[Federal Register Volume 81, Number 2 (Tuesday, January 5, 2016)]
[Rules and Regulations]
[Pages 363-370]
[FR Doc No: 2015-33163]

Vol. 81

Tuesday,

No. 2

January 5, 2016

Part IV

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 884

 Effective Date of Requirement for Premarket Approval for Surgical Mesh
for Transvaginal Pelvic Organ Prolapse Repair; Final Rule

Federal Register / Vol. 81 , No. 2 / Tuesday, January 5, 2016 / Rules
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2014-N-0298]

Effective Date of Requirement for Premarket Approval for Surgical
Mesh for Transvaginal Pelvic Organ Prolapse Repair

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing a final order to require the filing of a premarket approval
application (PMA) or notice of completion of a product development
protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse
(POP) repair.

DATES: This order is effective on January 5, 2016.

FOR FURTHER INFORMATION CONTACT: Sharon Andrews, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G110, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as
amended, establishes a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories (classes) of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (section 510(k) of the FD&C Act (21 U.S.C. 360(k))
procedures to such a preamendments device or to a device within that
type (both the preamendments and substantially equivalent devices are
referred to as preamendments class III devices) may be marketed without
submission of a PMA until FDA issues a final order under section 515(b)
of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.
Section 515(b)(1) of the FD&C Act directs FDA to issue an order
requiring premarket approval for a preamendments class III device.
    Under section 515(f) of the FD&C Act, the manufacturer of a
preamendments class III device may comply with a call for PMAs by
filing a PMA or notice of completion of a PDP. In practice, however,
the option of filing a notice of completion of a PDP has rarely been
used. For simplicity, although the PDP option remains available to
manufacturers in response to a final order under section 515(b) of the
FD&C Act, this document will refer only to the requirement for the
filing and obtaining approval of a PMA.
    On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) was enacted. Section 608(b)
of FDASIA amended section 515(b) of the FD&C Act, changing the process
for requiring premarket approval for a preamendments class III device
from rulemaking to an administrative order.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order requiring premarket approval. Specifically, prior
to the issuance of a final order requiring premarket approval for a
preamendments class III device, the following must occur: (1)
Publication of a proposed order in the Federal Register; (2) a meeting
of a device classification panel described in section 513(b) of the
FD&C Act; and (3) consideration of comments from all affected
stakeholders, including patients, payors, and providers. FDA published
a proposed order to require PMAs for surgical mesh for transvaginal POP
repair in the Federal Register of May 1, 2014 (79 FR 24642), and
convened a meeting of a device classification panel (the ``Panel'') as
discussed in the proposed order preamble and in this document. FDA
received and has considered approximately 25 comments on this proposed
order, as discussed in section III.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination.
    A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order (a final
rule issued under section 515(b) of the FD&C Act prior to the enactment
of FDASIA is considered to be a final order for purposes of section
501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval
for the device, or 30 months after final classification of the device
under section 513 of the FD&C Act, whichever is later. For surgical
mesh for transvaginal POP repair, the later of these two time periods
is 30 months after final classification of the device.
    Therefore, section 501(f)(2)(B) of the FD&C Act requires that a PMA
for such devices be filed by the last day of the 30th calendar month
following the effective date of the final order to reclassify these
devices into class III. If a PMA is not filed by this date, then the
device would be deemed adulterated under section 501(f) of the FD&C
Act.
    Also, a preamendments device subject to the order process under
section 515(b) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see part 812 (21 CFR part 812))
contemporaneous with its interstate distribution until the date
identified by FDA in the final order requiring the filing of a PMA for
the device. At that time, an IDE is required only if a PMA has not been
filed. If the manufacturer, importer, or other sponsor of the device
submits an IDE application and FDA approves it, the device may be
distributed for investigational use. If a PMA is not filed by the later
of the two dates, and the device is not distributed for investigational
use under an IDE, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if
its distribution continues. Other enforcement actions include, but are
not limited to, the following: Shipment of devices in interstate
commerce may be subject to injunction under section 302 of the FD&C Act
(21 U.S.C. 332), and the individuals responsible for such shipment may
be subject to prosecution under section 303 of the FD&C Act (21 U.S.C.
333). FDA requests that manufacturers take action

to prevent the further use of devices for which no PMA has been filed.

II. Regulatory History of the Device

    Surgical mesh is a preamendments device, which was classified into
class II (Sec.  878.3300 (21 CFR 878.3300)) in 1988. Beginning in 1992,
FDA cleared premarket notification (510(k)) submissions for surgical
mesh indicated for POP repair under the general surgical mesh
classification regulation (Sec.  878.3300). FDA has cleared over 100
510(k) submissions for surgical mesh with a POP repair indication.
    In September 2011, FDA held a meeting of a device classification
panel described in section 513(b) of the FD&C Act with respect to
surgical mesh for transvaginal POP repair (Ref. 1). The Panel discussed
a number of serious adverse events associated with use of surgical mesh
for transvaginal POP repair. The Panel consensus was that the safety of
surgical mesh for transvaginal POP repair is not well established and
that, depending on the compartment, vaginal placement of surgical mesh
for POP repair may not be more effective than traditional ``native-
tissue'' repair without mesh. As such, the Panel concluded that the
risk/benefit profile of surgical mesh for transvaginal POP repair is
not well established. The Panel consensus was that general controls and
special controls together would not be sufficient to provide reasonable
assurance of the safety and effectiveness of surgical mesh indicated
for transvaginal POP repair, and that these devices should be
reclassified from class II to class III (Ref. 1). FDA is not aware of
new information since the Panel meeting that would provide a basis for
a different recommendation or findings. FDA published proposed orders
to reclassify surgical mesh for transvaginal POP repair from class II
to class III (the 513(e) proposed order) and to require the filing of a
PMA if the reclassification is finalized (the 515(b) proposed order) in
the Federal Register of May 1, 2014 (79 FR 24634; 79 FR 24642).
Elsewhere in this issue of the Federal Register, FDA is issuing a final
order to reclassify these devices from class II to class III.

