5694 Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Rules and Regulations 

List of Subjects in 14 CFR Part 97 

Air Traffic Control, Airports, 

Incorporation by reference, and 

Navigation (air). 

Issued in Washington, DC, on January 20, 

2012. 

John M. Allen, 

Director, Flight Standards Service. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me, Title 14, 

Code of Federal Regulations, part 97 (14 

CFR part 97) is amended by 

establishing, amending, suspending, or 

revoking Standard Instrument Approach 

Procedures and/or Takeoff Minimums 

and/or Obstacle Departure Procedures 

effective at 0902 UTC on the dates 

specified, as follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40113, 40114, 40120, 44502, 44514, 44701, 

44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

Effective 9 FEB 2012 

Wilmington, DE, New Castle, VOR RWY 9, 

Amdt 7 

Houston, TX, Ellington Field, TACAN RWY 

4, Orig 

Houston, TX, Ellington Field, TACAN RWY 

35L, Orig 

Effective 8 MAR 2012 

Wilmington, DE, New Castle, ILS OR LOC 

RWY 1, Amdt 23A 

New Castle, IN, New Castle-Henry Co Muni, 

Takeoff Minimums and Obstacle DP, Orig 

Terre Haute, IN, Sky King, Takeoff 

Minimums and Obstacle DP, Amdt 3 

Lewiston, ME, Auburn/Lewiston Muni, ILS 

OR LOC RWY 4, Amdt 10C 

Brunswick, ME, Brunswick Executive, RNAV 

(GPS) RWY 1R, Amdt 1 

Brunswick, ME, Brunswick Executive, RNAV 

(GPS) RWY 19L, Amdt 1 

Sault Ste Marie, MI, Chippewa County Intl, 

ILS OR LOC RWY 16, Amdt 8A 

Pine River, MN, Pine River Rgnl, Takeoff 

Minimums and Obstacle DP, Orig 

Omaha, NE, Eppley Airfield, ILS OR LOC 

RWY 36, Orig-A 

Wilmington, OH, Clinton Field, VOR–A, 

Amdt 2, CANCELLED 

Erie, PA, Erie Intl/Tom Ridge Field, ILS OR 

LOC RWY 6, Amdt 16B 

Greer, SC, Greenville Spartanburg Intl, ILS 

OR LOC/DME RWY 4, ILS RWY 4 (SA CAT 

I), ILS RWY 4 (CAT II), ILS RWY 4 (CAT 

III), Amdt 23A 

Sioux Falls, SD, Joe Foss Field, ILS OR LOC 

RWY 21, Amdt 10A 

Memphis, TN, General Dewitt Spain, Takeoff 

Minimums and Obstacle DP, Amdt 4 

Racine, WI, John H Batten, ILS OR LOC RWY 

4, Amdt 4C 

Racine, WI, John H Batten, RNAV (GPS) RWY 

22, Orig-A 

Effective 5 APR 2012 

Jacksonville, FL, Jacksonville Intl, RNAV 

(GPS) RWY 32, Amdt 2A 

Titusville, FL, NASA Shuttle Landing 

Facility, TACAN RWY 15, Orig, 

CANCELLED 

Titusville, FL, NASA Shuttle Landing 

Facility, TACAN RWY 33, Orig, 

CANCELLED 

Dublin, GA, W H ‘BUD’ Barron, ILS OR LOC 

RWY 2, Amdt 2A 

Concordia, KS, Blosser Muni, GPS RWY 17, 

Orig-B, CANCELLED 

Concordia, KS, Blosser Muni, GPS RWY 35, 

Orig-A, CANCELLED 

Concordia, KS, Blosser Muni, RNAV (GPS) 

RWY 17, Orig 

Concordia, KS, Blosser Muni, RNAV (GPS) 

RWY 35, Orig 

Crisfield, MD, Crisfield Muni, RNAV (GPS) 

RWY 32, Orig, CANCELLED 

Crisfield, MD, Crisfield Muni, RNAV (GPS)- 

B, Orig 

Rocky Mount, NC, Rocky Mount-Wilson 

Rgnl, Takeoff Minimums and Obstacle DP, 

Amdt 2 

Florence, SC, Florence Rgnl, RNAV (GPS) 

RWY 9, Orig-B 

Greenville, TN, Greenville-Greene Co Muni, 

LOC RWY 5, Amdt 4, CANCELLED 

RESCINDED: On January 9, 2012 (77 FR 

1015), the FAA published an Amendment in 

Docket No. 30819, Amdt No. 3458 to Part 97 

of the Federal Aviation Regulations under 

section 97.33. The following entries, effective 

9 February 2012, are hereby rescinded in 

their entirety: 

