Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Rules and Regulations 49847

§ 71.1 [Amended]

n 2. The incorporation by reference in 14 

CFR 71.1 of the Federal Aviation 

Administration Order 7400.9M, 

Airspace Designations and Reporting 

Points, dated August 30, 2004, and 

effective September 16, 2004, is 

amended as follows:

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth.

* * * * *

AWP AZ E5 Marana Regional, AZ [New] 

Marana Regional, AZ 

(Lat. 32°24′34′′ N, long. 111°13′06′′ W)

That airspace extending upward from 700 

feet above the surface within a 6.6-mile 

radius of the Marana Regional, excluding that 

portion within the Tucson Class E airspace 

area.

* * * * *

Issued in Los Angeles, California, on July 

29, 2005. 

John Clancy, 

Area Director, Western Terminal Operations.

[FR Doc. 05–16926 Filed 8–24–05; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 71

[Docket No. FAA–2005–22160; Airspace 

Docket No. 2005–ASW–12] 

Modification to Class E Airspace; 

Ruidoso, NM

AGENCY: Federal Aviation 

Administration (FAA), DOT.

ACTION: Direct final rule; request for 

comments. 

SUMMARY: This action modifies the Class 

E airspace area at Santa Elena, TX to 

provide adequate controlled airspace for 

the Instrument Landing System (ILS) 

standard instrument approach 

procedure (SIAP) at the Sierra Blanca 

Regional Airport (SRR).

DATES: Effective 0901 UTC, October 27, 

2005. 

Comments for inclusion in the Rules 

Docket must be received on or before 

September 27, 2005.

ADDRESSES: Send comments on the rule 

to the Docket Management System, U.S. 

Department of Transportation, Room 

Plaza 401, 400 Seventh Street, SW., 

Washington, DC 20490–0001. You must 

identify the docket number, FAA–2005–

22160/Airspace Docket No. 2004–ASW–

12, at the beginning of your comments. 

You may also submit comments on the 

Internet at the DOT docket Web site, 

http://dms.dot.gov or the governmentwide Web site, http://

www.regulations.gov. Anyone can find 

and read the comments received in this 

docket, including the name, address and 

any other personal information placed 

in the docket by a commenter. You may 

hand deliver your comments and review 

the public docket containing any 

comments received and this direct final 

rule in person at the Dockets Office 

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

through Friday, except Federal holidays. 

The Docket Office (telephone 1–800–

647–5527) is located on the plaza level 

of the Department of Transportation 

NASSIF Building at the street address 

stated previously. 

An informal docket may also be 

examined during normal business hours 

at the office of the Air Traffic Division, 

Airspace Branch, Federal Aviation 

Administration, Southwest Region, 2601 

Meacham Boulevard, Fort Worth, TX. 

Call the manager, Airspace Branch, 

ASW–520, telephone (817) 222–5520; 

fax (718) 222–5981, to make 

arrangements for your visit.

FOR FURTHER INFORMATION CONTACT:

Joseph R. Yadouga, Air Traffic Division, 

Airspace Branch, Federal Aviation 

Administration, Southwest Region, Fort 

Worth, TX 76193–0520; telephone: (817) 

222–5597.

SUPPLEMENTARY INFORMATION: This 

amendment to 14 CFR part 71 modifies 

the Class E airspace area extending 

upward from 700 feet above the surface 

of Ruidoso, NM in conjunction with the 

Sierra Blanca Regional Airport for 

which a new standard instrument 

approach has been prescribed and will 

be published in paragraph 6005 of FAA 

Order 7400.9M, dated August 30, 2004, 

and effective September 16, 2004, which 

is incorporated by reference in 14 CFR 

71.1. 

The Direct Final Rule Procedure 

The FAA anticipates that this 

regulation will not result in an adverse 

or negative comment, and, therefore, 

issues it as a direct final rule. The FAA 

has determined that this regulation only 

involves an established body of 

technical regulations for which frequent 

and routine amendments are necessary 

to keep them operationally current. 

Unless a written adverse or negative 

comment, or a written notice of intent 

to submit an adverse or negative 

comment is received within the 

comment period, the regulation will 

become effective on the date specified. 

After the close of the comment period, 

the FAA will publish a document in the 

Federal Register indicating that no 

adverse or negative comments were 

received and confirming the date on 

which the final rule will become 

effective. If the FAA does receive, 

within the comment period, an adverse 

or negative comment, or written notice 

of an intent to submit such a comment, 

a document withdrawing the direct final 

rule will be published in the Federal 

Register, and a notice of proposed 

rulemaking may be published with a 

new comment period.

Comments Invited 

Although this action is in the form of 

a direct final rule, and was not preceded 

by a notice of proposed rulemaking, 

interested persons are invited to 

comment on this rule by submitting 

such written data, views, or arguments 

as they may desire. Communications 

must identify both docket numbers. All 

communications received on or before 

the closing date for comments will be 

considered, and this rule may be 

amended or withdrawn in light of the 

comments received. Factual information 

that supports the commenter’s ideas and 

suggestions is extremely helpful in 

evaluating the effectiveness of this 

action and determining whether 

additional rulemaking action would be 

needed. 

Comments are specifically invited on 

the overall regulatory, economic, 

environmental, and energy aspects of 

the rule that might suggest a need to 

modify the rule. All comments 

submitted will be available, both before 

and after the closing date for comments, 

in the Rules Docket for examination by 

interested persons. A report that 

summarizes each FAA-public contact 

concerned with the substance of this 

action will be filed in the Rules Docket. 

