[Federal Register: August 12, 2008 (Volume 73, Number 156)]
[Proposed Rules]
[Page 46823-46826]
[DOCID:fr12au08-15]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0858; Directorate Identifier 2008-NM-054-AD]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-8-11, DC-8-
12, DC-8-21, DC-8-31, DC-8-32, DC-8-33, DC-8-41, DC-8-42, and DC-8-43
Airplanes; Model DC-8-50 Series Airplanes; Model DC-8F-54 and DC-8F-55
Airplanes; Model DC-8-60 Series Airplanes; Model DC-8-60F Series
Airplanes; Model DC-8-70 Series Airplanes; and Model DC-8-70F Series
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
McDonnell Douglas airplanes identified above. This proposed AD would
require repetitive inspections of the lower skin and stringers at
stations Xw = 408 and Xw = -408 and corrective actions if necessary.
This proposed AD results from reports of cracks in the skins and
stringers at the end fasteners common to the stringer end fittings at
station Xw = 408 and Xw = -408 wing splice joints. We are proposing
this AD to detect and correct fatigue cracking in the skins and
stringers at the end fasteners common to the stringer end fittings at a
certain station and wing splice joints, which could result in wing
structure that might not sustain limit load, and consequent loss of
structural integrity of the wing.

DATES: We must receive comments on this proposed AD by September 26,
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, Long Beach Division, 3855 Lakewood Boulevard,
Long Beach, California 90846, Attention: Data and Service Management,
Dept. C1-L5A (D800-0024).

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: Dara Albouyeh, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; 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-2008-0858;
Directorate Identifier 2008-NM-054-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 numerous reports of cracks in the skins and
stringers at the end fasteners common to the stringer end fittings at
station Xw = 408 and Xw = -408 wing splice joints. Results of an
investigation conducted by Boeing Engineering revealed the cracks were
due to fatigue. The area where the cracks were found is identified as a
principal structural element (PSE). The earliest cracks were discovered
at 21,519 total flight cycles, and 58,935 total flight hours. The
cracks were discovered by visual inspections and findings of fuel
leaks. In addition to unscheduled maintenance for repair of the PSE,
this condition, if not corrected, could result in wing structure that
might not sustain limit load, and consequent loss of structural
integrity of the wing.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin DC8-57A102, dated
February 12, 2008. The service bulletin describes the following
procedures.

                 Described Actions and Compliance Times
------------------------------------------------------------------------
          Condition                  Action           Compliance times
------------------------------------------------------------------------
Initial inspection for all    Do initial high       Before the
 airplanes.                    frequency eddy        accumulation of
                               current (HFEC)        20,000 total flight
                               inspection of the     cycles, or within
                               lower wing skin or    1,500 flight cycles
                               stringers at the      or 2 years after
                               affected fastener     the date of the
                               hole areas--          service bulletin,
                               stations Xw = 408     whichever occurs
                               and Xw = -408,        latest.
                               stringers 51 to 64
                               (for sequence 101,
                               inspection sequence
                               1, inspection
                               method 01; or
                               sequence 103,
                               inspection sequence
                               1, inspection
                               method 03), or a
                               visual inspection
                               of any accessible
                               area along the
                               cross section of
                               the stringer in the
                               area of the
                               affected fastener
                               holes (for sequence
                               102, inspection
                               sequence 1,
                               inspection method
                               02).
Condition 1: No cracks at     Repeat the HFEC or    Intervals not to
 any of the locations--and     visual inspection,    exceed 600 flight
 prior inspection was done     as applicable.        cycles after doing
 by external skin eddy                               the external skin
 current inspection as given                         eddy current
 in sequence 103.                                    inspection.
Condition 1: No cracks at     Repeat the HFEC or    Intervals not to
 any of the locations--prior   visual inspection,    exceed 1,200 flight
 inspection was done by        as applicable.        cycles after doing
 external skin eddy current                          the external skin
 inspection as given in                              eddy current
 sequence 103--and--internal                         inspection and
 stringer inspection as                              internal stringer
 given in sequence 101 or                            inspection.
 102 is done.
Condition 2: Skin cracks      Repair crack and      Before further
 less than 3.7 inches long     repeat the            flight (repair
 in wing skin at stringer      applicable            only).
 end fittings.                 inspection
                               specified for
                               Condition 2, as
                               applicable.
Condition 2: Skin cracks      Repeat the HFEC or    Intervals not to
 less than 3.7 inches long     visual inspection,    exceed 600 flight
 in wing skin at stringer      as applicable.        cycles after doing
 end fittings-- and prior                            the external skin
 inspection was done by                              eddy current
 external skin eddy current                          inspection.
 inspection as given in
 sequence 103.
Condition 2: Skin cracks      Repeat the HFEC or    Intervals not to
 less than 3.7 inches long     visual inspection,    exceed 1,200 flight
 in wing skin at stringer      as applicable.        cycles after doing
 end fittings-- and prior                            the external skin
 inspection was done by                              eddy current
 external skin eddy current                          inspection and
 inspection as given in                              internal stringer
 sequence 103--and--internal                         inspection.
 stringer inspection as
 given in sequence 101 or
 102 is done.
Condition 3: Skin cracks      Contact Boeing for    Before further
 greater than 3.7 inches at    repair instructions.  flight.
 stringer end fittings.
Condition 4: Stringer cracks  Repair crack and      Before further
 at stringer end fittings.     repeat the            flight (repair
                               applicable            only).
                               inspection
                               specified for
                               Condition 4, as
                               applicable.
Condition 4: Stringer cracks  Repeat the HFEC or    Repeat at intervals
 at stringer end fittings--    visual inspection,    not to exceed 600
 and prior inspection was      as applicable.        flight cycles after
 done by external skin eddy                          doing the external
 current inspection as given                         skin eddy current
 in sequence 103.                                    inspection.
Condition 4: Stringer cracks  Repeat the HFEC or    Repeat at intervals
 at stringer end fittings--    visual inspection,    not to exceed 1,200
 and prior inspection was      as applicable.        flight cycles after
 done by external skin eddy                          doing the external
 current inspection as given                         skin eddy current
 in sequence 103--and--                              inspection and
 internal stringer                                   internal stringer
 inspection as given in                              inspection.
 sequence 101 or 102 is done.
Condition 5: Cracks at more   Contact Boeing for    Before further
 than two adjacent stringers.  repair instructions.  flight.
------------------------------------------------------------------------

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the(se) same type
design(s). This proposed AD would require accomplishing the actions
specified in the service information described previously, except as
discussed under ``Difference Between the Proposed AD and the Service
Bulletin.''

