[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Proposed Rules]
[Pages 28689-28696]
[FR Doc No: 2011-12088]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2011-N-0103]

Microbiology Devices; Classification of In Vitro Diagnostic
Device for Bacillus Species Detection

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
classify in vitro diagnostic devices for Bacillus species (spp).
detection into

class II (special controls), in accordance with the recommendation of
the Microbiology Devices Advisory Panel (the Panel). In addition, the
proposed rule would establish as a special control limitations on the
distribution of this device. FDA is publishing in this document the
recommendations of the Panel regarding the classification of this
device. After considering public comments on the proposed
classification, FDA will publish a final regulation classifying this
device. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability for comment of the draft guidance document
that FDA proposes to designate as a special control for this device.

DATES: Submit electronic or written comments by August 16, 2011. See
section IV of this document for the proposed effective date of a final
rule based on the proposed rule in this document.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0103, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-N-0103 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Request for Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), 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:  Beena Puri, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5553, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Legal Authority

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (Pub.
L. 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-
629), the Food and Drug Administration Modernization Act of 1997
(FDAMA) (Pub. L. 105-115), the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), and the Food and
Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85),
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) establishes three categories (classes) of devices, depending on
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 of the FD&C Act, FDA refers to devices that were
in commercial distribution before May 28, 1976 (the date of enactment
of the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after it: (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. (See also section 513(d) (21 U.S.C. 360c(d)).
FDA has classified most preamendments devices under these procedures.
    FDA refers to devices that were not in commercial distribution
before May 28, 1976, as ``postamendments devices.'' These devices are
classified automatically by statute (section 513(f)) of the FD&C Act
(21 U.S.C. 360c(f)) into class III without any FDA rulemaking process.
Those devices remain in class III and require premarket approval,
unless and until: (1) FDA reclassifies the device into class I or II;
(2) FDA issues an order classifying the device into class I or class II
in accordance with section 513(f)(2) of the FD&C Act (21 U.S.C.
360(f)(2)), as amended by FDAMA; or (3) FDA issues an order finding the
device to be substantially equivalent, under section 513(i) of the FD&C
Act (21 U.S.C. 360c(i)), to a predicate device that does not require
premarket approval. The Agency determines whether a postamendments
device is substantially equivalent to a predicate device by means of
premarket notification procedures described in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807.
    A person may market a preamendments device that has been classified
into class III through premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval. Consistent with the FD&C Act and
the regulations, FDA consulted with the Panel, regarding the
classification of this device.

B. Regulatory History of In Vitro Diagnostic Devices for Bacillus Spp.
Detection

    After the enactment of the Medical Device Amendments of 1976, FDA
undertook to identify and classify all preamendments devices, in
accordance with section 513(b) of the FD&C Act (21 U.S.C. 360c(b)).
However, in vitro diagnostic devices for Bacillus spp. detection were
not identified and classified in this initial effort. FDA subsequently
identified several preamendments devices for Bacillus spp. detection,
including Bacillus spp. antisera conjugated with a fluorescent dye
(immunofluorescent reagents) used to presumptively identify bacillus-
like organisms in clinical specimens, antigens used to identify
antibodies to B. anthracis (anti-toxin and anti-capsular) in serum, and
bacteriophage used for differentiating B. anthracis from other Bacillus
spp. based on susceptibility to lysis by the phage.
    Consistent with the FD&C Act and the regulations, FDA held a Panel
meeting on March 7, 2002, regarding the classification of the
preamendments in vitro diagnostic devices for Bacillus spp. detection.
After the Panel meeting, FDA found three additional in vitro diagnostic
devices for Bacillus spp. detection to be substantially equivalent to
another device within that type. These three devices have the same
intended use as their predicate devices, but make use of newer nucleic
acid amplification technology (NAAT). While they exhibit technological
differences from the preamendments Bacillus spp. detection devices, FDA
has determined that they are as safe and effective as, and do not raise
different

questions of safety and effectiveness than, their predicates. (See
section 513(i) of the FD&C Act (21 U.S.C. 360c(i).)

II. Panel Recommendation

    During a public meeting held on March 7, 2002, the Panel made the
following recommendation regarding the classification of in vitro
diagnostic devices for Bacillus spp. detection (Ref. 1).

A. Identification

    FDA is proposing the following identification based on the Panel's
recommendation and the available information. An in vitro diagnostic
device for Bacillus spp. detection is used to detect and differentiate
among Bacillus spp. and presumptively identify B. anthracis (B.
anthracis) and other Bacillus spp. from cultured isolates or clinical
specimens as an aid in the diagnosis of anthrax and other diseases
caused by Bacillus spp. This device may consist of Bacillus spp.
antisera conjugated with a fluorescent dye (immunofluorescent reagents)
used to presumptively identify bacillus-like organisms in clinical
specimens; or bacteriophage used for differentiating B. anthracis from
other Bacillus spp. based on susceptibility to lysis by the phage; or
antigens used to identify antibodies to B. anthracis (anti-toxin and
anti-capsular) in serum. Bacillus infections include anthrax
(cutaneous, inhalational, or gastrointestinal) caused by B. anthracis,
and gastrointestinal disease and non-gastrointestinal infections caused
by Bacillus cereus (B. cereus).

