[Federal Register Volume 81, Number 2 (Tuesday, January 5, 2016)]
[Rules and Regulations]
[Pages 353-361]
[FR Doc No: 2015-33165]

Vol. 81

Tuesday,

No. 2

January 5, 2016

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 884

 Obstetrical and Gynecological Devices; Reclassification of 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-0297]

Obstetrical and Gynecological Devices; Reclassification of
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 reclassify surgical mesh for transvaginal
pelvic organ prolapse (POP) repair from class II to class III. FDA is
reclassifying these devices based on the determination that general
controls and special controls together are not sufficient to provide
reasonable assurance of safety and effectiveness for this device, and
these devices present a potential unreasonable risk of illness or
injury. The Agency is reclassifying surgical mesh for transvaginal POP
repair on its own initiative based on new information.

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

FOR FURTHER INFORMATION CONTACT: Sharon Andrews, Center for Devices and
Radiological Health, 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, established 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.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
    On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) was enacted. Section 608(a)
of FDASIA amended section 513(e) of the FD&C Act, changing the
mechanism for reclassifying a device from rulemaking to an
administrative order. Section 513(e) of the FD&C Act provides that FDA
may, by administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a device. The term ``new information,'' as used in section 513(e) of
the FD&C Act, includes information developed as a result of a
reevaluation of the data before the Agency when the device was
originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos
Co. v. United States Department of Health, Education, and Welfare, 587
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., Gen. Medical Co. v. FDA,
770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766
F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
    To be considered in the reclassification process, the ``valid
scientific evidence'' upon which the Agency relies must be publicly
available. Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
premarket approval application (PMA). (See section 520(c) of the FD&C
Act (21 U.S.C. 360j(c)).)
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final reclassification order. Specifically, prior to the
issuance of a final order reclassifying a 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 to a public docket.
    FDA published a proposed order (the 513(e) proposed order) to
reclassify this device in the Federal Register of May 1, 2014 (79 FR
24634). FDA received and has considered approximately 200 comments on
this 513(e) proposed order, as discussed in section II.
    FDA held a meeting on September 8 and 9, 2011 (76 FR 41507, July
14, 2011) of the Obstetrics and Gynecology Devices Panel of the Medical
Devices Advisory Committee (``the Panel''), a device classification
panel described in section 513(b) of the FD&C Act, to discuss whether
surgical mesh for transvaginal POP repair should be reclassified into
class III or remain in class II (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, placement of surgical mesh for
transvaginal 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 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.
    In the 513(e) proposed order, FDA also proposed to reclassify
surgical instrumentation for urogynecologic surgical mesh procedures
from class I to class II and establish special controls. FDA is not
finalizing the proposed reclassification and special controls for
surgical instrumentation for use with urogynecologic surgical mesh at
this time. As stated in the 513(e) proposed order preamble, FDA will
convene a panel to discuss specialized surgical instrumentation for use
with urogynecologic surgical mesh prior to finalizing reclassification
of instrumentation for this use. On February 26, 2016, the
Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee will have a panel meeting to discuss and make
recommendations for reclassification of these specialized surgical
instrumentation devices.

II. Public Comments in Response to the 513(e) Proposed Order

    In response to the 513(e) proposed order to reclassify surgical
mesh for transvaginal POP repair, FDA received approximately 200
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) Approximately 70 comments were received from
individuals or family members of individuals who underwent mesh repair
for POP, stress urinary incontinence (SUI), and/or hernias and reported
complications or adverse events experienced during or after their
procedures. The complications and adverse events reported included
organ perforation, bleeding, chronic pain, mesh exposure or extrusion
into the vagina and/or visceral organs (in some cases requiring
additional surgery), infection, atypical vaginal discharge, painful
sexual intercourse, self-catheterization, recurrent prolapse and/or
incontinence, 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, SUI,
and/or hernias. The complications and adverse events reported by these
commenters are consistent with those addressed in the 513(e) proposed
order preamble and discussed at the 2011 Panel meeting. The comments
did not identify any adverse event information that was not already
considered by FDA and the Panel.
    (Comment 2) Approximately 50 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 is outside the scope of the 513(e) proposed order and this
document. In the 513(e) proposed order (79 FR 24634 at 24636), FDA
stated that 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) Approximately 50 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 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.
    FDA does not believe 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 there is sufficient evidence at this time
to support a mandatory recall of this device. Under section 518(e) of
the FD&C Act (21 U.S.C. 360h(e)), 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 the safety and effectiveness of surgical mesh
for transvaginal POP repair.
    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 under section 522 of the FD&C
Act (21 U.S.C. 360l) 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. Elsewhere in this issue of the Federal
Register, FDA is issuing a final order under section 515(b) of the FD&C
Act (21 U.S.C. 360e(b)) (the 515(b) final order) to require the filing
of a PMA or notice of completion of a product development protocol for
surgical mesh for transvaginal POP repair. The preamble of the 515(b)
final order provides further information regarding the data and
scientific evidence needed for a PMA.
    FDA will consider other regulatory actions relating to this device
as appropriate in the future.
    (Comment 4) Approximately 20 comments stated that the polypropylene
material used to fabricate surgical mesh is inappropriate for
implantation. These comments contend that the degradation of the
polypropylene mesh in vivo may lead to systemic effects that can cause
serious complications.
    (Response) FDA believes that a thorough evaluation of the material
used to fabricate surgical mesh for transvaginal POP repair is needed
to provide a reasonable assurance of safety and effectiveness of the
device. The findings set forth in the 515(b) proposed order preamble,
as discussed in this document, address this issue (these findings are
adopted, as amended, in the 515(b) final order that is published
elsewhere in this issue of the Federal Register).
    In the 515(b) proposed order preamble, FDA stated that
manufacturers should provide information in their PMAs regarding
biocompatibility, preclinical bench testing and preclinical animal
studies, among other proposed 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 515(b) proposed order preamble also stated
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.
    (Comment 5) One comment stated that FDA should not include non-
crosslinked biologic grafts in this reclassification and that such
grafts should not be subject to postmarket surveillance studies. The
comment stated that the 513(e) proposed order cited relatively few
studies that examine the use of biologically derived grafts for POP
repair. The comment also noted that FDA's analysis did not distinguish
crosslinked versus non-crosslinked biologic grafts. The comment
requested that FDA review additional data, including a summary of 18
publications regarding non-crosslinked biologic grafts submitted by the
commenter, and consider the different risk profiles of biologic grafts
and specifically whether non-crosslinked biologic grafts should be
reclassified.
    (Response) As discussed in the response to comment 9, FDA performed
an updated review of the literature to consider new clinical
information available since publication of the 513(e) and 515(b)
proposed orders and additional publications cited by the commenter, and
whether non-crosslinked biologic grafts should be reclassified. Based
on this review, FDA believes that there is currently insufficient
evidence to support a finding that the benefit-risk profile of non-
crosslinked biologic grafts differs from that of synthetic meshes.
There is little evidence overall on biologic grafts (as compared to
synthetic meshes), and the majority of studies evaluating non-
crosslinked biologic grafts are on small populations and are not
prospective. Moreover, the limited clinical evidence that is available
indicates that like synthetic surgical mesh for transvaginal POP
repair, non-crosslinked biologic mesh is associated with adverse events
and does not demonstrate effectiveness compared to traditional (i.e.,
native tissue) repair of POP.
    The commenter cited 18 publications reporting outcomes for non-
crosslinked biologic graft for use in transvaginal or transabdominal
POP repair (Refs. 2 through 19). As described in this document, these
publications in totality do not provide sufficient evidence of the
reasonable safety and effectiveness of non-crosslinked biologic grafts.
    Of these publications, 6 of the 18 report outcomes on fewer than 15
study subjects (Refs. 2 through 7). Due to the small sample size, the
outcomes from these publications are difficult to interpret and FDA
could not conclude that the risk profiles of non-crosslinked biologic
grafts were different than synthetic meshes.
    Of the remaining 12 publications, 1 describes outcomes after
sacrocolpopexy (Ref. 2), 1 describes use of a non-crosslinked biologic
graft to cover a vaginal wall defect following explantation of a
synthetic mesh to treat prolapse (Ref. 3), and 1 describes
transperineal repair of rectocele (Ref. 4). These uses are outside the
scope of the reclassification.
    One publication reported a retrospective review of non-
contemporaneous mesh-augmented (non-crosslinked biologic and synthetic)
versus native tissue anterior compartment repair (Ref. 5). One author
in that report switched to the mesh-augmented technique part way
through the period covered by the study due to dissatisfaction with
native tissue repair. This may affect the objectivity of the study
results and may lead to a conclusion that inappropriately favors mesh-
augmented repair. Anatomic success was greater in mesh-augmented
patients; however, objective anatomic success was defined as Stage 0 or
1 using the Baden-Walder system (Stage 0--normal position, Stage 1--
descent halfway to the hymen). This may represent an ideal outcome, but
does not necessarily represent a clinically relevant outcome. As
discussed in the 513(e) proposed order preamble, prolapse staging
systems like the Pelvic Organ Prolapse Quantification (POP-Q) are ``not
correlated with POP symptoms or patient assessment of improvement
[(Barber et al., 2009)].''
    Another publication reported long-term followup in a retrospective
patient cohort (N = 41) who had undergone graft repair of anterior or
posterior vaginal prolapse compared to a contemporaneous cohort of
``matched'' native tissue repair controls (Ref. 6). Subjective outcomes
were significantly better in the graft cohort; however, recurrence
tended to be greater in the graft cohort when defined strictly as
>=POP-Q Stage 2. This means that the graft cohort experienced greater
anatomic failure when using POP-Q

