[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Proposed Rules]
[Pages 38417-38419]
[FR Doc No: 2015-16518]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0423]
RIN 1625-AA09

Drawbridge Operation Regulation; Rancocas Creek, Centerton, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to change the regulation that governs
the operation of the SR#38 Bridge in Centerton (Burlington County Route
635) over Rancocas Creek, mile 7.8, at Mt. Laurel, Westampton and
Willingboro Townships in Burlington County, NJ. The proposed rule
intends to change the current operating regulation and allow the bridge
to remain in the closed position for the passage of vessels. There have
been no requests for openings since the early 1990's. This proposed
rule will also reflect a name change.

DATES: Comments and related material must reach the Coast Guard on or
before September 4, 2015. Requests for public meetings must be received
by the Coast Guard on or before August 5, 2015.

ADDRESSES:  You may submit comments identified by docket number USCG-
2015-0423 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments. To avoid duplication, please use only one of these
three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Jim Rousseau, Fifth Coast Guard District Bridge
Administration Division, Coast Guard; telephone<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section Symbol
U.S.C. United States Code

A. Public Participation and Request for Comments

    We encourage you to participate in this proposed rulemaking by
submitting comments and related materials. All comments received will
be posted, without change to http://www.regulations.gov and will
include any personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
proposed rulemaking (USCG-2015-0423), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online (http://www.regulations.gov), or by fax, mail or hand
delivery, but please use only one

of these means. If you submit a comment online via http://www.regulations.gov, it will be considered received by the Coast Guard
when you successfully transmit the comment. If you fax, hand deliver,
or mail your comment, it will be considered as having been received by
the Coast Guard when it is received at the Docket Management Facility.
We recommend that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that we can
contact you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2015-0423] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit them by mail
and would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number USCG-2015-0423 in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not plan to hold a public meeting but you may submit a
request for one that reaches the Coast Guard on or before August 5,
2015 using one of the four methods specified under ADDRESSES. Please
explain why one would be beneficial. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register.

B. Basis and Purpose

    The current operating schedule for the SR#38 bridge is set out in
33 CFR 117.745 (b) which allows the SR#38 Bridge to operate as follows:
From April 1 through October 31 open on signal from 7 a.m. to 11 p.m.
From November 1 through March 31 from 7 a.m. to 11 p.m. open on signal
if at least 24 hours notice is given. Year round from 11 p.m. to 7 a.m.
need not open for the passage of vessels.
    The bridge owner, County of Burlington, NJ requested a change in
the operation regulation for the SR#38 Bridge, mile 7.8, across
Rancocas Creek in Mt. Laurel, NJ and that its name is changed to what
it is known locally. The County of Burlington provided information to
the Coast Guard about the lack of any openings of the draw spans dating
back to the early 1990's. The bridge is currently closed to navigation
and vehicular traffic due to emergency repairs and emergency
inspections since May 2015. The last requested opening was in the early
1990's as an emergency request. There have been monthly openings as per
maintenance requirements.
    In the closed-to-navigation position, the SR#38 Bridge has vertical
clearances of six feet above mean high water. Typical waterway users
include very small recreational vessels including canoes and kayaks.

C. Discussion of Proposed Rule

    In order to align the operating schedule of the SR#38 bridge with
observed marine traffic the proposed change amends the regulation by
adding a paragraph (c) to state ``that the bridge need not open.'' The
lack of requests for vessel openings of the drawbridge for over 20
years illustrates that the vessels that use this waterway can safely
navigate while the bridge is in the closed-to-navigation position. The
current regulation also incorrectly identifies the bridge as the SR#38
Bridge. This proposed change will change the name to the Centerton
County Route 635 Bridge. All language in existing paragraph (b) will
remain the same except for the removal of the SR#38 bridge reference.
    While this proposed rule will allow the bridge to remain closed to
navigation, it does not alleviate the bridge owner of his
responsibility under 33 CFR 117.7.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders. Based on County of Burlington
bridge tender logs, there will not be any vessels impacted by this
proposed change. No bridge openings have been requested in over 20
years.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities. This action will not have a
significant economic impact on a substantial number of small entities
for the following reasons: There have been no requests for the bridge
to open since the early 1990's, and the bridge has been unable to open
since May of 2015.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in

understanding this proposed rule. If the rule would affect your small
business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the ``For Further
Information Contact'' section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

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

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a
preliminary determination that this action is one of a category of
actions which do not individually or cumulatively have a significant
effect on the human environment. This proposed rule simply promulgates
the operating regulations or procedures for drawbridges. This rule is
categorically excluded, under figure 2-1, paragraph (32)(e), of the
Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.745, revise paragraph (b) introductory text and add
paragraph (c) to read as follows:

Sec.  117.745  Rancocas Creek

* * * * *
    (b) The drawspan for the Riverside-Delanco/SR#543 Drawbridge, mile
1.3 at Riverside must operate as follows:
* * * * *
    (c) The draw of the Centerton County Route 635 Bridge, mile 7.8, at
Mt. Laurel, need not open for the passage of vessels.

    Dated: June 11, 2015.
Robert J. Tarantino,
Captain, United States Coast Guard, Acting Commander, Fifth Coast Guard
District.
[FR Doc. 2015-16518 Filed 7-2-15; 8:45 am]
 BILLING CODE 9110-04-P


understanding may expire; the natural persons and entities subject to
such an agreement, arrangement or understanding; any exceptions under
such an agreement, arrangement or understanding; and any terms that
would result in an earlier expiration of such an agreement, arrangement
or understanding.

    (b) Conflicts of interest. Describe any actual or potential
material conflict of interest, including any material conflict of
interest in determining whether to proceed with a de-SPAC transaction
and any material conflict of interest arising from the manner in which
the special purpose acquisition company compensates the SPAC sponsor,
executive officers and directors or the manner in which the SPAC
sponsor compensates its executive officers and directors, between:
    (1) The SPAC sponsor or its affiliates or the special purpose
acquisition company's officers, directors, or promoters; and
    (2) Unaffiliated security holders.
    (c) Briefly describe the fiduciary duties of each officer and
director of the special purpose acquisition company to other companies
to which they have fiduciary duties.

Sec.  229.1604  (Item 1604) De-SPAC transactions.

    (a) Forepart of registration statement and outside cover page of
the prospectus. In addition to the information required by Sec.
229.501 (Item 501 of Regulation S-K), provide the following information
on the outside front cover page of the prospectus in plain English as
required by Sec.  230.421(d) of this chapter:
    (1) State whether the special purpose acquisition company
reasonably believes that the de-SPAC transaction is fair or unfair to
unaffiliated security holders, and whether the special purpose
acquisition company or the SPAC sponsor has received a report, opinion
or appraisal from an outside party regarding the fairness of the
transaction.
    (2) Describe briefly any material financing transactions that have
occurred since the initial public offering of the special purpose
acquisition company or will occur in connection with the consummation
of the de-SPAC transaction.
    (3) State the amount of the compensation received or to be received
by the SPAC sponsor, its affiliates and promoters in connection with
the de-SPAC transaction or any related financing transaction, and
whether this compensation may result in a material dilution of the
equity interests of non-redeeming shareholders who hold the securities
until the consummation of the de-SPAC transaction. Provide a cross-
reference, highlighted by prominent type or in another manner, to the
locations of related disclosures in the prospectus.
    (4) State whether there may be material actual or potential
conflicts of interest between the SPAC sponsor or its affiliates or
promoters and unaffiliated security holders in connection with the de-
SPAC transaction. Provide a cross-reference, highlighted by prominent
type or in another manner, to the locations of related disclosures in
the prospectus.
    (b) Prospectus summary. The information required by Sec.
229.503(a) (Item 503(a) of Regulation S-K) shall include, but not be
limited to, a brief description of the following in plain English as
required by Sec.  230.421(d) of this chapter:
    (1) The background and material terms of the de-SPAC transaction;
    (2) Whether the special purpose acquisition company reasonably
believes that the de-SPAC transaction is fair or unfair to unaffiliated
security holders, the bases for such belief, and whether the special
purpose acquisition company or the SPAC sponsor has received any
report, opinion or appraisal from an outside party concerning the
fairness of the de-SPAC transaction;
    (3) Any material actual or potential conflicts of interest between
the SPAC sponsor or its affiliates or promoters and unaffiliated
security holders in connection with the de-SPAC transaction;
    (4) In a tabular format, the terms and amount of the compensation
received or to be received by the SPAC sponsor and its affiliates in
connection with the de-SPAC transaction or any related financing
transaction, and whether that compensation has resulted or may result
in a material dilution of the equity interests of unaffiliated security
holders of the special purpose acquisition company;
    (5) The material terms of any financing transactions that have
occurred or will occur in connection with the consummation of the de-
SPAC transaction, the anticipated use of proceeds from these financing
transactions and the dilutive impact, if any, of these financing
transactions on unaffiliated security holders; and
    (6) The rights of security holders to redeem the outstanding
securities of the special purpose acquisition company and the potential
impact of redemptions on the value of the securities owned by non-
redeeming shareholders.
    (c) Dilution. Describe each material potential source of future
dilution that non-redeeming shareholders may experience by electing not
to tender their shares in connection with the de-SPAC transaction.
    (1) Provide sensitivity analysis disclosure in tabular format that
expresses the amount of potential dilution under a range of reasonably
likely redemption levels. At each redemption level in the sensitivity
analysis, quantify the dilutive impact on non-redeeming shareholders of
each source of dilution, such as the amount of compensation paid or to
be paid to the SPAC sponsor, the terms of outstanding warrants and
convertible securities, and underwriting and other fees. For each
redemption level in the sensitivity analysis, state the company
valuation at or above which the potential dilution results in the
amount of the non-redeeming shareholders' interest per share being at
least the initial public offering price per share of common stock.
    (2) Provide a description of the model, methods, assumptions,
estimates, and parameters necessary to understand the sensitivity
analysis disclosure.