Pender, NE, Pender Muni, RNAV (GPS) RWY 

15, Orig 

Pender, NE, Pender Muni, RNAV (GPS) RWY 

33, Orig 

Pender, NE, Pender Muni, Takeoff 

Minimums and Obstacle DP, Orig 

[FR Doc. 2012–2247 Filed 2–3–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 30825; Amdt. No. 3463] 

Standard Instrument Approach 

Procedures, and Takeoff Minimums 

and Obstacle Departure Procedures; 

Miscellaneous Amendments 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This rule establishes, amends, 

suspends, or revokes Standard 

Instrument Approach Procedures 

(SIAPs) and associated Takeoff 

Minimums and Obstacle Departure 

Procedures for operations at certain 

airports. These regulatory actions are 

needed because of the adoption of new 

or revised criteria, or because of changes 

occurring in the National Airspace 

System, such as the commissioning of 

new navigational facilities, adding new 

obstacles, or changing air traffic 

requirements. These changes are 

designed to provide safe and efficient 

use of the navigable airspace and to 

promote safe flight operations under 

instrument flight rules at the affected 

airports. 

DATES: This rule is effective February 6, 

2012. The compliance date for each 

SIAP, associated Takeoff Minimums, 

and ODP is specified in the amendatory 

provisions. 

The incorporation by reference of 

certain publications listed in the 

regulations is approved by the Director 

of the Federal Register as of February 6, 

2012. 

ADDRESSES: Availability of matter 

incorporated by reference in the 

amendment is as follows: 

For Examination— 

1. FAA Rules Docket, FAA 

Headquarters Building, 800 

Independence Avenue SW., 

Washington, DC 20591; 

2. The FAA Regional Office of the 

region in which the affected airport is 

located; 

3. The National Flight Procedures 

Office, 6500 South MacArthur Blvd., 

Oklahoma City, OK 73169 or 

4. The National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Availability—All SIAPs are available 

online free of charge. Visit nfdc.faa.gov 

to register. Additionally, individual 

SIAP and Takeoff Minimums and ODP 

copies may be obtained from: 

1. FAA Public Inquiry Center (APA– 

200), FAA Headquarters Building, 800 

Independence Avenue SW., 

Washington, DC 20591; or 

2. The FAA Regional Office of the 

region in which the affected airport is 

located. 

FOR FURTHER INFORMATION CONTACT: 

Richard A. Dunham III, Flight Procedure 

Standards Branch (AFS–420) Flight 

Technologies and Programs Division, 

Flight Standards Service, Federal 

Aviation Administration, Mike 

Monroney Aeronautical Center, 6500 

South MacArthur Blvd., Oklahoma City, 

OK 73169 (Mail Address: P.O. Box 

25082, Oklahoma City, OK 73125) 

telephone: (405) 954–4164. 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Rules and Regulations 5695 

SUPPLEMENTARY INFORMATION: This rule 

amends Title 14, Code of Federal 

Regulations, Part 97 (14 CFR part 97) by 

amending the referenced SIAPs. The 

complete regulatory description of each 

SIAP is listed on the appropriate FAA 

Form 8260, as modified by the National 

Flight Data Center (FDC)/Permanent 

Notice to Airmen (P–NOTAM), and is 

incorporated by reference in the 

amendment under 5 U.S.C. 552(a), 1 

CFR part 51, and § 97.20 of Title 14 of 

the Code of Federal Regulations. 

The large number of SIAPs, their 

complex nature, and the need for a 

special format make their verbatim 

publication in the Federal Register 

expensive and impractical. Further, 

airmen do not use the regulatory text of 

the SIAPs, but refer to their graphic 

depiction on charts printed by 

publishers of aeronautical materials. 

Thus, the advantages of incorporation 

by reference are realized and 

publication of the complete description 

of each SIAP contained in FAA form 

documents is unnecessary. This 

amendment provides the affected CFR 

sections and specifies the types of SIAP 

and the corresponding effective dates. 

This amendment also identifies the 

airport and its location, the procedure 

and the amendment number. 

The Rule 

This amendment to 14 CFR part 97 is 

effective upon publication of each 

separate SIAP as amended in the 

transmittal. For safety and timeliness of 

change considerations, this amendment 

incorporates only specific changes 

contained for each SIAP as modified by 

FDC/P–NOTAMs. 

