[Federal Register: December 17, 2007 (Volume 72, Number 241)]
[Proposed Rules]
[Page 71277-71279]
[DOCID:fr17de07-19]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0270; Directorate Identifier 2007-NM-211-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 757-200, -200PF, and -
200CB Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Boeing Model 757-200, -200PF, and -200CB series airplanes.
This proposed AD would require doing an ultrasound inspection for
disbonded tear straps not mechanically fastened to the skin, and
related investigative and corrective actions, if necessary. This
proposed AD results from reports indicating that bonded skin panels may
not have been correctly anodized in phosphoric acid before the tear
strap doubler was bonded to the skin. We are proposing this AD to
detect and correct a weak bond between the skin and tear strap. Such
disbonding could reduce the ability of the skin to resist cracks and
could adversely affect the structural integrity of the airplane.

DATES: We must receive comments on this proposed AD by January 31,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

    For service information identified in this AD, contact Boeing
Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207,
for the service information identified in this proposed AD.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Jason Deutschman, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6449; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-0270;
Directorate Identifier 2007-NM-211-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports indicating that bonded skin panels may not
have been correctly anodized in phosphoric acid before the tear strap
doubler was bonded to the skin between stations 439 to 900, and 1180 to
1621, and between stringers 10 left and 10 right, on Boeing Model 757-
200, -200PF, and -200CB series airplanes. The cause of the disbonded
tear straps has been attributed to a manufacturing process error. A
weak bond between the skin and tear strap, if not corrected, could
reduce the ability of the skin to resist cracks and could adversely
affect the structural integrity of the airplane.

Relevant Service Information

    We have reviewed Boeing Special Attention Service Bulletin 757-53-
0077, Revision 1, dated August 6, 2007. The service bulletin describes
procedures for doing an ultrasound inspection for disbonded tear straps
not mechanically fastened to the skin between stations 439 to 900, and
1180 to 1621, and between stringers 10 left and 10 right, and doing
applicable related investigative and corrective actions. The related
investigative actions include doing a high frequency eddy current
inspection to detect cracks around the fasteners, and doing a low
frequency eddy current inspection to detect corrosion on the surface,
as applicable. The corrective actions include installing rivets to
repair disbonding, and contacting Boeing for crack and/or corrosion
repair, as applicable.
    The service bulletin also specifies the following compliance times
for:
     Related investigative actions: Before further flight.
     Corrective actions: Before further flight or within 3,000
flight cycles after the disbonding is found, depending on the location
of the disbond.
    Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other airplanes
of this same type design. For this reason, we are proposing this AD,
which would require accomplishing the actions specified in the service
information described previously.

Costs of Compliance

    There are about 744 airplanes of the affected design in the
worldwide fleet. This proposed AD would affect about 487 airplanes of
U.S. registry. The proposed actions would take about 16 work hours per
airplane, at an average labor rate of $80 per work hour. Based on these
figures, the estimated cost of the proposed AD for U.S. operators is
$623,360, or $1,280 per airplane.

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

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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.

Sec.  39.13  [Amended]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13

by adding the following new airworthiness directive (AD):

Boeing: Docket No. FAA-2007-0270; Directorate Identifier 2007-NM-
211-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by January
31, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 757-200, -200PF, and -200CB
series airplanes, certificated in any category; as identified in
Boeing Special Attention Service Bulletin 757-53-0077, Revision 1,
dated August 6, 2007.

Unsafe Condition

    (d) This AD results from reports indicating that bonded skin
panels may not have been correctly anodized in phosphoric acid
before the tear strap doubler was bonded to the skin. We are issuing
this AD to detect and correct a weak bond between the skin and tear
strap. Such disbonding could reduce the ability of the skin to
resist cracks and could adversely affect the structural integrity of
the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Initial Inspection

    (f) At the applicable initial compliance time in paragraph
(f)(1) or (f)(2) of this AD, do an external ultrasound inspection
for disbonded tear straps not mechanically fastened to the skin
between stations 439 to 900, and 1180 to 1621, and between stringers
10 left and 10 right, in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 757-53-
0077, Revision 1, dated August 6, 2007.
    (1) For airplanes with less than or equal to 21,000 total flight
cycles: Before the accumulation of 24,000 total flight cycles, but
no earlier than 18,000 total flight cycles.
    (2) For airplanes with more than 21,000 total flight cycles:
Within 3,000 flight cycles after the effective date of this AD.

Repetitive Inspection

    (g) If no disbonding is found during the ultrasound inspection
required by paragraph (f) of this AD, repeat the inspection once
before 36,000 total flight cycles, but no earlier than 30,000 total
flight cycles.

