[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Proposed Rules]
[Pages 60299-60304]
[FR Doc No: 2016-21062]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2016-N-1149]

Manufacturer Communications Regarding Unapproved Uses of Approved
or Cleared Medical Products; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a 2-day public hearing to obtain input on issues related to
communications by manufacturers, packers, and distributors, including
their representatives (collectively ``firms''), regarding FDA-regulated
drugs and medical devices for humans, including those that are licensed
as biological products, and animal drugs (collectively, ``medical
products''). FDA is engaged in a comprehensive review of its
regulations and policies governing firms' communications about
unapproved uses of approved/cleared medical products, and the input
from this meeting will inform FDA's policy development in this area.
FDA is seeking input on a number of specific questions, but is
interested in any other pertinent information participants would like
to share.

DATES: The public hearing will be held on November 9 and 10, 2016, from
9 a.m. to 5 p.m. The meeting may be extended or end early depending on
the level of public participation. Persons seeking to attend or present
at the public hearing must register by October 19, 2016. Electronic or
written comments will be accepted after the public hearing until
January 9, 2017.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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-N-1149 for ``Manufacturer Communications Regarding Unapproved
Uses of Approved or Cleared Medical Products; Public Hearing; Request
for Comments.'' 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.
    A link to the live Webcast of this public hearing will be available
at http://www.fda.gov/CommunicationsPublicMeeting on the day of the
public hearing. A video record of the public hearing will be available
at http://www.fda.gov/CommunicationsPublicMeeting following the
meeting. A video record of the public hearing will be available at the
same Web site address for 1 year.

FOR FURTHER INFORMATION CONTACT: Kristin Davis, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252,
Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is responsible for regulating medical products (i.e., drugs and
medical devices for humans, including those that are licensed as
biological products, and animal drugs) under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) and the Public Health Service Act (PHS
Act) as well as all relevant implementing regulations (collectively,
``FDA Authorities'') to promote and protect the public health by
helping to ensure that these products are safe and effective for their
intended uses. As we announced in 2014, FDA is currently engaged in a
comprehensive review of the regulatory framework related to firms'
communications about unapproved uses of approved/cleared medical
products \1\--medical products that may be legally introduced into
interstate commerce for at least one other intended use.\2\ The purpose
of this review is to help ensure that our implementation of the FDA
Authorities (including promulgating and amending regulations, issuing
guidance, developing policies, and taking enforcement action) best
protects and promotes the public health in view of ongoing developments
in science and technology, medicine, health care delivery, and
constitutional law.
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    \1\ In this document, the term ``unapproved use'' encompasses
additional intended uses of approved drugs and approved/cleared
devices, including devices that are currently marketed pursuant to a
510(k) clearance or exemption.
    \2\ See FDA response letter, Docket Nos. FDA-2011-P-0512 and
FDA-2013-P-1079 (June 6, 2014), available at http://www.regulations.gov.
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    Under the FDA Authorities, in general, firms are required to submit
data and other information to FDA for premarket review demonstrating a
medical product is safe and effective for each of its intended uses
before they introduce the product into interstate commerce for those
intended uses. During FDA premarket review of medical products, the
Agency also generally reviews proposed labeling for the intended use(s)
of the product to ensure that the labeling provides adequate
information for the safe and effective use of the product. The FDA
Authorities also prohibit firms from marketing medical products with
false or misleading labeling and similarly restrict certain medical
product advertising.
    The premarket review and labeling and advertising provisions of the
FDA Authorities address critical public health objectives. The current
regulatory framework was developed in response to public health
tragedies, particularly those that occurred when firms could distribute
drugs and devices without independent, premarket review of scientific
evidence of the products' safety and efficacy.\3\ Medical product firms
are required to develop high-quality data to demonstrate that medical
products are safe and effective for their intended uses before
marketing of the products for those uses. This requirement helps ensure
that the use of medical products is based on sound science, not mere
anecdotal experience or misleading promotional tactics, and helps
prevent direct and indirect patient harm from products and uses that
are unsafe and/or ineffective. When using a medical product for its FDA
approved/cleared intended use, health care professionals and patients
and their caregivers can be assured that the decision to use the
product is supported by robust premarket review of scientific data and
other appropriate scientific evidence by an independent scientific
agency and that the benefits and risks of the use are described in the
product's FDA-approved or required labeling. These important assurances
are absent for unapproved uses. The premarket review requirements also
reflect Congress's determination that exclusive reliance on postmarket
remedies, such as enforcement actions for false or misleading labeling,
is unacceptable as a public health strategy because it does not prevent
harm and injury to patients.
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    \3\ The Federal Food, Drug, and Cosmetic Act of 1938, which
introduced the requirement that firms demonstrate a drug product to
be safe before being marketed, followed the deaths of approximately
100 people, mostly children, from ingesting ``Elixir
Sulfanilamide,'' in which the lethal substance diethylene glycol was
used as a solvent. Prior to 1938, there were no premarket
requirements that mandated that the firm test its product's safety.
The passage of the 1962 drug amendments was precipitated in part by
the distribution of thalidomide, a sedative that caused birth
defects when taken by pregnant women. See Wallace F. Janssen,
Outline of the History of U.S. Drug Regulation and Labeling, 36 Food
Drug-Cosm. L.J. 420 (1981). Significant problems with medical
devices likewise preceded the Medical Device Amendments of 1976,
including significant defects in cardiac pacemakers that led to 34
voluntary recalls involving 23,000 units, and serious side effects
following implantation of intraocular lenses, including serious
impairment of vision and the need to remove the eyes of some
patients (H.R. Rep. No. 94-853, at 8 (1976)). See also Henry A.
Waxman, A History of Adverse Drug Experiences: Congress Had Ample
Evidence to Support Restrictions on the Promotion of Prescription
Drugs, 58 Food & Drug L.J. 299 (2003); see also Kate Greenwood, The
Ban on ``Off-Label'' Pharmaceutical Promotion: Constitutionally
Permissible Prophylaxis Against False and Misleading Commercial
Speech?, 37 Am. J. L. and Med. 278, 291-92 (2011) (describing the
history of misleading firm claims in promoting unapproved uses).

