[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Proposed Rules]
[Pages 11151-11160]
[FR Doc No: 2016-04579]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-M-0035]

Effective Date of Requirement for Premarket Approval for Blood
Lancets

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
administrative order to require the filing of a premarket approval
application (PMA) following the reclassification of multiple use blood
lancets for multiple patient use from class I to class III. FDA is
summarizing its proposed findings regarding the degree of risk of
illness or injury designed to be eliminated or reduced by requiring
this device to meet the PMA requirements of the Federal Food, Drug,

and Cosmetic Act (the FD&C Act) and the benefits to the public from the
use of the device.

DATES: Submit either electronic or written comments on this proposed
order by June 1, 2016. See section X of the SUPPLEMENTARY INFORMATION
section of this document for the proposed effective date of any final
order that may publish based on this proposal.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-M-0035 for ``Effective Date of Requirement for Premarket
Approval for Blood Lancets.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G422, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act, as amended, establishes a comprehensive system for
the regulation of medical devices intended for human use. Section 513
of the FD&C Act (21 U.S.C. 360c) established three categories (classes)
of devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Under section 513(d)(1) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as ``preamendments devices''), are
classified after FDA: (1) Receives a recommendation from a device
classification panel (an FDA advisory committee); (2) publishes the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) publishes a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as ``postamendments devices''), are
classified automatically by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, FDA reclassifies
the device into class I or II, or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 of the regulations (21 CFR part 807).
    A person may market a preamendments device that has been classified
into class III through premarket notification procedures, and devices
found substantially equivalent by means of premarket notification
(510(k)) procedures to such a preamendments device or to a device
within that type (both the preamendments and substantially equivalent
devices are referred to as preamendments class III devices) may be
marketed without submission of a PMA until FDA issues a final order
under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring
premarket approval. Section 515(b)(1) of the FD&C Act directs FDA to
issue an order requiring premarket approval for a preamendments class
III device.
    Section 515(f) of the FD&C Act provides an alternative pathway for
meeting the premarket approval

requirement. Under section 515(f), manufacturers may meet the premarket
approval requirement if they file a notice of completion of a product
development protocol (PDP) approved under section 515(f)(4) of the FD&C
Act and FDA declares the PDP completed under section 515(f)(6)(B) of
the FD&C Act. Accordingly, the manufacturer of a class III
preamendments device may comply with a call for PMAs by filing a PMA or
a notice of completion of a PDP. In practice, however, the option of
filing a notice of completion of a PDP has rarely been used. For
simplicity, although the PDP option remains available to manufacturers
in response to a final order under section 515(b) of the FD&C Act, this
document will refer only to the requirement for the filing and
obtaining approval of a PMA.
    On July 9, 2012, Congress enacted the Food and Drug Administration
Safety and Innovation Act (FDASIA). Section 608(b) of FDASIA (126 Stat.
1056) amended section 515(b) of the FD&C Act, changing the process for
requiring premarket approval for a preamendments class III device from
rulemaking to an administrative order.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order requiring premarket approval for a preamendments class III
device, the following must occur: Publication of a proposed order in
the Federal Register, a meeting of a device classification panel
described in section 513(b) of the FD&C Act, and consideration of
comments to a public docket.
    In June 2013, FDA held a meeting of a device classification panel
described in section 513(b) of the FD&C Act to discuss the
classification of multiple use blood lancets for multiple patient use.
Although, to FDA's knowledge, no device is currently being marketed for
this use, one device has been cleared for this use. As explained
further in section V.A of this document, this device classification
panel meeting discussed whether multiple use blood lancets for multiple
patient use should be reclassified into class III or remain in class I,
and the discussion included whether PMAs should be required for these
devices. The panel recommended that, because multiple use blood lancets
for multiple patient use present a potential unreasonable risk of
illness or injury and insufficient information exists to establish
special controls for multiple use blood lancets for multiple patient
use, the device should be reclassified into class III. FDA is not aware
of new information that would provide a basis for a different
recommendation or findings.
    Section 515(b)(2) of the FD&C Act provides that a proposed order to
require premarket approval shall contain: (1) The proposed order, (2)
proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to
have an approved PMA and the benefit to the public from the use of the
device, (3) an opportunity for the submission of comments on the
proposed order and the proposed findings, and (4) an opportunity to
request a change in the classification of the device based on new
information relevant to the classification of the device.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360f).
    A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order requiring
premarket approval for the device, or 30 months after final
classification of the device under section 513 of the FD&C Act becomes
effective, whichever is later (section 501(f) of the FD&C Act (21
U.S.C. 351(f)). Elsewhere in this issue of the Federal Register, FDA is
issuing a proposed order to reclassify multiple use blood lancets for
multiple patient use from class I to class III. Therefore, assuming
both the reclassification order and the order to require PMAs are
finalized at the same time, the date by which a PMA for multiple use
blood lancets for multiple patient use must be filed will be 30 months
after the date FDA issues the final order reclassifying multiple use
blood lancets for multiple patients. If a PMA is not filed for such
device by the later of the two dates, as specified in section
501(f)(2)(B) of the FD&C Act, then the device would be deemed
adulterated under section 501(f) of the FD&C Act unless the device is
distributed for investigational use under an approved application for
an investigational device exemption (IDE).
    In accordance with section 515(b) of the FD&C Act, interested
persons are being offered the opportunity to request reclassification
of multiple use blood lancets for multiple patient use.

II. Regulatory History of the Device

    Elsewhere in this issue of the Federal Register, FDA is proposing
to reclassify multiple use blood lancets for multiple patient use into
class III under section 513(e) of the FD&C Act.
    Blood lancets were classified in part 878 (21 CFR part 878) by a
final rule published in the Federal Register on June 24, 1988 (53 FR
23856) that classified 51 general and plastic surgery devices. This
1988 rule classified blood lancets into class I (general controls).
These devices were grouped with other devices under ``Manual surgical
instrument for general use,'' 21 CFR 878.4800. At the time, blood
lancets had been in common use in medical practice for many years, and
FDA believed that general controls were sufficient to provide
reasonable assurance of the safety and effectiveness of those devices.
This rule was amended on April 5, 1989 (54 FR 13826) to clarify that
manual surgical instruments for general use made of the same materials
as used in preamendment devices were exempt from premarket notification
510(k) review.
    On December 7, 1994, FDA further amended the classification when it
published a final rule in the Federal Register (59 FR 63005) that
exempted 148 class I devices from premarket notification, with
limitations. Blood lancets were one of those devices. FDA determined
that manufacturers' submissions of premarket notifications were
unnecessary for the protection of the public health and that FDA's
review of such submissions would not advance its public health mission.
    On August 26, 2010, FDA and the Centers for Disease Control and
Prevention (CDC) issued joint initial communications warning that the
use of fingerstick devices (blood lancets) to obtain blood from more
than one patient posed a risk of transmitting bloodborne pathogens. The
communication was updated on November 29, 2010 (Ref. 1). FDA's
communication update, ``Use of Fingerstick Devices on More Than One
Person Poses Risk for Transmitting Bloodborne Pathogens: Initial
Communication: Update 11/29/2010'', stated that ``[o]ver the past 10-15
years, the CDC and the FDA have noted a progressive increase in reports
of bloodborne infection transmission (primarily hepatitis B virus)
resulting from the shared use of fingerstick and POC [or `Point of
Care'] blood testing devices.'' FDA and CDC recommended, among other
things, that health care