Related Investigative and Corrective Actions

    (h) If any disbonding is found during the ultrasound inspection
required by paragraph (f) or (g) of this AD, do the applicable
related investigative and corrective actions by accomplishing all
the actions specified in the Accomplishment Instructions of Boeing
Special Attention Service Bulletin 757-53-0077, Revision 1, dated
August 6, 2007, at the applicable compliance time specified in 1.E.,
``Compliance,'' of the service bulletin; except as provided by
paragraph (i) of this AD.
    (i) If any crack and/or corrosion is found during any inspection
required by this AD, and Boeing Special Attention Service Bulletin
757-53-0077, Revision 1, dated August 6, 2007, specifies to contact
Boeing for appropriate action: Before further flight, repair the
crack and/or corrosion using a method approved in accordance with
the procedures specified in paragraph (j) of this AD.

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with 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, and the approval must specifically refer to this
AD.

    Issued in Renton, Washington, on December 7, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E7-24383 Filed 12-14-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]
[Page 77868-77869]
[DOCID:fr19de08-193]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Random Drug and Alcohol Testing Percentage Rates of Covered
Aviation Employees for the Period of January 1, 2009, through December
31, 2009

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA has determined that the minimum random drug and
alcohol testing percentage rates for the period January 1, 2009,
through December 31, 2009, will remain at 25 percent of safety-
sensitive employees for random drug testing and 10 percent of safety-
sensitive employees for random alcohol testing.

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Stookey, Office of Aerospace
Medicine, Drug Abatement Division, Program Administration Branch (AAM-
810), Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone<PHONE_NUMBER>.
    Discussion: Pursuant to 14 CFR part 121, appendix I, section V.C,
the FAA Administrator's decision on whether to change the minimum
annual random drug testing rate is based on the reported random drug
test positive rate for the entire aviation industry. If the reported
random drug test positive rate is less than 1.00%, the Administrator
may continue the minimum random drug testing rate at 25%. In 2007, the
random drug test positive rate was 0.60%. Therefore, the minimum random
drug testing rate will remain at 25% for calendar year 2009.
    Similarly, 14 CFR part 121, appendix J, section III.C, requires the
decision on the minimum annual random alcohol testing rate to be based
on the random alcohol test violation rate. If the violation rate
remains less than 0.50%, the Administrator may continue the minimum
random alcohol testing rate at 10%. In 2007, the random alcohol test
violation rate was 0.13%. Therefore, the minimum random alcohol testing
rate will remain at 10% for calendar year 2009.

SUPPLEMENTARY INFORMATION: If you have questions about how the annual
random testing percentage rates are determined please refer to the Code
of Federal Regulations Title 14: part 121, appendix I, section V.C (for
drug testing), and appendix J, section III.C (for alcohol testing).

    Issued in Washington, DC on December 15, 2008.
James R. Fraser,
Deputy Federal Air Surgeon.
 [FR Doc. E8-30191 Filed 12-18-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 251 (Thursday, December 31, 2020)]
[Notices]
[Page 86917]
[FR Doc No: 2020-28995]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0687; FRL-10016-58-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Submission of Unreasonable Adverse Effects
Information Under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) Section 6(a)(2) (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), Submission of Unreasonable
Adverse Effects under FIFRA Section 6(a)(2) (EPA ICR Number 1204.14,
OMB Control Number 2070-0039) to the Office of Management and Budget
(OMB) for review and approval in accordance with the Paperwork
Reduction Act. This is a proposed extension of the ICR, which is
currently approved through February 28, 2021. Public comments were
previously requested via the Federal Register on August 17, 2020 during
a 60-day comment period. This notice allows for an additional 30 days
for public comments. A fuller description of the ICR is given below,
including its estimated burden and cost to the public. An agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before February 1,
2021.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OPP-2017-0687, online using www.regulations.gov, or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI), or other information whose disclosure is
restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Carolyn Siu, Mission Support Division
(7101M), Office of Program Support, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number:
(703) 347-0159; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) section 6(a)(2) requires pesticide registrants to submit
information to the Agency which may be relevant to the balancing of the
risks and benefits of a pesticide product. The statute requires the
registrant to submit any factual information that it acquires regarding
adverse effects associated with its pesticidal products, and it is up
to the Agency to determine whether or not that factual information
constitutes an unreasonable adverse effect. In order to limit the
amount of less meaningful information that might be submitted to the
Agency, the EPA has limited the scope of factual information that the
registrant must submit. The Agency's regulations at 40 CFR part 159
provide a detailed description of the reporting obligations of
registrants under FIFRA section 6(a)(2).
    Form Numbers: None.
    Respondents/affected entities: Pesticide and other agricultural
chemical manufacturing.
    Respondent's obligation to respond: Mandatory under FIFRA section
6(a)(2).
    Estimated number of respondents: 1,452 (total).
    Frequency of response: On occasion.
    Total estimated burden: 301,118 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $19,999,815 (per year), includes no
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in the total estimated
respondent burden compared with the ICR currently approved by OMB.