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    Congress also determined that safety and effectiveness must be
evaluated for each intended use of a medical product to prevent the
harm that occurs when patients are prescribed or use ineffective
treatments and to ensure that the benefits of an intended use outweigh
its risks. Under the FDA Authorities, FDA evaluates whether a medical
product is safe for a particular use by comparing the expected
therapeutic benefits against the risk associated with that use. The
weighing of benefit and risk for each intended use is necessary as a
matter of science to protect the public health: A product considered
``safe and effective'' for one disease or condition or patient
population cannot automatically be considered ``safe and effective''
for another disease or condition or patient population. For example, a
drug with severe adverse effects may be considered safe and effective
for treating metastatic lung cancer, but be unlikely to have a positive
benefit-risk balance for treating high blood pressure. Similarly, a
non-absorbable suture cleared or approved for wound closure on the
skin's surface might raise significant new safety and effectiveness
concerns if used internally.
    Notwithstanding the importance of the FDA Authorities in protecting
public health, health care professionals are generally permitted to
prescribe or use approved/cleared medical products for unapproved uses
when they judge that the unapproved use is medically appropriate for
their individual patients,\4\ and relevant, truthful, and non-
misleading scientific or medical information regarding unapproved uses
of approved medical products may help health care professionals make
better individual patient decisions. For example, health care
professionals may consider prescribing or using approved/cleared
medical products for unapproved uses in circumstances where a patient
has a disease for which there is no approved treatment or has exhausted
all approved treatments. In such a situation, relevant, truthful, and
non-misleading scientific or medical information about an unapproved
use may help a health care professional to make treatment decisions in
the absence of scientific data or information that is capable of
satisfying FDA's premarket review requirements.
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    \4\ FDA generally does not seek to interfere with the exercise
of the professional judgment of health care providers in
prescribing, for unapproved uses for individual patients, most
legally marketed medical products. This longstanding position has
been codified with respect to devices. See 21 U.S.C. 396. While FDA
generally recognizes the professional judgment of veterinarians,
certain unapproved uses of drugs in animals are not permitted and
result in the drug being deemed unsafe under section 512 of the FD&C
Act. See section 512(a)(4) and (5) of the FD&C Act (21 U.S.C.
360b(a)(4) and (5)) and 21 CFR part 530.
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    Health care professionals already can access considerable
scientific information about unapproved uses, for example, through
public sources such as scientific journals, clinical practice
guidelines, and compendia or by requesting that information from
firms.\5\ FDA is interested in comment on the extent to which
additional communications from firms about unapproved uses can provide
access to information that is relevant, scientifically sound,
responsibly presented, and provides as full an understanding as
possible about the limitations of the available evidence, as well as
comment on the extent to which health care professionals currently face
impediments to accessing such information, whether from firms or from
other sources. FDA is interested in comment and information addressing
whether and in what ways firms' communications of unapproved use
information are distinct and perhaps provide unique benefits compared
to other sources.
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    \5\ See ``Guidance for Industry: Responding to Unsolicited
Requests for Off-Label Information About Prescription Drugs and
Medical Devices--Draft Guidance'' (December 2011), available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf. FDA
has also issued guidance documents to describe some of the
circumstances when it would not consider a manufacturer's
distribution of reprints, clinical practice guidelines, or reference
texts regarding unapproved uses of approved drugs to be evidence of
intended use and/or false or misleading. See ``Revised Draft
Guidance for Industry: Distributing Scientific and Medical
Publications on Unapproved New Uses--Recommended Practices''
(February 2014), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf
(``Revised Good Reprint Practices Draft Guidance''); and ``Guidance
for Industry: Good Reprint Practices for Distribution of Medical
Journal Articles and Medical or Scientific Reference Publications on
Unapproved New Uses of Approved Drugs and Approved or Cleared
Medical Devices'' (January 2009), available at http://www.fda.gov/oc/op/goodreprint.html (``Good Reprint Practices Guidance'').
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    Not all communications of information about unapproved uses help
support public health. For example, communications that emphasize a
medical product's claimed benefits, while minimizing the limitations of
the supporting evidence, or minimizing the product's known or potential
adverse effects, may inappropriately influence prescribing or use
decisions in a manner that is not in a patient's best interest. FDA is
interested in comment on both the pros and cons for public health
associated with firms' communications of unapproved use information and
the kinds of limitations or requirements that would be appropriate to
protect patients from harm. We are also interested in any supporting
data related to these issues. In addition, allowing additional
communications about unapproved uses could have other indirect
consequences on public health, which are important to understand and
anticipate. For example, FDA is interested in information to better
understand how increased communications about unapproved uses would
impact incentives to conduct biomedical research submitted for FDA
review and subjects' willingness to participate in such research.
    The Agency is aware of technological and business changes that are
increasingly affecting medical decision making and prescribing. There
are a growing number of entities in the health care system with a stake
in evaluating evidence to assess the rational and systematic use of
medical products. As medical providers have increasingly been
consolidated into integrated systems, the use of system measurements of
quality and measurements of the appropriate use of medical products has
increased, and insurance carriers, health care systems, and similar
entities may restrict coverage for medical products based on
assessments of value and employ performance measures to monitor
appropriate use and outcomes. FDA is interested in understanding
whether and how these changes may be able to provide an impetus for the
development of additional high-quality data to address the balance of
benefits and risks of each use of a medical product and, if so, in what
way they would affect incentives for submission of this data to the
Agency for marketing authorization.

