[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Rules and Regulations]
[Pages 70117-70121]
[FR Doc No: 2012-28456]

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

SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 270

[Release No. IC-30268; File No. S7-07-11]
RIN 3235-AL02

Purchase of Certain Debt Securities by Business and Industrial
Development Companies Relying on an Investment Company Act Exemption

AGENCY: Securities and Exchange Commission.

ACTION: Final rule.

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

SUMMARY: The Securities and Exchange Commission (``Commission'') is
adopting a new rule under the Investment Company Act of 1940
(``Investment Company Act'') to establish a standard of credit-
worthiness in place of a statutory reference to credit ratings that the
Dodd-Frank Wall Street Reform and Consumer Protection Act (``Dodd-Frank
Act'') removes. The rule will establish the standard of credit quality
that must be met by certain debt securities purchased by entities
relying on the Investment Company Act exemption for business and
industrial development companies.

DATES: Effective date: December 24, 2012.

FOR FURTHER INFORMATION CONTACT: Anu Dubey, Senior Counsel, or Penelope
Saltzman, Assistant Director<PHONE_NUMBER>, Office of Regulatory
Policy, Division of Investment Management, Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-8549.

SUPPLEMENTARY INFORMATION: The Commission is adopting new rule 6a-5 [17
CFR 270.6a-5] under the Investment Company Act.\1\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 80a-1. Unless otherwise noted, all references to
statutory sections are to the Investment Company Act, and all
references to rules under the Investment Company Act are to Title
17, Part 270 of the Code of Federal Regulations [17 CFR part 270].
---------------------------------------------------------------------------

Table of Contents

I. Background
II. Discussion
III. Paperwork Reduction Act
IV. Economic Analysis
V. Final Regulatory Flexibility Analysis
Statutory Authority
Text of Rule

I. Background

    The Dodd-Frank Act was enacted on July 21, 2010.\2\ Section 939(c)
of the Dodd-Frank Act removes a reference to credit ratings from
section 6(a)(5) of the Investment Company Act and replaces it with a
reference to ``such standards of credit-worthiness as the Commission
shall adopt.'' \3\ To implement this mandate, last year the Commission
proposed new rule 6a-5 under the Investment Company Act that would
establish a credit-worthiness standard to replace the credit rating
reference in section 6(a)(5) of that Act that the Dodd-Frank Act
eliminates.\4\ We received one comment letter regarding proposed rule
6a-5, which we discuss below.\5\ Today, we are adopting new rule 6a-5,
which implements section 939(c) of the Dodd-Frank Act.
---------------------------------------------------------------------------

    \2\ Public Law 111-203, 124 Stat. 1376 (2010).
    \3\ Section 939(c) of the Dodd-Frank Act (amending section
6(a)(5)(A)(iv)(I) of the Investment Company Act). This amendment to
the Investment Company Act becomes effective on July 21, 2012. See
section 939(g) of the Dodd-Frank Act.
    \4\ See References to Credit Ratings in Certain Investment
Company Act Rules and Forms, Investment Company Act Release No.
29592 (Mar. 3, 2011) [76 FR 12896 (Mar. 9, 2011)] (``2011 Proposing
Release''). In that release, we also proposed amendments to replace
references to credit ratings in rules 2a-7 and 5b-3 under the
Investment Company Act and Forms N-1A, N-2, N-3 and N-MFP under the
Investment Company Act and the Securities Act of 1933 (15 U.S.C.
77a). Those proposed amendments would implement section 939A of the
Dodd-Frank Act, which requires the Commission to review its
regulations for any references to or requirements regarding credit
ratings that require the use of an assessment of the credit-
worthiness of a security or money market instrument, remove these
references or requirements, and substitute in those regulations
other standards of credit-worthiness that we determine to be
appropriate. We intend to address the proposed amendments to rule
2a-7, rule 5b-3 and Forms N-1A, N-2, N-3 and N-MFP separately. Rule
3a-7 under the Investment Company Act also contains a reference to
ratings. In August 2011, in a concept release soliciting comment on
the treatment of asset-backed issuers under the Investment Company
Act, we sought comment on the role, if any, that credit ratings
should continue to play in the context of rule 3a-7. See Treatment
of Asset-Backed Issuers under the Investment Company Act, Investment
Company Act Release No. 29779 (Aug. 31, 2011) [76 FR 55308 (Sept. 7,
2011)] at Section III.A.1.
    \5\ The comment letters on the 2011 Proposing Release (File No.
S7-07-11) are available at http://www.sec.gov/comments/s7-07-11/s70711.shtml. In addition, to facilitate public input on the Dodd-
Frank Act, we provided a series of email links, organized by topic
on our Web site at http://www.sec.gov/spotlight/regreformcomments.shtml. The public comments we received in response
to our solicitation for comment on Title IX of the Dodd-Frank Act
(which includes sections 939 and 939A) are available on our Web site
at http://www.sec.gov/comments/df-title-ix/credit-rating-agencies/credit-rating-agencies.shtml.
---------------------------------------------------------------------------

II. Discussion

    Business and industrial development companies (``BIDCOs'') are
companies that operate under state statutes that provide direct
investment and loan financing, as well as managerial assistance, to
state and local enterprises.\6\ Because they invest in securities,
BIDCOs frequently meet the definition of ``investment company'' under
the Investment Company Act.\7\ In 1996, the Investment Company Act was
amended to add section 6(a)(5) to exempt these companies from most
provisions of the Act subject to certain conditions.\8\ The statutory
exemption was premised on states having a strong interest in overseeing
the structure and operations of these companies, thus rendering
regulation under the Investment Company Act largely duplicative and
unnecessary.\9\
---------------------------------------------------------------------------

