[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Proposed Rules]
[Pages 3631-3635]
[FR Doc No: 2018-01467]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 600

[Docket No. FDA-2017-N-7007]
RIN 0910-AH49

Removal of Certain Time of Inspection and Duties of Inspector
Regulations for Biological Products; Companion to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
proposing to amend the general biologics regulations relating to time
of inspection requirements and also removing duties of inspector
requirements. FDA is proposing this action to remove outdated
requirements and accommodate new approaches,

such as a risk-based inspection frequency for drug establishments,
thereby providing flexibility without diminishing public health
protections. This action is part of FDA's implementation of Executive
Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively
reviewing existing regulations to identify opportunities for repeal,
replacement, or modification that will result in meaningful burden
reduction while allowing the Agency to achieve our public health
mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments on the proposed
rule or its companion direct final rule by April 11, 2018. If FDA
receives any timely significant adverse comments on the direct final
rule with which this proposed rule is associated, the Agency will
publish a document withdrawing the direct final rule within 30 days
after the comment period ends. FDA will apply any significant adverse
comments received on the direct final rule to the proposed rule in
developing the final rule. FDA will then proceed to respond to comments
under this proposed rule using the usual notice and comment procedures.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 11, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-7007 for ``Removal of Certain Time of Inspection and Duties
of Inspector Regulations for Biological Products.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, 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: Melissa Segal, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to amend the general biologics regulations
relating to time of inspection requirements and to remove duties of
inspector requirements. FDA is proposing this action to remove outdated
requirements and accommodate new approaches, such as a risk-based
inspection frequency for drug establishments, thereby providing
flexibility without diminishing public health protections.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule would revise the time of inspection requirements
contained in Sec.  600.21 (21 CFR 600.21) and also remove the duties of
inspector requirements contained in Sec.  600.22 (21 CFR 600.22). These
changes to the biological product regulations would eliminate outdated
requirements and accommodate new approaches, such as a risk-based
inspection frequency for drug establishments, thereby providing
flexibility without diminishing public health protections. Revision and
removal of these regulations would not change the biological product
establishment inspection requirements and duties of an investigator
requirements that apply under sections 704 and 510(h) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 374 and 360(h)) and
section 351(c) of the Public Health Service Act (PHS Act) (42 U.S.C.
262(c)).

C. Legal Authority

    FDA is proposing this action under the biological product
provisions of the PHS Act, and the drugs and general administrative
provisions of the FD&C Act, including sections 704 and 510(h) of the
FD&C Act and section 351(c) of the PHS Act.

D. Costs and Benefits

    Because this proposed rule would not impose any additional
regulatory burdens, this regulation is not anticipated to result in any
compliance costs and the economic impact is expected to be minimal.

II. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule
published in the rules section of this issue of the Federal Register.
This companion proposed rule provides the procedural framework to
finalize the rule in the event that the direct final rule receives any
significant adverse comment and is withdrawn. The comment period for
this companion proposed rule runs concurrently with the comment period
for the direct final rule. Any comments received in response to this
companion proposed rule will also be considered as comments regarding
the direct final rule. FDA is publishing the direct final rule because
we believe the rule contains noncontroversial changes and there is
little likelihood that there will be significant adverse comments
opposing the rule.
    A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. In determining whether an adverse comment is
significant and warrants terminating a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process. Comments that
are frivolous, insubstantial, or outside the scope of the rule will not
be considered significant or adverse under this procedure. A comment
recommending a regulation change in addition to those in the direct
final rule would not be considered a significant adverse comment unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to a part of the direct final rule and that part can be severed
from the remainder of the rule, we may adopt as final those provisions
of the rule that are not the subject of the significant adverse
comment.
    If any significant adverse comments to the direct final rule are
received during the comment period, FDA will publish, within 30 days
after the comment period ends, a notice of significant adverse comment
and withdraw the direct final rule. If we withdraw the direct final
rule, any comments received will be considered comments on the proposed
rule and will be considered in developing a final rule using the usual
notice-and-comment procedure.
    If no significant adverse comment is received in response to the
direct final rule during the comment period, no further action will be
taken related to this proposed rule. Instead, we will publish a
document confirming the effective date within 30 days after the comment
period ends. Additional information about direct final rulemaking
procedures is set forth in the document entitled ``Guidance for FDA and
Industry: Direct Final Rule Procedures,'' announced and provided in the
Federal Register of November 21, 1997 (62 FR 62466). The guidance may
be accessed at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

