Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations 19793 

1Airworthiness Review Program—Amendment 

No. 4: Powerplant Amendments (42 FR 15034). 

Actions Compliance Procedures 

(6) Adjust the position of the fuel line fitting at 

the engine-driven fuel pump.

Within 15 days after April 25, 2007 (the effective date of this AD).Follow Air Plains Services Corporation Mandatory Service Bulletin APS–07–01–01, 

dated March 5, 2007. 

Alternative Methods of Compliance 

(AMOCs) 

(f) The Manager, Wichita Aircraft 

Certification Office (ACO), FAA, ATTN: 

Trenton Shepherd, Aerospace Engineer, 1801 

Airport Road, Room 100, Wichita, Kansas 

67209; telephone: (316) 946–4143; fax: (316) 

946–4107, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. Before 

using any approved AMOC on any airplane 

to which the AMOC applies, notify your 

appropriate principal inspector (PI) in the 

FAA Flight Standards District Office (FSDO), 

or lacking a PI, your local FSDO. 

Material Incorporated by Reference 

(g) You must use Air Plains Services 

Corporation Mandatory Service Bulletin 

APS–07–01–01, dated March 5, 2007, to do 

the actions required by this AD, unless the 

AD specifies otherwise. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service information under 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) For service information identified in 

this AD, contact Air Plains Services 

Corporation, P.O. Box 541, Wellington, KS 

67152; phone: 620–326–8904; Internet: 

http://www.airplains.com. 

(3) You may review copies at the FAA, 

Central Region, Office of the Regional 

Counsel, 901 Locust, Kansas City, Missouri 

64106; or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, or go 

to: http://www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Kansas City, Missouri, on April 

13, 2007. 

Charles L. Smalley, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E7–7519 Filed 4–19–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Parts 121, 135 

[Docket No.: FAA–2007–26969; Amendment 

Nos. 121–331 and 135–109] 

RIN 2120–AI99 

Change in Extinguishing Agent 

Container Requirements 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Direct final rule; request for 

comments. 

SUMMARY: This action aligns the 

operational and certification safety 

requirements regarding overpressurization of airplane extinguishing 

agent containers or fire bottles to 

prevent bursting; and it removes an 

obsolete section reference from part 135. 

This action eliminates the requirement 

for an over-pressurized fire bottle to 

discharge extinguishing agent outside 

an airplane to prevent bursting, because 

newer non-corrosive extinguishing 

agents can now be discharged inside an 

airplane without degrading an airframe. 

DATES: Effective June 4, 2007. 

Comments for inclusion in the Rules 

Docket must be received on or before 

May 21, 2007. 

ADDRESSES: Commenting on this Direct 

Final Rule. You may send comments 

identified by Docket Number FAA–

2007–26969, using any of the following 

methods: 

• DOT Docket Web site: Go to 

http://dms.dot.gov and follow the 

instructions for sending your comments 

electronically. 

• Government-wide rulemaking Web 

site: Go to http://www.regulations.gov 

and follow the instructions for sending 

your comments electronically. 

• Mail: Docket Management Facility; 

U.S. Department of Transportation, 400 

Seventh Street, SW., Nassif Building, 

Room PL–401, Washington, DC 20590–

0001. 

• Fax: 1–202–493–2251. 

• Hand Delivery: Room PL–401 on 

the plaza level of the Nassif Building, 

400 Seventh Street, SW., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: Joel 

Schlossberg, Aircraft Maintenance 

Division, Flight Standards Service, 

Federal Aviation Administration, 800 

Independence Avenue, SW., 

Washington, DC 20591. Telephone: 

(202–267–8908); facsimile: (202–267–

5115); e-mail: joel.schlossberg@faa.gov. 

SUPPLEMENTARY INFORMATION: Later in 

this preamble under the Additional 

Information section, we discuss how 

you can comment on this direct final 

rule and how we will handle your 

comments. Included in this discussion 

is related information about the docket. 

We also discuss how you can get a copy 

of this direct final rule and any related 

rulemaking documents. 