Difference Between the Proposed AD and the Service Bulletin

    The service bulletin specifies to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     Using a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by an Authorized Representative
for the Boeing Commercial Airplanes Delegation Option Authorization
Organization whom we have authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD would affect 87 airplanes of U.S.
registry. The following table provides the estimated costs for U.S.
operators to comply with this proposed AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                                          Average                                                  U.S.-
                  Action                    Work hours   labor rate     Parts           Cost per product         registered           Fleet cost
                                                          per hour                                               airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection...............................            6          $80           $0  $480, per inspection cycle..           87  $41,760, per inspection
                                                                                cycle.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 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 this 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.
    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, 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 FAA amends Sec.  39.13 by adding the following new AD:

McDonnell Douglas: Docket No. FAA-2008-0858; Directorate Identifier
2008-NM-054-AD.

Comments Due Date

    (a) We must receive comments by September 26, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all McDonnell Douglas Model DC-8-11, DC-
8-12, DC-8-21, DC-8-31, DC-8-32, DC-8-33, DC-8-41, DC-8-42, DC-8-43,
DC-8-51, DC-8-52, DC-8-53, DC-8-55, DC-8F-54, DC-8F-55, DC-8-61, DC-
8-62, DC-8-63, DC-8-61F, DC-8-62F, DC-8-63F, DC-8-71, DC-8-72, DC-8-
73, DC-8-71F, DC-8-72F, and DC-8-73F airplanes; certificated in any
category.

Unsafe Condition

    (d) This AD results from reports of cracks in the skins and
stringers at the end fasteners common to the stringer end fittings
at stations Xw = 408 and Xw = -408 wing splice joints. We are
issuing this AD to detect and correct fatigue cracking in the skins
and stringers at the end fasteners common to the stringer end
fittings at a certain station and wing splice joints, which could
result in wing structure that might not sustain limit load, and
consequent loss of structural integrity of the wing.

Compliance

    (e) Comply with this AD within the compliance times specified,
unless already done.

Repetitive Inspections and Corrective Actions

    (f) At the times specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin DC8-57A102, dated February 12, 2008,
except as provided by paragraph (g) of this AD: Do the applicable
inspections for fatigue cracking of the lower skin and stringers at
stations Xw = 408 and Xw = -408, and do all applicable corrective
actions, by accomplishing all applicable actions specified in the
Accomplishment Instructions of the service bulletin, except as
provided by paragraph (h) of this AD. Do all corrective actions
before further flight, in accordance with the service bulletin.
Thereafter, repeat the inspections at the applicable intervals
specified in paragraph 1.E. of the service bulletin.
    (g) Where Boeing Alert Service Bulletin DC8-57A102, dated
February 12, 2008, 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.
    (h) If any cracking is found during any inspection required by
this AD, and Boeing Alert Service Bulletin DC8-57A102, dated
February 12, 2008, specifies to contact Boeing for appropriate
action: Before further flight, repair the cracking using a method
approved in accordance with the procedures specified in paragraph
(i) of this AD.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, ATTN: Dara Albouyeh, Aerospace Engineer, Airframe
Branch, ANM-120L, 3960 Paramount Boulevard, Lakewood, California
90712-4137; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; 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, Los Angeles ACO, to make those findings. For a
repair method to be approved, the repair must meet the certification
basis of the airplane and 14 CFR 25.571, Amendment 45, and the
approval must specifically refer to this AD.
    (4) Accomplishing the requirements of this AD is an acceptable
AMOC with the requirements of paragraph (b) of AD 93-01-15,
amendment 39-8469, for those areas of principal structural element
57.08.037/038.

    Issued in Renton, Washington, on July 31, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-18560 Filed 8-11-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Rules and Regulations]
[Pages 64167-64168]
[FR Doc No: 2013-25185]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30923; Amdt. No. 3558]

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 October 28, 2013. 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 28, 2013.

ADDRESSES: Availability of matters 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 and Takeoff Minimums and ODPs are available
online free of charge. Visit http://www.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
Divisions, 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 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS.
The complete regulators description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA
Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, in addition
to their complex nature and the need for a special format make
publication in the Federal Register expensive and impractical.
Furthermore, airmen do not use the regulatory text of the SIAPs,
Takeoff Minimums or ODPs, but instead refer to their depiction on
charts printed by publishers of aeronautical materials. The advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP, Takeoff Minimums and ODP listed on
FAA forms is unnecessary. This amendment provides the affected CFR
sections and specifies the types of SIAPs and the effective dates of
the, associated Takeoff Minimums and ODPs. 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, Takeoff Minimums and ODP as contained in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP and Takeoff Minimums
and ODP amendments may require making them effective in less than 30
days. For the remaining SIAPS and Takeoff Minimums and ODPS, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPS contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPS and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedures before

adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and
contrary to the public interest and, where applicable, that good cause
exists for making some 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 September 27, 2013.
John Duncan,
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

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:

