[Federal Register Volume 85, Number 238 (Thursday, December 10, 2020)]
[Proposed Rules]
[Pages 79443-79446]
[FR Doc No: 2020-27059]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0831; Project Identifier 2019-CE-031-AD]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Gulfstream Aerospace Corporation (Gulfstream) Model GV
airplanes. This

proposed AD was prompted by notification of corrosion present in floor
beam support links. This proposed AD would require inspecting the right
butt line 6 floor beam inboard support links and bushings for
corrosion. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by January 25,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Gulfstream
Aerospace Corporation, Technical Publications Dept., P.O Box 2206,
Savannah, GA 31402-2206; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>internet: https://www.gulfstream.com/en/customer-support/. You may view this referenced service information at
the FAA, Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-0831; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Ronald ``Ron'' Wissing, Aviation
Safety Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College
Park, Georgia 30337; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2020-0831;
Project Identifier 2019-CE-031-AD'' at the beginning of your comments.
The most helpful comments reference a specific portion of the proposal,
explain the reason for any recommended change, and include supporting
data. The FAA will consider all comments received by the closing date
and may amend this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Ronald ``Ron'' Wissing, Aviation Safety Engineer, Atlanta ACO Branch,
FAA, 1701 Columbia Avenue, College Park, Georgia 30337. Any commentary
that the FAA receives which is not specifically designated as CBI will
be placed in the public docket for this rulemaking.

Background

    The FAA was advised of a failed floor beam support link at right
butt line (RBL) 6 on a Gulfstream Model GV airplane. The failed support
link resulted from seizure of the retaining sleeve and bushing at the
lower attachment point due to undetected corrosion. The floor beam
support links at RBL 6, fuselage stations (FS) 499, 531, and 569.5 have
a two-piece installation with straight bushings rather than spherical
bearings in the inboard link lower end. Design of the support links
allows floor beam movement when the cabin is pressurized. Seizure of
the lower bushing will not allow the link assembly to move as designed,
resulting in bending stress and potential failure of the link, which
may compromise the integrity of the pressure vessel floor.
    Gulfstream determined that the procedures for the existing Aircraft
Maintenance Manual (AMM) inspection does not reliably detect corrosion
in the floor beam support link lower bushings. Accordingly, Gulfstream
has revised the airworthiness limitation requirements to the AMM by
adding a detailed inspection with an initial and repetitive inspections
at intervals of 96 months and including references for removal and
installation instructions for RBL 6 Floor Beam Support Links.
    This condition, if not addressed, could result in link failure,
which can compromise the integrity of the pressure vessel floor and
lead to loss of pressurization to the airplane.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Gulfstream GV Customer Bulletin Number 231,
Revision A, dated July 30, 2019 (Gulfstream CB 231A). The service
information contains procedures for the inspection of the RBL 6, FS
499, 531, and 569.5, and the bushing in the lower end of the link and
all attachments for corrosion.
    The FAA reviewed Gulfstream GV AMM, Section 05-10-10, Revision 51,
dated February 28, 2020. The service information identifies tasks for a
recurring detailed inspection of the floor beam and wing links FS 465
through FS 576.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require a one-time inspection of the RBL 6
floor beam inboard support links and bushings for corrosion along with
any repairs necessary. This proposed AD would require a recurring
inspection of

the floor beam support links. This proposed AD also recommends sending
the inspection results to Gulfstream.

Differences Between This Proposed AD and the Service Information

    Gulfstream CB 231A requires reporting the results of the inspection
to Gulfstream and this proposed AD would not.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 148 airplanes
of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost              Parts cost          product        operators
----------------------------------------------------------------------------------------------------------------
Inspection per the Customer        120 work-hours x $85 per  Not applicable.....         $10,200      $1,509,600
 Bulletin, all 3 locations.         hour = $10,200.
Revise the AMM...................  1 work-hour x $85 per     Not applicable.....              85          12,580
                                    hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that would be required based on the results of the
proposed inspection. The FAA has no way of determining the number of
airplanes that might need these replacements:

                                               On-condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                  Action                                Labor cost                 Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of all 3 links................  40 work-hours x $85 per hour =                $316           $3,716
                                             $3,400.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected operators. As a result, the FAA has included all costs in this
cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Gulfstream Aerospace Corporation: Docket No. FAA-2020-0831; Project
Identifier 2019-CE-031-AD.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 25, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Gulfstream Aerospace Corporation Model GV
airplanes, all serial numbers, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 53: Fuselage
Structure.

(e) Reason

    This AD was prompted by a report that current inspection
procedures of floor beam support links, which can fail due to
corrosion, are inadequate. The FAA is issuing this AD to detect and
correct corrosion on a floor beam support link lower bushing. This
condition, if not addressed, could result in link failure, which can
compromise the integrity of the pressure vessel floor and lead to
loss of pressurization of the airplane.

(f) Actions and Compliance

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

(g) Action

    (1) Within 24 months after the effective date of this AD,
inspect the right butt line 6 floor beam inboard support links at
fuselage stations (FS) 499, 531, and 569.5 for corrosion by
following the Accomplishment Instructions, steps A through M, of
Gulfstream GV Customer Bulletin No. 231,

Revision A, dated July 30, 2019 (Gulfstream CB 231A). Where
Gulfstream CB 231A specifies contacting Gulfstream for procedures if
any corrosion is found, you must replace the support link in
accordance with a method approved by the Manager, Atlanta ACO
Branch, FAA, before further flight. For a method to be approved by
the Manager, Atlanta ACO Branch, as required by this paragraph, the
Manager's approval letter must specifically refer to this AD.
    (2) Within 24 months after the effective date of this AD, revise
the airworthiness limitations section of your maintenance manual or
inspection program to incorporate the airworthiness limitations
specified in Table 13: Fuselage Inspection Table, of Gulfstream GV
Aircraft Maintenance Manual, Section 05-10-10, Revision 51, dated
February 28, 2020. Thereafter, except as provided in paragraph (h)
of this AD, no alternative inspection intervals may be approved for
the fuselage floor beam and wing link FS 465-FS 576.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (i)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) Except as required by paragraph (g) of this AD: For service
information that contains steps that are labeled as Required for
Compliance (RC), the following provisions apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(i) Related Information

    (1) For more information about this AD, contact Ronald ``Ron''
Wissing, Aviation Safety Engineer, Atlanta ACO Branch, FAA, 1701
Columbia Avenue, College Park, Georgia 30337; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O
Box 2206, Savannah, GA 31402-2206; phone:<PHONE_NUMBER>; fax: (912)
965-3520; email<EMAIL_ADDRESS>internet: https://www.gulfstream.com/en/customer-support/. You may view this
referenced service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 901 Locust, Kansas City,
Missouri 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.

