[Federal Register Volume 83, Number 240 (Friday, December 14, 2018)]
[Proposed Rules]
[Pages 64299-64302]
[FR Doc No: 2018-27098]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 601

[Docket No. FDA-2013-N-0500]

Withdrawal of Proposed Rule on Supplemental Applications
Proposing Labeling Changes for Approved Drugs and Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the withdrawal of the proposed rule on ``Supplemental
Applications Proposing Labeling Changes for Approved Drugs and
Biological Products'' that published in the Federal Register of
November 13, 2013. FDA is taking this action in light of concerns
expressed by commenters and considerations regarding Agency resources.
FDA is continuing to consider ways to improve the communication of
important, newly acquired drug safety information to healthcare
providers and the public and to facilitate efforts to keep drug product
labeling up to date throughout the product lifecycle.

DATES: The proposed rule published November 13, 2013 (78 FR 67985), is
withdrawn as of December 14, 2018.

ADDRESSES: For access to the docket, go to https://www.regulations.gov
and insert the docket number found in brackets in the heading of this
document into the ``Search'' box and follow the prompts, and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Janice L. Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-
796-3601<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under the Federal Food, Drug, and Cosmetic Act, the Public Health
Service Act, and FDA regulations, the Agency makes decisions regarding
the approval of marketing applications, including supplemental
applications, based on a comprehensive analysis of the product's risks
and benefits under the conditions of use prescribed, recommended, or
suggested in the labeling (see 21 U.S.C. 355(c) and (d); 42 U.S.C.
262). All drugs have risks, and healthcare practitioners and patients
must balance the risks and benefits of a drug when making decisions
about medical therapy. As a drug is used more widely or under diverse
conditions, new information regarding the risks and benefits of a drug
may become available, and may include new risks or new information
about known risks. Accordingly, all holders of new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and biologics
license applications (BLAs) are required to develop written procedures
for the surveillance, receipt, evaluation, and reporting of
postmarketing adverse drug experiences to FDA (see 21 CFR 314.80(b),
314.98(a), and 600.80(b)). Application holders also must comply with
applicable reporting and recordkeeping requirements, including
submission of an annual report (which contains, among other things, a
brief summary of significant new information from the previous year
that might affect the safety, effectiveness, or labeling of the drug
product, and a description of the actions the applicant has taken or
intends to take as a result of this new information) and, if
appropriate, proposed revisions to product labeling (see 21 U.S.C.
355(k) and 21 CFR 314.81).
    When new information becomes available that causes labeling to be
inaccurate, false, or misleading, all drug and biological product
application holders must take steps to change the content of their
product labeling in accordance with Sec. Sec.  314.70, 314.97, and
601.12 (21 CFR 314.70, 314.97, and 601.12) (see 21 CFR 201.56(a)(2);
see also 21 U.S.C. 331(a) and (b) and 352(a), (f), and (j)). While all
drug and biological product application holders have these obligations,
under current regulations, the procedures available to ANDA holders to
update the labeling of generic drugs differ in certain respects from
the procedures available to NDA holders and BLA holders to update
product labeling. In addition, there are limitations on the procedures
available to NDA holders and BLA holders to make certain updates to the
Highlights of Prescribing Information of drug and biological product
labeling that are subject to the content and format labeling
requirements described in Sec. Sec.  201.56(d) and 201.57 (21 CFR
201.56(d) and 201.57) (commonly referred to as the ``Physician Labeling
Rule'' (PLR) format).
    In the Federal Register of November 13, 2013 (78 FR 67985), FDA
proposed to amend its regulations to revise and clarify procedures for
application holders of an approved drug or biological product to change
the product labeling to reflect certain types of newly acquired safety-
related information in advance of FDA's review of the change by
submitting a ``changes being effected'' (CBE-0) supplement to FDA. A
CBE-0 supplement is an exception to the general requirement for FDA
approval of a prior approval supplement containing revised product
labeling before distribution. The proposed rule, if finalized, would
have enabled ANDA holders for generic drugs to independently update and
promptly distribute revised product labeling to reflect certain types
of newly acquired safety-related information, even though the revised
labeling may temporarily differ from that of the corresponding
reference listed drug (RLD or brand drug) upon submission of a CBE-0
supplement to FDA. FDA's proposed revisions to its regulations to allow
generic drug manufacturers to update product labeling through CBE-0
supplements in the same manner as brand drug manufacturers were
intended to improve communication of important, newly acquired drug
safety information to healthcare providers and the public. The proposed
rule, if finalized, also would have removed the limitation on
submission of CBE-0 supplements by any application holder for certain
changes to the Highlights of Prescribing Information in PLR-format
product labeling. For further information about these and other
proposed regulatory changes described in the proposed rule, see 78 FR
67985.
    FDA received numerous comments on the proposed rule from a diverse
group of stakeholders. In view of requests to meet with FDA to present
alternatives to the proposed regulatory changes described in the
proposed rule and to promote transparency, FDA held a public meeting on
March 27, 2015, at which any stakeholder had the opportunity to present
or comment on the proposed rule or any alternative proposals intended
to improve communication of important, newly acquired drug safety
information to healthcare professionals and the public. In the February
18, 2015, document announcing the public meeting (80 FR 8577), FDA
reopened the docket for the proposed rule until April 27, 2015, to
receive submissions of additional written comments on the proposed rule
as well as alternative proposals presented during the public meeting.
    Several comments supported finalizing the rule as originally
proposed. Other comments supported the goals of the proposed rule, but
expressed concern that temporary labeling differences between generic
drugs and the corresponding brand drug could complicate healthcare
decision making. Comments in support of the proposed rule maintained
that it would enhance drug safety by making healthcare practitioners
and the public aware of new safety-related information about a drug
more quickly. Several comments also opined that tort liability for
failure to adequately warn patients of a known hazard may be an
incentive for drug manufacturers to ensure that their product labeling
reflects the most current safety information.
    Comments in opposition to the proposed rule raised policy, legal,
and cost considerations. A number of