Effective 14 NOVEMBER 2013

Malvern, AR, Malvern Muni, RNAV (GPS) RWY 22, Orig-A
Daggett, CA, Barstow-Daggett, RNAV (GPS) RWY 26, Amdt 2A
Jacksonville, FL, Jacksonville Intl, RNAV (RNP) Y RWY 26, Amdt 1
Mount Sterling, KY, Mount Sterling-Montgomery County, NDB RWY 21, Amdt
2A
Ludington, MI, Mason County, RNAV (GPS) RWY 8, Orig-A
Duluth, MN, Duluth Intl, COPTER ILS OR LOC RWY 27, Amdt 2
Duluth, MN, Duluth Intl, ILS OR LOC RWY 9, ILS RWY 9 (SA CAT I), ILS
RWY 9 (CAT II), Amdt 22
Duluth, MN, Duluth Intl, ILS OR LOC RWY 27, Amdt 10
Duluth, MN, Duluth Intl, VOR/DME OR TACAN RWY 21, Amdt 15
Duluth, MN, Duluth Intl, VOR OR TACAN RWY 3, Amdt 21
Mountain View, MO, Mountain View, RNAV (GPS) RWY 10, Orig-A
Mountain View, MO, Mountain View, RNAV (GPS) RWY 28, Orig-A
Reno, NV, Reno/Tahoe Intl, RNAV (RNP) Y RWY 16L, Amdt 1
Reno, NV, Reno/Tahoe Intl, RNAV (RNP) Y RWY 16R, Amdt 1
Waverly, OH, Pike County, RNAV (GPS) RWY 7, Orig-A
Woodsfield, OH, Monroe County, RNAV (GPS) RWY 25, Orig
Woodsfield, OH, Monroe County, VOR/DME RWY 25, Amdt 7
Anderson, SC, Anderson Rgnl, RNAV (GPS) RWY 17, Amdt 1
Anderson, SC, Anderson Rgnl, RNAV (GPS) RWY 35, Amdt 1
Madison, WI, Dane County Rgnl-Truax Field, ILS OR LOC/DME RWY 18, Amdt
1C
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 14, Amdt 2B
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 18, Amdt 2B
Madison, WI, Dane County Rgnl-Truax Field, RNAV (GPS) RWY 32, Amdt 2B
Martinsburg, WV, Eastern WV Rgnl/Shepherd Fld, RNAV (GPS) RWY 8, Amdt 1
Martinsburg, WV, Eastern WV Rgnl/Shepherd Fld, VOR-A, Amdt 10

Effective 12 DECEMBER 2013

Fort Yukon, AK, Fort Yukon, DF RWY 22, Amdt 1, CANCELED
Fort Yukon, AK, Fort Yukon, RNAV (GPS) RWY 4, Amdt 1
Fort Yukon, AK, Fort Yukon, RNAV (GPS) RWY 22, Amdt 1
Fort Yukon, AK, Fort Yukon, VOR/DME OR TACAN RWY 22, Amdt 3
Fort Yukon, AK, Fort Yukon, VOR/DME OR TACAN-A, Amdt 1
Destin, FL, Destin-Fort Walton Beach, RNAV (GPS) RWY 14, Amdt 2
Carmi, IL, Carmi Muni, RNAV (GPS) RWY 36, Orig-A
Belleville, KS, Belleville Muni, NDB RWY 18, Amdt 5, CANCELED
Belleville, KS, Belleville Muni, NDB RWY 36, Amdt 5, CANCELED
Old Town, ME, Dewitt Fld,Old Town Muni, NDB RWY 22, Amdt 6A
Fort Leonard Wood, MO, Waynesville-St. Robert Rgnl Forney Fld, NDB/DME
RWY 14, Amdt 1B, CANCELED
Laurel, MT, Laurel Muni, Takeoff Minimums and Obstacle DP, Amdt 3
Trenton, NJ, Trenton Mercer, RNAV (GPS) Z RWY 24, Amdt 1
The Dalles, OR, Columbia Gorge Rgnl/The Dalles Muni, COPTER LDA/DME RWY
25, Amdt 1
The Dalles, OR, Columbia Gorge Rgnl/The Dalles Muni, LDA/DME RWY 25,
Amdt 1
The Dalles, OR, Columbia Gorge Rgnl/The Dalles Muni, RNAV (GPS)-A, Amdt
1
Gillette, WY, Gillette-Campbell County, Takeoff Minimums and Obstacle
DP, Amdt 4A

[FR Doc. 2013-25185 Filed 10-25-13; 8:45 am]
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TEMPLATE:

E.I. du Pont de Nemours and Company

PP No. (to be assigned)

	EPA has received a pesticide petition (PP No. to be assigned) from the
Interregional Research Project No. 4 (IR-4), 681 U.S. Highway #1 South,
North Brunswick, New Jersey  08902-3390, proposing, pursuant to section
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), to amend 40 CFR Part 180.587 by establishing a tolerance for
residues of the fungicide famoxadone in or on the raw agricultural
commodity Caneberries at 11 parts per million (ppm).  EPA has determined
that the petition contains data or information regarding the elements
set forth in section 408 (d)(2) of the FDDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data supports granting of the petition. Additional data may be
needed before EPA rules on the petition

A. Residue Chemistry

	1. Plant metabolism

The plant metabolism of famoxadone is adequately understood in 3
distinct crops to support these tolerances: tomatoes, potatoes, and
grapes. These studies showed no significant metabolites  (all < 10%
total radioactive residue (TRR)) in the RACs (tubers, tomato fruit, and
grape berries). The only significant residue in any of the studies was
the parent compound, famoxadone, occurring primarily as surface residues
(grape berries, and tomato fruit). No residues were detected in potato
tubers. Thus, the proposed tolerance expression is for the parent
compound, famoxadone (DPX-JE874) only.

	2. Analytical method.

An analytical enforcement method is available for determining famoxadone
plant residues in or on potatoes, cucurbit vegetables (cucumbers,
melons, and squash), fruiting vegetables (tomatoes, peppers), and head
lettuce using gas-liquid chromatography (GC) with nitrogen phosphorus
detection (NPD). The method is applicable to high and medium moisture,
oily and non-oily crops and related matrices. The limit of quantitation
(LOQ) is 0.02 ppm.

The analytical enforcement for use on tomato processed fractions and
also the RAC, tomato, utilizes column switching liquid chromatography
with ultraviolet (UV) detection. The LOQ is 0.02 ppm.

The LOQ in each method allows monitoring of crops with famoxadone
residues at or above the levels proposed in these tolerances.

	3. Magnitude of residues.

Caneberries

Magnitude of residue data were collected from field trials conducted in
Washington (region 12), Oregon (region 12), California (region 10) and
Canada (regions 5 and 12).  Residues of famoxadone ranged from 0.41 to
6.6 ppm.

