[Federal Register Volume 83, Number 206 (Wednesday, October 24, 2018)]
[Notices]
[Page 53652]
[FR Doc No: 2018-23159]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4386-DR; Docket ID FEMA-2018-0001]

Iowa; Amendment No. 1 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-4386-DR), dated August 20, 2018, and
related determinations.

DATES: This amendment was issued October 9, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include the following area
among those areas determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
August 20, 2018.

    Woodbury County for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-23159 Filed 10-23-18; 8:45 am]
 BILLING CODE 9111-11-P


[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Proposed Rules]
[Pages 12966-12969]
[FR Doc No: 2019-06438]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2019-N-1132]

The Future of Insulin Biosimilars: Increasing Access and
Facilitating the Efficient Development of Biosimilar and
Interchangeable Insulin 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 the Agency) is
announcing a public hearing to discuss access to affordable insulin
products and issues related to the development and approval of
biosimilar and interchangeable insulin products.

DATES: The public hearing will be held on May 13, 2019, from 9 a.m. to
5 p.m. The public hearing may be extended or may end early depending on
the level of public participation. Persons seeking to present at the
public hearing must register by April 29, 2019. Persons seeking to
speak at the public hearing must register by May 9, 2019. Persons
seeking to attend, but not present at, the public hearing must register
by May 9, 2019. Section III provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until May 31, 2019.

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. 1503B), Silver Spring, MD 20993-0002. Entrance for public hearing
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before May 31, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of May 31, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-1132 for ``The Future of Insulin Biosimilars: Increasing
Access and Facilitating the Efficient Development of Insulin Biosimilar
and Interchangeable Products; Public Hearing; Request for Comments.''
Received comments, those filed in a timely manner (see

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

FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3138, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected] (please use
``Insulin Biosimilars part 15'' as subject line).

SUPPLEMENTARY INFORMATION:

I. Background

    The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) requires that on March 23, 2020, an approved marketing application
for a biological product under section 505 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355) will be deemed to be a
license for the biological product under section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C. 262) and regulated under the
PHS Act. The transition of biological products currently approved under
the FD&C Act to the PHS Act will open the pathway to market for new
products that are biosimilar to, or interchangeable with, these
transitioned products. The biological products affected by this
transition include insulin products, insulin mix products, and insulin
analog products (collectively described in this notification as
``insulin products''), which historically have been approved under the
FD&C Act.
    Insulin is a lifesaving drug that many Americans depend on to treat
their diabetes. In recent years, however, increases in the prices of
insulin products have raised serious concerns about the ability for
many patients to access the insulin needed to survive. FDA is holding
this public hearing to receive input from stakeholders as the Agency
prepares for the submission and review of applications for biosimilar
and interchangeable insulin products. FDA anticipates that these
products, once they are approved, will bring new competition to the
insulin market and help provide affordable treatment options to
patients with diabetes without compromising safety and effectiveness.
    The BPCI Act amended the PHS Act and other statutes to create an
abbreviated licensure pathway for biological products shown to be
biosimilar to, or interchangeable with, an FDA-licensed biological
reference product. This abbreviated pathway allows an applicant to rely
on certain existing knowledge about the safety and effectiveness of a
biological reference product to support approval, provided the sponsor
can demonstrate that its product meets the applicable statutory
standards, including biosimilarity. Thus, the sponsor may be able to
develop the biosimilar at a lower cost, relative to the development of
a novel biological product submitted in a stand-alone marketing
application. The PHS Act defines biosimilarity to mean ``that the
biological product is highly similar to the reference product
notwithstanding minor differences in clinically inactive components''
and that ``there are no clinically meaningful differences between the
biological product and the reference product in terms of the safety,
purity, and potency of the product'' (section 351(i)(2) of the PHS
Act).
    An interchangeable biosimilar may be substituted for the reference
product without the intervention of the prescribing healthcare provider
(see section 351(i)(3) of the PHS Act). To meet the standard of
``interchangeability,'' an applicant must provide sufficient
information to demonstrate: (1) Biosimilarity; (2) that the biological
product can be expected to produce the same clinical result as the
reference product in any given patient; and (3) for products
administered more than once to an individual, that the risk in terms of
safety or diminished efficacy of alternating or switching between the
use of the biological product and the reference product is not greater
than the risk of using the reference product without such alternation
or switch (section 351(k)(4) of the PHS Act).
    After the March 23, 2020, transition, insulin products that will be
deemed to be licensed under the PHS Act will be able to act as
reference products for proposed biosimilar or interchangeable insulin
products. There are currently no approved prescription insulin products
that can be substituted at the pharmacy level. An interchangeable
insulin product can be substituted for the reference insulin product at
the pharmacy, potentially leading to increased access and lower costs
for patients.
    This public hearing is a component of FDA's broader effort to
facilitate the growth of a competitive market for biologics. In July
2018, FDA issued its Biosimilars Action Plan, which focuses on four
areas of FDA activities: (1) Improving the efficiency of the biosimilar
and interchangeable product development and approval process; (2)
maximizing scientific and regulatory clarity for the biosimilar product
development community; (3) developing effective communications to
improve understanding of biosimilars among patients, clinicians, and
payors; and (4) supporting market competition by reducing gaming of FDA
requirements or other attempts to unfairly delay competition. On
September 4, 2018, FDA held a public meeting entitled ``Facilitating
Competition and Innovation in the Biological Products Marketplace''
(see 83 FR 35154, July 25, 2018) and received submissions to an
associated docket (Docket No. FDA-2018-N-2689).