professionals and patients never use a blood lancet for more than one
person.
    On November 29, 2010, FDA published a guidance entitled ``Guidance
for Industry and Food and Drug Administration Staff; Blood Lancet
Labeling'' (75 FR 73107) (Ref. 2). This guidance includes labeling
recommendations to address concerns that both health care providers and
patients may be unaware of the serious adverse health risks associated
with using the same blood lancet for assisted withdrawal of blood from
more than one patient, even when the blood lancet blade is changed for
each blood draw. FDA recommends in the guidance that all blood lancets
be labeled for use only on a single patient. FDA recommends in the
guidance that a statement limiting use to a single patient should also
appear on the label attached to the device, if possible. The guidance
was for immediate implementation. When final, this order will supersede
this labeling guidance.
    On June 26, 2013, FDA held a meeting of the General and Plastic
Surgery Devices Panel of the Medical Devices Advisory Committee (the
Panel) to discuss the potential reclassification of blood lancets (Ref.
3). The Panel discussed new scientific information, the risks to health
from blood lancets, whether blood lancets should be reclassified or
remain in class I, and possible special controls for these devices if
reclassified into class II. The Panel agreed that general controls were
not sufficient to provide a reasonable assurance of safety and
effectiveness of blood lancets. The Panel believed that because
multiple use blood lancets for multiple patient use presented a
potential unreasonable risk of illness or injury, and insufficient
information existed to establish special controls for these devices,
they should be reclassified into class III. The Panel recommended that
all other blood lancet devices be reclassified into class II (special
controls). FDA is not aware of new information since this Panel meeting
that would provide a basis for a different recommendation or finding.

III. Dates New Requirements Apply

    Assuming FDA finalizes the order proposing reclassification of
multiple use blood lancets for multiple patient use found elsewhere in
this issue of the Federal Register, this device will be classified into
class III. In accordance with sections 501(f)(2)(B) and 515(b) of the
FD&C Act, FDA is proposing to require that a PMA be filed with the
Agency for multiple use blood lancets for multiple patient use devices
and accessories by the last day of the 30th calendar month beginning
after the month in which the classification of the device in class III
became effective, or on the 90th day after the date of the issuance of
a final order under 515(b), whichever is later. Assuming this order is
finalized at or near the same time the final order to reclassify these
devices into class III, this requirement will take effect 30 months
after the reclassification order issues. An applicant whose device was
legally in commercial distribution before May 28, 1976, or whose device
has been found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III devices during FDA's
review of the PMA provided that a PMA is timely filed. FDA intends to
review any PMA for the device within 180 days. FDA cautions that under
section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into
an agreement to extend the review period for a PMA beyond 180 days
unless the Agency finds that ``. . . the continued availability of the
device is necessary for the public health.''
    Under the FD&C Act, if any multiple use blood lancets for multiple
patient use are currently in distribution and no PMA is submitted for
these devices by the last day of the 30th calendar month beginning
after the month in which the classification of the device in class III
became effective or within 90 days of a final order calling for PMAs,
or a denial is rendered on a filed PMA, these devices would be
considered adulterated under section 501(f)(1) of the FD&C Act. In
addition, no new devices will be permitted in interstate commerce
without approval of a PMA. The device may be distributed for
investigational use only if the requirements of the IDE regulations are
met. The requirements for significant risk devices include submitting
an IDE application to FDA for review and approval. An approved IDE is
required to be in effect before an investigation of the device may be
initiated or continued under Sec.  812.30 (21 CFR 812.30). FDA,
therefore, recommends that IDE applications be submitted to FDA at
least 30 days before the end of the 30-month period after the issuance
of the final order to avoid interrupting any ongoing investigations.
    FDA intends that under Sec.  812.2(d), the publication in the
Federal Register of any final order based on this proposal will include
a statement that, as of the date on which the filing of a PMA is
required, the exemptions in Sec.  812.2(c)(1) and (2) from the
requirements of the IDE regulations for preamendments class III devices
will cease to apply to any device that is: (1) Not legally on the
market on or before that date, or (2) legally on the market on or
before that date but for which a PMA is not filed by that date, or for
which PMA approval has been denied or withdrawn.

IV. Device Subject to This Proposal

Multiple Use Blood Lancet for Multiple Patient Use (21 CFR 878.4850(d))

    Elsewhere in this issue of the Federal Register, FDA is proposing
to identify multiple use blood lancet for multiple patient use in a new
21 CFR 878.4850(d) in the following way: A multiple use capable blood
lancet intended for use on multiple patients that is comprised of a
single use blade attached to a solid, reusable base that is used to
puncture the skin to obtain a drop of blood for diagnostic purposes.

V. Proposed Findings With Respect to Risks and Benefits Multiple Use
Blood Lancet for Multiple Patient Use

    As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that this
device have an approved PMA, and (2) the benefits to the public from
the use of the device.
    These findings are based on the reports and recommendations of the
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee (the Panel) from the meeting on June 26, 2013 (Ref.
3) and any additional information that FDA has obtained. Additional
information regarding the risks as well as classification associated
with this device type can be found in section V.C as well as in the
proposed order published elsewhere in this issue of the Federal
Register proposing to reclassify these devices into class III. The
device has the potential to benefit the public by puncturing the skin
to obtain small blood specimens for testing blood glucose, hemoglobin,
and other blood components. In addition, acute care hospitals may
consider reusing a single device or using one device with multiple
blades to have benefits in that doing so may expedite procedures. The
risks associated with the device include bloodborne pathogen
transmission, sharp object injuries, local tissue infections, and
adverse tissue reaction (not infection).

A. Summary of Data

    FDA uses the bloodborne pathogens definition in 29 CFR
1910.1030(b). Bloodborne pathogens, such as HBV, may be transmitted
between patients by blood and certain body fluids (Ref. 4).