III. Public Comments in Response to the Proposed Order

    In response to the 515(b) proposed order, FDA received 26 comments.
The comments and FDA's responses to the comments are summarized in this
section. Certain comments are grouped together under a single number
because the subject matter of the comments is similar. The number
assigned to each comment is purely for organizational purposes and does
not signify the comment's value or importance or the order in which it
was submitted.
    (Comment 1) Nine comments were received from individuals or family
members of individuals who underwent mesh repair for POP and/or stress
urinary incontinence (SUI) and reported complications or adverse events
experienced during or after their procedures. The complications and
adverse events reported including organ perforation, mesh exposure, or
extrusion into the vagina and/or visceral organs (in some cases
requiring additional surgery), chronic pain, infection, lack of
mobility, painful sexual intercourse, self-catheterization, recurrent
prolapse and/or incontinence, blood loss during surgery (in some cases
requiring transfusion), nerve damage, need for mesh removal and/or
additional corrective surgery, and other permanent and/or life-altering
adverse events.
    (Response) FDA appreciates the comments received from individuals
sharing their experiences following surgical mesh repair for POP and
SUI. The complications and adverse events reported by these commenters
are consistent with those addressed in the 513(e) and 515(b) proposed
order preambles, and discussed at the 2011 meeting of the Panel. The
comments did not identify any adverse event information that was not
already considered by FDA and the Panel.
    (Comment 2) Thirteen comments requested reclassification of
surgical mesh for indications other than transvaginal POP repair,
including for SUI and hernia.
    (Response) Surgical mesh for indications other than transvaginal
POP repair are outside the scope of the proposed order and this final
order. As stated in the 513(e) proposed order preamble, ``This proposed
order does not include surgical mesh indicated for surgical treatment
of stress urinary incontinence, sacrocolpopexy (transabdominal POP
repair), hernia repair, and other non-urogynecologic indications.''
    (Comment 3) Eight comments requested a ban, recall, or ``suspension
of use'' of all surgical mesh devices.
    (Response) As stated previously, surgical mesh for indications
other than transvaginal POP repair is outside the scope of this final
order. For the reasons discussed in this document, FDA does not believe
that a ban, recall, or suspension of use of surgical mesh indicated for
transvaginal POP repair is warranted at this time.
    Section 516 of the FD&C Act (21 U.S.C. 360f) authorizes FDA to ban
a device when, on the basis of all available data and information, FDA
finds that the device presents substantial deception or an unreasonable
and substantial risk of illness or injury and, where such deception or
risk could be corrected or eliminated by labeling or change in labeling
and with respect to which the Secretary of the Department of Health and
Human Services (Secretary) provided written notice to the manufacturer
specifying the deception or risk of illness or injury, the labeling or
change in labeling to correct the deception or eliminate or reduce such
risk, and the period within which such labeling or change in labeling
was to be done, such labeling or change in labeling was not done within
such period.
    As stated earlier in this document, FDA issued a proposed order (79
FR 24642) under section 515(b) of the FD&C Act to require the filing of
PMAs for these devices following reclassification, which would require
an individual demonstration of a reasonable assurance of safety and
effectiveness for surgical mesh for transvaginal POP repair. In the
515(b) proposed order preamble, FDA recognized the recommendations from
the Panel that additional work should be focused on patient labeling
and providing patients with benefit-risk information on available
treatment options for POP, including surgical and nonsurgical options,
so patients understand potential long-term safety and effectiveness
outcomes. In the 515(b) proposed order, FDA tentatively asserted that
it expects PMAs for these devices to include professional and patient
labeling, and that the patient labeling include, among other things,
the risks and benefits of the device and all available treatment
options. These findings are adopted, in part, in the final order (see
section IV, ``The Final Order'').
    Therefore, FDA does not believe that there is sufficient evidence
at this time to support the banning of this device. Based on a review
of the published literature as described in the 513(e) proposed order
preamble and this document, input from clinical organizations, and the
Panel's recommendations, FDA has determined that the safety and
effectiveness of surgical mesh for transvaginal POP repair has not been
established and that the collection of additional clinical evidence on
these devices is needed. Such additional evidence may provide
information to allow FDA to impose controls to mitigate the risks and
more clearly characterize the benefits of these devices. In addition,
FDA believes there are potential benefits from surgical

