[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Notices]
[Pages 17448-17451]
[FR Doc No: 2011-7261]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0034]

Subpart A (``General Provisions'') and Subpart B (``Confined and
Enclosed Spaces and Other Dangerous Atmospheres in Shipyard
Employment''); Extension of the Office of Management and Budget's (OMB)
Approval of Information Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend OMB approval of the information collection requirements
specified in 29 CFR part 1915, subpart A (``General Provisions'') and
subpart B (``Confined and Enclosed Spaces and Other Dangerous
Atmospheres in Shipyard Employment'').

DATES: Comments must be submitted (postmarked, sent, or received) by
May 31, 2011.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit your comments and attachments
to the OSHA Docket Office, Docket No. OSHA-2011-0034, U.S. Department
of Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC
20210. Deliveries (hand, express mail, messenger, and courier service)
are accepted during the Department of Labor's and Docket Office's
normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2011-
0034). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You also may contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney, Directorate of Standards
and Guidance, OSHA, U.S. Department of Labor, Room N-3609, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the

Paperwork Reduction Act of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)).
    This program ensures that information is in the desired format,
reporting burden (time and costs) is minimal, collection instruments
are clearly understood, and OSHA's estimate of the information
collection burden is accurate. The Occupational Safety and Health Act
of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes information
collection by employers as necessary or appropriate for enforcement of
the OSH Act or for developing information regarding the causes and
prevention of occupational injuries, illnesses, and accidents (29
U.S.C. 657). The OSH Act also requires that OSHA obtain such
information with minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of efforts in obtaining information
(29 U.S.C. 657).
    The following is a description of the requirements in subparts A
and B that pertain to the collection and retention of information:

Designation (Sec.  1915.7(b)); and Recordkeeping (Sec.  1915.7(d))

    Paragraph (b)(2) states that employers must designate one or more
competent persons to perform required inspections and tests, unless a
Marine Chemist will do so. The paragraph also requires that employers
maintain a roster of designated competent persons or a statement that a
Marine Chemist will perform all required inspections and tests. In
addition, employers are to ensure that the rosters contain, at a
minimum, the employer's name, the name of the designated competent
persons, and the date the worker completed training as a competent
person. If requested, employers must make the roster or statement
available to workers, their representatives, OSHA compliance officers,
and representatives from the National Institute for Occupational Safety
and Health (NIOSH).
    Paragraph (d)(1) specifies that employers ensure that competent
persons, Marine Chemists, and Certified Industrial Hygienists (CIHs)
make a record of each inspection and test they conduct. The record of
the inspection or test must contain the employer's location; time,
date, and location of the inspected space; the operations performed;
test results; and any instructions. Paragraph (d)(2) requires that
employers post the record in the immediate vicinity of the inspected
space while workers are working in the space. Employers must maintain
the record in a file for at least three months after work in the space
is complete. In addition, paragraph (d)(3) requires that employers make
inspection and test records available, upon request, to workers, their
representatives, OSHA compliance officers, and NIOSH.

Oxygen Content (Sec.  1915.12(a)(1) and (a)(2)); Flammable Atmospheres
(Sec.  1915.12(b)(1) and (b)(2)); and Toxic, Corrosive, Irritant or
Fumigated Atmospheres and Residues (Sec.  1915.12(c)(1), (c)(2), and
(c)(3))

    Before a worker initially enters a space, paragraph (a)(1) requires
employers to ensure that a competent person visually inspects and tests
it to determine its atmospheric oxygen content. Spaces subject to this
requirement include:
    Sealed spaces, such as, but not limited to, coated and closed-up
spaces, and freshly painted non-ventilated spaces;
    Spaces that contain materials or residues of material that can
cause it to become oxygen deficient; spaces and adjacent spaces that
contain or have contained combustible or flammable liquids or gases, or
that contain or previously contained toxic, corrosive, or irritant
liquids, gases, or solids; and
    Fumigated and adjacent spaces.
    If the space has an oxygen-deficient atmosphere, paragraph (a)(2)
specifies that employers must label the space ``Not Safe for Workers.''
For oxygen-enriched spaces, the label must read ``Not Safe for
Workers--Not Safe for Hot Work.'' Employers must ventilate these spaces
with a sufficient volume and flow rate to maintain the oxygen content
at or above 19.5 percent and below 22.0 percent by volume, at which
point they may remove the warning label.
    Under paragraph (b)(1), employers must have a competent person
visually inspect a space or adjacent space for combustible or flammable
liquids or gases. If such liquids or gases are present, the competent
person must test the atmospheric concentration prior to worker entry.
If the concentration is equal to or greater than 10 percent of the
lower explosive limit (LEL), paragraph (b)(2) specifies that the
employer must label the space ``Not Safe for Workers--Not Safe for Hot
Work.'' Employers must provide ventilation at a volume and flow rate
that maintains the concentration of flammable vapors below 10 percent
of the LEL; the employer may remove the warning label when the vapors
reach this level.
    Paragraph (c)(1) mandates that if a space or adjacent space
contains or previously contained liquids, gases, or solids that are
toxic, corrosive, or an irritant, employers must have a competent
person visually inspect the space to determine whether these substances
are present. If so, the competent person must test the atmospheric
concentration before a worker may enter the space. Under paragraph
(c)(2), employers must label the space ``Not Safe for Workers'' if the
air concentration of these substances exceeds the permissible exposure
limit (PEL), specified by 29 CFR 1915, subpart Z (``Toxic and Hazardous
Substances''), or is immediately dangerous to life or health (IDLH).
Employers must provide a sufficient ventilation volume and flow rate to
maintain the atmospheric concentration at or below the PEL or below the
IDLH if there is no PEL, after which they may remove the warning
labels. Paragraph (c)(3) specifies that if, after ventilation, the
concentrations are not at or below the PEL or below the IDLH, employers
must have a Marine Chemist or CIH retest the space until they can
certify it as ``Enter with Restrictions'' or ``Safe for Workers.''

Training of Employees Entering Confined and Enclosed Spaces or Other
Dangerous Atmospheres and Training Certification Records (Sec.
1915.12(d))

    Paragraphs (d)(1) through (d)(4) require employers to train workers
who enter a confined and enclosed space or other dangerous atmospheres
so they can perform their duties safely. Workers must receive the
required training before they begin to work in a confined space, and if
a change in operations or their duties results in a new hazard not
previously addressed by the training. Employers must train workers to
recognize the characteristics of the confined space; anticipate and be
aware of the hazards that may be present in the space; recognize the
adverse health effects that exposure to these hazards may cause;
understand the physical signs and reactions that may result from
exposure to these hazards; know what personal protective equipment is
needed for safe entry into and exit from the space; and be aware of and
know the proper use of barriers that may be needed to protect workers
from the hazards. In addition, paragraph (d)(3) specifies that workers
be trained to exit the space if the employer or employer representative
orders an evacuation, an evacuation signal or alarm is activated, or
the worker perceives that a dangerous condition exists.
    Under paragraph (d)(5), employers must certify that each worker
received the required training in accordance with paragraphs (d)(1)
through (d)(4). The certification is to contain the worker's

name, the name of the certifier, and the certification date, and be
available for inspection by OSHA compliance officers, NIOSH, and
workers and their representatives.