Agency Findings 

This rule does not have federalism 

implications, as defined in Executive 

Order No. 13132, because it does not 

have a substantial direct effect on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

FAA has not consulted with state 

authorities prior to publication of this 

rule. 

The FAA has determined that this 

regulation is noncontroversial and 

unlikely to result in adverse or negative 

comments. For the reasons discussed, I 

certify that this 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 

49848 Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Rules and Regulations 

warrant preparation of a Regulatory 

Evaluation as these routine matters will 

only affect air traffic procedures and air 

navigation. I certify that this rule will 

not have a significant economic impact 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Authority for This Rulemaking 

The FAA authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. 

This rulemaking is promulgated 

under the authority described in subtitle 

VII, part A, subpart I, section 40103, 

‘‘Sovereignty and use of airspace.’’ 

Under that section, the FAA is charged 

with developing plans and policy for 

the use of the navigable airspace and 

assigning by regulation or order the 

airspace necessary to ensure the safety 

of aircraft and the efficient use of 

airspace. The FAA may modify or 

revoke an assignment when required in 

the public interest. This regulation is 

within the scope of that authority 

because it is in the public interest to 

provide greater control of the airspace 

for the safety of aircraft operating in the 

vicinity of the newly established 

standard instrument approach 

procedure.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, 

Navigation (air).

Adoption of the Amendment

n Accordingly, pursuant to the authority 

delegated to me, the Federal Aviation 

Administration amends part 71 of the 

Federal Aviation Regulations (14 CFR 

part 71) as follows:

PART 71—DESIGNATION OF CLASS A, 

CLASS B, CLASS C, CLASS D, AND 

CLASS E AIRSPACE AREAS; 

AIRWAYS; ROUTES; AND REPORTING 

POINTS

n 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]

n 2. The incorporation by reference in 14 

CFR 71.1 of Federal Aviation 

Administration Order 7400.9M, 

Airspace Designations and Reporting 

Points, dated August 30, 2004, and 

effective September 16, 2004, is 

amended as follows:

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth. 

ASW NM E5 Ruidoso, NM [Revised] 

Sierra Blanca Regional Airport, NM 

Lat. 33°27′46.30′′ N, Long. 105°32′05.10′′ W

That airspace extending upward from 700 

feet above the surface within a 7.1-mile 

radius of the Sierra Blanca Airport and 

within 4 miles each side of the 241° bearing 

from the airport extending from 7.1-mile 

radius to 20.60 miles northeast of the Sierra 

Blanca Regional Airport.

* * * * *

Issued in Fort Worth, TX, on August 18, 

2005. 

Samuel J. Gill, Jr., 

Acting Area Director, Central En Route and 

Oceanic Operations.

[FR Doc. 05–16925 Filed 8–24–05; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 3

[Docket No. 2004N–0194]

Definition of Primary Mode of Action of 

a Combination Product

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

combination product regulations to 

define ‘‘mode of action’’ (MOA) and 

‘‘primary mode of action’’ (PMOA). 

Along with these definitions, the final 

rule sets forth an algorithm the agency 

will use to assign combination products 

to an agency component for regulatory 

oversight when the agency cannot 

determine with reasonable certainty 

which mode of action provides the most 

important therapeutic action of the 

combination product. Finally, the final 

rule will require a sponsor to base its 

recommendation of the agency 

component with primary jurisdiction for 

regulatory oversight of its combination 

product by using the PMOA definition 

and, if appropriate, the assignment 

algorithm. The final rule is intended to 

promote the public health by codifying 

the agency’s criteria for the assignment 

of combination products in transparent, 

consistent, and predictable terms.

DATES: The regulation is effective 

November 23, 2005.

FOR FURTHER INFORMATION CONTACT:

Leigh Hayes, Office of Combination 

Products (HFG–3), Food and Drug 

Administration, 15800 Crabbs Branch 

Way, suite 200, Rockville, MD 20855, 

301–427–1934.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of May 7, 2004 

(69 FR 25527), FDA published a 

proposed rule that proposed to define 

‘‘mode of action’’ (MOA) and ‘‘primary 

mode of action’’ (PMOA) (the proposed 

rule). Along with these definitions, the 

proposal set forth an algorithm the 

agency proposed to use to assign 

combination products to an agency 

component for regulatory oversight 

when the agency cannot determine with 

reasonable certainty which mode of 

action provides the most important 

therapeutic action of the combination 

product. Finally, the proposal put forth 

a requirement that a sponsor make its 

recommendation of the agency 

component with primary jurisdiction for 

regulatory oversight of its combination 

product by using the PMOA definition 

and, if appropriate, the assignment 

algorithm.

As set forth in part 3 (21 CFR part 3), 

and as described in the proposed rule, 

a combination product is a product 

comprised of any combination of a drug 

and a device; a device and a biological 

product; a biological product and a 

drug; or a drug, a device, and a 

biological product. A combination 

product includes: (1) A product 

comprised of two or more regulated 

components, i.e., drug/device, biological 

product/device, drug/biological 

product, or drug/device/biological 

product, that are physically, chemically, 

or otherwise combined or mixed and 

produced as a single entity; (2) two or 

more separate products packaged 

together in a single package or as a unit 

and comprised of drug and device 

products, device and biological 

products, or biological and drug 

products; (3) a drug, device, or 

biological product packaged separately 

that, according to its investigational 

plan or proposed labeling, is intended 

for use only with an approved 

individually specified drug, device, or 

biological product where both are 

required to achieve the intended use, 

indication, or effect and where upon 

approval of the proposed product the 

labeling of the approved product would 

need to be changed, e.g., to reflect a 

change in intended use, dosage form, 

strength, route of administration, or 

significant change in dose; or (4) any 

investigational drug, device, or