[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Notices]
[Page 79525-79527]
[DOCID:fr29de08-100]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59108; File No. SR-FINRA-2008-063]

Self-Regulatory Organizations: Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change Relating to Adoption of NASD Rules 12805 and 13805
as FINRA Rules in the New Consolidated FINRA Rulebook

December 16, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 15, 2008, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a National Association of Securities Dealers, Inc.
(``NASD'')) filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as concerned solely with the
administration of the self-regulatory organization under Section
19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(3) thereunder,\4\ which
renders the proposal effective upon receipt of this filing by the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(3).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to adopt Rule 12805 of the NASD Code of
Arbitration Procedure for Customer Disputes (``Customer Code'') and
Rule 13805 of the NASD Code of Arbitration Procedure for Industry
Disputes (``Industry Code'') (collectively, the ``NASD Codes'') as
FINRA rules into a new consolidated rulebook. Below is the text of
Rules 12805 and 13805. FINRA is not proposing any changes to the rule
text.
* * * * *
Customer Code
12805. Expungement of Customer Dispute Information under Rule 2130
    In order to grant expungement of customer dispute information under
Rule 2130, the panel must:

    (a) Hold a recorded hearing session (by telephone or in person)
regarding the appropriateness of expungement. This paragraph will apply
to cases administered under Rule 12800 even if a customer did not
request a hearing on the merits.
    (b) In cases involving settlements, review settlement documents and
consider the amount of payments made to any party and any other terms
and conditions of a settlement.
    (c) Indicate in the arbitration award which of the Rule 2130
grounds for expungement serve(s) as the basis for its expungement order
and provide a brief written explanation of the reason(s) for its
finding that one or more Rule 2130 grounds for expungement applies to
the facts of the case.
    (d) Assess all forum fees for hearing sessions in which the sole
topic is the determination of the appropriateness of expungement
against the parties requesting expungement relief.
* * * * *
Industry Code
13805. Expungement of Customer Dispute Information under Rule 2130
    In order to grant expungement of customer dispute information under
Rule 2130, the panel must:
    (a) Hold a recorded hearing session (by telephone or in person)
regarding the appropriateness of expungement. This paragraph will apply
to cases administered under Rule 13800 even if a claimant did not
request a hearing on the merits.
    (b) In cases involving settlements, review settlement documents and
consider the amount of payments made to any party and any other terms
and conditions of a settlement.
    (c) Indicate in the arbitration award which of the Rule 2130
grounds for expungement serve(s) as the basis for its expungement order
and provide a brief written explanation of the reason(s) for its
finding that one or more Rule 2130 grounds for expungement applies to
the facts of the case.
    (d) Assess all forum fees for hearing sessions in which the sole
topic is the determination of the appropriateness of expungement
against the parties requesting expungement relief.
* * * * *

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

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    FINRA is in the process of developing the new consolidated rulebook
(``Consolidated FINRA Rulebook'').\5\ That process involves FINRA
submitting to the Commission for approval a series of proposed rule
changes over time to adopt rules in the Consolidated FINRA Rulebook.
The phased adoption and implementation of those rules necessitates
periodic amendments to update rule cross-references and other non-
substantive technical changes in the Consolidated FINRA Rulebook.
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    \5\ The current FINRA rulebook includes, in addition to FINRA
Rules, (1) NASD Rules and (2) rules incorporated from NYSE
(``Incorporated NYSE Rules'') (together, the NASD Rules and
Incorporated NYSE Rules are referred to as the ``Transitional
Rulebook''). While the NASD Rules generally apply to all FINRA
members, the Incorporated NYSE Rules apply only to those members of
FINRA that are also members of the NYSE (``Dual Members''). For more
information about the rulebook consolidation process, see FINRA
Information Notice, March 12, 2008 (Rulebook Consolidation Process).
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    On September 25, 2008, the Commission approved, among other
matters, a proposed rule change to adopt the NASD Codes as FINRA rules
into a new consolidated rulebook.\6\ Those rules will be implemented on
December 15, 2008.\7\
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    \6\ See Securities Exchange Act Release No. 58643 (September 25,
2008), 73 FR 57174 (October 1, 2008) (Order Approving File No. SR-
FINRA-2008-021).
    \7\ See FINRA Regulatory Notice 08-57 (October 2008) (FINRA
Announces SEC Approval and Effective Date for New Consolidated FINRA
Rules).
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    The Commission approved new Rules 12805 and 13805 of the NASD
Codes, which FINRA has not yet made effective.\8\ In a Regulatory
Notice to be issued on December 15, 2008, FINRA will announce the
effective date for new Rules 12805 and 13805. The proposed rule change
would permit FINRA to include new Rules 12805 and 13805 with the rules
that will be implemented in the Consolidated FINRA Rulebook on December
15, 2008.
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    \8\ See Securities Exchange Act Release No. 58886 (October 30,
2008), 73 FR 66086 (November 6, 2008) (Order Approving File No. SR-
FINRA-2008-010).
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2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\9\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes the proposed rule change will provide
greater clarity to members and the public regarding FINRA's rules.
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    \9\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \10\ and paragraph (f)(3) of Rule 19b-4
thereunder.\11\ At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(3).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2008-063 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2008-063. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of FINRA.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2008-063
and should be submitted on or before January 20, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence Harmon,
Acting Secretary.
 [FR Doc. E8-30785 Filed 12-24-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: October 7, 2005 (Volume 70, Number 194)]
[Notices]
[Page 58734]
[DOCID:fr07oc05-103]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Notice of Adjustment of Countywide Per Capita Impact Indicator

AGENCY: Federal Emergency Management Agency, Emergency Preparedness and
Response Directorate, Department of Homeland Security.

ACTION: Notice.

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SUMMARY: FEMA gives notice that the countywide per capita impact
indicator under the Public Assistance program for disasters declared on
or after October 1, 2005 will be increased.

EFFECTIVE DATE: October 1, 2005 and applies to major disasters declared
on or after October 1, 2005.

FOR FURTHER INFORMATION CONTACT: James A. Walke, Recovery Division,
Federal Emergency Management Agency, Washington, DC 20472, (202) 646-
3834.

SUPPLEMENTARY INFORMATION: Response and Recovery Directorate Policy No.
9122.1 provides that FEMA will adjust the countywide per capita impact
indicator under the Public Assistance program to reflect annual changes
in the Consumer Price Index for All Urban Consumers published by the
Department of Labor.
    FEMA gives notice of an increase in the countywide per capita
impact indicator to $2.94 for all disasters declared on or after
October 1, 2005.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 3.6 percent for the 12-month period
ended in August 2005. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 15, 2005.