    Issued on December 2, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-27059 Filed 12-9-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Rules and Regulations]
[Pages 51567-51570]
[FR Doc No: 2017-24162]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2015-N-3455]

Medical Devices; Exemption From Premarket Notification; Class II
Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection
System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
an order to exempt autosomal recessive carrier screening gene mutation
detection systems from the premarket notification requirements, subject
to certain limitations. This exemption from 510(k), subject to certain
limitations, is immediately in effect for autosomal recessive carrier
screening gene mutation detection systems. This exemption will decrease
regulatory burdens on the medical device industry and will eliminate
private costs and expenditures required to comply with certain Federal
regulations. FDA is also amending the codified language for the
autosomal recessive carrier screening gene mutation detection system
devices classification regulation to reflect this final determination.

DATES: This order is effective November 7, 2017.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR
part 807 subpart E, require persons who intend to market a device to
submit and obtain FDA clearance of a premarket notification (510(k))
containing information that allows FDA to determine whether the new
device is ``substantially equivalent'' within the meaning of section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device
that does not require premarket approval.
    On December 13, 2016, the 21st Century Cures Act (Pub. L. 114-255)
(Cures Act) was signed into law. Section 3054 of the Cures Act amended
section 510(m) of the FD&C Act. As amended, section 510(m)(2) provides
that, 1 calendar day after the date of publication of the final list
under paragraph (1)(B), FDA may exempt a class II device from the
requirement to submit a report under section 510(k) of the FD&C Act,
upon its own initiative or a petition of an interested person, if FDA
determines that a 510(k) is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. This section
requires FDA to publish in the Federal Register a notice of intent to
exempt a device, or of the petition, and to provide a 60-calendar-day
comment period. Within 120 days of publication of such notice, FDA must
publish an order in the Federal Register that sets forth its final
determination regarding the exemption of the device that was the
subject of the notice. If FDA fails to respond to a petition under this
section within 180 days of receiving it, the petition shall be deemed
granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (referred to
herein as the Class II 510(k) Exemption Guidance) (Ref. 1).

III. Device Description

    On February 19, 2015, FDA completed its review of a De Novo request
for classification of the 23andMe

Personal Genome Service (PGS) Carrier Screening Test for Bloom
syndrome. FDA classified the 23andMe PGS Carrier Screening Test for
Bloom syndrome, and substantially equivalent devices of this generic
type, into class II (special controls) under the generic name
``Autosomal recessive carrier screening gene mutation detection
system.'' This type of device is a qualitative in vitro molecular
diagnostic system used for genotyping of clinically relevant variants
in genomic DNA isolated from human specimens intended for prescription
use or over-the-counter (OTC) use. The device is intended for autosomal
recessive disease carrier screening in adults of reproductive age. The
device is not intended for copy number variation, cytogenetic, or
biochemical testing.
    FDA believes that De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for determining
substantial equivalence for future devices within that type (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not
have to submit a De Novo request or a premarket approval application in
order to market a substantially equivalent device (see 21 U.S.C.
360c(i), defining ``substantial equivalence''). Instead, sponsors can
use the less-burdensome 510(k) process, when necessary, to market their
device.
    In the Federal Register of October 27, 2015 (80 FR 65774), FDA
published a notice (``October 2015 notice'') announcing its intent to
exempt autosomal recessive carrier screening gene mutation detection
system devices from premarket notification requirements, subject to
certain limitations, and provided opportunity for interested persons to
submit comments by November 27, 2015. After reviewing comments received
(summarized in section IV), FDA is now providing its final
determination for autosomal recessive carrier screening gene mutation
detection system devices by exempting this type of device from
premarket notification requirements, subject to certain limitations as
identified in this notice. FDA is also amending the codified language
for the autosomal recessive carrier screening gene mutation detection
system devices classification regulation to reflect this final
determination. Persons with pending 510(k) submissions for devices that
are now exempt from premarket notification, subject to the limitations,
should withdraw their submissions.

IV. Comments on the Proposed Exemption and FDA Response

    In response to the October 2015 notice announcing FDA's intent to
exempt autosomal recessive carrier screening gene mutation detection
system devices from premarket notification requirements, FDA received
submissions from three commenters--a device industry manufacturer, a
professional organization, and a health care organization--supporting
an exemption from premarket notification for this type of device.
    To make it easier to identify comments and our responses, the word
``Comment'' and a comment number appear in parentheses before each
comment's description, and the word ``Response'' in parentheses
precedes each response. Similar comments are grouped together under the
same number. Specific issues raised by the comments and the Agency's
responses follow.
    (Comment 1) Two commenters requested that FDA clarify that the list
of autosomal recessive carrier diseases included in the October 2015
notice is not exhaustive or expand the list of diseases and conditions
covered by the exemption to include all diseases and conditions
described in the scientific literature as inherited in an autosomal
recessive manner. One commenter further requested that FDA clarify that
the determination of the applicability of Sec.  866.5940 (21 CFR
866.5940) should be based upon scientific and clinical literature as to
the autosomal recessive nature of the disease or condition.
    (Response) The diseases and conditions listed in table 1 of the
October 2015 notice were based upon a limited review of the scientific
and clinical literature at that time. After consideration of the public
comments, FDA agrees that the autosomal recessive diseases and
conditions listed in that table should be treated as illustrative, and
not an exhaustive list. Based on FDA's review of current scientific and
clinical literature, FDA would not consider screening for autosomal
recessive carrier status by detection of clinically relevant gene
mutations associated with a large variety of diseases and conditions,
in addition to those listed in table 1 of the October 2015 notice, to
constitute a different intended use from that of a legally marketed
device in the generic type under Sec.  866.5940 for purposes of Sec.
866.9 (21 CFR 866.9). Because FDA agrees that the list of diseases and
conditions provided in the October 2015 notice is not comprehensive,
and that applicability of Sec.  866.5940 should be based upon
scientific and clinical literature as to the autosomal recessive nature
of a particular disease or condition, we are not providing a revised
list in this final order.
    (Comment 2) One commenter requested clarification that Sec.
866.5940 applies to OTC carrier detection devices for the determination
of carrier status by detection of clinically relevant gene mutations
associated with cystic fibrosis.
    (Response) In the October 2015 notice, FDA stated ``[a] gene
mutation detection system indicated for the determination of carrier
status by detection of clinically relevant gene mutations associated
with Cystic Fibrosis is not 510(k)-exempt since it is a class II device
subject to premarket notification and special controls under 21 CFR
866.5900--Cystic fibrosis transmembrane conductance regulator (CFTR)
gene mutation detection system.'' Similarly, in the final order
announcing the classification of an autosomal recessive carrier
screening gene mutation detection system into class II (80 FR 65626,
October 27, 2015), FDA stated ``A gene mutation detection system
indicated for the determination of carrier status by detection of
clinically relevant gene mutations associated with cystic fibrosis is
separately classified under 21 CFR 866.5900--Cystic fibrosis
transmembrane conductance regulator (CFTR) gene mutation detection
system (class II, special controls), and is thus not included in the de
novo classification.''
    However, after considering the comments regarding this exemption
action, and after reviewing the devices that are classified as CTFR
gene mutation detection systems under Sec.  866.5900 (21 CFR 866.5900),
FDA is now clarifying that an OTC gene mutation detection system
indicated for the determination of autosomal recessive carrier status
by detection of clinically relevant gene mutations associated with
cystic fibrosis (``OTC Cystic Fibrosis carrier screening test'') is
included within the scope of the classification regulation for an
autosomal recessive carrier screening gene mutation detection system
(Sec.  866.5940) and this exemption action.
    At the time FDA classified a CFTR gene mutation detection system
under Sec.  866.5900, we were not aware of any OTC Cystic Fibrosis
carrier screening tests, and it was not our intent at the time to
classify this test for OTC use. We also note that, to date, the only
Cystic Fibrosis carrier screening tests that have been cleared by FDA
under Sec.  866.5900 are for prescription use only. Finally,

