59494 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 

this AD to the U.S. operators to be 

$197,120, or $320 per product. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. 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. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

This AD will not have federalism 

implications under Executive Order 

13132. This AD will 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. 

For the reasons discussed above, I 

certify that this AD: 

(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) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

You can find our regulatory 

evaluation and the estimated costs of 

compliance in the AD Docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

■ Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new AD: 

2008–21–03 Boeing: Amendment 39–15687. 

Docket No. FAA–2008–0357; Directorate 

Identifier 2008–NM–005–AD. 

Effective Date 

(a) This airworthiness directive (AD) is 

effective November 13, 2008. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to all Boeing Model 

737–300, –400, and –500 series airplanes, 

certificated in any category. 

Unsafe Condition 

(d) This AD results from a report of 

corrosion damage of the chrome runout on 

the head side found on all four midspar fuse 

pins of the nacelle strut. Additionally, a large 

portion of the chrome plate was missing from 

the corroded area of the shank. We are 

issuing this AD to detect and correct damage 

of the fuse pins of the inboard and outboard 

midspar fittings of the nacelle strut, which 

could result in reduced structural integrity of 

the fuse pins and consequent loss of the strut 

and separation of the engine from the 

airplane. 

Compliance 

(e) Comply with this AD within the 

compliance times specified, unless already 

done. 

Repetitive Inspections/Corrective Actions 

(f) At the applicable time specified in 

paragraph 1.E., ‘‘Compliance’’ of Boeing 

Special Attention Service Bulletin 737–54– 

1044, dated December 10, 2007; except, 

where the service bulletin specifies a 

compliance time after the date on the service 

bulletin, this AD requires compliance within 

the specified compliance time after the 

effective date of this AD: Do a detailed 

inspection for discrepancies of the fuse pins 

of the inboard and outboard midspar fittings 

of the nacelle strut by doing all the actions, 

including all applicable corrective actions, in 

accordance with the Accomplishment 

Instructions of the service bulletin. Do all 

applicable corrective actions before further 

flight. Repeat the inspection at the time 

specified in paragraph 1.E. of the service 

bulletin. 

Alternative Methods of Compliance 

(AMOCs) 

(g)(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, ATTN: 

Allen Rauschendorfer, Aerospace Engineer, 

Airframe Branch, ANM–120S, FAA, Seattle 

ACO, 1601 Lind Avenue, SW., Renton, 

Washington 98057–3356; telephone (425) 

917–6432; fax (425) 917–6590; has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. 

(2) To request a different method of 

compliance or a different compliance time 

for this AD, follow the procedures in 14 CFR 

39.19. Before using any approved AMOC on 

any airplane to which the AMOC applies, 

notify your appropriate principal inspector 

(PI) in the FAA Flight Standards District 

Office (FSDO), or lacking a PI, your local 

FSDO. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by an 

Authorized Representative for the Boeing 

Commercial Airplanes Delegation Option 

Authorization Organization who has been 

authorized by the Manager, Seattle ACO, to 

make those findings. For a repair method to 

be approved, the repair must meet the 

certification basis of the airplane. 

Material Incorporated by Reference 

(h) You must use Boeing Special Attention 

Service Bulletin 737–54–1044, dated 

December 10, 2007, to do the actions 

required by this AD, unless the AD specifies 

otherwise. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service information under 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, P.O. Box 3707, Seattle, 

Washington 98124–2207. 

(3) You may review copies of the service 

information incorporated by reference at the 

FAA, Transport Airplane Directorate, 1601 

Lind Avenue, SW., Renton, Washington; or at 

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. 

Issued in Renton, Washington, on 

September 29, 2008. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E8–23658 Filed 10–8–08; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 30630; Amdt. No. 3289] 

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 


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Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 59495 

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 October 9, 

2008. 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 October 9, 

2008. 

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: 

Harry J. Hodges, 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. 

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 

DOT Regulatory 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 September 

19, 2008. 

James J. Ballough, 

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: 

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: 

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, ISMLS, MLS/DME, MLS/ 

RNAV; § 97.31 RADAR SIAPs; § 97.33 

RNAV SIAPs; and § 97.35 COPTER 

SIAPs, Identified as follows: 

* * * Effective Upon Publication 


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59496 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 

FDC date State City Airport FDC 

No. Subject 

07/10/08 ...... MI ......... MANISTEE ...................... MANISTEE CO.–BLACKER ................ 8/6401 VOR RWY 27, ORIG 

09/04/08 ...... GQ ....... AGANA ............................ GUAM INTL ......................................... 8/6576 ILS OR LOC/DME RWY 6L, 

AMDT 3B 

09/05/08 ...... CO ........ DENVER ......................... ROCKY MOUNTAIN METROPOLITAN 8/6770 GPS RWY 29L, ORIG–A 

09/05/08 ...... CO ........ DENVER ......................... ROCKY MOUNTAIN METROPOLITAN 8/6771 GPS RWY 29R, ORIG–A 

09/05/08 ...... MT ........ BUTTE ............................. BERT MOONEY .................................. 8/6864 ILS Y RWY 15, AMDT 6 

09/05/08 ...... MT ........ ANACONDA .................... BOWMAN FIELD ................................. 8/6866 VOR/DME OR GPS A, AMDT 1 