Authority for This Rulemaking 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. This 

rulemaking is promulgated under the 

authority described in Subtitle VII, Part 

A, Subpart III, Section 44701, ‘‘General 

requirements.’’ Under that section, the 

FAA is charged with promoting safe 

flight of civil aircraft in air commerce by 

prescribing: 

• Minimum standards required in the 

interest of safety for the design and 

performance of aircraft; and 

• Regulations for other practices, 

methods, and procedures the 

Administrator finds necessary for safety 

in air commerce and national security. 

This regulation is within the scope of 

that authority because it prescribes: 

• Standards for the safe operation of 

transport category airplanes; and 

• Practices, methods, and procedures 

that the Administrator finds necessary 

for safety in air commerce and national 

security. 

Background 

Since at least 1949, the FAA has 

required fire extinguishing containers 

(fire bottle) to have a pressure relief line 

to prevent a container from bursting in 

case of excessive internal pressure. This 

pressure relief line would discharge the 

extinguishing agent from the fire bottle. 

Historically, fire extinguishing agents 

were corrosive materials that could 

degrade an airframe. Therefore, in both 

airplane certification and operational 

rules, the FAA required any discharge 

for pressure relief to be only outside the 

airplane. 

Eventually, industry developed noncorrosive extinguishing agents. 

Therefore, on March 17, 1977, the FAA 

published in the Federal Register a final 

rule 1 that amended the airplane 

certification rules in 14 CFR 25.1199 to 

adopt a performance standard. This rule 

changed the airplane certification 

standards, to require airplane 

manufacturers to place pressure relief 

discharge lines in such a way to not 

damage an airplane. See 40 FR 21866, 

21871. Thus, the pressure relief 

discharge line could be located either 


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19794 Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations 

2 Docket FAA–2006–25325. 

3Commuter Operations and General Certification 

and Operations Requirements; Air Carrier and 

Commercial Operator Training Programs; Final 

Rules (60 FR 65832). 

inside or outside the airplane, as long as 

a discharge would not damage the 

airplane. 

However, the corresponding 

operational requirements in § 121.267, 

and by reference in § 135.169, were not 

changed in 1977 and therefore only 

allow for the termination of the fire 

bottle discharge line outside the 

airplane. As a result of this discrepancy, 

in a request dated July 5, 2006, 

Aeronautical Charters, Inc. submitted a 

petition for exemption 2 from § 121.267 

for their part 135 airplane model 

(Citation 550). The difference between 

the certification and operational 

requirements has caused confusion, 

which is likely to result in more 

exemption requests. The FAA proceeds 

with this direct final rule to align the 

certification and operational 

requirements. This rule maintains safety 

because the reason for the original 

limitation (outside discharge) is no 

longer a concern with the development 

and use of non-corrosive extinguishing 

agents. 

This direct final rule also removes an 

obsolete section reference from part 135. 

In a December 20, 1995 rulemaking,3 the 

FAA removed and reserved § 121.213, 

which contained special airworthiness 

requirements. We included those 

requirements in § 121.211 

(Applicability). However, we 

inadvertently left a reference to 

§ 121.213 in § 135.169(a). This direct 

final rule amends part 135 to remove the 

reference to § 121.213. 

The Direct Final Rule Process 

The FAA anticipates that this 

regulation will not result in adverse or 

negative comment and, therefore, we are 

issuing it as a direct final rule. We 

believe we will not get adverse 

comments because this action will—

• Correct a discrepancy in the 

certification and operational rules that 

could potentially ground affected 

airplanes. 

• Eliminate the need for operators to 

petition the FAA for an exemption from 

the fire bottle requirements in § 121.267. 

• Not place any new requirements or 

additional burden on affected operators. 

Unless we receive a written adverse or 

negative comment, or a written notice of 

intent to submit an adverse or negative 

comment within the comment period, 

the regulation will become effective on 

the date specified above. After the close 

of the comment period, the FAA will 

publish a document in the Federal 

Register that indicates we received no 

adverse or negative comments and 

confirms the date the final rule will 

become effective. If the FAA does 

receive, within the comment period, an 

adverse or negative comment, or written 

notice of intent to submit such a 

comment, we will publish a document 

withdrawing the direct final rule in the 

Federal Register, and a notice of 

proposed rulemaking may be published 

with a new comment period. 

Paperwork Reduction Act 

There are no current or new 

requirements for information collection 

associated with these amendments. 

