[Federal Register Volume 87, Number 15 (Monday, January 24, 2022)]
[Notices]
[Pages 3597-3599]
[FR Doc No: 2022-01226]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93995; File No. SR-CboeEDGA-2022-001]

Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend the Fees Applicable to Various Market Data Products

January 18, 2022.
    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 January 4, 2022, Cboe EDGA Exchange, Inc. (``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe EDGA Exchange, Inc. (``EDGA'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to amend the fees applicable to various market
data products. The text of the proposed rule change is provided in
Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/edga/), 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
    The Exchange proposes to amend the Market Data section applicable
to its equities trading platform (``EDGA Equities''). Particularly, the
Exchange proposes to (i) adopt a New External Distributor Credit
applicable to Cboe One Premium, and (ii) extend the New External
Distributor Credit applicable to EDGA Summary Depth Feed from one (1)
month to three (3) months.
    By way of background, Cboe One Premium is a data feed that
disseminates, on a real-time basis, the aggregate best bid and offer
(``BBO'') of all displayed orders for securities traded on EDGA and its
affiliated exchanges (i.e., Cboe BYX Exchange, Inc. (``BYX''), Cboe
EDGX Exchange, Inc. (``EDGX''), and Cboe BZX Exchange, Inc. (``BZX''))
and contains optional functionality which enables recipients to receive
aggregated two-sided quotations from EDGA and its affiliated equities
exchanges for up to five (5) price levels.\3\ Currently, the Exchange
charges an external distribution fee of $12,500 per month to External
Distributors \4\ of Cboe One Premium. The Exchange now proposes to
adopt a New External Distributor Credit which provide that new External
Distributors of the Cboe One Premium Feed will not be charged an
External Distributor Fee for their first three (3) months in order to
allow them to enlist new Users to receive the Cboe One Summary[sic]
Feed. The Exchange believes the proposal will incentivize External
Distributors to enlist new users to receive Cboe One Premium. To ensure
consistency across the Cboe Equity Exchanges, BZX, BYX, and EDGX will
be filing companion proposals to reflect this proposal in their
respective fee schedules.
---------------------------------------------------------------------------

    \3\ The Cboe Aggregated Market (``Cboe One'') Feed is a data
feed that contains the aggregate best bid and offer of all displayed
orders for securities traded on the Exchange and its affiliated
exchanges (i.e., BYX, BZX, and EDGX). See Exchange Rule 13.8(b). The
Cboe One Feed contains optional functionality which enables
recipients to receive aggregated two-sided quotations from the Cboe
Equities Exchanges for up to five (5) price levels (``Cboe One
Premium Feed''). See Exchange Rule 13.8(b)(i). The Cboe One Premium
external distribution fee is equal to the aggregate EDGA Summary
Depth, BYX Summary Depth, EDGA Summary Depth, and BZX Summary Depth
external distribution fees.
    \4\ An External Distributor of an Exchange Market Data product
is a Distributor that receives the Exchange Market Data product and
then distributes that data to a third party or one or more Users
outside the Distributor's own entity.
---------------------------------------------------------------------------

    The Exchange notes that it offers similar credits for other market
data products. For example, the Exchange currently offers a one (1)
month New External Distributor Credit applicable to Cboe One
Summary,\5\ which is a data feed that disseminates, on a real-time
basis, the aggregate BBO of all displayed orders for securities traded
on EDGA and its affiliated equities exchanges and also contains
individual last sale information for the EDGA and its affiliated
equities exchanges.\6\ It also offers a New External Distributor Credit
of one (1) month for subscribers of EDGA Summary Depth, which is a data
feed that offers aggregated two-sided quotations for all displayed
orders entered into the System for up to five (5) price levels. EDGA
Summary Depth also contains the individual last sale information,
Market Status, Trading

Status, and Trade Break messages.\7\ As noted above, the External
Distribution fees for Cboe One Summary is equivalent to the aggregate
EDGA Summary Depth, BZX Summary Depth, BYX Summary Depth, and EDGX
Summary Depth External Distribution fees. In order to alleviate any
competitive issues that may arise with a vendor seeking to offer a
product similar to the Cboe One Premium Feed based on the underlying
data feeds, the Exchange proposes to also extend the current New
External Distributor Credit for EDGA Summary Depth from one (1) month
to three (3) months and the Exchange's affiliates BYX, BZX and EDGX are
also submitting similar proposals to increase the length of their
respective Summary Depth New External Distributor Credits from one (1)
month to three (3) months. The respective proposals to extend these
credits to three months ensures the proposed New External Distributor
Credit for Cboe One Premium will continue to not cause the combined
cost of subscribing to EDGA, EDGX, BYX, and BZX Summary Depth feeds for
new External Distributors to be greater than those currently charged to
subscribe to the Cboe One Premium feed.
---------------------------------------------------------------------------

    \5\ See Exchange Rule 13.8(b).
    \6\ The Exchange notes that when it first adopted the New
External Distributor Credit for Cboe One Summary, it similarly
applied for a new External Distributor's first three (3) months. See
Securities Exchange Act Release No. 74283 (February 18, 2015), 80 FR
9809 (February 24, 2015) (SR-EDGA-2015-09).
    \7\ See Exchange Rule 13.8(f).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\8\ in general, and
furthers the objectives of Section 6(b)(4),\9\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its members and other recipients of
Exchange data. In addition, the Exchange believes that the proposed
rule change is consistent with Section 11(A) of the Act as it supports
(i) fair competition among brokers and dealers, among exchange markets,
and between exchange markets and markets other than exchange markets,
and (ii) the availability to brokers, dealers, and investors of
information with respect to quotations for and transactions in
securities.\10\ Finally, the proposed rule change is also consistent
with Rule 603 of Regulation NMS,\11\ which provides that any national
securities exchange that distributes information with respect to
quotations for or transactions in an NMS stock do so on terms that are
not unreasonably discriminatory.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
    \10\ 15 U.S.C. 78k-1.
    \11\ See 17 CFR 242.603.
---------------------------------------------------------------------------

    The Exchange believes that adopting a New External Distributor
Credit for Cboe One Premium is equitable and reasonable. As discussed
above, a similar New External Distributor Fee Credit was initially
adopted at the time the Exchange began to offer the Cboe One Summary to
subscribers. It was intended to incentivize new Distributors to enlist
Users to subscribe to Cboe One Summary in an effort to broaden the
product's distribution. Now, the Exchange proposes to adopt a similar
credit for Cboe One Premium subscribers for their first three (3)
months to similarly incentivize new Distributors to enlist Users to
subscribe to Cboe One Premium in an effort to broaden the product's
distribution. While this incentive is not available to Internal
Distributors of Cboe One Premium, the Exchange believes it is
appropriate as Internal Distributors have no subscribers outside of
their own firm. The Exchange believes extending the New External
Distributor Credit for EDGA Summary Depth from one (1) month to three
(3) months is also equitable and reasonable, as it (along with
simultaneous corresponding proposals by the Exchange's affiliates)
ensures the proposed New External Distributor Credit for Cboe One
Premium will continue to not cause the combined cost of subscribing to
EDGA, EDGX, BYX, and BZX Summary Depth feeds for new External
Distributors to be greater than those currently charged to subscribe to
the Cboe One Premium feed.

