[Federal Register: December 5, 2008 (Volume 73, Number 235)]
[Notices]
[Page 74169]
[DOCID:fr05de08-78]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER08-633-002]

ISO New England, Inc.; Notice of Filing

November 28, 2008.
    Take notice that on November 18, 2008, ISO New England, Inc.
submitted an informational filing with proration results from the
Forward Capacity Auction pursuant to the Commission's June 20, 2008
Order Accepting Filing, 123 FERC ] 61,290 (2008).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 9, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-28786 Filed 12-4-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]
[Page 36229]
[DOCID:fr22jy09-83]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0606]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Export of Food and Drug
Administration Regulated Products: Export Certificates

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Export of Food and Drug
Administration Regulated Products: Export Certificates'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 3, 2009 (74
FR 9247), the agency announced that the proposed information collection
had been submitted to OMB for review and clearance under 44 U.S.C.
3507. 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. OMB has now approved the
information collection and has assigned OMB control number 0910-0498.
The approval expires on October 31, 2010. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17331 Filed 7-21-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74503]
[DOCID:fr12de06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-81-000]

Northwest Pipeline Corporation; Notice of Proposed Changes in
FERC Gas Tariff and Filing of Non-Conforming Service Agreement

December 4, 2006.
    Take notice that on November 29, 2006, Northwest Pipeline
Corporation (Northwest) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, Thirteenth Revised Sheet No. 373 to
become effective December 30, 2006. Northwest also tendered for filing
a restated Rate Schedule TF-2 non-conforming service agreement.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21060 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Page 68799]
[FR Doc No: 2012-27886]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3352-EM; Docket ID FEMA-2012-0002]

District of Columbia; Amendment No. 1 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the District of Columbia (FEMA-3352-EM), dated October 28, 2012, and
related determinations.

DATES: Effective Date: November 5, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Jack Schuback,
of FEMA is appointed to act as the Federal Coordinating Officer for
this emergency.
    This action terminates the appointment of Steven S. Ward as Federal
Coordinating Officer for this emergency.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-27886 Filed 11-15-12; 8:45 am]
BILLING CODE 9111-23-P


                              BMD Analysis (Cmax)

                                   Kan Shao                                September 5, 2013

Becci et al 1982, Table 5, Sternabrae (missing), Litter size                                Dose, Cmax (mg/L)                                        N                                     Effect                                        0                                       24                                        1                                      202.4                                       22                                        0                                      641.1                                       23                                        4                                     2049.6                                       22                                       17

                            BMD Estimation Results                                         Model P-Value AIC BMD  (BMR=10%) BMDL (BMR=10%)  BMD (BMR=5%) BMDL  (BMR=5%) Gamma 0.29 60.88 563.27 333.82 420.35 209.39 Logistic 0.42 59.93 653.38 475.06 424.13 282.05 LogLogistic 0.29 60.86 558.66 344.90 421.06 228.25 LogProbit 0.32 60.59 552.53 352.30 436.81 252.13 Multistage 0.53 59.17 548.73 315.68 382.87 168.76 Probit 0.45 59.72 594.26 439.12 380.16 256.35 Weibull 0.26 61.16 566.77 319.70 399.58 190.16 Quantal-Linear 0.04 66.13 220.23 153.18 107.22 74.57 Note: Quantal-Linear cannot fit properly. Multistage model (degree 2) is the best fitted model and should be selected.

Becci et al 1982, Table 5, Vertebrae (Incomplete ossification), Litter size                                Dose, Cmax (mg/L)                                        N                                     Effect                                        0                                       24                                       12                                      202.4                                       22                                       11                                      641.1                                       23                                       14                                     2049.6                                       22                                       18

                            BMD Estimation Results                                         Model P-Value AIC BMD  (BMR=10%) BMDL (BMR=10%)  BMD (BMR=5%) BMDL  (BMR=5%) Gamma 0.84 121.46 347.23 117.60 204.7 57.25 Logistic 0.97 119.49 271.17 170.45 135.45 85.27 LogLogistic 0.87 121.45 361.44 65.84 227.21 31.19 LogProbit 0.99 119.43 393.99 210.39 273.97 146.30 Multistage 0.80 121.49 302.83 117.31 153.46 57.11 Probit 0.97 119.49 280.19 182.93 139.97 91.50 Weibull 0.83 121.47 333.97 117.52 188.83 57.21 Quantal-Linear 0.94 119.55 212.68 116.58 103.54 56.75 Note: LogProbit Model is the best fitted model, but the BMDLs exceed the range of 3-fold. So, the lowest BMDL should be selected.


[Federal Register: December 16, 2008 (Volume 73, Number 242)]
[Notices]
[Page 76358-76360]
[DOCID:fr16de08-57]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0633]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Adverse Drug Experience Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on postmarketing adverse drug
experience reporting and recordkeeping requirements.

DATES: Submit written or electronic comments on the collection of
information by February 17, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets

Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments should be identified with
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Postmarketing Adverse Drug Experience Reporting--21 CFR 310.305 and
314.80 (OMB Control Number 0910-0230)--Extension

    Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 321, 352, 355, and 371) require that
marketed drugs be safe and effective. In order to know whether drugs
that are not safe and effective are on the market, FDA must be promptly
informed of adverse experiences occasioned by the use of marketed
drugs. In order to help ensure this, FDA issued regulations at
Sec. Sec.  310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose
reporting and recordkeeping requirements on the drug industry that
would enable FDA to take the action necessary to protect the public
health from adverse drug experiences.
    All applicants who have received marketing approval of drug
products are required to report to FDA serious, unexpected adverse drug
experiences, as well as followup reports when needed (Sec.
314.80(c)(1)). This includes reports of all foreign or domestic adverse
experiences as well as those based on information from applicable
scientific literature and certain reports from postmarketing studies.
Section 314.80(c)(1)(iii) pertains to such reports submitted by non-
applicants. Under Sec.  314.80(c)(2), applicants must provide periodic
reports of adverse drug experiences. A periodic report includes, for
the reporting interval, reports of serious, expected adverse drug
experiences and all nonserious adverse drug experiences and an index of
these reports, a narrative summary and analysis of adverse drug
experiences and a history of actions taken because of adverse drug
experiences. Under Sec.  314.80(i), applicants must keep records of all
adverse drug experience reports known to the applicant for 10 years.
    For marketed prescription drug products without approved new drug
applications or abbreviated new drug applications, manufacturers,
packers, and distributors are required to report to FDA serious,
unexpected adverse drug experiences as well as followup reports when
needed (Sec.  310.305(c)). Section 310.305(c)(5) pertains to the
submission of followup reports to reports forwarded by FDA. Under Sec.
310.305(f), each manufacturer, packer, and distributor shall maintain
for 10 years records of all adverse drug experiences required to be
reported.
    The primary purpose of FDA's adverse drug experience reporting
system is to provide a signal for potentially serious safety problems
with marketed drugs. Although premarket testing discloses a general
safety profile of a new drug's comparatively common adverse effects,
the larger and more diverse patient populations exposed to the marketed
drug provide the opportunity to collect information on rare, latent,
and long-term effects. Signals are obtained from a variety of sources,
including reports from patients, treating physicians, foreign
regulatory agencies, and clinical investigators. Information derived
from the adverse drug experience reporting system contributes directly
to increased public health protection because the information enables
FDA to make important changes to the product's labeling (such as adding
a new warning), decisions about risk evaluation and mitigation
strategies or the need for postmarket studies or clinical trials, and
when necessary, to initiate removal of a drug from the market.
    Respondents to this collection of information are manufacturers,
packers, distributors, and applicants. FDA estimates the burden of this
collection of information as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual Frequency per     Total Annual        Hours per
                    21 CFR Section                         Respondents           Response            Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(c)(5)                                                           1                     1                  1                  1                  1
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.80(c)(1)(iii)                                                       5                     1                  5                  1                  5
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.80(c)(2)                                                          642                 17.88             11,478                 60            688,680
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                688,686
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec.  Sec.   310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) was reported under OMB No. 0910-0291.
  The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual Frequency per     Total Annual
                    21 CFR Section                        Recordkeepers        Recordkeeping          Records        Hours per Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(f)                                                             25                     1                 25                 16                400
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.80(i)                                                             642                   623            400,000                 16          6,400,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                7,088,680
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually.

    These estimates are based on FDA's knowledge of adverse drug
experience reporting, including the time needed to prepare the reports,
and the number of reports submitted to the agency.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29664 Filed 12-15-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Notices]
[Pages 51936-51937]
[FR Doc No: 2018-22355]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-191-000]

Wolverine Power Supply Cooperative, Inc.; Notice of Petition for
Declaratory Order

    Take notice that on October 4, 2018, pursuant to section 292.402 of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 292.402, Wolverine Power Supply
Cooperative, Inc. (Wolverine or Petitioner) on behalf of itself and its
distribution cooperative members (Distribution Members), filed a
petition for declaratory order requesting a partial waiver of certain
obligations imposed on Wolverine and its

Distribution Members under the Commission's regulations \1\
implementing Section 210 of the Public Utility Regulatory Policies Act
of 1978, all as more fully explained in the petition.
---------------------------------------------------------------------------

    \1\ 18 CFR 292.303(a)-(b).
---------------------------------------------------------------------------

    Any person desiring to intervene or to protest in this proceeding
must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
will be considered by the Commission in determining the appropriate
action to be taken, but will not serve to make protestants parties to
the proceeding. Any person wishing to become a party must file a notice
of intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above proceeding are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the website that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email [email protected], or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on October 19, 2018.

    Dated: October 9, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-22355 Filed 10-12-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Rules and Regulations]
[Pages 68899-68902]
[FR Doc No: 2021-26330]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0157; Project Identifier AD-2020-00483-T;
Amendment 39-21806; AD 2021-23-08]
RIN 2120-AA64

Airworthiness Directives; Learjet Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Learjet Inc. (Learjet) Model 45 airplanes. This AD was prompted
by reports of corrosion found on the upper surface of the lower center
wing mid spar splice plate. This AD requires repetitively inspecting
the center wing area for corrosion and deterioration of protective
treatments, removing any corrosion, and treating any deteriorated
areas. The FAA is issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective January 10, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 10,
2022.

ADDRESSES: For service information identified in this final rule,
contact Learjet Inc., One Learjet Way, Wichita, KS 67209; phone: (316)
946-2000; email: [email protected]; website: https://
businessaircraft.bombardier.com/en/aircraft/learjet.html. You may view
this referenced service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 901 Locust, Kansas City, MO 64106.
For information on the availability of this material at the FAA, call
(816) 329-4148.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0157; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, any
comments received, and other information. The address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tara Shawn, Aviation Safety Engineer,
Wichita ACO Branch, FAA, 1801 Airport Road, Wichita, KS 67209; phone:
(316) 946-4141; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain serial numbered
Learjet Inc. (Learjet) Model 45 (Learjet 40), Model 45 (Learjet 45),
Model 45 (Learjet 70), and Model 45 (Learjet 75) airplanes. The NPRM
published in the Federal Register on July 28, 2021 (86 FR 40379). The
NPRM was prompted by a report from Learjet of corrosion found in the
center wing area of a Model 45 (Learjet 45) airplane. Exfoliating
corrosion was found on the upper surface of the lower center wing mid
spar splice plate during unrelated maintenance. The corrosion appeared
to extend half way through the thickness of the splice plate. Since the
initial report, the FAA has received 23 additional reports of corrosion
from Learjet.
    The FAA determined areas of the wing center section are not sealed
against the elements; in addition, the fuselage has drain holes that
allow condensation to drain into the center wing. The accumulation and
retention of moisture in the center wing section may lead to corrosion.
In the NPRM, the FAA proposed to require repetitively inspecting the
center wing area for corrosion and deterioration of protective
treatments, removing any corrosion, and treating any deteriorated
areas. This