Stage 1 as the cutoff for anatomic success.
    One publication described a retrospective case review without
native tissue control (Ref. 7). This review (N = 65) found a subjective
success (no symptoms and no bulge beyond the hymen) rate of 92 percent.
Reoperation rate for de novo and recurrent prolapse was 7.7 percent,
and three women had repeat surgery at the same anatomic site (anterior
compartment). Because this study did not include a control group, we
are unable to compare safety and effectiveness outcomes between
patients who received mesh and patients who underwent native tissue
repair.
    Two publications described prospective cohorts. In one small series
(N = 21), women with recurrent prolapse underwent anterior, posterior,
or combined anterior/posterior repair with non-crosslinked biologic
mesh (Ref. 8). Mean POP-Q scores preoperatively were Ba = 0.63 versus
Ba = 1.75 postoperatively. Preoperative Bp score was -0.2 versus Bp -
2.2 postoperatively. The authors reported a mean followup of 29 months.
Six patients reported persistent bulge, and eight patients reported
vaginal discomfort. This study has a small sample size and does not
allow for comparison to native tissue repair.
    The other prospective cohort study (N = 50) evaluated patient-
reported outcomes at 6 months following posterior compartment repair
augmented with non-crosslinked mesh (Ref. 9). Although significant
improvements were noted for vaginal symptoms, sexual matters score and
quality of life on the International Consultation on Incontinence
Questionnaire vaginal symptoms questionnaire, anatomic outcomes were
not collected. Therefore, effectiveness outcomes cannot be evaluated
from this study.
    Only three of the remaining publications described prospective
randomized controlled trials (RCTs) comparing anterior or posterior
vaginal repair using non-crosslinked biologic graft versus native
tissue repair (Refs. 10 through 12). None of the three RCTs defined
anatomic success as the leading edge of prolapse at or above the
hymenal ring, which is considered a more clinically relevant outcome
compared to POP-Q score. The criterion for anatomic success of prolapse
repair in the American Urogynecologic Society (AUGS) Pelvic Floor
Disorders Registry is leading edge at or above the hymen (Ref. 13).
    The final publication identified by the commenter described
prospective followup of a cohort assembled from a retrospective chart
review (N = 59) (Ref. 14). This report does define anatomic success at
the hymenal ring. Objective recurrence of prolapse in this study was
approximately 31 percent.
    Regarding mesh exposure/erosion, the publications cited by the
commenter suggests that the risk of vaginal exposure/erosion for the
non-crosslinked mesh is low. In the 513(e) proposed order preamble, FDA
noted that the incidence of mesh exposure did not differ between
nonabsorbable synthetic mesh (10.3 percent) and biologic graft material
(10.1 percent) (Ref. 15).
    For other types of surgical complications, one RCT (N = 56) found
that the number of complications in the mesh group was greater compared
to the native tissue repair group (Ref. 10). Blood loss was greater for
mesh versus native tissue rectocele repair in another RCT (N = 160)
(Ref. 12). In the same RCT, there was a trend towards increased risk of
wound separation following non-crosslinked graft repair versus native
tissue repair; however, the outcome did not reach statistical
significance.
    In addition, serious adverse events are reported in association
with non-crosslinked biologic graft, including pain necessitating
resurgery (Ref. 14). In this study, surgical complications included
cystotomy (6.8 percent) and enterotomy (1.7 percent). Twenty-four
percent of subjects had postoperative voiding dysfunction, and there
was a 5.1 percent rate of hemorrhage requiring transfusion. (It is
unclear whether these complications were device-related). The rate of
dyspareunia at followup was 8.3 percent. The study did not include a
control group, so it is unknown how the benefits and risks of graft-
augmented repair with the non-crosslinked biologic graft would have
compared with a native tissue repair.
    In summary, there is insufficient available evidence from
prospective studies using an appropriate primary endpoint for anatomic
success on which to evaluate the effectiveness of transvaginal POP
repair using non-crosslinked biologic mesh versus native tissue repair.
The available clinical outcomes provide evidence that non-crosslinked
biologic mesh is associated with adverse events. There are no data from
RCTs with long-term followup that demonstrate clinical effectiveness of
this material for transvaginal POP repair compared to native tissue
repair.
    As a result of these findings, FDA is not differentiating between
non-crosslinked biologic grafts and synthetic mesh for transvaginal POP
repair in this reclassification order and is reclassifying all of these
devices from class II to class III. FDA's decision is in line with the
2011 Panel, which did not recommend stratification of surgical mesh for
transvaginal POP repair by material characteristics.
    (Comment 6) Approximately 20 comments stated that patients were not
adequately informed of the possible complications following mesh
implantation or that patients were not informed prior to surgery that
mesh would be implanted.
    (Response) FDA believes that patients should be adequately informed
regarding the possible complications associated with surgical mesh. As
stated in the FDA Safety Communication published in July 2011 (Ref.
16), health care providers should: (1) Inform patients that
implantation of surgical mesh is permanent and that some complications
associated with the implanted mesh may require additional surgery that
may or may not correct the complication; (2) inform patients about the
potential for serious complications and their effect on quality of
life, including pain during sexual intercourse, scarring, and narrowing
of the vaginal wall in POP repair using surgical mesh; and (3) provide
patients with a copy of the patient labeling from the surgical mesh
manufacturer, if available. The 2011 Safety Communication also includes
recommendations for patients to help them obtain the appropriate
information prior to a surgical mesh repair.
    The Panel recommended that FDA focus on development of patient
labeling and provide patients with benefit-risk information on
available treatment options for POP, including surgical and nonsurgical
options, to help patients understand long-term safety and effectiveness
outcomes (Ref. 1, p. 150).
    For these reasons, in the findings of the 515(b) proposed order,
which are adopted as amended in the 515(b) final order that is being
published elsewhere in this issue of the Federal Register, FDA asserted
that manufacturers should include in their PMAs for these devices
professional and patient labeling, and that the patient labeling would
be expected to include, among other things, the risks and benefits of
the device and available treatment options. Therefore, it is expected
that PMAs for these devices include professional and patient labeling,
and that the patient labeling include, among other things, the risks
and benefits of the device and available treatment options.
    (Comment 7) Approximately 30 comments stated that surgical mesh
should be adequately tested, including

