[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64469-64472]
[FR Doc No: 2015-26916]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76192; File No. SR-CBOE-2015-091]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the Fees Schedule

October 19, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 9, 2015, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend its Fees Schedule. The text of the
proposed rule change is available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's
Office of the Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    In March 2015, the Exchange launched Extended Trading Hours
(``ETH'') for options on the S&P 500

Index (``SPX'') and CBOE Volatility Index[supreg] (``VIX''), two of the
Exchange's exclusively listed options,\3\ as alternatives for hedging
and other investment purposes, particularly as a complementary
investment tool to VIX futures.\4\ Rule 6.1A(c) provides that the
Exchange may designate as eligible for trading during ETH any
exclusively listed index option designated for trading under Rules 24.2
and 24.9. In response to customer demand for additional options to
trade during ETH for similar purposes, the Exchange recently designated
p.m.-settled options on the Standard & Poor's 500 Stock Index
(``SPXpm'') to be eligible for trading during ETH. The Exchange
commenced trading of SPXpm during ETH on October 1, 2015. As such, the
Exchange proposes to establish fees for the trading of SPXpm during ETH
(all fees referenced herein are per-contract unless otherwise
stated).\5\ First, the Exchange proposes to amend Footnote 37, which
provides general information regarding the two trading sessions and
indicates which products will be available in ETH, to include trading
of SPXpm.
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    \3\ An ``exclusively listed option'' is an option that trades
exclusively on an exchange because the exchange has an exclusive
license to list and trade the option or has the proprietary rights
in the interest underlying the option. An exclusively listed option
is different than a ``singly listed option,'' which is an option
that is not an ``exclusively listed option'' but that is listed by
one exchange and not by any other national securities exchange.
    \4\ See Securities Exchange Act Release No. 34-73704 (November
28, 2014), 79 FR 72044 (December 4, 2014) (SR-CBOE-2014-062) (order
granting accelerated approval of proposed rule change to adopt
Extended Trading Hours for SPX and VIX).
    \5\ The Exchange initially filed the proposed fee changes on
October 1, 2015 (SR-CBOE-2015-083). On October 9, 2015, the Exchange
withdrew that filing and submitted this filing.
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Transaction Fees
    The Exchange proposes to assess the same fees for SPXpm in the ETH
session as are assessed for SPXpm in the Regular Trading Hours session
(``RTH'').\6\ As in RTH, the Proprietary Index Options Rate Table will
apply during ETH. Transaction fees for SPXpm options will be as follows
(all listed rates are per contract):
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    \6\ Rule 1.1(qqq) defines ``Regular Trading Hours'' as the hours
during which transactions in options may be made on the Exchange as
set forth in Rule 6.1 (which hours are from 8:30 a.m. to either.
3:00 p.m. or 3:15 p.m. Chicago time).

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

------------------------------------------------------------------------
Customer (Premium > or = $1)............................           $0.44
Customer (Premium < $1).................................            0.35
Clearing Trading Permit Holder Proprietary..............            0.25
CBOE Market-Maker/LMM...................................            0.20
Joint Back-Office, Broker-Dealer, Non-Trading Permit                0.40
 Holder Market-Maker....................................
Professional/Voluntary Professional.....................            0.40
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    Additionally, the Exchange notes that SPXpm transactions executed
via AIM during ETH will be assessed AIM Agency/Primary and AIM Contra
fees based on an order's origin code (which is currently the case
during RTH as well).
Surcharges
    The Exchange also proposes to apply in ETH, like RTH, an Index
License Surcharge Fee of $0.13 per contract for SPXpm options for all
non-customer orders. The surcharges are assessed to help the Exchange
recoup license fees the Exchange pays to index licensors for the right
to list S&P 500 Index-based products for trading.
LMM Rebate
    CBOE Rule 6.1A (Extended Trading Hours) provides that the Exchange
may approve one or more Market-Makers to act as Lead Market-Makers
(``LMMs'') in each class during ETH in accordance with Rule 8.15A for
terms of at least one month.\7\ However, to the extent the Exchange
approves Market-Makers to act as LMMs during ETH, subparagraph
(e)(iii)(B) of Rule 6.1A provides that LMMs must comply with the
continuous quoting obligation and other obligations of Market-Makers
described in subparagraph (ii) of Rule 6.1A,\8\ but not the obligations
set forth in Rule 8.15A \9\ during ETH for their allocated classes. It
further provides that LMMs do not receive a participation entitlement
as set forth in Rules 6.45B and 8.15B during ETH. Rather, pursuant to
subparagraph (e)(iii)(C) of Rule 6.1A, if an LMM (1) provides
continuous electronic quotes in at least the lesser of 99% of the non-
adjusted series or 100% of the non-adjusted series minus one call-put
pair in an ETH allocated class (excluding intra-day add-on series on
the day during which such series are added for trading) during ETH in a
given month and (2) ensures an opening of the same percentage of series
by 2:05 a.m. for at least 90% of the trading days during ETH in a given
month, the LMM will receive a rebate for that month in an amount to be
set forth in the Fees Schedule.\10\ Specifically, for TPHs acting as
LMMs in SPXpm options during ETH, the Exchange proposes to provide in
the Fees Schedule (new Footnote 39) that if a LMM meets the heightened
standard described above, the LMM will receive a rebate of $1,000 per
month. The Exchange believes it is more fitting to implement an
incentive program with a rebate during ETH, rather than the obligation/
benefit structure that currently exists during RTH. LMMs will not be
obligated to satisfy heightened continuous quoting and opening quoting
standards during ETH. Instead, LMMs must satisfy a heightened standard
to receive a rebate, which the Exchange believes will encourage LMMs to
provide liquidity during ETH. Additionally, the Exchange notes that
LMMs may have to undertake other expenses to be able to quote at the

