[Federal Register Volume 77, Number 108 (Tuesday, June 5, 2012)]
[Proposed Rules]
[Pages 33125-33127]
[FR Doc No: 2012-13555]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0588; Directorate Identifier 2012-NM-017-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model DHC-8-400 series airplanes. This
proposed AD was prompted by reports of chafing between the wire harness
along the wing leading edge and the inboard end rib of the wing leading
edge due to insufficient clearance. This proposed AD would require
inspecting the wire harness along the leading edge for chafing damage,
and repair if necessary; and relocating and installing new anchor nuts.
We are proposing this AD to detect and correct chafing damage to the
wire harness along the wing leading edge which, if not corrected, could
lead to the loss of the airframe de-icing system, and could become a
possible ignition source causing fire.

DATES: We must receive comments on this proposed AD by July 20, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>; fax 416-375-
4539; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,

Avionics and Flight Test Branch, ANE-172, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0588;
Directorate Identifier 2012-NM-017-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2012-05, dated January 13, 2012 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    There have been several in-service reports of chafing between
the wire harness along the wing leading edge and the wing leading
edge inboard end rib. The chafing condition was found to be caused
by insufficient clearance between the wire harness and the
structure. Chafing and damage to this wire harness could lead to the
loss of the airframe de-icing system and could be a possible
ignition source causing fire and the subsequent loss of the
aeroplane.
    This [TCCA] Airworthiness Directive (AD) mandates [a detailed]
inspection of the wire harness along the leading edge [for chafing
damage, and repair if necessary] and the relocation [and
installation of new] anchor nut[s].

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier, Inc. has issued Service Bulletin 84-57-24, dated
September 30, 2011. The actions described in this service information
are intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 83 products of U.S. registry. We also estimate that
it would take about 9 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these parts.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $63,495, or $765 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2012-0588; Directorate Identifier
2012-NM-017-AD.

(a) Comments Due Date

    We must receive comments by July 20, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model DHC-8-400, -401, and -
402 airplanes; certificated in any category; serial numbers 4001
through 4382 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 57: Wings.

(e) Reason

    This AD was prompted by reports of chafing between the wire
harness along the wing leading edge and the inboard end rib of the
wing leading edge due to insufficient

clearance. We are issuing this AD to detect and correct chafing
damage to the wire harness along the wing leading edge which, if not
corrected, could lead to the loss of the airframe de-icing system,
and could become a possible ignition source causing fire.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection and Repair

    Within 3,000 flight hours or 18 months after the effective date
of this AD, whichever occurs first: Perform a detailed inspection
for chafing damage of the wire harness at the leading edge, in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 84-57-24, dated September 30, 2011. If any chafing
damage is found: Before further flight, repair in accordance with
the Accomplishment Instructions of Bombardier Service Bulletin 84-
57-24, dated September 30, 2011.

(h) Install New Anchor Nut

    Within 3,000 flight hours or 18 months after the effective date
of this AD, whichever occurs first: Relocate and install new anchor
nuts on the leading edge, in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 84-57-24, dated
September 30, 2011.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax 516-794-
5531. Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(j) Related Information

    (1) Refer to MCAI Canadian Airworthiness Directive CF-2012-05,
dated January 13, 2012; and Bombardier Service Bulletin 84-57-24,
dated September 30, 2011; for related information.
    (2) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on May 24, 2012.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-13555 Filed 6-4-12; 8:45 am]
BILLING CODE 4910-13-P


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SOU 1997:132
141
5
Toxicological and related effects of
antibacterial feed additives
5.1
Introduction
As animals are fed AFA for long periods of time, knowledge on
bioaccumulation, chronic toxicity and problems associated with residues is
imperative. AFA are defined chemical substances and might as such have
toxic or allergenic properties. According to directive 70/524/EEC and the
guidelines provided in 94/40/EC, satisfactory information relating to these
topics has to be presented before approval.
Toxic effects, if any, could be seen either in target animal species (or non-
target animals as a result of accidental intake) or in humans.
Animals and humans may be exposed via residues in animal products and
humans also when handling products containing the substances. If the
product has unwanted properties, such as organ toxicity, mutagenicity or
allergenicity, both ways of exposure could be harmful.
Some AFA are poorly absorbed from the gut. Residues are therefore
normally not an issue for these substances. Other AFA such as ardacin and
avilamycin are absorbed to some extent, and tylosin, spiramycin, olaquindox
and carbadox are well absorbed after oral administration (FAO/WHO, 1991;
Magnussen
½ET½AL
, 1991; FAO/WHO, 1994). Further, the possibility of
accumulation in the animal must also be addressed.
In the following, some information with relevance to the topic will be
discussed. Toxicological aspects of coccidiostats, nitroimidazoles and
ionophoric AFA are discussed in chapter 7.
5.2
Toxicity for target species
With a few exceptions, AFA are not expected to cause toxic reactions in
target species at the levels permitted.
Bacitracin is nephrotoxic (Prescott and Baggot, 1993), but is not absorbed
from the gut. Toxic effects are therefore not to be expected. Flavomycin is
reported to have very low toxicity (Huber, 1979) and is only absorbed in
small quantities (Sambeth
½ET½AL
, 1974).
Some macrolides have been reported to cause gastrointestinal disorders,
mainly diarrhoea, at therapeutic levels (Prescott and Baggot, 1993). This is
not likely to pose a clinical problem as the concentrations used for growth
promotion are comparatively low. Moreover, this should probably be

5. Toxicological aspects
SOU 1997:132
142
regarded as a disturbance of the intestinal microflora and not as a toxic effect
on the animal.
Carbadox and olaquindox are known to cause adrenal damage at growth
promoting levels (van der Molen, 1988; Nabuurs
½ET½AL
, 1990). Lowered
aldosterone production is found in porcine adrenal glands exposed to
carbadox
IN½VITRO
(Spierenburg
½ET½AL
, 1988b; Spierenburg
½ET½AL
, 1988a). Van
Der Molen (1988) demonstrated a dose-response as well as a time-response
relationship between in-feed carbadox and adrenal damage in pigs. After 10
weeks of carbadox at 25 ppm or more, damage to adrenal glomerular cells
could be observed histologically at post-mortem examination. Adrenal
damage leads to profound hormonal disturbances. This means that the use of
carbadox as a feed additive probably results in, at least to some degree,
Addisons disease (a syndrome caused by impaired function of the adrenal
glands) in pigs.
The clinical signs observed are dose-related, ranging from mild to severe.
At 50 ppm, mild effects of increased faecal dryness may be observed. Other
signs include symptoms indicating salt imbalance (urine drinking), decreased
abdominal volume and lowered haematocrit values. Further, changes in hair
quality, with hair becoming longer and withered, irritable behaviour and a
decrease in feed intake and weight gain may be observed.
Olaquindox has the same toxic effects, although less pronounced, at
dosages of 100 ppm or more (Nabuurs
ET½AL
, 1990). Also in other respects,
there is a difference in activity between the substances. Carbadox is
permitted in feed at a concentration of 50 ppm, whereas olaquindox is used at
100 ppm (see table 3.III). Accidental overdosing of olaquindox
(Köfer
½ET½AL
,
1990; Stockhofe-Zurwieden
½ET½AL
, 1991) and carbadox (Power
½ET½AL
, 1989)
has been reported to cause death and severe adrenal damage in piglets.
As the main early sign of intoxication with quinoxalines, i.e. dry faeces,
may be mistaken for recovery from enteric disease, mild intoxications are
expected to be overlooked by farmers and farm workers.
Most AFA are not expected to cause toxic reactions in target species at the
levels used.
Quinoxalines and carbadox in particular, cause adrenal damage in pigs at
doses used for growth promotion. This poses a serious risk for the well-being
of the animals.
5.3
Toxicity for non-target species
There are various possibilities for ingestion of AFA by non-target species,
like mix-ups or contamination of feed at the feed mill, inadvertent feeding or
inclusion of poultry litter in animal feed. Problems associated with residues