B. Toxicological Profile

	1. Acute toxicity.

A battery of acute toxicity tests on technical famoxadone places it in
the following Toxicity Categories:

Oral LD50		Rat		> 5000 mg/kg				Category IV

Dermal LD50		Rabbit		>2000 mg/kg				Category III

Inhalation LC50	Rat		>5.3 mg/L				Category IV

Eye irritation		Rabbit		Moderately irritating			Category  III

Dermal irritation	Rabbit		Moderately irritating			Category  III

Dermal sensitization	Guinea Pig	Not a Sensitizer

In an acute neurotoxicity test, famoxadone was not neurotoxic to rats.
The no observed adverse effect level (NOAEL) was 1,000 mg/kg in males,
based on systemic toxicity at 2,000 mg/kg.  The NOAEL in females was
2,000 mg/kg, the highest dose tested (HDT).

	2. Genotoxicty.

Famoxadone was tested in a battery of assays to evaluate genotoxicity
and chromosome aberrations with the following results. Based on the
weight-of-evidence, famoxadone is not considered to be genotoxic or
clastogenic.

Bacterial gene mutation           		Salmonella and E. Coli    	Negative

Mammalian gene mutation in vitro  	CHO/HGPRT           		Negative

Mammalian chromosome aberrations	 Human Lymphocytes		Positive without
activation

in vitro							Negative with activation

Mammalian chromosome aberrations 	Mouse micronucleus  		Negative

in vivo

Unscheduled DNA synthesis in vitro 	Primary rat hepatocytes	Negative

Unscheduled DNA synthesis in vivo 	Primary rat hepatocytes 	Negative

	3. Reproductive and developmental toxicity.

The results of a series of studies indicated that there were no
reproductive or developmental hazards associated with famoxadone.

In a 2-generation rat reproduction study, the NOAEL for both adults and
offspring was 200 ppm (11.3-17.5 mg/kg/day depending on gender and
generation) based on clinical signs, decreased body weights, effects on
nutritional parameters, and liver toxicity in adults and decreased
weight of pups.  Effects on pups occurred only at a maternal effect
level and may have been secondary to altered growth and nutrition in the
dams.  There were no effects on reproduction (mating, fertility,
reproductive organs) up to and including the highest concentration
tested, 800 ppm (44.7-71.8 mg/kg/ day).

In studies conducted to evaluate developmental toxicity potential,
famoxadone was neither teratogenic nor uniquely toxic to the conceptus.
In a rat developmental toxicity study, the maternal NOAEL was 250
mg/kg/day based on decreased weight gain and food consumption at 500
mg/kg/day.  The fetal NOAEL was 1,000 mg/kg/day, the HDT.  In rabbits,
the maternal and developmental NOAEL was 350 mg/kg/day based on weight
loss, decreased food consumption, clinical signs, fecal impactions, and
subsequent abortion, resorptions, and post implantation loss at 1,000
mg/kg/day.  These effects were considered related to the physical
properties of the dosing solution at the highest concentration.

	4. Subchronic toxicity.

Subchronic (90-day) feeding studies were conducted with rats, mice, and
dogs. In addition, the following subchronic feeding studies were
conducted: A 90-day in rats to evaluate neurotoxicity and 28-day feeding
studies in rats and mice to evaluate immunotoxicity.  A 28-day dermal
study was conducted in rats.

In a 90-day feeding study in rats, EPA considered the NOAEL to be 50 ppm
(3.3 and 4.2 mg/kg/day in male and females, respectively) based on
changes in weight gain, food consumption and mild hemolytic anemia at
200 ppm (13 and 17 mg/kg/day, respectively).  In a subchronic
neurotoxicity study in rats, there was no evidence of neurotoxicity up
to and including the highest concentration tested, 800 ppm (46.9 and
59.3 mg/kg/day for males and females, respectively).  The NOAEL for
systemic toxicity was 200 ppm (11.7 and 14.4 mg/kg/day in males and
females, respectively) based on body weight and nutritional effects at
800 ppm.

In mice, the subchronic NOAEL was 350 ppm (62.4 and 79.4 mg/kg/day in
males and females, respectively), based on hepatotoxicity and mild
anemic effects at higher concentrations.

In a 90-day feeding study in dogs, the NOAEL was 40 ppm (1.3 mg/kg/day)
in males.  In females, 40 ppm (1.4 mg/kg/day) was a marginal effect
level for lens lesions.  Effects observed at 300 ppm (10 mg/kg/day) or
higher included lens lesions, body weight and nutritional effects,
hemolytic anemia, and hyperkalemia with associated clinical signs.

Famoxadone was tested in 28-day feeding studies in rats and mice,
designed to evaluate immunotoxicity.  There was no evidence of
immunotoxicity in either species.  The NOAEL for systemic toxicity was
200 ppm (14 and 16 mg/kg/day in males and females, respectively) in rats
and 2,000 ppm (417 mg/kg/day) in female mice.  There were no effects in
males at 7000 ppm (1186 mg/kg/day), the HDT.

In a 28-day repeated dose dermal study, the NOAEL for male rats was 250
mg/kg/day based on changes in liver enzymes at 500 mg/kg/day.  The NOAEL
for female rats was 1,000 mg/kg/day, the HDT.

	5. Chronic toxicity.

Chronic studies with famoxadone were conducted on rats, mice, dogs, and
monkeys to determine oncogenic potential and/or chronic toxicity of the
compound.  Effects generally similar to those observed in the 90-day
studies were seen in the chronic studies.

There was no evidence of carcinogenicity in the lifetime feeding studies
in rats and mice.  In rats, the chronic NOAEL was 200 ppm (8.4
mg/kg/day) in male rats and 40 ppm (2.2 mg/kg/day) in female rats based
on body weight changes, nutritional effects, slight hemolytic anemia,
and mild hepatotoxicity at higher dietary concentrations.  In mice, the
chronic NOAEL was 700 ppm (96 and 130 mg/kg/day for males and females,
respectively) based on slight hepatotoxicity in males and females and
amyloidosis in females at 2,000 ppm (274 and 392 mg/kg/day in males and
females, respectively).

In a 1-year feeding study in dogs, the only effect observed was lens
lesions at 300 ppm (8.8 and 9.3 mg/kg/day for males and females,
respectively). The NOAEL for these lesions was 40 ppm (1.2 mg/kg/day in
both sexes).  In a 1-year gavage study, the NOAEL in cynomolgus monkeys
was 100 mg/kg/day in both males and females based on slight hemolytic
anemia in both sexes at the 1,000 mg/kg/day dose level. There were no
other effects observed at any level.  No eye lesions were found at any
dose level.

