[Federal Register: September 21, 2009 (Volume 74, Number 181)]
[Notices]
[Page 48083-48088]
[DOCID:fr21se09-58]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0441]

Promotion of Food and Drug Administration-Regulated Medical
Products Using the Internet and Social Media Tools; Notice of Public
Hearing

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research (CDER), in collaboration with FDA's Center for
Biologics Evaluation and Research (CBER), Center for Veterinary
Medicine (CVM), and Center for Devices and Radiological Health (CDRH),
is announcing a public hearing to discuss issues related to the
promotion of FDA-regulated medical products (including prescription
drugs for humans and animals, prescription biologics, and medical
devices) using the Internet and social media tools. FDA is seeking
participation in the public hearing and written comments from all
interested parties, including, but not limited to, consumers, patients,
caregivers, health care professionals, patient groups, Internet
vendors, advertising agencies, and the regulated industry. This meeting
and the written comments are intended to help guide FDA in making
policy decisions on the promotion of human and animal prescription
drugs and biologics and medical devices using the Internet and social
media tools. FDA is seeking input on a number of specific questions but
is interested in any other pertinent information participants in the
hearing would like to share.
    Dates and Times: The public hearing will be held on November 12 and
13, 2009, from 8 a.m. to 5 p.m. each day. Submit written or electronic
registration by close of business on October 9, 2009. Written and
electronic comments will be accepted until February 28, 2010.
    Location: The public hearing will be held at the National
Transportation Safety Board Conference Center, 429 L'Enfant Plaza, SW.,
Washington, DC 20594,<PHONE_NUMBER>; Metro: L'Enfant Plaza station on
the yellow, green, orange, and blue lines; see: http://ntsb.gov/events/
newlocation.htm. (FDA has verified the Web site address, but FDA is not
responsible for any changes to the Web site after this document
publishes in the Federal Register.)

ADDRESSES:  Submit written registration and written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Submit electronic registration and electronic comments, identified
with the docket number found in brackets in the heading of this
document, to http://www.regulations.gov.
    Transcripts of the hearing will be available for review at the
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 30 days after the hearing (see
section VI of this document).
    Registration to Attend and/or to Participate in the Meeting:
Seating at the hearing is limited. People interested in attending
should submit written or electronic registration as specified above

(see ADDRESSES) by close of business on October 9, 2009. Registration
is free and will be accepted on a first-come, first-served basis.
Written or electronic comments will be accepted until February 28,
2010.
    The procedures governing the hearing are found in 21 CFR part 15
(see section IV of this document). If you wish to make an oral
presentation at the hearing, you must state your intention on your
registration submission (see ADDRESSES). To speak, submit your name,
title, business affiliation, addresses, telephone and fax numbers, and
e-mail address. FDA has included questions for comment in section III
of this document. You should also identify by number each question you
wish to address in your presentation and the approximate time
requested. FDA will do its best to accommodate requests to speak.
Individuals and organizations with common interests should consolidate
or coordinate their presentations and request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin. Once FDA notifies registered participants of their
scheduled times, presenters should submit to FDA two copies of each
presentation to be given (see FOR FURTHER INFORMATION CONTACT).
    If you need special accommodations because of a disability, please
inform Jean-Ah Kang (see FOR FURTHER INFORMATION CONTACT) at the time
of registration.

FOR FURTHER INFORMATION CONTACT:  Jean-Ah Kang, Division of Drug
Marketing, Advertising, and Communications, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 3270, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>, FAX:
301-796-8444, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Internet has become a widely used medium for companies,
including manufacturers, packers, or distributors of medical products
regulated by FDA, to disseminate information about their products. The
Internet's ability to facilitate communication, information sharing,
information exchange between systems, user-centered design, and
collaboration has also evolved as a result of the second generation of
Web development and Web design, or ``Web 2.0.'' Web 2.0 has led to the
emergence of a variety of social media tools (i.e., Web properties
whose online content is primarily created and published by users rather
than the property owners).
    The continually evolving nature of the Internet, including Web 2.0
and social media tools, as well as their expansion to applications such
as mobile technology, have raised questions and concerns over how to
apply existing regulations to promotion in these newer media. FDA is
evaluating how the statutory provisions, regulations, and policies
concerning advertising and promotional labeling should be applied to
product-related information on the Internet and newer technologies.
Although the agency believes that many issues can be addressed through
existing FDA regulations, special characteristics of Web 2.0 and other
emerging technologies may require the agency to provide additional
guidance to the industry on how the regulations should be applied.

A. Regulation of Advertising and Labeling

    Under the Federal Food, Drug, and Cosmetic Act (the act), FDA has
responsibility for regulating the labeling of prescription drugs and
medical devices and the advertising of prescription drugs and
restricted medical devices. If an activity or material is considered to
be either advertising or labeling, it must meet certain requirements.
    Under section 201(m) of the act (21 U.S.C. 321(m)), labeling is
defined as ``all labels and other written, printed, or graphic''
materials ``upon'' or ``accompanying'' an article. The term
``accompanying'' has been broadly defined by the Supreme Court (Kordel
v. United States, 335 U.S. 345, 349-350 (1948)). FDA's regulations give
examples of labeling materials, including brochures, mailing pieces,
detailing pieces, calendars, price lists, letters, motion picture
films, and sound recordings (Sec.  202.1(l)(2) (21 CFR 202.1(l)(2))).
    FDA regulates the labeling of all drugs and devices under its
jurisdiction. Labeling must be truthful and nonmisleading (section
502(a) of the act (21 U.S.C. 352(a))).
    FDA also regulates the advertising for prescription drugs and
biologics. Although the act does not define what constitutes an
``advertisement,'' FDA generally interprets the term to include
information (other than labeling) that is issued by, or on behalf of, a
manufacturer, packer, or distributor and is intended to promote a
product. This includes, for example, ``advertisements in published
journals, magazines, other periodicals, and newspapers, and
advertisements broadcast through media such as radio, television, and
telephone communication systems'' (Sec.  202.1(l)(1)). According to the
act (section 502(n)), a prescription drug is misbranded if its
advertising does not include, in addition to the product's established
name and quantitative composition, a ``true statement'' of information
in brief summary ``relating to side effects, contraindications and
effectiveness'' of the advertised product. For prescription drug
advertisements, FDA's implementing regulations (21 CFR part 202)
specify that, among other things, the statutory requirement of a ``true
statement'' is not satisfied if an advertisement is false or misleading
with respect to side effects, contraindications or effectiveness or if
it fails to reveal material facts about ``consequences that may result
from the use of the drug as recommended or suggested in the
advertisement'' (Sec.  202.1(e)(5)). The prescription drug regulations
also specify that advertisements must ``present a fair balance between
information relating to side effects and contraindications and
information relating to effectiveness of the drug,'' which is achieved
when ``the presentation of true information relating to side effects
and contraindications is comparable in depth and detail with the claims
for effectiveness or safety'' (Sec.  202.1(e)(5)(ii)).
    FDA similarly regulates advertising for restricted devices. A
``restricted device'' is a device that may be restricted to sale,
distribution, or use only with the written or oral authorization of a
licensed practitioner, or in accordance with other conditions if FDA
determines that there cannot otherwise be reasonable assurance of its
safety and effectiveness (21 U.S.C. 360j(e)). FDA also restricts
devices through the approval orders granted to many class III devices
(21 U.S.C. 360e(d)(1)(B)(ii)). According to the act, a restricted
device is misbranded if its advertising is false or misleading in any
particular (section 502(q) of the act), or if its advertising does not
contain a brief statement of the intended uses of the device and
relevant warnings, precautions, side effects, and contraindications
(section 502(r) of the act). There are currently no regulations
establishing specific requirements for the content and format of
advertisements for restricted devices.
    Although FDA has not comprehensively addressed when Internet
promotion of prescription drugs and medical devices is labeling versus
advertising, the agency has jurisdiction over all prescription drug and
biologic product promotion as well as all restricted device advertising
and all