comments asserted that generic drug application holders do not
generally receive or possess all the data necessary to evaluate
postmarket safety information and to support safety-related labeling
changes. Comments expressed concern that additional or different
warnings in generic drug labeling, even if temporary, may undermine
confidence in generic drugs and their therapeutic equivalence to the
brand drug. Comments throughout the healthcare delivery system also
expressed concern about the confusion that might result if there were
different versions of safety labeling for multiple generic versions of
the same drug until FDA decided whether to approve the labeling changes
proposed in the CBE-0 supplements. Several comments asserted that the
proposed rule would impose significant burdens on the generic drug
industry that would necessarily increase the cost of generic drugs or
lead to market exit, which may increase the risk of drug shortages.
However, most concerns regarding economic impact focused on the
increased risk of tort litigation against generic drug manufacturers
and others in the healthcare system.

II. Withdrawal of the Proposed Rule

    Having reviewed the comments on the proposed rule and further
considered the proposal, FDA is withdrawing the proposed rule on
``Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products'' published in the Federal Register of
November 13, 2013. The concerns raised in the comments reflect
significant competing interests, and FDA acknowledges that the proposed
rule, if finalized, would present significant potential downsides. In
light of those potential downsides, the Agency does not believe that
finalizing the proposed rule would be an appropriate use of Agency
resources. Rather, the Agency believes that such resources would be
better used on other efforts to improve the communication of important,
newly acquired drug safety information to healthcare professionals and
the public, as discussed in greater detail below.
    The withdrawal of this proposed rule does not alter the ongoing
obligation under FDA's current regulations for all holders of marketing
applications for drug and biological products--including ANDA holders--
to ensure their product labeling is accurate, and not false or
misleading, and to take steps to update their product labeling when new
information becomes available that causes the labeling to become
inaccurate, false, or misleading (see Sec.  201.56(a)(2); see also 21
U.S.C. 331(a) and (b) and 352(a), (f), and (j)). This obligation serves
an important public health function because new information regarding
the risks and benefits of a drug may become available over time from
various sources, including from postmarketing adverse drug experience
reports and published literature, and updates to product labeling may
be necessary.
    In addition to the ongoing obligation described above, ANDA holders
must generally maintain the same labeling as the RLD throughout the
lifecycle of the generic drug product. ANDA holders can, however,
propose certain updates to product labeling by submitting a prior
approval supplement that contains adequate supporting information for
the proposed change. FDA will determine whether the proposed labeling
change is appropriate, and whether the labeling for the RLD and
corresponding generic drug(s) should be revised. If the approval of the
NDA for the RLD has been withdrawn at the NDA holder's request because
the RLD is no longer being marketed and certain other conditions are
satisfied (see 21 CFR 314.150(c)), the NDA holder can no longer update
labeling for the withdrawn RLD, but ANDA holders can still propose
labeling updates through the submission of a prior approval supplement.
In such cases, if FDA determines that the proposed labeling change is
appropriate and approves the supplement, the Agency may request that
other ANDA holders and any ANDA applicants relying on the same
withdrawn RLD make the same updates (see FDA draft guidance for
industry ``Updating ANDA Labeling After the Marketing Application for
the Reference Listed Drug Has Been Withdrawn,'' 81 FR 44883, July 11,
2016) (Draft Guidance on Updating ANDA Labeling) (Ref. 1).
    As noted, the proposed rule would have removed the current
prohibition against the submission of CBE-0 supplements by NDA and BLA
holders to change information in the Highlights of Prescribing
Information portion of drug labeling. If an NDA holder or a BLA holder
seeks to submit a CBE-0 supplement to change information in the
Highlights of Prescribing Information to reflect newly acquired