	6. Animal metabolism.

Famoxadone was rapidly eliminated in the rat, primarily by fecal
excretion and to a lesser extent in the urine.  Absorption and
metabolism of famoxadone was limited.  There was no accumulation in
organs or tissues.  Parent famoxadone was the major component recovered.
Hydroxylated parent compound and sulfated cleavage products were also
recovered to a much lesser extent.

	7. Metabolite toxicology.

There are no metabolites of toxicological significance to mammals.

	8. Endocrine disruption.

Chronic, lifespan, and multi-generational bioassays in mammals and acute
and subchronic studies on aquatic organisms and wildlife did not reveal
endocrine effects. Any endocrine-related effects would have been
detected in this definitive array of required tests. The probability of
any such effect due to agricultural uses of famoxadone is negligible.

C. Aggregate Exposure

Famoxadone is a fungicide currently registered in the United States for
use on cucurbits, head lettuce, peppers, potatoes and tomatoes, with
proposed uses on grapes and hops submitted previously. This tolerance
petition proposes the following new uses in the United States:
caneberries. There are no residential uses.

	1. Dietary exposure.

For the chronic dietary endpoint, EPA selected the marginal effect level
of 1.4 mg/kg/day for lens lesions from the subchronic dog study and
added an additional uncertainty factor of 10x for no NOEL and use of a
subchronic study.  With inter- and intraspecies factors the total
uncertainty factor is 1000x for a chronic RfD of 0.0014 mg/kg/day.  No
acute dietary endpoint was selected since no effects attributable to a
single oral exposure were identified in toxicology studies with
famoxadone.

	i. Food.

Chronic Dietary Exposure Assessment

Chronic dietary exposure, resulting from the proposed use of famoxadone
on cucurbit vegetables, fruiting vegetables, head lettuce, potatoes,
grapes, hops, and caneberries is well within acceptable limits for all
sectors of the population. The chronic module of the Dietary Exposure
Evaluation Model with the Food Commodity Intake Database (DEEM-FCIDTM),
Exponent, Inc., 2003, Version 2.14 was used to conduct the assessment
with a chronic RfD of 0.0014 mg/kg/day. The analysis employed
overall-mean field-trial values and employed crop treated percentages
based on 5 year annual averages for currently labeled crops and
projections of the 5 year annual averages for proposed crops.

For the general U.S. population, the estimated chronic dietary exposure
to famoxadone is 0.000146 mg/kg/day, corresponding to 10% of the chronic
RfD. The exposure for the potentially most highly exposed subgroup in
the population, adults 20-49 years, is 0.000188 mg/kg/day or 14% of the
chronic RfD. The table below lists the results of this analysis, which
indicate large margins of exposure for each population subgroup from
chronic exposure to famoxadone. Since the %RfD for each population
subgroup are well below 100%, the chronic dietary safety of famoxadone
clearly meets the standard of reasonable certainty of no harm.

Results of Chronic Dietary Analysis with Famoxadone

 PRIVATE

Population Group	Maximum Dietary Exposure (mg/kg/day)

% RfD

U.S. population	0.000146	10

All infants (<1 yr.)	0.000027	2

Children (1-2 yr.)	0.000158	11

Children (3-5 yr.)	0.000145	10

Children (6-12 yr.)	0.000101	7

Youth (13-19 yr.)	0.000094	7

Adults 20-49 years	0.000188	14

Adults 50+ years	0.000117	8

Females 13-49 years	0.000120	9

Acute Dietary Exposure

Based on the results of toxicity studies, including an acute
neurotoxicity study, no endpoint attributable to a single oral dose of
famoxadone was identified.

	ii. Drinking Food.

Famoxadone is highly unlikely to contaminate ground water resources due
to its immobility in soil, low water solubility, high soil sorption,
moderate soil half-life, and resulting low ground and surface water
exposure.  Chronic drinking water exposure analyses were calculated
using EPA screening concentration models for ground water (SCI-GROW ver.
2.3) and surface water (EXPRESS ver. <IP_ADDRESS> containing PRZM-EXAMS).
Results indicate that a reasonable certainty exists that famoxadone
residues in drinking water will not contribute significantly to the
aggregate human risk.

The predicted chronic concentration for famoxadone under worst-case
conditions was 0.006459 parts per billion (ppb) in ground water and
0.0342 ppb in surface water.  When the higher surface water
concentration was included in the dietary risk assessment there was
little change from the food only chronic risk assessment; the following
table provides the results.

Results of Chronic Dietary Analysis Including Water with Famoxadone

 PRIVATE

Population Group	Maximum Dietary Exposure (mg/kg/day)

% RfD

U.S. population	0.000147	11

All infants (<1 yr.)	0.000029	2

Children (1-2 yr.)	0.000159	11

Children (3-5 yr.)	0.000146	10

Children (6-12 yr.)	0.000101	7

Youth (13-19 yr.)	0.000094	7

Adults 20-49 years	0.000189	14

Adults 50+ years	0.000117	8

Females 13-49 years	0.000121	9

Since the %cRfD for each population subgroup is well below 100%, the
chronic dietary safety of famoxadone, including the contribution of
drinking water, clearly meets the standard of reasonable certainty of no
harm.

	2. Non-dietary exposure.

Famoxadone products are not labeled for residential non-food uses,
thereby eliminating the potential for residential exposure.
Non-occupational, non-dietary exposure for famoxadone has not been
estimated because the proposed products are limited to commercial crop
production. Therefore, the potential for non-occupational exposure is
insignificant.

D. Cumulative Effects

 EPA's consideration of a common mechanism of toxicity is not necessary
at this time because there is no indication that toxic effects of
famoxadone should be cumulative with those of any other chemical.
Famoxadone is a member of a new class of fungicides that acts by
inhibition of mitochondrial respiration. Famoxadone's biochemical mode
of action on fungi and toxicological profile in animals appear to be
unique.

Given the distinct chemical, biological and toxicological profile,
famoxadone's low acute toxicity, absence of genotoxic, oncogenic,
developmental or reproductive effects and low exposure potential, the
expression of cumulative human health effects with any other natural or
synthetic pesticide is not anticipated.

