[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32157-32160]
[FR Doc No: 2015-13695]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0286]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Formal Meetings Between the Food and Drug Administration and
Biosimilar Biological Product Sponsors or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by July 6,
2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the title. Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on Formal Meetings Between FDA and Biosimilar
Biological Product Sponsors or Applicants OMB Control Number 0910--NEW

    In the Federal Register of April 1, 2013 (78 FR 19492), FDA
announced the availability of a draft guidance for industry entitled
``Formal Meetings Between FDA and Biosimilar Biological Product
Sponsors or Applicants.'' The guidance provided recommendations to
industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of biosimilar biological
products regulated by the Center for Drug Evaluation and Research
(CDER) and the Center for Biologics Evaluation and Research (CBER).
This guidance assists sponsors and applicants in generating and
submitting a meeting request and the associated meeting package to FDA
for biosimilar biological products.
    The Biologics Price Competition and Innovation Act of 2009 amended
the Public Health Service (PHS) Act and other statutes to create an
abbreviated licensure pathway in section 351(k) of the PHS Act (42
U.S.C. 262(k)) for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological product (see sections
7001 through 7003 of the Patient Protection and Affordable Care Act
(Pub. L. 111-148)). The Biosimilar User Fee Act of 2012 (BsUFA),
enacted as part of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 11 2-144), amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to authorize a new user fee program for
biosimilar biological products. FDA has committed to meeting certain
performance goals in connection with the new user fee program. The
performance goals, which are set forth in a letter from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, include meeting management goals for formal meetings
that occur between FDA and sponsors or applicants during the
development phase of a biosimilar biological product. This guidance
described the Agency's current thinking on how it intends to interpret
and apply certain provisions of BsUFA, and also provides information on
specific performance goals for the management of meetings associated
with the development and review of biosimilar biological products.
    The guidance reflects a unified approach to all formal meetings
between sponsors or applicants and FDA for biosimilar biological
product development (BPD) programs. It is intended to assist sponsors
and applicants in generating and submitting a meeting request and the
associated meeting package to FDA for biosimilar biological products.
The guidance does not apply to new drug or abbreviated new drug
applications under section 505 of the FD&C Act or to biologics license
applications (BLAs) under section 351(a) of the PHS Act.
    FDA expects that review staff will participate in many meetings
with biosimilar biological product sponsors or applicants who seek
guidance relating to the development and review of biosimilar
biological products. Because these meetings often will represent
critical points in the regulatory process, it is important that there
are efficient, consistent procedures for the timely and effective
conduct of such meetings. The good meeting management practices in this
guidance are intended to provide consistent procedures that will
promote well-managed meetings and to ensure that such meetings are
scheduled within a reasonable time, conducted efficiently, and
documented appropriately. The following five meeting types that occur
between sponsors or applicants and FDA staff during the biosimilar BPD
phase are described in the guidance: (1) Biosimilar Initial Advisory
meeting; (2) BPD Type 1 meeting; (3) BPD Type 2 meeting; (4) BPD Type 3
meeting; and (5) BPD Type 4 meeting.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance will represent the
Agency's current thinking on formal meetings between FDA and sponsors
or applicants regarding biosimilar biological products. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.
    The guidance on the procedures for formal meetings between FDA and
biosimilar biological product sponsors or applicants describes
procedures for requesting, scheduling, conducting, and documenting such
formal meetings.
    The guidance describes two types of collections of information: (1)
The submission of a meeting request containing certain information and
(2) the submission of an information package that accompanies the
meeting request. The guidance also refers to previously approved
collections of information found in FDA regulations. The collections of
information for 21 CFR 312.48 have been approved under OMB control
number 0910-0014.

A. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting
with CDER or CBER should submit a meeting request to the sponsor's or
applicant's application (e.g., investigational new drug application,
BLA) through the controlled document system. If there is no
application, the request should be submitted to either the appropriate
CDER division director with a copy sent to the division's chief of
project management staff or to the division director of the appropriate
product office within CBER. Before submitting any meeting request by
fax or email when there is no application, the sponsor or applicant
should contact the appropriate review division or the Biosimilars
Program staff, CDER, Office of New Drugs, to determine to whom the
request should be directed, how the request should be submitted, and
the appropriate format for the request, and to arrange for confirmation
of receipt of the request.
    FDA recommends that a request be submitted in this manner to
prevent the possibility of faxed or emailed requests being overlooked
because of the volume of emails received daily by FDA staff. Faxed or
emailed requests should be sent during official business hours (8 a.m.
to 4:30 p.m. EST/EDT) Monday through Friday (except Federal government
holidays). Processing and receipt may be delayed for requests where
confirmation of receipt has not been prearranged.
    Under the guidance, FDA requests that sponsors and applicants
include in meeting requests certain information about the proposed
meeting. This information includes:
    1. Product Name.
    2. Application Number (if applicable).
    3. Proposed Proper Name (or proper name if post-licensure).
    4. Structure (if applicable).
    5. Reference Product Name.
    6. Proposed Indication(s) or Context of Product Development.

    7. Meeting Type Being Requested (i.e., Biosimilar Initial Advisory
meeting, BPD Type 1, 2, 3, or 4 meeting). The rationale for requesting
the meeting type should be included.
    8. A Brief Statement of the Purpose of the Meeting. This statement
should include a brief background of the issues underlying the agenda.
It also can include a brief summary of completed or planned studies and
clinical trials or data that the sponsor or applicant intends to
discuss at the meeting, the general nature of the critical questions to
be asked, and where the meeting fits in overall development plans.
Although the statement need not provide detailed documentation of trial
designs or completed studies and clinical trials, it should provide
enough information to facilitate understanding of the issues, such as a
small table that summarizes major results.
    9. A List of the Specific Objectives/Outcomes the Requester Expects
from the Meeting.
    10. A Proposed Agenda, Including Estimated Times Needed for Each
Agenda Item.
    11. A List of Questions, Grouped by Discipline. For each question
there should be a brief explanation of the context and purpose of the
question.
    12. A List of All Individuals with Their Titles and Affiliations
Who Will Attend the Requested Meeting from the Sponsor's or Applicant's
Organization and Consultants.
    13. A List of FDA Staff, if Known, or Disciplines, Asked to
Participate in the Requested Meeting.
    14. Suggested Dates and Times (e.g., morning or afternoon) for the
Meeting Which are Within or Beyond the Appropriate Time Frame of the
Meeting Type Being Requested.
    15. The Proposed Format of the Meeting (i.e., face-to-face meeting,
teleconference, or videoconference).
    This information will be used by FDA to determine the utility of
the meeting, to identify FDA staff necessary to discuss proposed agenda
items, and to schedule the meeting.