Since HBV-infected patients, who often lack clinical symptoms of
hepatitis, have high concentrations of HBV in their blood and HBV is
stable at ambient temperatures, transmission of HBV may result from
exposure to equipment that has not been adequately disinfected or by
the misuse of ``single use only'' medical devices (e.g., needles and
syringes) (Ref. 5).
    The history of recognized bloodborne pathogen transmission by blood
lancets may have started in 1923 when an outbreak of jaundice occurred
in the Goteborg Hospital diabetic clinic in Sweden, which was described
by Schmid et al. (Ref. 6). All patients had blood drawn for glucose
testing from their ear lobes by a spring-activated ``Schnepper''
device, which was cleaned ``perfunctorily'' between uses. As a result,
26 clinic patients developed jaundice. Outbreaks of hepatitis in
English diabetic patients were described by Graham in 1938 (Ref. 7) and
by Droller in 1945 (Ref. 8). In both of these outbreaks, venous blood
for glucose measurement was drawn using syringes that were only
chemically disinfected between uses while the needles were boiled;
cleaning procedures were not mentioned in the reports. Syringes and
needles are now single-use-only devices because the procedures used to
reprocess these devices many years ago have long been recognized to be
inadequate, resulting in outbreaks of hepatitis transmission (Ref. 6).
There were also two case reports, in 1985 and 1997, of the transmission
of HBV infection due to sharing personal use blood lancets for home
glucose monitoring with one other person who already had HBV. One
report was from the United States and one was from Hungary (Refs. 9 and
10). In addition, Mendez et al. reported a 75-year-old patient with
diabetes who died of acute hepatitis, whose only risk factor for HBV
infection appeared to be her diabetic care at a local outpatient
facility where she had repeated fingersticks for blood glucose
monitoring (Ref. 11).
    During the 1990s, several bloodborne transmission issues led to CDC
and FDA involvement. In 1990, CDC learned of a nosocomial outbreak of
HBV transmission due to the use of a spring-loaded lancet device whose
disposable platform was not removed and discarded after each use of the
device while it was used for the care of multiple patients (Ref.
12).\1\ CDC reported this outbreak to FDA; FDA then issued a safety
alert warning users of the precautions needed for the safe use of this
device (Ref. 13). This was the first reported outbreak of HBV
transmission associated with the use of a blood lancet device in the
United States (Refs. 13 and 14).
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    \1\ Hepatitis B and hepatitis C infections, as well as other
bloodborne infections such as HIV infection, are reported to State
health departments and, by them, to CDC; FDA does not usually
receive such reports directly from health care facilities or
personnel, even when a medical device has transmitted the infection.
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    CDC's outbreak investigation revealed that a patient who had
diabetes and also a chronic HBV infection caused by a relatively rare
viral subtype was admitted to the outbreak ward in 1989. Twelve of the
23 patients who acquired hepatitis B after admission to the same ward
as the chronic HBV source patient were serotyped, and all were found to
have the same viral subtype causing their hepatitis B infections. The
first nosocomially infected patient had a very long-term stay on the
ward and so served as a source of transmission to other patients over a
period of 12 months. Twenty of the 23 outbreak patients had diabetes;
they and the three other case-patients all experienced numerous POC
fingerstick blood draws with the same type of blood lancet while
hospitalized on the outbreak ward. The implicated blood lancet device
included a disposable platform to stabilize the patient's finger; the
single use lancet blade penetrated a hole in that platform to reach the
patient's skin. Half the ward nursing staff who performed fingersticks
with this lancet acknowledged not changing the device platform with
each use of the lancet. A similar outbreak of hepatitis transmission
was reported in 1990 in France in which a similar blood lancet device
was implicated. Douvin et al. (Ref. 15) reported that examination of
the device implicated in the French outbreak showed visible blood
contamination of the lancet platform in 24 percent of studied uses of
that device. Shier et al. (Ref. 16) reported in 1993 that the use of
another spring-loaded lancet device in a volunteer study of blood
glucose levels resulted in visible blood contamination on 29 percent of
the device end caps. This device was intended for ``personal'' use
only.
    As a result of the 1990 outbreak of HBV transmission due to blood
lancet use in the United States, FDA and CDC recommended that spring-
loaded blood lancet devices should have only single use only
``platforms'' as well as single use only blades; the devices were to be
cleaned and disinfected per the manufacturer's instructions (Refs. 12
and 13). The 1990 FDA Safety Alert also advised ``Devices (blood
lancets) without a removable platform should only be used with one
patient in the hospital or outpatient setting. After the patient is
discharged, the device may be reused only if it is disinfected
according to the manufacturer's instructions. If there are no
instructions for disinfection, the device should be discarded.''
    Since 1990, the incidence of diabetes mellitus has increased
significantly in the United States, especially in adults aged 65-79
(Refs. 17 and 18). At the same time, clinical practice in the care of
these patients increasingly emphasized the need for improved blood
glucose level control, resulting in the increased use of POC blood
glucose monitoring both in health care facilities and at home (Refs.
19-21). Unfortunately, along with the increased incidence of diabetes
has come a progressive increase in the reports of bloodborne infection
transmission (primarily HBV), resulting from the shared use of
fingerstick and POC blood testing devices (Ref. 1). In 2011, the CDC
reported that 25 of 29 outbreaks of HBV infection occurring in long-
term care facilities since 1996 involved adults with diabetes receiving
blood glucose monitoring (Ref. 22).
    In 1997, CDC reported two outbreaks of HBV transmission, one in a
nursing home in Ohio and one in a hospital in New York City (NYC) (Ref.
23). Two different blood lancet devices were used at the two sites.
However, both lancet devices included the use of an ``end cap'' that
came in contact with patient skin. This was a separate, individual use
component of the lancet device used in Ohio; the nursing home was
reusing both the lancet and the cap for multiple patients. The end cap
was a part of the disposable, single use only lancet blade assembly in
the device used in NYC. The exact mechanism of blood transmission was
not entirely clear in the NYC setting; staff claimed they had discarded
the end cap after each use. CDC postulated that either blood-
contaminated nurses gloves worn for the care of multiple patients or
the pen-like lancet-holding device itself might have been the source of
the blood cross-contamination of the lancet. A similar outbreak was
reported by Quale et al. in 1998 from a hospital in New York (Ref. 24).
The recognition of 3 cases of nosocomially acquired HBV infection
resulted in an investigation that uncovered another 11 cases. Reuse by
hospital staff of a disposable lancet end cap with the lancet in
multiple patients was identified as the probable cause of hepatitis
cross-transmission to patients; contamination of the lancet wound from