SOU 1997:132
5. Toxicological aspects
143
in animal products in pet food could occur if the raw material contains
residues. The latter is a direct parallel to residue problems in products
intended for human consumption.
The susceptibility to accidental intoxication varies between different non-
target species. Even AFA that are innocuous for the target species may cause
adverse reactions in non-target species. For example, ruminants and horses
are generally very sensitive to disturbance of the intestinal microflora by
antimicrobial substances. Such disturbances may, in severe cases, cause
fatalities.
Accidental feeding of low doses of tylosin to cows has been reported to
cause ruminal stasis, inappetence, decreased milk production and
hypersensitivity (Crossman and Poyser, 1981; Prescott and Baggot, 1993).
Contamination of concentrate feed for dairy cows with bacitracin has also
been reported. This may cause sudden drops in milk production (Woodger,
1979). Feeding of olaquindox at a concentration of 400 ppm to turkeys and
broiler chickens caused adrenal damage in the birds (Reetz
½ET½AL
, 1991).
The severity of the consequences of accidental feeding of some AFA to
non-target species underlines the importance that maximum care should be
taken to avoid such events.
Accidental intake of AFA by non-target species can result in serious
consequences. Adequate procedures for risk management, such as adherence
to Good Manufacturing Procedures, have to be applied.
5.4
Adverse effects in humans
If the substance used has unwanted properties, ingestion of residues in meat
or occupational exposure could produce toxic effects of AFA in humans.
Substances with a potential for causing allergic reactions may be harmful
at extremely low concentrations. Ingestion of a very small dose of any of
these substances might trigger a reaction in an already sensitised person
(Rico, 1985).
5.4.1
Exposure to residues
Regulations such as withdrawal times are meant to ensure that no harmful
residues remain in animal products after slaughter. With the exception of the
quinoxalines, AFA do not have regulated withdrawal times but the use is
usually restricted to a maximum age (see table 5.I.). The maximum age limits
are often equal to, or perhaps in some regions even longer than, the life span
of the animals. In reality, this means that some animals, particularly broilers
and slaughter pigs, will be fed AFA right up to the time of slaughter.

5. Toxicological aspects
SOU 1997:132
144
Table 5.I. Examples of MRLs and withdrawal times for some AFA within
the EU. Data compiled from Council directive 70/524/EEC annex I and
Commission regulation EC 1442/95 unless otherwise indicated
4ABELL½)½%XEMPEL½P¥½-2,
V¤RDEN½MAXIMAL½RESTKONCENTRATION	½OCH
KARENSTIDER½F¶R½N¥GRA½!&4½INOM½%5½$ATA½SAMMANST¤LLDA½FR¥N½2¥DSDIREKTIV
%%'½ANNEX½)½OCH½+OMMISSIONENS½REGLERING½%'½½OM½INTE
ANNAT½ANGES
Substance
Animal
species
Maximum
age
Withdrawal
time
MRL
(µg/kg)
Tissue
Comments
Avilamycin
swine
6 months
ND
1
Bacitracin
slaughter
hogs
6 months
ND
Bacitracin
broilers
16 weeks
ND
Carbadox
piglets
4 months,
28 days
5
2
30
muscle
liver
MRL based
on sensitivity
of analytical
method
available
Flavomycin
broilers
16 weeks
Flavomycin
slaughter
hogs
6 months
ND
Olaquindox
piglets
4 months,
28 days
ND
temporary
acceptance,
no ADI
Spiramycin
broilers
16 weeks
400
300
200
liver
fat, skin
muscle
Spiramycin
slaughter
pigs
6 months
(600)
(200)
(300)
liver
fat
kidney,
muscle
provisional
MRL,
expired July
1997.
Presently no
MRLs for
pigs
Tylosin
slaughter
pigs
6 months
100
muscle,
liver,
kidney,
skin ,fat
Virginiamycin
broilers
16 weeks
ND
Virginiamycin
slaughter
pigs
6 months
ND
<s>1</s>
ND = not determined
2
According to JECFA (FAO/WHO, 1991)

SOU 1997:132
5. Toxicological aspects
145
Residue problems are addressed in reports from the Joint FAO/WHO
Expert Committee on Food Additives (JECFA). The Committee for
Veterinary Medicinal Products (CVMP) are responsible for fixing acceptable
daily intake (ADI) and maximum residue levels (MRL) for veterinary drugs
in the European Union. For AFA that are at present only used for growth
promoting purposes, MRLs have not yet been set.
For substances that are poorly absorbed from the gut, no residues in meat
would be expected. Little is known about the possibility of residues due to
faecal contamination. If the pharmacokinetics of these substances are similar
in humans, ingested residues would not be absorbed to any large extent and
would thus not be expected to cause toxic reactions.
Spiramycin
Spiramycin, when fed to pigs at 16 mg/kg per day for 7 days, resulted in
residues of around 6000 µg/kg in liver at 0.5 days withdrawal time
(FAO/WHO, 1991). The dosage used corresponds to 400 mg to a pig
weighing 25 kg, roughly equivalent to 400 ppm in feed. For poultry receiving
300 ppm for 10 days, at zero-withdrawal liver residues were 3800 µg/kg.
Neospiramycin is a major active metabolite which is included in the MRL

Maximum approved doses for growth promotion are 8 (swine) and 15
(poultry) times lower than the dosages used above. Assuming a linear
relationship, MRLs are not likely to be reached in poultry even at zero-
withdrawal. For pigs, the assumed residues at zero withdrawal are above
MRL. ADI (50µg/kg bodyweight, based on microbiological data) may be
exceeded for pig liver and possibly also for poultry liver. Further
investigations into residues of spiramycin, including neospiramycin, should
be considered.
Tylosin
When tylosin was fed to pigs at 200 ppm for 17 days, residues of 30 µg/kg
were detected in liver at zero withdrawal time (FAO/WHO, 1991). At
dosages approved for growth promotion, MRLs are not expected to be
reached. However, tylosin is extensively metabolised in the animal and there
is still some uncertainty as to the appropriate marker residue(s).
Carbadox
During storage, carbadox is rapidly decomposed to desoxycarbadox in
kidney and liver samples, but is stable in eggs and muscle (Keukens
½ET½AL
,
1990; Binnendijk
½ET½AL
, 1991). Carbadox has shown dose-related increases of
benign and malignant liver tumours in long-term feeding studies in rats, and

