Federal Register / Vol. 76, No. 243 / Monday, December 19, 2011 / Rules and Regulations 78529 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2011–0578; Airspace 

Docket No. 11–ASO–24] 

Establishment of Class D and E 

Airspace and Amendment of Class E; 

Brooksville, FL 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action establishes Class 

D and E airspace and amends existing 

Class E airspace at Brooksville, FL, to 

accommodate a new air traffic control 

tower at Hernando County Airport This 

action enhances the safety and 

management of Instrument Flight Rules 

(IFR) operations for standard instrument 

approach procedures at the airport. This 

action also makes a minor adjustment to 

the geographic coordinates of the 

airport. 

DATES: Effective 0901 UTC, February 9, 

2012. The Director of the Federal 

Register approves this incorporation by 

reference action under title 1, Code of 

Federal Regulations, part 51, subject to 

the annual revision of FAA Order 

7400.9 and publication of conforming 

amendments 

FOR FURTHER INFORMATION CONTACT: John 

Fornito, Operations Support Group, 

Eastern Service Center, Federal Aviation 

Administration, P.O. Box 20636, 

Atlanta, Georgia 30320; telephone (404) 

305–6364. 

SUPPLEMENTARY INFORMATION: 

History 

On September 7, 2011, the FAA 

published in the Federal Register a 

notice of proposed rulemaking (NPRM) 

to establish Class D and E airspace and 

amend existing Class E airspace at 

Brooksville, FL, to accommodate a new 

air traffic control tower at Hernando 

County Airport (76 FR 55298). 

Interested parties were invited to 

participate in this rulemaking effort by 

submitting written comments on the 

proposal to the FAA. No comments 

were received. 

Class D and E airspace designations 

are published in Paragraphs 5000, 6002, 

and 6005, respectively, of FAA Order 

7400.9V dated August 9, 2011, and 

effective September 15, 2011, which is 

incorporated by reference in 14 CFR 

71.1. The Class D and E airspace 

designations listed in this document 

will be published subsequently in the 

Order. 

The Rule 

This amendment to Title 14, Code of 

Federal Regulations (14 CFR) part 71 

establishes Class D airspace extending 

upward from the surface to and 

including 1,500 feet MSL within a 5.1- 

mile radius of Hernando County 

Airport, Brooksville, FL, and Class E 

surface area airspace within a 5.1-mile 

radius of the airport. This action also 

amends Class E airspace extending 

upward from 700 feet above the surface 

within a 7.6-mile radius of the airport. 

Additional controlled airspace is 

necessary to support the new air traffic 

control tower and new standard 

instrument approach procedures 

developed for continued safety and 

management of IFR operations at 

Hernando County Airport. Also, the 

geographic coordinates of the airport are 

adjusted to be in concert with the FAAs 

aeronautical database. 

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, is non-controversial and 

unlikely to result in adverse or negative 

comments. It, therefore, (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 that 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 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. 

Under that section, the FAA is charged 

with prescribing regulations to assign 

the use of 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 

establishes and amends controlled 

airspace at Hernando County Airport, 

Brooksville, FL. 

List 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 7400.9V, Airspace 

Designations and Reporting Points, 

dated August 9, 2011, and effective 

September 15, 2011, is amended as 

follows: 

Paragraph 5000 Class D Airspace 

* * * * * 

ASO FL D Brooksville, FL [NEW] 

Hernando County Airport, FL 

(Lat. 28°28′42′′ N., long. 82°27′33′′ W.) 

That airspace extending upward from the 

surface up to and including 1,500 feet MSL 

within a 5.1-mile radius of the Hernando 

County Airport. This Class D airspace area is 

effective during 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 

* * * * * 

ASO FL E2 Brooksville, FL [NEW] 

Hernando County Airport, FL 

(Lat. 28°28′42′′ N., long. 82°27′33′′ W.) 

That airspace extending from the surface 

within a 5.1-mile radius of Hernando County 

Airport. This Class E airspace area is effective 

during 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. 

* * * * * 

ASO FL E5 Brooksville, FL [AMENDED] 

Hernando County Airport, FL 

(Lat. 28°28′42′′ N., long. 82°27′33′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 7.6-mile 

radius of Hernando County Airport. 


srobinson on DSK4SPTVN1PROD with RULES
78530 Federal Register / Vol. 76, No. 243 / Monday, December 19, 2011 / Rules and Regulations 

Issued in College Park, Georgia, on 

December 5, 2011. 