blood on unchanged gloves worn by nurses during collection of blood
samples from multiple patients may also have contributed to the
nosocomial transmission of HBV in this outbreak.
    CDC reviewed the incidence of reported outbreaks of HBV and
hepatitis C infection in nonhospital health care settings between 1998
and 2008 and noted a significant increase in such nosocomial
transmission of bloodborne pathogens (Refs. 25-28). N.D. Thompson et
al. identified 33 outbreaks of nosocomial hepatitis transmission in
nonhospital health care settings (Ref. 25). Of these 33 outbreaks, 15
were found to be due to blood glucose monitoring in long-term care and
assisted living facilities. Only half of these outbreak investigations
were published in the scientific literature; the others were recognized
by health department investigations and reports to CDC. In 9 of the 15
outbreaks of nosocomial hepatitis in patients with diabetes, blood
lancet devices were shared among multiple patients. In two additional
outbreaks, lancets were not noted to be shared, but blood-soiled
glucose meters were stored together with lancets without cleaning/
disinfection of the devices and gloves were not regularly changed
between each patient. These failures of proper infection control
practice could have led to blood contamination of individual blood
lancets in these two facilities.
    N.D. Thompson et al. also investigated blood glucose monitoring
practices in long-term care facilities in Pinellas County, Florida, in
2007 and found that 22 percent of the participating facilities that
used reusable fingerstick devices used them in multiple patients (Ref.
29). Patel et al. reported in 2009 on the efforts of the Virginia
Department of Health to improve blood glucose monitoring practices in
assisted living facilities (ALFs) in Virginia (Ref. 30). This effort
followed two separate outbreaks of HBV infections in two assisted
living facilities. In those outbreaks, one of the three acutely
symptomatic initial patients died of HBV infection. Of 68 patients
undergoing blood glucose monitoring in these two facilities, a total of
11 patients acquired HBV infection. Both facilities used reusable blood
lancets to obtain blood from multiple patients and did not clean or
disinfect the lancets between uses. The Virginia Department of Health
then mailed an educational packet on safe blood glucose monitoring
practices to all ALFs (640) in the State. A random sample of ALFs was
contacted after the educational intervention and invited to participate
in a survey to evaluate the response to the educational packet. The
results found that 16 percent of the facilities that used lancets to
monitor blood glucose levels were still using these devices to obtain
blood from multiple patients.
    Y.G. McIntosh et al. investigated outbreaks of nosocomial HBV
transmission in four ALFs between 2009 and 2011 and found that in all
four facilities, pen-style lancets were used to obtain blood for
glucose monitoring from multiple patients even though two facilities
provided each patient with dedicated ``single patient use only pen-
style lancets'' according to their policies (Ref. 31). Z. Moore et al.
reported another outbreak of nosocomial HBV transmission in an ALF in
NC in 2010 in which blood lancet devices were shared among multiple
patients. Six of the eight elderly patients who acquired acute HBV in
this outbreak died from complications of hepatitis (Ref. 32). M.K.
Schaefer et al. surveyed a stratified, random sample of ambulatory
surgery centers (ACS) in three volunteer states in 2009 (Ref. 33). Of
the 53 ACS that performed blood glucose monitoring, 11 (21 percent)
reused pen-style blood lancets on multiple patients and 17 (32 percent)
also failed to clean and disinfect blood glucose meters after each use.
    Thompson and Schaefer reported the analysis of four outbreaks of
nosocomial HBV in ALFs in 2009-2010 (Ref. 34). One was also reported
separately by Z. Moore et al. (Ref. 32). Two of the three other
outbreaks occurred in Virginia and one in Florida; these 3 outbreaks
resulted in 21 new patients acquiring acute hepatitis B. In two of the
three facilities, use of reusable blood lancets to draw blood from
multiple patients was observed or reported. The third facility denied
that it permitted the sharing of reusable lancets. However, used
lancets and glucose meters were stored together, along with clean
supplies; visible blood contamination was observed on several glucose
meters and one reusable lancet by the investigator. Thompson and
Schaefer also reported in their paper on two patient notification
campaigns resulting from the misuse of reusable blood lancets with
preloaded lancet cartridges, intended and cleared only for single
patient use, which were used to obtain blood from multiple patients.
One episode involved a community health center and was reported when
personnel noted that the lancet blades were not retracting properly,
which might have resulted in blade use for more than one patient. The
second episode occurred at a community health fair in which physician
assistant students were offering diabetes screening. During the fair,
the students realized that the lancet blades had not been advanced
properly so that each patient received a new blade. The first episode
exposed 283 patients to a contaminated lancet blade; the second
incident exposed approximately 60 patients. The results of the patient
notification studies were not reported.
    As a result of this significant increase in such nosocomial
transmission of bloodborne pathogens, on August 26, 2010, FDA and the
CDC issued a Safety Communication (Ref. 1) and a Clinical Reminder
(Ref. 35), respectively, warning that the use of blood lancets to
obtain blood from more than one patient risks the transmission of
bloodborne pathogen infections from one patient to other patients. Both
FDA and CDC recommended that blood lancets should never be used to
obtain blood from more than one patient. In addition, the Centers for
Medicare and Medicaid Services issued a Survey and Certification
Memorandum for Point of Care Devices and Infection Control in Nursing
Homes identifying the use of blood lancet devices for more than one
patient as an infection control standards deficiency (Ref. 36). On
November 29, 2010, FDA issued ``Guidance for Industry and Food and Drug
Administration Staff: Blood Lancet Labeling'', which provided guidance
for lancet manufacturers on the labeling of all blood lancets,
including those capable of reuse, as ``single patient use only''
devices (Ref. 2).
    In 2012, another outbreak of acute HBV was reported in an ALF in
Virginia (Ref. 37). The source patient had been recently transferred
from another ALF where she had acquired nosocomial HBV infection from
the shared use of blood lancets for multiple patients (Ref. 31). This
ALF also reused blood lancets to obtain blood from multiple patients
for glucose monitoring. This dangerous practice resulted in two new
nosocomial HBV infections in this ALF.
    Outbreaks of hepatitis transmission due to use of blood lancets to
draw blood from more than one patient for blood glucose monitoring have
not been limited to the United States. In 2001, Desenclos et al.
described an outbreak of nosocomial hepatitis C transmission in an
inpatient ward for children with cystic fibrosis and diabetes in a
French hospital in 1994-1995 (Ref. 38). Blood glucose monitoring was
done by the nursing staff for the patients with cystic fibrosis as well
as for the patients with diabetes using a spring-loaded lancet with a
disposable platform to stabilize the finger. These devices were shared
among patients between 1986 and 1992