B. Information Package

    FDA requests that a sponsor or applicant submit a meeting package
to the appropriate review division with the meeting request. FDA
recommends that information packages generally include:
    1. Product Name and Application Number (if applicable).
    2. Proposed Proper Name (or proper name if postlicensure).
    3. Structure (if applicable).
    4. Reference Product Name.
    5. Proposed Indication(s) or Context of Product Development.
    6. Dosage Form, Route of Administration, Dosing Regimen (frequency
and duration), and Presentation(s).
    7. A List of Sponsor or Applicant Attendees, Affiliations, and
Titles.
    8. A Background Section that Includes the Following:
    a. A brief history of the development program.
    b. The status of product development (e.g., chemistry,
manufacturing, and controls; nonclinical; and clinical, including any
development outside the United States, as applicable).
    9. A Brief Statement Summarizing the Purpose of the Meeting.
    10. A Proposed Agenda.
    11. A List of Questions for Discussion Grouped by Discipline and
with a Brief Summary for Each Question to Explain the Need or Context
for the Question.
    12. Data to Support Discussion Organized by Discipline and
Question. The level of detail of the data should be appropriate to the
meeting type requested and the product development stage.
    The purpose of the information package is to provide FDA staff the
opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product.
    Description of Respondents: A sponsor or applicant for a biosimilar
biological product who requests a formal meeting with FDA regarding the
development and review of a biosimilar biological product.
    Burden Estimate: Provided below is an estimate of the annual
reporting burden for the submission of meeting requests and information
packages under the guidance.
    The estimated number of respondents submitting meeting requests and
information packages is based on the current workload and development
expectations for biosimilar biological products. The burden hour
estimate includes any time that may be needed by sponsors or applicants
for rescheduling and canceling meetings, for premeetings and other
communications with FDA about the meetings, and for resolution of
disputes about meeting minutes.
    Based on the current workload and development expectations, FDA
estimates that approximately 15 sponsors and applicants (respondents)
may request approximately a total of 30 formal meetings, and submit
approximately 30 information packages, with CDER annually, and
approximately 1 respondent may request approximately 2 formal meetings,
and submit approximately 2 information packages, with CBER annually.
    For a meeting request, the hours per response, which is the
estimated number of hours that a respondent would spend preparing the
information to be submitted with a meeting request in accordance with
the guidance, is estimated to be approximately 15 hours. Based on FDA's
experience, we expect it will take respondents this amount of time to
gather and copy brief statements about the product and a description of
the purpose and details of the meeting.
    For an information package, the hours per response, which is the
estimated number of hours that a respondent would spend preparing the
information package in accordance with the guidance, is estimated to be
approximately 30 hours. Based on FDA's experience, we expect it will
take respondents this amount of time to gather and copy brief
statements about the product, a description of the details for the
anticipated meeting, and data and information that generally would
already have been compiled for submission to FDA. In total, we expect
sponsors to spend 480 hours preparing meeting requests and 960 hours
preparing information packages each year.
    In the Federal Register of April 1, 2013 (78 FR 19492), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. None of the comments pertained to the
information collection provisions in the draft guidance.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
 Guidance for industry on formal
    meetings between FDA and         Number of       Number of     Total annual   Average burden
  biosimilar biological product     respondents    responses per     responses     per response     Total hours
     sponsors or applicants                         respondent                        (hours)
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
    CDER........................              15               2              30              15             450

    CBER........................               1               2               2              15              30
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             480
----------------------------------------------------------------------------------------------------------------
Information Packages:
    CDER........................              15               2              30              30             900
    CBER........................               1               2               2              30              60
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             960
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           1,440
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

C. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address in this reference section, but we are not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)

    1. See http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf.

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13695 Filed 6-4-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7740-7742]
[FR Doc No: 2018-03605]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0405]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Recall Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection related to Medical
Device Recall Authority.

DATES: Submit either electronic or written comments on the collection
of information by April 23, 2018.

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 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 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-2018-N-0405 for ``Medical Device Recall Authority.'' 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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

Medical Device Recall Authority--21 CFR Part 810

OMB Control Number 0910-0432--Extension

    This collection of information implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and
part 810 (21 CFR part 810), mandatory medical device recall authority
provisions. Section 518(e) of the FD&C Act provides FDA with the
authority to issue an order requiring an appropriate person, including
manufacturers, importers, distributors, and retailers of a device, if
FDA finds that there is reasonable probability that the device intended
for human use would cause serious adverse health consequences or death,
to: (1) Immediately cease distribution of such device and (2)
immediately notify health professionals and device-user facilities of
the order and to instruct such professionals and facilities to cease
use of such device.
    FDA will then provide the person named in the cease distribution
and notification order with the opportunity for an informal hearing on
whether the order should be amended to require a mandatory recall of
the device.
    If, after providing the opportunity for an informal hearing, FDA
determines that such an order is necessary, the Agency may amend the
order to require a mandatory recall.
    FDA issued part 810 to implement the provisions of section 518 of
the FD&C Act. The information collected under the mandatory recall
authority provisions will be used by FDA to implement mandatory
recalls.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   Collection activity/21 CFR        Number of     responses per   Total annual     burden per      Total hours
             section                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Collections Specified in the                   2               1               2               8              16
 Order--810.10(d)...............
Request for Regulatory Hearing--               1               1               1               8               8
 810.11(a)......................
Written Request for Review--                   1               1               1               8               8
 810.12(a)-(b)..................
Mandatory Recall Strategy--                    2               1               2              16              32
 810.14.........................
Periodic Status Reports--                      2              12              24              40             960
 810.16(a)-(b)..................
Termination Request--810.17(a)..               2               1               2               8              16
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total Hours.................  ..............  ..............  ..............  ..............           1,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                     Average  burden
   Collection activity/21 CFR       Number of       records per     Total annual         per         Total hours
            section               recordkeepers     recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Documentation of Notifications                 2                1               1                8             8
 to Recipients--810.15(b)......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
  Collection activity/21 CFR       Number of     disclosures per   Total annual     burden per      Total hours
            section               respondents       respondent      disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients--                  2                1               2              12              24
 810.15(a)-(c)................
Notification to Recipients;                   2                1               2               4               8
 Follow-up--810.15(d).........
Notification of Consignees by                10                1              10               1              10
 Recipients--810.15(e)........
                               ---------------------------------------------------------------------------------
    Total.....................  ...............  ...............  ..............  ..............              42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate has not changed for information collection
related to section 518(e) of the FD&C Act and part 810 since the last
OMB approval.

    Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03605 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 7, 2008 (Volume 73, Number 4)]
[Notices]
[Page 1259-1260]
[DOCID:fr07ja08-71]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice; Receipt of Noise Compatibility Program
and Request for Review; Ocala International Airport; Ocala, FL

AGENCY: Federal Aviation Administration, DOT.
SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the Noise Exposure Maps submitted by the City of
Ocala for Ocala International Airport under the provisions of 49 U.S.C.
47501 et seq. (Aviation Safety and Noise Abatement Act) and 14 CFR Part
150 are in compliance with applicable requirements. The FAA also
announces that it is reviewing a proposed Noise Compatibility Program
that was submitted for Ocala International Airport under Part 150 in
conjunction with the Noise Exposure Map, and that this program will be
approved or disapproved on or before June 25, 2008.

EFFECTIVE DATE:  The effectie date of the FAA's determination on the
Noise Exposure Maps and of the start of its review of the associated
Noise Compatibility Program is December 28, 2007. The public comment
period ends February 26, 2008.

FOR FURTHER INFORMATION CONTACT: Lindy McDowell, Federal Aviation
Administration, Orlando Airports District Office, 5950 Hazeltine
National Drive, Suite 400, Orlando, FL 32822,<PHONE_NUMBER>. Comments on
the proposed Noise Compatibility Program should also be submitted to
the above office.