information for any of the reasons described in Sec.  314.70(c)(6)(iii)
or Sec.  601.12(f)(2), as applicable, the NDA holder or BLA holder can
normally obtain permission to do so under the current regulation by
contacting FDA. In response to an applicant's inquiry about submission
of a CBE-0 supplement for a change that would affect the Highlights of
drug labeling, FDA typically waives the limitation on submission of a
CBE-0 supplement under 21 CFR 314.90 or specifically requests that the
applicant proceed with a CBE-0 supplement under Sec.
314.70(c)(6)(iii)(E) or Sec.  601.12(f)(2)(i)(E).
    FDA is continuing to consider ways to improve the communication of
important, newly acquired drug safety information to healthcare
professionals and the public, and to facilitate efforts to keep drug
product labeling up to date throughout the product lifecycle. Although
the proposed rule focused on labeling updates to reflect newly acquired
information related to drug safety, we recognize that there are general
challenges for keeping generic drug labeling up to date when the RLD
labeling is no longer being updated, including when FDA has withdrawn
approval of the NDA for reasons other than safety or effectiveness. The
Agency is actively evaluating ways to facilitate the updating of
generic drug labeling to help ensure that drug labeling reflects the
most current information. For example, FDA's fiscal year (FY) 2019
Budget Request includes an investment to support efforts to update
generic drug labeling, with an initial focus on oncology products, as
part of the Agency's efforts to ensure that patients and their
providers have access to up-to-date information to inform clinical
decisions (Ref. 2). These efforts to ensure that more generic drugs
have up-to-date product labeling reflecting the latest treatment
information can also encourage wider adoption of generic drugs,
broadening access to lower-cost alternatives to brand drugs for the
American people.
    The withdrawal of this proposed rule does not preclude the Agency
from reinstituting rulemaking concerning the issues addressed in the
proposal. Should we decide to undertake such rulemaking in the future,
we will re-propose the action and provide new opportunities for
comment. Furthermore, this proposed rule is only intended to address
the withdrawal of the proposed rule on ``Supplemental Applications
Proposing Labeling Changes for Approved Drugs and Biological Products''
published in the Federal Register of November 13, 2013, and not any
other pending proposals that the Agency has issued or is considering,
including the Draft Guidance on Updating ANDA Labeling (Ref. 1) or the
Agency's efforts to update the labeling of certain oncology drug
products under FDA's FY2019 Budget Request (Ref. 2). If you need
additional information about the subject matter of

the withdrawn proposed rule, you may review the Agency's website
(https://www.fda.gov) for any current information on the matter.

III. References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

    1. FDA, draft guidance for industry, ``Updating ANDA Labeling
After the Marketing Application for the Reference Listed Drug Has
Been Withdrawn,'' July 2016 (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm510240.pdf).
    2. U.S. Department of Health and Human Services, Food and Drug
Administration, ``Fiscal Year 2019 Justification of Estimates for
Appropriations Committees'' (available at https://www.fda.gov/downloads/aboutfda/reportsmanualstorms/reports/budgetreports/ucm603315.pdf).

    Dated: December 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27098 Filed 12-13-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Proposed Rules]
[Pages 14346-14348]
[FR Doc No: 2011-6096]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0231; Directorate Identifier 2011-CE-003-AD]
RIN 2120-AA64

Airworthiness Directives; Diamond Aircraft Industries GmbH Model
DA 42 Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Cracks have been reportedly found on DA 42 Main Landing Gear
(MLG) Damper-to-Trailing Arm joints during standard maintenance.
Depending on environmental-, operating- and runway conditions, the
affected MLG joint, Part Number (P/N) D60-3217-23-5x (4 different
lengths are available), which is made of aluminum, is susceptible to
cracking.
    This condition, if not detected and corrected, may lead to
failure of the joint and subsequent damage or malfunction of the
MLG, possibly resulting in damage to the aeroplane during landing
and injury to occupants.

