(ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (q) Universal product code (UPC) means the product identifier used
to identify a company and product name of an item sold at retail in the
United States.
    23. Amend Sec.  814.84 by adding paragraph (b)(4) to read as
follows:

Sec.  814.84  Reports.

* * * * *
    (b) * * *
    (4) Identify each device identifier currently in use for the
device, and each device identifier for the device that has been
discontinued since the previous periodic report. It is not necessary to
identify any device identifier discontinued prior to [A DATE WILL BE
ADDED 90 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER].

PART 820--QUALITY SYSTEM REGULATION

    24. The authority citation for part 820 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

    25. Amend Sec.  820.3 by adding paragraphs (bb) and (cc) to read as
follows:

Sec.  820.3  Definitions.

* * * * *
    (bb) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A unique
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (cc) Universal product code (UPC) means the product identifier used
to identify a company and product name of an item sold at retail in the
United States.
    26. Amend Sec.  820.120 by revising the first sentence of paragraph
(b) to read as follows:

Sec.  820.120  Device labeling.

* * * * *
    (b) Labeling inspection. Labeling shall not be released for storage
or use until a designated individual(s) has examined the labeling for
accuracy including, where applicable, the correct unique device
identifier (UDI) or universal product code (UPC), expiration date,
control number, storage instructions, handling instructions, and any
additional processing instructions. * * *
* * * * *
    27. Amend Sec.  820.184 by revising paragraph (f) to read as
follows:

Sec.  820.184  Device history record.

* * * * *
    (f) Any unique device identifier (UDI) or universal product code
(UPC), and any other device identification(s) and control number(s)
used.
    28. Amend Sec.  820.198 by revising paragraph (e)(3) to read as
follows:

Sec.  820.198  Complaint files.

* * * * *
    (e) * * *
    (3) Any unique device identifier (UDI) or universal product code
(UPC), and any other device identification(s) and control number(s)
used;
* * * * *
    29. Amend Sec.  820.200 by revising paragraph (d)(2) to read as
follows:

Sec.  820.200  Servicing.

* * * * *
    (d) * * *
    (2) Any unique device identifier (UDI) or universal product code
(UPC), and any other device identification(s) and control number(s)
used;
* * * * *

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

    30. The authority citation for part 821 continues to read as
follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371,
374.

    31. Amend Sec.  821.3 by adding paragraph (n) to read as follows:

Sec.  821.3  Definitions.

* * * * *
    (n) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A unique
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    32. Amend Sec.  821.25 by revising paragraphs (a)(2)(i) and
(a)(3)(i) to read as follows:

Sec.  821.25  Device tracking system and content requirements:
manufacturer requirements.

    (a) * * *
    (2) * * *
    (i) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier
necessary to provide for effective tracking of the devices;
* * * * *
    (3) * * *
    (i) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier
necessary to provide for effective tracking of the devices;
* * * * *
    33. Amend Sec.  821.30 by revising paragraphs (a)(2), (b)(2), and
(c)(1)(i) to read as follows:

Sec.  821.30  Tracking obligations of persons other than device
manufacturers: distributor requirements.

    (a) * * *
    (2) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier used
by the manufacturer to track the device;
* * * * *
    (b) * * *
    (2) The unique device identifier (UDI), lot number, batch number,
model

number, or serial number of the device or other identifier used by the
manufacturer to track the device;
* * * * *
    (c) * * *
    (1) * * *
    (i) The unique device identifier (UDI), lot number, batch number,
model number, or serial number of the device or other identifier used
by the manufacturer to track the device;
* * * * *

PART 822--POSTMARKET SURVEILLANCE

    34. The authority citation for part 822 continues to read as
follows:

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

    35. Amend Sec.  822.3 by adding paragraph (n) to read as follows:

Sec.  822.3  How do you define the terms used in this part?

* * * * *
    (n) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec.  830.20 of this chapter. A unique
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    36. Amend Sec.  822.9 by revising paragraph (a)(4) to read as
follows:

Sec.  822.9  What must I include in my submission?

* * * * *
    (a) * * *
    (4) Premarket application/submission number and device identifiers
for your device;
* * * * *
    37. Add part 830 to read as follows:

PART 830--UNIQUE DEVICE IDENTIFICATION

Subpart A--General Provisions
Sec.
830.3 Definitions.
Subpart B--Requirements for a Unique Device Identifier (UDI)
830.10 Incorporation by reference--Technical standards applicable to
part 830.
830.20 Requirements for a unique device identifier.
830.40 Use and discontinuation of a device identifier.
830.50 Changes that result in a new version or model.
830.60 Relabeling of a device that is required to bear a unique
device identifier.
Subpart C--FDA Accreditation of an Issuing Agency
830.100 FDA accreditation of an issuing agency.
830.110 Application for accreditation as an issuing agency.
830.120 Responsibilities of an FDA-accredited issuing agency.
830.130 Suspension or revocation of the accreditation of an issuing
agency.
Subpart D--FDA as an Issuing Agency
830.200 When FDA will act as an issuing agency.
830.210 Eligibility for use of FDA as an issuing agency.
830.220 Termination of FDA service as an issuing agency.
Subpart E--Global Unique Device Identification Database
830.300 Devices subject to device identification data submission
requirements.
830.310 Information required for unique device identification.
830.320 Submission of unique device identification information.
830.330 Times for submission of unique device identification
information.
830.340 Voluntary submission of ancillary device identification
information.
830.350 Records to be maintained by the labeler.

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j,
371.

Subpart A--General Provisions

Sec.  830.3  Definitions.

    Automatic identification and data capture (AIDC) means any
technology that conveys the unique device identifier (UDI) or the
device identifier of a device in a form that can be entered into an
electronic patient record or other computer system via an automated
process.
    Center Director means the Director of the Center for Devices and
Radiological Health or the Director of the Center for Biologics
Evaluation and Research, depending on which Center has been assigned
lead responsibility for the device.
    Device package means a package that contains a fixed quantity of
devices.
    Expiration date means the date by which the label of a device
states the device must or should be used.
    FDA, we, or us means the Food and Drug Administration.
    Federal Food, Drug, and Cosmetic Act means 21 U.S.C. 321 et seq.,
as amended.
    Global Unique Device Identification Database (GUDID) means the
database that serves as a repository of information to facilitate the
identification of medical devices through their distribution and use.
    Issuing agency means an organization accredited by FDA to operate a
system for the issuance of unique device identifiers.
    Label has the meaning set forth in section 201(k) of the Federal
Food, Drug, and Cosmetic Act.
    Labeler means:
    (1) Any person who causes a label to be applied to a device with
the intent that the device will be introduced into interstate commerce
without any subsequent replacement or modification of the label; and
    (2) Any person who causes the label of a device to be modified with
the intent that the device will be introduced into interstate commerce
without any subsequent replacement or modification of the label, except
that the addition of the name of, and contact information for, a person
who distributes the device, without making any other changes to the
label, is not a modification for the purposes of determining whether a
person is a labeler.
    Lot or batch means one finished device (any device or accessory to
any device that is suitable for use or capable of functioning) or more
that consist of a single type, model, class, size, composition, or
software version that are manufactured under essentially the same
conditions and that are intended to have uniform characteristics and
quality within specified limits.
    Premarket submission means a premarket approval application; a
product development protocol; a premarket report; a humanitarian device
exemption application; a biologics license application; a supplement; a
premarket notification submission; or a new drug application for a
transitional device:
    (1) Premarket approval application means an application for
approval of a device submitted under section 515(c) of the Federal
Food, Drug, and Cosmetic Act;
    (2) Product development protocol means the application described in
section 515(f) of the Federal Food, Drug, and Cosmetic Act.

