the requester 

to pay the full amount owed plus any 

applicable interest as provided in 

paragraph (b)(5)(iv) of this section or 

demonstrate that he/she has, in fact, 

paid the fee, and to make an advance 

payment of the full amount of the 

estimated fee before the Council begins 

to process a new request or a pending 

request from that requester. 

(C) When the Council acts under 

paragraph (b)(5)(vii) (A) or (B) of this 

section, the administrative time limits 

prescribed in subsection (a)(6) of the 

FOIA (i.e., 20 working days from receipt 

of initial requests, plus permissible 

extensions of these time limits) will 

begin only after the Council has 

received the fee payments described. 

(6) Records of another agency. If a 

requested record originated with or 

incorporates the information of another 

state or federal agency or department, 

upon receipt of a request for the record 

the Council will promptly inform the 

requester of this circumstance and 

immediately shall forward the request to 

the originating agency or department 

either for processing in accordance with 

the latter’s regulations or for guidance 

with respect to disposition. 

Dated at Arlington, Virginia, November 16, 

2010. 

Federal Financial Institutions Examination 

Council. 

Paul Sanford, 

Executive Secretary. 

[FR Doc. 2010–29282 Filed 11–19–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 526 

[Docket No. FDA–2010–N–0002] 

Intramammary Dosage Form New 

Animal Drugs; Cloxacillin Benzathine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplementary new 

animal drug application (NADA) filed 

by Boehringer Ingelheim Vetmedica, 

Inc. The supplement provides for minor 

revisions to labeling. 

DATES: This rule is effective November 

22, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Boehringer Ingelheim Vetmedica, Inc., 

2621 North Belt Highway, St. Joseph, 

MO 64506–2002 has filed a supplement 

to NADA 55–058 for DRY-CLOX 

(cloxacillin benzathine) Intramammary 

Infusion for dry dairy cattle. The 

supplemental NADA provides for 

various minor revisions to labeling. The 

supplemental application is approved as 

of October 21, 2010, and the regulations 

in § 526.464a (21 CFR 526.464a) are 

amended to reflect the approval. 

In addition, FDA has noticed that 

certain portions of § 526.464a were 

inadvertently removed when the 

regulations were amended to reflect a 

change of sponsorship (75 FR 10165, 

March 5, 2010). At this time, the 

regulations are being amended to reflect 

fully the approved conditions of use of 

this new animal drug product. This 

change is being made to improve the 

accuracy of the animal drug regulations. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The Agency has determined under 21 

CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Rules and Regulations 71017 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 526 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 526 is amended as follows: 

PART 526—INTRAMAMMARY DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 526 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Revise the heading for part 526 to 

read as set forth above. 

■ 3. In § 526.464a, revise paragraph (c) 

to read as follows: 

§ 526.464a Cloxacillin benzathine. 

* * * * * 

(c) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter for use in 

dairy cows. 

(1) Amount. Administer aseptically 

into each quarter immediately after last 

milking. 

(2) Indications for use. For the 

treatment of mastitis caused by 

Staphylococcus aureus and 

Streptococcus agalactiae including 

penicillin resistant strains in dairy cows 

during the dry period. 

(3) Limitations. For use in dry cows 

only. Not to be used within 30 days of 

calving. Animals infused with this 

product must not be slaughtered for 

food use for 30 days after the latest 

infusion. Federal law restricts this drug 

to use by or on the order of a licensed 

veterinarian. 

Dated: November 16, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–29326 Filed 11–19–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0972] 

Drawbridge Operation Regulations; 

Bayou Liberty, St. Tammany Parish, 

Slidell, LA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations; request for comments. 

SUMMARY: The Commander, Eighth 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the S433 

bridge over Bayou Liberty, mile 2.0, St. 

Tammany Parish, Slidell, LA. This 

deviation will test a change to the 

drawbridge operation schedule to 

determine whether a permanent change 

to the schedule is needed. It will allow 

the bridge to remain unmanned during 

most of the day by requiring a two-hour 

notice for an opening of the draw. This 

deviation will be in conjunction with a 

Notice of Proposed Rulemaking to make 

this deviation permanent. 

DATES: This deviation is effective from 

December 7, 2010 through January 6, 

2011. 

Comments and related material must 

be received by the Coast Guard on or 

before January 21, 2011. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2010–0972 using any one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. 

• Fax: 202–493–2251. 

• Mail: Docket Management Facility 

(M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590– 

0001. 

• Hand delivery: Same as mail 

address above, between 9 a.m. and 

5 p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

To avoid duplication, please use only 

one of these four methods. See the 

‘‘Public Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this proposed 

rule, call or e-mail Jim Wetherington; 

Bridge Administration Branch, Eighth 

Coast Guard District, telephone 504– 

671–2128, e-mail 

james.r.wetherington@uscg.mil. If you 

have questions on viewing or submitting 

material to the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related materials. All 

comments received will be posted, 

without change, to http:// 

www.regulations.gov and will include 

any personal information you have 

provided. 

Submitting Comments 

If you submit a comment, please 

include the docket number for this 

rulemaking (USCG–2010–0972), 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. You 

may submit your comments and 

material online (http:// 

www.regulations.gov), or by fax, mail or 

hand delivery, but please use only one 

of these means. If you submit a 

comment online via http:// 

www.regulations.gov, it will be 

considered received by the Coast Guard 

when you successfully transmit the 

comment. If you fax, hand deliver, or 

mail your comment, it will be 

considered as having been received by 

the Coast Guard when it is received at 

the Docket Management Facility. We 

recommend that you include your name 

and a mailing address, an e-mail 

address, or a phone number in the body 

of your document so that we can contact 

you if we have questions regarding your 

submission. 

To submit your comment online, go to 

http://www.regulations.gov, click on the 

‘‘submit a comment’’ box, which will 

then become highlighted in blue. In the 

‘‘Keyword’’ box insert ‘‘USCG–2010– 

0972,’’ click ‘‘Search,’’ and then click on 

the balloon shape in the ‘‘Actions’’ 

column. If you submit your comments 

by mail or hand delivery, submit them 

in an unbound format, no larger than 

81⁄2 by 11 inches, suitable for copying 

and electronic filing. If you submit them 

by mail and would like to know that 

they reached the Facility, please enclose 

a stamped, self-addressed postcard or 

envelope. We will consider all 

comments and material received during 

the comment period and may change 

the rule based on your comments. 


jlentini on DSKJ8SOYB1PROD with RULES