FDA does not believe that the special controls under Sec.  866.5900(b)
would reasonably assure the safety and effectiveness of OTC Cystic
Fibrosis carrier screening tests, as such special controls were
developed to be applicable to prescription use only tests. For example,
when classifying a CFTR gene mutation detection system into class II,
FDA determined that the special controls under Sec.  866.5900(b), in
conjunction with general controls, provided a reasonable assurance of
the safety and effectiveness of the device. One risk to health that FDA
identified was that ``errors in interpretation of results may lead to
improper clinical recommendations and medical patient management.'' The
special controls concerning generation of test results, interpretation
of test results, and precautions for interpretation of the test results
were developed only for prescription use only tests with health care
providers in mind (see Section 6--Device Description; Test Results/
Reporting, Section 10--Labeling; Interpretation of Results, and Section
10--Labeling; Precautions for interpretations of the ``Class II Special
Controls Guidance Document: CFTR Gene Mutation Detection Systems''
(October 26, 2005) (Ref. 2).
    Therefore, FDA is clarifying that with regard to gene mutation
detection systems indicated for the determination of carrier status by
detection of clinically relevant gene mutations associated with cystic
fibrosis, the classification regulation Sec.  866.5900 is only
applicable to prescription use only tests. FDA is further clarifying
that we would not consider a gene mutation detection system indicated
for use as an OTC device for the determination of carrier status by
detection of clinically relevant gene mutations associated with cystic
fibrosis to constitute a different intended use from that of a legally
marketed device in the generic type Sec.  866.5940 for purposes of
Sec.  866.9(a). As such, OTC Cystic Fibrosis carrier screening tests
are within the scope of the classification regulation for an autosomal
recessive carrier screening gene mutation detection system (Sec.
866.5940) and are included within the scope of this action.
    (Comment 3) One commenter requested that the exemption be expanded
to include carrier screening for X-linked conditions. The commenter
further requested that the exemption be expanded to allow for the
reporting of diagnostic results.
    (Response) The October 2015 notice and this final order concern the
exemption from premarket notification of autosomal recessive carrier
screening gene mutation detection systems in the generic type Sec.
866.5940. Devices within the scope of the Sec.  866.5940 regulation for
autosomal recessive carrier screening gene mutation detection systems
are intended for autosomal recessive carrier screening in adults of
reproductive age. The requested indications for carrier screening for
X-linked conditions and for reporting of diagnostic results are outside
the scope of the Sec.  866.5940 regulation. As this final order
concerns only exemption of devices within the Sec.  866.5940
regulation, the request to expand the exemption to include carrier
screening for X-linked conditions or for the reporting of diagnostic
results is outside the scope of this action.
    (Comment 4) The three commenters were generally supportive of the
regulation and special controls established for the device type,
including for the special controls that relate to genetic counseling
(e.g., Sec.  866.5940(b)(1) and (b)(4)(iii)(A)). Two commenters
requested FDA provide additional recommendations that relate to the
special control requirements related to genetic counseling.
    (Response) FDA appreciates the comments supporting the regulation
and special controls established for the device type. FDA believes that
the class II special controls established for the device type, along
with the applicable general controls, provides reasonable assurance of
the safety and effectiveness of the device type. FDA notes that while
the comments received did not propose specific amendments to the
special control requirements, such discussion is outside the scope of
the October 2015 notice and this final order, which concerns the
exemption from premarket notification of autosomal recessive carrier
screening gene mutation detection systems in the generic type Sec.
866.5940.

V. Exemption for Autosomal Recessive Carrier Screening Gene Mutation
Detection System Devices

    FDA has assessed the need for 510(k) clearance for this type of
device by considering the factors discussed in the January 21, 1998,
Federal Register notice (63 FR 3142) and subsequently in the Class II
510(k) Exemption Guidance, as previously discussed in the October 2015
notice, and has determined they weigh in favor of 510(k) exemption,
subject to certain limitations discussed later in this order.
Therefore, for the reasons set forth in the Federal Register of October
27, 2015, and as informed by the comments received and FDA's
understanding and experience with autosomal recessive carrier screening
gene detection systems, FDA has determined that premarket notification
is not necessary to assure the safety and effectiveness of autosomal
recessive carrier screening gene detection systems, so long as the
limitations on exemption described later in this document are not met.

VI. Limitations on Exemption

    This exemption from 510(k) for an autosomal recessive carrier
screening gene mutation detection system applies only to those devices
that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type, or, in the
case of in vitro diagnostic devices, for which a misdiagnosis, as a
result of using the device, would not be associated with high morbidity
or mortality. Therefore, a manufacturer of an autosomal recessive
carrier screening gene mutation detection system would still be
required to submit a premarket notification to FDA before introducing a
device or delivering it for introduction into commercial distribution
when the device meets any of the conditions described in Sec.  866.9,
except Sec.  866.9(c)(2) to the extent it may include an autosomal
recessive carrier screening gene mutation detection system, for the
reasons explained in the October 2015 notice.
    Specifically, an autosomal recessive carrier screening gene
mutation detection system is not exempt from the premarket notification
requirement if such device: (1) Has an intended use that is different
from the intended use of a legally marketed device in that generic
type; e.g., the device is intended for a different medical purpose, or
the device is intended for lay use where the former intended use was by
health care professionals only; or (2) operates using a different
fundamental scientific technology than that used by a legally marketed
device in that generic type; e.g., a surgical instrument cuts tissue
with a laser beam rather than with a sharpened metal blade, or an in
vitro diagnostic device detects or identifies infectious agents by
using a DNA probe or nucleic acid hybridization or amplification
technology rather than culture or immunoassay technology; or (3) is an
in vitro device that is intended: for use in the diagnosis, monitoring
or screening of neoplastic diseases with the exception of
immunohistochemical devices; for measuring an analyte which serves as a
surrogate marker for screening, diagnosis, or monitoring of life
threatening diseases, such as acquired immune deficiency syndrome
(AIDS), chronic or active hepatitis, tuberculosis, or myocardial
infarction, or to monitor therapy; for assessing the

risk of cardiovascular diseases; for use in diabetes management; for
identifying or inferring the identity of a microorganism directly from
clinical material; for detection of antibodies to microorganisms other
than immunoglobulin G (IgG) and IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma; for
noninvasive testing; or for near-patient testing (point of care).
    Exemption from the requirement of premarket notification does not
exempt a device from other applicable regulatory controls under the
FD&C Act, including the applicable general and special controls.
Indeed, FDA's decision to grant 510(k) exemption for these devices is
based, in part, on the special controls, in combination with general
controls, providing sufficiently rigorous mitigations for the risks
identified for this generic type.
    This exemption from 510(k), subject to the limitations described
above, is immediately in effect for autosomal recessive carrier
screening gene mutation detection systems. This exemption will decrease
regulatory burdens on the medical device industry and will eliminate
private costs and expenditures required to comply with Federal
regulation. Specifically, regulated industry will no longer have to
invest time and resources in premarket notifications, including
preparation of documents and data for submission to FDA, payment of
user fees associated with 510(k) submissions, and responding to
questions and requests for additional information from FDA during
510(k) review for devices in this exempted type.