condition, if not addressed, could result in failure of the wing
centerline joint and lead to partial wing separation with consequent
loss of control of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received one comment from an individual. The following
presents the comment received on the NPRM and the FAA's response to the
comment.
    An individual requested the FAA allow credit for previous visual
inspections using Inspection Reference Number (IRN) 5710190. The
commenter stated that IRN 5710190 requires the same inspection as the
applicable service bulletin. The commenter noted that while some
operators might not have used the service bulletin listed in paragraph
(k) of the NPRM, operators of aircraft over 8 years old will have used
IRN 5710190.
    The FAA agrees and has added the applicable maintenance manual
references for IRN 5710190 to paragraph (k) of this AD, which provides
credit for previous actions.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for the changes described
previously, this AD is adopted as proposed in the NPRM. None of the
changes will increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed the following service documents required for
compliance with this AD:
     Bombardier Learjet 40 Service Bulletin 40-57-06, Revision
1, dated October, 26, 2020;
     Bombardier Learjet 45 Service Bulletin 45-57-13, Revision
1, dated October, 26, 2020;
     Bombardier Learjet 70 Service Bulletin 70-57-02, Revision
1, dated October, 26, 2020; and
     Bombardier Learjet 75 Service Bulletin 75-57-01, Revision
2, dated April 19, 2021.
    As applicable to the model configuration specified, each service
bulletin contains procedures for inspecting for corrosion and
deterioration of protective treatments of the center wing area from the
front spar to the rear spar between wing stations 33.00L to 33.00R,
treating deteriorated areas, and removing any corrosion. Bombardier
Learjet 75 Service Bulletin 75-57-01, Revision 2, dated April 19, 2021,
does not apply to newly- manufactured airplanes, since Learjet added
this inspection to the Airworthiness Limitation Section, which will be
delivered with new airplanes starting at S/N 45-597.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 450 airplanes of U.S.
registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost             Parts Cost           product        operators
----------------------------------------------------------------------------------------------------------------
Inspect...........................  7.5 work-hours x $85   Not applicable.......         $637.50        $286,875
                                     per hour = $637.50.
Report to FAA.....................  1 work-hours x $85     Not applicable.......              85          38,250
                                     per hour = $85.
----------------------------------------------------------------------------------------------------------------

    The extent of corrosion and deterioration of protective treatments
may vary significantly from airplane to airplane. The FAA has no way of
determining how much damage may be found on each airplane, the cost to
remove the corrosion or treat deteriorated areas (or replacing the
part, if needed), or the number of airplanes that may require repair.
    If corrosion is found and removed, the FAA estimates that it would
take 2 work-hours per airplane to provide data to Learjet. With an
average labor rate of $85 per work-hour, the FAA estimates a cost of
$170 per airplane.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 3 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.

    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:
    2021-23-08 Learjet Inc.: Amendment 39-21806; Docket No. FAA-
2021-0157; Project Identifier AD-2020-00483-T.

(a) Effective Date

    This airworthiness directive (AD) is effective January 10, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Learjet Inc. Model 45 (Learjet 40), Model 45
(Learjet 45), Model 45 (Learjet 70), and Model 45 (Learjet 75)
airplanes, serial numbers 45-002 through 45-596 and 45-2001 through
45-2146, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 5714, Wing, Center
Box.

(e) Unsafe Condition

    This AD was prompted by reports of corrosion found on the upper
surface of the lower center wing mid spar splice plate. The FAA is
issuing this AD to detect and correct corrosion or deterioration of
protective treatments on the center wing area. The unsafe condition,
if not addressed, could result in failure of the wing centerline
joint and lead to partial wing separation with consequent loss of
control of the airplane.

(f) Compliance

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

(g) Applicable Service Bulletins

    Use the following service bulletin, as applicable to your
airplane model configuration, to perform the actions required by
paragraph (h) of this AD:
    (1) Bombardier Learjet 40 Service Bulletin 40-57-06, Revision 1,
dated October 26, 2020;
    (2) Bombardier Learjet 45 Service Bulletin 45-57-13, Revision 1,
dated October 26, 2020;
    (3) Bombardier Learjet 70 Service Bulletin 70-57-02, Revision 1,
dated October 26, 2020; or
    (4) Bombardier Learjet 75 Service Bulletin 75-57-01, Revision 2,
dated April 19, 2021.

(h) Wing Center Spar Inspection, Related Investigative Inspections, and
Corrective Actions

    At the applicable initial compliance time specified in paragraph
(h)(1) or (2) of this AD and thereafter at intervals not to exceed 8
years, inspect the center wing area for corrosion and deterioration
of protective treatments and perform all related corrective actions
by following the Accomplishment Instructions, steps 3.A. and 3.B.,
of the applicable service bulletin listed in paragraph (g) of this
AD.
    (1) For airplanes with 8 or fewer years since the date of
issuance of the original airworthiness certificate or the date of
issuance of the original export certificate of airworthiness,
whichever date is earlier: Before or upon accumulating 8 years or
within 12 months after the effective date of this AD, whichever
occurs later; or
    (2) For airplanes that have accumulated more than 8 years since
the date of issuance of the original airworthiness certificate or
the date of issuance of the original export certificate of
airworthiness, whichever date is earlier: Within 12 months after the
effective date of this AD.