Sec.  229.1605  (Item 1605) Background of and reasons for the de-SPAC
transaction; terms of the de-SPAC transaction; effects.

    (a) Furnish a summary of the background of the de-SPAC transaction.
Such summary shall include, but not be limited to, a description of any
contacts, negotiations or transactions that have occurred concerning
the de-SPAC transaction.
    (b) State the material terms of the de-SPAC transaction, including
but not limited to:
    (1) A brief description of the de-SPAC transaction;
    (2) A brief description of any related financing transaction,
including any payments from the SPAC sponsor to investors in connection
with the financing transaction;
    (3) A reasonably detailed discussion of the reasons for engaging in
the de-SPAC transaction and for the structure and timing of the de-SPAC
transaction and any related financing transaction;
    (4) An explanation of any material differences in the rights of
security holders of the combined company as a result of the de-SPAC
transaction after the completion of the de-SPAC transaction;
    (5) A brief statement as to the accounting treatment of the de-SPAC
transaction, if material; and
    (6) The Federal income tax consequences of the de-SPAC transaction,
if material.
    (c) Describe the effects of the de-SPAC transaction and any related
financing transaction on the special purpose acquisition company and
its affiliates, the SPAC sponsor and its affiliates, the target company
and its affiliates, and unaffiliated security holders of the special
purpose acquisition company. The description must include a

reasonably detailed discussion of both the benefits and detriments of
the de-SPAC transaction and any related financing transaction to the
special purpose acquisition company and its affiliates, the SPAC
sponsor and its affiliates, the target company and its affiliates, and
unaffiliated security holders. The benefits and detriments of the de-
SPAC transaction and any related financing transaction must be
quantified to the extent practicable.
    (d) Disclose any material interests in the de-SPAC transaction or
any related financing transaction held by the SPAC sponsor and the
special purpose acquisition company's officers and directors, including
fiduciary or contractual obligations to other entities as well as any
interest in, or affiliation with, the target company.
    (e) State whether or not security holders are entitled to any
redemption or appraisal rights. If so, summarize the redemption or
appraisal rights. If there are no redemption or appraisal rights
available for security holders who object to the de-SPAC transaction,
briefly outline any other rights that may be available to security
holders.

Sec.  229.1606  (Item 1606) Fairness of the de-SPAC transaction and any
related financing transaction.

    (a) Fairness. State whether the special purpose acquisition company
reasonably believes that the de-SPAC transaction and any related
financing transaction are fair or unfair to unaffiliated security
holders of the special purpose acquisition company. If any director
voted against, or abstained from voting on, approval of the de-SPAC
transaction or any related financing transaction, identify the
director, and indicate, if known, after making reasonable inquiry, the
reasons for the vote against the transaction or abstention.
    (b) Factors considered in determining fairness. Discuss in
reasonable detail the material factors upon which the belief stated in
paragraph (a) of this section is based and, to the extent practicable,
the weight assigned to each factor. Such factors shall include, but not
be limited to, the valuation of the target company, the consideration
of any financial projections, any report, opinion or appraisal
described in Sec.  229.1607 (Item 1607 of Regulation S-K), and the
dilutive effects described in Sec.  229.1604(c) (Item 1604(c) of
Regulation S-K).
    (c) Approval of security holders. State whether or not the de-SPAC
transaction or any related financing transaction is structured so that
approval of at least a majority of unaffiliated security holders is
required.
    (d) Unaffiliated representative. State whether or not a majority of
directors who are not employees of the special purpose acquisition
company has retained an unaffiliated representative to act solely on
behalf of unaffiliated security holders for purposes of negotiating the
terms of the de-SPAC transaction or any related financing transaction
and/or preparing a report concerning the fairness of the de-SPAC
transaction or any related financing transaction.
    (e) Approval of directors. State whether or not the de-SPAC
transaction or any related financing transaction was approved by a
majority of the directors of the special purpose acquisition company
who are not employees of the special purpose acquisition company.
    Instruction 1 to Item 1606: A statement that the special purpose
acquisition company has no reasonable belief as to the fairness or
unfairness of the de-SPAC transaction or any related financing
transaction to unaffiliated security holders will not be considered
sufficient disclosure in response to paragraph (a) of this section.

Sec.  229.1607  (Item 1607) Reports, opinions, appraisals and
negotiations.

    (a) Report, opinion or appraisal. State whether or not the special
purpose acquisition company or SPAC sponsor has received any report,
opinion or appraisal from an outside party relating to the
consideration or the fairness of the consideration to be offered to
security holders or the fairness of the de-SPAC transaction or any
related financing transaction to the special purpose acquisition
company, SPAC sponsor or security holders who are not affiliates.
    (b) Preparer and summary of the report, opinion or appraisal. For
each report, opinion or appraisal described in response to paragraph
(a) of this section or any negotiation or report described in response
to Sec.  229.1606(d) (Item 1606(d) of Regulation S-K) concerning the
terms of the transaction:
    (1) Identify the outside party and/or unaffiliated representative;
    (2) Briefly describe the qualifications of the outside party and/or
unaffiliated representative;
    (3) Describe the method of selection of the outside party and/or
unaffiliated representative;
    (4) Describe any material relationship that existed during the past
two years or is mutually understood to be contemplated and any
compensation received or to be received as a result of the relationship
between:
    (i) The outside party, its affiliates, and/or unaffiliated
representative; and
    (ii) The special purpose acquisition company, the SPAC sponsor and/
or their respective affiliates,
    (5) State whether the special purpose acquisition company or SPAC
sponsor determined the amount of consideration to be paid to the target
company or its security holders, or the valuation of the target
company, or whether the outside party recommended the amount of
consideration to be paid or the valuation of the target company; and
    (6) Furnish a summary concerning the negotiation, report, opinion
or appraisal. The summary must include, but need not be limited to, the
procedures followed; the findings and recommendations; the bases for
and methods of arriving at such findings and recommendations;
instructions received from the special purpose acquisition company or
SPAC sponsor; and any limitation imposed by the special purpose
acquisition company or SPAC sponsor on the scope of the investigation.
    Instruction 1 to Item 1607(b): The information called for by
paragraphs (b)(1), (2), and (3) of this section must be given with
respect to the firm that provides the report, opinion, or appraisal
rather than the employees of the firm that prepared the report.
    (c) All reports, opinions or appraisals referred to in paragraph
(a) of this section shall be, as applicable, filed as exhibits to the
registration statement or schedule or included in the schedule if the
schedule does not have exhibit filing requirements.

Sec.  229.1608   (Item 1608) Tender offer filing obligations in de-SPAC
transactions.

    If the special purpose acquisition company files a Schedule TO
(Sec.  240.14d-100) pursuant to Sec.  240.13e-4(c)(2) (Rule 13e-
4(c)(2)) for any redemption of securities offered to security holders,
such Schedule TO must provide the information required by General
Instruction L.2. to Form S-4, General Instruction I.2. to Form F-4, and
Item 14(f) of Schedule 14A, as applicable, in addition to the
information otherwise required by Schedule TO. Such redemption shall be
conducted in compliance with all other provisions of Rule 13e-4 and
Regulation 14E.

Sec.  229.1609   (Item 1609) Financial projections in de-SPAC
transactions.

    (a) With respect to any projections disclosed in the filing,
disclose the purpose for which the projections were prepared and the
party that prepared the projections.