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by May 2, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Diamond Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700
Wiener Neustadt, Austria, telephone: +43 2622 26700; fax: +43 2622
26780; e-mail<EMAIL_ADDRESS>Internet: http://www.diamond-air.at. You may review copies of the referenced service information at
the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-0231;
Directorate Identifier 2011-CE-003-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD No.: 2011-0020, dated February 7, 2011 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Cracks have been reportedly found on DA 42 Main Landing Gear
(MLG) Damper-to-Trailing Arm joints during standard maintenance.
Depending on environmental-, operating- and runway conditions, the
affected MLG joint, Part Number (P/N) D60-3217-23-5x (4 different
lengths are available), which is made of aluminum, is susceptible to
cracking.
    This condition, if not detected and corrected, may lead to
failure of the joint and subsequent damage or malfunction of the
MLG, possibly resulting in damage to the aeroplane during landing
and injury to occupants.
    To address this unsafe condition, EASA issued AD 2010-0155 to
require repetitive inspections of the MLG joint and, depending on
findings, replacement with a serviceable part. Since that AD was
issued, DAI developed an improved design MLG joint, P/N D64-3217-23-
0x (also 4 different lengths available), which is made of steel and
less susceptible to cracking.
    For the reasons described above, this new AD retains the
requirements of EASA AD 2010-0155R1, which is superseded, and adds
the terminating action requirement to modify the aeroplane by
installing the improved steel part. This new AD also prohibits re-
installation of the aluminum part.

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Diamond Aircraft Industries GmbH has issued Mandatory Service
Bulletin No. MSB 42-088/2, dated February 3, 2011, and Work Instruction
WI-MSB 42-088, dated February 3, 2011. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of the 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 our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 162 products of U.S.
registry. We also estimate that it would take about 1 work-hour per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Required parts would cost
about $729 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $131,868, or $814 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures

the Administrator finds necessary for safety in air commerce. This
regulation is within the scope of that authority because it addresses
an unsafe condition that is likely to exist or develop on products
identified in this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Diamond Aircraft Industries GmbH: Docket No. FAA-2011-0231;
Directorate Identifier 2011-CE-003-AD.

Comments Due Date

    (a) We must receive comments by May 2, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Diamond Aircraft Industries GmbH Model DA
42 airplanes, all serial numbers, certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 32: Landing
Gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Cracks have been reportedly found on DA 42 Main Landing Gear
(MLG) Damper-to-Trailing Arm joints during standard maintenance.
Depending on environmental-, operating- and runway conditions, the
affected MLG joint, Part Number (P/N) D60-3217-23-5x (4 different
lengths are available), which is made of aluminum, is susceptible to
cracking.
    This condition, if not detected and corrected, may lead to
failure of the joint and subsequent damage or malfunction of the
MLG, possibly resulting in damage to the aeroplane during landing
and injury to occupants.
    To address this unsafe condition, EASA issued AD 2010-0155 to
require repetitive inspections of the MLG joint and, depending on
findings, replacement with a serviceable part. Since that AD was
issued, DAI developed an improved design MLG joint, P/N D64-3217-23-
0x (also 4 different lengths available), which is made of steel and
less susceptible to cracking.
    For the reasons described above, this new AD retains the
requirements of EASA AD 2010-0155R1, which is superseded, and adds
the terminating action requirement to modify the aeroplane by
installing the improved steel part. This new AD also prohibits re-
installation of the aluminum part.

Actions and Compliance

    (f) Unless already done, do the following actions following
Diamond Aircraft Industries GmbH Mandatory Service Bulletin No. MSB
42-088/2, dated February 3, 2011; and Work Instruction WI-MSB 42-
088, dated February 3, 2011:
    (1) Within 100 hours time-in-service (TIS) after the effective
date of this AD, replace each main landing gear (MLG) joint P/N D60-
3217-23-5x with a MLG joint P/N D64-3217-23-0x.
    (2) After the effective date of this AD, all replacements of MLG
joint P/N D60-3217-23-5x must be done with MLG joint P/N D64-3217-
23-0x.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: EASA originally established an initial and repetitive
inspection of the MLG joint part. We are not establishing an initial
or repetitive inspection, and instead we are just requiring a
mandatory one-time replacement of the part within 100 hours TIS
after the effective date of this AD.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to Attn: Mike Kiesov, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a Federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

Related Information

    (h) Refer to MCAI EASA AD No.: 2011-0020, dated February 7,
2011; Diamond Aircraft Industries GmbH Mandatory Service Bulletin
No. MSB 42-088/2, dated February 3, 2011; and Work Instruction WI-
MSB 42-088, dated February 3, 2011, for related information. For
service information related to this AD, contact Diamond Aircraft
Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700 Wiener Neustadt,
Austria, telephone: +43 2622 26700; fax: +43 2622 26780; e-mail:
<EMAIL_ADDRESS>Internet: http://www.diamond-air.at. You may
review copies of the referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri on March 10, 2011.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2011-6096 Filed 3-15-11; 8:45 am]
BILLING CODE 4910-13-P


            2014 Compliance Recertification Application (CRA-2014)
        Compliance Application Review Document (CARD for Section 194.53)
            Consideration of Underground Sources of Drinking Water

53.0 Background

	Section 194.53 requires the U.S. Department of Energy (DOE or Department) to consider, in compliance assessments, underground sources of drinking water near the Waste Isolation Pilot Plant (WIPP) and their interconnections.  An underground source of drinking water is defined at 40 CFR 191.22 as "an aquifer or its portion that supplies a public water system, or contains a sufficient quantity of ground water to do so and (i) currently supplies drinking water for human consumption or (ii) contains fewer than 10,000 mg per liter of total dissolved solids."  The groundwater protection requirements limit releases to the maximum contamination level (MCL) established in 40 CFR Part 141 of the Safe Drinking Water Act.