heightened standard during ETH such as purchase additional bandwidth.
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    \7\ See CBOE Rule 6.1A(e)(iii)(A).
    \8\ Rule 6.1A(e)(ii) provides that notwithstanding the 20%
contract volume requirement in Rule 8.7(d)(ii), Market-Makers with
appointments during Extended Trading Hours must comply with the
quoting obligations set forth in Rule 8.7(d)(ii) (except during ETH
the Exchange may determine to have no bid/ask differential
requirements as set forth in subparagraph (A) and there will be no
open outcry quoting obligation as set forth in subparagraph (C)) and
all other obligations set forth in Rule 8.7 during that trading
session. Additionally, notwithstanding the 90-day and next calendar
quarter delay requirements in Rule 8.7(d), a Market-Maker with an
ETH appointment in a class must immediately comply with the quoting
obligations in Rule 8.7(d)(ii) during ETH.
    \9\ Rule 8.15A (and Rule 1.1(ccc)) requires LMMs to provide
continuous electronic quotes in at least the lesser of 99% of the
non-adjusted series or 100% of the non-adjusted series minus one
call-put pair within their appointed classes, with the term call-put
pair referring to one call and one put that cover the same
underlying instrument and have the same expiration date and exercise
price, for 90% of the time.
    \10\ Notwithstanding Rule 1.1(ccc), for purposes of subparagraph
(C) of Rule 6.1A, an LMM is deemed to have provided ``continuous
electronic quotes'' if the LMM provides electronic two-sided quotes
for 90% of the time during Extended Trading Hours in a given month.
If a technical failure or limitation of a system of the Exchange
prevents the LMM from maintaining, or prevents the LMM from
communicating to the Exchange, timely and accurate electronic quotes
in a class, the duration of such failure shall not be considered in
determining whether the LMM has satisfied the 90% quoting standard
with respect to that option class. The Exchange may consider other
exceptions to this quoting standard based on demonstrated legal or
regulatory requirements or other mitigating circumstances.
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    The Exchange also proposes to make a corollary change to Footnote
38. The Exchange notes that currently, for SPX and VIX options, LLMs
[sic] are subject to a different rebate program.\11\ As such, the
Exchange proposes to clarify that such rebate program is for TPHs
acting as a LMM during ETH for SPX and VIX options only.
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    \11\ See CBOE Fees Schedule, Footnote 38. If a LMM meets the
heightened quoting standard, the LMM will receive a pro-rata share
of an LMM compensation pool totaling an amount of $25,000 per month,
per LMM, per class for SPX and VIX.
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    The Exchange lastly notes that fees, rebates and programs that
excluded SPXpm, during RTH will also not apply in ETH.\12\
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    \12\ See e.g., Exchange Fees Schedule, Liquidity Provider
Sliding Scale, Marketing Fee, Clearing Trading Permit Holder Fee
Cap, and Volume Incentive Program (``VIP'').
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\13\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \14\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitation
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with
Section 6(b)(4) of the Act,\15\ which requires that Exchange rules
provide for the equitable allocation of reasonable dues, fees, and
other charges among its Trading Permit Holders and other persons using
its facilities.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ 15 U.S.C. 78f(b)(4).
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    The proposed transaction fee amounts for SPXpm orders during the
ETH session are reasonable, equitable and not unfairly discriminatory
because they are the same as the amounts of corresponding fees for
SPXpm orders during the RTH session. The Exchange notes that the fee
amounts for each separate type of market participant will be assessed
equally for each product to all such market participants (i.e. all
Broker-Dealer orders will be assessed the same amount, all Joint Back-
Office orders will be assessed the same amount, etc).
    Assessing the Index License Surcharge Fee of $0.13 per contract to
SPXpm during ETH is reasonable because the amount is the same as the
amount of the corresponding surcharge for SPXpm orders during RTH. The
surcharge fee is equitable and not unfairly discriminatory because it
will be assessed to all market participants to whom the SPXpm will
apply in both RTH and ETH.
    The Exchange believes it is reasonable, equitable and not unfairly
discriminatory to offer LMMs in SPXpm during ETH that meet a certain
heightened quoting standard (described above) a rebate of $1,000 per
month given added costs that a LMM may undertake (e.g., purchase of an
additional bandwidth) and because it will encourage LMMs in SPXpm to
provide increased liquidity. More specifically, the Exchange believes
the amount of the proposed rebate is reasonable because it takes into
consideration certain additional costs an LMM may incur and the
Exchange believes the proposed amount is such that it will incentivize
LMMs to meet the heighted quoting standard. Additionally, if a LMM does
not satisfy the heightened quoting standard, then it will not receive
the proposed rebate. The Exchange believes it is equitable and not
unfairly discriminatory to only offer the rebate to LMMs because it
benefits all market participants in ETH to encourage LMMs to satisfy
the heightened quoting standards, which may increase liquidity during
those hours and provide more trading opportunities and tighter spreads.
The Exchange also believes it is more fitting, as well as equitable and
not unfairly discriminatory to implement an incentive program with a
rebate during ETH, rather than the obligation/benefit structure that
exists during RTH. Particularly, the Exchange notes that creating an
incentive program in which LMMs must satisfy a heightened standard to
receive the rebate, encourages LMMs to provide significant liquidity
during ETH, which is important as the Exchange expects lower trading
liquidity and trading levels during ETH and thus fewer opportunities
for an LMM to receive a participation entitlement (as they currently do
during RTH). Therefore, a rebate is more appropriate than imposing an
obligation to receive a participation entitlement. The Exchange notes
that offering a rebate during ETH is merely a different type of
financial benefit that may be given to LMMs during ETH if it achieves a
heightened quoting level. The Exchange believes it is equitable and not
unfairly discriminatory to provide a lesser rebate for LMMs appointed
in SPXpm options as compared to LMMs for SPX and VIX options because
the Exchange expects lower trading volume in SPXpm options during ETH
as compared to volume for SPX and VIX. Therefore, it would not be
economically viable for the Exchange to offer the same amount of rebate
to LMMs in SPXpm as is offered to LMMs for SPX and VIX.
    Finally, not applying in ETH fees, rebates and programs that
exclude SPXpm during RTH is reasonable because these fees, rebates and
programs will not apply to all TPHs and will be consistent across
sessions.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition that are not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe that the proposed rule change will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because, while different fees
and rebates are assessed to different market participants in some
circumstances, these different market participants have different
obligations and different circumstances. For example, Clearing TPHs
have clearing obligations that other market participants do not have.
Market-Makers have quoting obligations that other market participants
do not have. There is a history in the options markets of providing
preferential treatment to Customers, as they often do not have as
sophisticated trading operations and systems as other market
participants, which often makes other market participants prefer to
trade with Customers. Further, the proposed fees, rebates and programs
for ETH are intended to encourage market participants to bring
liquidity to the Exchange during ETH (which benefits all market
participants), while still covering Exchange costs (including those
associated with the upgrading and maintenance of Exchange systems).
    The Exchange does not believe that the proposed rule changes will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because SPXpm is
a proprietary product that will only be traded on CBOE. To the extent
that the proposed changes

make CBOE a more attractive marketplace for market participants at
other exchanges, such market participants are welcome to become CBOE
market participants.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \16\ and paragraph (f) of Rule 19b-4 \17\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2015-091 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2015-091. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-CBOE-2015-091,
and should be submitted on or before November 13, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-26916 Filed 10-22-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: March 30, 2010 (Volume 75, Number 60)]
[Proposed Rules]
[Page 15639-15642]
[DOCID:fr30mr10-24]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. FDA-2010-N-0099]
RIN 0910-AG15

Revision of the Requirements for Constituent Materials

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA) is proposing to amend
the biologics regulations to permit the Director of the Center for
Biologics Evaluation and Research (CBER) or the Director of the Center
for Drug Evaluation and Research (CDER), as appropriate, to approve
exceptions or alternatives to the regulation for constituent materials.
FDA is taking this action due to advances in developing and
manufacturing safe, pure, and potent biological products licensed under
a section of the Public Health Service Act (the PHS Act) that, in some
instances, render the existing constituent materials regulation too
prescriptive and unnecessarily restrictive. This rule provides
manufacturers of licensed biological products with flexibility, as
appropriate, to employ advances in science and technology as they
become available, without diminishing public health protections.

