Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 56391 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

2. The Federal Aviation 

Administration (FAA) amends § 39.13 

by adding the following new 

airworthiness directive (AD): 

Airbus: Docket No. FAA–2005–22524; 

Directorate Identifier 2005–NM–135–AD. 

Comments Due Date 

(a) The FAA must receive comments on 

this AD action by October 27, 2005. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Airbus Model A330–

201, –202, –203, –223, –243, –301, –321, 

–322, –323, –341, –342, and –343 airplanes; 

Model A340–211, –212, –213, –311, –312, 

and –313 airplanes; and Model A340–541 

and –642 airplanes; certificated in any 

category; as identified in Airbus All 

Operators Telex (AOT) A330–25A3272–2005, 

Revision 01, dated March 24, 2005; Airbus 

AOT A340–25A4259–2005, Revision 01; 

dated March 24, 2005; or Airbus AOT A340–

25A5091, Revision 02, dated June 1, 2005; as 

applicable. 

Unsafe Condition 

(d) This AD results from a report that an 

emergency escape slide/slide raft (referred to 

hereafter as a ‘‘slide/raft’’) failed to deploy 

properly during a deployment test. We are 

issuing this AD to detect and correct 

improper routing of the electrical harnesses 

of certain slide/rafts, which could prevent 

proper deployment of the slide/raft and delay 

evacuation of passengers and flightcrew 

during an emergency. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Inspections and Corrective Actions 

(f) Within 1,700 flight hours after the 

effective date of this AD: Inspect certain 

crew/passenger doors as required by 

paragraph (f)(1) or (f)(2), as applicable, of this 

AD to determine if slide/rafts having certain 

part numbers (P/N) are installed. A review of 

airplane maintenance records is acceptable in 

lieu of this inspection if the presence of the 

subject slide/rafts can be conclusively 

determined from that review. 

(1) For Model A330–201, –202, –203, –223, 

–243, –301, –321, –322, –323, –341, –342, 

and –343 airplanes and Model A340–211, 

–212, –213, –311, –312, and –313 airplanes: 

On both right and left hand sides, inspect to 

determine the P/N of the slide/rafts of crew/ 

passenger doors 1 and 4, and, only if it is a 

type 1 door, crew/passenger door 3. If crew/ 

passenger door 3 is not a type 1 door, it is 

not subject to any requirement of this AD. 

(i) If a slide/raft does not have P/N 

7A1508–( ) or 7A1509–( ), no further action 

is required for that slide/raft by this AD. 

(ii) If a slide/raft has P/N 7A1508–( ) or 

7A1509–( ), before further flight, perform a 

general visual inspection of the electrical 

harness of the slide/raft and reroute the 

harness, as applicable, in accordance with 

paragraphs 4.2 through 4.2.4 of Airbus All 

Operators Telex (AOT) A330–25A3272–2005, 

Revision 01, or Airbus AOT A340–25A4259–

2005, Revision 01; both dated March 24, 

2005; as applicable. 

(2) For Model A340–541 and –642 

airplanes: On both right and left hand sides, 

inspect to determine the P/N of the slide/rafts 

of crew/passenger doors 1 and 4. 

(i) If a slide/raft does not have P/N 

7A1508–( ), no further action is required for 

that slide/raft by this AD. 

(ii) If a slide/raft has P/N 7A1508–( ), 

before further flight, perform a general visual 

inspection of the electrical harness of that 

slide/raft and reroute the harness, as 

applicable, in accordance with paragraphs 

4.2 through 4.2.4 of Airbus AOT A340–

25A5091, Revision 02, dated June 1, 2005. 

Note 1: For the purposes of this AD, a 

general visual inspection is: ‘‘A visual 

examination of an interior or exterior area, 

installation, or assembly to detect obvious 

damage, failure, or irregularity. This level of 

inspection is made from within touching 

distance unless otherwise specified. A mirror 

may be necessary to ensure visual access to 

all surfaces in the inspection area. This level 

of inspection is made under normally 

available lighting conditions such as 

daylight, hangar lighting, flashlight, or 

droplight and may require removal or 

opening of access panels or doors. Stands, 

ladders, or platforms may be required to gain 

proximity to the area being checked.’’