II. Purpose and Scope of the Public Hearing

    FDA is holding this public hearing to receive input from patients,
families,

healthcare providers, and other stakeholders who live with diabetes or
care for someone with diabetes about the challenges and opportunities
FDA should consider as we prepare for the submission and review of
applications for biosimilar and interchangeable insulin products. We
also want to hear from manufacturers and other stakeholders about the
development process for biosimilar and interchangeable insulin
products. FDA has determined that a public hearing is the most
appropriate way to ensure public engagement on these topics.
    Questions for Commenters to Address: FDA is soliciting input on
steps the Agency can take to facilitate increased access to insulin
products, including biosimilar and interchangeable insulin products.
FDA is interested in how we can encourage the development of biosimilar
and interchangeable insulin products, while achieving the balance
between competition and innovation intended by Congress in the BPCI
Act. Although FDA welcomes all feedback on any public health,
scientific, regulatory, or legal considerations relating to this topic,
we particularly encourage commenters to consider the following topics
and questions as they prepare their comments or statements.
    1. Scientific standards for evaluating the biosimilarity and
interchangeability of an insulin product.
    a. What considerations should FDA take into account when evaluating
data and other information submitted by an applicant, including from
analytical and clinical studies, to determine whether an insulin
product is biosimilar to a reference product?
    b. What considerations should FDA take into account when evaluating
data and other information submitted by an applicant, to determine
whether an insulin product is interchangeable with a reference product?
    2. Other regulatory considerations: Do certain insulin products,
for example, those that include use in insulin pumps for continuous
subcutaneous infusion among the approved uses or those approved with
over-the-counter marketing status, raise unique scientific
considerations? What factors should FDA consider when evaluating a
proposed biosimilar or interchangeable insulin product if the reference
product raises such considerations? Are there additional factors FDA
should evaluate for interchangeable insulin products, which may be
substituted at the pharmacy for the reference product without the
involvement of the prescriber?
    3. Patient experience: What aspects of the patient experience with
insulin products should FDA consider when evaluating a proposed
biosimilar or interchangeable insulin product?
    4. Information resources for patients, clinicians, pharmacists, and
other stakeholders: What information is needed to develop effective
communications to improve understanding and promote awareness among
patients, clinicians, pharmacists, and other stakeholders about
biosimilar and interchangeable insulin products?