      The disposal standards in 40 CFR 191.24(a) (l) require that "Disposal systems for waste and any associated radioactive material shall be designed to provide a reasonable expectation that 10,000 years of undisturbed performance after disposal shall not, cause the levels of radioactivity in any underground source of drinking water, in the accessible environment, to exceed the limits specified in 40 CFR part 141 as they exist on January 19, 1994".

53.1 Requirement (194.53)

      "In compliance assessments that analyze compliance with part 191, subpart C of this chapter, all underground sources of drinking water in the accessible environment that are expected to be affected by the disposal system over the regulatory time frame shall be considered.   In determining whether underground sources of drinking water are expected to be affected by the disposal system, underground interconnections among bodies of surface water, groundwater, and underground sources of drinking water shall be considered."

53.2 1998 Certification Decision

	The U.S, Environmental Protection Agency (EPA or Agency) expected the Compliance Certification Application (CCA) to discuss the assumptions and approaches used to consider underground sources of drinking water, as well as the uncertainty associated with the analyses.  EPA expected DOE to provide detailed information on the location and nature of underground sources of drinking water and indicated the estimated concentrations of radionuclides in the underground sources of drinking water (USDWs) in the accessible environment and show that the MCLs for radionuclides will not be exceeded during the regulatory time period.

      In the CCA, DOE presented an evaluation of the USDWs to the accessible environment around the WIPP that were expected to be affected by the disposal system over the regulatory time frame.  This information was included in CCA Chapter 8 and CCA Appendix USDW.   Based on the definitions in 40 CFR Part 191.22, DOE identified three sub-criteria to determine whether a water-bearing horizon located within the WIPP controlled area would qualify as USDW.  These were:

      (1) a minimum pumping rate of five gallons per minute,

      (2) supply of water at that rate of 5 gallons per minute for a 40 year period, and

      (3) a maximum of 10,000 milligrams per liter (mg/l) of Total Dissolved Solids (TDS).

      These requirements characterize the capacity and quality of a public water system.  A public water system is defined in 40 CFR Part 191.22, as a system providing piped water for human consumption to 25 individuals, or has at least 15 service connections.  (CCA Chapter 8.2.1)

      Using the above criteria, DOE selected the Culebra, Dewey Lake, and Santa Rosa as potential USDW's (CCA Chapter 8.2.2) to be evaluated.  DOE conducted a bounding analysis of the concentrations of the contaminants to assess compliance (Subpart C of 40 CFR part 191).  In this analysis DOE assumed 10,000 parts per million total dissolved solids (TDS), which is much less than the observed concentration of brine derived from the Salado anhydrite marker beds.  Also, a USDW was assumed to be present near the WIPP Land Withdrawal Boundary (LWB).   DOE indicated in the CCA that in spite of this conservative approach, the bounding analysis showed that radionuclide concentrations in the USDWs would be less than half of the EPA's groundwater protection standard, and the dose to a receptor drinking from the USDW would be a factor of ten less than the standard (CCA Chapter 8.2.3).

      Overall, DOE believed that the bounding analysis, using very conservative ("unrealistic") assumptions, resulted in an overestimation of the potential doses and contaminant concentrations.  In addition DOE assumed a USDW in close proximity to the land withdrawal boundary.  DOE's findings indicated that even with these "unrealistic" assumptions the estimated potential dose to an individual were below the 40 CFR 191 requirements.  The CCA analysis also assumed that all contaminants reaching the accessible environment were directly available to the receptor so that the interconnections of surface, ground and underground drinking water were all considered and treated as one USDW source. (CCA Chapter <IP_ADDRESS> and 8.3)

      EPA examined DOE's approach and assumptions associated with the USDW determination in the CCA.  EPA found the analyses to be well supported and accurate, including the uncertainty associated with these analyses.  In addition, EPA assessed all possible aquifers to determine how USDWs were identified and discussed in the CCA.  EPA also examined whether the flow rates and directions were included in the description.  The modeling assumptions and specifications for the bounding analysis were examined thoroughly to assess reliability and assurance of safety.   EPA reviewed the estimated concentrations of radionuclides to determine if they adequately comply with the groundwater protection standard. (see CCA CARD 53 for details of our CCA review)

      EPA found that DOE's determination of USDWs were in accordance with the Section 191.22 definitions and Section 194.53.  The bounding analysis was performed with conservative assumptions for a hypothetical USDW to estimate contamination and potential doses to a receptor.

