XXI  SEQ CHAPTER \h \r 1 .  Comments on Records and Recordkeeping

(Final Subpart P)

A.  Organization of Final Subpart P

     In the 2003 CGMP Proposal, the requirements for records and
recordkeeping were set forth in proposed § 111.125.  As shown in table
17, we are reorganizing the requirements for records and recordkeeping
into a distinct subpart (final Subpart P – Records and Recordkeeping).
 Table 17 lists the sections in final Subpart P and identifies the
proposed provisions that form the basis for the final rule.

Table 17. - Derivation of Sections in Final Subpart P

Final Rule	2003 CGMP Proposal

§ 111.605  What Requirements Apply to the Records You Make and Keep?	§
111.125(a) and (b)

§ 111.610 What Records Must be Made Available to FDA?	§ 111.125(b) and
(c)

  B.  Highlights of Changes to the Proposed Requirements

for Records and Recordkeeping

1.  Revisions

    The final rule reflects that it applies to persons who manufacture,
package, label, or hold a dietary supplement unless subject to an
exclusion in § 111.1.

2.  Changes After Considering Comments

	This final rule requires you to keep written records required by this
subpart for either one year past the shelf life date, if shelf life
dating is used, or 23 years beyond the date of distribution of the last
batch of dietary supplements associated with those records (final §
111.605(a)).

C.  General Comments on Proposed § 111.125

     (Comment 324) Some comments support the requirements in proposed §
111.125 because documentation helps to ensure CGMPs are consistently
followed and retention of records provides an effective trail when
subsequent problems need to be identified and corrected.

     Another comment asserts the recordkeeping requirements would
represent a large burden for companies that manufacture vitamin and
mineral supplements with a large number of active ingredients.

     (Response)  We agree that records are useful in identifying
manufacturing problems and tracking the source of failures in CGMPs.

	We understand the burden on manufacturers may be heavier for
manufacturers who use many dietary ingredients and discuss the burden of
the recordkeeping requirements in sections XXVIII and XXIV.  However, we
do not believe that a manufacturer who elects to put several components
into one finished batch of dietary supplement would necessarily have any
larger burden than one who, instead, elects to manufacture multiple
dietary supplements each containing one component.   A manufacturer can
decide whether it wants to manufacture and market a dietary supplement
containing a single component or ingredient or one containing multiple
components or ingredients.  We believe that the requirements, for
example, for ensuring the identity, purity, strength, and composition of
each component in a dietary supplement need to be the same for a dietary
supplement containing one ingredient or component and one containing
multiple ingredients or components.  To the extent the comment is
suggesting that the recordkeeping requirements for those who manufacture
multivitamin/mineral dietary supplements (containing components) are too
large and should be less, the comment provided no basis for such a
change.suggestion,

D.  What Requirements Apply to the Records You Make and Keep?

 (Final § 111.605)

1.  Final § 111.605(a)

     Final § 111.605(a) requires you to keep written records for 1 year
past the shelf life date, if shelf life dating is used, or 23 years
beyond the date of distribution of the last batch of dietary supplements
associated with those records.  Final § 111.605(a) derives from
proposed § 111.125(a).

     (Comment 325) Several comments suggest that the requirement in
proposed § 111.125(a) to keep records for 3 years beyond the date of
manufacture should be modified.  One comment favors record retention for
3 years beyond the date of manufacture or for the shelf life of the
product, whichever is longer.  Some comments state the rule should
require establishment of an expiration date and that the manufacturer
should have the option of retaining records for 1 year beyond the
expiration date, when an expiration date has been established by the
manufacturer.  Some comments point out that under section 306(a) of the
Bioterrorism Act, FDA is authorized to issue recordkeeping regulations
with a record retention period of “not longer than two years.”  One
comment, therefore, asserts CGMP records should not be kept for more
than 2 years.

     (Response)  We believe a record retention period for records
related to CGMP requirements should correlate generally with the length
of time that product complaints are likely to arise related to the
manufacture of a dietary supplement. is likely to be in the marketplace,
including the time during which consumers may be using such product.,
and generally, with the length of time between facility inspections.
Such correlation will increase the likelihood that, if a problem with a
dietary supplement is identified that may be associated with a violation
of CGMP, the dietary supplement manufacturer, packager, labeler, or
holder will have access to the CGMP records associated with that dietary
supplement.  In addition, we will have access to such records at
inspection.

For non-high risk establishments, we (in conjunction with State
agencies) generally inspect food establishments at an annual rate of
once every 3.4 years. We have modified the final rule to require a
record retention period of 2 years beyond the date of distribution of
the last batch of dietary supplements associated with those records or 1
year past the shelf life date, if shelf life dating is used.

A significant portion of the dietary supplement industry use shelf life
dating.  It is likely that if there are product complaints related to a
product these will arise during the shelf life of these products.  To
ensure there is adequate time to examine the records, determine if there
are related manufacturing problems, and implement corrective actions, it
is necessary to require the retention of records for one year past the
shelf life date.  This will help ensure that establishments have access
to such records to perform the necessary CGMP actions.

For those dietary supplements without shelf life or expiration dating,
wWe believe that 23 years from the date of distribution is a reasonable
estimate of the time needed to retain records in order to address CGMP
problems identified in product complaints. most dietary supplements are
in the marketplace after distribution.  When a dietary supplement has a
shelf life date (or expiration date) we believe that the dietary
supplement would be expected to remain in the marketplace only for one
year past the shelf life date.  Therefore, we believe that a period of
one year past the shelf life date would provide a reasonable period
during which consumers may still be using the product and the CGMP
records could be needed in the event of a product complaint.

It is important to note that, as discussed in this section, the term
“shelf life dating,” includes shelf life dating as well as
expiration dating and “best if used by” dating.  A 3 year period is
similar to other foods (e.g., canned foods) which we expect to remain in
the marketplace for extended periods of time (see §§ 108.25(g),
113.100(e), and 114.100(e)).

Maintaining records for 3 years after the date of distribution of the
last batch of dietary supplements associated with those records may
create unnecessary recordkeeping requirements for manufacturers that
have determined and declared a shelf life for their product.  For
example, if the shelf-life of the product was only one year, it would be
unlikely that there would be a need to keep records for 3 years, rather
than for 2 years (1 year past the shelf life date), since consumers
would be unlikely to purchase such outdated product and retailers would
be unlikely to keep it on their shelves.

We disagree with the comment that suggests we require an expiration date
on all products.  Many products will not have a determinable expiration
date due to the state of knowledge about these products.  We believe the
manufacturer is in the best position to determine if its product
requires an expiration date.

Finally, we disagree with the comments stating a record retention period
beyond 2 years is in conflict with the Bioterrorism Act regulations.
Section 306 of the Bioterrorism Act amended the act by adding section
414; it did not amend section 402(g) which provides the authority for
this final rule.  Therefore, for purposes of this final rule, we are not
bound by the two year retention period established under the
Bioterrorism Act.  Although the products regulated by the Bioterrorism
Act encompass the dietary supplement products regulated by this final
rule and the ultimate goal of both is to protect the public health, the
purpose of the two provisions is different.  The Bioterrorism Act’s
recordkeeping provisions provide that the Secretary, may by regulation,
establish requirements regarding the establishment and maintenance, for
not longer than 2 years, of records by persons (excluding farms and
restaurants) who manufacture, process, pack, transport, distribute,
receive, hold, or import food.  The records required to be kept by the
Bioterrorism regulations are those needed by the Secretary for
inspection to allow the Secretary to identify the immediate previous
sources and immediate subsequent recipients of food, including its
packaging, to address credible threats of serious adverse health
consequences or death to humans or animals.  FDA envisions using these
records primarily in “traceback” investigations to trace backwards
to locate the source of any similarly adulterated food, then to trace
forward from that source point to all other locations where similarly
adulterated food has been shipped.  The records are needed not only to
help remove contaminated food from commerce, but also to help identify
the source of the contamination.

Records required to be maintained under this final rule are focused on
the manufacture, packaging, labeling, and holding of dietary supplements
under CGMP.  The purpose of the recordkeeping requirements is not
limited to addressing credible threats of serious adverse health
consequences or death to humans and animals through the identification
of immediate previous sources and immediate subsequent recipients of
food.  The records must be retained for a sufficient period of time to
ensure that the records are available during the period that the dietary
supplements are likely to be in the marketplace (and consumed by
consumers).

We recognize that some of the products covered by the Bioterrorism Act
may be in commerce longer than two years and consumed by consumers after
this time; however, the Bioterrorism Act expressly limited the period of
time that we could require records to be retained in any regulations
issued under that authority to two years; thus, we were not able to
require longer retention periods in that rule.  As noted above, this
CGMP rule is not being issued under the authority in section 414 of the
act and thus there is no similar limitation.