VII. Analysis of Environmental Impact

    We have 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.

VIII. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart, E have been
approved under OMB control number 0910-0120 and the collections of
information in 21 CFR parts 801 and 809 have been approved under OMB
control number 0910-0485.

IX. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) 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 https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance, ``Procedures for Class II Device Exemptions from
Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.
2. FDA Guidance for Industry and FDA Staff ``Class II Special
Controls Guidance Document: CFTR Gene Mutation Detection Systems,''
October 26, 2005, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071104.pdf.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, 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
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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

0
2. In Sec.  866.5940, revise paragraph (b) introductory text to read as
follows:

Sec.  866.5940  Autosomal recessive carrier screening gene mutation
detection system.

* * * * *
    (b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  866.9, except
Sec.  866.9(c)(2). Autosomal recessive carrier screening gene mutation
detection system must comply with the following special controls:
* * * * *

    Dated: November 1, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24162 Filed 11-6-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 4 (Friday, January 6, 2017)]
[Rules and Regulations]
[Pages 1598-1603]
[FR Doc No: 2016-31862]

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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 Instrumentation for Use With Urogynecologic Surgical Mesh

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reclassifying surgical instrumentation for use with urogynecologic
surgical mesh from class I (general controls) exempt from premarket
notification to class II (special controls) and subject to premarket
notification, and identifying them as ``specialized surgical
instrumentation for use with urogynecologic surgical mesh.'' FDA is
designating special controls that are necessary to provide a reasonable
assurance of safety and effectiveness of the device. FDA is
reclassifying this device on its own initiative based on new
information.

DATES: This order is effective January 6, 2017. See further discussion
in section V, ``Implementation Strategy.''

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) (21 U.S.C.
301 et seq.), 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).
    Devices that were in commercial distribution before the enactment
of the 1976 amendments on May 28, 1976, are generally referred to as
preamendments devices. Under section 513(d) of the FD&C Act,
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, are generally referred to as postamendments devices.
Postamendments devices are automatically classified into class III
without any FDA rulemaking process (section 513(f) of the FD&C Act).
Postamendments 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, under 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 Sec.  860.7(c)(2) (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)).)
    The process for issuing a final reclassification order is specified
in section 513(e)(1) of the FD&C Act. 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.
    In the Federal Register of May 1, 2014, FDA published a proposed
order to reclassify surgical mesh for transvaginal pelvic organ
prolapse (POP) repair from class II to class III (79 FR 24634). In the
same order, FDA also proposed to reclassify specialized surgical
instrumentation for use with urogynecologic surgical mesh (hereafter
referred to as urogynecologic surgical mesh instrumentation) from class
I--regulated under Sec.  876.4730 (21 CFR 876.4730) (manual
gastroenterology-urology surgical instrument and accessories) and Sec.
878.4800 (21 CFR 878.4800) (manual surgical instrument for general
use)--to class II and subject to premarket notification. In the Federal
Register of January 5, 2016, FDA published two final orders that: (1)
Reclassified surgical mesh for transvaginal POP repair from class II to
class III (81 FR 354) and (2) required the filing of a PMA or notice of
completion of a product development protocol for surgical mesh for
transvaginal POP repair (81 FR 364).
    In the May 1, 2014 proposed order, FDA stated that it would convene
a panel specifically to discuss reclassification of urogynecologic
surgical mesh instrumentation before finalizing reclassification of
those devices. FDA held a meeting on February 26, 2016 (81 FR 938,
January 8, 2016), of the Gastroenterology-Urology Devices Panel of the
Medical Devices Advisory Committee (``the Panel''), a device
classification panel described in section 513(b) of the FD&C Act. Prior
to the meeting, all panel members were provided a comprehensive
Executive Summary regarding the reclassification of urogynecologic
surgical mesh instrumentation, which included information contained in
the May 1, 2014, proposed order, a summary of comments submitted to the
public docket on the proposed reclassification of urogynecologic
surgical mesh instrumentation, and information regarding FDA's risk-
based classification and regulation of medical devices (Ref. 1).
    The Executive Summary also included a new FDA analysis of
perioperative adverse events related to urogynecologic surgical mesh
procedures. FDA conducted a new analysis to supplement the adverse
event information discussed in the May 1, 2014, proposed order, which
included adverse events related to POP procedures that were: (1)
Reported in clinical studies and systematic literature reviews in the
published literature or (2) submitted to the Manufacturer and User
Facility Device Experience (MAUDE) database between January 1, 2011,
and December 31, 2013. FDA's new analysis was a more comprehensive
analysis of perioperative adverse events associated with stress urinary
incontinence (SUI) procedures (retropubic, transobturator, mini-sling)
and POP procedures (transvaginal repair and transabdominal repair
(transabdominal POP repair is referred to as sacrocolpopexy)).
    Adverse events related to a urogynecologic surgical mesh procedure,
and that might be attributable to the specialized instrumentation used
during the procedure, are typically submitted to FDA or described in
published literature with reference to the surgical mesh and not the
instrumentation. Therefore, it can be difficult to distinguish adverse
events related to the urogynecologic surgical mesh instrumentation from
those related to the surgical mesh. As noted in the proposed order, FDA
believes it is reasonable to assume that perioperative adverse events--
i.e., those observed during the procedure or shortly thereafter (e.g.,
organ perforation, hemorrhage and bleeding, nerve injury and pain)--are
caused by or related to the use of specialized surgical instrumentation
to insert, place, fix, or anchor the surgical mesh during the
urogynecologic procedure. Hereafter, the term ``perioperative adverse
events'' will be used in this document to refer to adverse events that
FDA believes are caused by or related to the specialized
instrumentation that is the subject of this reclassification.
    In its new, more comprehensive analysis, FDA conducted a search of
the relevant, scientific literature published between January 1, 1997,
and December 8, 2015, to identify perioperative adverse events
associated with urogynecologic surgical mesh procedures (see the 207
studies included as references in the Executive Summary provided to the
Panel (Ref. 1). The search criteria consisted of a combination of terms
related to adverse events (type, timing with respect to surgery), type
of urogynecologic condition, type of surgical instrumentation, study
design, device name, and manufacturer name. FDA then filtered the
results to identify those studies that describe perioperative adverse
events during one of the following urogynecologic surgical mesh
procedures: SUI-retropubic, SUI-transobturator, SUI-mini-sling, POP-
transvaginal, and POP-sacrocolpopexy. All perioperative adverse events
were classified into one of the following categories: ``organ
perforation and injury,'' ``vascular injury and bleeding,'' or ``nerve
injury and pain.'' FDA then computed an adverse event rate for each
study by dividing the number of patients that experienced one of these
types of events by the total number of patients included in the study.
    FDA also conducted a search of the Medical Device Reporting (MDR)
database for relevant adverse events reported between January 1, 2008,
and December 2, 2015. There are no FDA product codes specifically
assigned to urogynecologic surgical mesh instrumentation; therefore,
FDA first identified reports that were associated with a product code
assigned to urogynecologic surgical mesh. FDA filtered the resulting
injury and death reports to identify and analyze those that described
perioperative adverse events. By stratifying its analysis by product
code for the urogynecologic surgical mesh, which depends, in part, on
the procedure type (e.g., OTP is assigned to mesh used during POP-
transvaginal procedures, OTN for mesh used during SUI-retropubic or
transobturator procedures), FDA characterized the perioperative adverse
events associated with the different kinds of urogynecologic surgical
mesh instrumentation used during SUI and POP procedures.
    After completing its review of the published literature and MDR
database, and aggregating its findings, FDA determined that
perioperative adverse events occur during all types of urogynecologic
surgical mesh procedures to treat female SUI and POP. Moreover, and as
discussed in the Executive Summary (Ref. 1, Attachments 6-8), FDA made
the following findings from its review of the published literature:
     The rate of ``vascular injury and bleeding'' varied
between 0.4-29.4 percent in studies describing retropubic SUI
procedures; 0.2-11.9 percent in studies describing transobturator SUI
procedures; 1-20.5 percent in studies describing mini-sling SUI
procedures; 0.7-7.7 percent in studies describing transvaginal POP
repair procedures; and 2.8 percent for one study describing
sacrocolpoplexy procedures;
     the rate of ``organ perforation and injury'' varied
between 0.3-23.8 percent for retropubic SUI procedures; 0.2-5.8 percent
for transobturator SUI procedures, 0.2-2.6 percent for mini-sling SUI
procedures; 0.7-13.1 percent for transvaginal POP repair procedures;
and 3.6 percent for one study describing sacrocolpoplexy procedures;
and

