[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Proposed Rules]
[Pages 41149-41152]
[FR Doc No: 2014-16374]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2014-N-0824]

Confidentiality of Interim Results in Cardiovascular Outcome
Safety Trials; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing that will provide a forum to discuss confidentiality of interim
results for certain cardiovascular outcomes trials (CVOTs) submitted to
the Agency while the trials are still ongoing. The purpose of the
public hearing is to initiate constructive discussion among regulators,
researchers, health care providers, representatives from the
pharmaceutical industry and health care organizations, and the general
public, about appropriate handling of interim analysis results of these
ongoing CVOTs. FDA is also opening a public docket to receive comments
on this topic.

DATES: The public hearing will be held on August 11, 2014, from 8 a.m.
to 5 p.m. Individuals who wish to present at the public hearing must
register by July 28, 2014. Section IV provides attendance and
registration information. To ensure consideration, submit comments by
July 28, 2014. Electronic or written comments will be accepted after
the public hearing until October 10, 2014.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
hearing participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Identify comments with the docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Indira Hills, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 21, rm. 4508, Silver Spring, MD 20993, 301-796-
9686, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. The Requirement for Postmarketing Studies To Assess the Risk of a
New Drug

    In some cases, studies submitted to FDA as part of a new drug
application or biologics license application will demonstrate that a
drug is safe and effective for its intended use (i.e., that its
benefits outweigh its identified risks), but the Agency will
nevertheless require a sponsor to conduct additional postmarketing
studies or trials under section 505(o)(3) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act)

(21 U.S.C. 355(o)(3)) for the following reasons: To assess a known
serious risk related to use of the drug, to assess signals of a serious
risk related to use of the drug, or to identify an unexpected risk when
available data indicate the potential for a serious risk.

B. FDA's Approach to the Approval of Drugs To Treat Type II Diabetes

    For most drugs, clinical trials of reasonable size can establish a
favorable relationship of benefit to relatively common risks, but they
are not large enough to assess the risk of rare serious events such as
heart attacks, strokes, or death. Where there is concern about these
risks (e.g., concern about drugs to treat Type II diabetes mellitus
(T2DM) or to promote weight loss), development programs include CVOTs
to help assess the risk to meet the requirements for drug approval. In
some cases, applicants have conducted a metaanalysis of cardiovascular
(CV) risk from Phase 2/3 trials to help establish the safety of a drug
and a separate larger CVOT as a postmarketing requirement under section
505(o)(3) of the FD&C Act. In other cases, analyses of interim data
from a single CVOT will demonstrate that a drug is safe with regard to
CV risk for its intended use, and, if the overall risk-benefit analysis
supports approval, the applicant will further assess the CV risks by
continuing the trial as a postmarketing requirement.
    The Agency has described its expectations for CV outcome data for
drugs to treat T2DM in the guidance for industry ``Diabetes Mellitus
Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat
Type 2'' (available at Diabetes'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071627.pdf), which
was issued based on the discussion at an advisory committee meeting,\1\
as well as in other available data and information. The guidance makes
recommendations about how to demonstrate that a new therapy to treat
T2DM is not associated with an unacceptable increase in CV risk.
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    \1\ On July 1 and 2, 2008, the Endocrinologic and Metabolic Drug
Advisory Committee met to discuss the role of CV assessment in the
premarketing and postmarketing settings (http://www.fda.gov/ohrms/dockets/ac/cder08.html#endocrinologicmetabolic).
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    The guidance states that before submission of a new drug
application (NDA) or biologics license application, the premarketing CV
outcome data should show that the incidence of important CV events
occurring with the investigational agent is not more than 80 percent
increase compared to the control group (i.e., that the upper bound of
the 2-sided 95 percent confidence interval for the estimated risk ratio
for CV events is less than 1.8). The guidance also states that if the
risk ratio is between 1.3 and 1.8 and the overall risk-benefit analysis
supports approval, a postmarketing trial will generally be necessary to
show that the upper bound of the 2-sided 95 percent confidence interval
for the estimated risk ratio is less than 1.3. This showing can be
achieved by conducting an adequately powered new postmarketing trial,
by combining results of separate premarketing and postmarketing trials,
or by continuing a large CVOT in which a planned interim analysis is
the basis for concluding that the risk ratio is less than 1.8. If the
risk ratio of 1.3 is ruled out based on premarket data, then a
postmarketing requirement may not be necessary.

C. Interim Analyses, the Importance of Their Confidentiality, and the
Role of the Data Monitoring Committee

    Interim analyses are analyses of study data conducted partway
through an ongoing clinical trial. They can play an integral role in
clinical trials by allowing for the safety of enrolled patients to be
monitored at various intervals in the study and also by allowing for
the possibility of stopping the trial early for safety concerns, for
futility, or for early evidence of efficacy that would make it
unethical for the trial to proceed. Confidentiality of interim data is
a paramount concern: The 1998 International Conference on Harmonization
(ICH) guidance for industry ``E9 Statistical Principles for Clinical
Trials'' (ICH E9 guidance) (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073137.pdf)
reflects a collective view across regulatory agencies in the European
Union, Japan, and the United States when it states that ``All staff
involved in the conduct of the trial should remain blind to the results
of such analyses, because of the possibility that their attitudes to
the trial will be modified and cause changes in the characteristics of
patients to be recruited or biases in treatment comparisons.''
    An independent Data Monitoring Committee (DMC) is usually
established to review the interim analysis results and make
recommendations to the sponsor about any action needed based on those
results, allowing the sponsor and other personnel associated with the
trial to remain masked to interim results. In 2006, FDA issued the
guidance for clinical trial sponsors ``Establishment and Operation of
Clinical Trial Data Monitoring Committees'' (DMC guidance) (available
at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127073.pdf) that reiterated many of the best practices for interim
analyses and DMCs outlined in the ICH E9 guidance. Specifically, the
guidance states that ``[p]rocedures should be established to safeguard
confidential interim data from the project team, investigators, sponsor
representatives, or anyone else outside the DMC and the statistician(s)
performing the interim analyses (see 21 CFR 314.126(b)(5) (drugs) and
21 CFR 860.7(f)(1) (devices)).'' An exception is made in considering
the need to disseminate safety data to allow for appropriate monitoring
of patients' safety.

D. Potential Adverse Consequences of Disclosure of Interim Results

    The concern with widespread disclosure of interim results in an
ongoing trial, as described in the DMC guidance, stems from the
potential of the disclosure to negatively affect the conduct of the
remaining portion of the trial. The impact could include unanticipated
changes in recruitment, treatment administration, or other aspects of
trial conduct, as well as loss of objectivity in safety event
reporting. Sponsors and other interested parties with access to interim
data may have difficulty managing the remainder of the trial in an
objective manner, particularly if changes to the trial protocol are
needed for other reasons. Knowledge of interim data may influence
decisions about the trial going forward, and it is nearly impossible to
assess the impact of that influence on the trial's final results. To
ensure the integrity of the trial and the validity of its findings, the
DMC guidance strongly recommends maintaining the confidentiality of
interim data until the trial completion.