III. Background

    On February 24, 2017, President Donald Trump issued Executive Order
13777, ``Enforcing the Regulatory Reform Agenda'' (82 FR 12285, March
1, 2017). One of the provisions in the Executive Order requires
Agencies to evaluate existing regulations and make recommendations to
the Agency head regarding their repeal, replacement, or modification,
consistent with applicable law. As one step in implementing the
Executive Order, FDA published a notice in the Federal Register of
September 8, 2017 (82 FR 42492) entitled ``Review of Existing Center
for Biologics Evaluation and Research Regulatory and Information
Collection Requirements.'' In that notice, FDA announced that it was
conducting a review of existing regulations to determine, in part,
whether they can be made more effective in light of current public
health needs and to take advantage of, and support, advances in
innovation that have occurred since those regulations took effect. As
part of this initiative, FDA is updating outdated regulations as
specified in this rule.
    FDA's general biological products regulations in part 600 (21 CFR
part 600) are intended to help ensure the safety, purity, and potency
of biological products administered to humans. The proposed revision
and removal of certain general biological products regulations are
designed to eliminate outdated requirements and accommodate new
approaches, such as a risk-based inspection frequency for drug
establishments and provide flexibility without diminishing public
health protections.

A. Section 600.21

    The authority for FDA to conduct establishment inspections is
included in both the FD&C Act and the PHS Act. Specifically, section
704 of the FD&C Act and section 351(c) of the PHS Act authorize the
Agency to inspect establishments that manufacture biological products.
Before July 9, 2012--the date the Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L. 112-144) was signed into law--
section 510(h) of the FD&C Act further provided, among other things,
that drug and device establishments registered with FDA must be
inspected at least once in the 2-year period beginning with the date of
registration and at least once in every successive 2-year period
thereafter. Section 510(h) of the FD&C Act applies to biological
product establishments because all biological products are subject to
regulation under the drug or device provisions of the FD&C Act (in
addition to the biological product provisions of the PHS Act). Since
1983, FDA's biological product regulation at Sec.  600.21 has also
included a biennial inspection requirement (``[A]n inspection of each
licensed establishment and its additional location(s) shall be made at
least once every 2 years''); this was consistent with the pre-FDASIA
biennial inspection requirement in section 510(h) of the FD&C Act.
    With the enactment of FDASIA, however, the biennial inspection
requirement for drug establishments in section 510(h) of the FD&C Act
was replaced with a requirement that FDA inspect drug establishments in
accordance with a risk-based schedule established by FDA. Accordingly,
for biological product establishments that are registered as drug
establishments under section 510(h), the requirement in Sec.  600.21
regarding the frequency of inspections is no longer consistent with the
FD&C Act and is outdated (e.g., the risk-based inspection schedule for
drug establishments may result in scheduling inspections at intervals
of greater than 2 years for certain biological product establishments).
For this reason, and to provide for greater flexibility in general with
respect to determining the frequency of biological product
establishment inspections under the

authority provided in the FD&C Act and the PHS Act, FDA proposes to
revise Sec.  600.21 to remove the biennial inspection requirement for
biological product establishments that are registered as drug
establishments and for those that are registered as device
establishments.
    In addition, Sec.  600.21 includes provisions concerning
inspectional notice and the timing of pre-licensure reinspections of
biological product establishments. These provisions are outdated and
unnecessary. Inspectional notice is addressed in the Agency's practices
for inspections in its Standard Operating Procedures and Policies and
in the Investigations Operations Manual (IOM). With respect to the
timing of a reinspection of a biological product establishment
following the denial of a biologics license application, the general
biologics licensing provision at 21 CFR 601.4, which was issued
subsequent to Sec.  600.21, sets forth the administrative procedures
following the denial of a license; accordingly, the specific provision
in Sec.  600.21 regarding timing of a reinspection following denial of
a license is unnecessary. Therefore, FDA is proposing to remove these
provisions.

B. Section 600.22

    Current Sec.  600.22 requires specific duties of an FDA inspector.
These existing codified requirements are unnecessary because they are
duplicative of statutory requirements that apply to biological product
inspections under section 704 of the FD&C Act. Specifically, the
inspection requirements in section 704 of the FD&C Act encompass all of
the requirements outlined in Sec.  600.22. Thus, we are proposing to
remove Sec.  600.22(a) through (h).
    The removal of these regulations, however, would not change the
establishment inspection requirements and duties of an investigator
requirements specified in sections 704 and 510(h) of the FD&C Act,
section 351(c) of the PHS Act, or the procedures described in the IOM.
Additionally, it would not change the established process for risk-
based inspection planning and work planning.