III. Participating in the Public Hearing

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance will
be free and on a first-come, first-served basis. An agenda for the
hearing and any other background materials will be made available 5
days before the hearing at https://www.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm632081.htm. If you need special
accommodations because of a disability, please contact Allison Hoffman
(see FOR FURTHER INFORMATION CONTACT) at least 7 days before the
hearing.
    Registration and Requests for Formal Oral Presentations: For those
interested in presenting at the meeting with a formal oral
presentation, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person presenter''.
Presenter registrations are due April 29, 2019.
    FDA will try to accommodate all persons who wish to make a formal
oral presentation. Formal oral presenters may use an accompanying slide
deck. Individuals wishing to present should identify their name,
affiliation (if appropriate), and the number of the specific question,
or questions, they wish to address. This will help FDA organize the
presentations. Individuals and organizations with common interests
should consider consolidating or coordinating their presentations and
request time for a joint presentation. Individual organizations are
limited to a single presentation slot. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Registered presenters making a formal oral presentation are
encouraged to submit an electronic copy of their presentation
(PowerPoint or PDF) to [email protected] with the subject line
``Insulin Biosimilars part 15 Presentation'' on or before May 6, 2019.
Persons registered to present are encouraged to arrive at the hearing
room early and check in at the onsite registration table to confirm
their designated presentation time. Actual presentation times, however,
may vary based on how the meeting progresses in real time.
    Registration and Requests for Open Public Hearing Speaker slots:
For those interested in participating as an Open Public Hearing
speaker, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person Open Public
Hearing presenter''. Open Public Hearing registrations are due May 9,
2019; however, you may sign up as an Open Public Hearing speaker the
day of the meeting. Time and space are limited and available on a
first-come, first-served basis. Open Public Hearing speakers have less
allotted time than formal oral presenters and will deliver oral
testimony only (no accompanying slide deck).
    Persons registered to participate during the Open Public Hearing
are encouraged to arrive at the hearing room early and check in at the
onsite registration table to confirm their Open Public Hearing
participation.
    Those without internet or email access can request to participate
as a formal presenter or an open public hearing speaker by contacting
Allison Hoffman by the above dates (see FOR FURTHER INFORMATION
CONTACT).
    In-person attendance: For those who would like to attend in-person,
but who are not making a formal presentation or participating in the
Open Public Hearing, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person
attendee--no participation''. You may choose not to register; however,
seating is limited, and space will be available on a first-come, first-
served basis.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://collaboration.fda.gov/insulin051319. Please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``online (webcast only)''.
    Media: Please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``Media'' by May 9, 2019.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm632081.htm and https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES).

IV. Notice of 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, who will be
accompanied by FDA senior management from the Office of the
Commissioner, the Center for Devices and Radiological Health, the
Center for Drug Evaluation and Research, and the Office of the Chief
Counsel. Under Sec.  15.30(f) (21 CFR 15.30(f)), the hearing is
informal, and the rules of evidence do not apply. No participant may
interrupt the presentation of another participant. 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). Under 21 CFR 10.205, representatives of the media may
be permitted, subject to certain limitations, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. Persons attending FDA's hearings are
advised that the Agency is not responsible for providing access to
electrical outlets. The hearing will be transcribed as stipulated in
Sec.  15.30(b) (see Transcripts). To the extent that the conditions for
the hearing, as described in this notification, conflict with any
provisions set out in part 15, this notification acts as a waiver of
those provisions as specified in Sec.  15.30(h).

    Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06438 Filed 4-2-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Notices]
[Pages 26147-26148]
[FR Doc No: 2017-11609]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80825; File No. SR-CHX-2017-06]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Order Granting Approval of a Proposed Rule Change To Shorten the
Standard Settlement Cycle From Three Business Days After the Trade Date
to Two Business Days After the Trade Date

May 31, 2017.

I. Introduction

    On April 6, 2017, the Chicago Stock Exchange, Inc. (``CHX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to conform its rules to an amendment adopted by
the Commission to Rule 15c6-1(a) under the Act \3\ to shorten the
standard settlement cycle for most broker-dealer transactions from
three business days after the trade date (``T+3'') to two business days
after the trade date (``T+2'').\4\ The Commission adopted the amendment
to Rule 15c6-1(a) under the Act to shorten the standard settlement
cycle to T+2 on March 22, 2017 and set a compliance date of September
5, 2017.\5\ The Exchange's proposed rule change was published for
comment in the Federal Register on April 21, 2017.\6\ The Commission
did not receive any comment letters on the proposed rule change. This
order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.15c6-1.
    \4\ See Securities Exchange Act Release No. 80295 (March 22,
2017), 82 FR 15564 (March 29, 2017) (``SEC Adopting Release'').
    \5\ See id.
    \6\ See Securities Exchange Act Release No. 80467 (April 17,
2017), 82 FR 18800.