II. Purpose and Scope of the Public Hearing

    The purpose of this public hearing is to obtain comments on FDA's
regulation of firms' communications about medical products, with a
particular focus on firms' communications about unapproved uses of
their approved/cleared medical products. FDA is seeking feedback from a
broad group of stakeholders, including, but not limited to, health care
professionals and professional societies, patients and their
caregivers, patient advocates, representatives from regulated industry,
health care organizations, payors and insurers, academic institutions,
public interest groups, and the general public.
    To facilitate stakeholder feedback, FDA sets forth some questions
in this section. These questions are not meant to be exhaustive. We
encourage

interested stakeholders to address these and/or other issues related to
firms' communications about their medical products. In all cases, FDA
encourages stakeholders to provide the rationale and basis for their
comments, including any available data and information, and to
explicitly articulate any underlying assumptions. FDA also encourages
commenters to explain the basis for any distinctions they would draw as
to audience, vehicle of communication, type of medical product, type
and source of information, or any other aspect of communication.
    1. FDA is interested in input from stakeholders on how increased
communications from firms about unapproved uses could impact the public
health, and on whether the impact would differ across different
categories of medical products. For example,
    a. What are the benefits for clinical decision making, research,
coverage, reimbursement, or other purposes (please specify) if firms
communicate to health care professionals, payors, researchers, and/or
patients more information, including preliminary or inconclusive
information, about unapproved uses of approved/cleared medical
products? What are the drawbacks and risks? Are there safeguards or
requirements that would effectively mitigate any drawbacks or risks?
    b. What information or systems exist to help FDA determine how
firms' increased communication of information about unapproved uses of
approved/cleared medical products could affect prescribing as well as
medical product development and research into new uses of approved/
cleared products?
    c. How could firms' increased communication of information about
unapproved uses of approved/cleared medical products affect patient
incentives to enroll in clinical trials? Related to this, FDA is
interested in information on how firms' increased communication of this
information could impact their incentives to generate robust data to
fully assess the risks and benefits of new uses and to apply for FDA
marketing authorization for new uses of approved/cleared products.
    d. Do the answers to the previous questions vary for different
categories of medical products (e.g., human drugs and biologics,
medical devices, animal drugs) or for different disease areas or
patient populations?
    2. FDA is aware of changes happening in the health care system that
are outside of FDA's role, which may provide an impetus for the
development of high-quality data to fully assess the risks and benefits
of new uses of medical products.
    a. To what extent do changes occurring in the health care system
that give payors and formulary committees more influence on prescribing
decisions (including by denying, limiting, or endorsing coverage of
unapproved uses of approved medical products) provide incentives for
firms to generate the high-quality data needed to demonstrate safety
and effectiveness for new uses?
    b. To what extent do these changes affect (to preserve, enhance, or
suppress) incentives for firms to seek FDA approval/clearance of new
uses?
    3. FDA recognizes that information about medical products,
including information about unapproved uses of approved/cleared medical
products, is now broadly available from a wide variety of sources
(e.g., academic and governmental organizations, scientific journals,
professional societies, compendia) in both traditional and new
communication vehicles and platforms, particularly electronic
communication platforms (e.g., the Internet). What is the impact of the
increasing availability of this information on firms' incentives to
communicate information about unapproved uses of approved/cleared
products? FDA is also interested in input on other factors that firms
may consider when making decisions about providing information about
unapproved uses of their approved/cleared medical product, including
financial considerations.
    4. Given the importance of the scientific integrity of the
information that may be relied on in making decisions about the use of
medical treatments, FDA is interested in input from stakeholders on the
standards that should apply to unapproved use communications to
minimize the potential of these communications to be misleading or
otherwise cause harm. For example:
    a. Given the wide range of quality of information potentially
available to firms on unapproved uses of their approved/cleared medical
products, what processes do firms use to evaluate whether such
information is scientifically appropriate to communicate to health care
professionals and other entities?
    b. What criteria should the Agency consider in determining whether
a study or analysis that is the basis of a firm's communication is
scientifically appropriate to support the presentations or conclusions
in the communication?
    c. What do health care professionals generally understand about the
quality and utility of different kinds or levels of scientific evidence
related to unapproved uses? Can the same information be misleading to
some audiences of health professionals and not others?
    d. What information is most important to health care professionals
and other entities in allowing them to judge the validity and utility
of firms' communications about unapproved uses, including the level of
uncertainty of the evidence, and why? Does the answer to this question
differ depending on the recipient's purpose--e.g., making treatment
decisions for an individual patient, informing the direction of further
research, making formulary or institutional supply chain contracting
decisions, or making coverage determinations?
    5. FDA is interested in input from stakeholders on factors that the
Agency should consider in evaluating whether firms' communications
about unapproved uses of approved/cleared medical products are truthful
and non-misleading, including what information firms should disclose in
these communications to help ensure audiences are not misled, and on
general considerations related to the audience for these communications
and on communication vehicles and techniques. For example:
    a. What information should firms communicate to make audiences
aware that the medical product is unapproved for the use discussed and
to otherwise distinguish between the approved/cleared use(s) of the
medical product and the unapproved use? How could the means of
communication affect a recipient's ability to distinguish between
unapproved and approved/cleared uses or otherwise impede the disclosure
of necessary contextual information?
    b. What factors are most relevant to determining whether a firms'
communication about a medical product concerns an unapproved use? How
do firms evaluate whether or not their communications concern
unapproved uses and whether the messages communicated are accurate and
non-misleading?
    c. What other information should firms' disclose in these
communications to help ensure audiences are not misled (e.g., about the
risks of the product, the nature and weight of the evidence supporting
the unapproved use, the regulatory history relating to the unapproved
use, the financial involvement of firms in the research described,
etc.)?
    d. How can disclosures in firms' unapproved use communications be