rigorous clinical evaluation prior to marketing. Comments also
emphasized the need to understand the long-term effects of surgical
mesh.
    (Response) FDA agrees that surgical mesh for transvaginal POP
repair should be adequately tested prior to marketing to provide a
reasonable assurance of safety and effectiveness. FDA believes that
surgical mesh for transvaginal POP repair should undergo mechanical and
chemical characterization and performance evaluation, biocompatibility,
sterilization validation, shelf life, and preclinical in vivo testing
to provide a reasonable assurance of safety and effectiveness of the
device prior to marketing. In addition, surgical mesh for transvaginal
POP repair should be evaluated clinically, specifically to evaluate the
safety and effectiveness of the device compared to native tissue
repair. In the 515(b) final order that is being published elsewhere in
this issue of the Federal Register, FDA is requesting that
manufacturers provide this information to support premarket approval of
surgical mesh for transvaginal POP repair.
    With respect to long-term effects of surgical mesh, FDA believes
that the clinical evaluation of surgical mesh for transvaginal POP
repair should include long-term followup. FDA issued postmarket
surveillance orders under section 522 of the FD&C Act for these devices
that will collect long-term followup out to 3 years post implantation.
    The comments also referenced surgical mesh for SUI and
sacrocolpopexy. As stated previously, surgical mesh for indications
other than transvaginal repair of POP is outside the scope of this
final order.
    (Comment 8) Approximately five comments stated the mesh for
treatment of female SUI and sacrocolpopexy should not be reclassified
to class III.
    (Response) As stated previously, surgical mesh for indications
other than transvaginal POP repair are outside the scope of this final
order.
    (Comment 9) One comment stated that FDA should evaluate recent data
on POP mesh repair as the recent literature is more representative of
current technologies, instructions for use, and physician training of
currently marketed devices and that erosion rates and complication
rates are lower in current literature than compared to rates cited in
the 513(e) proposed order.
    (Response) FDA conducted an updated review of the literature
published since the 513(e) and 515(b) proposed orders were issued and
reviewed additional publications cited by the commenter, summarized in
further detail in this document, and determined that the weight of the
evidence indicates that use of surgical mesh for transvaginal POP
repair is not strongly or consistently associated with increased
benefits over native tissue repair in the treatment of stage 2 or
higher POP. Overall, the evidence indicates that mesh surgeries take
longer to perform, result in greater blood loss, and have a
considerable risk of postoperative mesh erosion in comparison to native
tissue repair. In addition, there is suggestive evidence that use of
surgical mesh for transvaginal POP repair may pose a higher risk of de
novo POP relative to native tissue repair.
    The majority of studies identified by the commenter, and considered
in the updated literature review conducted by FDA, assessed the
anterior compartment; therefore, it is difficult to draw conclusions on
the differential effects of mesh by compartment, relative to native
tissue repair. Furthermore, data from prospective, randomized studies
comparing surgical mesh and native tissue repair using a clinically
relevant definition of success are limited at this time. The benefit-
risk profile comparison favors native tissue repair over use of
surgical mesh for transvaginal POP repair. FDA concludes that the
updated literature review further supports the reclassification of
surgical mesh for transvaginal POP repair from class II to class III as
reasonable assurance of safety and effectiveness for the device has not
been demonstrated.
    The comment stated that four recent systematic reviews on surgical
options for POP continue to support use of transvaginal mesh to treat
anterior wall prolapse (Refs. 17 through 20). One of these systematic
reviews was cited in the 513(e) proposed order preamble (Ref. 19) and
therefore is not discussed in detail here. This systematic review
evaluated surgical management of POP in women and concluded that ``The
use of grafts (biological or synthetic) reduces the risk of prolapse
symptoms and recurrent anterior vaginal prolapse on examination when
compared to native tissue repairs (colporrhaphy). However, the
advantages of a permanent polypropylene mesh must be weighed against
disadvantages including longer operating time, greater blood loss,
prolapse in other areas of the vagina, new onset urinary stress
incontinence, and the mesh becoming exposed in the vagina in 11 percent
of women. In general, there is a lack of evidence to support
transvaginal mesh operations used in apical or posterior compartment
surgery.'' The second of these two reviews reported on anterior vaginal
compartment repair specifically (Ref. 18). The review specific to
anterior vaginal compartment repair noted that improved anatomic
outcomes conferred by surgical mesh used for anterior POP repair are
not always accompanied by improvement in subjective outcomes. Whereas
polypropylene mesh appears to lead to improvement in both anatomic and
subjective outcomes, these results did not lead to improved functional
outcomes using validated questionnaires or to a lower reoperation rate
for POP. This review concluded that surgical mesh is significantly
associated with longer operating time, greater blood loss, and
development of POP in another vaginal compartment. The author also
noted a nonsignificant tendency towards higher cystotomy, de novo
dyspareunia, and de novo SUI rate compared to native tissue anterior
repair.
    The third systematic review cited by the commenter was to address
nonsurgical treatments for POP, effects of POP surgery by vaginal
compartment, and how different mesh materials affect surgical repair of
POP (Ref. 17). Regarding anterior prolapse repair with mesh, the author
did not reach a conclusion regarding the need for reoperation for POP
or SUI following index POP surgery; however, anterior repair using
surgical mesh was found to increase risk for revision of the vaginal
wound due to mesh exposure.
    The focus of the fourth systematic review cited by the commenter
described complications following POP repair using surgical mesh (Ref.
20). The review found that the mean total complication rate in the
anterior compartment was 27 percent and that there was an 8 percent
rate of complications >= grade III on the Clavien-Dindo classification
system (i.e., requiring surgical, endoscopic, or radiological
intervention).
    The comment also stated that these recent systematic reviews report
complication rates that required surgical intervention ranging from 6.3
to 9 percent in the anterior compartment versus the ``upper bound of 22
percent cited in the proposed order.'' In the 513(e) proposed order
preamble, FDA stated the following: ``From the one RCT that directly
compared sacrocolpopexy to transvaginal POP repair with mesh (both
using synthetic nonabsorbable mesh), overall re-surgery within 2 years
postoperative was significantly more common following transvaginal POP
repair with mesh than laparoscopic sacrocolpopexy, with rates of 22
percent (12/55) and 5 percent (3/53),