IV. Highlights of the Proposed Rule

    FDA is proposing to amend the general biologics regulations by
revising time of inspection requirements contained in Sec.  600.21 and
also by removing the duties of inspector requirements contained in
Sec.  600.22. These proposed changes are designed to remove the
existing codified requirements that are outdated and to accommodate new
approaches, such as a risk-based inspection frequency for biological
product establishments, thereby providing flexibility without
diminishing public health protections.

V. Legal Authority

    FDA is issuing this proposed rule under the biological products
provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a, 264, and
300aa-25) and the drugs and general administrative provisions of the
FD&C Act (21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360, 360i,
371, 374, and 379k-l). Under these provisions of the PHS Act and the
FD&C Act, we have the authority to issue and enforce regulations
designed to ensure that biological products are safe, pure, and potent,
and prevent the introduction, transmission, and spread of communicable
disease.

VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the proposed rule does not impose any additional
regulatory burdens, we propose to certify that the proposed rule will
not have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $148 million, using the most current (2016) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    This proposed rule proposes amendments to the general biologics
regulations by removing time of inspection requirements and the duties
of inspector requirements. FDA is proposing this action to remove
outdated requirements, accommodate new approaches, and provide
flexibility without diminishing public health protections. Because this
rulemaking proposes removal of regulations to be consistent with
updated practice and does not impose any additional regulatory burdens,
this proposed rulemaking is not anticipated to result in any compliance
costs and the economic impact is expected to be minimal.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects 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. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

List of Subjects in 21 CFR Part 600

    Biologics, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public

Health Service Act, and under authority delegated to the Commissioner
of Food and Drugs, it is proposed that 21 CFR part 600 be amended as
follows:

PART 600--BIOLOGICAL PRODUCTS: GENERAL

0
1. The authority citation for part 600 continues to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360,
360i, 371, 374, 379k-l; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-
25.

Sec.  600.21  [Amended]

0
2. Amend Sec.  600.21 by removing the last three sentences.

Sec.  600.22  [Removed and Reserved]

0
3. Remove and reserve Sec.  600.22.

    Dated: January 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01467 Filed 1-25-18; 8:45 am]
 BILLING CODE 4164-01-P


Standard bcc's: official file copy w/ attachment( s) originator's file copy w/ attachment( s) originating organization reading file w/ attachment( s)

Other bcc's: ORA reading file Kay Hudson Naimah Karim Felicia Williams Shari Holloway William Dew ( electronic copy) Jennifer Manville ( electronic copy) Rita Cestaric R. Damberg, OAQPS ( electronic copy) L. Wallace, OAQPS ( electronic copy)

Path/ Filename: C:\ dmautop\ temp\ dwcgi 27635 1090409308 7885050 00. wpd Creation Date: July 21, 2004 ( 7: 50AM) Addresses Lynn Hall, Bad River


IMPORTANT NOTE TO USER:

This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font (Times New Roman 8pt).

 Do not change table lines (although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5. 1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request: United States Environmental Protection Agency/ Office of Solid Waste 2. OMB control number b. G None a_ 2050 0053 3. Type of information collection (check one) a. X New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested (check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes G No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title: Cathode Ray Tubes 8. Agency form number( s) (If applicable) EPA ICR# 1189.10 9. Keywords: Cathode Ray Tubes, exclusion from hazardous waste 10. Abstract The Agency is proposing to exclude cathode ray tubes (CRT) from the definition of solid waste and clarify the status of used cathode ray tubes and processed CRTs sent for reuse and recycling. The rule proposes a conditional exclusion from the definition of solid waste for CRTs sent for recycling.

11. Affected public (Mark primary with "P" and all others that apply with "X") a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. X Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond (Mark primary with "P" and all others that apply with "X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 2, 432 b. Total annual responses 0 1. Percentage of these responses collected electronically 0 % c. Total hours requested 47,679 d. Current OMB inventory 0 e. Difference 47,565 f. Explanation of difference 1. Program Change Newly proposed requirements 2. Adjustment 14. Annual reporting and recordkeeping cost burden (in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs (O& M) 0 c. Total annualized cost requested 687.3 d. Current OMB inventory 0 e. Difference 687.3 f. Explanation of difference 1. Program change Newly proposed requirements 2. Adjustment 15. Purpose of information collection (Mark Primary With "P" and all others that apply with "X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting (check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other (describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact (person who can best answer questions regarding the content of this submission) Name: Teena Wooten Phone: 703 308 8751 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

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

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

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

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

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

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

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

(g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): (I) Why the information is being collected' (ii) Use of information; (iii) Burden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory); (v) Nature and extent of confidentiality; and (vi) Need to display currently valid OMB control number;