SUPPLEMENTARY INFORMATION: This Notice announces that the FAA finds
that the Noise Exposure Maps submitted for Ocala International Airport
are in compliance with applicable requirements of Part 150, effective
December 28, 2007. Further, FAA is reviewing a proposed Noise
Compatibility Program for that Airport

which will be approved or disapproved on or before June 25, 2008. This
notice also announces the availability of this Program for public
review and comment.
    Under 49 U.S.C., section 47503 (the Aviation Safety and Noise
Abatement Act (the Act)), an airport operator may submit to the FAA
Noise Exposure Maps which meet applicable regulations and which depict
non-compatible land uses as of the date of submission of such maps, a
description of projected aircraft operations, and the ways in which
such operations will affect such maps. The Act requires such maps to be
developed in consultation with interested and affected parties in the
local community, government agencies, and persons using the airport.
    An airport operator who has submitted Noise Exposure Maps that are
found by FAA to be in compliance with the requirements of Part 150,
promulgated pursuant to the Act, may submit a Noise Compatibility
Program for FAA approval which sets forth the measures the operator has
taken or proposes to take to reduce existing non-compatible uses and
prevent the introduction of additional non-compatible uses.
    The City of Ocala submitted to the FAA on October 2, 2007 Noise
Exposure Maps, descriptions and other documentation that were produced
during the Ocala International Airport FAR Part 150 Noise Study Update
conducted between August 2004 and October, 2005. It was requested that
the FAA review this material as the Noise Exposure Maps, as described
in section 47503 of the Act, and that the noise mitigation measures, to
be implemented jointly by the airport and surrounding communities, be
approved as a Noise Compatibility Program under section 47504 of the
Act.
    The FAA has completed its review of the Noise Exposure Maps and
related descriptions submitted by City of Ocala. The specific
documentation determined to constitute the Noise Exposure Maps
includes: Figure ES-1, Existing Conditions 2005 Noise Exposure
Contours; Figure ES-2, Future Conditions 2010 Noise Exposure Contours
Runway Safety Area Adjustments; Table 9.1 Modeled Average Daily
Aircraft Operations, Existing Conditions 2005; Table 9.2, Existing
Conditions 2005 Noise Contour Interval Exposure Area, In Acres,
Dwelling Units and Population, By Local Jurisdiction; Table 9.3,
Modeled Average Daily Aircraft Operations, Existing Conditions 2010;
Figure 9.1, Existing Conditions 2005 Noise Exposure Contours; Figure
9.2, Existing Conditions 2005 Noise Exposure Contours Residential and
Future Residential with Sensitive Receptors; Table 9.4, Five-Year
Forecast Conditions 2010 Noise Exposure Area, in Acres, Dwelling Units
and Population, By Local Jurisdiction; Figure 9.3 Future Conditions
2010 Noise Exposure Contours Runway Safety Area Adjustments; and Figure
9.4, Future Conditions 2010 Noise Exposure Contours Runway Safety Area
Adjustments Residential and Future Residential with Sensitive
Receptors. The FAA has determined that these maps for Ocala
International Airport are in compliance with applicable requirements.
This determination is effective on December 28, 2007. FAA's
determination on the airport operator's Noise Exposure Maps is limited
to a finding that the maps were developed in accordance with the
procedures contained in Appendix A of FAR Part 150. Such determination
does not constitute approval of the airport operator's data,
information or plans, or a commitment to approve a Noise Compatibility
Program or to fund the implementation of that Program.
    If questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a Noise Exposure Map
submitted under section 47503 of the Act, it should be noted that the
FAA is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise exposure
contours, or in interpreting the Noise Exposure Maps to resolve
questions concerning, for example, which properties should be covered
by the provisions of section 47506 of the Act. These functions are
inseparable from the ultimate land use control and planning
responsibilities of local government. These local responsibilities are
not changed in any way under Part 150 or through FAA's review of Noise
Exposure Maps. Therefore, the responsibility for the detailed
overlaying of noise exposure contours onto the map depicting properties
on the surface rests exclusively with the airport operator that
submitted those maps, or with those public agencies and planning
agencies with which consultation is required under section 47503 of the
Act. The FAA has relied on the certification by the airport operator,
under section 150.21 of Part 150, that the statutorily required
consultation has been accomplished.
    The FAA has formally received the Noise Compatibility Program for
Ocala International Airport, also effective on December 28, 2007.
Preliminary review of the submitted material indicates that it conforms
to the requirements for the submittal of Noise Compatibility Programs,
but that further review will be necessary prior to approval or
disapproval of the program. The formal review period, limited by law to
a maximum of 180 days, will be completed on or before June 25, 2008.
    The FAA's detailed evaluation will be conducted under the
provisions of Part 150, section 150.33. The primary considerations in
the evaluation process are whether the proposed measures may reduce the
level of aviation safety, create an undue burden on interstate or
foreign commerce, or be reasonably consistent with obtaining the goal
of reducing existing non-compatible land uses and preventing the
introduction of additional non-compatible land uses.
    Interested persons are invited to comment on the proposed program
with specific reference to these factors. All comments, other than
those properly addressed to local land use authorities, will be
considered by the FAA to the extent practicable. Copies of the Noise
Exposure Maps, the FAA's evaluation of the maps, and the proposed Noise
Compatibility Program are available for examination at the following
locations: Federal Aviation Administration, Orlando Airports District
Office, 5950 Hazeltine National Drive, Suite 400, Orlando, Florida
32822.
    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Orlando, FL, December 28, 2007.
Krystal Hudson,
Acting Manager, Orlando Airports District Office.
[FR Doc. 08-5 Filed 1-4-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: October 25, 2005 (Volume 70, Number 205)]
[Notices]
[Page 61612-61613]
[DOCID:fr25oc05-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Privacy Act of 1974: Notice of New System of Records

October 19, 2005.
AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of new system of records.

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

SUMMARY: The Federal Energy Regulatory Commission (the Commission),
under the requirements of the Privacy Act of 1974, 5 U.S.C. 552a, is
publishing a description of a new system of records.

ADDRESSES: Comments should be directed to the following address:
Commission Security and Safety Officer, Security and Safety Office,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.

FOR FURTHER INFORMATION CONTACT: Tod M. Henby, Commission Security and
Safety Officer, Security and Safety Office, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426, (202) 502-
6030.

SUPPLEMENTARY INFORMATION:

I. Report on the New System

A. Background

    The Privacy Act of 1974, 5 U.S.C. 552a, requires that each agency
publish a notice of the existence and character of each new or altered
``system of records.'' 5 U.S.C. 552a(a)(5). This Notice identifies and
describes the Commission's new system of records. A copy of this report
has been distributed to the Speaker of the House of Representatives and
the President of the Senate as the Act requires.
    The Commission has adopted a new system of records under the
Privacy Act of 1974. This system does not duplicate any existing agency
system. The notice includes for the system of records the name;
location; categories of individuals on whom the records are maintained;
categories of records in the system; authority for maintenance of the
system; each routine use; the policies and practices governing storage,
retrievability, access controls, retention and disposal; the title and
business address of the agency official responsible for the system of
records; procedures for notification, access and contesting the records
of each system; and the sources for the records in the system. 5 U.S.C.
552(a)(4).

B. New System of Records

FERC-55 Personal Identity Verification (PIV) Records.

FERC-55

SYSTEM NAME:
    Personal Identity Verification Records.

SECURITY CLASSIFCATION:
    Unclassified.

SYSTEM LOCATION:
    Federal Energy Regulatory Commission, Office of the Executive
Director, 888 First Street, NE., Washington, DC 20426.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Current and former employees, consultants and contractors.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Individual's name, individual's address, individual's telephone
number, individual's office of assignment, individual's signature,
individual's digital photograph, individual's digital and/or paper
fingerprint images, individual's social security number, results of
individual's background check, PIV sponsor's signature, PIV credential
number and PIV expiration date.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    41 CFR 101-20.103, HSPD-12/FIPS 201.

PURPOSE(S):
    For Federal Government identity management.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    To document the identity and background of agency employees,
contractors and consultants.