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II. Description of the Proposal

    The Exchange proposes to amend Article 1, Rule 2(e) and Article 9,
Rule 7 to conform to the Commission's amendment to Rule 15c6-1(a) under
the Act \7\ which shortens the standard settlement cycle from T+3 to
T+2 for most broker-dealer transactions.
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    \7\ See id; see also supra note 4.
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    Current Article 1, Rule 2(e)(1) relating to order settlement terms
defines ``Regular Way Settlement'' as ``a transaction for delivery on
the third full business day following the day of the contract.'' The
Exchange proposes to shorten the ``third full business day'' time
period to ``second full business day.''
    Current Article 1, Rule 2(e)(2)(C) defines ``Seller's Option'' as
``a transaction for delivery within the time specified in the option,
which time shall not be less than four (4) full business days nor more
than 60 days following the day of the contract; except that the
Exchange may provide otherwise in specific issues of stocks or classes
of stocks.'' The Exchange proposes to shorten the ``four (4) full
business days'' time period to ``three (3) full business days.''
    Current Article 9, Rule 7(a) governing ex-dividend transactions
provides in part that transactions in stocks shall be ex-dividend or
ex-rights two full business days immediately preceding the date of
record fixed by the corporation for the determination of stockholders
entitled to receive such dividends or rights, except when such record
date occurs upon a holiday or half-holiday, transactions in the stock
shall be ex-dividend or ex-rights three full business days immediately
preceding the record date. The Exchange proposes amendments to shorten
the ``two full business days'' time period to a ``business day'' under
Rule 7(a) and the ``three full business days'' time period to ``two
full business days'' under Rule 7(a)(1).
    The Exchange proposes similar changes to current Article 9, Rule
7(b) pertaining to ex-warrants that provides, in pertinent part, that
transactions in securities which have subscription warrants attached
(except those made for ``cash'') shall be ex-warrants on the second
full business day preceding the date of expiration of the warrants,
except when the day of expiration occurs on a holiday or Sunday, the
transactions shall be ex-warrants on the third full business day
preceding the day of expiration. The Exchange proposes to shorten the
``second full business day'' time period to a ``business day'' under
Rule 7(b) and the ``third full business day'' time period to ``second
full business day'' under Rule 7(b)(1).

III. Discussion and Commission's Findings

    After careful review of the proposed rule change, the Commission
finds that the proposal is consistent with the requirements of the Act
and the rules and regulations thereunder that are applicable to a
national securities exchange.\8\ Specifically, the Commission finds
that the proposed rule change is consistent with Section 6(b)(5) of the
Act,\9\ which requires that the rules of a national securities exchange
be designed, among other things, to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and to protect investors and the public interest.
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    \8\ In approving this proposed rule change the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Commission notes that the proposed rule change would amend
Exchange rules to conform to the amendment that the Commission has
adopted to Rule 15c6-1(a) under the Act \10\ and support a move to a
T+2 standard settlement cycle. In the SEC Adopting Release, the
Commission stated its belief that shortening the standard settlement
cycle from T+3 to T+2 will result in a reduction of credit, market, and
liquidity risk,\11\ and as a result, a reduction in systemic risk for
U.S. market participants.\12\ The compliance date for the amendment to
Rule 15c6-1(a) under the Act is September 5, 2017.\13\ The Exchange has
represented that the operative date of the proposed rule change would
correspond to the compliance date of the amendment to Rule 15c6-1(a)
under the Act.
---------------------------------------------------------------------------

    \10\ See SEC Adopting Release, supra note 4.
    \11\ Credit risk refers to the risk that the credit quality of
one party to a transaction will deteriorate to the extent that it is
unable to fulfill its obligations to its counterparty on settlement
date. Market risk refers to the risk that the value of securities
bought and sold will change between trade execution and settlement
such that the completion of the trade would result in a financial
loss. Liquidity risk describes the risk that an entity will be
unable to meet financial obligations on time due to an inability to
deliver funds or securities in the form required though it may
possess sufficient financial resources in other forms. See id., 82
FR at 15564 n. 3.
    \12\ See id., 82 FR at 15564.
    \13\ See id.
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    For the reasons noted above, the Commission finds that the proposal
is consistent with the requirements of the Act and would foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and protect investors and the public interest.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\14\ that the proposed rule change, (SR-CHX-2017-06), be and hereby
is, approved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-11609 Filed 6-5-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26477-26481]
[FR Doc No: 2018-12221]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0961]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Environmental Impact Considerations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public

comment on the proposed collection of certain information by the
Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal
Agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the reporting requirements contained in the FDA
collection of information ``Environmental Impact Considerations.''