(i) Service Information Exception

    Where Bombardier Learjet 40 Service Bulletin 40-57-06, Revision
1, dated October 26, 2020, Bombardier Learjet 45 Service Bulletin
45-57-13, Revision 1, dated October 26, 2020, Bombardier Learjet 70
Service Bulletin 70-57-02, Revision 1, dated October 26, 2020, and
Bombardier Learjet 75 Service Bulletin 75-57-01, Revision 2, dated
April 19, 2021, specify contacting Learjet Inc. for appropriate
action: Before further flight, repair using a method approved in
accordance with the procedures specified in paragraph (l) of this
AD.

(j) Reporting Requirement

    Within 30 days after completing the initial inspection required
by paragraph (h) of this AD or within 30 days after the effective
date of this AD, whichever occurs later, submit a report of the
findings (both positive and negative) of the inspection to: [email protected]; or Ann Johnson, Wichita ACO Branch, FAA, 1801 Airport
Road, Wichita, KS 67209. This reporting requirement is limited to
the initial inspection results only. The report must include: The
name of the owner; the address of the owner; the name of the
organization doing the actions required by this AD; the date the
inspection was completed; the name of the person submitting the
report; the address, telephone number, and email of the person
submitting the report; the airplane serial number; the date of
issuance of the original airworthiness certificate, or the date of
issuance of the original export certificate of airworthiness
(whichever date is earlier); whether protective treatments are
deteriorated, and if so, the location of deteriorated areas; whether
corrosion was detected, and if so, the location of corrosion; and a
list of parts replaced if the level of corrosion required
replacement of parts.

(k) Credit for Previous Actions

    You may take credit for the initial wing spar inspection
required by the introductory text to paragraph (h) of this AD if you
performed the visual inspection before the effective date of this AD
using Bombardier Learjet 40 Service Bulletin 40-57-06, Basic Issue,
dated February 25, 2019; Bombardier Learjet 40 Maintenance Manual
MM-105, Temporary Revision No. 4-32, Inspection Reference Number
AC5710190, dated March 25, 2021; Bombardier Learjet 40 Maintenance
Manual MM-105, Inspection Reference Number AB5710190, dated April
29, 2019, or November 14, 2019; Bombardier Learjet 45 Service
Bulletin 45-57-13, Basic Issue, dated February 25, 2019; Bombardier
Learjet 45 Maintenance Manual MM-104, Temporary Revision No. 4-47,
Inspection Reference Number AC5710190, dated March 25, 2021;
Bombardier Learjet 45 Maintenance Manual MM-104, Inspection
Reference Number AB5710190, dated April 29, 2019, or November 14,
2019; Bombardier Learjet 70 Service Bulletin 70-57-02, Basic Issue,
dated February 25, 2019; Bombardier Learjet 70/75 eINSPECTOR version
(2019.2.25) thru version (2021.4.23), Inspection Reference Number
5710190; Bombardier Learjet 75 Service Bulletin 75-57-01, Basic
Issue, dated February 25, 2019; or Bombardier Learjet 75 Service
Bulletin 75-57-01, Revision 1, dated October 26, 2020.
    (1) To take credit for the initial inspection, you must comply
with paragraph (j) of this AD within 30 days after the effective
date of this AD.
    (2) You cannot take credit for the recurring inspections, only
the initial inspection.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (m) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this

AD if it is approved by a Learjet Inc. Designated Engineering
Representative, or a Unit Member of the Learjet Organization
Designation Authorization, that has been authorized by the Manager,
Wichita ACO Branch, to make those findings. To be approved, the
repair, modification, or alteration method must meet the
certification basis of the airplane, and the approval must
specifically refer to this AD.

(m) Related Information

    For more information about this AD, contact Tara Shawn, Aviation
Safety Engineer, Wichita ACO Branch, FAA, 1801 Airport Road,
Wichita, KS 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Bombardier Learjet 40 Service Bulletin 40-57-06, Revision 1,
dated October, 26, 2020.
    (ii) Bombardier Learjet 45 Service Bulletin 45-57-13, Revision
1, dated October, 26, 2020.
    (iii) Bombardier Learjet 70 Service Bulletin 70-57-02, Revision
1, dated October, 26, 2020.
    (iv) Bombardier Learjet 75 Service Bulletin 75-57-01, Revision
2, dated April 19, 2021.
    (3) For service information identified in this AD, contact
Learjet Inc., One Learjet Way, Wichita, KS 67209; phone: (316) 946-
2000; email: [email protected]; website:
businessaircraft.bombardier.com/en/aircraft/learjet.html.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 901 Locust, Kansas
City, MO 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 28, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-26330 Filed 12-3-21; 8:45 am]
BILLING CODE 4910-13-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2060 0335 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NESHAP for the Printing and Publishing Industry ( 40 CFR part 63, subpart KK)

8. Agency form number( s) ( If applicable) EPA ICR Number 1739.04 9. Keywords Printing, rotogravure, flexographic, printing presses.

10. Abstract This standard applies to owners and operators of printing and publishing industry. The provision of this subpart applies to publication rotogravure, product and packaging rotogravure, or wide web flexographic printing presses located at major sources of hazardous air pollutants ( HAP). Respondents are required to submit reports, perform record keeping activities and maintain records of specific requirements needed by EPA to determine if compliance has been achieved in accordance with 40 CFR part 63, subpart KK.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 352 b. Total annual responses 508 1. Percentage of these responses collected electronically 20 _________ % c. Total hours requested 50,796 d. Current OMB inventory 52,495 e. Difference ( 1,699)

f. Explanation of difference 1. Program Change 2. Adjustment ( 1,699) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 7 b. Total annual costs ( O& M) 405 c. Total annualized cost requested 412 d. Current OMB inventory 403 e. Difference 9 f. Explanation of difference 1. Program change 2. Adjustment 9 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) Initially 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Learia Williams Phone: 202 564 4113 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