during repeated admissions to the inpatient unit. After 1992, patients
were supposed to use only their own lancet devices for blood glucose
monitoring. The retrospective prevalence of prior hepatitis C infection
was found to be 58 percent in patients with cystic fibrosis and 17
percent in patients with diabetes in 1994. At the time (1994), the
prevalence of antibody to hepatitis C in the general public in France
was 1.1 percent. The patients with cystic fibrosis had more frequent
and longer admissions to the inpatient ward, and more of the exposed
cystic fibrosis patients (66.7 percent) were screened for hepatitis C
infection than were the patients with diabetes admitted to the
inpatient ward during the exposure period (39.5 percent). These factors
may have influenced the apparent difference in hepatitis C transmission
in these two groups of exposed patients.
    In 2005, De Schrijver et al. described an outbreak of acute HBV
infection in a nursing home in Antwerp (Ref. 39). The initial report of
a fulminant case of acute HBV infection in an 83-year-old resident of
the home resulted in an investigation that identified acute hepatitis B
infection in another four patients there. Four of the five acutely
infected patients had diabetes and received assisted blood glucose
sampling by the nursing home staff. The two blood lancet models used in
the facility (one each in two sections) were used to obtain blood from
multiple patients. The device platforms were not disposable. The
lancets were washed only when blood was visible on the device and were
not disinfected. Nurses did not routinely wash their hands or wear
gloves when obtaining blood. Two of the five patients with acute
nosocomial hepatitis B died of their infections.
    In 2008, Gotz et al. reported the investigation of two cases of
acute HBV infection among patients at a nursing home in the Netherlands
(Ref. 40). The nursing home stay of these two patients overlapped with
that of a patient with known chronic HBV infection. Early in this time
period, the nursing home changed the lancet device used for glucose
monitoring from a spring-loaded device with a disposable platform (used
for multiple patients) to a device with a rotating drum dispensing new
lancet blades, which was also used to draw blood from multiple
patients, although it was labeled for single patient use only. This
device was used for about a month until the staff realized that active
rotation of the drum was occasionally forgotten, resulting in the reuse
of a lancet blade on more than 1 patient. The new device was then
removed from the facility and the spring-loaded lancet was returned to
use. The two patients with acute HBV received blood glucose monitoring
as did the source patient with chronic HBV, sometimes on the same day.
Two other patients who also received blood glucose monitoring escaped
infection. The investigators stated that they believed the rotating
lancet drum device was likely the means of transmission of HBV
infection between patients.
    In 2011, Duffell et al. reported on the investigations of five
reports of HBV transmission in community health care settings in the
United Kingdom (Ref. 4). All of the nine initially reported patients
with HBV had diabetes and were receiving blood glucose monitoring.
Further investigation identified another 12 patients with acute HBV
infection. The care settings in which hepatitis transmission occurred
were described as a ``private residential home'' (1 patient), nursing
and residential home (1 patient), ``private nursing and residential''
(1 patient) and ``local care home'' (2 patients). Eleven of the 21
acutely infected patients had symptomatic HBV; seven of these patients
died, five due to the HBV infection. All of the care sites in which
acute HBV transmission occurred were using blood lancets designed
intended for single patient use only; these devices were either
routinely or occasionally used for multiple patients. One facility also
used a single glucometer for multiple patients and did not clean or
disinfect it between patients. The authors also noted that information
reported on patients found to have acute HBV infection between 1990 and
2003 identified only four patients with blood glucose monitoring as a
possible risk factor; one of these patients was infected as a result of
in-hospital transmission from another patient on the same ward,
although details were not provided. Between 2004 and 2006, the 9
patients described previously in this document were reported and
investigation led to the discovery of an additional 12 cases of health
care-related HBV transmission due to the improper use of blood lancets
during patient blood glucose monitoring.

B. Benefits of the Device

    A blood lancet is used to puncture the skin to obtain small blood
specimens for testing blood glucose, hemoglobin, and other blood
components. Some blood lancets are used with POC blood testing devices,
such as blood glucose meters and Prothrombin Time and International
Normalized Ratio (PT/INR) anticoagulation meters. Today, probably the
most common use for a blood lancet is in diabetes monitoring. These
devices are used in both home and professional health care settings.
Only a small blood sample is needed for testing of blood glucose level.
The blood sample is dropped onto a test strip and inserted into a blood
glucose meter for results.
    Some blood lancets are also used with PT/INR anticoagulation
meters. These devices are used in both home and professional health
care settings. The PT and INR are used to monitor the effectiveness of
the anticoagulant warfarin. Warfarin helps inhibit the formation of
blood clots. The formation of blood clots may be associated with atrial
fibrillation, the presence of artificial heart valves, deep venous
thrombosis, and some cases of pulmonary embolism. Because the use of
warfarin may cause excessive bleeding, patients are monitored,
typically by PT/INR.
    Because newborns have relatively small amounts of blood compared to
adults, it is usually preferred to use as small amount of blood as
possible for any screening or other laboratory tests for newborns.
Blood lancets may be used to perform heel sticks in newborns. Heel
stick is a minimally invasive way of obtaining capillary blood samples.
In newborns, heel sticks are the preferred collection method for small
volumes of blood.
    The possible benefit of multiple use blood lancets for multiple
patient use is that acute care hospitals may consider reusing a single
device or using one device with multiple blades to have benefits, in
that doing so may expedite procedures.

C. Risks to Health

    FDA has evaluated the risks to health associated with use of
multiple use blood lancets for multiple patient use. In doing so, FDA
considered information from the reports and recommendations of the
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee from the meeting of June 26, 2013, the adverse event
reports for these devices in FDA's Manufacturer and User Facility
Device Experience (MAUDE) database, and the published scientific
literature, which is discussed in FDA's executive summary for the June
26, 2013, panel. Based on this information, FDA has determined the
following risks:
1. Bloodborne Pathogen Transmission
    Bloodborne pathogens such as HBV, hepatitis C virus, and
potentially any other pathogen present in the bloodstream of a patient
can be

transmitted from one patient to another by the following mechanisms:
     Reuse of the same lancet blade to draw blood from more
than one patient or
     Failure/inability to adequately clean the base of a
multiple use blood lancet resulting in the blood contamination of the
next ``new'' lancet blade when blood is drawn from more than one
patient.
2. Sharp Object Injuries
    The blade of a lancet device is designed to pierce the skin and
draw blood. Except when the used lancet blade is immediately and
automatically covered by a sharps safety feature, which renders the
blade inaccessible, the exposed sharp blade of a blood lancet presents
a puncture hazard to anyone coming in contact with it. Blade exposure
can result due to either the lack of a sharps safety feature or device
breakage.
3. Local Tissue Infections
    Human skin always carries a population of bacteria and often fungi
(normal skin flora), which causes no problem for the host when skin is
intact. However, puncture injuries to the skin by sharp objects such as
lancet blades can carry these microbes into the normally sterile tissue
below the skin. Such injuries have the potential to cause local skin/
soft tissue infections.
4. Adverse Tissue Reaction (Not Infection)
    Skin contact with some materials, metals and material colorants can
cause skin inflammation, irritation or exanthems (rashes). These
reactions may be due to either hypersensitivity to a specific compound/
metal or to a non-specific reaction.