    \6\ See Report of the Senate Committee on Banking, Housing and
Urban Affairs to Accompany S. 479, S. Rep. No. 103-166, at 11 (1993)
(``1993 Senate Report'').
    \7\ For purposes of the Investment Company Act, an ``investment
company'' means any issuer that: (A) Is or holds itself out as being
engaged primarily, or proposes to engage primarily, in the business
of investing, reinvesting, or trading in securities; (B) is engaged
or proposes to engage in the business of issuing face-amount
certificates of the installment type, or has been engaged in such
business and has any such certificate outstanding; or (C) is engaged
or proposes to engage in the business of investing, reinvesting,
owning, holding, or trading in securities, and owns or proposes to
acquire investment securities having a value exceeding 40 per centum
of the value of such issuer's total assets (exclusive of government
securities and cash items) on an unconsolidated basis. 15 U.S.C.
80a-3(a)(1).
    \8\ 15 U.S.C. 80a-6(a)(5); Public Law 104-290 Sec.  501, 110
Stat. 3416, 3444 (1996). Section 6(a)(5)(B) provides that section 9
and, to the extent necessary to enforce section 9, sections 38
through 51, apply to a BIDCO as though the company were a registered
investment company. Among other conditions to reliance on the
exemption in section 6(a)(5), a BIDCO may not issue redeemable
securities.
    \9\ See 1993 Senate Report, supra note 6, at 19 (further stating
that states are well positioned to monitor these companies and
address the needs of resident investors). Prior to the addition of
section 6(a)(5), the Commission had granted orders to exempt BIDCOs
from regulation under the Act. See, e.g., The Idaho Company,
Investment Company Release Nos. 18926 (Sept. 3, 1992) (notice) and
18985 (Sept. 30, 1992) (order).
---------------------------------------------------------------------------

    BIDCOs that seek to rely on the exemption in section 6(a)(5) are
limited with respect to the types of securities issued by investment
companies and companies exempt from the definition of investment
company under section 3(c)(1) or 3(c)(7) of the Investment Company Act
(``private funds'') that they may purchase. Specifically, section
6(a)(5)(A)(iv) prohibits these BIDCOs from purchasing securities issued
by investment companies and private funds other than debt securities
that are rated investment grade by at least one NRSRO and securities
issued by registered open-end investment companies that invest at least
65 percent of their assets in investment grade

securities or securities that the fund determines are comparable in
quality.\10\ This provision was intended to provide limited flexibility
to invest capital not immediately needed for the company's long-term
commitments.\11\ Although the legislative history of the provision does
not specifically explain why Congress restricted BIDCOs to acquiring
``investment grade'' debt of investment companies and private funds, as
we noted in the 2011 Proposing Release, it may have been designed to
limit BIDCOs to investing in debt securities of sufficiently high
credit quality that they are likely to maintain a fairly stable market
value and that could be liquidated easily, as appropriate, for the
BIDCO to support its investment and financing activities.\12\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 80a-6(a)(5)(A), as in effect prior to July 21,
2012 (exempting any company that is not engaged in the business of
issuing redeemable securities, the operations of which are subject
to regulation by the State in which the company is organized under a
statute governing entities that provide financial or managerial
assistance to enterprises doing business, or proposing to do
business in that state if, among other things, the company does not
purchase any security issued by an investment company or by any
company that would be an investment company except for the
exclusions from the definition of the term ``investment company''
under sections 3(c)(1) or 3(c)(7), other than (I) any debt security
that is rated investment grade by not less than 1 nationally
recognized statistical rating organization; or (II) any security
issued by a registered open-end fund that is required by its
investment policies to invest not less than 65% of its total assets
in securities described in subclause (I) or securities that are
determined by such registered open-end fund to be comparable in
quality to securities described in subclause (I)).
    \11\ See 1993 Senate Report, supra note 6, at 20.
    \12\ See 2011 Proposing Release, supra note 4, at Section II.D.
---------------------------------------------------------------------------

    As described above, section 939(c) of the Dodd-Frank Act eliminates
the credit rating reference in section 6(a)(5)(A)(iv) of the Investment
Company Act. Instead of limiting BIDCOs to purchasing debt securities
issued by investment companies and private funds that are rated
``investment grade,'' the amendment requires such debt securities to
meet ``such standards of credit-worthiness as the Commission shall
adopt.''
    We do not understand that the statutory amendment was intended to
change the standard of credit quality represented by an investment
grade rating. Accordingly, we are adopting rule 6a-5, as proposed, to
establish a standard of credit-worthiness designed to achieve the same
degree of risk limitation as the credit rating it replaces. Rule 6a-5
deems a BIDCO to have met the requirements for credit-worthiness of
certain debt securities under section 6(a)(5)(A)(iv)(I) if the board of
directors or members of the company (or its or their delegate)
determines, at the time of purchase, that the debt security is (i)
subject to no greater than moderate credit risk and (ii) sufficiently
liquid that the security can be sold at or near its carrying value
within a reasonably short period of time.\13\ The board of directors or
members of a BIDCO (or its or their delegate) would have to make this
determination at the time of acquisition of the securities.\14\ As a
result of rule 6a-5, section 6(a)(5) of the Investment Company Act will
also limit a BIDCO's investments in registered open-end funds to those
funds that invest at least 65 percent of their assets in debt
securities that meet our standard.\15\
---------------------------------------------------------------------------

    \13\ Rule 6a-5. The standard for credit-worthiness that we are
adopting in rule 6a-5 is similar to the standard that we adopted in
rule 10f-3 under the Investment Company Act. Rule 10f-3 defines
eligible municipal securities as securities that are sufficiently
liquid that they can be sold at or near their carrying value within
a reasonably short period of time and either are subject to no
greater than moderate credit risk or, if the issuer has been in
operation for less than three years, the securities are subject to a
minimal or low amount of credit risk. See rule 10f-3(a)(3).
    \14\ Rule 6a-5.
    \15\ Section 6(a)(5)(A)(iv)(II) (permitting a BIDCO to purchase
any security issued by a registered open-end fund that is required
by its investment policies to invest not less than 65% of its total
assets in securities described in subclause (I) (i.e., securities
that meet the standards of credit-worthiness that the Commission
adopts) or securities that are determined by such registered open-
end fund to be comparable in quality to securities described in
subclause (I)).
---------------------------------------------------------------------------

    The final rule does not, as one commenter suggested, include
specific factors or tests that the board must apply in performing its
credit analysis.\16\ We believe that the new credit quality standards
(that the debt security be subject to no greater than moderate credit
risk and be sufficiently liquid that it can be sold at or near its
carrying value within a reasonably short period of time) are clear
enough for a BIDCO's board or members (or its or their delegate) to
understand the risks acceptable under the rule. We note that the number
and scope of factors that may be appropriate to making a credit quality
determination with respect to a security may vary significantly
depending on the particular security. We are concerned that prescribing
a list of specific factors in a rule today might function as a limit to
the credit quality analysis that boards or members would undertake and
may not address information that would be relevant to credit quality
determinations regarding new types of debt securities that investment
companies or private funds may issue and in which BIDCOs may invest in
the future.\17\
---------------------------------------------------------------------------