    (3) Premarket report means a report submitted under section
515(c)(2) of the Federal Food, Drug, and Cosmetic Act;
    (4) Humanitarian device exemption application means an application
for approval of a humanitarian use device submitted under section
520(m) of the Federal Food, Drug, and Cosmetic Act;
    (5) Biologics license application means an application for approval
of a device submitted under section 351 of the Public Health Service
Act.
    (6) Premarket notification submission means a report submitted
under section 510(k) of the Federal Food, Drug, and Cosmetic Act;
    (7) New drug application for a transitional device means a new drug
application for a medical device that was regulated by FDA as a new
drug prior to May 28, 1976, the date of enactment of the Medical Device
Amendments of 1976.
    Shipping container means a package, container, or pallet used
during the shipment or transportation of devices from one point to
another, and whose contents may vary from one shipment to another.
    Small business means a medical device manufacturer with 500 or
fewer employees, or a medical device relabeler or repackager with 100
or fewer employees.
    Specification means any requirement with which a device must
conform.
    Unique device identifier (UDI) means an identifier that adequately
identifies a device through its distribution and use by meeting the
requirements of Sec.  830.20. A unique device identifier is composed
of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    Universal product code (UPC) means the product identifier used to
identify a company and product name of an item sold at retail in the
United States.
    Version or model means a device package containing one or more
devices that have identical specifications, performance, size, and
composition, within specified limits.

Subpart B--Requirements for a Unique Device Identifier (UDI)

Sec.  830.10  Incorporation by reference--technical standards
applicable to part 830.

    (a) The following technical standards are incorporated by reference
with the approval of the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51:
    (1) ISO/IEC 646:1991, Information technology--ISO 7-bit coded
character set for information interchange (third edition, December 15,
1991).
    (2) ISO/IEC 15459-2:2006(E), Information technology--Unique
identifiers--Part 2: Registration procedures (second edition, March 1,
2006);
    (3) ISO/IEC 15459-4:2008, Information technology--Unique
identifiers--Part 4: Individual items (second edition, July 7, 2008);
    (4) ISO/IEC 15459-6:2007, Information technology--Unique
identifiers--Part 6: Unique identifier for product groupings (first
edition, June 15, 2007);
    (b) Copies are available for purchase from: ISO Central
Secretariat, International Organization for Standardization (ISO), 1,
ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland,
telephone (dialing from the United States): 011-41-22-749-0111,
Internet: www.standardsinfo.net, and are available for inspection at:
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, and at
the National Archives and Records Administration (NARA). For
information on how to review these standards at NARA, call 202-741-
6030, or go to: www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Sec.  830.20  Requirements for a unique device identifier.

    A unique device identifier (UDI) must:
    (a) Be issued under a system operated by FDA or an FDA-accredited
issuing agency;
    (b) Conform to international standards incorporated by reference by
Sec.  830.10;
    (c) Use only characters and numbers from the invariant character
set of ISO/IEC 646:1991, Information technology--ISO 7-bit coded
character set for information interchange.

Sec.  830.40  Use and discontinuation of a device identifier.

    (a) Only one device identifier from any particular system for the
issuance of unique device identifiers may be used to identify a
particular version or model of a device. A particular version or model
may be identified by unique device identifiers (UDIs) from two or more
systems for the issuance of UDIs.
    (b) A device identifier shall be used to identify only one version
or model.
    (c) In the event that a version or model of a device is
discontinued, its device identifier may not be reassigned to another
device. If a discontinued version or model is re-introduced and no
changes have been made that would require the use of a new device
identifier, the device identifier that was previously in use may be
used to identify the device.
    (d) In the event that an issuing agency relinquishes or does not
renew its accreditation, you may continue to label a device with a
previously-issued UDI until such time as Sec.  830.50 requires you to
discontinue use of the UDI.

Sec.  830.50  Changes that result in a new version or model.

    If you make any of the following changes to a device that is
required to bear a UDI on its label, the change results in a new
version or model and you must assign a new device identifier to the new
version or model:
    (a) You change the specifications, performance, size, or
composition of the device to an extent greater than the specified
limits;
    (b) You change the quantity in a device package or add a new device
package;
    (c) You make a change that could significantly affect the safety or
effectiveness of the device;
    (d) You change from a nonsterile package to a sterile package, or
from a sterile package to a nonsterile package; or
    (e) You relabel the device.

Sec.  830.60  Relabeling of a device that is required to bear a unique
device identifier.

    If you relabel a device that is required to bear a unique device
identifier (UDI), you must keep a record showing the relationship of
the prior device identifier to your new device identifier.

Subpart C--FDA Accreditation of an Issuing Agency

Sec.  830.100  FDA accreditation of an issuing agency.

    (a) Eligibility. A private nonprofit organization or a State agency
may apply for accreditation as an issuing agency.
    (b) Accreditation criteria. FDA may accredit an organization as an
issuing agency, if the system it will operate:

    (1) Will employ unique device identifiers (UDIs) that meet the
requirements of this part to adequately identify a device through its
distribution and use;
    (2) Conforms to the international standards incorporated by
reference at Sec.  830.10;
    (3) Will be available to all users according to a single set of
consistent, fair, and reasonable terms and conditions.

Sec.  830.110  Application for accreditation as an issuing agency.

    (a) Application for initial accreditation. (1) An applicant seeking
initial FDA accreditation as an issuing agency shall notify FDA of its
desire to be accredited by sending a notification to: Division of Small
Manufacturers, Consumer, and International Assistance (DSMICA), Center
for Devices and Radiological Health, Bldg. 66, rm. 4621, 10903 New
Hampshire Ave., Silver Spring, MD 20993.
    (2) Following receipt of the notification. FDA will provide the
applicant with additional information to aid in submission of an
application for approval as an issuing agency, together with an email
address for submission of an application.
    (3) The applicant shall furnish to FDA, via email to the email
address we provide, an application containing the following
information, materials, and supporting documentation:
    (i) Name, address, and phone number of the applicant and, if the
applicant is not a State agency, evidence of nonprofit status (for
example, how it meets Internal Revenue Service requirements for a
nonprofit organization);
    (ii) Detailed descriptions of any standards or criteria the
applicant will apply to participating labelers;
    (iii) A detailed description of the guidelines that govern
assignment of a unique device identifier (UDI) to a device;
    (iv) A detailed description of the review and decision-making
process the applicant will apply when determining whether a particular
labeler may use the applicant's UDI system, including:
    (A) Copies of the application forms, guidelines, instructions, and
other materials the applicant will send to medical device labelers who
wish to use the applicant's unique device identification system;
    (B) Policies and procedures for notifying a labeler of deficiencies
in its use of unique device identifiers;
    (C) Procedures for monitoring a labeler's correction of
deficiencies in its use of unique device identifiers;
    (D) Policies and procedures for suspending or revoking a labeler's
use of the applicant's UDI system, including any appeals process.
    (v) Description of the applicant's electronic data management
system with respect to its review and decision processes and the
applicant's ability to provide electronic data in a format compatible
with FDA data systems;
    (vi) Fee schedules, if any, together with an explanation of any fee
waivers or reductions that are available; and
    (vii) Other information required by FDA to clarify the application
for accreditation.
    (b) Application for renewal of accreditation. An accredited issuing
agency that intends to continue to serve as an issuing agency beyond
its current term shall apply to FDA for renewal or notify FDA of its
plans not to apply for renewal in accordance with the following
procedures and schedule:
    (1) At least 9 months before the date of expiration of its
accreditation, an issuing agency shall inform FDA, at the address given
in paragraph (a)(1) of this section, of its intent to seek renewal.
    (2) FDA will notify the issuing agency of the relevant information,
materials, and supporting documentation that we will require the
issuing agency to submit as part of the renewal procedure. We will
tailor these requirements to reflect our experience with the issuing
agency during the current and any prior period of accreditation. We
will limit our request to the types of the information required by
paragraph (a)(3) of this section, and we will require less information
if experience shows that we need only a subset of that information.
    (3) At least 6 months before the date of expiration of its
accreditation, an issuing agency shall furnish to FDA, at the email
address we provide, a copy of a renewal application containing the
information, materials, and supporting documentation requested by FDA
in accordance with paragraph (b)(2) of this section.
    (4) Any issuing agency that does not plan to renew its
accreditation shall so notify FDA at the address given in paragraph
(a)(1) of this section at least 9 months before the expiration of the
issuing agency's term of accreditation and shall include a description
of its plans for allowing continued use of unique device identifiers
issued prior to the expiration of the current term of accreditation.
    (c) FDA action on an application for initial or renewal
accreditation. (1) FDA will conduct a review and evaluation to
determine whether the applicant meets the requirements of this subpart
and whether the UDI system proposed by the applicant will meet the
requirements of this subpart.
    (2) Within 60 days of receipt of an application for accreditation,
FDA will notify the applicant of any deficiencies in its application
and will request correction of those deficiencies within 60 days. The
applicant may request an extension if it needs additional time to
correct deficiencies in its application. If the deficiencies are not
resolved to FDA's satisfaction within the specified time period, the
application for accreditation as an issuing agency may be denied.
    (3) FDA shall notify the applicant whether the application for
accreditation has been granted or denied. That notification shall list
any conditions of approval or state the reasons for denial.
    (4) If FDA denies an application, we will advise the applicant of
the circumstances under which a denied application may be resubmitted.
    (5) If FDA does not reach a final decision on a renewal application
before the expiration of an issuing agency's current accreditation, the
approval will be deemed extended until FDA reaches a final decision on
the application.
    (d) Relinquishment of accreditation. If an issuing agency decides
to relinquish its accreditation before expiration of the current term
of accreditation, it shall submit a letter of such intent to FDA, at
the address provided in paragraph (a)(1) of this section, at least 9
months before relinquishing its accreditation.
    (e) Notice of termination of accreditation. An issuing agency that
does not apply for renewal of its accreditation, is denied renewal of
accreditation by FDA, or relinquishes its accreditation and duties
before expiration of the current term of accreditation, shall notify
all labelers that are using the issuing agency's UDI system, in a
manner and time period approved by FDA, of the date that the issuing
agency will cease to serve as an FDA-accredited issuing agency.
    (f) Term of accreditation. The initial term of accreditation for an
issuing agency shall be for a period of 3 years. An issuing agency's
term of accreditation may be periodically renewed for a period of 7
years.

