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

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.

SUPPLEMENTARY INFORMATION:

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:

mstockstill on DSKH9S0YB1PROD with RULES

■

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:

VerDate Nov<24>2008

15:47 Apr 22, 2010

Jkt 220001

§ 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
Bureau of Prisons, Justice.
Interim rule.

AGENCY:
ACTION:

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.

PO 00000

Frm 00007

Fmt 4700

Sfmt 4700

21163

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

E:\FR\FM\23APR1.SGM

23APR1

21164

Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Rules and Regulations
Executive Order 13132, we determine
that this regulation does not have
sufficient Federalism implications to
warrant the preparation of a Federalism
Assessment.

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.

mstockstill on DSKH9S0YB1PROD with RULES

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

VerDate Nov<24>2008

15:47 Apr 22, 2010

Jkt 220001

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.

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.

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.

Coast Guard

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

PO 00000

Frm 00008

Fmt 4700

Sfmt 4700

*
*
*
*
(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

33 CFR Part 165
[Docket No. USCG–2010–0256]
RIN 1625–AA00

Safety Zone; Neuse River, New Bern,
NC
Coast Guard, DHS.
Temporary final rule.

AGENCY:
ACTION:

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’’

E:\FR\FM\23APR1.SGM

23APR1