respectively (p = 0.006) (79 FR 24637).'' The 22 percent cited by FDA
in the 513(e) proposed order preamble was not specific for anterior
repair, but rather included all vaginal compartments.
    In addition to the four recent systematic reviews discussed
previously, the commenter cited 43 published reports, of which 31 are
abstracts or poster presentations. Based on the limited scientific
evidence in these abstracts and poster presentations, they are
difficult to evaluate, and therefore, FDA was unable to draw any
conclusions from these publications. The comment stated that
collectively, the studies report mesh exposure rates of 0 to 8 percent
and of the mesh exposures, only approximately 38 percent required
surgical intervention. The comment stated this outcome represents a
reduction compared to the 7.2 percent rate cited in the 513(e) proposed
order. However, the 7.2 percent rate cited by FDA in the 513(e)
proposed order preamble was the rate of reoperation due to any
complication, and not specifically for mesh exposure-related
complications.
    The comment also stated that the more recent literature defines
success as improved anatomic and subjective outcomes compared to native
tissue repair. Of the publications that were not abstracts or posters,
there is only one in which surgical mesh repair was compared to native
tissue (Ref. 21). In that study, the primary outcome was ideal anatomic
support based on POP-Q stage, and not subjective outcomes. Anatomic
success, defined as POP-Q stage 0 or 1 was greater for the surgical
mesh repair in the anterior compartment; however, improvement in
quality of life was not statistically significant between groups. In
addition, subjects in the surgical mesh group had statistically
significant longer hospital stays, operative time, and estimated blood
loss.
    With one exception, of the publications cited by the commenter to
represent success rates for one line of mesh products, the definition
of a success was ideal anatomic support (Refs. 22 through 27). As noted
in the 513(e) proposed order preamble, ideal anatomic support is not a
prerequisite for improvement in patient symptoms. As stated previously
in this document, the anatomic criterion for success following surgical
repair of prolapse in the AUGS Pelvic Floor Disorders Registry is
absence of leading edge of prolapse beyond the hymen, not POP-Q Stage
<= 1. In addition, because these studies did not compare outcomes
between mesh repair and native tissue repair, it is unknown whether the
success among mesh subjects would have exceeded that of native tissue
repair.
    One publication that evaluated more clinical and/or subjective
outcomes compared two mesh products (Ref. 26). The failure of the mesh
repair ranged from 24 percent to 46 percent, depending on the outcome
measure. Mesh exposure occurred at a rate of 8 percent. Pelvic pain was
reported at 7.4 percent, and of study subjects who were sexually
active, 12.7 percent reported painful intercourse. In one prospective
study (N = 30), no anatomic outcomes were reported; however, the report
stated that no patients had symptoms of recurrent prolapse at 12 months
of followup. Two patients in this cohort had mesh erosion which
required partial mesh excision (Ref. 28).
    The remaining publications cited in the comment address mesh
exposure, mesh repair as an ambulatory procedure, and stability of an
anchor device used to attach the mesh to an anatomic target (Refs. 29
through 31). The rate of mesh exposure in the first study was 8.1
percent (Ref. 28). None of these publications compared mesh repair to
native tissue repair, nor does any reflect a study designed to evaluate
surgical success.
    In summary, FDA concludes that the literature published since the
513(e) and 515(b) proposed orders were issued and the additional
literature cited by the commenter further supports the reclassification
of surgical mesh for transvaginal POP repair from class II to class
III.
    (Comment 10) One comment noted that direct comparison of safety
results between sacrocolpopexy, transvaginal repair, and native tissue
repair can be misleading if the vaginal repair does not have a vaginal
vault component.
    (Response) Based on the evidence cited in the 513(e) proposed order
preamble, FDA concluded that the types of risks associated with
transvaginal mesh for POP repair are similar across different vaginal
compartments. FDA is unaware of any new evidence that supports the
conclusion that the types of risk associated with transvaginal mesh for
POP are different across different vaginal compartments. However, FDA
acknowledges that the frequency of different types of adverse events
may vary across different vaginal compartments. FDA's conclusion is in
line with the Panel, which did not recommend that reclassification be
stratified by compartment. For the reasons discussed in the 513(e)
proposed order preamble and in this document, the reclassification
applies to all transvaginal mesh for POP repair regardless of location
of repair.
    (Comment 11) One comment stated that the 513(e) proposed order
makes definitive statements regarding benefit/risk, when in fact
additional studies are needed to establish benefit/risk.
    (Response) FDA disagrees that the 513(e) proposed order makes
definitive statements regarding benefit/risk. Throughout the 513(e)
proposed order preamble, FDA described its conclusions as
``tentative.''

III. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings
as published in the preamble to the 513(e) proposed order (79 FR
24634). FDA is issuing this final order to reclassify surgical mesh for
transvaginal POP repair from class II to class III. FDA is
reclassifying these devices based on the determination that general
controls and special controls together are not sufficient to provide
reasonable assurance of safety and effectiveness for this device. In
addition, in the absence of an established positive benefit-risk
profile, FDA has determined that the risks to health associated with
the use of surgical mesh for transvaginal POP repair identified
previously present a potential unreasonable risk of illness or injury.
    FDA has modified the proposed identification in Sec.  884.5980(a)
for surgical mesh for transvaginal pelvic organ prolapse repair to
clarify that the materials of construction may include synthetic
material, non-synthetic material, or a combination of synthetic and
non-synthetic materials.

IV. 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.

V. 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 814, subpart B, have been
approved under OMB control number 0910-0231; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.

VI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) of the FD&C Act, as amended, requires FDA to issue final
orders rather than regulations, FDASIA also provides for FDA to revoke
previously issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the
FD&C Act, as amended by FDASIA, in this final order, we are codifying
the reclassification of surgical mesh for transvaginal POP repair into
class III in 21 CFR 884.5980.