DISCLOSURE TO CONSUMER REPORTING AGENCIES:
    None.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Paper and computer.

RETRIEVABILITY:
    By individual name, PIV credential number.

SAFEGUARDS:
    Paper records are in lockable file cabinets in a lockable room with
access limited to those employees whose official duties require access;
computer data is password protected and backed up.

RETENTION AND DISPOSAL:
    Records are maintained for 3 years after final separation.
Identification credentials are destroyed after return to security
department.

SYSTEM MANAGER(S) AND ADDRESS:
    Commission Security and Safety Officer, Security and Safety Office,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.

NOTIFICATION PROCEDURE:
    Requests from individuals to determine if a system of records
contains information about them should be directed to the System
Manager.

RECORD ACCESS PROCEDURES:
    Same as notification procedure above.

CONTESTING RECORD PROCEDURES:
    Same as notification procedure above.

RECORD SOURCE CATEGORIES:
    Employee, contractor, or consultant.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    None.

Magalie R. Salas,
Secretary.
[FR Doc. 05-21270 Filed 10-24-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: July 14, 2008 (Volume 73, Number 135)]
[Notices]
[Page 40338-40343]
[DOCID:fr14jy08-57]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8690-8; EPA-HQ-OW-2008-0238]

Final National Pollutant Discharge Elimination System (NPDES)
General Permit for Stormwater Discharges From Construction Activities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final permit issuance.

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

SUMMARY: EPA Regions 1, 3, 6, 7, 8, 9, and 10 today are issuing their
2008 National Pollutant Discharge Elimination System general permits
for stormwater discharges from new dischargers engaged in large and
small construction activities. Hereinafter, these NPDES general permits
will be referred to as ``permit'' or ``2008 construction general
permit'' or ``2008 CGP.'' ``New dischargers'' are those who did not
file a notice of intent (``NOI'') to be covered under the 2003
construction general permit (``2003 CGP'') before it expired. Existing
dischargers who properly filed an NOI to be covered under the 2003 CGP
continue to be authorized to discharge under that permit according to
its terms. The 2008 CGP contains the same limits and conditions as the
Agency's 2003 CGP with the exception of a few minor modifications which
are detailed below. EPA is issuing this CGP for a period not to exceed
two (2) years and will make the permit available to new construction
activities and unpermitted ongoing activities only.

DATES: This permit shall be effective on June 30, 2008. This effective
date is necessary to provide dischargers with the immediate opportunity
to comply with Clean Water Act requirements in light of the expiration
of the 2003 CGP on July 1, 2008. In accordance with 40 CFR Part 23,
this permit shall be considered issued for the purpose of judicial
review on July 28, 2008. Under section 509(b) of the Clean Water Act,
judicial review of this general permit can be had by filing a petition
for review in the United States Court of Appeals within 120 days after
the permit is considered issued for purposes of judicial review. Under
section 509(b)(2) of the Clean Water Act, the requirements in this
permit may not be challenged later in civil or criminal proceedings to
enforce these requirements. In addition, this permit may not be
challenged in other agency proceedings. Deadlines for submittal of
notices of intent are provided in Part 2.3 of the permit. This permit
also provides additional dates for compliance with the terms of these
permits.

FOR FURTHER INFORMATION CONTACT: Greg Schaner, Water Permits Division,
Office of Wastewater Management (Mail Code: 4203M), Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., EPA East, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    If a discharger chooses to apply to be authorized to discharge
under the 2008 construction general permit (``2008 CGP''), the permit
provides specific requirements for preventing contamination of
stormwater discharges from the following construction activities:

------------------------------------------------------------------------
                                                               North
                                                             American
                                   Examples of affected      Industry
            Category                     Entities         Classification
                                                          System (NAICS)
                                                               code
------------------------------------------------------------------------
Industry.......................   Construction site operators disturbing
                                   1 or more acres of land, or less than
                                    1 acre but part of a larger common
                                    plan of development or sale if the
                                    larger common plan will ultimately
                                  disturb 1 acre or more, and performing
                                         the following activities:
                                ----------------------------------------
                                 Building, Developing                233
                                  and General
                                  Contracting.
                                 Heavy Construction.....             234
------------------------------------------------------------------------

    EPA does not intend the preceding table to be exhaustive, but
provides it as a guide for readers regarding entities likely to be
regulated by this action. This table lists the types of activities that
EPA is now aware of that could potentially be affected by this action.
Other types of entities not listed in the table could also be affected.
To determine whether your facility is affected by this action, you
should carefully examine the definition of ``construction activity''
and ``small construction activity'' in existing EPA regulations at 40
CFR 122.26(b)(14)(x) and 122.26(b)(15), respectively. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed for technical information in the
preceding FOR FURTHER INFORMATION CONTACT section.
    Eligibility for coverage under the 2008 CGP is limited to operators
of ``new projects'' or ``unpermitted ongoing projects.'' A ``new
project'' is one that commences after the effective date of the 2008
CGP. An ``unpermitted ongoing project'' is one that commenced prior to
the effective date of the 2008 CGP, yet never received authorization to
discharge under the 2003 CGP or any other NPDES permit covering its
construction-related stormwater discharges. This permit is effective
only in those areas where EPA is the permitting authority. A list of
eligible areas is included in Appendix B of the 2008 CGP.

B. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this
action under Docket ID No. EPA-HQ-OW-2008-0238. Publicly available
docket materials are available either electronically through http://
www.regulations.gov or in hard copy at the Water Docket in the EPA
Docket Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution Ave.,
NW., Washington, DC 20460. Publicly available docket materials are
available in hard copy at the EPA Docket Center Public Reading Room,
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the Water Docket is (202)
566-2426.
    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. Electronic versions of the
final permit and fact sheet are available at EPA's stormwater Web site
http://www.epa.gov/npdes/stormwater.
    An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.regulations.gov/fdmspublic/component/main
to view public comments, access the index listing of the contents of
the official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, select
``search'', then key in the appropriate docket identification number.
    Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the docket
facility identified in Section I.B.1.
    Response to public comments. EPA received 9 comments on the
proposed permit from industry (7), state government (1), and the public
(1). EPA has responded to all significant comments received and has
included these responses in a separate document in the public docket
for this permit. See the document titled Proposed 2008 CGP: EPA's
Response to Public Comments.

C. Who Are The EPA Regional Contacts for This Permit?

    For EPA Region 1, contact Thelma Murphy at tel.:<PHONE_NUMBER> or
e-mail at<EMAIL_ADDRESS>    For EPA Region 2, contact Stephen Venezia at tel.:<PHONE_NUMBER>
or e-mail at<EMAIL_ADDRESS>or for Puerto Rico, contact
Sergio Bosques at tel.:<PHONE_NUMBER> or e-mail at
<EMAIL_ADDRESS>    For EPA Region 3, contact Garrison Miller at tel.:<PHONE_NUMBER>
or e-mail at<EMAIL_ADDRESS>    For EPA Region 5, contact Brian Bell at tel.:<PHONE_NUMBER> or e-
mail at<EMAIL_ADDRESS>    For EPA Region 6, contact Brent Larsen at tel.:<PHONE_NUMBER> or
e-mail at<EMAIL_ADDRESS>    For EPA Region 7, contact Mark Matthews at tel.:<PHONE_NUMBER> or
e-mail at<EMAIL_ADDRESS>    For EPA Region 8, contact Greg Davis at tel.:<PHONE_NUMBER> or e-
mail at<EMAIL_ADDRESS>    For EPA Region 9, contact Eugene Bromley at tel.:<PHONE_NUMBER> or
e-mail at<EMAIL_ADDRESS>    For EPA Region 10, contact Misha Vakoc at tel.:<PHONE_NUMBER> or
e-mail at<EMAIL_ADDRESS>
II. Background of Permit

A. Statutory and Regulatory History.

    The Clean Water Act (``CWA'') establishes a comprehensive program
``to restore and maintain the chemical, physical, and biological
integrity of the Nation's waters.'' 33 U.S.C. 1251(a). The CWA also
includes the objective of attaining ``water quality which provides for
the protection and propagation of fish, shellfish and wildlife.'' 33
U.S.C. 1251(a)(2)). To achieve these goals, the CWA requires EPA to
control discharges through the issuance of National Pollutant Discharge
Elimination System (``NPDES'') permits.