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

    The Exchange does not believe that the proposed rule change would
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
operates in a highly competitive environment, and its ability to price
these data products is constrained by competition among exchanges that
offer similar data products to their customers. The Exchange believes
that the proposed fees do not put any market participants at a relative
disadvantage compared to other market participants. As discussed, the
proposed credits would apply to all External Distributors Cboe One
Premium and EDGA Depth on an equal and non-discriminatory basis.
Further, the Exchange believes that the proposed fees do not impose a
burden on competition or on other SROs that is not necessary or
appropriate in furtherance of the purposes of the Act. As discussed
above, the proposed amendments are designed to enhance competition by
providing an incentive to new Distributors to enlist new subscribers.

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 \12\ and paragraph (f) of Rule 19b-4 \13\
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.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-CboeEDGA-2022-001 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-CboeEDGA-2022-001. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeEDGA-2022-001 and should be
submitted on or before February 14, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-01226 Filed 1-21-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53262-53264]
[FR Doc No: 2018-22954]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2434]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Formal Meetings With Sponsors and Applicants for Prescription Drug
User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by
November 21, 2018.

ADDRESSES: To ensure that comments on the 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>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0429.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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

Guidance for Industry on Formal Meetings With Sponsors and Applicants
for Prescription Drug User Fee Act Products

OMB Control Number 0910-0429--Extension

    This information collection supports the above captioned Agency
guidance document. The guidance document was issued to help individuals
with procedures on formal meetings between FDA and sponsors or
applicants regarding the development and review of Prescription Drug
User Fee Act (PDUFA) products. The guidance describes procedures for
requesting, scheduling, conducting, and documenting such formal
meetings. The guidance provides information on how FDA interprets and
applies section 119(a) of the Food and Drug Administration
Modernization Act of 2007 (Pub. L. 105-115), specific PDUFA goals for
the management of meetings associated with the review of human drug
applications for PDUFA products, and provisions of existing regulations
describing certain meetings (Sec. Sec.  12.47 and 312.82 (21 CFR 312.47
and 312.82)). The collection of information described in the guidance
reflects the current and past practice of sponsors and applicants to
submit meeting requests and background information prior to a scheduled
meeting. Agency regulations currently permit such requests and
recommend the submission of an information package before an ``end-of-
phase 2 meeting'' (Sec. Sec.  [thinsp]312.47(b)(1)(ii) and (iv)) and a
``pre-NDA meeting'' (Sec.  [thinsp]312.47(b)(2)). While the information
collection provisions of Sec.  [thinsp]312.47 are currently approved
under OMB control number 0910-0014, the guidance provides additional
recommendations for submitting information to FDA in support of a
meeting request. The guidance document is available on our website at:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf.
    Request for a Meeting--Consistent with recommendations found in the
guidance, a sponsor or applicant interested in meeting with the Center
for Drug Evaluation and Research (CDER) or the Center for Biologics
Evaluation and Research (CBER) should submit a

meeting request to the appropriate FDA component as an amendment to the
application for the underlying product in accordance with our
regulations (Sec. Sec.  [thinsp]312.23, 314.50, and 601.2 (21 CFR
312.23, 314.50, and 601.2)). Information provided to the Agency as part
of an investigational new drug application (IND), new drug application
(NDA), or biological license application (BLA) must be submitted with
an appropriate cover form. Form FDA 1571 must accompany IND
submissions, and Form FDA 356h must accompany NDA and BLA submissions.
These Agency forms are approved under OMB control numbers 0910-0014 and
0910-0338, respectively.
    We recommend that a request be submitted in this manner to ensure
that each request is kept in the administrative file with the complete
application, and to ensure that pertinent information about the request
is entered into appropriate tracking databases. Using information from
our tracking databases enables us to monitor progress on activities
attendant to scheduling and holding a formal meeting and to ensure that
appropriate steps will be taken in a timely manner.
    The guidance recommends that meeting requests include the following
information:

 Information identifying and describing the product
 the type of meeting being requested
 a brief statement of the purpose of the meeting
 a list of objectives and expected outcomes from the meeting
 a preliminary proposed agenda
 a draft list of questions to be raised at the meeting
 a list of individuals who will represent the sponsor or
applicant at the meeting
 a list of Agency staff requested to be in attendance
 the approximate date that the information package will be sent
to the Agency
 suggested dates and times for the meeting

    We use the information to determine the purpose of the meeting, the
necessary participants, the proposed agenda, and to schedule the
meeting.
    Information Package--The guidance also recommends that a sponsor or
applicant submitting an information package provide summary information
relevant to the product and supplementary information pertaining to any
issue raised by the sponsor, applicant, or FDA. Information packages
should generally include:

 Identifying information about the underlying product
 a brief statement of the purpose of the meeting
 a list of objectives and expected outcomes of the meeting
 a proposed agenda for the meeting
 a list of specific questions to be addressed at the meeting
 a summary of clinical data that will be discussed (as
appropriate)
 a summary of preclinical data that will be discussed (as
appropriate)
 chemistry, manufacturing, and controls information that may be
discussed (as appropriate)