Accident Report Detail
Accident: 200781342 - Employee Killed In Fall Into Pit Of Hot Water And Chemicals
      Accident: 200781342 -- Report ID: 0626300 -- Event Date: 07/12/2000
                                  Inspection
                                   Open Date
                                      SIC
                              Establishment Name
300561644
08/04/2000
1771
B & C Concrete
Employee #1 was carrying a piece of concrete form past a 10 ft deep pit that contained water at 136 degrees F and with a pH of 10.5. He stumbled, tripped, and fell into the pit, sustaining chemical and thermal burns from contact with the hot chemical mixture. Employee #1 was killed. The form he was carrying had been used by coworkers as a cover for the pit.
Keywords: fall, pit, chemical, hot water, cover, tripped, chemical burn, burn, work rules, unguarded
                                    End Use
                                   Proj Type
                                   Proj Cost
                                    Stories
                                   NonBldgHt
                                   Fatality
Manufacturing plant
New project or new addition
$50,000 to $250,000
1
20
X
                                       #
                                  Inspection
                                      Age
                                      Sex
                                    Degree
                                    Nature
                                  Occupation
                                 Construction
1
300561644

Fatality
Burn(Chemical)
Occupation not reported
FallDist: 10
FallHt:10
Cause: Exterior masonry
FatCause: Fall, other

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

Accident Report Detail
      Accident: 120240411 - Employee Burned When Splashed With Chemicals
      Accident: 120240411 -- Report ID: 0950631 -- Event Date: 11/18/1999
                                  Inspection
                                   Open Date
                                      SIC
                              Establishment Name
120241773
02/04/2000
7363
Kimco Staffing Services
Early in the morning of November 18, 1999, Employee #1, a 19-year-old temporary worker, was on the graveyard shift as a parts washer at Textron Aerospace. At the start of the shift, his supervisor told him to add caustic soda to dip tank #1, which contained heated, 150 to 160 degrees F, aqueous sodium hydroxide, to adjust the liquid pH into the range between 11and 12. He weighed out approximately 49 lb of solid sodium hydroxide into a plastic container and then manually poured it directly into the tank. A chemical reaction occurred, and Employee #1's chest, face, and eyes were splashed with chemicals. Coworkers immediately helped him to flush himself with water from a nearby chemical safety shower and eye wash, and then he was transported to a local hospital for medial treatment. Employee #1 sustained chemical burns over approximately 15 percent of his body. Subsequent investigation revealed that he had been involved in a similar incident two months earlier that had not resulted in injury. Textron Aerospace had provided him with additional training to supplement previous training on the proper method and precautions of adding caustic soda to the tank. These precautions and procedures included remotely adding the caustic soda using a conveyor system, something he did not follow in either instance. The cause of this accident appears to be Employee #1 failing to follow proper procedures. The employer was cited for an accident-related violation for failing to ensure that proper body protection was worn.
Keywords: chemical, caustic, sodium hydroxide, chemical reaction, protective clothing, work rules, ppe, chemical burn, manual mat handling, face
                                       #
                                  Inspection
                                      Age
                                      Sex
                                    Degree
                                    Nature
                                  Occupation

1
120241773

Hospitalized injury
Burn(Chemical)
Occupation not reported

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

Accident Report Detail
            Accident: 201630829 - Employee Suffers Chemical Burns
      Accident: 201630829 -- Report ID: 1054191 -- Event Date: 11/06/1999
                                  Inspection
                                   Open Date
                                      SIC
                              Establishment Name
303129811
11/10/1999
1751
Under Construction Inc
Employee #1 and some coworkers were shoveling slurry from the laundry ring into the primary clarifier. The slurry had a pH of approximately 9.9. The laundry ring is an elevated ring, like a trough, encircling a large holding tank. The tank is called the primary clarifier. The primary clarifier separates the solid sludge from the liquids. All of the effluent pipes at this facility are pumped into the clarifier for separation. A breach was discovered leaking from the primary clarifier. Employee #1 suffered chemical burns on the lower extremities and was hospitalized.
      Keywords: leak, chemical, chemical burn, sludge, leg, maintenance
                                    End Use
                                   Proj Type
                                   Proj Cost
                                    Stories
                                   NonBldgHt
                                   Fatality
Manufacturing plant
Maintenance or repair
$50,000 to $250,000

                                       #
                                  Inspection
                                      Age
                                      Sex
                                    Degree
                                    Nature
                                  Occupation