    Section 405 of the Water Quality Act of 1987 (WQA) added section
402(p) of the Clean Water Act (CWA), which directed EPA to develop a
phased approach to regulate stormwater discharges under the NPDES
program. EPA published a final regulation in the Federal Register on
the first phase of this program on November 16, 1990, establishing
permit application requirements for ``storm water discharges associated
with industrial activity.'' See 55 FR 47990. EPA defined the term
``storm water discharge associated with industrial activity'' in a
comprehensive manner to cover a wide variety of facilities.
Construction activities, including activities that are part of a larger
common plan of development or sale, that ultimately disturb at least
five acres of land and have point source discharges to waters of the
U.S. were included in the definition of ``industrial activity''
pursuant to 40 CFR 122.26(b)(14)(x). Phase II of the stormwater program
was published in the Federal Register on December 8, 1999, and required
NPDES permits for discharges from construction sites disturbing at
least one acre, but less than five acres, including sites that are part
of a larger common plan of development or sale that will ultimately
disturb at least one acre but less than five acres, pursuant to 40 CFR
122.26(b)(15)(i). See 64 FR 68722. EPA is issuing the 2008 CGP under
the statutory and regulatory authority cited above.
    NPDES permits issued for construction stormwater discharges are
required under Section 402(a)(1) of the CWA to include conditions for
meeting technology-based effluent limits established under Section 301
and, where applicable, Section 306. Once an effluent limitations
guideline or new source performance standard is promulgated in
accordance with these sections, NPDES permits are required to
incorporate limits based on such limitations and standards. See 40 CFR
122.44(a)(1). Prior to the promulgation of national effluent
limitations and standards, permitting authorities incorporate
technology-based effluent limitations on a best professional judgment
basis. CWA section 402(a)(1)(B); 40 CFR 125.3(a)(2)(ii)(B).

B. Summary of Permit

    Construction operators choosing to be covered by the 2008 CGP must
certify in their notice of intent (NOI) that they meet the requisite
eligibility requirements, described in Part 1.3 of the permit. If
eligible, operators are authorized to discharge under this permit in
accordance with Part 2. Permittees must install and implement control
measures to meet the effluent limits applicable to all dischargers in
Part 3, and must inspect such stormwater controls and repair or modify
them in accordance with Part 4. The permit in Part 5 requires all
construction operators to prepare a stormwater pollution prevention
plan (SWPPP) that identifies all sources of pollution, and describes
control measures used to minimize pollutants discharged from the
construction site. Part 6 details the requirements for terminating
coverage under the permit.
    The 2008 CGP is effective for a period of not to exceed two years.
The 2008 CGP includes conditions and limits that are nearly identical
to the 2003 CGP, with the exception that the 2008 CGP only applies to
new and unpermitted ongoing construction projects. Discharges from
ongoing projects (or ``existing dischargers'') will continue to be
covered under the existing 2003 CGP. (However, EPA clarifies that if an
operator of a permitted ongoing project transfers ownership of the
project, or a portion thereof, to a different operator, that subsequent
operator is required to submit a complete and accurate NOI for a new
project under the 2008 CGP.) Although the existing permit expired on
July 1, 2008, dischargers who filed notices of intent (NOIs) to be
authorized under that permit prior to the expiration date will continue
to be authorized to discharge in accordance with EPA's regulations at
40 CFR 122.6. The 2008 CGP only applies to dischargers who were not
authorized under the 2003 CGP, which includes both ``new projects'' and
``unpermitted ongoing projects.'' Operators of new projects or
unpermitted ongoing projects seeking coverage under the 2008 CGP would
be expected to use the same electronic Notice of Intent (eNOI) system
that is currently in place for the 2003 CGP.
    The other significant difference between the 2003 and 2008 CGPs is
that this permit has been reorganized so that it is clearer which
requirements are effluent limitations, which are inspection
requirements, and which are SWPPP documentation requirements. As a
result, the 2008 CGP now includes new sections (Part 3--Effluent
Limits, Part 4--Inspections, and Part 5--Stormwater Pollution
Prevention Plans) reflecting this reorganization. However, EPA
emphasizes that although the requirements in the 2008 CGP have been
placed in different sections, the requirements are substantially the
same as they were in the 2003 CGP. The reorganized permit will be
discussed further in Section III.B, Summary of Significant Changes from
the 2003 CGP.

C. What Is EPA's Rationale for the Two-Year Duration of the 2008 CGP?

    As stated, EPA is issuing the 2008 CGP for a period not to exceed
two years. As a result of recent litigation brought against EPA
concerning the promulgation of effluent limitations guidelines and
standards for the construction and development (``C&D'') industry, EPA
is required by court order to propose effluent limitations guidelines
and new source performance standards (hereinafter, ``effluent
guidelines'') for the C&D industry by December 2008, and promulgate
those effluent guidelines by December 2009. See Natural Resources
Defense Council, et al. v. U.S. Environmental Protection Agency, No.
CV-0408307-GH (C.D. Cal.) (Permanent Injunction and Judgment, December
5, 2006). EPA projects that the Agency may publish a proposed rule
ahead of the court-ordered deadlines. If EPA publishes the proposed
rule ahead of schedule, this may allow the Agency to promulgate a final
rule ahead of schedule as well. The Agency currently hopes to
promulgate a final rule as early as the end of this calendar year.
However, completion of the tasks necessary to do so is dependent on the
timing of numerous future activities and factors associated with the
effluent guidelines rulemaking process.
    EPA believes it will be appropriate to propose a revised CGP once
EPA has issued C&D effluent guidelines. The maximum two-year duration
for this permit is intended to coincide with the court-ordered
deadlines for the C&D rule. EPA intends to propose and finalize a new,
revised CGP sooner, if the C&D rule is promulgated earlier than the
date directed by the court.