D. Summary of FDA Findings

    FDA believes multiple use blood lancets for multiple patient use
should be reclassified from class I to class III. The Panel held on
June 26, 2013, discussed and made recommendations regarding the
regulatory classification of blood lancets to reclassify multiple use
blood lancets for multiple patient use to class III under 513(e) of the
FD&C Act. The Panel strongly agreed with FDA that based on the
available scientific evidence, multiple use blood lancets for multiple
patient use should be reclassified to class III because multiple use
blood lancets for multiple patient use present a potential unreasonable
risk of illness or injury. They also agreed that insufficient
information exists to establish special controls for multiple use blood
lancets for multiple patient use, because there is no evidence that
these devices can be adequately cleaned and disinfected and that there
is no proven method of doing so. Therefore, it is appropriate to
regulate them in class III.
    FDA agrees with the Panel's recommendation that these devices
present a potential unreasonable risk of illness or injury due to the
inherent and significantly increased risk of bloodborne pathogen
transmission risk as compared to single use only or single patient only
blood lancets. FDA does not believe existing valid scientific evidence,
as defined in Sec.  860.7 (21 CFR 860.7), supports a reasonable
assurance that the device can be adequately reprocessed between uses on
different patients. FDA also believes sufficient information does not
exist to establish special controls for blood lancets intended for
multiple patient use. Given the availability of safer single patient
use blood lancet devices, FDA further believes that the probable
benefits to health from use of the device do not outweigh the probable
risks. Currently FDA is unaware of technology or other controls that
would adequately mitigate against the inherent and significantly
increased risk of blood borne pathogen transmission in multiple use
blood lancets for use in multiple patients. Therefore, the safety and
effectiveness of the multiple use blood lancets for multiple patients,
particularly the effectiveness of their reprocessing instructions/
methods to render the device safe for use on more than one patient and
the ability of health care providers to follow these instructions
completely should be independently demonstrated for each device of this
type via a PMA application. FDA is proposing to require an individual
demonstration that a reasonable assurance of safety and effectiveness
exists for each device within this type. The manufacturer of each
individual device will have the opportunity to demonstrate the safety
and effectiveness of the device for its intended use by submitting a
PMA.

VI. PMA Requirements

    A PMA for this device must include the information required by
section 515(c)(1) of the FD&C Act. Such a PMA should also include a
detailed discussion of the risks identified previously in this
document, as well as a discussion of the effectiveness of the device
for which premarket approval is sought. In addition, a PMA must include
all data and information on: (1) Any risks known, or that should be
reasonably known, to the applicant that have not been identified in
this document; (2) the effectiveness of the device that is the subject
of the application; and (3) full reports of all preclinical and
clinical information from investigations on the safety and
effectiveness of the device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (Sec.  860.7(c)(2)). FDA defines valid scientific
evidence in Sec.  860.7(c)(2)).
    To present reasonable assurance of safety and effectiveness of
multiple use blood lancets for multiple patient use, FDA believes
manufacturers should submit performance testing, including clinical
trials of their device, in order to support PMA approval. Existing
published clinical literature may also be leveraged as part of the PMA
submission.

VII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA, FDA is required by section
515(b)(2)(D) of the FD&C Act to provide an opportunity for interested
persons to request a change in the classification of the device based
on new information relevant to the classification. Any proceeding to
reclassify the device will be under the authority of section 513(e) of
the FD&C Act.
    A request for a change in the classification of this device is to
be in the form of a reclassification petition containing the
information required by 21 CFR 860.123, including new information
relevant to the classification of the device.

VIII. Analysis of Environmental Impact

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

IX. Paperwork Reduction Act of 1995

    This proposed order refers to collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814, subparts B and E, have
been approved under OMB control number 0910-0231. The collections of
information in part 807, subpart E, have been approved under OMB
control number 0910-0120. The collections of information under 21

CFR part 801 have been approved under OMB control number 0910-0485.

X. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final order.

XI. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) of the FD&C Act
provided for FDA to issue regulations to require approval of an
application for premarket approval for preamendments devices or devices
found substantially equivalent to preamendments devices. Section 515(b)
of the FD&C Act, as amended by FDASIA, provides for FDA to require
approval of an application for premarket approval for such devices by
issuing a final order, following the issuance of a proposed order in
the Federal Register. FDA will continue to codify the requirement for
an application for premarket approval, resulting from changes issued in
a final order, in the Code of Federal Regulations (CFR). Therefore,
under section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in
the proposed order, we are proposing to require approval of an
application for premarket approval for multiple use blood lancets for
multiple patient use and, if this proposed order is finalized, we will
make the language in 21 CFR 878.4850(d) consistent with the final
version of this proposed order.

XII. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

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2. U.S. Food and Drug Administration, ``Guidance for Industry and
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Hepatitis B in an Endocrinology Unit Traced to a Capillary-Blood-
Sampling Device'', New England Journal of Medicine, 1990; 322:57-58.
16. Shier, N., J. Warren, M. Torabi, et al., ``Contamination of a
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328:969-997.
17. Centers for Disease Control and Prevention (CDC), ``Increasing
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1995-2010'', MMWR Morbidity and Mortality Weekly Report, 2012;
61(45):918-921. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6145a4.htm?s_cid=mm6145a4_w.)
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Diagnosed Diabetes per 1,000 Population Aged 18-79 Years, by Age,
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19, 2014.
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Meters and Their Role in Self-Monitoring of Diabetes Mellitus'',
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20. Yoo, E.-H. and S.-Y. Lee, ``Glucose Biosensors: An Overview of
Use in Clinical Practice'', Sensors, 2010; 10(5):4558-4576.
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(ACIP)'', MMWR Morbidity and Mortality Weekly Report, 2011;
60(50):1709-1711. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm?s_cid=mm6050a4_w.)
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Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring
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32. Centers for Disease Control and Prevention (CDC), ``Notes From
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Mortality Weekly Report, 2011; 60(6):182. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a5.htm?s_cid=mm6006a5_w.)
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the Field: Transmission of HBV Among Assisted-Living-Facility
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Report, 2013; 62(19):389. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6219a4.htm?s_cid=mm6219a4_w.)
38. Desenclos, J.C., M. Bourdiol-Razes, B. Rolin, et al.,
``Hepatitis C in a Ward for Cystic Fibrosis and Diabetic Patients:
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Hospital Epidemiology, 2001; 22(11):701-707.
39. De Schrijver, K., I. Maes, P. Van Damme, et al., ``An Outbreak
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List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 878, as proposed to be amended elsewhere in
this issue of the Federal Register, be further amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

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

0
2. Add paragraph (d)(3) to Sec.  878.4850, under subpart E, to read as
follows:

Sec.  878.4850  Blood Lancets.