device promotional labeling when conducted by or on behalf of a
manufacturer, packer, or distributor. There are no regulations that
specifically address Internet promotion separately from the other types
of promotion discussed above, nor are there any regulations that
prohibit the use of certain types of media to promote drugs and medical
devices. Although no rule has specifically addressed Internet
promotion, it is fairly clear that some promotional efforts are
substantially similar in presentation and content to promotional
materials in other media or publications. At the same time, FDA
recognizes that the Internet possesses certain unique technological
features and that some online tools that may be used for promotion
offer novel presentation and content features. Another emerging issue
involves the reporting of adverse event data because such information
may initially be revealed using social media platforms in the context
of Internet promotion for FDA-regulated medical products.

B. 1996 Meeting on Promotion of FDA-Regulated Products on the Internet

    On October 16 and 17, 1996, FDA held a public meeting to discuss
issues related to the promotion of FDA-regulated medical products on
the Internet (see 61 FR 48707, September 16, 1996). The agency's
objective was to receive broad public input and to hear various points
of view and opinions on Internet issues from a discussion among
interested persons. A discussion group format was used and covered the
following topics: Investigational product information, chatrooms and
newsgroups, and Web site links. A transcript of the meeting is
available at http://www.fda.gov/AboutFDA/CentersOffices/CDER/
ucm175775.htm.)

C. New Internet Tools and Technology

    Since the 1996 public meeting, there has been a massive expansion
of new tools and technologies, such as blogs, microblogs, podcasts,
social network sites (``social networks'') and online communities,
video sharing, widgets, and wikis, which are defined as follows:\1,2\
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    \1\ Adapted from http://newmedia.hhs.gov/socialmedia101.html
Social Media 101 Overview: The WHAT and the WHY. Accessed on August
14, 2009.
    \2\ Adapted from http://www.usa.gov/webcontent/technology/
other_tech.shtml Social Media and Web 2.0 in Government. Accessed
on August 14, 2009.
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     Blogs (e.g., Blogger, WordPress, TypePad): Blogs are Web
sites with regular updates (in reverse chronological order--newest
update at the top) that typically combine text, images (graphics or
video), and links to other Web pages. Blogs are usually informal and
take on the tone of a diary or journal entry. Some blogs are very
personal, while others provide mainstream news updates. Most blogs
encourage dialogue by allowing their readers to leave comments.
     Microblogs (e.g., Twitter): Microblogs are comprised of
extremely short written blog posts, similar to text messages, and
provide real-time updates. Twitter is an example of a popular microblog
service that lets users broadcast short messages up to 140 characters
long (``tweets'') using computers or mobile phones.
     Podcasts (e.g., audio sharing): Podcasts (a blend of the
terms ``iPod'' and ``broadcast'') are audio or video files that users
can listen to or watch on computers or on a variety of portable media
devices (like an iPod, Zune, and certain cell phones). Podcasts are
usually short and often free, and users can arrange via subscription to
receive new podcasts automatically via their computers or other media
devices.
     Social networks and online communities (e.g., Facebook,
MySpace, LinkedIn, Friendster, Sermo): Social networks and online
communities give users opportunities to connect with or provide
resources to clients, colleagues, family, and friends who share common
interests. In many social networks, users create profiles and then
invite people to join as ``friends.'' There are many different types of
social networks and online communities, many of which are free, and
they range from general to those tailored for a specific demographic or
interest area.
     Video sharing (e.g., YouTube, Blip.tv, Vimeo): Also called
a ``video hosting service,'' video sharing allows individuals to upload
video clips to an Internet Web site. The video host will then store the
video on its server and show the individual different types of code to
allow others to view or comment on the video.
     Widgets: Supposedly short for ``window gadget,'' a widget
is a graphic control on a Web page that allows the user to interact
with it in some way. Widgets can also be easily posted on multiple Web
sites, have the added benefit of hosting ``live'' content, and often
take the form of on-screen tools (clocks, event countdowns, auction-
tickers, stock market tickers, flight arrival information, daily
weather, etc.).
     Wikis (e.g., Wikipedia, Medpedia): The term ``wiki'' comes
from the Hawaiian word for ``fast.'' Wiki technology creates a Web page
that anyone with access can modify--quickly and easily. A wiki can be
either open or closed, depending on the preferences of the community
using it. An open wiki allows anybody to make changes and view content.
A closed wiki allows only community members to make changes and view
its content. Some wikis allow anyone to view content but only members
to edit the content.
    As the use of social media tools on the Internet has proliferated,
the agency has engaged in a fact-finding process by communicating with
companies, third-party providers, trade associations, and other groups
to gain a better understanding of the nature of, and the technical
aspects to, promotion of FDA-regulated medical products using these
tools. FDA appreciates the time and effort that these individuals,
companies, and associations have invested in assisting the agency in
understanding the challenges and issues involved with Internet
promotion using these newer Web 2.0 technologies.

II. Purpose and Scope of the Hearing

    This hearing is intended to provide an opportunity for broad public
participation and comment concerning Internet promotion of FDA-
regulated medical products, including human and animal prescription
drugs and biologics and medical devices. Please note that this hearing
does not address nonprescription drug promotion. FDA is particularly
interested in hearing views from the public as to how expanding Web 2.0
technologies may be used to promote medical products to both health
care professionals and consumers in a truthful, nonmisleading, and
balanced manner. In addition, FDA is seeking public comment on Internet
adverse event reporting.