B. Classification Recommendation

    The Panel recommended that in vitro diagnostic devices for Bacillus
spp. Detection be classified into class II. The Panel believed that
class II with the special controls (special controls guidance document
and distribution limitations) would provide reasonable assurance of the
safety and effectiveness of the device. Elsewhere in this issue of the
Federal Register, FDA is announcing the availability of the guidance
document that will serve as a special control for this device.

C. Summary of Reasons and Data To Support the Recommendations

    At the March 7, 2002, meeting, the Panel considered information
from the literature presented by FDA (Refs. 2 to 5), information
presented at the meeting by representatives from the United States Army
Medical Research Institute for Infectious Diseases (USAMRIID) who
shared the historical perspective on their institution's use of devices
for the detection of B. anthracis and their personal experience using
these devices, and the Panel's personal knowledge and experience.
    Evidence presented to the Panel addressed how the preamendments
devices of this type work and some of their limitations. Bacteriophage
tests are used for differentiating B. anthracis from other Bacillus
spp. based on susceptibility to lysis by the phage. They have been
shown to specifically lyse vegetative B. anthracis and not B. cereus
strains, although the phage can fail to lyse rare strains of B.
anthracis. Bacillus spp. antisera tests conjugated with a fluorescent
dye (immunofluorescent reagents) are used to microscopically visualize
specific binding with cultured bacteria. Gram positive rods with
capsules that fluoresce is presumptive evidence for identification of
B. anthracis and must be confirmed with further testing. Antigen tests
are used to identify antibodies to B. anthracis (anti-toxin and anti-
capsular) in serum. They can be used for confirmation of anthrax if the
patient survives the disease, because early antibiotic treatment does
not abrogate antibody expression. However, such serological testing is
most useful for monitoring responses to anthrax vaccines and for
epidemiological investigations.
    The Panel recommended prescription use of the device, with the
added restrictions that use of these devices be limited to persons with
specific training or experience in the applicable testing methods, and
only in facilities under the oversight of public health laboratories,
so that the laboratories would coordinate and communicate with state
and local public health directors and that performance of the device in
the laboratory hands might be systematically collated for interagency
review (including FDA).
    The Panel believes that in vitro diagnostic devices for Bacillus
spp. should be classified into class II because special controls, in
addition to general controls, would provide reasonable assurance of the
safety and effectiveness of the device, and there is sufficient
information to establish special controls to provide such assurance.

D. Risks to Health

    Based on the Panel's discussion and recommendations, and FDA's
experience with these devices, we believe the following are risks to
health associated with the use of the device type.
    Failure of in vitro diagnostic devices for Bacillus spp. detection
to perform as indicated or an error in interpretation of results may
lead to misdiagnosis and improper patient management or inaccurate
epidemiological information that may contribute to inappropriate public
health responses. FDA believes that this type of device presents risks
associated with a false negative test result, and a false positive test
result, as explained below. In addition, there may be risks to
laboratory workers resulting from handling cultures and control
materials.
    A false positive result may lead to a medical decision causing a
patient to undergo unnecessary or ineffective treatment, as well as
inaccurate epidemiological information on the presence of anthrax
disease in a community. A false negative result may lead to delayed
recognition by the physician of the presence or progression of disease
and inaccurate epidemiological information to control and prevent
additional infections. A false negative result could potentially delay
diagnosis and treatment of infection caused by B. anthracis or other
Bacillus spp.
    Because handling the quality control organisms and those
potentially present in the specimen may pose a risk to laboratory
workers, use of these products and the needed laboratory control
materials would be restricted to laboratories with the appropriate
biosafety facilities and training.

E . Special Controls

    The Panel suggested the following special controls: (1) That FDA
partner with the Centers for Disease Control and Prevention (CDC),
USAMRIID, and other appropriate Agencies involved in laboratory
performance issues to develop practical ways to evaluate the
performance of these devices; (2) that appropriate biosafety handling
of the diagnostic specimens be followed; and (3) that FDA develop
testing guidelines to include recommendations on specimen selection,
procedures, interpretation of results, and possibly public health
notification.
    Based on the Panel's discussion and recommendations, FDA believes
that, in addition to general controls, the special controls discussed
in the following paragraphs are adequate to address the risks to
health.
    FDA believes that the draft guidance document entitled ``Class II
Special Controls Guidance Document: ``In Vitro Diagnostic Devices for
Bacillus spp. Detection'' and limitations on distribution of these
devices, set forth in the proposed classification regulation, will help
to address the issues identified previously and provide a reasonable

assurance of safety and effectiveness of the device. Elsewhere in this
issue of the Federal Register, FDA is announcing the availability for
comment of the draft of the guidance document that is proposed to serve
as a special control for this device. The class II special controls
guidance provides information on how to meet premarket (510(k))
submission requirements for the assays in the sections that discuss
performance characteristics and labeling. The performance
characteristics section describes studies to demonstrate appropriate
performance and control against assays that may otherwise fail to
perform to acceptable standards. The labeling section addresses factors
such as directions for use, quality control and precautions for use and
interpretation.
    In addition, FDA proposes to require as a special control in the
proposed classification regulation that distribution of the device be
limited to laboratories with experienced personnel who have training in
principles and use of microbiological culture identification methods
and infectious disease diagnostics, and with appropriate biosafety
equipment and containment. As noted, the Panel was concerned that these
devices be used by personnel sufficiently skilled to maximize their
performance and to appropriately interpret and make use of test
results. FDA believes that this proposed distribution limitation will
appropriately help assure the safe and effective use of these devices,
and that it is consistent with the intent of the Panel in its
discussion of limitations on the use of the devices and on monitoring
of test results.

