[Federal Register: August 31, 2007 (Volume 72, Number 169)]
[Notice]
[Page 50425-50426]
[DOCID:fr31au07-151]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56321; File No. SR-FINRA-2007-003]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Amend NASD Rules 4632C, 6130C and 6130

August 24, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 3, 2007, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a National Association of Securities Dealers, Inc.
(``NASD'')) 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 substantially prepared by FINRA.
FINRA has designated the proposal as a ``non-controversial'' proposed
rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule
19b-4(f)(6) thereunder,\4\ which rendered the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA proposes to amend NASD Rules 4632C and 6130C relating to the
NASD/NSX Trade Reporting Facility (the ``NASD/NSX TRF'') to reflect
certain changes in the facility's functionality and to conform, to the
extent practicable, to the trade reporting rules relating to FINRA's
other Trade Reporting Facilities (the ``TRFs'').\5\ FINRA also is
proposing to amend NASD Rule 6130(a) to clarify that the NASD/Nasdaq
Trade Reporting Facility (the ``NASD/Nasdaq TRF'') and the OTC
Reporting Facility will compare and submit to the National Securities
Clearing Corporation (``NSCC'') trades reported as other than regular
way settlement.
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    \5\ Effective July 30, 2007, FINRA was formed through the
consolidation of NASD and the member regulatory functions of NYSE
Regulation. Accordingly, the NASD/NSX TRF is now doing business as
the FINRA/NSX TRF. The formal name change of each TRF is pending and
once completed, FINRA will file a separate proposed rule change to
reflect those changes in the Manual.
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    The text of the proposed rule change is available at the FINRA, the
Commission's Public Reference Room, and http://www.finra.org.

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

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

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

1. Purpose
    The TRFs,\6\ including the NASD/NSX TRF, provide members mechanisms
for reporting trades in exchange-listed securities executed otherwise
than on an exchange. Currently, the functionality offered by the NASD/
NSX TRF differs from the functionality offered by some of the other
TRFs and, as a result, the rules relating to the NASD/NSX TRF differ
from the rules relating to the other TRFs. Specifically, pursuant to
NASD Rule 4632C(a)(8), the NASD/NSX TRF does not accept trade reports
for Stop Stock Transactions (as such term is defined in Rule 4200C),
transactions occurring at prices based on average-weighting or other
special pricing formulae or transactions that reflect a price different
from the current market when the execution price is based on a prior
reference point in time. In addition, pursuant to NASD Rule 6130C(a),
the NASD/NSX TRF does not accept trades reported as other than regular
way settlement (i.e., Cash, Next Day and Seller's Option). Under the
current rules, members must use an alternative electronic mechanism to
report these transactions to FINRA.
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    \6\ In addition to the NASD/NSX TRF, there are three other TRFs
in operation: the NASD/Nasdaq TRF, the NASD/BSE Trade Reporting
Facility (the ``NASD/BSE TRF'') and the NASD/NYSE Trade Reporting
Facility (the ``NASD/NYSE TRF''). As noted in footnote 5 above, the
formal name change of each TRF is pending.
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    FINRA is proposing to expand the NASD/NSX TRF's functionality such
that members will be able to report the above-described transactions to
the NASD/NSX TRF. FINRA is proposing to amend NASD Rules 4632C and
6130C to reflect this change in functionality and conform, to the
extent practicable, the NASD/NSX TRF rules to the rules relating to the
other TRFs.
    FINRA also is proposing to amend NASD Rule 6130(a) to clarify that
the ``System'' (defined in Rule 6110 to include the NASD/Nasdaq TRF and
the OTC Reporting Facility) will compare and submit to NSCC trades
reported as other than regular way settlement. This amendment is
consistent with current practice and reflects recent changes in the way
that such trades are processed by NSCC.\7\ Additionally, this amendment
conforms the text of NASD Rule 6130(a) to the text of amended NASD Rule
6130C(a), to the extent practicable.\8 \
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    \7\ See Securities Exchange Release No. 54816 (November 27,
2006), 71 FR 69604 (December 1, 2006) (order approving SR-NSCC-2006-
09).
    \8\ The corresponding rules relating to the other TRFs differ in
this regard. NASD Rule 6130D(a) provides that trades reported as
other than regular way settlement will not be accepted by the NASD/
BSE TRF. NASD Rule 6130E(a) provides that trades reported as other
than regular way settlement will be accepted by the NASD/NYSE TRF,
but will not be submitted to clearing. The NASD/NYSE TRF will not
submit any trades (including regular way settlement trades) to
clearing; members must have a Qualified Service Representative
(``QSR'') agreement or similar arrangement in place to clear trades
submitted to the NASD/NYSE TRF.
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    FINRA has filed the proposed rule change for immediate
effectiveness. FINRA will announce the operative date of the proposed
rule change on its Web site, which date will be at least 30 days after
the date of filing.
2. Statutory Basis
    FINRA believes that its proposal is consistent with the provisions
of Section 15A(b)(6) of the Act,\9\ which requires, among other things,
that FINRA rules be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
and, in general, to protect investors and the public interest. FINRA
believes that the proposed rule change is in the public interest and

appropriate for the maintenance of fair and orderly markets because it
will provide members another mechanism to report the types of trades
described above with the necessary regulatory information.
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    \9\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were either solicited or received.

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

    The proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \10\ and Rule 19b-(f)(6) thereunder,\11 \because
the foregoing proposed rule does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest. FINRA believes that the proposed rule change
is appropriately designated as a ``non-controversial'' rule change
because the proposal is substantially similar to the trade reporting
requirements for the other TRFs.\12\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). Rule 19b-4(f)(6) also requires the
self-regulatory organization to give the Commission notice of its
intent to file the proposed rule change, along with a brief
description and text of the proposed rule change, at least five
business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. FINRA
has satisfied the five-day pre-filing requirement.
    \12\ See, e.g., NASD Rules 4632 and 6130 (relating to the NASD/
Nasdaq TRF), 4632D and 6130D (relating to the NASD/BSE TRF) and
4632E and 613E (relating to the NASD/NYSE TRF).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.\13\
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    \13\ See 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2007-003 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2007-003. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 am and 3 pm. Copies of the filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2007-003 and should be
submitted on or before September 21, 2007.
    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).

Nancy M. Morris,
Secretary.
 [FR Doc. E7-17271 Filed 8-30-07; 8:45 am]

BILLING CODE 8010-01-P


TITLE:

Notice of Filing to Support the Uses of Fenhexamid ( Elevate 50 WDG, TM 402) on Ginseng, Pomegranate, Non bell Pepper, and Cilantro AUTHOR: Doina Bujor REPORT COMPLETION DATE: August 13, 2004 SUBMITTER: TM 402 ( KBR 2738) Fungicide Task Force Comprised of Arvesta Corporation and Bayer Corporation EPA Consortium No. 69436 STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS No claims of confidentiality are made for any information in this study on the basis of its falling within the scope of FIFRA § 10( d)( 1)( A), ( B), or ( C).