III. Issues for Discussion

    Questions have arisen regarding the application of the prescription
drug and device advertising and labeling provisions, regulations, and
policies of promotion on the Internet, especially with regard to the
use of emerging technologies such as blogs, microblogs, podcasts,
social networks and online communities, video sharing, widgets, and
wikis. This section briefly discusses the issues the agency has
identified as most frequently raised by regulated companies and other
interested parties. It should be noted that although a question may
raise a particular issue, that does not necessarily mean that the
agency will issue guidance or a regulation on that issue.
    The agency invites comment at the public hearing on the general
concept of Internet promotion, positive or negative; on any aspect of
Internet promotion that

is of interest to the presenter; and on the topics outlined in the
following paragraphs. We are specifically interested in data and
research on the use of social media tools in promotion, including data
from companies on their own experiences, the extent to which health
care professionals and consumers are using and are influenced by
various social media tools, and the impact of Internet and social media
promotion on the public health.
1. For what online communications are manufacturers, packers, or
distributors accountable?
    FDA regulates promotion of medical products that is conducted by or
on behalf of a manufacturer, packer, or distributor. In determining
whether a manufacturer, packer, or distributor is accountable for a
communication about its product(s), the agency considers whether the
manufacturer, packer, or distributor or anyone acting on behalf of the
manufacturer, packer, or distributor, such as an ad agency, created the
promotional communication. In addition, the agency considers whether
the manufacturer, packer, or distributor or anyone acting on behalf of
the manufacturer, packer, or distributor is influencing or controlling
the promotional activity or communication in whole or in part.
    Manufacturers, packers, and distributors may have a variety of
options for how much control they exert over activities on the
Internet, regardless of whether the promotional activity occurs on
company-sponsored venues or on third-party venues. For example, in
setting up a program about its product(s) through a chatroom, a
manufacturer, packer, or distributor may allow comments to be posted in
real time with no editing or review by the manufacturer, packer, or
distributor; alternatively, the manufacturer, packer, or distributor
may have the option of reviewing and editing comments before they are
posted. Furthermore, the manufacturer, packer, or distributor may have
control over the length of time comments are visible. As a result,
information may be available to a much broader audience than originally
engaged in the communication or program if the comments/entries are
posted for an indefinite period of time (``archived materials'').
Similarly, a manufacturer, packer, or distributor posting a video on a
video-sharing site such as YouTube may choose whether or not to allow
viewers to post comments.
    In addition, various Web sites and tools can allow manufacturers,
packers, or distributors to prompt others to communicate about their
products. For example, a manufacturer, packer, or distributor may ask
or otherwise encourage users to post their own videos about its
product(s) on sites such as YouTube. A manufacturer, packer, or
distributor may also send out packets of information to prominent
bloggers with the aim of prompting the blogger to write about its
product(s). Alternatively, a manufacturer, packer, or distributor may
create an online community for patients or health care professionals to
discuss disease states, which may prompt discussion about the
manufacturer's, distributor's, or packer's product(s). The agency is
interested in hearing the views of the public on the following topics:
     What parameters or criteria should be applied to determine
when third-party communications occurring on the Internet and through
social media technologies are subject to substantive influence by
companies that market products related to the communication or
discussion?
     In particular, when should third-party discussions be
treated as being performed by, or on behalf of, the companies that
market the product, as opposed to being performed independent of the
influence of the companies marketing the products?
     How should companies disclose their involvement or
influence over discussions or material, particularly discussions or
material on third-party sites?
     Are there different considerations that should be weighed
depending on the specific social media platform that is used or based
on the intended audience? If so, what are these considerations?
     With regard to the potential for company communications to
be altered by third parties, what is the experience to date with
respect to the unauthorized dissemination of modified product
information (originally created by a company) by noncompany users of
the Internet?
2. How can manufacturers, packers, or distributors fulfill regulatory
requirements (e.g., fair balance, disclosure of indication and risk
information, postmarketing submission requirements) in their Internet
and social media promotion, particularly when using tools that are
associated with space limitations and tools that allow for real-time
communications (e.g., microblogs, mobile technology)?
    FDA's regulations require that any promotional communications that
make claims about a company's product include certain required
disclosures, such as the indicated use of the product and the risks
associated with the use of the product (note that ``reminder''
promotion, which calls attention to the name of a product but does not
make any representations or suggestions about the product, is exempt
from these disclosure requirements (see 21 CFR 200.200, 201.100(f),
201.105(d)(2), 202.1(e)(2)(i), 801.109(d)). The prescription drug
regulations also require that drug advertisements present a fair
balance between information relating to risk and information relating
to benefit (Sec.  202.1(e)(5)(ii)). They also specify that risk
information must be presented with a prominence and readability
reasonably comparable to claims about drug benefits (Sec.
202.1(e)(7)(viii)). Furthermore, for advertisements to be truthful and
nonmisleading, they must contain risk information in each part as
necessary to qualify any representations and/or suggestions made in
that part about the drug (Sec.  202.1(e)(3)(i)). Similarly, section
502(r) of the act requires a ``brief statement'' of intended use and
relevant risk information for restricted device advertising. In
addition, section 201(n) of the act provides that a determination of
whether product advertising or labeling is misleading relies in part on
the extent to which labeling or advertising reveals facts material with
respect to possible consequences of the use of the products as
represented in the labeling or advertising material. Except for medical
device applicants, applicants are also responsible for submitting
copies of promotional materials to FDA (see, e.g., Sec. Sec.
314.81(b)(3)(i), 314.550, 314.640, 514.80(b)(5)(ii), 601.12(f)(4),
601.45, and 601.94 (21 CFR 314.81(b)(3)(i), 314.550, 314.640,
514.80(b)(5)(ii), 601.12(f)(4), 601.45, and 601.94)).
     How should product information be presented using various
social media tools to ensure that the user has access to a balanced
presentation of both risks and benefits of medical products?
     Are there data to support conclusions about whether
different types or formats of presentations have a positive or negative
impact on the public health?
     Are there proposed solutions that may help address
regulatory concerns when using social media tools associated with space
limitations or tools that allow for real-time communications to present
product information?
     How should companies address the potential volume of
information shared on various social media sites with regard to real-
time information that is continuously posted and regulatory