Because many dietary supplements are expected to have a shelf life
longer than 2 years, we believe it is important for the manufacturer,
packager, labeler, holder, and us to have access to CGMP records while
the dietary supplement is in the marketplace and for the period between
our expected inspection cycle.

     (Comment 326)  One comment requests clarification of the “date of
manufacture.”  The comment asserts if an expiration date is shown on
the label of a product, the date of manufacture should be considered to
be the date on which the expiration date is based.  The comment gives an
example of vitamin C tablets having a two year shelf life.  The comment
explains if the tablets are compressed, tested, and approved for
packaging in August 2003, they would generally be assigned an expiration
date of August 2005 regardless of the date of packaging.  The comment
argues if the tablets are held and later packaged in February 2004,
records for this batch should only have to be kept for 1 year beyond the
expiration date (i.e., August 2006), rather than 3 years beyond the
packaging date (i.e., February 2007).

     (Response)  In the scenario described above, where an expiration
date (shelf life) has been determined, records for this batch must only
be kept for 1 year beyond the expiration date (i.e., shelf life date).
The packaging date in the above scenario has no effect on the amount of
time records must be kept.  However, in the final rule, we have decided
that it is more appropriate to determine the record retention period
from the date of distribution rather than the “date of manufacture.”
The date on which the manufacturer completes the manufacture of a batch
of a dietary supplement (the date of manufacture) does not necessarily
indicate the availability of the dietary supplement product in the
marketplace.  It is possible that such product could be held for a
period of time before entry into the marketplace and possible consumer
consumption.  A more accurate time period for entry is calculated by the
date of distribution.  Final § 111.605(a)(2) requires that
manufacturers, packagers, labelers, and holders keep their records for
23 years from the date of distribution of the last batch of dietary
supplement associated with those records.  For products with a shelf
life date, the records associated with those dietary supplements are
required to be kept for one year past the shelf life date of that
particular dietary supplement.  Packagers and labelers that return the
product to the manufacturer for distribution are not required to keep
separate records under this subpart.

2.  Final § 111.605(b)

     Final § 111.605(b) requires you to keep records as original
records, true copies (such as photocopies, microfilm, etc.), or as
electronic records.  Final § 111.605(b) derives from proposed §
111.125(b).

     We did not receive comments specific to proposed § 111.125(b).

3.  Final § 111.605(c)

     Final § 111.605(c) requires that all electronic records comply
with part 11 of this chapter.  Final § 111.605(c) derives from proposed
§ 111.125(b).

     (Comment 327) One comment believes part 11 should only apply to
records that do not have paper counterparts.

     (Response) This comment is beyond the scope of this CGMP
rulemaking.

     (Comment 328) One comment suggests the proposed requirement that
CGMP electronic records must comply with part 11 should be deleted
because the FDA guidelines on part 11 have not yet been finalized.

     (Response) Part 11 applies to electronic CGMP records.  Therefore,
final § 111.605(c) requires that all electronic records, including
electronic signatures, must comply with part 11.  We have finalized
guidance for industry.  The guidance entitled “Part 11, Electronic
Records; Electronic Signatures Scope and Application,” sets out our
enforcement policies with respect to certain aspects of part 11. (Ref.
330) The guidance is available at http://  HYPERLINK
"http://www.fda.gov/cder/guidance/"  www.fda.gov/cder/guidance/
5667fnl.htm.

The guidance applies to any CGMP electronic records and signatures.

E.  What Records Must be Made Available to FDA?

 (Final § 111.610)

1.  Final § 111.610(a)

     Final § 111.610(a) requires you to keep records, or copies of such
records, required by this final rule, readily available during the
retention period for inspection and copying by FDA when requested.
Final § 111.610(a) derives from proposed § 111.125(c).  We responded
to comments that we received on FDA's statutory authority to inspect and
copy records in section V.  We made one editorial, non-substantive
change from the language in proposed § 111.125(c).  We removed the word
“authorized” to prevent any confusion regarding whether some
authorization other than the statutory authority that provides the legal
basis for this final rule is necessary for our access to inspect and
copy records.

2.  Final § 111.610(b)

     Final § 111.610(b) requires that if you use reduction techniques,
such as microfilming, you must make suitable reader and photocopying
equipment readily available to us.  Final § 111.610(b) derives from
proposed § 111.125(b).

     We did not receive any comments specific to proposed § 111.125(b)
and final § 111.610(b).

XXII.   Other Comments and Miscellaneous

A.  Comments on Guidance Documents to be Used

with the Final Rule

In the 2003 CGMP Proposal, we invited comment on the usefulness of
guidance documents, education, training, or other approaches and
potential sources of education and training that would assist industry
efforts to implement the 2003 CGMP Proposal, if finalized as proposed
(68 FR 12157 at 12163).

     (Comment 329) A few comments state booklets, videos, seminars, and
other training would be useful on topics such as sanitation,
recordkeeping, quality assurance methods, microbiological testing, and
botany.  Another comment states a subset of CGMPs that focuses on plant
authenticity, purity, proper handling, and hygiene should be developed
for parties who exclusively deal with bulk raw agricultural commodities
(with the exception of individual wildcrafters).  If such CGMPs are not
developed, the comment requests we develop guidance documents on the
identification, cultivation, and handling of botanicals.  The same
comment also notes guidance specifically is needed on the use of
microscopy to identify plants.

     (Response) We acknowledge these comments and, in the future, we may
issue guidance that relates to certain dietary supplement CGMP
requirements.

B.  Comments on Consideration for Other CGMP Programs

     (Comment 330) One comment asserts several existing dietary
supplement CGMP programs (e.g., those developed by the NNFA, NSF
International, ANSI, and USP) are well designed and represent useful
examples for us to follow.  The comment notes section 12(d) of the
National Technology Transfer and Advancement Act directs Federal
agencies to use such voluntary consensus standards whenever possible, as
long as the standards are consistent with federal law and are practical.
 The comment recommends we include standards from these existing CGMP
programs where suitable in the final rule.

      (Response) In the development of the 2003 CGMP Proposal and this
final rule, we carefully considered the comments that recommended
aspects of other CGMP programs.  For example, as discussed previously,
the 1997 ANPRM for this rule contained the entire text of an outline
presented to us by representatives of the dietary supplement industry.
Furthermore, where comments recommended aspects of other CGMP programs,
we considered those recommendations and, in some cases, incorporated
certain recommendations into requirements in this final rule (e.g., the
use of a certificate of analysis).

	In 2006, ANSI updated its Standard 173 (ANSI Standard 173) regarding
dietary supplements. (Ref. 35  ).  ANSI Standard 173 contains provisions
for dietary supplement CGMP that are based, in part, on the industry
submission to FDA in November 1995, which the agency published as part
of its 1997 ANPRM.  We considered comments to the 1997 ANPRM, many of
which commented on the provisions of the industry submission, and the
comments to the 2003 CGMP Proposal in the course of developing this CGMP
final rule.  We have considered the provisions contained in the updated
ANSI Standard 173 and many of the specific provisions contained in ANSI
Standard 173 are similar to provisions adopted in this final rule.  For
example, both the ANSI standard and this CGMP final rule have similar
requirements on written procedures, personnel qualifications, record
retention, and quality control.  However, we determined that adopting
the entire ANSI Standard 173 would be impracticable.  There are key
provisions which reflect major differences between the latest ANSI
Standard 173 and the CGMP final rule.  Many of these differences are in
the product testing environment.  For example, the ANSI standard
contains different product testing frequency and production stage
requirements.  We have extensively discussed the justification for the
particular testing requirements adopted in this CGMP final rule, which
we believe are no more burdensome than the ANSI Standard 173
requirements.  For example, the ANSI Standard 173 contains testing
methods for metal or microbiological contaminants not included in the
final rule.  We found that providing flexibility for manufacturers to
choose their own specific test methods was a more efficient way of
reaching the goals of the CGMP final rule than specifying and requiring
particular tests.  We support, however, the use of the ANSI Standard 173
testing methods by manufacturers, where appropriate, in complying with
the requirements of this rule.

     (Comment 331) Another comment states CGMPs that reflect common
elements and areas of uniqueness should be placed in sub-categories of
CGMPs as is the case with the current food CGMP model.  The comment
recommends we follow a similar approach and establish sub-categories of
CGMPs for dietary supplements (e.g., for vitamin-mineral and probiotic
tablets).

     (Response) In the 1997 ANPRM, we asked for comment about whether
broad CGMP regulations would be adequate, or whether it would be
necessary to address the operations of particular segments of the
dietary supplement industry (68 FR 12157 at 12174).  Based on the
comments received to the 1997 ANPRM, we were persuaded that a broad
final rule is preferable to multiple regulations focused on particular
segments of the dietary supplement industry, or to general CGMP
provisions plus subcategories applicable to segments of the dietary
supplement industry.  We stated in the 2003 CGMP Proposal that we would
consider whether we needed to reevaluate our decision to establish one
set of requirements for all dietary supplements (id.).  This comment did
not provide any basis to persuade us to reevaluate the decision we made
that a broad CGMP rule was appropriate.  Thus, in this final rule, we
are establishing one set of requirements for all persons who
manufacture, package, label, or hold dietary supplements and not subject
to an exclusion under final § 111.1.