    \16\ See Better Markets Comment Letter (Apr. 25, 2011) (``Better
Markets Comment Letter'') (asserting that the proposed standard is
vague and would undermine the reliability of a board's credit risk
determinations and the board's accountability for such
determinations).
    \17\ We also agree with this commenter, who acknowledged that a
reliable and objective shorthand measure of credit risk that could
be incorporated into Commission regulations is currently
unavailable. See Better Markets Comment Letter.
---------------------------------------------------------------------------

    The standard we are adopting is designed to limit BIDCOs to
purchasing debt securities issued by investment companies or private
funds of sufficiently high credit quality that they are likely to
maintain a fairly stable market value and may be liquidated easily, as
appropriate, for the BIDCO to support its investment and financing
activities.\18\ Debt securities (or their issuers) subject to a
moderate level of credit risk would demonstrate at least average
credit-worthiness relative to other similar debt issues (or issuers of
similar debt).\19\ Moderate credit risk would denote current low
expectations of default risk associated with the security, with an
adequate capacity for payment by the issuer of principal and
interest.\20\ In making their credit quality determinations, a BIDCO's
board of directors or members (or its or their delegate) can also
consider credit quality reports prepared by outside sources, including
NRSRO ratings, that the BIDCO board or members conclude are credible
and reliable for this purpose.
---------------------------------------------------------------------------

    \18\ See supra note 12 and accompanying text.
    \19\ See References to Ratings of Nationally Recognized
Statistical Rating Organizations, Investment Company Act Release No.
28939 (Oct. 5, 2009) [74 FR 52358 (Oct. 9, 2009)] at n.86 (release
adopting amendments to rule 10f-3).
    \20\ Id.
---------------------------------------------------------------------------

III. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (``PRA'') imposes certain
requirements on federal agencies in connection with their conducting or
sponsoring any collection of information as defined by the PRA. Rule
6a-5 does not create any new collections of information.

IV. Economic Analysis

    As discussed above, we are adopting a new rule to implement section
939(c) of the Dodd-Frank Act to replace a statutory reference to a
credit rating with an alternative credit-worthiness standard. We
considered the economic effects, including costs and benefits, of our
proposed new rule in the 2011 Proposing Release and we discuss below
the comment received related to our analysis.
    The Commission has discretion in adopting the alternative standard
of credit-worthiness, and we undertake

below to discuss the economic effects of the new rule that are within
our discretion under the Dodd-Frank Act, in addition to the economic
effects of removing rating references from statutory provisions, as
mandated by the Dodd-Frank Act itself. The two types of costs and
benefits may not be entirely separable to the extent that our
discretion is exercised to realize the benefits intended by the Dodd-
Frank Act. In evaluating the economic effects of new rule 6a-5, we
compare section 6(a)(5) of the Investment Company Act, as currently in
effect (which includes a reference to a rating), with the new rule we
are adopting.
    Rule 6a-5 establishes a credit-worthiness standard under section
6(a)(5)(A)(iv)(I) of the Investment Company Act. BIDCOs that seek to
rely on the exemption in section 6(a)(5) of the Act are limited to
investing in debt securities issued by investment companies and private
funds if, at the time of purchase, the board of directors or members of
the BIDCO (or its or their delegate) determines that the debt security
is (i) subject to no greater than moderate credit risk and (ii)
sufficiently liquid that the security can be sold at or near its
carrying value within a reasonably short period of time.
    We anticipate that the adoption of rule 6a-5 may result in certain
benefits. First, we do not understand that by amending section 6(a)(5),
Congress intended to change the credit quality of the debt securities
that BIDCOs may purchase and our rule is designed to establish a
similar credit quality standard in order to achieve the same limitation
on risk as the credit rating it replaces. In particular, the amended
standard is designed to limit BIDCOs to purchasing debt securities
issued by investment companies or private funds of sufficiently high
credit quality that they are likely to maintain a fairly stable market
value and may be liquidated easily, as appropriate, for the BIDCO to
support its investment and financing activities. Second, the subjective
credit quality standard in amended rule 6a-5 may provide BIDCOs greater
flexibility in determining the pool of eligible debt securities in
which they may invest. Finally, the credit quality standard in new rule
6a-5 may further Congress' stated purpose of reducing reliance on
ratings in the context of a BIDCO's purchase of certain debt
securities.\21\
---------------------------------------------------------------------------

    \21\ See Report of the House of Representatives Financial
Services Committee to Accompany H.R. 4173, H. Rep. No. 111-517, at
871 (2010).
---------------------------------------------------------------------------

    We also recognize that BIDCOs may incur some costs as a result of
the adoption of new rule 6a-5. These may be internal costs or costs to
consult outside legal counsel to evaluate whether changes to any
policies and procedures the BIDCOs may have currently for acquiring
debt securities issued by investment companies or private funds may be
appropriate in light of the new rule. We expect that, although not
required by the Investment Company Act, as a matter of good business
practice, directors or members of most BIDCOs that do not currently
have them may prepare policies and procedures to make the credit
quality and liquidity determinations required by the new rule. Staff
estimates that BIDCOs will incur the costs of preparing the procedures
for making determinations of credit quality and liquidity under the
rule once, and directors and members of BIDCOs (or their delegates)
will be able to follow these procedures for purposes of making future
determinations under the rule. Commission staff estimated in the 2011
Proposing Release that each BIDCO would incur, on average, an initial
one-time cost of $1000 to prepare policies and procedures and an
average of $1000 in annual costs for making credit determinations with
respect to the acquisition of debt securities.\22\ We received no
comments on those estimates. We note however, that under rule 6a-5, in
evaluating whether debt securities issued by investment companies and
private funds present moderate credit risk, boards of directors and
members of BIDCOs (or its or their delegates) can consider credit
quality determinations prepared by outside sources, including NRSRO
ratings, that they conclude are credible and reliable for purposes of
making these determinations, and we anticipate that many BIDCOs that
invest cash in these types of debt securities will continue to do so.
We expect that the ability to consider outside assessments will help
minimize the burden on BIDCOs and contribute to a BIDCO's ability to
make consistent and reliable credit quality determinations.
Nevertheless, we recognize that some BIDCO boards or members may choose
to hire consultants to assist in developing procedures and to make or
oversee the determinations. Staff estimated in the 2011 Proposing
Release that the cost to hire such consultants would be, on average,
$8000 for each BIDCO.\23\ We received no comments on this estimate.
---------------------------------------------------------------------------