requirements to submit promotional materials to FDA as applicable (see,
e.g., Sec. Sec.  314.81(b)(3)(i), 314.550, 314.640, 514.80(b)(5)(ii),
601.12(f)(4), 601.45, and 601.94)?
3. What parameters should apply to the posting of corrective
information on Web sites controlled by third parties?
    Some manufacturers, packers, or distributors have expressed a
desire to correct what are, in their belief, misconceptions or
misinformation about their products, including unapproved uses of their
products that are being conveyed on a Web site outside their control,
such as on a blog, social networking site, or a wiki Web site (i.e.,
Wikipedia). Other companies have stated that they have not corrected
what they believe is misinformation in the belief that they could be
viewed by such an action as being responsible for all the information
on the target Web site rather than just the information that they post
or submit.
     The agency is interested in any data or research on how
companies have approached these issues.
     Are there any parameters or criteria that could be used to
determine the appropriateness of correcting misinformation and/or scope
of information a company can provide when trying to correct
misinformation on a Web site outside a company's control?
     Should the parameters differentiate with regard to the
prominence of the third-party site (i.e., readership), its intended
audience (e.g., general public, health care professionals, patients),
its intended purpose (e.g., personal diary, encyclopedia-type
reference), and/or the author of the information on the site?
4. When is the use of links appropriate?
    The Internet allows users to move easily between Web sites or
sources that provide information on many related topics. Under the act,
companies are prohibited from promoting approved human and animal
drugs, biologics, and medical devices for unapproved uses. However,
sponsors sometimes provide links from their branded (e.g., mentions a
product) Web sites to other informational sources about diseases, such
as support groups, some of which may contain information about
unapproved disease conditions or unapproved uses of approved products.
Furthermore, some companies are using unbranded (e.g., does not mention
a product) uniform resource locators (URLs) that, when clicked on, take
users directly to branded information.
     The agency is interested in any comments about the
appropriateness of various techniques regarding the use of links
(including between various social media tools) and data or research
about whether or not users find these approaches to be misleading.
     Should parameters be established for links to and from Web
sites?
     In addition, the agency is interested in any data or
research concerning the frequency with which users actually click on
different categories of links (e.g., banner ads, links within Web
sites, sponsored links, organic search result links) to get additional
information about products.
5. Questions specific to Internet adverse event reporting
    FDA regulations require the submission of postmarketing adverse
event reports.
    For drugs, adverse event reporting obligations are described for
approved new drug applications (NDAs), abbreviated new drug
applications (ANDAs), and prescription drugs marketed without an
approved application under Sec. Sec.  310.305, 314.80, and 314.98 (21
CFR 310.305, 314.80, and 314.98, respectively. For new animal drugs,
adverse event reporting obligations are described for approved new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) under Sec.  514.80. Licensed manufacturers that
hold biological license applications (BLAs) are also subject to adverse
event reporting requirements under Sec.  600.80 (21 CFR 600.80). These
regulations cover requirements for submission of individual case safety
reports on either an expedited basis (i.e., 15-day ``Alert reports'')
or on a less frequent (periodic) basis, as specified in the
regulations.
    Nonprescription (over-the-counter or OTC) drugs marketed without an
approved application also have reporting obligations under the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Public Law
109-462). Under this act, reports of serious adverse events associated
with OTC products must be submitted to FDA within 15 days.
    FDA's Medical Device Reporting (MDR) regulation, 21 CFR part 803,
requires medical device manufacturers to identify and monitor
significant adverse events involving their medical devices. The
regulation requires manufacturers of medical devices to report device-
related deaths, serious injuries, and malfunctions to FDA whenever they
become aware of information that reasonably suggests that a reportable
event occurred (i.e., one of their devices has or may have caused or
contributed to the event).
    The expectation is that entities responsible for reporting will
promptly review all adverse event information received or otherwise
obtained, which potentially includes information from the Internet and
social media tools. According to FDA's March 2001 draft guidance for
industry entitled ``Postmarketing Safety Reporting for Human Drug and
Biological Products Including Vaccines'' (available at http://
www.fda.gov/downloads/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/
ucm092257.pdf), adverse experience information that is submitted via
the Internet to an entity with postmarketing reporting obligations
under Sec. Sec.  310.305, 314.80, and 600.80 should be reported to FDA
if there is knowledge of the four basic elements for submission of an
individual case safety report (see section IV.B in the draft guidance).
The draft guidance also states that those entities should review any
Internet sites sponsored by them for adverse experience information,
but are not responsible for reviewing any Internet sites that they do
not sponsor; however, if they become aware of an adverse experience on
an Internet site that they do not sponsor, they should review the
adverse experience and determine if it should be reported to FDA. For
OTC products, the July 2009 guidance for industry entitled
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application'' (available at
http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm171672.pdf) lists
the Internet as an example of a means for a reporter to convey adverse
event information associated with an OTC product to the responsible
person (i.e., ``manufacturer, packer, or distributor whose name * * *
appears on the label of an OTC drug marketed in the United States
without an approved application'').
    With the increasing use of Web-based technology by manufacturers of
FDA-regulated medical products, health care systems, and patients, and
the continual emergence of different types of Web-based media, FDA is
interested in hearing the views of the public on the following topics
related to Web-based media:
     How are entities with postmarketing reporting
responsibilities and other stakeholders using the Internet and social
media tools with regard to monitoring adverse event information about
their products?

     How is adverse event information from these sources being
received, reviewed, and processed?
     What challenges are presented in handling adverse event
information from these sources?
     What uncertainties are there regarding what should be
reported from these sources to meet FDA adverse event reporting
obligations?

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner 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 Center for Drug Evaluation
and Research.
    Under Sec.  15.30, the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10), subpart C). 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). To the extent that the conditions for the hearing, as
described in this document, conflict with any provisions set out in
part 15, this document acts as a waiver of those provisions as
specified in Sec.  15.30(h).

V. Comments

    Regardless of attendance at the public hearing, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified 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.

VI. 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. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.

    Dated: September 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22618 Filed 9-18-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 199 (Thursday, October 15, 2015)]
[Notices]
[Pages 62080-62082]
[FR Doc No: 2015-26194]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2015-0637]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0108

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0108,
Standard Numbering System for Undocumented Vessels. Our ICR describe
the information we seek to collect from the public. Before submitting
this ICR to OIRA, the Coast Guard is inviting comments as described
below.