    The information package enables Agency staff to prepare for the
meeting and allows appropriate time for reviewing relevant product
data. Although FDA reviews similar information in the meeting request,
the information package should provide updated data reflecting the most
current and accurate information available to the sponsor or applicant.
    In the Federal Register of July 11, 2018 (83 FR 32130), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Guidance recommendations         Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
    CDER........................           1,319            2.31           3,058              10          30,580
    CBER........................             301            1.21             363              10           3,630
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
        Subtotal................  ..............  ..............  ..............  ..............          34,210
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Information Packages:
    CDER........................           1,149            2.19           2,522              18          45,396
    CBER........................             187            1.12             210              18           3,780
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
        Subtotal................  ..............  ..............  ..............  ..............          49,176
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
            Total...............  ..............  ..............  ..............  ..............          83,386
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall increase since the previous OMB approval. We attribute this
adjustment to an increase in the number of meeting requests and
information packages received over the last few years.
    Based on Agency data, we estimate 1,319 sponsors and applicants
(respondents) request 3,058 formal meetings with CDER annually, and 301
respondents request 363 formal meetings with CBER annually regarding
the development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent spends
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be 10 hours. We expect it
takes this amount of time to gather and copy brief statements about the
product as well as a description of the purpose and details of the
meeting.
    Also consistent with Agency data, we estimate 1,149 respondents
submitted 2,522 information packages to CDER annually, and 187
respondents submitted 210 information packages to CBER annually, prior
to a formal meeting regarding the development and review of a PDUFA
product. We estimate 18 hours is needed to prepare

the information package in accordance with the guidance.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22954 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P


1 August 29, 2003 Establishing Site specific Fuel Contaminant Input ( FCI) Values for Boiler MACT I. Introduction AF& PA's written comments on EPA's proposed Boiler MACT rule expressed serious concerns regarding, among other things, requirements for: 1) setting fuel contaminant input ( FCI) operating limits for chlorides ( Cl), mercury ( Hg) and, when applicable, Total Selected Metals ( TSM), 2) identifying " worst case fuel" mixtures for conducting performance tests, 3) conducting performance tests when the maximum FCI for the fuel mixture will be below the applicable emission standard, 4) testing for FCI whenever there was a new fuel, change in fuel supplier or change in fuel mix, 5) continuously demonstrating that fuels used during operation result in lower emissions than fuels burned during performance tests, and 6) no provision for adjusting an FCI established during the initial performance test to an FCI commensurate with the emission limit.

To address these concerns, AF& PA prepared a white paper ( Establishing Default Fuel Contaminant Input Values for Fuel Classes and Performing Compliance Demonstrations for Boiler MACT) which discussed ways in which default or site specific FCI values could be employed. Subsequently, in response to discussions with EPA, AF& PA has pursued the development of a method for establishing national default FCI values. As a demonstration of the method, NCASI is collecting and analyzing samples of bark which is one of the primary fuel classes burned in the paper and forest products industry. A sampling methodology for this program was submitted to the agency ( see A Proposed Data Collection Effort to Establish Default Fuel Contaminant Input Values for Certain Solid Fuel Classes) and the program is now underway.

AF& PA believes that national default FCI values should be established wherever possible. However, development of national FCI default values for all fuel classes may not be feasible. The forest products and other industries use a large number of miscellaneous solid fuels such as board trim, culls, paper cores, and agricultural and sludge residuals that would have local FCI characteristics. Additionally, a facility may want to establish a FCI for local fuels. It is clear that an acceptable methodology must be found for establishing site specific FCI values which addresses the issues raised in AF& PA comments noted above. The purpose of this paper is to propose such a methodology and to describe the key principles for establishing a site specific FCI value that AF& PA believes are critical to the successful implementation of the Boiler MACT rule.

II. Use of a Site specific FCI Value In the previously submitted white paper Establishing Default Fuel Contaminant Input Values for Fuel Classes and Performing Compliance Demonstrations for Boiler MACT, there are conceptually three different uses for establishing an FCI value. These are: a. Initial and continuous compliance demonstration in the case of " no control" 2 b. Establishing a " worst case" fuel mixture for permitting and performance of the initial performance test ( IPT) c. Establishing an FCI " threshold" value for evaluation of new fuel mixtures in the case that " controls" are employed.

In each of these situations an FCI value must be established for each fuel class. A facility may choose whether to conduct fuel testing to establish a site specific FCI value for a given fuel class or elect to use an established default value.

III. Establishing the Site specific Value AF& PA recommends that EPA include language in the rule identifying basic criteria for establishing site specific values. While some details of a particular site's sampling program may vary to address regional and local issues, AF& PA believes that a site specific sampling plan for establishing FCI values should adhere to basic principles that would be identified in the rule. Review of such plans, therefore, would be straight forward and not unduly burdensome on the permitting authority. As such, AF& PA proposes that the following principles be included in the rule.

a. Analytical Methods AF& PA recommends that the agency specify required test methods in the rule. Analytical and sampling methods for bark are discussed in Appendix B of the document A Proposed Data Collection Effort to Establish Default Fuel Contaminant Input values for Certain Solid Fuel Classes for the development of a national default value for bark. These methods should also apply for sampling programs conducted on a site by site basis and be applicable to a wide variety of fuel classes.

Standardization of site specific sampling and analytical methods will also facilitate the consolidation of data for the development of national default FCI values.

b. Site specific Sampling Plan Criteria 1. AF& PA recommends that the agency establish a minimum number of five ( 5) samples for establishing an FCI on a site specific basis. AF& PA examined various theoretical distributions and confidence intervals for contaminants as a function of the number of samples collected. The analysis revealed that a point of diminishing returns was reached very quickly ( between five and seven samples). Distributions with low and high standard deviations showed that little improvement was made ( i. e. the confidence interval about the mean was not reduced significantly) after about five samples, but significant improvement ( reduction) in the confidence bounds was achieved up to about five. AF& PA believes, therefore, that the minimum number of samples for establishing a mean FCI value is five. 3 While the type of analysis just described demonstrates that diminishing value is achieved by analyzing samples in excess of five, AF& PA believes that sites should be allowed to sample more than the minimum if they so choose.

2. AF& PA believes that samples should be collected at a location that most accurately represents the fuel class, where possible, at a point prior to mixing with other dissimilar fuel types. AF& PA recommends that the agency require that a description of the fuel, sample location and, if applicable, contributing processes be included in the site specific sampling plan so that the permitting authority may be confident that the samples are representative of the fuel class.

3. Analytical and sampling methods should be specified in the site specific sampling plan with the expected MDLs. Analytical techniques and MDLs should correspond to the contaminant levels expected in the fuel class.

4. The site specific sampling plan should specify the nature and frequency of sampling for each fuel class ( e. g. grab samples daily, composite samples weekly). The rationale for the sampling approach should be described.

