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Rules and Regulations Federal Register

Vol. 73, No. 27

Friday, February 8, 2008

This section of the FEDERAL REGISTER Virginia 22102–5090, (703) 883–4020, Independence Avenue, SW.,
contains regulatory documents having general TTY (703) 883–4020. Washington, DC 20591;
applicability and legal effect, most of which 2. The FAA Regional Office of the
Authority: (12 U.S.C. 2252(a)(9) and (10)).
are keyed to and codified in the Code of region in which the affected airport is
Federal Regulations, which is published under Dated: January 31, 2008. located;
50 titles pursuant to 44 U.S.C. 1510. Roland E. Smith, 3. The National Flight Procedures
The Code of Federal Regulations is sold by
Secretary, Farm Credit Administration Board. Office, 6500 South MacArthur Blvd.,
the Superintendent of Documents. Prices of [FR Doc. E8–2381 Filed 2–7–08; 8:45 am] Oklahoma City, OK 73169 or,
new books are listed in the first FEDERAL BILLING CODE 6705–01–P 4. The National Archives and Records
REGISTER issue of each week. Administration (NARA). For
information on the availability of this
DEPARTMENT OF TRANSPORTATION material at NARA, call 202–741–6030,
Federal Aviation Administration federal_register/
12 CFR Part 630 code_of_federal_regulations/
RIN 3052–AC40 14 CFR Part 97 ibr_locations.html.
Availability—All SIAPs and Takeoff
[Docket No. 30591; Amdt. No. 3254] Minimums and ODPs are available
Disclosure to Investors in System-
Wide and Consolidated Bank Debt Standard Instrument Approach online free of charge. Visit
Obligations of the Farm Credit System; Procedures, and Takeoff Minimums to register. Additionally, individual
Effective Date and Obstacle Departure Procedures; SIAP and Takeoff Minimums and ODP
Miscellaneous Amendments copies may be obtained from:
AGENCY: Farm Credit Administration. 1. FAA Public Inquiry Center (APA–
ACTION: Notice of effective date. AGENCY: Federal Aviation 200), FAA Headquarters Building, 800
Administration (FAA), DOT. Independence Avenue, SW.,
SUMMARY: The Farm Credit Washington, DC 20591; or
ACTION: Final rule.
Administration (FCA or Agency), 2. The FAA regional Office of the
through the FCA Board (Board), issued SUMMARY: This Rule establishes, region in which the affected airport is
a direct final rule with opportunity for amends, suspends, or revokes Standard located.
comment under part 630 on November Instrument Approach Procedures FOR FURTHER INFORMATION CONTACT:
15, 2007 (72 FR 64129) amending our (SIAPs) and associated Takeoff Harry. J. Hodges, Flight Procedure
regulation on the external auditor’s Minimums and Obstacle Departure Standards Branch (AFS–420), Flight
assessment of internal control over Procedures for operations at certain Technologies and Programs Division,
financial reporting concerning the airports. These regulatory actions are Flight Standards Service, Federal
System-wide annual report to investors. needed because of the adoption of new Aviation Administration, Mike
The opportunity for comment expired or revised criteria, or because of changes Monroney Aeronautical Center, 6500
on December 17, 2007. The FCA occurring in the National Airspace South MacArthur Blvd., Oklahoma City,
received no comments and therefore, System, such as the commissioning of OK 73169 (Mail Address: P.O. Box
the direct final rule becomes effective new navigational facilities, adding new 25082 Oklahoma City, OK 73125)
without change. In accordance with 12 obstacles, or changing air traffic telephone: (405) 954–4164.
U.S.C. 2252, the effective date of the requirements. These changes are
final rule is 30 days from the date of SUPPLEMENTARY INFORMATION: This rule
designed to provide safe and efficient
publication in the Federal Register amends Title 14 of the Code of Federal
use of the navigable airspace and to
during which either or both Houses of Regulations, Part 97 (14 CFR part 97), by
promote safe flight operations under
Congress are in session. Based on the establishing, amending, suspending, or
instrument flight rules at the affected
records of the sessions of Congress, the revoking SIAPs, Takeoff Minimums
effective date of the regulations is and/or ODPs. The complete regulatory
DATES: This rule is effective February 8, description of each SIAP and its
January 31, 2008.
2008. The compliance date for each associated Takeoff Minimums or ODP
DATES: Effective Date: The regulation SIAP, associated Takeoff Minimums, for an identified airport is listed on FAA
amending 12 CFR part 630 published on and ODP is specified in the amendatory form documents which are incorporated
November 15, 2007 (72 FR 64129) is provisions. by reference in this amendment under 5
effective January 31, 2008. The incorporation by reference of U.S.C. 552(a), 1 CFR part 51, and 14
FOR FURTHER INFORMATION CONTACT: certain publications listed in the CFR part 97.20. The applicable FAA
Wade Wynn, Policy Analyst, Office of regulations is approved by the Director Forms are FAA Forms 8260–3, 8260–4,
Regulatory Policy, Farm Credit of the Federal Register as of February 8, 8260–5, 8260–15A, and 8260–15B when
Administration, McLean, Virginia 2008. required by an entry on 8260–15A.
22102–5090, (703) 883–4414, TTY ADDRESSES: Availability of matters The large number of SIAPs, Takeoff
(703) 883–4434 incorporated by reference in the Minimums and ODPs, in addition to
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or amendment is as follows: their complex nature and the need for

