[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Pages 20167-20172]
[FR Doc No: 2021-07759]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-Z-0025]

Medical Devices; Class I Surgeon's and Patient Examination Gloves

AGENCY: Department of Health and Human Services (HHS), Food and Drug
Administration (FDA).

ACTION: Notice; request for comments.

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SUMMARY: The Department of Health and Human Services (HHS or ``the
Department'') issued a Notice in the Federal Register of January 15,
2021, that, among other things, identified seven types of reserved
class I devices that the Department had determined no longer require
premarket notification. The Department and the Food and Drug
Administration (FDA or ``the Agency'') have reviewed the prior
determination, including the record supporting it, and believe that the
determination is flawed. This notice explains the basis for HHS and
FDA's current view that the seven types of reserved class I devices
identified in the January 15, 2021, Notice require a premarket
notification, and explains why the reasoning supporting the prior
determination was unsound. HHS and FDA are seeking comment on the
matters discussed in this notice and will issue a future notice in the
Federal Register containing a final determination regarding the class I
medical gloves listed in the January 15, 2021, Notice.

DATES: Submit either electronic or written comments on this Notice by
May 17, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Comments must be
submitted by May 17, 2021. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of May 17, 2021. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-Z-0025 for ``Medical Devices; Class I Reserved Surgeon's and
Patient Examination Gloves.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the

Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1660, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background Regarding Section 510(l) of the FD&C Act

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (Pub. L. 94-295) and the Safe Medical
Devices Act of 1990 (Pub. L. 101-629), devices are classified into
class I (``general controls'') if there is information showing that the
general controls of the FD&C Act are sufficient to assure safety and
effectiveness; into class II (``special controls''), if general
controls, by themselves, are insufficient to provide reasonable
assurance of safety and effectiveness, but there is sufficient
information to establish special controls to provide such assurance;
and into class III (premarket approval), if there is insufficient
information to support classifying a device into class I or class II
and the device is a life sustaining or life supporting device, or is
for a use which is of substantial importance in preventing impairment
of human health, or presents a potential unreasonable risk of illness
or injury.
    Unless a device is exempt from premarket notification, section
510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing
regulations, part 807 (21 CFR part 807), require persons who intend to
market a new device to submit a premarket notification (510(k))
demonstrating that the new device is ``substantially equivalent''
within the meaning of section 513(i) of the FD&C Act to a legally
marketed device that does not require premarket approval. Section
510(l) of the FD&C Act, added to the statute by the Food and Drug
Administration Modernization Act of 1997 (FDAMA and now codified as
section 510(l)(1), provides that a 510(k) is not required for a class I
device, except for a class I device intended for a use that is of
substantial importance in preventing impairment of human health, or any
class I device that presents a potential unreasonable risk of illness
or injury. FDA refers to these as the ``reserved criteria'' and to
class I devices subject to 510(k) as ``class I reserved devices.''
Thus, class I devices are exempt from the 510(k) requirements unless a
class I device type meets the reserved criteria under section 510(l)(1)
of the FD&C Act.
    After the enactment of FDAMA, FDA evaluated all class I devices in
interstate commerce at that time to determine which device types met
the reserved criteria. On February 2, 1998, FDA published in a notice
in the Federal Register: (1) A list of device types that FDA believed
met the reserved criteria and thus would remain subject to premarket
notification and (2) a list of device types that FDA believed did not
meet these criteria and thus would be exempt from such requirement as
of February 19, 1998 (the statutory effective date for what is now
section 510(l)(1)) (63 FR 5387). As part of the evaluation, where FDA
determined a device type did not meet the reserved criteria, FDA also
considered limitations on that exemption--that is, the circumstances
under which an exempt device could, depending on the device's intended
use or potential unreasonable risk, meet the reserved criteria and thus
remain subject to the premarket notification requirement (63 FR 5387 at
5388 to 5389). Although devices that did not meet the reserved criteria
became exempt on February 19, 1998, the February 2, 1998, notice
invited public comment on FDA's determinations concerning the status of
various class I devices. On November 12, 1998, FDA published a proposed
rule to amend the applicable classification regulations in the Code of
Federal Regulations to designate which class I devices require
premarket notification and which devices are exempt from premarket
notification under section 510(l) of the FD&C Act (63 FR 63222). This
took into account FDA's determinations in the February 1998 notice,
comments received in response to that notice, and other information
available to the Agency. At the same time, FDA evaluated devices the
Agency had, prior to FDAMA, exempted from the premarket notification
requirement by rulemaking. FDA determined that five such device types
met the reserved criteria and thus proposed to amend the applicable
classification regulations accordingly (63 FR 63222). FDA issued a
final rule amending those classification regulations on January 14,
2000 (65 FR 2296).
    On December 13, 2016, the 21st Century Cures Act (Cures Act)
amended section 510(l) of the FD&C Act, reorganizing section 510(l)
into subsections 510(l)(1) and (2). Section 510(l)(2) of the FD&C Act
requires FDA to identify at least once every 5 years, through
publication in the Federal Register, any type of class I device that
the Agency determines no longer requires a report under section 510(k)
of the FD&C Act to provide reasonable assurance of safety and
effectiveness. Section 510(l)(2) of the FD&C Act further provides that
upon publication of the Agency's determination in the Federal Register,
these devices shall be exempt from 510(k) and the classification
regulation applicable to each such type of device shall be deemed
amended to incorporate such exemption. Following the enactment of the
Cures Act, FDA published in a notice in the Federal Register a list of

class I device types that it had determined no longer meet the reserved
criteria and are thus exempt from 510(k) (82 FR 17841, April 13, 2017).
In 2019, FDA amended the classification regulations to reflect the
exemption determinations (84 FR 71794, December 30, 2019). That final
order and amendment also addressed exemption determinations for class
II devices, which are subject to a different process.

II. Criteria for Exemption From Section 510(k) of the FD&C Act

    FDA has explained, following the enactment of both FDAMA and the
Cures Act, that it determines whether class I devices are subject to,
or exempt from, 510(k) based on the reserved criteria. The Department
concurs. As previously noted, the statute sets forth the relevant
criteria for when a class I device is subject to section 510(k) of the
FD&C Act. Specifically, section 510(l)(1) of the FD&C Act provides that
a class I device is not exempt from the premarket notification
requirements of section 510(k) if the device is intended for a use that
is of substantial importance in preventing impairment of human health,
or it presents a potential unreasonable risk of illness or injury (63
FR 5387, 82 FR 17841).
    Because all devices must have a reasonable assurance of safety and
effectiveness (see discussion regarding classification and the level of
regulation necessary to provide such assurance in section I of this
document), the reserved criteria delineate which class I devices
require a 510(k) to provide a reasonable assurance of safety and
effectiveness and which do not. Thus, the directive in section
510(l)(2) of the FD&C Act that FDA must identify class I devices it
determines no longer require a report under section 510(k) to provide
reasonable assurance of safety and effectiveness means that FDA must
identify which class I devices that FDA previously determined meet the
reserved criteria no longer meet these criteria, in which case a 510(k)
is no longer required to provide reasonable assurance of safety and
effectiveness. FDA has explained that in determining whether either of
these criteria are met, the Agency considers for example, its
experience in reviewing premarket notifications for each device,
focusing on the risk inherent with the device and the disease being
treated or diagnosed (e.g., devices with rapidly evolving technology or
expansions of intended uses) (63 FR 5387, 82 FR 17841). The Agency also
considers the history of adverse event reports under the medical device
reporting program for these devices, as well as their history of
product recalls.