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

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

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

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads "As part of the agency submission to OMB of a proposed collection of information, the agency (through the head of the agency, the Senior Official or their designee) shall certify (and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection (together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit (citing authority), or mandatory (citing authority); "( v) the nature and extent of confidentiality to be provided, if any (citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I (Instructions) 10/ 95


[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Rules and Regulations]
[Pages 24843-24846]
[FR Doc No: 2017-11127]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0506; Directorate Identifier 2017-CE-019-AD;
Amendment 39-18907; AD 2017-11-08]
RIN 2120-AA64

Airworthiness Directives; Diamond Aircraft Industries GmbH
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments

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SUMMARY: We are adopting a new airworthiness directive (AD) for Diamond
Aircraft Industries GmbH Model DA 42 airplanes. This AD results from
mandatory continuing airworthiness information (MCAI) issued by the
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as failure of the propeller regulating valve caused by hot
exhaust gases coming from fractured engine exhaust pipes. We are
issuing this AD to require actions to address the unsafe condition on
these products.

DATES: This AD is effective May 31, 2017.

    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of May 31, 2017.
    We must receive comments on this AD by July 17, 2017.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Diamond
Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700 Wiener
Neustadt, Austria, telephone: +43 2622 26700; fax: +43 2622 26780;
email<EMAIL_ADDRESS>Internet: http://www.diamondaircraft.com.
You may review this 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 (816)
329-4148. It is also available on the Internet at http://www.regulations.gov by searching for locating Docket No. FAA-2017-0506.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0506; 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 AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
(800) 647-5527) 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>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No. 2017-0090, dated May 17, 2017 (referred to after this as ``the
MCAI''), to correct an unsafe condition for Diamond Aircraft Industries
GmbH Model DA 42 and DA 42 M airplanes. The MCAI states:

    Two cases were reported of uncommanded engine in-flight shutdown
(IFSD) on DA 42 aeroplanes. Subsequent investigations identified
that these occurrences were due to failure of the propeller
regulating valve, caused by hot exhaust gases coming from fractured
engine exhaust pipes. The initiating cracks on the exhaust pipes
were not detected during previous inspections, since those exhaust
pipes are equipped with non-removable heat shields that do not allow
inspection for certain sections of the exhaust pipe.
    This condition, if not corrected, could lead to further cases of
IFSD or overheat damage, possibly resulting in a forced landing,
with consequent damage to the aeroplane and injury to occupants.
    To address this potential unsafe condition, Diamond Aircraft
Industries (DAI) developed an exhaust pipe without a directly
attached integral heat shield that allows visual inspection over the
entire exhaust pipe length. DAI issued Mandatory Service Bulletin
(MSB) 42-120 and relevant Working Instruction (WI) WI-MSB 42-120,
providing instructions to install the modified exhaust pipes. As an
interim measure, an additional bracket was designed to hold the
exhaust pipe in place in case of a pipe fracture. EASA issued AD
2016-0156 (later revised), requiring replacement of the exhaust
pipes with pipes having the new design, or installation of the
additional brackets.
    Since EASA AD 2016-0156R1 was issued, cracks were found during
inspection on modified exhaust pipes. Further investigation
determined that, with the modified exhaust pipe design, vibration
leads to cracking.
    To address this potential unsafe condition, DAI published MSB
42-129 providing instructions for inspection of modified exhaust
pipes.
    For the reasons described above, this AD retains the
requirements of EASA AD 2016-0156R1, which is superseded, and
requires repetitive inspections of modified exhaust pipes and,
depending on findings, repair or replacement. This AD is considered
interim action and further AD action may follow upon availability of
an improved exhaust pipe design.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0506.

Related Service Information Under 1 CFR Part 51

    Diamond Aircraft Industries GmbH has issued Mandatory Service
Bulletin MSB-42-129, dated May 17, 2017, and Work Instruction WI-OSB-
42-122, Revision 2, dated June 24, 2016. Mandatory Service Bulletin
MSB-42-129, dated May 17, 2017, describes procedures for inspecting the
DAI part number (P/N) D60-9078-06-01_01 and Technify P/N 52-7810-H0014
01 engine exhaust pipes. Work Instruction WI-OSB-42-122, Revision 2,
dated June 24, 2016, describes procedures for (among other things)
replacing the engine exhaust pipes. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section of the final rule.