Actions Accomplished According to 

Previous Issues of AOTs 

(g) Actions accomplished before the 

effective date of this AD in accordance with 

Airbus AOT A330–25A3272, Airbus AOT 

A340–25A4259 (for Model A340–200 and 

–300 airplanes), or Airbus AOT A340–

25A5091 (for Model A340–541 and –642 

airplanes); all dated March 17, 2005; or 

A340–25A5091–2005, Revision 01, dated 

March 24, 2005; as applicable; are considered 

acceptable for compliance with the 

corresponding actions specified in paragraph 

(f) of this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(h)(1) The Manager, International Branch, 

ANM–116, Transport Airplane Directorate, 

FAA, has the authority to approve AMOCs 

for this AD, if requested in accordance with 

the procedures found in 14 CFR 39.19. 

(2) Before using any AMOC approved in 

accordance with 14 CFR 39.19 on any 

airplane to which the AMOC applies, notify 

the appropriate principal inspector in the 

FAA Flight Standards Certificate Holding 

District Office. 

Related Information 

(i) French airworthiness directive F–2005–

077, dated May 11, 2005, also addresses the 

subject of this AD. 

Issued in Renton, Washington, on 

September 16, 2005. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 05–19235 Filed 9–26–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2005–22398; Airspace 

Docket No. 05–ASO–7] 

RIN 2120–AA66 

Proposed Establishment of High 

Altitude Area Navigation Routes 

(RNAV); South Central United States 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This action proposes to 

establish 16 high altitude area 

navigation (RNAV) routes in the South 

Central United States to support the 

High Altitude Redesign (HAR) program. 

The FAA is proposing this action to 

enhance safety and to improve the 

efficient use of the navigable airspace. 

DATES: Comments must be received on 

or before November 14, 2005. 

ADDRESSES: Send comments on this 

proposal to the Docket Management 

System, U.S. Department of 

Transportation, Room Plaza 401, 400 

Seventh Street, SW., Washington, DC 

20590–0001. You must identify FAA 

Docket No. FAA–2005–22398 and 

Airspace Docket No. 05–ASO–7, at the 

beginning of your comments. You may 

also submit comments through the 

Internet at http://dms.dot.gov. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gallant, Airspace and Rules, Office of 

System Operations Airspace and AIM, 

Federal Aviation Administration, 800 

Independence Avenue, SW., 

Washington, DC 20591; telephone: (202) 

267–8783. 

SUPPLEMENTARY INFORMATION: 

56392 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 

Comments Invited 

Interested parties are invited to 

participate in this proposed rulemaking 

by submitting such written data, views, 

or arguments, as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. Comments 

are specifically invited on the overall 

regulatory, aeronautical, economic, 

environmental, and energy-related 

aspects of the proposal. 

Communications should identify both 

docket numbers (FAA Docket No. FAA–

2005–22398 and Airspace Docket No. 

05–ASO–7) and be submitted in 

triplicate to the Docket Management 

System (see ADDRESSES section for 

address and phone number). You may 

also submit comments through the 

Internet at http://dms.dot.gov. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this action must submit with those 

comments a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to FAA 

Docket No. FAA–2005–22398 and 

Airspace Docket No. 05–ASO–7.’’ The 

postcard will be date/time stamped and 

returned to the commenter. 

All communications received on or 

before the specified closing date for 

comments will be considered before 

taking action on the proposed rule. The 

proposal contained in this action may 

be changed in light of comments 

received. All comments submitted will 

be available for examination in the 

public docket both before and after the 

closing date for comments. A report 

summarizing each substantive public 

contact with FAA personnel concerned 

with this rulemaking will be filed in the 

docket. 

