4306 Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Rules and Regulations 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket FAA No. FAA–2012–1253; Airspace 

Docket No. 12–AWP–10] 

Amendment of Class D and Class E 

Airspace; Twentynine Palms, CA 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: This action amends Class D 

and Class E airspace at Twentynine 

Palms SELF Airport, Twentynine Palms, 

CA. This action changes the airport 

name formerly called Twentynine Palms 

Expeditionary Air Field (EAF), Marine 

Corps Base. This action also adjusts the 

geographic coordinates of the airport to 

enhance the safety and management of 

aircraft operations at Twentynine Palms 

SELF Airport, Twentynine Palms, CA. 

This action does not change the 

boundaries of the airspace. 

DATES: Effective date, 0901 UTC, March 

7, 2013. The Director of the Federal 

Register approves this incorporation by 

reference action under 1 CFR Part 51, 

subject to the annual revision of FAA 

Order 7400.9 and publication of 

conforming amendments. 

FOR FURTHER INFORMATION CONTACT: 

Eldon Taylor, Federal Aviation 

Administration, Operations Support 

Group, Western Service Center, 1601 

Lind Avenue SW., Renton, WA 98057; 

telephone (425) 203–4537. 

SUPPLEMENTARY INFORMATION: 

History 

The FAA’s Aeronautical Products 

Office requested the change to the 

airport name and geographic 

coordinates of Twentynine Palms SELF 

Airport, Twentynine Palms, CA. 

The Class D airspace and Class E 

airspace designations are published in 

paragraphs 5000 and 6004, respectively, 

of FAA Order 7400.9W, dated August 8, 

2012, and effective September 15, 2012, 

which is incorporated by reference in 14 

CFR 71.1. The Class D airspace and 

Class E airspace designation listed in 

this document will be published 

subsequently in the Order. 

The Rule 

The FAA amends Title 14 Code of 

Federal Regulations (14 CFR) Part 71 by 

changing the airport name described in 

Class D airspace and Class E airspace 

designated as an extension to Class D 

surface area at Twentynine Palms, CA, 

to Twentynine Palms SELF Airport, 

formerly Twentynine Palms 

Expeditionary Air Field (EAF), Marine 

Corps Base. The geographic coordinates 

of the airport are also adjusted to be in 

accordance with the FAA’s aeronautical 

database. Accordingly, since this is an 

administrative change and does not 

involve a change in the dimensions or 

operation requirements of that airspace, 

notice and public procedures under 5 

U.S.C. 553(b) are unnecessary. 

The FAA has determined this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation; (1) Is 

not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under 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 this 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. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the U.S. Code. Subtitle 1, 

Section 106, describes the authority for 

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. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of the airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it amends 

controlled airspace at Twentynine 

Palms SELF Airport, Twentynine Palms, 

CA. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1E, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 311a. This airspace action is 

not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 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 Federal Aviation 

Administration Order 7400.9W, 

Airspace Designations and Reporting 

Points, dated August 8, 2012, and 

effective September 15, 2012, is 

amended as follows: 

Paragraph 5000 Class D airspace. 

* * * * * 

AWP CA D Twentynine Palms, CA 

[Amended] 

Twentynine Palms SELF Airport, CA 

(Lat. 34°17′46′′ N., long. 116°09′44′′ W.) 

That airspace extending upward from the 

surface to and including 4,600 feet MSL 

within a 4.3-mile radius of the Twentynine 

Palms SELF Airport. This Class D airspace 

area is effective during the specific dates and 

times established in advance by a Notice to 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Airport/Facility Directory. 

Paragraph 6004 Class E airspace designated 

as an extension to a Class D surface area. 

* * * * * 

AWP CA E4 Twentynine Palms, CA 

[Amended] 

Twentynine Palms SELF Airport, CA 

(Lat. 34°17′46′′ N., long. 116°09′44′′ W.) 

Twentynine Palms VORTAC 

(Lat. 34°06′44′′ N., long. 115°46′12′′ W.) 

That airspace extending upward from the 

surface within 1.8 miles each side of the 

Twentynine Palms VORTAC 298° radial 

extending from the 4.3-mile radius of 

Twentynine Palms SELF Airport to 13.9 

miles west of the VORTAC. This Class E 

airspace area is effective during the specific 

dates and times established in advance by a 

Notice to Airmen. The effective date and time 

will thereafter be continuously published in 

the Airport/Facility Directory. 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Rules and Regulations 4307 

1For purposes of part 3 and this rule, a 

‘‘biological product’’’ means a biological product 

subject to regulation under section 351 of the Public 

Health Service Act (the PHS Act) (42 U.S.C. 262). 

All biological products regulated under the PHS Act 

meet the definitions of drug or device in section 201 

of the Federal Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 321). 