    \22\ See 2011 Proposing Release, supra note 4, at n.112. Staff
does not have reliable data and is not aware of any databases that
compile information regarding the number of existing BIDCOs.
Moreover, we received no data from commenters. We note that some
state regulators disclose the number of BIDCOs registered in the
state on the regulators' Web sites. Of those that do, the number of
registered BIDCOs ranges from one to 10. See, e.g., Louisiana Office
of Financial Institutions at http://www.ofi.state.la.us/ (listing 10
BIDCOs in a directory of active BIDCOs); California Department of
Financial Institutions at http://www.dfi.ca.gov/directory/bidco.asp
(listing one BIDCO in a directory of BIDCOs). We estimate that each
BIDCO would incur on average a one-time burden of 4 hours for a
senior business analyst (under board or member delegation) to
develop policies and procedures for evaluating credit and liquidity
risk (4 hours x $237 per hour = $948). The staff estimates that the
internal cost for time spent by a senior business analyst is $237
per hour. This estimate, as well as other internal time cost
estimates made in this analysis, are derived from SIFMA's Management
and Professional Earnings in the Securities Industry 2011, modified
by Commission staff to account for an 1800-hour work week and
multiplied by 5.35 to account for bonuses, firm size, employee
benefits and overhead. Commission staff believes that additional
costs incurred by boards or members for review of procedures would
be incorporated into BIDCOs' overall board or member costs and would
not add any particular costs. In addition, Commission staff
estimates that a BIDCO board or member is likely to delegate the
credit risk determinations, and that such determinations would take
on average 1 hour of a senior business analyst's time (at $237 per
hour) to evaluate the credit quality for each of an average of four
investment company or private fund debt securities that a BIDCO
would purchase each year (4 hours x $237 per hour) for a total cost
of $948 per year. Staff has calculated these estimates using an
internal cost estimate for a business analyst's time that is updated
from the one used in calculating the estimates in the 2011 Proposing
Release.
    \23\ See 2011 Proposing Release, supra note 4, at n.114 and
accompanying text. Staff estimates that a BIDCO may need up to 16
hours of consulting advice to assist in developing procedures and to
make or oversee the proposed determinations. Staff estimates that
this advice would cost a BIDCO $500 per hour based on an
understanding of the rates typically charged by outside consulting
firms resulting in an average cost of $8000 for each BIDCO.
---------------------------------------------------------------------------

    Adopting a new credit quality standard in place of the ratings
requirement in section 6(a)(5)(A)(iv) of the Investment Company Act may
result in other costs for BIDCOs and their investors. The minimum
rating requirement in section 6(a)(5)(A)(iv) of the Act, before it was
amended by the Dodd-Frank Act, established an objective standard that
is easy to apply and may have limited BIDCOs from investing in
securities that posed greater credit risks. The new rule instead
requires BIDCO boards or members to assess credit quality by applying a
subjective standard. We acknowledge that a BIDCO could invest in lower
quality debt securities that it determines meets the standard in new
rule 6a-5, and that it may be difficult for the Commission to challenge
the determination of a BIDCO's directors or members (or their
delegates). In addition, because credit quality assessments could
differ across BIDCOs, the range of risk of investments may be broader
than it is currently. We do not,

however, believe that the new rule is likely to lead BIDCOs to invest
in riskier securities because the standard we are adopting is very
similar to the standard articulated by the rating agencies for
investment grade securities.\24\
---------------------------------------------------------------------------

    \24\ See Moody's Investor Service, Ratings Symbols and
Definitions (June 2012), http://www.moodys.com/researchdocumentcontentpage.aspx?docid=PBC_79004, at 5
(``Obligations rated Baa are judged to be medium-grade and subject
to moderate credit risk and as such may possess certain speculative
characteristics.''); FitchRatings, Definitions of Ratings and Other
Forms of Opinion (Apr. 2012), http://www.fitchratings.com/web_content/ratings/fitch_ratings_definitions_and_scales.pdf, at 12
(```BBB' ratings indicate that expectations of credit risk are
currently low. The capacity for payment of financial commitments is
considered adequate but adverse business or economic conditions are
more likely to impair this capacity.'') The term ``investment
grade'' is generally used to describe the categories `BBB' (or
comparable) or above. See id., at 6.
---------------------------------------------------------------------------

    As part of our economic analysis, we considered alternatives to the
standard that we are adopting in rule 6a-5. In particular, we
considered including specific factors or tests that a fund board must
apply in performing its credit analysis in the rule. As noted above, we
believe that this alternative could function as a limit to a fund's
credit quality analysis \25\ and thus might result in a less effective
credit quality determination than a BIDCO would perform under the
credit quality standard in the new rule, which could result in
investments that expose the BIDCO to greater risk.
---------------------------------------------------------------------------

    \25\ See supra paragraph accompanying note 17.
---------------------------------------------------------------------------

V. Final Regulatory Flexibility Analysis

    The Commission has prepared the following Final Regulatory
Flexibility Analysis (``FRFA'') in accordance with section 4(a) of the
Regulatory Flexibility Act regarding new rule 6a-5, which we are
adopting today to give effect to provisions of the Dodd-Frank Act.\26\
We prepared an Initial Regulatory Flexibility Analysis (``IRFA'') in
conjunction with the 2011 Proposing Release in March 2011.\27\
---------------------------------------------------------------------------

    \26\ 5 U.S.C. 604(a).
    \27\ See 2011 Proposing Release, supra note 4, at Section VIII.
---------------------------------------------------------------------------

A. Need for and Objectives of the Rule and Form Amendments and New Rule

    As described more fully in Sections I and II of this Release, the
Commission is adopting new rule 6a-5 to set forth a standard of credit-
worthiness for purposes of section 6(a)(5)(A)(iv) of the Investment
Company Act, as anticipated by section 939(c) the Dodd Frank Act, which
eliminates the investment grade standard from section 6(a)(5) of the
Investment Company Act.

B. Significant Issues Raised by Public Comment

    In the Proposing Release, we requested comment on the IRFA. In
particular, we sought comment on how many small entities would be
subject to the proposed new rule and whether the effect of the proposed
new rule on small entities subject to it would be economically
significant. None of the comment letters we received specifically
addressed the IRFA. None of the comment letters specifically addressed
the effect of the new rule on small BIDCOs.