Availability of NPRM’s 

An electronic copy of this document 

may be downloaded through the 

Internet at http://dms.dot.gov. Recently 

published rulemaking documents can 

also be accessed through the FAA’s Web 

page at http://www.faa.gov, or the 

Federal Register’s web page at http:// 

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

You may review the public docket 

containing the proposal, any comments 

received, and any final disposition in 

person in the Dockets Office (see 

ADDRESSES section for address and 

phone number) between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. An informal docket 

may also be examined during normal 

business hours at the office of the 

Regional Air Traffic Division, Federal 

Aviation Administration, 1701 

Columbia Avenue, College Park, GA 

30337. 

Persons interested in being placed on 

a mailing list for future NPRM’s should 

contact the FAA’s Office of Rulemaking, 

(202) 267–9677, for a copy of Advisory 

Circular No. 11–2A, Notice of Proposed 

Rulemaking Distribution System, which 

describes the application procedure. 

Background 

As part of the on-going National 

Airspace Redesign, the FAA 

implemented the HAR program. The 

HAR program’s focus is to develop and 

implement fundamental improvements 

in navigation structure and operating 

methods to allow more flexible and 

efficient high altitude en route 

operations. In support of this program, 

the FAA is establishing new RNAV 

routes for use by suitably equipped 

aircraft. These new routes would allow 

users greater flexibility in route 

selection. In addition, users should 

achieve economic benefits derived from 

less restrictive routing options than are 

currently available in the jet route 

structure. 

These high altitude RNAV routes will 

be identified by the letter prefix ‘‘Q,’’

followed by a number consisting of from 

one to three digits. 

Related Rulemaking 

On April 8, 2003, the FAA published 

the Designation of Class A, B, C, D, and 

E Airspace Areas; Air Traffic Service 

Routes, and Reporting Points rule in the 

Federal Register (68 FR 16943). The 

purpose of the rule was to facilitate the 

establishment of RNAV routes in the 

National Airspace System (NAS) for use 

by aircraft with advanced navigation 

system capabilities. This rule adopted 

certain amendments proposed in Notice 

No. 02–20, Area Navigation and 

Miscellaneous Amendments. The rule 

revised and adopted several definitions 

in FAA regulations, including Air 

Traffic Service Routes, to be in concert 

with ICAO definitions; and reorganized 

the structure of FAA regulations 

concerning the designation of Class A, 

B, C, D, and E airspace areas, airways, 

routes, and reporting points. 

The Proposal 

The FAA is proposing an amendment 

to Title 14 Code of Federal Regulations 

(14 CFR) part 71 to establish 16 RNAV 

routes in the South Central United 

States within the airspace assigned to 

the Memphis Air Route Traffic Control 

Center (ARTCC). These routes are 

proposed as part of the HAR program to 

enhance safety, and to facilitate the 

more flexible and efficient use of the 

navigable airspace for en route 

instrument flight rules (IFR) operations 

within the Memphis ARTCC’s area of 

responsibility. 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. 

Therefore, this proposed regulation: (1) 

Is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a regulatory 

evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this proposed rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389. 

§ 71.1 [Amended] 

2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.9N, 

Airspace Designations and Reporting 

Points, dated September 1, 2005 and 

effective September 15, 2005, is 

amended as follows: 

Paragraph 2006—Area Navigation Routes. 

* * * * * 

Q–19 PLESS to BNA [New] 

PLESS ............................................................ Fix .................................................................. (Lat. 37°48′35′′ N., long. 88°57′48′′ W.) 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 56393 

BNA ............................................................... VORTAC ........................................................ (Lat. 36°08′13′′ N., long. 86°41′05′′ W.) 

* * * * * * * 

Q–21 JONEZ to RZC [New] 

JONEZ ............................................................ Fix .................................................................. (Lat. 34°30′57′′ N., long. 95°27′34′′ W.) 

RZC ................................................................ VORTAC ........................................................ (Lat. 36°14′47′′ N., long. 94°07′17′′ W.) 