E. Partial Disclosure of Interim Trial Results by FDA and the Purpose
of This Hearing

    Once FDA sends an approval letter for a new drug, the FD&C Act and
FDA regulations require that a summary or summaries of the safety and
effectiveness data and information submitted with or incorporated by
reference in the application be made available immediately for public
disclosure, with certain limited redactions. FDA's analyses of the
safety and effectiveness data and information from clinical studies
that support the approval of a new drug are typically disclosed with
little or no redaction. However, data relied on to make approval
decisions are ordinarily

derived from fully completed clinical trials. In the case of T2DM
therapies where a single, large CVOT to rule out CV risk was designed
to meet both the requirement for approval and the postmarketing
requirements, approval would indicate that the study had indeed ruled
out the risk ratio of 1.8, so this aspect of the interim results would
be known. But that fact would not reveal the detailed result, e.g., a
finding that CV events were actually reduced by the drug in the interim
analysis. Disclosure of detailed and more extensive information or
analyses from an ongoing trial, that is, the results of an interim
analysis, could undermine the integrity of the trial and jeopardize its
continuation, which could delay or even prevent obtaining the safety
data about serious risks that were required to be assessed at the time
of approval.
    For example, in connection with a recent approval decision of a
drug to treat T2DM (see MEMORANDA: Disclosure of Interim Cardiovascular
Risk Study Data, NDA 22271, Nesina (alogliptin) tablets, and Its Fixed-
Dose Combination Product NDAs 22426 and 203414, dated March 12, 2013,
and Disclosure of Interim Cardiovascular Risk Study Data and
Information Relied on to Approve, NDA 22271, Nesina (alogliptin)
tablets, and Its Fixed-Dose Combination Product NDAs 22426 and 203414,
dated March 12, 2013, available at http://www.fda.gov/Drugs/NewsEvents/ucm398454.htm), FDA released information at the time of approval that
was considered not likely to undermine the integrity of the ongoing
trial, including (1) general background and study information; (2)
high-level summary conclusions that the trial ruled out the
prespecified risk margin recommended by FDA guidance; and (3) other
data and information from the trial unrelated to CV risk. FDA decided,
however, to delay disclosure of other information that it determined
could jeopardize successful completion of the trial, specifically point
estimates of hazard ratios and associated confidence intervals for CV
risk and detailed data on CV events and rates. Based on the
circumstances of this case, FDA determined that delaying disclosure of
these data was appropriate for a limited time. This information would
become available when FDA completed its review of the final CV risk
study report and had taken any related regulatory action based on the
final results.
    The Agency is holding this hearing to solicit input from
stakeholders on the effects of disclosing information or analyses, at
various levels of detail, from an ongoing trial, and whether general
information about the trial can be disclosed without significant risk
to the integrity of the trial or its completion. Making a determination
about the effect of disclosure on a particular trial requires
consideration of the details of that trial and relevant context.

II. Scope of Public Input Requested

    FDA is seeking input from the various stakeholders on the following
issues:

 When a trial to evaluate CV safety of a new treatment is
ongoing at the time a drug is approved, do stakeholders agree that
disclosure of detailed analyses (such as point estimates of hazard
ratios and the associated confidence intervals) could undermine the
integrity of an ongoing trial and jeopardize its continuation,
potentially eliminating or substantially delaying the Agency's ability
to obtain needed long-term safety information?
    [cir] What interim findings, if disclosed, would represent the
greatest risk to trial integrity or jeopardize trial continuation?
    [cir] Can partial disclosure of interim findings at the time of
approval, essentially disclosing only that the standard for approval
has been met, offer protection of trial integrity and also provide
health care practitioners with the essential scientific information
needed to inform their use of the drug?
    [cir] If the detailed interim results were disclosed at the time of
approval, and the ongoing study was discontinued at that time, would it
be feasible to conduct a new large trial as a postmarketing requirement
that would fulfill the original study objective?
 Are there other, alternative trial designs that would allow
for disclosure of interim results on safety risks at the time of
product approval while also allowing for further information to be
obtained postmarket?

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner and the Center for Drug Evaluation and Research.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under
Sec.  10.205, representatives of the electronic media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see section VI for more details). To the extent that the
conditions for the hearing, as described in this notice, conflict with
any provisions set out in part 15, this notice acts as a waiver of
those provisions as specified in Sec.  15.30(h).

IV. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Individuals who
wish to attend the public hearing must register on or before July 28,
2014, by visiting https://www.surveymonkey.com/s/7L8Z66Q and contacting
Indira Hills (see FOR FURTHER INFORMATION CONTACT). Early registration
is recommended. Registration is free and will be on a first-come,
first-served basis. However, FDA may limit the number of participants
from each organization based on space limitations. Onsite registration
on the day of the hearing will be based on space availability.
    FDA will provide additional background information at the time the
Federal Register notice is published and an agenda approximately 2
weeks before the hearing at FDA Meeting Information page, which is
available online at http://www.fda.gov/Drugs/NewsEvents/ucm398454.htm.
    Time will be reserved during the hearing for planned presentations
from the audience. If you would like to present at the hearing, please
indicate this in your hearing registration. Time for audience
presentations is limited and will be assigned on a first-come, first-
served basis. Note also that time will be designated throughout the day
for general comments and questions from the audience following the
panel discussions.
    In this Federal Register notice, FDA has included specific issues
that will be addressed by the panel. If you wish to address one or more
of these issues in your presentation, please indicate this at the time
you register so that FDA can consider that in organizing the

presentations. FDA will do its best to accommodate requests to speak,
and will determine the amount of time allotted to each presenter and
the approximate time that each oral presentation is scheduled to begin.
    If you need special accommodations because of disability, please
contact Indira Hills (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the hearing.
    A live webcast of this hearing will be viewable at https://collaboration.fda.gov/dmcidcvtpart15/ on the day of the hearing. A
video record of the hearing will be available at the same Web address
for 1 year.