Sec.  830.120  Responsibilities of an FDA-accredited issuing agency.

    To maintain its accreditation, an issuing agency must:
    (a) Operate a system for assignment of unique device identifiers
that meets the requirements of Sec.  830.20 and the standards
incorporated by reference at Sec.  830.10;

    (b) Make available information concerning its system for the
assignment of unique device identifiers;
    (c) Maintain a list of labelers that use its system for the
assignment of unique device identifiers and provide FDA a copy of such
list in electronic form by December 31 of each year;
    (d) Upon request, provide FDA with information concerning a labeler
that is employing the issuing agency's system for assignment of unique
device identifiers; and
    (e) Remain in compliance with the eligibility and accreditation
criteria set forth in Sec.  830.100.

Sec.  830.130  Suspension or revocation of the accreditation of an
issuing agency.

    FDA may suspend or revoke the accreditation of an issuing agency if
FDA finds, after providing the issuing agency with notice and
opportunity for an informal hearing in accordance with part 16 of this
chapter, that the issuing agency or any employee of the issuing Agency:
    (a) Has been guilty of misrepresentation in obtaining
accreditation;
    (b) Has failed to fulfill the responsibilities outlined in Sec.
830.120; or
    (c) Has violated or aided and abetted in the violation of any
regulation issued under section 510(e) or section 519(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360(e) and 21 U.S.C. 360i(f),
respectively).

Subpart D--FDA as an Issuing Agency

Sec.  830.200  When FDA will act as an issuing agency.

    (a) During any period where there is no accredited issuing agency,
FDA will act as an issuing agency.
    (b) If FDA determines that a significant number of small businesses
would be substantially and adversely affected by the fees required by
all accredited issuing agencies, FDA will act as an issuing agency.
    (c) FDA may, in its discretion, act as an issuing agency if we
determine it is necessary for us to do so to ensure the continuity or
the effectiveness of the system for the identification of medical
devices.
    (d) FDA may, in its discretion, act as an issuing agency if we
determine it is appropriate for us to do so in order to facilitate or
implement an alternative granted under Sec.  801.35 of this chapter.

Sec.  830.210  Eligibility for use of FDA as an issuing agency.

    When FDA acts as an issuing agency, any labeler will be permitted
to use FDA's unique device identification system, regardless of whether
the labeler is considered a small business.

Sec.  830.220  Termination of FDA service as an issuing agency.

    (a) FDA may end our services as an issuing agency if we determine
that the conditions that prompted us to act no longer exist and that
ending our services would not be likely to lead to a return of the
conditions that prompted us to act.
    (b) If FDA has ended our services as an issuing agency, a labeler
may continue to use a device identifier assigned under FDA's unique
device identification system until such time as Sec.  830.50 requires
the use of a new device identifier.

Subpart E--Global Unique Device Identification Database

Sec.  830.300  Devices subject to device identification data submission
requirements.

    (a) In general. The labeler of a device must provide the
information required by this subpart for each version or model required
to be labeled with a unique device identifier.
    (b) Exception. The labeler is not required to submit information
concerning any device whose label is not required to bear a unique
device identifier (UDI) because the device is subject to a labeling
exception under Sec.  801.30, Sec.  801.35, or Sec.  801.128(f)(2) of
this chapter, regardless of whether the labeler voluntarily includes a
UDI on the label of the device.
    (c) Voluntary submission of information. If a labeler voluntarily
includes a UDI on the label of a device under Sec.  801.40, or, for
devices sold at retail, the label includes a Universal Product Code
(UPC), the labeler may also voluntarily submit information concerning
that device under this part.
    (d) Exclusions. FDA may reject or remove any device identification
data where:
    (1) The device identifier submitted does not conform to Sec.
830.20;
    (2) The information concerns a device that is neither manufactured
in the United States nor in interstate commerce in the United States,
    (3) The information concerns a product that FDA determines is not a
device or a combination product that includes a device constituent
part,
    (4) The information concerns a device or a combination product that
requires, but does not have, FDA premarket approval or clearance;
    (5) A device that FDA has banned under section 516 of the Federal
Food, Drug, and Cosmetic Act; or
    (6) FDA has suspended the accreditation of the issuing agency that
operates the system used by the labeler.

Sec.  830.310  Information required for unique device identification.

    The contact for device identification shall provide FDA with the
following information concerning each version or model of a device
required to be labeled with a unique device identifier (UDI):
    (a) Concerning the labeler:
    (1) The name of the labeler;
    (2) A telephone number or email address that will allow FDA to
communicate with the contact for device identification designated under
Sec.  830.320(a); and
    (3) The name of each issuing agency whose system is used by the
labeler to assign unique device identifiers used by the labeler.
    (b) Concerning each version or model of a device labeled with a
UDI:
    (1) The device identifier portion of the unique device identifier
assigned to the version or model;
    (2) When reporting a substitution of a new device identifier that
will be used in lieu of a previously-reported identifier, the device
identifier that was previously assigned to the version or model;
    (3) If Sec.  801.50 of this chapter requires the device to bear a
UDI as a permanent marking on the device itself, either:
    (i) A statement that the device identifier that appears as a
permanent marking on the device is identical to that reported under
paragraph (b)(1) of this section, or
    (ii) The device identifier portion of the unique device identifier
that appears as a permanent marking on the device;
    (4) The proprietary, trade, or brand name of the device as it
appears on the label of the device;
    (5) Any version or model number or similar reference that appears
on the label of the device;
    (6) If the device is labeled as sterile, a statement to that
effect;
    (7) If the device is labeled as containing natural rubber latex
that contacts humans, or is labeled as having packaging containing
natural rubber latex that contacts humans, as described by Sec. Sec.
801.437(b)(1), 801.437(b)(3), and 801.437(f) of this chapter, a
statement to that effect;
    (8) If the device is available in more than one size, the size of
the particular version or model, together with the unit of measure, as
it appears on the label of the device;
    (9) The type of production identifiers that appear on the label of
the device;
    (10) The FDA premarket submission number of a cleared or approved
device,

or a statement that FDA has by regulation exempted the device from
premarket notification;
    (11) The FDA listing number assigned to the device;
    (12) The Global Medical Device Nomenclature (GMDN) code for the
device;
    (13) The total number of individual devices contained in the device
package.