Rescue Teams (Sec.  1915.12(e))

    Under paragraph (e), employers must establish a shipyard rescue
team, or arrange for an outside rescue team that will respond promptly
to a request for rescue service. For shipyard-based rescue teams,
paragraph (e)(1) specifies that employers must provide and train team
members to use personal protective equipment necessary to make a
rescue, train each team member to perform his/her rescue functions,
ensure that the team practices its skills at least annually, and have
at least one person on a team maintain current first-aid certification.
If employers use an outside rescue team, paragraph (e)(2) requires the
employer to inform the members of the team of the hazards they may
encounter when called to rescue workers from confined and enclosed
spaces or other dangerous atmospheres at the shipyard facility.

Exchanging Hazard Information Between Employers (Sec.  1915.12(f))

    If an employer has workers who work in confined and enclosed spaces
or other dangerous atmospheres, this paragraph requires the employer to
inform other employers whose workers may enter the same space, about
the hazards, safety rules, and emergency procedures concerning those
spaces and atmospheres.

Requirements for Performing Cleaning and Cold Work (Sec.
1915.13(b)(10))

    Paragraph (b)(2) requires that a competent person test the
concentration of flammable, combustible, toxic, corrosive, or irritant
vapors within the confined or enclosed space prior to workers beginning
cleaning or cold work. Paragraph (b)(3) specifies that continuous
ventilation must be provided at volumes and flow rates sufficient to
ensure that the concentration of flammable vapor is maintained below 10
percent of the LEL, and toxic, corrosive, or irritant vapors are
maintained within the PELs and below IDLH levels. Paragraph (b)(4)
requires that the competent person conduct testing of the confined or
enclosed space as often as necessary during cleaning or cold work to
ensure that air concentrations remain at the levels specified in
paragraph (b)(3).
    Paragraph (b)(7) requires that the competent person test
ventilation discharge areas and other areas where discharge vapors may
collect to determine whether those vapors are accumulating in
concentrations that are hazardous to workers. If accumulations are
hazardous, all work in the contaminated areas must be stopped until the
vapors have dissipated or been removed.
    Paragraph (b)(10) requires that employers post signs in a prominent
location that prohibit sources of ignition within or near a space that
previously contained flammable or combustible liquids or gases in bulk
quantities. Employers must post these signs at the entrance to the
space, in adjacent spaces, and in the open area adjacent to those
spaces.

Hot Work Requiring Testing by a Marine Chemist or Coast Guard
Authorized Person (Sec.  1915.14(a)(1) and (a)(2))

    Under paragraph (a)(1), employers must have a Marine Chemist or a
U.S. Coast Guard authorized person test and certify a work area as safe
for hot work if the area is in or on any of the following confined and
enclosed spaces and other dangerous atmospheres, boundaries of spaces,
or pipelines: within, on, or immediately adjacent to spaces that
contain or previously contained combustible or flammable liquids or
gases or fuel tanks that contain or previously contained fuel; or
pipelines, heating coils, pump fittings, or other accessories connected
to spaces that contain or previously contained fuel. Under paragraph
(a)(2), employers must post the certificate in the immediate vicinity
of the hot work operation while the operation is in progress. On
completion of the operation, they must file the certificate for at
least three months.

Hot Work Requiring Testing by a Competent Person (Sec.  1915.14(b)(1)
and (b)(2))

    Paragraph (b)(1) specifies that before starting any hot work in or
on the following spaces or adjacent spaces or other dangerous
atmospheres, employers must have a competent person test and determine
that the space does not contain concentrations of flammable vapors
equal to or greater than 10 percent of the LEL: Dry cargo holds;
bilges; engine rooms; boiler spaces; vessels and vessel sections; land-
side confined and enclosed spaces; or other dangerous atmospheres not
requiring certification by a Marine Chemist or Coast Guard authorized
person. If the concentration of flammable vapors or gases is equal to
or greater than 10 percent of the LEL in these or adjacent spaces,
paragraph (b)(2) specifies that the employer must label the space ``Not
Safe for Hot Work.'' Employers must provide ventilation in the space at
a volume and flow rate that maintains the concentration of flammable
vapors below 10 percent of the LEL, after which they may remove the
warning label.

Alteration of Existing Conditions (Sec.  1915.15(b))

    If a change occurs that may alter the atmospheric conditions within
a previously tested confined or enclosed space or other dangerous
atmosphere (e.g., opening a manhole or other closures, adjusting a
valve that regulates the flow of hazardous materials), paragraph (b)(2)
requires employers to stop work in the affected space or work area.
Work may only resume after the affected space or area is visually
inspected and retested and found to comply with the requirements of the
subpart (Sec. Sec.  1915.12, 1915.13, 1915.14).

Tests To Maintain the Conditions of a Marine Chemist's or Coast Guard
Authorized Person's Certificates (Sec.  1915.15(c))

    This paragraph requires employers to ensure that a competent person
visually inspect and test each space certified as ``Safe for Workers''
or ``Safe for Hot Work'' as often as necessary to ensure that the
atmospheric conditions in the space are maintained within the
conditions established by the issued certificate.

Change in the Conditions of a Marine Chemist's or Coast Guard
Authorized Person's Certificates (Sec.  1915.15(d))

    If a competent person finds that the atmospheric conditions in a
certified space fail to meet the applicable requirements of the
subpart, employers must stop work in the space until a Marine Chemist
or Coast Guard authorized person retests the space and issues a new
certificate.

Tests To Maintain a Competent Person's Findings (Sec.  1915.15(e)); and
Changes in the Conditions Determined by a Competent Person's Findings
(Sec.  1915.15(f))

    Paragraph (e) specifies that after a competent person conducts the
required initial visual inspection and tests and determines that a
space is safe for worker entry, employers must ensure that the required
atmospheric conditions are being maintained by having a competent
person continue to test and visually inspect the space as often as
necessary. Paragraph (f) specifies that if the atmospheric conditions
do not meet the requirements of the subpart, employers must stop

work in the space until conditions in the space are brought into
compliance.

Warning Signs and Labels (Sec.  1915.16)

    This paragraph establishes protocols for preparing signs and labels
required in previous paragraphs.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the collection
of information (paperwork) requirements necessitated by Subpart A
(``General Provisions'') and Subpart B (``Confined and Enclosed Spaces
and Other Dangerous Atmospheres in Shipyard Employment'') of 29 CFR
part 1915. The Agency is requesting an adjustment decrease of 10 burden
hours (from 312,774 to 312,764 hours). This decrease is due to a drop
in the job opening and labor turnover rate from 3.7 percent to 3.2
percent. The Agency will summarize the comments submitted in response
to this notice and will include this summary in its request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Subpart A (``General Provisions'') and Subpart B (``Confined
and Enclosed Spaces and Other Dangerous Atmospheres in Shipyard
Employment'') (29 CFR part 1915).
    OMB Number: 1218-0011.
    Affected Public: Business or other for-profits; Not-for-profit
organizations; Federal Government; State, Local or Tribal Government.
    Frequency: On occasion.
    Average Time per Response: Varies from 10 minutes (.17 hour) for a
secretary to maintain a training certification record to 10 minutes
(.17 hour) for a supervisory shipyard production worker to update,
maintain and post either the required roster or statement at each
shipyard.
    Estimated Total Burden Hours: 312,764.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for this ICR (Docket No. OSHA-2011-0034).
You may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or a facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and docket number so the Agency can attach them to
your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger or courier service, please contact the OSHA
Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site, and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 4-2010
(75 FR 55355).

