Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Rules and Regulations 21163 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Orion 

Corp., Orionintie 1, 02200 Espoo, 

Finland, filed NADA 141–306 for 

veterinary prescription use of 

DORMOSEDAN GEL (detomidine 

hydrochloride) for sedation and 

restraint of horses. The application is 

approved as of March 22, 2010, and the 

regulations in 21 CFR part 529 are 

amended by adding new § 529.536 to 

reflect the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), 

summaries of the safety and 

effectiveness data and information 

submitted to support approval of these 

applications may be seen in the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852, between 9 a.m. and 4 p.m., 

Monday through Friday. 

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 

nor an environmental impact statement 

is required. 

Under section 512(c)(2)(F)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(ii)), this 

approval qualifies for 3 years of 

marketing exclusivity beginning on the 

date of approval. 

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 529 

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 529 is amended as follows: 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

■ 2. Add § 529.536 to read as follows: 

§ 529.536 Detomidine. 

(a) Specifications. Each milliliter of 

gel contains 7.6 milligrams (mg) of 

detomidine hydrochloride. 

(b) Sponsor. See No. 052483 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in horses—(1) 

Amount. Administer 0.018 mg per 

pound (mg/lb) (0.040 mg/kilogram (kg) 

sublingually. 

(2) Indications for use. For sedation 

and restraint. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: April 19, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–9371 Filed 4–22–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Bureau of Prisons 

28 CFR Part 540 

[BOP–1149–I] 

RIN 1120–AB49 

Inmate Communication With News 

Media: Removal of Byline Regulations 

AGENCY: Bureau of Prisons, Justice. 

ACTION: Interim rule. 

SUMMARY: In this interim rule, the 

Bureau of Prisons (Bureau) revises its 

regulations regarding inmate contact 

with the community to delete two 

current Bureau regulations that prohibit 

inmates from publishing under a byline, 

due to a recent court ruling invalidating 

Bureau regulation language containing 

this prohibition. 

DATES: Comments are due by June 22, 

2010. 

ADDRESSES: Rules Unit, Office of 

General Counsel, Bureau of Prisons, 320 

First Street, NW., Washington, DC 

20534. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Qureshi, Office of General 

Counsel, Bureau of Prisons, phone (202) 

307–2105. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and made available for 

public inspection online at http:// 

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also locate 

all the personal identifying information 

you do not want posted online in the 

first paragraph of your comment and 

identify what information you want 

redacted. 

If you want to submit confidential 

business information as part of your 

comment but do not want it to be posted 

online, you must include the phrase 

‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment 

contains so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted on http:// 

www.regulations.gov. 

Personal identifying information 

identified and located as set forth above 

will be placed in the agency’s public 

docket file, but not posted online. 

Confidential business information 

identified and located as set forth above 

will not be placed in the public docket 

file. If you wish to inspect the agency’s 

public docket file in person by 

appointment, please see the FOR

FURTHER INFORMATION CONTACT

paragraph. 

In this interim rule, the Bureau 

revises its regulations regarding inmate 

contact with the community to delete 

two current Bureau regulations that 

prohibit inmates from publishing under 

a byline, due to a recent court ruling 

invalidating Bureau regulation language 

containing this prohibition. 

Currently, 28 CFR 540.20(b) states as 

follows: ‘‘The inmate may not receive 

compensation or anything of value for 

correspondence with the news media. 

The inmate may not act as reporter or 

publish under a byline.’’ 

Also, current 28 CFR 540.62(d) states 

as follows: ‘‘An inmate currently 

confined in an institution may not be 

employed or act as a reporter or publish 

under a byline.’’ 

On August 9, 2007, in Jordan v. Pugh, 

504 F.Supp.2d 1109 (D. Colo. 2007), the 

court issued a decision invalidating the 

byline language of § 540.20(b). The court 

found that not all inmate publishing 

under a byline jeopardizes security, and 

overruled the byline portion of the 

provision as facially overbroad for 

prohibiting all such activity. The Bureau 

is not appealing this decision. We 

mstockstill on DSKH9S0YB1PROD with RULES

21164 Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Rules and Regulations 

therefore alter the regulations 

accordingly. 

Further, due to the court’s findings 

regarding § 540.20(b), the identical 

provision in § 540.62(d) will also be 

deleted. 

Administrative Procedure Act 

The Administrative Procedure Act (5 

U.S.C. 553(b)(3)(B)) allows exceptions to 

notice-and-comment rulemaking ‘‘when 

the agency for good cause finds * * * 

that notice and public procedure 

thereon are impracticable, unnecessary, 

or contrary to the public interest.’’ 

Further, § 553(d) provides an exception 

to the usual requirement of a delayed 

effective date when an agency finds 

‘‘good cause’’ that the rule be made 

immediately effective. 