     the rate of ``nerve injury and pain'' varied between 0.1-
5.3 percent for retropubic SUI procedures; 0.8-30.8 percent for
transobturator SUI procedures, 1.1-4.1 percent for mini-sling SUI
procedures; 6.0-39.1 percent for transvaginal POP repair procedures;
and 14.9 percent for one study describing sacrocolpoplexy procedures.
    FDA presented a summary of the information contained in the
Executive Summary during the February 26, 2016, panel meeting (Ref. 2).
The Panel then discussed whether urogynecologic surgical mesh
instrumentation should be reclassified, and if so, whether it should be
reclassified from class I (general controls) to class II (special
controls) or class III (premarket approval) (Ref. 3). The Panel
discussed a variety of potential causes for the perioperative adverse
events identified by FDA (e.g., instrumentation design, surgeon error,
and surgeon experience). The Panel consensus was that the risks to
health of urogynecologic surgical mesh instrumentation that FDA
identified in the proposed order and Executive Summary (i.e.,
perioperative risks; damage to blood vessels, nerves, connective
tissue, and other structures; adverse tissue reaction; and infection)
was a complete and accurate list.
    The Panel agreed with FDA that the device is not purported or
represented for a use in supporting or sustaining human life, or for a
use which is of substantial importance in preventing impairment of
human health, or presents a potential unreasonable risk of illness or
injury. In light of this assessment, the Panel consensus was that
urogynecologic surgical mesh instrumentation did not meet the
definition of a class III device. The Panel also agreed with FDA that
general controls alone are not sufficient to provide reasonable
assurance of safety and effectiveness for the device, and that there is
sufficient information to establish special controls to provide such
assurance. When considering the specific special controls proposed by
FDA, two Panel members requested that an additional special control be
the submission of clinical data. However, after additional discussion,
the Panel unanimously agreed that the special controls proposed by FDA,
which did not include the submission of clinical data, would
appropriately mitigate the risks to health of this device. As such, the
Panel recommended that urogynecologic surgical mesh instrumentation be
reclassified from class I (general controls) exempt from premarket
notification to class II (special controls).

II. Key Changes From Proposed Order

    In the final order, FDA is modifying two of the special controls
included in the proposed order. First, FDA is revising Sec.
884.4910(b)(2) (21 CFR 884.4910(b)(2)) to require a demonstration that
the device, if reusable, can be adequately reprocessed. Reprocessing
validation will help to ensure that reusable urogynecologic surgical
mesh instrumentation is fit for subsequent use after being previously
used or contaminated. The validated processes are designed to remove
soil and contaminants by cleaning and to inactivate microorganisms by
disinfection or sterilization. Although FDA recognized in the proposed
order that ``the risk of infection due to inadequate sterilization and/
or reprocessing instructions/procedures can be mitigated through
sterilization validation testing and the inclusion of validated
reprocessing instructions in the device labeling,'' proposed Sec.
884.4910(b)(2) addressed sterilization only. FDA believes this revised
special control will help to mitigate the risks posed by infection from
reusable urogynecologic surgical mesh instrumentation.
    Second, FDA is revising Sec.  884.4910(b)(4) to require that non-
clinical performance testing demonstrate that the device: (1) Meets all
design specifications and performance requirements and (2) performs as
intended under anticipated conditions of use. In the proposed order,
FDA specified that ``[b]ench and/or cadaver testing must demonstrate
safety and effectiveness in expected-use conditions.'' FDA has revised
the reference to ``bench and/or cadaver testing'' to ``non-clinical
performance testing'' to allow for additional types of non-clinical
testing that will also mitigate the corresponding risks to health. FDA
is making other revisions to this provision as noted previously to
provide further clarity.

III. Public Comments in Response to the Proposed Order

    FDA received comments regarding the proposed reclassification of
urogynecologic surgical mesh instrumentation from class I to class II.
A summary of the comments and FDA's responses are provided in this
section. Certain comments are grouped together under a single number
because the subject matter is similar. The number assigned to each one
is purely for organizational purposes and does not signify the
comment's value, importance, or the order in which it was received.
    (Comment 1) Several comments supported reclassification of
urogynecologic surgical mesh instrumentation, with some comments
supporting reclassification into class II and others supporting
reclassification into class III.
    (Response 1) FDA agrees with comments supporting reclassification
of urogynecologic surgical mesh instrumentation into class II and
disagrees with comments that support reclassification into class III.
Based on information set forth in the proposed order (79 FR 24634), FDA
tentatively concluded in that order that certain specified special
controls, in addition to general controls, were necessary to mitigate
the risks to health for urogynecologic surgical mesh instrumentation,
and as such, proposed to reclassify the device from class I to class II
(79 FR 24634 at 24640). FDA continues to believe that there is
sufficient information to establish special controls to provide a
reasonable assurance of safety and effectiveness for this device, and
thus does not believe this device should be reclassified into class
III.
    FDA's new, more comprehensive, adverse event analysis provides
further support for the risks to health of this device that FDA
identified in the proposed order (see section I; Ref. 1), and the
special controls established by FDA are specifically intended to
mitigate those risks. For example, FDA's new MDR analysis revealed that
failures of urogynecologic surgical mesh instrumentation (e.g., needle
detachments, breaks, or bends; covering sheath breaks or tears) occur
during both SUI and POP procedures, and these failures are associated
with perioperative adverse events. The special control established at
Sec.  884.4910(b)(4) addresses these failures and the risk of
perioperative injuries by requiring a demonstration that the device
meets all design specifications and performance requirements.
    Based on all of this information, the Panel consensus was that
urogynecologic surgical mesh instrumentation meets the statutory
definition of a class II device and does not meet the statutory
definition of a class III device (see section I; Ref. 3).
    Because FDA has determined that general controls alone are not
sufficient to provide a reasonable assurance of safety and
effectiveness for this device, and there is sufficient information to
establish special controls to provide such an assurance, FDA is
reclassifying the device into class II.
    (Comment 2) One comment requested that urogynecologic surgical mesh