                                Table 1--Risks to Health and Mitigation Measures
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               Identified risks                                        Mitigation measures
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A false negative test result may lead to delay  Device description--Recommended.
 of therapy and progression of disease and      Performance Studies--Recommended.
 epidemiological failure to promptly recognize  Labeling--Recommended.
 disease in the community.                      Limited Distribution--Required.
A false positive test result may lead to        Device description--Recommended.
 unnecessary treatment and incorrect            Performance Studies--Recommended.
 epidemiological information that leads to      Labeling--Recommended.
 unnecessary prophylaxis and management of      Limited Distribution--Required.
 others.
Biosafety and risks to laboratory workers       Labeling--Recommended.
 handling test specimens and control materials. Limited Distribution--Required.
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III. Proposed Classification

    FDA agrees with the Panel's recommendation that in vitro diagnostic
devices for Bacillus spp. detection should be classified into class II
because special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device, and
there is sufficient information to establish special controls to
provide such assurance.

IV. Proposed Effective Date

    FDA proposes that any final regulation based on this proposal
become effective 30 days after its date of publication in the Federal
Register.

V. Environmental Impact

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

VI. Analysis of Impacts

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs Agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive Order.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because of the minor impact expected from this
proposed rule, the Agency proposes to certify that the final rule will
not have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross National Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

B. Objective

    The objective of the proposed regulation is to ensure the continued
safety and effectiveness of in vitro diagnostic test kits for the
identification of potential Bacillus (Bacillus spp.) infections.

C. Baseline

    Since the 1950s, diagnostic tests have been used to detect Bacillus
spp., differentiate between species, and identify B. anthracis from
culture isolates or clinical specimens. Over the 10-year period 1999 to
2009, there have been approximately 8,000 such tests (using the
estimated annual testing rate), the vast majority of which were for the
purposes of proficiency testing and training. No accidents have been
reported associated with these tests.
    There are currently five diagnostic test kits cleared from
different manufacturers, as well as devices developed by CDC and
Department of Defense. The CDC test kits have been distributed to
approximately 114 laboratories that belong to the national LRN
(Laboratory Response Network). Kits are able to test between 10 and 100
samples depending on the testing capability of the different test kits.
The alternative to using in vitro diagnostic test kits to identify
potential exposure to

B. anthracis is to use blood, fluid, and tissue specimens to grow
cultures that may be used to identify the bacillus. This method is more
time-consuming and presents risks that the disease (if present) will
progress and be more difficult to treat when identified. It also means
increased patient anxiety while the culture is growing, whether the
patient has been exposed or not. A patient that may have contracted
inhalational anthrax would be expected to have high levels of anxiety
while awaiting diagnosis. The diagnostic test kits offer significant
public health benefits by providing rapid diagnosis that can both save
lives by identifying patients with anthrax and rapidly beginning
treatment as well as avoiding unnecessary prophylactic treatments for
patients that are found to not have the bacillus.
    Currently most marketed diagnostic test kits have extremely high
predictive values. Sensitivities of these devices (proportion of
positive patients correctly identified by the test) have been tested to
be over 99 percent and specificities (proportion of negative patients
correctly identified by the test) approach 100 percent.
    However, after the 2001 incident of inhalational anthrax exposures,
there was an increased public awareness of the risk of contracting
anthrax due to the media publicity that surrounded the event. Fourteen
manufacturers reacted to this increased public attention by submitting
inquiries to FDA about obtaining marketing clearance for additional
products that would diagnose the presence of the bacillus. Two of the
14 inquiries have resulted in diagnostic products getting cleared
through the Premarket Notification (510(k)) process and one
manufacturer submitting an Investigational Device Exemption (IDE). The
remaining manufacturers expressed interest but decided not to conduct
the necessary investigations to ensure the safety and effectiveness of
the test kits.
    The increased level of public attention and concern towards
potential inhalational anthrax exposures that result from any incident
(such as in 2001) is likely to have similar responses from potential
manufacturers in the future. In the absence of this proposed rule,
there will continue to be ambiguity as to the specific testing criteria
for the device to be cleared for marketing. In addition, FDA resources
will be spent responding to these inquiries for potential products that
are not destined to be marketed.

D. The Proposed Regulation

    We are proposing to classify anthrax diagnostic test kits as Class
II, and designate special controls. The special controls include
limitations of distribution for all Bacillus spp. detection devices and
the special controls guidance will include recommendations for the
performance data, quality control information, and labeling. This
guidance document will be unlikely to affect the number of laboratory
tests for Bacillus spp. or the number of tests used for training
purposes. Generally, these recommendations are already being practiced.
The document is also not likely to result in any procedural changes in
how laboratories handle the diagnostic test kits because we have been
interacting with manufacturers individually to ensure safety and
effectiveness and the guidance document is designed to clearly
articulate the best current practices. The proposed rule will ensure
that information provided to manufacturers and users of these
diagnostic test kits is consistent and appropriate and limit
distribution to laboratories that have experienced personnel and
appropriate biosafety equipment.