mesh used for transvaginal POP repair including treatment of POP in
appropriately selected women with severe or recurrent prolapse. As
such, FDA has not determined that this device presents ``an
unreasonable and substantial risk of illness or injury.''
    FDA also does not believe that there is sufficient evidence at this
time to support a mandatory recall of this device. Under section
518(e)(1) of the FD&C Act (21 U.S.C. 360h(e)(1)) if the Secretary finds
that there is a reasonable probability that a device intended for human
use would cause serious, adverse health consequences or death, the
Secretary shall issue an order requiring the appropriate person
(including the manufacturers, importers, distributors, or retailers of
the device) to immediately cease distribution of such device and to
immediately notify health professionals and device user facilities of
the order and to instruct such professionals and facilities to cease
use of such device.
    FDA does not believe a mandatory recall of all currently marketed
surgical mesh for transvaginal POP repair is warranted. Based on a
review of the published literature as described in the 513(e) proposed
order preamble and this document, input from clinical organizations,
and the Panel's recommendations, FDA believes that there is not
sufficient evidence at this time to support a finding that there is a
reasonable probability that surgical mesh for transvaginal repair of
POP would cause serious adverse health consequences or death. As
described in the 513(e) proposed order preamble and discussed at the
2011 Panel meeting, the safety and effectiveness of surgical mesh for
transvaginal repair of POP has not been established and these devices
should be evaluated in clinical studies that compare the device to
native tissue repair in order to establish a reasonable assurance of
safety and effectiveness.
    It is unclear what commenters were referencing when they asked FDA
to ``suspend the use'' of these devices. As stated previously, FDA does
not believe a ban or recall is warranted at this time, and as stated in
this document, there are other actions FDA has taken and may take in
the future to ensure that there is a reasonable assurance of safety and
effectiveness of surgical mesh for transvaginal POP repair based on
valid scientific evidence.
    FDA believes other regulatory actions it has taken will help the
Agency to better understand the risk-benefit profile of these devices.
FDA issued postmarket surveillance orders to manufacturers of surgical
mesh for transvaginal POP repair starting on January 3, 2012. The
postmarket surveillance orders allow FDA to continue to evaluate the
benefit-risk profile of the device. Further, by reclassifying these
devices to class III and requiring PMA approval, FDA can require an
independent demonstration that a reasonable assurance of safety and
effectiveness exists for each device within this type.
    FDA will consider other regulatory actions relating to this device
as appropriate in the future.
    (Comment 4) Two comments were related to the need for testing prior
to marketing, including an evaluation of the polypropylene material
used to fabricate surgical mesh. One commenter stated that
polypropylene material is inappropriate for implantation.
    (Response) FDA believes that a thorough evaluation of the material
used to fabricate the surgical mesh is needed to provide a reasonable
assurance of safety and effectiveness of the device. FDA discussed in
the 515(b) proposed order preamble information that should be submitted
in a PMA to address these issues. FDA is adopting these findings, in
part, in the final order (see section IV, ``The Final Order'').
    Specifically, in the proposed order, FDA stated that manufacturers
should provide biocompatibility, preclinical bench testing and
preclinical animal studies, among other information, to demonstrate
reasonable assurance of safety and effectiveness of surgical mesh for
transvaginal POP repair. Such performance data, which may generally
include assessment of the mesh chemical and physical characteristics,
in vitro chemical characterization studies, and in vivo preclinical
implantation studies, will be reviewed by FDA to determine whether the
risks associated with implantation of the polypropylene material are
appropriately mitigated. The proposed order preamble also states that a
PMA would need to include the information required by section 515(c)(1)
of the FD&C Act, which includes manufacturing information. FDA's review
of such manufacturing information will allow the Agency to evaluate
whether the polypropylene material is safe and effective for
transvaginal POP repair. FDA is adopting these findings in the final
order (see section IV, ``The Final Order'').
    (Comment 5) Two comments were related to the timeline for requiring
PMAs and requested that the requirement for premarket approval be
immediately implemented. One commenter requested that the PMA
requirement be retroactively applied to devices currently on the
market.
    (Response) Section 501(f)(2)(B) of the FD&C Act outlines the
timeframe in which a PMA must be filed by manufacturers of currently
marketed devices that are subject to a 515(b) order for the
manufacturers to continue legally marketing their device. For devices
subject to a 515(b) order, the provision states that a PMA must be
submitted by the 90th day after the date the order to require PMAs is
issued or the last day of the 30th calendar month beginning after the
month in which the classification in class III becomes effective,
whichever occurs later. For surgical mesh for transvaginal POP repair,
the later of these two time periods is 30 months after final
classification of the device. FDA must abide by the timeframe outlined
in the FD&C Act, and therefore may not require manufacturers of devices
subject to the final order to submit a PMA immediately.
    (Comment 6) One comment suggested that the timeframe for filing a
PMA (within 30 months of the final reclassification) may not allow for
adequate patient followup of ongoing clinical studies and requested
that FDA consider the current status of clinical studies that may be
used to support PMA submission.
    (Response) FDA has carefully considered the current status of
ongoing clinical studies of currently marketed surgical mesh for
transvaginal POP repair, including studies being conducted in response
to FDA postmarket surveillance study orders issued starting on January
3, 2012, under section 522 of the FD&C Act (21 U.S.C. 360l), and has
concluded that the statutory timeframe for filing a PMA (the last day
of the 30th calendar month beginning after the month in which the
classification in class III becomes effective) is appropriate to allow
adequate patient followup of ongoing clinical studies. In the 515(b)
proposed order preamble, FDA stated the expectation that ``[a]t least 1
year of outcome data should be provided in the PMA and an additional 2-
4 years of followup should be conducted postmarket.'' FDA believes it
is reasonable to expect that a manufacturer of surgical mesh who is
subject to a section 522 postmarket surveillance study order issued in
2012 or 2013 will be able to collect 1 year of outcome data within 30
months of the final reclassification.
    (Comment 7) One comment addressed FDA's ability to review a PMA
submitted for surgical mesh for transvaginal POP repair within 180
days. The comment stated that a 180-day PMA review commitment may not

be attainable and the timeline does not allow for panel review. The
commenter requested clarification regarding what actions will be taken
should the PMA not be approved within the 180-day review period.
    (Response) Under section 515(d)(1)(A) of the FD&C Act, unless an
exception applies, FDA must either issue an order approving or deny
approval of a PMA within 180 days after receipt of a PMA. FDA can
provide an extension for review when a major amendment is submitted by
the applicant or requested by FDA (21 CFR 814.37(c)(1)). The extended
time period for submitting an amendment allows for, among other things,
additional time for panel review of specific device data. Generally, a
major amendment includes a previously unreported study, significant
updated data from a previously reported study, detailed new analyses of
previously submitted data, or required information previously omitted.
    FDA intends to review any submitted PMA for this device type within
the required timeframe. As soon as it completes its review of a PMA,
FDA will issue an approval order (Sec.  814.45(d) (21 CFR 814.45(d))),
an approvable letter (Sec.  814.45(e)), a not approvable letter (Sec.
814.45(e)), or an order denying approval (Sec.  814.45(a)). FDA
strongly encourages manufacturers to meet with the Agency early through
the presubmission program for any assistance in preparation of their
PMA to help to expedite the PMA review process.
    (Comment 8) One comment questioned FDA's reviewing urogynecologic
surgical mesh instrumentation in a PMA if the instrumentation is
packaged with the surgical mesh versus reviewing instrumentation in a
510(k) notification if the instrumentation is packaged separately from
the surgical mesh. The commenter stated that the regulatory
requirements for instrumentation should be based on indication and not
its packaging configuration.
    (Response) FDA agrees that the regulatory requirements for
urogynecological surgical mesh instrumentation should be based upon the
indications for use of the instruments and the risk of the
instrumentation when used as intended. Based on the indications for use
and the risks posed by these devices, in the 515(e) proposed order, FDA
proposed to reclassify these devices from class I to class II and
establish special controls. FDA is not finalizing this proposed
reclassification and special controls at this time. On February 26,
2016, FDA will convene a panel to discuss these devices prior to
finalizing their reclassification. These devices are currently
classified as class I under (21 CFR 876.4730) (Manual gastroenterology-
urology surgical instrument and accessories) and may be legally
marketed without premarket review, but would require 510(k)
notification if the proposed reclassification of the devices is
finalized.
    When these devices and surgical mesh for transvaginal POP repair
are packaged together, after 510(k) notification is required for the
instrumentation, manufacturers may wish to include both products in a
PMA for convenience. Manufacturers are permitted but not required to do
so. If such instrumentation is included in a PMA, FDA is clarifying
that information regarding the manufacturing process of the
instrumentation does not need to be submitted in a premarket
submission, as previously stated in the 515(b) proposed order preamble
(see section IV, ``The Final Order'').
    (Comment 9) One comment related to the types of bench testing FDA
outlined in the 515(b) proposed order that should be included in a PMA
and whether the various type of tests apply to all mesh types. For
example, the commenter noted that many currently marketed surgical
meshes indicated for transvaginal POP repair use integrated anchors or
are self-fixating and do not utilize sutures; therefore suture pullout
strength, which was identified in the 515(b) proposed order as a mesh
characteristic that should be evaluated, would not be a relevant
performance specification for these types of meshes. The commenter
requested that FDA allow manufacturers to include a justification as to
why certain testing is not relevant to performance specifications of a
particular device design.
    (Response) FDA recognizes that the data required to support
premarket approval may vary by device. In the 515(b) proposed order
preamble, FDA identified the information that should be included in a
PMA to provide a reasonable assurance of safety and effectiveness of
surgical mesh for transvaginal POP repair, including evaluation of
specific mechanical characteristics. FDA agrees that manufacturers
should be allowed to justify why specific tests are not relevant to
their specific mesh design in lieu of testing. As noted in the 515(b)
proposed order preamble, FDA strongly encourages manufacturers to meet
with the Agency early through the presubmission program for any
assistance in preparation of their PMA.
    (Comment 10) One comment related to FDA's expectations regarding
biocompatibility and preclinical animal study evaluation. The commenter
requested clarification regarding why FDA recommended conducting
biocompatibility testing prior to initiation of animal studies. The
commenter also noted that in the 515(b) proposed order, FDA identified
a biocompatibility test (haemocompatibility), which is not outlined in
the Center for Devices and Radiological Health (CDRH) Blue Book Memo
#G-95-1--``Use of International Standard ISO-10993, `Biological
Evaluation of Medical Devices Part 1: Evaluation and Testing,' '' as a
test for consideration for a permanent implant with tissue/bone
contact. The commenter seeks clarity regarding the specific
biocompatibility testing FDA believes should be conducted and a
rationale for any testing not outlined in the Blue Book Memo.
    (Response) The biocompatibility testing outlined in the 515(b)
proposed order preamble is consistent with that recommended in the FDA
guidance document ``Guidance for Industry and/or for FDA Reviewers/
Staff and/or Compliance: Guidance for the Preparation of a Premarket
Notification Application for a Surgical Mesh'' issued on March 2, 1999
(Ref. 2). There are two biocompatibility studies recommended in the
guidance document (and the 515(b) proposed order) that are not included
in CDRH's Blue Book Memorandum #G95-1--``Use of International Standard
ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation
and Testing,' '' dated May 1, 1995 (Ref. 3)--pyrogenicity and
hemolysis. FDA recommended pyrogenicity testing to help protect
patients from the risk of febrile reaction (Ref. 4). FDA recommended
hemolysis testing on surgical mesh for transvaginal POP repair because
red blood lysis in the surgical field may adversely affect the healing
process.
    FDA generally recommends that biocompatibility testing be completed
prior to preclinical animal study evaluation to ensure that the
preclinical animal study evaluation results are valid and can be used
to support the final device design. If biocompatibility testing and the
preclinical animal study evaluation are conducted simultaneously and
biocompatibility testing results are problematic or identify a safety
concern resulting in changes to the device design or materials, the
preclinical animal study evaluation may need to be repeated. In
addition, the results of biocompatibility