VII. 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. Transcript of the September 8 and 9, 2011, Meeting of the
Obstetrics and Gynecological Devices Panel. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM275043.pdf and http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM275061.pdf.
2. Deprest, J., D. de Ridder, J.P. Roovers, et al., ``Medium Term
Outcome of Laparoscopic Sacrocolpopexy With Xenografts Compared to
Synthetic Grafts.'' Journal of Urology 182: 2362-2368, 2009.
3. Jeffery, S.T . and A. Nieuwoudt, ``Beyond the Complications:
Medium-Term Anatomical, Sexual and Functional Outcomes Following
Removal of Trocar-Guided Transvaginal Mesh. A Retrospective Cohort
Study.'' International Urogynecology Journal 23(10): 1391-1396,
2012.
4. Ellis, C. N., ``Outcomes After the Repair of Rectoceles With
Transperineal Insertion of a Bioprosthetic Graft.'' Diseases of the
Colon and Rectum 53: 213-218, 2010.
5. Reid, R. I. and K. Luo, ``Site-Specific Prolapse Surgery. II.
Vaginal Paravaginal Repair Augmented With Either Synthetic Mesh or
Remodeling Xenograft.'' International Urogynecology Journal 22(5):
601-609, 2011.
6. Mouritsen, L., M. Kronschnabl, and G. Lose, ``Long-Term Results
of Vaginal Repairs With and Without Xenograft Reinforcement.''
International Urogynecology Journal 21:467-473, 2010.
7. Armitage, S., E. I. Seman, and M. J. Keirse, ``Use of Surgisis
for Treatment of Anterior and Posterior Vaginal Prolapse.''
Obstetrics and Gynecology International 376251, January 15, 2012.
8. Jeffery, S. T., S. K. Doumouchtsis, S. Parappallil, et al.,
``Outcomes, Recurrence Rates, and Postoperative Sexual Function
After Secondary Vaginal Prolapse Surgery Using the Small Intestinal
Submucosal Graft.'' Female Pelvic Medicine & Reconstructive Surgery
15: 151-156, 2009.
9. Madhu, C., J. Cooke, P. Harber, and D. Holmes, ``Functional
Outcomes of Posterior Vaginal Wall Repair and Prespinous Colpopexy
With Biological Small Intestinal Submucosal (SIS) Graft.'' Archives
of Gynecology and Obstetrics May 8, 2014.
10. Feldner, P. C., R. A. Castro, L. A. Cipolotti, et al.,
``Anterior Vaginal Wall Prolapse: A Randomized Controlled Trial of
SIS Graft Versus Traditional Colporrhaphy.'' International
Urogynecology Journal 21: 1057-1063, 2010.
11. Robert, M., I. Girard, E. Brennand, et al., ``Absorbable Mesh
Augmentation Compared With No Mesh for Anterior Prolapse: A
Randomized Controlled Trial.'' Obstetrics & Gynecology 123: 288-294,
2014.
12. Sung, V., C. Rardin, C. Raker, et al., ``Porcine Subintestinal
Submucosal Graft Augmentation for Rectocele Repair.'' Obstetrics &
Gynecology 119: 125-133, 2012.
13. Pelvic Floor Disorders Registry. Frequently Asked Questions.
Available at http://www.pfdr.org/p/cm/ld/fid=440.
14. Geoffrion, R., M. Murphy, and M. Robert, ``Vaginal Paravaginal
Repair With Porcine Small Intestine Submucosa: Midterm Outcomes.''
Female Pelvic Medicine & Reconstructive Surgery 17(4): 174-179,
2011.
15. Abed, H., D. D. Rahn, L. Lowenstein, et al., ``Incidence and
Management of Graft Erosion, Wound Granulation, and Dyspareunia
Following Vaginal Prolapse Repair With Graft Materials: A Systematic
Review.'' International Urogynecology Journal 22:789-798, 2011.
16. ``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.
17. Onwude, J. L., ``Genital Prolapse in Women.'' BMJ Clinical
Evidence (Online) March 14, 2012.
18. Maher, C., ``Anterior Vaginal Compartment Surgery.''
International Urogynecology Journal 24: 1791-1802, 2013.
19. Maher, C., B. Feiner, K. Baessler, and C. Schmid, ``Surgical
Management of Pelvic Organ Prolapse in Women.'' Cochrane Database of
Systematic Reviews 4:CD004014, April 30, 2013.
20. Barski, D., T. Otto, and H. Gerullis, ``Systematic Review and
Classification of Complications After Anterior, Posterior, Apical,
and Total Vaginal Mesh Implantation for Prolapse Repair.'' Surgical
Technology International 24:217-224, March 2014.
21. Su, T. H., H. H. Lau, W. C. Huang, et al., ``Single-Incision
Mesh Repair Versus Traditional Native Tissue Repair for Pelvic Organ
Prolapse: Results of a Cohort Study.'' International Urogynecology
Journal January 28, 2014.
22. Azais, H., C. J. Charles, P. Delporte, and P. Debondinance,
``Prolapse Repair Using the Elevate Kit: Prospective Study on 70
Patients.'' International Urogynecology Journal March 1, 2012.
23. Stanford, E. J., R. D. Moore, J. P. Roovers, et al., ``Elevate
Anterior/Apical: 12-month Data Showing Safety and Efficacy in
Surgical Treatment of Pelvic Organ Prolapse.'' Female Pelvic
Medicine & Reconstructive Surgery 19(2): 79-83, March-April, 2013.
24. Lubkan J., J. P. Roovers, D. M. Vandrie, et al., ``Single-
Incision Apical and Posterior Mesh Repair: 1-year Prospective
Outcomes.'' International Urogynecology Journal March 15, 2012.
25. Rapp, D. E., A. B. King, B. Rowe, and J. P. Wolters,
``Comprehensive Evaluation of Anterior Elevate System in the
Treatment of Anterior and Apical Pelvic Floor Descent: 2-year
Follow-up.'' Journal of Urology 191(2): 389-394, February 2014.
26. Wong, V., K. L. Shek, A. Rane, et al., ``A Comparison of Two
Different Mesh Kit Systems for Anterior Compartment Prolapse
Repair.'' Australian and New Zealand Journal of Obstetrics and
Gynaecology February 25, 2014.
27. Moore, R. D., G. K. Mitchell, and J. R. Miklos, ``Single-
Incision Vaginal Approach To Treat Cystocele and Vault Prolapse With
an Anterior Wall Mesh Anchored Apically to the Sacrospinous
Ligaments.'' International Urogynecology Journal 23(1): 85-91, 2012.
28. Gustapane, S., M. Leombroni, E. Falo, et al., ``Surgical Repair
of Pelvic Organ Prolapse and Follow-Up: An Institutional Multi-
Center Experience.'' World Journal of Obstetrics and Gynecology
2(4): 176-180, 2013.
29. Sirls, L. T., G. P. McLennan, K. A. Killinger, et al.,
``Exploring Predictors of Mesh Eexposure After Vaginal Prolapse
Repair.'' Female Pelvic Medicine & Reconstructive Surgery 19(4):
206-209, 2013.
30. Sinhal, D., J. Iyer, M. Mous, et al., ``Anterior-Apical Mesh
Repair System in

an Ambulatory Setting.'' Ambulatory Surgery 19(4): 130-133, 2013.
31. Brennand, E. A., D. Bhayana, S. Tang, et al., ``Anchor Placement
and Subsequent Movement in a Mesh Kit With Self-Fixating Tips: 6-
Month Follow-Up of a Prospective Cohort.'' British Journal of
Obstetrics and Gynaecology; DOI:10.1111/1471-0528.12536, 2014.