made most effective in conveying material information while minimizing
chances of confusion or inattention? How effective are disclosures in
ensuring that limitations concerning data about unapproved uses are
adequately communicated and comprehended? For example, how could the
content and format of disclosures be developed to optimize the
usefulness of this information for audiences? FDA is interested in
empirical evidence to assess whether health care professionals or other
entities follow or disregard different types or formats of disclosures
or disclaimers.
    e. To what extent is it appropriate for firms to communicate
information about unapproved uses of their approved/cleared medical
products to patient and consumer audiences? What disclosures and
additional information would be needed to help ensure that a
communication to lay audiences is truthful and non-misleading, given
consumers' lack of medical training and expertise in critically
evaluating this type of information?
    6. Another important consideration in the changing health care
environment is transparency, including the growing expectation that
data from human studies will be made available for public review. If a
firm bases a communication on data that is not publicly available,
should information be provided publicly to ensure that the quality and
integrity of the supportive scientific information can be adequately
evaluated before any prescribing or use decision? If so, how should
transparency of this information be monitored?
    7. FDA is interested in public input on how the Agency should
monitor firms' communications about unapproved uses of their medical
products, and what actions FDA should take with respect to firms'
communications that are determined to be false or misleading or that
otherwise raise public health issues. For example, what kinds of
surveillance and monitoring could be undertaken to measure and assess
the public health impacts of unapproved use communications and by whom?
    8. As discussed previously, the Agency is evaluating its
regulations and policies governing firms' communications about
unapproved uses of approved/cleared medical products and considering
whether revisions are appropriate in order to provide greater legal
certainty and clarity to regulated entities. As an initial step, in the
Federal Register of September 25, 2015 (80 FR 57756), FDA issued a
notice of proposed rulemaking that proposed changes to existing
regulations at 21 CFR 201.128 and 801.4 to provide clarity for drug and
device firms regarding FDA's interpretation and application of its
existing intended use regulations.
    a. What additional changes, if any, should FDA consider in its
regulations related to firms' communications about medical products,
such as the regulations related to what is false or misleading,
adequate directions for use, the definition of labeling, or other
relevant provisions?
    b. With respect to proposed alternatives to the current
regulations, as well as other proposed alternatives suggested in
litigation briefs and journal articles, what are the advantages and
disadvantages of these approaches as they relate to the public health
objectives that the FDA Authorities are designed to advance?

III. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance is
free and early registration is recommended. Individuals who wish to
attend must register on or before October 19, 2016, at http://www.fda.gov/CommunicationsPublicMeeting and provide complete contact
information, including name, title, affiliation, email, and phone
number. Those without Internet access may register by contacting
Kristin Davis at<PHONE_NUMBER>. FDA may allow onsite registration if
space is available. If registration reaches maximum capacity, FDA will
post a notice closing registration at http://www.fda.gov/CommunicationsPublicMeeting.
    Individuals who wish to present at the public hearing must register
as noted at http://www.fda.gov/CommunicationsPublicMeeting and identify
the questions (see section II) they wish to address in their
presentation to help FDA organize the presentations. Individuals and
organizations with common interests should consolidate or coordinate
their presentations and request time for a joint presentation. FDA will
do its best to accommodate requests to speak and will determine the
amount of time allotted for each oral presentation and the approximate
time that each oral presentation is scheduled to begin. FDA will notify
registered presenters of their scheduled times and make available an
agenda at http://www.fda.gov/CommunicationsPublicMeeting on or before
November 2, 2016. Once FDA notifies registered presenters of their
scheduled times, presenters must submit an electronic copy of their
presentation to<EMAIL_ADDRESS>by October 26,
2016.
    If you need special accommodations because of a disability, please
send an email to<EMAIL_ADDRESS>at least 7
days before the meeting.
    A link to the live Webcast of this public hearing will be available
at http://www.fda.gov/CommunicationsPublicMeeting on the day of the
public hearing. A video record of the public hearing will be available
at http://www.fda.gov/CommunicationsPublicMeeting following the
meeting. A video record of the public hearing will be available at the
same Web site address for 1 year.

IV. Notice of Public Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, accompanied by FDA
senior management from the Office of the Commissioner and the relevant
centers/offices.
    Under Sec.  15.30(f) (21 CFR 15.30(f)), the hearing is informal and
the rules of evidence do not apply. Only the presiding officer and
panel members may question any person during or at the conclusion of
each presentation (Sec.  15.30(e)). Public hearings under part 15 are
subject to FDA's policy and procedures for electronic media coverage of
FDA's public administrative proceedings (21 CFR part 10, subpart C)
(Sec.  10.203(a)). Under Sec.  10.205, representatives of the
electronic media may be permitted, subject to certain limitations, to
videotape, film, or otherwise record FDA's public administrative
proceedings, including presentations by participants. The hearing will
be transcribed as stipulated in Sec.  15.30(b) (see section V). To the
extent that the conditions for the hearing as described in this
document conflict with any provisions set out in part 15, this notice
acts as a waiver of those provisions as specified in Sec.  15.30(h).

V. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a

Freedom of Information request. The Freedom of Information office
address is available on the Agency's Web site at http://www.fda.gov.

    Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21062 Filed 8-31-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Proposed Rules]
[Pages 76492-76495]
[FR Doc No: 2020-26337]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1038; Project Identifier MCAI-2020-00569-E]
RIN 2120-AA64

Airworthiness Directives; Safran Helicopter Engines, S.A. (Type
Certificate Previously Held by Turbomeca, S.A.) Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Safran Helicopter Engines, S.A. (Safran) Arriel 2D and Arriel
2E model turboshaft engines. This proposed AD was prompted by the
manufacturer revising the maintenance and overhaul manuals to introduce
new or more restrictive airworthiness limitations and maintenance
tasks. This proposed AD would require the replacement of certain
critical parts before reaching their published in-service life limits,
performing scheduled maintenance tasks before reaching their published
periodicity, and performing unscheduled maintenance tasks when the
engine meets certain conditions. As a terminating action, this proposed
AD would require operators to revise the airworthiness limitation
section (ALS) of their existing approved aircraft maintenance program
(AMP) by incorporating the revised airworthiness limitations and
maintenance tasks. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by January 14,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12 140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Safran
Helicopter Engines, S.A., 64511 Bordes--Cedex, France; phone: (33) 05
59 74 40 00; fax: (33) 05 59 74 45 15. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call (781)
238-7759.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1038; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other

information. The street address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
(781) 238-7134; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2020-1038; Project Identifier
MCAI-2020-00569-E'' at the beginning of your comments The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Wego
Wang, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2018-0273, dated December 13, 2018 (referred to after
this as ``the MCAI''), to address the unsafe condition on these
products. The MCAI states:

    The airworthiness limitations and maintenance tasks for the
SAFRAN ARRIEL 2D, ARRIEL 2E and ARRIEL 2N engines, which are
approved by EASA, are currently defined and published in the SAFRAN
ARRIEL 2 Maintenance and Overhaul Manuals, as applicable. These
instructions have been identified as mandatory for continued
airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition.
    SAFRAN recently revised the applicable Maintenance and Overhaul
Manuals (the applicable ALS), introducing new and/or more
restrictive airworthiness limitations and maintenance tasks.
    For the reason described above, this [EASA] AD requires
accomplishment of the actions specified in the applicable ALS.

    You may obtain further information by examining the MCAI in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2020-1038.

FAA's Determination

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

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Chapter 05-10-00 of Safran Helicopter Engines
ARRIEL 2D Maintenance Manual (MM) No. X292 R1 450 2, Update No. 20,
dated June 15, 2020. Safran Helicopter Engines ARRIEL 2D MM X292 R1 450
2 identifies the terms used in tables for limits and mandatory
maintenance tasks, usage counters of the engine log book, life limits
for life-limited parts, and mandatory inspection tasks to be carried
out to reach the airworthiness objectives on Safran Arriel 2D model
engines.
    The FAA reviewed Chapter 05-10-00 of Safran Helicopter Engines
ARRIEL 2E MM No. X292 R2 300 2, Update No. 16, dated June 15, 2020.
Safran Helicopter Engines ARRIEL 2E MM X292 R2 300 2 identifies the
terms used in tables for limits and mandatory maintenance tasks, usage
counters of the engine log book, life limits for life-limited parts,
and mandatory inspection tasks to be carried out to reach the
airworthiness objectives on Safran Arriel 2E model engines.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Proposed AD Requirements in This NPRM

    This proposed AD would require the replacement of certain critical
parts before reaching their published in-service life limits,
performance of schedule maintenance tasks before reaching the published
periodicity in the applicable Safran Arriel MM chapter, and performance
of unscheduled maintenance tasks when the engine meets certain
conditions specified in the applicable Safran Arriel MM chapter. As a
terminating action, this proposed AD would require operators to revise
the ALS of their existing approved AMP by incorporating the revised
airworthiness limitations and maintenance tasks.

Differences Between This Proposed AD and the MCAI

    The MCAI is applicable to Safran Arriel 2D, Arriel 2E, and Arriel
2N model turboshaft engines. This AD is only applicable to Safran
Arriel 2D and 2E model turboshaft engines. Safran Arriel 2N model
turboshaft engines are not type certificated in the U.S.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 426 engines installed on helicopters of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Remove and replace critical parts.....  12 work-hours x $85 per           $1,152          $2,172        $925,272
                                         hour = $1,020.
Perform maintenance tasks.............  1 work-hour x $85 per              1,152           1,237         526,962
                                         hour = $85.
Revise the ALS and AMP................  1 work-hour x 85 per                   0              85          36,210
                                         hour = 85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
corrective actions that would be required based on the results of the
proposed maintenance tasks. The agency has no way of determining the
number of aircraft that might need these actions.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Perform corrective action.....................  1 work-hour x $85 per hour = $85              $0             $85
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Safran Helicopter Engines, S.A., (Type Certificate previously held
by Turbomeca, S.A.): Docket No. FAA-2020-1038; Project Identifier
MCAI-2020-00569-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 14, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Safran Helicopter Engines, S.A. (Safran)
(Type Certificate previously held by Turbomeca, S.A.) Arriel 2D and
Arriel 2E model turboshaft engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by the manufacturer revising the
maintenance and overhaul manuals to introduce new or more
restrictive airworthiness limitations and maintenance tasks. The FAA
is issuing this AD to prevent failure of the engine. The unsafe
condition, if not addressed, could result in uncontained release of
a critical part, damage to the engine, and damage to the helicopter.