DATES:  Submit electronic or written comments on the proposed rule on
or before June 28, 2010. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by April 29, 2010,
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2010-
N-0099 and/or RIN number 0910-AG15, by any of the following methods,
except that comments on information collection issues under the
Paperwork Reduction Act of 1995 must be submitted to the Office of
Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section of this document).
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name
and Docket No. and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Information Collection Provision: The information collection
provisions of this proposed rule have been submitted to OMB for review.
Interested persons are requested to fax comments regarding information
collection by April 29, 2010, to the Office of Information and
Regulatory Affairs, OMB. To ensure that comments on information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Constituent materials regulated under Sec.  610.15 (21 CFR 610.15)
include ingredients, preservatives, diluents, adjuvants, extraneous
protein and antibiotics that are contained in a biological product. FDA
is proposing to amend the regulation for constituent materials at Sec.
610.15 to allow the Director of CBER or the Director of CDER, as
appropriate, to approve an exception or alternative to the requirements
under Sec.  610.15, when data submitted with the exception or
alternative establish the safety, purity, and potency of the biological
product. This proposed rule provides manufacturers of biological
products with flexibility, as appropriate, to employ advances in
science and technology as they become available, without diminishing
public health protections. Examples of how the proposed rule would
provide flexibility to manufacturers in the use of preservatives and
aluminum in biological products are provided below. However, the
proposed rule would also provide flexibility to the existing
requirements regarding extraneous protein and antibiotics (Sec.
610.15(b) and (c)), provided that each request for an alternative or
exception to these requirements is submitted with data that establish
the safety, purity, and potency of the biological product.
    Standards for certain constituent materials present in biological
products are provided under Sec.  610.15. Section 610.15(a) requires
that all ingredients used in a licensed product, and any diluent
provided as an aid in the administration of the product, meet generally
accepted standards of purity and quality. Any preservative used shall
be sufficiently nontoxic so that the amount present in the recommended
dose of the product will not be toxic to the recipient, and in the
combination used it shall not denature the specific substances in the
product to result in a decrease below the minimum acceptable potency
within the dating period when stored at the recommended temperature.
Products in multiple-dose containers shall contain a preservative,
except that a preservative need not be added to Yellow Fever Vaccine;
Poliovirus Vaccine Live Oral; viral vaccines labeled for use with the
jet injector; dried vaccines when the accompanying diluent contains a
preservative; or to an Allergenic Product in 50 percent or more volume
in volume glycerin. An adjuvant shall not be introduced into a product
unless there is satisfactory evidence that it does not affect adversely
the safety or potency of the product.
    These regulations also require that the amount of aluminum in the
recommended individual dose of a biological product not exceed the
following:

     0.85 milligrams if determined by assay;
     1.14 milligrams if determined by calculation on the basis
of the amount of aluminum compound added; or
     1.25 milligrams determined by assay provided that data
demonstrating that the amount of aluminum used is safe and necessary to
produce the intended effect are submitted to and approved by the
Director of CBER or the Director of CDER.
    This regulation establishes requirements for the presence of
certain constituent materials in final licensed, biological products
and/or strictly limits the amount of certain constituent materials
present in licensed biological products. For example, the regulation
contains requirements as to preservatives. Preservatives are compounds
that kill or prevent the growth of microorganisms, particularly
bacteria and fungi. In the Federal Register of January 10, 1968 (33 FR
367 at 369), the National Institutes of Health (NIH) issued the
precursor regulation to constituent materials (Sec.  610.15) (the 1968
regulation).\1\ This regulation, in part, set forth the requirements
for preservatives in biological products in multiple-dose containers
and included exceptions to this requirement. Prior to NIH's issuance of
the 1968 regulation, there had been reports in the scientific
literature of serious injuries and deaths associated with bacterial
contamination of multiple-dose containers of vaccines that did not
contain a preservative. This concern regarding contamination was the
scientific basis for the requirement that products in multiple-dose
containers contain a preservative.\2\ However, the regulation also
provided for certain exceptions from the preservative requirement.
These exceptions included live viral vaccines that had been licensed
under section 351 of the PHS Act (42 U.S.C. 262) and that were in
production when NIH issued the 1968 regulation.\3\
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    \1\ In 1968, NIH regulated biological products, through its
Division of Biologics Standards. In the Federal Register of June 29,
1972 (37 FR 12865), an amended Statement of Organization, Functions
and Delegations of Authority of the Department of Health, Education
and Welfare was published reflecting a transfer of the Division of
Biologics Standards to the Food and Drug Administration. In the
Federal Register of August 9, 1972 (37 FR 15993), FDA published
regulations that further reflected these organizational changes. As
a result of this organizational change, the regulations pertaining
to biological products under Part 73 of Title 42 of the Code of
Federal Regulations were transferred to the newly established Part
273 of Title 21 of the Code of Federal Regulations.
    \2\ See ``The National Vaccine Advisory Committee Sponsored
Workshop on Thimerosal Vaccines'' at 21-24 (August 11, 1999). See
also Wilson, Hazards of Immunization, 1967.
    \3\ Biological products had contained preservatives prior to
1968. ``The National Vaccine Advisory Committee Sponsored Workshop
on Thimerosal Vaccines'' at 24 (August 11, 1999).
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    Preservatives in multiple-dose containers have a long record of
safe and effective use in preventing microbial growth in the event that
the vaccine is accidentally contaminated, as might occur with repeated
punctures of multiple-dose containers. The use of preservatives has
significantly declined in recent years with the development of new
products presented in single-dose containers. However, some biological
products, such as inactivated influenza virus vaccines, are still
presented in multi-dose containers and contain a preservative.
    However, the requirements in connection with preservatives are too
prescriptive and unnecessarily restrictive because, for example, state-
of-the art technologies, such as the development of devices to ensure
aseptic withdrawing, offer an alternative to the use of preservatives
in multiple-dose containers. FDA believes that providing the option to
manufacture vaccine in multiple-dose containers without use of a
preservative would be acceptable, provided that appropriate safeguards,
such as adequate storage, aseptic withdrawing techniques and timely use
of the product (e.g., use of the vaccine within a defined period of
time) are followed to ensure that the safety, purity, and potency of
the product are not compromised. Furthermore, the current regulation
under Sec.  610.15(a) does not provide FDA with flexibility to consider
situations (outside of the listed exceptions) in which to allow the use
of preservative-free vaccines in multiple-dose containers. The proposed
rule would permit the Director of CBER or the Director of CDER, as
appropriate, to approve a request to market a biological product in
multiple-dose containers without use of a preservative, if the
manufacturer demonstrates the safety, purity, and potency of the
product.
    Another example where the current requirements are too prescriptive
and unnecessarily restrictive pertains to the amount of aluminum
permitted under Sec.  610.15(a) in the recommended single human dose of
a biological product. Aluminum, in the form of an aluminum salt, is
used as an adjuvant in certain biological products. The existing
regulation limits the amount of aluminum per dose to no more than 0.85
milligrams (mg) if determined by assay or 1.14 mg if determined by
calculation on the basis of the amount of aluminum compound added. In
the Federal Register of October 23, 1981 (46 FR 51903), FDA published a
rule entitled ``General Biological Products Standards; Aluminum in
Biological Products'' (the October 1981 rule). The October 1981 rule
amended Sec.  610.15(a) to increase the permissible level of aluminum
per dose to 1.25 mg both to make the regulation consistent with World
Health Organization standards,\4\ and because it appeared that certain
groups (such as renal dialysis patients), who were understood to be at
high risk of contracting hepatitis, might require a higher dosage of
the hepatitis B vaccine, which would in turn, require amounts of
aluminum as high as 1.25 mg per dose. (See also ``General Biological
Products Standards for Aluminum in Biological Products'' (46 FR 23765,
April 28, 1981)).
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    \4\ More specifically, the amendment permitted the use of up to
1.25 mg of aluminum determined by assay provided that data
demonstrating that the amount of aluminum used is safe and necessary
to produce the intended effect are submitted to and approved by the
Director, Bureau of Biologics.
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    The aluminum content per dose in the formulation of a licensed
biological product, as specified in Sec.  610.15(a), reflects the NIH
Minimum Requirements for Diphtheria Toxoid (1947)\5\ and Tetanus Toxoid
(1952)\6\. The proposed rule would not alter the existing requirements
regarding the amount of aluminum in a biological product. Instead, in a
change that is analogous to the one FDA issued in the October 1981
rule, involving the groups who were at high risk of contracting
hepatitis, the proposed rule would allow either the Director of CBER or
the Director of CDER to approve an exception or alternative when the
Director determines that a biological product meets the requirements
for safety, purity, and potency but contains an amount of aluminum that
is higher than currently permitted by Sec.  610.15, such as a
therapeutic vaccine for treating patients with cancer that contains
aluminum salts at levels higher than currently allowed, but still meets
the requirements of safety, purity, and potency.
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    \5\ National Institute of Health, ``Minimum Requirements for
Diphtheria Toxoid,'' 4th Revision, 1947.
    \6\ National Institutes of Health, ``Minimum Requirements for
Tetanus Toxoid,'' 4th Revision, 1952.
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    The proposed rule enables FDA to assess the constituent materials
in these and other products and provides sufficient flexibility for FDA
to employ advances in science and technology as they become available,
without diminishing public health protection.
    Manufacturers seeking approval of an exception or alternative to a
requirement under Sec.  610.15 would be required to submit a request in
writing.