Laura McFarland, Senior Attorney, For Examination— a special format make publication in the
Office of General Counsel, Farm 1. FAA Rules Docket, FAA Federal Register expensive and
Credit Administration, McLean, Headquarters Building, 800 impractical. Furthermore, airmen do not

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7462 Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Rules and Regulations

use the regulatory text of the SIAPs, ‘‘significant rule’’ under DOT Dothan, AL, Dothan Regional, RNAV (GPS)
Takeoff Minimums or ODPs, but instead Regulatory Policies and Procedures (44 RWY 32, Orig
refer to their depiction on charts printed FR 11034; February 26, 1979); and (3) Dothan, AL, Dothan Regional, VOR OR
TACAN–A, Amdt 12
by publishers of aeronautical materials. does not warrant preparation of a
Dothan, AL, Dothan Regional, Takeoff
Thus, the advantages of incorporation regulatory evaluation as the anticipated Minimums and Obstacle DP, Orig
by reference are realized and impact is so minimal. For the same Evergreen, AL, Middleton Field, RNAV (GPS)
publication of the complete description reason, the FAA certifies that this RWY 1, Orig
of each SIAP, Takeoff Minimums and amendment will not have a significant Evergreen, AL, Middleton Field, RNAV (GPS)
ODP listed on FAA forms is economic impact on a substantial RWY 10, Orig
unnecessary. This amendment provides number of small entities under the Evergreen, AL, Middleton Field, RNAV (GPS)
the affected CFR sections and specifies criteria of the Regulatory Flexibility Act. RWY 19, Orig
the types of SIAPs and the effective Evergreen, AL, Middleton Field, RNAV (GPS)
List of Subjects in 14 CFR Part 97 RWY 28, Orig
dates of the SIAPs, the associated
Air Traffic Control, Airports, Evergreen, AL, Middleton Field, VOR/DME
Takeoff Minimums, and ODPs. This RWY 10, Amdt 3
amendment also identifies the airport Incorporation by reference, and
Evergreen, AL, Middleton Field, Takeoff
and its location, the procedure, and the Navigation (Air). Minimums and Obstacle DP, Amdt 1
amendment number. Issued in Washington, DC, on January 25, Anaktuvuk Pass, AK, Anaktuvuk Pass, RNAV
2008. (GPS)–A, Orig
The Rule Anaktuvuk Pass, AK, Anaktuvuk Pass, NDB–
James J. Ballough,
This amendment to 14 CFR part 97 is Director, Flight Standards Service.
B, Amdt 1
effective upon publication of each Anaktuvuk Pass, AK, Anaktuvuk Pass, GPS–
separate SIAP, Takeoff Minimums and Adoption of the Amendment A, Orig, CANCELLED
ODP as contained in the transmittal. Anaktuvuk Pass, AK, Anaktuvuk Pass,
■ Accordingly, pursuant to the authority Takeoff Minimums and Obstacle DP, Amdt
Some SIAP and Takeoff Minimums and delegated to me, under Title 14, Code of 1
textual ODP amendments may have Federal Regulations, Part 97 (14 CFR Galena, AK, Edward G. Pitka, Sr. ILS OR
been issued previously by the FAA in a part 97) is amended by establishing, LOC/DME RWY 25, Amdt 1A
Flight Data Center (FDC) Notice to amending, suspending, or revoking St Mary’s, AK, St. Marys, RNAV (GPS) Y
Airmen (NOTAM) as an emergency Standard Instrument Approach RWY 17, Amdt 2
action of immediate flight safety relating Procedures and/or Takeoff Minimums St Mary’s, AK, St. Marys, RNAV (GPS) Y
directly to published aeronautical and/or Obstacle Departure Procedures
RWY 35, Amdt 1