E. Impact of the Proposed Regulation

    If the proposed regulation is implemented, potential marketers of
these kits would clearly know what criteria and what evidence would be
needed to ensure clearance of their devices. In addition, laboratory
personnel would have assurance that they were handling the test kits
appropriately, thus both ensuring the predictive value of the test kits
were maximized and any potential risk of exposure to pathogens due to
careless handling of the test kits remain minimized. That being said,
we do not expect any change from current conditions that would result
from the proposed regulation. The current predictive values of the test
kits are already extremely high. Of the five products currently
cleared, there were no reports of false positive (specificity of 100
percent) and few reports of false negatives (estimated sensitivity of
99.6 percent combining all products). Therefore, we do not expect any
change in either use of the test kits by laboratories or in the
predictive value of the test kits in patients. The proposed rule will,
however, provide additional levels of assurance that the test kits will
provide accurate and timely diagnosis and the proper laboratory
procedures will maintain the safe and effective use of the test kits.

F. Costs

    The costs of the proposed rule are due to manufacturers' ensuring
that product labeling will be consistent with the language suggested in
the guidance document as well as likely periodic quality control
testing to ensure that marketed test kits maintain levels of safety and
effectiveness. The costs associated with ensuring consistent labeling
are expected to be minor. The labeling recommendation is based on the
labeling of the currently cleared devices and little or no change from
current conditions is expected. Nevertheless, we have estimated that
manufacturers may incur minor revisions to their labels in response to
the new guidance after regulatory staff review and compare current
labeling language and design to the language and design recommendations
(including photographs or diagrams) proposed in the guidance document.
To account for these reviews and any possible labeling revisions, we
have estimated that typical label changes for typical medical devices
or diagnostic products would cost manufacturers approximately $2,200
per label change per brand. This estimate is based on market driven
label revisions and was derived from estimates for a variety of devices
similar to test kits (Cost Analysis of the Labeling and Related Testing
Requirements for Medical Glove Manufacturers, Eastern Research Group
(ERG), 2002) and account for only simple language and design
alterations. We have further estimated that changes of this sort
typically occur about every 5 years in response to market changes and
improvements to the specific product. The manufacturers of each of the
4 currently marketed test kits are likely to review and perhaps revise
labels for a total cost of $8,800. Over an expected 5-year evaluation
period (based on a typical labeling cycle), the annualized cost of
reviewing and revising labels is only $1,900 (3-percent annual discount
rate) or $2,100 (7-percent annual discount rate).
    In addition, the draft guidance document will include a description
of the quality control tests recommended to ensure the safety and
effectiveness of the diagnostics. While these tests are currently used
to develop marketed products, it is possible that the frequency of
testing to ensure continued quality may increase as a result of the
proposed rule. We have estimated that additional quality control
testing may require expenditures of as much as $100 per product per
year for each brand. This cost is based on a sampling of typical
laboratory control tests (including ELISHA, Lowry, and other ASTM
(American Society for Testing of Materials) recommended tests) for

devices (ERG, 2002). Therefore, for the duration of a 5-year evaluation
period, we expect the industry may incur additional quality control
testing costs of about $400 per year.
    The proposed rule is designed to articulate current practices for
the currently marketed test kits. However, because of this regulatory
classification, it is possible that these additional activities will
result in minor cost increases. We have estimated that the proposed
rule could result in, at most, annualized costs of approximately $2,300
(3 percent) or $2,500 (7 percent).