DATES: Comments must reach the Coast Guard on or before December 14,
2015.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2015-0637] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2100 2ND STREET SW., STOP 7101, WASHINGTON, DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will consider all comments
and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2015-0637], and
must be received by December 14, 2015.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Information Collection Request:
    Title: Standard Numbering System for Undocumented Vessels.
    OMB Control Number: 1625-0108.
    Summary: The Standard Numbering System collects information on
undocumented vessels and vessel owners operating on waters subject to
the jurisdiction of the United States, Federal, State, and local law
enforcement agencies use information from the system for enforcement of
boating laws or theft and fraud investigations. Since the September 11,
2001 terrorist attacks on the United States, the need has increased for
identification of undocumented vessels to meet port security and other
missions to safeguard the homeland.
    Need: Subsection 12301(a) of title 46 United States Code, requires
undocumented vessels equipped with propulsion machinery of any kind to
be numbered in the State where the vessel is principally operated. In
46 U.S.C. 12302(a), Congress authorized the Secretary to prescribe, by
regulation, a Standard Numbering System (SNS). The Secretary shall
approve a State numbering system if that system is consistent with the
SNS. The Secretary has delegated his authority under 46 U.S.C. 12301
and 12302 to Commandant of the U.S. Coast Guard. DHS Delegation No.
0170.1. The regulations requiring the numbering of undocumented vessels
are in 33 CFR part 173 and regulations establishing the SNS for States
to voluntarily carry out this function are contained in 33 CFR part
174.
    In States that do not have an approved system, the Federal
Government (U.S. Coast Guard) must administer the vessel numbering
system. Currently, all 56 States and Territories have approved
numbering systems. The approximate number of undocumented vessels
registered by the States in 2014 was nearly 12 million.
    The SNS collects information on undocumented vessels and vessel
owners. States submit reports annually to the Coast Guard on the
number, size, construction, etc., of vessels they have numbered. That
information is used by the Coast Guard in (1) publication of an annual
``Boating Statistics'' report required by 46 U.S.C. 6102(b), and (2)
for allocation of Federal funds to assist States in carrying out the
Recreational Boating Safety (RBS) Program established by 46 U.S.C.
chapter 131.
    On a daily basis or as warranted, Federal, State, and local law
enforcement personnel use SNS information from the States' numbering
systems for enforcement of boating laws or theft and fraud
investigations. In addition, when encountering a vessel suspected of
illegal activity, information from the SNS increases officer safety by
assisting boarding officers in determining how best to approach a
vessel. Since the September 11, 2001 terrorist attacks on the United
States, the need has increased for identification of undocumented
vessels and their owners for port security and other missions to
safeguard the homeland, although the statutory requirement for
numbering of vessels dates back to 1918.
    Forms: None.
    Respondents: Owners of all undocumented vessels propelled by

machinery are required by Federal law to apply for a number from the
issuing authority of the State in which the vessel is to be principally
operated. In addition, States may require other vessels, such as
sailboats or even canoes and kayaks, to be numbered. ``Owners'' may
include individuals or households, non-profit organizations, and small
businesses (e.g., liveries that offer recreational vessels for rental
by the public) or other for-profit organizations.
    Frequency: There are no recordkeeping requirements for this
information collection. The frequency for the reporting requirements
is, one time.
    Hour Burden Estimate: The estimated annual burden has decreased
from 286,458 hours to 257,986 hours a year due to a change in
methodology.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: October 5, 2015.
Thomas P. Michelli,
U.S. Coast Guard, Deputy Chief Information Officer.
[FR Doc. 2015-26194 Filed 10-14-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 107 (Friday, June 3, 2022)]
[Rules and Regulations]
[Pages 33627-33630]
[FR Doc No: 2022-11758]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0143; Project Identifier MCAI-2021-01401-T;
Amendment 39-22061; AD 2022-11-11]
RIN 2120-AA64

Airworthiness Directives; De Havilland Aircraft of Canada Limited
(Type Certificate Previously Held by Bombardier, Inc.) Airplanes

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

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain De Havilland Aircraft of Canada Limited (type certificate
previously held by Bombardier, Inc.) Model DHC-8-401 and -402
airplanes. This AD was prompted by reports of a certain bolt at the
pivot pin link being found missing or having stress corrosion cracking.
This AD requires a modification to the nose landing gear (NLG) shock
strut assembly. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective July 8, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 8,
2022.

ADDRESSES: For service information identified in this final rule,
contact De Havilland Aircraft of Canada Limited, Q-Series Technical
Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected];
internet https://dehavilland.com. You may view this service information
at the FAA, Airworthiness Products Section, Operational Safety Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0143.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0143; 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 final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Antariksh Shetty, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued AD CF-2009-29R4, dated October 1, 2021
(TCCA AD CF-2009-29R4) (also referred to after this as the Mandatory
Continuing Airworthiness Information, or the MCAI), to correct an
unsafe condition for certain De Havilland Aircraft of Canada Limited
Model DHC-8-401 and -402 airplanes. You may examine the MCAI in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2022-0143.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain De Havilland
Aircraft of Canada Limited (type certificate previously held by
Bombardier, Inc.) Model DHC-8-401 and -402 airplanes. The NPRM
published in the Federal Register on February 23, 2022 (87 FR 10112).
The NPRM was prompted by reports of a certain bolt at the pivot pin
link being found missing or having stress corrosion cracking. The NPRM
proposed to require a modification to the NLG shock strut assembly. The
FAA is issuing this AD to address failure of the pivot pin retention
bolt, which could result in a loss of directional control or loss of an
NLG tire during takeoff or landing, which could lead to runway
excursions. See the MCAI for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from Air Line Pilots Association,
International (ALPA), who supported the NPRM without change.
    The FAA received additional comments from Horizon Air. The
following presents the comments received on the NPRM and the FAA's
response to each comment.

Request to Issue a Single AD

    Horizon Air requested that the FAA issue a single AD instead of
both AD 2021-25-12, Amendment 39-21856 (86 FR 72174, December 21, 2021)
(AD 2021-25-12), and this AD. Horizon Air noted that in the
``Relationship Between Proposed AD and AD 2021-25-12'' paragraph of the
NPRM, it stated it was determined that a stand-alone AD would be more
appropriate. Horizon Air pointed out this AD and AD 2021-25-12 were
both prompted by the same unsafe condition and the applicability is the
same. Horizon Air suggested that this final rule replace AD 2021-25-12
in order to have the subject matter mandates in a singular rule.
Horizon Air concluded that having the new AD state the retained
requirements and new requirements would promote compliance, be
historically consistent, and be congruent with the related Transport
Canada airworthiness directive (TCCA AD CF-2009-29R4).
    The FAA disagrees with the commenter's request. The FAA
acknowledges that a single AD is typically more appropriate. However,
AD 2021-25-12 is an immediately adopted rule (i.e., a final rule;
request for comment) that includes actions with short compliance times.
The FAA could not include Part I of TCCA AD CF-2009-29R4 in AD 2021-25-
12 due to the longer compliance time for the required modification,
which necessitated issuing an NPRM with a public comment period. The
FAA considered superseding AD 2021-25-12 to include retained actions
and the modification, which has a 1,600 flight cycles or 9-month
compliance time. However, issuing an NPRM to supersede AD 2021-25-12
would have delayed the rulemaking process. The FAA determined issuing a
stand-alone NPRM for the modification addresses the unsafe condition in
a timely manner as the final rule for the stand-alone NPRM (this AD)
will be published sooner than when a final rule for an NPRM that
supersedes AD 2021-25-12 would be published. The FAA has not changed
this AD in this regard.