C.  Comments on Public Involvement

1.  Public Involvement

    (Comment 332) Several comments express general concerns with our
public involvement process.  Several comments state additional public
meetings and workshops are necessary to permit FDA, industry, and other
stakeholders to work together to seek a more workable solution to
dietary supplement CGMPs and to resolve differences of opinion.  One
comment states the differences of opinion identified by the comment
process will not be meaningfully resolved without active and forthright
communication with stakeholders.  According to the comment, we should
establish a forum prior to the publication of the final rule to
communicate our perception of these differences of opinion.  Another
comment - a trade association – expresses disappointment that our 2003
CGMP Proposal disregards industry efforts to draft CGMPs over the last
decade.  Another comment contends the proposal was rushed and the
comment period was established without publication of a core economic
analysis to support it.

     (Response) We disagree with these comments.  We believe there has
been sufficient public involvement given the public meetings that were
held and the opportunity for comment during the comment periods
provided.  We discuss the public involvement in section I.  Further, the
2003 CGMP Proposal did contain an economic analysis.  We received
extensive comments on the economic analysis in the 2003 CGMP Proposal.
We have made several changes to the economic analysis of this final rule
in response to these comments as discussed in section XXIV.
Furthermore, we have made various changes in response to comments to the
CGMP requirements in this final rule.

D.  Comments on Implementation and Enforcement

    (Comment 333) Several comments suggest postponing the effective date
of the rule for 24 months to allow a voluntary inspection and compliance
program to take effect in the interim.  One comment recommends adoption
of a voluntary program similar to that of OSHA regulations in Volume 29
of the CFR, where companies would invite FDA inspection without penalty
or cost unless a serious violation occurs.  In cases of serious
violation, companies would have the option to voluntarily correct the
problem and inform the public before the effective date of the rule.

     (Response) We disagree with these comments regarding the
establishment of a voluntary compliance period.  The effective date of
this final rule is 60 days after its publication in the Federal
Register.  However, as discussed in section VI and XXIV, we have
staggered compliance dates to 12 months, 24 months, and 36 months,
respectively, after the final rule’s publication date for businesses
of over 500 employees, businesses with under 500 employees but 20 or
more employees, and businesses with less than 20 employees.

     (Comment 334) Several comments indicate they want differential
treatment under the final rule based on the seriousness of a violation,
others ask for strict enforcement, and others ask how FDA would enforce
against those who continually adulterate dietary supplements.

     (Response) We consider these comments to be outside the scope of
this final rule.  In general, we would provide guidance on our
enforcement policy through the issuance of guidance documents if we
determine that any variance from full enforcement is warranted.

     (Comment 335) Another comment expresses concern the 2003 CGMP
Proposal works at “cross purposes” with recent regulations
associated with bioterrorism.  The comment recommends these rules be
harmonized to reduce costs and increase efficiencies for manufacturers.

     (Response) It is not clear what the comment means when it states
the 2003 CGMP Proposal works at “cross purposes” with the
regulations issued under the Bioterrorism Act or that we should
“harmonize” the regulations issued under the Bioterrorism Act with
the final rule establishing dietary supplement CGMP requirements.  We
have made every effort to consider the regulations issued under the
Bioterrorism Act and their relationship to this final rule.  As
discussed in this section, Tthere are different purposes to the
Bioterrorism Act and these CGMP requirements; however, we have
harmonized the respective requirements to the extent possible.  We are
not making any changes in response to this comment.

     (Comment 336) One comment states the 1-year compliance period for
large firms is reasonable as long as we modify the rule to better
reflect existing CGMPs already in practice among responsible companies.
The comment also notes the 3-year compliance period for small firms may
be reasonable, but urges us to enforce compliance of basic food GMP
requirements, which some of these firms may not be observing.

     (Response) The effective date for this final rule is 60 days from
its date of publication in the Federal Register, though we are
staggering the compliance dates as described in sections VI and XXIV.
Dietary supplement products in the marketplace must already be in
compliance with all other statutory and regulatory provisions that
affect dietary supplements under this chapter.

E. Removal of References to Part 112

	The 2003 CGMP Proposal (68 FR 12157 at 12175) had proposed the heading
and table of contents for part 112.  Proposed part 112 had the heading
“Restrictions for Substances Used in Dietary Supplements.”  At the
time, we said that it was necessary to amend part 112 because at that
time the 2003 CGMP Proposal for dietary supplements containing ephedrine
alkaloids (62 FR 30678, June 4, 1997) had not been finalized and
included proposed revisions to part 111.  The 2003 CGMP Proposal for
dietary supplement CGMPs proposed using part 111 and proposed the
relocation of the  “Restrictions for Substances Used in Dietary
Supplements” to part 112.  Since the issuance of the 2003 CGMP
Proposal, the final rule for dietary supplements containing ephedrine
alkaloids has been finalized (69 FR 6788, February 11, 2004) and has
been included in part 119.  Thus, there is no need to reserve part 112
in this final rule.  The references to part 112 have been removed from
the final rule.

FDA-Internal-Confidential-Deliberative

Final Subpart P- Misc 9-28-05, 6-26-06, 3-30-07, 5-04-07

page   PAGE  938


[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61769-61772]
[FR Doc No: 2011-25678]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 29825; 812-13575]

Destra Capital Investments LLC and Destra Unit Investment Trust;
Notice of Application

September 29, 2011.
AGENCY:  Securities and Exchange Commission (``Commission'').

ACTION:  Notice of application for an order under section 12(d)(1)(J)
of the Investment Company Act of 1940 (``Act'') for an exemption from
sections 12(d)(1)(A), (B), and (C) of the Act and under sections 6(c)
and 17(b) of the Act for an exemption from section 17(a) of the Act.

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

SUMMARY OF THE APPLICATION:  Destra Capital Investments LLC (the
``Depositor''), Destra Unit Investment Trust (the ``Trust''), on behalf
of itself and any existing and future series, and any future registered
unit investment trust (``UIT'') sponsored by the Depositor (or an
entity controlling, controlled by or under common control with the
Depositor) and their respective series (the future UITs, together with
the Trust, are collectively the ``Trusts,'' the series of the Trusts
are the ``Series,'' and the Trusts together with the Depositor are
collectively, the ``Applicants''), request an order to permit each
Series to acquire shares of registered investment companies or series
thereof (the ``Funds'') both within and outside the same group of
investment companies, and to permit any Funds that are open-end
companies (``Open-end Funds''), their principal underwriters and any
broker or dealer registered under the Securities Exchange Act of 1934
(``Broker'') to sell such shares to a Series.

Applicants:  The Depositor and the Trust.

Filing Dates:  The application was filed on September 15, 2008, and
amended on June 1, 2011, and September 23, 2011.

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 October 24, 2011, and should be accompanied by proof of service
on applicants in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, 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, 901 Warrenville
Road, Suite 15, Lisle, IL 60532.

FOR FURTHER INFORMATION CONTACT:  Bruce R. MacNeil, Senior Counsel, at
(202) 551-6817, or Daniele Marchesani, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

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

Applicants' Representations

    1. The Trust is a UIT registered under the Act. Each Series will be
a series of a Trust and will offer units for sale to the public
(``Units'').\1\ Each Series will be created pursuant to a trust
agreement which will incorporate by reference a master trust agreement
between the Depositor and a financial institution that satisfies the
criteria in section 26(a) of the Act (the ``Trustee''). The Depositor
is a broker dealer registered under the Securities Exchange Act of 1934
(``Exchange Act'') and member of the Financial Industry Regulatory
Authority, Inc. (``FINRA'').
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    \1\ All existing entities that currently intend to rely on the
requested order are named as applicants. Any other entity that
relies on the order in the future will comply with the terms and
conditions of the application.
---------------------------------------------------------------------------

    2. Applicants request relief to permit a Series to invest in Funds
that are (a) part of the same ``group of investment companies'' (as
that term is defined in section 12(d)(1)(G) of the Act) as the Series
(``Affiliated Funds''), and (b) not part of the same group of
investment companies as the Series (``Unaffiliated Funds''). An
Unaffiliated Fund that is a UIT is referred to as an ``Unaffiliated
Underlying Trust.'' An Unaffiliated Fund that is a closed-end or open-
end management investment company is referred to as an ``Unaffiliated
Underlying Fund''. Certain of the Funds may be registered as an open-
end investment company or a UIT, but have received exemptive relief in
order that their shares may be traded at ``negotiated prices'' on a
national securities exchange in the same manner as other equity
securities (the ``Exchange-traded Funds''). Shares of Exchange-traded
Funds and closed-end Funds will be deposited in a Series at prices
which are based on the market value of the securities, as determined by
an evaluator. The Depositor will not have discretion as to when
portfolio securities of a Series will be sold, except that the
Depositor is authorized to sell securities in extremely limited
circumstances described in the Series' prospectus. Applicants state
that the Depositor is not obligated to maintain a secondary market for
Units of each Series, but may seek to do so in the future. Other
broker-dealers may or may not maintain a secondary market for Units of
a Series.
    3. Applicants state that the requested relief will provide
investors with a practical, cost-efficient means of investing in a
diversified portfolio of securities of investment companies that has
been professionally selected by the Depositor.