V. Comments

    Regardless of attendance at the public hearing, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. Transcripts

    As soon as a transcript is available, it will be accessible at
http://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A transcript will also be available in
either hard copy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16374 Filed 7-14-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 81 (Monday, April 27, 2020)]
[Proposed Rules]
[Pages 23262-23264]
[FR Doc No: 2020-08754]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0338; Product Identifier 2020-NM-047-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus SAS Model A350-941 and -1041 airplanes. This
proposed AD was prompted by the results of laboratory tests on non-
rechargeable lithium batteries installed in certain emergency locator
transmitters (ELT), which highlighted a lack of protection against
current injections of 28 volts direct current (DC) or 115 volts
alternating current (AC) that could lead to thermal runaway and a
battery fire. This proposed AD would require modifying a certain ELT by
installing a diode between the ELT and the terminal block, as specified
in a European Union Aviation Safety Agency (EASA) AD, which will be
incorporated by reference. The FAA is proposing this AD to address the
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by June 11,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For the material identified in this proposed AD that will be
incorporated by reference (IBR), contact the EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 89990 1000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this IBR
material on the EASA website at https://ad.easa.europa.eu. You may view
this IBR material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. It is also available in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0338.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0338; 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 NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2020-0338;
Product Identifier 2020-NM-047-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM based on those comments.
    The FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this NPRM.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0070, dated March 24, 2020
(``EASA AD 2020-0070'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A350-941 and -1041 airplanes.
    This proposed AD was prompted by the results of laboratory tests on
non-rechargeable lithium batteries installed in certain ELTs, which
highlighted a lack of protection against current injections of 28 volts
DC or 115 volts AC that could lead to thermal runaway and a battery
fire. The FAA is proposing this AD to address local fires in non-
rechargeable lithium batteries installed in certain ELTs, which could
result in damage to the airplane and injury to occupants. See the MCAI
for additional background information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0070 describes procedures for modifying a certain ELT
by installing a diode between the ELT and the terminal block. This
material 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 section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD after evaluating all the
relevant information and determining the unsafe condition described
previously is likely to exist or develop in other products of the same
type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2020-0070 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0070
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require

compliance with EASA AD 2020-0070 in its entirety, through that
incorporation, except for any differences identified as exceptions in
the regulatory text of this proposed AD. Using common terms that are
the same as the heading of a particular section in the EASA AD does not
mean that operators need comply only with that section. For example,
where the AD requirement refers to ``all required actions and
compliance times,'' compliance with this AD requirement is not limited
to the section titled ``Required Action(s) and Compliance Time(s)'' in
the EASA AD. Service information specified in EASA AD 2020-0070 that is
required for compliance with EASA AD 2020-0070 will be available on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2020-0338 after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 7 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this
proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
5 work-hours x $85 per hour = $425...........................            $400             $825           $5,775
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in the cost estimate.

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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) 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 Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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 (AD):

Airbus SAS: Docket No. FAA-2020-0338; Product Identifier 2020-NM-
047-AD.

(a) Comments Due Date

    The FAA must receive comments by June 11, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category, as identified in European
Union Aviation Safety Agency (EASA) AD 2020-0070, dated March 24,
2020 (``EASA AD 2020-0070'').

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
Furnishings.

(e) Reason

    This AD was prompted by the results of laboratory tests on non-
rechargeable lithium batteries installed in certain emergency
locator transmitters (ELTs), which highlighted a lack of protection
against current injections of 28 volts direct current (DC) or 115
volts alternating current (AC) that could lead to thermal runaway
and a battery fire. The FAA is issuing this AD to address local
fires in non-rechargeable lithium batteries installed in ELTs, which
could result in damage to the airplane and injury to occupants.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2020-0070.

(h) Exceptions to EASA AD 2020-0070

    (1) Where EASA AD 2020-0070 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0070 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 International Section, send it to the attention of
the person identified in paragraph (j)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>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.

    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2020-0070 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    (1) For information about EASA AD 2020-0070, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>Internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0338.
    (2) For more information about this AD, contact Kathleen
Arrigotti, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on April 17, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-08754 Filed 4-24-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Proposed Rules]
[Pages 42679-42682]
[FR Doc No: 2012-17772]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 122

[EPA-HQ-OW-2011-0188; FRL-9693-5]
RIN 2040-AF22

National Pollutant Discharge Elimination System (NPDES)
Concentrated Animal Feeding Operation (CAFO) Reporting Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; Withdrawal.

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

SUMMARY: On October 21, 2011, the EPA proposed a rulemaking to improve
and restore water quality by collecting certain information about
concentrated animal feeding operations (CAFOs). The EPA also solicited
comments on improving water quality by promoting environmental
stewardship and compliance rather than collecting facility-specific
information. The EPA is withdrawing the proposal to collect CAFO
information by rule. Instead, the EPA, where appropriate, will collect
CAFO information using existing sources of information, including state
NPDES programs, other regulations, and other programs at the federal,
state, and local level. The EPA believes, at this time, it is more
appropriate to obtain CAFO information by working with federal, state,
and local partners instead of requiring CAFO information to be
submitted pursuant to a rule. Today's withdrawal does not preclude the
Agency from initiating the same or similar rulemaking at a future date.

ADDRESSES: Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, will
be publicly available only in hard copy. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Water Docket, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC 20004. The Public Reading Room is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
federal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the Water Docket is (202)
566-2426.

FOR FURTHER INFORMATION CONTACT: For additional information, contact
Becky

Mitschele, Water Permits Division, Office of Wastewater Management
(4203M), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
I. General Information
    A. What entities are potentially interested in this action?
    B. Legal Authority
II. Background
III. Summary of Comments Received
IV. The EPA's Considerations Since Proposal
V. The EPA's Rationale for Withdrawal of the Proposed Rule
VI. Impact Analysis
VII. Statutory and Executive Order Reviews

I. General Information

A. What entities are potentially interested in this final action?

    Entities potentially interested in this final action include animal
feeding operations (AFOs), including AFOs that are CAFOs as defined in
the National Pollutant Discharge Elimination System (NPDES) regulations
at 40 CFR 122.23(b)(2), pursuant to section 502(14) of the Clean Water
Act (CWA). An AFO is a CAFO if it meets the regulatory definition of a
Large or Medium CAFO (40 CFR 122.23(b)(4) or (6)) or has been
designated as a CAFO (40 CFR 122.23(c)) by an authorized state or by
the EPA. The following table provides the size thresholds for Large,
Medium, and Small CAFOs in each animal sector.

                            Table 1--Summary of CAFO Size Thresholds for All Sectors
----------------------------------------------------------------------------------------------------------------
             Sector                        Large                    Medium \1\                 Small \2\
----------------------------------------------------------------------------------------------------------------
Cattle or cow/calf pairs.......  1,000 or more............  300-999..................  Less than 300.
Mature dairy cattle............  700 or more..............  200-699..................  Less than 200.
Veal calves....................  1,000 or more............  300-999..................  Less than 300.
Swine (weighing over 55 pounds)  2,500 or more............  750-2,499................  Less than 750.
Swine (weighing less than 55     10,000 or more...........  3,000-9,999..............  Less than 3,000.
 pounds).
Horses.........................  500 or more..............  150-499..................  Less than 150.
Sheep or lambs.................  10,000 or more...........  3,000-9,999..............  Less than 3,000.
Turkeys........................  55,000 or more...........  16,500-54,999............  Less than 16,500.
Laying hens or broilers (liquid  30,000 or more...........  9,000-29,999.............  Less than 9,000.
 manure handling system).
Chickens other than laying hens  125,000 or more..........  37,500-124,999...........  Less than 37,500.
 (other than a liquid manure
 handling system).
Laying hens (other than a        82,000 or more...........  25,000-81,999............  Less than 25,000.
 liquid manure handling system).
Ducks (other than a liquid       30,000 or more...........  10,000-29,999............  Less than 10,000.
 manure handling system).
Ducks (liquid manure handling    5,000 or more............  1,500-4,999..............  Less than 1,500.
 system).
----------------------------------------------------------------------------------------------------------------
Notes:
\1\ May be designated or must meet one of the following two criteria to be defined as a Medium CAFO: (1)
  Discharges pollutants through a man-made device; or (2) directly discharges pollutants into waters of the
  United States which pass over, across, or through the facility or otherwise come into direct contact with the
  confined animals. 40 CFR 122.23(b)(6).
\2\ Not a CAFO by regulatory definition, but may be designated as a CAFO on a case-by-case basis. 40 CFR
  122.23(b)(9).