E. Safety Determination

	1. U.S. population.

Based on the completeness and reliability of the toxicity data and the
conservative exposure assessments, there is a reasonable certainty that
no harm will result from the aggregate exposure of residues of
famoxadone including all anticipated dietary exposure and all other
non-occupational exposures.  No additional safety factors are warranted.

	2. Infants and children.

Based on the completeness and reliability of the toxicity data, the lack
of toxicological endpoints of special concern, the lack of any
indication of greater sensitivity of children, and the conservative
exposure assessment, there is a reasonable certainty that no harm will
result to infants and children from the aggregate exposure to residues
of famoxadone from all anticipated sources of dietary and
non-occupational exposure. Accordingly, there is no need to apply an
additional safety factor for infants and children.

F. International Tolerances

1. EU

MRL's established for famoxadone are available at the following link:

http://europa.eu.int/comm/food/plant/protection/pesticides/index_en.htm

2. CODEX

MRL's for famoxadone were adopted as final (CXL) at the July 2005 CODEX
alimentarius meeting, however these MRL's have not yet been updated into
the database.  MRL's established for famoxadone will eventually be
available at the following link:

http://faostat.fao.org/faostat/collections?hasbulk=0&subset=FoodQuality&
&language=EN

3. Canada

Famoxadone MRL's are established by Canada (finalized on April 20, 2005)
and are available in the link below:

http://www.pmra-arla.gc.ca/english/legis/maxres-e.html - proposedmrls

Pesticide Petition for Tolerance
                 	AGRICULTURAL COMMODITIES

for Famoxadone
                       Caneberries

Copyright by E.I. du Pont de Nemours and Company

Wilmington, DE 19880-0038 (July 2006)


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30960-30961]
[FR Doc No: 2021-12214]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0362]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice for Finished Pharmaceuticals, Including Medical
Gases, and Active Pharmaceutical Ingredients

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by July 12, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0139. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice for Finished Pharmaceuticals,
Including Medical Gases, and Active Pharmaceutical Ingredients--21 CFR
Parts 210 and 211 and 21 U.S.C 351(a)(2)(B)

OMB Control Number 0910-0139--Extension

    This information collection supports FDA regulations that govern
the manufacture, processing, packing, or holding of finished
pharmaceuticals, including medical gases, and active pharmaceutical
ingredients (APIs). Under section 501(a)(2)(B) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C 351(a)(2)(B)), a drug is
adulterated if the methods used in, or the facilities or controls used
for its manufacture, processing, packing, or holding do not conform to
or are not operated or administered in conformity with current good
manufacturing practice (CGMP) regulations. FDA is responsible for
enforcing the FD&C Act as well as related statutes, including the
Public Health Service Act. Congress enacted these laws to ensure that
covered products meet applicable requirements regarding the safety,
identity and strength, and the quality

and purity characteristics they purport or are represented to possess,
and are labeled with adequate warnings and instructions for use.
    The pharmaceutical or drug quality-related regulations appear in
several parts of Title 21 Code of Federal Regulations (CFR) (Food and
Drugs), including sections in parts 1 through 99, 200 through 299, 300
through 499, 600 through 799, and 800 through 1,299. The regulations
enable a common understanding of the regulatory process by describing
requirements to be followed by drug manufacturers, applicants, and FDA.
Under part 211 (21 CFR part 211; see 21 CFR 211.94(e)(1)), specific
requirements for medical gas containers and closures are also found in
the regulations. Finally, the information collection also supports
regulations codified under parts 610 and 680 (21 CFR parts 610 and
680), which reference certain CGMP regulations in part 211 (see
Sec. Sec.  610.12(g), 610.13(a)(2), 610.18(d), 680.2(f), and 680.3(f)).
    These regulations set forth information collection requirements
that allow FDA to meet its public health protection responsibilities.
Products that fail to comply with CGMP requirements may be rendered
adulterated under section 501(a)(2)(B) of the FD&C Act. To demonstrate
that their products comply with the requirements of section
501(a)(2)(B), API manufacturers must maintain CGMP records; therefore,
we have counted them among respondents who incur burden for the
information collection. In the table below, we have included an
additional 1,260 respondents to reflect API manufacturers not included
in our previous submission for renewal.
    To assist respondents with the information collection requirements
for medical gases, we developed a draft guidance for industry entitled
``Current Good Manufacturing Practice for Medical Gases.'' This
guidance, when finalized will discuss our recommendations regarding
compliance with applicable requirements found in the regulations as
they apply to these products. The guidance is available for download
from our internet site at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-medical-gases. We believe the recommendations, if followed, will help
respondents focus their information collection activities most
efficiently with regard to demonstrating regulatory compliance.
    In the Federal Register of March 3, 2021 (86 FR 12466), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received requesting
clarification on FDA's basis in calculating its burden estimate. At the
same time, the comment offered no formula or method upon which
alternative figures might be derived. For details regarding all
approved information collections currently in use by FDA, we invite
readers to visit https://www.reginfo.gov/public/jsp/PRA/praDashboard.myjsp. With regard to this information collection
specifically, our estimate of burden, as defined in 44 U.S.C. 3502(2),
is based on our experience with routine inspections and informal
communications with industry. Additionally, as noted in our 60-day
notice, we account for burden that may be applicable to API and
finished dosage manufacturers along with other respondents to the
information collection. The estimate we provide reflects burden we
attribute to activities associated with recordkeeping requirements
found in applicable regulations, as well as recommendations that may be
found in Agency guidance.\1\ These activities include, among others,
establishing and maintaining standard operating procedures; the need to
consult outside experts; recommendations pertaining to documenting
equipment cleaning and maintenance; and requirements and
recommendations pertaining to master production records, control
records, and distribution records.
---------------------------------------------------------------------------

    \1\ See also, ``Q7 Good Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients; Guidance for Industry''
(September 2016).
---------------------------------------------------------------------------

    We retain our estimate of the information collection burden, which
is as follows:

      Table 1--Estimated Annual Recordkeeping Burden--APIs, Finished Pharmaceuticals, and Medical Gases 1 2
----------------------------------------------------------------------------------------------------------------
                                                  Number of
 Section 501(a)(2)(B) of the      Number of      records per    Total annual     Average burden     Total hours
 FD&C Act; Parts 210 and 211    recordkeepers   recordkeeper       records     per recordkeeping
----------------------------------------------------------------------------------------------------------------
CGMP API Manufacturers.......           1,260             256         322,560         0.82 (49.2         264,499
                                                                                minutes)
CGMP Finished Pharmaceuticals           3,270             299         977,730  0.64 (38 minutes)         625,747
 Manufacturers (excludes
 medical gases)..............
CGMP Medical Gases                      2,284             280         639,520  0.62 (37 minutes)         396,502
 Manufacturers...............
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............       1,939,810  .................       1,286,748
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
\2\ Records and burden per activity have been averaged and rounded.