Applicants' Legal Analysis

A. Section 12(d)(1)

    1. Section 12(d)(1)(A) of the Act prohibits a registered investment
company from acquiring shares of an investment company if the
securities represent more than 3% of the total outstanding voting stock
of the acquired company, more than 5% of the total assets of the
acquiring company, or, together with the securities of any other
investment companies, more than 10% of the value of the total assets of
the acquiring company. Section 12(d)(1)(B) of the Act prohibits a
registered open-end investment company, any principal underwriter
therefor, and any broker or dealer registered under the Exchange Act,
from selling the shares of the investment company to another investment
company if the sale will cause the acquiring company to own more than
3% of the acquired company's voting stock, or if the sale will cause
more than 10% of the acquired company's voting stock to be owned by
investment companies generally. Section 12(d)(1)(C) prohibits an
investment company, other investment companies having the same
investment adviser, and companies controlled by such investment
companies, from acquiring more than 10% of the outstanding voting stock
of a registered closed-end management investment company.
    2. Section 12(d)(1)(G) provides, in relevant part, that section
12(d)(1) will not apply to securities of a registered

open-end investment company or UIT acquired by a registered UIT if the
acquired company and the acquiring company are part of the same group
of investment companies, provided that certain other requirements
contained in section 12(d)(1)(G) are met. Applicants state that they
may not rely on section 12(d)(1)(G) because a Series will invest in
Unaffiliated Funds and other securities in addition to Affiliated
Funds.
    3. Section 12(d)(1)(J) 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 provision of section
12(d)(1) if the exemption is consistent with the public interest and
the protection of investors. Applicants seek an exemption under section
12(d)(1)(J) to permit a Series to purchase or acquire shares of the
Funds in excess of the percentage limitations of section 12(d)(1)(A)
and (C) and the Open-end Funds, their principal underwriters and any
Broker to sell their shares to the Series in excess of Section
12(d)(1)(B).
    4. Applicants state that the proposed arrangement will not give
rise to the policy concerns underlying sections 12(d)(1)(A), (B), and
(C), which include concerns about undue influence by a fund of funds
over underlying funds, excessive layering of fees, and overly complex
fund structures. Accordingly, applicants believe that the requested
exemption is consistent with the public interest and the protection of
investors.
    5. Applicants state that the concern about undue control does not
arise with respect to a Series' investment in Affiliated Funds, as
reflected in section 12(d)(1)(G) of the Act. Applicants also state that
the proposed arrangement will not result in undue influence by a Series
or its affiliates over Unaffiliated Funds. Applicants have agreed that
(a) the Depositor, (b) any person controlling, controlled by or under
common control with the Depositor, and (c) any investment company and
any issuer that would be an investment company but for section 3(c)(1)
or 3(c)(7) of the Act, sponsored or advised by the Depositor (or any
person controlling, controlled by or under common control with the
Depositor) (collectively, the ``Group'') will not control (individually
or in the aggregate) an Unaffiliated Fund within the meaning of section
2(a)(9) of the Act. Applicants also note that conditions 2, 3, 5 and 6
set forth below will address the concern about undue influence with
respect to the Unaffiliated Funds.
    6. As an additional assurance that an Unaffiliated Underlying Fund
understands the implications of an investment by a Series under the
requested order, prior to a Series' investment in the Unaffiliated
Underlying Fund in excess of the limit in section 12(d)(1)(A)(i), the
Series and the Unaffiliated Underlying Fund will execute an agreement
stating, without limitation, that the Depositor and Trustee and the
board of directors or trustees of the Unaffiliated Underlying Fund and
the investment adviser(s) of the Unaffiliated Underlying Fund,
understand the terms and conditions of the order and agree to fulfill
their responsibilities under the order (``Participation Agreement'').
Applicants note that an Unaffiliated Underlying Fund, including a
closed-end Fund or an Exchange-traded Fund, may choose to reject an
investment from the Series by declining to execute the Participation
Agreement.
    7. Applicants do not believe that the proposed arrangement will
involve excessive layering of fees. Applicants state that any sales
charges and/or service fees (as those terms are defined in Rule 2830 of
the Conduct Rules of the NASD, Inc. (``NASD Conduct Rules'') charged
with respect to Units of a Series will not exceed the limits applicable
to a fund of funds as set forth in Rule 2830 of the NASD Conduct
Rules.\2\ In addition, the Trustee or Depositor will waive fees
otherwise payable to it by the Series in an amount at least equal to
any compensation (including fees paid pursuant to any plan adopted by
an Unaffiliated Underlying Fund under rule 12b-1 under the Act)
received from an Unaffiliated Fund by the Trustee or Depositor, or an
affiliated person of the Trustee or Depositor, other than any advisory
fees paid to the Trustee or Depositor or its affiliated person by an
Unaffiliated Underlying Fund, in connection with the investment by the
Series in the Unaffiliated Fund.
---------------------------------------------------------------------------

    \2\ With respect to purchasing closed-end Fund or Exchange-
traded Fund shares, a Series may incur the customary brokerage
commissions associated with purchasing any equity security on the
secondary market.
---------------------------------------------------------------------------

    8. Applicants state that the proposed arrangement will not create
an overly complex fund structure. Applicants note that a Fund will be
prohibited from acquiring securities of any investment company or
company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of
the limits contained in section 12(d)(1)(A), except to the extent
permitted by exemptive relief from the Commission permitting the Fund
to purchase shares of other investment companies for short-term cash
management purposes. Applicants also represent that a Series'
prospectus and sales literature will contain concise, ``plain English''
disclosure designed to inform investors of the unique characteristics
of the trust of funds structure, including, but not limited to, its
expense structure and the additional expenses of investing in Funds.

B. Section 17(a)

    1. Section 17(a) of the Act generally prohibits sales or purchases
of securities between a registered investment company and any
affiliated person of the company. Section 2(a)(3) of the Act defines an
``affiliated person'' of another person to include (a) Any person
directly or indirectly owning, controlling, or holding with power to
vote, 5% or more of the outstanding voting securities of the other
person; (b) any person 5% or more of whose outstanding voting
securities are directly or indirectly owned, controlled, or held with
power to vote by the other person; and (c) any person directly or
indirectly controlling, controlled by, or under common control with the
other person.
    2. Applicants state that a Series and an Affiliated Fund might be
deemed to be under the common control of the Depositor or an entity
controlling, controlled by, or under common control with the Depositor.
Applicants also state that a Series and a Fund might become
``affiliated persons'' if the Series acquires more than 5% of the
Fund's outstanding voting securities. The sale or redemption by a Fund
of its shares to or from a Series therefore could be deemed to be a
principal transaction prohibited by Section 17(a) of the Act.\3\
---------------------------------------------------------------------------

    \3\ Applicants state that to the extent purchases and sales of
shares of an Exchange-traded Fund occur in the secondary market (and
not through principal transactions directly between a Series and an
Exchange-traded Fund), relief from Section 17(a) would not be
necessary. The requested relief is intended to cover, however,
transactions directly between Exchange-traded Funds and a Series.
Applicants are not seeking relief from Section 17(a) for, and the
requested relief will not apply to, transactions where an Exchange-
traded Fund could be deemed an affiliated person, or an affiliated
person of an affiliated person, of a Series because the investment
adviser to the Exchange-traded Fund or an entity controlling,
controlled by or under common control with the investment adviser is
also a depositor to the Series. In addition, the request for relief
does not cover principal transactions with closed-end Funds.
---------------------------------------------------------------------------

    3. Section 17(b) of the Act authorizes the Commission to grant an
order permitting a transaction otherwise prohibited by section 17(a) if
it finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c)

the proposed transaction is consistent with the general purposes of the
Act. Section 6(c) of the Act permits the Commission to exempt any
person or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act.
    4. Applicants submit that the proposed transactions satisfy the
standards for relief under sections 17(b) and 6(c) of the Act.
Applicants state that the terms of the proposed transactions are fair
and reasonable and do not involve overreaching. Applicants note that
the consideration paid for the sale and redemption of shares of the
open-end Funds and Funds that are UITs will be based on the net asset
values of the Funds. Finally, Applicants state that the proposed
transactions will be consistent with the policies of each Series and
Fund, and with the general purposes of the Act.