The request may be submitted as part of the original biologics license
application, as an amendment to the original, pending application or as
a prior approval supplement to an approved application.

II. Highlights of the Proposed Rule

    FDA is proposing to amend Sec.  610.15 by adding new paragraph (d)
that would permit the Director of CBER or the Director of CDER, as
appropriate, to approve exceptions or alternatives to the regulatory
requirements for constituent materials, when the data submitted with
the exception or alternative establish the safety, purity, and potency
of the biological product. All requirements under Sec.  610.15 would
remain in effect, except those for which the Director approves an
exception or alternative. Manufacturers seeking approval of an
exception or alternative must submit a request in writing, as described
in section I of this document.
    FDA is proposing this rule to permit the Director of CBER or the
Director of CDER, as appropriate, to approve exceptions or alternatives
to the regulations for constituent materials, when the data submitted
with the exception or alternative establish the safety, purity, and
potency of the biological product. All requirements under Sec.  610.15
would remain in effect, except those for which the Director approves an
exception or alternative. Manufacturers seeking approval of an
exception or alternative must submit a request in writing, as described
in section I of this document.

III. Legal Authority

    FDA is issuing this regulation under the biological products
provisions of the Public Health Service Act (42 U.S.C. 262 and 264) and
the drugs and general administrative provisions of the Federal Food,
Drug, and Cosmetic Act (sections 201, 301, 501, 502, 503, 505, 510,
701, and 704 (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, and
374)). Under these provisions of the Public Health Service Act and the
Federal Food, Drug, and Cosmetic Act, we have the authority to issue
and enforce regulations designed to ensure that biological products are
safe, pure, and potent; and prevent the introduction, transmission, and
spread of communicable disease.

IV. Analysis of Impacts

A. Review Under Executive Order 12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Reform Act of 1995

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule would allow the Director
of CBER or the Director of CDER, as appropriate, to approve exceptions
or alternatives to the regulations for constituent materials, this
action would increase flexibility and reduce the regulatory burden for
affected entities. Therefore, the agency proposes to certify that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. We request detailed comment
regarding any potential economic impact of this proposed rule.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The benefits of this regulatory action are that the proposed rule
would reduce burdens on industry (e.g., developers of biological
products) due to greater flexibility and reduced regulatory
requirements. These issues are discussed in greater detail in section I
of this document.
    Any costs associated with this regulatory action are expected to be
minimal and widely dispersed among affected entities. Based on FDA
experience, we estimate that we would receive a total of approximately
three requests annually for an exception or alternative under Sec.
610.15. FDA experience with similar information collection requirements
suggests that approximately 1 hour would be required to prepare and
submit such a request.

B. Environmental Impact

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

C. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency has concluded that the proposed rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement is not
required.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). A description of these provisions is given below with an
estimate of the annual reporting burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    FDA invites comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.

    Title: Revision of the Requirements for Constituent Materials.
    Description: The proposed rule would permit the Director of CBER or
the Director of CDER, as appropriate, to approve a manufacturer's
request for exceptions or alternatives to the regulation for
constituent materials. This proposed rule provides manufacturers of
biological products with flexibility, as appropriate, to employ
advances in science and technology as they become available, without
diminishing public health protections. Manufacturers seeking approval
of an exception or alternative must submit a request in writing. The
request must be clearly identified with a brief statement describing
the basis for the request and supporting data. The request may be
submitted as part of the original biologics license application, as an
amendment to the original, pending application or as a prior approval
supplement to an approved application. The information to be collected
will assist FDA in identifying and reviewing requests for an exception
or alternative to the requirements for constituent materials.
    Description of Respondents: Manufacturers of biological products.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
610.15                             3                  1                  3                  1                  3
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on FDA experience, we estimate that we will receive a total
of approximately 3 requests annually for an exception or alternative
under Sec.  610.15. The hours per response are based on FDA experience
with similar information collection requirements.
    In compliance with the PRA (44 U.S.C. 3507(d)), the agency has
submitted the information collection provisions of this proposed rule
to OMB for review. Interested persons are requested to send comments
regarding information collection to OMB (see DATES and ADDRESSES).

VI. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

List of Subjects in 21 CFR Part 610

    Biologics, Labeling, Reporting and Recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 610 be
amended as follows:

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

    1. The authority citation for 21 CFR part 610 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
    2. Amend Sec.  610.15 by adding new paragraph (d) to read as
follows:

Sec.  610.15  Constituent materials.

* * * * *
    (d) The Director of the Center for Biologics Evaluation and
Research or the Director of the Center for Drug Evaluation and Research
may approve an exception or alternative to any requirement in this
section. Requests for such exceptions or alternatives must be in
writing.

