Federal Register / Vol. 76, No. 119 / Tuesday, June 21, 2011 / Proposed Rules 36017 

[FR Doc. 2011–15407 Filed 6–20–11; 8:45 am] 

BILLING CODE 4910–13–C 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2011–0439; Airspace 

Docket No. 11–ANM–10] 

Proposed Amendment of Class D and 

Class E Airspace and Establishment of 

Class E Airspace; Casper, WY 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This action proposes to 

amend Class D and Class E airspace at 

Casper, Natrona County International 

Airport, Casper, WY, by adjusting the 

geographic coordinates of the airport. 

This action also would establish Class E 

En Route Domestic airspace at the 

airport, to facilitate vectoring of 

Instrument Flight Rules (IFR) traffic 

from en route airspace to Casper, WY. 

The FAA is proposing this action to 

enhance the safety and management of 

aircraft operations at Casper, Natrona 

County International Airport. 

DATES: Comments must be received on 

or before August 5, 2011. 

ADDRESSES: Send comments on this 

proposal to the U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590; telephone (202) 

366–9826. You must identify FAA 

Docket No. FAA–2011–0439; Airspace 

Docket No. 11–ANM–10, at the 

beginning of your comments. You may 

also submit comments through the 

Internet at http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Eldon Taylor, Federal Aviation 

Administration, Operations Support 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1EP21JN11.025</GPH>
36018 Federal Register / Vol. 76, No. 119 / Tuesday, June 21, 2011 / Proposed Rules 

Group, Western Service Center, 1601 

Lind Avenue, SW., Renton, WA 98057; 

telephone (425) 203–4537. 

SUPPLEMENTARY INFORMATION: 

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 

2011–0439 and Airspace Docket No. 11– 

ANM–10) 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://www.regulations.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–2011–0439 and 

Airspace Docket No. 11–ANM–10’’. 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 NPRMs 

An electronic copy of this document 

may be downloaded through the 

Internet at http://www.regulations.gov. 

Recently published rulemaking 

documents can also be accessed through 

the FAA’s web page at http:// 

www.faa.gov/airports_airtraffic/ 

air_traffic/publications/ 

airspace_amendments/. 

You may review the public docket 

containing the proposal, any comments 

received, and any final disposition in 

person in the Dockets Office (see the 

ADDRESSES section for the 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 Northwest 

Mountain Regional Office of the Federal 

Aviation Administration, Air Traffic 

Organization, Western Service Center, 

Operations Support Group, 1601 Lind 

Avenue, SW., Renton, WA 98057. 

Persons interested in being placed on 

a mailing list for future NPRMs 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. 

The Proposal 

The FAA is proposing an amendment 

to Title 14 Code of Federal Regulations 

(14 CFR) part 71 by amending the Class 

D and Class E airspace areas by 

adjusting the geographic coordinates of 

Casper, Natrona County International 

Airport to be in concert with the FAA’s 

aeronautical database. Also, this action 

would establish Class E en route 

domestic airspace extending upward 

from 1,200 feet above the surface at the 

airport that would enhance the safety 

and management of IFR operations by 

vectoring IFR aircraft from en route 

airspace to the airport. 

Class E airspace designations are 

published in paragraphs 5000, 6002, 

6004, 6005 and 6006, respectively, of 

FAA Order 7400.9U, dated August 18, 

2010, and effective September 15, 2010, 

which is incorporated by reference in 14 

CFR part 71.1. The Class E airspace 

designation listed in this document will 

be published subsequently in this 

Order. 

The FAA has determined 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 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 proposed rule, when 

promulgated, would 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 creates 

additional controlled airspace at Casper, 

Natrona County International Airport, 

Casper, WY. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

Accordingly, pursuant to the 

authority delegated to me, 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 14 CFR 

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 part 71.1 of the Federal Aviation 

Administration Order 7400.9U, 

Airspace Designations and Reporting 

Points, dated August 18, 2010, and 

effective September 15, 2010 is 

amended as follows: 

Paragraph 5000 Class D airspace. 

* * * * * 

ANM WY D Casper, WY [Amended] 

Casper, Natrona County International 

Airport, WY 

(Lat. 42°54′29′′ N., long. 106°27′52′′ W.) 

That airspace extending upward from the 

surface to and including 7,800 feet MSL 

within a 4.3-mile radius of Natrona County 

International 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 6002 Class E airspace designated 

as surface areas. 

* * * * * 

ANM WY E2 Casper, WY [Amended] 

Casper, Natrona County International 

Airport, WY 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 76, No. 119 / Tuesday, June 21, 2011 / Proposed Rules 36019 

1Sterility tests are not currently required to be 

performed for Whole Blood, Cryoprecipitated 

Antihemophilic Factor (AHF), Platelets, Red Blood 

Cells, Plasma, Source Plasma, Smallpox Vaccine, 

Reagent Red Blood Cells, Anti-Human Globulin, or 

Blood Grouping Reagents; or in cases where the 

Director of the Center for Biologics Evaluation and 

Research (CBER) or the Center for Drug Evaluation 

and Research (CDER), as appropriate, determines 

that the mode of administration, method of 

Continued 

(Lat. 42°54′29′′ N., long. 106°27′52′′ W.) 