Sec.  830.320  Submission of unique device identification information.

    (a) Designation of contact for device identification. Each labeler
must designate an individual to serve as the point of contact with FDA
on matters relating to the identification of medical devices marketed
by the labeler. The contact for device information is responsible for
ensuring FDA is provided with all information required by this part.
The contact for device information may authorize an issuing agency or
any other person to provide information to FDA on behalf of the
labeler.
    (b) Information shall be submitted via electronic means. All
information required by this subpart shall be submitted electronically
to FDA's Global Unique Device Identification Database (GUDID) in a
format that we can process, review, and archive, unless the labeler has
obtained a waiver from electronic submission of unique device
identifier (UDI) data.
    (c) Waiver from electronic submission. (1) A labeler may request a
waiver from electronic submission of UDI data by submitting a letter
addressed to the appropriate Center Director explaining why electronic
submission is not technologically feasible; send the letter to:
Division of Small Manufacturers, Consumer, and International Assistance
(DSMICA), Center for Devices and Radiological Health, White Oak Bldg.
66, rm. 4621, 10903 New Hampshire Ave., Silver Spring, MD 20993.
    (2) If the establishment where the labeler is located has obtained
a waiver from electronic submission of registration and listing
information under section 510(p) of the Federal Food, Drug, and
Cosmetic Act, the labeler is deemed to have a waiver from electronic
submission of UDI data.
    (3) A labeler that has a waiver from electronic submission of UDI
data must send a letter containing all of the information required by
Sec.  830.310, as well as any ancillary information permitted to be
submitted under Sec.  830.340 that the labeler wishes to submit, within
the time permitted by Sec.  830.330, addressed to: Division of Small
Manufacturers, Consumer, and International Assistance (DSMICA), Center
for Devices and Radiological Health, White Oak Bldg. 66, rm. 4621,
10903 New Hampshire Ave., Silver Spring, MD 20993.

Sec.  830.330  Times for submission of unique device identification
information.

    (a) The labeler shall submit to FDA the information required by
Sec.  830.310 no later than the date the label of the device must bear
a unique device identifier under Sec.  801.20 of this chapter.
    (b) The labeler of a device shall submit to FDA an update to the
information required by Sec.  830.310 whenever the information changes.
The updated information must be submitted no later than the date a
device is first labeled with the changed information. If the
information does not appear on the label of a device, the updated
information must be submitted within 10 business days of the change.

Sec.  830.340  Voluntary submission of ancillary device identification
information.

    (a) You may not submit any information to the Global Unique Device
Identification Database (GUDID) other than that specified by Sec.
830.310, except where FDA acts to permit the submission of specified
additional types of information, termed ancillary information.
    (b) FDA will provide information through the FDA Web site at http://www.fda.gov/udi concerning the types of ancillary information that may
be submitted to the GUDID.
    (c) FDA may periodically change the types of ancillary information
that may be submitted to the GUDID. We will seek comment on any
proposed change in accordance with the Paperwork Reduction Act and on
the FDA Web site at http://www.fda.gov/udi at least 60 days before
making the change.

Sec.  830.350  Records to be maintained by the labeler.

    (a) Each labeler shall retain, and submit to FDA upon specific
request, records showing all unique device identifiers (UDIs) used to
identify devices that must be labeled with a UDI, and the particular
version or model associated with each device identifier. These records
must be retained for 3 years from the date the labeler ceases to market
the version or model.
    (b) Compliance with this section does not relieve the labeler of
the need to comply with recordkeeping requirements of any other FDA
regulation.

    Dated: July 2, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16621 Filed 7-3-12; 4:15 pm]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Proposed Rules]
[Pages 36519-36522]
[FR Doc No: 2020-12866]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0590; Product Identifier 2020-NM-055-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2017-25-04, which applies to certain Airbus SAS Model A318 series
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes; Model A320 211, 212, 214, 231, 232, and 233 airplanes; and
Model A321 111, 112, 131, 211, 212, 213, 231, and 232 airplanes. The
FAA also proposes to supersede AD 2019-03-17, which applies to certain
Airbus SAS Model A318 series airplanes; Model A319-111, -112, -113, -
114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214,
-216, -231, -232, -233, -251N, and -271N airplanes; and Model A321
series airplanes. AD 2019-03-17 requires revising the existing
maintenance or inspection program, as applicable, to incorporate new
maintenance requirements and airworthiness limitations. Since the FAA
issued AD 2019-03-17, the FAA has determined that new or more
restrictive airworthiness limitations are necessary. This proposed AD
would require revising the existing maintenance or inspection program,
as applicable, to incorporate new or more restrictive airworthiness
limitations, as specified in a European Union Aviation Safety Agency
(EASA) AD, which will be incorporated by reference. The FAA is
proposing this AD to address the unsafe condition on these products.

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

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For EASA material that will be incorporated by reference (IBR) in
this AD, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 89990 1000; email<EMAIL_ADDRESS>
internet www.easa.europa.eu. You may find this IBR material on the EASA
website at https://ad.easa.europa.eu.
    For the Airbus material identified in this proposed AD that will
continue to be IBR, contact Airbus SAS, Airworthiness Office--EIAS,
Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France;
telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
<EMAIL_ADDRESS>internet https://www.airbus.com. You
may view this IBR material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. It is also available in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0590.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0590; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2020-0590;
Product Identifier 2020-NM-055-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM based on those comments.
    The FAA will post all comments that are received, without change,
to https://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact the FAA receives about this NPRM.

Discussion

    The FAA issued AD 2019-03-17, Amendment 39-19569 (84 FR 6315,
February 27, 2019) (``AD 2019-03-17''), for all Airbus SAS Model A318
series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplane; Model A320-211, -212, -214, -216, -231, -232, -233,
-251N, and -271N airplanes; and Model A321-111, -112, -131, -211, -212,
-213, -231, -232, -251N, -251NX, -252N, -252NX, -253N, -253NX, -271N, -
271NX, -272N, and -272NX airplanes. AD 2019-03-17 requires revising the
existing maintenance or inspection program, as applicable, to
incorporate new maintenance requirements and airworthiness limitations.
The FAA issued AD 2019-03-17 to address a safety-significant latent
failure (that is not annunciated), which, in combination with one or
more other specific failures or events, could result in a hazardous or
catastrophic failure condition. AD 2019-03-17 specifies that
accomplishing the revision required by paragraph (g) of that AD
terminates all requirements of AD 2017-25-04, Amendment 39-19118 (82 FR
58098, December 11, 2017) (``AD 2017-17-04'').