09/05/08 ...... OR ........ EUGENE ......................... MAHLON SWEET FIELD .................... 8/6867 ILS OR LOC/DME RWY 16L, 

ORIG 

09/05/08 ...... AK ........ PERRYVILLE .................. PERRYVILLE ....................................... 8/6868 RNAV (GPS) RWY 2, ORIG 

09/08/08 ...... KY ........ DANVILLE ....................... STUART POWELL FIELD ................... 8/7015 LOC/DME RWY 30, AMDT 1A 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7062 RNAV (GPS) RWY 7, ORIG–B 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7064 VOR/DME OR TACAN RWY 7, 

AMDT 11B 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7065 RNAV (GPS) RWY 25, ORIG–B

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7067 ILS OR LOC RWY 25, AMDT 

21D 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7068 ILS OR LOC RWY 7, ORIG–B 

09/08/08 ...... AR ........ FORT SMITH .................. FORT SMITH RGNL ............................ 8/7069 VOR OR TACAN RWY 25, 

AMDT 20G 

09/10/08 ...... OK ........ TULSA ............................. TULSA INTL ......................................... 8/7352 ILS OR LOC RWY 18R, AMDT 7 

09/10/08 ...... CA ........ VAN NUYS ...................... VAN NUYS ........................................... 8/7460 ILS RWY 16R, AMDT 5A 

09/11/08 ...... VA ........ DUBLIN ........................... NEW RIVER VALLEY .......................... 8/7673 ILS OR LOC RWY 6, AMDT 4A 

09/12/08 ...... LA ........ LAFAYETTE .................... LAFAYETTE REGIONAL ..................... 8/7965 TAKEOFF MINIMUMS AND (OBSTACLE) DEPARTURE PROCEDURES (ODP), AMDT 1 

[FR Doc. E8–23916 Filed 10–8–08; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 203 and 205 

[Docket No. FDA–2005–N–0345] (formerly 

Docket No. 2005N–0428) 

Distribution of Certain Drug Products 

by Registered Blood Establishments 

and Comprehensive Hemophilia 

Diagnostic Treatment Centers That 

Qualify as Health Care Entities; 

Prescription Drug Marketing Act of 

1987; Prescription Drug Amendments 

of 1992; Policies, Requirements and 

Administrative Procedures 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to allow certain registered 

blood establishments and 

comprehensive hemophilia diagnostic 

treatment centers that are also health 

care entities to distribute certain drug 

products. The final rule amends limited 

provisions of the regulations 

implementing the Prescription Drug 

Marketing Act of 1987 (PDMA), as 

modified by the Prescription Drug 

Amendments of 1992 (PDA). These 

regulations, among other things, restrict 

the sale, purchase, or trade of, or the 

offer to sell, purchase, or trade, 

prescription drugs purchased by 

hospitals and other health care entities. 

DATES: This rule is effective November 

10, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Center for Biologics 

Evaluation and Research (HFM–10), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–0372. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The PDMA (Public Law 100–293) was 

enacted on April 22, 1988, and was 

modified by the PDA (Public Law 102– 

353) on August 26, 1992. The PDMA, as 

modified, amended the Federal Food, 

Drug, and Cosmetic Act (the act) to 

establish restrictions and requirements 

relating to various aspects of human 

prescription drug marketing and 

distribution. Among other things, the 

PDMA prohibited, with certain 

exceptions, the sale, purchase, or trade 

(or offer to sell, purchase, or trade) of 

any prescription drug that was 

purchased by a hospital or other health 

care entity. Section 503(c)(3)(A)(ii)(I) of 

the act (21 U.S.C. 353(c)(3)(A)(ii)(I)). 

Section 503(c)(3) also states that ‘‘[f]or 

purposes of this paragraph, the term 

‘entity’ does not include a wholesale 

distributor of drugs or a retail pharmacy 

licensed under State law * * *.’’ 

In the Federal Register of March 14, 

1994 (59 FR 11842), we issued a 

proposed rule to implement certain 

provisions of the PDMA. The proposed 

rule contained provisions on 

prescription drug reimportation; 

wholesale distribution of prescription 

drugs by unauthorized distributors; the 

resale of prescription drugs by hospitals, 

health care entities, and charitable 

institutions; and distribution of 

prescription drug samples. After 

consideration of comments, we issued a 

final rule in the Federal Register of 

December 3, 1999 (64 FR 67720) (the 

December 1999 final rule), with an 

effective date of December 4, 2000. 

After publication of the December 

1999 final rule, we received many 

comments on, and held several meetings 

to discuss the implications of, the final 

regulations for registered blood 

establishments that distribute bloodderived products and provide limited 

health care services to hospitals and 

patients. According to comments, 

implementing the December 1999 final 

rule as published would interfere with 

longstanding relationships between 

blood centers and other health care 

providers such as hospitals and 

hemophilia treatment centers. 

Section 203.20(a) (21 CFR 203.20(a)) 

of the December 1999 final rule stated, 

in relevant part, that no person may sell, 

purchase, or trade, or offer to sell, 

purchase, or trade any prescription drug 

that was purchased by a health care 

entity. ‘‘Health care entity,’’ in turn, was 

defined in § 203.3(q) (21 CFR 203.3(q)) 


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