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 Sec.  884.5980 to subpart F to read as follows:

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

    (a) Identification. Surgical mesh for transvaginal pelvic organ
prolapse repair is a prescription device intended to reinforce soft
tissue in the pelvic floor. This device is a porous implant that is
made of synthetic material, non-synthetic material, or a combination of
synthetic and non-synthetic materials. This device does not include
surgical mesh for other intended uses (Sec.  878.3300 of this chapter).
    (b) Classification. Class III (premarket approval).

    Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33165 Filed 1-4-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Rules and Regulations]
[Pages 67077-67079]
[FR Doc No: 2018-28146]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-1089]
RIN 1625-AA00

Safety Zone; Sacramento New Year's Eve Fireworks Display,
Sacramento River, Sacramento, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing three temporary safety zones
in the navigable waters of the Sacramento River near River Walk Park
and the Tower Bridge in Sacramento, CA in support of the Sacramento New
Year's Eve Fireworks Display on December 31, 2018. These safety zones
are necessary to protect personnel, vessels, and the marine environment
from the dangers associated with pyrotechnics. Unauthorized persons or
vessels are prohibited from entering into, transiting through, or
remaining in the safety zones without permission of the Captain of the
Port or a designated representative.

DATES: This rule is effective from 8:30 p.m. to 9:46 p.m. on December
31, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-1089 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Junior Grade Jennae Cotton, U.S. Coast Guard
Sector San Francisco; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

APA Administrative Procedure Act
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule. Since the Coast Guard received notice of
this event on December 10, 2018, notice and comment procedures would be
impracticable in this instance.
    For similar reasons as those stated above, under 5 U.S.C.
553(d)(3), the Coast Guard finds that good cause exists for making this
rule effective less than 30 days after publication in the Federal
Register.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port (COTP) San Francisco has determined that
potential hazards associated with the Sacramento New Year's Eve
fireworks display on December 31, 2018, will be a safety concern for
anyone within a 175-foot radius of the fireworks firing sites. This
rule is needed to protect spectators, vessels, and other property from
hazards associated with pyrotechnics.

IV. Discussion of the Rule

    This rule establishes three temporary safety zones from 8:30 p.m.
to 9:46 p.m. on December 31, 2018. At 8:30 p.m. on December 31, 2018,
30 minutes prior to the commencement of the 16 minute fireworks
display, the safety zones for the Sacramento New Year's Eve Fireworks
Display will encompass the navigable waters around the fireworks firing
sites within a radius of 175 feet in approximate positions:
    Near River Walk Park at 38[deg]35'02'' N, 121[deg]30'30'' W,
    Near River Walk Park at 38[deg]34'54'' N, 121[deg]30'33'' W, and
    Near the Tower Bridge at 38[deg]34'50'' N, 121[deg]30'30'' W
(NAD83).
    This portion of the Sacramento River is depicted on National
Oceanic and Atmospheric Administration (NOAA) Chart 18662, available
for free at http://www.charts.noaa.gov/OnLineViewer/18662.shtml. The
safety zones will terminate at 9:46 p.m. on December 31, 2018.
    The effect of the temporary safety zones is to restrict navigation
in the vicinity of the fireworks firing sites during the scheduled
display. Except for persons or vessels authorized by the COTP or a
designated representative, no person or vessel may enter or remain in
the restricted areas. These regulations are needed to keep spectators
and vessels away from the immediate vicinity of the fireworks firing
sites to ensure the safety of participants, spectators, and transiting
vessels.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the limited
duration and narrowly tailored geographic area of the safety zones.
Although this rule restricts access to the waters encompassed by the
safety zones, the effect of this rule will not be significant because
the local waterway users will be notified via public Notice to Mariners
to ensure the safety zone will result in minimum impact. The entities
most likely to be affected are waterfront facilities, commercial
vessels, and pleasure craft engaged in recreational activities.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule may affect the following entities, some of which may be
small entities: Owners and operators of waterfront facilities,
commercial

vessels, and pleasure craft engaged in recreational activities and
sightseeing, if these facilities or vessels are in the vicinity of the
safety zones at times when these zones are being enforced. This rule
will not have a significant economic impact on a substantial number of
small entities for the following reasons: (i) This rule will encompass
only a small portion of the waterway for a limited period of time, and
(ii) the maritime public will be advised in advance of these safety
zones via Broadcast Notice to Mariners.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
safety zones of limited size and duration. It is categorically excluded
from further review under Categorical Exclusion L60(a) of Appendix A,
Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES.

E. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T11-965 to read as follows:

Sec.  165.T11-965  Safety zone; Sacramento New Year's Eve Fireworks
Display, Sacramento River, Sacramento, CA.

    (a) Location. These temporary safety zones are established in the
navigable waters of the Sacramento River within a radius of 175 feet of
the fireworks firing sites, near River Walk Park and the Tower Bridge
in Sacramento, CA, in approximate positions: Near River Walk Park at
38[deg]35'02'' N, 121[deg]30'30'' W, Near River Walk Park at
38[deg]34'54'' N, 121[deg]30'33'' W, and Near the Tower Bridge at
38[deg]34'50'' N, 121[deg]30'30'' W (NAD83).
    (b) Enforcement period. The zones described in paragraph (a) of
this section will be enforced from 8:30 p.m. until approximately 9:46
p.m. on December 31, 2018. The Captain of the Port San Francisco (COTP)
will notify the maritime community of periods during which these zones
will be enforced via Notice to Mariners in accordance with Sec.  165.7.
    (c) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer on a Coast Guard
vessel or a Federal, State, or local officer designated by or assisting
the COTP in the enforcement of the safety zones.
    (d) Regulations. (1) Under the general regulations in subpart C of
this part, entering into, transiting through, or anchoring within these
safety zones is prohibited unless authorized by the COTP or a
designated representative.
    (2) The safety zones are closed to all vessel traffic, except as
may be permitted by the COTP or a designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or a designated representative to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zones must comply with all directions given to
them by the COTP or a designated representative. Persons and vessels
may

request permission to enter the safety zones on VHF-23A or through the
24-hour Command Center at telephone<PHONE_NUMBER>.

    Dated: December 19, 2018.
Anthony J. Ceraolo,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2018-28146 Filed 12-27-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65163-65165]
[FR Doc No: 2023-20469]

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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: EC23-131-000.
    Applicants: Cascade Energy Storage, LLC, Sierra Energy Storage,
LLC, BRP Capital & Trade LLC, ENGIE Flexible Generation NA LLC.

    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Cascade Energy Storage, LLC, et al.
    Filed Date: 9/14/23.
    Accession Number: 20230914-5154.
    Comment Date: 5 p.m. ET 10/5/23.

    Docket Numbers: EC23-132-000.
    Applicants: Earp Solar, LLC, BCD 2023 Fund 1 Lessee, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Earp Solar, LLC.
    Filed Date: 9/14/23.
    Accession Number: 20230914-5156.
    Comment Date: 5 p.m. ET 10/5/23.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-288-000.
    Applicants: Maverick Clean Energy Center, LLC.
    Description: Maverick Clean Energy Center, LLC. submits Notice of
Self-Certification of Exempt Wholesale Generator Status.
    Filed Date: 9/14/23.
    Accession Number: 20230914-5087.
    Comment Date: 5 p.m. ET 10/5/23.