    Signed at Washington, DC on March 23, 2011.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2011-7261 Filed 3-28-11; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13339-13343]
[FR Doc No: 2012-5302]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0169]

Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: Under the Food and Drug Administration Modernization Act of
1997 (Modernization Act), the Food and Drug Administration (FDA) is
required to report annually in the Federal Register on the status of
postmarketing requirements and commitments required of, or agreed upon
by, holders of approved drug and biological products. This notice is
the Agency's report on the status of the studies and clinical trials
that applicants have agreed to, or are required to, conduct.

FOR FURTHER INFORMATION CONTACT: Meg Pease-Fye, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4156, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Modernization Act

    Section 130(a) of the Modernization Act (Pub. L. 105-115) amended
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a new
provision requiring reports of certain postmarketing studies, including
clinical trials, for human drug and biological products (section 506B
of the FD&C Act (21 U.S.C. 356b)). Section 506B of the FD&C Act
provides FDA with additional authority to monitor the progress of a
postmarketing study or clinical trial that an applicant has been
required to, or has agreed to, conduct by requiring the applicant to
submit a report annually providing information on the status of the
postmarketing study/clinical trial. This report must also include
reasons, if any, for failure to complete the study/clinical trial.
These studies and clinical trials are intended to further define the
safety, efficacy, or optimal use of a product, and therefore play a
vital role in fully characterizing the product.
    Under the Modernization Act, commitments to conduct postmarketing
studies or clinical trials included both studies/clinical trials that
applicants agreed to conduct, as well as studies/clinical trials that
applicants were required to conduct under FDA regulations.\1\
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    \1\ Before passage of the Food and Drug Administration
Amendments Act of 2007 (FDAAA), FDA could require postmarketing
studies and clinical trials under the following circumstances: To
verify adn describe clinical benefit for a human drug approved in
accordance with the accelerated approval provisions in section
506(b)(2)(A) of the FD&C Act (21 CFR 314.510 and 601.41); for a drug
approved on the basis of animal efficacy data because human efficacy
trials are not ethical or feasible (21 CFR 314.610(b)(1) and
601.91(b)(1)): and for marketed drugs that not adequately labeled
for children under section 505B of the FD&C Act (Pediatric Research
Equity Act (21 U.S.C. 355c; Pub. L. 108-155)).
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B. The Food and Drug Administration Amendments Act of 2007

    On September 27, 2007, the President signed Public Law 110-85, the
Food and Drug Administration Amendments Act of 2007 (FDAAA). Section
901, in Title IX of FDAAA, created a new section 505(o) of the FD&C Act
authorizing FDA to require certain studies and clinical trials for
human drug and biological products approved under section 505 of the
FD&C Act or section 351 of the Public Health Service Act. Under FDAAA,
FDA has been given additional authority to require applicants to
conduct and report on postmarketing studies and clinical trials to
assess a known serious risk, assess signals of serious risk, or
identify an unexpected serious risk related to the use of a product.
This new authority became effective on March 25, 2008. FDA may now take
enforcement action against applicants who fail to conduct studies and
clinical trials required under FDAAA, as well as studies and clinical
trials required under FDA regulations (see sections 505(o)(1), 502(z),
and 303(f)(4) of the FD&C Act (21 U.S.C. 355(o)(1), 352(z), and
333(f)(4))).
    Although regulations implementing the Modernization Act
postmarketing authorities use the term ``postmarketing commitment'' to
refer to both required

studies and studies applicants agree to conduct, in light of the new
authorities enacted in FDAAA, FDA has decided it is important to
distinguish between enforceable postmarketing requirements and
unenforceable postmarketing commitments. Therefore, in this notice and
report, FDA refers to studies/clinical trials that an applicant is
required to conduct as ``postmarketing requirements'' (PMRs) and
studies/clinical trials that an applicant agrees to but is not required
to conduct as ``postmarketing commitments'' (PMCs). Both are addressed
in this notice and report.

C. FDA's Implementing Regulations

    On October 30, 2000 (65 FR 64607), FDA published a final rule
implementing section 130 of the Modernization Act. This rule modified
the annual report requirements for new drug applications (NDAs) and
abbreviated new drug applications (ANDAs) by revising Sec.
314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The rule also created a
new annual reporting requirement for biologics license applications
(BLAs) by establishing Sec.  601.70 (21 CFR 601.70). The rule described
the content and format of the annual progress report, and clarified the
scope of the reporting requirement and the timing for submission of the
annual progress reports. The rule became effective on April 30, 2001.
The regulations apply only to human drug and biological products
approved under NDAs, ANDAs, and BLAs. They do not apply to animal drugs
or to biological products regulated under the medical device
authorities.
    The reporting requirements under Sec. Sec.  314.81(b)(2)(vii) and
601.70 apply to PMRs and PMCs made on or before the enactment of the
Modernization Act (November 21, 1997), as well as those made after that
date. Therefore, studies and clinical trials required under FDAAA are
covered by the reporting requirements in these regulations.
    Sections 314.81(b)(2)(vii) and 601.70 require applicants of
approved drug and biological products to submit annually a report on
the status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study/clinical trial either
required by FDA or that they have committed to conduct, either at the
time of approval or after approval of their NDA, ANDA, or BLA. The
status of PMCs concerning chemistry, manufacturing, and production
controls and the status of other studies/clinical trials conducted on
an applicant's own initiative are not required to be reported under
Sec. Sec.  314.81(b)(2)(vii) and 601.70 and are not addressed in this
report. It should be noted, however, that applicants are required to
report to FDA on these commitments made for NDAs and ANDAs under Sec.
314.81(b)(2)(viii). Furthermore, section 505(o)(3)(E) of the FD&C Act,
as amended by FDAAA, requires that applicants report periodically on
the status of each required study/clinical trial and each study/
clinical trial ``otherwise undertaken * * * to investigate a safety
issue * * *.''
    According to the regulations, once a PMR has been required, or a
PMC has been agreed upon, an applicant must report on the progress of
the PMR/PMC on the anniversary of the product's approval until the PMR/
PMC is completed or terminated and FDA determines that the PMR/PMC has
been fulfilled or that the PMR/PMC is either no longer feasible or
would no longer provide useful information. The annual progress report
must include a description of the PMR/PMC, a schedule for completing
the PMR/PMC, and a characterization of the current status of the PMR/
PMC. The report must also provide an explanation of the PMR/PMC status
by describing briefly the progress of the PMR/PMC. A PMR/PMC schedule
is expected to include the actual or projected dates for the following:
(1) Submission of the final protocol to FDA, (2) completion of the
study/clinical trial, and (3) submission of the final report to FDA.
The status of the PMR/PMC must be described in the annual report
according to the following definitions:
     Pending: The study/clinical trial has not been initiated
(i.e., no subjects have been enrolled or animals dosed), but does not
meet the criteria for delayed (i.e., the original projected date for
initiation of subject accrual or initiation of animal dosing has not
passed);
     Ongoing: The study/clinical trial is proceeding according
to or ahead of the original schedule;
     Delayed: The study/clinical trial is behind the original
schedule;
     Terminated: The study/clinical trial was ended before
completion, but a final report has not been submitted to FDA; or
     Submitted: The study/clinical trial has been completed or
terminated, and a final report has been submitted to FDA.
    Databases containing information on PMRs/PMCs are maintained at the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER).