    This table is not intended to be exhaustive. It provides a guide
for entities likely to be interested in today's action. If you have
questions regarding this action, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

B. Legal Authority

    This action withdraws the proposed NPDES CAFO Reporting Rule. 76 FR
65431, October 21, 2011. Today's final action is issued pursuant to
sections 301, 304, 305, 308, 309, 402, 501, and 504 of the CWA (33
U.S.C. 1311, 1314, 1315, 1318, 1319, 1342, 1361, and 1364).

II. Background

    A core provision of the CWA is the NPDES permit program which
authorizes and regulates the discharge of pollutants from point sources
to waters of the United States. 33 U.S.C. 1342. Section 502(14) of the
CWA includes ``concentrated animal feeding operation'' (CAFO) in the
definition of ``point source.'' The EPA initially issued national
effluent guidelines and standards (ELGs) for feedlots on February 14,
1974, and NPDES CAFO regulations on March 18, 1976. 39 FR 5704,
February 14, 1974; 41 FR 11458, March 18, 1976.
    In 2008, the EPA issued revised NPDES permitting regulations for
CAFOs. 73 FR 70418, November 20, 2008. Subsequently, environmental
groups and industry filed petitions for review of the 2008 rule, which
were consolidated in the U.S. Court of Appeals for the Fifth Circuit.
On May 25, 2010, the EPA signed a settlement agreement with the
environmental petitioners in which the EPA committed to propose a rule,
pursuant to CWA section 308, 33 U.S.C. 1318, to require all owners or
operators of CAFOs to submit certain information to the EPA.
    On October 21, 2011, the EPA proposed a rulemaking that contained
regulatory options for obtaining specified information from CAFOs to
support the EPA in meeting its water quality protection
responsibilities under the CWA. The EPA solicited comment on the
additional items listed in the settlement agreement that the Agency did
not propose to collect. The EPA also requested comment on three
alternative approaches to improve water quality including: Collecting
data from existing sources, requiring states to submit the information
to the EPA, and expanding the EPA's network of compliance assistance
and outreach tools. The Federal Register notice contains detailed
descriptions and a discussion of each option proposed. 76 FR 65431,
October 21, 2011.
    In the settlement agreement, the EPA committed to take final action
on the proposal by July 13, 2012. The settlement agreement does not
commit the EPA to any particular final action. The settlement agreement
expressly states that nothing in the agreement shall be construed to
limit or modify the discretion accorded the EPA by the CWA or by
general principles of administrative law. Today's final action fulfills
the Agency's commitments per the settlement agreement with the
petitioners.

III. Summary of Comments Received

    The comment period for the proposed rule ended on January 19, 2012,
and the EPA received 1,403 comment letters. The commenters on the
proposed rule included, among others, states, state associations,
industry organizations, environmental advocacy groups, and individuals.
The public comments and the EPA's supporting documents are

available in Docket EPA-HQ-OW-2011-0188.
    Generally, state and state association commenters questioned the
need for new regulations in light of states already having the
information the EPA was seeking by virtue of existing CAFO programs at
the state and local level. Industry commenters opposed the proposed
rule arguing, among other things, that much of the data had already
been submitted to the states and the EPA and that the information could
be collected through means other than a rule. Environmental advocacy
groups commented in support of the proposed rule and argued that the
EPA should collect more than the five items of information proposed.
Individual comments ranged from opposition of the proposed rule to
support of the proposed rule. Individuals who opposed the proposal
commented that it would be too burdensome for CAFOs to comply with the
proposed rule. Individuals who supported the proposal commented that
the proposed rule is necessary to implement the CAFO program and that
more information than proposed should be collected from CAFOs.

IV. The EPA's Considerations Since Proposal

    Since the EPA proposed the rulemaking on October 21, 2011, the EPA
conducted a preliminary evaluation of information publicly available on
the Internet from all state permitting authorities, expanding on the
effort the Agency conducted prior to proposal. Prior to proposal, the
EPA evaluated a subset of existing state programs and identified
publicly accessible site-specific information for CAFOs. That
information informed the EPA's decision to develop the voluntary state
submission process and the alternative approach that relies on existing
data sources in the proposed NPDES CAFO Reporting Rule. 76 FR 65437,
October 21, 2011. The docket contains examples of CAFO site-specific
information that is publicly available on the Internet.
    The EPA's post-proposal evaluation of available information
included a review of 37 state permitting authority Web sites to
determine if information about CAFOs is accessible online. The EPA
notes that although, at present, there are 47 states authorized to
implement the NPDES program, a number of those states either have no
CAFOs or are not authorized to implement the CAFO portion of the NPDES
program. In states where the EPA administers the NPDES program for
CAFOs, the EPA has information for CAFOs with NPDES permit coverage
from permit applications or notices of intent. The review of the 37
state permitting Web sites yielded information on 7,473 operations that
confine animals. Some of the information includes operations that are
not federally defined as CAFOs or operations that are required under
state law to have state non-NPDES permits. The EPA compiled these
results into a summary report, which can be found in the docket.
    In July 2012, the EPA also established a Memorandum of
Understanding (MOU) with the Association of the Clean Water
Administrators (ACWA) that specifically will assist the Agency in
collecting information about CAFOs. ACWA is an independent,
nonpartisan, non-profit corporation of state and interstate water
program managers. The EPA believes cooperation with the states will
assist the EPA in obtaining needed CAFO information. This collaborative
effort between the EPA and ACWA will focus on identifying CAFOs and
assist the EPA in obtaining pertinent information about CAFOs on a
state-by-state basis.