III. Determination Regarding Surgeon's Gloves and Patient Examination
Gloves and Premarket Notification

    Based on the risks inherent with surgeon's gloves and patient
examination gloves and the diseases being prevented, FDA's experience
with these devices, and other relevant considerations, HHS and FDA
believe that gloves with the product codes LYY, LYZ, OIG, OPC, OPH,
LZC, and OPA are intended for uses which are of substantial importance
in preventing impairment of human health or present a potential
unreasonable risk of illness or injury and thus require a report under
section 510(k) of the FD&C Act. Surgeon's gloves and patient
examination gloves are generally intended to prevent contamination and
the spread of pathogens (see 21 CFR 878.4460 and 880.6250). They can be
the key barrier that protects against the spread of infection between
individuals, including infections transmitted through bodily fluids,
such as hepatitis or human immunodeficiency virus (HIV) (Refs. 1-3).
Surgeon's gloves, in particular, prevent against contamination in the
operating room, where patients are highly vulnerable to infection
(Refs. 4 and 5). Medical gloves also serve other key purposes, such as
protecting against occupational exposure to chemotherapy drugs, which
have potential mutagenic, carcinogenic, and teratogenic effects (Refs.
6 and 7). Thus, these gloves play an important role in preventing risks
to the public, and 510(k) review is necessary to provide reasonable
assurance of their safety and effectiveness, including by helping to
assure that the gloves are durable and impermeable, among other things.
    Because of their importance in preventing impairment of human
health, FDA has long considered these seven types of gloves to meet the
reserved criteria under section 510(l) of the FD&C Act and to be
subject to the 510(k) requirement. In 1998, after considering its
experience in reviewing premarket notifications for those devices, as
well as the history of adverse event reports and recalls, FDA
determined that surgeon's gloves and patient examination gloves meet
the reserved criteria (63 FR 5387). FDA invited comments on the
February 2, 1998, Notice, and received no comments regarding gloves.
When FDA proposed to amend the classification regulations in November
1998 to reflect its determinations as to which class I devices were
exempt and which were not (63 FR 63222), FDA again received no comments
regarding these surgeon's gloves and patient examination gloves. FDA's
January 2000 final rule to amend the classification regulations
reflected this determination (65 FR 2296).
    Following the enactment of the Cures Act, in 2017, FDA again
evaluated all class I reserved devices to determine whether they
continued to meet the reserved criteria. In doing so, FDA identified a
number of class I devices that, based on the considerations discussed
above, do not meet those criteria and thus no longer require premarket
notification (82 FR 17841). FDA also considered applicable limitations
for the device types that it determined were exempt. During this
evaluation, FDA specifically considered the seven types of gloves
discussed above. FDA took into account its experiences with 510(k)
submissions for the gloves, the risk inherent with the devices and the
diseases they prevent, and other relevant considerations. After
conducting this evaluation, FDA determined that surgeon's gloves and
patient examination gloves met the reserved criteria and therefore
remained subject to premarket notification.
    FDA has issued an enforcement policy concerning these gloves in
response to the COVID-19 public health emergency (PHE). However, this
policy, which is limited in duration and scope, is fundamentally
different from a determination that the gloves no longer meet the
reserved criteria or otherwise no longer require a 510(k). Enforcement
policies communicate an Agency's nonbinding views about how it should
allocate its enforcement resources based on current facts and
circumstances. Such policies do not alter the legal obligation to
comply with the relevant requirements and do not preclude the Agency
from taking action to enforce those requirements where appropriate.
This particular enforcement policy was issued in response to a highly
unusual set of facts and circumstances: The most sweeping PHE to occur
in over a century. The public health threat posed by COVID-19, the
disease caused by the SARS-CoV-2 virus, is substantial. Global demand
for infection control measures has increased significantly and is a
critical part of the response to the COVID-19 outbreak. FDA's March
2020 guidance entitled ``Enforcement Policy for Gown, Other Apparel,
and Gloves During the Coronavirus Disease (COVID-19) Public Health
Emergency'' (``Gloves PHE Guidance'') provides information,
recommendations, and policies to help address the urgent need for
appropriate clinical management and infection control and to help

expand the availability of surgical apparel for healthcare
professionals during the COVID PHE (Ref. 8).
    Specifically for gloves, the guidance explains that it should help
expand the availability of certain gloves to help address the urgent
public health concerns caused by shortages of such products by taking a
risk-based approach to them. In issuing this policy, FDA sought to
balance the various public health considerations related to the PHE and
specifically limited the policy to the duration of the PHE. As part of
this balancing, the Agency also limited the enforcement policy in
scope. In the guidance, FDA stated its intention not to object to the
distribution and use of certain patient examination gloves \1\ and
surgeon's gloves \2\ that do not comply with the premarket notification
requirements of section 510(k) where the products ``do not create an
undue risk in light of the public health emergency.'' FDA then
identified factors in determining whether such gloves could create
undue risk, such as whether the gloves are labeled for use with
chemotherapy drugs, fentanyl, and other opioids, use for allergy or
dermatitis prevention, use for antimicrobial or antiviral protection,
or use for infection prevention or reduction.
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    \1\ The policies in the Gloves PHE Guidance apply to those
patient examination gloves with product codes FMC, LYY, LZA, LZB,
LYZ, OIG, OPC, OPH, and LZC.
    \2\ The policies in the Gloves PHE Guidance apply to those
surgeon's gloves with product codes KGO and OPA.
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    As with all FDA guidance, the Agency invited public comment at any
time. FDA has not received any comments on the guidance that such
gloves, rather than being subject to an enforcement policy, should be
exempt from the premarket notification requirement because they do not
meet the reserved criteria. More broadly, given the context in which
the guidance was issued and the limitations in its scope and duration,
this policy does not diminish the important legal and policy reasons
for determining that surgeon's gloves and patient examination gloves
are required to have a 510(k). If in March 2020 FDA had believed that
the gloves no longer met the reserved criteria and thus were exempt
under the statute, the Agency could have undertaken the process
specified in 510(l)(2) of the FD&C Act; instead it chose an enforcement
policy, which reflected FDA's careful balancing of the public-health
considerations in response to the PHE.