II. Summary of Information From Postmarketing Status Reports

    This report, published to fulfill the annual reporting requirement
under the Modernization Act, summarizes the status of PMRs and PMCs as
of September 30, 2011. If a requirement or commitment did not have a
schedule, or a postmarketing progress report was not received in the
previous 12 months, the PMR/PMC is categorized according to the most
recent information available to the Agency.\2\
---------------------------------------------------------------------------

    \2\ Although the data included in this report do not include a
summary of reports that applicants have failed to file by their due
date, the Agency notes that it may take appropriate regulatory
action in the event reports are not filed on a timely basis.
---------------------------------------------------------------------------

    Information in this report covers any PMR/PMC that was made, in
writing, at the time of approval or after approval of an application or
a supplement to an application, including PMRs required under FDAAA
(section 505(o)(3) of the FD&C Act), PMRs required under FDA
regulations (e.g., PMRs required to demonstrate clinical benefit of a
product following accelerated approval (see footnote 1 of this
document)), and PMCs agreed to by the applicant.
    Information summarized in this report includes the following: (1)
The number of applicants with open (uncompleted) PMRs/PMCs, (2) the
number of open PMRs/PMCs, (3) the status of open PMRs/PMCs as reported
in Sec.  314.81(b)(2)(vii) or Sec.  601.70 annual reports, (4) the
status of concluded PMRs/PMCs as determined by FDA, and (5) the number
of applications with open PMRs/PMCs for which applicants did not submit
an annual report within 60 days of the anniversary date of U.S.
approval.
    Additional information about PMRs/PMCs submitted by applicants to
CDER and CBER is provided on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.'' Neither the Web site nor
this notice include information about PMCs concerning chemistry,
manufacturing, and controls. It is FDA policy not to post information
on the Web site until it has been reviewed for accuracy. Numbers
published in this notice cannot be compared with the numbers resulting
from searches of the Web site because this notice incorporates totals
for all PMRs/PMCs in FDA databases, including PMRs/PMCs undergoing
review for accuracy. In addition, the report in this notice will be
updated annually while the Web site is updated quarterly (i.e., in
January, April, July, and October).

    Many applicants have more than one approved product and for many
products there is more than one PMR or PMC. Specifically, there were
175 unique applicants with 198 NDAs/ANDAs that had open PMRs/PMCs.
There were 72 unique applicants with 99 BLAs that had open PMRs/PMCs.
    Annual status reports are required to be submitted for each open
PMR/PMC within 60 days of the anniversary date of U.S. approval of the
original application. In fiscal year 2011 (FY11), 21 percent (43/208)
of NDA/ANDA and 41 percent (41/99) of BLA annual status reports were
not submitted within 60 days of the anniversary date of U.S. approval
of the original application. Of the annual status reports due but not
submitted on time, 100 percent of the NDA/ANDA and 56 percent (23/41)
of the BLA reports were submitted before the close of FY11 (September
30, 2011).
    Most PMRs are progressing on schedule (87 percent for NDAs/ANDAs;
88 percent for BLAs). Most PMCs are also progressing on schedule (80
percent for NDAs/ANDAs; 75 percent for BLAs). Most of the PMCs that are
currently listed in the database were developed before the
postmarketing requirements section of FDAAA took effect.\3\
---------------------------------------------------------------------------

    \3\ There are existing PMCs established before FDAAA that might
meet current FDAAA standards for required safety studies/clinical
trials under section 505(o)(3)(B) of the FD&C Act. Under section
505(o)(3)(c) of the FD&C Act, the Agency may convert pre-existing
PMCs into PMRs if it becomes aware of new safety information.
---------------------------------------------------------------------------

III. About This Report

    This report provides six separate summary tables. The tables in
this document distinguish between PMRs and PMCs and between on-schedule
and off-schedule PMRs and PMCs according to the original schedule
milestones. On-schedule PMRs/PMCs are categorized as pending, ongoing,
or submitted. Off-schedule PMRs/PMCs that have missed one of the
original milestone dates are categorized as delayed or terminated. The
tables include data as of September 30, 2011.
    Table 1 of this document provides an overall summary of the data on
all PMRs and PMCs. Tables 2 and 3 of this document provide detail on
PMRs. Table 2 of this document provides additional detail on the status
of on-schedule PMRs.
    Table 1 of this document shows that most PMRs (87 percent for NDAs/
ANDAs and 88 percent for BLAs) and most PMCs (80 percent for NDAs/ANDAs
and 75 percent for BLAs) are on schedule. Overall, of the PMRs that are
pending (i.e. , have not been initiated), 92 percent were created
within the past 3 years. Table 2 of this document shows that 49 percent
of pending PMRs for drug and biological products are in response to the
Pediatric Research and Equity Act (PREA), under which FDA requires
sponsors to study new drugs, when appropriate, for pediatric
populations. Under section 505B(a)(3) of the FD&C Act, the initiation
of these studies generally is deferred until required safety
information from other studies has first been submitted and reviewed.
PMRs for products approved under the animal efficacy rule (21 CFR
314.600 for drugs; 21 CFR 601.90 for biological products) can be
conducted only when the product is used for its indication as a
counterterrorism measure. In the absence of a public health emergency,
these studies/clinical trials will remain pending indefinitely. The
next largest category of pending PMRs for drug and biological products
(49 percent) comprises those studies/clinical trials required by FDA
under FDAAA, which became effective on March 25, 2008.
    Table 3 of this document provides additional detail on the status
of off-schedule PMRs. The majority of off-schedule PMRs (which account
for 13 percent of the total for NDAs/ANDAs and 12 percent for BLAs) are
delayed according to the original schedule milestones (98 percent (83/
85) for NDAs/ANDAs; 95 percent (20/21) for BLAs). In certain
situations, the original schedules may have been adjusted for
unanticipated delays in the progress of the study/clinical trial (e.g.
, difficulties with subject enrollment in a trial for a marketed drug
or need for additional time to analyze results). In this report, study/
clinical trial status reflects the status in relation to the original
study/clinical trial schedule regardless of whether FDA has
acknowledged that additional time may be required to complete the
study/clinical trial.
    Tables 4 and 5 of this document provide additional detail on the
status of PMCs. Table 4 of this document provides additional detail on
the status of on-schedule PMCs. Pending PMCs comprise 48 percent (141/
295) of the on-schedule NDA/ANDA PMCs and 39 percent (81/209) of the
on-schedule BLA PMCs.
    Table 5 of this document provides additional details on the status
of off-schedule PMCs. The majority of off-schedule PMCs (which account
for 20 percent for NDAs/ANDAs and 25 percent for BLAs) are delayed
according to the original schedule milestones (93 percent (69/74) for
NDAs/ANDAs; 97 percent (69/71) for BLAs). As noted previously in this
document, this report reflects the original due dates for study/
clinical trial results and does not reflect discussions between the
Agency and the sponsor regarding studies/clinical trials that may
require more time for completion.
    Table 6 of this document provides details about PMRs and PMCs that
were concluded in the previous year. The majority of concluded PMRs and
PMCs were fulfilled (70 percent of NDA/ANDA PMRs and 84 percent of BLA
PMRs; 85 percent of NDA/ANDA PMCs and 80 percent of BLA PMCs).