DATES: Submit either electronic or written comments on the collection
of information by August 6, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 6, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 6, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-0961 for ``Environmental Impact Considerations.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Environmental Impact Considerations--21 CFR Part 25

OMB Control Number 0910-0322--Extension

I. Background

    FDA is requesting OMB approval for the reporting requirements
contained in the FDA collection of information

``Environmental Impact Considerations.'' The National Environmental
Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental
objectives and imposes upon each Federal Agency the duty to consider
the environmental effects of its actions. Section 102(2)(C) of NEPA
requires the preparation of an environmental impact statement (EIS) for
every major Federal action that will significantly affect the quality
of the human environment.
    FDA's NEPA regulations are in part 25 (21 CFR part 25). All
applications or petitions requesting Agency action require the
submission of a claim for categorical exclusion or an environmental
assessment (EA). A categorical exclusion applies to certain classes of
FDA-regulated actions that usually have little or no potential to cause
significant environmental effects and are excluded from the
requirements to prepare an EA or EIS. Section 25.15(a) and (d)
specifies the procedures for submitting to FDA a claim for a
categorical exclusion. Extraordinary circumstances (Sec.  25.21), which
may result in significant environmental impacts, may exist for some
actions that are usually categorically excluded. An EA provides
information that is used to determine whether an FDA action could
result in a significant environmental impact. Section 25.40(a) and (c)
specifies the content requirements for EAs for non-excluded actions.
    This collection of information is used by FDA to assess the
environmental impact of Agency actions and to ensure that the public is
informed of environmental analyses. Firms wishing to manufacture and
market substances regulated under statutes for which FDA is responsible
must, in most instances, submit applications requesting approval.
Environmental information must be included in such applications for the
purpose of determining whether the proposed action may have a
significant impact on the environment. Where significant adverse events
cannot be avoided, the Agency uses the submitted information as the
basis for preparing and circulating to the public an EIS, made
available through a Federal Register document also filed for comment at
the Environmental Protection Agency. The final EIS, including the
comments received, is reviewed by the Agency to weigh environmental
costs and benefits in determining whether to pursue the proposed action
or some alternative that would reduce expected environmental impact.
    Any final EIS would contain additional information gathered by the
Agency after the publication of the draft EIS, a copy or a summary of
the comments received on the draft EIS, and the Agency's responses to
the comments, including any revisions resulting from the comments or
other information. When the Agency finds that no significant
environmental effects are expected, the Agency prepares a finding of no
significant impact.
    FDA estimates the burden of this collection of information as
follows:

II. Estimated Annual Reporting Burden for Human Drugs (Including
Biologics in the Center for Drug Evaluation and Research)

    Under Sec. Sec.  312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i)), each investigational new drug application (IND), new
drug application (NDA), and abbreviated new drug application (ANDA)
must contain a claim for categorical exclusion under Sec.  25.30 or
Sec.  25.31, or an EA under Sec.  25.40. Annually, FDA receives
approximately 3,687 INDs from 2,456 sponsors; 140 NDAs from 116
applicants; 3,192 supplements to NDAs from 443 applicants; 28 biologic
license applications (BLAs) from 22 applicants; 464 supplements to BLAs
from 52 applicants; 1,152 ANDAs from 248 applicants; and 6,774
supplements to ANDAs from 384 applicants. FDA estimates that it
receives approximately 15,437 claims for categorical exclusions as
required under Sec.  25.15(a) and (d) and 10 EAs as required under
Sec.  25.40(a) and (c). Based on information provided by the
pharmaceutical industry, FDA estimates that it takes sponsors or
applicants approximately 8 hours to prepare a claim for a categorical
exclusion and approximately 3,400 hours to prepare an EA.

                         Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................           3,724          4.1453          15,437               8         123,496
25.40(a) and (c)................              10               1              10           3,400          34,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         157,496
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Estimated Annual Reporting Burden for Medical Devices

    Under Sec.  814.20(b)(11) (21 CFR 814.20(b)(11)), premarket
approvals (PMAs) (original PMAs and supplements) must contain a claim
for categorical exclusion under Sec.  25.30 or Sec.  25.34 or an EA
under Sec.  25.40. In 2017, FDA received an average of 50 claims
(original PMAs and supplements) for categorical exclusions as required
under Sec.  25.15(a) and (d), and 0 EAs as required under Sec.
25.40(a) and (c). FDA estimates that approximately 50 respondents will
submit an average of 1 application for categorical exclusion annually.
Based on information provided by sponsors, FDA estimates that it takes
approximately 6 hours to prepare a claim for a categorical exclusion.