IV. Issues Raised by HHS's January 15, 2021, Notice

    On January 15, 2021, HHS published a notice (``the January 15,
2021, Notice'' or ``Notice'') (86 FR 4088) determining that six types
of reserved class I patient examination gloves with the product codes
LYY, LYZ, OIG, OPC, OPH, and LZC, and one type of reserved class I
surgeon's glove device with the product code OPA, no longer require a
report under section 510(k) of the FD&C Act. We did not find any
evidence that HHS consulted with, otherwise involved, or even notified
FDA before issuing the Notice. The Notice explained that HHS based
these exemption determinations on its conclusion that premarket
notification is no longer required to provide reasonable assurance of
the safety and effectiveness of these devices, which it in turn based
solely on its evaluation of adverse events in FDA's Manufacturer and
User Facility Device Experience database (MAUDE). HHS concluded that
the fact that there were few if any (depending on the glove type)
adverse events reported in MAUDE following FDA's issuance of its Gloves
PHE Guidance meant that premarket notification is no longer required to
provide a reasonable assurance of the safety and effectiveness of these
devices. The January 15, 2021, Notice did not discuss any applicable
limitations on the exemption for gloves, or even discuss whether it
considered that issue.
    HHS and FDA have now reexamined the January 15, 2021, Notice,
including its class I exemption determinations, and believes it is
appropriate to reverse these determinations. This reexamination was
prompted primarily by two things. One is that certain staff and
leadership in FDA's Center for Devices and Radiological Health that
conduct regulatory oversight of personal protective equipment,
including the types of gloves covered in the Notice, identified the
flaws below and brought them to the Department's attention. The other
is that HHS has received dozens of inquiries about the January 15,
2021, Notice, both formally through https://www.regulations.gov as well
as directly to the contact listed in that Notice and to various FDA
staff and FDA program email addresses.
    Comments received regarding the seven types of gloves support HHS
and FDA's position that these gloves remain subject to 510(k).
Generally, comments received to date note the risk of leaching
chemotherapy drugs, the risk of radiation exposure, and the importance
of barrier protection from infection. One comment remarked on the
unreliability of adverse event data alone. Further, the direct
inquiries indicate a pattern of uncertainty about whether the class I
devices described in the Notice are exempt. In addition, some
commenters expressed confusion about the Notice, such as why the Notice
discussed some, but not all, of the product codes for surgeon's gloves
and patient examination gloves covered by the Gloves PHE Guidance. For
example, some commenters asked whether this was intentional or
inadvertent, finding no explanation in the Notice. Other inquiries
asked whether, regardless of the Notice, FDA would review new 510(k)
premarket notifications voluntarily submitted for such devices and/or
whether FDA would continue its review of already-submitted premarket
notifications. HHS and FDA believe that the determinations in the
January 15, 2021, Notice lack adequate legal and scientific support,
and that the Notice is otherwise flawed, for the reasons explained
below.
    First, the January 15, 2021, Notice neither discusses the reserved
criteria nor explains how HHS came to determine the gloves no longer
meet the reserved criteria; i.e., that the gloves are not intended for
a use that is of substantial importance in preventing impairment of
human health, or do not present a potential unreasonable risk of
illness or injury. The January 15, 2021, Notice contains no mention of
or cite to this statutory standard, nor an explanation as to why it was
left out. Moreover, even under the standard applied--``reasonable
assurance of safety and effectiveness''--the Notice did not consider
the gloves' effectiveness.
    Second, as mentioned above, in evaluating a device to determine
whether it is exempt, FDA has considered its experience in reviewing
premarket notifications, focusing on the risk inherent with the device
and the disease being treated or diagnosed, as well as other relevant
considerations, including the history of adverse event reports for
these products and their history of product recalls. The January 15,
2021, Notice, however, HHS relied solely upon adverse event reports in
MAUDE as its basis for determining the products to be exempt from
510(k). Although adverse event reports are a valuable source of
information, the reports have limitations, as noted in the January 15,
2021, Notice, including the potential submission of incomplete,
inaccurate, untimely, unverified, or biased data. The incidence or
prevalence of an event cannot be determined from adverse event reports
alone, due to underreporting of events, inaccuracies in reports, lack
of

verification that the device caused the reported event, and lack of
information about frequency of device use. Adverse event data is not
adequate on its own for assessing safety, let alone whether to
determine a device to be exempt from 510(k). The Notice does not, for
example, take into account FDA's experience in reviewing 510(k)s for
these devices, which FDA typically does with a focus on the risk
inherent with the device and the relevant disease(s) being treated or
diagnosed, or the products' recall history. FDA recognized, in a
previous regulatory action, that certain gloves may pose an
unreasonable risk of illness or injury when it banned powdered
surgeon's gloves and powdered patient examination gloves (see 81 FR
91722, December 19, 2016).
    Further, even on its own terms, the adverse event information
proffered to support the January 15, 2021, Notice has key limitations.
For example, some subset of the gloves on the market following issuance
of the Gloves PHE Guidance would have entered the market prior to
issuance of the guidance and thus gone through 510(k) review. For that
subset, there is no reason to anticipate any change in adverse event
reports based on the guidance because they were cleared by FDA. The
January 15, 2021, Notice assumes that new or modified gloves, which had
never undergone 510(k) review, entered the market following the Gloves
PHE Guidance in significant enough proportions that they would skew the
adverse-event trends had 510(k) been necessary to assure safety and
effectiveness. But the Notice does not explain the basis for this
assumption. There is no indication the adverse event evaluation
considered whether or how many new or changed gloves entered the market
during this time that would justify the Notice's overall conclusions.
In addition, the Notice did not explain why it was reasonable to draw
conclusions based on adverse events for these products in such a narrow
time period, which was from whenever any new or modified gloves started
to be used after the March 30, 2020, guidance until November 30, 2020,
which was the end of the adverse event review period. Likewise, the
Notice did not address other potential data limitations, such as the
likelihood that adverse event reporting has been more difficult during
a public health emergency and thus may have been more limited than
usual. FDA discussed the challenges of adverse event reporting during a
pandemic in its guidance, issued in May 2020, entitled, ``Postmarketing
Adverse Event Reporting for Medical Products and Dietary Supplements
During a Pandemic.'' \3\
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    \3\ Although January 15, 2021, Notice concluded that 510(k)s are
no longer necessary for these devices ``[i]n view of the complete
lack of or de minimis number of adverse events in MAUDE following
[the March 2020 Gloves PHE Guidance],'' the adverse event tables in
the Notice included adverse events going back to 2010. To the extent
that the quantity of adverse events between 2010 and 2020 informed
the conclusion in the Notice regarding the need for 510(k) for the
class I gloves, the discussion in this paragraph would not apply.
However, this would not impact our analysis of the other flaws in
the Notice or our view that these gloves meet the reserved criteria.
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    Finally, we did not find any evidence that HHS consulted with or
otherwise involved FDA in its exemption determination or issuance of
the Notice. Section 1003(d) of the FD&C Act (21 U.S.C. 393(d)) provides
that the Secretary ``shall be responsible for executing'' the FD&C Act
``through the [FDA] Commissioner.'' Here, the Notice is clearly an
action ``executing'' the FD&C Act. Moreover, it is particularly
important that FDA have at least some level of involvement in this type
of an action given the expertise needed to evaluate whether particular
device types meet the reserved criteria.
    In evaluating whether the gloves discussed in the January 15, 2021,
Notice require a report under section 510(k) of the FD&C Act, the
Department and FDA have considered regulated entities' reliance on the
Notice. As an initial matter, HHS and FDA observe that, as described
above, the Notice contained a number of flaws that have led to
significant questions about the status of these devices. HHS and FDA
have not only received over 60 inquiries about the Notice, reflecting a
pattern of uncertainty, but have also received requests for review of
510(k) premarket notifications that have been voluntarily submitted for
such devices. Based on these facts, HHS and FDA believe that only a
limited subset of regulated entities may have placed legitimate
reliance on the January 15, 2021, Notice. For any such entities, given
the short time period between now and when the Notice was issued, HHS
and FDA also believe that few (if any) long-term investments,
contracts, or other significant business decisions relying on the
Notice are likely to have been made. Furthermore, to the extent that
any such decisions have been made, HHS and FDA strongly believe that
those interests cannot outweigh the directive of the statute for FDA to
review class I devices that meet the reserved criteria, and also cannot
outweigh the public-health importance of conducting 510(k) review for
these devices, for the reasons discussed in section III above.
Elsewhere in this issue of the Federal Register, HHS and FDA are
announcing the withdrawal of the proposed exemptions for the 83 class
II devices and 1 unclassified device included in the January 15, 2021,
Notice.