* * * * * * * 

Q–23 FSM to RZC [New] 

FSM ................................................................ VORTAC ........................................................ (Lat. 35°23′18′′ N., long. 94°16′18′′ W.) 

RZC ................................................................ VORTAC ........................................................ (Lat. 36°14′47′′ N., long. 94°07′17′′ W.) 

* * * * * * * 

Q–25 MEEOW to PXV [New] 

MEEOW ......................................................... Fix .................................................................. (Lat. 34°19′05′′ N., long. 93°31′25′′ W.) 

ARG ................................................................ VORTAC ........................................................ (Lat. 36°06′36′′ N., long. 90°57′13′′ W.) 

WLSUN .......................................................... WP ................................................................. (Lat. 37°35′00′′ N., long. 88°08′00′′ W.) 

PXV ................................................................ VORTAC ........................................................ (Lat. 37°55′42′′ N., long. 87°45′45′′ W.) 

Q–26 ARG to ABROC [New] 

ARG ................................................................ VORTAC ........................................................ (Lat. 36°06′36′′ N., long. 90°57′13′′ W.) 

ABROC ........................................................... Fix .................................................................. (Lat. 34°37′05′′ N., long. 87°26′07′′ W.) 

Q–27 FSM to ZALDA [New] 

FSM ................................................................ VORTAC ........................................................ (Lat. 35°23′18′′ N., long. 94°16′18′′ W.) 

ZALDA ........................................................... WP ................................................................. (Lat. 36°04′55′′ N., long. 93°37′37′′ W.) 

Q–28 GRAZN to PXV [New] 

GRAZN .......................................................... WP ................................................................. (Lat. 34°15′00′′ N., long. 94°21′29′′ W.) 

PYRMD .......................................................... WP ................................................................. (Lat. 34°34′00′′ N., long. 93°44′00′′ W.) 

HAKAT .......................................................... WP ................................................................. (Lat. 36°17′00′′ N., long. 91°04′00′′ W.) 

ESTEE ............................................................ WP ................................................................. (Lat. 37°41′00′′ N., long. 88°17′00′′ W.) 

PXV ................................................................ VORTAC ........................................................ (Lat. 37°55′42′′ N., long. 87°45′45′′ W.) 

Q–29 HARES to PXV [New] 

HARES ........................................................... WP ................................................................. (Lat. 33°00′′00′′ N., long. 91°44′00′′ W.) 

MEM .............................................................. VORTAC ........................................................ (Lat. 35°00′54′′ N., long. 89°59′00′′ W.) 

SIDAE ............................................................ WP ................................................................. (Lat. 37°20′00′′ N., long. 87°50′00′′ W.) 

PXV ................................................................ VORTAC ........................................................ (Lat. 37°55′42′′ N., long. 87°45′45′′ W.) 

Q–30 SQS to VUZ [New] 

SQS ................................................................ VORTAC ........................................................ (Lat. 33°27′50′′ N., long. 90°16′38′′ W.) 

VUZ ................................................................ VORTAC ........................................................ (Lat. 33°40′13′′ N., long. 86°53′59′′ W.) 

Q–31 DHART to PXV [New] 

DHART .......................................................... Fix .................................................................. (Lat. 33°23′52′′ N., long. 92°25′10′′ W.) 

TOROS ........................................................... WP ................................................................. (Lat. 33°40′00′′ N., long. 92°10′00′′ W.) 

UJM ................................................................ VOR/DME ...................................................... (Lat. 34°34′30′′ N., long. 90°40′28′′ W.) 

TIIDE .............................................................. WP ................................................................. (Lat. 37°28′00′′ N., long. 87°59′00′′ W.) 

PXV ................................................................ VORTAC ........................................................ (Lat. 37°55′42′′ N., long. 87°45′45′′ W.) 

Q–32 ELD to SWAPP [New] 

ELD ................................................................ VORTAC ........................................................ (Lat. 33°15′22′′ N., long. 92°44′38′′ W.) 