1
303129811

Hospitalized injury
Burn(Chemical)
Helpers, construction trades

Accident Report Detail
  Accident: 200550200 - One Employee Killed, Four Injured, By Chemical Spill
      Accident: 200550200 -- Report ID: 0625700 -- Event Date: 10/31/1997
                                  Inspection
                                   Open Date
                                      SIC
                              Establishment Name
300398435
11/02/1997
2621
International Paper Company - Louisiana Mill
At approximately 10:00 a.m. on October 31, 1997, Employees #1 through #5 were near the north heavy black liquor storage tank. Black liquor is a highly corrosive combination of sodium hydroxide, sodium sulfide, wood fibers, and other components of negligible quantities, with a pH of between 12 and 14; in this tank, the mixture was 45 percent solids. The 40 ft diameter by 60 ft tall tank was on the east side of the facility and was receiving black liquor from the power plant during a normal boil-out of the concentrators. The liquor entered the tank from the side, at a height of approximately 8 ft, under 60 psi pressure, and at 295 degrees F, as opposed to the contents of the tank, which was at 235 degrees F. Steam at 60 psi and weak liquor also entered the tank through the same location during boil-out. On the day of the accident, the boil-out process started at approximately 7:45 a.m. and the liquid level in the tank rose dramatically over a short period of time. At about 8:00 a.m., the level started to rise from 36 to 45 ft; just prior to 10:00 a.m., the level spiked to 55 ft. It was normal for the liquor level to rise rapidly during the boil-out of the concentrators, which was done approximately every three weeks. During normal operations, black liquor circulated through the north heavy black liquor storage tank from the evaporators, with the level running at approx 37 ft. On this day, the tank had filled to approximately the 43 ft level, as indicated from control room readings, when it failed and ruptured at the 20 ft level. Approximately 300,000 gallons of the hot, heavy, black liquor was released. Employee #1 was coated with the material and was killed. Employees #2 and #5 suffered burns and were admitted to the LSU/Shreveport burn unit. Employees #3 and #4 were treated locally and released. The storage tank was an atmospheric tank constructed to API 650 standards and inspected using API 653. It was made of A36 carbon steel plate in 6 ft to 10 ft rings of various thickness ranging from 0.5 in. for the top course (#6) to 0.645 in. for the bottom course (#1), with a 08125 in. thick base. The tank was placed in service in 1992 and had been experiencing a high rate of corrosion (between 0.03 and 0.07 in. per year) on the interior surface. From 1992 until 1996, the company had used it only for black liquor, with flashing as the only major problem occurring. Since the liquor entered the tank from the top, flashing would occur near the outlet. The company solved this problem by installing a bell-shaped covering at the end of the inlet pipe. The company did not consider black liquor to be a covered process under the PSM standard.
Keywords: burn, tank, chemical burn, storage tank, rupture, equipment failure, spill, high temperature, accidental discharge, corrosive
                                       #
                                  Inspection
                                      Age
                                      Sex
                                    Degree
                                    Nature
                                  Occupation

1
300398435

Fatality
Burn(Chemical)
Machine operators, not specified

2
300398435

Hospitalized injury
Burn(Chemical)
Machinery maintenance occupations

3
300398435

Non Hospitalized injury
Burn(Chemical)
Electricians

4
300398435

Non Hospitalized injury
Burn(Chemical)
Supervisors, production occupations

5
300398435

Hospitalized injury
Burn(Chemical)
Chemical engineers

Accident Report Detail
    Accident: 170630495 - Employee Burned After Fall Into Molten Salt Bath
      Accident: 170630495 -- Report ID: 0950642 -- Event Date: 07/23/1995
                                  Inspection
                                   Open Date
                                      SIC
                              Establishment Name
119870095
08/01/1995
3316
Precision Specialty Metals
Employee #1, of Precision Speciality Metals, Inc., Los Angeles, CA, was lowering a large heavy metal cover onto an elevated opening atop a 7 ft high molten salt bath. The molten salt bath operates at 875 degrees Fahrenheit. It contains sodium hydroxide with a pH of 10 to 14. In an attempt to position himself better so that he could align the cover to the opening, Employee #1 stepped on a metal plate that he thought was welded. The plate gave way and he fell halfway into the molten salt bath. Employee #1 received chemical and thermal burns on both legs and was hospitalized.
Keywords: work rules, fall, unstable position, burn, sodium hydroxide, leg, chemical burn, high temperature
                                       #
                                  Inspection
                                      Age
                                      Sex
                                    Degree
                                    Nature
                                  Occupation

1
119870095

Hospitalized injury
Burn/Scald(Heat)
Supervisors, production occupations

------------------------------------------------------------------------------------------------------------------------------------------
Accident Report Detail
   Accident: 170670582 - One Employee Killed, One Burned When Pump Ruptures
      Accident: 170670582 -- Report ID: 0418400 -- Event Date: 05/07/1995
                                  Inspection
                                   Open Date
                                      SIC
                              Establishment Name
110098928
05/23/1995
2611
Browning Trucking
Employees #1 and #2 were attempting to pull a pump away from its casing. The impellers on the pump were in the casing. Employee #1 was between the pump and a 320,000 gal tank which was two-thirds full. A valve normally used to shut off the hydraulic pressure from a 12 in. pipe coming from the tank would not close. The liquid in the tank was 180 to 185 degrees Fahrenheit and had a pH level of 12 to 12 1/2. Employees #1 and #2 had left three to six bolts in the pump. Employee #2 obtained a pry bar and wedged it between the pump and its housing to move the pump away from its casing. The liquid pressure from the tank stripped the bolts out of the pump and pushed it out of its casing. Black liquid poured out of the casing like a fire hose onto the two employees. Employee #1 was burned over 55 percent of his body and was sent to a burn center, where he later died. Employee #2 was also burned, but was treated by the plant nurse after a local hospital had seen and released him on the day of the accident.
Keywords: chemical burn, high pressure, valve, equipment failure, work rules, struck by, pump, high temperature, burn, bolt
                                       #
                                  Inspection
                                      Age
                                      Sex
                                    Degree
                                    Nature
                                  Occupation

1
110098928

Fatality
Burn(Chemical)
Occupation not reported


[Federal Register: January 5, 2010 (Volume 75, Number 2)]
[Notices]
[Page 482-485]
[DOCID:fr05ja10-150]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61251; File No. SR-NYSE-2009-129]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by New York Stock Exchange LLC
Extending the Operative Date of NYSE Rule 92(c)(3) From December 31,
2009 to July 31, 2010

December 29, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on December 23, 2009, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is

publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the operative date of NYSE Rule
92(c)(3) from December 31, 2009 to July 31, 2010. The text of the
proposed rule change is available at the Exchange, on the Commission's
Web site at http://www.sec.gov, the Commission's Public Reference Room,
and http://www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to extend the delayed operative date of
NYSE Rule 92(c)(3) from December 31, 2009 to July 31, 2010. The
Exchange believes that this extension will provide the time necessary
for the Exchange and the Financial Industry Regulatory Authority, Inc.
(``FINRA'') to harmonize their respective rules concerning customer
order protection to achieve a standardized industry practice.
Background
    On July 5, 2007, the Commission approved amendments to NYSE Rule 92
to permit riskless principal trading at the Exchange.\4\ These
amendments were filed in part to begin the harmonization process
between Rule 92 and FINRA's Manning Rule.\5\ In connection with those
amendments, the Exchange implemented for an operative date of January
16, 2008, NYSE Rule 92(c)(3), which permits Exchange member
organizations to submit riskless principal orders to the Exchange, but
requires them to submit to a designated Exchange database a report of
the execution of the facilitated order. That rule also requires members
to submit to that same database sufficient information to provide an
electronic link of the execution of the facilitated order to all of the
underlying orders.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 34-56017 (July 5,
2007), 72 FR 38110 (July 12, 2007), SR-NYSE-2007-21.
    \5\ See NASD Rule 2111 and IM-2110-2.
---------------------------------------------------------------------------