This report is the property of Arvesta Corporation Company Agent: _____________________________________ ________________________

Doina Bujor Date Project Manager Registrations and Regulatory Affairs Arvesta Corporation GOOD LABORATORY PRACTICE STATEMENT This summary is not subject to the requirements of 40 CFR Part 160.

Submitter: _____________________________________ ________________________

Doina Bujor Date Project Manager Registrations and Regulatory Affairs Arvesta Corporation For:

TM 402 ( KBR 2738) Fungicide Task Force EPA Registration Division contact: [ insert name and telephone number with area code]

[ 3E6799]

Summary of Petitions EPA has received pesticide petitions ( xxxxx) from the Interregional Research Project Number 4 ( IR 4), 681 U. S. Highway # 1 South, North Brunswick, NJ 08902 3390 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing a tolerance for residues of N( 2,3 dichloro 4 hydroxyphenyl) 1 methyl cyclohexane carboxamide in or on the following raw agricultural commodity: ginseng at 0.3 parts per million ( ppm), pomegranate at 3.0 parts per million ( ppm), non bell pepper at 0.02 parts per million ( ppm) and cilantro ( as part of the Crop Sub group 4A) at 30.0 parts per million ( ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. The qualitative nature of fenhexamid residues in plants is adequately understood. 2. Analytical method. An adequate method for purposes of enforcement of the proposed fenhexamid tolerances in plant commodities is available. 3. Magnitude of Residues. The magnitude of residues for fenhexamid on the proposed commodity is adequately understood.

B. Toxicological Profile 1. Acute toxicity. The acute oral toxicity study resulted in a lethal dose ( LD 50) of > 5,000 mg/ kg for both sexes. The acute dermal toxicity in rats resulted in an LD 50 of > 5,000 mg/ kg for both sexes. The acute inhalation was investigated in two studies in rats. Inhalation by aerosol at the maximum technically possible concentration of 0.322 milligram/ liter ( mg/ L) resulted in no deaths or symptoms ( LC 50 > 0.322 mg/ L). A dust inhalation study resulted in an LC 50 > 5.057 mg/ L. Fenhexamid was not irritating to the skin or eyes after a 4 hour exposure period. The Buehler dermal sensitization study in guinea pigs indicated that fenhexamid is not a sensitizer. Based on these results fenhexamid technical is placed in toxicity Category IV and does not pose any acute dietary risks. 2. Genotoxicty. The potential for genetic toxicity of fenhexamid was evaluated in six assays including two Ames tests, an HGPRT forward mutation assay, a unscheduled DNA synthesis ( UDS) assay, an in vitro chromosomal aberration assay in Chinese hamster ovary ( CHO) cells, and a micronucleus test in mice. The compound was found to be devoid of any mutagenic activity in each of these assays; including those tests that investigated the absence or presence of metabolic activating systems. The weight of evidence indicates that fenhexamid technical does not pose a risk of mutagenicity or genotoxicity.

3. Reproductive and developmental toxicity. i. In a 2 generation reproduction study ( one mating per generation), 30 Sprague Dawley rats per sex per dose were administered 0, 100, 500, 5000, or 20000 ppm of fenhexamid in the diet. The reproductive toxicity no observed adverse effect level ( NOAEL) was 20,000 ppm. The neonatal NOAEL was 500 ppm, and the lowest observed adverse effect level ( LOAEL) was 5,000 ppm based on decreased pup body weight. The parental toxicity NOAEL was 500 ppm based on lower adult pre mating body weights at 5,000 and 20,000 ppm, lower gestation body weights at 20,000 ppm, lower lactation body weights at 5,000 and 20,000 ppm, and statistically significant changes in clinical chemistry parameters, terminal body weights, and organ weights at 5,000 and 20,000 ppm. Based on this study, it is clear that the only toxic effects in the neonates occurred at parentally toxic doses. ii. In rats, fenhexamid was administered by gavage at doses of 0 or 1000 mg/ kg for gestation days 6 15. No maternal toxicity, embryotoxicity, fetotoxicity, or teratogenic effects were observed at the limit dose of 1000 mg/ kg/ day. Therefore, the NOAEL for maternal and developmental toxicity was 1000 mg/ kg/ day. iii. In rabbits, fenhexamid was administered by gavage at doses of 0,100, 300, and 1000 mg/ kg for gestation days 6 18. Body weight gain and feed consumption of the dams were reduced at the two top doses. One abortion occurred in each of the top two dose groups and two total resorptions occurred in the top dose group. The placental weights were slightly decreased at 300 mg/ kg/ day and above. In the 1000 mg/ kg/ day group, slightly decreased fetal weights and a slightly retarded skeletal ossification were observed. All other parameters investigated in the study were unaffected. Therefore, the NOAELs for maternal and developmental toxicity were 100 mg/ kg/ day in this study. Based on the 2 generation reproduction study in rats, fenhexamid is not considered a reproductive toxicant and shows no evidence of endocrine effects. The data from the developmental toxicity studies on fenhexamid show no evidence of a potential for developmental effects ( malformations or variations) at doses that are not maternally toxic. The NOAEL for both maternal and developmental toxicity in rats was 1000 mg/ kg/ day, and for rabbits the NOAEL for both maternal and developmental toxicity was 100 mg/ kg/ day.

4. Subchronic toxicity. i. Fenhexamid was administered in the diet to rats for 13 weeks at doses of 0, 2500, 5000, 10000, and 20000 ppm. The NOAEL was 5000 ppm ( 415 mg/ kg/ day in males and 549 mg/ kg/ day in females). Reversible liver effects were observed at 10,000 ppm. ii. Fenhexamid was administered in the diet to mice for approximately 14 weeks at doses of 0, 100, 1000, and 10000 ppm. The NOAEL was 1000 ppm ( 266.6 mg/ kg/ day in males and 453.9 mg/ kg/ day in females). Increased feed and water consumption and kidney and liver effects were observed at 10,000 ppm. iii. Fenhexamid was administered in the diet to beagle dogs for 13 weeks at doses of 0, 1000, 7000, and 50000 ppm. The NOAEL was 1000 ppm ( 33.9 mg/ kg/ day in males and 37.0 mg/ kg/ day in females). Increased Heinz bodies were observed at 7000 ppm.

5. Chronic toxicity. i. Fenhexamid was administered in the feed at doses of 0, 500, 3500, or 25000 ppm to 4 male and 4 female beagle dogs per group for 52 weeks. A systemic NOAEL of 500 ppm ( an average dose of 17.4 mg/ kg/ day over the course of the study) was observed based on decreased food consumption and decreased body weight gain at 25000 ppm, decreased erythrocyte, hemoglobin and hematocrit values at 25000 ppm, increased Heinz bodies at 3500 ppm and above, and a dose dependent increase of alkaline phosphatase at 3500 ppm and above. There were no treatment related effects on either macroscopic or histologic pathology. ii. A combined chronic/ oncogenicity study was performed in Wistar rats. Fifty animals/ sex/ dose were administered doses of 0, 500, 5000, or 20000 ppm for 24 months in the feed. A further 10 animals/ sex/ group received the same doses and were sacrificed after 52 weeks. The doses administered relative to body weight were 0, 28, 292, or 1280 mg/ kg/ day for males and 0, 40, 415, or 2067 mg/ kg/ day for females. The NOAEL in the study was 500 ppm ( 28 mg/ kg/ day for males and 40 mg/ kg/ day for females) based on body weight decreases in females at 5000 ppm and above, changes in biochemical liver parameters in the absence of morphological changes in both sexes at 5000 ppm and above, and caecal mucosal hyperplasia evident at 5000 ppm and above. The NOAEL in the chronic dog study was 17.4 mg/ kg/ day based on body weight, hematology and clinical chemistry effects. The lowest NOAEL in the 2 year rat study was determined to be 28 mg/ kg/ day based on body weight, clinical chemistry parameters in the liver, and caecal mucosal hyperplasia.