5. Toxicological aspects
SOU 1997:132
146
gave positive results in 14 out of 15 mammalian and non-mammalian
genotoxicity studies (FAO/WHO, 1990).
Quinoxaline-2-carboxylic acid (QCA) is another major residual metabolite
of carbadox. Studies on QCA elimination from liver after feeding of 50 ppm
carbadox yielded residues above 30 µg/kg in liver and kidney for 4 to 5
weeks (Baars
½ET½AL
, 1990; Baars
½ET½AL
, 1991). The authors’ opinion was that
a withdrawal time of 8 weeks should be recommended. In an experiment by
Rutalj (1996), QCA was still present at around 10 µg/kg at 62 days after
cessation of feeding of carbadox at 50 ppm. Detection of QCA is dependent
on the extraction method used, and it has been suggested that this is due to
other intermediate metabolites in the pathway of carbadox to QCA (Baars
ET
AL
, 1991).
In the 36th report of JECFA (FAO/WHO, 1990) it was concluded that an
ADI could not be established, due to the carcinogenic and genotoxic nature
of carbadox and some of its metabolites. MRLs set in 1990 (FAO/WHO,
1990) for QCA as marker substance were apparently based on the detection
limit of the analytical method.
Olaquindox
Olaquindox is extensively metabolised in the animal. The metabolites found
vary between tissues and between animal species (FAO/WHO, 1995). One of
the metabolites, 3-methylquinoxaline-2-carboxylic acid (MQCA), is known
to be responsible for the
IN½VITRO
mutagenicity of other quinoxaline
derivatives and has therefore been chosen as a marker compound
(FAO/WHO, 1995). The drug is rapidly absorbed from the gut and mainly
excreted via urine. No bound residues appear to be present in tissue
(FAO/WHO, 1995). In pigs given 60 ppm in-feed olaquindox up to 16 weeks
of age, and with a withdrawal period of 28 days, olaquindox residues were
below 0.005 ppm in muscle and below 0.01 ppm in kidney (FAO/WHO,
1995). An ADI could not be allocated by JECFA 1995, because of the
genotoxic potential of the parent compound and the absence of specific
toxicity studies on the metabolites. No MRL has been set.
Some comments on the quinoxalines
Carbadox has, and olaquindox is suspected of having carcinogenic and
genotoxic properties (Cihák and Srb, 1983; Nunoshiba and Nishioka, 1989;
FAO/WHO, 1990; FAO/WHO, 1994; FAO/WHO, 1995). Carcinogenic and
genotoxic effects in consumers could be possible at very low intake levels,
especially if the substance in question is ingested regularly over a number of
years. Farm and feedmill workers are a special risk group, frequently
exposed to AFA when handling animal feed. If appropriate protection cannot

SOU 1997:132
5. Toxicological aspects
147
be ensured, the handling of animal feed containing quinoxalines and other
AFA with potentially toxic effects must be regarded as an occupational
hazard. A conservative approach is often recommended for genotoxic
substances in order to prevent underestimation of the risks.
Avilamycin
Experimental feeding of 60 ppm radiolabelled avilamycin to swine for 14
days resulted in residues of 140 µg/kg in muscle, 660 µg/kg in liver, 340
µg/kg in kidney and 550µg/kg in fat at zero withdrawal time (Magnussen
ET
AL
, 1991). The majority of the parent compound is metabolised or degraded
and most of the residue is derived from the oligosaccharide portion of
avilamycin (Magnussen
ET½AL
, 1991). MRL has not been determined.
Ardacin
Experimental feeding of broiler chickens with 15 ppm ardacin for 30 days
resulted in liver residues of up to 50 µg/kg after a 7 day withdrawal period
(Gottschall
½ET½AL
, 1995). Ardacin is not biotransformed to any large extent
(Gottschall
ET½AL
, 1995). No MRL has been established.
5.4.2
Allergy
Humans may be exposed to AFA substances during production and mixing in
feed. Allergic reactions due to macrolides (including spiramycin and tylosin)
are reported to be frequent in farmers and other people who handle these
substances daily (Veien
½ET½AL
, 1980; Gollins, 1989; Lee
½ET½AL
, 1989;
Caraffini
½ET½AL
, 1994; Danese
½ET½AL
, 1994). Allergic reactions to
streptogramins (Pillette
½ET½AL
, 1990) and bacitracin (Katz and Fisher, 1987;
Grandinetti and Fowler, 1990) have been reported in association with clinical
therapy. Photoallergic reactions due to exposure to olaquindox are well
known (de Vries
½ET½AL
, 1990; Schauder
½ET½AL
, 1996).
Although the population at risk for these reactions must be regarded as
comparatively small, the consequences of an allergy can be debilitating. This
occupational hazard for farmers handling AFA cannot be ignored.
Most AFA, if present in food, would be expected to be at concentrations too
low for toxic effects.
Quinoxalines have a genotoxic potential which may be harmful even at
extremely low concentrations.

5. Toxicological aspects
SOU 1997:132
148
Many AFA have allergenic properties. Such properties are clearly unwanted
in substances of common use. The consequences of an allergy can be
debilitating
As some AFA can cause allergic reactions and are potentially genotoxic, the
risks of long term continuous exposure to low dosages of genotoxic
substances (e.g. workers at feed mills and farmers) need to be evaluated.
5.5
Interactions
As AFA are fed continuously, other substances such as therapeuticals are
likely to be administered simultaneously at some time. Therefore, there is a


[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Page 48158]
[FR Doc No: 2013-19075]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9843-9]

Intent To Grant an Exclusive Patent License

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of intent to grant an exclusive license.

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

SUMMARY: EPA hereby gives notice of its intent to grant an exclusive,
royalty-bearing, revocable license to practice the invention described
and claimed in the U.S. patent entitled PROCESS FOR THE BIODEGRADATION
OF HYDROCARBONS AND ETHERS IN SUBSURFACE SOIL BY INTRODUCTION OF A
SOLID OXYGEN SOURCE BY HYDRAULIC FRACTURING, filed as U.S. serial
number 10/395,893 on March 25, 2003 and issued as U.S. Patent 7,252,986
on August 7, 2007 to Foremost Environmental Solutions, L.L.C. of
Denver, Colorado.

DATES: Comments on this notice must be received by EPA at the address
listed below by August 22, 2013.

FOR FURTHER INFORMATION CONTACT: Laura Scalise, Patent Attorney, Office
of General Counsel (Mail Code 2377A), Environmental Protection Agency,
Washington, DC 20460, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Pursuant to 35 U.S.C. 207 (Patents) and 37
CFR part 404 (U.S. Government patent licensing regulations), EPA hereby
gives notice of its intent to grant an exclusive, royalty-bearing,
revocable license to practice the invention described and claimed in
the U.S. patent entitled PROCESS FOR THE BIODEGRADATION OF HYDROCARBONS
AND ETHERS IN SUBSURFACE SOIL BY INTRODUCTION OF A SOLID OXYGEN SOURCE
BY HYDRAULIC FRACTURING, filed as U.S. serial number 10/395,893 on
March 25, 2003 and issued as U.S. Patent 7,252,986 on August 7, 2007 to
Foremost Environmental Solutions, L.L.C. of Denver, Colorado.
    The proposed exclusive license will contain appropriate terms,
limitations, and conditions to be negotiated in accordance with 35
U.S.C. 209 and 37 CFR 404.5 and 404.7 of the U.S. Government patent
licensing regulations.
    EPA will negotiate the final terms and conditions and grant the
exclusive license, unless within 15 days from the date of this notice
EPA receives, at the address below, written objections to the grant,
together with supporting documentation. The documentation from
objecting parties having an interest in practicing the above patent
should include an application for an exclusive or nonexclusive license
with the information set forth in 37 CFR 404.8. The EPA Patent Attorney
and other EPA officials will review all written responses and then make
recommendations on a final decision to the Director or Deputy Director
of the National Risk Management Research Laboratory who have been
delegated the authority to issue patent licenses under EPA Delegation
1-55.

    Dated: July 31, 2013.
Kevin Miller,
Acting Associate General Counsel, General Law Office.
[FR Doc. 2013-19075 Filed 8-6-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Pages 59994-59995]
[FR Doc No: 2013-23684]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70486; File No. SR-OCC-2013-12]

Self-Regulatory Organizations; The Options Clearing Corporation;
Order Approving Proposed Rule Change to Revise OCC By-Laws and Rules to
Make Structural Changes to OCC's Membership/Risk Committee Regarding
Public Directors and the Process for Designating Membership/Risk
Committee Members

September 24, 2013.