charts. The circumstances which St Mary’s, AK, St. Marys, RNAV (GPS) Z
effective at 0901 UTC on the dates RWY 17, Orig
created the need for some SIAP and
specified, as follows: St Mary’s, AK, St. Marys, RNAV (GPS) Z
Takeoff Minimums and ODP
RWY 35, Orig
amendments may require making them PART 97—STANDARD INSTRUMENT St Mary’s, AK, St. Marys, LOC/DME RWY 17,
effective in less than 30 days. For the APPROACH PROCEDURES Amdt 4
remaining SIAPs and Takeoff St Mary’s, AK, St. Marys, NDB RWY 35,
Minimums and ODPs, an effective date ■ 1. The authority citation for part 97 Amdt 1
at least 30 days after publication is continues to read as follows: Oroville, CA, Oroville Muni, NDB RWY 1,
provided. Authority: 49 U.S.C. 106(g), 40103, 40106, Amdt 3, CANCELLED
Further, the SIAPs and Takeoff 40113, 40114, 40120, 44502, 44514, 44701, Petaluma, CA, Petaluma Muni, VOR RWY 29,
Minimums and ODPs contained in this 44719, 44721–44722. Orig, CANCELLED
amendment are based on the criteria Red Bluff, CA, Red Bluff Muni, NDB RWY
■ 2. Part 97 is amended to read as 33, Amdt 2A, CANCELLED
contained in the U.S. Standard for follows:
Terminal Instrument Procedures Middletown, DE, Summit, VOR OR GPS–B
Effective 13 MAR 2008 Amdt 1B, CANCELLED
(TERPS). In developing these SIAPs and Preston, MN, Fillmore County, RNAV (GPS)
Takeoff Minimums and ODPs, the Ontario, CA, Ontario Intl, ILS OR LOC RWY RWY 29, Orig.
TERPS criteria were applied to the 8L, Amdt 8A Preston, MN, Fillmore County, (GPS) RWY
conditions existing or anticipated at the Fairmont, MN, Fairmont Muni, ILS OR LOC 29, Orig, CANCELLED
affected airports. Because of the close RWY 31, Orig-C Newport, OR, Newport Muni, ILS OR LOC
Las Cruces, NM, Las Cruces Intl, ILS OR LOC RWY 16, Amdt 1B
and immediate relationship between RWY 30, Amdt 2A
these SIAPs, Takeoff Minimums and North Bend, OR, Southwest Oregon Regional,
Hobart, OK, Hobart Muni, RNAV (GPS) RWY
ODPs, and safety in air commerce, I find ILS OR LOC RWY 4, Amdt 6B
17, Amdt 1
that notice and public procedure before Myrtle Beach, SC, Myrtle Beach Intl, RADAR
Hobart, OK, Hobart Muni, RNAV (GPS) RWY
adopting these SIAPs, Takeoff 35, Amdt 1
Rock Hill, SC, Rock Hill/York Co/Bryant
Minimums and ODPs are impracticable Hobart, OK, Hobart Muni, VOR RWY 35,
Amdt 9 Field, ILS OR LOC RWY 2, Amdt 1
and contrary to the public interest and, Rock Hill, SC, Rock Hill/York Co/Bryant
Hobart, OK, Hobart Muni, Takeoff Minimums
where applicable, that good cause exists and Obstacle DP, Amdt 1 Field, RNAV (GPS) RWY 2, Orig
for making some SIAPs effective in less Blacksburg, VA, Virginia Tech/Montgomery Rock Hill, SC, Rock Hill/York Co/Bryant
than 30 days. Executive, Takeoff Minimums and Field, RNAV (GPS) RWY 20, Orig
Obstacle DP, Amdt 4 Rock Hill, SC, Rock Hill/York Co/Bryant
Conclusion Field, GPS RWY 2, Orig-C, CANCELLED
Roanoke, VA, Roanoke Regional/Woodrum
The FAA has determined that this Field, VOR/DME–A, Amdt 6 Rock Hill, SC, Rock Hill/York Co/Bryant
regulation only involves an established Seattle, WA, Boeing Field/King County Intl, Field, GPS RWY 20, Orig-C, CANCELLED
body of technical regulations for which RNAV (RNP) Z RWY 13R, Orig-A Rock Hill, SC, Rock Hill/York Co/Bryant
Field, VOR OR GPS–A, Amdt 9C,
frequent and routine amendments are
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Effective 10 APR 2008 CANCELLED