    (b) Disclose all material bases of the disclosed projections and
all material assumptions underlying the projections, and any factors
that may impact such assumptions. The disclosure referred to in this
section should include a discussion of any material growth rates or
discount multiples used in preparing the projections, and the reasons
for selecting such growth rates or discount multiples.
    (c) If the projections relate to the performance of the special
purpose acquisition company, state whether the projections reflect the
view of the special purpose acquisition company's management or board
about its future performance as of the date of the filing. If the
projections relate to the target company, disclose whether the target
company has affirmed to the special purpose acquisition company that
its projections reflect the view of the target company's management or
board about its future performance as of the date of the filing. If the
projections no longer reflects the views of the special purpose
acquisition company's or the target company's management or board
regarding the future performance of their respective companies as the
date of the filing, state the purpose of disclosing the projections and
the reasons for any continued reliance by the management or board on
the projections.

Sec.  229.1610   (Item 1610) Structured data requirement.

    Provide the disclosure required by this subpart 229.1600 in an
Interactive Data File in accordance with Rule 405 of Regulation S-T and
the EDGAR Filer Manual.

PART 230--GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933

0
14. The general authority citation for part 230 continues to read as
follows:

    Authority:  15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h,
77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o-
7 note, 78t, 78w, 78ll(d), 78mm, 80a-8, 80a-24, 80a-28, 80a-29, 80a-
30, and 80a-37, and Public Law 112-106, sec. 201(a), sec. 401, 126
Stat. 313 (2012), unless otherwise noted.
* * * * *
0
15. Revise Sec.  230.137(d)(1) to read as follows:

Sec.  230.137   Publications or distributions of research reports by
brokers or dealers that are not participating in an issuer's registered
distribution of securities.

* * * * *
    (d) * * *
    (1) A blank check company issuing penny stock, as defined in Sec.
230.405 (Rule 405);
* * * * *
0
16. Revise Sec.  230.138(a)(4)(i) to read as follows:

Sec.  230.138   Publications or distributions of research reports by
brokers or dealers about securities other than those they are
distributing.

    (a) * * *
    (4) * * *
    (i) A blank check company issuing penny stock, as defined in Sec.
230.405 (Rule 405);
* * * * *
0
17. Revise Sec.  230.139(a)(1)(ii)(A) to read as follows:

Sec.  230.139   Publications or distributions of research reports by
brokers or dealers distributing securities.

    (a) * * *
    (1) * * *
    (ii) * * *
    (A) A blank check company issuing penny stock, as defined in Sec.
230.405 (Rule 405);
* * * * *
0
18. Add Sec.  230.140a to read as follows:

Sec.  230.140a   Definition of ``distribution'' in section 2(a)(11) for
certain parties.

    A person who has acted as an underwriter of the securities of a
special purpose acquisition company and takes steps to facilitate the
de-SPAC transaction, or any related financing transaction, or otherwise
participates (directly or indirectly) in the de-SPAC transaction will
be deemed to be engaged in the distribution of the securities of the
surviving public entity in a de-SPAC transaction within the meaning of
section 2(a)(11) of the Act. Terms used in this subsection have the
same definitions as in Item 1601 of Regulation S-K (17 CFR 229.1601).
0
19. Add Sec.  230.145a to read as follows:

Sec.  230.145a   Business combinations with reporting shell companies.

    With respect to a reporting shell company's shareholders, any
direct or indirect business combination of a reporting shell company
that is not a business combination related shell company involving
another entity that is not a shell company, as those terms are defined
in Sec.  230.405, is deemed to involve an offer, offer to sell, offer
for sale, or sale within the meaning of section 2(a)(3) of the Act. For
purposes of this rule, a reporting shell company is a company other
than an asset-backed issuer as defined in Item 1101(b) of Regulation AB
(Sec.  229.1101(b) of this chapter), that has:
    (1) No or nominal operations;
    (2) Either:
    (i) No or nominal assets;
    (ii) Assets consisting solely of cash and cash equivalents; or
    (iii) Assets consisting of any amount of cash and cash equivalents
and nominal other assets; and
    (3) an obligation to file reports under Section 13 (15 U.S.C. 78m)
or Section 15(d) (15 U.S.C. 78o(d)) of the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.).
* * * * *
0
20. Amend Sec.  230.163A by:
0
a. Removing the preliminary note;
0
b. Adding an introductory paragraph; and
0
c. Revising paragraph (b)(3)(i).
    The revision and addition read as follows:

Sec.  230.163A   Exemption from section 5(c) of the Act for certain
communications made by or on behalf of issuers more than 30 days before
a registration statement is filed.

    Attempted compliance with this section does not act as an exclusive
election and the issuer also may claim the availability of any other
applicable exemption or exclusion. Reliance on this section does not
affect the availability of any other exemption or exclusion from the
requirements of section 5 of the Act.
* * * * *
    (b) * * *
    (3) * * *
    (i) A blank check company issuing penny stock, as defined in Sec.
230.405 (Rule 405);
* * * * *
0
21. Amend Sec.  230.164 by:
0
a. Removing the preliminary notes;
0
b. Adding an introductory paragraph; and
0
c. Revising paragraph (e)(2)(i).
    The revision and addition read as follows:

Sec.  230.164   Post-filing free writing prospectuses in connection
with certain registered offerings.

    This section is not available for any communication that, although
in technical compliance with this section, is part of a plan or scheme
to evade the requirements of section 5 of the Act. Attempted compliance
with this section does not act as an exclusive election and the person
relying on this section also may claim the availability of any other
applicable exemption or exclusion. Reliance on this section does not
affect the availability of any other exemption or exclusion from the
requirements of section 5 of the Act.
* * * * *
    (e) * * *
    (2) * * *

    (i) A blank check company issuing penny stock, as defined in Sec.
230.405 (Rule 405);
* * * * *
0
22. Amend Sec.  230.174 by revising the heading and paragraph (g) to
read as follows:

Sec.  230.174   Delivery of prospectus by dealers; exemptions under
section 4(a)(3) of the Act.

* * * * *
    (g) If the registration statement relates to an offering of
securities of a blank check company issuing penny stock, as defined in
Rule 405 (Sec.  230.405), the statutory period for prospectus delivery
specified in section 4(a)(3) of the Act shall not terminate until 90
days after the date funds and securities are released from the escrow
or trust account pursuant to Rule 419 under the Act (17 CFR 230.419).
* * * * *
0
23. Amend Sec.  230.405 by:
0
a. Adding the definition for ``blank check company'' in alphabetical
order;
0
b. Adding the definition for ``blank check company issuing penny
stock'' in alphabetical order;
0
c. Revising paragraph (1)(ii)(A) in the definition for ``ineligible
issuer''; and
0
d. Adding paragraph (3)(iv) to the definition for ``smaller reporting
company''.
    The additions and revisions read as follows:

Sec.  230.405   Definitions of terms.

* * * * *
    Blank check company. The term blank check company means a company
that has no specific business plan or purpose or has indicated that its
business plan is to engage in a merger or acquisition with an
unidentified company or companies, or other entity or person.
* * * * *
    Blank check company issuing penny stock. The term blank check
company issuing penny stock means a company that is subject to Sec.
230.419 of this chapter.
* * * * *
    Ineligible issuer. (1) * * *
    (ii) * * *
    (A) A blank check company issuing penny stock (as defined in Sec.
230.405);
* * * * *
    Smaller reporting company. * * *
    (3) * * *
    (iv) Upon the consummation of a de-SPAC transaction, as defined in
Sec.  229.1601(a) (Item 1601(a) of Regulation S-K), an issuer must re-
determine its status as a smaller reporting company pursuant to the
thresholds set forth in paragraphs (1) and (2) of this definition prior
to its first filing, other than pursuant to Items 2.01(f), 5.01(a)(8),
and/or 9.01(c) of Form 8-K, following the de-SPAC transaction and
reflect this re-determination in its next periodic report.
    (A) Public float is measured as of a date within four business days
after the consummation of the de-SPAC transaction and is computed by
multiplying the aggregate worldwide number of shares of its voting and
non-voting common equity held by non-affiliates as of that date by the
price at which the common equity was last sold, or the average of the
bid and asked prices of common equity, in the principal market for the
common equity; and
    (B) Annual revenues are the annual revenues of the target company,
as defined in Sec.  229.1601(d) (Item 1601(d) of Regulation S-K), as of
the most recently completed fiscal year reported in the Form 8-K filed
pursuant to Items 2.01(f), 5.01(a)(8), and/or 9.01(c) of Form 8-K.
* * * * *
0
24. Amend Sec.  230.419 by:
0
a. Revising the heading;
0
b. Revising paragraph (a)(1);
0
c. Removing paragraph (a)(2);
0
d. Redesignating paragraph (a)(3) as paragraph (a)(2); and
0
e. Revising paragraph (b)(1)(i).
    The revisions read as follows:

Sec.  230.419   Offerings by blank check companies issuing penny stock.