V. Further Information for Regulated Entities

    HHS and FDA are concerned about the public health risks posed by
the January 15, 2021, Notice, particularly as the Notice applies to
medical gloves that could pose undue risk as described in the Gloves
PHE Guidance. HHS and FDA remind regulated entities that various
requirements under the FD&C Act and FDA regulations apply to the class
I medical gloves described in this notice, regardless of their status
under section 510(k) and (l). For example, section 502(a) and (f)(1) of
the FD&C Act prohibits device labeling that is false or misleading in
any particular or that lacks adequate directions for use (21 U.S.C.
352(a) and (f)(1)). Section 201(n) of the FD&C Act provides that, in
determining whether labeling is misleading, ``there shall be taken into
account (among other things) not only representations made or
suggested. . .but also the extent to which the labeling or advertising
fails to reveal facts material in the light of such representations or
material with respect to consequences which may result from the use of
the article. . . .'' (21 U.S.C. 321(n)). FDA regulations further
provide that ``[a]mong representations in the labeling of a device
which render such device misbranded is a false or misleading
representation with respect to another device or a drug or food or
cosmetic'' (21 CFR 801.6). Regulated entities should bear in mind that
device labeling that makes certain representations or fails to disclose
certain information could misbrand the product in violation of the FD&C
Act and FDA regulations. FDA emphasizes the importance of compliance
with these requirements with respect to the gloves that are the subject
of this notice. For more information concerning the labeling of class I
medical gloves during the COVID-19 PHE, please see the Gloves PHE
Guidance.
    Furthermore, because of the potential risks posed by gloves that
have not undergone FDA's premarket review, FDA intends to increase its
surveillance of the seven types of gloves subject to the January 15,
2021, Notice, taking into account its enforcement policy in the Gloves
PHE Guidance. This increased surveillance could, for example, include a
labeling review and a physical examination to assess for physical

defects. Because we expect that most such gloves are imported, FDA's
focus will be on products at the time of importation. We also draw your
attention to the guidance from 2008 entitled ``Surveillance and
Detention Without Physical Examination of Surgeons' and/or Patient
Examination Gloves'', which also discusses the acceptable quality
criteria defined in 21 CFR 800.20 for the importation of gloves (Ref.
9). Nothing in this Notice alters the legal obligation to comply with
the relevant statutory requirements and does not preclude the Agency
from taking action to enforce those requirements where appropriate.
    If the gloves discussed in this notice meet the reserved criteria,
such gloves require a 510(k). Following consideration of the comments,
FDA intends to issue a future notice in the Federal Register containing
its final determination concerning whether these seven types of gloves
are reserved. Previously, during 510(k) review for these types of
gloves, FDA has evaluated the dimensional and physical properties of
the gloves, and nonclinical data regarding barrier performance,
biocompatibility, and residual powders, among other information, to
support the safety and effectiveness of the gloves for their intended
use. FDA also evaluates the indications for use and labeling to ensure
the devices are appropriately labeled, consistent with their intended
use. For any gloves that are distributed after FDA issues its final
determination, the Agency would consider and take appropriate
enforcement action, taking into account the enforcement policy in the
Gloves PHE Guidance.

VI. References

    The following references marked with an asterisk (*) are on display
at 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. Centers for Disease Control, ``Perspectives in Disease Prevention
and Health Promotion Update: Universal Precautions for Prevention of
Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and
Other Bloodborne Pathogens in Health-Care Settings.'' Morbidity and
Mortality Weekly Report, 1988; 37(25):377-388.
2. World Health Organization, ``Glove Use Information Leaflet.''
2009. https://www.who.int/gpsc/5may/Glove_Use_Information_Leaflet.pdf.
3. Collins, A.S., ``Preventing Health Care-Associated Infections.''
In: Hughes, R.G., Ed. Patient Safety and Quality: An Evidence-Based
Handbook for Nurses. Rockville (MD): Agency for Healthcare Research
and Quality (U.S.); April 2008, chapter 41.
4. Alexander, J.W., J.S. Solanki, and M.J. Edwards, ``Updated
Recommendations for Control of Surgical Site Infections,'' Annals of
Surgery, 253(6):1082-1093, 2011.
5. Sugarbaker, P.H., ``Increased Safety of Surgical Glove
Application: The Under/Over Method,'' Annals of the Royal College of
Surgeons of England, 100(4):339-340, 2018.
6. Landeck, L., E. Gonzalez, and O.M. Koch, ``Handling Chemotherapy
Drugs--Do Medical Gloves Really Protect?'' International Journal of
Cancer, 137(8):1800-1805, 2015. doi: 10.1002/ijc.29058. Epub 2014
July 22. PMID: 24978061.
7. Nalin, M., G. Hug, E. Boeckmans, et al., ``Permeation Measurement
of 27 Chemotherapy Drugs After Simulated Dynamic Testing on 15
Surgical and Examination Gloves: A Knowledge Update,'' Journal of
Oncology Pharmacy Practice, 2020 August 26:1078155220950423. doi:
10.1177/1078155220950423. Epub ahead of print. PMID: 32847481.
8. *FDA Guidance for Industry and FDA Staff, ``Enforcement Policy
for Gowns, Other Apparel, and Gloves During the Coronavirus Disease
(COVID-19) Public Health Emergency,'' March 2020; available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health.
9. *FDA Guidance for Industry and FDA Staff, ``Surveillance and
Detention Without Physical Examination of Surgeons' and/or Patient
Examination Gloves,'' July 2008; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surveillance-and-detention-without-physical-examination-surgeons-andor-patient-examination-gloves.

    Dated: April 12, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
    Dated: April 12, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07759 Filed 4-15-21; 8:45 am]
BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story:

As a smoking alternative, I have been vaping. I am still addicted to nicotine. However, I have been slowly lowering the milligrams of nicotine along the way. I started with 36mg e-liquid, and am now vaping 6mg e-liquid. In a perfect world, I would have just quit. But, that did not happen in 42 years! I did not quit, when I was diagnosed with COPD and emphysema. I did not quit, when they identified and continued to monitor more 'nodules' in my lungs than I can count. I did not quit, when I was no longer able to sleep laying down. I did not quit, when I was told I would to be on oxygen within a year. I quit, when I found vaping.

The difference in my lungs is incredible! I can sleep laying down! I no longer have to avoid laughter. My 'quality of life' has changed drastically!