    Dated: March 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7073 Filed 3-29-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
[Notices]
[Page 52144]
[FR Doc No: 2021-20274]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3777-000]

Town of Rollinsford, New Hampshire; Notice of Authorization for
Continued Project Operation

    On August 29, 2019, the Town of Rollinsford, New Hampshire,
licensee for the Rollinsford Hydroelectric Project No. 3777, filed an
Application for a Subsequent License pursuant to the Federal Power Act
(FPA) and the Commission's regulations thereunder. The Rollinsford
Hydroelectric Project is located on the Salmon Falls River in Strafford
County, New Hampshire and York County, Maine.
    The license for Project No. 3777 was issued for a period ending
August 31, 2021. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee(s) under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 3777 is issued to
the Town of Rollinsford, New Hampshire for a period effective September
1, 2021 through August 31, 2022 or until the issuance of a new license
for the project or other disposition under the FPA, whichever comes
first. If issuance of a new license (or other disposition) does not
take place on or before August 31, 2022, notice is hereby given that,
pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1)
of the FPA is renewed automatically without further order or notice by
the Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the Town of Rollinsford, New Hampshire is authorized
to continue operation of the Rollinsford Hydroelectric Project, until
such time as the Commission acts on its application for a subsequent
license.

    Dated: September 14, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-20274 Filed 9-17-21; 8:45 am]
BILLING CODE 6717-01-P


and maintenance receptors and a nationally uniform approach to
contribution threshold analysis.\62\ For these reasons, the
Administrator intends, if this proposed action is finalized, to
exercise the complete discretion afforded to him under the CAA to make
and publish a finding that this action is based on one or more
determinations of nationwide scope or effect for purposes of CAA
section 307(b)(1).\63\
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    \62\ A finding of nationwide scope or effect is also appropriate
for actions that cover states in multiple judicial circuits. In the
report on the 1977 Amendments that revised section 307(b)(1) of the
CAA, Congress noted that the Administrator's determination that the
``nationwide scope or effect'' exception applies would be
appropriate for any action that has a scope or effect beyond a
single judicial circuit. See H.R. Rep. No. 95-294 at 323, 324,
reprinted in 1977 U.S.C.C.A.N. 1402-03.
    \63\ EPA may take a consolidated, single final action on all of
the proposed SIP disapproval actions with respect to obligations
under CAA section 110(a)(2)(D)(i)(I) for the 2015 8-hour ozone
NAAQS. Should EPA take a single final action on all such
disapprovals, this action would be nationally applicable, and EPA
would also anticipate, in the alternative, making and publishing a
finding that such final action is based on a determination of
nationwide scope or effect.
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List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: February 3, 2022.
Daniel Blackman,
Regional Administrator, Region 4.
[FR Doc. 2022-02948 Filed 2-18-22; 8:45 am]
BILLING CODE 6560-50-P


WDFW  WA State Forage Fish: Pacific Herring Biology Name: Pacific herring, Clupea harengus pallasi Geographical range: Baja California, Mexico, to the Bering Sea and northeast to the Beaufort Sea. Also along the Asian coast from the Arctic Ocean to Japan.

Related species: Common local members of the herring family, Clupeidae, are the Pacific sardine, ( Sardinops sagax) and the American shad, ( Alosa sapdissima). Other forage fish species include surf smelt, sand lance, and anchovy.

Life history: Most Washington State herring stocks spawn from late January through early April. The notable exception is the Cherry Point stock ( the largest in the state), which spawns from early April through early June. Herring deposit transparent, adhesive eggs on intertidal and shallow subtidal eelgrass and marine algae. Eggs may be deposited anywhere between the upper limits of high tide to a depth of  40 feet, but most spawning takes place between 0 and  10 feet in tidal elevation. Eggs hatch in http:// www. wa. gov/ wdfw/ fish/ forage/ herring. htm ( 1 of 6) [ 4/ 2/ 2003 4: 03: 44 PM] WDFW  WA State Forage Fish: Pacific Herring about 14 days, producing slender, transparent larvae about 13 mm long. At this stage, they are at the mercy of currents and subject to heavy predation by larger organisms. At about three months of age and at about 38 mm in length, herring metamorphose into their adult form and coloration. They will mature and return to their spawning ground in their second or third year. Herring do not normally die after spawning, and continue to spawn in successive years.

Natural mortality is quite high, approximately 50 70 percent of the adult herring from Washington will fall to predation each year. Thus, the typical Puget Sound herring is relatively short lived, rarely surviving beyond age five. Some herring stocks appear to have an annual migration from inshore spawning grounds to open ocean feeding areas, while others appear to be more " resident", remaining inside the Puget Sound basin year around. Adult herring feed primarily on planktonic crustaceans, and in turn are food for many marine animals such as seabirds, marine mammals, and other fishes.

Spawning stocks: Herring stocks are defined by spawning grounds. At least 18 stocks spawn inside Puget Sound and one on the Washington coast in central Willapa Bay. Spawning has been reported but not documented in the Columbia River estuary near the Illwaco and Hammond. The approximate location of spawning grounds inside Puget Sound and those spawning grounds grouped by stock are pictured in the figure below.

( Documented herring spawning grounds GIF , 24k.)

Although homing is not absolute, and is less specific than that demonstrated by salmon, herring spawning populations appear to maintain some biological separation from each other. Each geographically distinct spawning population is defined as a discrete stock. Other stock specific characteristics such as unique age structures, distinctive spawning timing and prespawner holding area behavior support the stock definitions.

The adjacent chart shows, in yellow, the approximate location of the documented herring spawning grounds in Puget Sound. Herring populations which spawn each year at these individual grounds form the 18 stocks. Each stock in Puget Sound is assessed annually by one of two assessment methods. The annual assessments are published each year in the Stock Status Report.

Herring  Management The Pacific herring is of considerable interest to the citizens of the Puget Sound region because of the species' value as forage, its popularity as recreational fishing bait, its significance to local commercial fisheries, and its importance as an indicator of the general " health and productivity" of Puget Sound.

Management Principles http:// www. wa. gov/ wdfw/ fish/ forage/ herring. htm ( 2 of 6) [ 4/ 2/ 2003 4: 03: 44 PM] WDFW  WA State Forage Fish: Pacific Herring For management planning, Washington is divided into four geographic regions: South central Puget Sound, north Puget Sound, Strait of Juan de Fuca and the Washington coast. Profiles have been developed for known herring stocks within these geographic regions. These profiles are detailed in the Stock Status Report.

Herring were included in the 1974 " Boldt Decision" regarding Native American fishing rights, and local stocks and fisheries are cooperatively monitored and managed by Washington Department of Fish and Wildlife ( WDFW) and local area Tribal governments.

The appropriate harvest rate for herring has been shown to be about 20 percent of the spawning stock, and herring are harvested at that rate worldwide. Significant fisheries for herring also occur in Alaska, British Columbia, Oregon and California. ( To learn more about Canadian herring management visit their web site at DFO Canada.) Presently, Puget Sound herring are fished at an extremely conservative level; at a total annual exploitation rate of about 6 percent. Two commercial herring fisheries occur in Washington, both in Puget Sound: A sport bait fishery and a spawn on kelp fishery.

The sport bait fishery occurs primarily in the South central Puget Sound Region and is assumed to exploit an aggregate of stocks within the region. The fishery is regulated by area, season, gear type, and harvest guidelines. Harvest guidelines are generally based on an annual average of the pooled South central Puget Sound stock biomass estimates.

The spawn on kelp fishery is currently limited to specific north Puget Sound spawning stocks. The fishery is managed among WDFW and four tribes. A Herring Technical Team, comprised of representatives from the management bodies, is responsible for developing annual management plans that include run forecasts, harvest guidelines, and fishery protocols. The fishery is regulated by area, season, gear type and harvest guidelines. Harvest guidelines are based on annual stock biomass estimates.