	A complete description of EPA's 1998 Certification Decision for Section 194.53 can be obtained from EPA Air Docket, A-93-02, Items V-A-1 and V-B-2.

53.3 Changes in the 2004 Complication Recertification Application (2004 CRA)

      In Chapter 8 of the 2004 Compliance Recertification Application (2004 CRA), DOE updated some aspects of the analysis of USDWs.  DOE updated the data for ground water quantity determination to define a USDW.  In the CCA, DOE used 1990 census data to determine the average water usage per person per day and the estimated quantity was 282 gallons.  In the 2004 CRA, DOE used 2000 census data to determine that the average water usage per person per day increased to 305 gallons.  DOE did not believe it was necessary to change the sub-criterion of 5 gallons per minute rate of production from a well to define a USDW (2004 CRA Chapter <IP_ADDRESS>).

      DOE monitored and evaluated new wells drilled in the area since the completion of CCA.
A new well, C-2737, was drilled to replace H-1 in 2001.  Water sampled from the Dewey Lake Formation showed 2,590 parts per million (ppm), Total Dissolved Solids (TDS) concentration (2004 CRA Chapter 8.2.2).  Additional wells were drilled at the WIPP site to investigate the extent of groundwater at the contact of Santa Rosa and Dewey Lake Formations.  The groundwater samples indicate TDS at both below and above 10,000 ppm TSD.  DOE was unable to pump water from any one of these holes at a rate of 5 gpm or more (2004 CRA Chapter 8.2.2).

      The updates and changes made by DOE in the 2004 CRA did not significantly impact the conclusions regarding USDWs in the CCA.  In the 2004 CRA, DOE continued to identify the Culebra, Dewey Lake, and Santa Rosa as the only potential USDW's (CCA Chapter 8.2.2).  DOE states that the conservative bounding analysis used for the 1998 Certification Decision compliance assessment is still applicable.

53.3.1 Evaluation of Compliance for 2004 Recertification

      EPA evaluated the information on USDWs contained in the 2004 CRA, Chapter 8 and Appendix USDW.  EPA examined the data from the new wells drilled within the study area since the 1998 Certification Decision and determined that DOE applied adequately conservative assumptions to the data for a hypothetical USDW to determine compliance with Section 194.53.

      Because of the lack of significant changes to the parameters for the protected individual, the potential exposure pathways and the sources of underground drinking water, DOE determined that the bounding analysis that was performed for the dose calculation in the CCA still applies.  See 2004 CRA CARD 55 for more information on the results of the compliance assessment.

      In performing the compliance assessment for the 2004 CRA DOE concluded that the maximum concentrations of contamination in the hypothetical USDW would be much less than half of the EPA groundwater protection limits, and the maximum potential dose to a receptor who drinks from the hypothetical USDW would be well below one-quarter of the standard (Appendix IGP).

	EPA did not receive any public comments on DOE's continued compliance with the consideration of underground sources of drinking water requirements of Section 194.53.

53.3.2 2004 Recertification Decision

	Based on a review and evaluation of the 2004 CRA and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2004-0025, Air Docket A-98-49), EPA determines that DOE continues to comply with the requirements for Section 194.53.

53.4. Changes in the 2009 Complication Recertification Application (2009 CRA)

      In Section 53 and Appendix IGP-2009 of the 2009 Compliance Recertification Application (2009 CRA), DOE reviewed and updated information related to USDWs.

      DOE updated the data for ground water quantity determination to define a USDW.  In the 2009 CRA, DOE continued to use 2000 census data as in the 2004 CRA (2009 CRA Appendix IGP-2009 page IGP-15), but updated average household water consumption values with data obtained from the New Mexico Office of the State Engineer (Longworth et al. 2008).  The water consumption data show that the average per capita consumption decreased to 273 gpd (Appendix IGP-2009 Table IGP-7).  Using these new data the updated average consumption value, the rate of consumption for 15 service connections is 7.51 gpm.  For 25 people, the value is 4.74 gpm.  DOE concludes that the sub-criterion of 5 gallons per minute rate (gpm) of production from a well continues to accurately define a USDW (Appendix IGP-2009) and any change in this sub- criterion is not warranted as a result of applying more current water-consumption data to the calculation.