6. Animal metabolism. i. A lactating goat was dosed at 10 milligrams ( mg) 14Cfenhexamid per kilograms/ bodyweight on 3 consecutive days at 24 hour intervals. Fenhexamid was rapidly and almost completely absorbed, distributed and eliminated ( 24.9% in urine, 38.6% in feces, and 0.03% in milk). The half life of biliary fecal elimination ( primary pathway) was 0.5 hours. The primary residues in tissues were unreacted fenhexamid, its glucuronide derivative and the 4 hydroxy derivative. ii. Rats were administered radiolabeled fenhexamid ( a single oral low dose of 1 mg/ kg, a single oral high dose of 100 mg/ kg, or 15 repeated low doses of 1 mg/ kg/ day). Radiolabeled fenhexamid was rapidly eliminated and tissue residues declined rapidly. After 48 hours the total radioactivity residue in the body excluding the GI tract, was < 0.3% of the administered dose in all dose groups. Excretion was rapid and almost complete with feces as the major route of excretion. Approximately 62 84% of the recovered radioactivity was found in feces, and 15 36% in urine within 48 hours post dosing. Metabolite characterization studies showed that the main components detected in excreta were the unchanged parent compound ( 62 75%) and the glucuronic acid conjugate of the parent compound ( 4 23%). The proposed major pathway for biotransformation is via conjugation of the aromatic hydroxyl group with glucuronic acid. Identification of radioactive residues ranged from 88% to 99% and was independent of dose and sex.

7. Metabolite toxicology. As the primary residues found in rats and goat were the parent compound fenhexamid and its glucuronic acid conjugate, no additional metabolite toxicology studies are warranted.

8. Endocrine disruption. Fenhexamid has no endocrine modulation characteristics as demonstrated by the lack of endocrine effects in developmental, reproductive, subchronic, and chronic studies.

C. Aggregate Exposure 1. Dietary exposure.

i. Food. Dietary exposure to fenhexamid is limited to the established tolerances for residues of fenhexamid on grapes ( at 4.0 ppm), raisins ( at 6.0 ppm), strawberries ( at 3.0 ppm), almond nutmeat ( at 0.02 ppm), almond hulls ( at 2.0 ppm), stonefruit except plum, prune, fresh, post harvest ( at 10.0 ppm), plum, prune, dried ( at 2.5 ppm); plum, prune, fresh ( at 1.5 ppm); pear ( at 15 ppm), bushberries ( at 5.0 ppm), caneberries ( at 20 ppm), pistachios ( at 0.02 ppm); cucumber ( at 2.0 ppm); fruiting vegetables, except non bell peppers ( at 2.0 ppm); kiwi, postharvest ( at 15.0 ppm); leafy greens, except spinach ( at 30.0 ppm); the previously proposed tolerances for pome fruit ( at 10 ppm); and apple pomace ( at 25 ppm); and the proposed tolerances through this petition for ginseng ( at 0.3 ppm), pomegranate ( 3.0 ppm), non bell pepper ( 0.02 ppm) and cilantro ( 30.0 ppm).

ii. Drinking water. Review of the environmental fate data indicates that fenhexamid is relatively immobile and rapidly degrades in the soil and water. Fenhexamid dissipates in the environment via several processes. Therefore, a significant contribution to aggregate risk from drinking water is unlikely. 2. Non dietary exposure. There is no significant potential for non occupational exposure to the general public. The proposed uses are limited to agricultural and horticultural use.

D. Cumulative Effects Consideration of a common mechanism of toxicity is not appropriate at this time since it has a unique mode of action. Moreover, there is no significant toxicity observed for fenhexamid. Even at toxicology limit doses, only minimal toxicity is observed for fenhexamid. Therefore, only the potential risks of fenhexamid are considered in the exposure assessment.

E. Safety Determination 1. U. S. population. The percent of the cPAD utilized by all current uses ( almonds, bushberries, caneberries, cucumbers, fruiting vegetables ( except non bell peppers), grapes, kiwifruits, leafy greens ( except spinach), pears, pistachios, raisins, stonefruits, strawberries) was estimated by EPA to be 9.9% ( Federal Register, September 26, 2003). Arvesta Corporation estimated the chronic dietary exposure to fenhexamid resulting from the use on pome fruit, ginseng, pomegranate, non bell pepper ( greenhouse transplant) and pomegranate using the DEEM FCIDTM software version as had the US EPA and assuming 100 % of the crop treated and residues equal to the MRL. The percent cPAD utilized by all current and proposed uses was estimated to be 18%. Therefore, the estimates of dietary exposure indicate adequate safety margins for the overall U. S. population.

2. Infants and children. The percent of the cPAD utilized by all current uses ( almonds, bushberries, caneberries, cucumbers, fruiting vegetables ( except non bell peppers), grapes, kiwifruits, leafy greens ( except spinach), pears, pistachios, raisins, stonefruits and strawberries) was estimated by EPA to be 19.6% ( infants < 1 year) and 21.8% ( children 1 to 2 years) ( Federal Register, September 26, 2003). Arvesta Corporation estimated the chronic dietary exposure to fenhexamid resulting from the use on pome fruit, as above. There is no exposure to infants and children from usind fenhexamid on ginseng, pomegranate, non bell peppers and cilantro. The percent cPAD utilized by all current and proposed uses was estimated to be 61.5% ( infants < 1 year) and 60.0% ( children 1   6 years). Therefore, the estimates of dietary exposure indicate adequate safety margins for children. In assessing the potential for additional sensitivity of infants and children to residues of fenhexamid, the available developmental toxicity and reproductive toxicity studies and the potential for endocrine modulation by fenhexamid were considered. Developmental toxicity studies in two species indicate that fenhexamid does not impose additional risks to developing fetuses and is not a teratogen. The 2 generation reproduction study in rats demonstrated that there were no adverse effects on reproductive performance, fertility, fecundity, pup survival, or pup development at non maternally toxic levels. Maternal and developmental NOAELs and LOAELs were comparable, indicating no increase in susceptibility of developing organisms. No evidence of endocrine effects was noted in any study. It is therefore concluded that fenhexamid poses no additional risk for infants and children and no additional uncertainty factor is warranted.