FAA's Determination and Requirements of the 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 issuing this AD because we
evaluated all information provided by the State of Design Authority and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

Differences Between the AD and MCAI

    The MCAI allows for either replacement or repair if a cracked
exhaust pipe is found during an inspection. This AD will only allow for
replacement. If there were to become a parts availability issue at some
time, we would consider the welding repair as an alternative method of
compliance.
    In addition, the MCAI supersedes the previous EASA AD 2016-0156R1,
which introduced the DAI part number (P/N) D60-9078-06-01_01 and
Technify P/N 52-7810-H0014 01 engine exhaust pipes that are the subject
of this AD. The FAA is not superseding the corresponding AD 2017-01-12,
Amendment 39-18779 (82 FR 5359; January 18, 2017) because there were
other options in that AD that would not be affected by this action.
Thus AD 2017-01-12 establishes the baseline for the applicability of
this AD, and if any of the affected exhaust pipes were installed per AD
2017-01-12 they would be subject to the actions of this AD action.
    The airplane models affected by the MCAI are the Models DA 42 and
DA 42 M. Only the DA 42 is type certificated in the United States so
this AD action will only affect the Model DA 42 airplanes.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because the
affected engine exhaust pipes could crack and cause hot gases to leak
from fractured exhaust pipes and lead to an uncommanded engine in-
flight shutdown. Therefore, we determined that notice and opportunity
for public comment before issuing this AD are impracticable and that
good cause exists for making this amendment effective in fewer than 30
days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2017-0506; Directorate
Identifier 2017-CE-019-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this 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 AD.

Costs of Compliance

    We estimate that this AD will affect 130 products of U.S. registry.
We also estimate that it would take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $22,100, or $170 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 2 work-hours and require parts costing $2,100, for a cost of
$2,270 per product. We have no way of determining the number of
products that may need these actions.
    According to the design approval holder, some of the costs of this
AD (cost of parts) may be covered under warranty, thereby reducing the
cost impact on affected individuals. We do not control warranty
coverage for affected individuals. As a result, we have included all
costs in our 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.
    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 AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2017-11-08 Diamond Aircraft Industries GmbH: Amendment 39-18907;
Docket No. FAA-2017-0506; Directorate Identifier 2017-CE-019-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective May 31,
2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Diamond Aircraft Industries GmbH Model DA 42
airplanes, serial numbers 42.004 through 42.427 and 42.AC001 through
42.AC151, certificated in any category, that have:
    (1) either a TAE 125-02-99 or TAE 125-02-114 engine installed;
and
    (2) either DAI part number (P/N) D60-9078-06-01_01 or Technify
P/N 52-7810-H0014 01 engine exhaust pipes installed.

(d) Subject

    Air Transport Association of America (ATA) Code 78: Engine
Exhaust.

(e) Reason

    This AD was prompted by cracks in the affected engine exhaust
pipes, which could cause failure of the propeller regulating valve
because of hot exhaust gases coming from the fractured pipes. We are
issuing this AD to prevent an uncommanded engine in-flight shutdown
or overheat damage, which could result in a forced landing,
consequent damage, and occupant injury.

(f) Actions and Compliance

    Unless already done, do the following actions.
    (1) Before or upon accumulating 40 hours time-in-service (TIS)
on the affected engine exhaust pipes or within the next 10 hours TIS
after the effective date of this AD, whichever occurs later, and
repetitively thereafter at intervals not to exceed 50 hours TIS,
inspect each engine exhaust pipe following Diamond Aircraft
Industries GmbH Mandatory Service Bulletin MSB-42-129, dated May 17,
2017.
    (2) If any crack(s) is/are found on any engine exhaust pipe
during any inspection required by this AD, before further flight,
replace the affected engine exhaust pipe(s) following Step 14 (page
8) of Diamond Aircraft Industries GmbH Work Instruction WI-OSB-42-
122, Revision 2, dated June 24, 2016.
    (3) The replacement required by paragraph (f)(2) of this AD does
not terminate the repetitive inspections required by paragraph
(f)(1) of this AD when a DAI part number (P/N) D60-9078-06-01_01 or
Technify P/N

52-7810-H0014 01 engine exhaust pipe is installed.

(g) Other FAA AD Provisions

    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>; email:
<EMAIL_ADDRESS>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.

(h) Related Information

    Refer to MCAI EASA AD No.: 2017-0090, dated May 17, 2017, for
related information. You may examine the MCAI on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2017-0506.