instrumentation have the same classification as the surgical mesh with
which it is indicated to be used.
    (Response 2) Surgical mesh indicated for urogynecologic procedures
is a class III device when it is indicated for transvaginal POP repair
(see 81 FR 354; Sec.  884.5980) and a class II device when it is
indicated for all other urogynecologic procedures, such as
sacrocolpopexy and treatment of female SUI (see Sec.  878.3300). FDA
characterized the risk profile of different kinds of urogynecologic
surgical mesh instrumentation by analyzing adverse events associated
with the use of this specialized instrumentation and stratifying them
by the type of urogynecologic procedure for which they were used. The
results indicate that the risk profile of urogynecologic surgical mesh
instrumentation used with class III surgical mesh during transvaginal
POP repair is comparable to that of urogynecologic surgical mesh
instrumentation used with class II surgical mesh during other kinds of
urogynecologic procedures (see section I; Ref. 1). Urogynecologic
surgical mesh instrumentation used in all types of urogynecologic
surgical mesh procedures appears to have a similar risk-benefit
profile, and therefore FDA believes these devices should have the same
classification.
    Moreover, as previously discussed, based on information included in
the proposed order (79 FR 24634), FDA's comprehensive adverse event
analysis (see Ref. 1), and the Panel's deliberations and
determinations, FDA has determined that urogynecologic surgical mesh
instrumentation is a class II device because general controls alone
cannot provide a reasonable assurance of safety and effectiveness, but
there is sufficient information to establish special controls to
provide such assurance. As such, FDA is reclassifying these devices
from class I to class II.
    (Comment 3) One comment stated that the scope of the urogynecologic
surgical mesh instrumentation reclassification was unclear, and it
could be interpreted that the reclassification applies only to
instrumentation used for transvaginal POP repair rather than for
instrumentation used for any urogynecologic surgical mesh procedure.
    (Response 3) FDA disagrees that the scope of the instrumentation
reclassification was unclear in the May 1, 2014, proposed order. FDA
included the description in the identification of urogynecologic
surgical mesh instrumentation in proposed Sec.  884.4910(a) stating
that surgical instrumentation for use with surgical mesh for
urogynecological procedures is a prescription device used to aid in
insertion, placement, fixation, or anchoring of surgical mesh for
procedures including transvaginal POP repair, sacrocolpopexy
(transabdominal POP repair), and treatment of female SUI. This
description, which is not substantively changing in the final order,
makes clear that all urogynecologic surgical mesh instrumentation--
whether used for transvaginal POP repair or other urogynecologic
surgical mesh procedures--falls under this reclassification.
    (Comment 4) One comment stated that data provided in the proposed
order to support the instrumentation reclassification was based only on
POP procedures, that valid scientific evidence had not been provided to
support the instrumentation reclassification, and that no evidence was
provided to support the risks that were identified in the proposed
order.
    (Response 4) First, FDA acknowledges that the data provided to
support the instrumentation reclassification in the May 1, 2014,
proposed order derived only from surgical mesh procedures indicated for
POP. FDA subsequently conducted a new, more comprehensive analysis of
perioperative adverse events associated with a variety of SUI
procedures (retropubic, transobturator, mini-sling) and POP procedures
(transvaginal repair and sacrocolpoplexy) by reviewing adverse events
included in the relevant, scientific, published literature and adverse
events submitted to the MDR database. Based on this analysis, FDA
determined that perioperative adverse events occur during all types of
SUI and POP procedures (see section I; Ref. 1). FDA also discovered
that in the published literature, the highest reported rates of ``organ
perforation and injury,'' ``vascular injury and bleeding,'' and ``nerve
injury and pain'' were distributed across different types of
urogynecologic surgical mesh procedures rather than only occurring
during one specific type, such as transvaginal POP repair. FDA believes
these results provide further support for the reclassification of these
devices into class II, and also supports the scope of this
reclassification, which encompasses specialized instrumentation used
during all types of urogynecologic surgical mesh procedures. After
presenting the proposed order and this new information to the Panel at
the February 26, 2016, meeting, the Panel recommended that
urogynecologic surgical mesh instrumentation be reclassified from class
I (general controls) exempt from premarket notification to class II
(special controls) (Ref. 3). FDA agrees with the Panel's
recommendations and is reclassifying these devices from class I to
class II.
    Second, FDA disagrees that valid scientific evidence was not
provided in the May 1, 2014, proposed order to support reclassification
of urogynecologic surgical mesh instrumentation. Valid scientific
evidence is defined in Sec.  860.7(c)(2) as evidence from well-
controlled investigations, other types of studies and case histories
conducted by qualified experts, and reports of significant human
experience with a marketed device, from which it can fairly and
responsibly be concluded by qualified experts that there is reasonable
assurance of the safety and effectiveness of a device under its
conditions of use. (See also section 513 of the FD&C Act). In the
proposed order, FDA reviewed perioperative adverse events included in
published studies of surgical mesh used during POP procedures. These
publications constitute ``valid scientific evidence'' because they are
controlled studies (Refs. 7-10, 12, 14) and collections of well-
documented case histories conducted by qualified experts (Refs. 4-6,
11, 13).
    Finally, FDA disagrees that no evidence was provided to support the
risks of urogynecologic surgical mesh instrumentation identified in the
proposed order. In the proposed order, FDA specifically referenced
clinical studies and systematic literature reviews in the published
literature that included reports of perioperative adverse events (e.g.,
bleeding, hematoma, and blood loss; organ perforation; and
neuromuscular problems) to support the proposed reclassification.
Moreover, the risks of ``perioperative injury'' and ``pelvic pain and
neuromuscular problems'' were also identified during FDA's search of
the MAUDE database. As discussed in the proposed order, 843 reports in
the MAUDE database analysis related to bleeding, hematoma, and blood
loss; 42 reports related to organ perforation; and 196 reports of
neuromuscular problems. FDA acknowledges that no data were provided to
support the identified risks of ``infection'' and ``adverse tissue
reaction.'' Although there are many possible causes for ``infection''
and ``adverse tissue reaction'' during a urogynecologic surgical mesh
procedure, as FDA noted in the proposed order (see 79 FR 24634 at
24639), FDA believes ``infection'' and ``adverse tissue reaction'' are
general risks that apply to all devices that