    Docket Numbers: EG23-289-000.
    Applicants: Harris Spencer BESS, LLC.
    Description: Harris Spencer BESS, LLC. submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 9/14/23.
    Accession Number: 20230914-5092.
    Comment Date: 5 p.m. ET 10/5/23.

    Docket Numbers: EG23-290-000.
    Applicants: Brazoria Winmil BESS, LLC.
    Description: Brazoria Winmil BESS, LLC. submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 9/14/23.
    Accession Number: 20230914-5094.
    Comment Date: 5 p.m. ET 10/5/23.

    Docket Numbers: EG23-291-000.
    Applicants: Harris CenterPoint BESS, LLC.
    Description: Harris CenterPoint BESS, LLC. submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 9/14/23.
    Accession Number: 20230914-5100.
    Comment Date: 5 p.m. ET 10/5/23.

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

    Docket Numbers: ER15-1365-004.
    Applicants: Morris Cogeneration, LLC.
    Description: Compliance filing: Compliance to 593 to be effective
N/A.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5125.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2843-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No. 7072; Queue No. AE2-299 to be effective 8/16/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5011.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2844-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Notice of Cancellation of WMPA,
Service Agreement No. 5803; Queue No. AF2-270 to be effective 11/15/
2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5016.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2845-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: SPS Attachment O--CIAC
Workpaper Filing to be effective 1/1/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5033.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2847-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2023-09-15_ICAP Deferral
Clean-Up Filing to be effective 11/15/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5050.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2848-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 4128 Omaha Public Power
District Sponsored Upgrade Agreement to be effective 8/23/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5052.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2849-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Notice of Cancellation of WMPA, SA
No. 5726; Queue No. AE1-188/AF1-224 to be effective 11/15/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5054.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2850-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: NYISO 205: LGIA Sunrise
Offshore Wind Project SA2795 (CEII) to be effective 8/31/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5058.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2851-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2023-09-15 New DTBAOA and
Terminate DSHBAOA--CAISO and APS to be effective 11/15/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5072.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2852-000.
    Applicants: Airport Solar LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 11/15/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5076.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2853-000.
    Applicants: Arroyo Solar LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 11/15/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5079.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2854-000.
    Applicants: Arroyo Energy Storage LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 11/15/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5080.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2855-000.
    Applicants: Assembly Solar III, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 11/15/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5081.
    Comment Date: 5 p.m. ET 10/6/23.

    Docket Numbers: ER23-2856-000.
    Applicants: Willow Springs Solar, LLC.
    Description: Sec.  205(d) Rate Filing: Willow Springs Solar, LLC to
be effective 11/15/2023.
    Filed Date: 9/15/23.
    Accession Number: 20230915-5082.
    Comment Date: 5 p.m. ET 10/6/23.

    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, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) 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>. The Commission's Office of
Public Participation (OPP) supports meaningful public engagement and
participation in Commission proceedings. OPP can help members of the
public, including landowners, environmental justice communities, Tribal
members and others, access publicly available information and navigate
Commission processes. For public inquiries and assistance with making
filings such as interventions, comments, or requests for rehearing, the
public is encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: September 15, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-20469 Filed 9-20-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Page 41306]
[FR Doc No: 2017-18366]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0069]

Notice To Extend the Public Comment Period for the Notice of
Intent To Prepare an Environmental Impact Statement for Model Year
2022-2025 Corporate Average Fuel Economy Standards

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of extension.

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

SUMMARY: NHTSA is extending the public comment period for the Notice of
Intent (NOI) to Prepare an Environmental Impact Statement (EIS) for
Model Year 2022-2025 Corporate Average Fuel Economy (CAFE) Standards to
Monday, September 25, 2017. The NOI was published in the Federal
Register on Wednesday, July 26, 2017. The public comment period for the
NOI was originally scheduled to end on Friday, August 25, 2017.

DATES: To ensure that NHTSA has an opportunity to fully consider
scoping comments, scoping comments should be received on or before
Monday, September 25, 2017. NHTSA will consider comments received after
that date to the extent the rulemaking schedule allows.

ADDRESSES: You may submit comments to the docket number identified in
the heading of this document by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery or Courier: U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m. Eastern
time, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, you must include the
docket number identified in the heading of this notice. Note that all
comments received, including any personal information provided, will be
posted without change to http://www.regulations.gov. Please see the
``Privacy Act'' heading below.
    You may call the Docket Management Facility at<PHONE_NUMBER>.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. We will continue to file relevant information in
the Docket as it becomes available.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at https://www.transportation.gov/privacy. Anyone is able to search the
electronic form of all comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you should submit three
copies of your complete submission, including the information you claim
to be confidential business information, to the Chief Counsel, NHTSA,
at the address given below under FOR FURTHER INFORMATION CONTACT. When
you send a comment containing confidential business information, you
should include a cover letter setting forth the information specified
in NHTSA's confidential business information regulation. See 49 CFR
part 512. In addition, you should submit a copy from which you have
deleted the claimed confidential business information to the Docket by
one of the methods set forth above.

FOR FURTHER INFORMATION CONTACT: For technical issues, contact Ken
Katz, Fuel Economy Division, Office of International Policy, Fuel
Economy, and Consumer Programs, telephone:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>for legal issues, contact Russell Krupen, Legislation
& General Law Division, Office of the Chief Counsel, telephone: 202-
366-1834, email<EMAIL_ADDRESS>at the National Highway
Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington,
DC 20590. Requests to be placed on the project mailing list may be sent
to either individual by mail or email.

SUPPLEMENTARY INFORMATION: On Wednesday, July 26, 2017, NHTSA published
in the Federal Register a document titled ``Notice of Intent to Prepare
an Environmental Impact Statement for Model Year 2022-2025 Corporate
Average Fuel Economy Standards.'' 82 FR 34740. The public comment
period for the NOI was scheduled to end on Friday, August 25, 2017.
    On Tuesday, August 15, 2017, NHTSA received a request for a 30-day
extension of the public comment period from the Sierra Club, the Center
for Biological Diversity, Environment America, the Safe Climate
Campaign, and the Environment Law & Policy Center. NHTSA has reviewed
the request and is extending the public comment period for the NOI by
31 days to Monday, September 25, 2017. NHTSA will consider comments
received after that date to the extent the rulemaking schedule allows.

    Issued in Washington, DC, under authority delegated in 49 CFR
parts 1.81 and 1.95.
Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2017-18366 Filed 8-25-17; 11:15 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Page 45647]
[FR Doc No: 2011-19167]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Special
Awareness Training for the Washington DC Metropolitan Area

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on May 26, 2011, vol. 76, no. 102, page 30753. This
collection of information is required of persons who must receive
training and testing under 14 CFR 91.161 in order to fly within 60
nautical miles (NM) of the Washington, DC omni-directional range/
distance measuring equipment (DCA VOR/DME).