Applicants' Conditions

    Applicants agree that the order granting the requested relief will
be subject to the following conditions:
    1. The members of the Group will not control (individually or in
the aggregate) an Unaffiliated Fund within the meaning of section
2(a)(9) of the Act. If, as a result of a decrease in the outstanding
voting securities of an Unaffiliated Fund, the Group, in the aggregate,
becomes a holder of more than 25% of the outstanding voting securities
of the Unaffiliated Fund, the Group will vote its shares of the
Unaffiliated Fund in the same proportion as the vote of all other
holders of the Unaffiliated Fund's shares.
    2. No Series or its Depositor, promoter, principal underwriter, or
any person controlling, controlled by, or under common control with any
of those entities (each, a ``Series Affiliate'') will cause any
existing or potential investment by the Series in an Unaffiliated Fund
to influence the terms of any services or transactions between the
Series or Series Affiliate and the Unaffiliated Fund or its investment
adviser(s), sponsor, promoter, principal underwriter, or any person
controlling, controlled by, or under common control with any of those
entities.
    3. Once an investment by a Series in the securities of an
Unaffiliated Underlying Fund exceeds the limit in section
12(d)(1)(A)(i) of the Act, the board of directors or trustees of the
Unaffiliated Underlying Fund, including a majority of the disinterested
board members, will determine that any consideration paid by the
Unaffiliated Underlying Fund to the Series or Series Affiliate in
connection with any services or transactions: (a) Is fair and
reasonable in relation to the nature and quality of the services and
benefits received by the Unaffiliated Underlying Fund; (b) is within
the range of consideration that the Unaffiliated Underlying Fund would
be required to pay to another unaffiliated entity in connection with
the same services or transactions; and (c) does not involve
overreaching on the part of any person concerned. This condition does
not apply with respect to any services or transactions between an
Unaffiliated Underlying Fund and its investment adviser(s), or any
person controlling, controlled by, or under common control with such
investment adviser(s).
    4. The Trustee or Depositor will waive fees otherwise payable to it
by the Series in an amount at least equal to any compensation
(including fees received pursuant to any plan adopted by an
Unaffiliated Underlying Fund under rule 12b-1 under the Act) received
from an Unaffiliated Fund by the Trustee or Depositor, or an affiliated
person of the Trustee or Depositor, other than any advisory fees paid
to the Trustee or Depositor or its affiliated person by an Unaffiliated
Underlying Fund, in connection with the investment by a Series in the
Unaffiliated Fund.
    5. No Series or Series Affiliate (except to the extent it is acting
in its capacity as an investment adviser to an Unaffiliated Underlying
Fund or sponsor to an Unaffiliated Underlying Trust) will cause an
Unaffiliated Fund to purchase a security in an offering of securities
during the existence of any underwriting or selling syndicate of which
a principal underwriter is the Depositor or a person of which the
Depositor is an affiliated person (each, an ``Underwriting Affiliate,''
except any person whose relationship to the Unaffiliated Fund is
covered by section 10(f) of the Act is not an Underwriting Affiliate).
An offering of securities during the existence of an underwriting or
selling syndicate of which a principal underwriter is an Underwriting
Affiliate is an ``Affiliated Underwriting.''
    6. The board of an Unaffiliated Underlying Fund, including a
majority of the disinterested board members, will adopt procedures
reasonably designed to monitor any purchases of securities by the
Unaffiliated Underlying Fund in an Affiliated Underwriting once an
investment by a Series in the securities of the Unaffiliated Underlying
Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, including
any purchases made directly from an Underwriting Affiliate. The board
of the Unaffiliated Underlying Fund will review these purchases
periodically, but no less frequently than annually, to determine
whether the purchases were influenced by the investment by the Series
in the Unaffiliated Underlying Fund. The board of the Unaffiliated
Underlying Fund will consider, among other things: (a) Whether the
purchases were consistent with the investment objectives and policies
of the Unaffiliated Underlying Fund; (b) how the performance of
securities purchased in an Affiliated Underwriting compares to the
performance of comparable securities purchased during a comparable
period of time in underwritings other than Affiliated Underwritings or
to a benchmark such as a comparable market index; and (c) whether the
amount of securities purchased by the Unaffiliated Underlying Fund in
Affiliated Underwritings and the amount purchased directly from an
Underwriting Affiliate have changed significantly from prior years. The
board of the Unaffiliated Underlying Fund will take any appropriate
actions based on its review, including, if appropriate, the institution
of procedures designed to assure that purchases of securities in
Affiliated Underwritings are in the best interests of shareholders.
    7. An Unaffiliated Underlying Fund will maintain and preserve
permanently in an easily accessible place a written copy of the
procedures described in the preceding condition, and any modifications
to such procedures, and will maintain and preserve for a period of not
less than six years from the end of the fiscal year in which any
purchase in an Affiliated Underwriting occurred, the first two years in
an easily accessible place, a written record of each purchase of
securities in Affiliated Underwritings once an investment by a Series
in the securities of the Unaffiliated Underlying Fund exceeds the limit
of section 12(d)(1)(A)(i) of the Act, setting forth from whom the
securities were acquired, the identity of the underwriting syndicate's
members, the terms of the purchase, and the information or materials
upon which the determinations of the board of the Unaffiliated
Underlying Fund were made.
    8. Before investing in an Unaffiliated Underlying Fund in excess of
the limit in section 12(d)(1)(A)(i), each Series and the Unaffiliated
Underlying Fund will execute a Participation Agreement stating, without
limitation, that the Depositor and Trustee and the board of directors
or trustees of the Unaffiliated

Underlying Fund and the investment adviser(s) to the Unaffiliated
Underlying Fund, understand the terms and conditions of the order and
agree to fulfill their responsibilities under the order. At the time of
its investment in shares of an Unaffiliated Underlying Fund in excess
of the limit in section 12(d)(1)(A)(i), a Series will notify the
Unaffiliated Underlying Fund of the investment. At such time, the
Series also will transmit to the Unaffiliated Underlying Fund a list of
the names of each Series Affiliate and Underwriting Affiliate. The
Series will notify the Unaffiliated Underlying Fund of any changes to
the list of names as soon as reasonably practicable after a change
occurs. The Unaffiliated Underlying Fund and the Series will maintain
and preserve a copy of the order, the Participation Agreement, and the
list with any updated information for the duration of the investment,
and for a period of not less than six years thereafter, the first two
years in an easily accessible place.
    9. Any sales charges and/or service fees charged with respect to
Units of a Series will not exceed the limits applicable to a fund of
funds as set forth in Rule 2830 of the NASD Conduct Rules.
    10. No Fund will acquire securities of any other investment company
or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess
of the limits contained in section 12(d)(1)(A) of the Act, except to
the extent permitted by exemptive relief from the Commission permitting
the Fund to purchase shares of other investment companies for short-
term cash management purposes.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-25678 Filed 10-4-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4068-4070]
[FR Doc No: 2021-00904]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-OW-2013-0610; FRL-10017-57-OW]

Proposed Information Collection Request; Comment Request; Clean
Water Act 404 State-Assumed Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Clean Water Act
Section 404 State-Assumed Programs'' (EPA ICR No. 0220.14, OMB Control
No. 2040-0168) to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act. Before
doing so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This is a proposed
extension of the ICR, which is currently approved through July 31,
2021. An Agency may not conduct, or sponsor and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.