D. Why Is EPA Using Requirements That Are Nearly Identical to the 2003
CGP?

    The expiration of the 2003 CGP on July 1, 2008, made it incumbent
upon EPA to make available a similar general permit that provided
coverage for the estimated 4,000 new dischargers per year commencing
construction in the areas where EPA is the permitting authority.
Without such a permit vehicle, the only other available option for
construction site operators is to obtain coverage under an individual
permit. As has been described in the past, issuance of individual
permits for every construction activity disturbing one acre or more is
infeasible given the resources required for the Agency to issue
individual permits. EPA is issuing a CGP that adopts the same limits
and conditions as the previous permit (the 2003 CGP) for a limited
period of time. This action is appropriate for several

reasons. First, as discussed above, EPA is working on the development
of a new effluent guideline that will address stormwater discharges
from the same industrial activities (i.e., construction activities
disturbing one or more acres) as the CGP. Because the development of
the C&D rule and the issuance of the CGP are on relatively similar
schedules, and the C&D rule will establish national technology-based
effluent limitations and standards for construction activities, EPA
believes that it is more appropriate to proceed along two tracks to
permit construction discharges. The first track entails issuing the
2008 CGP for a limited period of time, not to exceed 2 years, that
contains the 2003 CGP limits and conditions, but for only operators of
new and unpermitted ongoing projects, so that such entities can obtain
valid permit coverage for their discharges. The second track involves
proposing and issuing a revised 5-year CGP that incorporates the
requirements of the new C&D rule shortly after the rule is promulgated.
    Second, EPA believes that issuing a substantially revised CGP by
July 1, 2008, would have been impracticable given the number of
unknowns concerning the outcome of the C&D rule. EPA does not believe
that it would be appropriate to issue a permit containing technology-
based limitations that would be outdated so quickly, given the fact
that the C&D rule may be promulgated only a few months after permit
issuance. For similar reasons, if EPA had attempted to approximate the
requirements of the new C&D rule and incorporate such limits into a new
CGP, such a permit would presuppose the outcome of the C&D rule and
potentially conflict with the scope and content of the effluent
limitation guideline prior to full consideration of public comments.
Instead, the Agency believes it is a much better use of Agency
resources to wait the short time until after the C&D rule promulgation
to issue a revised CGP that is fully reflective of the new effluent
limitation guideline. In the meantime, during this relatively short
period of time prior to the C&D rule's promulgation and prior to the
issuance of the revised CGP that incorporates those standards, EPA is
using the permit limits and conditions from the 2003 CGP as an
effective vehicle to control new discharges. EPA notes that it has
minimized the amount of time during which the 2008 CGP will remain
effective in order to underscore the Agency's intention to issue a
revised CGP once the C&D rule is finalized.
    Third, EPA found the alternative of allowing the 2003 CGP to expire
without a replacement, relying instead on an enforcement discretion
approach prior to the issuance of the next permit (similar to the
practice used for the NPDES Multi-Sector General Permit (MSGP) for
stormwater discharges from industrial activities), to be an
unacceptable option for stormwater discharges from construction
activities. The CGP potentially has an estimated 4,000 new dischargers
per year that seek coverage. EPA has made progress with the regulated
community in terms of compliance assistance that would be compromised
if a permit is not in place during the interim period prior to the
promulgation of the C&D rule. For instance, EPA Regional offices have
led substantial efforts to boost compliance with the CGP, resulting in
an increased rate of compliance among construction operators. EPA
anticipated that such efforts would have been undermined, and the
compliance rate would have declined, if a new permit were not issued by
July 1, 2008. Additionally, the enforcement discretion approach would
leave construction operators without a reasonable way to obtain
authorization to discharge and would expose them to liability from
third party lawsuits for violating the Clean Water Act for unpermitted
discharges. A short-term permit that mirrors the existing 2003 CGP
addresses these concerns by providing a Federal permit with provisions
that have already been reviewed in the previous permit issuance
process, and by avoiding any period of time during which dischargers
are not able to obtain permit coverage.

III. Scope and Availability of the 2008 CGP

A. Geographic Coverage

    This permit provides coverage for discharges from construction
sites that occur in areas not covered by an approved State NPDES
program. EPA Regions 1, 3, 6, 7, 8, 9, and 10 are issuing the 2008 CGP
to replace the expiring 2003 CGP for operators of new and unpermitted
ongoing construction projects. The geographic coverage and scope of the
2008 CGP is listed in Appendix B of the permit. The only change from
the scope of coverage in the 2003 CGP is that the State of Maine is now
the permitting authority for all discharges in the state, including
operators in Tribal Lands, and as such, discharges in the State of
Maine are no longer eligible for coverage under EPA's CGP. In addition,
because certifications required by section 401 of the Clean Water Act,
and for a few states, certifications required by the Coastal Zone
Management Act, were not received in time, new and unpermitted ongoing
construction projects in the following areas are not yet eligible for
coverage under this permit:
     The State of New Hampshire;
     Indian country within the State of New York;
     The Commonwealth of Puerto Rico;
     Indian country within the State of Michigan;
     Indian country within the State of Minnesota;
     Indian country within the State of Wisconsin, except the
Sokaogon Chippewa (Mole Lake) Community;
     Indian country within the State of Oklahoma;
     Indian country within the State of New Mexico;
     Oil and gas, or geothermal energy, operations in Texas;
     Oil and gas operations, or certain point source discharges
associated with agriculture and silviculture in Oklahoma;
     Federal Facilities in the State of Colorado, except those
located on Indian country;
     Indian country within the State of Colorado, as well as
the portion of the Ute Mountain Reservation located in New Mexico; and
     Indian country within the State of Montana.
    EPA will announce the availability of coverage under the CGP for
these areas in separate Federal Register notice(s) as soon as possible
after the certifications are completed. In the meantime, EPA has
decided to make administrative or civil enforcement for lack of permit
coverage against dischargers in the above areas a low priority because
the 2008 CGP will not yet apply to those areas. The Agency's position
is outlined in a memorandum from EPA's Office of Enforcement and
Compliance Assurance, available in the docket for this permit. This low
enforcement priority does not apply to criminal violations or to
situations where there are egregious circumstances, such as those
resulting in serious actual harm or which may present an imminent and
substantial endangerment to public or the environment, or where no
control measures are in place to protect public health or the
environment. The Office of Enforcement and Compliance Assurance also
reserves the right, at any time, to initiate an appropriate enforcement
response with respect to a specific discharger should circumstances
warrant. Under this low enforcement priority approach, EPA will not
pursue actions against dischargers that lack a permit but are meeting
the obligations that would have been imposed by the expired 2003 CGP.
These obligations include, but are not limited to,

complying with the required effluent limitations, Stormwater Pollution
Prevention Plan development and implementation, inspections, and proper
installation and maintenance of storm water control measures.

B. Summary of Significant Changes From the 2003 CGP.

    As discussed above, EPA is issuing the 2008 CGP for a period not to
exceed two years. This permit includes the same limits and conditions
as the 2003 CGP with the following differences:
     Type of Construction Projects That Can Be Covered:
Eligibility for coverage under the 2008 CGP is limited to operators of
new and unpermitted ongoing construction projects. However, dischargers
from existing dischargers, otherwise referred to as ongoing permitted
construction projects, are not eligible for coverage under the 2008
CGP.
     Distinction Between Effluent Limits and SWPPP
Documentation Requirements: In response to comments, the permit was
clarified to clearly distinguish between the effluent limits from the
documentation requirements relating to the development of the SWPPP.
The effluent limitations (in Part 3) are permit requirements to which
all permittees are subject in order to minimize the discharge of
pollutants from the site, while the SWPPP (in Part 5) is a planning
document that must be prepared by all construction operators that
describes the site and the pollutants discharged, and documents the
control measures selected, installed, and maintained to meet the
effluent limitations in Part 3. Additionally, the inspection
requirements, which were previously included in the SWPPP section, have
been moved to a separate section (Part 4) to highlight their
importance. EPA emphasizes that though the permit has been reorganized,
the requirements themselves have not been substantially changed.
However, in response to recommendations received by two commenters, EPA
included the following two new requirements: (1) A requirement to
educate employees or subcontractors as necessary so that they
understand their role in implementing stormwater controls (Part 3.6),
and (2) a requirement to remove sediment from silt fences before the
deposit reaches fifty percent of the above-ground fence height.
     Eligibility for Tribal Lands in Maine: Because the State
of Maine now has permit authority over Tribal Lands in its state, EPA
removed eligibility for operators in Tribal Lands in Maine from the
list of areas in Appendix B where this permit is effective.