Mark D. Ward, 

Manager, Operations Support Group, Eastern 

Service Center, Air Traffic Organization. 

[FR Doc. 2011–32037 Filed 12–16–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 314 

[Docket No. FDA–2011–N–0898] 

Applications for Food and Drug 

Administration Approval To Market a 

New Drug; Revision of Postmarketing 

Reporting Requirements— 

Discontinuance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Interim final rule; request for 

comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

issuing an interim final rule amending 

its postmarketing reporting regulations 

implementing certain provisions of the 

Federal Food, Drug and Cosmetic Act. 

The provisions of the Federal Food, 

Drug and Cosmetic Act require 

manufacturers who are the sole 

manufacturers of certain drug products 

to notify FDA at least 6 months before 

discontinuance of manufacture of the 

products. This interim final rule 

modifies the term ‘‘discontinuance’’ and 

clarifies the term ‘‘sole manufacturer’’ 

with respect to notification of 

discontinuance requirements. The 

broader reporting resulting from these 

changes will enable FDA to improve its 

collection and distribution of drug 

shortage information to physician and 

patient organizations and to work with 

manufacturers and other stakeholders to 

respond to potential drug shortages. 

DATES: This interim final rule is 

effective January 18, 2012. Submit either 

electronic or written comments on the 

provisions of this interim final rule by 

February 17, 2012. Submit comments on 

the information collection requirements 

under the Paperwork Reduction Act of 

1995 by January 3, 2012 (see the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0898 by any of the following methods, 

except that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

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–N–0898 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: 

Kalah Auchincloss, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, (301) 796–0659, or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448, (301) 827– 

6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 18, 

2007 (72 FR 58993), we (FDA) issued a 

final rule to revise our postmarketing 

reporting requirements to implement 

section 506C of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 356c). 

Section 506C of the Federal Food, Drug, 

and Cosmetic Act (section 506C) 

requires manufacturers who are the sole 

manufacturers of certain drug products 

to notify us at least 6 months before 

discontinuance of manufacture of the 

products. Section 506C applies to sole 

manufacturers of products that meet the 

following three criteria: 

1. The products are life supporting, 

life sustaining, or intended for use in 

the prevention of a debilitating disease 

or condition; 

2. The products are approved under 

section 505(b) or (j) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

355(b) or (j)); and 

3. The products are not originally 

derived from human tissue and replaced 

by a recombinant product. 

These three criteria are statutory 

requirements. FDA assesses whether a 

drug is ‘‘life supporting, life sustaining, 

or intended for use in the prevention of 

a debilitating disease or condition’’ on 

a case-by-case basis, but intends to 

provide further guidance on this issue 

in the near future. 

Section 506C also requires us to 

distribute certain information about 

covered discontinuances to appropriate 

physician and patient organizations. 

Under section 506C, FDA may reduce 

the 6-month notification period if we 

find good cause exists for the reduction. 

Recent experience with drug 

shortages in the United States has 

shown the serious and immediate 

impacts they can have on patients and 

healthcare providers, particularly those 

shortages involving drugs that are 

manufactured by a small number of 

firms and for which there are no good 

therapeutic substitutes available. The 

number of drug shortages annually has 

tripled from 61 in 2005 to 178 in 2010. 

Some shortages delay or deny needed 

care for patients, because they involve 

critical drugs used to treat cancer, to 

provide required parenteral nutrition, or 

to address other serious medical 

conditions. Other shortages can result in 

providers prescribing second-line 

alternatives, which may be less effective 

and higher risk than first-line therapies. 

A survey of 1,800 health practitioners 

conducted by the Institute for Safe 

Medication Practices (ISMP) concluded 

that drug shortages could lead to 

medication errors and poor patient 

outcomes because shortages can result 

in the use of secondary alternative 

therapies (Ref. 1). 

In light of increasing concerns about 

the impact of drug shortages on health 

care in the United States, on October 31, 

2011, the President issued Executive 

Order 13588 directing the FDA to ‘‘take 

steps that will help to prevent and 

reduce current and future disruptions in 

the supply of lifesaving medicines’’ and 

noting that ‘‘one important step is 

ensuring that the FDA and the public 


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