C. Small Entities Subject to the Rule and Form Amendments and New Rule

    New rule 6a-5 under the Investment Company Act would affect BIDCOs,
including entities that are considered to be a small business or small
organization (collectively, ``small entity'') for purposes of the
Regulatory Flexibility Act. Under the standards adopted by the Small
Business Administration, small entities in the financial investment
industry include entities with $7 million or less in annual
receipts.\28\ We do not have any data and are not aware of any
databases that compile information regarding how many BIDCOs would be
small entities under this definition. We also did not receive any
comments from BIDCOs.
---------------------------------------------------------------------------

    \28\ 13 CFR 121.201.
---------------------------------------------------------------------------

D. Projected Reporting, Recordkeeping, and Other Compliance
Requirements

    Rule 6a-5 imposes no reporting, recordkeeping or other compliance
requirements.

E. Agency Action To Minimize Effect on Small Entities

    The Regulatory Flexibility Act directs us to consider significant
alternatives that would accomplish our stated objectives, while
minimizing any significant adverse effect on small entities. In
connection with the new rule, the Commission considered the following
alternatives: (i) Establishing different compliance standards or
timetables that take into account the resources available to small
entities; (ii) clarifying, consolidating, or simplifying compliance and
reporting requirements under the rule for small entities; (iii) use of
performance rather than design standards; and (iv) exempting small
entities from all or part of the requirements.
    We believe that special compliance or reporting requirements for
small entities, or an exemption from coverage for small entities, is
not appropriate or consistent with investor protection or section
939(c) of the Dodd-Frank Act, which rule 6a-5 implements. With respect
to rule 6a-5, we believe that special compliance requirements or
timetables for small entities, or an exemption from coverage for small
entities, may create a risk that those BIDCOs could acquire debt
securities that are not of sufficiently high credit quality that they
would be likely to maintain a fairly stable market value or be
liquidated easily, as we believe may have been intended for the BIDCO
to support its long-term commitments. Further consolidation or
simplification of rule 6a-5 for BIDCOs that are small entities is
inconsistent with the Commission's goals of fostering investor
protection. Finally, rule 6a-5 uses performance rather than design
standards for determining the credit quality of specific debt
securities.

Statutory Authority

    The Commission is adopting new rule 6a-5 under the authority set
forth in section 38(a) of the Investment Company Act [15 U.S.C. 80a-
37(a)] and section 939 of the Dodd-Frank Act, to be codified at section
6(a)(5)(A)(iv)(I) of the Investment Company Act [15 U.S.C. 80a-
6(a)(5)(A)(iv)(I)].

List of Subjects in 17 CFR Part 270

    Investment companies, Reporting and recordkeeping requirements,
Securities.

Text of Rule

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

0
1. The authority citation for part 270 is amended by adding a sub-
authority in numerical order to read as follows:

    Authority: 15 U.S.C. 80a-1 et seq., 80a-34(d), 80a-37, and 80a-
39, unless otherwise noted.
* * * * *

    Section 270.6a-5 is also issued under 15 U.S.C. 80a-
6(a)(5)(A)(iv)(I).

* * * * *

0
2. Section 270.6a-5 is added to read as follows:

Sec.  270.6a-5  Purchase of certain debt securities by companies
relying on section 6(a)(5) of the Act.

    For purposes of reliance on the exemption for certain companies
under section 6(a)(5)(A) of the Act (15 U.S.C. 80a-6(a)(5)(A)), a
company shall be deemed to have met the requirement for credit-
worthiness of certain debt securities under section 6(a)(5)(A)(iv)(I)
of the Investment Company Act (15 U.S.C. 80a-6(a)(5)(A)(iv)(I)) if, at
the time of purchase, the board of directors

(or its delegate) determines or members of the company (or their
delegate) determine that the debt security is:
    (a) Subject to no greater than moderate credit risk; and
    (b) Sufficiently liquid that it can be sold at or near its carrying
value within a reasonably short period of time.

    By the Commission.

    Dated: November 19, 2012.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-28456 Filed 11-21-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Notices]
[Pages 41980-41981]
[FR Doc No: 2012-17319]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Uniontown Hydro, LLC, Project No. 12958-001-Kentucky and Indiana,
Uniontown Hydroelectric Project; Newburgh Hydro, LLC, Project No.
12962-001-Kentucky and Indiana, Newburgh Hydroelectric Project; Notice
of Revised Restricted Service List for a Programmatic Agreement

    Rule 2010 of the Federal Energy Regulatory Commission's
(Commission's) Rules of Practice and Procedure, 18 CFR 385.2010,
provides that, to eliminate unnecessary expense or improve
administrative efficiency, the Secretary may establish a restricted
service list for a particular phase or issue in a proceeding. The
restricted service list should contain the names of persons on the
service list who, in the judgment of the decisional authority
establishing the list, are active participants with respect to the
phase or issue in the proceeding for which the list is established.
    The Commission staff is consulting with the Kentucky State Historic
Preservation Officer (SHPO), the Indiana SHPO, and the Advisory Council
on Historic Preservation (Advisory Council) pursuant to the Advisory
Council's regulations, 36 CFR Part 800, implementing section 106 of the

National Historic Preservation Act, as amended (16 U.S.C. 470f), to
prepare a programmatic agreement for managing properties included in,
or eligible for inclusion in, the National Register of Historic Places
that could be affected by issuances of licenses for the proposed
Uniontown Hydroelectric Project and Newburgh Hydroelectric Project.
    The programmatic agreement, when executed by the Commission, the
Kentucky SHPO, the Indiana SHPO, and the Advisory Council would satisfy
the Commission's section 106 responsibilities for all individual
undertakings carried out in accordance with the licenses until the
licenses expire or are terminated (36 CFR 800.13(e)). The Commission's
responsibilities pursuant to section 106 for the proposed projects
would be fulfilled through the programmatic agreement, which the
Commission staff proposes to draft in consultation with certain
parties.
    On December 8, 2010, the Commission staff established a restricted
service list for the proposed Uniontown Hydroelectric Project and
Newburgh Hydroelectric Project.
    The Commission staff is updating the restricted service list to
reflect the parties as follows:

John Fowler, Executive Director, Advisory Council on Historic
Preservation, The Old Post Office Building, Suite 803, 1100
Pennsylvania Avenue NW., Washington, DC 20004.
Jill A. McNutt, Kentucky Heritage Council, 300 Washington Street,
Frankfort, KY 40601.
Phillip Johnson, Kentucky Heritage Council, 300 Washington Street,
Frankfort, KY 40601.
Cathy Draeger-Williams, Indiana Division of Historic Preservation &
Archaeology, 402 W. Washington Street, W274, Indianapolis, IN 46204.
Chad Slider, Indiana Division of Historic Preservation & Archaeology,
402 W. Washington Street, W274, Indianapolis, IN 46204.
Erik Steimle or Representative, Symbiotics, 2950 SE Stark Street, Suite
110, Portland, OR 97214.
Julie Olds, Miami Tribe of Oklahoma, P.O. Box 1326, Miami, OK 74355.
Bill Anoatubby, Governor, The Chickasaw Nation, P.O. Box 1548, Ada, OK
74821-1548.
Gingy Nail, THPO, The Chickasaw Nation, P.O. Box 1548, Ada, OK 74821-
1548.
Ken Lamkin or Representative, U.S. Army Corps of Engineers, P.O. Box
59, Louisville, KY 40201-0059.