V. The EPA's Rationale for Withdrawal of the Proposed Rule

    In today's final action, the EPA has chosen not to promulgate a
regulation. Instead, the EPA is pursuing an approach that relies on a
range of existing sources of information, other regulations, and other
programs at the federal, state, and local level to gather basic
information about CAFOs. The EPA believes at this time it is more
appropriate to obtain CAFO information from existing sources. Some
states commented that they have the information proposed to be
collected by the rule and expressed interest in working with the EPA to
exchange that information. Since the EPA has established relationships
with states, as well as the U.S. Department of Agriculture (USDA), U.S.
Geological Survey (USGS), and other federal partners, the EPA believes
that working through existing partnerships will yield timely and useful
results in obtaining much of the needed CAFO information. In developing
animal agricultural programs since the 2003 CAFO rule, states have
longstanding relationships with owners and operators of operations that
confine animals. These relationships will facilitate information
sharing between relevant stakeholders.
    CAFOs play an important role in water quality planning, due to the
fact that they are potential sources of nitrogen, phosphorus,
pathogens, and other pollutants. The EPA continues to believe that the
gathering and evaluating of information about CAFOs can assist local,
state, and federal governments, regulated entities, interest groups,
and the public in making more informed decisions toward meeting the
objective of the CWA to ``restore and maintain the chemical, physical,
and biological integrity of the Nation's waters.'' 33 U.S.C. 1251(a).
EPA explained how information about CAFOs would assist in
implementation of CWA programs in the proposed rule. 76 FR 65436,
October 21, 2011. Through the approach outlined in this notice, the EPA
will seek to collect CAFO information items listed in the proposed
rule, as well as other information that is available from existing
resources, which includes continuing to work with USDA, USGS, and other
agencies to address sources of nutrient pollution.
    Based on the comments received, the EPA believes that it can obtain
much of the desired CAFO information from federal agencies, states, and
other existing data sources. The EPA noted in the proposal that the
existing NPDES permitting program requires CAFOs with NPDES permit
coverage to submit information as part of the application process as
well as in annual reports. 76 FR 65439, October 21, 2011. Pursuant to
40 CFR 122.21(i), information on a CAFO permit application must include
the following: (1) Name of the owner or operator, (2) facility location
and mailing address, (3) latitude and longitude of the production area
(entrance of the production area), (4) a topographic map of the
geographic area in which the CAFO is located showing the specific
location of the production area, (5) specific information about the
number and type of animals, whether in open confinement or housed under
roof, (6) the type of containment and storage and total capacity for
manure, litter, or process wastewater, (7) the total number of acres
under control of the applicant available for land application of
manure, litter, or process wastewater, (8) estimated amounts of manure,
litter, and process wastewater generated per year, (9) estimated
amounts of manure, litter, and process wastewater transferred to other
persons per year, and (10) a nutrient management plan that at a minimum
satisfies the requirements specified in 40 CFR 122.42(e), including,
for all CAFOs subject to the effluent limitations and standards, the
requirements of 40 CFR 412.4(c), as applicable. Also, pursuant to 40
CFR 123.24(b)(3), a memorandum of agreement between State Directors and
the Regional Administrators specifies the frequency and content of
reports, documents, and other

information which the state is required to submit to the EPA. States
are required to allow the EPA to routinely review state records,
reports, and files relevant to the administration and enforcement of
the approved program. See also 40 CFR 123.41, 40 CFR 123.43. Because
these two provisions are part of the NPDES program, the EPA believes,
at this time, NPDES authorized states have basic information from the
permit application for at least those CAFOs with NPDES permit coverage,
and that states will share that information with the EPA. In states
where the EPA administers the NPDES program for CAFOs, the EPA has
information for CAFOs with NPDES permit coverage from permit
applications or notices of intent.
    The EPA believes an efficient approach that does not duplicate
efforts is the appropriate next step to collecting CAFO information.
Thus, the EPA believes that before determining whether to issue a rule
requiring CAFOs to submit information, the Agency should obtain
existing information from federal agencies, states, local partners, and
other resources that already collect data. This decision also
recognizes that many CAFOs have provided their information to some
governmental entity, although perhaps not to the EPA. While the EPA may
not be the entity that received the information initially, it is
reasonable at this time for the EPA to work with its federal, state,
and local partners to obtain existing information rather than asking
CAFOs to re-submit information that they have already submitted to
another governmental entity. Collecting existing information,
evaluating it, and compiling it in one format will better inform the
Agency of what additional information may be needed and the best way to
collect that information, if necessary.
    Continued implementation of the permitting program for CAFOs likely
will result in improvements in data tracking and availability and
analysis of CAFO information. For example, some states with established
programs have comprehensive data on CAFOs. The EPA described existing
data sources in the proposed CAFO Reporting Rule, of which state
permitting authorities are just one source. In addition to working with
the state permitting authorities to exchange information mainly on
CAFOs with NPDES permit coverage, the EPA may need to use other
existing sources of data to obtain information about CAFOs without
NPDES permit coverage. The EPA acknowledges some states will have
information about CAFOs without NPDES permit coverage through other
state programs, such as state operating permits. To fill in information
gaps, the Agency may use existing tools, such as site visits and
individual information collection requests.
    At this time, the EPA has concluded that working with USDA and
states, who maintain direct relationships with CAFO owners or operators
is an effective approach to obtaining CAFO information that will
minimize the burden on states and CAFOs.

VI. Impact Analysis

    Because the EPA is not promulgating a regulatory reporting
requirement, there are no compliance costs or impacts associated with
today's final action.

VII. Statutory and Executive Order Reviews

    Today's action does not establish new regulatory requirements.
Hence, the requirements of other regulatory statutes and Executive
Orders that generally apply to rulemakings (e.g., the Unfunded Mandate
Reform Act) do not apply to this action.

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 122

    Administrative practice and procedure, Confidential business
information, Hazardous substances, Reporting and recordkeeping
requirements, Water pollution control.

    Dated: July 13, 2012.
Lisa P. Jackson,
Administrator.
[FR Doc. 2012-17772 Filed 7-19-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Page 6143]
[FR Doc No: 2011-2315]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0023]

Draft Guidance for Industry on ``Target Animal Safety and
Effectiveness Protocol Development and Submission,'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (215) entitled
``Target Animal Safety and Effectiveness Protocol Development and
Submission.''
    The purpose of this document is to provide sponsors guidance in
preparation of study protocols for review by the Center for Veterinary
Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce
the time to protocol concurrence.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 19, 2011.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Angela Clarke, Center for Veterinary
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(215) entitled ``Target Animal Safety and Effectiveness
Protocol Development and Submission.'' The purpose of this document is
to provide sponsors guidance in preparation of study protocols for
review by the CVM, ONADE, to reduce the time to protocol concurrence.
This guidance makes recommendations to aid in the preparation of
protocols used to generate data to support new animal drug
applications, specifically target animal safety and substantial
evidence of effectiveness.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the Agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB Control No. 0910-0032 (expiration date 04/30/2011).

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2315 Filed 2-2-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25662-25663]
[FR Doc No: 2016-10079]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC16-78-000.
    Applicants: Tonopah Solar Energy, LLC.
    Description: Supplement to February 24, 2016 Application for
Authorization Under Section 203 of the Federal Power Act and Request
for Expedited Action of Tonopah Solar Energy, LLC.
    Filed Date: 3/17/16.
    Accession Number: 20160317-5039.
    Comments Due: 5 p.m. ET 3/28/16.