                       Table 2--Estimated Annual Reporting Burden for Medical Devices \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................              50               1              50               6             300
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

IV. Estimated Annual Reporting Burden for Biological Products, Drugs,
and Medical Devices in the Center for Biologics Evaluation and Research

    Under 21 CFR 601.2(a), BLAs as well as INDs (Sec.  312.23), NDAs
(Sec.  314.50), ANDAs (Sec.  314.94), and PMAs (Sec.  814.20) must
contain either a claim of categorical exclusion under Sec.  25.30 or
Sec.  25.32 or an EA under Sec.  25.40. Annually, FDA receives
approximately 34 BLAs from 18 applicants, 801 BLA supplements to
license applications from 156 applicants, 345 INDs from 256 sponsors, 1
NDA from 1 applicant, 26 supplements to NDAs from 8 applicants, 1 ANDA
from 1 applicant, 1 supplement to ANDAs from 1 applicant, 8 PMAs from 3
applicants, and 33 PMA supplements from 16 applicants. FDA estimates
that approximately 10 percent of these supplements would be submitted
with a claim for categorical exclusion or an EA.
    FDA has received approximately 481 claims for categorical exclusion
as required under Sec.  25.15(a) and (d) annually and 2 EAs as required
under Sec.  25.40(a) and (c) annually. Therefore, FDA estimates that
approximately 247 respondents will submit an average of 2 applications
for categorical exclusion and 2 respondents will submit an average of 1
EA. Based on information provided by industry, FDA estimates that it
takes sponsors and applicants approximately 8 hours to prepare a claim
of categorical exclusion and approximately 3,400 hours to prepare an EA
for a biological product.

                     Table 3--Estimated Annual Reporting Burden for Biological Products \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................             247               2             494               8           3,952
25.40(a) and (c)................               2               1               2           3,400           6,800
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,752
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

V. Estimated Annual Reporting Burden for Animal Drugs

    Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1)
supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new
animal drug applications (INADs) and generic investigational new animal
drug applications (JINADs), and 21 CFR 571.1(c) food additive petitions
must contain a claim for categorical exclusion under Sec.  25.30 or
Sec.  25.32 or an EA under Sec.  25.40. Annually, FDA's Center for
Veterinary Medicine has received approximately 810 claims for
categorical exclusion as required under Sec.  25.15(a) and (d) and 22
EAs as required under Sec.  25.40(a) and (c). Assuming an average of 10
claims per respondent, FDA estimates that approximately 81 respondents
will submit an average of 10 claims for categorical exclusion. FDA
further estimates that 22 respondents will submit an average of 1 EA.
FDA estimates that it takes sponsors/applicants approximately 3 hours
to prepare a claim of categorical exclusion and an average of 2,160
hours to prepare an EA.

                         Table 4--Estimated Annual Reporting Burden for Animal Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................              81              10             810               3           2,430
25.40(a) and (c)................              22               1              22           2,160          47,520
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          49,950
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

VI. Estimated Annual Reporting Burden for Tobacco Products

    Under sections 905, 910, and 911 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 387e, 387j, and 387k), product applications and
supplements (PMTAs), SEs, Exemption from SEs, and modified risk tobacco
products must contain a claim for categorical exclusion or an EA. FDA's
estimates are based on actual report data from fiscal year (FY) 2015 to
FY 2017, on average FDA estimated it received approximately 260
premarket review of new tobacco PMTAs from 260 respondents, 3,601
provisional reports intended to demonstrate the substantial equivalence
of a new tobacco product (SEs) from 3,601 respondents, 2,375 regular SE
reports from 2,375 respondents, 101 exemption from substantial
equivalence requirements applications (SE Exemptions) from 101
respondents, and 27 modified risk tobacco product applications (MRTPAs)
from 27 respondents. Based on updated data FDA estimates 5,832 EAs from
5,832 respondents as required under Sec.  25.40(a) and (c). A total of
5,832 respondents will submit an average of 1 application for
environmental assessment. Part of the information in the EA will be
developed while writing other parts of a PMTA, SE, Exemption from SE,
or MRTPA. Based on FDA's experience, previous information provided by
potential sponsors and knowledge that part of the EA information has
already been produced in one of the tobacco product applications, FDA
estimates that it takes approximately 80 hours to prepare an EA.

                       Table 5--Estimated Annual Reporting Burden for Tobacco Products \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.40(a) and (c)................           5,832               1           5,832              80         466,560
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The Estimated Annual Reporting Burden for Human Foods is no longer
a part of this information collection. The burden has now been
incorporated into OMB control number 0910-0541.
    Our estimated burden for the information collection reflects an
overall increase of 453,834 hours (currently approved 231,224) and a
corresponding increase of 7,108 annual responses (currently approved
15,527). The new estimated totals are 685,058 hours and 22,635 annual
responses. We attribute this adjustment to an increase in the number of
EA submissions we received since the last extension.

    Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12221 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Rules and Regulations]
[Pages 17615-17617]
[FR Doc No: 2016-07093]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-8429]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Patricia Suber, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain

management measures after this rule is published but prior to the
actual suspension date. These communities will not be suspended and
will continue to be eligible for the sale of NFIP flood insurance. A
notice withdrawing the suspension of such communities will be published
in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community     cancellation of    Current effective map   Date certain federal
      State and location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
          Region III

Virginia:
    Albemarle County,                 510006  May 9, 1973,        May 16, 2016..........  May 16, 2016
     Unincorporated Areas.                     Emerg; December
                                               16, 1980, Reg;
                                               May 16, 2016,
                                               Susp.
    Hampton, City of,                 515527  March 27, 1970,     ......* do............   Do.
     Independent City.                         Emerg; January
                                               15, 1971, Reg;
                                               May 16, 2016,
                                               Susp.
    King and Queen County,            510082  June 20, 1974,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               5, 1990, Reg; May
                                               16, 2016, Susp.
    Scottsville, Town of,             510007  April 12, 1973,     .....do...............   Do.
     Albemarle and Fluvanna                    Emerg; September
     Counties.                                 5, 1979, Reg; May
                                               16, 2016, Susp.

           Region V

Wisconsin:
    Cambria, Village of,              550057  June 11, 1975,      ......do..............   Do.
     Columbia County.                          Emerg; September
                                               18, 1985, Reg;
                                               May 16, 2016,
                                               Susp.
    Columbia County,                  550581  July 31, 1975,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; April 15,
                                               1980, Reg; May
                                               16, 2016, Susp.
    Columbus, City of,                550058  October 7, 1974,    ......do..............   Do.
     Columbia and Dodge                        Emerg; December
     Counties.                                 1, 1981, Reg; May
                                               16, 2016, Susp.
    Doylestown, Village of,           550059  April 30, 1976,     ......do..............   Do.
     Columbia County.                          Emerg; September
                                               18, 1985, Reg;
                                               May 16, 2016,
                                               Susp.
    Fall River, Village of,           550060  April 17, 1975,     ......do..............   Do.
     Columbia County.                          Emerg; September
                                               4, 1985, Reg; May
                                               16, 2016, Susp.
    Lodi, City of, Columbia           550061  June 13, 1974,      ......do..............   Do.
     County.                                   Emerg; November
                                               15, 1984, Reg;
                                               May 16, 2016,
                                               Susp.
    Pardeeville, Village of,          550062  August 19, 1976,    ......do..............   Do.
     Columbia County.                          Emerg; August 15,
                                               1983, Reg; May
                                               16, 2016, Susp.
    Portage, City of, Columbia        550063  June 11, 1974,      ......do..............   Do.
     County.                                   Emerg; August 15,
                                               1983, Reg; May
                                               16, 2016, Susp.

    Poynette, Village of,             550064  July 29, 1975,      ......do..............   Do.
     Columbia County.                          Emerg; September
                                               18, 1985, Reg;
                                               May 16, 2016,
                                               Susp.
    Wisconsin Dells, City of,         550065  July 17, 1975,      ......do..............   Do.
     Adams, Columbia, Juneau                   Emerg; December
     and Sauk Counties.                        18, 1984, Reg;
                                               May 16, 2016,
                                               Susp.
    Wyocena, Village of,              550066  May 22, 1975,       ......do..............   Do.
     Columbia County.                          Emerg; January
                                               18, 1984, Reg;
                                               May 16, 2016,
                                               Susp.
          Region VIII

Colorado:
    Crook, Town of, Logan             080311  May 6, 1977,        ......do..............   Do.
     County.                                   Emerg; February
                                               5, 1986, Reg; May
                                               16, 2016, Susp.
    Iliff, Town of, Logan             080207  March 20, 1984,     ......do..............   Do.
     County.                                   Emerg; August 4,
                                               1987, Reg; May
                                               16, 2016, Susp.
    Logan County,                     080310  January 3, 1977,    ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               29, 1989, Reg;
                                               May 16, 2016,
                                               Susp.
    Sterling, City of, Logan          080294  August 4, 1977,     ......do..............   Do.
     County.                                   Emerg; September
                                               29, 1989, Reg;
                                               May 16, 2016,
                                               Susp.
----------------------------------------------------------------------------------------------------------------
* .....do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: March 16, 2016.
Roy E. Wright,
Deputy Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2016-07093 Filed 3-29-16; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register: March 30, 2009 (Volume 74, Number 59)]
[Rules and Regulations]
[Page 14007-14008]
[DOCID:fr30mr09-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1108; Airspace Docket No. 08-AWP-11]