5. When burning a new fuel class is planned, the facility may either establish a site specific FCI for the new fuel class or use a national, regional, or fuel supplier specific FCI value that has already been established. If there are no FCI values established for a fuel class, the facility would need to establish a site specific FCI for that fuel. For example, if a coal contract specifying coal from Mine A changes to Mine B, the facility may use a FCI established by the vendor, or a national default value for coal, or conduct the fuel sampling to establish a FCI for the " new" fuel class from Mine B.

c. Outlier Test AF& PA strongly recommends that individual values within a given data set that are suspiciously low or high should be subjected to an outlier test. It is suggested that procedures recommended in an EPA document issued in 2000 ( Guidance for Data Quality Assessment  Practical Methods for Data Analysis) be used for these outlier tests. As the document describes, for data sets with more than 25 values, Rosner's test may be used, and the Extreme Value Test ( Dixon's test) may be used for data sets with 25 or fewer samples. If the test indicates the value is indeed an outlier, it should be discarded from the data set and supplemental data should be obtained.

d. Average Value AF& PA recommends that average values should be used for site specific FCI determinations. Since data collected are representative of site conditions, more conservative values are not necessary to assure long term compliance. Mean values should be calculated in lb/ 106 BTU ( lb/ 1012BTU for mercury) using individual sample lb/ 106 BTU numbers. 4 e. Verification AF& PA opposes the concept of periodic testing for updating FCI values. Periodic updating of FCI values would result in a moving compliance target unrelated to actual compliance. Average results of periodic testing are expected to vary in accordance with statistical principles. As long as the results are within the expected variability, there is no reason to believe that the fuel characteristics or the actual average emission rates have changed. Constant small changes in FCI values would have no real meaning or impact on compliance, and, as proposed in the rule, could potentially lead to costly and unnecessary performance testing. Furthermore, periodically changing FCI default values could lead to unnecessary questioning of retrospective compliance status.

Instead, AF& PA recommends that once an FCI value has been established based on the criteria described in Item b. above, that the value not be changed unless there is reasonable cause to believe that the FCI has changed. Reasonable cause could be an event that would be known to change the fuel characteristics ( for example, fuel derived from board trim where the resin formulation used in manufacture of the bard is changed to one containing a different amount of salt), or if verification tests show that the FCI has changed. We recognize that the agency may wish to " verify" the FCI value, 1 and, therefore, AF& PA proposes the following verification approach.

For an FCI value that was established using the minimum proposed number of samples, five ( 5), a sample set of three ( 3) should be collected and analyzed using equally representative criteria ( location, sample type ( grab or composite), etc.) as for the initial FCI determination. A simplified student's t test could be applied to evaluate whether any difference between the two data sets is statistically significant. This procedure is as follows: The difference between the verification test average ( VTA) and the established fuel contaminant input value ( EFCI) is divided by 0.73 times the standard deviation of the data used to establish the fuel contaminant value ( SEFCI)), and the result is compared to the significance value of 1.94.

Eq. 1 ( VTA  EFCI) / ( 0.73 SEFCI) < 1.94 2 1 Note that the FCI verification is not intended to represent periodic testing. Verification, as described here, may be a one time only verification conducted either one year later or upon permit renewal. This verification approach would also be applicable to enforcement inspections. 2 This equation is derived from a simplifying assumption of the student's t test that the standard deviation of the verification sample results will be the same as the standard deviation of the data set used to establish the default value. The equation also assumed that initial data set contained 5 samples and 3 verification samples. ( avg x  avg y) < A ta/ 2; n where A = [( nx  1) sx2 +( ny  1) sy2 / ( nx + ny  2)] 1/ 2 * [ 1/ nx + 1/ ny] 1/ 2 Assuming sx = sy: A = s * [ 1/ nx + 1/ ny] 1/ 2 With nx = 5 and ny = 3then: A = 0.73 s 5 Where the result of this equation is less than 1.94, the established FCI is " verified" and should remain the same.

Where the result of this equation is greater than 1.94, the facility should re establish the FCI using one of the following methods: a. Collect a minimum of five samples ( either five new samples or collect an additional two to supplement the three VTA samples) to establish a new FCI for the fuel, or b. Use the VTA as the new FCI3.

The new FCI may be used in the same way a fuel class FCI would be used as described in the previously submitted white paper, Establishing Default Fuel Contaminant Input Values for Fuel Classes and Performing Compliance Demonstrations for Boiler MACT.

For example, in the case of " no control" where the FCI is used to demonstrate compliance with the standard: A new emission rate will be calculated using the new FCI value. For controlled sources the FCI threshold approach may be used to determine whether a new IPT needs to be conducted. Appendix A shows a complete calculation example of how this would be applied.

f. Option for Substituting Vendor Fuel Certifications AF& PA also recommends that the Agency allow the use of vendor fuel certifications in lieu of site specific sampling and analysis. To support the certification, the fuel vendor should be required to perform sampling and analysis of the fuel using the same sampling and analytical methods required by the rule.

From the t tables at   / 2 = 0.05 and n 2 = 6 t   / 2; n 2 = 1.94 3 For units with a very large compliance margin, there may be no need to do additional sampling. 6 Appendix A Example 1: Threshold Determination and FCI Verification 1. Boiler Information:

Rated Heat Input: 340 Million BTU per hour Control Device: Wet Scrubber  Metals and HCl No Credit for Controls  Hg Fuels Burned: Hog Fuel ( HF), Coal Permitted Operation: Boiler permitted to burn coal up to 75% of heat input HF   Max. Fuel Input   40 Wet Tons/ Hour ( WTPH) ( 100% rated capacity) Site specific Fuel Cl Input Value   0.0047 lb Cl/ 106BTU Fuel Heat Content   8.5x106BTU/ WT Coal Max. Fuel Input   10 TPH ( max. allowed feed rate) Site specific Fuel Cl Input Value   0.20 lb Cl/ 106BTU Fuel Heat Content   26x106BTU/ Ton 2. Determination of Maximum Fuel Chloride Input The affected source will comply with the HCl limit using the wet scrubber and establish scrubber operating parameter limits during the initial performance test. Coal has the highest fuel Cl input rate. Therefore, the maximum fuel Cl input will occur when coal is fired at maximum permitted capacity ( 10 TPH x 26x106BTU/ ton = 260x106BTU/ hr) and the remaining rated heat input to the boiler is from hog fuel ( 9.5 WTPH x 8.5x106 BTU/ WT = 80x106BTU/ hr). Sitespecific FCI values have been established for Coal and Hog Fuel.