Request To Include a Statement To Indicate the Association With AD
2021-25-12

    Horizon Air requested that the FAA include a statement to indicate
the association with AD 2021-25-12. Horizon Air stated that the actions
required by AD 2021-25-12 are only applicable to airplanes with pivot
pin retention bolt part number (P/N) NAS6204-14D installed on the NLG
assembly; consequently, if this part is not installed the rule is not
applicable. Horizon Air also stated that this AD mandates the
installation of this part. Horizon Air concluded that a statement
indicating the association with AD 2021-25-12 would enhance the
awareness of the compliance requirements.
    The FAA concurs with the commenter's request. The actions required
by AD 2021-25-12 only apply to airplanes that have installed pivot pin
retention bolt P/N NAS6204-14D in the NLG assembly and therefore do not
apply to those airplanes that do not have that pivot pin retention bolt
installed. The modification required by paragraph (g) of this AD
results in the installation of pivot pin retention bolt P/N NAS6204-
14D. After an operator has complied with this AD, the operator is then
subject to AD 2021-25-12. As specified in paragraph (g) of AD 2021-25-
12, the operator must revise the existing maintenance or inspection
program ``. . . within 30 days after the installation of pivot pin
retention bolt part number P/N NAS6204-14D. . . .'' As specified in
paragraph (i) of AD 2021-25-12, repetitive lubrications of the part are
required at intervals not to exceed 400 flight cycles. The FAA has
added Note 1 to paragraph (g) of this AD to refer to AD 2021-25-12
after installing pivot pin retention bolt P/N NAS6204-14D.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, and any other changes
described previously, this AD is adopted as proposed in the NPRM. None
of the changes will increase the economic burden on any operator.
Accordingly, the FAA is issuing this AD to address the unsafe condition
on these products.

Related Service Information Under 1 CFR Part 51

    De Havilland Aircraft of Canada Limited has issued Service Bulletin
84-32-161, Revision B, dated March 31,

2021, including UTC Aerospace Systems Service Bulletin 47100-32-145,
Revision 3, dated March 26, 2021. This service information describes
procedures for modifying the NLG shock strut assembly by replacing
special bolt, part number (P/N) 47205-1 or 47205-3, with a new
retention bolt, P/N NAS6204-14D (the modification includes a reverse
orientation of the retention bolt and a rework of the weight on wheel
(WOW) proximity sensor cover to provide clearance for the re-oriented
retention bolt).
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Difference Between This AD and the MCAI

    This AD only requires the modification specified in Part I of TCCA
AD CF-2009-29R4. The other actions specified in TCCA AD CF-2009-29R4
are required by FAA AD 2021-25-12.

Costs of Compliance

    The FAA estimates that this AD affects 54 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $85 per hour = $340...........................              $8             $348          $18,792
----------------------------------------------------------------------------------------------------------------

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

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2022-11-11 De Havilland Aircraft of Canada Limited (Type Certificate
Previously Held by Bombardier, Inc.): Amendment 39-22061; Docket No.
FAA-2022-0143; Project Identifier MCAI-2021-01401-T.

(a) Effective Date

    This airworthiness directive (AD) is effective July 8, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to De Havilland Aircraft of Canada Limited (type
certificate previously held by Bombardier, Inc.) Model DHC-8-401 and
-402 airplanes, certificated in any category, serial numbers 4001
and 4003 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Unsafe Condition

    This AD was prompted by reports of a certain bolt at the pivot
pin link being found missing or having stress corrosion cracking.
The FAA is issuing this AD to address failure of the pivot pin
retention bolt, which could result in a loss of directional control
or loss of a nose landing gear (NLG) tire during takeoff or landing,
which could lead to runway excursions.

(f) Compliance

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

(g) Modification

    For any airplane having an NLG shock strut assembly, part number
(P/N) 47100-XX (where XX represents any number), that has special
bolt P/N 47205-1 or 47205-3: Within 1,600 flight cycles or 9 months
after the effective date of this AD, whichever occurs first, modify
the NLG shock strut assembly, in accordance with paragraph 3.B.,
``Procedure,'' of the Accomplishment Instructions of De Havilland
Aircraft of Canada Limited Service Bulletin 84-32-161, Revision B,
dated March 31, 2021, including UTC Aerospace Systems Service
Bulletin 47100-32-145, Revision 3, dated March 26, 2021.

    Note 1 to paragraph (g):  After installing pivot pin retention
bolt part number NAS6204-14D, AD 2021-25-12, Amendment 39-21856 (86
FR 72174, December 21, 2021) applies to pivot pin retention bolt
part number NAS6204-14D.

(h) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using De Havilland Aircraft of Canada Limited
Service Bulletin 84-32-161, dated April 7, 2020, including UTC
Aerospace Systems Service Bulletin 47100-32-145, dated April 3,
2020; or De Havilland Aircraft of Canada Limited Service Bulletin
84-32-161, Revision A, dated January 27, 2021, including UTC
Aerospace Systems Service Bulletin 47100-32-145, Revision 2, dated
January 4, 2021.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or De
Havilland Aircraft of Canada Limited's TCCA Design Approval
Organization (DAO). If approved by the DAO, the approval must
include the DAO-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) TCCA AD CF-2009-29R4, dated October 1, 2021, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2022-0143.
    (2) For more information about this AD, contact Antariksh
Shetty, Aerospace Engineer, Airframe and Propulsion Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected].
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) De Havilland Aircraft of Canada Limited Service Bulletin 84-
32-161, Revision B, dated March 31, 2021, including UTC Aerospace
Systems Service Bulletin 47100-32-145, Revision 3, dated March 26,
2021.

    Note 2 to paragraph (k)(2)(i): De Havilland issued De Havilland
Service Bulletin 84-32-161, Revision B, dated March 31, 2021, with
UTC Aerospace Systems Service Bulletin 47100-32-145, Revision 3,
dated March 26, 2021, attached as one ``merged'' file for the
convenience of affected operators.

    (ii) [Reserved]
    (3) For service information identified in this AD, contact De
Havilland Aircraft of Canada Limited, Q-Series Technical Help Desk,
123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone
416-375-4000; fax<PHONE_NUMBER>; email [email protected]; internet
https://dehavilland.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 17, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-11758 Filed 6-2-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 14016-14017]
[FR Doc No: 2018-06579]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1141]

Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of five new drug applications (NDAs) from multiple applicants. The
holders of the applications notified the Agency in writing that the
drug products were no longer marketed and requested that the approval
of the applications be withdrawn.

DATES: Approval is withdrawn as of May 2, 2018.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table have informed FDA that these drug products are no longer
marketed and have requested that FDA withdraw approval of the
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 006383..................  Methadone             Mallinckrodt Inc.,
                               Hydrochloride (HCl)   675 McDonnell
                               Powder, 50 grams      Blvd., Hazelwood,
                               (g)/bottle, 100 g/    MO 63042.
                               bottle, and 500 g/
                               bottle.