These changes are discussed in greater detail in the 2008 CGP fact
sheet.

C. Permit Appeal Procedures

    In accordance with 40 CFR part 23, this permit shall be considered
issued for the purpose of judicial review on July 28, 2008. Under
section 509(b) of the Clean Water Act, judicial review of this general
permit can be had by filing a petition for review in the United States
Court of Appeals with 120 days after the permit is considered issued
for purposes of judicial review. Under section 509(b)(2) of the Clean
Water Act, the requirements in this permit may not be challenged later
in civil or criminal proceedings to enforce these requirements. In
addition, this permit may not be challenged in other agency
proceedings. In addition, rather than submitting an NOI to be covered
under this permit, persons may apply for an individual permit as
specified at 40 CFR 122.21 (and authorized at 40 CFR 122.28), and then
petition the Environmental Appeals Board to review any conditions of
the individual permit (40 CFR 124.19 as modified on May 15, 2000, 65 FR
30886).

IV. Qualified Local Programs

    EPA requested comments in the proposal on a draft set of criteria
to use in determining which local erosion and sediment control
requirements satisfy the 40 CFR 122.44(s) requirements for
incorporating qualified local programs (QLPs) into future CGPs. The
Agency received several comments relating to the draft QLP criteria.
EPA appreciates the feedback provided by these comments. EPA's
responses are included in the response to comment document associated
with this Federal Register notice. EPA clarifies that the draft
criteria were not intended to be promulgated as changes to the NPDES
regulations. The purpose of the proposal was to share with the public
the Agency's current thinking with regard to factors that would be
taken into account when proposing to incorporate a QLP into future
CGPs. In addition, should the Agency propose to incorporate a QLP into
the CGP, it will first need to propose such a modification for public
comment as a permit modification.

V. Compliance With the Regulatory Flexibility Act

A. EPA's Approach to Compliance With the Regulatory Flexibility Act for
General Permits

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    The legal question of whether a general permit (as opposed to an
individual permit) qualifies as a ``rule'' or as an ``adjudication''
under the Administrative Procedure Act (APA) has been the subject of
periodic litigation. In a recent case, the court held that the CWA
Section 404 Nationwide general permit before the court did qualify as a
``rule'' and therefore that the issuance of that general permit needed
to comply with the applicable legal requirements for the issuance of a
``rule.'' National Ass'n of Home Builders v. U.S. Army Corps of
Engineers, 417 F.3d 1272, 1284-85 (DC Cir. 2005) (Army Corps general
permits under Section 404 of the Clean Water Act are rules under the
APA and the Regulatory Flexibility Act; ``Each NWP [nationwide permit]
easily fits within the APA's definition `rule'.* * * As such, each NWP
constitutes a rule * * *'').
    As EPA stated in 1998, ``the Agency recognizes that the question of
the applicability of the APA, and thus the RFA, to the issuance of a
general permit is a difficult one, given the fact that a large number
of dischargers may choose to use the general permit.'' 63 FR 36489,
36497 (July 6, 1998). At that time, EPA ``reviewed its previous NPDES
general permitting actions and related statements in the Federal
Register or elsewhere,'' and stated that ``[t]his review suggests that
the Agency has generally treated NPDES general permits effectively as
rules, though at times it has given contrary indications as to whether
these actions are rules or permits.'' Id. at 36496. Based on EPA's
further legal analysis of the issue, the Agency ``concluded, as set
forth in the proposal, that NPDES general permits are permits [i.e.,
adjudications] under the APA and thus not subject to APA rulemaking
requirements or the RFA.'' Id. Accordingly, the Agency stated that
``the APA's rulemaking requirements are inapplicable to issuance of
such permits,'' and thus ``NPDES permitting is not subject to the
requirement to publish a general notice of proposed rulemaking under
the APA or any other law * * * [and] it is not subject to the RFA.''
Id. at 36497.
    However, the Agency went on to explain that, even though EPA had
concluded that it was not legally

required to do so, the Agency would voluntarily perform the RFA's
small-entity impact analysis. Id. EPA explained the strong public
interest in the Agency following the RFA's requirements on a voluntary
basis: ``[The notice and comment] process also provides an opportunity
for EPA to consider the potential impact of general permit terms on
small entities and how to craft the permit to avoid any undue burden on
small entities.'' Id. Accordingly, with respect to the NPDES permit
that EPA was addressing in that Federal Register notice, EPA stated
that ``the Agency has considered and addressed the potential impact of
the general permit on small entities in a manner that would meet the
requirements of the RFA if it applied.'' Id.
    Subsequent to EPA's conclusion in 1998 that general permits are
adjudications rather than rules, as noted above, the DC Circuit
recently held that Nationwide general permits under section 404 are
``rules'' rather than ``adjudications.'' Thus, this legal question
remains ``a difficult one'' (supra). However, EPA continues to believe
that there is a strong public policy interest in EPA applying the RFA's
framework and requirements to the Agency's evaluation and consideration
of the nature and extent of any economic impacts that a CWA general
permit could have on small entities (e.g., small businesses). In this
regard, EPA believes that the Agency's evaluation of the potential
economic impact that a general permit would have on small entities,
consistent with the RFA framework discussed below, is relevant to, and
an essential component of, the Agency's assessment of whether a CWA
general permit would place requirements on dischargers that are
appropriate and reasonable. Furthermore, EPA believes that the RFA's
framework and requirements provide the Agency with the best approach
for the Agency's evaluation of the economic impact of general permits
on small entities. While using the RFA framework to inform its
assessment of whether permit requirements are appropriate and
reasonable, EPA will also continue to ensure that all permits satisfy
the requirements of the Clean Water Act.
    Accordingly, EPA has committed to operating in accordance with the
RFA's framework and requirements during the Agency's issuance of CWA
general permits (in other words, the Agency has committed that it will
apply the RFA in its issuance of general permits as if those permits do
qualify as ``rules'' that are subject to the RFA). In satisfaction of
this commitment, during the course of this CGP proceeding, the Agency
conducted the analysis and made the appropriate determinations that are
called for by the RFA. In addition, and in satisfaction of the Agency's
commitment, EPA will apply the RFA's framework and requirements in any
future issuance of other NPDES general permits. EPA anticipates that
for most general permits the Agency will be able to conclude that there
is not a significant economic impact on a substantial number of small
entities. In such cases, the requirements of the RFA framework are
fulfilled by including a statement to this effect in the permit fact
sheet, along with a statement providing the factual basis for the
conclusion. A quantitative analysis of impacts would only be required
for permits that may affect a substantial number of small entities,
consistent with EPA guidance regarding RFA certification.\1\

B. Application of RFA Framework to Issuance of 2008 CGP
---------------------------------------------------------------------------

    \1\ EPA's current guidance, entitled Final Guidance for EPA
Rulewriters: Regulatory Flexibility Act as Amended by the Small
Business Regulatory Enforcement and Fairness Act, was issued in
November 2006 and is available on EPA's Web site: http://
www.epa.gov/sbrefa/documents/rfafinalguidance06.pdf. After
considering the Guidance and the purpose of CWA general permits, EPA
concludes that general permits affecting less than 100 small
entities do not have a significant economic impact on a substantial
number of small entities.
---------------------------------------------------------------------------

    EPA has concluded, consistent with the discussion in Section IV.A
above, that the issuance of the 2008 CGP could affect a substantial
number of small entities. In the areas where the CGP is effective (see
Section III.A), an estimated 4,000 construction projects per year were
authorized under the 2003 CGP, a substantial number of which could be
operated by small entities. However, EPA has concluded that the
issuance of the 2008 CGP is unlikely to have an adverse economic impact
on small entities. The 2008 CGP includes substantially the same
requirements as those of the 2003 CGP. EPA intends to include an
updated economic screening analysis with the issuance of the next CGP.
EPA concludes that this action will not have a significant economic
impact on a substantial number of small entities.