testing may prompt the need for additional preclinical evaluation. As
noted in the 515(b) proposed order preamble, FDA strongly encourages
manufacturers to meet with the Agency early through the presubmission
program for any assistance in preparation of their PMA.
    (Comment 11) One comment stated that the preclinical animal study
requirements outlined in the 515(b) proposed order are not clearly
defined and requested that FDA provide additional information on study
design and animal model selection as well as the risks that are
intended to be mitigated by the proposed animal study.
    (Response) Preclinical animal studies are intended to evaluate the
safety of the device, specifically the local and systemic effects of
the device. Preclinical animal studies may not be needed to evaluate
all surgical mesh for transvaginal POP repair; however, preclinical
animal studies may be appropriate in some situations, for example, to
evaluate a new mesh material or characterize the resorption rate of a
resorbable surgical mesh product. FDA strongly encourages manufacturers
to meet with the Agency early through the presubmission program to
receive feedback regarding the need for preclinical animal studies,
study design, and animal model selection to evaluate a specific
surgical mesh for transvaginal POP repair.
    (Comment 12) One comment stated that the use of postmarket
surveillance studies to fulfill clinical requirements for the PMA
creates confusion regarding how such a study can have two purposes
(postmarket surveillance and PMA approval) without compromising the
study design and statistical rigor of the study. The comment also
stated that the 5-year followup implied in the 515(b) proposed order is
not in line with 3-year followup requested in the postmarket
surveillance orders.
    (Response) In the 515(b) proposed order preamble, FDA outlined
expectations for data collection, safety and effectiveness outcomes,
and study followup. FDA noted that we intend to consider proposals for
different study designs and will decide on a case-by-case basis whether
each proposed study design is likely to generate data adequate to
support a PMA (79 FR 24642 at 24647). In addition, we noted that FDA
intends to consider the use of study data collected by manufacturers in
response to FDA issued postmarket surveillance study orders (79 FR
24642 at 24647). FDA believes that data from the section 522 postmarket
surveillance studies may be able to fulfill the clinical requirements
to support PMA approval--in addition to fulfilling the regulatory
requirements of the orders issued under section 522 of the FD&C Act--if
appropriately designed. However, as noted in the 515(b) proposed order
preamble, FDA strongly encourages manufacturers to meet with the Agency
to discuss specific proposals utilizing the presubmission program.
    In addition, FDA noted the following in the postmarket surveillance
orders issued under section 522 of the FD&C Act: ``Although FDA has not
come to a final decision on reclassification, you may wish to consider
the data requirements for a PMA in deciding the design of your 522
study. If you are interested in utilizing data collected to fulfill
this 522 order to also fulfill a possible future PMA, we suggest you
indicate your interest on the cover letter of your 522 study plan and
discuss with FDA possible 522 study designs that may be sufficient to
support a PMA application.'' For those manufacturers who indicated
interest in using a 522 study to support a future PMA, FDA's review of
their 522 protocol assessed both the requirements of the 522 order and
the ability to generate sufficient data to support premarket approval.
    FDA also notes that the 522 orders requested collection of safety
and effectiveness outcomes for surgical mesh for transvaginal POP
repair at 6 months, 12 months, 18 months, 24 months, and 36 months
following surgery. Therefore, FDA expects that the 522 studies should
be designed to collect the 1-year outcomes requested to support
premarket approval. FDA acknowledges that the 522 orders requested 3-
year followup. However, FDA notes that based on its detailed review of
the information provided in a PMA, we may request additional postmarket
followup.
    (Comment 13) One comment stated that FDA's expectation, set forth
in the 515(b) proposed order, that patient labeling include a notice of
availability of an FDA Safety Communication could be ``conflicting''
and lead to confusion because it is unclear how a reference to this
communication would be appropriate for a device with an approved PMA
establishing its safety and effectiveness. The commenter stated that
the patient labeling should be focused on the benefit-risk profile of
each product as established in the related PMA and requested that FDA
consider alternative methods for providing the information found in the
FDA communication to patients.
    (Response) FDA agrees that patient labeling should be reflective of
the risks and benefits of individual devices. FDA also believes that
there is important, relevant information in FDA's Safety Communication
that may be helpful to patients even after PMAs are approved for this
device type (Ref. 5). For example, the Safety Communication included
information regarding the potential risks of surgical mesh for
transvaginal POP repair, nonsurgical options, and recommended questions
that patients should ask their surgeon, which may be relevant even
after PMAs are approved for this device type. However, FDA acknowledges
that including the notice of availability of the Safety Communication
may not be the best way to provide patients with the relevant
information. As a result, FDA is revising this expectation and is now
recommending that patient labeling include relevant information from
FDA's Safety Communication and/or FDA's Urogynecologic Surgical Mesh
Implants Web page (Ref. 6), including but not limited to, recommended
patient questions for their surgeon, FDA activities related to surgical
mesh for transvaginal POP repair, and FDA contact information.
    To help ensure that patients are adequately informed, FDA also
recommends that a link to FDA's Urogynecologic Surgical Mesh Implants
Web page be included in the patient labeling because it provides timely
and transparent information to the public, including appropriate
stakeholders and patients.
    (Comment 14) One comment regarding the patient identification card
discussed in the 515(b) proposed order noted that the card can be
easily provided by the manufacturer, compliance with use of the card is
dependent on the implanting physician, and should not lead to followup
activities for the manufacturer.
    (Response) FDA recognizes that a successful identification system
requires support from parties other than the manufacturer, such as the
implanting physician and patient. FDA's expectation, as set forth in
the 515(b) proposed order preamble, was that patient labeling include a
patient identification card, which would be initially provided by the
manufacturer. FDA does not anticipate further followup actions by the
manufacturer. These findings are adopted, in part, in the final order
(see section IV, ``The Final Order'').