necessary to keep them operationally Dothan, AL, Dothan Regional, ILS OR LOC Ogden, UT, Ogden-Hinckley, Takeoff
current. It, therefore—(1) is not a RWY 32, Amdt 8 Minimums and Obstacle DP, Amdt 2
‘‘significant regulatory action’’ under Dothan, AL, Dothan Regional, RNAV (GPS) Newport, VT, Newport State, NDB–A, Amdt
Executive Order 12866; (2) is not a RWY 14, Amdt 1 3, CANCELLED

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Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Rules and Regulations 7463

Riverton, WY, Riverton Regional, ILS OR revising, or updating specific FDA agrees with the comment and
LOC RWY 28, Amdt 1B regulations applicable to blood, blood therefore, is revising the regulation to
Martinsburg, WV, Eastern WV Regional/ components and Source Plasma to be use ‘‘toward’’ rather than ‘‘at’’.
Shepherd, LOC/DME BC RWY 8, Amdt 6, more consistent with current practices One comment requested that under 21
CANCELLED CFR 640.24(d) the pH be revised from
in the blood industry and to remove
The FAA published an Amendment in unnecessary or outdated requirements. ‘‘not less than 6.0’’ to ‘‘not less than 6.2’’
Docket No. 30587, Amdt No. 3251 to Part 97 to be consistent with the change in 21
of the Federal Aviation Regulations (Vol. 73,
In addition, FDA is making technical
FR No. 16, Page 4073 dated Thursday, amendments to the biologics regulations CFR 640.25(b)(2) (§ 640.25(b)(2)) and
January 24, 2008) under section 97.29 in response to comments received on with industry practice.
effective March 13, 2008, which is hereby the direct final rule. Because both of these provisions refer
corrected to read as follows: to the same pH requirement, FDA agrees
DATES: The effective date for the and is revising 21 CFR 640.24(d) as
Waterville, ME, ILS OR LOC RWY 5, Amdt regulation is confirmed as February 19,
2B requested.
2008. The effective date of the technical One comment agreed with the change
The FAA published an Amendment in amendment is also February 19, 2008.
Docket No. 30587, Amdt No. 3251 to Part 97 in pH under § 640.25(b)(2) but stated
of the Federal Aviation Regulations (Vol. 73, FOR FURTHER INFORMATION CONTACT: that there was no mention of the
FR No. 16, Page 4073 dated Thursday, Stephen Ripley, Center for Biologics number of units that must meet this
January 24, 2008) under section 97.29 Evaluation and Research (HFM–17), requirement and therefore the
effective April 10, 2008, which is hereby Food and Drug Administration, 1401 assumption is that 100 percent of the
rescinded: units must meet the requirement which
Rockville Pike, suite 200N, Rockville,
Burlington, VT, Burlington Intl, ILS OR LOC/ MD 20852–1448, 301–827–6210. they believe is unachievable.
DME RWY 33, Amdt 1 We believe that the four units we
The FAA published an Amendment in SUPPLEMENTARY INFORMATION: In the require to be tested for quality control
Docket No. 30587, Amdt No. 3251 to Part 97 Federal Register of August 16, 2007 (72 purposes under § 640.25(b) must meet
of the Federal Aviation Regulations (Vol. 73, FR 45883), FDA solicited comments the criteria listed under this regulation.
FR No. 16, Page 4073 dated Thursday, concerning the direct final rule for a 75- However, FDA recently issued a
January 24, 2008) under section 97.29 day period ending October 30, 2007. document entitled ‘‘Guidance for
effective February 14, 2008, which is hereby FDA stated that the effective date of the Industry and FDA Review Staff:
corrected to read as follows:
direct final rule would be on February Collection of Platelets by Automated
Omaha, NE, Epply Airfield, ILS OR LOC 19, 2008, 6 months after the end of the Methods,’’ dated December 2007
RWY 32L, Amdt 1
comment period, unless any significant (December 17, 2007; 72 FR 71418). In