DATES: Comments must be received on or before March 16, 2021.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2013-0610, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our

preferred method). Follow the online instruction for submitting
comments.
     Email<EMAIL_ADDRESS>Include Docket ID No. EPA-HQ-OW-
2013-0610 in the subject line of the message.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Water Docket, Mail Code 28221T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.
     Hand Delivery or Courier (by scheduled appointment only):
EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution
Avenue NW, Washington, DC 20004. The Docket Center's hours of
operations are 8:30 a.m. to 4:30 p.m., Monday through Friday (except
Federal Holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. Out of an abundance of caution for members of the public and
our staff, the EPA Docket Center and Reading Room are closed to the
public, with limited exceptions, to reduce the risk of transmitting
COVID-19. Our Docket Center staff will continue to provide remote
customer service via email, phone, and webform. We encourage the public
to submit comments via https://www.regulations.gov/ or email, as there
may be a delay in processing mail and faxes. Hand deliveries and
couriers may be received by scheduled appointment only. For further
information on EPA Docket Center services and the current status,
please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Dolores Wesson, Oceans, Communities,
and Wetlands Division, Environmental Protection Agency, 1200
Pennsylvania Ave. NW (4504T), Washington, DC 20460; telephone number:
202-566-2755; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that EPA will be collecting are available in the public
docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. The EPA is temporarily
suspending its Docket Center and Reading Room for public visitors, with
limited exceptions, to reduce the risk of transmitting COVID-19. Our
Docket Center staff will continue to provide remote customer service
via email, phone, and webform. We encourage the public to submit
comments via https://www.regulations.gov/ as there may be a delay in
processing mail and faxes. Hand deliveries or couriers will be received
by scheduled appointment only. For further information and updates on
EPA Docket Center services, please visit us online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.
    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act,
EPA is soliciting comments and information to enable it to: (i)
Evaluate 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) 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; (iii) enhance the quality, utility, and clarity
of the information to be collected; and (iv) 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. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Section 404(g) of the Federal Water Pollution Control Act
(FWPCA), or the Clean Water Act (CWA) as it is commonly called,\1\
authorizes States and Tribes to assume the section 404 permit program
for discharges of dredged or fill material into certain waters of the
United States. This ICR covers the collection of information EPA needs
to perform its program approval and oversight responsibilities and the
State or Tribe needs to implement its program.
---------------------------------------------------------------------------

    \1\ The FWPCA is commonly referred to as the CWA following the
1977 amendments to the FWPCA. Public Law 95-217, 91 Stat. 1566
(1977). For ease of reference, EPA will generally refer to the FWPCA
in this document as the CWA or the Act.
---------------------------------------------------------------------------

    Request to assume CWA section 404 permit program. States and Tribes
must demonstrate that they meet the statutory and regulatory
requirements at 40 CFR part 233 for an approvable program. Specified
information and documents must be submitted by the State or Tribe to
EPA to request assumption and must be sufficient to enable EPA to
undertake a thorough analysis of the State or tribal program. The
information contained in the assumption request submission is provided
to the other involved federal agencies (e.g., U.S. Army Corps of
Engineers, U.S. Fish and Wildlife Service, and National Marine
Fisheries Service) and to the general public for review and comment.
    Permit application information. States and Tribes with assumed
programs must be able to issue permits that assure compliance with all
applicable statutory and regulatory requirements, including the CWA
section 404(b)(1) Guidelines. Sufficient information must be provided
in the application so that States or Tribes and federal agencies
reviewing the permit are able to evaluate, avoid, minimize, and
compensate for any anticipated impacts resulting from the proposed
project. EPA's assumption regulations at 40 CFR 233.30 establish
required and recommended elements that should be included in the State
or Tribe's permit application, so that sufficient information is
available to make a thorough analysis of anticipated impacts. These
minimum information requirements generally reflect the information that
must be submitted when applying for a section 404 permit from the U.S.
Army Corps of Engineers. (CWA section 404(h); CWA section 404(j); 40
CFR 230.10, 233.20, 233.21, 233.34, and 233.50; 33 CFR 325)).
    Annual report and program information. EPA has an oversight role
for assumed section 404 permitting programs to ensure that State or
tribal programs are in compliance with applicable requirements and that
State or tribal permit decisions adequately consider, avoid, minimize,
and compensate for anticipated impacts. States and tribes must evaluate
their programs annually and submit the results in a report to EPA.
EPA's assumption regulations at 40 CFR 233.52 establish minimum
requirements for the annual report.
    The information included in the State or Tribe's assumption request
and the information included in a permit application is made available
for public review and comment. The information included in the annual
report to EPA is made available to the public. EPA does not make any
assurances of confidentiality for this information.
    Form numbers: None.

    Respondents/affected entities: Entities potentially affected by
this action are those States requesting assumption of the CWA section
404 permit program; States with approved assumed programs; and permit
applicants for assumed State programs. No Tribes are expected to assume
at this time.
    Respondent's obligation to respond: Required to obtain or retain a
benefit (40 CFR 233).
    Estimated number of respondents: Two States to request program
assumption; 9,022 permit applicants (2,255.5 applications per State);
and four States with assumed programs (the two current programs and
potentially two that may be approved under this ICR) which will submit
an annual report.
    Frequency of response: States will respond one time to request
assumption; if the program is approved, they will respond annually for
the annual report; permit applicants will respond one time when
requesting a permit.
    Total estimated burden: The public reporting and recordkeeping
burden for this collection of information is estimated to be 165,755.4
hours per year (1,012 hours to request program assumption times two
States (2,024 hours) over a three-year period (675 hours); 2,255.5
permit applications reviewed by four States times 12.7 hours per
application (114,579.40 hours); 4,511 permit applications in the two
State-assumed programs times 11 hours per permit application (49,621);
and 110 hours to prepare an annual report times four State assumed
programs (440 hours)). The burden to EPA for related activities is
8,455 hours per year (442 hours to review assumption requests times two
States (884 hours) over a three-year period (295); 100 permit
applications times 80 hours per application review (8,000 hours); and
40 hours to review an annual report times four State assumed programs
(160 hours). Burden is defined at 5 CFR 1320.03(b).
    Total estimated cost: Costs to States for assumed section 404
permit programs will vary widely by State and permit; however, the
total estimated costs for four programs is $5,641,625.21 and costs to
permittees in State-assumed programs is $1,266,824.13. There are $0
capital or operation and maintenance costs. The cost to EPA for related
activities is $502,251.20 in labor costs (per year), includes $0
annualized capital or operation and maintenance costs.
    Changes in estimates: There is an increase of 45,250.4 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB (128,960 hours in the current ICR). There are several
reasons for this increase: (1) A small increase in the estimate of
hours required to assume a program based on information provided by
Michigan and New Jersey, the two States that are currently approved by
EPA to administer a State dredged and fill program; (2) recent changes
to policy in 2020 addressing endangered species and historic
preservation requiring additional burden for States and federal
agencies; (3) this estimate for the first time includes and reports
burden to State-assumed programs of permit review and burden to
permittees (prior ICRs did not calculate this burden due to lack of
data); and (4) adjustments reflecting a small increase in the estimate
of hours reported for review of permits by Michigan and New Jersey, as
well as a small increase in the time reported to complete the annual
report by Michigan. The estimate for number of permits per state has
been reduced based on data provided by New Jersey and Michigan (down to
2,255.5 per state from the prior estimate of 2,975).

John Goodin,
Director, Office of Wetlands, Oceans and Watersheds, Office of Water.
[FR Doc. 2021-00904 Filed 1-14-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Notices]
[Pages 39057-39061]
[FR Doc No: 2013-15608]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2007-28043]

Hours of Service of Drivers; Renewal and Expansion of American
Pyrotechnics Association Exemption From the 14-Hour Rule During
Independence Day Celebrations

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition; granting of application for
exemption.

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SUMMARY: FMCSA announces the granting of an exemption of 55 member-
companies of the American Pyrotechnics Association (APA) from FMCSA's
regulation prohibiting drivers of commercial motor vehicles (CMVs) from
driving after the 14th hour after coming on duty. The FMCSA renews the
exemption for 45 APA member-companies and grants 10 additional carriers
coverage by the exemption, which is applicable during the periods June
28-July 8, 2013, and June 28-July 8, 2014, inclusive. The requested
renewal of the exemption for one motor carrier is being denied.
Additionally, the APA advised FMCSA of the removal from the original
renewal application of two companies that are no longer in business or
no longer members of the APA. The original application was for 58
carriers; two were removed by APA and one denied by FMCSA, leaving 55
carriers being granted the exemption. Drivers who operate these CMVs in
conjunction with staging fireworks shows celebrating Independence Day
will be allowed to exclude off-duty and sleeper-berth time of any
length from the calculation of the 14 hours. These drivers will
continue to be subject to a prohibition from driving after accumulating
14 hours on duty, the 11-hour driving time limit, and the 60- and 70-
hour limits. FMCSA believes that with the terms and conditions in
place, APA-member motor carriers will maintain a level of safety that
is equivalent to, or greater than, the level of safety that would be
obtained by complying with the regulation.

DATES: This exemption is effective during the periods of June 28 (12:01
a.m.) through July 8, 2013 (11:59 p.m.)

and from June 28 (12:01 a.m.) through July 8, 2014 (11:59 p.m.).