    Dated: December 16, 2020.
Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-28995 Filed 12-30-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48476-48477]
[FR Doc No: 2022-17055]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD21-15-000]

Joint Federal-State Task Force on Electric Transmission; Notice
Inviting Post-Meeting Comments

    On July 20, 2022, the Joint Federal-State Task Force on Electric
Transmission convened for a public meeting.
    All interested persons are invited to file post-meeting comments to
address issues raised during the meeting and identified in the Agenda
issued June 30, 2022. For reference, questions asked by the meeting
moderator are included below. Comments must be submitted on or before
30 days from the date of this Notice.
    Comments may be filed electronically via the internet.\1\
Instructions are available on the Commission's website http://
www.ferc.gov/docs-filing/

efiling.asp. For assistance, please contact FERC Online Support at
[email protected] or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. Although the Commission strongly encourages electronic
filing, documents may also be paper-filed. To paper-file, submissions
sent via the U.S. Postal Service must be addressed to: Federal Energy
Regulatory Commission, Office of the Secretary, 888 First Street NE,
Washington, DC 20426. Submissions sent via any other carrier must be
addressed to: Federal Energy Regulatory Commission, Office of the
Secretary, 12225 Wilkins Avenue, Rockville, Maryland 20852.
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    \1\ See 18 CFR 385.2001(a)(1)(iii) (2021).
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    For more information about this Notice, please contact: Gretchen
Kershaw (Legal Information), Office of the General Counsel, (202) 502-
8213, [email protected].

    Dated: August 3, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-17055 Filed 8-8-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 79 (Tuesday, April 24, 2012)]
[Rules and Regulations]
[Pages 24371-24373]
[FR Doc No: 2012-9738]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30838; Amdt. No. 3475]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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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 April 24, 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 April 24, 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:<PHONE_NUMBER>.

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
Sec.  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 April 13, 2012.
Ray Towles,
Deputy 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

0
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.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.25   [Amended]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV

SIAPs; and Sec.  97.35 COPTER SIAPs, identified as follows:

Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
       AIRAC date              State              City               Airport         FDC No.      FDC date                     Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
31-May-12...............  KS              Manhattan..........  Manhattan Rgnl....       1/9111      4/10/12  Takeoff Minimums and Obstacle DP, Amdt 7.
31-May-12...............  GA              Atlanta............  Fulton County            2/0683      4/10/12  VOR A, Orig-A.
                                                                Airport-Brown
                                                                Field.
31-May-12...............  GA              Atlanta............  Fulton County            2/0684      4/10/12  ILS OR LOC RWY 8, Amdt 16A.
                                                                Airport-Brown
                                                                Field.
31-May-12...............  GA              Atlanta............  Fulton County            2/0685      4/10/12  RNAV (GPS) RWY 26, Orig-A.
                                                                Airport-Brown
                                                                Field.
31-May-12...............  GA              Atlanta............  Fulton County            2/0686      4/10/12  RNAV (GPS) Y RWY 8, Orig-A.
                                                                Airport-Brown
                                                                Field.
31-May-12...............  NC              Charlotte..........  Charlotte/Douglas        2/0925      4/10/12  ILS OR LOC RWY 18R, ILS RWY 18R (CAT II),
                                                                Intl.                                         ILS RWY 18R (CAT III), Orig-A.
31-May-12...............  NC              Charlotte..........  Charlotte/Douglas        2/0926      4/10/12  ILS OR LOC RWY 36L, ILS RWY 36L (CAT II),
                                                                Intl.                                         ILS RWY 36L (CAT III), Orig-A.
31-May-12...............  TX              Dallas-Fort Worth..  Dallas/Fort Worth        2/1044      4/10/12  VOR RWY 31L, Orig.
                                                                Intl.
31-May-12...............  TX              Dallas-Fort Worth..  Dallas/Fort Worth        2/1048      4/10/12  VOR RWY 13R, Amdt 1.
                                                                Intl.
31-May-12...............  TN              Covington..........  Covington Muni....       2/1215      4/10/12  RNAV (GPS) RWY 1, Orig.
31-May-12...............  IN              Indianapolis.......  Indianapolis Intl.       2/7773      4/10/12  ILS OR LOC RWY 5L, ILS RWY 5L (CAT II), ILS
                                                                                RWY 5L (CAT III), Amdt 3C.
31-May-12...............  IN              Indianapolis.......  Indianapolis Intl.       2/7774      4/10/12  ILS OR LOC RWY 5R, ILS RWY 5R (CAT II), ILS
                                                                                RWY 5R (CAT III), Amdt 5B.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2012-9738 Filed 4-23-12; 8:45 am]
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[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8884-8885]
[FR Doc No: 2012-3550]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0602]