Coal FCI = 0.20 lb Cl/ 106BTU Hog Fuel FCI = 0.0047 lb Cl/ 106BTU Coal  ( 260x106BTU/ hr)( 0.20 lb Cl/ 106BTU) = 52.00 lb Cl/ hr HF  ( 80x106BTU/ hr)( 0.0047 lb Cl/ 106BTU)= 0.38 lb Cl/ hr Max. Fuel Cl Input = 52.38 lb Cl/ hr Max. Heat Input  340x106BTU/ hr Max. Fuel Cl Input = 52.38 lb HCl/ hr = 0.154 lb Cl/ 106BTU 340x106BTU/ hr 3. Setting FCI Threshold During Initial Performance Test:

During the initial performance test the boiler is operated at " worst case" conditions with coal fired at the maximum permitted capacity.

Calculated IPT Fuel Chloride Input ( see item 2)   0.154 lb Cl/ 106BTU Hydrogen Chloride Mass Emissions During IPT   4.6 lb HCl/ hr Heat Input During IPT   340x106BTU/ hr IPT HCl Emission Rate = 4.6 lb Cl/ hr = 0.014 lb HCl/ 106BTU ( after scrubber) 340x106BTU/ hr 7 Scrubber Efficiency for HCl = 0.154   0.014 = 90.9% 0.154 Fuel Chloride Input Threshold = IPT Fuel Chloride Input x HCl Emission Std. IPT HCl Emission Rate = 0.154 lb Cl/ 106BTU X 0.09 lb HCl/ 106BTU 0.014 lb HCl/ 106BTU = 0.99 lb Cl/ 106BTU This is the approach referred to in item II. c. above: the development of a value which considers the control device efficiency to define the maximum allowable fuel contaminant input without a new performance test. The fuel chloride input threshold is the ratio of the compliance value in the rule to the observed emission rate times the observed value during the test.

4A. FCI Verification ( Case 1):

HF Established Fuel Chloride Input ( EFCI) = 0.0047 lb Cl/ 106BTU Verification Test Average ( VTA) = 0.007 lb Cl/ 106BTU Standard Deviation for EFCI ( SEFCI) = 0.003 lb Cl/ 106BTU Eq. 1 ( VTA  EFCI) / ( 0.73 SEFCI) < 1.94 ( 0.007 lb Cl/ 106BTU  0.0047 lb Cl/ 106BTU) = 1.05 < 1.94 ( 0.73 x 0.003 lb Cl/ 106BTU)

Since 1.05 < 1.94 then the EFCI for Hog Fuel has been successfully verified; EFCI remains the same at 0.0047.

4B. FCI Verification ( Case 2):

Coal Established Fuel Chloride Input( EFCI) = 0.20 lb Cl/ 106BTU Verification Test Average ( VTA) = 0.52 lb Cl/ 106BTU Standard Deviation for EFCI ( SEFCI) = 0.10 lb Cl/ 106BTU Eq. 1 ( VTA  EFCI) / ( 0.73 SEFCI) < 1.94 ( 0.52 lb Cl/ 106BTU  0.20 lb Cl/ 106BTU) = 4.38 > 1.94 ( 0.73 x 0.10 lb Cl/ 106BTU)

Since 4.38 > 1.94 then a new FCI must be established and evaluated.

5. Threshold Evaluation of New FCI Using the heat input from the IPT and the new Coal FCI, a comparison is made to the threshold value. Assume that the new VTA is used for the new FCI.

Coal FCI = 0.52 lb Cl/ 106BTU Hog Fuel FCI = 0.0047 lb Cl/ 106BTU Coal  ( 260x106BTU/ hr)( 0.52 lb Cl/ 106BTU) = 135.20 lb Cl/ hr 8 HF  ( 80x106BTU/ hr)( 0.0047 lb Cl/ 106BTU)= 0.38 lb Cl/ hr Max. Fuel Cl Input = 135.58 lb Cl/ hr Max. Heat Input  340x106BTU/ hr Max. Fuel Chloride Input = 135.58 lb HCl/ hr = 0.398 lb Cl/ 106BTU 340x106BTU/ hr Comparing this value to the Threshold in Item 3 above, no new IPT is needed.

0.398 lb Cl/ 106BTU < 0.99 lb Cl/ 106BTU


[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Page 17765]
[FR Doc No: 2015-07562]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0045]

Abuse-Deterrent Opioids--Evaluation and Labeling; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Abuse-Deterrent
Opioids--Evaluation and Labeling''. This guidance explains FDA's
current thinking about the studies that should be conducted to
demonstrate that a given formulation has abuse-deterrent properties.
This guidance also makes recommendations about how those studies should
be performed and evaluated, and discusses how to describe those studies
and their implications in product labeling. It is intended to assist
sponsors who wish to develop opioid drug products with potentially
abuse-deterrent properties and is not intended to apply to products
that are not opioids or opioid products that do not have the potential
for abuse.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brutrinia D. Cain, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Abuse-Deterrent Opioids--Evaluation and Labeling.''
Prescription opioid products are an important component of modern pain
management. However, abuse and misuse of these products have created a
serious and growing public health problem. One potentially important
step towards the goal of creating safer opioid analgesics has been the
development of opioids that are formulated with some properties
intended to deter abuse. FDA considers development of these products a
high public health priority.
    The guidance is intended to provide industry with a framework for
evaluating and labeling abuse-deterrent opioid products. The guidance
discusses how the potentially abuse-deterrent properties of an opioid
analgesic formulated to deter abuse should be studied, specifically
addressing in vitro studies, pharmacokinetic studies, clinical abuse
potential studies, and postmarket studies. The guidance also describes
the types of information that may be suitable for inclusion in
labeling.
    Providing a clear framework for the evaluation and labeling of the
abuse-deterrent properties of opioid analgesics intended to deter abuse
should help to incentivize the development of safer, less abusable
opioid analgesics, and should also facilitate the dissemination of fair
and accurate information regarding such products.
    In the Federal Register of January 14, 2013 (78 FR 2676), FDA
announced the availability of a draft version of this guidance and
provided interested parties an opportunity to submit comments. The
Agency has carefully reviewed and considered the comments it received
in developing this final version of the guidance. The Agency has made
revisions to the guidance as it deemed appropriate.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the evaluation and labeling of abuse-
deterrent opioids. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07562 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4164-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

			Issued by the Department of Transportation on March 21, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-14057

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Aerovias Nacionales de Colombia, S.A. (AVIANCA)			Date
Filed: February 10, 2005

Relief requested: Renew exemption from 49 U.S.C. § 41301 to conduct
foreign air transportation of persons, property and mail between
currently authorized points in Colombia, via currently authorized U.S.
gateways, to Atlanta, Boston, Chicago, Dallas/Ft. Worth, Denver,
Houston, Orlando, New York, Philadelphia, Tampa, and Washington, D.C.,
on a code-share basis only, with Delta Air Lines.