Actions Since AD 2019-03-17 Was Issued

    Since the FAA issued AD 2019-03-17, the FAA has determined that new
or more restrictive airworthiness limitations are necessary.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0067, dated March 23, 2020
(``EASA AD 2020-0067'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Model A318-111, -112, -121, and -122 airplanes; Model
A319-111, -112, -113, -114, -115, -131, -132, -133, -151N, and -153N
airplanes; Model A320-211, -212, -214, -215,

-216, -231, -232, -233, -251N, -252N, -253N, -271N, -272N, and -273N
airplanes; Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -252N, -253N, -271N, -272N, -251NX, -252NX, -253NX, -271NX, and -
272NX airplanes. Model A320-215 airplanes are not certificated by the
FAA and are not included on the U.S. type certificate data sheet; this
AD therefore does not include those airplanes in the applicability.
    Airplanes with an original airworthiness certificate or original
export certificate of airworthiness issued after January 17, 2020, must
comply with the airworthiness limitations specified as part of the
approved type design and referenced on the type certificate data sheet;
this AD therefore does not include those airplanes in the
applicability.
    This proposed AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
proposing this AD to address a safety-significant latent failure (that
is not annunciated), which, in combination with one or more other
specific failures or events, could result in a hazardous or
catastrophic failure condition. See the MCAI for additional background
information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0067 describes airworthiness limitations for
certification maintenance requirements.
    This AD would also require Airbus A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 3, Certification Maintenance
Requirements (CMR), Revision 06, dated June 13, 2018, which the
Director of the Federal Register approved for incorporation by
reference as of April 3, 2019 (84 FR 6315, February 27, 2019).
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI and
service information referenced above. The FAA is proposing this AD
because the FAA has evaluated all pertinent information and determined
an unsafe condition exists and is likely to exist or develop on other
products of the same type design.

Proposed AD Requirements

    This proposed AD would retain the requirements of AD 2019-03-17.
This proposed AD would also require revising the existing maintenance
or inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations, which are specified in EASA AD
2020-0067 described previously, as incorporated by reference. Any
differences with EASA AD 2020-0067 are identified as exceptions in the
regulatory text of this AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(l)(1) of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0067
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2020-0067 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD.
    Service information specified in EASA AD 2020-0067 that is required
for compliance with EASA AD 2020-0067 will be available on the internet
at https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0590 after the FAA final rule is published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c).

Costs of Compliance

    The FAA estimates that this proposed AD affects 1,553 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2019-03-17 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. In the past, the agency has estimated that this action
takes 1 work-hour per airplane. Since operators incorporate maintenance
or inspection program changes for their affected fleet(s), the FAA has
determined that a per-operator estimate is more accurate than a per-
airplane estimate.
    The FAA estimates the total cost per operator for the new proposed
actions to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2017-25-04, Amendment 39-19118
(82 FR 58098, December 11, 2017); and AD 2019-03-17, Amendment 39-19569
(84 FR 6315, February 27, 2019); and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2020-0590; Product Identifier 2020-NM-
055-AD.

(a) Comments Due Date

    The FAA must receive comments by August 3, 2020.

(b) Affected ADs

    This AD replaces AD 2017-25-04, Amendment 39-19118 (82 FR 58098,
December 11, 2017) (``AD 2017-25-04''); and AD 2019-03-17, Amendment
39-19569 (84 FR 6315, February 27, 2019) (``AD 2019-03-17'').

(c) Applicability

    This AD applies to the Airbus SAS airplanes specified in
paragraphs (c)(1) through (4) of this AD, certificated in any
category, with an original airworthiness certificate or original
export certificate of airworthiness issued on or before January 17,
2020.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, -133, -
151N, and -153N airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N, -
252N, -253N, -271N, -272N, and -273N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -252N, -253N, -271N, -272N, -251NX, -252NX, -253NX, -271NX,
and -272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address a safety-significant latent failure (that
is not annunciated), which, in combination with one or more other
specific failures or events, could result in a hazardous or
catastrophic failure condition.

(f) Compliance

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

(g) Retained Maintenance or Inspection Program Revision, With No
Changes

    This paragraph restates the requirements of paragraph (g) of AD
2019-03-17, with no changes. For airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or before June 13, 2018: Within 90 days
after April 3, 2019 (the effective date of AD 2019-03-17), revise
the existing maintenance or inspection program, as applicable, to
incorporate the information specified in Airbus A318/A319/A320/A321
Airworthiness Limitations Section (ALS) Part 3, Certification
Maintenance Requirements (CMR), Revision 06, dated June 13, 2018.
The initial compliance time for accomplishing the tasks specified in
Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS)
Part 3, Certification Maintenance Requirements (CMR), Revision 06,
dated June 13, 2018, is at the applicable time specified in Airbus
A318/A319/A320/A321 ALS Part 3, Certification Maintenance
Requirements (CMR), Revision 06, dated June 13, 2018, or within 90
days after April 3, 2019, whichever occurs later. Accomplishing the
maintenance or inspection program revision required by paragraph (i)
of this AD terminates the requirements of this paragraph.

(h) Retained Restrictions on Alternative Actions and Intervals With a
New Exception

    This paragraph restates the requirements of paragraph (i) of AD
2019-03-17, with a new exception. Except as required by paragraph
(i) of this AD, after the maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (l)(1) of this AD.

(i) New Maintenance or Inspection Program Revision

    Except as specified in paragraph (j) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0067, dated March 23, 2020 (``EASA AD 2020-0067'').
Accomplishing the maintenance or inspection program revision
required by this paragraph terminates the requirements of paragraph
(g) of this AD.

(j) Exceptions to EASA AD 2020-0067

    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2020-0067 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2020-0067 specifies revising ``the
AMP'' within 12 months after its effective date, but this AD
requires revising the existing maintenance or inspection program, as
applicable, to incorporate the ``tasks and associated thresholds and
intervals'' specified in paragraph (3) of EASA AD 2020-0067 within
90 days after the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2020-0067 is at the applicable ``associated
thresholds'' specified in paragraph (3) of EASA AD 2020-0067, or
within 90 days after the effective date of this AD, whichever occurs
later.
    (4) The provisions specified in paragraphs (4) and (5) of EASA
AD 2020-0067 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2020-0067 does not apply
to this AD.

(k) New Provisions for Alternative Actions and Intervals

    After the maintenance or inspection program has been revised as
required by paragraph (i) of this AD, no alternative actions (e.g.,
inspections) or intervals are allowed except as specified in the
provisions of the ``Ref. Publications'' section of EASA AD 2020-
0067.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch,

FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the Large Aircraft Section, International
Validation Branch, send it to the attention of the person identified
in paragraph (m)(2) of this AD. Information may be emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (ii) AMOCs approved previously as specified in paragraph
(j)(1)(ii) of AD 2019-03-17 are approved as AMOCs for the
corresponding provisions of paragraph (g) of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2020-0067 that contains RC procedures and
tests: Except as required by paragraph (l)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(m) Related Information

    (1) For information about EASA AD 2020-0067, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu.
    (2) For information about the Airbus material identified in this
AD, contact Airbus SAS, Airworthiness Office--EIAS, Rond-Point Emile
Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93
36 96; fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
internet https://www.airbus.com.
    (3) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-0590.
    (4) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on June 9, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-12866 Filed 6-16-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Notices]
[Page 22975]
[FR Doc No: 2016-08922]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC16-99-000.
    Applicants: Westar Energy, Inc.
    Description: Application for Authorization for Consolidation of
Jurisdictional Facilities and Request for Expedited Action and Certain
Waivers of Westar Energy, Inc.
    Filed Date: 4/12/16.
    Accession Number: 20160412-5112.
    Comments Due: 5 p.m. ET 5/3/16.

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

    Docket Numbers: ER16-1379-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Section 205(d) Rate Filing: 2016-04-11_SA 2914
Northern States Power-Ashtabula Wind IV FCA (C019) to be effective 4/
12/2016.
    Filed Date: 4/11/16.
    Accession Number: 20160411-5260.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: ER16-1380-000.
    Applicants: Rocky Mountain Reserve Group.
    Description: Tariff Cancellation: RMRG Cancellation 20160411 to be
effective 4/14/2016.
    Filed Date: 4/11/16.
    Accession Number: 20160411-5279.
    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: ER16-1381-000.
    Applicants: Nevada Power Company.
    Description: Initial rate filing: Rate Schedule No. 152 NPC and MGM
EPC Agreement to be effective 4/13/2016.
    Filed Date: 4/12/16.
    Accession Number: 20160412-5005.
    Comments Due: 5 p.m. ET 5/3/16.