Modification of Class E Airspace; Reno, NV

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action will modify Class E airspace at Reno/Tahoe
International Airport, Reno, NV. Additional controlled airspace is
necessary to accommodate aircraft using the Localizer (LOC) Z Runway
16R approach at Reno/Tahoe International Airport, Reno, NV. This action
will enhance the safety and management of aircraft operations at the
airport. This action also amends the airport name and makes a minor
change to the geographic coordinates of the airport and the VORTAC.

DATES: Effective Date: 0901 UTC, July 2, 2009. 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: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On December 18, 2008, the FAA published in the Federal Register a
notice of proposed rulemaking to establish additional controlled
airspace at Reno/Tahoe International Airport, Reno, NV, (73 FR 76986).
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Subsequent to publication, the FAA found that a
minor change to the geographic coordinates of the airport and the
VORTAC is needed to coincide with the FAA's National Aeronautical
Charting Office. Also, the airport's name will be amended to read as
Reno/Tahoe International Airport, from Reno/Cannon International
Airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9S signed October 3, 2008, and effective October 31,
2008, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying the Class E airspace at Reno, NV. Additional
controlled airspace is necessary to accommodate aircraft using the
Localizer (LOC) Z Runway 16R approach at Reno/Tahoe International
Airport, Reno, NV. With the exception of editorial changes, and the
changes described above, this rule is the same as that proposed in the
NPRM.
    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 will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will 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, discusses 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 modifies
controlled airspace at Reno/Tahoe International Airport, Reno, NV.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
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 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008 is amended as follows:

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

* * * * *

AWP NV E5 Reno, NV [Modified]

Reno/Tahoe International Airport, NV
    (Lat. 39[deg]29'57'' N., long. 119[deg]46'05'' W.)
Mustang VORTAC
    (Lat. 39[deg]31'53'' N., long. 119[deg]39'22'' W.)

    That airspace extending upward from 700 feet above the surface
beginning at lat. 40[deg]00'20'' N., long. 120[deg]00'04'' W.;
thence clockwise via the 32.0-mile radius of the Reno/Tahoe
International Airport to lat. 40[deg]01'31'' N., long.
119[deg]40'01'' W.; to lat. 39[deg]49'35'' N., long. 119[deg]34'05''
W.; thence clockwise via the 21.7-mile radius to lat. 39[deg]25'12''
N., long. 119[deg]18'45'' W.; to lat 39[deg]13'00'' N., long
119[deg]47'04'' W.; to lat. 39[deg]08'20'' N., long. 119[deg]47'04''
W.; to lat. 39[deg]10'20'' N., long.120[deg]00'04'' W., to the point
of beginning. That airspace extending upward from 1,200 feet above
the surface within a 39.1-mile radius of the Mustang VORTAC
excluding the area east of long.119[deg]00'04'' W., and west of
long. 120[deg]19'04'' W.; and that airspace northwest of the Reno/
Tahoe International Airport extending from the 39.1-mile radius
bounded on the northeast by the southwest edge of V-452 and on the
west by long. 120[deg]19'04'' W. That airspace extending upward from
13,100 feet MSL beginning at lat. 38[deg]54'56'' N., long.
119[deg]22'47'' W.; thence clockwise via the 39.1-mile radius to the
eastern edge of V-165, thence southbound along the eastern edge of
V-165 to the northern edge of V-244, thence eastbound to
lat.38[deg]04'00'' N., long. 119[deg]15'24'' W., to the point of
beginning. That airspace extending upward from 12,300 feet MSL
beginning at lat. 38[deg]52'20'' N., long. 119[deg]35'44'' W.; to
lat. 38[deg]52'20'' N., long.119[deg]47'54'' W.; to lat.
38[deg]28'00'' N., long. 119[deg]52'44'' W.; to lat. 38[deg]01'30''
N., long.119[deg]51'34'' W.; to lat. 38[deg]01'00'' N.,
long.119[deg]38'04'' W.; to lat. 38[deg]27'30'' N.,
long.119[deg]33'44'' W., to the point of beginning.
* * * * *

    Issued in Seattle, Washington, on March 19, 2009.
H. Steve Karnes,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. E9-6994 Filed 3-27-09; 8:45 am]

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