F. International Tolerances International tomato tolerances are in effect in France, Germany, Greece, Italy, Slovenia, Spain, Turkey ( 1 ppm) and other EU countries ( 2 ppm). Kiwi tolerances are as follows: Greece, Italy and Slovenia ( 10 ppm). Stonefruit tolerances already exist in the USA for pre harvest applications as well as in Canada ( 6 ppm), Austria ( cherry, 5 ppm; plum, 2 ppm); Belgium ( cherry, 5 ppm); Germany and Slovenia ( cherry, 5 ppm; peach and plum, 2 ppm), Italy ( cherry, 5 ppm; apricot, peach and plum, 2 ppm); Japan ( peach, 1 ppm), Switzerland ( cherry, 2 ppm) and the UK ( plum, 1 ppm) and other EU countries ( peach and plum, 1 ppm; cherry, 5 ppm).


[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Rules and Regulations]
[Pages 77387-77388]
[FR Doc No: 2014-30141]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 860

[Docket No. FDA-2013-N-1529]

Medical Device Classification Procedures; Reclassification
Petition: Content and Form; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations for petitioning for device reclassification to update
mailing addresses for the petitions. This action is being taken to
improve the accuracy of the regulations.

DATES: This rule is effective December 24, 2014.

FOR FURTHER INFORMATION CONTACT: Nancy Pirt, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4438, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is updating mailing addresses for device
reclassification petitions (21 CFR 860.123). For devices regulated by
the Center for Devices and Radiological Health, the room number is now
4438. In addition, the Center for Biologics Evaluation and Research has
moved to a new location at FDA's White Oak Campus. The address remains
the same for the Center for Drug Evaluation and Research. The
regulations are being amended to ensure clarity and to improve the
accuracy and readability of the regulations.
    Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment and a delayed effective date
are unnecessary because these corrections are nonsubstantive.

List of Subjects in 21 CFR Part 860

    Administrative practice and procedure, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part
860 is amended as follows:

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
1. The authority citation for 21 CFR part 860 continues to read as
follows:

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

0
2. Revise Sec.  860.123(b)(1) to read as follows:

Sec.  860.123  Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, addressed to the Food and Drug Administration,
Center for Devices and Radiological Health, Regulations Staff, 10903
New Hampshire Ave., Bldg. 66, Rm. 4438, Silver Spring, MD 20993-0002;
for devices regulated by the Center for Biologics Evaluation and
Research, addressed to the Food and Drug Administration, Center for
Biologics Evaluation and Research, Document Control Center, 10903 New
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for
devices regulated by the Center for Drug Evaluation and Research,
addressed to the Food and Drug Administration, Center for Drug
Evaluation and Research, Central Document Control Room, 5901-B
Ammendale Rd., Beltsville, MD 20705-1266, as applicable.
* * * * *

    Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30141 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Notices]
[Pages 52769-52770]
[FR Doc No: 2017-24560]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2017-0116]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on November 1, 2017, BNSF
Railway (BNSF) petitioned the Federal Railroad Administration (FRA) for
a waiver of compliance from certain

provisions of the Federal railroad safety regulations contained at
Title 49 Code of Federal Regulations (CFR) part 231. FRA assigned the
petition Docket Number FRA-2017-0116.
    Pursuant to 49 CFR 231.35, BNSF seeks relief from AAR Standard S-
2044, Appendix D1, the approved industry standard for safety appliances
for flatcars with full decks. BNSF requests permission to alter Boeing
aircraft fuselage flatcars and idler cars by modifying the transverse
end and side handhold arrangement at the BL and AR corners of the
flatcars. In order to transport the aircraft fuselages safely, the BR
and AL side and end handholds will be positioned six (6) inches above
the deck of the flatcar which will allow employees to safely utilize
the handholds. BNSF states that ergonomic analysis of this arrangement
indicates this modification does not compromise rail safety.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing about these proceedings since the facts do
not appear to warrant a hearing. If any interested parties desire an
opportunity for oral comment and a public hearing, they should notify
FRA, in writing, before the end of the comment period and specify the
basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by January 3, 2018, will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2017-24560 Filed 11-13-17; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 239 (Tuesday, December 13, 2011)]
[Rules and Regulations]
[Pages 77383-77386]
[FR Doc No: 2011-31847]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0527; Airspace Docket No. 11-AWA-2]

Amendment of Class C Airspace; Palm Beach International Airport,
FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies the Palm Beach International Airport, FL,
Class C airspace area by raising the floor of Class C airspace over
Palm Beach County Park Airport. The FAA is taking this action to
enhance safety and increase the efficiency of air traffic operations in
the Palm Beach, FL, terminal area.

DATES: Effective Date: 0901 UTC, February 9, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On June 21, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to modify the Palm Beach, FL, Class C
airspace area (76 FR 36014). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal. Five comments were received.

Discussion of Comments

    Two commenters wrote in support of the proposal. Three commenters
suggested a larger expansion of the 1,600-foot mean sea level (MSL)
cutout area in the vicinity of Palm Beach County Park Airport (LNA)
than was proposed in the NPRM. The commenters said that further
expanding the cutout would benefit LNA traffic that primarily arrives
from, or departs to, the west and east of the airport. The commenters
believed that this would also allow more room for transient traffic not
under the control of Palm Beach Approach to maneuver, provide better
transit to the practice areas to the west and permit straight-out
departures from LNA for aircraft headed eastbound to the Bahama
Islands. The FAA considered these suggestions but determined that
expanding the cutout as requested is not possible due to the impact on
Palm Beach International Airport (PBI) traffic flows and the provision
of Class C services. Procedures for departures from PBI runways 10L/R
include dispersing aircraft headings for separation and to expedite
departures. Turboprop and prop departures climb to 1,500 feet to allow
the faster climbing jets to climb above. The dispersal headings vary
from 030 to 160 degrees and the southern most heading would exit Class
C airspace if the cutout was expanded. Additionally, accommodating PBI
arrivals to runways 28L/R (especially the shorter general aviation
runway) requires aircraft to basically line up with runway 32 (modified
base leg). These aircraft are vectored at 1,500 feet to allow a better
chance of seeing the airport while allowing vertical separation from
Instrument Flight Rules (IFR) traffic to runway 28L/R. PBI runway 32
allows for relief from runway 28L/R finals during busy periods. Runway
32 aircraft must be afforded Class C services while being vectored and
descending on final. PBI runway 14 departures are capped at 1,500 feet
to allow for crossing downwind runway 10R Visual Flight Rules traffic
at 2,000 feet and IFR aircraft at 3,000 feet. These departures also
require Class C services as they depart and start their climbs to
higher altitudes. Most aircraft departing LNA that are headed
northbound contact Palm Beach Approach for approval. When PBI is
landing/departing runways 10L/R and 14, the LNA departures are afforded
the opportunity to stay just east of the shoreline at 500 feet, fly one
mile off shore at 1,000 feet, or proceed overhead PBI at 2,000 feet.
They are also allowed to proceed west of PBI, depending on traffic.
When PBI is departing west (runways 28L/R and 32) aircraft are offered
overhead or following the intracoastal waterway at 2,000 feet to top
the arrivals into PBI. Regarding aircraft headed to the Bahama Islands,
most aircraft call Palm Beach Approach for advisories/flight following
due to the Atlantic Ocean crossing. These aircraft are rarely
restricted unless traffic becomes a factor. However, the ability to
turn/level off these aircraft affords Air Traffic Control the ability
to climb above them. Expanding the 1,600-foot cutout would reduce the
availability of Class C airspace and adversely affect the operations
discussed above.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by raising the floor of Class C airspace from 1,200 feet to
1,600 feet MSL within an area overlying, and to the south of, Palm
Beach County Park Airport (see attached chart). Raising the Class C
floor to 1,600 feet MSL enhances safety by providing additional
clearance between rotorcraft and fixed-wing aircraft entering the
traffic pattern at Palm Beach County Park Airport. This allows fixed-
wing aircraft entering the traffic pattern to safely overfly the
existing helicopter patterns and also allows Palm Beach County Park
Airport helicopter training activities to take place at higher
altitudes.
    In addition, a minor correction is made to the latitude/longitude
coordinates of Palm Beach County Park Airport to reflect the current
information in FAA's aeronautical database.
    Class C airspace areas are published in paragraph 4000 of FAA Order
7400.9V, dated August 9, 2011 and effective September 15, 2011, which
is incorporated by reference in 14 CFR 71.1. The Class C airspace area
amendment in this document will be published subsequently in the Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends a portion of the terminal airspace structure to enhance
the safety of aircraft operating in the vicinity of Palm Beach, FL.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental

Impacts: Policies and Procedures,'' paragraph 311a. This airspace
action is not expected to cause any potentially significant
environmental impacts, and no extraordinary circumstances exist that
warrant preparation of an environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

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

0
1. The authority citation for part 71 continues to read as follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9V,
Airspace Designations and Reporting Points, dated August 9, 2011 and
effective September 15, 2011, is amended as follows:

Paragraph 4000 Class C Airspace

* * * * *

ASO FL C Palm Beach International Airport, FL [Amended]

Palm Beach International Airport, FL
    (Lat. 26[deg]40'59'' N., long. 80[deg]05'44'' W.)
Palm Beach County Park Airport
    (Lat. 26[deg]35'35'' N., long. 80[deg]05'06'' W.)

Boundaries

    Area A. That airspace extending upward from the surface to and
including 4,000 feet MSL within a 5-mile radius of the Palm Beach
International Airport, excluding that airspace within a 2-mile
radius of the Palm Beach County Park Airport.
    Area B. That airspace extending upward from 1,600 feet MSL to
and including 4,000 feet MSL within an area bounded on the north by
a line direct from the intersection of the Florida Turnpike (highway
91) and Lantana Road to the intersection of a 5-mile radius of the
Palm Beach International Airport and a 2-mile radius west of the
Palm Beach County Park Airport and a 2-mile radius north of the Palm
Beach County Park Airport, on the east by a line direct from the
intersection of a 5-mile radius of the Palm Beach International
Airport and a 2-mile radius east of the Palm Beach County Park
Airport to the intersection of a 10-mile radius of the Palm Beach
International Airport and US 1, on the south by a 10-mile radius of
the Palm Beach International Airport, and on the west by the Florida
Turnpike.
    Area C. That airspace extending upward from 1,200 feet MSL to
and including 4,000 feet MSL within a 10-mile radius of the Palm
Beach International Airport, excluding Area B.

    Issued in Washington, DC, on December 5, 2011.
Gary A. Norek,
Acting Manager, Airspace, Regulations and ATC Procedures Group.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TR13DE11.000

[FR Doc. 2011-31847 Filed 12-12-11; 8:45 am]
BILLING CODE 4910-13-C


[Federal Register Volume 88, Number 223 (Tuesday, November 21, 2023)]
[Notices]
[Page 81150]
[FR Doc No: 2023-25660]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98945; File No. SR-CboeBZX-2023-072]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To List and Trade Shares of the Franklin Bitcoin ETF Under BZX
Rule 14.11(e)(4), Commodity-Based Trust Shares

November 15, 2023.
    On September 26, 2023, Cboe BZX Exchange, Inc. (``BZX'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the Franklin Bitcoin ETF under BZX Rule 14.11(e)(4),
Commodity-Based Trust Shares. The proposed rule change was published
for comment in the Federal Register on October 3, 2023.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 98562 (Sept. 27,
2023), 88 FR 68240. The Commission has received no comments on the
proposal.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is November 17, 2023. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change and the issues
raised therein. Accordingly, the Commission, pursuant to Section
19(b)(2) of the Act,\5\ designates January 1, 2024 as the date by which
the Commission shall either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-CboeBZX-2023-072).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25660 Filed 11-20-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 106 (Thursday, June 2, 2022)]
[Notices]
[Pages 33579-33580]
[FR Doc No: 2022-11835]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. OST 2022-0014]

Agency Information Collection Activities: Notice of Request for
New Information Collection

AGENCY: Office of the Secretary of Transportation (OST), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The OST invites public comments about our intention to request
the Office of Management and Budget's (OMB) approval to submit one
information collection, which is summarized below under SUPPLEMENTARY
INFORMATION. We are required to publish this notice in the Federal
Register by the Paperwork Reduction Act of 1995.

DATES: Please submit comments by August 1, 2022.

ADDRESSES: You may submit comments identified by Docket ID OST 2022-
0014 by any of the following methods:
    Website: For access to the docket to read background documents or
comments received go to the Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility, U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001.
    Hand Delivery or Courier: U.S. Department of Transportation, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590, between 9 a.m. and 5 p.m. ET, Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tara Lanigan ([email protected]),
Department of Transportation, Office of the Secretary of
Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. Office
hours are from 7 a.m. to 4:30 p.m., Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:
    Title: Strengthening Mobility and Revolutionizing Transportation
(SMART) Grant Program.
    OMB Control Number: Not applicable; this is a new collection.
    Summary: The Bipartisan Infrastructure Law (BIL, also known as the
Infrastructure Investment and Jobs Act), enacted on November 15, 2021
provides for significant investments in America's transportation
infrastructure. A key program of the legislation is the Strengthening
and Revolutionizing Transportation (SMART) Grant Program ($100 million
per year), under which ``the Secretary shall provide grants to eligible
entities to conduct demonstration projects focused on advanced smart
city or community technologies and systems in a variety of communities
to improve transportation efficiency and safety'' (BIL Sec.  25005; 23
U.S.C. 502(b)). More specifically, SMART Grants may be used to carry
out a project that demonstrates at least one of the following:

 Coordinated Automation
 Connected Vehicles
 Systems Integration
 Commerce Delivery and Logistics
 Leveraging Use of Innovative Aviation Technology
 Smart Grid
 Smart Technology Traffic Signals