Omaha, NE, Epply Airfield, ILS OR LOC/
DME RWY 14L, Amdt 1 adverse comment was submitted to FDA this guidance, we provide
Omaha, NE, Epply Airfield, ILS OR LOC/ during the comment period. FDA recommendations on quality control
DME RWY 14R, ILS RWY 14R (CAT II), ILS received several letters of comment on monitoring. Therefore, no additional
RWY 14R (CAT III), Amdt 4 the direct final rule; however, FDA did changes are warranted.
Omaha, NE, Epply Airfield, RNAV (GPS) not receive any significant adverse Two comments requested that FDA
RWY 14L, Amdt 1 comments. Therefore, FDA is revise the definition under 21 CFR
Omaha, NE, Epply Airfield, Takeoff confirming the effective date of the 640.30(a) to include ‘‘for intravenous or
Minimums and Obstacle DP, Amdt 5 direct final rule and making two further manufacturing use’’ to facilitate
[FR Doc. 08–535 Filed 2–7–08; 8:45 am] technical amendments in response to use of plasma for further manufacturing
BILLING CODE 4910–13–M comments received. Comments were use that has been collected concurrently
received from private industry, an with the collection of another blood
individual, organizations representing component by apheresis. In addition,
DEPARTMENT OF HEALTH AND the blood industry, and an employee of the comments requested that 21 CFR
HUMAN SERVICES the Food and Drug Administration. The 640.34 and other provisions in the
comments received and FDA’s regulations be revised and harmonized
Food and Drug Administration responses to the comments are to allow interchangeability of the
discussed below as follows: plasma from intravenous use to
21 CFR Parts 606, 607, 610, and 640 Two comments stated that under manufacturing use after blood
paragraph (c) of 21 CFR 610.53, there collection.
[Docket No. FDA–2008–N–0067] FDA presently has this issue under
was an error in a temperature listed in
the table under Red Blood Cells consideration and may address this in
Revisions to the Requirements
Deglycerolized and Red Blood Cells future rulemaking, if warranted. This
Applicable to Blood, Blood
Frozen. comment is beyond the scope of this
Components and Source Plasma;
Confirmation of Effective Date and FDA agrees. In the Federal Register of One comment requested that FDA
Technical Amendment September 24, 2007 (72 FR 54208), FDA provide the rationale for the revision to
AGENCY: Food and Drug Administration, issued a notice to correct a 21 CFR 640.34(b) requiring fresh frozen
HHS. typographical error in the codified plasma collected by an apheresis
section of the direct final rule. The table procedure to be prepared from blood
ACTION: Direct final rule; confirmation of in paragraph (c) of section 610.53 was
effective date and technical amendment. collected by single uninterrupted
corrected by replacing 65°C with -65°C. venipuncture, and why it was
SUMMARY: The Food and Drug One comment requested clarification differentiated from other components
Administration (FDA) is confirming the of the proposed change in wording from collected by apheresis. The comment
effective date of February 19, 2008, for ‘‘toward’’ to ‘‘at’’ concerning the also questioned whether the current
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the direct final rule that appeared in the specified temperature range under 21 practice of using a sterile connecting
Federal Register of August 16, 2007 (72 CFR 640.4(h) because coolers do not device to attach a sterile needle in the
FR 45883). The direct final rule amends have the capacity to maintain a event of blood flow interruption would
the biologics regulations by removing, temperature range between 1 and 10°C. be prohibited in the future.

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