I. Introduction

    On August 2, 2013, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change SR-OCC-2013-12 pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on August 21, 2013.\3\ The Commission received no
comment letters. For the reasons discussed below, the Commission is
granting approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Exchange Act Release No. 34-70207 (August 15, 2013), 78 FR
51786 (August 21, 2013).
---------------------------------------------------------------------------

II. Description

    OCC is amending its By-Laws and Rules to make structural changes to
OCC's Membership/Risk Committee (``MRC'') regarding Public Directors
\4\

and the process for designating MRC members. Specifically, OCC is
amending Article III, Section 9 of OCC's By-Laws to provide that at
least one Public Director is required to serve on the MRC. The Public
Director(s) will be nominated to serve on the MRC by the Chairman of
the Board and such nomination will be subject to approval by the Board
of Directors. OCC is also amending Article III, Section 9 of OCC's By-
Laws to provide that the Chairman of the MRC will be required to be a
Public Director. If more than one Public Director is nominated to serve
on the MRC, the Chairman of the Board will nominate one of the Public
Directors to serve as the MRC Chairman.
---------------------------------------------------------------------------

    \4\ In relevant part, Article III, Section 6A of OCC's By-Laws
defines a Public Director as a person who is not affiliated with any
national securities exchange, national securities association, or
any broker or dealer engaging in securities transactions.
---------------------------------------------------------------------------

    In addition, OCC is amending Article III, Section 9 of OCC's By-
Laws to eliminate the requirement that MRC members must be designated
at the first meeting of OCC's Board of Directors that follows each
annual meeting. Instead, OCC's By-Laws will require MRC members to be
designated annually.
    OCC is also amending Article III, Section 9 to eliminate specific
references to Article V of the By-Laws and Chapter VI of the Rules in
order to avoid any erroneous inference that those are the only
provisions of OCC's By-Laws and Rules that set forth powers and duties
of the MRC, which are in fact contained in a number of other provisions
of its By-Laws and Rules as well.

III. Discussion

    Section 19(b)(2)(C) of the Act \5\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that the proposed rule change is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to such
organization. Section 17A(b)(3)(F) of the Act\6\ requires that the
rules of a registered clearing agency be designed to, among other
things, assure the safeguarding of securities and funds which are in
the custody or control of the clearing agency or for which it is
responsible, and, in general, protect investors and the public
interest. Section 17A(b)(3)(F) \7\ of the Act also requires that the
rules of a registered clearing agency not be designed to permit unfair
discrimination in the admission of participants or among participants
in the use of the clearing agency.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2)(C).
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
    \7\ Id.
---------------------------------------------------------------------------

    The Commission finds that the rule change is consistent with
Section 17A(b)(3)(F) of the Act \8\ because amending OCC's By-Laws to
require that OCC's Board of Directors appoints at least one Public
Director to the MRC and designates a Public Director as Chairman of the
MRC, should help ensure that diverse viewpoints contribute to the
decision-making process at the MRC, which should ultimately lead to
decisions that assure the safeguarding of securities and funds which
are in OCC's custody or control or for which OCC is responsible, and
generally protect investors and the public interest. Furthermore, by
proposing rules that require the appointment of a Public Director to
the MRC, the rule change should help diminish the likelihood of unfair
discrimination in the evaluation of prospective OCC members and the
treatment of current OCC members by interested participants.
---------------------------------------------------------------------------

    \8\ Id.
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \9\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (File No. SR-OCC-2013-12) be and
hereby is approved.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).
    \11\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-23684 Filed 9-27-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70207-70209]
[FR Doc No: 2011-29104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65679, File No. SR-MSRB-2011-17]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Order Granting Approval of Proposed Rule Change Regarding
Professional Qualifications and Information Concerning Associated
Persons

November 3, 2011.

I. Introduction

    On September 13, 2011, the Municipal Securities Rulemaking Board
(``MSRB'' or ``Board''), filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Exchange Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change consisting of amendments to Rule
G-3, on professional qualifications, and Rule G-7, on information
concerning associated persons. The proposed rule change was published
for comment in the Federal Register on September 30, 2011.\3\ The
Commission received one comment letter regarding the proposed rule
change and the MSRB's response to that comment letter.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 65393 (September 26,
2011), 76 FR 60953 (the ``Commission's Notice'').
    \4\ See letter from Marian H. Desilets, President, Association
of Registration Management, Inc., dated October 7, 2011, and letter
from Margaret C. Henry, General Counsel, Market Regulation, MSRB,
dated October 28, 2011.
---------------------------------------------------------------------------

    This order approves the proposed rule change.

II. Background and Description of Proposal

    MSRB Rule G-3(a)(i) defines a municipal securities representative
as a natural person associated with a broker, dealer or municipal
securities dealer (``dealer''), other than a person whose functions are
solely clerical or ministerial, whose activities include one or more of
the following:
    1. Underwriting, trading or sales of municipal securities;
    2. Financial advisory or consultant services for issuers in
connection with the issuance of municipal securities;
    3. Research or investment advice with respect to municipal
securities; or
    4. Any other activities that involve communication, directly or
indirectly, with public investors in municipal securities provided,
however, that the

activities enumerated in 3 and 4 above are limited to such activities
as they relate to the activities enumerated in 1 and 2 above.
    An individual seeking to become qualified as a municipal securities
representative must pass either of two qualification examinations--the
Municipal Securities Representative Qualification Examination (Series
52) or the General Securities Registered Representative Examination
(Series 7).
    On September 7, 2011, FINRA filed with the Commission a proposed
rule change to restructure the Series 7 examination to focus on a
broader range of securities products available for sale by registered
representatives. The effect of these changes would be a de-emphasis on
non-sales aspects of the activities of securities professionals. In
focusing on general principles applicable to the buying and selling of
a broad range of securities, rather than specific products, the
restructured Series 7 examination would reduce the number of questions
that test for specific knowledge of municipal securities and the rules
of the MSRB. Given the shift in emphasis of the Series 7 examination
and the reduced number of municipal questions, in the view of the MSRB,
passage of the Series 7 examination would no longer represent a useful
gauge of whether a securities professional was qualified to perform
municipal securities activities other than sales to, and purchases
from, customers \5\ of municipal securities (``sales activities'').
---------------------------------------------------------------------------

    \5\ ``Customer'' is defined in MSRB Rule D-9 as ``any person
other than a broker, dealer or municipal securities dealer acting in
its capacity as such or an issuer in transactions involving the sale
by the issuer of a new issue of its securities.''
---------------------------------------------------------------------------