G. Benefits

    There are unlikely to be any direct public health benefits of the
proposed rule, because the rule articulates current industry practice
and does not change the expected use of the diagnostic product.
However, the proposed regulation is designed to ensure continued
quality of this important diagnostic tool. The Bacillus spp. test kit
provides important public health benefits through rapid diagnosis and
thus, rapid treatment of a fatal disease, or rapid identification that
treatment is not necessary. The absence of this diagnostic test kit, or
even a decrease in the performance of the kit, would increase the
negative outcomes of any future anthrax event, including increases in
potential mortalities. The proposed regulation will provide additional
assurance that the current level of public health protection is
maintained.
    In addition, it is possible that any slight label revisions or
standardization of information in the labeling, as well as an increased
emphasis on laboratory training, may decrease the likelihood of
potential mishandling of either the diagnostic test kits or the test
medium. There is currently no way to quantify this effect because there
has been no reported exposure or risk associated with these diagnostic
tests or the test medium in this country. We acknowledge that it is
possible that mishandling could occur in the future and it is possible
that clear, consistent instructions may avoid some potential future
mishandling, but cannot quantify any benefit based on this eventuality.
    However, the response of potential marketers of Bacillus spp. test
kits to the publicity that surrounded the 2001 anthrax event indicates
that a potential benefit could be derived from clearly articulating the
tests needed to provide sufficient data to ensure adequate safety and
effectiveness of these products. By having consistent and easily
available criteria, potential marketers will easily be able to
ascertain whether or not to pursue market clearance. The availability
of this information is expected to result in better, and perhaps fewer,
potential marketing applications that may arise in response to future
incidents of public inhalation anthrax exposure. Of course we hope that
future events do not occur; however, there is a low level of
probability that an incident could occur in the future. We have
estimated the annual probability of a public inhalational anthrax
incident to be approximately between 2 percent and 5 percent based on
historical occurrences. We received 14 inquiries in regards to
obtaining clearances which have resulted in 3 applications and 2
clearances. Using the success rate of 14 percent (2 successes from 14
inquiries), we expect a reduction of approximately 0.24 to 0.6
unsuccessful inquiries or applications each year. (Twelve unsuccessful
inquiries or applications multiplied by the annual probability of an
incident). The estimated effort to potential marketers of contacting
FDA, obtaining advice concerning the clearance process, and
preliminarily preparing a marketing application is estimated to take
approximately 5 days of review, market research, and internal
decisionmaking. The mean salary for employees within NAICS 325413 (In
Vitro Diagnostic Substance Manufacturing) is approximately $80,000
(Census, 2007). A week of FTE (full-time employee) time would thus have
an average cost to manufacturers of about $1,500. By avoiding
unnecessary (and ultimately unsuccessful) inquiries for potential
marketing applications, we expect the proposed rule to result in
savings of between $400 and $900 per year. ($1,500 multiplied by 0.24
and 0.6 avoided inquiries each year).
    In addition, FDA resources will not be spent responding to
inquiries or reviewing unsuccessful applications that would not be
submitted with the clear information that would be the result of the
proposed rule. The average FDA full-time equivalent employee is valued
at approximately $130,000, including salary, benefits, overhead, and
support). Responding to inquiries concerning a potential application
may consume a few hours of resources per inquiry while reviewing an
application may consume as much as 2 weeks of review time. On average,
we expect each avoided inquiry or application to save approximately 8
hours of FDA resources. Thus, with the clear information available as a
result of the proposed rule, FDA is expected to save between $100 and
$300 per year ($130,000 divided by 235 days times 0.24 and 0.6 annual
inquiries avoided).
    Thus, we estimate the proposed regulation will result in
quantifiable benefits of avoiding unnecessary inquiries and potential
applications to be between $500 and $1,200 per year. We believe that
the unquantified benefits of providing an additional level of quality
assurance, maintaining the predictive value of the marketed test kits,
and avoiding any potential future laboratory errors cannot be
estimated, but represent real benefits to the public health.

H. Alternatives to the Proposed Rule

    We identified four plausible alternatives to the proposed rule.
    1. Continue to regulate as an unclassified device. This alternative
would not provide an assurance of safety and effectiveness and would
continue the current level of inconsistent information for potential
new marketers.
    2. Regulate this diagnostic test as a Class I device. Because
sufficient information was available to develop special controls for
this device, this alternative, which would require general controls
only, was not considered sufficient for the potential risks of this
device.
    3. Regulate this diagnostic test as a Class III device. Premarket
approval and clinical data collection are not appropriate for the
potential risks of this device, which are more appropriately dealt with
using the proposed special controls. Classifying the test as Class III
would increase the cost of marketing the devices without an increase in
assurances of safety and effectiveness.
    4. Regulate this diagnostic test as a Class II device with
alternative special controls. The proposed guidance document is
sufficient to provide assurances of safety and effectiveness. Other
potential special controls were deemed to not be cost-effective and not
provide additional assurances of safety and effectiveness.

I. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because of the minor costs to manufacturing entities
attributable to the proposed rule, the Agency believes the proposed
rule will not have a significant economic impact on a substantial
number of small manufacturing entities. In addition, the proposed rule
will not affect testing laboratories because we do not expect any
change in current use of the diagnostic test kit.

    There are currently five cleared diagnostic kits for the
identification of Bacillus spp. marketed by five companies. These
companies are classified in the In Vitro Diagnostic Substance
Manufacturing Industry (NAICS 325413) by the Census of Manufacturers.
This industry is typified by small entities. For this industry, the
Small Business Administration classifies any establishment with 500 or
fewer employees as small. The typical establishment in this industry
employs only about 120 employees, so virtually every company is small.
Value of shipments for this industry is approximately $50,000,000 per
establishment. The expected annualized cost per affected establishment
($800) represents less than 0.002 percent of annual shipments.
    Testing Laboratories (NAICS 541380) are considered small by the
Small Business Administration if they generate $12,000,000 or less in
annual revenue. There is no change in activity expected by this
industry from the proposed rule, so we do not expect any impact on
laboratories.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain state requirements ``different from or
in addition to'' certain Federal requirements applicable to devices. 21
U.S.C. 360k; See Medtronic v. Lohr 518 U.S. 470 (1996); Riegel v.
Medtronic, 552 U.S. 312 (2008). The special control regarding limited
distribution set out in the proposed regulation, if finalized, would
create a requirement. The other special controls, if finalized, would
create ``requirements'' to address each identified risk to health
presented by these specific medical devices under 21 U.S.C. 360k, even
though product sponsors may have flexibility in how they meet those
requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th
Cir. 1997).

VIII. Paperwork Reduction Act of 1995

    FDA concludes that this proposed rule contains no new collections
of information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520) is not required.
    The proposed rule would establish as special control a draft
guidance document that refers to previously approved collections of
information found in other FDA regulations. These collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 807, subpart E, regarding premarket
notification submissions, have been approved under OMB control no.
0910-0120. The collections of information in 21 CFR part 801 and 21 CFR
809.10, regarding labeling, have been approved under OMB control no.
0910-0485.