    (a) * * *
    (1) The provisions of this section shall apply to every
registration statement filed under the Act relating to an offering by a
blank check company that:
    (i) Is a development stage company; and
    (ii) Is issuing ``penny stock,'' as defined in Sec.  240.3a51-1 of
this chapter (Rule 3a51-1) under the Securities Exchange Act of 1934
(``Exchange Act'').
* * * * *
    (b) * * *
    (1) * * *
    (i) Except as otherwise provided in this section or prohibited by
other applicable law, all securities issued in connection with an
offering by a blank check company subject to this section and the gross
proceeds from the offering shall be deposited promptly into:
* * * * *
0
25. Revise Sec.  230.430B(b)(2)(iv)(A) to read as follows:

Sec.  230.430B   Prospectus in a registration statement after effective
date.

    (b) * * *
    (2) * * *
    (iv) * * *
    (A) A blank check company issuing penny stock, as defined in Sec.
230.405 (Rule 405);
* * * * *
0
26. Revise Sec.  230.437a(a)(1) to read as follows:

Sec.  230.437a   Written consents.

    (a) * * *
    (1) Are not a blank check company issuing penny stock, as defined
in Sec.  230.405 (Rule 405); and
* * * * *

PART 232--REGULATION S-T--GENERAL RULES AND REGULATIONS FOR
ELECTRONIC FILINGS

0
27. The general authority citation for part 232 continues to read in
part as follows:

    Authority:  15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s(a), 77z-3,
77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a-6(c),
80a-8, 80a-29, 80a-30, 80a-37, 7201 et seq.; and 18 U.S.C. 1350,
unless otherwise noted.
* * * * *
0
28. Amend Sec.  232.405 by:
0
a. Revising the introductory text and paragraphs (a)(2) and (4);
0
b. Removing ``and'' from the end of the paragraph (b)(1)(i);
0
c. Removing the period and adding in its place ``; and'' in paragraph
(b)(1)(ii);
0
d. Adding paragraph (b)(1)(iii);
0
e. Adding paragraph (b)(4); and
0
f. Revising Note 1 to Sec.  232.405.
    The revisions and additions read as follows:

Sec.  232.405   Interactive Data File Submissions.

    This section applies to electronic filers that submit Interactive
Data Files. Section 229.601(b)(101) of this chapter (Item 601(b)(101)
of Regulation S-K), paragraph (101) of Part II--Information Not
Required to be Delivered to Offerees or Purchasers of Form F-10 (Sec.
239.40 of this chapter), Note D.5 of Exchange Act Rule 14a-101 (Sec.
240.14a-101 of this chapter), General Instruction L of Exchange Act
Rule 14d-100 (240.14d-100 of this chapter), paragraph 101 of the
Instructions as to Exhibits of Form 20-F (Sec.  249.220f of this
chapter), paragraph B.(15) of the General Instructions to Form 40-F
(Sec.  249.240f of this chapter), paragraph C.(6) of the General
Instructions to Form 6-K (Sec.  249.306 of this chapter), General
Instruction C.3.(g) of Form N-1A (Sec. Sec.  239.15A and 274.11A of
this chapter), General Instruction I of Form N-2 (Sec. Sec.  239.14 and
274.11a-1 of this chapter), General Instruction C.3.(h) of Form N-3
(Sec. Sec.  239.17a and 274.11b of

this chapter), General Instruction C.3.(h) of Form N-4 (Sec. Sec.
239.17b and 274.11c of this chapter), General Instruction C.3.(h) of
Form N-6 (Sec. Sec.  239.17c and 274.11d of this chapter), and General
Instruction C.4 of Form N-CSR (Sec. Sec.  249.331 and 274.128 of this
chapter) specify when electronic filers are required or permitted to
submit an Interactive Data File (Sec.  232.11), as further described in
note 1 to this section. This section imposes content, format, and
submission requirements for an Interactive Data File, but does not
change the substantive content requirements for the financial and other
disclosures in the Related Official Filing (Sec.  232.11).
    (a) * * *
    (2) Be submitted only by an electronic filer either required or
permitted to submit an Interactive Data File as specified by Sec.
229.601(b)(101) of this chapter (Item 601(b)(101) of Regulation S-K),
paragraph (101) of Part II--Information Not Required to be Delivered to
Offerees or Purchasers of Form F-10 (Sec.  239.40 of this chapter),
Note D.5 of Exchange Act Rule 14a-101 (Sec.  240.14a-101 of this
chapter), General Instruction L of Exchange Act Rule 14d-100 (240.14d-
100 of this chapter), paragraph 101 of the Instructions as to Exhibits
of Form 20-F (Sec.  249.220f of this chapter), paragraph B.(15) of the
General Instructions to Form 40-F (Sec.  249.240f of this chapter),
paragraph C.(6) of the General Instructions to Form 6-K (Sec.  249.306
of this chapter), General Instruction C.3.(g) of Form N-1A (Sec. Sec.
239.15A and 274.11A of this chapter), General Instruction I of Form N-2
(Sec. Sec.  239.14 and 274.11a-1 of this chapter), General Instruction
C.3.(h) of Form N-3 (Sec. Sec.  239.17a and 274.11b of this chapter),
General Instruction C.3.(h) of Form N-4 (Sec. Sec.  239.17b and 274.11c
of this chapter), General Instruction C.3.(h) of Form N-6 (Sec. Sec.
239.17c and 274.11d of this chapter), or General Instruction C.4 of
Form N-CSR (Sec. Sec.  249.331 and 274.128 of this chapter), as
applicable;
* * * * *
    (4) Be submitted in accordance with the EDGAR Filer Manual and, as
applicable, Item 601(b)(101) of Regulation S-K (Sec.  229.601(b)(101)
of this chapter), paragraph (101) of Part II--Information Not Required
to be Delivered to Offerees or Purchasers of Form F-10 (Sec.  239.40 of
this chapter), Note D.5 of Exchange Act Rule 14a-101 (Sec.  240.14a-101
of this chapter), General Instruction L of Exchange Act Rule 14d-100
(240.14d-100 of this chapter), paragraph 101 of the Instructions as to
Exhibits of Form 20-F (Sec.  249.220f of this chapter), paragraph
B.(15) of the General Instructions to Form 40-F (Sec.  249.240f of this
chapter), paragraph C.(6) of the General Instructions to Form 6-K
(Sec.  249.306 of this chapter), General Instruction C.3.(g) of Form N-
1A (Sec. Sec.  239.15A and 274.11A of this chapter), General
Instruction I of Form N-2 (Sec. Sec.  239.14 and 274.11a-1 of this
chapter), General Instruction C.3.(h) of Form N-3 (Sec. Sec.  239.17a
and 274.11b of this chapter), General Instruction C.3.(h) of Form N-4
(Sec. Sec.  239.17b and 274.11c of this chapter), General Instruction
C.3.(h) of Form N-6 (Sec. Sec.  239.17c and 274.11d of this chapter);
or General Instruction C.4 of Form N-CSR (Sec. Sec.  249.331 and
274.128 of this chapter).
* * * * *
    (b) * * *
    (1) * * *
    (iii) The disclosure set forth in paragraph (4) of this section.
* * * * *
    (4) The disclosure provided under Regulation S-K (17 CFR 229) and
related provisions that is required to be tagged, including, as
applicable:
    (a) The information required by Subpart 1600 of Regulation S-K
(Sec.  229.1601 through Sec.  229.1610 of this chapter).
* * * * *