    Docket Numbers: ER16-1382-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Section 205(d) Rate Filing: 2016-04-12_SA 2916 Prairie
Power-Prairie Power GIA (J291) to be effective 4/13/2016.
    Filed Date: 4/12/16.
    Accession Number: 20160412-5075.
    Comments Due: 5 p.m. ET 5/3/16.

    Docket Numbers: ER16-1383-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: 3193 Rush County Wind Farm
GIA to be effective 3/22/2016.
    Filed Date: 4/12/16.
    Accession Number: 20160412-5115.
    Comments Due: 5 p.m. ET 5/3/16.

    Docket Numbers: ER16-1384-000.
    Applicants: Southern California Edison Company.
    Description: Section 205(d) Rate Filing: GIA and Distribution
Service Agmt EUI Wind Park I Project to be effective 4/1/2016.
    Filed Date: 4/12/16.
    Accession Number: 20160412-5118.
    Comments Due: 5 p.m. ET 5/3/16.

    Docket Numbers: ER16-1385-000.
    Applicants: Southern California Edison Company.
    Description: Section 205(d) Rate Filing: GIA and Distribution
Service Agmt EUI Wind Park II Project to be effective 4/1/2016.
    Filed Date: 4/12/16.
    Accession Number: 20160412-5119.
    Comments Due: 5 p.m. ET 5/3/16.

    Docket Numbers: ER16-1386-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Amendment to ISA No. 3324,
Queue No. V1-028 per an Assignment to DIV--AR to be effective 5/2/2012.
    Filed Date: 4/12/16.
    Accession Number: 20160412-5121.
    Comments Due: 5 p.m. ET 5/3/16.

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

    Dated: April 12, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-08922 Filed 4-18-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Pages 19950-19951]
[FR Doc No: 2023-06857]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2544-052]

Hydro Technology, Inc.; Notice of Application Accepted for
Filing, Ready For Environmental Analysis and Soliciting Comments,
Recommendations, Terms and Conditions, And Prescriptions

    Take notice that the following license application has been filed
with the Commission and is available for public inspection.
    a. Type of Application: Subsequent License.
    b. Project No.: P-2544-052.
    c. Date filed: December 27, 2021.
    d. Applicant: Hydro Technology, Inc.
    e. Name of Project: Meyers Falls Hydroelectric Project (Project).
    f. Location: The existing project is located on the Colville River
near the city of Kettle Falls, Stevens County, Washington. The project
does not affect federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Benjamin Hendrickson, President, Hydro
Technology Systems, Inc., 897 Greenwood Loop Rd., PO Box 245, Kettle
Falls, WA 99141; Telephone<PHONE_NUMBER>.
    i. FERC Contact: Maryam Zavareh,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at https://ferconline.ferc.gov/FERC.aspx. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at https://ferconline.ferc.gov/Quick.aspx. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-2544-052.
    The Commission's Rules of Practice require all intervenors filing
documents

with the Commission to serve a copy of that document on each person on
the official service list for the project. Further, if an intervenor
files comments or documents with the Commission relating to the merits
of an issue that may affect the responsibilities of a particular
resource agency, they must also serve a copy of the document on that
resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The existing Meyers Falls Project consists of: (1) a 10-acre
reservoir; (2) a 24.5-foot-high, 306-foot-long, concrete and earth-fill
embankment dam; (3) a 100-foot-long concrete spillway section
containing five 20 feet, 3.5 inch wide, 6 feet high bulkheads; (3) a
46-foot-wide, 20-foot-deep, 360-foot-long intake channel with a 19-
foot-wide and 11-foot-deep trashrack at the entrance point; (4) a 4-
foot-diameter, 323-foot-long steel penstock conveying flow from intake
to powerhouse; (5) a 31.5-foot-wide, 55.5-foot-long, 15.5-foot-high
steel reinforced concrete powerhouse containing two generating units
with a total installed capacity of 1.2 megawatts; (7) a 4,600-foot-
long, 13.8-kilovolt transmission line; and (8) appurtenant facilities.
The Meyers Falls Project is operated in a run-of-river mode with an
average annual generation of 7,883 megawatt-hours per year.
    m. A copy of the application can be viewed on the Commission's
website at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support.
    All filings must (1) bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS'', ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.
    You may also register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. The applicant must file no later than 60 days following the date
of issuance of this notice either: (1) evidence of the date on which
the certifying agency received the certification request; (2) a copy of
the water quality certification; or (3) evidence of waiver of water
quality certification. Please note that the certification request must
comply with 40 CFR 121.5(b), including documentation that a pre-filing
meeting request was submitted to the certifying authority at least 30
days prior to submitting the certification request. Please also note
that the certification request must be sent to the certifying authority
and to the Commission concurrently
    o. Procedural schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.

Deadline for Filing Comments, Recommendations, and Agency Terms and
Conditions/Prescriptions: May 2023
Licensee's Reply to REA Comments: July 2023

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.

    Dated: March 28, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-06857 Filed 4-3-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65828-65830]
[FR Doc No: 2020-22977]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2018]

Quality Management Maturity for Active Pharmaceutical Ingredients
Pilot Program for Foreign Facilities; Program Announcement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency), Center for
Drug Evaluation and Research (CDER) is announcing its Quality
Management Maturity for Active Pharmaceutical Ingredients Pilot Program
(QMM API Pilot Program) for foreign facilities manufacturing active
pharmaceutical ingredients (APIs), including facilities manufacturing
drug substance intermediates used to produce APIs, that are used in
FDA-regulated prescription and over-the-counter (OTC) drug products.
The purpose of the QMM API Pilot Program is to gain insight from third-
party assessments of a facility's quality management system to inform
future development of an FDA rating system to characterize quality
management maturity (QMM). Such a rating system would allow a cross-
sectional comparison of facilities. Facilities that choose to disclose
their facility ratings to drug product manufacturers could benefit from
a competitive advantage, as knowledge of QMM ratings would enable drug
product manufacturers to differentiate among facilities when purchasing
APIs. This notice invites foreign facilities that are interested in
participating in the QMM API Pilot Program to submit a request to
participate.

DATES: FDA will accept requests to participate in the QMM API Pilot
Program through November 30, 2020, and the QMM API Pilot Program will
run through December 31, 2021. See the ``Participation'' section for
selection criteria and instructions on how to submit a request to
participate.