 (i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Diamond Aircraft Industries Mandatory Service Bulletin MSB-
42-129, dated May 17, 2017.
    (ii) Diamond Aircraft Industries Work Instruction WI-OSB 42-122,
Revision 2, dated June 24, 2016.
    (3) For Diamond Aircraft Industries GmbH service information
identified in 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; email:
<EMAIL_ADDRESS>Internet: http://www.diamondaircraft.com.
    (4) You may view this 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
(816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for locating Docket No. FAA-2017-
0506.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on May 19, 2017.
Melvin Johnson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-11127 Filed 5-30-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Proposed Rules]
[Pages 44042-44043]
[FR Doc No: 2013-17617]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0643; Directorate Identifier 2012-SW-096-AD]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A. Helicopters (Type
Certificate Currently Held By AgustaWestland S.P.A) (AgustaWestland)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
AgustaWestland Model A109S, AW109SP, A119, and AW119 MKII helicopters
to require removing certain rod end assemblies from service. This
proposed AD is prompted by reports of fractures on the rod end
assemblies that could damage the main rotor assembly and lead to loss
of control of the helicopter.

DATES: We must receive comments on this proposed AD by September 23,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
evaluation, the foreign authority's AD, any comments received, and
other information. The street address for the Docket Operations Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed AD, contact
Agusta Westland, Customer Support & Services, Via Per Tornavento 15,
21019 Somma Lombardo (VA) Italy, ATTN: Giovanni Cecchelli; telephone
39- 0331-711133; fax 39 0331 711180; or at http://www.agustawestland.com/technical-bullettins. You may review the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.

FOR FURTHER INFORMATION CONTACT: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth,
Texas 76137; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rule. Before acting on this proposal, we will
consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2012-0208, dated October 5, 2012, to correct an unsafe condition
for the AgustaWestland Model A109LUH, A109S, AW109SP, A119, and AW119
MKII helicopters. EASA advises that cases of in-flight fractures of rod
end assembly, part number (P/N) M004-01H007-045, installed on main
rotor lag dampers have been reported on Model A109LUH and AW109SP
helicopters. An investigation revealed that two batches of rod end
assemblies, P/N M004-01H007-041 and M004-01H007-045, could have cracks,
according to EASA. EASA states that this condition, if not corrected,
could lead to main rotor damage, possibly resulting in loss of control
of the helicopter.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in its AD. We are
proposing this AD because we evaluated all known relevant information
and determined that an unsafe condition is likely to exist or develop
on other products of the same type design.

Related Service Information

    AgustaWestland issued Bollettino Tecnico (BT) No. 109S-49 for Model
A109S helicopters, BT No. 109SP-052 for Model AW109SP helicopters, and
BT No. 119-50 for Model AW119 and AW119 MKII helicopters. All of the
BTs are dated October 3, 2012. The BTs specify a one-time inspection of
each rod end assembly, P/Ns M004-01H007-041 and M004-01H007-045, to
determine its serial number. The BTs then require removal from service
of certain serial-numbered rod end assemblies because fractures had
been reported on rod ends in these batches. According to the BTs, no
one was injured in the helicopters and no helicopters were damaged
because of these fractures.

Proposed AD Requirements

    Within 25 hours time-in-service (TIS), this proposed AD would
require removing each affected rod end assembly from service.

Differences Between This Proposed AD and the EASA AD

    EASA requires compliance with the inspection and removal of any
affected parts from service within 25 hours flight hours or three
months. We propose to require removal of the affected parts from
service within 25 hours TIS. The EASA AD applies to AgustaWestland
Model A109LUH, and this proposed AD would not because that model has no
U.S. type certificate.

Costs of Compliance

    We estimate that this proposed AD would affect 91 helicopters of
U.S.

Registry and that labor costs average $85 a work-hour. Based on these
estimates, we expect the following costs:
     Replacing a rod end assembly would require 1.5 work-hours
for a labor cost of $128. Parts would cost $3,918 for a total cost of
$4,046 per helicopter, $368,186 for the U.S. fleet.
    According to the manufacturer's service information, costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. We do not control warranty coverage by
manufacturers. Accordingly, we have included all costs in our 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.
    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 proposed 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, 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);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. 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 an economic 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

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):

Agusta S.p.A. Helicopters (Type Certificate Currently Held By
Agustawestland S.p.A) (AgustaWestland): Docket No. FAA-2013-0643;
Directorate Identifier 2012-SW-096-AD.

(a) Applicability

    This AD applies to AgustaWestland Model A109S, AW109SP, A119,
and AW119 MKII helicopters with a main rotor lag damper assembly
(lag damper), part number (P/N) 109-0112-39-103, 109-0112-39-105,
109-0112-05-105, or 109-0112-05-107, installed with a rod end
assembly, P/N M004-01H007-041 or M004-01H007-045, with a serial
number (S/N) 84 through 132, or 4964 through 5011, certificated in
any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a rod end
assembly, which could result in fracture of the rod end assembly,
damage to the main rotor, and subsequent loss of control of the
helicopter.