(f) Compliance

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

(g) Required Actions

    (1) Replace each critical part before reaching the in-service
life limits specified in paragraph 1.C., ``Table of authorized in-
service life limits for the ARRIEL 2D,'' or ``Table of authorized
in-service life limits for the ARRIEL 2E,'' Chapter 05-10-00 of the
Safran ARRIEL Maintenance Manual (MM) for that engine.
    (2) Before reaching the periodicity specified in paragraph 1.,
``Tables of Mandatory Maintenance Tasks,'' table D., ``Scheduled
inspection,'' Chapter 05-10-00 of the Safran ARRIEL MM for that
engine, perform all maintenance tasks specified in table D.
    (3) When the engine meets the conditions specified in paragraph
1., table E., ``Unscheduled inspection,'' Chapter 05-10-00 of the
Safran ARRIEL MM for that engine, perform the maintenance tasks
specified in table E.
    (4) If, during performance of the maintenance tasks required by
paragraph (g)(2) or (3) of this AD, a discrepancy is found, as
defined in the applicable ALS, perform the corrective actions
specified in paragraph 1., ``Tables of Mandatory Maintenance
Tasks,'' table D., ``Scheduled inspection,'' or E. ``Unscheduled
inspection,'' Chapter 05-10-00 of the Safran ARRIEL MM for the
engine.
    (5) If no compliance time is identified in Chapter 05-10-00 of
the Safran ARRIEL MM, perform the corrective action before further
flight.

(h) Exception to Paragraphs (g)(2) and (3)

    Where the applicable Safran ARRIEL MM chapters provide
instructions to send the Module 03 to a Safran Helicopter Engines-
approved repair center, the operator may choose to send the Module
03 to any FAA-approved repair center capable of performing the
required actions.

(i) Mandatory Terminating Action

    As terminating action to the requirements in paragraph (g) of
this AD, within 365 days after the effective date of this AD, revise
the ALS of the existing approved aircraft maintenance program (AMP)
by incorporating:
    (i) Task 05-10-00-150-801-A01, ``Airworthiness Limitations--
General,'' from the applicable Safran ARRIEL MM chapter.
    (ii) Task 05-10-00-200-801-A01, ``Airworthiness Limitations--
Authorized In-Service Life Limits,'' from the applicable Safran
ARRIEL MM chapter.
    (iii) Task 05-10-10-200-801-A01, ``Airworthiness Limitations--
Tables of Mandatory Maintenance Tasks,'' from the applicable Safran
ARRIEL MM chapter.

(j) Definitions

    (1) For the purpose of this AD, a ``critical part'' is a part
identified in paragraph 1.C., ``Table of authorized in-service life
limits for the ARRIEL 2D,'' or ``Table of authorized in-service life
limits for the ARRIEL 2E,''

Chapter 05-10-00 of the Safran ARRIEL MM for that engine.
    (2) For the purpose of this AD, the ``Chapter 05-10-00 of the
Safran ARRIEL MM'' is:
    (i) Chapter 05-10-00 of Safran Aircraft Engines ARRIEL 2D MM No.
X292 R1 450 2, Update No. 20, dated June 15, 2020; or
    (ii) Chapter 05-10-00 of Safran Aircraft Engines ARRIEL 2E MM
No. X292 R2 300 2, Update No. 16, dated June 15, 2020.
    (3) For the purpose of this AD, the ``approved maintenance
program'' is defined as the basis for which the operator ensures the
continuing airworthiness of each operated helicopter.

(k) Credit for Previous Actions

    (1) For affected Safran Arriel 2D model turboshaft engines, you
may take credit for revising the ALS of the existing approved AMP
that is required by paragraph (i) of this AD if you incorporated the
tasks before the effective date of this AD using Chapter 05-10-00 of
Safran ARRIEL 2D MM No. X292 R1 450 2, Update No. 19, dated December
30, 2019.
    (2) For affected Safran Arriel 2E model turboshaft engines, you
may take credit for revising the ALS of the existing approved AMP
that is required by paragraph (i) of this AD if you incorporated the
tasks before the effective date of this AD using Chapter 05-10-00 of
Safran ARRIEL 2E MM No. X292 R2 300 2, Update No. 15, dated December
30, 2019.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in Related Information. You may email your request to:
<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(m) Related Information

    (1) For more information about this AD, contact Wego Wang,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2018-0273, dated December 13, 2018, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating it in Docket No. FAA-2020-1038.
    (3) For service information identified in this AD, contact
Safran Helicopter Engines, S.A., 64511 Bordes--Cedex, France; phone:
(33) 05 59 74 40 00; fax: (33) 05 59 74 45 15. You may view this
referenced service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued on November 24, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-26337 Filed 11-27-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 25, 2007 (Volume 72, Number 79)]
[Notices]
[Page 20573-20576]
[DOCID:fr25ap07-122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55646; File No. SR-NYSE-2007-02]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto To
Adopt New Rule 447 (``Emergency Powers'')