      Three shallow (77 feet deep) piezometer wells were drilled on the WIPP site in 2007 to determine whether shallow subsurface water exists in this area (DOE 2008b Section 3.2).  Two wells showed TDS concentrations significantly in excess of 10,000 mg/L; the third showed levels below that concentration (DOE 2008b Table 3-2).  None of the wells met the 5-gpm pumping rate sub-criterion, so there is no indication of the presence of a USDW.  In the 2009 CRA, DOE continues to identify the Culebra, Dewey Lake, and Santa Rosa as the only potential USDW's (2009 CRA Section 53).  In Appendix IGP-2009, Section IGP-3.2  DOE presents recent TDS data available through the WIPP WQSP (detection monitoring program) operated under the provisions of the WIPP Hazardous Waste Facility Permit.  One WQSP well, WQSP  -  6A, in the Dewey Lake shows TDS concentration below 10,000mg/L and all the other WQSP wells 1  -  6, completed in the Culebra show TDS concentration above 10,000mg/L.  The Department concluded that the recent data from the WQSP wells are consistent with earlier data in reference to the USDW determinations and changes to the earlier USDW determinations are not necessary.

      The updates made by DOE in the 2009 CRA did not significantly impact the conclusions regarding USDWs in the CCA.  DOE did not change the criteria for making USDW determinations, and for the 2009 CRA evaluation, the maximum potential dose remains below the CCA value calculated and continued compliance with the individual protection standard is maintained.   DOE states that the conservative bounding analysis used for the 1998 Certification Decision compliance assessment is still applicable for 2009 CRA.

53.4.1 Evaluation of Compliance for 2009 Recertification

      EPA evaluated the information on USDWs contained in the 2009 CRA, Section 53 and Appendix IGP-2009.  EPA examined the data from the new wells drilled within the study area since the 1998 Certification and the 2004 Recertification Decisions and determined that DOE applied adequately conservative assumptions to the data for a hypothetical USDW to determine compliance with 40 CFR 194.53.

      Because of the lack of significant changes to the parameters for the protected individual, the potential exposure pathways, and the sources of underground drinking water, DOE determined that the bounding analysis that was performed for the dose calculation in the CCA still applies.  See 2009 CRA CARD 55 for more information on the results of the compliance assessment.

      For the 2009 CRA evaluation (Appendix IGP-2009), DOE notes that the maximum potential dose remains below the CCA value and continued compliance with the individual protection standard is maintained.  The potential concentrations of contaminants in the hypothetical USDW and the maximum potential dose to a receptor that drinks from the hypothetical USDW continue to be bounded by the CCA analysis results.

      EPA did not receive any public comments on DOE's continued compliance with the consideration of underground sources of drinking water requirements of Section 194.53.

53.4.2 2009 Recertification Decision

	Based on a review and evaluation of the 2009 CRA and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2009-0330, Air Docket A-98-49), EPA determines that DOE continues to comply with the requirements for Section 194.53.

53.5. Changes in the 2014 Complication Recertification Application (2014 CRA)

      In Section 53.8 and Appendix IGP-2014 of DOE's 2014 Compliance Recertification Application (2014 CRA), DOE reviewed and updated information related to USDWs.

      DOE updated the data for ground water quantity determination to define a USDW.  In the 2014 CRA, DOE used 2011 (U.S. Bureau of Census 2013) census data to determine the number of Persons Per Household (2014 CRA Appendix IGP-2014, Table IGP-3).  DOE continued to use the CRA-2009 data for the average household water consumption values as noted in Table IGP-3, no new data were available.  The water consumption data show that the average per capita consumption is 273 gpd (Appendix IGP-2014, Table IGP-3). For 25 people, the value is 4.74 gpm.  DOE continues to conclude that the sub-criterion of 5 gallons per minute rate (gpm) of production from a well continues to accurately define a USDW (Appendix IGP-2014, Section IGP-3.1.1) and any change in this sub- criterion is not warranted as a result of applying more current water-consumption data to the calculation.

      DOE replaced five existing water monitor wells since the 2009 CRA; however no new information related to USDWs was generated. In the 2014 CRA, DOE continued to identify the Culebra, Dewey Lake, and Santa Rosa as the only potential USDW's in the vicinity of the WIPP LWB (2014 CRA DOE Section 53.8).  In the 2012 Annual Site Environmental Report (ASER) (DOE 2013) DOE presents recent TDS date available from the WIPP WQSP detection monitoring program wells.  One WQSP well, well WQSP -  6A, drilled in the Dewey Lake shows TDS concentration below 10,000mg/L (DOE 2013[1], Table 6.6), all the other WQSP wells 1  -  6 are completed in the Culebra, and show TDS concentration above 10,000mg/L (DOE 2013a, Tables F.2 through F.7).  The Department concluded that the recent data from the WQSP wells are consistent with earlier data in reference to the USDW determinations, therefore changes to the earlier USDW determinations are not necessary. DOE also continues to monitor the PZ WIPP site wells, as noted in the ASER 2012 (DOE 2013a), the 2009 conclusions have not changed (see Section 53.4 above).