International Compatibility 

The FAA has reviewed corresponding 

International Civil Aviation 

Organization International Standards 

and Recommended practices and 

similar regulations of foreign 

authorities, where they exist, and has 

identified no differences in these 

proposed amendments and the foreign 

regulations. 

Economic Evaluation, Regulatory 

Flexibility Act, Trade Impact 

Assessment, and Unfunded Mandates 

Assessment 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 directs that 

each Federal agency shall propose or 

adopt a regulation only upon a reasoned 

determination that the benefits of the 

intended regulation justify its costs. 

Second, the Regulatory Flexibility Act 

of 1980 (Pub. L. 96–354) requires 

agencies to analyze the economic 

impact of regulatory changes on small 

entities. Third, the Trade Agreements 

Act (Pub. L. 96–39) prohibits agencies 

from setting standards that create 

unnecessary obstacles to the foreign 

commerce of the United States. In 

developing U.S. standards, the Trade 

Act requires agencies to consider 

international standards and, where 

appropriate, that they be the basis of 

U.S. standards. Fourth, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4) requires agencies to prepare a 

written assessment of the costs, benefits, 

and other effects of proposed or final 

rules that include a Federal mandate 

likely to result in the expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more annually (adjusted 

for inflation with base year of 1995). 

This portion of the preamble 

summarizes the FAA’s analysis of the 

economic impacts of this final rule. 

Department of Transportation Order 

DOT 2100.5 prescribes policies and 

procedures for simplification, analysis, 

and review of regulations. If the 

expected cost impact is so minimal that 

a proposed or final rule does not 

warrant a full evaluation, this order 

permits a statement to that effect and 

the basis for it to be included in the 

preamble if a full regulatory evaluation 

of the cost and benefits is not prepared. 

Such a determination has been made for 

this final rule. The reasoning for this 

determination follows: This action 

aligns the operational and certification 

safety requirements regarding overpressurization of airplane extinguishing 

agent containers or fire bottles to 

prevent bursting; and it removes an 

obsolete section reference from part 135. 

This action eliminates the requirement 

for an over-pressurized fire bottle to 

discharge extinguishing agent outside 

an airplane to prevent bursting, because 

newer non-corrosive extinguishing 

agents can now be discharged inside an 

airplane without degrading an airframe. 

Regulatory Flexibility Determination 

The Regulatory Flexibility Act of 1980 

(Pub. L. 96–354) (RFA) establishes ‘‘as a 

principle of regulatory issuance that 

agencies shall endeavor, consistent with 

the objectives of the rule and of 

applicable statutes, to fit regulatory and 

informational requirements to the scale 

of the businesses, organizations, and 

governmental jurisdictions subject to 

regulation. To achieve this principle, 

agencies are required to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ The RFA 

covers a wide-range of small entities, 

including small businesses, not-forprofit organizations, and small 

governmental jurisdictions. 

Agencies must perform a review to 

determine whether a rule will have a 

significant economic impact on a 

substantial number of small entities. If 

the agency determines that it will, the 

agency must prepare a regulatory 

flexibility analysis as described in the 

RFA. 

However, if an agency determines that 

a rule is not expected to have a 

significant economic impact on a 

substantial number of small entities, 

section 605(b) of the RFA provides that 

the head of the agency may so certify 

and a regulatory flexibility analysis is 

not required. The certification must 

include a statement providing the 

factual basis for this determination, and 

the reasoning should be clear. 

This final rule aligns the operational 

and certification safety requirements 

regarding over-pressurization of 

airplane extinguishing agent containers 


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Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations 19795 

or fire bottles to prevent bursting; and 

it removes an obsolete section reference 

from part 135. Its economic impact is 

minimal. Therefore, as the FAA 

Administrator, I certify that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

Trade Impact Assessment 

The Trade Agreements Act of 1979 

prohibits Federal agencies from 

engaging in any standards or related 

activities that create unnecessary 

obstacles to the foreign commerce of the 

United States. Legitimate domestic 

objectives, such as safety, are not 

considered unnecessary obstacles. The 

statute also requires consideration of 

international standards and where 

appropriate, that they be the basis for 

U.S. standards. The FAA has assessed 

the potential effect of this final rule and 

has determined that it will have the 

same cost relieving impact on domestic 

and international entities and thus has 

a neutral trade impact. 