(Catalog of Federal Domestic Assistance No. 97.036, Public
Assistance Grants.)
R. David Paulison,
Acting Under Secretary, Emergency Preparedness and Response, Department
of Homeland Security.
[FR Doc. 05-20293 Filed 10-6-05; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register: January 13, 2006 (Volume 71, Number 9)]
[Notices]
[Page 2200]
[DOCID:fr13ja06-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-701-001]

ANR Pipeline Company; Notice of Compliance Filing

January 6, 2006.
    Take notice that on December 22, 2005, ANR Pipeline Company (ANR)
tendered for filing as part of its FERC Gas Tariff, Second Revised
Volume No. 1, the following tariff sheets, to be effective on December
16, 2005:

Substitute Nineteenth Revised Sheet No. 2
Substitute Original Sheet No. 19A
Substitute Second Revised Sheet No. 24
Substitute Second Revised Sheet No. 28
Substitute Third Revised Sheet No. 34
Substitute Third Revised Sheet No. 41
Substitute Fourth Revised Sheet No. 42D
Substitute Fourth Revised Sheet No. 44
Substitute Third Revised Sheet No. 45J
Substitute Third Revised Sheet No. 57
Substitute Fourth Revised Sheet No. 64
Substitute Fifth Revised Sheet No. 68
Substitute Second Revised Sheet No. 68D.01
Substitute Eighth Revised Sheet No. 92
Substitute Fifth Revised Sheet No. 195
Substitute Third Revised Sheet No. 196
Substitute Original Sheet No. 196.01

    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-293 Filed 1-12-06; 8:45 am]

BILLING CODE 6717-01-P


regulation is found in Sec.  600.80. In proposing Sec.  600.80, FDA
indicated that information made available to the Agency through the
adverse experience reports contemplated under Sec.  600.80 could
establish that a biological product is not safe or properly labeled and
that the license should be revoked (55 FR 11611 at 11613, March 29,
1990). FDA used section 351 of the PHS Act as statutory authority,
along with other sources of statutory authority, in issuing the BPDR
regulations for biological products. These regulations are found in
Sec. Sec.  600.14 and 606.171. In issuing these regulations, FDA stated
that these reports would enable FDA to respond when public health may
be at risk, provide FDA with uniform data to track trends that may
indicate broader threats to the public health, and help ensure
facilities are taking appropriate actions to investigate and correct
biological product deviations. (65 FR 66621 at 66623, November 7,
2000).
    There is considerable overlap in the PMSR requirements for drugs,
devices, and biological products. The regulatory schemes for adverse
event reporting for drugs and biological products are identical in most
respects. The MDR regulation has many similarities to the drug and
biological product PMSR regulations. Overall, the regulatory framework
governing PMSR for each type of product is intended to achieve the same
general goals.
    Nevertheless, these three sets of regulations differ somewhat
because each is tailored to the characteristics of the types of
products for which it was designed. For instance, each set of
regulations contains certain specific requirements pertaining to
particular products or types of postmarketing safety events that are
not found in the other sets of regulations. The additional requirements
for combination product applicants that FDA considers necessary are as
follows: 5-day reports, 15-day reports, malfunction reports, correction
or removal reports, field alert reports, and BPDRs. As set forth in
this rule, it is crucial that these additional requirements be met if
they apply.
    The legal framework underlying this proposed rule is twofold. The
first is that drugs, devices, and biological products do not lose their
discrete regulatory identities when they become constituent parts of a
combination product. In general, the PMSR requirements specific to each
constituent part of a combination product also apply to the combination
product itself. Therefore, all combination products are subject to at
least two sets of PMSR requirements. For example, in the case of a
device and biological product combination product, the PMSR
requirements applicable to devices and to biological products would
apply to the combination product. However, this rule is intended to
clarify that a combination product applicant may comply only with the
PMSR requirements associated with the application under which the
combination product received marketing authorization and certain,
specified PMSR requirements associated with the other constituent
part(s). Taking the example of a device-biologic combination product,
if the combination product has an approved BLA, the combination product
applicant (holder of the BLA) would use parts 600 and 606 to make
postmarketing safety reports for the combination product. In addition,
as explained in this rule, the combination product applicant must also
comply with all of the specified requirements that apply to the
product. Thus, in this case, the combination product applicant must
also comply with the reporting requirements for 5-day reports,
correction or removal reports, and malfunction reports if the criteria
for such reports are met. Under this legal framework, if you
demonstrate compliance with the applicable requirements of the set of
regulations (e.g., biological product PMSR) associated with the
approved application (e.g., BLA), and comply with any applicable
specified additional provisions (e.g., 5-day reports, correction or
removal reports, and malfunction reports), you will be considered to
have satisfied all applicable PMSR requirements associated with the
combination product, including its constituent parts.
    The legal authority for this streamlining approach is based on the
following. Although combination products retain the regulatory
identities of their constituent parts, the FD&C Act also recognizes
combination products as a category of products that are distinct from
products that are solely drugs, devices, or biological products. For
example, section 503(g)(4)(A) of the FD&C Act (21 U.S.C. 353b(g)(4)(A))
requires OCP to ``designate'' a product as a combination product as
well as to

ensure ``consistent and appropriate postmarket regulation of like
products subject to the same statutory requirements.'' Further, section
563 of the FD&C Act (21 U.S.C. 360bbb-2) governs the ``classification''
of products as ``drug, biological product, device, or a combination
product subject to section 503(g)'' (emphasis added). In this respect,
the FD&C Act identifies a combination product as a distinct type of
product that could be subject to specialized regulatory controls. In
addition, for the efficient enforcement of the FD&C Act under section
701 (21 U.S.C. 371), FDA has the authority to develop regulations to
ensure sufficient and appropriate ongoing assessment of the risks
associated with combination products.
    The second legal framework for this rule is founded on the
postmarket safety reporting regulatory scheme associated with the
application under which the combination product is approved, plus any
applicable requirements associated with the additional six specified
report types listed in this rule. Although similar in effect to the
previously discussed framework, this approach is based on the legal
authority FDA used to issue each of its three existing regulations for
postmarketing safety reporting for drugs, devices, and biological
products. In the context of this rule, such authority would include,
but not be limited to, sections 505(k) and 519 of the FD&C Act, and
section 351 of the PHS Act. Under this authority FDA is now issuing
additional requirements based on the six additional specified report
types. This means that in the case, for example, of a device-biologic
combination product, approved under a BLA, section 351 of the PHS Act
(in addition to other applicable authorities) would provide the
authority for FDA to require postmarketing safety reporting in
accordance with parts 600 and 606. Furthermore, section 351 of the PHS
Act also would provide the authority for the Agency to require
additional reporting for the device-biologic combination product (5-day
reports, malfunction reports, and correction or removal reports) if the
criteria for such reports are met.

V. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(a), 25.30(h), and 25.31(a)
through (c) that this action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual reporting and recordkeeping burdens. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
    Title: Postmarketing Safety Reporting for Combination Products.
    Description: This final rule describes the PMSR requirements for
combination products. In the development of this final rule, the Agency
considered the fact that a combination product is subject to the PMSR
provisions applicable to its constituent parts (drug, device, and/or
biological product). The Agency reviewed each set of regulations
governing PMSR for new drugs (part 314), biological products (parts 600
and 606), and devices (parts 803 and 806). The review determined that
each set of regulations contains many substantially similar
requirements.
    Given the broad similarities in the PMSR regulations, the Agency
determined that, to ensure consistent, appropriate PMSR for combination
products that received marketing authorization under a single
application, we need only require that combination product applicants
comply with the regulatory requirements for PMSR associated with the
application, and with additional, specified provisions from the other
set(s) of PMSR requirements applicable to the other constituent part(s)
of the combination product. This approach recognizes and addresses PMSR
considerations relevant to each type of constituent part of a
combination product while avoiding unnecessary redundancy and burden.
    Specifically, the additional reporting requirements specified in
this rule, along with any associated followup reports, are: (1)
Submission of a ``5-day report'' as described in Sec.  803.53 if the
combination product contains a device constituent part; (2) submission
of a ``malfunction report'' as described in Sec.  803.50 if the
combination product contains a device constituent part; (3) submission
of a ``correction or removal report'' as described in Sec.  806.10 if
the combination product contains a device constituent part; (4)
submission of a ``field alert report'' as described in Sec.  314.81 if
the combination product contains a drug constituent part; (5)
submission of a 15-day report as described in Sec.  314.80 or Sec.
600.80 if the combination product contains a drug or biological product
constituent part, respectively; and (6) submission of a ``BPDR'' as
described in Sec. Sec.  600.14 and 606.171 if the combination product
contains a biological product constituent part.
    For combination products for which the constituent parts received
marketing authorization under separate applications held by different
entities, the Agency has determined that compliance with the PMSR
requirements associated with the application type for the constituent
part is sufficient. In addition, constituent part applicants must share
safety information they receive related to certain events with the
other constituent part applicant(s).
    We note that the PMSR information collections for drugs, biological
products, and devices found in Sec. Sec.  314.80, 314.81, 600.80,
600.81, 606.170, 606.171, 803.50, 803.53, 803.56, 806.10, and 806.20
have already been approved and are in effect. The pertinent PMSR
information collection provisions for Sec.  314.80(c) and (e), as well
as for Sec.  314.81(b) are approved under OMB control numbers 0910-
0001, 0910-0230, and 0910-0291. The information collection provisions
for Sec. Sec.  600.80 and 600.81 are approved under OMB control number
0910-0308. Those for Sec.  606.170 are approved under OMB control
number 0910-0116. Those for Sec.  606.171 are approved under OMB
control number 0910-0458. The information collection provisions for
Sec. Sec.  803.50, 803.53, and 803.56 are approved under OMB control
numbers 0910-0291 and 0910-0437. The information collection provisions
for Sec. Sec.  806.10 and 806.20 are approved under OMB control number
0910-0359.
    While this rule serves to permit combination product applicants to
comply with a streamlined subset of the PMSR requirements applicable to
all of their constituent parts, we recognize that some combination
product applicants have been complying with only the reporting
requirements associated with their application type. As a result, the
information collection described here refers to the reporting and
recordkeeping requirements for the six additional report types
specified in this rule. It also refers to the new information sharing
and related recordkeeping requirement applicable to constituent parts
marketed under separate applications.

    These requirements are necessary to ensure: (1) Consistent PMSR for
combination products and constituent parts, (2) that the Agency
receives necessary information to promote and protect the public
health, (3) appropriate ongoing assessment of risks, and (4) consistent
and appropriate postmarketing regulation of combination products. This
rule enables applicants to comply with these requirements while
avoiding unnecessary duplicative reporting, for example, by limiting
the number of PMSR requirements with which combination product
applicants must comply and by authorizing applicants to submit only a
single, complete report for an event even if multiple reporting duties
apply to the same event.
    Description of Respondents: This rule applies to combination
product applicants and constituent part applicants. Any person holding
the application(s) under which a combination product received marketing
authorization is a combination product applicant. Any person holding an
application under which a constituent part (drug, device, or biological
product) of a combination product received marketing authorization is a
constituent part applicant if the other constituent part received
marketing authorization under an application held by a different
person.
    FDA estimates the burden for this information collection as
follows:

                                   Table 3--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
4.102(c)(1)(i) Submitting 5-day               15              98           1,470            1.21           1,779
 reports........................
4.102(c)(1)(ii) Submitting                    15              98           1,470            1.21           1,779
 malfunction reports............
4.102(c)(1)(iii) Submitting                   20               1              20              10             200
 correction or removal reports..
4.102(c)(2)(i) Submitting field               92            10.8             994               8           7,949
 alerts.........................
4.102(c)(2)(ii) and (3)((ii)                   1               1               1               1               1
 Submitting 15-day reports......
4.102(c)(3) Submitting BPDRs....              24               6             144               2             288
4.102(d)........................               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Totals *....................  ..............  ..............  ..............  ..............          11,709
----------------------------------------------------------------------------------------------------------------

                                                     Table 4--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
4.103(b)/4.105(a)(2) Records of information                33              18             594  .1 (6 minutes)...........................              59
 shared by constituent part applicants.
4.105(b) additional record-keeping by device-             279             .45             126  .5 (30 minutes)..........................              63
 led combination products.
4.105(b) additional recordkeeping by drug and             186               6           1,116  .5 (30 minutes)..........................             558
 biologic-led combination products.
                                              ----------------------------------------------------------------------------------------------------------
    Totals...................................  ..............  ..............  ..............  .........................................             680
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                 Table 5--Estimated Annual Third Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of      disclosures    Total annual         Average burden per disclosure          Total hours
                                                 respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
4.103 Sharing information with other                       33              18             594  .35 (21 minutes).........................             208
 constituent part applicants.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Based on FDA's experience regarding receipt of postmarketing safety
reports for combination products, the Agency estimates that there will
be 401 reporters (who will keep corresponding records) submitting a
total of 11,709 reports annually under Sec.  4.102(c) and (d) and 33
reporters (who will keep corresponding records) sharing information
eighteen times annually under Sec.  4.103. Further, FDA estimates,
based on its experience with information collection regarding
postmarketing safety reporting provisions for drugs, biological
products, and devices, that each report (or information sharing event
under Sec.  4.103) may take from approximately 20 minutes to 10 hours,
depending on report type, to prepare and submit, and from approximately
6 to 30 minutes to fulfill the corresponding recordkeeping
requirements. FDA believes that there are no significant new operating
and maintenance costs associated with this collection of information
because, in order to legally market their products, all applicants are
required to develop and maintain systems for reporting and maintaining
records of postmarketing safety events. Therefore, appropriate
mechanisms for PMSR should already be in place, and combination product
applicants and constituent part applicants will accrue no significant
additional costs to fulfill the requirements set forth here.
    In addition, we estimate that there will no significant new costs
for 15-day reporting (Sec.  4.102(c)(2)(ii) and (3)(ii)) and periodic
reporting (Sec.  4.102(d)(1)) under the rule because there is
significant overlap between the types of events that trigger a 15-day
report for drugs and biological products and the

events that trigger expedited reporting for devices. We also estimate
there will be no significant new costs for other non-expedited
reporting (Sec.  4.102(d)(2)) because of the expected rarity of the
agency seeking such additional information.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless the Agency
displays a currently valid OMB control number.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, the Agency has concluded
that the final rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.\9\
---------------------------------------------------------------------------