(c) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(d) Required Actions

    (1) Within 25 hours time-in-service, remove the rod end assembly
from service.
    (2) Do not install a rod end assembly, P/N M004-01H007-041 or
M004-01H007-045, with a S/N 84 through 132 or 4964 through 5011, on
any helicopter.

 (e) Special flight permit

    Special flight permits are prohibited.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort
Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) AgustaWestland S.p.A. Helicopters Bollettino Tecnico No.
109S-49, No. 109SP-052, and No. 119-50, all dated October 3, 2012,
which are not incorporated by reference, contain additional
information about the subject of this AD. For service information
identified in this AD, contact AgustaWestland, Customer Support &
Services, Via Per Tornavento 15, 21019 Somma Lombardo (VA) Italy,
ATTN: Giovanni Cecchelli; telephone 39- 0331-711133; fax 39 0331
711180; or at http://www.agustawestland.com/technical-bullettins.
You may review the referenced service information at the FAA, Office
of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room
663, Fort Worth Texas 76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency AD No. 2012-0208, dated October 5, 2012. You may view
the EASA AD at http://www.regulations.gov by searching for and
locating it in Docket No. FAA-2013-0643.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 6200, Main Rotor
System.

    Issued in Fort Worth, Texas, on July 17, 2013.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2013-17617 Filed 7-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Proposed Rules]
[Pages 7899-7901]
[FR Doc No: 2023-02463]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-0235; Airspace Docket No. 22-ANM-52]
RIN 2120-AA66

Revocation of Segments of V-330 and Establishment T-470 Near
Boise, ID

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to revoke the portion of the Very High
Frequency (VHF) Omnidirectional Range (VOR) Federal airway V-330
between the Boise VHF Omnidirectional Range (VOR) Tactical Air
Navigation (VORTAC) and the intersection of Liberator VOR 084[deg]
radial and Burley VOR 323[deg] radial. This action also proposes to
establish United States Area Navigation (RNAV) route T-470. These
actions are due to the planned decommissioning of the Liberator ID, VOR
(LIA).

DATES: Comments must be received on or before March 24, 2023.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2023-0235; Airspace Docket No. 22-ANM-52 at the beginning of your
comments. You may also submit comments through the internet at
www.regulations.gov.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Steven Roff, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the airway structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments

are specifically invited on the overall regulatory, aeronautical,
economic, environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2023-0235; Airspace Docket No. 22-ANM-52 and be submitted to the
Docket Management Facility (see ADDRESSES section for address and phone
number). You may also submit comments through the internet at
www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2023-0235; Airspace Docket No. 22-ANM-52.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Federal
Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11G, Airspace
Designations and Reporting Points, dated August 19, 2022, and effective
September 15, 2022. FAA Order JO 7400.11G is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11G
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Background

    The FAA is decommissioning underutilized navigational aids
(NAVAIDS) throughout the National Airspace System (NAS) through the VOR
Minimal Operation Network (MON) program. The goal is to transition the
NAS to use of Performance-Based Navigation (PBN) through use of the
Global Positioning System (GPS) as the primary means of aircraft
navigation, retaining a reduced number of ground-based NAVAIDS to
provide backup in the event of a loss of GPS. The decommissioning of
Liberator VOR is part of this program.
    With the planned decommissioning of Liberator VOR, the remaining
ground-based coverage in the area is insufficient to enable the
continuity of certain segments of V-330. As such, this proposal would
result in these unsupported segments being revoked. The segment between
the Boise VORTAC and the intersection of the Boise VORTAC 130[deg]
radial and Liberator VOR 084[deg] radial requires no mitigation as it
shares routing with V-4 and V-253. The establishment of T-470 is
proposed to replace the revoked segment between the intersection of the
Boise VORTAC 130[deg] and Liberator VOR 084[deg] radials and the
intersection of the Liberator VOR 084[deg] radial and the Burley VOR
323[deg] radial. Additionally, T-470 is proposed to continue eastward
beyond the intersection of the Liberator VOR 084[deg] radial and the
Burley VOR 323[deg] radial. This continuance of T-470 will increase NAS
efficiency and aviation safety by providing routing through the Snake
River Valley in Idaho and south of the Wind River Range in Wyoming.
This routing will allow for lower Minimum Enroute Altitudes and will
avoid areas of downslope winds.