     Table 1--Summary of Postmarketing Requirements and Commitments
                   [Numbers as of September 30, 2011]
------------------------------------------------------------------------
                                             NDA/ANDA
                                            (percent of    BLA (percent
                                           total PMR or    of total PMR
                                            percent of     or percent of
                                            total PMC)    total PMC) \1\
------------------------------------------------------------------------
Number of open PMRs.....................            675             176
    On-schedule open PMRs (see table 2         590 (87%)       155 (88%)
     of this document)..................
    Off-schedule open PMRs (see table 3         85 (13%)        21 (12%)
     of this document)..................
Number of open PMCs.....................            369             280
    On-schedule open PMCs (see table 4         295 (80%)       209 (75%)
     of this document)..................

    Off-schedule open PMCs (see table 5         74 (20%)        71 (25%)
     of this document)..................
------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain
  therapeutic products formerly regulated by CBER into CDER.
  Consequently, CDER now reviews many BLAs. Fiscal year statistics for
  postmarketing requirements and commitments for BLAs reviewed by CDER
  are included in BLA totals in this table.

       Table 2--Summary of On-Schedule Postmarketing Requirements
                   [Numbers as of September 30, 2011]
------------------------------------------------------------------------
                                             NDA/ANDA      BLA (percent
          On-Schedule open PMRs             (percent of    of total PMR)
                                            Total PMR)          \1\
------------------------------------------------------------------------
Pending (by type):
    Accelerated approval................              8               1
    PREA \2\............................            238              34
    Animal efficacy \3\.................              1               0
    FDAAA safety (since March 25, 2008).            199              72
                                         -------------------------------
        Total...........................       446 (66%)       107 (61%)
Ongoing:
    Accelerated approval................             13               9
    PREA \2\............................             35               5
    Animal efficacy \3\.................              0               0
    FDAAA safety (since March 25, 2008).             41              23
                                         -------------------------------
        Total...........................        89 (13%)        37 (21%)
Submitted:
    Accelerated approval................              3               2
    PREA \2\............................             24               4
    Animal efficacy \3\.................              0               0
    FDAAA safety (since March 25, 2008).             28               5
                                         -------------------------------
        Total...........................         55 (8%)         11 (6%)
                                         -------------------------------
            Combined total..............       590 (87%)       155 (88%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
\2\ Many PREA studies have a pending status. PREA studies are usually
  deferred because the product is ready for approval in adults.
  Initiation of these studies also may be deferred until additional
  safety information from other studies has first been submitted and
  reviewed.
\3\ PMRs for products approved under the animal efficacy rule (21 CFR
  314.600 for drugs; 21 CFR 601.90 for biological products) can be
  conducted only when the product is used for its indication as a
  counterterrorism measure. In the absence of a public health emergency,
  these studies/clinical trials will remain pending indefinitely.

       Table 3--Summary of Off-Schedule Postmarketing Requirements
                   [Numbers as of September 30, 2011]
------------------------------------------------------------------------
                                             NDA/ANDA      BLA (percent
         Off-Schedule open PMRs             (percent of    of total PMR)
                                            total PMR)          \1\
------------------------------------------------------------------------
Delayed:
    Accelerated approval................               5               2
    PREA................................              64              12
    Animal efficacy.....................               1               0
    FDAAA safety (since March 25, 2008).              13               6
                                         -------------------------------
        Total...........................        83 (12%)        20 (11%)
Terminated..............................        2 (0.3%)        1 (0.6%)
                                         -------------------------------
        Combined total..................        85 (13%)        21 (12%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

        Table 4--Summary of On-Schedule Postmarketing Commitments
                   [Numbers as of September 30, 2011]
------------------------------------------------------------------------
                                             NDA/ANDA      BLA (percent
          On-Schedule open PMCs             (percent of    of total PMC)
                                            total PMC)          \1\
------------------------------------------------------------------------
Pending.................................       141 (38%)        81 (29%)
Ongoing.................................        77 (21%)        72 (26%)
Submitted...............................        77 (21%)        56 (20%)
                                         -------------------------------
    Combined total......................       295 (80%)       209 (75%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

       Table 5--Summary of Off-Schedule Postmarketing Commitments
                   [Numbers as of September 30, 2011]
------------------------------------------------------------------------
                                             NDA/ANDA      BLA (percent
         Off-Schedule open PMCs             (percent of    of total PMC)
                                            total PMC)          \1\
------------------------------------------------------------------------
Delayed.................................        69 (19%)        69 (25%)
Terminated..............................          5 (1%)        2 (0.7%)
                                         -------------------------------
    Combined total......................        74 (20%)        71 (25%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

Table 6--Summary of Concluded Postmarketing Requirements and Commitments
                  [October 1, 2010 to October 1, 2011]
------------------------------------------------------------------------
                                             NDA/ANDA
                                            (percent of    BLA (percent
                                              total)       of total) \1\
------------------------------------------------------------------------
Concluded PMRs:
    Requirement met (fulfilled).........        55 (70%)        16 (84%)
    Requirement not met (released and           21 (27%)          0 (0%)
     new revised requirement issued)....
    Requirement no longer feasible or             3 (4%)         3 (16%)
     product withdrawn (released).......
                                         -------------------------------
        Total...........................              79              19
Concluded PMCs:
    Commitment met (fulfilled)..........       109 (85%)        44 (80%)
    Commitment not met (released and new         12 (9%)          2 (4%)
     revised requirement/commitment
     issued)............................
    Commitment no longer feasible or              7 (5%)         9 (16%)
     product withdrawn (released).......
                                         -------------------------------
        Total...........................             128              55
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.

    Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
 [FR Doc. 2012-5302 Filed 3-5-12; 8:45 am]
BILLING CODE 4160-01-P


March 31, 2006

Ms. Deborah Edwards

Director

Special Review and Reregistration

US Environmental Protection Agency

Office of Pesticide Programs (7508C)

Ariel Rios Building

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460

Re: Azinphos Methyl Ecological Risk Assessment

Dear Ms. Edwards:

The U.S. Apple Association (USApple) is the national trade association
representing all segments of the apple industry.  Members include 36
state apple associations representing 7,500 apple growers throughout the
country, as well as over 300 individual firms involved in the apple
business.  The apple industry is interested in assisting the agency in
its efforts to protect the environment while finding a way to provide
apple growers with effective and affordable tools to control important
insect pests.  The purpose of this letter is to discuss potential
additional mitigations that the apple industry would be willing to
consider.

By way of background, the apple industry has already agreed to
significant restrictions on the use of azinphos methyl, which have
contributed to substantive environmental risk reduction.  Effective Dec.
31, 1999 the apple industry agreed to reduce maximum yearly azinphos
methyl use from 6 lbs to 4.5 lbs of active ingredient, increase the
pre-harvest interval to 21days if the last application is greater than 1
lb. of active ingredient and eliminate chemigation and fixed wing aerial
applications.

In 2002, the apple industry agreed to further restrictions on the
azinphos methyl use including establishing a 30 day preharvest interval
for “pick your own” operations, limiting total annual use to 4 lbs.
of active ingredient, increasing the reentry interval from 7 days to 14
days for all activities, requiring closed mixing systems or water
soluble bags and closed transfer systems for mixing and loading
activities, requiring maximum personal protective equipment for
applicators, prohibiting aerial applications, prohibiting dormant use
and adding a 25-foot buffer between orchards and permanent surface
water.