NDA 020716..................  Vicoprofen            AbbVie Inc., 1 North
                               (hydrocodone          Waukegan Rd., North
                               bitartrate and        Chicago, IL 60064.
                               ibuprofen) Tablets,
                               7.5 milligrams (mg)/
                               200 mg.
NDA 021692..................  Ultram ER (tramadol   Valeant
                               HCl) Extended-        Pharmaceuticals
                               Release Tablets,      North America LLC,
                               100 mg, 200 mg, and   400 Somerset
                               300 mg.               Corporate Blvd.,
                                                     Bridgewater, NJ
                                                     08807.
NDA 207621..................  Troxyca ER            Pfizer Inc., 235
                               (oxycodone HCl and    East 42nd St., New
                               naltrexone HCl)       York, NY 10017.
                               Extended-Release
                               Capsules, 10 mg/1.2
                               mg, 20 mg/2.4 mg,
                               30 mg/3.6 mg, 40 mg/
                               4.8 mg, 60 mg/7.2
                               mg, and 80 mg/9.6
                               mg.
NDA 207975..................  Vantrela ER           Teva Branded
                               (hydrocodone          Pharmaceutical
                               bitartrate)           Products R&D, Inc.,
                               Extended-Release      41 Moores Rd., P.O.
                               Tablets, 15 mg, 30    Box 4011, Frazer,
                               mg, 45 mg, 60 mg,     PA 19355.
                               and 90 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of May
2, 2018. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on May 2, 2018 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06579 Filed 3-30-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Proposed Rules]
[Pages 12136-12138]
[FR Doc No: 2014-04783]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2013-0707; FRL-9907-45-Region 10]

Revision to the Washington State Implementation Plan; Update to
the Solid Fuel Burning Devices Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
Washington State Department of Ecology (Ecology) received on January
30, 2014. The SIP submission contains revisions to Washington's solid
fuel burning device rules to control fine particulate matter
(PM2.5) from residential wood combustion. The updated
regulations reflect Washington State statutory changes made in 2012,
setting revised PM2.5 trigger levels for impaired air
quality burn bans and setting criteria for prohibiting solid fuel
burning devices that are not certified. The submission also contains
updates to the regulations to improve the clarity of the language. We
are proposing to approve these changes because they meet the
requirements of the Clean Air Act and strengthen the Washington SIP.

DATES: Written comments must be received on or before April 3, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2013-0707, by any of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Jeff Hunt, EPA Region 10, Office of Air, Waste and
Toxics (AWT-107), 1200 Sixth Avenue, Suite 900, Seattle WA, 98101
     Hand Delivery/Courier: EPA Region 10, 1200 Sixth Avenue,
Suite 900, Seattle WA, 98101. Attention: Jeff Hunt, Office of Air,
Waste and Toxics, AWT--107. Such deliveries are only accepted during
normal hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2013-0707. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
www.regulations.gov or email. The www.regulations.gov Web site is an
``anonymous access'' system, which means the 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 directly to the EPA without
going through www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, the 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 the EPA cannot read your comment due
to technical difficulties and cannot contact you for clarification, the
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
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
the disclosure of which 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. Publicly available
docket materials are available either electronically in
www.regulations.gov or in hard copy during normal business hours at the
Office of Air, Waste and Toxics, EPA Region 10, 1200 Sixth Avenue,
Seattle, WA 98101.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt at<PHONE_NUMBER>,
<EMAIL_ADDRESS>or the above EPA, Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA.
    The following outline is provided to aid in locating information in
this preamble:

Table of Contents

I. Background
II. Summary of SIP Revision
III. Proposed Action
IV. Statutory and Executive Order Reviews

I. Background

    On July 18, 1997, the EPA promulgated the 1997 PM2.5
National Ambient Air Quality Standards (NAAQS), including an annual
standard of 15.0 micrograms per cubic meter ([mu]g/m\3\) based on a
three-year average of annual mean PM2.5 concentrations, and
a 24-hour (or daily) standard of 65 [mu]g/m\3\ based on a three-year
average of the 98th percentile of 24-hour concentrations (62 FR 38652).
The EPA established the standards based on significant evidence and
numerous health studies demonstrating that serious health effects are
associated with exposures to PM2.5. On October 17, 2006, the
EPA revised the PM2.5 24-hour standard from 65 [mu]g/m\3\ to
35 [mu]g/m\3\ based on additional evidence and health studies (71 FR
61144).
    Following promulgation of a new or revised NAAQS, the EPA is
required by the Clean Air Act (CAA) to designate areas throughout the
United States as attaining or not attaining the NAAQS; this designation
process is described in section 107(d)(1) of the CAA. Effective
December 14, 2009, the EPA designated Tacoma-Pierce County, Washington
(partial county designation) as a nonattainment area for the 2006 24-
hour PM2.5 standard (74 FR 58688; published on November 13,
2009). Under the CAA, a state is required to submit a revision to its
SIP to meet nonattainment requirements within three years of the
effective date of designation.
    In 2012, the Washington State Legislature revised Chapter 70.94
Revised Code of Washington (RCW) Washington Clean Air Act (Washington
Clean Air Act) to address the Tacoma-Pierce County PM2.5
nonattainment area (Tacoma-Pierce County area) and other areas at risk
for nonattainment statewide. On November 28, 2012, Ecology, in close
coordination with the Puget Sound Clean Air Agency (PSCAA), submitted
Regulation 1--Article 13: Solid Fuel Burning Device Standards, adopted
by the PSCAA Board on October 25, 2012. These local air agency
regulations, covering the Tacoma-Pierce County area, incorporated the
PM2.5 related statutory changes to Chapter 70.94 RCW. On May
29, 2013, the EPA approved the PSCAA regulations into the Washington
SIP and approved Ecology's ``2008 Baseline Emissions Inventory and
Documentation'' satisfying the attainment planning requirements due at
the time for the Tacoma-Pierce County area (78 FR 32131).
    On January 30, 2014, Ecology submitted to the EPA a SIP revision
updating Chapter 173-433 of the

Washington Administrative Code (WAC) Solid Fuel Burning Devices for
purposes of aligning the regulations with the statutory changes made in
2012 by the Washington State Legislature, and supporting the local
PSCAA regulations approved on May 29, 2013 by the EPA (78 FR 32131).
The SIP revision also helps provide the necessary regulatory framework
to support an anticipated maintenance plan and redesignation request
for the Tacoma-Pierce County area in the future.