    \9\ The rule clarifies which PMSR requirements apply when drugs,
devices, and biological products are used to create combination
products. The Agency notes that there are no express preemption
provisions of the FD&C act applicable to prescription drugs or
biological products. Section 521 of the FD&C Act (21 U.S.C. 360k)
contains an express preemption provision that applies to devices;
nonetheless, the Supreme Court concluded in Medtronic, Inc. v. Lohr,
581 U.S. 470, 500-01 (1996), that requirements not applicable to a
particular device do not preempt State law under section 521. Device
adverse event reporting requirements, like the good manufacturing
practice requirements at issue in the Medtronic case, are general
requirements that do not preempt under section 521 of the FD&C Act.
---------------------------------------------------------------------------

VIII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. We believe that this final rule
is not a significant regulatory action as defined by Executive Order
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the final rule essentially describes the application
of existing postmarketing safety reporting regulations to certain
combination products, we certify that the final rule will not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    The full analysis of economic impacts is available in the docket
for this final rule at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

B. Summary of Costs and Benefits

    The final rule will generate one-time administrative costs from
reading and understanding the rule, assessing current compliance,
modifying existing standards of practice, changing storage and
reporting software, and training personnel on the requirements under
this rule. Firms that do not currently comply with the reporting
requirements specified by the final rule will also incur annual
reporting costs from the submission of field alert reports, 5-day
reports, malfunction reports, correction or removal reports, and
biological product deviation reports, as applicable. The annualized
total costs of the rule are between $1.36 and $2.68 million at a 7
percent discount rate and between $1.35 and $2.65 million at a 3
percent discount rate.
    The final rule will benefit firms through reduced uncertainty about
the reporting requirements for their specific combination product and
through decreased potentially duplicative reporting. The final rule
will also benefit public health by helping to ensure that important
safety information is submitted and directed to the appropriate
components within the Agency, so that we may receive and review this
important information in a timely manner for the protection of public
health.

                                      Table 6--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                              Primary                                    ------------------------------------------------
                Category                     estimate      Low estimate    High estimate                   Discount rate  Period covered       Notes
                                                                                Year dollars         (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized..........................  ..............  ..............  ..............            2016               7              10
    Monetized ($millions/year)..........  ..............  ..............  ..............            2016               3              10
    Annualized..........................  ..............  ..............  ..............            2016               7              10
    Quantified..........................  ..............  ..............  ..............            2016               3              10
                                         ------------------------------------------------

    Qualitative.........................  Firms will benefit from reduced uncertainty
                                          about reporting requirements. The rule will
                                          benefit public health by helping to ensure
                                          Agency components' timely receipt of
                                          postmarketing safety reports.
                                         ------------------------------------------------
Costs:
    Annualized..........................  ..............           $1.36           $2.68            2016               7              10
    Monetized ($millions/year)..........  ..............           $1.35           $2.65            2016               3              10
    Annualized..........................  ..............  ..............  ..............            2016               7              10
    Quantified..........................  ..............  ..............  ..............            2016               3              10
                                         ------------------------------------------------
    Qualitative.........................
                                         ------------------------------------------------
Transfers:
    Federal.............................  ..............  ..............  ..............            2016               7              10
    Annualized..........................  ..............  ..............  ..............            2016               3              10
                                         ------------------------------------------------------------------------------------------------
    Monetized ($millions/year)..........  From:
                                          To:
                                         ------------------------------------------------------------------------------------------------
    Other...............................  ..............  ..............  ..............            2016               7              10
    Annualized..........................  ..............  ..............  ..............            2016               3              10
                                         ------------------------------------------------------------------------------------------------
    Monetized ($millions/year)..........  From:
                                          To:
                                         ------------------------------------------------------------------------------------------------
Effects:
                                          State, Local or Tribal Government:
                                          Small Business:
                                          Wages:
                                          Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

IX. References

    The following references are on display in the Division of Dockets
Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

    1. FDA Regulation of Combination Products, November 25, 2002,
accessed at: http://www.fda.gov/downloads/CombinationProducts/MeetingsConferencesWorkshops/UCM117123.pdf.
    2. Innovative Systems for Delivery of Drugs and Biologics:
Scientific, Clinical and Regulatory Challenges, July 8, 2003,
accessed at: http://www.fda.gov/ohrms/dockets/dockets/03n0203/03n0203.htm.
    3. Individual Case Study Reports, accessed at: (http://www.fda.gov/ForIndustry/DataStandards/IndividualCaseSafetyReports/default.htm).

List of Subjects in 21 CFR Part 4

    Biological products, Combination products, Drugs, Medical devices,
Regulation of combination products, Reporting and recordkeeping
requirements, Safety.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 4 is amended as follows:

PART 4--REGULATION OF COMBINATION PRODUCTS

0
1. The authority citation for part 4 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-
360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 371(a), 372-374,
379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.

0
2. Add subpart B, consisting of Sec. Sec.  4.100 through 4.105, to read
as follows:
Subpart B--Postmarketing Safety Reporting for Combination Products
Sec.
4.100 What is the scope of this subpart?
4.101 How does FDA define key terms and phrases in this subpart?
4.102 What reports must you submit to FDA for your combination
product or constituent part?
4.103 What information must you share with other constituent part
applicants for the combination product?
4.104 How and where must you submit postmarketing safety reports for
your combination product or constituent part?
4.105 What are the postmarketing safety reporting recordkeeping
requirements for your combination product or constituent part?

Subpart B--Postmarketing Safety Reporting for Combination Products

Sec.  4.100  What is the scope of this subpart?

    (a) This subpart identifies postmarketing safety reporting
requirements for combination product applicants and constituent part
applicants.
    (b) This subpart does not apply to investigational combination
products, combination products that have not received marketing
authorization, or to persons other than combination product

applicants and constituent part applicants.
    (c) This subpart supplements and does not supersede other
provisions of this chapter, including the provisions in parts 314, 600,
606, 803, and 806 of this chapter, unless a regulation explicitly
provides otherwise.

Sec.  4.101  How does the FDA define key terms and phrases in this
subpart?