If renewal, date and citation of last action:  February 17, 2004, as
amended February 9, 2005 (adding New York, New York), in this docket

Applicant representative: Richard D. Mathias<PHONE_NUMBER>		DOT
analyst:  Shelita Smith<PHONE_NUMBER>

Responsive pleadings:  None

	DISPOSITION

Action: Approved									Action date:  March 21, 2005

Effective dates of authority granted: March 21, 2005 – March 21, 2006

Basis for approval (bilateral agreement/reciprocity):  U.S.-Colombia Air
Transport Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

   X  Standard exemption conditions (attached) and the otherwise
applicable conditions imposed on AVIANCA and Delta in the Notice of
Action Taken, dated February 3, 2003, in this docket.

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
____________________________________________________________

We found that the applicant was qualified to perform its proposed
operations.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that  (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004


[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Rules and Regulations]
[Pages 37735-37736]
[FR Doc No: 2022-13345]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2022-0475]
RIN 1625-AA08

Special Local Regulation; Marine Events; Annual Bayview Mackinac
Race, Lake Huron, MI

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the special local regulations
found in 33 CFR 100.902 for the annual Bayview Yacht Club Port Huron to
Mackinac Race. These special local regulations are necessary to safely
control vessel movements in the vicinity of the race and provide for
the safety of the general boating public and commercial shipping.
During this enforcement period, no person or vessel may enter the
regulated area without the permission of the Coast Guard Patrol
Commander (PATCOM).

DATES: The regulation in 33 CFR 100.902 will be enforced from 10 a.m.
through 3 p.m. on July 16, 2022.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Tracy Girard, Waterway Management
Division, U.S. Coast Guard Sector Detroit, 110 Mt. Elliott Street,
Detroit, MI at<PHONE_NUMBER> or [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulation in 33 CFR 100.902 for the Annual Bayview Mackinac Race
from 10 a.m. through 3 p.m. on July 16, 2022. This notice of
enforcement is necessary to safely control vessel movements in the
vicinity of the race and provide for the safety of the general boating
public and commercial shipping. This notice of enforcement applies to
all U.S. navigable waters of the Black River, St. Clair River, and
lower Lake Huron, bound by a line starting at latitude 042[deg]58'47''
N, longitude 082[deg]26'0'' W; then easterly to latitude
042[deg]58'24'' N, longitude 082[deg]24'47'' W; then northward along
the International Boundary to latitude 043[deg]02'48'' N, longitude
082[deg]23'47'' W; then westerly to the shoreline at approximate
location latitude 043[deg]02'48'' N, longitude 082[deg]26'48'' W; then
southward along the U.S. shoreline to latitude 042[deg]58'54'' N,
longitude 082[deg]26'01'' W; then back to the beginning [DATUM: NAD
83].

    In order to ensure the safety of spectators and participating
vessels, the Coast Guard will patrol the race area under the direction
of a designated Coast Guard Patrol Commander (PATCOM). Vessels desiring
to transit the regulated area may do so only with prior approval of the
PATCOM and when so directed by that officer. The PATCOM may be
contacted on Channel 16 (156.8 MHz) by the call sign ``Coast Guard
Patrol Commander.'' Vessels permitted to transit the regulated area
will operate at no wake speed and in a manner which will not endanger
participants in the event or any other craft. The rules contained above
shall not apply to participants in the event or vessels of the patrol
operating in the performance of their assigned duties.
    This notice of enforcement is issued under the authority of 33 CFR
100.902 and 5 U.S.C. 552(a). If the District Commander, Captain of the
Port or PATCOM determines that the regulated area need not be enforced
for the full duration stated in this notice, he or she may use a
Broadcast Notice to Mariners to grant general permission to enter the
regulated area.

    Dated: June 16, 2022.
Brad W. Kelly,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2022-13345 Filed 6-23-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Page 14022]
[FR Doc No: 2012-5629]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0112]

Guidance for Industry on Chemistry, Manufacturing, and Controls
Information--Fermentation-Derived Intermediates, Drug Substances, and
Related Drug Products for Veterinary Medicinal Use; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry 216 entitled
``Chemistry, Manufacturing, and Controls (CMC) Information--
Fermentation-Derived Intermediates, Drug Substances, and Related Drug
Products for Veterinary Medicinal Use.''
    The purpose of this document is to provide recommendations on what
documentation to submit to support the CMC information for
fermentation-derived intermediates, drug substances, and related drug
products for veterinary medicinal use.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael J. Popek, Center for
Veterinary Medicine (HFV-144), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 14, 2011 (76 FR 13629), FDA
published the notice of availability for a draft guidance entitled
``Chemistry, Manufacturing, and Controls (CMC) Information--
Fermentation-Derived Intermediates, Drug Substances, and Related Drug
Products for Veterinary Medicinal Use'' giving interested persons until
May 30, 2011, to comment on the draft guidance. FDA received one
comment on the draft guidance. No substantive changes were made in
finalizing this guidance document.
    The guidance announced in this notice finalizes the draft guidance
dated March 14, 2012.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance will
represent the Agency's current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB control number 0910-0032.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments 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.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: March 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5629 Filed 3-7-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: February 10, 2010 (Volume 75, Number 27)]
[Notices]
[Page 6656]
[DOCID:fr10fe10-55]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0001; FRL-8811-3]

SFIREG Pesticide Operations and Management Working Committee
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY:  The Association of American Pesticide Control Officials
(AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG),
Pesticide Operations and Management (POM) Working Committee will hold a
2-day meeting, beginning on March 29, 2010 and ending March 30, 2010.
This notice announces the location and times for the meeting and sets
forth the tentative agenda topics.

DATES: The meeting will be held on Monday, March 29, 2010 from 8:30
a.m. to 5 p.m. and 8:30 a.m to 12 noon on Tuesday March 30, 2010.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES:  The meeting will be held at the Ocean Plaza Resort, 15th
Street, on Tybee Island, GA.

FOR FURTHER INFORMATION CONTACT:  Ron Kendall, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>or contact Grier Stayton, SFIREG
Executive Secretary, P.O. Box 466, Milford, DE 19963; telephone number
(302) 422-8152; fax<PHONE_NUMBER>; e-mail address: grierstaytonaapco-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are
interested in SFIREG information exchange relationship with EPA
regarding important issues related to human health, environmental
exposure to pesticides, and insight into EPA's decision-making process.
You are invited and encouraged to attend the meetings and participate
as appropriate. Potentially affected entities may include, but are not
limited to:
    Those persons who are or may be required to conduct testing of
chemical substances under the Federal Food, Drug and Cosmetics Act
(FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA).