The SIAPs, as modified by FDC 

P–NOTAM, and contained in this 

amendment are based on the criteria 

contained in the U.S. Standard for 

Terminal Instrument Procedures 

(TERPS). In developing these changes to 

SIAPs, the TERPS criteria were applied 

only to specific conditions existing at 

the affected airports. All SIAP 

amendments in this rule have been 

previously issued by the FAA in a FDC 

NOTAM as an emergency action of 

immediate flight safety relating directly 

to published aeronautical charts. The 

circumstances which created the need 

for all these SIAP amendments requires 

making them effective in less than 30 

days. 

Because of the close and immediate 

relationship between these SIAPs and 

safety in air commerce, I find that notice 

and public procedure before adopting 

these SIAPs are impracticable and 

contrary to the public interest and, 

where applicable, that good cause exists 

for making these SIAPs effective in less 

than 30 days. 

Conclusion 

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. 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. For the same reason, the 

FAA certifies that this amendment 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 97 

Air Traffic Control, Airports, 

Incorporation by reference, and 

Navigation (air). 

Issued in Washington, DC, on January 20, 

2012. 

John M. Allen, 

Director, Flight Standards Service. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me, Title 14, 

Code of Federal regulations, Part 97, 14 

CFR part 97, is amended by amending 

Standard Instrument Approach 

Procedures, effective at 0901 UTC on 

the dates specified, as follows: 

97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40113, 40114, 40120, 44502, 44514, 44701, 

44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

By amending: § 97.23 VOR, VOR/ 

DME, VOR or TACAN, and VOR/DME 

or TACAN; § 97.25 LOC, LOC/DME, 

LDA, LDA/DME, SDF, SDF/DME; 

§ 97.27 NDB, NDB/DME; § 97.29 ILS, 

ILS/DME, MLS, MLS/DME, MLS/RNAV; 

§ 97.31 RADAR SIAPs; § 97.33 RNAV 

SIAPs; and § 97.35 COPTER SIAPs, 

Identified as follows: 

* * * * * 

Effective Upon Publication 

AIRAC Date State City Airport FDC No. FDC Date Subject 

8–Mar–12 ..... AL Birmingham .............. Birmingham-Shuttlesworth Intl .. 1/3755 1/12/12 LOC RWY 18, Amdt 2 

8–Mar–12 ..... AL Birmingham .............. Birmingham-Shuttlesworth Intl .. 1/3759 1/12/12 RNAV (GPS) RWY 18, Amdt 1 

8–Mar–12 ..... CA Atwater .................... Castle ........................................ 1/4927 1/12/12 RNAV (GPS) RWY 31, Orig-B 

8–Mar–12 ..... CA Atwater .................... Castle ........................................ 1/4928 1/12/12 RNAV (GPS) RWY 13, Orig-B 

8–Mar–12 ..... NV Las Vegas ............... McCarran Intl ............................ 1/5302 1/12/12 ILS OR LOC RWY 25L, Amdt 3B 

8–Mar–12 ..... NY Syracuse .................. Syracuse Hancock Intl .............. 2/1481 1/12/12 RNAV (GPS) RWY 15, Amdt 1 

[FR Doc. 2012–2242 Filed 2–3–12; 8:45 am] 

BILLING CODE 4910–13–P 


tkelley on DSK3SPTVN1PROD with RULES
5696 Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Rules and Regulations 

1 In the Federal Register of November 18, 2008 

(73 FR 68332), FDA issued a technical amendment 

to reincorporate a regulation that was inadvertently 

revised by the interim final rule. 

2As noted in the preamble to the interim final 

rule, medical products stockpiled in the SNS may 

also include products that will ultimately be used 

in an emergency under section 564 of the FD&C Act 

(21 U.S.C. 360bbb–3). 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 201, 312, 314, 601, 610, 

801, 807, 809, 812, and 814 

[Docket No. FDA–2006–N–0364] 

Exceptions or Alternatives to Labeling 

Requirements for Products Held by the 

Strategic National Stockpile 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is adopting as a 

final rule, without change, the interim 

final rule that issued regulations 

permitting FDA Center Directors to 

grant exceptions or alternatives to 

certain regulatory labeling requirements 

applicable to human drugs, biological 

products, or medical devices that are or 

will be included in the Strategic 

National Stockpile (SNS). FDA is taking 

this action to complete the rulemaking 

initiated with the interim final rule. 