Licensing In 1973, the Washington State Legislature enacted limited entry for non treaty commercial herring fishing. The maximum number of herring fishing licenses was " frozen" for each gear type ( dipbag, lampara seine, purse seine, beach seine and gill net). Anyone interested in commercially fishing for herring must purchase an existing license from a current license holder. The treaty herring fishing fleet is not under growth restriction, although fishing effort is limited by management plans defined by the Herring Technical Team.

Stock Assessment Two methods are used by WDFW to provide quantitative estimates of herring abundance: spawn deposition surveys and acoustic/ trawl surveys. Using one of either of the two methods, WDFW currently estimates the abundance ( spawning biomass) of each of the 18 recognized herring stocks in Puget Sound each year. Occasional assessments are conducted on the Washington coastal stock.

http:// www. wa. gov/ wdfw/ fish/ forage/ herring. htm ( 3 of 6) [ 4/ 2/ 2003 4: 03: 44 PM] WDFW  WA State Forage Fish: Pacific Herring Spawn deposition surveys provide a direct estimate of herring spawning abundance measured as biomass. The marine vegetation on documented herring spawning grounds is sampled for the presence of herring eggs. If eggs are present their density and coverage is estimated and that data is converted to an estimate of spawning escapement. These surveys are generally conducted weekly during a stock's spawning season to document cumulative spawn deposition.

Acoustic/ trawl surveys are conducted on the prespawner holding areas. Prior to spawning, ripening adult herring congregate and hold in a region usually adjacent to the spawning grounds. In the adjacent drawing, the spawning ground is shown in pink and the holding area in blue. The schooling process usually begins 3 4 weeks before the first spawning event. Acoustic/ trawl surveys are conducted early in the spawning season when holding area stock abundance peaks. This method utilizes echosounding equipment ( sonar) with a computer interface. The acoustic gear produces a realtime estimate of total fish abundance. The estimate of total fish abundance is apportioned to herring biomass based on data collected by a mid water trawl which samples the schooling fish. Analyses of the trawl catch also provides herring size, age, and maturity data.

Total Puget Sound Herring Spawning Biomass Estimates, 1977 96.

Annual estimates of herring spawning stocks size can vary greatly between years and spawning grounds for a variety of reasons unrelated to fishing pressure. The best indicator of overall herring viability for each of the four regions is the cumulative estimate of all stocks that spawn within each region. Any extensive environmental changes or deleterious factors resulting in a negative impact on herring productivity would readily become apparent by trends in these cumulative regional estimates.

Of the four management regions, the South central Puget Sound combined stock spawning biomass has shown the least variation during the 20 year time frame presented in the figure below. The cumulative spawning biomass for the period is 6,059 tons.

The cumulative north Puget Sound spawning biomass has typically been the largest within the state. From the period 1975 through 1983, the standing spawning biomass exceeded 10,000 tons each year, primarily because of large Cherry Point stock estimate. The period 1984 1987 saw a substantial decline in the biomass, again largely related to a decline in the Cherry Point stock estimates. From 1988 to 1994, a gradual increase in total spawning biomass has taken place, and then a decline in 1995 and 1996. All stocks in the region have, to some degree, contributed to this escalation.

The Strait of Juan de Fuca collection of stocks contains the smallest spawning biomass among the four regions. Discovery Bay is the location of the predominant stock. From the mid 1980s to the present, stock estimates from this region have shown a continuing decline. The reason for the decrease in abundance is unknown. Commercial landings from the area during the 1977 96 period have been insignificant and no known major environmental changes in the area have occurred.

The cumulative total Puget Sound spawning biomass for the 1977 96 period is 15,994 tons. Annual cumulative estimates above 15,000 tons are presently considered the baseline level for a healthy regional herring population. During three of the last five years the total cumulative estimate has exceeded or been within five percent of the baseline. The 1996 cumulative estimate of 12,966 tons falls below this threshold.

While spawning populations of herring are known to occur in the Washington coastal region, only occasional monitoring or http:// www. wa. gov/ wdfw/ fish/ forage/ herring. htm ( 4 of 6) [ 4/ 2/ 2003 4: 03: 44 PM] WDFW  WA State Forage Fish: Pacific Herring assessment of coastal herring currently takes place. Variable spawn deposition survey effort in Willapa Bay during 1974, 1988, 1989 and 1997 suggest a spawner escapement ranging from 50 to 700 tons.

Natural Mortality Herring spawning stock size fluctuations are primarily influenced by ecological factors that affect survival, and to a smaller extent growth. Changes in sea temperature, for example, can affect herring food supplies and or change the abundance of predators.

With appropriate stock assessment methodology, survival and mortality can be estimated. Mortality can be divided into two types: fishing and natural mortality ( all causes other than fishing). An annual estimate of herring mortality in Washington has been calculated since 1976. The figure below shows the annual mortality experienced by all adult Puget Sound herring combined. For the purpose of this figure, it is assumed that the cumulative spawner biomass estimate is reflective of the total spawner biomass and that variation in annual mortality between stocks is small.

The annual natural mortality rate estimates for herring in Puget Sound have increased from the 30 40 percent range in the 1970s to the 60 70 percent range at present. Worldwide, natural mortality rates in the 30 40 percent range are considered typical, while higher rates, like those presently observed for the Puget Sound stocks are considered unusual. Relatively good two year old recruitment in recent years has been sustaining most stocks in Puget Sound despite high natural mortality rates. Recruitment failure, under the present natural mortality, would lead to dramatic stock biomass declines.

The adjacent graph indicates that in the last 20 years, herring natural mortality has increased while fishing mortality has decreased. Therefore, declines in herring abundance can most likely be attributed to increased predation. Increases in some herring predators, such as harbor seals, California sea lions and mackerel may contribute significantly to herring population declines. Similarly environmental changes may contribute to the increase in natural mortality.

Herring  Habitat Issues The location of herring spawn deposition in lower intertidal and upper subtidal habitats and the geographically specific nature of herring spawning behavior makes herring spawning grounds vulnerable to shoreline development. Documented herring spawning grounds are protected from habitat loss by the Washington Administrative Code Hydraulic Code Rules.

Each herring spawning ground is assumed to represent a discrete stock. WDFW's ongoing assessment survey results, which indicate stock specific age structures, and strong site specificity, spawn timing, and prespawner holding area characteristics continue to support the assumption of stock autonomy for Puget Sound herring. Therefore, conservation of herring spawning habitat, and minimizing disturbance in the prespawning holding areas is key to the preservation of the herring stocks inside Puget Sound. Herring stock assessment data is very useful for localized habitat management and planning.