FOR FURTHER INFORMATION CONTACT: For general questions about the QMM
API Pilot Program: Jennifer Maguire, Center for Drug Evaluation and
Research (CDER), 10903 New Hampshire Ave., Bldg. 51, Rm. 4134, Silver
Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>    To submit a request to participate in the QMM API Pilot Program:
Seongjin (Cindy) Pak, CDER, 10903 New Hampshire Ave., Bldg. 51, Rm.
4220,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In 2002, FDA launched an initiative ``Pharmaceutical CGMPs for the
21st Century--A Risk-Based Approach,'' to enhance and modernize the
regulation of pharmaceutical manufacturing and product quality.\1\ One
objective, among others, was to facilitate the implementation of a
modern, risk-based

pharmaceutical quality assessment system. The desired goal has been
described as a maximally efficient, agile, flexible pharmaceutical
manufacturing sector that reliably produces high-quality drug products
without extensive regulatory oversight.
---------------------------------------------------------------------------

    \1\ See FDA's final report: ``Pharmaceuticals CGMPs for the 21st
Century--A Risk-Based Approach'' (September 2004) at https://www.fda.gov/media/77391/download.
---------------------------------------------------------------------------

    There has been significant progress toward this vision as evidenced
by FDA programs and initiatives in such areas as pharmaceutical
development and quality by design, quality risk management and
pharmaceutical quality systems, process validation, and emerging
technologies. These programs and initiatives promote use of the best
pharmaceutical science and engineering principles throughout the
product life cycle.
    Another example is the FDA Quality Metrics Program, described in
the November 2016 revised draft guidance for industry, ``Submission of
Quality Metrics Data'' (81 FR 85226). When final, this guidance will
represent FDA's current thinking on this issue. In June 2018, FDA
initiated two voluntary programs that sought additional industry input
on quality metrics. FDA solicited industry participation for a Site
Visit Program (83 FR 30751) for manufacturing establishments to present
the advantages and challenges associated with implementing and managing
a quality metrics program and for a Quality Metrics Feedback Program
(83 FR 30748) to engage stakeholders in identifying mutually useful and
objective quality metrics.
    The Agency continues to develop the FDA Quality Metrics Program but
recognizes that quality metrics are only one element within a
manufacturer's larger effort to increase the maturity of their quality
management system. Manufacturers that demonstrate QMM \2\ operate under
an enhanced quality management system that exceeds the minimum
standards specified in current good manufacturing practice regulations
and focuses on continual improvement. Characteristics of a mature
quality management system include, for example, the ability to
consistently and reliably deliver quality product over time,
operational stability, and a strong quality culture. Additionally, for
manufacturers with a mature quality management system, FDA can exercise
a more flexible regulatory approach, leading toward the goal of
producing high-quality drug products without extensive regulatory
oversight.
---------------------------------------------------------------------------

    \2\ For additional information on quality management maturity,
see FDA's Report: ``Drug Shortages: Root Causes and Potential
Solutions'' (October 2019) at https://www.fda.gov/media/131130/download.
---------------------------------------------------------------------------

    A transparent method of evaluating and communicating QMM is needed
to fully realize the 21st century pharmaceutical quality vision. Toward
that end, FDA is announcing the start of the QMM API Pilot Program.
Through this pilot program, a third-party contractor identified by the
FDA will conduct an assessment of a facility's quality management
system, accompanied by FDA staff. The Agency will gain insight from the
results of the QMM assessments to inform the development of a rating
system to measure and rate QMM. Assessments under the QMM API Pilot
Program will cover multiple topics. Examples include but are not
limited to:
    1. Supply chain management;
    2. manufacturing strategy and operations;
    3. safety, environmental, and regulatory compliance;
    4. inventory management;
    5. performance management and continual improvement;
    6. risk management;
    7. management review and responsibility;
    8. planning;
    9. workforce management;
    10. quality culture; and
    11. customer experience.
    In the same timeframe as the QMM API Pilot Program, FDA will
conduct a QMM pilot program for domestic manufacturers of finished
dosage forms (FDF). These pilot programs are funded separately and are
intended to provide FDA with representative information about QMM from
different types of drug manufacturers (API and FDF). Elsewhere in this
issue of the Federal Register, FDA is publishing ``Quality Management
Maturity for Finished Dosage Forms Pilot Program for Domestic Drug
Product Manufacturers; Program Announcement.''

II. Participation

    Facilities located outside the United States that manufacture APIs
or drug substance intermediates used to produce APIs and are interested
in participating in the QMM API Pilot Program should submit a written
request directly to Seongjin (Cindy) Pak (see FOR FURTHER INFORMATION
CONTACT). Participation is voluntary. Participants in the Quality
Metrics Feedback Program are encouraged to participate in the QMM API
Pilot Program. FDA will select up to nine participants for the QMM API
Pilot Program. Participation in the QMM API Pilot Program is limited to
foreign manufacturing facilities since FDA's funding source for this
program is specific to activities related to the surveillance of
foreign sites.

A. Selection Criteria

    To be considered for the QMM API Pilot Program, participants must
meet the following selection criteria:
    1. Participant is a facility located outside the United States that
manufactures APIs or drug substance intermediates used to produce APIs
for FDA-regulated prescription and OTC drug products. Facilities
located in Puerto Rico or other U.S. territories are not considered to
be foreign facilities and thus are not eligible to participate in the
QMM API Pilot Program.
    2. All FDA inspection(s) of the manufacturing facility conducted
within the 5 years prior to September 15, 2020, received a final
classification of ``No Action Indicated'' or ``Voluntary Action
Indicated.''
    3. Participant agrees to:
    a. Permit a third-party contractor to conduct a QMM assessment,
whether the assessment is conducted on-site or remotely. FDA will
identify an external contractor having the expertise to assess QMM, and
FDA staff will join the contractor for the assessment.
    b. Collect and submit metric data to FDA and the contractor by an
agreed upon date, prior to the assessment. As part of the scoping
discussions for the assessment, FDA will provide the facility with
templates and additional details about the data collection.
    c. Be available for consultations with the contractor and FDA prior
to and after the assessment, including discussions regarding the
participant's established QMM-related activities and the contractor's
post-assessment recommendations regarding these activities.
    During this QMM API Pilot Program, the contractor and FDA staff
will be available to answer questions and address concerns that arise.

B. Information To Include in the Request

    When submitting a request to participate in the QMM API Pilot
Program, include the information below to aid in FDA's selection and
planning. FDA will not consider requests submitted without the
following minimal information:
    1. A contact person (name and email);
    2 facility location;
    3. facility FDA Establishment Identifier and Data Universal
Numbering System numbers;
    4. a brief description of the manufacturing operations conducted at
the facility;
    5. preferred dates for the assessment;

    6. written confirmation that the facility meets the selection
criteria in section II.A, including agreement to items 3a-c;
    7. written confirmation that the facility can handle a visit of up
to 10 FDA staff and contractors; and
    8. a brief description of prior experiences undergoing an
assessment related to the maturity of the facility's quality culture,
including the name of the organization that conducted the assessment
and date of the assessment.

    Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22977 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P


         UNITED STATES OF AMERICA

   DEPARTMENT OF TRANSPORTATION

           OFFICE OF THE SECRETARY

                  WASHINGTON, D.C.

Issued by the Department of Transportation

on the 23rd day of April, 2003

Essential Air Service at

BROOKINGS, SOUTH DAKOTA, and

HURON, SOUTH DAKOTA

under 49 U.S.C. 41731 et seq.

       Served: April 28, 2003

     Docket OST-1997-2785

     Docket OST-2000-7138

Notice of Extension

This serves as notice to the public of the action described below, taken
by the Department official indicated.  (No additional confirming order
will be issued in this matter.)

By Order 2003-4-5, issued April 3, 2003, served April 8, 2003, the
Department requested proposals from air carriers interested in providing
essential air service at Brookings and Huron, South Dakota.  These
proposals were due within 20 days after the date of service of
Order 2003-4-5, i.e., by April 23, 2003.

We have received a request from MultiAero, Inc., for a twenty-day
extension of this due date.  In support of its request, MultiAero
affirms that it will deliver to the Department of Transportation all
required documentation on or before May 13, 2003.

We will grant this request.  As is our normal practice, we will
therefore grant all potentially interested applicants until May 13,
2003, to submit service proposals for any or all of the subject points.

This action is effective immediately.

Action taken by:	Dennis DeVany, Chief

					EAS and Domestic Analysis Division, X-53

					Office of Aviation Analysis

					Office of the Secretary

An electronic version of this document is available on the World Wide
Web at

  HYPERLINK "http://dms.dot.gov/"  http://dms.dot.gov/

 PAGE

-  PAGE   2  -


[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43085-43086]
[FR Doc No: 2015-17849]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9930-90-OA]

Notification of a Public Teleconference of the Chartered Clean
Air Scientific Advisory Committee (CASAC) and the CASAC Oxides of
Nitrogen Primary NAAQS Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces a
public teleconference of the Chartered Clean Air Scientific Advisory
Committee (CASAC) and the CASAC Oxides of Nitrogen Primary National
Ambient Air Quality Standards (NAAQS) Review Panel to discuss CASAC
draft reviews of EPA's Integrated Science Assessment (ISA) for Oxides
of Nitrogen--Health Criteria (Second External Review Draft--January
2015) and Review of the Primary National Ambient Air Quality Standards
for Nitrogen Dioxide: Risk and Exposure Assessment Planning Document.