    Our estimated burden for the information collection reflects an
overall decrease of 29,073 hours and 1,762 records annually for CGMP
for finished pharmaceutical manufacturers, excluding those
manufacturers of medical gases. Our estimated burden for the
information collection also reflects an overall decrease of 486 hours
and 1,574 records annually for medical gas manufacturers. Our inclusion
of API manufacturers in this collection represents an addition of
264,499 hours and 322,560 records prepared.

    Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12214 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 37 (Friday, February 26, 2021)]
[Proposed Rules]
[Pages 11680-11681]
[FR Doc No: 2021-03982]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2020-0467; FRL-10020-71-Region 5]

Air Plan Approval; Illinois; Public Participation in the Permit
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Illinois State Implementation Plan (SIP) that
were submitted on August 27, 2020 by the Illinois Environmental
Protection Agency (IEPA). These revisions affect the public notice rule
provisions for the New Source Review (NSR) and title V Operating Permit
programs (title V) of the Clean Air Act (CAA). The revisions remove the
mandatory requirement to provide public notice of draft CAA permits in
a newspaper and allow electronic notice (e-notice) as an alternate
noticing option. EPA is proposing to approve these revisions pursuant
to the CAA and implementing Federal regulations.

DATES: Comments must be received on or before March 29, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2020-0467 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Wolski, Physical Scientist, Air
Permitting Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>The EPA Region 5
office is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays and facility closures due to COVID-19.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Background

    On October 5, 2016, EPA finalized revised public notice rule
provisions for the NSR, title V, and Outer Continental Shelf permitting
programs of the CAA. See 81 FR 71613 (October 18, 2016). These rule
provisions remove the mandatory requirement to provide public notice of
a draft air permit through publication in a newspaper and allow for
internet e-notice as an option for permitting authorities implementing
their own EPA-approved SIP rules and title V rules. Permitting
authorities are not required to adopt e-notice. A permitting authority
with an EPA-approved permitting program, such as IEPA, may continue to
use newspaper notification or supplement e-notice with newspaper
notification or additional means of notification. When e-notice is
provided, EPA's rule requires electronic access (e-access) to the draft
permit. Generally, state and local agencies are expected to post the
draft permits and public notices in a designated location on their
agency websites. For the noticing of draft permits issued by permitting
authorities with EPA-approved programs, the rule requires the
permitting authority to use ``a consistent noticing method'' for all
permit notices under the specific permitting program. Permitting
authorities must also provide the public with reasonable access to the
other materials that support the permit decision (e.g., the permit
application, statement of basis, fact sheet, preliminary determination,
final determination and response to comments) as required by existing
regulations, however such materials which comprise the permit record
may be provided either electronically, at a physical location, or a
combination of both.
    EPA anticipates that e-notice, which is already being practiced by
many

permitting authorities, will enable permitting authorities to
communicate permitting and other affected actions to the public more
quickly and efficiently and will provide cost savings over newspaper
publication. EPA further anticipates that e-access will expand access
to permit-related documents. A full description of the e-notice and e-
access provisions are contained in EPA's October 18, 2016, rulemaking
(81 FR 71613).

II. Analysis of Illinois' E-Notice Rule Revisions

    IEPA revised Chapter 35 Illinois Administrative Code (IAC) part
252, Public Participation in the Air Pollution Control Permit Program,
to incorporate EPA's amendments to the Federal public notice
regulations discussed above. Specifically, IEPA revised 35 IAC 252
section 201, ``Notice and Opportunity to Comment'' and section 204,
``Availability of Documents''. IEPA's revisions to 35 IAC 252 section
201 add language to allow for the use of e-notice for certain air
permit hearings, including those regarding major stationary source
construction and modification (IEPA's nonattainment NSR program), CAA
Permit Program permits (IEPA's title V program), and others, by
providing notice to the public by prominent placement at a dedicated
page on IEPA's website. Revisions to part 252 section 204 specify the
location of certain permitting documents and allow a copy of the draft
permit to be placed on a dedicated page on IEPA's website for the
duration of the public comment period.
    IEPA's regulations were the subject of a public hearing on January
11, 2018 and were adopted on August 17, 2018 with an effective date of
August 1, 2018. EPA received IEPA's SIP submittal on August 27, 2020.
Based on a review of the proposed revisions, EPA has preliminarily
determined that IEPA's revisions meet the requirements of the Federal
e-notice provisions.\1\
---------------------------------------------------------------------------

    \1\ IEPA has submitted additional SIP revision requests which
will impact part 252. These submittals will be the subject of
forthcoming EPA actions.
---------------------------------------------------------------------------

III. What Action is EPA Taking?

    EPA is proposing to approve IEPA's August 27, 2020 SIP program
revisions addressing public notice requirements for CAA permitting. EPA
has preliminarily concluded that the State's submittal meets the plan
revisions requirements of CAA section 110 and the implementing
regulations at 40 CFR 51.161, 40 CFR 70.4 and 70.7.

IV. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference revisions to 35 IAC part 252 section 201 ``Notice and
Opportunity to Comment'' and section 204, ``Availability of
Documents'', effective August 1, 2018. EPA has made, and will continue
to make, these documents generally available through
www.regulations.gov and at the EPA Region 5 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because it is not a significant regulatory
action under Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Administrative
practice and procedure, Incorporation by reference, Intergovernmental
relations, Operating permits, Reporting and recordkeeping requirements.