    Note 1 to Sec.  232.405:  Section 229.601(b)(101) of this
chapter (Item 601(b)(101) of Regulation S-K) specifies the
circumstances under which an Interactive Data File must be submitted
and the circumstances under which it is permitted to be submitted,
with respect to Sec.  239.11 of this chapter (Form S-1), Sec.
239.13 of this chapter (Form S-3), Sec.  239.25 of this chapter
(Form S-4), Sec.  239.18 of this chapter (Form S-11), Sec.  239.31
of this chapter (Form F-1), Sec.  239.33 of this chapter (Form F-3),
Sec.  239.34 of this chapter (Form F-4), Sec.  249.310 of this
chapter (Form 10-K), Sec.  249.308a of this chapter (Form 10-Q), and
Sec.  249.308 of this chapter (Form 8-K). Note D.5 of Section
240.14a-101 of this chapter (Note D.5 of Exchange Act Rule 14a-101)
specifies the circumstances under which an Interactive Data File
must be submitted with respect to Sec.  240.14a-101 of this chapter
(Schedule 14A). General Instruction L of Section 240.14d-100 of this
chapter (General Instruction L) of Exchange Act Rule 14d-100)
specifies the circumstances under which an Interactive Data File
must be submitted with respect to Sec.  240.14d-100 of this chapter
(Schedule TO). Paragraph (101) of Part II--Information not Required
to be Delivered to Offerees or Purchasers of Sec.  239.40 of this
chapter (Form F-10) specifies the circumstances under which an
Interactive Data File must be submitted and the circumstances under
which it is permitted to be submitted, with respect to Form F-10.
Paragraph 101 of the Instructions as to Exhibits of Sec.  249.220f
of this chapter (Form 20-F) specifies the circumstances under which
an Interactive Data File must be submitted and the circumstances
under which it is permitted to be submitted, with respect to Form
20-F. Paragraph B.(15) of the General Instructions to Sec.  249.240f
of this chapter (Form 40-F) and Paragraph C.(6) of the General
Instructions to Sec.  249.306 of this chapter (Form 6-K) specify the
circumstances under which an Interactive Data File must be submitted
and the circumstances under which it is permitted to be submitted,
with respect to Sec.  249.240f of this chapter (Form 40-F) and Sec.
249.306 of this chapter (Form 6-K). Section 229.601(b)(101) (Item
601(b)(101) of Regulation S-K), paragraph (101) of Part II--
Information not Required to be Delivered to Offerees or Purchasers
of Form F-10, paragraph 101 of the Instructions as to Exhibits of
Form 20-F, paragraph B.(15) of the General Instructions to Form 40-
F, and paragraph C.(6) of the General Instructions to Form 6-K all
prohibit submission of an Interactive Data File by an issuer that
prepares its financial statements in accordance with 17 CFR 210.6-01
through 210.6-10 (Article 6 of Regulation S-X). For an issuer that
is a management investment company or separate account registered
under the Investment Company Act of 1940 (15 U.S.C. 80a et seq.) or
a business development company as defined in Section 2(a)(48) of the
Investment Company Act of 1940 (15 U.S.C. 80a-2(a)(48)), General
Instruction C.3.(g) of Form N-1A (Sec. Sec.  239.15A and 274.11A of
this chapter), General Instruction I of Form N-2 (Sec. Sec.  239.14
and 274.11a-1 of this chapter), General Instruction C.3.(h) of Form
N-3 (Sec. Sec.  239.17a and 274.11b of this chapter), General
Instruction C.3.(h) of Form N-4 (Sec. Sec.  239.17b and 274.11c of
this chapter), General Instruction C.3.(h) of Form N-6 (Sec. Sec.
239.17c and 274.11d of this chapter), and General Instruction C.4 of
Form N-CSR (Sec. Sec.  249.331 and 274.128 of this chapter), as
applicable, specifies the circumstances under which an Interactive
Data File must be submitted.

PART 239--FORMS PRESCRIBED UNDER THE SECURITIES ACT OF 1933

0
29. The general authority citation for part 239 continues to read as
follows:

    Authority:  15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-
3, 77sss, 78c, 78l, 78m, 78n, 78o(d), 78o-7 note, 78u-5, 78w(a),
78ll, 78mm, 80a-2(a), 80a-3, 80a-8, 80a-9, 80a-10, 80a-13, 80a-24,
80a-26, 80a-29, 80a-30, and 80a-37; and sec. 107, Pub. L. 112-106,
126 Stat. 312, unless otherwise noted.
* * * * *
0
30. Amend Form S-1 (referenced in Sec.  239.11) by adding General
Instruction VIII to read as follows:

    Note: The text of Form S-1 does not, and this amendment will
not, appear in the Code of Federal Regulations.

Form S-1

* * * * *

General Instructions

* * * * *

VIII. Offering by a Special Purpose Acquisition Company

    If a registration statement on this Form S-1 is being used to
register an offering of securities of a special purpose acquisition
company, as defined in Item 1601(b) of Regulation S-K (17 CFR
229.1601(b)), other than in connection with a de-SPAC transaction, as
defined in Item 1601(a) of Regulation S-K (17 CFR 229.1601(a)), the
registrant must furnish in the prospectus the information required by
Items 1602 and 1603 of Regulation S-K (17 CFR 229.1602 and 229.1603),
in the manner set forth by the structured data provision of Item 1610
of Regulation S-K (17 CFR 229.1610), in addition to the Items that are
otherwise required by this Form. If the securities to be registered on
this Form will be issued in a de-SPAC transaction, attention is
directed to the requirements of Form S-4 applicable to de-SPAC
transactions, including, but not limited to, General Instruction L.
0
31. Amend Form S-4 (referenced in Sec.  239.25) by:
0
a. Adding General Instruction L;
0
b. Revising paragraph (b)(7) introductory text of Item 17 and
Instruction 1 of paragraph (b)(7) of Item 17; and
0
c. Revising Instruction 1 to the signature block.
    The addition and revisions read as follows:

    Note: The text of Form S-4 does not, and this amendment will
not, appear in the Code of Federal Regulations.

Form S-4

* * * * *

General Instructions

* * * * *

L. De-SPAC Transactions

    1. If securities to be registered on this Form will be issued in a
de-SPAC transaction, as defined in Item 1601(a) of Regulation S-K (17
CFR 229.1601(a)), then the disclosure provisions of Items 1603 through
1607 and 1609 of Regulation S-K (17 CFR 229.1603 through 229.1607 and
229.1609), as well as the structured data provision of Item 1610 of
Regulation S-K (17 CFR 229.1610), shall apply in addition to the
provisions of this Form. To the extent that the applicable disclosure
requirements of Subpart 229.1600 are inconsistent with the disclosure
requirements of this Form, the requirements of Subpart 229.1600 are
controlling. If the securities to be registered on this Form will be
issued by a special purpose acquisition company, as defined in Item
1601(b) of Regulation S-K (17 CFR 229.1601(b)), in a de-SPAC
transaction, the term ``registrant'' for purposes of the disclosure
requirements of this Form shall mean the special purpose acquisition
company.
    2. If the target company, as defined in Item 1601(d) of Regulation
S-K (17 CFR 229.1601(d)), in a de-SPAC transaction is not subject to
the reporting requirements of either Section 13(a) or 15(d) of the
Exchange Act, provide the following additional information with respect
to the target company:
    a. Item 101 of Regulation S-K (Sec.  229.101 of this chapter),
description of business;
    b. Item 102 of Regulation S-K (Sec.  229.102 of this chapter),
description of property;
    c. Item 103 of Regulation S-K (Sec.  229.103 of this chapter),
legal proceedings;
    d. Item 304 of Regulation S-K (Sec.  229.304 of this chapter),
changes in and disagreements with accountants on accounting and
financial disclosure;
    e. Item 403 of Regulation S-K (Sec.  229.403 of this chapter),
security ownership of certain beneficial owners and management,
assuming the completion of the de-SPAC transaction and any related
financing transaction; and
    f. Item 701 of Regulation S-K (Sec.  229.701 of this chapter),
recent sales of unregistered securities.
    If the target company is a foreign private issuer, as defined in
Rule 405 (Sec.  230.405 of this chapter), information with respect to
the target company may be provided in accordance with Items 3.C, 4,
6.E, 7.A, 8.A.7, and 9.E of Form 20-F, in lieu of the information
specified above.
    3. If securities to be registered on this Form will be issued in a
de-SPAC transaction, as defined in Item 1601(a) of Regulation S-K (17
CFR 229.1601(a)), the prospectus must be distributed to security
holders no later than the lesser of 20 calendar days prior to the date
on which action is to be taken or the maximum number of days permitted
for disseminating the prospectus under the applicable laws of the
jurisdiction of incorporation or organization.
* * * * *

Item 17. Information With Respect to Companies Other Than S-3 Companies

* * * * *
    (7) Financial statements that would be required in an annual report
sent to security holders under Rules 14a-3(b)(1) and (b)(2) (Sec.
240.14b-3 of this chapter), if an annual report was required. In a de-
SPAC transaction, provide the financial statements required by Sec.
240.15-01 (Rule 15-01 of Regulation S-X). If the registrant's security
holders are not voting, the transaction is not a roll-up transaction
(as described by Item 901 of Regulation S-K (Sec.  229.901 of this
chapter)), and:
* * * * *

Instructions

    1. The financial statements required by paragraph for the latest
fiscal year need be audited only to the extent practicable. The
financial statements for the fiscal years before the latest fiscal year
need not be audited if they were not previously audited. If the company
being acquired will be a predecessor to a registrant that is a shell
company, see Sec.  210.15-01(a).
* * * * *

Signatures

* * * * *

Instructions

    1. The registration statement shall be signed by the registrant,
its principal executive officer or officers, its principal financial
officer, its controller or principal accounting officer, and by at
least a majority of the board of directors or persons performing
similar functions. If the registrant is a foreign person, the
registration statement shall also be signed by its authorized
representative in the United States. Where the registrant is a limited
partnership, the registration statement shall be signed by a majority
of the board of directors of any corporate general partner signing the
registration statement. If the securities to be registered on this Form
will be issued by the special purpose acquisition company in a de-SPAC
transaction, as such terms are defined in Items 1601(b) and (a) of
Regulation S-K, the term ``registrant'' for purposes of this
instruction shall mean the special purpose acquisition and the target
company, as such term is defined in Item 1601(d) of Regulation S-K.
* * * * *
0
32. Amend Form F-1 (referenced in Sec.  239.31) by adding General
Instruction VII to read as follows:

    Note: The text of Form F-1 does not, and this amendment will
not, appear in the Code of Federal Regulations.