IV. The Final Order

    Under section 515(b)(3) of the FD&C Act, FDA is adopting its
findings, in part, as published in the preamble of the 515(b) proposed
order (79 FR 24642) and issuing this final order to require the filing
of a PMA for surgical mesh for

transvaginal POP repair. As discussed in this document, FDA is amending
certain previous findings. The Agency now finds that: (1) Manufacturing
process information of the specialized instrumentation should not be
included in a premarket submission and (2) patient labeling should
include relevant information from FDA's Safety Communication and/or
FDA's Urogynecologic Surgical Mesh Implants Web page rather than the
notice of availability of FDA's Safety Communication. The patient
labeling should also include a link to the FDA's Urogynecologic
Surgical Mesh Implants Web page. This final order will revise 21 CFR
part 884.
    Under the final order, a PMA for surgical mesh for transvaginal POP
repair is required to be filed on or before July 5, 2018, for any
preamendments class III devices that were in commercial distribution
before May 28, 1976, or that has been found by FDA to be substantially
equivalent to such a device on or before July 5, 2018. Any other device
subject to this order is required to have an approved PMA in effect
before it may be marketed.
    If a PMA for any of the preamendments class III devices subject to
this order is not filed by this date, that device will be deemed
adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial
distribution of the device must cease immediately.
    The device may, however, be distributed for investigational use, if
the applicable requirements of the IDE regulations (part 812),
including obtaining IDE approval, are met on or before 30 months after
the effective date of this order. There will be no extended period for
filing an IDE, nor exemption from the IDE requirements (see Sec.
812.2(d)), and studies may not be initiated without appropriate IDE
approvals, as required.

V. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
    The collections of information in 21 CFR part 807, subpart E, have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B, have been approved under OMB
control number 0910-0231; the collections of information in part 812
have been approved under OMB control number 0910-0078; the collections
of information under 21 CFR 822 have been approved under OMB control
number 0910-0449; and the collections of information under 21 CFR 801
have been approved under OMB control number 0910-0485.

VII. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) of the FD&C Act
provided for FDA to issue regulations to require PMA approval for
preamendments devices or devices found substantially equivalent to
preamendments devices. Section 515(b) of the FD&C Act, as amended by
FDASIA, provides for FDA to require PMA approval for such devices by
issuing a final order following the issuance of a proposed order in the
Federal Register. FDA will continue to codify the requirement for a PMA
approval in the Code of Federal Regulations. Therefore, under section
515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in this final
order, we are requiring PMA approval for surgical mesh for transvaginal
POP repair and we are making the language in 21 CFR 884.5980 consistent
with this final order.

VIII. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852 and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

1. FDA Meeting of the Obstetrics & Gynecological Devices Panel,
September 8-9, 2011. Available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm262488.htm.
2. ``Guidance for Industry and/or for FDA Reviewers/Staff and/or
Compliance: Guidance for the Preparation of a Premarket Notification
Application for a Surgical Mesh'' issued on March 2, 1999. Available
at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073791.pdf.
3. Blue Book Memorandum #G95-1--''Use of International Standard ISO-
10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation
and Testing' '' issued on May 1, 1995. Available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm080735.htm.
4. ``Guidance for Industry Pyrogen and Endotoxins Testing: Questions
and Answers,'' June 2012. Available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm310098.pdf.
5. ``Update on Serious Complications Associated with Transvaginal
Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety
Communication'' issued on July 13, 2011. Available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.
6. FDA's Urogynecologic Surgical Mesh Implants Web page. Available
at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm.

List of Subjects in 21 CFR Part 884

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 884 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add paragraph (c) to Sec.  884.5980 to read as follows:

Sec.  884.5980  Surgical mesh for transvaginal pelvic organ prolapse
repair.

* * * * *
    (c) Date premarket application approval or notice of completion of
a product development protocol is required. A premarket application
approval or notice of completion of a product development protocol for
a device is required to be filed with the Food and Drug Administration
on or before July 5, 2018, for any surgical mesh described in paragraph
(a) of this section that was in commercial distribution before May 28,
1976, or that has, on or before July 5, 2018, been found substantially
equivalent to a surgical mesh described in paragraph (a) of this
section that was in commercial distribution before May 28, 1976. Any
other surgical mesh for transvaginal

pelvic organ prolapse repair shall have an approved premarket
application or declared completed product development protocol in
effect before being placed in commercial distribution.

    Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33163 Filed 1-4-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 9, 2008 (Volume 73, Number 111)]
[Notices]
[Page 32586-32587]
[DOCID:fr09jn08-55]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee; Notice of
Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Cardiovascular and Renal Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 25, 2008, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, Maryland Ballroom,
8727

Colesville Rd., Silver Spring, MD,<PHONE_NUMBER>.
    Contact Person: Elaine Ferguson, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512533. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA) 22-
275, tolvaptan (proposed trade name SAMSKA), Otsuka Pharmaceutical
Development & Commercialization, Inc., for the proposed indication of
treatment of hypervolemic and euvolemic, hyponatremia. The committee
will hear presentations from FDA and the sponsors specifically
regarding change in sodium level as basis for drug approval.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
20, 2008. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before June 13, 2008. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by June 16,
2008.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Elaine Ferguson at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    FDA regrets that it was unable to publish this notice 15 days prior
to the June 25, 2008, Cardiovascular and Renal Drugs Advisory Committee
meeting. Because the agency believes there is some urgency to bring
this issue to public discussion and qualified members of the
Cardiovascular and Renal Drugs Advisory Committee were available at
this time, the Commissioner of Food and Drugs concluded that it was in
the public interest to hold this meeting even if there was not
sufficient time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 2, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-12868 Filed 6-6-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: January 6, 2009 (Volume 74, Number 3)]
[Notices]
[Page 475]
[DOCID:fr06ja09-70]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form NP-X; SEC File No. 270-524; OMB Control No. 3235-0582.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget a
request for extension of the previously approved collection of
information discussed below.
    The title of the collection of information is ``Form N-PX (17 CFR
274.129) under the Investment Company Act of 1940 (15 U.S.C. 80a-1 et
seq.) (``Investment Company Act''), Annual Report of Proxy Voting
Record.'' Rule 30b1-4 (17 CFR 270.30b1-4) under the Investment Company
Act of 1940 requires every registered management investment company,
other than a small business investment company (``Fund''), to file Form
N-PX not later than August 31 of each year. Funds use Form N-PX to file
annual reports with the Commission containing their complete proxy
voting record for the most recent twelve-month period ended June 30.
Funds also use Form N-PX to inform the Commission that certain of their
portfolios do not hold any equity securities and have no proxy record
to file.
    The Commission requires the dissemination of this information in
order to meet the filing and disclosure requirements of the Investment
Company Act and to enable Funds to provide investors with the
information necessary to evaluate an investment in the Fund. The
information filed with the Commission also permits the verification of
compliance with securities law requirements and assures the public
availability and dissemination of the information. Requiring a Fund to
file its annual reports on Form N-PX has the advantages of making each
Fund's proxy voting record available within a relatively short period
of time after the proxy voting season, and of providing disclosure of
all Funds' proxy voting records over a uniform period of time.
    There are approximately 3,800 Funds registered with the Commission,
representing approximately 9,400 Fund portfolios, which are required to
file Form N-PX.\1\ The 9,400 portfolios are comprised of 6,200
portfolios holding equity securities and 3,200 portfolios holding no
equity securities. The staff estimates that portfolios holding no
equity securities require approximately a 0.17 hour burden per response
and those holding equity securities require 14.4 hours per response.
The overall estimated annual burden is therefore 89,824 hours ((6,200
responses x 14.4 hours per response for equity holding portfolios) +
(3,200 responses x 0.17 hours per response for non-equity holding
portfolios)).
---------------------------------------------------------------------------

    \1\ The estimate of 3,800 Funds is based on the number of
management investment companies currently registered with the
Commission. We estimate, based on data from the Investment Company
Institute and other sources, that there are approximately 5,700 Fund
portfolios that invest primarily in equity securities, 500
``hybrid'' or bond portfolios that may hold some equity securities,
2,400 bond Funds that hold no equity securities, and 800 money
market Funds, for a total of 9,400 portfolios required to file Form
N-PX.
---------------------------------------------------------------------------

    Form N-PX does not involve any recordkeeping requirements.
Providing the information required by the rule is mandatory and
information provided under the rule will not be kept confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid control number.
    Please direct general comments regarding the above information to
the following persons: (i) Desk Officer for the Securities and Exchange
Commission, Office of Management and Budget, Room 10102, New Executive
Office Building, Washington, DC 20503 or send an e-mail to: Shagufta_
<EMAIL_ADDRESS>and (ii) Charles Boucher Director/CIO, Securities
and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way,
Alexandria, VA 22312; or send an e-mail to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: December 29, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-31354 Filed 1-5-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Notices]
[Pages 7985-7988]
[FR Doc No: 2020-02822]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-21-000]

Port Arthur Pipeline, LLC; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Louisiana Connector Amendment
Project, Request for Comments on Environmental Issues, and Notice of
Public Scoping Session

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of

the Louisiana Connector Amendment Project (Project) involving
construction and operation of facilities by Port Arthur Pipeline, LLC
(PAPL) in Beauregard Parish, Louisiana. The Commission will use this EA
in its decision-making process to determine whether the Project is in
the public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies about issues regarding the Project. The National Environmental
Policy Act (NEPA) requires the Commission to take into account the
environmental impacts that could result from its action whenever it
considers the issuance of a Certificate of Public Convenience and
Necessity. NEPA also requires the Commission to discover concerns the
public may have about proposals. This process is referred to as
``scoping.'' The main goal of the scoping process is to focus the
analysis in the EA on the important environmental issues. By this
notice, the Commission requests public comments on the scope of issues
to address in the EA. To ensure that your comments are timely and
properly recorded, please submit your comments so that the Commission
receives them in Washington, DC on or before 5:00 p.m. Eastern Time on
March 6, 2020.
    You can make a difference by submitting your specific comments or
concerns about the Project. Your comments should focus on the potential
environmental effects, reasonable alternatives, and measures to avoid
or lessen environmental impacts. Your input will help the Commission
staff determine what issues they need to evaluate in the EA. Commission
staff will consider all filed comments during the preparation of the
EA.
    If you sent comments on this Project to the Commission before the
opening of this docket on December 9, 2019, you will need to file those
comments in Docket No. CP20-21-000 to ensure they are considered as
part of this proceeding. If you have already filed comments in Docket
No. CP20-21-000, you do not need to file those comments again.
    This notice is being sent to the Commission's current environmental
mailing list for this Project. State and local government
representatives should notify their constituents of this proposed
Project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable easement agreement. You
are not required to enter into an agreement. However, if the Commission
approves the Project, that approval conveys with it the right of
eminent domain. Therefore, if you and the company do not reach an
easement agreement, the pipeline company could initiate condemnation
proceedings in court. In such instances, compensation would be
determined by a judge in accordance with state law.
    PAPL provided landowners with a fact sheet prepared by the FERC
entitled ``An Interstate Natural Gas Facility On My Land? What Do I
Need To Know?'' This fact sheet addresses a number of typically asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC website (www.ferc.gov) at https://www.ferc.gov/resources/guides/gas/gas.pdf.