Herring  Commercial Fisheries In Washington, the majority of commercial herring fisheries have historically occurred inside Puget Sound. There are no directed fisheries on any herring populations on the Washington coast. From the early 1930s until the late 1950s, herring caught commercially in Puget Sound were primarily used as bait for halibut, crab, and shark fisheries. During the early 1950s, fishing emphasis began shifting to supply bait needs for a rapidly growing recreational salmon fishery. In addition, beginning in the late 1950s over all herring catches rose substantially due to an expanding reduction fishery in north Puget Sound that processed herring into fish meal.

http:// www. wa. gov/ wdfw/ fish/ forage/ herring. htm ( 5 of 6) [ 4/ 2/ 2003 4: 03: 44 PM] WDFW  WA State Forage Fish: Pacific Herring In 1972, a large scale fishery for herring sac roe began in the Strait of Georgia ( north Sound region ). Total landings of herring in Puget Sound peaked by the mid 1970'. Harvest levels decreased in the late 1970' when north Puget Sound stocks began to decline, and both the reduction fishery and the sac roe fishery were closed in the early 1980s.

Currently, WDFW is responsible for the management of two commercial herring fisheries in Washington: the sport bait fishery and the spawn on kelp fishery. The sport bait fishery is the principal commercial herring fishery which occurs primarily in the South central Puget Sound region. Annual landings from 1992 96 averaged 510 tons, with most of the harvest taken by small ( 200 foot) lampara seines. This predominately non treaty fishery targets 1 1/ 2 year old " plug" herring almost exclusively.

The spawn on kelp fishery ( treaty and non treaty) predominantly occurs in the north Puget Sound region, although occasionally a small treaty only spawn onkelp fishery is conducted in central Puget Sound. In this fishery, purse seines capture herring which are congregating in the prespawning holding areas. The fish are impounded in floating pens hung with lines of kelp; ( Macrocystis integrifolia). The impounded herring spawn on the kelp, and then are released, and the spawn laden kelp is harvested. In a variation of this fishery, the kelp is hung from floating lines near the spawning beaches where it is spawned upon by fish which are not impounded. The combined treaty/ non treaty spawn onkelp fishery has averaged 241 tons of fish impounded or utilized per year.

Herring  Recreational Fisheries Recreational landings of herring in Washington State are relatively insignificant. Sport anglers occasionally jig herring or dip herring " balls" for salmon bait, but most purchase commercially caught bait herring. Herring are also commonly caught incidentally in surf smelt recreational jig fisheries, and some are likely kept and consumed.

Go to the top of this document Go to the Forage Fish Index Page Go to the WDFW Home Page For more information on fish management issues, please contact WDFW Fish Management Program.

E mail: fishpgm@ dfw. wa. gov Find a bug or error in the system? Let us know about it! © 1997 Washington Department of Fish and Wildlife E mail < webmaster@ dfw. wa. gov>

http:// www. wa. gov/ wdfw/ fish/ forage/ herring. htm ( 6 of 6) [ 4/ 2/ 2003 4: 03: 44 PM]


[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Rules and Regulations]
[Pages 63167-63169]
[FR Doc No: 2011-26001]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0687; Directorate Identifier 2011-CE-017-AD;
Amendment 39-16833; AD 2011-21-10]
RIN 2120-AA64

Airworthiness Directives; Diamond Aircraft Industries GmbH
Airplanes With Supplemental Type Certificate (STC) SA03674AT

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Diamond
Aircraft Industries GmbH Model (Diamond) DA 40 airplanes equipped with
cabin air conditioning vapor cycle system (VCS) installed per STC
SA03674AT held by Premier Aircraft Services (originally held by DER
Services, Inc.) following DER Services Master Document List MDL-2006-
020-1, Revision C, dated February 3, 2009; Revision D, dated April 22,
2009; Revision E, dated May 12, 2010; or Revision F, dated July 6,
2010. This AD was prompted by reports of damage around the VCS
compressor mounting areas found during maintenance inspections. This AD
requires deactivation of the VCS, removal of the compressor and
bracket, and revision to the airplane weight and balance. We are
issuing this AD to correct the unsafe condition on these products.

DATES: This AD is effective November 16, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of November 16,
2011.

ADDRESSES: For service information identified in this AD, contact
Premier Aircraft Service, 5540 NW 23 Avenue Hangar 14, Ft. Lauderdale,
FL 33309, telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Internet:
http://www.flypas.com. You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust St.,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Hal Horsburgh, Aerospace Engineer,
FAA, Atlanta Aircraft Certification Office, 1701 Columbia Avenue,
College Park, Georgia 30337; telephone:<PHONE_NUMBER>; fax: (404) 474-
5606; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on June 28, 2011 (76 FR
37684). That NPRM proposed to require removal of the VCS mount, which
could result in the air conditioner compressor disconnecting in the
engine compartment. This condition could result in engine stoppage or
additional damage to the engine.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (76 FR 37684, June 28,
2011) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes and the addition of an optional terminating
action after the compressor is removed which will allow for the
reinstallation and reactivation of the air conditioning system. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (76 FR 37684, June 28, 2011) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Costs of Compliance

    We estimate that this AD affects 11 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Remove the VCS compressor,            3 work-hours x $85 per      Not applicable            $255          $2,805
 deactivate system, and revise         hour = $255.
 weight and balance.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, all of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2011-21-10 Diamond Aircraft Industries GmbH Airplanes Equipped With
Supplemental Type Certificate (STC) SA03674AT: Amendment 39-16833;
Docket No. FAA-2011-0687; Directorate Identifier 2011-CE-017-AD.

(a) Effective Date

    This AD is effective November 16, 2011.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Diamond Aircraft Industries GmbH Model DA 40
airplanes, all serial numbers, that:
    (1) Are equipped with vapor cycle system (VCS) cabin air
conditioning installed per Premier Aircraft Service STC SA03674AT
following DER Services Master Document List MDL-2006-020-1, Revision
C, dated February 3, 2009; Revision D, dated April 22, 2009;
Revision E, dated May 12, 2010; or Revision F, dated July 6, 2010;
and
    (2) are certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2150, Cabin Cooling
System.

(e) Unsafe Condition

    This AD was prompted by reports of damage around the VCS
compressor mounting area found during maintenance inspections. We
are issuing this AD to remove the VCS compressor and mount, as a
result of excessive wear, which could result in the air conditioner
compressor disconnecting in the engine compartment. This condition
could result in engine stoppage or additional damage to the engine.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within the next 100 hours time-in-service after installation of
the VCS installed per STC SA03674AT held by Premier Aircraft Service
(originally held by DER Services, Inc.) following DER Services
Master Document List MDL-2006-020-1, Revision C, dated February 3,
2009; Revision D, dated April 22, 2009; Revision E, dated May 12,
2010; or Revision F, dated July 6, 2010, or within 30 days after
November 16, 2011 (the effective date of this AD), whichever occurs
later, do the following actions following Premier Aircraft Service
Work Instruction PAS-WI-MSB-40-2011-001, dated March 4, 2011; and
Premier Aircraft Service Mandatory Service Bulletin No. PAS-MSB-40-
2011-001, dated March 4, 2011:
    (1) Deactivate the VCS system.
    (2) Pull and collar the compressor breaker and place a placard
above the breaker stating ``INOP.''
    (3) Remove the VCS compressor and associated mounting hardware.
    (4) Revise the airplane weight and balance.