* * * * *
    (d) * * *
    (3) Date PMA or notice of completion of a PDP is required: A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before [A DATE WILL BE ADDED 90 DAYS
AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER CALLING FOR PMAs IN
THE FEDERAL REGISTER OR 30 MONTHS AFTER DATE OF PUBLICATION OF A FUTURE
FINAL ORDER RECLASSSIFYING INTO CLASS III, WHICHEVER IS LATER] for any
multiple use blood lancet for multiple patient use described in
paragraph (d)(1) of this section that was in commercial distribution
before May 28, 1976, or that has, on or before [A DATE WILL BE ADDED 90
DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER CALLING FOR PMAs
IN THE FEDERAL REGISTER OR 30 MONTHS AFTER DATE OF PUBLICATION OF A
FUTURE FINAL ORDER RECLASSSIFYING INTO CLASS III, WHICHEVER IS LATER],
been found to be substantially equivalent to a multiple use blood
lancet for multiple patient use described in paragraph (d)(1) of this
section that was in commercial distribution before May 28, 1976. Any
other multiple use blood lancet for multiple patient use shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.

    Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04579 Filed 3-2-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Notices]
[Pages 22404-22406]
[FR Doc No: 2010-9460]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0760;FRL-8822-1]

Clofencet; Notice of Receipt of Request to Voluntarily Cancel
Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of a request by the registrant to voluntarily cancel
their registrations of certain products containing the pesticide
clofencet. The request would delete clofencet use as a plant growth
regulator registered for use in the production of hybrid wheat seed.
The request would terminate the last clofencet products registered for
use in the United States. EPA intends to grant this request at the
close of the comment period for this announcement unless the Agency
receives substantive comments within the comment period that would
merit its further review of the request, or unless the registrant
withdraws its request. If this request is granted, any sale,
distribution, or use of products listed in this notice will be
permitted after the registrations have been cancelled only if such
sale, distribution, or use is consistent with the terms as described in
the final order.

DATES: Comments must be received on or before May 28, 2010.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0760, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.

     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0760. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
     All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although, listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Wilhelmena Livingston, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also, may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests to Cancel

    This notice announces receipt by EPA of a request from the
registrant, Monsanto Company, to cancel certain clofencet product
registrations. Clofencet is a plant growth regulator for use in the
production of hybrid wheat seed. Clofencet is applied to female wheat
plants during specific growth phases in order to suppress pollen
development, thereby, forcing fertilization to occur from male plants
located adjacent to the treated plants. In a letter dated February 5,
2010, Monsanto Company requested EPA to cancel the pesticide product
registrations identified in Table 1. Specifically, Monsanto Company,
the sole registrant of this active ingredient, no longer wishes to
support the registration of this active ingredient or support it in the
Registration Review process. The action on the registrant's request
will terminate the last clofencet products registered in the United
States.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of a request from a registrant
to cancel certain uses of clofencet product registrations. The affected
products and the registrant making the requests are identified in
Tables 1 and 2 of this unit.
     Unless a request is withdrawn by the registrant or if the Agency
determines that there are substantive comments that warrant further
review of this request, EPA intends to issue an order canceling the
affected registrations.

   Table 1.--Clofencet Product Registrations with Pending Requests for
                              Cancellation
------------------------------------------------------------------------
       Registration Number           Product Name           Company
------------------------------------------------------------------------
524-479                           Genesis             Monsanto Company
                                   Hybridizing Agent
------------------------------------------------------------------------
524-481                           Mon 21200           Monsanto Company
                                   Technical
                                   Registration
------------------------------------------------------------------------
524-482                           Mon 21233           Monsanto Company
                                   Manufacturing Use
                                   Product
------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record for
the registrant of the products listed in Table 1 of this unit. This
number corresponds to the first part of the EPA registration numbers of
the products listed above.

         Table 2.--Registrants Requesting Voluntary Cancellation
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
524                                         Monsanto Company
                                            1300 I Street N.W.
                                            Suite 450 East
                                            East Washington, DC 20005
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Section
6(f)(1)(B) of FIFRA requires that before acting on a request for
voluntary cancellation, EPA must provide a 30-day public comment period
on the request for voluntary cancellation or use termination. In
addition, section 6(f)(1)(C) of FIFRA requires that EPA provide a 180-
day comment period on a request for voluntary cancellation or
termination of any minor agricultural use before granting the request,
unless:
    1. The registrants request a waiver of the comment period, or
    2. The Administrator determines that continued use of the pesticide
would pose an unreasonable adverse effect on the environment.
     The clofencet registrant has requested that EPA waive the 180-day
comment period. Accordingly, EPA will provide a 30-day comment period
on the proposed requests.

V. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product
cancellation or use deletion should submit the withdrawal in writing to
the person listed under FOR FURTHER INFORMATION CONTACT. If the
products(s) have been subject to a previous cancellation action, the
effective date of cancellation and all other provisions of any earlier
cancellation action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
action. If the request for voluntary cancellation is granted, the
Agency intends to publish the cancellation order in the Federal
Register.
     In any order issued in response to this request for cancellation
of product registrations, EPA proposes to include the following
provisions for the treatment of any existing stocks of the products
listed in Table 1.
    For voluntary product cancellations, registrants will be permitted
to sell and distribute existing stocks of voluntarily canceled products
for 1 year after the effective date of the cancellation, which will be
the date of publication of the cancellation order in the Federal
Register. Thereafter, registrants will be prohibited from selling or
distributing the products identified in Table 1, except for export
consistent with section 17 of FIFRA or for proper disposal.
     Persons other than the registrant may sell, distribute, or use
existing stocks of canceled products until supplies are exhausted,
provided that such sale, distribution, or use is consistent with the
terms of the previously approved labeling on, or that accompanied, the
canceled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: April 16, 2010.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2010-9460 Filed 4-27-10; 8:45 a.m.]
BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Page 49306]
[FR Doc No: 2013-19513]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension:
    Regulation 12B;
    OMB Control No. 3235-0062, SEC File No. 270-70.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Regulation 12B (17 CFR 240.12b-1--12b-37) under the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act'')
includes rules governing the registration and periodic reporting
requirements under Sections 12(b), 12(g), 13(a), and 15(d) (15 U.S.C.
78l(b), 78l(g), 78m(a) and 78o(d)) of the Exchange Act. The purpose of
the regulation is to set forth guidelines for the uniform preparation
of Exchange Act registration statements and reports. Regulation 12B is
assigned one burden hour for administrative convenience because the
regulation simply prescribes the disclosure that must appear in other
filings under the federal securities laws.
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: August 7, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19513 Filed 8-12-13; 8:45 am]
BILLING CODE 8011-01-P


Teleconference between OSHA, SOL, and TSI Incorporated personnel  -  April 20, 2018

The following individuals participated in the teleconference:
U.S. Department of Labor Participants:
From OSHA - Thomas Nerad, Natalia Stakhiv, Thomas Mockler, Sutton Puglia.
From SOL -  Jennifer Levin
TSI participants - Derrick Niccum, Greg Olsen, Daniel Happe, Troy Tillman