DATES: Written comments should be submitted by August 29, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: OMB Control Number: 2120-0734.
    Title: Special Awareness Training for the Washington DC
Metropolitan Area.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The final rule containing this information collection
requirement was published on August 12, 2008 (73 FR 46797). The
collection of information is solicited by the FAA in order to maintain
a National database registry for those persons who are required to
receive training and be tested for flying in the airspace that is
within 60 NM of the DCA VOR/DME. This National database registry
provides the FAA with information on how many persons and the names of
those who have completed this training.
    Respondents: Approximately 366 pilots.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 122 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on July 25, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-300.
[FR Doc. 2011-19167 Filed 7-28-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 245 (Friday, December 20, 2013)]
[Rules and Regulations]
[Pages 76984-76986]
[FR Doc No: 2013-29140]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0524; Directorate Identifier 2012-SW-084-AD;
Amendment 39-17696; AD 2013-24-19]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter France (Eurocopter) Model AS332C, AS332L, AS332L1, AS332L2,
and EC225LP helicopters. This AD requires visually inspecting each
jettisonable emergency exit window panel (window) for sealant, and
removing any sealant that exists in the window's extruded sections.
This AD was prompted by jettison tests during routine maintenance
inspections that showed the windows failed to jettison. The actions of
this AD are intended to prevent failure of the windows to jettison, so
helicopter occupants can exit the aircraft during an emergency.

DATES: This AD is effective January 24, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of January 24,
2014.

ADDRESSES: For service information identified in this AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the European Aviation Safety
Agency (EASA) AD, any incorporated-by-reference service information,
the economic evaluation, any comments received, and other information.
The street address for the Docket Operations Office (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations Office,
M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE., Washington, DC 20590.

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

Discussion

    On June 20, 2013, at 78 FR 37156, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 by adding an AD that would apply to Eurocopter Model
AS332C, AS332L, AS332L1, AS332L2 and EC225LP helicopters that have
never undergone a window-jettison test. The NPRM proposed to require
visually inspecting each window for sealant, and removing any sealant
that exists in the window's extruded sections. The proposed
requirements were intended to prevent failure of the windows to
jettison, so helicopter occupants can exit the aircraft during an
emergency.
    The NPRM was prompted by AD No. 2012-0152, dated August 13, 2012,
issued by EASA, which is the Technical Agent for the Member States of
the European Union. EASA issued AD No. 2012-0152 to correct an unsafe
condition for certain Eurocopter Model AS 332 C, AS 332 C1, AS 332 L,
AS 332 L1, AS 332 L2 and EC 225 LP helicopters. EASA reports that
during required maintenance checks, there have been problems
jettisoning emergency exit windows. According to EASA, investigations
on several windows showed sealant between the extrusion and the window.
``This condition, if not detected and corrected, could prevent the
jettisoning of a window, possibly affecting the evacuation of
passengers in the event of an emergency situation,'' EASA states.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we received no comments on the NPRM (78 FR 37156, June 20,
2013).

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs and that air safety and the public interest require
adopting the AD requirements as proposed.

Differences Between This AD and the EASA AD

    The EASA AD applies to Model AS 332 C1 helicopters, and this AD
does not because that model is not FAA type-certificated. The EASA AD
requires the inspection of each window within 110 hours time-in-service
(TIS) or six months, while this AD requires the inspection within 110
hours TIS.

Related Service Information

    Eurocopter issued Alert Service Bulletin (ASB) No. AS332-56.00.04
for Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2 helicopters and
ASB No. EC225-56A002 for the EC225LP helicopter, both Revision 0, and
both dated August 8, 2012. Eurocopter advises of difficulties
jettisoning the window panel when performing a jettison test due to
sealant installed between the extrusion and the window. According to
Eurocopter, jettison tests are to be performed every two years. The
ASBs provide instructions to inspect each jettisonable window panel to
determine whether there is sealant between the extrusion and the
window.

Costs of Compliance

    We estimate that this AD affects 19 helicopters of U.S. Registry
and that labor rates average $85 a work-hour. Based on these estimates,
we expect the following costs:
     Visually inspecting the windows for sealant requires 1
work-hour for a labor cost of $85 per helicopter, and $1,615 for the
U.S. fleet.
     If needed, removing the sealant from the windows requires
2 work-hours for a labor cost of $170 per window.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-24-19 Eurocopter France Helicopters: Amendment 39-17696; Docket
No. FAA-2013-0524; Directorate Identifier 2012-SW-084-AD.

(a) Applicability

    This AD applies to Eurocopter France (Eurocopter) Model AS332C,
AS332L, AS332L1, AS332L2 and EC225LP helicopters, certificated in
any category, that have never undergone a window-jettison test.

(b) Unsafe Condition

    This AD defines the unsafe condition as the presence of sealant
on an emergency exit window panel. This condition could result in
the window failing to jettison, preventing the helicopter occupants
from exiting the aircraft during an emergency.

(c) Effective Date

    This AD becomes effective January 24, 2014.

(d) Compliance

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

(e) Required Actions

    Within 110 hours time-in-service (TIS), visually inspect each
jettisonable emergency exit window panel (window) by doing the
following:
    (1) Lift the extrusion slightly using a flat tool that does not
cause scoring.
    (2) Inspect for sealant on the inside and outside of the window
between the window and the extrusion and between the extrusion and
the structure.

    Note 1 to paragraph (e)(2) of this AD:  The presence of a
sealant bead on the extrusion parting lines, on the window pull-out
seal parting lines, and on the pull-out straps is expected, as shown
in Figure 1 of Eurocopter Alert Service Bulletin (ASB) No. AS332-
56.00.04 or ASB No. EC225-56A002, both Revision 0, and both dated
August 8, 2012, as applicable to your model helicopter.

    (3) If there is no sealant as shown in Photo 1 of Figure 2 of
Eurocopter ASB No. AS332-56.00.04 or ASB No. EC225-56A002, as
applicable to your model helicopter, no further action is required.
    (4) If there is sealant between the structure and the profile as
shown in Photo 2 of Figure 2 of Eurocopter ASB No. AS332-56.00.04 or
ASB No. EC225-56A002, as applicable to your model helicopter, or if
you cannot determine whether there is sealant, remove the extrusion.
    (5) Remove all sealant from the extrusion, the window, and the
structure.
    (6) If there is any crazing, cracking or other damage on the
extrusion, replace with an airworthy extrusion.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this

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

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2012-0152, dated August 13, 2012. You may view
the EASA AD at http://www.regulations.gov in Docket No. FAA-2013-
0524.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 5220, Emergency
Exits.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Eurocopter Alert Service Bulletin No. AS332-56.00.04,
Revision 0, dated August 8, 2012.
    (ii) Eurocopter Alert Service Bulletin No. EC225-56A002,
Revision 0, dated August 8, 2012.
    (3) For Eurocopter service information identified in this AD,
contact American Eurocopter Corporation, 2701 N. Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775; or at http://www.eurocopter.com/techpub.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on November 27, 2013.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2013-29140 Filed 12-19-13; 8:45 am]
BILLING CODE 4910-13-P