Form F-1

* * * * *

General Instructions

* * * * *

VII. Offering by a Special Purpose Acquisition Company

    If a registration statement on this Form F-1 is being used to
register an offering of securities of a special purpose acquisition
company, as defined in Item 1601(b) of Regulation S-K (17 CFR
229.1601(b)), other than in connection with a de-SPAC transaction, as
defined in Item 1601(a) of Regulation S-K (17 CFR 229.1601(a)), the
registrant must furnish in the prospectus the information required by
Items 1602 and 1603 of Regulation S-K (17 CFR 229.1602 and 229.1603),
in the manner set forth by the structured data provision of Item 1610
of Regulation S-K (17 CFR 229.1610), in addition to the Items that are
otherwise required by this Form. If the securities to be registered on
this Form will be issued in a de-SPAC transaction, attention is
directed to the requirements of Form F-4 applicable to de-SPAC
transactions, including, but not limited to, General Instruction I.
* * * * *
0
33. Amend Form F-4 (referenced in Sec.  239.34) by:
0
a. Adding General Instruction I;
0
b. Revising Instruction 1 to paragraph (b)(5) of Item 17; and
0
c. Revising the Instructions to paragraph (b)(5) and (b)(6) of Item 17;
and
0
d. Revising Instruction 1 to the signature block.
    The addition and revisions read as follows:

    Note: The text of Form F-4 does not, and this amendment will
not, appear in the Code of Federal Regulations.

Form F-4

* * * * *

General Instructions

* * * * *

I. De-SPAC Transactions

    1. If securities to be registered on this Form will be issued in a
de-SPAC transaction, as defined in Item 1601(a) of Regulation S-K (17
CFR 229.1601(a)), then the disclosure provisions of Items 1603 through
1607 and 1609 of Regulation S-K (17 CFR 229.1603 through 229.1607 and
1609), as well as the structured data provision of Item 1610 of
Regulation S-K (17 CFR 229.1610), shall apply in addition to the
provisions of this Form. To the extent that the disclosure requirements
of Subpart 229.1600 are inconsistent with the disclosure requirements
of this Form, the requirements of Subpart 229.1600 are controlling. If
the securities to be registered on this Form will be issued by a
special purpose acquisition company, as defined in Item 1601(b) of
Regulation S-K (17 CFR 229.1601(b)), in a de-SPAC transaction, the term
``registrant'' for purposes of the disclosure requirements of this Form
shall mean the special purpose acquisition company.
    2. If the target company, as defined in Item 1601(d) of Regulation
S-K (17 CFR 229.1601(d)), in a de-SPAC transaction is not subject to
the reporting requirements of either Section 13(a) or 15(d) of the
Exchange Act, provide the following additional information with respect
to the company:
    a. Item 101 of Regulation S-K (Sec.  229.101 of this chapter),
description of business;
    b. Item 102 of Regulation S-K (Sec.  229.102 of this chapter),
description of property;
    c. Item 103 of Regulation S-K (Sec.  229.103 of this chapter),
legal proceedings;
    d. Item 403 of Regulation S-K (Sec.  229.403 of this chapter),
security ownership of certain beneficial owners and management,
assuming the completion of the de-SPAC transaction and any related
financing transaction; and
    e. Item 701 of Regulation S-K (Sec.  229.701 of this chapter),
recent sales of unregistered securities.
    If the target company is a foreign private issuer, as defined in
Rule 405 (Sec.  230.405 of this chapter), information with respect to
the target company may be provided in accordance with Items 3.C, 4,
6.E, 7.A, 8.A.7, and 9.E of Form 20-F, in lieu of the information
specified above.
    3. If securities to be registered on this Form will be issued in a
de-SPAC transaction, as defined in Item 1601(a) of Regulation S-K (17
CFR 229.1601(a)), the prospectus must be distributed to security
holders no later than the lesser of 20 calendar days prior to the date
on which action is to be taken or the maximum number of days permitted
for disseminating the prospectus under the applicable laws of the
jurisdiction of incorporation or organization.
* * * * *

Part I

* * * * *

Item 17. Information With Respect to Foreign Companies Other Than F-3
Companies

* * * * *

Instructions

    1. The financial statements required by this paragraph for the
latest fiscal year need be audited only to the extent practicable. The
financial statements for the fiscal years before the latest fiscal year
need not be audited if they were not previously audited. If the foreign
company being acquired will be a predecessor to a registrant that is a
shell company, see Sec.  210.15-01(a).
* * * * *

Instructions to Paragraph (b)(5) and (b)(6)

    If the financial statements required by paragraphs (b)(5) and
(b)(6) are prepared on the basis of a comprehensive body of accounting
principles other than U.S. GAAP, provide a reconciliation to U.S. GAAP
in accordance with Item 18 of Form 20-F (Sec.  249.220f of this
chapter) if the foreign business being acquired will be a predecessor
to the issuer that is a shell company or, in all other circumstances,
with Item 17 of Form 20-F (Sec.  249.220f of this chapter) unless a
reconciliation is unavailable or not obtainable without unreasonable
cost or expense. At a minimum, provide a narrative description of all
material variations in accounting principles, practices and methods
used in preparing the non-U.S. GAAP financial statements from those
accepted in the U.S. when the financial statements are prepared on a
basis other than U.S. GAAP.

Signatures

* * * * *

Instructions

    1. The registration statement shall be signed by the registrant,
its principal executive officer or officers, its principal financial
officer, its controller or principal accounting officer, at least a
majority of the board of directors or persons performing similar
functions and its authorized representative in the United States. Where
registrant is a limited partnership, the registration statement shall
be signed by a majority of the board of directors of any corporate
general partner signing the registration statement. If the securities
to be registered on this Form will be issued by the special purpose
acquisition company in a de-SPAC transaction, as such terms are defined
in Items 1601(b) and (a) of Regulation S-K, the term ``registrant'' for
purposes of this instruction shall mean the special purpose acquisition
and the target company, as such term is defined in Item 1601(d) of
Regulation S-K.
* * * * *

PART 240--GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF
1934

0
34. The general authority citation for part 240 continues to read as
follows:

    Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3,
77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f,
78g, 78i, 78j, 78j-1, 78k, 78k-1, 78l, 78m, 78n, 78n-1, 78o, 78o4,
78o-10, 78p, 78q, 78q-1, 78s, 78u-5, 78w, 78x, 78ll, 78mm, 80a-20,
80a-23, 80a-29, 80a-37, 80b-3, 80b-4, 80b-11, 7201 et seq., and
8302; 7 U.S.C. 2(c)(2)(E); 12 U.S.C. 5221(e)(3); 18 U.S.C. 1350;
Pub. L. 111-203, 939A, 124 Stat. 1887 (2010); and sec. 503 and 602,
Pub. L. 112-106, 126 Stat. 326 (2012), unless otherwise noted.
* * * * *
0
35. Amend Sec.  240.12b-2 by adding paragraph (3)(iv) to the definition
of ``smaller reporting company'' to read as follows:

Sec.  240.12b-2   Definitions.

* * * * *
    Smaller reporting company. * * *
    (3) * * *
    (iv) Upon the consummation of a de-SPAC transaction, as defined in
Item 1601(a) of Regulation S-K (17 CFR 229.1601(a)), an issuer must re-
determine its status as a smaller reporting company pursuant to the
thresholds set forth in paragraphs (1) and (2) of this definition prior
to its first filing, other than pursuant to Items 2.01(f), 5.01(a)(8),
and/or 9.01(c) of Form 8-K, following the de-SPAC transaction and
reflect this re-determination in in its next periodic report.
    (A) Public float is measured as of a date within 4 business days
after the consummation of the de-SPAC transaction and is computed by
multiplying the aggregate worldwide number of shares of its voting and
non-voting common equity held by non-affiliates as of that date by the
price at which the common equity was last sold, or the average of the
bid and asked prices of common equity, in the principal market for the
common equity; and
    (B) Annual revenues are the annual revenues of the target company,
as defined in Item 1601(d) of Regulation S-K (17 CFR 229.1601(d)), as
of the most recently completed fiscal year reported in the Form 8-K
filed pursuant to Items 2.01(f), 5.01(a)(8), and/or 9.01(c) of Form 8-
K.
* * * * *
0
36. Amend Sec.  240.14a-6 by adding paragraph (q) to read as follows:

Sec.  240.14a-6   Filing requirements.