      The updates made by DOE in the 2014 CRA did not significantly impact the conclusions regarding USDWs in the CCA.  DOE did not change the criteria for making USDW determinations, and for the 2014 CRA evaluation, the maximum potential dose remains below the CCA value calculated and continued compliance with the individual protection standard is maintained.   DOE states that the conservative bounding analysis used for the 1998 Certification Decision compliance assessment is still applicable for 2014 CRA (see 2014 CRA Appendix IGP-2014, Section IGP-4.0).

53.5.1 Evaluation of Compliance for 2014 Recertification

      EPA evaluated the information on USDWs contained in DOE's 2014 CRA, Section 53 and Appendix IGP-2014.  EPA examined the data from the new wells drilled within the study area since the 1998 Certification and previous CRAs and determined that DOE applied adequately conservative assumptions to the data for a hypothetical USDW to determine compliance with 40 CFR 194.53.

      Because of the lack of significant changes to the parameters for the protected individual, the potential exposure pathways, and the sources of underground drinking water, EPA determined that the bounding analysis that was performed for the dose calculation in the CCA still applies.  See 2014 CRA CARD 55 for more information on the results of the compliance assessment.

      For the 2014 CRA evaluation (Appendix IGP-2014), DOE notes that the maximum potential dose remains below the CCA value and continued compliance with the individual protection standard is maintained (see 2014 CRA Appendix IGP-2014, Section IGP-4.0.  The potential concentrations of contaminants in the hypothetical USDW and the maximum potential dose to a receptor that drinks from the hypothetical USDW continue to be bounded by the CCA analysis results.

      EPA did not receive any public comments on DOE's continued compliance with the consideration of underground sources of drinking water requirements of Section 194.53.

53.5.2 2014 Recertification Decision

	Based on a review and evaluation of the 2014 CRA and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2014-0609), EPA determines that DOE continues to comply with the requirements for Section 194.53.


[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57577-57578]
[DOCID:fr03oc05-62]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF05-5031-000]

United States Department of Energy Western Area Power
Administration; Notice of Filing

September 23, 2005.
    Take notice that on September 14, 2005, the Deputy Secretary of the
Department of Energy, confirmed and approved Rate Order No. WAPA-122
and Rate Schedule UGP-FPT1 for firm point-to-point transmission
service, UGP-NFPT1 for non-firm transmission service, UGP-NT1 for
network integration transmission service, and UGP-AS1, UGP-AS2, UGP-
AS3, UGP-AS4, UGP-AS5, and UGP-AS6 for ancillary services. The rate
schedule services are confirmed and approved on an interim basis
effective on October 1, 2005 and will be in effect until the Commission
confirms and approve on a final basis effective October 1, 2005 and
ending September 30, 2010.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.

    This filing is accessible on-line at http://www.ferc.gov, using the

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on October 5, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5365 Filed 9-30-05; 8:45 am]

BILLING CODE 6717-01-P


JULY 31, 2008 DRAFT BIOLOGICAL OPINION ON EFFECTS OF

DIAZINON, CHLORPYRIFOS AND MALATHION

ON 28 PACIFIC SALMON AND STEELHEAD SPECIES

LISTED UNDER THE ENDANGERED SPECIES ACT

APPLICANT MEETING (MAKHTESHIM AGAN OF NORTH AMERICA, INC.; DOW
AGROSCIENCES, LLC; AND CHEMINOVA)

AUGUST 29, 2008

9:30 A.M. – 3:45 P.M.

Potomac Yard 1 South

Room PYS 4370-4380

AGENDA

9:30 – 9:45 	Introductions and Opening Remarks – Anne Lindsay, EPA -
facilitates

9:45 – 10:15 	NMFS introduction to the draft and explanation of the
basis for conclusions – Angela Somma, NMFS - facilitates

10:15 – 11:00	Registrants’ (applicants’) presentation regarding
common issues of concern

11:00 – 11:15 	Break

11:15 – 12:00	MANA presentation regarding diazinon-specific issues

12:00 – 12:45 	Lunch break (on your own)

12:45 – 1:30	DAS presentation regarding chlorpyrifos-specific issues

1:30 – 2:15	Cheminova presentation regarding malathion-specific issues

2:15 – 2:30 	Break

2:30 – 3:30	Discussion regarding risk mitigation and reasonable and
prudent alternatives – Angela Somma, NMFS - facilitates

3:30 – 3:45 	Closing remarks and next steps