My current statistics:  Quit Date: 10/2/2012  -  Today:  5/11/2014  -  Smober Time: 1 Year, 7 Months, 9 Days  -  Cigarettes Not Smoked: 48, 880

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Thank You!


[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
[Notices]
[Pages 19224-19226]
[FR Doc No: 2020-07119]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2020-0006]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemption; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from eight individuals
for an exemption from the vision requirement in the Federal Motor
Carrier Safety Regulations (FMCSRs) to operate a commercial motor
vehicle (CMV) in interstate commerce. If granted, the exemptions will
enable these individuals to operate CMVs in interstate commerce without
meeting the vision requirement in one eye.

DATES: Comments must be received on or before May 6, 2020.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2020-0006 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/docket?D=FMCSA-2020-0006. Follow the online
instructions for submitting comments.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., ET,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2020-0006), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission. To submit your comment online, go to http://www.regulations.gov/docket?D=FMCSA-2020-0006. Click on the ``Comment
Now!'' button and type your comment into the text box on the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2020-0006 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Operations in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays.

C. 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 www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The eight individuals listed in this notice have requested an
exemption from the vision requirement in 49 CFR 391.41(b)(10).
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.
    The physical qualification standard for drivers regarding vision
found in Sec.  391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of at least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal Meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing standard
red, green, and amber.

    On July 16, 1992, the Agency first published the criteria for the
Vision Waiver Program, which listed the conditions and reporting
standards that CMV drivers approved for participation would need to
meet (57 FR 31458). The current Vision Exemption Program was
established in 1998, following the enactment of amendments to the
statutes governing exemptions made by Sec.  4007 of the Transportation
Equity Act for the 21st Century (TEA-21), Public Law 105-178, 112 Stat.
107, 401 (June 9, 1998). Vision exemptions are considered under the
procedures established in 49 CFR part 381 subpart C, on a case-by-case
basis upon application by CMV drivers who do not meet the vision
standards of Sec.  391.41(b)(10).
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely in intrastate commerce with the vision
deficiency for the past 3 years. Recent driving performance is
especially important in evaluating future safety, according to several
research studies designed to correlate past and future driving
performance. Results of these studies support the principle that the
best predictor of future performance by a driver is his/her past record
of crashes and traffic violations. Copies of the studies may be found
at https://www.regulations.gov/docket?D=FMCSA-1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrated the driving
performance of experienced monocular drivers in the program is better
than that of all CMV drivers collectively.\1\ The fact that experienced
monocular drivers demonstrated safe driving records in the waiver
program supports a conclusion that other monocular drivers, meeting the
same qualifying conditions as those required by the waiver program, are
also likely to have adapted to their vision deficiency and will
continue to operate safely.
---------------------------------------------------------------------------

    \1\ A thorough discussion of this issue may be found in a FHWA
final rule published in the Federal Register on March 26, 1996 and
available on the internet at https://www.govinfo.gov/content/pkg/FR-1996-03-26/pdf/96-7226.pdf.
---------------------------------------------------------------------------

    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.

III. Qualifications of Applicants

Terry M. Baldwin

    Mr. Baldwin, 55, has had retinal dysplasia in his left eye since
birth. The visual acuity in his right eye is 20/20, and in his left
eye, light perception only. Following an examination in 2019, his
optometrist stated, ``Since Mr. Baldwin has been living his entire life
with his left eye vision deficit, he has obviously made compensatory
adaptations and has sufficient vision to perform driving tasks required
to operate a commercial vehicle.'' Mr. Baldwin reported that he has
driven straight trucks for 16 years, accumulating 166,400 miles. He
holds an operator's license from Pennsylvania. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Samuel L. Eakman, Jr.

    Mr. Eakman, 51, has a prosthetic in his right eye due to a
traumatic incident in childhood. The visual acuity in his right eye is
no light perception, and in his left eye, 20/20. Following an
examination in 2019, his optometrist stated, ``Considering Mr. Eakman
has had a Commercial Drivers License since 2011 and has performed those
tasks without issue, I feel he has sufficient vision to perform driving
tasks and has long ago recognized other ways of determining object
spacing other than actual binocular vision.'' Mr. Eakman reported that
he has driven straight trucks for 23 years, accumulating 575,000 miles.
He holds a Class AM CDL from Pennsylvania. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Raymond C. King

    Mr. King, 34, has had amblyopia in his left eye since childhood.
The visual acuity in his right eye is 20/30, and in his left eye, 20/
50. Following an examination in 2019, his ophthalmologist stated, ``Mr.
King has sufficient vision to operate a commercial vehicle.'' Mr. King
reported that he has driven straight trucks for 4 years, accumulating
200,000 miles, and tractor-trailer combinations for 6 years,
accumulating 525,000 miles. He holds a Class A CDL from Ohio. His
driving record for the last 3 years shows no crashes and one conviction
for speeding in a CMV; he exceeded the speed limit by 15 mph.

Robert G. Lanning

    Mr. Lanning, 58, has had amblyopia in his left eye since birth. The
visual acuity in his right eye is 20/20, and in his left eye, counting
fingers. Following an examination in 2019, his optometrist stated, ``I
certify that my patient, Robert G. Lanning, has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Lanning reported that he has driven straight trucks for 15 years,
accumulating 300,000 miles. He holds an operator's license from
Virginia. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Gary D. Larson

    Mr. Larson, 25, has a macular scar in his right eye due to a
traumatic incident in childhood. The visual acuity in his right eye is
20/150, and in his left eye, 20/20. Following an examination in 2020,
his optometrist stated, ``In my medical opinion, I believe Mr. Larson
has sufficient visual capabilities to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Larson reported that he
has driven straight trucks for 3 years, accumulating 156,000 miles. He
holds an operator's license from Nebraska. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Larry Owen

    Mr. Owen, 70, has had a retinal detachment in his right eye since
2014. The visual acuity in his right eye is counting fingers, and in
his left eye, 20/20. Following an examination in 2020, his optometrist
stated, ``In my medical opinion, Mr. Owen has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr.

Owen reported that he has driven buses for 14 years, accumulating
700,000 miles. He holds an operator's license from Texas. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

John C. Perrone, Jr.

    Mr. Perrone, 21, has had amblyopia in his right eye since
childhood. The visual acuity in his right eye is 20/150, and in his
left eye, 20/20. Following an examination in 2019, his ophthalmologist
stated, ``Patient has sufficient vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Perrone reported that
he has driven straight trucks for 3 years, accumulating 9,750 miles. He
holds an operator's license from Pennsylvania. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Ronald D. Wilson

    Mr. Wilson, 58, has had optic nerve atrophy in his left eye since
birth. The visual acuity in his right eye is 20/20, and in his left
eye, light perception only. Following an examination in 2019, his
optometrist stated, ``As far as I can conclude, Mr. Wilson is visually
competent to operate a commercial vehicle.'' Mr. Wilson reported that
he has driven straight trucks for 35 years, accumulating 1.4 million
miles, and tractor-trailer combinations for 12 years, accumulating
240,000 miles. He holds a Class DA CDL from Kentucky. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

IV. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments and material
received before the close of business on the closing date indicated
under the DATES section of the notice.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-07119 Filed 4-3-20; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 75, Number 212 (Wednesday, November 3, 2010)]
[Notices]
[Page 67807]
[FR Doc No: 2010-27774]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2010-0307]

Pipeline Safety: Emergency Preparedness Communications

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Notice; Issuance of Advisory Bulletin.