    As a result of this restructured Series 7 examination, the MSRB
filed the proposed rule change consisting of amendments to MSRB Rule G-
3, on professional qualifications. The proposed rule change would
provide that the Series 7 examination would no longer qualify
individuals as ``municipal securities representatives,'' unless they
were engaged solely in sales activities or they passed the Series 7
examination prior to the effective date of the proposed rule change.
Instead, passage of the Series 52 examination would be required for any
municipal securities activities other than sales activities.
    The proposed rule change would create a sub-category of municipal
securities representative referred to as a ``municipal securities sales
limited representative'' and would apply to individuals whose
activities with respect to municipal securities are limited exclusively
to sales activities. The proposed rule change would provide that an
individual could qualify as a municipal securities sales limited
representative by passage of the Series 7 examination. Other
individuals would be required to pass the Series 52 examination in
order to qualify as full municipal securities representatives, unless
they had passed the Series 7 examination prior to the effective date of
the proposed rule change and had maintained this registration.
    The proposed rule change would also require a municipal securities
limited representative who wished to become a municipal securities
principal to pass the Series 52 examination prior to taking the Series
53 municipal securities principal examination. Otherwise, the proposed
amendments to Rule G-3 would not distinguish between ``municipal
securities sales limited representatives'' and other ``municipal
securities representatives.''
    The MSRB also filed proposed amendments to MSRB Rule G-7, on
information concerning associated persons. Rule G-7 requires brokers,
dealers and municipal securities dealers (``dealers'') to keep records
concerning their associated persons, including the category of function
they perform ``whether municipal securities principal, municipal
securities sales principal, municipal securities representative or
financial and operations principal.'' The proposed rule change would
add ``municipal securities sales limited representative'' to that
list.\6\ Additionally, the proposed rule change would streamline Rule
G-7(b) by simply requiring that dealers obtain either Form U4 (in the
case of non-bank dealers) or Form MSD-4 (in the case of bank dealers),
rather than repeating the categories of information required by those
forms.
---------------------------------------------------------------------------

    \6\ The proposed rule change would also add ``municipal fund
securities limited principal'' to this list to reflect the previous
creation of this separate category.
---------------------------------------------------------------------------

III. Discussion of Comments and MSRB's Response

    The Commission received one comment letter from the Association of
Registration Management, Inc. and a response from the MSRB to the
comment letter.\7\
---------------------------------------------------------------------------

    \7\ See supra note 4.
---------------------------------------------------------------------------

    The commenter expressed concern about the number of individual
product and regulation specific examinations proposed, introduced or
reintroduced within the past 18 months, and stated that these have
caused considerable burden on the industry to effectively implement
standards within firms to comply with ongoing registration
requirements. The commenter further stated that this protocol of
individual exams is making it difficult for registered persons to fully
and easily understand what is required at all times to ensure and
remain compliant.
    The MSRB responded that the commenter's letter mistakenly states
that the MSRB's Series 52 and 53 examinations were among those new
examinations and that comments of that nature are more appropriately
addressed to the Commission or FINRA. The MSRB stated that it only took
action with respect to the Series 7 qualification because of FINRA's
decision to change the focus of the exam.
    The commenter further stated that the revised rule could
potentially require larger firms to have many of its registered
representatives obtain an additional license to ensure continuity and
coverage across all business lines, and that it is not clear if firms
will be required to apply for ``MR position codes'' in order for their
associated persons to be grandfathered. The MSRB responded that a
dealer need take no action in order for its associated persons to be
grandfathered.
    The commenter also inquired whether the MSRB will permit FINRA to
grandfather additional associated persons who might have let their
Series 7 registrations lapse before November 7, 2011. The MSRB
responded that the proposal would not permit such additional
grandfathering.
    The commenter requested that the effective date of the MSRB
proposal be delayed until late first quarter of 2012 at the earliest to
allow firms to be able to adequately identify and prepare (budget,
staffing, etc.) for compliance as well as allow member firms to meet
other already announced regulatory obligations along with year-end
renewal process workloads and annual training requirements. The
commenter further requested consideration of the fact that the industry
had not been apprised of the change until nearly 45 days prior to the
proposed implementation, stating that such timing will cause an
unnecessary hardship.
    The MSRB responded that it made the decision to have the changes to
Rule G-3 take effect at the same time as FINRA's changes to the Series
7 examination and that FINRA's revised Series 7 will begin to be
implemented on November 7, 2011. The MSRB further stated that at that
time, the number of municipal questions will be reduced, and those
questions will address only sales activities. Accordingly, the MSRB
stated that such examination would no longer assess an associated
person's ability to

perform other municipal securities activities in a competent manner, so
no delay in the effective date of the Rule G-3 changes is appropriate.
    The Commission has carefully considered the commenter's concerns
about the MSRB's proposed changes to the licensing requirements for
associated persons of brokers, dealers or municipal securities dealers
for municipal securities activities other than sales to customers, the
scope of the ``grandfather'' provisions, and the effective date of the
proposed rule change, and does not believe the proposed changes are
inconsistent with the Exchange Act.

IV. Discussion and Commission Findings

    The Commission has carefully considered the proposed rule change,
the comment letter received, and the MSRB's response to the comment
letter and finds that the proposed rule change is consistent with the
requirements of the Exchange Act and the rules and regulations
thereunder applicable to the MSRB.\8\ The Commission believes that the
proposed rule change is consistent with the provisions of Section
15B(b)(2)(A) of the Exchange Act, which authorizes the MSRB to
prescribe ``standards of training, experience, competence, and such
other qualifications as the Board finds necessary or appropriate in the
public interest or for the protection of investors and municipal
entities or obligated persons.'' Section 15B(b)(2)(A) of the Exchange
Act also provides that the Board may appropriately classify municipal
securities brokers, municipal securities dealers, and municipal
advisors and persons associated with municipal securities brokers,
municipal securities dealers, and municipal advisors and require
persons in any such class to pass tests prescribed by the Board.
---------------------------------------------------------------------------

    \8\ In approving the proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition and capital formation. 15 U.S.C. 78c (f).
---------------------------------------------------------------------------

    The proposed rule change is also consistent with the provisions of
Section 15B(b)(2)(A) of the Exchange Act in that the proposed rule
change will ensure that individuals seeking to engage in more than
sales activities will be tested on their qualification and competency
to engage in such other municipal securities activities. These
individuals will be required to pass an examination that includes
questions both on municipal securities and the municipal markets and on
U.S. government, Federal agency and other financial instruments,
economic activity, government policy, factors affecting interest rates,
and applicable Federal securities laws and regulations. The proposed
rule change will also more closely align the information dealers are
required to obtain pursuant to Rule G-7 with the information already
required by FINRA and the bank regulators, thereby reducing the
administrative burden on such dealers.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\9\ that the proposed rule change (SR-MSRB-2011-17) be,
and it hereby is, approved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-29104 Filed 11-9-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Notices]
[Pages 64526-64529]
[FR Doc No: 2022-23085]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96107; File No. SR-FINRA-2022-029]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Extend the Expiration Date of the Temporary
Amendments Set Forth in SR-FINRA-2020-027 and the Temporary Amendments
to FINRA Rule 9341(d) in SR-FINRA-2020-015

October 19, 2022.
    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 October 17, 2022, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as constituting a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 under the Act,\3\ which
renders the proposal effective upon receipt of this filing by the
Commission. 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.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    FINRA is proposing to extend the expiration date of the temporary
amendments set forth in SR-FINRA-2020-027 and the temporary amendments
to FINRA Rule 9341(d) in SR-FINRA-2020-015 from October 31, 2022, to
January 31, 2023.\4\ The proposed rule change would not make any
changes to the text of FINRA rules.
---------------------------------------------------------------------------