B. How Can I Get Copies of this Document and Other Related Information?

     EPA has established a docket for this action under docket ID
number EPA-HQ-OPP-2010-0001. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.
     You may access this Federal Register document electronically
through the EPA Internet under the ``Federal Register'' listings at
http://www.epa.gov/fedrgstr.

II. Background

     Topics may include but are not limited to:
    1. Supplemental labeling: Regulatory issues, expiration dates, etc.
    2. Suggested updates to the Section 24(c) guidance document.
    3. Discussion of label quality initiatives (training, SLITS, QA).
    4. Review of EPA/FDA Standard Operating Procedures document for
pesticide residues in food commodities.
    5. POM potential role in review of new labels.
    6. FIFRA compliances and Organic Materials Review Institute (OMRI)
products.
    7. Reviewing and updating the Label Review Manual.
    8. Soil fumigant label changes for 2010/11 and compliance
strategies

III. How Can I Request to Participate in this Meeting?

    This meeting is open for the public to attend. You may attend the
meeting without further notification.

List of Subjects

     Environmental Protection, Pesticide and pest.

    Dated: February 2. 2010.
 Jay S. Ellenberger,
Director, Field and External Affairs Division, Office of Pesticide
Programs.
[FR Doc. 2010-2790 Filed 2-10-10; 8:45 a.m.]
BILLING CODE 6560-50-S


[Federal Register: November 13, 2009 (Volume 74, Number 218)]
[Rules and Regulations]
[Page 58560-58562]
[DOCID:fr13no09-9]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 234

[Docket No. FRA-2009-0032; Notice No. 2]
RIN 2130-AC05

State Highway-Rail Grade Crossing Action Plans

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Removal of direct final rule provisions.

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

SUMMARY: On September 2, 2009, FRA published a direct final rule in the
Federal Register requiring the ten States with the most highway-rail
grade crossing collisions, on average, over the past three years, to
develop State highway-rail grade crossing action plans. FRA received
one adverse comment regarding the direct final rule. Under FRA
regulations, FRA must withdraw a direct final rule where an adverse
comment is submitted. FRA issued and submitted a notice of withdrawal
to the Federal Register; however, due to regulatory production
schedules and time constraints, the direct final rule was not withdrawn
before its effective date. As a result, FRA is now publishing this
removal of the direct final rule provisions, which removes the changes
effected by the direct final rule. In a separate document publishing
elsewhere in this issue of the Federal Register, FRA is publishing a
Notice of Proposed Rulemaking (NPRM).

DATES: This removal of the direct final rule becomes effective on
November 13, 2009.
    Docket Information: Docket: For access to the docket to read
background documents or comments received, go to http://
www.regulations.gov at any time, or to room W12-140 on the Ground level
of the West Building, 1200 New Jersey Ave., SE., Washington, DC

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

FOR FURTHER INFORMATION CONTACT: Ron Ries, Office of Safety, FRA, 1200
New Jersey Ave., SE., RRS-23, Mail Stop 25, Washington, DC 20590
(Telephone<PHONE_NUMBER>), or Zeb Schorr, Trial Attorney, Office of
Chief Counsel, FRA, 1200 New Jersey Ave., SE., Mail Stop 10,
Washington, DC 20590 (Telephone<PHONE_NUMBER>).

SUPPLEMENTAL INFORMATION:

I. Withdrawal of Direct Final Rule

    Pursuant to FRA's direct final rulemaking procedures set forth at
49 CFR 211.33, FRA published a direct final rule in the Federal
Register on September 2, 2009 (74 FR 45336). FRA received one adverse
comment regarding the direct final rule. Pursuant to 49 CFR 211.33(d),
FRA must withdraw a direct final rule where an adverse comment is
submitted. FRA issued and submitted a notice of withdrawal to the
Federal Register; however, due to regulatory production schedules and
time constraints, the direct final rule was not withdrawn before its
effective date. As a result, FRA is now publishing this removal of the
direct final rule provisions, which removes the changes effected by the
direct final rule. In addition, in a separate document, FRA is
contemporaneously publishing an NPRM in this issue of the Federal
Register.
    As discussed, this removal returns the regulatory text revised by
the direct final rule to its formulation prior to the direct final rule
going into effect. As noted, pursuant to 49 CFR 211.33(d), the direct
final rule could have been removed with a notice of withdrawal;
however, due to time constraints, such a notice was not published prior
to the direct final rule going into effect. Moreover, FRA is
contemporaneously publishing a proposed rule providing notice and
comment regarding these same revisions in this issue of the Federal
Register. Consequently, FRA believes that it is appropriate for this
removal to become effective on the date of its publication, and that
notice and comment in this instance is unnecessary.

II. Section-by-Section Analysis

    FRA believes that a section-by-section analysis is not necessary in
this document. As noted, FRA's direct final rulemaking procedures set
forth at 49 CFR 211.33 require FRA to withdraw a direct final rule
where an adverse comment is submitted. In order to comply with these
procedures, FRA is now publishing this removal in order to return the
regulatory text revised by the direct final rule to its formulation
prior to the direct final rule going into effect (November 2, 2009). In
addition, as noted, FRA is contemporaneously publishing an NPRM in this
issue of the Federal Register regarding these same provisions.

III. Regulatory Impact and Notices

    FRA likewise believes that a regulatory impact and notices
discussion is not necessary in this document. Again, in order to comply
with its direct final rulemaking procedures, FRA is now publishing this
removal in order to return the regulatory text revised by the direct
final rule to its formulation prior to the direct final rule going into
effect (November 2, 2009). Moreover, FRA is contemporaneously
publishing an NPRM in this issue of the Federal Register, which
provides notice of the changes originally existing in the direct final
rule, while also including a complete discussion regarding regulatory
impact.

List of Subjects in 49 CFR Part 234

    Highway safety; Penalties; Railroad safety; and Reporting and
recordkeeping requirements.

The Rule

0
In consideration of the foregoing, FRA amends part 234 of chapter II,
subtitle B of title 49, Code of Federal Regulations, as follows:

PART 234--GRADE CROSSING SIGNAL SYSTEM SAFETY

0
1. The authority citation for part 234 is revised to read as follows:

    Authority:  49 U.S.C. 20103, 20107; 28 U.S.C. 2461, note; and 49
CFR 1.49.