(h) Optional Actions

    If all actions in paragraphs (g)(1), (g)(2), (g)(3), and (g)(4)
of this AD have been completed, an optional terminating action
allows you to reinstall the VCS compressor and reactivate the air
conditioning system following Premier Aircraft Service Service
Bulletin No. PAS-SB-40-2011-002, dated August 18, 2011; Seamech
International Inc. Vapor Cycle Air Conditioning with Automatic
Climate Control Instructions for Continued Airworthiness, ASI-
772216A, Revision G, dated August 9, 2011; Seamech International
Inc. Kit Compressor Mounting, Drawing SII 2216155, Revision D, dated
July 21, 2011; and DER Services Installation Instructions
Engineering Order EO-2006-020-1, Revision F, dated August 18, 2011.

(i) Special Flight Permit

    The compressor drive belt must be cut and removed before the
airplane may be moved for one ferry flight to an approved repair
facility to comply with the remainder of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the

attention of the person identified in the Related Information
section of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Hal Horsburgh,
Aerospace Engineer, FAA, Atlanta ACO, 1701 Columbia Avenue, College
Park, Georgia 30337; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
e-mail<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the incorporation by
reference (IBR) under 5 U.S.C. 552(a) and 1 CFR part 51 of the
following service information on November 16, 2011:
    (i) Premier Aircraft Service Work Instruction PAS-WI-MSB-40-
2011-001, dated March 4, 2011; and
    (ii) Premier Aircraft Service Mandatory Service Bulletin No.
PAS-MSB-40-2011-001, dated March 4, 2011.
    (2) If you accomplish the optional actions specified by this AD,
you must use the following service information to perform those
actions. The Director of the Federal Register approved the
incorporation by reference (IBR) of the following service
information on November 16, 2011:
    (i) Premier Aircraft Service Service Bulletin No. PAS-SB-40-
2011-002, dated August 18, 2011;
    (ii) Seamech International Inc. Vapor Cycle Air Conditioning
with Automatic Climate Control Instructions for Continued
Airworthiness, ASI-772216A, Revision G, dated August 9, 2011;
    (iii) Seamech International Inc. Kit Compressor Mounting,
Drawing SII 2216155, Revision D, dated July 21, 2011;
    (iv) DER Services Installation Instructions Engineering Order
EO-2006-020-1, Revision F, dated August 18, 2011.
    (3) For service information identified in this AD, contact
Premier Aircraft Service, 5540 NW 23 Avenue Hangar 14, Ft.
Lauderdale, FL 33309, telephone:<PHONE_NUMBER>; fax: (954) 334-
1489; Internet: http://www.flypas.com.
    (4) You may review copies of the referenced service information
at the FAA, Small Airplane Directorate, 901 Locust, Kansas City,
Missouri 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Kansas City, Missouri, on October 3, 2011.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2011-26001 Filed 10-11-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 13, 2008 (Volume 73, Number 50)]
[Notices]
[Page 13535-13536]
[DOCID:fr13mr08-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC08-510-000; FERC-510]

Commission Information Collection Activities, Proposed
Collection; Comment Request; Extension

March 6, 2008.
AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of proposed information collection and request for
comments.

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SUMMARY: In compliance with the requirements of section 3506(c)(2)(a)
of the Paperwork Reduction Act of 1995 (Pub. L. No. 104-13), the
Federal Energy Regulatory Commission (Commission) is soliciting public
comment on the specific aspects of the information collection described
below.

DATES: Comments on the collection of information are due May 15, 2008.

ADDRESSES: Copies of sample filings of the proposed collection of
information can be obtained from the Commission's Web site (http://
www.ferc.gov/docs-filing/elibrary.asp) or to the Federal Energy
Regulatory Commission, Attn: Michael Miller, Office of the Executive
Director, ED-34, 888 First Street NE., Washington, DC 20426. Comments
may be filed either in paper format or electronically. Those parties
filing electronically do not need to make a paper filing. For paper
filing, the original and 14 copies of such comments should be submitted
to the Office of the Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426 and refer to Docket No.
IC08-510-000.
    Documents filed electronically via the Internet must be prepared in
an acceptable filing format and in compliance with the Federal Energy
Regulatory Commission submission guidelines. Complete filing
instructions and acceptable filing formats are available at (http://
www.ferc.gov/help/submission-guide/electronic-media.asp). To file the
document electronically, access the Commission's Web site and click on
Documents & Filing, E-Filing (http://www.ferc.gov/docs-filing/
efiling.asp), and then follow the instructions for each screen. First
time users will have to establish a username and password. The
Commission will send an automatic acknowledgement to the sender's e-
mail address upon receipt of comments.
    All comments may be viewed, printed or downloaded remotely via the
Internet through FERC's homepage using the eLibrary link. For user
assistance, contact<EMAIL_ADDRESS>or toll-free at (866)
208-3676. or for TTY, contact<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by
telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC-510 ``Application for Surrender of Hydropower
License'' (OMB No. 1902-0068) is used by the Commission to implement
the statutory provisions of sections 4(e) and 6 and 13

of the Federal Power Act (FPA) 16 U.S.C. sections 797(e), 799 and 806.
Section 4(e) gives the Commission authority to issue licenses for the
purposes of constructing, operating and maintaining dams, water
conduits, reservoirs, powerhouses, transmissions lines or other power
project works necessary or convenient for developing and improving
navigation, transmissions and utilization of power over which Congress
has jurisdiction. Section 6 gives the Commission the authority to
prescribe the conditions of licenses including the revocation or
surrender of the license. Section 13 defines the Commission's authority
to delegate time periods for when a license must be terminated if
project construction has not begun. Surrender of a license may be
desired by a licensee when a licensed project is retired or not
constructed or natural catastrophes have damaged or destroyed the
project facilities. The information collected under the designation
FERC-510 is in the form of a written application for surrender of a
hydropower license. The information is used by Commission staff to
determine the broad impact of such surrender. The Commission will issue
a notice soliciting comments from the public and other agencies and
conduct a careful review of the prepared application before issuing an
order for Surrender of a License. The order is the result of an
analysis of the information produced, i.e., economic, environmental
concerns, etc., which are examined to determine if the application for
surrender is warranted. The order implements the existing regulations
and is inclusive for surrender of all types of hydropower licenses
issued by FERC and its predecessor, the Federal Power Commission. The
Commission implements these mandatory filing requirements in the Code
of Federal Regulations (CFR) under 18 CRF 6.1-6.4.
    Action: The Commission is requesting a three-year extension of the
current expiration date, with no changes to the existing collection of
data.
    Burden Statement: Public reporting burden for this collection is
estimated as:

------------------------------------------------------------------------
    Number of          Number of       Average burden
   respondents       responses per        hours per       Total annual
     annually          respondent         response        burden hours
(1)                            (2)                (3)   (1) x (2) x (3)
------------------------------------------------------------------------
              8                  1                 10                80
------------------------------------------------------------------------

    Estimated cost burden to respondents is $4,861.00. (80 hours/2080
hours per year times $126,384 per year average per employee =
$4,861.00). The cost per respondent is $608.00.
    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) adjusting the existing ways
to comply with any previously applicable instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting, or otherwise disclosing the
information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) 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; (3) ways to enhance the quality,
utility and clarity of the information to be collected; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology e.g., permitting electronic submission of
responses.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-5028 Filed 3-12-08; 8:45 am]

BILLING CODE 6717-01-P