    Dated: July 9, 2012.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-17319 Filed 7-16-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 30 (Monday, February 14, 2011)]
[Proposed Rules]
[Pages 8322-8324]
[FR Doc No: 2011-3219]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-1264; Airspace Docket No. 10-AWP-23]

Proposed Amendment of Class D and Class E Airspace; Livermore, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace at Livermore,
CA, to accommodate aircraft using new Instrument Landing System (ILS)

Localizer (LOC) standard instrument approach procedures at Livermore
Municipal Airport, and would also correct the airspace designation.
This action also would correct a typographical error in the airspace
description for Class D airspace. The FAA is proposing this action to
enhance the safety and management of Instrument Flight Rules (IFR)
operations at the airport.

DATES: Comments must be received on or before March 31, 2011.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2010-
1264; Airspace Docket No. 10-AWP-23, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2010-1264 and Airspace Docket No. 10-AWP-23) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2010-1264 and Airspace Docket No. 10-AWP-23''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue, SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace extending
upward from 700 feet above the surface at Livermore Municipal Airport,
Livermore, CA. This action also would add the airport name and
geographic coordinates to the Class E airspace designation. Controlled
airspace is necessary to accommodate aircraft using the new ILS LOC
standard instrument approach procedures at Livermore Municipal Airport.
Also, this action would correct a typographic error in the regulatory
text of the Class D airspace area by correcting the word `iport' to
`Airport'. This action would enhance the safety and management of
aircraft operations at the Airport.
    Class D and Class E airspace designations are published in
paragraph 5000 and 6005, respectively, of FAA Order 7400.9U, dated
August 18, 2010, and effective September 15, 2010, which is
incorporated by reference in 14 CFR 71.1. The Class D and Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes additional controlled airspace at Livermore Municipal
Airport, Livermore, CA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010 is amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

AWP CA D Livermore, CA [Amended]

Livermore Municipal Airport, CA
    (Lat. 37[deg]41'36'' N., long. 121[deg]49'13'' W.)

    That airspace extending upward from the surface to and including
2,900 feet MSL within a 4-mile radius of Livermore Municipal
Airport. This Class D airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

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

* * * * *

AWP CA E5 Livermore, CA [Amended]

Livermore Municipal Airport, CA
    (Lat. 37[deg]41'36'' N., long. 121[deg]49'13'' W.)

    That airspace extending upward from 700 feet above the surface
within 8.1 miles north and 4 miles south of the Livermore Municipal
Airport 091[deg] bearing extending 23 miles east of Livermore
Municipal Airport, and within 3.5 miles north and 4 miles south of
the Livermore Municipal Airport 271[deg] bearing extending 2.6 miles
west of the airport.

    Issued in Seattle, Washington, on February 7, 2011.
John Warner,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2011-3219 Filed 2-11-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Pages 1419-1421]
[FR Doc No: 2022-00327]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0609]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Drug Supply Chain
Security Act Implementation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by February 10, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0806. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-45, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Drug Supply Chain Security Act Implementation

OMB Control Number 0910-0806--Revision

    This information collection supports Agency implementation of
provisions in section 582 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) regarding the pharmaceutical distribution supply chain.
Section 202 of the Drug Supply Chain Security Act (DSCSA) (Title II of
Pub. L. 113-54), added sections 581 and 582 to the FD&C Act (21 U.S.C.
360eee and 360eee-1) and governs the tracing of certain pharmaceutical
drugs, outlining critical steps for an electronic interoperable system
to identify these