    Abbreviated new drug application (ANDA) has the same meaning given
the term ``abbreviated application'' in Sec.  314.3(b) of this chapter.
    Agency or we means Food and Drug Administration.
    Applicant means, for the purposes of this subpart, a person holding
an application under which a combination product or constituent part of
a combination product has received marketing authorization (such as
approval, licensure, or clearance). For the purposes of this subpart,
applicant is used interchangeably with the term ``you.''
    Application means, for purposes of this subpart, a BLA, an NDA, an
ANDA, or a device application, including all amendments and supplements
to them.
    Biological product has the meaning given the term in section 351 of
the Public Health Service Act (42 U.S.C. 262).
    Biological product deviation report (BPDR) is a report as described
in Sec. Sec.  600.14 and 606.171 of this chapter.
    Biologics license application (BLA) has the meaning given the term
in section 351 of the Public Health Service Act (42 U.S.C. 262) and
Sec.  601.2 of this chapter.
    Combination product has the meaning given the term in Sec.  3.2(e)
of this chapter.
    Combination product applicant means an applicant that holds the
application(s) for a combination product.
    Constituent part has the meaning given the term in Sec.  4.2.
    Constituent part applicant means the applicant for a constituent
part of a combination product the constituent parts of which are
marketed under applications held by different applicants.
    Correction or removal report is a report as described in Sec.
806.10 of this chapter.
    De novo classification request is a submission requesting de novo
classification under section 513(f)(2) of the Federal Food, Drug, and
Cosmetic Act.
    Device has the meaning given the term in section 201(h) of the
Federal Food, Drug, and Cosmetic Act.
    Device application means a PMA, PDP, premarket notification
submission, de novo classification request, or HDE.
    Drug has the meaning given the term in section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act.
    Field alert report is a report as described in Sec.  314.81 of this
chapter.
    Fifteen-day report is a report required to be submitted within 15
days as described in Sec.  314.80 of this chapter or Sec.  600.80 of
this chapter, as well as followup reports to such a report.
    Five-day report is a report as described in Sec. Sec.  803.3 and
803.53 of this chapter, as well as supplemental or followup reports to
such a report as described in Sec.  803.56 of this chapter.
    Humanitarian device exemption (HDE) has the meaning given the term
in Sec.  814.3 of this chapter.
    Malfunction report is a report as described in Sec.  803.50 of this
chapter as well as supplemental or followup reports to such a report as
described in Sec.  803.56 of this chapter.
    New drug application (NDA) has the meaning given the term
``application'' in Sec.  314.3(b) of this chapter.
    Premarket approval application (PMA) has the meaning given the term
in Sec.  814.3 of this chapter.
    Premarket notification submission is a submission as described in
Sec.  807.87 of this chapter.
    Product Development Protocol (PDP) is a submission as set forth in
section 515(f) of the Federal Food, Drug, and Cosmetic Act.

Sec.  4.102  What reports must you submit to FDA for your combination
product or constituent part?

    (a) In general. If you are a constituent part applicant, the
reporting requirements applicable to you that are identified in this
section apply to your constituent part, and if you are a combination
product applicant, the reporting requirements applicable to you that
are identified in this section apply to your combination product as a
whole.
    (b) Reporting requirements applicable to both combination product
applicants and constituent part applicants. If you are a combination
product applicant or constituent part applicant, you must comply with
the reporting requirements identified in paragraphs (b)(1), (b)(2), or
(b)(3) of this section for your product based on its application type.
If you are a combination product applicant, you are required to submit
a report as specified in this paragraph unless you have already
submitted a report in accordance with paragraph (c) of this section for
the same event that: Includes the information required under the
applicable regulations identified in this paragraph, is required to be
submitted in the same manner under Sec.  4.104, and meets the deadlines
under the applicable regulations identified in this paragraph.
    (1) If your combination product or device constituent part received
marketing authorization under a device application, you must comply
with the requirements for postmarketing safety reporting described in
parts 803 and 806 of this chapter with respect to your product.
    (2) If your combination product or drug constituent part received
marketing authorization under an NDA or ANDA, you must comply with the
requirements for postmarketing safety reporting described in part 314
of this chapter with respect to your product.
    (3) If your combination product or biological product constituent
part received marketing authorization under a BLA, you must comply with
the requirements for postmarketing safety reporting described in parts
600 and 606 of this chapter with respect to your product.
    (c) Reporting requirements applicable only to combination product
applicants. If you are a combination product applicant, in addition to
compliance with paragraph (a) of this section, you must also comply
with the reporting requirements identified under this paragraph as
applicable to your product based on its constituent parts. If you are a
combination product applicant, you are required to submit a report as
specified in this paragraph unless you have already submitted a report
in accordance with paragraph (b) of this section for the same event
that: Includes the information required under the applicable
regulations for the report identified in this paragraph; is required to
be submitted in the same manner under Sec.  4.104 of this chapter; and,
unless otherwise specified in this paragraph, meets the deadlines under
the applicable regulations for the report identified in this paragraph.
    (1) If your combination product contains a device constituent part,
you must submit:
    (i) Five-day reports;
    (ii) Malfunction reports; and
    (iii) Correction or removal reports, and maintain records as
described in Sec.  806.20 of this chapter for corrections and removals
not required to be reported.
    (2) If your combination product contains a drug constituent part,
you must submit:
    (i) Field alert reports; and
    (ii) Fifteen-day reports as described in Sec.  314.80 of this
chapter, which must be

submitted within 30 calendar days instead of 15 calendar days if your
combination product received marketing authorization under a device
application.
    (3) If your combination product contains a biological product
constituent part, you must submit:
    (i) Biological product deviation reports; and
    (ii) Fifteen-day reports as described in Sec.  600.80 of this
chapter, which must be submitted within 30 calendar days instead of 15
calendar days if your combination product received marketing
authorization under a device application.
    (d) Other reporting requirements for combination product
applicants. (1) If you are the combination product applicant for a
combination product that contains a device constituent part and that
received marketing authorization under an NDA, ANDA, or BLA, in
addition to the information otherwise required in the periodic safety
reports you submit under Sec.  314.80 or Sec.  600.80 of this chapter,
your periodic safety reports must also include a summary and analysis
of the reports identified in paragraphs (c)(1)(i) and (ii) of this
section that were submitted during the report interval.
    (2) If you are the combination product applicant for a combination
product that received marketing authorization under a device
application, in addition to the reports required under paragraphs (b)
and (c) of this section, you must submit reports regarding
postmarketing safety events if notified by the Agency in writing that
the Agency requires additional information. We will specify what safety
information is needed and will require such information if we determine
that protection of the public health requires additional or clarifying
safety information for the combination product. In any request under
this section, we will state the reason or purpose for the safety
information request, specify the due date for submitting the
information, and clearly identify the reported event(s) related to our
request.

Sec.  4.103  What information must you share with other constituent
part applicants for the combination product?

    (a) When you receive information regarding an event that involves a
death or serious injury as described in Sec.  803.3 of this chapter, or
an adverse experience as described in Sec.  314.80(a) of this chapter
or Sec.  600.80(a) of this chapter, associated with the use of the
combination product, you must provide the information to the other
constituent part applicant(s) for the combination product no later than
5 calendar days of your receipt of the information.
    (b) With regard to information you must provide to the other
constituent part applicant(s) for the combination product, you must
maintain records that include:
    (1) A copy of the information you provided,
    (2) The date the information was received by you,
    (3) The date the information was provided to the other constituent
part applicant(s), and
    (4) The name and address of the other constituent part applicant(s)
to whom you provided the information.

Sec.  4.104  How and where must you submit postmarketing safety reports
for your combination product or constituent part?

    (a) If you are a constituent part applicant, you must submit
postmarketing safety reports in accordance with the regulations
identified in Sec.  4.102(b) that are applicable to your product based
on its application type.
    (b) If you are a combination product applicant, you must submit
postmarketing safety reports required under Sec.  4.102 in the manner
specified in the regulation applicable to the type of report, with the
following exceptions:
    (1) You must submit the postmarketing safety reports identified in
Sec.  4.102(c)(1)(i) and (ii) in accordance with Sec.  314.80(g) of
this chapter if your combination product received marketing
authorization under an NDA or ANDA or in accordance with Sec.
600.80(h) of this chapter if your combination product received
marketing authorization under a BLA.
    (2) You must submit the postmarketing safety reports identified in
Sec.  4.102(c)(2)(ii) and (c)(3)(ii) in accordance with Sec.  803.12(a)
of this chapter if your combination product received marketing
authorization under a device application.