    \4\ If FINRA seeks to provide additional temporary relief from
the rule requirements identified in this proposed rule change beyond
January 31, 2023, FINRA will submit a separate rule filing to
further extend the temporary extension of time. The amended FINRA
rules will revert to their original form at the conclusion of the
temporary relief period and any extension thereof.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA 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, 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
    In response to the COVID-19 global health crisis and the
corresponding need to restrict in-person activities, FINRA filed
proposed rule changes, SR-FINRA-2020-015 and SR-FINRA-2020-027, which
respectively provide temporary relief from some timing, method of
service and other procedural requirements in FINRA rules and allow
FINRA's Office of Hearing Officers (``OHO'') and the National
Adjudicatory Council (``NAC'') to conduct hearings, on a temporary
basis, by video conference, if warranted by the current COVID-19-
related public health risks posed by an in-person hearing. In July
2022, FINRA filed a proposed rule change, SR-FINRA-2022-018, to extend
the expiration date of the temporary amendments in both SR-FINRA-2020-
015 and SR-FINRA-2020-027 from July 31, 2022, to October 31, 2022.\5\
Due to the continued presence and uncertainty of COVID-19, FINRA
proposes to extend the expiration date of the temporary amendments in
SR-FINRA-2020-027 and the temporary amendments to FINRA Rule 9341(d) in
SR-FINRA-2020-015 from October 31, 2022, to January 31, 2023.\6\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 95281 (July 14,
2022), 87 FR 43335 (July 20, 2022) (Notice of Filing and Immediate
Effectiveness of File No. SR-FINRA-2022-018).
    \6\ In June 2022, the Commission approved FINRA's rule proposal
to make permanent the temporary amendments to the electronic service
and filing rules originally set forth in SR-FINRA-2020-015, with
some modifications, as described in the approval order. See
Securities Exchange Act Release No. 95147 (June 23, 2022), 87 FR
38803 (June 29, 2022) (Order Approving File No. SR-FINRA-2022-009).
Those amendments became effective on August 22, 2022. See Regulatory
Notice 22-16 (July 2022). In addition to the electronic service and
filing rules, SR-FINRA-2020-015 also included other temporary
amendments pertaining to certain adjudicatory and review processes.
All of these other temporary amendments expired on the effective
date of SR-FINRA-2022-009, except for the provisions to allow NAC
oral arguments by video conference (FINRA Rule 9341(d)).
---------------------------------------------------------------------------

    Due to the public health concerns and restrictions resulting from
the outbreak of COVID-19, along with a corresponding backlog of
disciplinary cases,\7\ FINRA filed, and subsequently extended to
October 31, 2022, SR-FINRA-2020-027 \8\ to temporarily amend FINRA
Rules 1015, 9261, 9524, and 9830 to grant OHO and the NAC authority \9\
to conduct hearings in connection with appeals of Membership
Application Program decisions, disciplinary actions, eligibility
proceedings and temporary and permanent cease and desist orders by
video conference, if warranted by the COVID-19-related public health
risks posed by an in-person hearing.\10\
---------------------------------------------------------------------------

    \7\ For example, FINRA began temporarily postponing in-person
hearings as a result of the COVID-19 impacts on March 16, 2020.
    \8\ The same COVID-19 public health concerns and restrictions
led FINRA to file SR-FINRA-2020-015, which included the temporary
amendments to allow NAC oral arguments by videoconference. See
Securities Exchange Act Release No. 88917 (May 20, 2020), 85 FR
31832 (May 27, 2020) (Notice of Filing and Immediate Effectiveness
of File No. SR-FINRA-2020-015).
    \9\ For OHO hearings under FINRA Rules 9261 and 9830, the
proposed rule change temporarily grants authority to the Chief or
Deputy Chief Hearing Officer to order that a hearing be conducted by
video conference. For NAC hearings under FINRA Rules 1015 and 9524,
this temporary authority is granted to the NAC or the relevant
Subcommittee. With respect to both OHO and NAC hearings, the
temporary authority of the adjudicator is discretionary, so in-
person hearings may continue to take place where safe and
appropriate.
    \10\ See Securities Exchange Act Release No. 89737 (September 2,
2020), 85 FR 55712 (September 9, 2020) (Notice of Filing and
Immediate Effectiveness of File No. SR-FINRA-2020-027); Securities
Exchange Act Release No. 90619 (December 9, 2020), 85 FR 81250
(December 15, 2020) (Notice of Filing and Immediate Effectiveness of
File No. SR-FINRA-2020-042); Securities Exchange Act Release No.
91495 (April 7, 2021), 86 FR 19306 (April 13, 2021) (Notice of
Filing and Immediate Effectiveness of File No. SR-FINRA-2021-006);
Securities Exchange Act Release No. 92685 (August 17, 2021), 86 FR
47169 (August 23, 2021) (Notice of Filing and Immediate
Effectiveness of File No. SR-FINRA-2021-019); Securities Exchange
Act Release No. 93758 (December 13, 2021), 86 FR 71695 (December 17,
2021) (Notice of Filing and Immediate Effectiveness of File No. SR-
FINRA-2021-031); Securities Exchange Act Release No. 94430 (March
16, 2022), 87 FR 16262 (March 22, 2022) (Notice of Filing and
Immediate Effectiveness of File No. SR-FINRA-2022-004); supra note
5.
---------------------------------------------------------------------------

    Although there has been a downward trend in the number of COVID-19
cases since FINRA filed SR-FINRA-2022-018 in July 2022, FINRA believes
there is a continued need for temporary relief beyond October 31, 2022.
In this regard, FINRA notes that COVID-19 still remains a public health
concern. For example, according to the Centers for Disease Control and
Prevention (``CDC''), the 7-day moving average of new deaths from
COVID-19 in the United States during September 2022 ranged from
approximately 300 to 500 deaths per day,\11\ and approximately 23
percent of counties in the United States have a medium or high COVID-19
Community Level based on the CDC's most recent calculations.\12\ Much
uncertainty also remains as to whether there will be a significant
increase in the number of cases of COVID-19 in the future given the
emergence of new Omicron variants that the CDC currently is tracking
\13\ and the dissimilar vaccination rates (completed primary series and
a first booster dose) throughout the United States.\14\
---------------------------------------------------------------------------

    \11\ See CDC, COVID Data Tracker--Trends in Number of COVID-19
Cases and Deaths in the US Reported to CDC, by State/Territory,
https://covid.cdc.gov/covid-data-tracker/#trends_dailydeaths_select_00 (last visited Oct. 11, 2022).
    \12\ See CDC, COVID Data Tracker--COVID-19 Integrated County
View, https://covid.cdc.gov/covid-data-tracker/#county-view?list_select_state=all_states&list_select_county=all_counties&data-type=CommunityLevels&null=CommunityLevels (last visited Oct. 11,
2022).
    \13\ These new Omicron variants include BA.4.6, BF.7, and
BA.2.75. See CDC, COVID Data Tracker--Variant Proportions, https://covid.cdc.gov/covid-data-tracker/#variant-proportions (last visited
Oct. 11, 2022).
    \14\ A state-by-state comparison of vaccination rates is
available at https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop.
---------------------------------------------------------------------------

    In addition, as set forth in the previous filings, FINRA relies on
the guidance of its health and safety consultant, in conjunction with
COVID-19 data and guidance issued by public health authorities, to
determine whether the current public health risks presented by an in-
person hearing may warrant a hearing by video conference.\15\ FINRA
strives to hold in-person hearings when it is safe to do so, but
because FINRA conducts hearings at locations throughout the United
States, FINRA believes that it may be difficult to conduct in-person
hearings at certain locations based on that data and guidance.
---------------------------------------------------------------------------

    \15\ As noted in SR-FINRA-2020-027, the temporary proposed rule
change grants discretion to OHO and the NAC to order a video
conference hearing. In deciding whether to schedule a hearing by
video conference, OHO and the NAC may consider a variety of other
factors in addition to COVID-19 trends. In SR-FINRA-2020-027, FINRA
provided a non-exhaustive list of other factors OHO and the NAC may
take into consideration, including a hearing participant's
individual health concerns and access to the connectivity and
technology necessary to participate in a video conference hearing.
---------------------------------------------------------------------------