April 19, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 9, 2007, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by NYSE. On April 18, 2007, NYSE submitted Amendment No. 1 to
the proposed rule change.\3\ The Commission is publishing this notice
to solicit comments on the proposed rule change, as amended, from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced and superseded the original filing
in its entirety.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt new Rule 447 (``Emergency Powers'')
which would allow the Exchange to grant exemptive regulatory relief in
the event of an emergency, e.g. a pandemic-like situation. The text of
the proposed rule change is available at NYSE, the Commission's Public
Reference Room, and http://www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it had received on the

proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in Sections A, B, and C below, of the most
significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
Introduction
    Currently, the Exchange does not, in the normal course, grant
plenary exemptive relief to member organizations from the requirements
of NYSE rules. The Exchange is proposing to obtain authorization to
provide such relief, in the rare event of overwhelming need, such as a
pandemic, by way of the new proposed NYSE Rule 447.
    In the wake of recent media attention and industry concern
regarding the potential for a pandemic flu outbreak,\4\ proposed Rule
447 would provide the Exchange with a basis of authority pursuant to
which it may consider granting exemptive regulatory relief during such
an emergency.
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    \4\ See NYSE Information Memo 06-30 (May 5, 2006) for further
guidance.
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    In implementation of the duty to enforce regulatory compliance,
self-regulatory organizations (``SROs'') possess inherent authority to
administer and interpret their own rules. This authority comprehends
the ability to grant relief from the formal strictures of a specific
provision where the conduct sought to be effected, in any single given
instance, is otherwise consistent with the purpose and intent of that
rule. However, the Exchange does not have a medium for granting
interim, but categorical relief to a class of its membership across
rule lines--as circumstances may necessitate, and/or to impose
additional and more rigorous requirements in response to emergency
conditions. The purpose of the proposed rule is to provide such a
mechanism and thereby grant the Exchange the regulatory flexibility to
grant member organizations relief in the event of an emergency, as
defined.
    Indeed, many of the types of relief envisioned under the proposed
rule illustrate the general circumspection with respect to which
requests for relief would be viewed. While recourse to the rule would
be limited to ``major disturbances'' in regard to which the Commission
is statutorily authorized to alter, suspend, or impose requirements or
restrictions of matters subject to regulation by it or SROs, the nature
of the relief to be granted would necessarily serve to mitigate the
effects of the disruption so that the markets may perform in a manner
consistent with customer expectations. Likely, the same manner of
consequences to affect the investing public would similarly impact
personnel of the securities industry such that they would equally need
to address these external forces and factors.
Background
Existing NYSE Rules
    NYSE Rule 446 (``Business Continuity and Contingency Plans'')
governs business continuity and contingency planning for member
organizations. While the rule does not require that member
organizations remain in business in the event of a significant business
disruption, it does require firms to have a plan in place establishing
procedures reasonably designed to enable the member organization to
meet existing obligations to customers, other broker-dealers, and
counter-parties.\5\ In an effort to assist and enable member
organizations in the context of an emergency to remain in compliance
with NYSE rules, the Exchange is proposing new Rule 447 to apply where
regulatory flexibility may be necessary to address the emergency
atmosphere which could result in the event of a pandemic or other
similar type event. Easing circumstances for facilitating member
organizations to remain in business would facilitate the orderly flow
of the markets while also providing for the protection of investors.
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    \5\ See NYSE Information Memos 04-24 (May 3, 2004) and 05-80
(October 13, 2005) for additional guidance.
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Federal Exemptive Relief
    Section 12(k)(2) of the Act \6\ empowers the SEC, in an emergency,
to take summary action to alter, suspend, or supplement requirements or
restrictions with respect to any matter subject to regulation by the
Commission or an SRO. Section 12(k)(7) of the Act \7\ defines the term
``emergency'' to include ``a major disturbance that substantially
disrupts, or threatens to substantially disrupt the functioning of
securities markets, investment companies, or any other significant
portion or segment of the securities markets* * *.''
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    \6\ 15 U.S.C. 78l(k)(2).
    \7\ 15 U.S.C. 78l(k)(7).
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Proposed NYSE Rule 447
General Rule
    Proposed Rule 447 allows the Exchange, with the concurrence of the
Commission that an ``emergency'' exists, where it is necessary in the
public interest and for the protection of investors, and on such
conditions, if any, which it may impose, to grant certain regulatory
relief to member organizations. The Exchange may take action in
implementation of the proposed rule at its discretion, after seeking
the concurrence of the Commission as to the type of relief that may be
appropriate in the circumstances, in respect of any member
organization, any class or category of member organization, or in
respect of all member organizations and/or their personnel.
    The Exchange would seek the concurrence of the SEC by alerting
Commission staff electronically or via telephone as to the type of
action the Exchange would take in implementation of the proposed rule.
NYSE staff would make a good faith effort to have a conversation with
Commission staff. However, if NYSE staff is unable to reach SEC staff,
it may take action and advise the SEC of such action in an expedient
manner. Pursuant to conversations with Commission staff, the Exchange
may move forward with the appropriate relief in good faith without
formal agreement from the Commission so as to provide timely relief to
member organizations in an emergency.
Specific Regulatory Relief
    Under the proposed rule, the Exchange may elect to defer or extend
Exchange-imposed time frames (otherwise applicable) for: Filing
documents or reports with the Exchange (other than trade reports or
reports arising from the settlement of transactions); obtaining
Exchange approval, where such approval is required; requesting margin
extensions via Exchange automated extension processing systems; or
complying with testing, training, or continuing education requirements.
The Exchange may ``defer'' time frames where it is appropriate to put
off or delay the due dates for submissions or approvals until an
unknown date, based on the circumstances of the emergency. Otherwise,
the Exchange may ``extend'' time frames to a fixed date in the future.
    In addition, the proposed rule gives the Exchange authority, upon
customer consent, to permit recourse to means and systems not
customarily utilized by broker-dealers for: The direct receipt,