DATES: This rule is effective February 6, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

For information concerning biological 

products: 

Melissa Reisman, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, (301) 827–6210. 

For information concerning drug 

products: 

Brad G. Leissa, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

rm. 2170, Silver Spring, MD 20993, 

(301) 796–1693. 

For information concerning medical 

devices: 

Larry Spears, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 3412, 

Silver Spring, MD 20993, (301) 796– 

5517. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 

28, 2007 (72 FR 73589), FDA issued an 

interim final rule entitled ‘‘Exceptions 

or Alternatives to Labeling 

Requirements for Products Held by the 

Strategic National Stockpile’’ 

(hereinafter referred to as the interim 

final rule).1 This rule became effective 

upon the date of publication in the 

Federal Register. 

We issued the interim final rule to 

facilitate the safety, effectiveness, and 

availability of appropriate medical 

countermeasures stored in the SNS in 

the event of a public health emergency. 

We also recognized that it may be 

appropriate for certain human drugs, 

biological products, or medical devices 

(hereinafter referred to collectively as 

medical products) that are or will be 

held in the SNS to be labeled in a 

manner that would not comply with 

certain FDA labeling requirements. 

However, noncompliance with these 

labeling requirements could render such 

products misbranded under section 502 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 352). 

Under this rule, the appropriate FDA 

Center Director may grant exceptions or 

alternatives to certain regulatory 

labeling requirements applicable to 

medical products that are or will be 

included in the SNS if he or she 

determines that compliance with the 

labeling requirements could adversely 

affect the safety, effectiveness, or 

availability of specified lots, batches, or 

other units of medical products that are 

or will be included in the SNS. An 

exception or alternative granted under 

this rule may include conditions or 

safeguards deemed appropriate by the 

FDA Center Director to ensure that the 

labeling for such products includes 

information necessary for the safe and 

effective use of the product given the 

product’s anticipated circumstances of 

use. 

For example, this rule applies to 

certain medical products that enter the 

SNS as investigational products in 

addition to medical products in the SNS 

that are approved, licensed, or cleared 

for marketing.2 Labels on investigational 

products ordinarily would not contain 

all elements required on licensed, 

approved, or cleared product labels. 

Certain information, such as expiration 

dates, warnings for users, license 

numbers of manufacturers and other 

information, may not be available or 

finalized for an investigational product, 

and thus could not be included on a 

container label if the investigational 

product was added to the SNS. Prior to 

the implementation of this rule, when 

investigational products were ultimately 

approved for marketing, the products 

would have been returned to the 

manufacturer or sent to relabelers for 

relabeling, a potentially timeconsuming, costly, and labor-intensive 

process. Further, requiring relabeling of 

such investigational products after 

approval, licensure or clearance could 

adversely affect the safety, effectiveness, 

or availability of the products. This rule 

allows the appropriate FDA Center 

Director to grant an exception or 

alternative to the relevant labeling 

requirements to enable the immediate 

use of a product in the event of a public 

health emergency. 

For these reasons, as explained in the 

interim final rule and the following 

section of this document, this rule 

allows FDA Center Directors to grant 

exceptions or alternatives to certain 

labeling requirements not explicitly 

required by statute for medical products 

that are or will be included in the SNS. 

II. Comments on the Interim Final Rule 

and FDA Responses 

We received 7 comments on the 

proposed rule. These comments were 

received from hospitals, biologics 

manufacturers, law firms, other 

government agencies, and other 

interested persons. To make it easier to 

identify comments and our responses, 

the word ‘‘Comment,’’ in parentheses, 

will appear before the comment’s 

description, and the word ‘‘Response,’’ 

in parentheses, will appear before our 

response. We have also numbered each 

comment to help distinguish between 

different comments. The number 

assigned to each comment is purely for 

organizational purposes and does not 

signify the comment’s value or 

importance or the order in which it was 

received. Certain comments were 

grouped together because the subject 

matter of the comments was similar. 

(Comment 1) One comment 

applauded the efforts put forth by the 

Agency to provide industry with the 

opportunity for exceptions or 

alternatives to FDA labeling 

requirements for products held by the 

SNS. The comment also recognized the 

importance of facilitating rapid access to 

large quantities of medical products in 

the event of an act of terrorism or 

natural disaster. Another comment 

expressed general agreement with the 

interim final rule. 

(Response) We appreciate these 

comments in support of the rule. 

Congress mandated the development of 

a SNS to provide for the emergency 


tkelley on DSK3SPTVN1PROD with RULES