Sec.  4.105  What are the postmarketing safety reporting recordkeeping
requirements for your combination product or constituent part?

    (a) If you are a constituent part applicant:
    (1) You must maintain records in accordance with the recordkeeping
requirements in the applicable regulation(s) described in Sec.
4.102(b).
    (2) You must maintain records required under Sec.  4.103(b) for the
longest time period required for records under the postmarketing safety
reporting regulations applicable to your product under Sec.  4.102(b).
    (b) If you are a combination product applicant, you must maintain
records in accordance with the longest time period required for records
under the regulations applicable to your product under Sec.  4.102.

    Dated: December 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30485 Filed 12-19-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6516-6517]
[FR Doc No: 2011-2451]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket: PHMSA-2010-0354]

Pipeline Safety: Agency Information Collection Activities: Notice
of Request for Extension of Currently Approved Information Collections

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below is being forwarded to the
Office of Management and Budget (OMB) for review and comments. A
Federal Register Notice with a 60-day comment period soliciting
comments on this ICR was published in the Federal Register on November
29, 2010 (75 FR 73160) under Docket No. PHMSA-2010-0354. No comments
were received. The purpose of this notice is to allow the public an
additional 30 days to submit comments to OMB on the information
collection described below.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to the Office of Management and
Budget, Office of Information and Regulatory Affairs, Attn: Desk
Officer for DOT/PHMSA, 725 17th Street, NW., Washington, DC 20503.

DATES: Interested persons are invited to submit comments on or before
March 7, 2011.

FOR FURTHER INFORMATION CONTACT: Angela Dow by telephone at 202-366-
1246, by e-mail at<EMAIL_ADDRESS>or by mail at U.S. Department of
Transportation, Pipeline and Hazardous Materials Safety Administration,
1200 New Jersey Avenue, SE., PHP-30, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

    Title: Reporting Safety-Related Conditions on Gas, Hazardous
Liquid, and Carbon Dioxide Pipelines and Liquefied Natural Gas
Facilities.
    OMB Control Number: 2137-0578.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: Each operator of a pipeline facility (except master meter
operators) must submit to DOT a written report on any safety-related
condition that causes or has caused a significant change or restriction
in the operation of a pipeline facility or a condition that is a hazard
to life, property or the environment.
    Affected Public: Operators of pipeline facilities (except master
meter operators).
    Estimated number of responses: 142.
    Estimated annual burden hours: 852 hours.
    Frequency of collection: On occasion.
    Comments are invited on: The need for the proposed collection of
information for the proper performance of the functions of the agency,
including whether the information will have practical utility; the
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; ways to enhance the quality, utility, and clarity
of the information to be collected; and ways to minimize the burden of
the collection of information on those who are to respond, including
the use of appropriate automated, electronic, mechanical, or other
technological collection techniques. A comment to OMB is most effective
if OMB receives it within 30 days of the date of publication in the
Federal Register.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR Part 1.

    Issued in Washington, DC, on January 31, 2011.
Linda Daugherty,
Deputy Associate Administrator for Policy and Programs.
[FR Doc. 2011-2451 Filed 2-3-11; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Pages 14989-14990]
[FR Doc No: 2020-05245]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 33813; 812-15062]

Guinness Atkinson Funds and Guinness Atkinson Asset Management,
Inc.; Notice of Application

March 10, 2020.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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

    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements in rule 20a-1 under the Act, Item 19(a)(3) of
Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of
Schedule 14A under the Securities Exchange Act of 1934, and Sections 6-
07(2)(a), (b), and (c) of Regulation S-X (``Disclosure Requirements'').
The requested exemption would permit an investment adviser to hire and
replace certain sub-advisers without shareholder approval and grant
relief from the Disclosure Requirements as they relate to fees paid to
the sub-advisers.
    Applicants: Guinness Atkinson Funds (the ``Trust''), a Delaware
statutory trust registered under the Act as an open-end management
investment company, and Guinness Atkinson Asset Management, Inc. (the
``Initial Adviser''), a corporation organized under the laws of
Delaware registered as an investment adviser under the Investment
Advisers Act of 1940.
    Filing Dates: The application was filed on August 28, 2019 and
amended on November 29, 2019 and February 25, 2020.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on April 6, 2020, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549-1090. Applicants: Guinness Atkinson
Funds, Attn: James J. Atkinson, 225 South Lake Avenue, Suite 216,
Pasadena, CA 91101.

FOR FURTHER INFORMATION CONTACT: Samuel K. Thomas, Senior Counsel, at
(202) 551-7952, or Andrea Ottomanelli Magovern, Branch Chief, at (202)
551-6821 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Summary of the Application

    1. The Initial Adviser is the investment adviser to the SmartETFs
Smart Transportation & Technology ETF (the ``Initial Fund''), a series
of the Trust, pursuant to an investment management agreement with the
Trust (``Investment Management Agreement'').\1\ Under the terms of the
Investment Management Agreement, the Adviser, subject to the
supervision of the board of trustees of the Trust (``Board''), provides
continuous investment management of the assets of each Subadvised Fund.
Consistent with the terms of the Investment Management Agreement, the
Adviser may, subject to the approval of the Board, delegate portfolio
management responsibilities of all or a portion of the assets of a
Subadvised Fund to one or more Sub-Advisers.\2\ The Adviser will
continue to have overall responsibility for the management and
investment of the assets of each Subadvised Fund. The Adviser will
evaluate, select, and recommend Sub-Advisers to manage the assets of a
Subadvised Fund and will oversee, monitor and review the Sub-Advisers
and their performance and recommend the removal or replacement of Sub-
Advisers.
---------------------------------------------------------------------------

    \1\ Applicants request relief with respect to the Initial Fund,
as well as to any future series of the Trust and any other existing
or future registered open-end management investment company or
series thereof that, in each case, is advised by the Initial Adviser
or any entity controlling, controlled by, or under common control
with, the Initial Adviser or its successors (each, also an
``Adviser''), uses the multi-manager structure described in the
application, and complies with the terms and conditions set forth in
the application (each, a ``Subadvised Fund''). For purposes of the
requested order, ``successor'' is limited to an entity that results
from a reorganization into another jurisdiction or a change in the
type of business organization. Future Subadvised Funds may be
operated as a master-feeder structure pursuant to section
12(d)(1)(E) of the Act. In such a structure, certain series of the
Trust (each, a ``Feeder Fund'') may invest substantially all of
their assets in a Subadvised Fund (a ``Master Fund'') pursuant to
section 12(d)(1)(E) of the Act. No Feeder Fund will engage any sub-
advisers other than through approving the engagement of one or more
of the Master Fund's sub-advisers.
    \2\ As used herein, a ``Sub-Adviser'' for a Subadvised Fund is
(1) an indirect or direct ``wholly owned subsidiary'' (as such term
is defined in the Act) of the Adviser for that Subadvised Fund, or
(2) a sister company of the Adviser for that Subadvised Fund that is
an indirect or direct ``wholly-owned subsidiary'' of the same
company that, indirectly or directly, wholly owns the Adviser (each
of (1) and (2) a ``Wholly-Owned Sub-Adviser'' and collectively, the
``Wholly-Owned Sub-Advisers''), or (3) not an ``affiliated person''
(as such term is defined in section 2(a)(3) of the Act) of the
Subadvised Fund, any Feeder Fund invested in a Master Fund, the
Trust, or the Adviser, except to the extent that an affiliation
arises solely because the Sub-Adviser serves as a sub-adviser to a
Subadvised Fund (``Non-Affiliated Sub-Advisers'').
---------------------------------------------------------------------------