    For this competitive grant program, the Office of the Secretary
will issue a Notice of Funding Opportunity (NOFO) that describes the
requirements of the SMART Grant program, including the criteria that
will be used to evaluate applications. The NOFO will provide a
description of the application requirements. All eligible entities must
submit a completed application in order to be considered for a grant
award.
    The applicants who are selected for a grant (i.e., the grantees)
will have additional reporting requirements associated with their SMART
grant, outlined below.
     Annual Implementation Reports. These annual reports
document project progress in meeting its goals. The first report is
submitted not later than 2 years after the date on which the SMART
grant is received and annually thereafter until the date on which the
SMART grant is expended.
    [cir] The Final Implementation Report will demonstrate how the
deployment and operational costs of the project compared to the
benefits and savings; the means by which each project has met its
original expectation, including data findings on the impacts of the
project (e.g., safety, mobility, access, system efficiency, etc.) and
lessons learned.
     Evaluation Plan. The evaluation plan describes how the
project will be evaluated, including the anticipated impacts of the
project (e.g., goals), the methods that will be used to measure those
impacts, and the performance measures.
     Data Management Plan. The data management plan provides
more detailed information on the types of data being collected by the
grantee and

how that data will be managed and stored (e.g., how privacy is
protected, the entities that have access to the data, etc.).
     Quarterly Progress Reports. The Quarterly progress reports
provide status updates, including activities accomplished during the
quarter, financial and schedule reporting, and anticipated activities
for the next quarter (among other updates, such as any project
challenges).
    Respondents: Eligible entities that may apply for the grant include
States, political subdivisions of a State, Tribal governments, public
transit agencies or authorities, public toll authorities, metropolitan
planning organizations; and groups of 2 or more eligible entities
applying through a single lead applicant.
    Estimated Average Burden per Response: The estimated annual
reporting burden per response is 100 hours for each entity that submits
an application. For the subset of applicants who are selected to
receive a grant, they have an additional estimated 62 hours of average
annual burden associated with the grant award.
    Estimated Total Annual Burden: The estimated total annual burden
for the grant applicants (approximately 80 applicants per year) is
8,000 hours. The subset of applicants who receive an award
(approximately 25 grantees per year) will have an additional total
average annual burden of 1,550 hours. The table below illustrates how
the estimated total annual burden was calculated.

------------------------------------------------------------------------
                                                             Estimated
                                    Calculation  (annual   total annual
                                       # respondents x        burden
                                       annual # hours)        (hours)
------------------------------------------------------------------------
Application Stage.................  80 respondents x 100          8, 000
                                     hours each.
Grant Stage.......................  25 respondents x 62            1,550
                                     hours each.
------------------------------------------------------------------------

Public Comments Invited

    You are asked to comment on any aspect of these information
collections, including: (1) Whether the proposed collections are
necessary for the OST's performance; (2) the accuracy of the estimated
burdens; (3) ways for the OST to enhance the quality, usefulness, and
clarity of the collected information; and (4) ways that the burdens
could be minimized, including use of electronic technology, without
reducing the quality of the collected information. The agency will
summarize and/or include your comments in the request for OMB's
clearance of these information collections.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Ch. 35,
as amended; and 49 CFR 1.48.

    Issued on: May 27, 2022.
Michael Howell,
Information Collection Officer.
[FR Doc. 2022-11835 Filed 6-1-22; 8:45 am]
BILLING CODE 4910-22-P


[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Rules and Regulations]
[Pages 44604-44606]
[FR Doc No: 2021-17019]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 241

[Release No. 34-92565]

Procedures for the Commission's Use of Certain Authorities Under
Rule 21F-3(b)(3) and Rule 21F-6 of the Securities Exchange Act of 1934

AGENCY: Securities and Exchange Commission.

ACTION: Policy statement.

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SUMMARY: The Securities and Exchange Commission (``Commission'' or
``SEC'') is issuing this statement to clarify how the SEC will proceed
when addressing certain issues under Exchange Act Rule 21F-3(b)(3) and
Exchange Act Rule 21F-6 while the staff is preparing and the Commission
is considering potential amendments to those rules (``Interim Policy-
Review Period''). These procedures will remain in effect until
withdrawn by the Commission.

DATES: The policy statement is effective: August 13, 2021.

FOR FURTHER INFORMATION CONTACT: Emily Pasquinelli, Acting Chief in the
Office of the Whistleblower, Division of Enforcement, at (202) 551-
5973; William K. Shirey, Counsel to the Solicitor, Office of the
General Counsel, at<PHONE_NUMBER>; Securities and Exchange Commission,
100 F Street NE, Washington, DC 20549.

SUPPLEMENTARY INFORMATION:

I. Background

    Pursuant to the Dodd-Frank Consumer Protection and Wall Street

Reform Act of 2010 (``Dodd-Frank Act''), Section 21F was added to the
Securities Exchange Act of 1934 (``Exchange Act''), 15 U.S.C. 78u-1 et
seq., to establish a new SEC whistleblower award program. Section 21F
provides that, pursuant to regulations adopted by the SEC, a monetary
award shall be paid to any eligible whistleblower who provides the SEC
with original information about a securities law violation that leads
to the SEC's success in obtaining a monetary order of more than a
million dollars in an SEC judicial or administrative enforcement action
(``covered action''). If an eligible whistleblower qualifies for an
award, the SEC must pay an award that is at least 10%, but no more than
30%, of the amount of the monetary sanctions collected in the SEC
enforcement action.
    Section 21F further provides that if the SEC makes a whistleblower
award in connection with its own enforcement action, the whistleblower
becomes potentially eligible for an award in connection with any
related enforcement actions (``related actions'') that are successfully
litigated using the whistleblower's same original information. The
potential related enforcement actions must be brought either by a self-
regulatory organization or certain statutorily identified governmental
authorities (such as the U.S. Department of Justice or a state attorney
general in connection with a criminal proceeding).\1\
---------------------------------------------------------------------------

    \1\ See Exchange Act 21F(a)(5) (defining related action);
Exchange Act Rule 21F-3(b)(1) (same).
---------------------------------------------------------------------------

    In May 2011, the Commission adopted rules to govern the operation
of the whistleblower award program. In September 2020, the Commission
adopted various amendments to the Whistleblower Program rules,
including two amendments that whistleblower advocates and others have
asserted are unfair to whistleblowers and may risk reducing the
willingness of individuals to blow the whistle. These amendments were
made to: (1) Exchange Act Rule 21F-3, which addresses the criteria for
making an award based on a whistleblower's contributions to the
successful resolution of a related action; and (2) Exchange Act Rule
21F-6, which establishes the criteria that the Commission may consider
when determining the appropriate award amount.
     Relevant Amendment to Exchange Act Rule 21F-3. The 2020
Amendments added new subparagraph (c) to Rule 21F-3 to govern
situations where a whistleblower has filed a claim for an award in
connection with a potential related action but that action is
potentially also covered by a second, separate award program (such as,
for example, the federal whistleblower award program that the Internal
Revenue Service administers, see 26 U.S.C. 7623). New paragraph (c)
authorizes the Commission to determine, based on the facts and
circumstances of the claims and misconduct at issue in the potential
related action (among other factors), whether the Commission's
whistleblower program or the other whistleblower program has the more
``direct or relevant connection to the [related] action.'' And
responsibility for making an award in connection with the potential
related action will then rest with whichever award program is
determined to have the more direct or relevant connection to the
action.
     Relevant Amendment to Exchange Act Rule 21F-6. The 2020
Amendments added language to permit the Commission to consider, in its
discretion, the dollar amount of a potential award when making an award
determination. Before this amendment, the text of the rule (with one
limited exception) did not expressly afford the Commission authority to
consider the potential dollar amount of an award when determining
awards; rather, the text of the rule generally referred to setting
awards as a percentage of the monetary sanctions recovered.