    For purposes of NYSE Rule 92(c)(3), the Exchange informed member
organizations that when executing riskless principal transactions,
firms must submit order execution reports to the Exchange's Front End
Systemic Capture (``FESC'') database linking the execution of the
riskless principal order on the Exchange to the specific underlying
orders. The information provided must be sufficient for both member
firms and the Exchange to reconstruct in a time-sequenced manner all
orders, including allocations to the underlying orders, with respect to
which a member organization is claiming the riskless principal
exception.
    Because the rule change required both the Exchange and member
organizations to make certain changes to their trading and order
management systems, the NYSE filed to delay to May 14, 2008 the
operative date of the NYSE Rule 92(c)(3) requirements, including
submitting end-of-day allocation reports for riskless principal
transactions and using the riskless principal account type
indicator.\6\ The Exchange filed for additional extensions of the
operative date of Rule 92(c)(3), the most recent of which was an
extension to December 31, 2009.\7\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 56968 (Dec. 14,
2007), 72 FR 72432 (Dec. 20, 2007), SR-NYSE-2007-114.
    \7\ See Securities Exchange Act Release Nos. 57682 (Apr. 17,
2008), 73 FR 22193 (Apr. 24, 2008) (SR-NYSE-2008-29); 59621 (Mar.
23, 2009), 74 FR 14179 (Mar. 30, 2009) (SR-NYSE-2009-30); and 60396
(July 30, 2009), 74 FR 39128 [sic] (Aug. 5, 2009) (SR-NYSE-2009-73).
---------------------------------------------------------------------------

Request for Extension \8\
---------------------------------------------------------------------------

    \8\ NYSE Amex LLC has filed a companion rule filing to conform
its Equities Rules to the changes proposed in this filing. See SR-
NYSEAmex-2009-92, formally submitted December 23, 2009).
---------------------------------------------------------------------------

    FINRA and the Exchange have been working diligently on fully
harmonizing their respective rules, including reviewing the
possibilities for a uniform reporting standard for riskless principal
transactions. However, because of the complexity of the existing
customer order protection rules, including the need for input from
industry participants as well as Commission approval, the Exchange and
FINRA will not have harmonized their respective customer order
protection rules by the current December 31, 2009 date for the
implementation of the FESC riskless principal reporting.
    The Exchange notes that it has agreed with FINRA to pursue efforts
to harmonize customer order protection rules. As authorized by their
respective Boards, FINRA and NYSE Regulation, Inc. (``NYSE
Regulation'') have each published a Regulatory Notice/Information Memo
that solicited comments from their respective member participants on
the proposed harmonized approach to customer order protection.\9\
Because industry participants need to code their trading systems to
comply with customer order protection rules, the Exchange believes that
industry input is vital to ensuring that the approach to customer order
protection both meets regulatory needs of protecting customer orders,
but is also feasible technologically.
---------------------------------------------------------------------------

    \9\ See NYSE Regulation Information Memo 09-13 (March 12, 2009);
FINRA Regulatory Notice 09-15 (March 12, 2009).
---------------------------------------------------------------------------

    Both FINRA and NYSE Regulation have received comments from the
public on the Regulatory Notice and Information Memo, including
comments from industry forums such as Securities Industry and Financial
Markets Association (``SIFMA'') and the Financial Information Forum
(``FIF'') that each jointly addressed the FINRA and NYSE Regulation
proposals. The comments have generally supported efforts to harmonize
the FINRA and NYSE rules. Among issues raised in the comment letters,
however, is the concern that FINRA and NYSE have a harmonized approach
for reporting riskless principal transactions. In addition, commenters
note the need for an implementation period to develop any technology
that would be needed to comply with the proposed reporting standard.
    On December 10, 2009, FINRA filed with the Commission its rule
proposal to adopt a new industry standard for customer order protection
as proposed FINRA Rule 5320.\10\ That proposed filing is based on the
draft rule text that FINRA and NYSE Regulation each circulated to their
respective member participants and includes copies of the comment
letters that FINRA and NYSE Regulation received on the rule proposal.
The Exchange intends to adopt a new customer order protection rule that
is substantially identical to proposed FINRA Rule 5320.
---------------------------------------------------------------------------

    \10\ See SR-FINRA-2009-090 (December 10, 2009).
---------------------------------------------------------------------------

    The Exchange continues to believe that pending full harmonization
of the respective customer order protection rules, it would be
premature to require

firms to meet the current Rule 92(c)(3) FESC reporting
requirements.\11\ Indeed, having differing reporting standards for
riskless principal orders would be inconsistent with the overall goal
of the harmonization process.
---------------------------------------------------------------------------

    \11\ The Exchange notes that it would also need to make
technological changes to implement the proposed FESC reporting
solution for Rule 92(c)(3).
---------------------------------------------------------------------------