* * * * *
    (q) De-SPAC transactions. If a transaction is a de-SPAC
transaction, as defined in Sec.  229.1601(a) of this chapter (Item
1601(a) of Regulation S-K), the proxy statement of the special purpose
acquisition company as defined in Sec.  229.1601(b) of this chapter
(Item 1601(b) of Regulation S-K) must be distributed to security
holders no later than the lesser of 20 calendar days prior to the date
on which the meeting of security holders is held or action is taken, or
the maximum number of days permitted for disseminating the proxy
statement under the applicable laws of the jurisdiction of
incorporation or organization.
0
37. Amend Sec.  240.14a-101 by adding paragraph D.5 to the Notes and
paragraph (f) to Item 14 to read as follows:
* * * * *

Sec.  240.14a-101   Schedule 14A. Information required in proxy
statement.

* * * * *
    Notes * * *
    D. * * *
    5. Interactive Data File. An Interactive Data File must be included
in accordance with Sec.  232.405 of this chapter (Rule 405 of
Regulation S-T) and the EDGAR Filer Manual where applicable pursuant to
Item 14(f) of this Schedule and Sec.  229.1610 of this chapter (Item
1610 of Regulation S-K).
* * * * *
Item 14. * * *
* * * * *
    (f) De-SPAC transactions. (1) If the transaction is a de-SPAC
transaction, as defined in Sec.  229.1601(a) (Item 1601(a) of
Regulation S-K), then the disclosure provisions of Sec. Sec.  229.1603
through 229.1607 and 229.1609 (Items 1603 through 1607 and 1609 of
Regulation S-K), as well as the structured data provision of Sec.
229.1610 (Item 1610 of Regulation S-K), shall apply to the transaction
in addition to the provisions of this schedule. To the extent that the
disclosure requirements of Subpart 229.1600 are inconsistent with the
disclosure requirements of this schedule, the requirements of Subpart
229.1600 are controlling.
    (2) Provide the following additional information for the target
company:
    (i) Information required by Sec.  229.101 of this chapter (Item 101
of Regulation S-K), description of business;
    (ii) Information required by Sec.  229.102 of this chapter (Item
102 of Regulation S-K), description of property;
    (iii) Information required by Sec.  229.103 of this chapter (Item
103 of Regulation S-K), legal proceedings;
    (iv) Section 229.304 of this chapter (Item 304 of Regulation S-K),
changes in and disagreements with accountants on accounting and
financial disclosure;
    (v) Information required by Sec.  229.403 of this chapter (Item 403
of Regulation S-K), security ownership of certain beneficial owners and
management, assuming the completion of the de-SPAC transaction and any
related financing transaction;
    (vi) Information required by Sec.  229.701 of this chapter (Item
701 of Regulation S-K), recent sales of unregistered securities; and
    (vii) If any directors are appointed without action by the security
holders of the special purpose acquisition company, Sec. Sec.
229.103(c)(2), 229.401, and 229.404(a) and (b) of this chapter (Items
103(c)(2), 401, and 404(a) and (b) of Regulation S-K).
* * * * *
0
38. Amend Sec.  240.14c-2 by adding paragraph (e) to read as follows:

Sec.  240.14c-2   Distribution of information statement.

* * * * *
    (e) If a transaction is a de-SPAC transaction, as defined in Sec.
229.1601(a) of this chapter (Item 1601(a) of Regulation S-K), the
information statement of the special purpose acquisition company as
defined in Sec.  229.1601(b) (Item 1601(b) of Regulation S-K) must be
distributed to security holders no later than the lesser of 20 calendar
days prior to the date on which the meeting of security holders is held
or action is taken, or the maximum number of days permitted for
disseminating the information statement under the applicable laws of
the jurisdiction of incorporation or organization.
0
39. Amend Sec.  240.14d-100 by:
0
a. Redesignating General Instruction K as General Instruction M; and
0
b. Adding new General Instructions K and L.
    The additions read as follows:
* * * * *

Sec.  240.14d-100   Schedule TO. Tender offer statement under section
14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934.

* * * * *
    General Instructions:
* * * * *
    K. De-SPAC Transactions. If the filing relates to a de-SPAC
transaction, as defined in Sec.  229.1601(a) of this chapter (Item
1601(a) of Regulation S-K), then the disclosure provisions of
Sec. Sec.  229.1603 through 229.1609 of this chapter (Items 1603
through 1609 of Regulation S-K), as well as the structured data
provision of Sec.  229.1610 of this chapter (Item 1610

of Regulation S-K), shall apply to the transaction in addition to the
provisions of this statement. To the extent that the disclosure
requirements of Subpart 229.1600 of this chapter are inconsistent with
the disclosure requirements of this filing, the requirements of Subpart
229.1600 of this chapter are controlling.
    L. Interactive Data File. An Interactive Data File must be included
in accordance with Sec.  232.405 of this chapter (Rule 405 of
Regulation S-T) and the EDGAR Filer Manual where applicable pursuant to
Item 14(f) of Sec.  240.14a-101 of this chapter (Schedule 14A) and
Sec.  229.1610 of this chapter (Item 1610 of Regulation S-K).
* * * * *

PART 249--FORMS, SECURITIES EXCHANGE ACT OF 1934

0
40. The authority citation for part 249 continues to read, in part, as
follows:

    Authority: 15 U.S.C. 78a et seq. and 7201 et seq.; 12 U.S.C.
5461 et seq.; 18 U.S.C. 1350; Sec. 953(b), Pub. L. 111-203, 124
Stat. 1904; Sec. 102(a)(3), Pub. L. 112-106, 126 Stat. 309 (2012);
Sec. 107, Pub. L. 112-106, 126 Stat. 313 (2012), and Sec. 72001,
Pub. L. 114-94, 129 Stat. 1312 (2015), unless otherwise noted.
    Section 249.220f is also issued under secs. 3(a), 202, 208, 302,
306(a), 401(a), 401(b), 406 and 407, Pub. L. 107-204, 116 Stat. 745,
and secs. 2 and 3, Pub. L. 116-222, 134 Stat. 1063.
* * * * *
    Section 249.308 is also issued under 15 U.S.C. 80a-29 and 80a-
37.
* * * * *
0
41. Amend Form 20-F (referenced in Sec.  249.220f) by adding
Instruction 4 to Item 8 to read as follows:

    Note: The text of Form 20-F does not, and this amendment will
not, appear in the Code of Federal Regulations.

Form 20-F

* * * * *
Item 8. Financial Information
* * * * *
    Instructions to Item 8:
* * * * *
    4. When the issuer is a shell company that will acquire a business
that will be its predecessor, provide the information required by Sec.
240.15-01 (Rule 15-01 of Regulation S-X).
* * * * *
0
42. Amend Form 8-K (referenced in Sec.  249.308) by revising paragraph
(f) of Item 2.01 by removing the phrase ``the registrant were filing a
general form for registration of securities on Form 10'' and adding in
its place ``the acquired business were filing a general form for
registration of securities on Form 10''. The revision reads as follows:

    Note: The text of Form 8-K does not, and this amendment will
not, appear in the Code of Federal Regulations.

Form 8-K

* * * * *

Item 2.01 Completion of Acquisition or Disposition of Assets

* * * * *
    (f) if the registrant was a shell company, other than a business
combination related shell company, as those terms are defined in Rule
12b-2 under the Exchange Act (17 CFR 240.12b-2), immediately before the
transaction in which the registrant acquired a business, disclose the
information that would be required if the acquired business were filing
a general form for registration of securities on Form 10 under the
Exchange Act reflecting all classes of the registrant's securities
subject to the reporting requirements of Section 13 (15 U.S.C. 78m) or
Section 15(d) (15 U.S.C. 78o(d)) of such Act upon consummation of the
transaction. Notwithstanding General Instruction B.3. to Form 8-K, if
any disclosure required by this Item 2.01(f) is previously reported, as
that term is defined in Rule 12b-2 under the Exchange Act (17 CFR
240.12b-2), the registrant may identify the filing in which that
disclosure is included instead of including that disclosure in this
report.
* * * * *

PART 270--RULES AND REGULATIONS, INVESTMENT COMPANY ACT OF 1940

0
43. The authority citation for part 270 continues to read in part as
follows:

    Authority:  15 U.S.C. 80a-1 et seq., 80a-34(d), 80a-37, 80a-39,
and Pub. L. 111-203, sec. 939A, 124 Stat. 1376, unless otherwise
noted.

0
44. Add Sec.  270.3a-10 to read as follows:

Sec.  270.3a-10   Special Purpose Acquisition Companies.