    Dated: February 22, 2021.
Cheryl Newton,
Acting Regional Administrator, Region 5.
[FR Doc. 2021-03982 Filed 2-25-21; 8:45 am]
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[Federal Register: October 7, 2010 (Volume 75, Number 194)]
[Notices]
[Page 62135]
[DOCID:fr07oc10-65]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Notice of Adjustment of Countywide Per Capita Impact Indicator

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: FEMA gives notice that the countywide per capita impact
indicator under the Public Assistance program for disasters declared on
or after October 1, 2010, will be increased.

DATES: Effective Date: October 1, 2010, and applies to major disasters
declared on or after October 1, 2010.

FOR FURTHER INFORMATION CONTACT: Tod Wells, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Response and Recovery Directorate Policy No.
9122.1 provides that FEMA will adjust the countywide per capita impact
indicator under the Public Assistance program to reflect annual changes
in the Consumer Price Index for All Urban Consumers published by the
Department of Labor.
    FEMA gives notice of an increase in the countywide per capita
impact indicator to $3.27 for all disasters declared on or after
October 1, 2010.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.1 percent for the 12-month period
ended in August 2010. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 17, 2010.

    Catalog of Federal Domestic Assistance No. 97.036, Public
Assistance Grants.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-25332 Filed 10-6-10; 8:45 am]
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[Federal Register Volume 78, Number 245 (Friday, December 20, 2013)]
[Notices]
[Pages 77112-77113]
[FR Doc No: 2013-30321]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2280-018]

FirstEnergy Generation, LLC; Notice of Application Tendered for
Filing With the Commission and Establishing Procedural Schedule for
Licensing and Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: P-2280-018.
    c. Date Filed: December 2, 2013.
    d. Applicant: FirstEnergy Generation, LLC.
    e. Name of Project: Kinzua Pumped Storage Project.
    f. Location: The existing project is located on the United States
Army Corps of Engineers (Corps) Kinzua Dam, and the United States
Forest Service (Forest Service) Allegheny National Forest, adjacent to
the Allegheny River and the Allegheny Reservoir near the City of
Warren, in Warren County, Pennsylvania. The project occupies 221.59
acres of federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Morgan E. Parke, Associate General Counsel,
FirstEnergy Service Company, 76 South Main Street, Akron, OH 44308;
Telephone<PHONE_NUMBER>.
    i. FERC Contact: Gaylord Hoisington,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. The existing Kinzua Pumped Storage Project pumps water from the
Corps' Allegheny Reservoir (lower reservoir) to the project's upper
reservoir to be used for power generation. The project has an installed
capacity of 451.8 megawatts. The project

produces an average annual generation of 559.06 gigawatthours (GWh).
The average pumping power used by the project is 747.355 GWh.
    The existing Kinzua Project consists of: an intake/outlet structure
in the Allegheny Reservoir, a discharge outlet in the Allegheny River,
an upper reservoir, water conduits, control facilities and a powerhouse
containing two reversible pump turbines (units 1 and 2) and one
traditional generating unit (unit 3). Unit 1 and 2, when pumping water
from or discharging water to the Allegheny Reservoir does so through
two 418-foot-long, 15-foot-diameter steel conduits. Unit 2 discharges
to the Allegheny River downstream of the dam, it uses a discharge
passage which is shared with unit 3. The intake structure located in
the floor of the upper reservoir leads to a 22-foot-long, 4-inch-
diameter pipe that transitions to a 21-foot-long, 6-inch-diameter
steel-lined pipe for 2,500 feet where it bifurcates with one pipe
extending 325.35 feet to unit 1 and the other pipe extending 245.95
feet where it bifurcates again. At the second bifurcation, one pipe
extends 98.29 feet to unit 2 and 100.3 feet to unit 3. Each of the 3
penstocks contains a spherical valve near the entrance to each unit.
The discharge passage for unit 2 consists of a 15-foot-diameter
butterfly valve downstream of unit 2 to allow unit 2 to either generate
into the discharge passage (open position) or pump/generate to the
Allegheny Reservoir (closed position). This valve opens into a 15-foot-
diameter steel discharge section tee and accepts water from both unit 2
and 3, up to 2,650 cubic feet per second (cfs) full gate capacity. The
discharge tee transitions to a concrete-lined rectangular section 99
feet wide which outlets into the Allegheny River downstream of the
Kinzua Dam.
    The project withdraws water from the Allegheny Reservoir, created
by the Kinzua Dam. Water used for electricity production is pumped from
the Allegheny Reservoir to the project's upper reservoir using one or
both reversible pump turbines (unit 1 and/or unit 2), and later passed
through unit 1 and/or unit 2 back to the Allegheny Reservoir. Another
portion of water used for electricity production can be pumped to the
upper reservoir using unit 1 and/or unit 2, and then released directly
into the Allegheny River using unit 2 and/or unit 3. FirstEnergy is
proposing to operate unit 2 to discharge to the Allegheny River on a
more frequent basis than under current operation. To facilitate these
operations, FirstEnergy proposes to install a system to automate
operation of the project's lower intake bulkheads and Corp's sluice
gates, and refurbish the unit 2 butterfly valve.
    Other project works include transformers, a transmission line
approximately 3,100 feet long, access roads, recreational and other
appurtenant facilities.
    FirstEnergy is proposing to raise the maximum operating level of
the upper reservoir from 2,072 feet to 2,073 feet, (increase of 1
foot), and by doing so would increase the average annual generation
from 559.06 GWh to 585.06 GWh.
    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Procedural Schedule:
    The application will be processed according to the following
preliminary Hydro Licensing Schedule. Revisions to the schedule may be
made as appropriate.

------------------------------------------------------------------------
                                                                Target
                         Milestone                               date
------------------------------------------------------------------------
Notice of Acceptance/Notice of Ready for Environmental         1/31/2014
 Analysis..................................................
Filing of recommendations, preliminary terms and                4/1/2014
 conditions, and fishway prescriptions.....................
Commission issues Draft EA.................................    9/28/2014
Comments on Draft EA.......................................   10/28/2014
Modified Terms and Conditions..............................   12/27/2014
Commission Issues Final EA.................................    3/27/2015
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: December 16, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-30321 Filed 12-19-13; 8:45 am]
BILLING CODE 6717-01-P