    Docket Numbers: EC16-88-000.
    Applicants: The Empire District Electric Company, Liberty Utilities
(Central) Co.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities of The Empire District Electric Company, et
al.
    Filed Date: 3/16/16.
    Accession Number: 20160316-5175.
    Comments Due: 5 p.m. ET 4/6/16.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-1776-006; ER14-474-004.
    Applicants: Broken Bow Wind II, LLC, Sempra Generation, LLC.
    Description: Supplement to December 14, 2015 Updated Market Power
Analysis for the Southwest Power Pool Region of Broken Bow Wind II,
LLC, et al.
    Filed Date: 3/16/16.
    Accession Number: 20160316-5172.
    Comments Due: 5 p.m. ET 4/6/16.

    Docket Numbers: ER15-1882-002.
    Applicants: PSEG Energy Resources & Trade LLC.
    Description: Compliance filing: Filing in compliance with Feb. 24,
2016 Letter Order to be effective 1/7/2016.
    Filed Date: 3/17/16.
    Accession Number: 20160317-5036.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-815-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2016-03-16--Amendment to Ramp True-
up Filing to be effective 5/1/2016.
    Filed Date: 3/16/16.
    Accession Number: 20160316-5150.
    Comments Due: 5 p.m. ET 3/31/16.

    Docket Numbers: ER16-1209-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: CDWR Work Performance
Agreement for the Thermalito Power Plant (SA 275) to be effective 3/17/
2016.
    Filed Date: 3/16/16.
    Accession Number: 20160316-5158.
    Comments Due: 5 p.m. ET 4/6/16.

    Docket Numbers: ER16-1210-000.
    Applicants: Idaho Power Company.
    Description: Initial rate filing: BPA Conditional Firm Service
Agreements to be effective 7/1/2016.

    Filed Date: 3/16/16.
    Accession Number: 20160316-5159.
    Comments Due: 5 p.m. ET 4/6/16.

    Docket Numbers: ER16-1211-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2016-03-17_SA 2906 IPL-IPL
GIA (J401) to be effective 3/18/2016.
    Filed Date: 3/17/16.
    Accession Number: 20160317-5052.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1212-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: First Revised Service
Agreement No. 3638; Queue Position AA1-101 to be effective 2/16/2016.
    Filed Date: 3/17/16.
    Accession Number: 20160317-5087.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1213-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: NYISO 205: Behind the Meter
Net Generation to be effective 5/19/2016.
    Filed Date: 3/17/16.
    Accession Number: 20160317-5090.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1214-000.
    Applicants: FirstEnergy Solutions Corp.
    Description: Request of FirstEnergy Solutions Corp. for
Authorization to Make Wholesale Power Sales to Affiliated Utility, West
Penn Power Company (10-26-15).
    Filed Date: 3/17/16.
    Accession Number: 20160317-5104.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1215-000.
    Applicants: FirstEnergy Solutions Corp.
    Description: Request of FirstEnergy Solutions Corp. for
Authorization to Make Wholesale Power Sales to Affiliated Utility, West
Penn Power Company (1-19-16).
    Filed Date: 3/17/16.
    Accession Number: 20160317-5110.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1216-000.
    Applicants: FirstEnergy Solutions Corp.
    Description: Request of FirstEnergy Solutions Corp. for
Authorization to Make Wholesale Power Sales to Affiliated Utility, The
Potomac Edison Company (4-20-15).
    Filed Date: 3/17/16.
    Accession Number: 20160317-5146.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1217-000.
    Applicants: FirstEnergy Solutions Corp.
    Description: Request of FirstEnergy Solutions Corp. for
Authorization to Make Wholesale Power Sales to Affiliated Utility, The
Potomac Edison Company (10-21-15).
    Filed Date: 3/17/16.
    Accession Number: 20160317-5149.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1218-000.
    Applicants: BE CA LLC.
    Description: Sec.  205(d) Rate Filing: Seller Category Change to be
effective 5/17/2016.
    Filed Date: 3/17/16.
    Accession Number: 20160317-5158.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1219-000.
    Applicants: J.P. Morgan Ventures Energy Corporation.
    Description: Sec.  205(d) Rate Filing: Change in Seller Category to
be effective 5/17/2016.
    Filed Date: 3/17/16.
    Accession Number: 20160317-5159.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1220-000.
    Applicants: Utility Contract Funding, L.L.C.
    Description: Sec.  205(d) Rate Filing: Seller Category Change to be
effective 5/17/2016.
    Filed Date: 3/17/16.
    Accession Number: 20160317-5160.
    Comments Due: 5 p.m. ET 4/7/16.

    Docket Numbers: ER16-1221-000.
    Applicants: FirstEnergy Solutions Corp.
    Description: Request of FirstEnergy Solutions Corp. for
Authorization to Make Wholesale Power Sales to Affiliated Utility, The
Potomac Edison Company (6-10-15).
    Filed Date: 3/17/16.
    Accession Number: 20160317-5161.
    Comments Due: 5 p.m. ET 4/7/16.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF16-547-000.
    Applicants: Regents of the University of Minnesota.
    Description: Form 556 of Regents of the University of Minnesota.
    Filed Date: 3/16/16.
    Accession Number: 20160316-5077.
    Comments Due: None Applicable.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 17, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-10079 Filed 4-28-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 19 (Friday, January 28, 2011)]
[Proposed Rules]
[Pages 5107-5110]
[FR Doc No: 2011-1906]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 260 and 261

[EPA-HQ-RCRA-2008-0808; FRL-9260-2]
RIN-2050-AE78

Regulation of Oil-Bearing Hazardous Secondary Materials From the
Petroleum Refining Industry Processed in a Gasification System To
Produce Synthesis Gas; Tentative Determination To Deny Petition for
Reconsideration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of action--tentative determination to deny petition for
reconsideration.

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

SUMMARY: EPA is providing notice of, and soliciting written comments
on, a tentative determination to deny an administrative petition
submitted by the Sierra Club under RCRA section 7004. EPA issued an
earlier notice denying this same petition in November 2008. However,
the Agency at that time failed to comply with notice and comment
provisions in its regulations. Accordingly, we are now giving the
public the opportunity to provide comments on this tentative decision.
This petition requests EPA to reconsider the final rule, ``Regulation
of Oil-Bearing

Hazardous Secondary Materials from the Petroleum Refining Industry
Processed in a Gasification System to Produce Synthesis Gas,''
published in the Federal Register on January 2, 2008. The EPA
considered the petition, along with information contained in the
rulemaking docket, and has tentatively decided to deny the petition. In
a letter from EPA Assistant Administrator Mathy Stanislaus dated
January 21, 2011, EPA provided the petitioner with its tentative
decision to deny the petition for reconsideration. The letter explains
EPA's reasons for tentatively deciding to deny the petition. After
evaluating all public comments, as well as any other information in the
rulemaking record, EPA will publish either a final denial of the
petition or issue a proposed rule to amend or repeal the regulation.