The apple industry also agreed to additional label language to reduce
spray drift by instructing growers to direct applications into the
canopy and turn off outward pointing nozzles at row ends and when
spraying the outer two rows.

In addition to these measures, the apple industry would agree to the
following mitigation to allow apple growers continued access to this
important tool:

Increase the ground cover buffer between orchards and permanent bodies
of water from 25 feet to 60 feet

Reduce the total seasonal use of azinphos methyl from 4 lbs. to 3 lbs of
active ingredient, which is equivalent to reducing the full product use
from 8 lbs. to 6 lbs.

USApple also plans to seek program support funding in the 2007 Farm Bill
to help apple growers transition to spray equipment that has a greater
capacity to reduce spray drift.  This assistance would augment the
transition growers are already making to “smart sprayers” that have
the capacity to turn off spray nozzles when gaps are detected in tree
rows or canopy.  Additionally, USApple plans to explore ways that apple
growers could access U.S. Department of Agriculture programs that
enhance water quality and prevent runoff.

We look forward to discussing this issue with you further, and would
welcome the opportunity to answer questions you might have about this
proposal.

Please contact me by telephone at<PHONE_NUMBER> or via e-mail at
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

Sincerely yours,

James R. Cranney, Jr.

Vice President

cc: USApple Board of Trustees

703 442-8850

800 781-4443

fax<PHONE_NUMBER>

Web site www.usapple.org

8233 Old Courthouse Road, Suite 200  (  Vienna, VA 22182-3816 USA


[Federal Register Volume 80, Number 58 (Thursday, March 26, 2015)]
[Notices]
[Page 16047]
[FR Doc No: 2015-06892]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74559; File No. SR-NYSEArca-2014-100]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change, as
Modified by Amendment No. 1 Thereto, Relating To Listing and Trading of
Shares of the SPDR SSgA Global Managed Volatility ETF Under NYSE Arca
Equities Rule 8.600

March 20, 2015.
    On September 5, 2014, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the SPDR SSgA Global Managed Volatility ETF (``Fund'') under
NYSE Arca Equities Rule 8.600. The proposed rule change was published
for comment in the Federal Register on September 24, 2014.\3\ On
November 4, 2014, pursuant to Section 19(b)(2) of the Act,\4\ the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\5\ On December 22, 2014, the Commission instituted proceedings
under Section 19(b)(2)(B) of the Act \6\ to determine whether to
approve or disapprove the proposed rule change.\7\ In the Order
Instituting Proceedings, the Commission solicited responses to
specified matters related to the proposal.\8\ The Commission received
no comment letters on the proposed rule change. The Exchange
subsequently filed Amendment No. 1 to the proposed rule change.\9\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 73141 (Sept. 18,
2014), 79 FR 57161 (``Notice'').
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 73515, 79 FR 66758
(Nov. 10, 2014). The Commission designated a longer period within
which to take action on the proposed rule change and designated
December 23, 2014 as the date by which it should approve,
disapprove, or institute proceedings to determine whether to
disapprove the proposed rule change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 73914, 79 FR 78524
(Dec. 30, 2014) (``Order Instituting Proceedings''). Specifically,
the Commission instituted proceedings to allow for additional
analysis of the proposed rule change's consistency with Section
6(b)(5) of the Act, which requires, among other things, that the
rules of a national securities exchange be ``designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade,'' and ``to protect investors and the
public interest.'' See id., 79 FR at 78530.
    \8\ See id. (specifically soliciting comment on the statements
of the Exchange contained in the Notice, including the statements
made in connection with information sharing procedures with respect
to certain non-U.S. equity security holdings and the Exchange's
arguments regarding the applicability of the definition of
``Actively-Traded Securities'' under Regulation M (``Reg M'')).
    \9\ See Letter from Martha Redding, Senior Counsel and Assistant
Secretary, New York Stock Exchange, to Kevin M. O'Neill, Deputy
Secretary, Commission (dated Jan. 22, 2015). Amendment No. 1
replaces and supersedes SR-NYSEArca-2014-100 in its entirety as
originally filed. In Amendment No. 1, the Exchange: (a) Deletes the
statement in the original filing that the exchange-listed and traded
equity securities in which the Fund's portfolio would be permitted
to invest would be limited to: (1) Equity securities that trade in
markets that are members of the Intermarket Surveillance Group
(``ISG'') or are parties to a comprehensive surveillance sharing
agreement (``CSSA'') with the Exchange, or (2) ``Actively-Traded
Securities'' as defined in Reg M under the Act that are traded on
U.S. and non-U.S. exchanges with last sale reporting; (b) represents
that the Fund's non-U.S. equity securities holdings will be subject
quantitative criteria that are substantially identical to the
``generic'' listing criteria in NYSE Arca Equities Rule 5.2(j)(3),
Commentary .01(a)(B), relating to an index or portfolio of U.S. and
non-U.S. stocks underlying a series of Investment Company Units; and
(c) deletes discussion relating to information sharing procedures in
the absence of CSSAs with, or ISG membership of, markets on which
``Actively-Traded Securities'' are listed or traded.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \10\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of the filing of the proposed rule
change. The Commission may, however, extend the period for issuing an
order approving or disapproving the proposed rule change by not more
than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on September 24, 2014.\11\ The 180th day after
publication of the notice of the filing of the proposed rule change in
the Federal Register is March 23, 2015.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).
    \11\ See supra note 3 and accompanying text.
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to issue an order approving or disapproving the
proposed rule change so that it has sufficient time to consider the
proposed rule change, as modified by Amendment No. 1 thereto.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\12\ designates May 7, 2015, as the date by which the Commission
shall either approve or disapprove the proposed rule change, as
modified by Amendment No. 1 thereto (File No. SR-NYSEArca-2014-100).
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-06892 Filed 3-25-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29723-29724]
[FR Doc No: 2015-12577]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0307]

Determination of Regulatory Review Period for Purposes of Patent
Extension; STIVARGA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for STIVARGA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Bldg., Rm. 3180, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product STIVARGA
(regorafenib). STIVARGA is indicated for treatment of patients with
metastatic colorectal cancer who have been previously treated with
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an
anti-VEGF therapy, and if KRAS wild type, an anti-EGRF therapy.
Subsequent to this approval, the USPTO received a patent term
restoration application for STIVARGA (U.S. Patent No. 7,351,834) from
Bayer HealthCare LLC, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 23, 2014, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of STIVARGA represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
STIVARGA is 2,234 days. Of this time, 2,080 days occurred during the
testing phase of the regulatory review period, while 154 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: August 18, 2006. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on August 18, 2006.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: April 27,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for STIVARGA (NDA 203085) was submitted on April 27,
2012.
    3. The date the application was approved: September 27, 2012. FDA
has verified the applicant's claim that NDA 203085 was approved on
September 27, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 898 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 21, 2015. Furthermore, any interested person
may petition FDA for a determination

regarding whether the applicant for extension acted with due diligence
during the regulatory review period by November 18, 2015. To meet its
burden, the petition must contain sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-
42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12577 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Rules and Regulations]
[Page 33718-33721]
[DOCID:fr13jn08-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1989-0008, Notice 3; FRL-8578-7]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List Update

AGENCY: Environmental Protection Agency.

ACTION: Direct Final Notice of deletion of the Double Eagle Refinery
Co. Superfund site from the National Priorities List.