0
2. The heading for part 234 is revised to read as set forth above.

0
3. Section 234.1 is revised to read as follows:

Sec.  234.1  Scope.

    This part imposes minimum maintenance, inspection, and testing
standards for highway-rail grade crossing warning systems. This part
also prescribes standards for the reporting of failures of such systems
and prescribes minimum actions railroads must take when such warning
systems malfunction. This part does not restrict a railroad from
adopting and enforcing additional or more stringent requirements not
inconsistent with this part.

0
4. Section 234.3 is revised to read as follows:

Sec.  234.3  Application.

    This part applies to all railroads except:
    (a) A railroad that exclusively operates freight trains only on
track which is not part of the general railroad system of
transportation;
    (b) Rapid transit operations within an urban area that are not
connected to the general railroad system of transportation; and
    (c) A railroad that operates passenger trains only on track inside
an installation that is insular; i.e., its operations are limited to a
separate enclave in such a way that there is no reasonable expectation
that the safety of the public--except a business guest, a licensee of
the railroad or an affiliated entity, or a trespasser--would be
affected by the operation. An operation will not be considered insular
if one or more of the following exists on its line:
    (1) A public highway-rail crossing that is in use;
    (2) An at-grade rail crossing that is in use;
    (3) A bridge over a public road or waters used for commercial
navigation; or
    (4) A common corridor with a railroad, i.e., its operations are
within 30 feet of those of any railroad.

0
5. Section 234.4 is revised to read as follows:

Sec.  234.4  Preemptive effect.

    Under 49 U.S.C. 20106 (formerly Sec.  205 of the Federal Railroad
Safety Act of 1970 (45 U.S.C. 434)), issuance of these regulations
preempts any State law, rule, regulation, order, or standard covering
the same subject matter, except a provision directed at an essentially
local safety hazard that is consistent with this part and that does not
impose an undue burden on interstate commerce.

0
6. Section 234.6 is revised to read as follows:

Sec.  234.6  Penalties.

    (a) Civil Penalty. Any person (an entity of any type covered under
1 U.S.C. 1, including but not limited to the following: a railroad; a
manager, supervisor, official, or other employee or agent of a
railroad; any owner, manufacturer, lessor, or lessee of railroad
equipment, track, or facilities; any independent contractor providing
goods or services to a railroad; and any employee of such owner,
manufacturer, lessor, lessee, or independent contractor) who violates
any requirement of this part or causes the violation of any such
requirement is subject to a civil penalty of at least $650, but not
more than $25,000 per violation,

except that: penalties may be assessed against individuals only for
willful violations, and where a grossly negligent violation or a
pattern of repeated violations has created an imminent hazard of death
or injury to persons, or has caused death or injury, a penalty not to
exceed $100,000 per violation may be assessed. Each day a violation
continues shall constitute a separate offense. Appendix A to this part
contains a schedule of civil penalty amounts used in connection with
this rule. The railroad is not responsible for compliance with respect
to any condition inconsistent with the technical standards set forth in
this part where such variance arises as a result of actions beyond the
control of the railroad and the railroad could not have prevented the
variance through the exercise of due diligence. The foregoing sentence
does not excuse any instance of noncompliance resulting from the
actions of the railroad's employees, agents, or contractors.
    (b) Criminal Penalty. Whoever knowingly and willfully makes, causes
to be made, or participates in the making of a false entry in reports
required to be filed by this part, or files a false report or other
document required to be filed by this part is subject to a $5,000 fine
and 2 years imprisonment as prescribed by 49 U.S.C. 522(a) and section
209(e) of the Federal Railroad Safety Act of 1970, as amended (45
U.S.C. 438(e)).

Subpart B--Reports

0
7. The heading to Subpart B--Reports and Plans is revised to read as
set forth above.

Sec.  234.11  [Removed]

0
8. Section 234.11 is removed.

    Issued in Washington, DC, on November 5, 2009.
Joseph C. Szabo,
Administrator, Federal Railroad Administration.
[FR Doc. E9-27241 Filed 11-12-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: March 5, 2010 (Volume 75, Number 43)]
[Notices]
[Page 10230-10231]
[DOCID:fr05mr10-36]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12783-003]

Inglis Hydropower, LLC; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene and Protests

February 26, 2010.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Major License.
    b. Project No.: P-12783-003.
    c. Date filed: July 22, 2009.
    d. Applicant: Inglis Hydropower, LLC.
    e. Name of Project: Inglis Hydropower Project.
    f. Location: The proposed project would be located at the existing
Inglis Bypass Channel and Spillway on the Withlacoochee River, west of
Lake Rousseau and Inglis dam, within the town of Inglis, in Levy,
Citrus, and Marion counties, Florida. No federal lands would be
occupied by the proposed project.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contacts: Mr. Dean Edwards, P.O. Box 1565, Dover, FL

33527; Mr. Kevin Edwards, P.O. Box 143, Mayodan, NC 27027.
    i. FERC Contact: Jennifer Adams at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice, or April 27, 2010.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and eight copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. This application has been accepted for filing, but is not ready
for environmental analysis at this time.
    l. The proposed 2.0-megawatt Inglis Hydropower Project would
operate in a run-of-river mode by using flows released to maintain the
surface elevation of Lake Rousseau at 27.5 feet mean sea level. Flow
releases would be determined by the Southwest Florida Water Management
District. The proposed powerhouse would be 60 feet long by 80 feet wide
by 30 feet high, and contain three vertical shaft turbines. The
penstock would be 130 feet in length. The project would generate about
12,300,000 kilowatt hours annually, which would be fed into the
interconnected transmission system via an existing 3.4-mile-long,
12,470-kilovolt transmission line.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room, or may be viewed on the
Commission's Web site at http://www.ferc.gov, using the ``eLibrary''
link. Enter the docket number, excluding the last three digits in the
docket number field, to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application no later than 120
days after the specified intervention deadline date. Applications for
preliminary permits will not be accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) names in this
public notice.
    Anyone may submit a protest or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210, 385.211, and 385.214. In determining the appropriate action to
take, the Commission will consider all protests filed, but only those
who file a motion to intervene in accordance with the Commission's
Rules may become a party to the proceeding. Any protests or motions to
intervene must be received on, or before, the specified deadline date
for the particular application.
    When the application is ready for environmental analysis, the
Commission will issue a public notice requesting comments,
recommendations, terms and conditions, or prescriptions.
    All filings must: (1) Bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-4621 Filed 3-4-10; 8:45 am]
BILLING CODE 6717-01-P