This rulemaking is exempt from 

normal notice-and-comment procedures 

because advance notice and public 

comment in this instance is 

impracticable. It is impracticable to 

invite public comment on the result of 

a court order which invalidated the 

regulatory provision which we now seek 

to remove. Further, prompt 

implementation of the court order is 

necessary to protect the Bureau from 

liability arising from potential 

application of an invalidated regulation, 

and to afford inmates the benefit of the 

court’s decision. Otherwise, this 

rulemaking makes no change to any 

rights or responsibilities of the agency 

or any regulated entities. For the same 

reasons, the Bureau finds that ‘‘good 

cause’’ exists to make this rule effective 

upon publication. Nevertheless, the 

Bureau invites public comment on this 

interim rule. 

Executive Order 12866 

This regulation falls within a category 

of actions that the Office of Management 

and Budget (OMB) has determined to 

constitute ‘‘significant regulatory 

actions’’ under section 3(f) of Executive 

Order 12866 and, accordingly, it was 

reviewed by OMB. 

The Bureau of Prisons has assessed 

the costs and benefits of this regulation 

as required by Executive Order 12866 

Section 1(b)(6) and has made a reasoned 

determination that the benefits of this 

regulation justify its costs. There will be 

no new costs associated with this 

regulation. 

Executive Order 13132 

This regulation will not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, under 

Executive Order 13132, we determine 

that this regulation does not have 

sufficient Federalism implications to 

warrant the preparation of a Federalism 

Assessment. 

Regulatory Flexibility Act 

The Director of the Bureau of Prisons, 

under the Regulatory Flexibility Act (5 

U.S.C. 605(b)), reviewed this regulation 

and by approving it certifies that it will 

not have a significant economic impact 

upon a substantial number of small 

entities for the following reasons: This 

regulation pertains to the correctional 

management of offenders and 

immigration detainees committed to the 

custody of the Attorney General or the 

Director of the Bureau of Prisons, and its 

economic impact is limited to the 

Bureau’s appropriated funds. 

Unfunded Mandates Reform Act of 

1995 

This regulation will not result in the 

expenditure by State, local and Tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

in any one year, and it will not 

significantly or uniquely affect small 

governments. Therefore, no actions were 

deemed necessary under the provisions 

of the Unfunded Mandates Reform Act 

of 1995. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This regulation is not a major rule as 

defined by § 804 of the Small Business 

Regulatory Enforcement Fairness Act of 

1996. This regulation will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 28 CFR Part 540 

Prisoners. 

Harley G. Lappin, 

Director, Bureau of Prisons. 

■ Under rulemaking authority vested in 

the Attorney General in 5 U.S.C 301; 28 

U.S.C. 509, 510 and delegated to the 

Director, Bureau of Prisons amends 28 

CFR part 540 as follows. 

PART 540—CONTACT WITH PERSONS 

IN THE COMMUNITY 

■ 1. Revise the authority citation for 28 

CFR part 540 to read as follows: 

Authority: 5 U.S.C. 301; 551, 552a; 18 

U.S.C. 1791, 3621, 3622, 3624, 4001, 4042, 

4081, 4082 (Repealed in part as to offenses 

committed on or after November 1, 1987), 

5006–5024 (Repealed October 12, 1984 as to 

offenses committed after that date), 5039; 28 

U.S.C. 509, 510. 

Subpart B—Correspondence 

■ 2. Revise § 540.20(b) as follows: 

§ 540.20 Inmate correspondence with 

representatives of the news media. 

* * * * * 

(b) The inmate may not receive 

compensation or anything of value for 

correspondence with the news media. 

The inmate may not act as reporter. 

* * * * * 

Subpart E—Contact With News Media 

■ 3. Revise § 540.62(d) as follows: 

§ 540.62 Institutional visits. 

* * * * * 

(d) An inmate currently confined in 

an institution may not be employed or 

act as a reporter. 

* * * * * 

[FR Doc. 2010–9373 Filed 4–22–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0256] 

RIN 1625–AA00 

Safety Zone; Neuse River, New Bern, 

NC 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the waters of the Neuse River in support 

of the New Bern, North Carolina 

Tercentennial Celebration. All vessels 

are prohibited from transiting the zone 

except as specifically authorized by the 

Captain of the Port or his designated 

representative. The temporary safety 

zone is necessary to provide for the 

safety of the crews, spectators, and other 

users and vessels of the waterway 

during a Civil War naval bombardment 

reenactment. 

DATES: This rule is effective from 11:30 

a.m. through 8 p.m. on May 8, 2010. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2010– 

0256 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0256 in the ‘‘Keyword’’ 

mstockstill on DSKH9S0YB1PROD with RULES