The Proposal

    V-330: V-330 is currently made up of two separate portions. The
first navigates between the Wildhorse, OR, VOR; and the intersection of
the Liberator VOR 084[deg] radial and the Burley VOR 323[deg] radial.
The second section navigates between the Idaho Falls, ID, VOR; and the
Muddy Mountain, WY, VOR. The FAA proposes changes to the first portion.
The FAA does not propose changes to the second portion.
    In the first portion, the FAA proposes to revoke two contiguous
segments. The first is the segment between the Boise VORTAC and the
intersection of the Boise VORTAC 130[deg] radial and Liberator VOR
084[deg] radial. The second is between the intersection of the Boise
VORTAC 130[deg] radial and Liberator VOR 084[deg] radial and the
intersection of the Liberator VOR 084[deg] radial and the Burley VOR
323[deg] radial.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
JO 7400.11G dated August 19, 2022 and effective September 15, 2022,
which is incorporated by reference in 14 CFR 71.1. The V-330 airway
listed in this document would be modified subsequently in FAA Order JO
7400.11.
    The FAA is proposing an amendment to 14 CFR part 71 to establish
RNAV T-route T-470 in the vicinity of Boise, ID.
    The new route is described as follows:
    T-470: RNAV route T-470 extends between ALKAL, ID; KINZE, ID;
VIPUC, WY; IDECA, WY; DEDNE, WY; DEKKR, WY; SWEAT, WY; and CHOMP, WY.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-330 [Amended]

    From Wildhorse, OR; to Boise, ID. From Idaho Falls, ID; Jackson,
WY; Dunoir, WY; Riverton, WY; to Muddy Mountain, WY.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

                                                                        * * * * *
T-470 ALKAL WP, ID TO CHOMP WP, WY

ALKAL, ID                                         Fix                           (Lat. 43[deg]00'58.35'' N, long. 115[deg]19'41.26'' W)
KINZE, ID                                         Fix                           (Lat. 43[deg]04'51.80'' N, long. 114[deg]23'19.23'' W)
VIPUC, WY                                         Fix                           (Lat. 43[deg]21'09.64'' N, long. 112[deg]14'44.08'' W)
IDECA, WY                                         Fix                           (Lat. 42[deg]51'31.06'' N, long. 110[deg]16'25.75'' W)
DEDNE, WY                                         WP                            (Lat. 42[deg]30'56.06'' N, long. 109[deg]35'23.93'' W)
DEKKR, WY                                         WP                            (Lat. 42[deg]21'25.98'' N, long. 109[deg]02'18.06'' W)
SWEAT, WY                                         Fix                           (Lat. 42[deg]26'35.02'' N, long. 108[deg]27'10.31'' W)
CHOMP, WY                                         Fix                           (Lat. 42[deg]36'23.25'' N, long. 106[deg]45'30.94'' W)

                                                                        * * * * *

    Issued in Washington, DC, on February 1, 2023.
Brian Konie,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-02463 Filed 2-6-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 5, 2010 (Volume 75, Number 150)]
[Notices]
[Page 47293-47294]
[DOCID:fr05au10-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

July 28, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP06-298-012.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Semi-Annual Report of Operation Sales of Gas of
National Fuel Gas Supply Corporation.
    Filed Date: 07/15/2010.
    Accession Number: 20100715-5020.
    Comment Date: 5 p.m. Eastern Time on Monday, August 2, 2010.

    Docket Numbers: RP10-877-002.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Cameron Interstate Pipeline, LLC submits tariff filing
per 154.205(a): Cameron Interstate Pipeline Letter, July 15, 2010.
    Filed Date: 07/15/2010.
    Accession Number: 20100715-5027.
    Comment Date: 5 p.m. Eastern Time on Monday, August, 2, 2010.

    Docket Numbers: RP08-462-001.
    Applicants: American Midstream (Midla), LLC.
    Description: American Midstream (Midla), LLC submits Request for
Extension of Time.
    Filed Date: 07/26/2010.

    Accession Number: 20100726-5178.
    Comment Date: 5 p.m. Eastern Time on Monday, August 9, 2010.

    Docket Numbers: RP05-473-001.
    Applicants: KO Transmission Company.
    Description: KO Transmission Company Amendment to Application of
Duke Energy.
    Filed Date: 07/27/2010.
    Accession Number: 20100727-5161.
    Comment Date: 5 p.m. Eastern Time on Monday, August 9, 2010.

    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed on or before 5 p.m. Eastern time on the specified comment
date. Anyone filing a protest must serve a copy of that document on all
the parties to the proceeding.
    The Commission encourages electronic submission of protests 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 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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-19240 Filed 8-4-10; 8:45 am]
BILLING CODE 6717-01-P