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SUMMARY: The Environmental Protection Agency (EPA) Region 6 is
publishing a direct final Notice of Deletion of the Double Eagle
Refinery Co. Site (Site), located in Oklahoma City, Oklahoma County,
Oklahoma from the National Priorities List (NPL). The NPL, promulgated
pursuant to section 105 of the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA) of 1980, as amended is
Appendix B of 40 CFR part 300 which is the National Oil and Hazardous
Substances Pollution Contingency Plan (NCP). This direct final deletion
is being published by EPA with the concurrence of the State of
Oklahoma, through the Oklahoma Department of Environmental Quality
(ODEQ), because EPA has determined that all appropriate response
actions under CERCLA, other than operation and maintenance and five-
year reviews, have been completed However, this deletion does not
preclude future actions under Superfund.

DATES: This direct final deletion will be effective August 12, 2008
unless EPA receives adverse comments by July 14, 2008. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final deletion in the Federal Register informing the public that
the deletion will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1989-0008, Notice 3, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Donn Walters, Community Involvement, U.S. EPA Region
6 (6SF-TS), 1445 Ross Avenue, Dallas, TX 75202-2733,<PHONE_NUMBER> or
1-800-533-3508.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
1989-0008, Notice 3. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the
following information repositories:

U.S. EPA Online Library System at http://www.epa.gov/natlibra/ols.htm;
U.S. EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-
2733,<PHONE_NUMBER>, by appointment only Monday through Friday 9 a.m.
to 12 p.m. and 1 p.m. to 4 p.m.
Ralph Ellison Library, 2000 Northeast 23, Oklahoma City, OK 73111,
(409) 643-5979, Monday through

Wednesday 9 a.m. to 9 p.m., Thursday and Friday 9 a.m. to 6 p.m.,
Saturday 10 a.m. to 4 p.m.
Oklahoma Department of Environmental Quality (ODEQ), 707 North
Robinson, Oklahoma City, Oklahoma 73101,<PHONE_NUMBER>, Monday through
Friday 8 a.m. to 5 p.m.

FOR FURTHER INFORMATION CONTACT: Bartolome Canellas (6SF-RL), Remedial
Project Manager, U.S. Environmental Protection Agency, Region 6, U.S.
EPA, 1445 Ross Avenue, Dallas, Texas 75202,<PHONE_NUMBER> or 1-800-
533-3508 or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Site Deletion
V. Deletion Action

I. Introduction

    The EPA Region 6 office is publishing this direct final notice of
deletion of the Double Eagle Refinery Co. Site, Oklahoma City, Oklahoma
County, Oklahoma from the NPL. The NPL constitutes Appendix B of 40 CFR
part 300, which is the Oil and Hazardous Substances Pollution
Contingency Plan (NCP), which EPA promulgated pursuant to section 105
of the Comprehensive Environmental Response, Compensation and Liability
Act (CERCLA) of 1980, as amended. EPA maintains the NPL as a list of
sites that appear to present a significant risk to public health,
welfare, or the environment. Sites on the NPL may be the subject of
remedial actions financed by the Hazardous Substance Superfund (Fund).
As described in. 300.425(e)(3) of the NCP, sites deleted from the NPL
remain eligible for remedial actions if conditions at the deleted sites
warrant such actions.
    Because EPA considers this action to be noncontroversial and
routine, EPA is taking it without prior publication of a notice of
intent to delete. This action will be effective August 12, 2008 unless
EPA receives adverse comments by July 14, 2008. Along with the direct
final Notice of Deletion, EPA is co-publishing a Notice of Intent to
Delete in the ``Proposed Rules'' section of the Federal Register. If
adverse comments are received within the 30-day public comment period
on this document, EPA will publish a timely withdrawal of this direct
final deletion before the effective date of the deletion and the
deletion will not take effect. EPA will, as appropriate, prepare a
response to comments and continue with the deletion process on the
basis of the notice of intent to delete and the comments already
received. There will be no additional opportunity to comment.
    Section II of this notice explains the criteria for deleting sites
from the NPL. Section III discusses procedures that EPA is using for
this action. Section IV discusses the Double Eagle Refinery Co.
Superfund Site and demonstrates how it meets the deletion criteria.
Section V discusses EPA actions to delete the Site from the NPL unless
adverse comments are received during the public comment period.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate to protect public
health and the environment. In making a determination pursuant to 40
CFR 300.425(e), EPA will consider, in consultation with the state,
whether any of the following criteria have been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed (Hazardous Substance Superfund
Response Trust Fund) response under CERCLA has been implemented, and no
further response action by responsible parties is appropriate; or
    iii. The remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Even if a site is deleted from the NPL, where hazardous substances,
pollutants, or contaminants remain at the deleted site above levels
that allow for unlimited use and unrestricted exposure, CERCLA section
121(c), 42 U.S.C. 9621(c) requires that a subsequent review of the site
be conducted at least every five years after the initiation of the
remedial action at the deleted site to ensure that the action remains
protective of public health and the environment. If new information
becomes available which indicates a need for further action, EPA may
initiate remedial actions. Whenever there is a significant release from
a site deleted from the NPL, the deleted site may be restored to the
NPL without application of the hazard ranking system.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    (1) EPA consulted with the state of Oklahoma prior to developing
this direct final Notice of Deletion and the Notice of Intent to Delete
copublished today in the ``Proposed Rules'' section of the Federal
Register.
    (2) EPA has provided the state 30 working days for review of this
notice and the parallel Notice of Intent to Delete prior to their
publication today, and the state, through the Oklahoma Department of
Environmental Quality, has concurred on the deletion of the Site from
the NPL.
    (3) Concurrent with the publication of this direct final Notice of
Deletion, a notice of availability is being published in The Oklahoman
and is being distributed to appropriate federal, state and local
government officials and other interested parties. The newspaper notice
announces the 30-day public comment period concerning the Notice of
Intent to Delete the Site from the NPL.
    (4) The EPA placed copies of documents supporting the deletion in
the Site information repositories identified above.
    (5) If adverse comments are received within the 30-day public
comment period on this document, EPA will publish a timely notice of
withdrawal of this direct final notice of deletion before its effective
date and will prepare a response to comments and continue with the
deletion process on the basis of the notice of intent to delete and the
comments already received.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion of a site from
the NPL does not in any way alter EPA's right to take enforcement
actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist EPA management of Superfund sites.
As mentioned in section II of this document, Sec. 300.425 (e)(3) of the
NCP states that the deletion of a site from the NPL does not preclude
eligibility for future response actions should future conditions
warrant such actions.

IV. Basis for Site Deletion

    The following information provides EPA's rationale for deleting
this Site from the NPL.

Site Background and History

    The Site occupies the Southeast Quarter (SE \1/4\) of section 35,
Township 12 North, Range 3 West, Indian Meridian, Oklahoma County,
Oklahoma City, Oklahoma. Located at 301 N Rhode Island (generally South
of NE 4th Street and West of Martin Luther King Boulevard), the Site
extends over approximately 12 acres. The Double Eagle Refinery
collected, stored, and re-refined used oils and distributed the

recycled product. The refinery was active as early as 1929.
    In 1986 through 1988, EPA conducted investigations of the Site. The
sampling results revealed elevated levels of volatile organic
compounds, semi-volatile organic compounds, and metals found in surface
water, soil, sediment, and ground water. The Site also was found to
contain acidic sludges in on-site lagoons or pits.
    The data from these sampling efforts resulted in the Site being
proposed for the Superfund NPL on June 24, 1988, 53 FR 23978, and the
Site was included on the NPL on March 31, 1989, 54 FR 10512.