transmission, or delivery of funds and securities, to and from
customers; the valuation of securities; and the transmission of
statements, confirmations, proxy materials, and other functionally
equivalent material. This would allow broker-dealers to work with the
Exchange to determine alternative means and systems to most effectively
serve their customers and the public interest in the event of an
emergency.
    The proposed rule would allow the Exchange to permit the closure of
main offices during an emergency. The Exchange may also elect to
recognize alternative testing and/or qualification criteria for tests
or criteria otherwise required as a prerequisite to the assumption of a
position or function.
    Under proposed Rule 447, the Exchange may modify or waive, in whole
or in part, requirements pertaining to the registration and supervision
of branch offices and their personnel and the payment of late fees.
This relief would not apply to the requirements relating to the
maintenance of books and records or the obligation for a member
organization to maintain essential supervision of all its associated
persons. The Exchange may provide relief which allows member
organizations to implement remote supervision \8\ of branch offices
(including locations otherwise not eligible for such) in an emergency,
which would provide flexibility for member organizations to retain the
essential supervision of associated persons.
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    \8\ See NYSE Information Memo 05-74 (October 6, 2005); see also
SEC Staff Legal Bulletin No. 17 (March 19, 2004) regarding
supervision of remote locations.
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    Pursuant to proposed Rule 447, the Exchange may take certain action
to restrict the activities of member organizations in an emergency. The
proposed rule would allow the Exchange to alter or rescind approval of
a member organization's outsourcing arrangements or expand the
requirements or prerequisites applicable to such. The Exchange may also
require the curtailment or reduction of business activity and/or
solicitation of new accounts or new products.\9\ Moreover, the Exchange
may require the enhancement of insurance coverage; the closure of
offices or locations; and/or the addition of supervisory personnel or
procedures.
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    \9\ Under NYSE Rule 326, the Exchange may impose restrictions on
a member organization's business activities if it fails to maintain,
among other things, the capital requirements of Rule 15c3-1 under
the Act. The proposed rule grants the Exchange authority to require
member organizations to limit or reduce business activities in an
emergency, regardless of whether the firm is in compliance with
these provisions.
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    In addition to the actions noted above, the proposed rule gives the
Exchange authority to take such other similar action, or withhold
taking similar action, in anticipation of, during the course of, or as
a consequence of, an emergency.

Timing

    In implementation of the proposed rule, the Exchange would grant
regulatory relief for a maximum of 90 days, and would be wary of
situations which would impede access by customers to their funds or
securities. Upon the passage of 90 days from the initial action by the
Exchange, the Exchange may find, with the concurrence of the
Commission, that an emergency continues to exist. Upon such a finding,
the Exchange would re-evaluate the types of relief granted and, after
seeking the concurrence of the Commission, determine whether to further
extend such relief, provide alternative relief, or cease the grant of
such relief.
    If the Exchange determines not to extend the regulatory relief past
90 days, it would alert member organizations to the date on which the
relief would expire via Information Memo and/or the Exchange's
Electronic Filing Platform (``EFP'').\10\ The Exchange would supply a
reasonable expiration date to allow adequate time for member
organizations to adjust to the reinstatement of customary regulatory
requirements.
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    \10\ EFP is an extranet built by the NYSE to support
authenticated, encrypted, two-way communications between the NYSE
and its membership. It is used to communicate information to certain
key personnel of member organizations.
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    Inasmuch as the purpose of this proposed rule is to grant authority
to the Exchange to act creatively in the event of an emergency, the
terms of the rule are, to a certain extent, broad and inclusive.
However, the Exchange would act in a manner consistent with the public
interest and for the protection of investors, and it intends to be
bound by and guided by these underlying precepts should there be need
to invoke the rule and exercise the power therein.
2. Statutory Basis
    The statutory basis for this proposed rule change is Section
6(b)(5) of the Act.\11\ Section 6(b)(5) requires, among other things,
that rules of an exchange be designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and national market system, and in general,
to protect investors and the public interest. The proposed rule will
provide the Exchange with the regulatory flexibility to grant member
organizations relief, as necessary, in the event of an emergency, as
defined.
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    \11\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period; (i) As the Commission
may designate up to 90 days of such date if it finds such longer period
to be appropriate and publishes its reasons for so finding, or (ii) as
to which NYSE consents, the Commission will:
    (A) By order approve such proposed rule change; or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSE-2007-02 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NYSE-2007-02. This
file number should be included on the subject line if e-mail is used.
To help the

Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's Internet Web site http://www.sec.gov/rules/sro.shtml.

Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room. Copies of such filing also will be
available for inspection and copying at the principal office of NYSE.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make publicly
available. All submissions should refer to File Number SR-NYSE-2007-02
and should be submitted on or before May 16, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-7836 Filed 4-24-07; 8:45 am]

BILLING CODE 8010-01-P


Appendix II.C.1.

The Sources of Residue Inputs for the Assessment of the Cumulative
Dietary Exposure to Organophosphorus Pesticides on Foods

This appendix is available on EPA’s website at

  HYPERLINK
"http://www.epa.gov/pesticides/cumulative/common_mech_groups.htm#op"
http://www.epa.gov/pesticides/cumulative/common_mech_groups.htm#op

A CD containing the data in this appendix may also be obtained by

contacting the Office of Pesticide Programs Public Docket

Docket #  EPA-HQ-OPP-2006-0618

One Potomac Yard

12777 S. Crystal Drive Room S-4400

Arlington, Virginia, 22202

703-305-5805

Monday through Friday, 8:30 am – 4:00 pm