II. Procedures Available During the Interim Policy-Review Period

    On August 2, 2021, Chair Gensler issued a public statement advising
that he has directed the staff to prepare for the Commission's
consideration later this year potential changes to Rules 21F-3(b)(3)
and Rule 21F-6 to address policy concerns raised by whistleblower
advocates and others about possible adverse effects of the 2020
Amendments.\2\
---------------------------------------------------------------------------

    \2\ See also SEC's Spring 2021 Regulatory Agenda (publicly
available at: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=3235-AN03) (``The Commission is
considering additional amendments to the rules governing the
Whistleblower Program established by the Dodd-Frank Act.'').
---------------------------------------------------------------------------

    While the staff is preparing and the Commission is considering
potential additional rulemaking, the procedures discussed below are
available to whistleblowers with claims pending during the Interim
Policy-Review Period so that they are not disadvantaged under the
components of Rule 21F-3(b)(3) and Rule 21F-6 that may be revised.
These interim procedures are consistent with the SEC's overarching goal
of protecting investors and the United States capital markets by
encouraging whistleblowers to come forward to report violations of the
federal securities laws and then rewarding them when their information
leads to successful enforcement actions.

A. Exchange Act Rule 21F-3(b)(3)

    For any claim that may be subject to Rule 21F-3(b)(3) during the
Interim Policy-Review Period, the Commission directs as follows:
    1. Before providing a preliminary determination to a claimant, or a
proposed recommendation to the Commission, the staff shall consider
whether to recommend that the Commission's exemptive authority under
Section 36(a) of the Exchange Act \3\ should be utilized to permit an
award on a potential related action irrespective of the limitations of
Rule 21F-3(b)(3) if:
---------------------------------------------------------------------------

    \3\ In pertinent part, Section 36(a) provides that ``by rule,
regulation, or order, may conditionally or unconditionally exempt
any person . . . from any provision or provisions of [the Exchange
Act] or of any rule or regulation thereunder, to the extent that
such exemption is necessary or appropriate in the public interest,
and is consistent with the protection of investors.''
---------------------------------------------------------------------------

    (a) The alternative whistleblower program has an award cap or award
range that could disadvantage the particular claimant; \4\ or
---------------------------------------------------------------------------

    \4\ See, e.g., 12 U.S.C. 4205(d)(1) (establishing a
whistleblower award program in connection with the Financial
Institutions Reform, Recovery, and Enforcement Act of 1989, but
capping awards at $1.6 million).
---------------------------------------------------------------------------

    (b) the Commission is aware or the claimant demonstrates a
likelihood that a condition or exclusion would apply to his or her
award claim under the alternative award program and the staff
determines that the claimant would likely obtain an award were he or
she permitted to proceed under the SEC's award program.
    2. For any other award claim under Rule 21F-3(b)(3) for which the
staff determines that an alternative whistleblower program has a ``more
direct or relevant connection'' to the potential related action than
the Commission's award program does, the staff will inform the claimant
of its assessment. The claimant may then request that the related-
action award claim held in abeyance during the Interim Policy-Review
Period.\5\ Further, any related-action award claim that is held in
abeyance shall not impact the

timely processing of any award claim arising from a covered Commission
enforcement action that is successfully litigated using the claimant's
same original information.
---------------------------------------------------------------------------

    \5\ The Commission contemplates that there should be no impact
on the timely processing of any related-action award claim that the
staff deems to have a ``more direct or relevant connection to the
Commission's whistleblower program.'' However, if a majority of the
Commission should subsequently disagree with that determination, the
claimant shall be notified and may request to have the related-
action award claim held in abeyance during the Interim Policy-Review
Period.
---------------------------------------------------------------------------

B. Exchange Act Rule 21F-6

    With respect to Rule 21F-6, the Commission at the time it adopted
the 2020 rulemaking amendments explained that the amendment in question
was a clarification of discretionary authority the Commission already
possessed.\6\ The Commission anticipates that, going forward, it will
continue its practice of considering dollar amounts only in connection
with provisions of the rules that explicitly contemplate the use of
such discretion to raise awards (i.e., law enforcement interest prong
of 21F-6(a)(3) and the application of the presumption embodied in Rule
21F-6(c)). In the unlikely event that the staff or the Commission
should consider deviating from this practice, the staff will inform the
claimant that such action is being considered. The claimant may then
request that the matter be held in abeyance during the Interim Policy-
Review Period.
---------------------------------------------------------------------------

    \6\ The extent to which the amendment was a clarification was a
point of disagreement at the time that the Commission adopted the
amended rules in 2020.
---------------------------------------------------------------------------

III. Other Matters

    Publication for notice and comment is not required under the
Administrative Procedure Act (``APA'') pursuant to the exemption for
agency rules of organization, procedure, or practice.\7\ It follows
that the requirements of the Regulatory Flexibility Act do not
apply.\8\ The effective date is August 13, 2021. In accordance with the
APA,\9\ we find that there is good cause to establish an effective date
less than 30 days after publication. The Commission believes that
establishing an effective date less than 30 days after publication of
this document is necessary to clarify how the SEC will proceed when
addressing certain issues under Exchange Act Rule 21F-3(b)(3) and
Exchange Act Rule 21F-6 while the staff is preparing and the Commission
is considering potential amendments to those rules.
---------------------------------------------------------------------------

    \7\ 5 U.S.C. 553(b)(A).
    \8\ 5 U.S.C. 601-612.
    \9\ 5 U.S.C. 553(d)(3).
---------------------------------------------------------------------------

    The Commission has determined that the foregoing relates only to
agency procedures and does not substantially affect the rights or
obligations of non-agency parties. The foregoing is therefore not a
``rule'' under the Congressional Review Act, 5 U.S.C. 804(3)(C).
    Finally, the Commission has adopted the foregoing under the
authority set forth in Sections 3(b), 21F, and 23(a) of the Exchange
Act.

    By the Commission.