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

SUMMARY: PHMSA is issuing an Advisory Bulletin to remind operators of
gas and hazardous liquid pipeline facilities that they must make their
pipeline emergency response plans available to local emergency response
officials. PHMSA recommends that operators provide their emergency
response plans to officials through their required liaison and public
awareness activities. PHMSA intends to evaluate the extent to which
operators have provided their emergency plans to local emergency
officials when PHMSA performs future inspections for compliance with
liaison and public awareness code requirements.

FOR FURTHER INFORMATION CONTACT: John Hess by phone at<PHONE_NUMBER> or
by e-mail at<EMAIL_ADDRESS>Information about PHMSA may be found at
http://phmsa.dot.gov.

SUPPLEMENTARY INFORMATION:

Background

    Federal regulations for both gas and hazardous liquid pipelines
require operators to have written procedures for responding to
emergencies involving their pipeline facility. Because pipelines are
often located in public space, the regulations further require that
operators include procedures for planning with emergency and other
public officials to ensure a coordinated response. Under 49 CFR
192.605, 192.615, and 195.402, operators must include in their
emergency plans provisions for coordinating with appropriate fire,
police, and other public officials both preplanned drills and actual
responses to pipeline emergencies. Operators must also establish and
maintain liaison with the emergency officials to, among other things,
acquaint the officials and the operator with their respective
responsibilities and resources in planning for and responding to
emergencies.
    Under Sec. Sec.  192.616 and 195.440, operators must also develop
and implement a written continuing public education program that
follows the American Petroleum Institute's (API) Recommended Practice
(RP) 1162. Incorporated by reference, API RP 1162 further requires
operators to develop their emergency response plans with appropriate
emergency officials to include in such plans information about how
emergency officials can access the operator's emergency response plan,
and to conduct emergency response drills.

Advisory Bulletin (ADB-10-08)

    To: Owners and Operators of Hazardous Liquid and Gas Pipeline
Systems.
    Subject: Emergency Preparedness Communications.
    Advisory: To further enhance the Department's safety efforts, PHMSA
is issuing this Advisory Bulletin about emergency preparedness
communications between pipeline operators and emergency responders.
    To ensure a prompt, effective, and coordinated response to any type
of emergency involving a pipeline facility, pipeline operators are
required to maintain an informed relationship with emergency responders
in their jurisdiction.
    PHMSA reminds pipeline operators of these requirements, and in
particular, the need to share the operator's emergency response plans
with emergency responders. PHMSA recommends that operators provide such
information to responders through the operator's liaison and public
awareness activities, including during joint emergency response drills.
PHMSA intends to evaluate the extent to which operators have provided
local emergency responders with their emergency plans when PHMSA
performs future inspections for compliance with relevant requirements.

    Issued in Washington, DC, on October 28, 2010.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2010-27774 Filed 11-2-10; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Page 4799]
[FR Doc No: 2014-01697]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending December
21, 2013

    The following Agreements were filed with the Department of
Transportation under the Sections 412 and 414 of the Federal Aviation
Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.
    Docket Number: DOT-OST-2013-0218.
    Date Filed: December 18, 2013.
    Parties: Members of the International Air Transport Association.
    Subject: Recommended Practice 1630.
    Finally Adopted Resolution dated 17 December 2013.
    CSC Mail Vote (S076) dated 23 August 2013.
    Intended effective date: 18 February 2014.

 Barbara J. Hairston,
Supervisory Dockets Officer, Docket Operations, Federal Register
Liaison.
[FR Doc. 2014-01697 Filed 1-28-14; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: February 26, 2009 (Volume 74, Number 37)]
[Rules and Regulations]
[Page 8728-8732]
[DOCID:fr26fe09-11]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0908; Directorate Identifier 2007-NM-190-AD;
Amendment 39-15788; AD 2009-01-09]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A310 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding an existing airworthiness directive
(AD) that applies to all Airbus Model A310 series airplanes. That AD
currently requires repetitive detailed inspections to detect cracks
propagating from the fastener holes that attach the left- and right-
hand pick-up angles at frame 40 to the wing lower skin and fuselage
panel, and corrective actions if necessary. This new AD revises the
intervals for accomplishing the repetitive detailed inspections and
provides for an optional terminating modification for the repetitive
inspections. This new AD also revises the applicability of the AD to
remove certain airplanes. This AD results from mandatory continuing
airworthiness information originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. We are issuing this AD to prevent reduced structural
integrity of the airplane due to fatigue damage, and consequent
cracking of the pick-up angles at frame 40.

DATES: This AD is effective April 2, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 2,
2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
February 9, 2001 (66 FR 1031, January 5, 2001).

ADDRESSES: For service information identified in this AD, contact
Airbus SAS-EAW (Airworthiness Office), 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; e-mail<EMAIL_ADDRESS>Internet http://
www.airbus.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116,

Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that supersedes AD
2000-26-14, amendment 39-12064 (66 FR 1031, January 5, 2001). The
existing AD applies to all Airbus Model A310 series airplanes. That
NPRM was published in the Federal Register on August 26, 2008 (73 FR
50250). A correction to that NPRM was published in the Federal Register
on September 8, 2008 (73 FR 51961). That NPRM proposed to continue to
require repetitive detailed inspections to detect cracks propagating
from the fastener holes that attach the left- and right-hand pick-up
angles at frame 40 to the wing lower skin and fuselage panel, and
corrective actions if necessary. That NPRM also proposed to revise the
intervals for accomplishing the repetitive detailed inspections and
provided for an optional terminating modification for the repetitive
inspections. That NPRM also proposed to revise the applicability of the
AD to remove certain airplanes.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed.

Costs of Compliance

    This AD affects about 68 Model A310 series airplanes of U.S.
registry.
    The inspections that are required by AD 2000-26-14 and retained in
this AD take about 2 work hours per airplane, at an average labor rate
of $80 per work hour. Based on these figures, the estimated cost of the
currently required actions is $10,880, or $160 per airplane, per
inspection cycle.

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 products 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), 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.
    You can find our regulatory evaluation and the estimated costs of
compliance 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

0
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 removing amendment 39-12064 (66 FR
1031, January 5, 2001) and by adding the following new AD:

2009-01-09 Airbus: Amendment 39-15788. Docket No. FAA-2008-0908;
Directorate Identifier 2007-NM-190-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective April 2,
2009.

Affected ADs

    (b) This AD supersedes AD 2000-26-14.

Applicability

    (c) This AD applies to Airbus Model A310 series airplanes,
certificated in any category, except those airplanes modified in-
service in accordance with Airbus Service Bulletin A310-53-2119,
dated October 25, 2005; or Revision 01, dated February 27, 2007.