products as they are distributed within the United States.
    To strengthen FDA's ability to help protect consumers from exposure
to drugs that may be counterfeit, stolen, contaminated, or otherwise
harmful, section 203 of the DSCSA added enhanced security provisions to
section 582 of the FD&C Act. The terms and definitions established in
section 581 of the FD&C Act are applicable to provisions set forth in
section 582, which require the capture, exchange, and verification of
pharmaceutical drug product transaction information, transaction
history, and transaction statements by respondents. Section 582 of the
FD&C Act also requires that certain notifications are made by
respondents to FDA and provides for respondent notification disclosures
applicable to suspect and illegitimate product data elements. The
recordkeeping and notification provisions included in section 582 also
provide for inspection of records by FDA and establish minimum
retention schedules. Finally, section 582 of the FD&C Act provides for
the establishment of waivers, exceptions, and exemptions from any of
the requirements.
    To assist respondents with reporting requirements, we developed
Form FDA 3911 entitled Drug Notification and the corresponding
instructional document ``INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911--
DRUG NOTIFICATION.'' Form FDA 3911 and the instructions are available
from, and may be completed using, our website at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions. Form FDA 3911 is intended to provide a
uniform format for initial notifications, followup notifications, and
requests for the termination of a notification. The guidance document
entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification'' (Revision 1, June
2021; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification) was developed to
assist respondents with identifying a suspect product as defined at
section 581(21) of the FD&C Act and in making determinations in this
regard.
    We also developed the draft guidance document entitled ``Waivers,
Exceptions, and Exemptions from the Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act'' (May 2018; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act). Respondents seeking waivers, exceptions,
or exemptions from any of the requirements may submit a request to FDA.
The draft guidance explains Agency established processes by which: (1)
A trading partner may request a waiver from certain requirements in
section 582 of the FD&C Act if it would result in an undue economic
hardship or for emergency medical reasons; (2) a manufacturer or
repackager may request an exception to the section 582 requirements
related to product identifiers if a product is packaged in a container
too small or otherwise unable to accommodate a label with sufficient
space to bear the required information; and (3) FDA may determine other
products or transactions that shall be exempt from requirements of
section 582.
    Respondents to the information collection are manufacturers,
wholesale distributors (``wholesalers''), dispensers, and repackagers,
as defined in section 581 of the FD&C Act, of pharmaceutical drug
products.
    In the Federal Register of September 3, 2021 (86 FR 49538), we
published a 60-day notice soliciting public comment on the proposed
collection of information. A few comments were received requesting that
FDA clarify the scope of the information collection request. We
appreciate these comments. Although our 60-day notice discussed both
draft and final guidance documents pertaining to topic-specific
statutory requirements found in section 582 of the FD&C Act, not all
the guidance documents discussed in the notice included information
collection as defined by the PRA and subject to review and approval by
OMB. Rather, consistent with regulations found in 21 CFR 10.115,
guidance documents are intended to communicate the Agency's thinking on
a particular topic and can therefore be helpful to respondents in
understanding related information collection activities.
    To clarify however, this information collection request is intended
to account for the burden respondents may incur from completing and
submitting notifications as required by section 582 of the FD&C Act
using Form FDA 3911, consistent with the corresponding instructions, as
well as the burden that may be attributable to information collection
associated with the required disclosures/notifications to trading
partners and discussed in the guidance document entitled ``Drug Supply
Chain Security Act Implementation: Identification of Suspect Product
and Notification.'' The information collection request is also intended
to account for the burden that respondents may incur associated with
requesting waivers, exceptions, and exemptions provided for in section
582(a)(3) of the FD&C Act. To enable respondents to make such requests,
we are currently utilizing information collection recommendations
discussed in the draft guidance document entitled ``Waivers,
Exceptions, and Exemptions from the Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act.'' Specifically, the draft
guidance instructs respondents on submitting requests and identifies
responsible Agency review components.
    The comments also provided feedback on the accuracy of our burden
estimates. In response to these comments, we have revised our estimate
of the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                     Average time
    Sec. 582 of the FD&C Act;        Number of     responses per   Total annual    per response     Total hours
            activity                respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
Notifications of illegitimate                500            28.2          14,100               8         112,800
 product: Form FDA 3911.........
Consultation/terminations of                 500               1             500               1             500
 notification of illegitimate
 product (Notifications
 Guidance, sec. IV.B)...........
----------------------------------------------------------------------------------------------------------------
                       582(a)(3); Waivers, exceptions, and exemptions of any requirement:
----------------------------------------------------------------------------------------------------------------
Request submissions (Waivers                  20               1              20              80           1,600
 Guidance, sec. III.A.).........
Material changes (Waivers                      1               1               1              16              16
 Guidance, sec. III.D)..........

Request renewals (Waivers                      1               1               1              16              16
 Guidance, sec. III)............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         114,932
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                 Table 2--Estimated Annual Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                     Average time
    Sec. 582 of the FD&C Act;        Number of      disclosures        Total      per disclosure    Total hours
            activity                respondents   per respondent    disclosures     (in hours)
----------------------------------------------------------------------------------------------------------------
Illegitimate product                         500             310         155,000               8       1,240,000
 notifications to trading
 partners (Notifications
 Guidance, sec. III.B)..........
Illegitimate product                         500             310         155,000               4         620,000
 notification terminations to
 trading partners (Notifications
 Guidance, sec. III)............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       1,860,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have reorganized the information collection by respondent
activity and clarified where information collection elements are
discussed in the respective guidance documents. Based on illegitimate
product notifications FDA has already received, we previously estimated
a total of 250 respondents. However, we have considered industry
feedback indicating that more notifications may be submitted based on
stakeholder understanding of FDA's recent clarification of stolen
product in the ``Definitions of Suspect Product and Illegitimate
Product for Verification Obligations Under the Drug Supply Chain
Security Act'' draft guidance (June 2021; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/definitions-suspect-product-and-illegitimate-product-verification-obligations-under-drug-supply). As such, we have increased our number
of estimated respondents to 500 and assume 40 percent are manufacturers
(200), 50 percent are wholesale distributors (250), and 10 percent are
pharmacies (50). Because manufacturers, repackagers, and wholesale
distributors are collectively responsible for prescription drugs from
the point of manufacturing through distribution in the drug supply
chain, we continue to assume that these three trading partners submit
most notifications of illegitimate products.
    In response to industry feedback, we have increased our estimate of
the average time per response from 1 hour to 8 hours to more accurately
reflect the burden respondents may incur in satisfying the information
collection. We have otherwise retained the average burden per response
for activities associated with consultations and waiver/exception/
exemption requests. Finally, also based on public comment and industry
feedback, we have increased our estimate of the average number of
disclosures/notifications per respondent, as well as our assumption of
the average time necessary for each disclosure notification, for an
increase from 66,070 to 1,860,000 hours annually.
    As a result of these adjustments, our estimated burden for the
information collection reflects a cumulative increase since the last
OMB review and approval. We attribute this increase to a more recent
evaluation of the information collection and informal communications
with industry and other interested stakeholders regarding burden
estimates.

    Dated: January 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00327 Filed 1-10-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 3, 2010 (Volume 75, Number 171)]
[Rules and Regulations]
[Page 54026-54028]
[DOCID:fr03se10-14]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0728]
RIN 1625-AA00

Safety Zone; Red Bull Flugtag, Delaware River, Camden, NJ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone in an
area of the Delaware River, Camden, NJ, described as North of the
Wiggins park Marina and South of the Benjamin Franklin Bridge. The
safety zone will restrict vessel traffic from a portion of the Delaware
River during the Red Bull Flugtag event. The safety zone is necessary
to protect event participants, life, and property.

DATES: This rule is effective from 10 a.m. until 5 p.m. on September 4,
2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0728 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0728 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail LT Corrina Ott, Coast Guard; telephone
215-271-4902, e-mail<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because publishing an NPRM is impracticable
and contrary to the public interest. Delaying the effective date by
first publishing an NPRM and holding a comment period would be contrary
to the rule's objectives of ensuring safety of life on the navigable
waters during this scheduled event as immediate action is needed to
protect participants of the event from vessels and vessels from any
debris in the water as a result from the event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Any delay in the effective date of
this regulation would be contrary to the public interest as immediate
action is participants of the event from vessels and vessels from any
debris in the water as a result from the event.

Basis and Purpose

    Red Bull has contracted to conduct a Flugtag event along the Camden
Riverfront. During this event participants will enter the Delaware
River from an elevated platform, utilizing makeshift flying apparatuses
with the intent to maintain a controlled descent into the Delaware
River. This safety zone will help protect both life and property on the
navigable waterways of the Delaware River in respect to event
participants and commercial and recreational vessel traffic.