IX. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this proposed
rule. It is only necessary to send one set of comments. It is no longer
necessary to send two copies of mailed comments. Identify comments with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

X. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday. We
have verified all Web site addresses, but we are not responsible for
subsequent changes to the Web sites after this document publishes in
the Federal Register.
    1. Transcript of the FDA Microbiology Devices Panel meeting, March
7, 2002, at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=348.
    2. Abshire, T.G. et al., ``Validation of the use of gamma phage for
identifying Bacillus anthracis,'' 102nd American Society for
Microbiology Annual Meeting poster C122, 2001.
    3. Brown, Eric R. and William B. Cherry, ``Specific identification
of Bacillus anthracis by means of a variant bacteriophage,'' vol. 96,
Journal of Infectious Disease, p. 34, 2001.
    4. Brown, Eric R. et al., ``Differential diagnosis of Bacillus
cereus, Bacillus anthracis and Bacillus cereus var. mycoides,'' vol.
75, Journal of Bacteriology, p. 499, 1957.
    5. Buck C.A. et al., ``Phage isolated from lysogenic Bacillus
anthracis,'' vol. 85, Journal of Bacteriology, p. 423, 1963.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 866 be amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    1. The authority citation for 21 CFR part 866 continues to read as
follows:

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

    2. Section 866.3045 is added to subpart D to read as follows:

Sec.  866.3045  In vitro diagnostic device for Bacillus spp. detection.

    (a) Identification. An in vitro diagnostic device for Bacillus spp.
detection is used to detect and differentiate among Bacillus spp. and
presumptively identify Bacillus anthracis and other Bacillus spp. from
cultured isolates or clinical specimens as an aid in the diagnosis of
anthrax and other diseases caused by Bacillus spp. This device may
consist of Bacillus spp. antisera conjugated with a fluorescent dye
(immunofluorescent reagents) used to presumptively identify bacillus-
like organisms in clinical specimens; or bacteriophage used for
differentiating B. anthracis from other Bacillus spp. based on
susceptibility to lysis by the phage; or antigens used to identify
antibodies to B. anthracis (anti-toxin and anti-capsular) in serum.
Bacillus infections include anthrax (cutaneous, inhalational, or
gastrointestinal) caused by B. anthracis, and gastrointestinal disease
and non-gastrointestinal infections caused by B. cereus.
    (b) Classification. Class II (special controls). The special
controls are:
    (1) FDA's guidance document entitled: ``Class II Special Controls
Guidance Document: In Vitro Diagnostic Devices for Bacillus spp.
Detection; Guidance for Industry and FDA.'' See Sec.  866.1(e) for
information on obtaining this document.
    (2) The distribution of these devices is limited to laboratories
with experienced personnel who have training in principles and use of
microbiological culture identification methods and infectious disease
diagnostics, and with appropriate biosafety equipment and containment.

    Dated: May 12, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-12088 Filed 5-17-11; 8:45 am]
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[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Notices]
[Pages 8861-8863]
[FR Doc No: 2012-3159]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0012; FRL-9333-8]

Pesticide Products; Receipt of Applications To Register New Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients, pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is
publishing this Notice of such applications, pursuant to section
3(c)(4) of FIFRA.

DATES: Comments must be received on or before March 16, 2012.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number specified below, 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 the docket ID number
specified for the pesticide of interest as shown in the registration
application summaries. 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
email. The regulations.gov Web site 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 email
comment to EPA without going through regulations.gov, your email
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.
    Docket: 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: A contact person is listed at the end
of each registration application summary and may be contacted by
telephone or email. The mailing address for each contact person listed
is: Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001, Antimicrobials Division (7510P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-00001 or Biopesticides and Pollution
Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System

(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. 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 email. 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).
If you are commenting on a docket that addresses multiple products,
please indicate to which registration number(s) or file symbol(s) your
comment applies.
    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. Registration Applications for New Uses