2Section 501 of the FD&C Act (21 U.S.C. 351) 

states circumstances under which drugs and 

devices (including biological products, which also 

meet the definition of either drug or device) are 

deemed adulterated. Adulteration includes the 

failure to manufacture a product in accordance with 

applicable CGMP requirements, regardless of 

whether the product appears to meet its final 

specifications. See, generally, 21 U.S.C. 351(a)(2)(B) 

and (h). 

Issued in Seattle, Washington, on 

December 19, 2012. 

Clark Desing, 

Manager, Operations Support Group, Western 

Service Center. 

[FR Doc. 2013–01071 Filed 1–18–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 4 

[Docket No. FDA–2009–N–0435] 

Current Good Manufacturing Practice 

Requirements for Combination 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing this regulation on the current 

good manufacturing practice (CGMP) 

requirements applicable to combination 

products. This rule is intended to 

promote the public health by clarifying 

which CGMP requirements apply when 

drugs, devices, and biological products 

are combined to create combination 

products. In addition, the rule sets forth 

a transparent and streamlined regulatory 

framework for firms to use when 

demonstrating compliance with CGMP 

requirements for ‘‘single-entity’’ and 

‘‘co-packaged’’ combination products. 

DATES: This rule is effective July 22, 

2013. 

FOR FURTHER INFORMATION CONTACT: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5130, Silver Spring, 

MD 20993, 301–796–8930. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. Rationale for the Rulemaking 

B. The Proposed Rule 

C. The Final Rule 

II. Comments on the Proposed Rule 

A. General 

B. What is the scope of this subpart? (§ 4.1) 

C. How does FDA define key terms and 

phrases in this subpart? (§ 4.2) 

D. What current good manufacturing 

practice requirements apply to my 

combination product? (§ 4.3) 

E. How can I comply with these current 

good manufacturing practice 

requirements for a co-packaged or singleentity combination product? (§ 4.4) 

E.1. How To Comply With QS Regulation 

Requirements Under § 4.4(b)(1) 

E.2. How To Comply With Drug CGMP 

Requirements Under § 4.4(b)(2) 

E.3. How To Comply With Biological 

Product and HCT/P Requirements Under 

§ 4.4(b)(3) 

F. Enforcement and Effective Date 

G. Alternate Approaches 

H. Guidance 

I. Other 

III. Legal Authority 

IV. Analysis of Economic Impacts 

A. Introduction 

B. Rationale for Final Rule 

C. Response to Comments 

D. Impact of Final Rule 

V. Environmental Impact 

VI. Paperwork Reduction Act of 1995 

VII. Executive Order 13132: Federalism 

I. Background 

A. Rationale for the Rulemaking 

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

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.1 Under § 3.2(e), a 

combination product includes: 

1. A product comprised of two or 

more regulated components, i.e., drug/ 

device, biologic/device, drug/biologic, 

or drug/device/biologic, that are 

physically, chemically, or otherwise 

combined or mixed and produced as a 

single entity (single-entity combination 

products); 

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 (co-packaged combination 

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 (a type of cross-labeled 

combination product); or 

4. Any investigational drug, device, or 

biological product packaged separately 

that according to its proposed labeling 

is for use only with another individually 

specified investigational drug, device, or 

biological product where both are 

required to achieve the intended use, 

indication, or effect (another type of 

cross-labeled combination product). 

The constituent parts of a 

combination product retain their 

regulatory status (as a drug or device, for 

example) after they are combined. 

Accordingly, the CGMP requirements 

that apply to each of the constituent 

parts continue to apply when they are 

combined to make combination 

products.2 To date, however, the 

Agency has not issued specific 

regulations clarifying the applicability 

of the CGMP requirements to 

combination products. While CGMP 

regulations are in place that establish 

requirements for drugs, devices, and 

biological products, there are currently 

no regulations that clarify and explain 

the application of these CGMP 

requirements when these drugs, devices, 

and biological products are constituent 

parts of a combination product. FDA 

believes that the absence of clear CGMP 

requirements for combination products 

could result in inconsistent or differing 

application of the various CGMP 

requirements applicable to the 

constituent parts, which could affect 

product safety and the public health. In 

addition, the absence of clear 

requirements could lead some 

manufacturers to develop and document 

manufacturing practices that are 

redundant and overly burdensome. 

In the Federal Register of October 4, 

2004 (69 FR 59239), the Agency 

announced the availability of a Draft 

Guidance for Industry and FDA entitled 

‘‘Current Good Manufacturing Practices 

for Combination Products.’’ The Agency 

received 15 comments, which were 

largely supportive of the regulatory 

approach described in the draft 

guidance. A common theme that 

emerged from these comments was the 

need to develop a clear regulatory 

framework that takes account of the fact 

that combination products are made up 

of drug, device, and biological product 

constituent parts. At the same time, 

commenters wanted to ensure that the 

framework would not lead to 

unnecessary redundancy in the 

operating systems used to meet CGMP 


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