GAGLE ........................................................... WP ................................................................. (Lat. 34°08′00′′ N., long. 90°17′00′′ W.) 

CRAMM ......................................................... Fix .................................................................. (Lat. 34°38′11′′ N., long. 88°53′55′′ W.) 

BNA ............................................................... VORTAC ........................................................ (Lat. 36°08′13′′ N., long. 86°41′05′′ W.) 

SWAPP .......................................................... Fix .................................................................. (Lat. 36°36′50′′ N., long. 85°10′56′′ W.) 

Q–33 PROWL to DHART [New] 

PROWL .......................................................... WP ................................................................. (Lat. 37°02′00′′ N., long. 91°15′00′′ W.) 

LIT .................................................................. VORTAC ........................................................ (Lat. 34°40′40′′ N., long. 92°10′50′′ W.) 

DHART .......................................................... Fix .................................................................. (Lat. 33°23′52′′ N., long. 92°25′10′′ W.) 

Q–34 TXK to SWAPP [New] 

TXK ................................................................ VORTAC ........................................................ (Lat. 33°30′50′′ N., long. 94°04′24′′ W.) 

MATIE ........................................................... Fix .................................................................. (Lat. 34°05′42′′ N., long. 92°33′02′′ W.) 

MEM .............................................................. VORTAC ........................................................ (Lat. 35°00′54′′ N., long. 89°59′00′′ W.) 

SWAPP .......................................................... Fix .................................................................. (Lat. 36°36′50′′ N., long. 85°10′56′′ W.) 

Q–36 RZC to SWAPP [New] 

RZC ................................................................ VORTAC ........................................................ (Lat. 36°14′47′′ N., long. 94°07′17′′ W.) 

TWITS ............................................................ WP ................................................................. (Lat. 36°08′32′′ N., long. 90°54′48′′ W.) 

DEPEC ............................................................ WP ................................................................. (Lat. 36°06′00′′ N., long. 87°31′00′′ W.) 

BNA ............................................................... VORTAC ........................................................ (Lat. 36°08′13′′ N., long. 86°41′05′′ W.) 

SWAPP .......................................................... Fix .................................................................. (Lat. 36°36′50′′ N., long. 86°10′56′′ W.) 

Q–38 ROKIT to BESOM [New] 

ROKIT ............................................................ Fix .................................................................. (Lat. 30°29′50′′ N., long. 94°30′50′′ W.) 

INCIN ............................................................. WP ................................................................. (Lat. 31°21′09′′ N., long. 92°45′18′′ W.) 

LAREY ........................................................... WP ................................................................. (Lat. 32°00′12′′ N., long. 91°22′22′′ W.) 

BESOM .......................................................... Fix .................................................................. (Lat. 33°35′11′′ N., long. 87°39′23′′ W.) 

Q–40 AEX to MISLE [New] 

AEX ................................................................ VORTAC ........................................................ (Lat. 31°15′24′′ N., long. 92°30′04′′ W.) 

DOOMS .......................................................... WP ................................................................. (Lat. 31°53′08′′ N., long. 91°09′56′′ W.) 

SALVA ........................................................... WP ................................................................. (Lat. 32°38′00′′ N., long. 89°21′56′′ W.) 

MISLE ............................................................ WP ................................................................. (Lat. 33°24′00′′ N., long. 87°38′00′′ W.) 

56394 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 

* * * * * 

Issued in Washington, DC, on September 

19, 2005. 

Edith V. Parish, 

Acting Manager, Airspace and Rules. 

[FR Doc. 05–19205 Filed 9–26–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 20, 510, 514, and 516 

[Docket No. 2005N–0329] 

RIN 0910–AF60 

Designation of New Animal Drugs for 

Minor Uses or Minor Species 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Minor Use and Minor 

Species Animal Health Act of 2004 

(MUMS act) amended the Federal Food, 

Drug, and Cosmetic Act (the act) to 

establish new regulatory procedures that 

provide incentives intended to make 

more drugs legally available to 

veterinarians and animal owners for the 

treatment of minor animal species and 

uncommon diseases in major animal 

species. At this time, FDA is issuing 

proposed regulations to implement the 

act. These regulations propose 

procedures for designating a new animal 

drug as a minor use or minor species 

drug. Such designation establishes 

eligibility for the incentives provided by 

the MUMS act. 