contact the patient and need to be used sterile.
    As discussed throughout this document, FDA subsequently conducted a
more comprehensive search of the relevant, scientific, published
literature and MDR database to evaluate the risks of urogynecologic
surgical mesh instrumentation. A summary of the findings from these
reviews is in the Executive Summary (Ref. 1) and was provided in our
presentation to the Panel on February 26, 2016 (Ref. 2). The findings
from the literature review--which were confirmed by the MDR database
review--provide further support for the risks identified and discussed
in the proposed order.
    Based on this information, the Panel consensus was that the four
risks to health of urogynecologic surgical mesh instrumentation that
FDA identified in the proposed order is a complete and accurate list
(Ref. 3).
    (Comment 5) One comment, which was submitted after the proposed
order issued and before the Panel meeting was held, stated that the
proposed order should be withdrawn until Panel input was obtained.
    (Response 5) FDA disagrees. The process followed by FDA in
reclassifying this device is in accordance with section 513(e)(1) of
the FD&C Act. This provision requires, in relevant part, that issuance
of a final administrative order reclassifying a device be preceded by a
proposed order and a meeting of a device classification panel. There is
no requirement that a proposed order be ``withdrawn'' after its
issuance but before the Panel meeting, and the rationale for doing so
is not clear to FDA.

IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings
as published in the proposed order for urogynecologic surgical mesh
instrumentation, with the modifications discussed in section II of this
document. For the reasons set forth in the proposed order and in this
document, FDA concludes that general controls are insufficient to
provide a reasonable assurance of safety and effectiveness for
urogynecologic surgical mesh instrumentation, and there is sufficient
information to establish special controls to provide such assurance.
    FDA is issuing this final order to reclassify urogynecologic
surgical mesh instrumentation from class I (general controls) exempt
from premarket notification to class II (special controls) and subject
to premarket notification, and identifying them as ``specialized
surgical instrumentation for use with urogynecologic surgical mesh.''
FDA is also establishing special controls, which are set forth in Sec.
884.4910(b)(1) through (5).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of urogynecologic surgical mesh instrumentation, and
therefore, this device is not exempt from premarket notification
requirements.

V. Implementation Strategy

    The order is effective January 6, 2017.
    Manufacturers of urogynecologic surgical mesh instrumentation that
have not been legally marketed prior to January 6, 2017, must obtain
510(k) clearance and demonstrate compliance with the special controls
included in this final order before marketing the device.
    Manufacturers of urogynecologic surgical mesh instrumentation that
have been legally marketed prior to January 6, 2017, must obtain 510(k)
clearance and demonstrate compliance with the special controls included
in this final order by January 8, 2018, for those devices if they wish
to continue offering them for sale.

VI. 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.

VII. Paperwork Reduction Act of 1995

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

VIII. 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 specialized surgical instrumentation for use
with urogynecologic surgical mesh into class II in Sec.  884.4910.

IX. 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 https://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. Executive Summary of the February 26, 2016, meeting of the
Gastroenterology-Urology Devices Panel (available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM487224.pdf).
    2. FDA presentation to Panel members at the February 26, 2016,
meeting of the Gastroenterology-Urology Devices Panel (available at
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM490205.pdf).
    3. Transcript of the February 26, 2016, meeting of the
Gastroenterology-Urology Devices Panel (available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM491862.pdf).
    4. Caquant, F., et al., ``Safety of Trans Vaginal Mesh
Procedure: Retrospective Study

of 684 Patients,'' Journal of Obstetrics and Gynecology Research,
34(4):449-456, 2008.
    5. Maher, C.F., et al., ``Surgical Management of Pelvic Organ
Prolapse in Women,'' Cochrane Database of Systematic Review, 4:
CD004014, 2010.
    6. Diwadkar, G.B., et al., ``Complication and Reoperation Rates
After Apical Vaginal Prolapse Surgical Repair: A Systematic
Review,'' Obstetrics & Gynecology, 113(2 Pt. 1):67-73, 2009.
    7. Maher, C.F., et al., ``Laparoscopic Sacral Colpopexy Versus
Total Vaginal Mesh for Vaginal Vault Prolapse: A Randomized Trial,''
American Journal of Obstetrics & Gynecology, 204(4):360.e1-360.e7,
2011.
    8. Altman, D., et al., ``Anterior Colporrhaphy Versus
Transvaginal Mesh for Pelvic-Organ Prolapse,'' New England Journal
of Medicine, 364:1826-1836, 2011.
    9. Iglesia, C.B., et al., ``Vaginal Mesh for Prolapse: A
Randomized Controlled Trial,'' Obstetrics & Gynecology, 116(2 Pt.
1):293-303, 2010.
    10. Withagen, M.I., et al., ``Trocar-Guided Mesh Compared With
Conventional Vaginal Repair in Recurrent Prolapse: A Randomized
Controlled Trial,'' Obstetrics & Gynecology, 117(2 Pt. 1):242-250,
2011.
    11. Sung, V.W., et al., Society of Gynecologic Surgeons
Systematic Review Group. ``Graft Use in Transvaginal Pelvic Organ
Prolapse and Urinary Incontinence,'' Obstetrics & Gynecology,
112(5):1131-1142, 2008.
    12. Hiltunen, R., et al., ``Low-Weight Polypropylene Mesh for
Anterior Vaginal Wall Prolapse: A Randomized Controlled Trial,''
Obstetrics & Gynecology, 110(2 Pt. 2):455-462, 2007.
    13. Jia, X., et al., ``Efficacy and Safety of Using Mesh or
Grafts in Surgery for Anterior and/or Posterior Vaginal Wall
Prolapse: Systematic Review and Meta-Analysis,'' British Journal of
Obstetrics and Gynecology, 115:1350-1361, 2008.
    14. Sivaslioglu, A.A., E. Unlubilgin, and I. Dolen, ``A
Randomized Comparison of Polypropylene Mesh Surgery With Site-
Specific Surgery in the Treatment of Cystocoele,'' International
Urogynecology Journal and Pelvic Floor Dysfunction, 19(4):467-471,
2008.

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 part 884 continues to read as follows:

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

0
2. Add Sec.  884.4910 to subpart E to read as follows:

Sec.  884.4910   Specialized surgical instrumentation for use with
urogynecologic surgical mesh.