Discussion of Rule

    The Coast Guard establishes a temporary safety zone on the Delaware
River in Camden, NJ from 10 a.m. to 5 p.m. on September 4, 2010. The
safety zone will restrict vessel traffic on the Delaware River in the
immediate area of the Red Bull Flugtag event taking place inside a
boundary described as originating from the shoreline then west to
39[deg]56'54'' N, 075[deg]07'59'' W then north to 39[deg]56'56'' N,
075[deg]07'58'' W then north to 39[deg]56'58'' N, 075[deg]07'58'' W
then east to 39[deg]56'58'' N, 075[deg]07'56'' W then east to the
shoreline. The safety zone will protect event participants, life, and
property while preventing vessel traffic from navigating on the
Delaware River in an area described as north of the Wiggins Park Marina
and south of the Benjamin Franklin Bridge. Except for persons or
vessels authorized by the Coast Guard Patrol Commander, no person or
vessel may enter or remain in the regulated area during the enforcement
period. The COTP will notify the public of specific enforcement times
by marine Radio Safety Broadcast.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. Due to the location of the safety zone
being outside of and East of Anchorage Area 13, as well as
being located in an area not subject to regular flow of vessel traffic,
the regulatory impact is expected to be minimal.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities: the owners or operator so vessel intending to transit East of
Anchorage Area 13 in the Delaware River South of the Benjamin
Franklin Bridge from 10 a.m. to 5 p.m. on September 4, 2010.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule will be enforced for seven hours on September 4, 2010.
Additionally, the safety zone is located in an area where vessel
traffic does not regularly transit, approximately 375 yards to the East
of the main ship channel located in the Delaware River. Vessel traffic
can pass safely around the zone. Before the enforcement period, the
Coast Guard will issue maritime advisories widely available to users of
the river.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.

Collection of Information

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

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and

Interference with Constitutionally Protected Property Rights.

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction and neither an environmental assessment nor an
environmental impact statement is required. This rule involves a
limited-in-duration safety zone intended to protect life and property
on the navigable waterways of the Delaware River. An environmental
analysis checklist and a categorical exclusion determination will be
made available in the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1

0
2. Add Sec.  165.T05-0728 to read as follows:

Sec.  165.T05-0728  Safety Zone; Red Bull Flugtag, Delaware River,
Camden, NJ

    (a) Location. The safety zone includes all waters inside a boundary
described as originating from the shoreline then west to 39[deg]56'54''
N, 075[deg]07'59'' W then north to 39[deg]56'56'' N, 075[deg]07'58'' W
then north to 39[deg]56'58'' N, 075[deg]07'58'' W then east to
39[deg]56'58'' N, 075[deg]07'56'' W then east to the shoreline.
    (b) Definitions. (1) Coast Guard Patrol Commander means a
commissioned, warrant, or petty officer of the Coast Guard who has been
designated by the COTP, Delaware Bay.
    (2) Official Patrol means any vessel assigned or approved by COTP,
Sector Delaware Bay with a commissioned, warrant, or petty officer on
board and displaying a Coast Guard ensign as well as any assisting
local law enforcement vessels.
    (c) Regulations:
    (1) Except for persons or vessels authorized by the Coast Guard
Patrol Commander, no person or vessel may enter or remain in the
regulated area.
    (2) The operator of any vessel in the regulated area shall:
    (i) Stop the vessel immediately when directed to do so by any
Official Patrol.
    (ii) Proceed as directed by any Official Patrol.
    (d) Effective Period. The safety zone will be in effect from 10
a.m. to 5 p.m. on September 4, 2010.

    Dated: July 29, 2010.
R.T. Gatlin,
Captain, U.S. Coast Guard, Acting Captain of the Port Delaware Bay.
[FR Doc. 2010-22032 Filed 9-2-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 40 (Friday, February 28, 2014)]
[Notices]
[Pages 11454-11455]
[FR Doc No: 2014-04415]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2014-0007; OMB No. 1660-0128]

Agency Information Collection Activities: Proposed Collection;
Comment Request, Federal Emergency Management Agency Individual
Assistance Program Effectiveness and Recovery Surveys

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the collection of Individual
Assistance Program Effectiveness & Recovery Survey responses and
information for assessment and improvement of the delivery of disaster
assistance to individuals and households.

DATES: Comments must be submitted on or before April 29, 2014.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2014-0007. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., Room 8NE, Washington, DC
20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Maggie Billing, Program Analyst,
Customer Satisfaction Analysis Section of the National Processing
Service Center Division, Recovery Directorate,<PHONE_NUMBER>. You may
contact the Records Management Division for copies of the proposed
collection of information at facsimile number<PHONE_NUMBER> or email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This collection is in accordance with
Executive Orders 12862 and 13571 requiring all Federal agencies to
survey customers to determine the kind and quality of services they
want and their level of satisfaction with existing services. The
Government Performance and Results Act (GPRA) requires Federal agencies
to set missions and goals and to measure agency performance against
them. The GPRA Modernization Act of 2010 requires quarterly performance
assessments of government programs for the purposes of assessing agency
performance and improvement. The Federal Emergency Management Agency
fulfills these requirements by collecting customer satisfaction program
information through surveys of individuals and households who are
disaster survivors.

Collection of Information

    Title: Federal Emergency Management Agency Individual Assistance
Program Effectiveness & Recovery Survey.
    Type of Information Collection: Revision of a currently approved
information collection.
    FEMA Forms: FEMA Form 007-0-20 Program Effectiveness & Recovery
Survey.
    Abstract: Federal agencies are required to survey their customers
to determine the kind and quality of services customers want and their
level of satisfaction with those services. FEMA managers use the survey
results to measure performance against standards for performance and
customer service, measure achievement of strategic planning objectives,
and generally gauge and make

improvements to disaster service that increase customer satisfaction.
    Affected Public: Individuals and Households.
    Number of Respondents: 8,976.
    Number of Responses: 8,976.
    Estimated Total Annual Burden Hours: 2,698.
    Estimated Cost: The estimated cost to respondents for traveling to
focus groups is estimated to be $8,064.00.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate 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; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through 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.

    Dated: February 20, 2014.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2014-04415 Filed 2-27-14; 8:45 am]
BILLING CODE 9111-23-P