FOR FURTHER INFORMATION CONTACT: Ms. Pearlie Robinson, FMCSA Driver and
Carrier Operations Division, Office of Bus and Truck Standards and
Operations, Telephone:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

APA Application for Exemption

    The hours-of-service (HOS) rule in 49 CFR 395.3(a)(2) prohibits a
property-carrying CMV driver from driving a CMV after the 14th hour
after coming on duty following 10 consecutive hours off duty. Under 49
U.S.C. 31315 and 31136(e), FMCSA may grant an exemption from the HOS
requirements in 49 CFR 395.3(a)(2) for a 2-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The procedures for requesting an exemption (including
renewals) are prescribed in 49 CFR part 381.
    The APA, a trade association representing the domestic fireworks
industry, applied for an exemption in 2004. Various APA members have
held 2-year exemptions during Independence Day periods from 2005
through 2012. The last exemption, for 45 of its members, expired on
July 9, 2012. The current application covers 45 members that previously
held exemptions and 10 additional member-companies. The original
application was for 58 carriers with two removed by APA and one denied
by FMCSA; 55 carriers are being granted the exemption.
    The initial APA exemption application for relief from the 14-hour
rule was submitted in 2004; a copy of the application is in the docket.
That application fully describes the nature of the pyrotechnic
operations during a typical Independence Day period.
    The CMV drivers employed by APA member-companies are trained
pyrotechnicians who hold commercial driver's licenses (CDLs) with
hazardous materials (HM) endorsements. They transport fireworks and
related equipment by CMVs on a very demanding schedule during a brief
Independence Day period, often to remote locations. After they arrive,
the drivers are responsible for set-up and staging of the fireworks
shows.
    The APA states that it is seeking an HOS exemption for the 2013 and
2014 Independence Day periods because compliance with the current 14-
hour rule in 49 CFR 395.3(a)(2) by its members would impose a
substantial economic hardship on numerous cities, towns and
municipalities, as well as its member-companies. To meet the demand for
fireworks shows under the current HOS rules, APA member-companies state
that they would be required to hire a second driver for most trips. The
APA advises that the result would be a substantial increase in the cost
of the fireworks shows--beyond the means of many of its members'
customers--and that many Americans would be denied this important
component of the celebration of Independence Day. The 55 APA member-
companies within the scope of this exemption approval are listed in an
appendix to this notice. A copy of the request for the exemption is
included in the docket referenced at the beginning of this notice.

Method To Ensure an Equivalent or Greater Level of Safety

    The APA believes that renewal of the exemption for previously
exempt carriers and the granting of relief for new carriers will not
adversely affect the safety of the fireworks transportation provided by
these motor carriers. According to APA, its member-companies have
operated under this exemption for eight previous Independence Day
periods without a reported motor carrier safety incident. Moreover, it
asserts, without the extra duty-period time provided by the exemption,
safety would decline because APA drivers would be unable to return to
their home base or other safe location after each show. They would be
forced to park the CMVs carrying HM 1.1G, 1.3G and 1.4G products in
areas less secure than the motor carrier's home base. As a condition of
holding the exemption, each motor carrier would be required to notify
FMCSA within 5 business days of any accident (as defined in 49 CFR
390.5) involving the operation of any its CMVs while under this
exemption. To date, FMCSA has received no accident notifications, nor
is the Agency aware of any accidents reportable under terms of the
prior APA exemptions.
    In its exemption request, APA asserted that the operational demands
of this unique industry minimize the risk of CMV crashes. In the last
few days before the 4th of July, these drivers transport fireworks over
relatively short routes from distribution points to the site of the
fireworks display, and normally do so in the early morning when traffic
is light. At the site, they spend considerable time installing, wiring,
and safety-checking the fireworks displays, followed by several hours
off duty in the late afternoon and early evening prior to the event.
During this time, the drivers are able to rest and nap, thereby
reducing or eliminating the fatigue accumulated during the day. Before
beginning another duty day, these drivers must take 10 consecutive
hours off duty, the same as other CMV drivers. FMCSA believes that
these APA operations conducted under the terms and conditions of this
limited exemption will provide a level of safety that, at a minimum, is
equivalent to the level of safety achieved without the exemption.

Public Comments

    On May 7, 2013, FMCSA published notice of this application, and
asked for public comment (78 FR 26690). One set of comments was
received. Advocates for Highway and Auto Safety (Advocates) opposed the
exemption from the HOS regulations. Their comments are available for
review in the docket for this notice.
    Advocates objected to this exemption on various grounds: (1)
Advocates opposes the issuance of any HOS exemptions, especially
``blanket'' exemptions; (2) the carriers for which this exemption is
requested have had out-of-service (OOS) orders issued during past
exemption periods, have OOS rates above National averages, and may be
``on alert'' in one or more violation categories under FMCSA's Safety
Measurement System; (3) the exemption is unnecessary because the APA
has had 8 years during which to develop alternative operational methods
that would not require an exemption; (4) claims that the exemption
allows safer storage of hazardous materials are questionable; (5)
Advocates objects to the length of time FMCSA has taken from receipt of
the application to issue this disposition notice; and (6) FMCSA did not
adequately investigate and announce the applicant-carriers' safety
records when it published the notice of APA's exemption application.

FMCSA Response

    Prior to publishing the Federal Register notice announcing the
receipt of the APA exemption request, FMCSA ensured that the motor
carriers involved have a current USDOT registration, Hazardous
Materials Safety Permit (if required), minimum required levels of
insurance, and are not subject to any ``imminent hazard'' or other OOS
orders. The Agency comprehensively investigated the safety history of
each applicant during the review process. FMCSA has reviewed its safety
records, including inspection and accident reports, for each applicant
motor carrier. The Agency also requested and received

a records review of each carrier from the Pipeline and Hazardous
Materials Safety Administration (PHMSA).
    Because each company is listed in the notice seeking public
comment, and each company's safety performance record is reviewed by
the Agency, there is no merit to Advocates' argument. FMCSA views
Advocates' comments about blanket exemptions versus individual
exemptions as a distinction without a substantive difference. Each
carrier is listed and subject to the notice-and-comment process, and
any individual carrier could be denied based on public comments and/or
FMCSA's assessment. Therefore, the only entity potentially adversely
affected by a lengthy process would be an applicant. FMCSA recognizes
no potential harm to the public due to the current process. To the
contrary, processing an application of this type too far in advance of
the relevant event could result in the status of the applicants having
changed between the time of the records review and the effective date
of the exemption.
    With regard to Advocates' suggestion that APA members should have
developed alternative means to comply with the HOS regulations without
an exemption, FMCSA does not believe reasonable alternatives are
necessarily available in many locations. Such alternatives would
include locating additional drivers with CDLs and HM endorsements. This
is difficult for part-time, holiday-specific work. CDL holders with HM
endorsements are likely to be in high demand, given the Transportation
Security Administration requirements for a security threat analysis for
such drivers. And, as indicated in this notice and APA's application,
potential alternatives could drive the cost of the fireworks displays
beyond the financial capabilities of many communities.
    With regard to the security of alternative storage locations
following a fireworks ``shoot,'' many sites do not provide security
following a display and may require all vehicles to depart the area.
Arrangements can be made for the next community at which a display is
planned to begin their access and security upon the planned arrival of
the fireworks team.

FMCSA Decision

    The FMCSA has evaluated APA's application, the safety records of
the companies to which the exemption would apply, and the public
comments. The Agency believes that APA member-companies will likely
achieve a level of safety that is equivalent to, or greater than, the
level of safety achieved without the exemption [49 CFR 381.305(a)], and
grants the requested exemption to the 55 APA member-companies listed in
an appendix to this notice.
    The exemption requested for one carrier is denied: Arthur Rozzi
Pyrotechnics (Rozzi), Maineville, OH, USDOT 2008107. Rozzi is subject
to an open investigation and enforcement action by PHMSA, involving
violations of the Hazardous Materials Regulations. Under the
circumstances, it would be inappropriate to grant Rozzi an exemption.

Terms and Conditions of the Exemption

Period of the Exemption

    The requested exemption from the requirements of 49 CFR 395.3(a)(2)
is effective during the periods of June 28 (12:01 a.m.) through July 8,
2013 (11:59 p.m.) and from June 28 (12:01 a.m.) through July 8, 2014
(11:59 p.m.). The exemption will expire on July 8, 2014, at 11:59 p.m.
local time.

Extent of the Exemption

    This exemption is restricted to the 55 motor carriers listed in the
appendix to this notice and their CMV drivers. The drivers are provided
a limited exemption from the requirements of 49 CFR 395.3(a)(2). This
regulation prohibits a driver from driving a CMV after the 14th hour
after coming on duty and does not permit off-duty periods to extend the
14-hour limit. Drivers covered by this exemption may exclude off-duty
and sleeper-berth time of any length from the calculation of the 14-
hour limit. This exemption is contingent on each driver driving no more
than 11 hours in the 14-hour period after coming on duty as extended by
any off-duty or sleeper-berth time in accordance with this exemption.
The exemption is further contingent on each driver having a minimum of
10 consecutive hours off duty prior to beginning a new duty period. The
carriers and drivers must comply with all other applicable requirements
of the Federal Motor Carrier Safety Regulations (49 CFR parts 350-399)
and Hazardous Materials Regulations (49 CFR parts 105-180).

Other Conditions

    This exemption is contingent upon each carrier maintaining USDOT
registration, a Hazardous Materials Safety Permit (if required),
minimum levels of public liability insurance, and not being subject to
any ``imminent hazard'' or other out-of-service (OOS) order issued by
FMCSA. Each driver covered by the exemption must maintain a valid CDL
with required endorsements, not be subject to any OOS order or
suspension of driving privileges, and meet all physical qualifications
required by 49 CFR part 391.