DATES: Submit comments on or before March 14, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2008-0808, by one of the following methods:
     Electronic docket at: http://www.regulations.gov: Follow
the on-line instructions for submitting comments.
     E-mail: Comments may be sent by electronic mail (e-mail)
to<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-RCRA-2008-0808.
In contrast to EPA's electronic public docket, EPA's e-mail system is
not an ``anonymous access'' system. If you send an e-mail comment
directly to the Docket without going through EPA's electronic public
docket, EPA's e-mail system automatically captures your e-mail address.
E-mail addresses that are automatically captured by EPA's e-mail system
are included as part of the comment that is placed in the official
public docket, and made available in EPA's electronic public docket.
     Fax: Comments may be faxed to<PHONE_NUMBER>; Attention
Docket ID No. EPA-HQ-RCRA-2008-0808.
     Mail: Send your comments to the RCRA Docket (28221T),
Attention Docket ID No. EPA-HQ-RCRA-2008-0808, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please
include a total of two copies.
     Hand Delivery: Deliver two copies of your comments to the
RCRA Docket, Attention Docket ID No. EPA-HQ-RCRA-2008-0808, EPA, EPA
West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC
20460. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2008-0808. 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. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm. For additional instructions on submitting
comments, go to the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Alan Carpien, U.S. Environmental
Protection Agency, Office of General Counsel, Mail Code 2366A, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone<PHONE_NUMBER>;
or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I get copies of this document and other related information?

    This Federal Register notice, the petition for reconsideration and
the letter providing a tentative determination for denial of the
petition for reconsideration are available in a docket EPA has
established for this action under Docket ID No. EPA-HQ-RCRA-2008-0808.
All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some
information may not be publicly available, because, for example, it may
be Confidential Business Information (CBI) or other information, the
disclosure of which is restricted by statute. Certain material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov or in hard copy at the RCRA Docket, EPA, EPA West
Building, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the RCRA
Docket is<PHONE_NUMBER>. A reasonable fee may be charged for copying
docket materials.

Appendix: Letter to Earthjustice Tentatively Denying the Request for a
Petition for Reconsideration

Ms. Lisa Gollin Evans, Earthjustice, 21 Ocean Avenue, Marblehead, MA
01945.

Dear Ms. Evans:

    This is in response to the petition for reconsideration you
submitted, dated April 1, 2008, to the U.S. Environmental Protection
Agency (EPA) under the Resource Conservation and Recovery Act (RCRA)
Sec.  7004(a), 42 U.S.C. 6974(a), on behalf of the Sierra Club and
the Louisiana Environmental Action Network (LEAN). Sierra Club and
LEAN request that EPA reconsider the final rule, ``Regulation of
Oil-Bearing Hazardous Secondary Materials from the Petroleum
Refining Industry Processed in a Gasification System to Produce
Synthesis Gas'' (Gasification Rule). This final rule was published
in the Federal Register on January 2, 2008 (73 FR 57, et seq.)
    Your petition raises both procedural (notice and comment) and
substantive grounds for seeking the agency's reconsideration of the
Gasification Rule. For the reasons stated below, EPA has made a
tentative determination to deny the petition for reconsideration.\1\
In accordance with the regulatory requirements of 40 CFR 260.20, EPA
is providing notice of and soliciting written comments on this
tentative determination to deny your petition for reconsideration in
the Federal Register.
---------------------------------------------------------------------------

    \1\ We would also note that section 7004(a) of RCRA provides
that any person may petition the Administrator for the promulgation,
amendment or repeal of any regulation under the Act. However, in
your petition for reconsideration, you fail to state whether the
Sierra Club and LEAN are requesting whether EPA amend or repeal the
Gasification Rule.
---------------------------------------------------------------------------

    EPA notes that we issued a letter with essentially the same
substantive response as stated in this letter in November 2008.\2\

However, the Agency at that time failed to comply with notice and
comment provisions in its regulations at 40 CFR 260.20. Accordingly,
we are now giving the public the opportunity to provide comments on
this tentative decision. A notice is appearing in the Federal
Register allowing the public to respond to this decision. The
comment period will be 45 days from the date of publication of the
Federal Register notice.
---------------------------------------------------------------------------

    \2\ Letter to Lisa Gollin Evans, Earthjustice, from Susan Parker
Bodine, EPA Assistant Administrator, dated November 14, 2008. This
letter is available in the docket (docket item EPA-HQ-RCRA-2008-
0808-0004).
---------------------------------------------------------------------------

Notice and Comment Issues

    Your petition states as grounds for reconsideration that the
rule violates the notice and comment requirements of the
Administrative Procedure Act (APA) set forth at 5 U.S.C. 553. Your
basis for this assertion is that EPA ``relied on'' a proposal
suggested in a 1998 Federal Register notice \3\ and ``not on the
2002 proposed rule'' \4\ to formulate the Gasification Rule. You
suggest that, as a result, the final rule ``is not a ``logical
outgrowth'' of the agency's proposed rule'' (Petition at pg. 7) and,
therefore, ``the public was denied the opportunity for notice and
comment in several critical areas.'' (Petition at pg. 8)
---------------------------------------------------------------------------

    \3\ Notice of Data Availability (NODA), 63 FR 38139 (July 15,
1998).
    \4\ ``Regulation of Hazardous Oil-Bearing Secondary Materials
From the Petroleum Refining Industry and Other Hazardous Secondary
Materials Processed in a Gasification System To Produce Synthesis
Gas,'' 67 FR 13684 (March 25, 2002).
---------------------------------------------------------------------------

    The ``critical areas'' to which you refer are noted below.
    (1) You assert that the Gasification Rule does not contain
``chemical and physical specifications of the synthesis gas fuel
product that is produced by gasifying the oil-bearing hazardous
secondary materials.'' (Petition at pg. 8-10) In support of this
assertion, you refer to statements in the preamble to the March 2002
proposal for the Gasification Rule (67 FR 13684, et seq.) and one
statement in the January 2, 2008, final rule. The statements in the
March 2002 proposal discuss various reasons why EPA thought, at the
time, there should be chemical and physical specifications for
synthesis gas produced and also express concerns as to what
concentrations of metals actually exist in synthesis gas.
    (2) You assert that the Gasification Rule ``fundamentally alters
the definition of gasification and entirely removes proposed
conditions pertaining to operation of the gasifier,'' particularly
requirements for slagging inorganic feed at temperatures above 2,000
degrees C. (Petition at pg. 10)
    (3) You assert that the Gasification Rule is not a logical
outgrowth of the proposed rule and that it is insufficiently
protective of human health and the environment because it did not
``require that co-products and residues generated by the
gasification system meet the Universal Treatment Standards if these
materials are applied to the land,'' even though the agency had
proposed such conditions in March 2002. (Petition at pg. 10-12)

Arbitrary and Capricious Issues

    You also make several arguments as to why the Gasification Rule
is arbitrary and capricious. Specifically, you argue that EPA's
decision not to impose the treatment requirements, for which you
claim notice and comment was inadequate, was arbitrary and
capricious based on certain details regarding particular chemicals.
(Petition at pg. 12-13) In addition, you argue that EPA is arbitrary
and capricious for relying on the Toxicity Characteristic Leaching
Procedure (TCLP) to predict leaching characteristics of gasification
residues. (Petition at pg. 15)
    Finally, you also argue that EPA fails to regulate facilities
that burn fuel made from hazardous wastes in contravention of RCRA
section 3004(q), 42 U.S.C. 6924(q). (Petition at pg. 13-15) This
argument presupposes that the material fed into the gasifier is a
solid and hazardous waste as opposed to a non-waste material that is
being recycled.