DATES: Submit written or electronic 

comments on this document by 

December 12, 2005. Submit comments 

on the information collection provisions 

by October 27, 2005. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005N–0329 

and/or RIN number 0910–AF60, by any 

of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301-827-6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure timely processing of 

electronic comments, FDA is no longer 

accepting comments submitted to the 

agency by e-mail. FDA encourages you 

to continue to submit electronic 

comments by using the Federal 

eRulemaking Portal and agency Web 

site, as described in the Electronic 

Submissions portion of this paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket number or regulatory 

information number for this rulemaking. 

All comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Beaulieu, Center for Veterinary 

Medicine (HFV–50), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9090, email: Andrew.Beaulieu@fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In enacting the MUMS act (Public 

Law 108–282), Congress sought to 

encourage the development of animal 

drugs that are currently unavailable to 

minor species (species other than cattle, 

horses, swine, chickens, turkeys, dogs, 

and cats) in the United States or to 

major species afflicted with uncommon 

diseases or conditions (minor uses). 

Congress recognized that the markets for 

drugs intended to treat these species, 

diseases, or conditions are so small that 

there are often insufficient economic 

incentives to motivate sponsors to 

develop data to support approvals. 

Further, Congress recognized that some 

minor species populations are too small 

or their management systems too 

diverse to make it practical to conduct 

traditional studies to demonstrate safety 

and effectiveness of these animal drugs. 

As a result of these limitations, sponsors 

have generally not been willing or able 

to collect data to support legal 

marketing of drugs for these species, 

diseases, or conditions. Consequently, 

Congress enacted the MUMS act, which 

amended the Federal Food, Drug, and 

Cosmetic Act (the act) to provide 

incentives to develop new animal drugs 

for minor species and minor uses, while 

still ensuring appropriate safeguards for 

animal and human health. 

At this time, FDA is issuing proposed 

regulations to implement section 573 of 

the act (21 U.S.C. 360ccc-2). These 

regulations propose procedures for 

designating a new animal drug as a 

minor use or minor species drug. Such 

designation provides eligibility for 

certain incentives established by the 

MUMS act, including exclusive 

marketing rights associated with the 

conditional approval or approval of 

designated new animal drugs and for 

grants to support designated new animal 

drug development. In accordance with 

section 573 of the act, these proposed 

regulations provide for designation of a 

new animal drug to be granted only 

when the drug is intended for a minor 

use or use in a minor species and only 

when the same new animal drug, in the 

same dosage form, for the same 

intended use is not already approved 

under section 512 of the act (21 U.S.C. 

360b), conditionally approved under 

section 571 of the act (21 U.S.C. 360ccc), 

or designated under section 573 of the 

act at the time that a sponsor requests 

designation. 

The incentives in the MUMS act and 

these proposed regulations are modeled 

on those provided by the human orphan 

drug program. These incentives include 

the following: (1) Eligibility for grants 

and contracts to defray the costs of 

qualified safety and effectiveness testing 

expenses and manufacturing expenses 

incurred in the development of 

designated new animal drugs and (2) a 

7-year period of exclusive marketing 

rights to enable sponsors to recover 

costs of drug development without 

competition. Marketing exclusivity for 

nondesignated drugs is limited to 3 or 

5 years of protection from generic 

copying (section 512(c)(2)(F) of the act). 

The exclusive marketing rights for 

designated drugs provide protection 

from generic copying and from approval 

of another pioneer application for the 

same drug, in the same dosage form, for 

the same intended use. 

Other major incentives of the MUMS 

act include the following: (1) 

Conditional approval, which is