Unfunded Mandates Assessment 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) 

requires each Federal agency to prepare 

a written statement assessing the effects 

of any Federal mandate in a proposed or 

final agency rule that may result in a 

$100 million or more expenditure 

(adjusted annually for inflation). The 

FAA currently uses an inflationadjusted value of $128.1 million in lieu 

of $100 million. 

This final rule does not contain such 

a mandate. Therefore, the requirements 

of Title II do not apply to this 

regulation. 

Executive Order 13132, Federalism 

The FAA has analyzed this final rule 

under the principles and criteria of 

Executive Order 13132, Federalism. We 

determined that this action will not 

have a substantial direct effect on the 

States, or the relationship between the 

national Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Therefore, we 

determined that this final rule does not 

have federalism implications. 

Environmental Analysis 

FAA Order 1050.1E identifies FAA 

actions that are categorically excluded 

from preparation of an environmental 

assessment or environmental impact 

statement under the National 

Environmental Policy Act in the 

absence of extraordinary circumstances. 

The FAA has determined this proposed 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 312 and involves no 

extraordinary circumstances. 

Regulations that Significantly Affect 

Energy Supply, Distribution, or Use 

The FAA has analyzed this final rule 

under Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

18, 2001). We have determined that it is 

not a ‘‘significant energy action’’ under 

the executive order because it is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866, and it is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. 

Additional Information 

Commenting on this Direct Final Rule 

You may send comments identified 

by Docket Number FAA–2007–26969, 

using any of the following methods: 

• DOT Docket Web site: Go to 

http://dms.dot.gov and follow the 

instructions for sending your comments 

electronically. 

• Government-wide rulemaking Web 

site: Go to http://www.regulations.gov 

and follow the instructions for sending 

your comments electronically. 

• Mail: Docket Management Facility; 

U.S. Department of Transportation, 400 

Seventh Street, SW., Nassif Building, 

Room PL–401, Washington, DC 20590–

0001. 

• Fax: 1–202–493–2251. 

• Hand Delivery: Room PL–401 on 

the plaza level of the Nassif Building, 

400 Seventh Street, SW., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

Availability of Rulemaking Documents 

You can get an electronic copy using 

the Internet by: 

1. Searching the Department of 

Transportation’s electronic Docket 

Management System (DMS) web page 

(http://dms.dot.gov/search); 

2. Visiting the FAA’s Regulations and 

Policies web page at http:// 

www.faa.gov/regulations_policies/; or 

3. Accessing the Government Printing 

Office’s web page at http:// 

www.gpoaccess.gov/fr/index.html. 

You can also get a copy by sending a 

request to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue, 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. Make sure to 

identify the docket number, notice 

number, or amendment number of this 

rulemaking. 

Small Business Regulatory Enforcement 

Fairness Act 

The Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996 requires FAA to comply with 

small entity requests for information or 

advice about compliance with statutes 

and regulations within its jurisdiction. If 

you are a small entity and you have a 

question regarding this document, you 

may contact your local FAA official, or 

the person listed under the FOR FURTHER

INFORMATION CONTACT heading at the 

beginning of the preamble. You can find 

out more about SBREFA on the Internet 

at http://www.faa.gov/ 

regulations_policies/rulemaking/ 

sbre_act/. 

List of Subjects 

14 CFR Part 121 

Air carriers, Aircraft, Airmen, Alcohol 

abuse, Aviation safety, Reporting and 

recordkeeping requirements, Safety, 

Transportation. 

14 CFR Part 135 

Aircraft, Airmen, Aviation safety, 

Reporting and recordkeeping 

requirements. 

The Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends Chapter I of Title 14, Code of 

Federal Regulations as follows: 

PART 121—OPERATING 

REQUIREMENTS: DOMESTIC, FLAG, 

AND SUPPLEMENTAL OPERATIONS 

■ 1.The authority citation for part 121 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 40119, 

41706, 44101, 44701–44702, 44705, 44709–

44711, 44713, 44716–44717, 44722, 44901, 

44903–44904, 44912, 45101–45105, 46105, 

46301. 

■ 2. Section 121.267 is revised to read 

as follows: 

§ 121.267 Extinguishing agent container 

pressure relief mechanism. 