    2. Applicants request an order to permit the Adviser, subject to
the approval of the Board, to enter into investment sub-advisory
agreements with the Sub-Advisers (each, a ``Sub-Advisory Agreement'')
and materially amend such Sub-Advisory Agreements without obtaining the
shareholder approval required under section 15(a) of the Act and rule
18f-2 under the Act.\3\ Applicants also seek an exemption from the
Disclosure Requirements to permit a Subadvised Fund to disclose (as
both a dollar amount and a percentage of the Subadvised Fund's net
assets): (a) The aggregate fees paid to the Adviser and any Wholly-
Owned Sub-Adviser; (b) the aggregate fees paid to Non-Affiliated Sub-
Advisers; and (c) the fee paid to each Affiliated Sub-Adviser
(collectively, Aggregate Fee Disclosure'').\4\
---------------------------------------------------------------------------

    \3\ The requested relief will not extend to any sub-adviser,
other than a Wholly-Owned Sub-Adviser, who is an affiliated person,
as defined in section 2(a)(3) of the Act, of the Subadvised Fund, of
any Feeder Fund, or of the Adviser, other than by reason of serving
as a sub-adviser to one or more of the Subadvised Funds
(``Affiliated Sub-Adviser'').
    \4\ For any Subadvised Fund that is a Master Fund, the relief
would also permit any Feeder Fund invested in that Master Fund to
disclose Aggregate Fee Disclosure.
---------------------------------------------------------------------------

    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the application.
Such terms and conditions provide for, among other safeguards,
appropriate disclosure to Subadvised Funds' shareholders and
notification about sub-advisory changes and enhanced Board oversight to
protect the interests of the Subadvised Funds' shareholders.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
any rule thereunder, if such relief is necessary or appropriate in the
public interest and consistent with the protection of investors and
purposes fairly intended by the policy and provisions of the Act.
Applicants believe that the requested relief meets this standard
because, as further explained in the application, the Investment
Management Agreements will remain subject to shareholder approval,
while the role of the Sub-Advisers is substantially equivalent to that
of individual portfolio managers, so that requiring shareholder
approval of Sub-Advisory Agreements would impose unnecessary delays and
expenses on the Subadvised Funds. Applicants believe that the requested
relief from the Disclosure Requirements meets this standard because it
will improve the Adviser's ability to negotiate fees paid to the Sub-
Advisers that are more advantageous for the Subadvised Funds.

    For the Commission, by the Division of Investment Management,
under delegated authority.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-05245 Filed 3-13-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 97 (Friday, May 18, 2018)]
[Notices]
[Pages 23336-23337]
[FR Doc No: 2018-10633]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket No. NHTSA-2018-0057]

Reports, Forms, and Record Keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Request for public comment on proposed collection of
information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatements of previously approved collections. This
document describes the collection of information for which NHTSA
intends to seek OMB approval.

DATES: Comments must be received on or before July 17, 2018.

ADDRESSES: You may submit comments identified by DOT Docket Number
NHTSA-2018-0057 using any of the following methods:
    Electronic submissions: Go to http://www.regulations.gov. Follow
the online instructions for submitting comments.
    Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590.
    Hand Delivery: West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Fax: 1-202-493-2251.
    Instructions: Each submission must include the agency name and the
docket number for this Notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided.

FOR FURTHER INFORMATION CONTACT: Dr. Kathy Sifrit, Contracting
Officer's Representative, Office of Behavioral Safety Research (NPD-
320), National Highway Traffic Safety Administration, 1200 New Jersey
Avenue SE, Washington, DC 20590. Dr. Sifrit's phone number is 202-366-
0868, and her email address is [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulations (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks public comment on
the following proposed collection of information:
    Title: Hazard Perception and Distracted Driving Training
Intervention for Teens.
    Type of Request: New information collection.
    OMB Clearance Number: None.
    Requested Expiration Date of Approval: Three years from date of
approval.
    Summary of the Collection of Information: The National Highway
Traffic Safety Administration (NHTSA) proposes to collect information
from licensed teen drivers for a one-time voluntary study to evaluate
Risk Awareness and Perception Training (RAPT), a hazard perception and
distracted driving training intervention for teens to improve driving
safety. NHTSA proposes to collect information from newly-licensed teen
drivers to determine (1) their eligibility to participate in a study to
evaluate RAPT hazard perception training; (2) their hazard perception
performance before and after they complete RAPT or placebo training,
and again six months after training; and (3) their driving exposure via
driving logs to account for potential differences across participants.
In addition, participants will agree to allow researchers to access
their crash and citation records for the first six months of driving to
support analyses of the effects of RAPT training on crash and citation
rates.
    These data will be analyzed to determine (1) whether, during the
first six months of driving, new drivers who complete RAPT training
have fewer crashes or traffic violations on their driving records than
comparison group members who receive placebo training, (2) when they do
crash, is there a difference in severity and at-fault between drivers
who took RAPT training versus those who received placebo training, (3)
is there a difference in driving exposure between those who