    Dated: August 5, 2021.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2021-17019 Filed 8-12-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 24, 2010 (Volume 75, Number 163)]
[Notices]
[Page 52060]
[DOCID:fr24au10-116]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with part 211 of title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Trackside Investments

[Docket Number FRA-2010-0012]

    The Trackside Investments, LLC (Trackside) petitioned FRA for
relief from the requirements of 49 CFR 223.15(c) Existing passenger
cars for ten (10) passenger cars. All of the passenger cars carry the
same reporting mark (OHCR) and are numbered: 3208, 5443, 5444, 5499,
5582, 5583, 5584, 5595, 5642, and 9300. They were built by the Canadian
Car and Foundry Company in 1954, and used by VIA Rail Canada until the
mid-1990's, in long distance passenger service.
    The equipment does not meet the definition of ``antiquated''
equipment. FRA's long-standing definition of ``antiquated'' applies to
equipment to built prior to the end of World War II. In this case, even
though the above listed equipment is used on in tourist/excursion/
educational service, relief from the Federal safety glazing
requirements is required because the cars were built in 1954. The cars
are equipped with double pane, sealed laminated safety glass, with
certain windows marked as emergency exits. Also, the cars have
emergency tools and instructional signage to break the marked windows,
as installed by VIA Rail.
    The above referenced passenger cars and cabooses have occasionally
been leased for excursion service purposes to similar organizations in
the Midwest region of the United States, and Trackside proposes to
continue this practice in the future. In all instances, the excursion
trains operate through urban, rural and wooded areas. The coaches are
used at speeds up to and including 45 mph. There have been no reported
incidents of stoning or acts of vandalism against the excursion trains.
Trackside believes that the cost to retrofit these cars is not
economically feasible due to the limited annual use of the cars and low
exposure to vandalism. For example, the average use of these cars over
the past 24 months was approximately 30 service days.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2010-0012) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (65 FR 19477) or at
http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on August 17, 2010.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2010-20979 Filed 8-23-10; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56734-56735]
[FR Doc No: 2022-20018]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-649; OMB Control No. 3235-0701]

Submission for OMB Review; Comment Request; Extension: Rule 18a-1

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget

(``OMB'') a request for approval of extension of the previously
approved collection of information provided for in Rule 18a-1 (17 CFR
240.18a-1), under the Securities Exchange Act of 1934 (15 U.S.C. 78a et
seq.) (``Exchange Act'').
    Rule 18a-1 establishes net capital requirements for nonbank
security-based swap dealers that are not also broker-dealers registered
with the Commission (``stand-alone SBSDs''). First, under paragraphs
(a)(2) and (d) of Rule 18a-1, a stand-alone SBSD may apply to the
Commission to be authorized to use internal value-at-risk (``VaR)
models to compute net capital and a stand-alone SBSD authorized to use
internal models must review and update the models it uses to compute
market and credit risk, as well as back-test the models. Second, under
paragraph (f) of Rule 18a-1, a stand-alone SBSD is required to comply
with certain requirements of Exchange Act Rule 15c3-4 (17 CFR 240.15c3-
4). Rule 15c3-4 requires OTC derivatives dealers and firms subject to
its provisions to establish, document, and maintain a system of
internal risk management controls to assist the firm in managing the
risks associated with business activities, including market, credit,
leverage, liquidity, legal, and operational risks. Third, for purposes
of calculating ``haircuts'' on credit default swaps, paragraph
(c)(1)(vi)(B)(1)(iii) of Rule 18a-1 requires stand-alone SBSDs that are
not using internal models to use an industry sector classification
system that is documented and reasonable in terms of grouping types of
companies with similar business activities and risk characteristics.
Fourth, under paragraph (h) of Rule 18a-1, stand-alone SBSDs are
required to provide the Commission with certain written notices with
respect to equity withdrawals. Fifth, under paragraph (c)(5) of
Appendix D to Rule 18a-1 (17 CFR 240.18a-1d), stand-alone SBSDs are
required to file with the Commission two copies of any proposed
subordinated loan agreement (including nonconforming subordinated loan
agreements) at least 30 days prior to the proposed execution date of
the agreement. Finally, under paragraph (c)(1)(ix)(C) of Rule 18a-1, a
nonbank SBSD may treat collateral held by a third-party custodian to
meet an initial margin requirement of a security-based swap or swap
customer as being held by the nonbank SBSD for purposes of the capital
in lieu of margin charge provisions of the rule if certain conditions
are met. In particular, the SBSD must execute an account control
agreement and must maintain written documentation of its analysis that
in the event of a legal challenge the account control agreement would
be held to be legal, valid, binding, and enforceable under the
applicable law.
    The aggregate annual burden for all respondents is estimated to be
21,024 hours. The aggregate annual cost burden for all respondents is
estimated to be $ 2,598,500.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent by October 17, 2022 to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom, Director/Chief Information
Officer, Securities and Exchange Commission, c/o John Pezzullo, 100 F
Street NE, Washington, DC 20549, or by sending an email to:
[email protected].

    Dated: September 12, 2022.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-20018 Filed 9-14-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42713-42714]
[FR Doc No: 2016-15475]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0065]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Food Facilities Under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002;
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the notice that appeared in the Federal Register of
May 5, 2016. In the notice, FDA announced an opportunity for public
comment on the proposed collection of certain information by the
Agency. We are taking this action due to maintenance on the Federal
eRulemaking portal from July 1 through July 5, 2016.

DATES: FDA is extending the comment period on the notice published May
5, 2016 (81 FR 27140). Submit either electronic or written comments by
July 12, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0065 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Registration of Food Facilities
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any

information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of May 5, 2016 (81
FR 27140), FDA published a notice giving interested persons until July
5, 2016, to comment on the information collection provisions of the
Agency's regulations that require registration for domestic and foreign
facilities that manufacture, process, pack, or hold food for human or
animal consumption in the United States.
    From July 1 through July 5, 2016, the Federal eRulemaking Portal,
http://www.regulations.gov, is undergoing maintenance. We are,
therefore, extending the comment period for commenting on the
information collection provisions of the Agency's regulations that
require registration for domestic and foreign facilities that
manufacture, process, pack, or hold food for human or animal
consumption in the United States. The extended comment period will
close on July 12, 2016.

    Dated: June 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15475 Filed 6-29-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Proposed Rules]
[Page 12373]
[FR Doc No: 2015-05223]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2014-0903; FRL-9924-03-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; State Boards Requirements; Infrastructure Requirements
for the 2008 Ozone, 2010 Nitrogen Dioxide, and 2010 Sulfur Dioxide
National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
the State Implementation Plan (SIP) revision submitted by the State of
West Virginia for the purpose of addressing the State Boards
requirements for all criteria pollutants of the National Ambient Air
Quality Standards (NAAQS). EPA is also proposing to approve a related
infrastructure element from the West Virginia February 21, 2012 SIP
submittal for the 2008 ozone (O3) NAAQS, the December 13,
2012 SIP submittal for the 2010 nitrogen dioxide (NO2)
NAAQS, and the July 1, 2013 SIP submittal for the 2010 sulfur dioxide
(SO2) NAAQS. In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action,
no further activity is contemplated. If EPA receives adverse comments,
the direct final rule will be withdrawn and all public comments
received will be addressed in a subsequent final rule based on this
proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time.

DATES: Comments must be received in writing by April 8, 2015.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2014-0903 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2014-0903, Marilyn Powers, Acting Associate
Director, Office of Air Program Planning, Air Protection Division,
Mailcode 3AP30, U.S. Environmental Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2014-0903. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the West Virginia Department of Environmental
Protection, Division of Air Quality, 601 57th Street SE., Charleston,
WV 25304.

FOR FURTHER INFORMATION CONTACT: Ellen Schmitt,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, with the same title,
that is located in the ``Rules and Regulations'' section of this
Federal Register publication. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

    Dated: February 12, 2015.
William C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2015-05223 Filed 3-6-15; 8:45 am]
 BILLING CODE 6560-50-P