Unsafe Condition

    (d) This AD results from mandatory continuing airworthiness
information originated by an aviation authority of another country
to identify and correct an unsafe condition on an aviation product.
We are issuing this AD to prevent reduced structural integrity of
the airplane due to fatigue damage and consequent cracking of the
pick-up angles at frame 40.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Requirements of AD 2000-26-14

Inspections and Corrective Actions

    (f) Perform a detailed inspection to detect cracks propagating
from the fastener holes that attach the left- and right-hand pick-up
angles at frame 40 to the wing lower skin and fuselage panel, at the
time specified in paragraph (g), (h), (i), (j), or (k) of this AD,
as applicable. Perform the actions in accordance with Figure 2,
Sheet 1, ``Synoptic Chart,'' of Airbus Service Bulletin A310-
53A2111, Revision 01, dated June 21, 2000, except as provided by
paragraph (l) of this AD.
    (1) If no cracking is found during the inspection required by
paragraph (f) of this AD, repeat the detailed inspection thereafter
at the interval specified in paragraph (f)(1)(i) or (f)(1)(ii) of
this AD, as applicable, except as provided by paragraph (n) of this
AD.
    (i) For Model A310-200 series airplanes: Except as provided by
paragraph (i) of this AD, repeat the inspection thereafter at
intervals not to exceed 1,000 flight cycles or 2,600 flight hours,
whichever occurs first.
    (ii) For Model A310-300 series airplanes: Except as provided by
paragraphs (i) of this AD, repeat the inspection thereafter at
intervals not to exceed 850 flight cycles or 2,800 flight hours,
whichever occurs first.
    (2) If any cracking is found during the inspection required by
paragraph (f) of this AD, prior to further flight, perform
applicable corrective actions (including repair (drilling and
reaming a crack stop hole in the pick-up angle, performing a
Rototest inspection and repetitive detailed inspections at the time
specified in the service bulletin, and replacing the pick-up angle
with a new angle at the time specified in the service bulletin,

except as provided by paragraph (o) of this AD); or immediate
replacement of any cracked angle with a new angle). Perform the
actions and repetitive inspections in accordance with Figure 2,
Sheet 1, ``Synoptic Chart,'' of Airbus Service Bulletin A310-
53A2111, Revision 01, dated June 21, 2000, except as provided by
paragraph (l) of this AD.

    Note 1: Accomplishment of the actions required by paragraph (f)
of this AD in accordance with Airbus Service Bulletin A310-53A2111,
dated April 21, 2000, is considered to be acceptable for compliance
with the requirements of that paragraph.

Compliance Times

    (g) For Model A310-200 series airplanes: Except as provided by
paragraphs (i), (j), and (k) of this AD, perform the initial
inspection at the later of the times specified in paragraphs (g)(1)
and (g)(2) of this AD.
    (1) Prior to the accumulation of 7,900 total flight cycles or
23,600 total flight hours, whichever occurs first.
    (2) Within 700 flight cycles or 1,200 flight hours after
February 9, 2001 (the effective date of AD 2000-26-14), whichever
occurs first.
    (h) For Model A310-300 series airplanes: Except as provided by
paragraphs (i), (j), and (k) of this AD, perform the initial
inspection required by paragraph (f) of this AD at the later of the
times specified in paragraphs (h)(1) and (h)(2) of this AD.
    (1) Prior to the accumulation of 6,700 total flight cycles or
24,700 total flight hours, whichever occurs first.
    (2) Within 700 flight cycles or 1,200 flight hours after
February 9, 2001, whichever occurs first.
    (i) For airplanes that have accumulated more than 18,000 total
flight cycles or 53,000 total flight hours as of February 9, 2001:
Perform the initial inspection required by paragraph (f) of this AD
within 350 flight cycles or 600 flight hours after February 9, 2001,
whichever occurs first. Repeat the inspection thereafter at
intervals not to exceed 350 flight cycles or 600 flight hours,
whichever occurs first.
    (j) For airplanes having manufacturer's serial number 0162
through 0326 inclusive, on which Airbus Service Bulletin A310-53-
2014 has been accomplished prior to February 9, 2001: The initial
inspection threshold may be counted from the date of accomplishment
of Airbus Service Bulletin A310-53-2014.
    (k) For airplanes on which a pick-up angle has been replaced:
For that pick-up angle only, the initial inspection threshold may be
counted from the date of installation of the new pick-up angle.

    Note 2: For the purposes of this AD, a detailed inspection is
defined as: ``An intensive visual examination of a specific
structural area, system, installation, or assembly to detect damage,
failure, or irregularity. Available lighting is normally
supplemented with a direct source of good lighting at intensity
deemed appropriate by the inspector. Inspection aids such as mirror,
magnifying lenses, etc., may be used. Surface cleaning and elaborate
access procedures may be required.''

New Requirements of This AD

New Revisions of Service Bulletin

    (l) As of the effective date of this AD, use only the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A310-53-2111, Revision 03, dated May 21, 2007, to do the inspections
and corrective actions required by paragraph (f) of this AD; except
where Figure 2 Sheet 2 of Airbus Mandatory Service Bulletin A310-53-
2111, Revision 03, dated May 21, 2007, specifies actions for crack
length of ``<54 mm (2.126 in.)'' and ``<69 mm (2.716 in.),'' this AD
requires the corresponding actions for crack lengths less than or
equal to those measurements.
    (m) Inspections and applicable corrective actions done before
the effective date of this AD in accordance with Airbus Mandatory
Service Bulletin A310-53-2111, Revision 02, dated October 25, 2005,
are acceptable for compliance with the requirements of paragraph (f)
of this AD.

Revised Repetitive Intervals for Detailed Inspections

    (n) As of the effective date of this AD, repeat the detailed
inspections for no crack findings required by paragraph (f)(1)(i),
(f)(1)(ii), or (i) of this AD, as applicable, at the applicable
times specified in Table 1 of this AD, until the modification
specified in paragraph (p) of this AD is done.

                     Table 1--Revised Repetitive Intervals for Certain Detailed Inspections
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
For model--                            Repeat the inspection at the later of the         And thereafter at
                                        following times--                                 intervals not to
                                                                                exceed--
----------------------------------------------------------------------------------------------------------------
(1) A310-200 series airplanes........  Within 950 flight        Within 50 flight cycles  950 flight cycles or
                                        cycles or 1,900 flight   or 250 flight hours      1,900 flight hours,
                                        hours since the last     after the effective      whichever occurs
                                        inspection required by   date of this AD,         first.
                                        paragraph (f)(1)(i) or   whichever occurs first.
                                        (i) of this AD,
                                        whichever occurs first.
----------------------------------------------------------------------------------------------------------------
(2) A310-300 series airplanes (short   Within 900 flight        Within 50 flight cycles  900 flight cycles or
 range).                                cycles or 2,550 flight   or 250 flight hours      2,550 flight hours,
                                        hours since the last     after the effective      whichever occurs
                                        inspection required by   date of this AD,         first.
                                        paragraph (f)(1)(ii)     whichever occurs first.
                                        or (i) of this AD,
                                        whichever occurs first.
----------------------------------------------------------------------------------------------------------------
(3) A310-300 series airplanes (long    Within 800 flight        Within 50 flight cycles  800 flight cycles or
 range).                                cycles or 4,000 flight   or 250 flight hours      4,000 flight hours,
                                        hours since the last     after the effective      whichever occurs
                                        inspection required by   date of this AD,         first.
                                        paragraph (f)(1)(ii)     whichever occurs first.
                                        or (i) of this AD,
                                        whichever occurs first.
----------------------------------------------------------------------------------------------------------------

Revised Threshold for Replacing the Pick-Up Angles

    (o) As of the effective date of this AD, do the replacement of
the pick-up angle required by paragraph (f)(2) of this AD, at the
applicable time specified in Table 2 of this AD.