    As a result, FINRA believes there will be a continued need for
temporary relief beyond October 31, 2022. Accordingly, FINRA proposes
to extend the expiration date of the temporary amendments originally
set forth in SR-FINRA-2020-027 and the temporary

amendments to FINRA Rule 9341(d) in SR-FINRA-2020-015 from October 31,
2022, to January 31, 2023.\16\ As previously noted, FINRA strives to
hold in-person hearings when it is safe to do so and the extension of
temporary relief therefore does not mean a video conference hearing
will be ordered in every case.\17\ Given the uncertainty regarding
COVID-19, however, the extension of these temporary amendments allowing
for specified OHO and NAC hearings to proceed by video conference will
ensure that FINRA's critical adjudicatory functions continue to operate
effectively in these circumstances--enabling FINRA to fulfill its
statutory obligations to protect investors and maintain fair and
orderly markets--while also protecting the health and safety of hearing
participants.\18\
---------------------------------------------------------------------------

    \16\ See supra note 5.
    \17\ In fact, FINRA began to hold in-person hearings at a single
location last year. In July 2021 FINRA held its first in-person
hearing since the temporary amendments were implemented. A
subsequent surge in case numbers for the Delta variant of the COVID-
19 virus caused FINRA's outside health and safety consultant to
recommend in early August 2021 against in-person hearings.
Accordingly, the Chief Hearing Officer converted hearings scheduled
after mid-September 2021 from in-person to video conference on a
case-by-case basis. In July 2022 FINRA scheduled another in-person
hearing but shortly before it began the parties jointly requested
that the hearing be conducted via video conference instead, and the
Chief Hearing Officer used her discretion to order that the hearing
be conducted by video conference.
    \18\ Since the temporary amendments were implemented, OHO and
the NAC have conducted several hearings by video conference. As of
October 10, 2022, OHO has conducted 17 disciplinary hearings by
video conference (decisions have been issued in all of these cases).
In six of these disciplinary hearings, all of the parties agreed to
proceed by video conference; the other 11 were ordered to proceed by
video conference by the Chief Hearing Officer. OHO currently has
hearings scheduled in five additional disciplinary matters. No
determination has yet been made regarding whether these five
hearings will be in-person or by video conference. Also, as of
October 10, 2022, the NAC, through the relevant Subcommittee, has
conducted 16 oral arguments by video conference in connection with
appeals of FINRA disciplinary proceedings pursuant to FINRA Rule
9341(d), as temporarily amended. Furthermore, the NAC has conducted
via video conference a one-day evidentiary hearing in a membership
application proceeding pursuant to FINRA Rule 1015, as temporarily
amended. The NAC also has conducted via video conference three
evidentiary hearings in eligibility matters pursuant to FINRA Rule
9524, as temporarily amended.
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness and has requested that the SEC waive the requirement that
the proposed rule change not become operative for 30 days after the
date of the filing, so FINRA can implement the proposed rule change
immediately.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\19\ which requires, among
other things, that FINRA rules must 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 also
consistent with Section 15A(b)(8) of the Act,\20\ which requires, among
other things, that FINRA rules provide a fair procedure for the
disciplining of members and persons associated with members.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78o-3(b)(6).
    \20\ 15 U.S.C. 78o-3(b)(8).
---------------------------------------------------------------------------

    The proposed rule change, which extends the expiration date of the
temporary amendments to FINRA rules set forth in SR-FINRA-2020-027 and
the temporary amendments to FINRA Rule 9341(d) in SR-FINRA-2020-015,
will continue to aid FINRA's efforts to timely conduct hearings in
connection with its core adjudicatory functions. Given that COVID-19
remains a public health concern and the uncertainty around a potential
spike in cases of the disease, without this relief allowing OHO and NAC
hearings to proceed by video conference, FINRA might be required to
postpone some or almost all hearings for a significant period of time.
FINRA must be able to perform its critical adjudicatory functions to
fulfill its statutory obligations to protect investors and maintain
fair and orderly markets. As such, this relief is essential to FINRA's
ability to fulfill its statutory obligations and allows hearing
participants to avoid the COVID-19-related health and safety risks
associated with in-person hearings.
    Among other things, this relief will allow OHO to conduct temporary
cease and desist proceedings by video conference so that FINRA can take
immediate action to stop ongoing customer harm and will allow the NAC
to timely provide members, disqualified individuals and other
applicants an approval or denial of their applications. As set forth in
detail in the original filings, this temporary relief allowing OHO and
NAC hearings to proceed by video conference accounts for fair process
considerations and will continue to provide fair process while avoiding
the COVID-19-related public health risks for hearing participants.
Accordingly, the proposed rule change extending this temporary relief
is in the public interest and consistent with the Act's purpose.

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

    FINRA does not believe that the temporary proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As set forth in
SR-FINRA-2020-027 and, with respect to FINRA Rule 9341(d), in SR-FINRA-
2020-015, the proposed rule change is intended solely to extend
temporary relief necessitated by the continued presence of COVID-19 and
the related health and safety risks of conducting in-person activities.
FINRA believes that the proposed rule change will prevent unnecessary
impediments to FINRA's critical adjudicatory processes and its ability
to fulfill its statutory obligations to protect investors and maintain
fair and orderly markets that would otherwise result if the temporary
amendments were to expire on October 31, 2022.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change 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, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \21\ and Rule 19b-
4(f)(6) thereunder.\22\
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(A).
    \22\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
pursuant to Rule 19b-4(f)(6)(iii), the Commission may designate a
shorter time if such action is consistent with the protection of
investors and the public interest. As FINRA requested in connection
with SR-FINRA-2020-015 and related extensions,\23\ FINRA has also asked
the

Commission to waive the 30-day operative delay so that this proposed
rule change may become operative immediately upon filing.
---------------------------------------------------------------------------

    \23\ See SR-FINRA-2020-015, 85 FR 31836. Although FINRA did not
request that the Commission waive the 30-day operative delay for SR-
FINRA-2020-027, FINRA did request that the Commission waive the 30-
day operative delay for SR-FINRA-2020-042, SR-FINRA-2021-006, SR-
FINRA-2021-019, SR-FINRA-2021-031, SR-FINRA-2022-004, and SR-FINRA-
2022-018 which extended the expiration date of the temporary
amendments originally set forth in SR-FINRA-2020-027.
---------------------------------------------------------------------------

    FINRA has indicated that extending the relief provided originally
in SR-FINRA-2020-015 and SR-FINRA-2020-027 will continue to provide
FINRA the ability to safely conduct hearings in connection with its
core functions during the COVID-19 outbreak. Importantly, extending the
relief provided in these prior rule changes immediately upon filing and
without a 30-day operative delay will allow FINRA to continue critical
adjudicatory and review processes in a reasonable and fair manner and
meet its critical investor protection goals, while also following best
practices with respect to the health and safety of its employees.\24\
The Commission also notes that this proposal, like SR-FINRA-2020-015
and SR-FINRA-2020-027, provides only temporary relief during the period
in which FINRA's operations are impacted by COVID-19. As proposed, the
changes would be in place through January 31, 2023.\25\ FINRA also
noted in both SR-FINRA-2020-015 and SR-FINRA-2020-027 that the amended
rules will revert back to their original state at the conclusion of the
temporary relief period and, if applicable, any extension thereof.\26\
For these reasons, the Commission believes that waiver of the 30-day
operative delay for this proposal is consistent with the protection of
investors and the public interest. Accordingly, the Commission hereby
waives the 30-day operative delay and designates the proposal operative
upon filing.\27\
---------------------------------------------------------------------------

    \24\ See supra Item II.A.1; see also SR-FINRA-2020-015, 85 FR
31833.
    \25\ As noted above, see supra note 4, FINRA stated that if it
requires temporary relief from the rule requirements identified in
this proposal beyond January 31, 2023, it may submit a separate rule
filing to extend the effectiveness of the temporary relief under
these rules.
    \26\ See SR-FINRA-2020-015, 85 FR 31833; see also SR-FINRA-2020-
027, 85 FR 55712.
    \27\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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 shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-FINRA-2022-029 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-FINRA-2022-029. 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 such filing also will be available for inspection
and copying at the principal office of FINRA. 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-FINRA-2022-029 and should be submitted
on or before November 15, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-23085 Filed 10-24-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Page 20049]
[FR Doc No: 2016-07916]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twenty-Sixth Meeting: RTCA Special Committee (216) Aeronautical
Systems Security

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

ACTION: Notice of Twenty-Sixth RTCA Special Committee 216 Meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
Twenty-Sixth RTCA Special Committee 216 meeting.