    (a) Identification. Specialized surgical instrumentation for use
with urogynecologic surgical mesh is a prescription device specifically
intended for use as an aid in the insertion, placement, fixation, or
anchoring of surgical mesh during urogynecologic procedures. These
procedures include transvaginal pelvic organ prolapse repair,
sacrocolpopexy (transabdominal pelvic organ prolapse repair), and
treatment of female stress urinary incontinence. Examples of
specialized surgical instrumentation include needle passers and
trocars, needle guides, fixation tools, and tissue anchors. This device
is not a manual gastroenterology-urology surgical instrument and
accessories (Sec.  876.4730) or a manual surgical instrument for
general use (Sec.  878.4800).
    (b) Classification. Class II (special controls). The special
controls for specialized surgical instrumentation for use with
urogynecologic surgical mesh are:
    (1) The device must be demonstrated to be biocompatible;
    (2) The device must be demonstrated to be sterile and, if reusable,
it must be demonstrated that the device can be adequately reprocessed;
    (3) Performance data must support the shelf life of the device by
demonstrating package integrity and device functionality over the
requested shelf life;
    (4) Non-clinical performance testing must demonstrate that the
device meets all design specifications and performance requirements,
and that the device performs as intended under anticipated conditions
of use; and
    (5) Labeling must include:
    (i) Information regarding the mesh design that may be used with the
device;
    (ii) Detailed summary of the clinical evaluations pertinent to use
of the device;
    (iii) Expiration date; and
    (iv) Where components are intended to be sterilized by the user
prior to initial use and/or are reusable, validated methods and
instructions for sterilization and/or reprocessing of any reusable
components.

    Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31862 Filed 1-5-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 7, 2009 (Volume 74, Number 87)]
[Notices]
[Page 21430]
[DOCID:fr07my09-146]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Recordkeeping Requirements, Agency Information
Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that an Information
Collection Request (ICR) in support of the New Car Assessment Program
has been forwarded to the Office of Management and Budget (OMB) for
review and comment. The ICR describes the nature of the information
collections and their expected burden. The Federal Register Notice with
a 60-day comment period was published on March 9, 2009 74 FR 44, pages
10122 and 10123, or U.S. DOT Docket Number NHTSA-2009-0032.

DATES: Comments must be submitted on or before June 8, 2009.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Johanna
Lowrie, U.S. Department of Transportation, NHTSA, Room W43-410, 1200
New Jersey Ave., SE., Washington, DC 20590. Ms. Lowrie's telephone
number is<PHONE_NUMBER>. Please identify the relevant collection of
information by referring to its OMB Control Number.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: Vehicle Information for the General Public.
    OMB Number: 2127-0629.
    Type of Request: Regular.
    Abstract: NHTSA's mission is to save lives, prevent injury, and
reduce motor vehicle crashes. Providing consumer information on vehicle
safety is an important means of improving vehicle safety through market
forces. NHTSA provides consumers with vehicle safety information such
as front and side crash results, rollover propensity, and the
availability of a wide array of safety features provided on each
vehicle model. NHTSA also uses this safety feature information when
responding to public inquiries and analyzing rulemaking petitions which
ask the agency to mandate certain safety features.
    The agency has attempted to coordinate and reduce the reporting
burden associated with this information collection. Another information
collection obtains data related to motor vehicle compliance with the
agency's Federal motor vehicle safety standards. Although the consumer
information collection data is distinct and unique from the compliance
data, respondents to both collections are the same. Consequently, the
consumer information collection is closely coordinated with the
compliance collection to enable responders to assemble the data most
efficiently. The burden is further made easier by sending electronic
files to the respondents in which the data is entered and
electronically returned to the agency.
    The consumer information collected is used on the agency's http://
www.safercar.gov Web site, in the ``Buying a Safer Car'' and ``Buying a
Safer Car for Child Passengers'' brochures, in other consumer
publications, as well as for internal agency analyses and responses to
consumer inquiries.
    Affected Public: Manufacturers that sell motor vehicles in the
United States under 10,000 lbs of Gross Vehicle Weight Rating.
    Estimated Total Annual Burden: 924 hours.
    ADDRESSES: Send comments, within 30 days, to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725-17th Street, NW., Washington, DC 20503, Attention: NHTSA Desk
Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A Comment to OMB is most effective if OMB
receives it within 30 days of publication.

    Issued in Washington, DC, on May 1, 2009.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. E9-10596 Filed 5-6-09; 8:45 am]


[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Notices]
[Pages 28508-28509]
[FR Doc No: 2014-11378]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0002; FRL-9910-15]

SFIREG Full Committee; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Association of American Pesticide Control Officials
(AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG), Full
Committee will hold a 2-day meeting, beginning on June 9, 2014 and
ending June 10, 2014. This notice announces the location and times for
the meeting and sets forth the tentative agenda topics.

DATES: The meeting will be held on Monday, June 9, 2014 from 8:30 a.m.
to 5:00 p.m. and 8:30 a.m. to 12 noon on Tuesday June 10, 2014.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at EPA One Potomac Yard (South
Bldg.), 2777 Crystal Dr., Arlington, VA. 1st Floor, South Conference
Room.

FOR FURTHER INFORMATION CONTACT: Ron Kendall, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>or Grier Stayton, SFIREG Executive
Secretary, P.O. Box 466, Milford DE 19963; telephone number (302) 422-
8152; fax<PHONE_NUMBER>; email address: Grier Stayton at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are
interested in pesticide regulation issues affecting States and any
discussion between EPA and SFIREG on FIFRA field implementation issues
related to human health, environmental exposure to pesticides, and
insight into EPA's decision-making process. You are invited and
encouraged to attend the meetings and participate as appropriate.
Potentially affected entities may include, but are not limited to:
Those

persons who are or may be required to conduct testing of chemical
substances under the Federal Food, Drug and Cosmetics Act (FFDCA), or
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
those who sell, distribute or use pesticides, as well as any Non-
Government Organization.
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, Identified by docket ID number EPA-HQ-
OPP-2014-0002 is available at http://www.regulations.gov, or at the
Office of Pesticide Programs Regulatory Public Docket Center (EPA/DC),
EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the OPP Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.

II. Tentative Agenda Topics

1. Issue Papers Status.
2. Pesticide Registration Review Update.
3. Endangered Species Act (ESA) Lawsuits Status.
4. ESA Consultation Process.
5. National Academy of Science Implementation Stakeholder Webinar.
6. Soil Fumigation Re-Registration, Other Re-Registration Issues.
7. Status of Pollinator Protection Issues Policy Development.
8. Pollinator Protection Label Language Issue Paper.
9. Environmental Hazards Statements Conflicts With Directions for Use
Statements.
10. National Pesticide Information Center/State Lead Agency Information
Exchange.
11. Project Officer Training Workgroup Report.
12. Results from Pre-State FIFRA Issues Research and Evaluation Group
(SFIREG) Meetings.
13. SFIREG/EPA Discussion--Role and Responsibilities of Working
Committees.
14. OECA Update.
15. Program Performance Measures Development and Implementation Pilot
Project.
16. Tribal Pesticide Program Council (TPPC) Report.
17. Tribal Pesticide Policy Council/SLA Project Initiative.

III. How can I request to participate in this meeting?

    This meeting is open for the public to attend. You may attend the
meeting without further notification.

List of Subjects

    Environmental protection.

    Dated: May 1, 2014.
Brian Frazer,
Acting Director, Field and External Affairs Division, Office of
Pesticide Programs.
[FR Doc. 2014-11378 Filed 5-15-14; 8:45 am]
BILLING CODE 6560-50-P