Draft Guidance for Industry on Quality Considerations in
Demonstrating Biosimilarity to a Reference Protein Product;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Quality
Considerations in Demonstrating Biosimilarity to a Reference Protein
Product.'' This draft guidance is intended to provide sponsors with an
overview of analytical factors to consider when assessing biosimilarity
between a proposed protein product and a reference product for the
purpose of submitting a marketing application through an abbreviated
licensure pathway. This draft guidance provides an overview of FDA's
approach to quality considerations in determining biosimilarity.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 16, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
Office of Communication, Outreach, and Development (HFM-40), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042, or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Quality Considerations in Demonstrating Biosimilarity to a
Reference Protein Product.'' This draft guidance is intended to provide
sponsors with an overview of analytical factors to consider when
assessing biosimilarity between a proposed protein product and a
reference product for the purpose of submitting a marketing application
through the abbreviated licensure pathway under section 351(k) of the
Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). Although the
351(k) pathway applies generally to biological products, this draft
guidance focuses on therapeutic protein products.
    The Biologics Price Competition and Innovation Act of 2009, enacted
as part of the Patient Protection and Affordable Care Act (Affordable
Care Act) (Pub. L. 111-148) on March 23, 2010, created an abbreviated
licensure pathway under section 351(k) of the PHS Act for biological
products demonstrated to be biosimilar to, or interchangeable with, a
reference product. Under this abbreviated licensure pathway, FDA will
license a proposed biological product submitted under section 351(k) of
the PHS Act if FDA ``determines that the information submitted in the
application * * * is sufficient to show that the biological product is
biosimilar to the reference product * * *'' and the 351(k) applicant
(or other appropriate person) consents to an inspection of the facility
that is the subject of the application (i.e., a facility in which the
proposed biological product is

manufactured, processed, packed, or held).\1\
---------------------------------------------------------------------------

    \1\ Section 7002(a)(2) of the Affordable Care Act, adding
section 351(k)(3) of the PHS Act (citing section 351(a)(2)(C) of the
PHS Act).
---------------------------------------------------------------------------

    All product applications should contain a complete and thorough
Chemistry, Manufacturing, and Controls (CMC) section that provides the
necessary and appropriate information (e.g., characterization,
adventitious agent safety, process controls, and specifications) for
the product to be adequately reviewed.\2\ This draft guidance describes
important factors for consideration when assessing whether therapeutic
protein products are highly similar, including:
---------------------------------------------------------------------------

    \2\ For CMC requirements for submission of a marketing
application, applicants should consult current regulations, the
Guidance for Industry for the Submission on Chemistry,
Manufacturing, and Controls Information for a Therapeutic
Recombinant DNA-Derived Product or a Monoclonal Antibody Product for
In-vivo Use (issued jointly by CBER and CDER, August 1996), and
other applicable FDA guidance documents.

 Expression System
 Manufacturing Process
 Assessment of Physiochemical Properties
 Functional Activities
 Receptor Binding and Immunochemical Properties
 Impurities
 Reference Product and Reference Standards
 Finished Drug Product
 Stability

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on quality
considerations in demonstrating biosimilarity to a reference protein
product. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. The Paperwork Reduction Act

    This draft guidance describes information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). In particular, the draft guidance refers to information
collections related to the submission of a 351(k) application. In
accordance with the PRA, FDA is soliciting public comment, in a
separate document published elsewhere in this issue of the Federal
Register (see ``Agency Information Collection Activities; Proposed
Collection; Comment Request; General Licensing Provisions; Section
351(k) Biosimilar Applications'') on the information collection
associated with the submission of a 351(k) application. FDA will also
seek OMB approval for this information collection.
    In addition, this draft guidance references other information
collections that are already approved by OMB and are not expected to
change as a result of the draft guidance. This includes information
collections related to the submission of (1) an investigational new
drug application which is covered under 21 CFR part 312 and approved
under OMB control number 0910-0014; (2) a new drug application which is
covered under 21 CFR 314.50 and approved under OMB control number 0910-
0001; and (3) a biologics license application which is covered under 21
CFR part 601 and approved under OMB control number 0910-0338.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3550 Filed 2-14-12; 8:45 am]
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