    Accordingly, to provide the Exchange and FINRA the time necessary
to obtain Commission approval for and implement a harmonized rule set
that would apply across their respective marketplaces, including a
harmonized approach to riskless principal trade reporting, the Exchange
is proposing to delay the operative date for NYSE Rule 92(c)(3) from
December 31, 2009 to July 31, 2010.
    Pending the harmonization of the two rules, the Exchange will
continue to require that, as of the date each member organization
implements riskless principal routing, the member organization have in
place systems and controls that allow them to easily match and tie
riskless principal execution on the Exchange to the underlying orders
and that they be able to provide this information to the Exchange upon
request. To make clear that this requirement continues, the Exchange
proposes to amend supplementary material .95 to Rule 92 to specifically
provide that the Rule 92(c)(3) reporting requirements are suspended
until July 31, 2010 and that member organizations are required to have
in place such systems and controls relating to their riskless principal
executions on the Exchange. Moreover, the Exchange will coordinate with
FINRA to examine for compliance with the rule requirements for those
firms that engage in riskless principal trading under Rule 92(c).
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Securities Exchange Act of 1934 (the ``Act''),\12\ in
general, and furthers the objectives of Section 6(b)(5) of the Act,\13\
in particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. The Exchange
believes the proposed extension provides the Exchange and FINRA the
time necessary to develop a harmonized rule concerning customer order
protection that will enable member organizations to participate in the
national market system without unnecessary impediments.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not:
    (i) Significantly affect the protection of investors or the public
interest;
    (ii) Impose any significant burden on competition; and
    (iii) Become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, if
consistent with the protection of investors and the public interest, it
has become effective pursuant to Section 19(b)(3)(A) of the Act \14\
and Rule 19b-4(f)(6) thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has requested the Commission to waive the 30-day
operative delay so that the Exchange can extend the operative date of
NYSE Rule 92(c)(3) without interruption. The Exchange notes that
extending the delayed operative date of Rule 92(c)(3) from December 31,
2009 to July 31, 2010 will provide sufficient time for the Exchange and
FINRA to obtain Commission approval for and implement a harmonized
approach to customer order protection rules, including how riskless
principal transactions should be reported. The Commission hereby grants
the Exchange's request and believes such waiver is consistent with the
protection of investors and the public interest.\16\ Accordingly, the
Commission designates the proposed rule change operative upon filing
with the Commission.
---------------------------------------------------------------------------

    \16\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2009-129 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2009-129. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal

office of the Exchange. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-NYSE-2009-129 and should be submitted on or before January 26, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-31271 Filed 1-4-10; 8:45 am]

BILLING CODE 8011-01-P


implementation plan to address the plan's deficiencies within one year
from this determination.

IV. What action is EPA proposing to take?

    EPA is proposing to approve New Hampshire's January 29, 2010
Regional Haze SIP revision, amended January 14, 2011, and August 26,
2011, as meeting the applicable implementing regulations found in 40
CFR 51.308. EPA is also proposing to approve, and incorporate into the
New Hampshire SIP, New Hampshire's regulation Env-A 2300 Mitigation of
Regional Haze and PSNH Merrimack Station Temporary Permit TP-0008 Flue
Gas Desulfurization System dated March 9, 2009, and reissued August 2,
2010, and July 8, 2011.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act 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 Clean Air Act.
Accordingly, this proposed 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 proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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 Clean Air Act; 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, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: February 15, 2012.
 H. Curtis Spalding,
Regional Administrator, EPA Region 1.
[FR Doc. 2012-4677 Filed 2-27-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 5, 2008 (Volume 73, Number 109)]
[Notices]
[Page 32029-32030]
[DOCID:fr05jn08-48]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0474] (formerly Docket No. 2005N-0210)

Agency Information Collection Activities; Proposed Collection;
Comment Request; Veterinary Feed Directive

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting and recordkeeping
requirements for distribution and use of Veterinary Feed Directive
drugs and animal feeds containing Veterinary Feed Directive drugs.

DATES:  Submit written or electronic comments on the collection of
information by August 4, 2008.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the

Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Veterinary Feed Directive--21 CFR Part 558 (OMB Control Number 0910-
0363)--Extension

    With passage of the Animal Drug Availability Act, Congress enacted
legislation establishing a new class of restricted feed use drugs
called Veterinary Feed Directive (VFD drugs). The VFD class of drugs
may be distributed without involving State pharmacy laws. Although
controls on the distribution and use of VFD drugs are similar to
controls for prescription drugs regulated under section 503(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 503(f), the
implementing VFD regulation under section 558.6 (21 CFR 558.6) is
tailored to the unique circumstances relating to the distribution of
medicated feeds. The content of the VFD is spelled out in the
regulation. All distributors of medicated feed containing VFD drugs
must notify FDA of their intent to distribute, and the distribution
records of all medicated feeds containing VFD must be maintained. The
VFD regulation ensures the protection of the public health while
enabling animal producers to obtain and use needed drugs as efficiently
and cost-effectively as possible.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Annual Frequency per      Total Annual
              21 CFR Section                 No. of Respondents          Response             Responses        Hours per Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)                                15,000                    25               375,000                   .25                93,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i) through (d)(1)(iii)                           300                     1                   300                   .25                    75
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(d)(1)(iv)                                               20                     1                    20                   .25                     5
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(d)(2)                                                1,000                     5                 5,000                   .25                 1,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.1(b)(9)                                                    1                     1                     1                  3.00                     3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                     16,321  ....................  ....................  ....................                95,083
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                            Annual Frequency per   Total Annual      Hours per
   21 CFR Section     No. of Recordkeepers      Recordkeeping         Records         Record        Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(c)(1) through                112,500                    10       1,125,000           .0167          18,788
 (c)(4)
----------------------------------------------------------------------------------------------------------------
558.6(e)(1) through                  5,000                    75         375,000           .0167           6,263
 (e)(4)
----------------------------------------------------------------------------------------------------------------
Total                              117,500  ....................  ..............  ..............          25,051
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of the times required for record preparation and
maintenance is based on agency communication with industry and agency
records and experience.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: May 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12648 Filed 6-4-08; 8:45 am]

BILLING CODE 4160-01-S