did and did not crash, and (4) is there an interaction between sex and
training group as measured by crashes or crash type.
    NHTSA will provide recruiting letters to an estimated 15,000 newly
licensed drivers ages 16 through 19. Participation will be voluntary
and solicited through the distribution of recruiting letters at
Department of Motor Vehicle locations (DMVs) when new drivers obtain
their license. The letter will contain the information a teen and their
guardian(s) need to make an informed decision about participating in
this study. Consent will be obtained through an informed consent
agreement approved by an Institutional Review Board (IRB).
    Consented study participants will be randomly assigned within age
(16, 17, 18 or 19 years) and sex categories to either participation in
the RAPT or the placebo condition. Participants in the RAPT condition
will complete the training protocol, which will include questions about
their driving exposure and crash/offence history in addition to hazard
recognition training. Those in the placebo condition will view a
vehicle maintenance video and respond to the same driving exposure and
crash/offence history questions. The RAPT training protocol is a
computerized training tool. Data regarding hazard perception skills
before and after the training will be captured as part of the
computerized program. Participants will also be invited to complete a
six month follow up test to see whether they retained the RAPT
training. The initial letter invitation will include a two-dollar
incentive. Participants who complete the first test will receive five
dollars, and those who complete the six month follow up will receive an
additional ten dollars. A subsample of participants will also be asked
to complete a trip log to record driving exposure, for which they will
receive another ten dollars.
    Background: The mission of the National Highway Traffic Safety
Administration (NHTSA) is to save lives, prevent injuries and reduce
economic costs due to motor vehicle crashes. In support of this
mission, NHTSA's Office of Behavioral Safety Research studies behaviors
and attitudes in highway safety, focusing on drivers, passengers,
pedestrians, and motorcyclists, and it uses the results to develop and
refine countermeasures to deter unsafe behaviors and promote safe
alternatives. The safety of teen drivers is of particular concern. In
2016 there were 1,908 young drivers 15 to 20 years old who died in
motor vehicle crashes. Nine percent of all drivers involved in fatal
crashes in 2016 were 15 to 20 years old, but these drivers only
accounted for 5.4 percent of the total number of licensed drivers. In
addition, motor vehicle traffic crashes were the leading cause of death
for youth (16 to 20) in 2015.
    Description of the Need for the Information and Proposed Use of the
Information: Exposure-based analyses of crash risk have consistently
shown that teens have an elevated crash risk. Further, crash risk
studies have identified that the lack of skills among teen drivers,
notably a limited ability to identify unexpected hazards on the road,
is one reason teen driver crash rates are so high. Previous evaluations
of RAPT have shown promise in terms of a training effect among teens. A
2017 NHTSA study showed RAPT training using software similar to that
proposed for the current study improved hazard detection in on-road
driving (DOT HS 812 379). A 2016 NHTSA evaluation of the effects of
RAPT on teen drivers' crashes in California, however, produced mixed
results (DOT HS 812 235). Crash analyses did not show an overall main
effect of the program but there was a significant effect for males.
Trained males had a 24% lower crash rate relative to the male
comparison group. There was no significant difference in females' crash
rates. While the results from the California study were encouraging,
promotion of this intervention requires additional evidence of
effectiveness in reducing crash risk.
    Data Collection Plan: Respondents will be drivers aged 16 to 19 who
received their provisional or unrestricted licenses (first licenses)
within the previous two weeks. Participants will be recruited within
two weeks of obtaining this license. Exclusion criteria are: Driver
received a provisional or first license more than two weeks ago; driver
is newly licensed but 20 years old or older; driver's parents do not
consent to inclusion of child in the study; driver is not able to
communicate in English; driver is not available for six-month follow-up
retest; driver is not planning on driving at least one trip per week;
driver has already received other hazard perception training. A roughly
equal distribution of males and females will be recruited within each
age cohort. Overall, 15,000 teens will be invited to participate in the
first jurisdiction; we expect 7,500 to agree to participate. Of those,
half will be randomly assigned to the treatment condition (RAPT
training) and the other half to the placebo condition (vehicle
maintenance video). To bolster the evaluation research design, we will
invite another 5,000 teens from a second jurisdiction to participate in
the placebo condition, and expect half of this group to agree. This
``external'' evaluation component will help rule out alternative
explanations in outcomes that are not associated with the RAPT
training.
    The initial invitation letter will be presented to 15,000 teens in
the first jurisdiction and 5,000 teens in the second. Teens and their
guardian(s) are expected to take an average of 2 minutes each to review
the letter, including study inclusion criteria, for a total of 2,000
hours (up to three respondents reviewing each letter). We expect to
recruit 10,000 participants (half of the 20,000 invitees). Teens who
agree to participate in the study are expected to spend 45 minutes
reading and signing the informed consent and completing the data
collection and training protocol for a total of 7,500 hours. A
subsample of 2,000 (of the 10,000) participants will also be asked to
complete a one-week trip log. Completing the trip log will take an
estimated 5 minutes per day or 35 minutes per week for a total of 1,167
hours. Finally, 7,500 (of the 10,000) participants will be asked to
complete the six-month follow-up test lasting 15 minutes for a total of
1,875 hours.
    Estimate of the Total Annual Reporting and Record Keeping Burden
Resulting from the Collection of Information: The total estimated
burden for recruitment (2,000 hours), the initial training and data
collection (7,500 hours), the trip log (1,167 hours) and the follow-up
data collection (1,875) is 12,542 hours.

    Authority: 44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC on May 15, 2018.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2018-10633 Filed 5-17-18; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Page 43654]
[FR Doc No: 2017-19687]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2017-0087]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
provides the public notice that on August 10, 2017, the Fort Worth
Transportation Authority (FWTA) on behalf of TexRail Commuter Railroad
(TEXR) petitioned the Federal Railroad Administration (FRA) for a
waiver of compliance from certain provisions of the Federal railroad
safety regulations for the purchase of eight new trainsets from Stadler
Bussnang AG (Stadler). Specifically, TEXR is requesting relief from 49
CFR part 229, Railroad Locomotive Safety Standards (Sec.  229.47); 49
CFR part 231, Railroad Safety Appliance Standards (Sec. Sec.
231.14(a)(2), (b)-(d), (f), (g)); and 49 CFR part 238, Passenger
Equipment Safety Standards (Sec.  238.305). FRA assigned the petition
docket number FRA-2017-0087.
    The TexRail commuter rail system consists of a single rail line,
running from Fort Worth, Texas, to the Dallas-Fort Worth International
Airport (DFW), a distance of 27-miles, with 9 stations. Service is
scheduled to begin in December 2018.
    TexRail will purchase eight new FLIRT Diesel Multiple Unit (DMU)
trainsets manufactured by Stadler in Salt Lake City, Utah. The delivery
of vehicles is expected to begin in October 2017 and end in May 2018.
TexRail asserts that the FLIRT trainset is a service-proven design
built to European design standards. It was first delivered to European
customers in 2004. There are approximately 1,100 FLIRT trainsets in
operation worldwide. TexRail vehicles will be the first FLIRT models in
the United States. The new vehicles are designed and built to current
European design and regulatory standards, which differ in several areas
from current U.S. design standards and regulations. TexRail believes
that the design characteristics of the Stadler FLIRT vehicles provide
an equivalent or higher level of safety and security to the passengers
and crew.
    TexRail has organized its regulatory compliance efforts into two
distinct but related parts: Part 1 represents the ``base'' compliance
assessment effort (this petition) and Part 2 represents a separate
petition to utilize Alternative Vehicle Technology crashworthiness
technology as outlined in ``Technical Criteria and Procedures for
Evaluating the Crashworthiness and Occupant Protection Performance of
Alternatively-Designed Passenger Rail Equipment for Use in Tier I
Service'' and the recent notice of proposed rulemaking (NPRM) on
Passenger Equipment Safety Standards; Standards for Alternative
Compliance and High-Speed Trainsets (81 FR 88006, December 6, 2016).
Noting that certain provisions in 49 CFR part 231 pertaining to safety
appliances are statutorily required, and therefore not subject to FRA's
waiver authority, TEXR also requested that FRA exercise its authority
under 49 U.S.C. 20306 to exempt TEXR from certain provisions of Chapter
203, Title 49 of the United States Code because the FLIRT DMU vehicles
will be equipped with their own array of safety devices resulting in
equivalent safety.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a new hearing. If any interested
parties desire an opportunity for oral comment and a public hearing,
they should notify FRA, in writing, before the end of the comment
period and specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by November 2, 2017 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.). In
accordance with 5 U.S.C. 553(c), DOT solicits comments from the public
to better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2017-19687 Filed 9-15-17; 8:45 am]
 BILLING CODE 4910-06-P