(a) Extinguishing agent containers 

must be provided with a pressure relief 

mechanism to prevent bursting of the 

container because of excessive internal 

pressures. The discharge line from the 

relief connection must be installed in a 

manner so it can be inspected from the 

ground. Depending upon whether the 

discharge line terminates outside or 

inside the airplane, the certificate 

holder must accomplish the following 

inspections pre-departure: 

(1) The discharge line terminates 

outside the airplane. As part of the predeparture check, visually inspect the 


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19796 Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations 

pressure indicator at the end of the 

discharge line to confirm that the 

container has not discharged. 

(2) The discharge line terminates 

inside the airplane. As part of a predeparture check, visually inspect the 

pressure indicator for the container for 

loss of pressure within the container. 

(b) The certificate holder also must 

ensure that only non-corrosive 

extinguishing agents are used in systems 

where the pressure discharge line 

terminates inside the airplane. 

PART 135—OPERATING 

REQUIREMENTS: COMMUTER AND 

ON DEMAND OPERATIONS AND 

RULES GOVERNING PERSONS ON 

BOARD SUCH AIRCRAFT 

■ 3. The authority citation for part 135 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 41706, 44113, 

44101, 44701–44702, 44705, 44709, 44711–

44713, 44715–44717, 44722. 

■ 4. Amend § 135.169 by revising 

paragraph (a) to read as follows: 

§ 135.169 Additional airworthiness 

requirements. 

(a) Except for commuter category 

airplanes, no person may operate a large 

airplane unless it meets the additional 

airworthiness requirements of 

§§ 121.215 through 121.283 and 121.307 

of this chapter. 

* * * * * 

Marion C. Blakey, 

Administrator. 

[FR Doc. 07–1937 Filed 4–19–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Clindamycin Solution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an abbreviated new animal 

drug application (ANADA) filed by First 

Priority, Inc. The ANADA provides for 

the veterinary prescription use of 

clindamycin hydrochloride oral 

solution in dogs and cats for the 

treatment of various infections due to 

susceptible bacterial pathogens. 

DATES: This rule is effective April 20, 

2007. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: First 

Priority, Inc., 1585 Todd Farm Dr., 

Elgin, IL 60123, filed ANADA 200–398 

for the veterinary prescription use of 

Clindamycin Hydrochloride Oral Drops 

in dogs and cats for the treatment of 

various infections due to susceptible 

bacterial pathogens. First Priority, Inc.’s 

Clindamycin Hydrochloride Oral Drops 

is approved as a generic copy of 

ANTIROBE AQUADROPS Liquid, 

sponsored by Pharmacia & Upjohn Co., 

a Division of Pfizer, Inc., under NADA 

135–940. The ANADA is approved as of 

March 19, 2007, and 21 CFR 520.447 is 

amended 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), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

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. 

FDA has determined under 21 CFR 

25.33(a)(1) 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. 

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 520 

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 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 2. In § 520.447 revise paragraph (b) to 

read as follows: 

§ 520.447 Clindamycin Solution. 

* * * * * 

(b) Sponsors. See Nos. 000009, 

051311, 058829, and 059130 in 

§ 510.600(c) of this chapter. 

* * * * * 

Dated: April 9, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–7472 Filed 4–19–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Oral Dosage Form New Animal Drugs; 

Dexmedetomidine; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending a 

final rule that appeared in the Federal 

Register of January 4, 2007 (72 FR 263), 

revising the animal drug regulations to 

reflect approval of an original new 

animal drug application (NADA). The 

document incorrectly listed the amount 

of drug per milliliter of 

dexmedetomidine hydrochloride 

injectable solution. This action is being 

taken to improve the accuracy of the 

regulations. 

DATES: This rule is effective April 20, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–267–9019, 

e-mail: george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA has 

discovered that an error has been 

incorporated into the agency’s 

regulations for 21 CFR part 522. This 

document corrects that error. 

Publication of this document constitutes 

final action under the Administrative 

Procedure Act (5 U.S.C. 553). FDA has 

determined that notice and public 

comment are unnecessary because this 

amendment is nonsubstantive. 

List of Subjects in 21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 


cprice-sewell on PRODPC61 with RULES