Response Actions

    The May 1992 Remedial Investigation (RI) reported potential
additional lifetime cancer risks to on-site workers that may have
access to the Site of 1.2 x 10E-04, which is two orders of magnitude
higher than the criterion of acceptability. Due to the unsecured nature
of the site, other unacceptable risks were possible to trespassers and
the resident of one nearby house. The shallow ground water was not
considered a potential source of drinking water and was reported of
limited potential beneficial use due to the high value of Total
Dissolved Solids (TDD), however concerns of potential contamination to
the deeper Garber-Wellington aquifer, triggered further investigations
into the ground water to ensure protection of this source. Regionally,
Oklahoma City receives its public water supply from reservoirs
surrounding the city.
    The Site was divided into two operable units, a source control
operable unit and a ground water operable unit. EPA issued a Record of
Decision on September 28, 1992 for the source control operable unit.
The remedial action activities for the source control operable unit,
initiated in August 1997, consisted of asbestos abatement and
demolition of existing structures, on-site neutralization and
stabilization of wastes, and off-site disposal at a permitted landfill.
The remedial action was completed in March 2000.
    EPA issued a ground water Record of Decision on April 19, 1994. The
remedial action activities for the ground water operable unit,
initiated in December 1996, consisted of quarterly ground water
monitoring for three years followed by semi-annual monitoring for three
years. EPA issued an Explanation of Significant Difference in January
2006, and documented a final decision to discontinue further semi-
annual monitoring.
    EPA issued a Final Close Out Report on March 7, 2006, which
affirmed that the remedial action activities for the source control
operable unit and ground water operable unit had been completed and
were consistent with CERCLA, as amended, and to the extent practicable,
the NCP.
    EPA issued a second Explanation of Significant in May 2008 to
clarify the final decision for clean up levels and document the need
for Institutional Controls and Five-Year Reviews.

Institutional Controls

    An element of the selected remedy is to place notices to the
property deed warning of the site hazards. These notices were filed
pursuant to Oklahoma Statutes, Title 27A (2000 Supp.), Section 2-7-
123(B), by the Oklahoma Department of Environmental Quality in 2001.
These notices declare the sites considered appropriate for activities
associated with industrial/commercial uses, the anticipated future land
use according to the ROD. Furthermore, the Oklahoma City Zoning maps
indicate the land use for the sites as classified for industrial.
    A component of the ground water ROD is to ensure future potential
users of the lower Garber-Wellington aquifer are not exposed to
contaminants from the site. As part of Operation and Maintenance
activities, the State maintains the institutional controls and reviews
records of wells drilled in the area to ensure shallow ground water is
not used, and additional wells are not installed in the area.

Cleanup Goals

    The remedial action cleanup activities at the Double Eagle Refinery
Site are consistent with the objectives of the NCP and will provide
protection to human health and the environment. The source control
operable unit cleanup goals were to provide for commercial/industrial
reuse of the Site. During the remedial action confirmation samples were
collected to ensure that all materials left at the Site were below the
cleanup goals. The remedial action objectives for the ground water
operable unit, to ensure that future potential users of the lower
Garber-Wellington aquifer are not exposed to contaminants from the Site
and to ensure that the North Canadian River is not impacted by
contaminants from the Site, have also been met by the remedial actions
at the Site.
    The Remedial Investigation identified the shallow aquifer as a
Class III aquifer (the water is not suitable for human consumption). As
indicated through the ground water monitoring events, and the
additional investigations conducted, it was confirmed that the shallow
ground water in the alluvium is not usable as a drinking water source.
During a 1996 investigation, additional wells were drilled below 200
feet in depth to document the presence of a shale aquitard, which is
approximately 160+ feet deep. This shale within the Garber Sandstone
acts as an ``aquitard'' to separate the upper and lower ground water
aquifers, and provides protection to the lower aquifer from the
migration of contaminants in the shallow ground water. The deeper
ground water of the Garber-Wellington aquifer below the shale aquitard
is below cleanup goals.
    The remedial action objective ``to ensure future potential users of
the deeper Garber-Wellington aquifer are not exposed to contaminants
from the site'' is achieved through the State monitoring of the
installation of any additional wells in the area.

Operation and Maintenance

    The ODEQ has committed to performing Operation and Maintenance
(O&M) activities at the Site. In March 2006, the ODEQ submitted the
Site O&M Plan to EPA, which defines the long-term O&M activities for
the Site. O&M activities consist of maintaining the institutional
controls on the Site and semi-annual search of well drilling records to
ensure that no drinking water wells are installed on or near the Site.

Five-Year Review

    Hazardous substances remain at the Site above levels that allow for
unlimited use and unrestricted exposure. Therefore, the EPA must
conduct a statutory five-year review of the remedy no less than every
five years after the initiation of the remedial action pursuant to
CERCLA section 121(c), and as provided in the current guidance on Five-
Year Reviews (OSWER Directive 9355.7-03B-P, Comprehensive Five-Year
Review Guidance, June 2001). Based on the five-year reviews, EPA will
determine whether human health and the environment continue to be
adequately protected by the implemented remedy. Five-year reviews for
this Site were completed in July 29, 2002 and May 15, 2007. The reviews
found that the remedy remains protective of human health and the
environment, and that the Site appears to have been properly maintained
during the period between reports. The next five-year review will occur
no later than May 15, 2012.

Community Involvement

    Public participation activities have been satisfied as required in
CERCLA

section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C.
9617. Documents in the deletion docket which EPA relied on for
recommendation of the deletion from the NPL are available to the public
in the information repositories.
    A Public Comment period was established when the site was proposed
to the National Priorities List, and Public Meetings were conducted on
July 1992 and August 1993 to discuss the proposed remedies for the soil
and the groundwater operable units. With this Notice of Deletion, a 30-
day public comment period is established before making this deletion
final.

V. Deletion Action

    The EPA, with concurrence of the State of Oklahoma, has determined
that all appropriate responses under CERCLA have been completed, and
that no further response actions under CERCLA, other than O&M and five-
year reviews, are necessary. Therefore, EPA is deleting the Site from
the NPL.
    Because EPA considers this action to be noncontroversial and
routine, EPA is taking it without prior publication. This action will
be effective August 12, 2008 unless EPA receives adverse comments by
July 14, 2008. If adverse comments are received within the 30-day
public comment period, EPA will publish a timely withdrawal of this
direct final notice of deletion before the effective date of the
deletion and it will not take effect and, EPA will prepare a response
to comments and continue with the deletion process on the basis of the
notice of intent to delete and the comments already received. There
will be no additional opportunity to comment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: May 23, 2008.
Richard E. Greene,
Regional Administrator, Region 6.

0
For the reasons set out in the preamble, 40 CFR part 300 is amended as
follows:

PART 300--[AMENDED]

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p.351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p.193.

Appendix B--[Amended]

0
2. Table 1 of appendix B to part 300 is amended under Oklahoma (``OK'')
by removing the site name ``Double Eagle Refinery Co.'' and the city
``Oklahoma City.''

[FR Doc. E8-13338 Filed 6-12-08; 8:45 am]

BILLING CODE 6560-50-P