    EPA received applications as follows to register pesticide products
containing currently registered active ingredients pursuant to the
provisions of section 3(c) of FIFRA, and is publishing this Notice of
such applications pursuant to section 3(c)(4) of FIFRA. Notice of
receipt of these applications does not imply a decision by the Agency
on the applications.
    1. Registration Numbers: 100-739, 100-1262, and 100-1386. Docket
Number: EPA-HQ-OPP-2011-0300. Company name and address: Syngenta Crop
Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active
ingredient: Difenoconazole. Proposed Uses: Fruiting vegetable group 8-
10, Low growing berry subgroup 13-07G, except cranberry, Citrus fruit
group 10-10, and Pome fruit group and post harvest use on potato.
Contact: Rose Kearns, Registration Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    2. Registration Numbers: 100-921 and 100-922. Docket Number: EPA-
HQ-OPP-2011-0086. Company name and address: Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27419. Active ingredient:
Acibenzolar-s-methyl. Proposed Uses: low growing berry subgroup 13-07G.
Contact: Rose Kearns, Registration Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    3. Registration Number: 100-1312. Docket Number: EPA-HQ-OPP-2011-
0300. Company name and address: Syngenta Crop Protection, LLC, P.O. Box
18300, Greensboro, NC 27419. Active ingredient: Difenoconazole and
Propiconazole. Proposed Uses: Fruiting vegetable group 8-10, Low
growing berry subgroup 13-07G, except cranberry, Citrus fruit group 10-
10, and Pome fruit group and post harvest use on potato. Contact: Rose
Kearns, Registration Division,<PHONE_NUMBER><EMAIL_ADDRESS>    4. Registration Number: 100-1313. Docket Number: EPA-HQ-OPP-2011-
0300. Company name and address: Syngenta Crop Protection, LLC, P.O. Box
18300, Greensboro, NC 27419. Active ingredient: Difenoconazole and
Azoxystrobin. Proposed Uses: Fruiting vegetable group 8-10, Low growing
berry subgroup 13-07G, except cranberry, Citrus fruit group 10-10, and
Pome fruit group and post harvest use on potato. Contact: Rose Kearns,
Registration Division,<PHONE_NUMBER><EMAIL_ADDRESS>    5. Registration Number: 100-1317. Docket Number: EPA-HQ-OPP-2011-
0300. Company name and address: Syngenta Crop Protection, LLC, P.O. Box
18300, Greensboro, NC 27419. Active ingredient: Difenoconazole and
Cyprodinil. Proposed Uses: Fruiting vegetable group 8-10, Low growing
berry subgroup 13-07G, except cranberry, Citrus fruit group 10-10, and
Pome fruit group and post harvest use on potato. Contact: Rose Kearns,
Registration Division,<PHONE_NUMBER><EMAIL_ADDRESS>    6. Registration Number 10163-277. Docket Number: EPA-HQ-OPP-2010-
0916. Company name and address: Gowan Company, 370 South Main Street,
Yuma, AZ 85364. Active ingredient: Hexythiazox. Proposed Use: Alfalfa,
timothy, wheat. Contact: Olga Odiott, Registration Division, (703) 308-
9369<EMAIL_ADDRESS>    7. Registration Number: 59441-RN. Docket Number: EPA-HQ-OPP-2011-
1007. Company name and address: Kodak Company, 343 State Street,
Rochester, New York 14650 .Active ingredient: Thymol. Proposed Use:
Preservative in manufacture and storage of photographic, imaging, and
thin film coating preparations. Contact: Jaclyn Carl, Antimicrobials
Division,<PHONE_NUMBER><EMAIL_ADDRESS>    8. Registration Number: 62719-442. Docket Number: EPA-HQ-OPP-2011-
0343. Company name and address: Dow AgroSciences LLC, 9330 Zionsville
Rd., Indianopolis, IN 46268-1054. Active ingredient: Methoxyfenozide.
Proposed Use: Citrus group 10-10 and Root vegetable subgroup 1B.
Contact: Clayton Myers, Registration Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    9. Registration Numbers: 71711-18 and 71711-19. Docket Number: EPA-
HQ-OPP-2011-0541. Company name and address: Nichino America, Inc., 4550
New Linden Hill Road, Suite 501, Wilmington, DE 19808. Active
ingredient: Fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate and its Z-
somer,(Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate. Proposed Uses: Avocado, sapote,
black, canistel, sapote, mamey, mango, papaya, sapodilla, star apple,
bean, snap, and tea, plucked leaves. Contact: Driss Benmhend,
Registration Division,<PHONE_NUMBER><EMAIL_ADDRESS>    10. File Symbol: 84059-RT. Docket Number: EPA-HQ-OPP-2010-0058.
Company name and address: Marrone Bio Innovations, Inc., 2121 Second
St., Suite B-107, Davis, CA 95618. Active ingredient: Chromobacterium
subtsugae strain PRAA4-1\T\. Proposed Use: Residential uses. Contact:
Jeannine Kausch, Biopesticides and Pollution

Prevention Division (7511P),<PHONE_NUMBER><EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: February 3, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-3159 Filed 2-14-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Proposed Rules]
[Pages 68507-68509]
[FR Doc No: 2023-21887]

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

Federal Aviation Administration

14 CFR Parts 1, 21, 22, 36, 43, 45, 61, 65, 91, and 119

[Docket No.: FAA-2023-1377; Notice No. 23-10]
RIN 2120-AL50

Modernization of Special Airworthiness Certification

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

ACTION: Notice of proposed rulemaking (NPRM); extension of comment
period.

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

SUMMARY: This action extends the comment period for the NPRM titled
``Modernization of Special Airworthiness Certification,'' that was
published on July 24, 2023. In that document, the FAA proposed to amend
rules for the manufacture, certification, operation, maintenance, and
alteration of light-sport aircraft. The proposed amendments would
enable enhancements in safety and performance and would increase
privileges under a number of sport pilot and light-sport aircraft
rules. These enhancements include increasing suitability for flight
training, limited aerial work, and personal travel. This proposed rule
would expand what aircraft sport pilots may operate. The NPRM also
proposed to amend the special purpose operations for restricted
category aircraft; amend the duration, eligible purposes, and operating
limitations for experimental aircraft; and add operating limitations
applicable to experimental aircraft engaged in space support vehicle
flights to codify statutory language. The FAA is extending the comment
period for this NPRM to allow commenters additional time to analyze the
proposed rule and prepare a response.