        Table 2--Revised Thresholds for Replacing Pick-Up Angles
------------------------------------------------------------------------

------------------------------------------------------------------------
For model--                       Replace at the earlier of the
                                   following times--
------------------------------------------------------------------------
(1) A310-200 series airplanes...  At the time         Within 1,500
                                   specified in        flight cycles or
                                   paragraph (f)(2)    3,000 flight
                                   of this AD for      hours since the
                                   replacing the       last detailed
                                   pick-up angle.      inspection, or
                                                       within 30 days
                                                       after the
                                                       effective date of
                                                       this AD,
                                                       whichever occurs
                                                       later.
------------------------------------------------------------------------
(2) A310-300 series airplanes     At the time         Within 1,600
 (short range).                    specified in        flight cycles or
                                   paragraph (f)(2)    4,600 flight
                                   of this AD for      hours since the
                                   replacing the       last detailed
                                   pick-up angle.      inspection, or
                                                       within 30 days
                                                       after the
                                                       effective date of
                                                       this AD,
                                                       whichever occurs
                                                       later.
------------------------------------------------------------------------
(3) A310-300 series airplanes     At the time         Within 1,400
 (long range).                     specified in        flight cycles or
                                   paragraph (f)(2)    7,200 flight
                                   of this AD for      hours since the
                                   replacing the       last detailed
                                   pick-up angle.      inspection, or
                                                       within 30 days
                                                       after the
                                                       effective date of
                                                       this AD,
                                                       whichever occurs
                                                       later.
------------------------------------------------------------------------

Optional Terminating Modification

    (p) Remove the existing pick-up angles and install a reinforced
doubler between frames (FR) FR40 and FR41, and perform applicable
related investigative and corrective actions by accomplishing all
the applicable actions specified in the Accomplishment Instructions
of Airbus Service Bulletin A310-53-2119, Revision 01, dated February
27, 2007; except as provided by paragraph (q) of this AD.
Accomplishing these actions ends the repetitive inspections required
by this AD.
    (q) If any crack is detected and Airbus Service Bulletin A310-
53-2119, Revision 01, dated February 27, 2007, specifies to contact
Airbus: Before further flight, repair the crack using a method
approved by either the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA; or the European Aviation Safety
Agency (EASA) (or its delegated agent).
    (r) Actions done before the effective date of this AD in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A310-53-2119, dated October 25, 2005, are acceptable for
compliance with the corresponding requirements of paragraph (p) of
this AD.

Alternative Methods of Compliance (AMOCs)

    (s) The Manager, International Branch, ANM-116, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Dan
Rodina, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC on any airplane to which the AMOC applies,
notify your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.

Related Information

    (t) EASA airworthiness directive 2007-0184, dated July 3, 2007,
also addresses the subject of this AD.

Material Incorporated by Reference

    (u) You must use the service information identified in Table 3
of this AD to do the actions required by this AD, unless the AD
specifies otherwise. If you do the optional terminating modification
provided in this AD, you must use Airbus Service Bulletin A310-53-
2119, Revision 01, including Appendix 01, dated February 27, 2007,
to do the optional terminating modification.

Table 3--Material Incorporated by Reference for Actions required by This
                                   AD
------------------------------------------------------------------------
                                  Revision
       Service bulletin            level                 Date
------------------------------------------------------------------------
Airbus Service Bulletin A310-            01  June 21, 2000.
 53A2111, including Appendix
 01.
Airbus Mandatory Service                 03  May 21, 2007.
 Bulletin A310-53-2111,
 including Appendix 01.
------------------------------------------------------------------------

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information identified in
Table 4 of this AD under 5 U.S.C. 552(a) and 1 CFR part 51.

             Table 4--New Material Incorporated by Reference
------------------------------------------------------------------------
                                  Revision
       Service bulletin            level                 Date
------------------------------------------------------------------------
Airbus Mandatory Service                 03  May 21, 2007.
 Bulletin A310-53-2111,
 including Appendix 01.
A310-53-2119, including                  01  February 27, 2007.
 Appendix 01.
------------------------------------------------------------------------

    (2) The Director of the Federal Register previously approved the
incorporation by reference of Airbus Service Bulletin A310-53A2111,
Revision 01, including Appendix 1, dated June 21, 2000, on February
9, 2001 (66 FR 1031, January 5, 2001).
    (3) For service information identified in this AD, contact
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; e-mail<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) You may review copies of the service information that is
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221 or<PHONE_NUMBER>.
    (5) You may also review copies of the service information 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/

code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on December 18, 2008.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
[FR Doc. E9-3765 Filed 2-25-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 99 (Wednesday, May 24, 2017)]
[Proposed Rules]
[Pages 23769-23770]
[FR Doc No: 2017-10547]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 770

[EPA-HQ-OPPT-2017-0244; FRL-9962-85]
RIN 2070-AK35

Compliance Date Extension; Formaldehyde Emission Standards for
Composite Wood Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to amend a final rule that published in the
Federal Register on December 12, 2016, concerning formaldehyde emission
standards for composite wood products. EPA is publishing this proposed
amendment to extend the Toxic Substances Control Act (TSCA) Title VI
final rule compliance dates including: extending the December 12, 2017
date for emission standards, recordkeeping, and labeling provisions
until March 22, 2018; extending the December 12, 2018 date for import
certification provisions until March 22, 2019; and extending the
December 12, 2023 date for provisions applicable to producers of
laminated products until March 22, 2024. Additionally, this proposed
amendment would extend the transitional period during which the
California Air Resources Board (CARB) Third Party Certifiers (TPC) may
certify composite wood products under TSCA Title VI without an
accreditation issued by an EPA TSCA Title VI Accreditation Body so long
as the TPC remains approved by CARB, is recognized by EPA, and complies
with all aspects of the December 12, 2016 final rule. Extension of
these compliance dates and the transitional period for CARB TPCs adds
regulatory flexibility for regulated entities, reduces compliance
burdens, and helps to prevent disruptions to supply chains. EPA
believes that the proposed amendment is non-controversial and does not
expect to receive any adverse comments. Therefore, in addition to this
Notice of Proposed Rulemaking, elsewhere in this issue of the Federal
Register, EPA is promulgating the amendment as a direct final rule.

DATES: Written comments must be received on or before June 8, 2017.
Comments postmarked after the close of the comment period will be
stamped ``late'' and may or may not be considered by the Agency.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0244, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Erik Winchester, National Program Chemicals Division, Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-6450; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information about the proposed
changes to the compliance dates, please see the information provided in
the direct final action, with the same title, that is located in the
``Rules and Regulations'' section of this issue of the Federal
Register.

List of Subjects in 40 CFR Part 770

    Environmental protection, Formaldehyde, Incorporation by reference,
Reporting and recordkeeping requirements, Third-party certification,
Toxic substances, Wood.

    Dated: May 17, 2017.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2017-10547 Filed 5-23-17; 8:45 am]
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