Within a 4.3-mile radius of Natrona County 

International Airport. 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. 

Paragraph 6004 Class E airspace designated 

as an extension to a Class D surface area. 

* * * * * 

ANM WY E4 Casper, WY [Amended] 

Casper, Natrona County International 

Airport, WY 

(Lat. 42°54′29′′ N., long. 106°27′52′′ W.) 

Muddy Mountain VORTAC 

(Lat. 43°05′27′′ N., long. 106°16′37′′ W.) 

Johno LOM 

(Lat. 42°54′26′′ N., long. 106°34′12′′ W.) 

That airspace extending upward from the 

surface within 4.3 miles each side of the 

Muddy Mountain VORTAC 216° radial 

extending from the VORTAC to 29 miles 

southwest of the VORTAC, and within 2.7 

miles each side of the ILS localizer west 

course extending from .9 miles east to 9 miles 

west of the Johno LOM. 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. 

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth. 

* * * * * 

ANM WY E5 Casper, WY [Amended] 

Casper, Natrona County International 

Airport, WY 

(Lat. 42°54′29′′ N., long. 106°27′52′′ W.) 

Muddy Mountain VORTAC 

(Lat. 43°05′27′′ N., long. 106°16′37′′ W.) 

Casper ASR 

(Lat. 42°55′16′′ N., long. 106°27′15′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 23.5-mile 

radius of the Casper ASR; that airspace 

extending upward from 1,200 feet above the 

surface within the 37.5-mile radius of the 

Casper ASR, and within an area extending 

from the 37.5-mile radius to the 36.6-mile 

radius of the Muddy Mountain VORTAC, 

bounded on the north by the Muddy 

Mountain VORTAC 060° radial and on the 

south by the Muddy Mountain VORTAC 111° 

radial; that airspace extending upward from 

11,500 feet MSL extending from the 37.5- 

mile radius to the 52.2-mile radius of the 

Muddy Mountain VORTAC, bounded on the 

east by the west edge of V–19 and on the 

south by the north edge of V–298. 

Paragraph 6006 En route domestic airspace 

areas. 

* * * * * 

ANM WY E6 Casper, WY [New] 

Casper, Natrona County International 

Airport, WY 

(Lat. 42°54′29′′ N., long. 106°27′52′′ W.) 

That airspace extending upward from 

1,200 feet above the surface within a 85-mile 

radius of Natrona County International 

Airport; excluding existing controlled 

airspace 7,100 feet MSL and above. 

Issued in Seattle, Washington, on June 14, 

2011. 

William Buck, 

Acting Manager, Operations Support Group, 

Western Service enter. 

[FR Doc. 2011–15393 Filed 6–20–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 600, 610, and 680 

[Docket No. FDA–2011–N–0080] 

Amendments to Sterility Test 

Requirements for Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) proposes to 

amend the sterility test requirements for 

biological products. This proposed rule 

is intended to provide manufacturers of 

biological products greater flexibility 

and to encourage use of the most 

appropriate and state-of-the-art test 

methods for assuring the safety of 

biological products. We are taking this 

action as part of our continuing effort to 

review and, as necessary, update the 

biologics regulations. 

DATES: Submit either electronic or 

written comments on this proposed rule 

by September 19, 2011. See section X of 

this document for the proposed effective 

date of any final rule that may publish 

based on this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0080, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

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 (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2011–0080 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, 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.regulations.gov 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: Paul 

E. Levine, Jr., Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Any product that purports to be 

sterile should be free of viable 

contaminating microorganisms to assure 

product safety (§ 600.3(q) (21 CFR 

600.3(q)). Absolute sterility of a lot 

cannot be practically demonstrated 

without complete destruction of every 

finished article in that lot (United States 

Pharmacopeia (USP) Chapter 1211). 

Therefore, sterility assurance is 

accomplished primarily by validation of 

the sterilization process or of the aseptic 

processing procedures under current 

good manufacturing practice (CGMP), 

and is supported by sterility testing 

using validated and verified test 

methods. (See e.g., USP Chapter 71>, 

European Pharmacopeia 2.6.2.) 

In the Federal Register of November 

20, 1973 (38 FR 32048), we reorganized 

and republished the biologics 

regulations, which included regulations 

governing sterility testing, as title 21 of 

the Code of Federal Regulations (CFR), 

subchapter F, parts 600 through 680 (21 

CFR parts 600 through 680). Section 

610.12 currently requires manufacturers 

to perform sterility tests for both bulk 

and final container material of most 

biological products 1 for the detection of 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1