DATES: The comment period for the NPRM published on July 24, 2023, at
88 FR 47650, and scheduled to close on October 23, 2023, is extended
January 22, 2024.

ADDRESSES: Send comments identified by docket number FAA-2023-1377
using any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov and
follow the online instructions for sending your comments
electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001 between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: 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 regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at dot.gov/privacy.
    Docket: Background documents or comments received may be read at
regulations.gov at any time. Follow the online instructions for
accessing the docket or go to the Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact James Newberger, Aircraft Certification Service
(AIR-632), Federal Aviation Administration, 800 Independence Ave. SW,
Washington, DC 20591, telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

A. Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. The FAA also
invites comments relating to the economic, environmental, energy, or
federalism impacts that might result from adopting the proposals in
this document. Additionally, the FAA requests comment on whether the
FAA should remove the definition of consensus standard from Sec.  1.1
altogether or revise the definition as proposed. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should submit only one time if comments are filed electronically or
commenters should send only one copy of written comments if comments
are filed in writing.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it receives on or before
the closing date for comments. The FAA will consider comments filed
after the comment period has closed if it is possible to do so without
incurring expense or delay. The FAA may change this proposal in light
of the comments it receives.

B. Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial
information that is both customarily and actually treated as private by
its owner. Under the Freedom of Information Act (FOIA), 5 U.S.C. 552,
CBI is exempt from public disclosure. If your comments responsive to
this NPRM contain commercial or financial information that is
customarily treated as private, that you actually treat as private, and
that is relevant or responsive to this NPRM, it is important that you
clearly designate the submitted comments as CBI. Please mark each page
of your submission containing CBI as ``PROPIN.'' The FAA will treat
such marked submissions as confidential under the FOIA, and they will
not be placed in the public docket of this NPRM. Submissions containing
CBI should be sent to the person identified in the FOR FURTHER
INFORMATION CONTACT section of this document. Any commentary the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

C. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the
internet by--
    1. Searching the Federal eRulemaking Portal at regulations.gov;
    2. Visiting the FAA's Regulations and Policies web page at faa.gov/regulations_policies/; or
    3. Accessing the Government Printing Office's web page at
GovInfo.com.
    Copies may also be obtained by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW, Washington, DC 20591, or by calling<PHONE_NUMBER>.
Commenters must identify the docket or notice number of this
rulemaking.
    All documents the FAA considered in developing this proposed rule,
including economic analyses and technical reports, may be accessed from
the internet through the Federal eRulemaking Portal referenced in item
(1) above.

Background

    On July 24, 2023, the FAA published an NPRM titled ``Modernization
of Special Airworthiness Certification,'' in the Federal Register (88
FR 47650; Notice No. 23-10). In the NPRM, the FAA proposed to amend
rules for the manufacture, certification, operation, maintenance, and
alteration of light-sport aircraft. The proposed amendments would
enable enhancements in safety and performance and would increase
privileges under a number of sport pilot and light-sport aircraft
rules. These enhancements include increasing suitability for flight
training, limited aerial work, and personal travel. This proposed rule
would expand what aircraft sport pilots may operate. The NPRM also
proposed to amend the special purpose operations for restricted
category aircraft; amend the duration, eligible purposes, and operating
limitations for experimental aircraft; and add operating limitations
applicable to experimental aircraft engaged in space support vehicle
flights to codify statutory language. Commenters were instructed to
provide comments on or before October 23, 2023 (i.e., 90 days from the
date of publication of the NPRM).
    Since publication, the FAA received 10 comments from individuals
requesting that comment period not be extended. The FAA has also
received requests from Aircraft Electronics Association, Aeronautical
Repair Station Association, Aviation Suppliers Association, Aviation
Technician Education Council, Helicopter Association International,
International Air Response, Inc., Modification and Replacement Parts
Association, and the National Air Transportation Association to extend
the comment period by an additional ninety (90) days. These

commenters requested more time to review the proposed rule and
associated guidance documents, and to develop comments and
recommendations.
    The FAA grants the requests for an extension of the comment period.
While some commentators opposed extending the comment period, the FAA
recognizes the importance of the proposed rule and that an extension
would help commenters craft complete and thoughtful responses. With
this extension, the comment period will now close on January 22, 2024.
This will provide the public with a total of one hundred and eighty
(180) days to conduct its review and submit comments to the docket.
    The FAA will not grant any additional requests to further extend
the comment period for this rulemaking.

Extension of Comment Period

    In accordance with Sec.  11.47(c) of title 14, Code of Federal
Regulations, the FAA has reviewed the requests for an extension of the
comment period for this notice. Those requesting an extension have
shown a substantive interest in the proposed policy and good cause for
the extension of the comment period. The FAA has determined that an
extension of the comment period for an additional ninety (90) days to
January 22, 2024 is consistent with the public interest, and that good
cause exists for taking this action.
    Accordingly, the comment period for Notice No. 23-10 is extended
until January 22, 2024.
    Issued under authority provided by 49 U.S.C. 106(f), 44701(a) and
44703 in Washington, DC.

Lirio Liu,
Executive Director, Aircraft Certification Service.
[FR Doc. 2023-21887 Filed 10-3-23; 8:45 am]
BILLING CODE 4910-13-P