DATES: The teleconference will be held on Thursday, August 13, 2015
from 1:00 p.m. to 5:00 p.m. (Eastern Time).

ADDRESSES: The public teleconference will be held by telephone only.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing to
obtain information concerning the public teleconference may contact Mr.
Aaron Yeow, Designated Federal Officer (DFO), EPA Science Advisory
Board Staff Office (1400R), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW., Washington, DC 20460; by telephone/voice mail
at<PHONE_NUMBER> or at<EMAIL_ADDRESS>General information about
the CASAC, as well as any updates concerning the meeting announced in
this notice, may be found on the EPA Web site at http://www.epa.gov/casac.

SUPPLEMENTARY INFORMATION: The CASAC was established pursuant to the
Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C.
7409(d)(2), to review air quality criteria and NAAQS and recommend any
new NAAQS and revisions of existing criteria and NAAQS as may be
appropriate. The CASAC shall also provide advice, information, and
recommendations to the Administrator on the scientific and technical
aspects of issues related to the criteria for air quality standards,
research related to air quality, sources of air pollution, and of
adverse effects which may result from various strategies to attain and
maintain air quality standards. The CASAC is a Federal Advisory
Committee chartered under the Federal Advisory Committee Act (FACA), 5
U.S.C., App. 2. Section 109(d)(1) of the CAA requires that the Agency
periodically review and revise, as appropriate, the air quality
criteria and the NAAQS for the six ``criteria'' air pollutants,
including oxides of nitrogen. EPA is currently reviewing the primary
(health-based) NAAQS for nitrogen dioxide (NO2), as an
indicator for health effects caused by the presence of oxides of
nitrogen in the ambient air.
    Pursuant to FACA and EPA policy, notice is hereby given that the
Chartered CASAC and the CASAC Oxides of Nitrogen Primary NAAQS Review
Panel will hold a public teleconference to discuss CASAC draft reviews
of these two EPA documents. The CASAC Oxides of Nitrogen Primary NAAQS
Review Panel and the CASAC will comply with the provisions of FACA and
all appropriate SAB Staff Office procedural policies.
    Technical Contacts: Any technical questions concerning the
Integrated Science Assessment for Oxides of Nitrogen--Health Criteria
(Second

External Review Draft--January 2015) should be directed to Dr. Molini
Patel (patel.molini@epa.gov), EPA Office of Research and Development,
and technical questions concerning the Review of the National Ambient
Air Quality Standards for Nitrogen Dioxide: Risk and Exposure
Assessment Planning Document should be directed to Dr. Scott Jenkins
(jenkins.scott@epa.gov), EPA Office of Air and Radiation.
    Availability of Meeting Materials: Prior to the meeting, the review
documents, agenda and other materials will be accessible through the
calendar link on the blue navigation bar at http://www.epa.gov/casac/.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office.
    Federal advisory committees and panels, including scientific
advisory committees, provide independent advice to EPA. Members of the
public can submit comments for a federal advisory committee to consider
as it develops advice for EPA. Interested members of the public may
submit relevant written or oral information on the topic of this
advisory activity, and/or the group conducting the activity, for the
CASAC to consider during the advisory process. Input from the public to
the CASAC will have the most impact if it provides specific scientific
or technical information or analysis for CASAC panels to consider or if
it relates to the clarity or accuracy of the technical information.
Members of the public wishing to provide comment should contact the DFO
directly. Oral Statements: In general, individuals or groups requesting
an oral presentation on a public teleconference will be limited to
three minutes. Each person making an oral statement should consider
providing written comments as well as their oral statement so that the
points presented orally can be expanded upon in writing. Interested
parties should contact Mr. Aaron Yeow, DFO, in writing (preferably via
email) at the contact information noted above by August 6, 2015 to be
placed on the list of public speakers. Written Statements: Written
statements should be supplied to the DFO via email at the contact
information noted above by August 6, 2015 so that the information may
be made available to the Panel members for their consideration. It is
the SAB Staff Office general policy to post written comments on the Web
page for the advisory meeting or teleconference. Submitters are
requested to provide an unsigned version of each document because the
SAB Staff Office does not publish documents with signatures on its Web
sites. Members of the public should be aware that their personal
contact information, if included in any written comments, may be posted
to the CASAC Web site. Copyrighted material will not be posted without
explicit permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Mr. Aaron Yeow at (202)
564-2050 or<EMAIL_ADDRESS>To request accommodation of a
disability, please contact Mr. Yeow preferably at least ten days prior
to each meeting to give EPA as much time as possible to process your
request.

    Dated: July 14, 2015.
Thomas H. Brennan,
Deputy Director, EPA Science Advisory Staff Office.
[FR Doc. 2015-17849 Filed 7-20-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: November 18, 2008 (Volume 73, Number 223)]
[Notices]
[Page 68426-68427]
[DOCID:fr18no08-84]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

November 7, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP04-274-011. RP00-157-02.1.

    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Company submits a refund
report detailing refunds paid on October 1, 2008, and October 3, 2008,
pursuant to the Settlement filed September 30, 2008, in accordance with
18 CFR 154.501(e).
    Filed Date: 10/31/2008.
    Accession Number: 20081031-5153.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 12, 2008.

    Docket Numbers: RP09-55-000.
    Applicants: Midwestern Gas Transmission Company.
    Description: Midwestern Gas Transmission Co submits its cashout
report for September 2007 through August 2008.
    Filed Date: 11/05/2008.
    Accession Number: 20081106-0104.
    Comment Date: 5 p.m. Eastern Time on Monday, November 17, 2008.

    Docket Numbers: RP09-56-000.
    Applicants: Algonquin Gas Transmission Company.
    Description: Algonquin Gas Transmission, LLC submits its Fifth
Revised Sheet 507 to FERC Gas Tariff, Fifth Revised Volume 1.
    Filed Date: 11/05/2008.
    Accession Number: 20081106-0103.
    Comment Date: 5 p.m. Eastern Time on Monday, November 17, 2008.

    Docket Numbers: RP09-57-000.
    Applicants: Texas Eastern Transmission LP.
    Description: Texas Eastern Transmission, LP submits Twenty-Ninth
Revised Sheet 25 et al. to FERC Gas Tariff, Seventh Revised Volume 1
and First Revised Volume 2 under RP09-57.
    Filed Date: 11/03/2008.
    Accession Number: 20081107-0003.
    Comment Date: 5 p.m. Eastern Time on Monday, November 17, 2008.

    Docket Numbers: RP09-58-000.
    Applicants: CenterPoint Energy Gas Transmission Co.
    Description: CenterPoint Energy Gas Transmission Co submits its
``Annual Report of Penalty Revenue Credits'' covering activity during
period ended 7/31/08.
    Filed Date: 11/06/2008.
    Accession Number: 20081107-0002.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 18, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-27332 Filed 11-17-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Notices]
[Page 29931]
[DOCID:fr24my06-58]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EG06-36-000]

ExTex LaPorte Limited Partnership; Notice of Application for
Commission Determination of Exempt Wholesale Generator Status

May 16, 2006.
    Take notice that on March 31, 2006, ExTex LaPorte Limited
Partnership (ExTex LaPorte) tendered for filing additional information
and analysis in support of its application filed on February 7, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on May 24, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-7883 Filed 5-23-06; 8:45 am]

BILLING CODE 6717-01-P