The purpose of the teleconference was for OSHA to learn how the new PortaCount(R) 8040/8048 models differ from the 8030/8038 models.  This was of interest to OSHA because only the 8030/8038 models were employed in the published studies that TSI conducted to demonstrate their new, abbreviated quantitative fit-testing protocols.  OSHA's concern was whether the new 8040/8048 models calculate fit factor in the same manner as the older 8030/8038 models.  If this were not the case, then the results of the published studies would not be applicable to the newer 8040/8048 models.  OSHA also wanted to determine if the 8030/8038 models could be upgraded with software that would allow them to do equivalent testing as the new 8040/8048 models.  If this were not the case it could have significantly affected the FEA calculations.
TSI stated that the new 8040/8048 models calculate fit factor in the same way as the 8030/8038 models, utilizing the same measurement engine and flow rates.  The 8040/8048 models differ from the 8030/8038 models only in ways that do not affect fit factor calculations, such as offering a new user interface, new packaging, and training.  Therefore, the results of the published studies are applicable to the new 8040/8048 models.  TSI confirmed that it is still selling, supporting, and calibrating the older 8030/8038 models at this time.  TSI stated that it makes available software upgrades at no cost to owners of 8030/8038 models.  Therefore, the same testing may be conducted using both the 8030/8038 models and the new 8040/8048 models, including the faster QNFT fit test protocols.


Lynn Hutchinson 09/ 19/ 2003 01: 52 PM To: Amy_ L._ Farrell@ omb. eop. gov, Arthur_ G._ Fraas@ omb. eop. gov cc: Bill Wehrum/ DC/ USEPA/ US@ EPA, Bill Harnett/ RTP/ USEPA/ US@ EPA, Dave Svendsgaard/ RTP/ USEPA/ US@ EPA, ( bcc: Pam Long/ RTP/ USEPA/ US)

Subject: ERP memos Here are the memos outlining the changes we would like the Administrator to sign on the ERP package. The first file contains minor, editorial type changes. The second file contains technical changes, although I believe most of these are still relatively minor.


[Federal Register: August 31, 2010 (Volume 75, Number 168)]
[Rules and Regulations]
[Page 53195-53197]
[DOCID:fr31au10-2]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0021]
RIN 1625-AA87

Security Zone; U.S. Coast Guard BSU Seattle, Pier 36, Seattle, WA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is establishing a security zone at U.S. Coast
Guard (USCG) Base Support Unit (BSU) Seattle, Pier 36, Elliot Bay,
Seattle, WA. This permanent security zone is necessary to protect
military and visiting foreign vessels, waterfront facilities, and the
maritime public from destruction, loss, or injury from sabotage,
subversive acts, or other malicious acts of a similar nature. Entry
into or movement within this security zone is prohibited without the
permission of the Captain of the Port Puget Sound or a Designated
Representative.

DATES: This rule is effective September 30, 2010.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2010-0021 and are available online by going to
http://www.regulations.gov, inserting USCG-2010-0021 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail LTJG Ashley M. Wanzer, Sector Puget Sound Waterways
Management, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On May 3, 2010, we published a notice of proposed rulemaking (NPRM)
entitled Security Zone; U.S. Coast Guard BSU Seattle, Pier 36, Seattle,
WA in the Federal Register (75 FR 23212). We received zero comments on
the proposed rule. We did not receive any requests for a public meeting
and a public meeting was not held regarding this regulation.

Basis and Purpose

    Heightened awareness of potential terrorist acts requires enhanced
security of our ports, harbors, and vessels. This rule establishes a
security zone to protect waterfront facilities, persons, and vessels
from subversive or terrorist acts on the waters surrounding USCG BSU
Seattle, Pier 36, Elliot Bay, WA. The Coast Guard Captain of the Port
Puget Sound finds sufficient cause to require this security zone to
protect military vessels, facilities and the maritime public located at
Pier 36, Elliot Bay, WA. This security zone will be continuously
activated in order to maintain the security of both moored vessels and
permanent facilities regardless of the physical presence of military
vessels within the zone.

Discussion of Comments and Changes

    We did not receive any comments on the NPRM. Accordingly, we have
made no changes from the proposed rule.

Discussion of Rule

    This rule establishes a permanent security zone necessary to
protect military and visiting foreign vessels, waterfront facilities,
and the maritime public from destruction, loss, or injury from
sabotage, subversive acts, or other malicious acts of a similar nature.
Entry into or movement within this security zone is prohibited without
the permission of the Captain of the Port Puget Sound or a Designated
Representative.
    Pier 36 is an inlet that provides vessel moorage to Coast Guard and
visiting military vessels. The permanent security zone established by
this rule extends from the north western tip of Pier 36 across the
inlet to the south western tip of Pier 36, effectively closing off the
access point such that unauthorized vessels are prohibited from
entering the pier.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. This rule is not a significant regulatory
action because it does not adversely affect the transit of maritime
vessels or the recreational boating public to major waterways.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This security zone will not have a significant economic impact on a
substantial number of small entities for the following reason: Vessel
traffic can pass safely around the security zone.
    This security zone will impact the following entities, some of
which may be small entities; those vessels or vessel operators who
intend to enter BSU Seattle at Pier 36, Seattle, WA.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g.),
of the Instruction. This rule involves a security zone located on all
waters east of a line from 47[deg]35.450' N 122[deg]20.585' W to
47[deg]35.409' N 122[deg]20.585' W at USCG BSU Seattle, Pier 36, Elliot
Bay, Seattle, WA. Under figure 2-1, paragraph (34)(g), of the
Instruction, an environmental analysis checklist and a categorical
exclusion determination are not required for this rule.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1

0
2. Add Sec.  165.1334 to read as follows:

Sec.  165.1334  Security Zone; U.S. Coast Guard BSU Seattle, Pier 36,
Elliot Bay, Seattle, WA.

    (a) Location: The following area is a security zone: All waters in
Elliot Bay east of a line from 47[deg]35.450' N 122[deg]20.585' W to
47[deg]35.409' N 122[deg]20.585' W at Pier 36, Elliot Bay, Seattle, WA.
    (b) Regulations: Under 33 CFR part 165, subpart D, no vessel may
enter, transit, moor, or anchor within this security zone located at
Pier 36, Elliot Bay, WA, except for vessels authorized by the Captain
of the Port Puget Sound or Designated Representative.

    (c) Authorization: To request authorization to operate within this
security zone, contact United States Coast Guard Sector Puget Sound
Joint Harbor Operations Center at<PHONE_NUMBER>.

    Dated: August 18, 2010.
S.W. Bornemann,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2010-21615 Filed 8-30-10; 8:45 am]
BILLING CODE 9110-04-P