Public Participation

    The Commission offers a free service called eSubscription which
makes it easy to stay informed of all issuances and submittals
regarding the dockets/projects to which you subscribe. These instant
email notifications are the fastest way to receive notification and
provide a link to the document files which can reduce the amount of
time you spend researching proceedings. To sign up go to www.ferc.gov/docs-filing/esubscription.asp.
    For your convenience, there are four methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to Documents and Filings. Using eComment is an easy
method for submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is located on the Commission's website (www.ferc.gov)
under the link to Documents and Filings. With eFiling, you can provide
comments in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making; a comment on a particular project is considered a ``Comment
on a Filing'';
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the Project docket number
(CP20-21-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426;
    (4) Newly affected landowners wishing to obtain legal status by
becoming a party to the proceeding for this project should, on or
before the comment date (March 6, 2020), file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 3 copies of filings made with the Commission and must provide a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding; or
    (5) In lieu of sending written comments, the Commission invites you
to attend the public scoping session its staff will conduct in the
Project area, scheduled as follows:

------------------------------------------------------------------------
           Date and time                          Location
------------------------------------------------------------------------
Wednesday, March 4, 2020, 4:00      South Beauregard Recreation District
 p.m. to 7:00 p.m., Central Time.    Community Center, 6719 Highway 12,
                                     Ragley, LA 70657,<PHONE_NUMBER>.
------------------------------------------------------------------------
Please note that staff may conclude the session at 6:30 p.m. if all
  attendees planning to provide comments have done so.

    The primary goal of the scoping session is to have you identify the
specific environmental issues and concerns that should be considered in
the EA. Individual verbal comments will be taken on a one-on-one basis
with a court reporter. This format is designed to receive the maximum
amount of verbal comments, in a convenient way during the timeframe
allotted.
    The scoping session is scheduled from 4:00 p.m. to 7:00 p.m.
Central Time. You may arrive any time at or after 4:00 p.m.. There will
not be a formal presentation by Commission staff when the session
opens. If you wish to speak, the Commission staff will hand out numbers
in the order of your arrival. Comments will be taken until 7:00 p.m.
However, if no additional numbers have been handed out and all
individuals who wish to provide comments have had an opportunity to do
so, staff may conclude the session at 6:30 p.m. Please see appendix 1
for additional information on the session format and conduct.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE, Washington,
DC 20426, or call<PHONE_NUMBER>. For instructions on connecting to
eLibrary, refer to the last page of this notice.
---------------------------------------------------------------------------

    Your scoping comments will be recorded by a court reporter (with
FERC staff or representative present) and become part of the public
record for this proceeding. Transcripts will be publicly available on
FERC's eLibrary system (see the last page of this notice for
instructions on using eLibrary). If a significant number of people are
interested in providing verbal comments in the one-on-one settings, a
time limit of 3 minutes may be implemented for each commentor.
    It is important to note that the Commission provides equal
consideration to all comments received, whether filed in written form
or provided verbally at a scoping session. Although there will not be a
formal presentation, Commission staff will be available throughout the
scoping session to answer your questions about the environmental review
process. Representatives from PAPL will also be present to answer
Project-specific questions.

Summary of the Proposed Project

    PAPL proposes to amend its April 18, 2019 Order Issuing Certificate
for the Louisiana Connector Project (CP18-7-000) by constructing and
operating a compressor station in Beauregard Parish, Louisiana (the
Beauregard Parish Compressor Station or BPCS) in lieu of the compressor
station previously certificated in Allen Parish, Louisiana. The
compressor station proposed for this Project would be constructed as
part of the Louisiana Connector Project.
    In its December 9, 2019 Amendment Application, PAPL proposed to
locate the BPCS within the previously certificated Beauregard Parish
Contractor Yard (LYBEA-01) and workspace associated with pipeline
construction at milepost (MP) 72.3. However, on January 31, 2020, PAPL
filed to relocate the new BPCS site approximately 0.75 mile south of
Gaytine Road, to a location adjacent to and west-southwest of Cameron
Interstate Pipeline, LLC's existing Ragley Compressor Station.\2\ The
proposed site would be approximately 2,750 feet directly south of the
initially proposed BPCS location described in PAPL's December 9, 2019
Amendment Application. The new location for the BPCS would be south of
and adjacent to the main pipeline corridor and would use the same
mainline connection and interconnect location points near MP 72.3 as
previously proposed.
---------------------------------------------------------------------------

    \2\ Newly affected landowners have an opportunity to file for
timely intervention during this scoping period, which ends on March
6, 2020.
---------------------------------------------------------------------------

    As part of the Project, PAPL would:
     Relocate the previously authorized compressor station
consisting of four Solar Titan 130E gas turbine driven compressors in
Allen Parish from MP 96.1, to MP 72.3 in Beauregard Parish, increasing
horsepower from 89,900 to 93,880;
     relocate an interconnect with the Texas Eastern
Transmission Company from MP 96.1 to MP 72.3;
     relocate pig launcher/receiver facilities from MP 96.1 to
MP 72.3;
     construct three new pipeline interconnections with Cameron
Intrastate Pipeline, Transcontinental Gas Pipeline, and Louisiana
Storage at MP 72.3;
     construct one new mainline block valve at MP 72.3,
resulting in a total of 10 mainline valves on the Louisiana Connector
Project; and
     use the former Allen Parish compressor station site at MP
96.1 as a contractor yard.
    The Project facilities would result in a slight increase in the
overall capacity of feed gas to the approved Port Arthur Liquefaction
facility from approximately 1.98 to 2.05 billion cubic feet per day.
The Project would allow gas from additional sources to supply the
liquefaction facility.
    The general location of the Project facilities is shown in appendix
2.

Land Requirements for Construction

    The Project facilities would disturb approximately 59.9 acres, all
of which would be permanently maintained as aboveground facilities or
right-of-way.

The EA Process

    The EA will discuss impacts that could occur as a result of the
construction and operation of the proposed Project under these general
headings:
     Geology and soils;
     water resources and wetlands;
     vegetation and wildlife;
     threatened and endangered species;
     socioeconomics;
     cultural resources;
     land use;
     air quality and noise;
     alternatives;
     public safety; and
     cumulative impacts
    Commission staff will also evaluate reasonable alternatives to the
proposed Project or portions of the Project, and make recommendations
on how to lessen or avoid impacts on the various resource areas.
    The EA will present Commission staffs' independent analysis of the
issues. The EA will be available in electronic format in the public
record through eLibrary \3\ and the Commission's website (https://www.ferc.gov/industries/gas/enviro/eis.asp). If eSubscribed, you will
receive instant email notification when the EA is issued. The EA may be
issued for an allotted public comment period. Commission staff will
consider all comments on the EA before making recommendations to the
Commission. To ensure Commission staff have the opportunity to address
your comments, please carefully follow the instructions in the Public
Participation section, beginning on page 2.
---------------------------------------------------------------------------