    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

    Dated: June 30, 2008.
Robert W. Varney,
Regional Administrator, EPA Region 1.
    Dated: June 30, 2008.
Jon M. Capacasa,
Director, Water Protection Division, EPA Region 3.
    Dated: June 30, 2008.
Miguel I. Flores,
Director, Water Quality Protection Division, EPA Region 6.
    Dated: June 30, 2008.
William A. Spratlin,
Director, Wetlands and Pesticides Division, EPA Region 7.
    Dated: June 30, 2008.
Stephen S. Tuber,
Assistant Regional Administrator, Office of Partnerships & Regulatory
Assistance, EPA Region 8.
    Dated: June 30, 2008.
Nancy Woo,
Acting Director, Water Division, EPA Region 9.
    Dated: June 30, 2008.
Michael F. Gearheard,
Director, Office of Water and Watersheds, EPA Region 10.
[FR Doc. E8-15829 Filed 7-11-08; 8:45 am]

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[Federal Register Volume 84, Number 232 (Tuesday, December 3, 2019)]
[Proposed Rules]
[Pages 66080-66082]
[FR Doc No: 2019-26079]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 84, No. 232 / Tuesday, December 3, 2019 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0970; Product Identifier 2018-SW-089-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for Airbus Helicopters Model AS332C, AS332C1, AS332L, AS332L1, and
AS332L2 helicopters. This proposed AD would require removing the drain
plugs from the fuel tank compartments located under the bottom
structure. This proposed AD is prompted by the discovery that a
modification to the fuel tank could lead to fuel accumulating in an
area containing electrical equipment and subsequent ignition of fuel
vapors. The actions of this proposed AD are intended to address an
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by February 3,
2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://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 https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0970; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received, and other information. The
street address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
review the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Jignesh Patel, Aerospace Engineer,
Safety Management Section, Rotorcraft Standards Branch, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views. The FAA also invites 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.
    The FAA will file in the docket all comments received, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal,
the FAA will consider all comments received on or before the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this proposal in light of the
comments received.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2018-0209, dated September 21,
2018 (EASA AD 2018-0209), to correct an unsafe condition for Airbus
Helicopters (formerly Eurocopter, Eurocopter France, Aerospatiale)
Model AS 332 C, AS 332 C1, AS 332 L, AS 332 L1, and AS 332 L2
helicopters, except those with modification 0726383.
    EASA advises that during production of AS332 helicopters, closure
of the fuel tank drains with plugs was implemented. EASA states that
this closure disregards compliance with an airworthiness certification
requirement and in the event of fuel leakage in flight, a closed fuel
drain creates the risk of fuel accumulation and/or migration to an
adjacent area. EASA advises this area may contain electrical equipment
that could be susceptible to creating a source of ignition. EASA states
this condition, if not corrected, could result in the ignition of fuel
vapors, resulting in a fire causing damage to the helicopter or injury
to the occupants.
    Accordingly, EASA AD 2018-0209 requires modification of the
draining system of the fuel tank compartments by removing the drain
plugs from the fuel tank compartments located under the bottom
structure.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that an
unsafe condition is likely to exist or develop on other products of the
same type designs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Airbus Helicopter Alert Service Bulletin No.
AS332-

53.01.62, Revision 1, dated May 28, 2019 (ASB AS332-53.01.62, Revision
1), for Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2
helicopters. This service information contains procedures for removing
the drain plugs from the fuel tank compartments located under the
bottom structure of the helicopter. This service information also
specifies that the number of drain plugs varies depending on the
version of the helicopter.
    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.

Other Related Service Information

    The FAA also reviewed Airbus Helicopters ASB No. AS332-53.01.62,
Revision 0, dated June 7, 2018 (AS332-53.01.62, Revision 0). AS332-
53.01.62, Revision 0, contains the same procedures as AS332-53.01.62,
Revision 1. However, AS332-53.01.62, Revision 1, also addresses
military versions.

Proposed AD Requirements

    This proposed AD would require removing the drain plugs from the
fuel tank compartments.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 11 helicopters
of U.S. Registry. The FAA estimates that operators may incur the
following costs in order to comply with this AD. Labor costs are
estimated at $85 per work-hour.
    Removing the 6 drain plugs installed on Model AS332C and AS332C1
helicopters would take about 2 work-hours for an estimated cost of $170
per helicopter and $170 for the U.S. fleet size of 1 helicopter.
    Removing the 7 drain plugs installed on Model AS332L, AS332L1, and
AS332L2 helicopters would take about 2 work-hours for an estimated cost
of $170 per helicopter and $1,700 for the U.S. fleet size of 10
helicopters.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,
    2. Will not affect intrastate aviation in Alaska, and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    The FAA 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):

Airbus Helicopters: Docket No. FAA-2019-0970; Product Identifier
2018-SW-089-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model AS332C, AS332C1,
AS332L, AS332L1, and AS332L2 helicopters, certificated in any
category, except those with modification 0726383 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as closure of fuel tank
drains. This condition could result in fuel accumulating in an area
containing electrical equipment and ignition of fuel vapors. This
condition could result in a fire and subsequent damage to the
helicopter or injury to the occupants.

(c) Comments Due Date

    The FAA must receive comments by February 3, 2020.

(d) 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.

(e) Required Actions

    Within 110 hours time-in-service or during the next scheduled
maintenance, whichever occurs first:
    (1) For Model AS332C and AS332C1 helicopters, remove the 6 fuel
tank drain plugs by following the Accomplishment Instructions,
paragraph 3.B.2. of Airbus Helicopters Alert Service Bulletin No.
AS332-53.01.62, Revision 1, dated May 28, 2019 (ASB AS332-53.01.62),
except you are not required to place the drain plugs in stock.
    (2) For Model AS332L, AS332L1, and AS332L2 helicopters, remove
the 7 fuel tank drain plugs by following the Accomplishment
Instructions, paragraph 3.B.2. of ASB AS332-53.01.62, except you are
not required to place the drain plugs in stock.

(f) Credit for Previous Actions

    Actions accomplished before the effective date of this AD in
accordance with the procedures specified in Airbus Helicopters Alert
Service Bulletin No. AS332-53.01.62, Revision 0, dated June 7, 2018,
are considered acceptable for compliance with the corresponding
actions specified in paragraph (e) of this AD.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Jignesh Patel, Aerospace Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; 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, the FAA suggests
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.

(h) Additional Information

    (1) Airbus Helicopters Alert Service Bulletin No. AS332-
53.01.62, Revision 0, dated June 7, 2018, which is not incorporated
by reference, contains additional information about the subject of
this AD. For service information identified in this AD, contact

Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html.
You may review the referenced service information at the FAA, Office
of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety (EASA) AD No. 2018-0209, dated September 21, 2018. You may
view the EASA AD on the internet at https://www.regulations.gov in
the AD Docket.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 2810, Fuel
Storage.

    Issued in Fort Worth, Texas, on November 25, 2019.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2019-26079 Filed 12-2-19; 8:45 am]
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