Response

    EPA does not believe that you have presented the agency with any
new information that would suggest or otherwise require that we
reconsider the Gasification Rule, nor have you raised any issues
that have not already been raised by the comments in the rulemaking
process. We also believe that the Gasification Rule meets the APA
notice and comment requirements and, therefore, disagree with your
view that the agency did not provide adequate notice to the public
and an opportunity to comment on the provisions of the final rule.
    In particular, in August 1998, EPA decided not to include
gasification in the petroleum refinery exclusion when it issued the
final rule ``Hazardous Waste Management System; Identification and
Listing of Hazardous Waste; Petroleum Refining Process Wastes; Land
Disposal Restrictions for Newly Identified Wastes; And CERCLA
Hazardous Substance Designation and Reportable Quantities,''
(``Petroleum Listing Rule''), 63 FR 42110, et seq. The rules, issued
in 1998, which were limited to the petroleum refinery industry, only
require that the materials reinserted into the petroleum refining
process not be speculatively accumulated nor be placed on the land
prior to reuse. In the March 2002 proposal, EPA made it very clear
that it was proposing to put gasification ``on the same regulatory
footing (i.e., excluded) as other hazardous secondary materials
returned to a petroleum refining process'' in the 1998 rule. In
March 2002, EPA proposed a definition of gasification systems to
ensure that the systems were not actually waste treatment systems,
but true synthesis gas production facilities. This definition
included certain operating conditions for the gasifiers, including a
condition that the gasifier slag organic feed materials at
temperatures above 2,000 degrees C. The proposal also suggested
specifications as to various contaminants that the fuels produced
contained, and specifications regarding residues. See 67 FR at
13693-96. These last three conditions are those to which you refer
in your Petition for Reconsideration, as noted above.
    Importantly, the March 2002 Gasification Proposal specifically
provided notice that the provisions of the 1998 NODA were still
being considered. It is significant that your petition for
reconsideration ignores this discussion in the March 2002 proposal.
In particular, the March 2002 proposal discusses in detail that the
agency had requested comment as to whether the exclusion from the
definition of solid waste issued in 1998 should apply to the
recycling of oil-bearing materials into gasification systems at
petroleum refineries and that the gasification and petroleum
industries favored this exclusion (63 FR 13685-86, footnote 2). We
also noted that reinserting secondary materials into gasification
systems ``is analogous'' to the August 1998 exclusion for
reinsertion of other petroleum residuals into the refining process.
Id. at 13686.
    In the Gasification Rule, EPA scaled back on its plans for a
more ``ambitious'' exclusion and returned largely to its original
views regarding exclusions for hazardous secondary materials
returned to the petroleum refining system. See 73 FR 58-59. The
final rule retained the conditions for speculative accumulation and
land placement, and added a definition of ``gasifier'' to ensure
that the gasification was indeed recycling of a product and not
waste treatment. The final rule, however, as you noted, did not
contain the slagging requirement in the definition, nor the fuel
specifications or the residue requirements. These changes were the
result of the agency's deliberations on each condition that took
into account all of the comments received. The preamble to the final
rule discussed in detail the fact that EPA received comments ranging
from demands for full hazardous waste regulation to those arguing
that the agency should not be regulating gasification at all since
it was an integral part of the petroleum refining process and did
not constitute waste management. See 73 FR at 59. Among the comments
were those that ``expressed concern with one or more of the proposed
conditions'' and, even if they disagreed with imposing any
conditions, provided ``comments on the specific conditions
proposed.'' \5\ Id.
---------------------------------------------------------------------------

    \5\ Your reference to an inadequacy of notice and comment with
respect to the synthesis gas specification (Petition at pg. 9) is
taken out of context. You claim that we only received comments on
the sufficiency of the specification but, in fact, EPA received a
range of comments some of which claimed the specification was too
lenient, but others argued against establishing any specification.
See 73 FR at 64.
---------------------------------------------------------------------------

    The variety and nature of comments submitted demonstrates that
EPA had a record upon which to make a decision that was based on a
wide range of opinions and information. Indeed, it is plain that
EPA's proposal succeeded in obtaining opinions and views from a wide
range of interests and allowed the agency to consider the form of
the final rule carefully. In fact, as noted above, EPA decided on a
far less ambitious final rule for a number of reasons. We understand
that you may disagree with EPA's conclusions, but we believe that
the regulatory choices made by the agency are reasonable based on
the rulemaking record. In the absence of any new information, it
would not be useful for the agency to revisit

evidence and arguments it has already carefully considered. In our
view, the notice and comment issues you have raised are actually
discussions of the merits of the agency's decision with which you
disagree. See 73 FR 61-67.\6\ In fact, you do not point to any
information which EPA lacks to make its decision.
    Finally, EPA disagrees with your legal argument that the final
rule does not comport with RCRA section 3004(q). (Petition at pg.
13-15) Because EPA is providing an exclusion from the definition of
solid waste for the hazardous secondary materials fed to gasifiers
subject to this rule, EPA does not implicate the provisions of
section 3004(q) of RCRA, 42 U.S.C. 6924(q), which requires that the
hazardous secondary material first be a solid waste.
---------------------------------------------------------------------------

    \6\ We also disagree with your assertion that the Agency
improperly relied on the use of the Toxicity Characteristic Leaching
Procedure (TCLP). The TCLP is a duly promulgated regulation of EPA
and has not been challenged within the appropriate statutory time
period for challenging regulations. EPA's use of the TCLP in this
regulation is entirely appropriate.
---------------------------------------------------------------------------

    As previously stated, a notice will be published in the Federal
Register announcing the agency's tentative decision to deny your
petition for reconsideration and will provide the public a 45 day
period to comment After considering any comments received, the
agency will make a final decision on the merits of your petition.
    If you should have any questions, you may contact Alan Carpien,
EPA's Office of General Counsel at<PHONE_NUMBER>.
 Sincerely,

Mathy Stanislaus
Assistant Administrator, Office of Solid Waste and Emergency
Response

    Dated: January 19, 2011.
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste and Emergency Response.
[FR Doc. 2011-1906 Filed 1-27-11; 8:45 am]
BILLING CODE 6560-50-P