    (a) Notwithstanding section 3(a)(1)(A) of the Act, a special
purpose acquisition company (``SPAC'') will not be deemed to be an
investment company; provided that:
    (1) The SPAC's assets consist solely of Government securities,
securities issued by government money market funds as defined in Sec.
270.2a-7(a)(14), and cash items prior to completion of the de-SPAC
transaction;
    (2) The assets set forth in paragraph (a)(1) of this section are
not at any time acquired or disposed of for the primary purpose of
recognizing gains or decreasing losses resulting from market value
changes;
    (3) The SPAC:
    (i) Seeks to complete a single de-SPAC transaction as a result of
which:
    (A) The surviving company, either directly or through a primarily
controlled company, will be primarily engaged in the business of the
target company or companies, which business is not that of an
investment company, and
    (B) The surviving company will have at least one class of
securities listed for trading on a national securities exchange;
    (ii) Files a Form 8-K with the Commission, no later than 18 months
after the effective date of its initial registration statement,
disclosing an agreement to engage in the de-SPAC transaction with at
least one target company; and
    (iii) Completes the de-SPAC transaction no later than 24 months
after the effective date of its initial registration statement.
    (4) Any assets of the SPAC:
    (i) That are not used in connection with the de-SPAC transaction;
or
    (ii) In the event of a failure of the SPAC to file a Form 8-K
within the time frame set forth in paragraph (a)(3)(ii) of this section
or complete a de-SPAC transaction within the time frame set forth in
paragraph (a)(3)(iii) of this section will be distributed in cash to
investors as soon as reasonably practicable thereafter;
    (5) The SPAC is primarily engaged in the business of seeking to
complete a single de-SPAC transaction, as set forth in paragraphs
(a)(3) of this section and evidenced by:
    (i) The activities of its officers, directors and employees;
    (ii) Its public representations of policies;
    (iii) Its historical development; and
    (iv) An appropriate resolution of its board of directors, which
resolution or action has been recorded contemporaneously in its minute
books or comparable documents; and
    (6) The SPAC does not hold itself out as being primarily engaged in
the business of investing, reinvesting or trading in securities.
    (b) For purposes of this section:
    (1) Initial registration statement means the registration statement
that the SPAC filed under the Securities Act of 1933 for its initial
public offering.
    (2) Primarily controlled company means an issuer that:
    (i) Is controlled within the meaning of section 2(a)(9) of the Act
by the

surviving company following a de-SPAC transaction with a degree of
control that is greater than that of any other person; and
    (ii) Is not an investment company.
    (3) Surviving company means the public company issuer that survives
a de-SPAC transaction and in which the shareholders of the SPAC
immediately prior to the de-SPAC transaction will own equity interests
immediately following the de-SPAC transaction.
    (4) De-SPAC transaction has the same meaning as defined in Sec.
229.1601(a) of this chapter (Item 1601(a) of Regulation S-K).
    (5) Special purpose acquisition company has the same meaning as
defined in Sec.  229.1601(b) of this chapter (Item 1601(b) of
Regulation S-K).
    (6) Target company has the same meaning as defined in Sec.
229.1601(d) of this chapter (Item 1601(d) of Regulation S-K).

    By the Commission.

     Dated: March 30, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-07189 Filed 5-9-22; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63771-63773]
[FR Doc No: 2016-22343]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-2084]

Determination of Regulatory Review Period for Purposes of Patent
Extension; RESQCPR SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for RESQCPR SYSTEM and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that medical
device.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
November 15, 2016. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by March 15,
2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food

and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-E-2084 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; RESQCPR SYSTEM.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device RESQCPR SYSTEM.
RESQCPR SYSTEM is indicated for use as a CPR adjunct to improve the
likelihood of survival in adult patients with non-traumatic cardiac
arrest. Subsequent to this approval, the USPTO received a patent term
restoration application for RESQCPR SYSTEM (U.S. Patent No. 5,454,779)
from University of California and Advanced Circulatory Systems, Inc.,
and the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated October 15,
2015, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of RESQCPR SYSTEM
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
RESQCPR SYSTEM is 3,608 days. Of this time, 2,247 days occurred during
the testing phase of the regulatory review period, while 1,361 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: April 21, 2005. The applicant claims that
the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
October 3, 2005. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
April 21, 2005, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 15,
2011. FDA has verified the applicant's claim that the premarket
approval application (PMA) for RESQCPR SYSTEM (PMA P110024) was
initially submitted June 15, 2011.
    3. The date the application was approved: March 6, 2015. FDA has
verified the applicant's claim that PMA P110024 was approved on March
6, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA

investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-
42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: September 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22343 Filed 9-15-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 9, 2006 (Volume 71, Number 217)]
[Notices]
[Page 65843]
[DOCID:fr09no06-138]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington,
DC 20549.
    Rule 17a-5; SEC File No. 270-155; OMB Control No. 3235-0123.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Rule 17a-5 (17 CFR 240.17a-5) is the basic financial reporting rule
for brokers and dealers.\1\ The Rule requires the filing of the
Financial and Operational Combined Uniform Single Report (``FOCUS
Report'') on Form X-17A-5 (17 CFR 240.15c3-1e), which was the result of
years of study and comments by representatives of the securities
industry through advisory committees and through the normal rule
proposal methods. The FOCUS Report was designed to eliminate the
overlapping regulatory reports required by various self-regulatory
organizations and the Commission and to reduce reporting burdens as
much as possible. The Rule also requires the filing of an annual
audited report of financial statements.
---------------------------------------------------------------------------

    \1\ Rule 17a-5(c) requires a broker or dealer to furnish certain
of its financial information to customers and is subject to a
separate PRA filing (OMB Control Number 3235-0199).
---------------------------------------------------------------------------

    The FOCUS Report consists of: (1) Part I, which is a monthly report
that must be filed by brokers or dealers that clear transactions or
carry customer securities; (2) one of three alternative quarterly
reports: Part II, which must be filed by brokers or dealers that clear
transactions or carry customer securities; Part IIA, which must be
filed by brokers or dealers that do not clear transactions or carry
customer securities; and Part IIB, which must be filed by specialized
broker-dealers registered with the Commission as OTC derivatives
dealers; \2\ (3) supplemental schedules, which must be filed annually;
and (4) a facing page, which must be filed with the annual audited
report of financial statements. Under the Rule, a broker or dealer that
computes certain of its capital charges in accordance with Appendix E
to Exchange Act Rule 15c3-1 (17 CFR 240.15c3-1e) must file additional
monthly, quarterly, and annual reports with the Commission.
---------------------------------------------------------------------------

    \2\ Part IIB of Form X-17A-5 must be filed by OTC derivatives
dealers under Exchange Act Rule 17a-12 and is subject to a separate
PRA filing (OMB Control Number 3235-0498).
---------------------------------------------------------------------------

    The variation in the size and complexity of brokers and dealers
subject to Rule 17a-5 and the differences in the FOCUS Report forms
that must be filed under the Rule make it difficult to calculate the
cost of compliance. However, we estimate, on average, that each report
will require approximately 12 hours. At year-end 2005, the Commission
estimates that there were approximately 6,200 brokers or dealers, and
that of those firms there were approximately 600 brokers or dealers
that clear transactions or carry customer securities. In addition,
approximately 400 firms filed annual reports. The Commission therefore
estimates that approximately 600 firms filed monthly reports,
approximately 5,600 firms filed quarterly reports, and approximately
400 firms filed annual reports. In addition, approximately 6,200 firms
filed annual audited reports. As a result, there were approximately
36,200 total annual responses ((600 x 12) + (5,600 x 4) + 400 + 6,200 =
36,200). This results in an estimated annual burden of 434,400 hours
(36,200 annual responses x 12 hours = 434,400).
    In addition, we estimate that approximately 11 brokers or dealers
will elect to use Appendix E to Rule 15c3-1 to compute certain of their
capital charges (as of June 2006, five brokers or dealers have elected
to use Appendix E). We estimate that the average amount of time
necessary to prepare and file the additional monthly reports that must
be filed by these firms is about 4 hours per month, or approximately 48
hours per year; the average amount of time necessary to prepare and
file the additional quarterly reports is about 8 hours per quarter, or
approximately 32 hours per year; and the average amount of time
necessary to prepare and file the additional supplemental reports with
the annual audit required is approximately 40 hours per year.
Consequently, we estimate that the total additional annual burden for
these 11 brokers or dealers is approximately 1,320 hours ((48 + 32 +
40) x 11 = 1,320).
    The Commission therefore estimates that the total annual burden
under Rule 17a-5 is approximately 435,700 hours (434,400 + 1,320 =
435,720, rounded to 435,700).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments regarding the estimated burden hours should be directed
to: (i) The Desk Officer for the Securities and Exchange Commission,
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10102, New Executive Office Building, Washington, DC 20503
or by e-mail to<EMAIL_ADDRESS>and (ii) R. Corey Booth,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312, or
by e-mail to<EMAIL_ADDRESS>Comments must be submitted to the
Office of Management and Budget within 30 days of this notice.

    November 3, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-18950 Filed 11-8-06; 8:45 am]

BILLING CODE 8011-01-P