    \3\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
---------------------------------------------------------------------------

    With this notice, the Commission is asking agencies with
jurisdiction by law and/or special expertise with respect to the
environmental issues of this Project to formally cooperate in the
preparation of the EA.\4\ Agencies that would like to request
cooperating agency status should follow the instructions for filing
comments provided under the Public Participation section of this
notice.
---------------------------------------------------------------------------

    \4\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's

implementing regulations for section 106 of the National Historic
Preservation Act, the Commission is using this notice to initiate
consultation with the Louisiana State Historic Preservation Office, and
to solicit its views and those of other government agencies, interested
Indian tribes, and the public on the Project's potential effects on
historic properties.\5\ The EA for this Project will document findings
on the impacts on historic properties and summarize the status of
consultations under section 106.
---------------------------------------------------------------------------

    \5\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Currently Identified Environmental Issues

    Commission staff have already identified several issues that
deserve attention based on a preliminary review of the proposed
facilities; the environmental information provided by PAPL; and
comments already received, as listed below. This preliminary list of
issues may change based on your comments and our analysis.

     Alternative compressor station locations
     Traffic on Gaytine Road
     Impact on property values
     Proposed developments near the compressor station
     Cumulative impacts

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the Project. Commission staff will update the environmental
mailing list as the analysis proceeds to ensure that Commission notices
related to this environmental review are sent to all individuals,
organizations, and government entities interested in and/or potentially
affected by the proposed Project.
    If the Commission issues the EA for an allotted public comment
period, a Notice of Availability of the EA will be sent to the
environmental mailing list and will provide instructions to access the
electronic document on the FERC's website (www.ferc.gov). If you need
to make changes to your name/address, or if you would like to remove
your name from the mailing list, please return the attached ``Mailing
List Update Form'' (appendix 3).

Additional Information

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number
in the ``Docket Number'' field, excluding the last three digits (i.e.,
CP20-21). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or<PHONE_NUMBER>, or for TTY, contact (202)
502-8659. The eLibrary link also provides access to the texts of all
formal documents issued by the Commission, such as orders, notices, and
rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along
with other related information.

    Dated: February 5, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-02822 Filed 2-11-20; 8:45 am]
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[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Notices]
[Pages 85626-85627]
[FR Doc No: 2020-28713]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP21-323-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: AGL Negotiated Rate to be
effective 1/1/2021.
    Filed Date: 12/18/20.
    Accession Number: 20201218-5013.
    Comments Due: 5 p.m. ET 12/30/20.

    Docket Numbers: RP21-324-000.
    Applicants: Midship Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Non-Conforming/Negotiated Rate
Gulfport 2nd Amendment to be effective 12/31/9998.
    Filed Date: 12/18/20.
    Accession Number: 20201218-5226.
    Comments Due: 5 p.m. ET 12/30/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: December 21, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-28713 Filed 12-28-20; 8:45 am]
BILLING CODE 6717-01-P


[ Federal Register: July 7, 2004 ( Volume 69, Number 129)] [ Notices] [ Page 40898 40899] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr07jy04 80]

ENVIRONMENTAL PROTECTION AGENCY [ OPPT 2003 0073; FRL 7782 5]

Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Reporting and Recordkeeping for Asbestos Abatement Worker Protection; EPA ICR No. 1246.09, OMB No. 2070 0072 AGENCY: Environmental Protection Agency ( EPA).

ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that an Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval. This is a request to renew an existing approved collection. This ICR is scheduled to expire on July 31, 2004. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before August 6, 2004.

ADDRESSES: Submit your comments to both ( 1) EPA, referencing docket ID number OPPT 2003 0073, online at http:// www. epa. gov/ edocket. ( our preferred meth od), or by mailto: oppt. ncic@ epa. gov. Mail to: Document Control Office ( DCO), Office o f Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, Mailcode: 7407T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503 ( reference OMB Control No. 2070 0072).

FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, Mailcode: 7408, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202 554 1404; e mail address: TSCA Hotline@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On January 12, 2004, EPA sought comments on this renewal ICR ( 69 FR 1738) pursuant to 5 CFR 1320.8( d). EPA received no comments during the comment period. EPA has established a public docket for this ICR under Docket ID No. OPPT 2003 0073, which is available for public viewing at the OPPT Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the [[ Page 40899]]

Reading Room is 202 566 1744, and the telephone number for the Pollution Prevention and Toxics Docket is 202 566 0280. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket .

ICR Title: Reporting and Recordkeeping for Asbestos Abatement Worker Protection. Abstract: EPA's asbestos worker protection rule is designed to provide occupational exposure protection to state and local government employees who are engaged in asbestos abatement activities in states that do not have state plans approved by the Occupational Safety and Health Administration ( OSHA). The rule provides protection for public employees not covered by the OSHA standard from the adverse health effects associated with occupational exposure to asbestos. This rule requires state and local governments to monitor employee exposure to asbestos, take action to reduce exposure, monitor employee health, train employees about asbestos hazards, and provide employees with information about exposures to asbestos and the associated health effects. The rule also requires state and local governments to notify EPA before commencing any asbestos abatement project. State and local governments must maintain medical surveillance and monitoring records and training records on their employees, must establish a set of written procedures for respirator programs and must maintain procedures and records of respirator fit tests. EPA will use the information to monitor compliance with the asbestos worker protection rule. Responses to the collection of information are mandatory ( see 40 CFR part 763, subpart G). Respondents may claim all or part of a notice as CBI. EPA will disclose information that is covered by a CBI claim only to the extent permitted by, and in accordance with, the procedures in 40 CFR part 2. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 0.33 hour per response. Burden means the total time, effort or financial resources expended by persons to generate, maintain, retain or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: State or local government agencies in states without an OSHA approved State Asbestos Plan or State Asbestos Worker Protection Plan that have employees engaged in asbestos related construction, custodial, and brake and clutch repair activities. Frequency of Collection: On occasion; includes third party notification requirement. Estimated No. of Respondents: 25,312. Estimated Total Annual Burden on Respondents: 412,243 hours. Estimated Total Annual Costs: $ 13,281,559. Changes in Burden Estimates: This request reflects a decrease of 24,046 hours ( from 436,289 hours to 412,243 hours) in the total estimated respondent burden from that currently in the OMB inventory. This decrease is due to a reduction in the number of supervisors at affected entities that need to read and interpret the regulation. In the previous ICR EPA anticipated that all supervisors undertook this activity. In the current ICR EPA expects that only new supervisors must do so. The change in burden represents an adjustment.

Dated: June 28, 2004. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 04 15344 Filed 7 6 04; 8: 45 am]

BILLING CODE 6560 50 P