Preemption

    During the periods the exemption is in effect, no State may enforce
any law or regulation that conflicts with or is inconsistent with this
exemption with respect to a person or entity operating under the
exemption (49 U.S.C. 31315(d)).

FMCSA Accident Notification

    Exempt motor carriers must notify FMCSA within 5 business days of
any accidents (as defined by 49 CFR 390.5) involving the operation of
any of its CMVs while under this exemption. The notification must
include the following information:
    a. Date of the accident,
    b. City or town, and State, in which the accident occurred, or
which is closest to the scene of the accident,
    c. Driver's name and driver's license number,
    d. Vehicle number and State license number,
    e. Number of individuals suffering physical injury,
    f. Number of fatalities,
    g. The police-reported cause of the accident,
    h. Whether the driver was cited for violation of any traffic laws,
or motor carrier safety regulations, and
    i. The total driving time and the total on-duty time of the CMV
driver at the time of the accident.

Termination

    The FMCSA does not believe the motor carriers and drivers covered
by this exemption will experience any deterioration of their safety
record. However, should this occur, FMCSA will take all steps necessary
to protect the public interest, including revocation of the exemption.
The FMCSA will immediately revoke the exemption for failure to comply
with its terms and conditions.

    Issued on: June 25, 2013.
T.F. Scott Darling,
Chief Counsel.

  Appendix to Notice of Renewal and Expansion of American Pyrotechnics Association (APA) Exemption for 55 Motor
              Carriers From the 14-Hour HOS Rule During 2013 and 2014 Independence Day Celebrations
----------------------------------------------------------------------------------------------------------------
            Motor Carrier                      Street Address             City, State & Zip Code       DOT No.
----------------------------------------------------------------------------------------------------------------
1. Alonzo Fireworks Display, Inc.....  846 Stillwater Bridge Rd.....  Schaghticoke, NY 12154.......       420639
2. American Fireworks Company........  7041 Darrow Road.............  Hudson, OH 44236.............       103972
3. American Fireworks Display, LLC...  P.O. Box 980.................  Oxford, NY 13830.............      2115608
4. AM Pyrotechnics, LLC..............  2429 East 535th Rd...........  Buffalo, MO 65622............      1034961
5. Atlas Enterprises Inc.............  6601 Nine Mile Azle Rd.......  Fort Worth, TX 76135.........      0116910
6. Atlas Pyrovision Productions, Inc.  136 Old Sharon Rd............  Jaffrey, NH 03452............       789777
7. B.J. Alan Company.................  555 Martin Luther King, Jr     Youngstown, OH 44502-1102....       262140
                                        Blvd.
8. Central States Fireworks, Inc.....  18034 Kincaid Street.........  Athens, IL 62613.............      1022659
9. Colonial Fireworks Company........  5225 Telegraph Road..........  Toledo, OH 43612.............       177274
10. East Coast Pyrotechnics, Inc.....  4652 Catawba River Rd........  Catawba, SC 29704............       545033
11. Entertainment Fireworks, Inc.....  13313 Reeder Road SW.........  Tenino, WA 98589.............       680942
12. Falcon Fireworks.................  3411 Courthouse Road.........  Guyton, GA 31312.............      1037954
13. Fireworks & Stage FX America.....  12650 Hwy 67S. Suite B.......  Lakeside, CA 92040...........       908304
14. Fireworks by Grucci, Inc.........  1 Grucci Lane................  Brookhaven, NY 11719.........       324490
15. Fireworks Extravaganza...........  174 Route 17 North...........  Rochelle Park, NJ 07662......      2064141
16. Fireworks West Internationale....  910 North 3200 West..........  Logan, UT 84321..............       245423
17. Garden State Fireworks, Inc......  383 Carlton Road.............  Millington, NJ 07946.........       435878
18. Gateway Fireworks Displays.......  P.O. Box 39327...............  St Louis, MO 63139...........      1325301
19. Great Lakes Fireworks............  24805 Marine.................  Eastpointe, MI 48021.........      1011216
20. Hamburg Fireworks Display Inc....  2240 Horns Mill Road SE......  Lancaster, OH................       395079
21. Hawaii Explosives & Pyrotechnics,  17-7850 N. Kulani Road.......  Mountain View, HI 96771......      1375918
 Inc.
22. Hi-Tech FX, LLC..................  18060 170th Ave..............  Yarmouth, IA 52660...........      1549055
23. Hollywood Pyrotechnics, Inc......  1567 Antler Point............  Eagan, MN 55122..............      1061068
24. Homeland Fireworks, Inc..........  P.O. Box 7...................  Jamieson, OR 97909...........      1377525
25. Island Fireworks Co., Inc........  N1597 County Rd VV...........  Hager City, WI 54014.........       414583
26. J&M Displays, Inc................  18064 170th Ave..............  Yarmouth, IA 52660...........       377461
27. Lantis Fireworks, Inc............  130 Sodrac Dr., Box 229......  N. Sioux City, SD 57049......       534052
28. Lantis Productions dba Lantis      799 N. 18150 W...............  Fairfield, UT 84013..........       195428
 Fireworks and Lasers.
29. Legion Fireworks Co., Inc........  10 Legion Lane...............  Wappingers Falls, NY 12590...       554391
30. Mad Bomber/Planet Productions....  P.O. Box 294, 3999 Hupp Road   Kingsbury, IN 46345..........       777176
                                        R31.
31. Martin & Ware Inc. dba Pyro City   P.P. Box 322.................  Hallowell, ME 04347..........       734974
 Maine & Central Maine Pyrotechnics.
32. Melrose Pyrotechnics, Inc........  1 Kingsbury Industrial Park..  Kingsbury, IN 46345..........       434586
33. Precocious Pyrotechnics, Inc.....  4420-278th Ave NW............  Belgrade, MN 56312...........       435931
34. Pyro Engineering Inc., dba/Bay     400 Broadhollow Rd. Ste        Farmindale, NY 11735.........       530262
 Fireworks.                             3.
35. Pyro Shows Inc...................  701 W. Central Ave...........  LaFollette, TN 37766.........       456818
36. Pyro Spectacluars, Inc...........  3196 N Locust Ave............  Rialto, CA 92376.............       029329
37. Pyro Spectaculars North, Inc.....  5301 Lang Avenue.............  McClellan, CA 95652..........      1671438
38. Pyrotechnic Display, Inc.........  8450 W. St. Francis Rd.......  Frankfort, IL 60423..........      1929883
39. Pyrotecnico (S. Vitale             302 Wilson Rd................  New Castle, PA 16105.........       526749
 Pyrotechnic Industries, Inc.).
40. Pyrotecnico, LLC.................  60 West Ct...................  Mandeville, LA 70471.........       548303
41. Pyrotecnico FX...................  6965 Speedway Blvd. Suite 115  Las Vegas, NV 89115..........      1610728
42. Rainbow Fireworks, Inc...........  76 Plum Ave..................  Inman, KS 67546..............      1139643
43. RES Specialty Pyrotechnics.......  21595 286th St...............  Belle Plaine, MN 56011.......       523981
44. Rozzi's Famous Fireworks, Inc....  11605 North Lebanon Rd.......  Loveland, OH 45140...........      0483686
45. Skyworks, Ltd....................  13513 W. Carrier Rd..........  Carrier, OK 73727............      1421047
46. Spielbauer Fireworks Co, Inc.....  220 Roselawn Blvd............  Green Bay, WI 54301..........       046479
47. Starfire Corporation.............  682 Cole Road................  Carrolltown, PA 15722........       554645
48. Stonebraker-Rocky Mountain         5650 Lowell Blvd, Unit E.....  Denver, CO 80221.............      0029845
 Fireworks Co.
49. Vermont Fireworks Co., Inc./       2235 Vermont Route 14 South..  East Montpelier, VT 05651....       310632
 Northstar Fireworks Co., Inc.
50. Western Display Fireworks, Ltd...  10946 S. New Era Rd..........  Canby, OR 97013..............       498941
51. Western Enterprises, Inc.........  P.O. Box 160.................  Carrier, OK 73727............       203517
52. Western Fireworks, Inc...........  14592 Ottaway Road NE........  Aurora, OR 97002.............       838585
53. Wolverine Fireworks Display, Inc.  205 W Seidlers...............  Kawkawlin, MI................       376857
54. Young Explosives Corp............  P.O. Box 18653...............  Rochester, NY 14618..........       450304
55. Zambelli Fireworks MFG, Co., Inc.  P.O. Box 1463................  New Castle, PA 16103.........       033167
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-15608 Filed 6-26-13; 8:45 am]
BILLING CODE 4910-EX-P