II. Summary of SIP Revision

    In the January 30, 2014 submission, Ecology revised the regulations
contained in Chapter 173-433 WAC Solid Fuel Burning Devices to reflect
two significant changes to the Washington Clean Air Act. Ecology
revised Chapter 173-433-140 WAC Criteria for Impaired Air Quality Burn
Bans to remove outdated course particulate matter (PM10)
burn ban trigger levels and replace them with more stringent
PM2.5 trigger levels to make it consistent with Chapter
70.94.473 of the Washington Clean Air Act. Ecology provided an analysis
covering former PM10 nonattainment areas in both Western and
Eastern Washington to demonstrate that the PM2.5 trigger
levels are more stringent and will provide continued maintenance of the
PM10 NAAQS, established on July 1, 1987 (52 FR 24663).
Ecology also removed an outdated carbon monoxide trigger level for
residential wood combustion curtailment. The EPA agrees with Ecology's
analysis that historic violations of the 1985 carbon monoxide NAAQS
centered on areas of high traffic congestion and have little connection
with dispersed residential woodstove emissions. The EPA's past approval
of maintenance plans for carbon monoxide areas located in Washington
applied specifically to transportation control measures, so this
revision will have no impact on control measures relied upon for
attainment and maintenance of the 1985 carbon monoxide NAAQS in these
areas of Washington. These transportation control measures combined
with continuing fleet turnover with cleaner new cars and trucks have
brought carbon monoxide levels to historic lows. Ecology cites
monitoring data from the Spokane carbon monoxide maintenance area where
carbon monoxide levels are roughly one-fifth of the federal limit, with
little to no potential for future violations.
    In the January 30, 2014 submission, Ecology also added a new
section, Chapter 173-433-155 WAC Criteria for Prohibiting Solid Fuel
Burning Devices that Are Not Certified to incorporate changes to
Chapter 70.94.477 of the Washington Clean Air Act. This provision
allows Ecology or a local air agency to prohibit the use of uncertified
solid fuel burning devices in a fine particulate matter nonattainment
or maintenance area, even in the absence of an air quality episode or
impaired air quality burn ban. The new Chapter 173-433-155 WAC is
consistent with and supports the local PSCAA corollary contained in
Regulation 1, Section 13.07 Prohibitions on Wood Stoves That Are Not
Certified Wood Stoves, already approved into the Washington SIP. This
Washington regulation and the local PSCAA corollary will be a key
component in Ecology's future maintenance plan demonstration showing
that the current low levels of PM2.5 for the Tacoma-Pierce
County area can be sustained over time. Lastly, Ecology updated other
sections of Chapter 173-433 WAC to improve clarity and ensure that
consistent terminology is used throughout all the sections.

III. Proposed Action

    The EPA is proposing to approve Washington's SIP revision received
January 30, 2014. Specifically, the EPA is proposing to approve and
incorporate by reference into the SIP the rules shown in Table 1 below.
In addition, Ecology submitted Chapter 173-433-200 WAC Regulatory
Actions and Penalties to demonstrate adequate enforcement authority to
implement the program. Regulations describing agency enforcement
authority are not generally incorporated into the SIP to avoid
potential conflict with the EPA's independent authorities. Therefore,
the EPA has reviewed and is proposing approval of Chapter 173-433-200
WAC as having adequate enforcement authority, but will not incorporate
this section by reference into the SIP codified in 40 CFR 52.2470(c).
We have made the determination that this action is consistent with
section 110 of the CAA. The EPA is soliciting public comments which
will be considered before taking final action.

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                        Citation                                       State
               Agency                     (WAC)                 Title             effective date     Submitted
----------------------------------------------------------------------------------------------------------------
Ecology............................     173-433-010  Purpose....................        02/23/14        01/30/14
Ecology............................     173-433-020  Applicability..............        02/23/14        01/30/14
Ecology............................     173-433-030  Definitions................        02/23/14        01/30/14
Ecology............................     173-433-100  Emission Performance               02/23/14        01/30/14
                                                      Standards.
Ecology............................     173-433-110  Opacity Standards..........        02/23/14        01/30/14
Ecology............................     173-433-120  Prohibited Fuel Types......        02/23/14        01/30/14
Ecology............................     173-433-140  Criteria for Impaired Air          02/23/14        01/30/14
                                                      Quality Burn Bans.
Ecology............................     173-433-150  Restrictions on the                02/23/14        01/30/14
                                                      Operation of Solid Fuel
                                                      Burning Devices.
Ecology............................     173-433-155  Criteria for Prohibiting           02/23/14        01/30/14
                                                      the Use of Solid Fuel
                                                      Burning Devices that Are
                                                      Not Certified.
----------------------------------------------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because this action does not involve technical standards; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because it will not impose substantial direct costs on tribal
governments or preempt tribal law. The SIP is not approved to apply in
Indian country located in the State of Washington, except for non-trust
land within the exterior boundaries of the Puyallup Indian Reservation,
also known as the 1873 Survey Area. Under the Puyallup Tribe of Indians
Settlement Act of 1989, 25 U.S.C. 1773, Congress explicitly provided
state and local agencies in Washington authority over activities on
non-trust lands within the 1873 Survey Area and the EPA is therefore
approving this SIP on such lands. Consistent with EPA policy, the EPA
nonetheless provided a consultation opportunity to the Puyallup Tribe
in a letter dated September 3, 2013. The EPA did not receive a request
for consultation.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, and Particulate
matter.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: February 25, 2014.
Dennis J. McLerran,
Regional Adminstrator, Region 10.
[FR Doc. 2014-04783 Filed 3-3-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Rules and Regulations]
[Pages 41838-41839]
[FR Doc No: 2013-16438]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1281; Airspace Docket No. 12-ASW-13]

Establishment of Class E Airspace; Colt, AR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes Class E airspace at Colt, AR.
Controlled airspace is necessary to accommodate new Area Navigation
(RNAV) Standard Instrument Approach Procedures at Delta Regional
Airport. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective date: 0901 UTC, October 17, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On April 30, 2013, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish Class E airspace for
the Colt, AR, area, creating controlled airspace at Delta Regional
Airport (78 FR 25231) Docket No. FAA-2012-1281. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received. Class E
airspace designations are published in paragraph 6005 of FAA Order
7400.9W dated August 8, 2012, and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by establishing Class E airspace extending upward from 700 feet
above the surface within a 7.1-mile radius of Delta Regional Airport,
Colt, AR, to ensure that required controlled airspace exists to contain
new standard instrument approach procedures at the airport. Controlled
airspace enhances the safety and management of IFR operations at the
airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at Delta Regional Airport, Colt,
AR.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially

significant environmental impacts, and no extraordinary circumstances
exist that warrant preparation of an environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW AR E5 Colt, AR [New]

Delta Regional Airport, AR
    (Lat. 35[deg]07'12'' N., long. 90[deg]49'35'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.1-mile radius of Delta Regional Airport.

    Issued in Fort Worth, Texas, on July 8, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-16438 Filed 7-11-13; 8:45 am]
BILLING CODE 4910-13-P