DATES: The meeting will be held May 3-5, 2016 from 9:00 a.m.-5:00 p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1150 18th Street
NW., Suite 910, Washington, DC 20036, Tel:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or
Karan Hofmann, Program Director, RTCA, Inc<EMAIL_ADDRESS>(202)
330-0680.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of RTCA Special Committee 216. The agenda
will include the following:

Tuesday, May 3, 2016 (9:00 a.m.-5:00 p.m.)

1. Welcome and Administrative Remarks
2. Introductions
3. Agenda Review
4. Meeting-Minutes Review
5. Reminder RTCA Overview Presentation
6. SC-216 New Scope and Terms of Reference review
7. Overview of WG-72
8. Overview of DO-356, Airworthiness Security Methods and
Considerations
9. SC-216 Structure and Organization of Work
10. Proposed Schedule
11. Date, Place and Time of Next Meeting
12. New Business
13. Adjourn Plenary

Wednesday, May 4, 2016 (9:00 a.m.-5:00 p.m.)

1. Continuation of Plenary or Working Group Sessions

Thursday, May 5, 2016 (9:00 a.m.-12:00 p.m.)

1. Continuation of Plenary or Working Group Sessions

Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Plenary information will be
provided upon request. Persons who wish to present statements or obtain
information should contact the person listed in the FOR FURTHER
INFORMATION CONTACT section. Members of the public may present a
written statement to the committee at any time.

    Issued in Washington, DC, on April 1, 2016.
Latasha Robinson,
Management & Program Analyst, NextGen, Enterprise Support Services
Division, Federal Aviation Administration.
[FR Doc. 2016-07916 Filed 4-5-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Page 16354]
[FR Doc No: 2014-06517]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3368-EM; Docket ID FEMA-2014-0003]

Georgia; Amendment No. 3 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the State of Georgia (FEMA-3368-EM), dated February 11, 2014, and
related determinations.

DATES: Effective Date: February 14, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective February 14, 2014.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-06517 Filed 3-24-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20146-20148]
[FR Doc No: 2019-09406]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1344]

Policy Clarification for Certain Fluoroscopic Equipment
Requirements; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Policy Clarification
for Certain Fluoroscopic Equipment Requirements.'' This guidance
document intends to clarify FDA's interpretation of certain aspects of
the performance standard requirements in FDA's regulations for
fluoroscopic equipment.

DATES: The announcement of the guidance is published in the Federal
Register on May 8, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2014-D-1344 for ``Policy Clarification for Certain Fluoroscopic
Equipment Requirements.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Policy Clarification for Certain Fluoroscopic Equipment
Requirements'' to the Office of Policy, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Donald Miller, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4318, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document intends to clarify FDA's interpretation of
certain aspects of the performance standard requirements in Sec. Sec.
1020.30 and 1020.32 (21 CFR 1020.30 and 1020.32) for fluoroscopic
equipment. Specifically, it clarifies FDA's interpretation of
fluoroscopic irradiation time (Sec.  1020.30(b)), the permissible
duration of the activation of the x-ray tube in the fluoroscopic mode
(Sec.  1020.32(c)), and on inclusion of an emergency fluoroscopy mode
in fluoroscopes.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of September 25, 2014 (79 FR 57559).
FDA revised the guidance as appropriate in response to the comments.

II. Significance of Guidance

    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 ``Policy Clarification for Certain
Fluoroscopic Equipment Requirements.'' 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. This guidance is not subject to Executive
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Policy Clarification
for Certain Fluoroscopic Equipment Requirements'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document 1806 to identify the guidance you
are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. 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
the following FDA regulations have been approved by OMB as listed in
the following table:

------------------------------------------------------------------------
                                                            OMB control
          21 CFR part                     Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
1020...........................  Reporting and                 0910-0025
                                  Recordkeeping for
                                  Electronic Products--
                                  General Requirements.
------------------------------------------------------------------------

    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09406 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 112 (Friday, June 10, 2022)]
[Notices]
[Page 35539]
[FR Doc No: 2022-12544]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4784-106]

Topsham Hydro Partners Limited Partnership (L.P.); Notice of
Availability of Draft Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed the application for license for the Pejepscot Hydroelectric
Project, located on the Androscoggin River in Sagadahoc, Cumberland,
and Androscoggin Counties in the village of Pejepscot and the town of
Topsham, Maine and has prepared a Draft Environmental Assessment (DEA)
for the project. No federal land is occupied by project works or
located within the project boundary.
    The DEA contains staff's analysis of the potential environmental
impacts of the project and concludes that licensing the project, with
appropriate environmental protective measures, would not constitute a
major federal action that would significantly affect the quality of the
human environment.
    The Commission provides all interested persons with an opportunity
to view and/or print the EA via the internet through the Commission's
Home Page (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. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact FERC Online Support at FERCOnlineSupport
@ferc.gov, or toll-free at<PHONE_NUMBER>, or for TTY,<PHONE_NUMBER>.
    You may also register online at https://ferconline.ferc.gov/eSubscription.aspx to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Any comments should be filed within 30 days from the date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/QuickComment .aspx. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support. In lieu
of electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
The first page of any filing should include docket number P-4784-106.
    Any questions regarding this notice may be directed to Ryan Hansen
at<PHONE_NUMBER> or [email protected].

    Dated: June 6, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-12544 Filed 6-9-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Page 33468]
[FR Doc No: 2021-13359]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Commercial Space Transportation Advisory Committee--Charter
Renewal

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

ACTION: Announcement of renewal of the Commercial Space Transportation
Advisory Committee (COMSTAC) charter.

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SUMMARY: FAA announces the renewal of the COMSTAC charter, a Federal
Advisory Committee that provides information, advice, and
recommendations to DOT and the FAA on the critical matters facing the
U.S. commercial space transportation industry. This renewal will take
effect the day of publication of this announcement, and will expire
after 2 years.

FOR FURTHER INFORMATION CONTACT: James A. Hatt, COMSTAC Designated
Federal Officer, FAA, Commercial Space Transportation, 800 Independence
Avenue SW, Rm. 331, Washington, DC 20591, telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FAA is giving notice of the
renewal of the COMSTAC charter. The primary goals of COMSTAC are to:
Evaluate economic, technological, and institutional developments
relating to the U.S. commercial space transportation industry; provide
a forum for the discussion of issues involving the relationship between
industry activities and government requirements; in order to provide
advice and recommendations to the Secretary on issues and approaches
for Federal policies and programs regarding the industry. COMSTAC
membership consists of senior executives from the commercial space
transportation industry; representatives from the satellite industry,
both manufacturers and users; state and local government officials;
representatives from firms providing insurance, financial investment
and legal services for commercial space activities; and representatives
from academia, space advocacy organizations, and industry associations.
Complete information regarding COMSTAC is available on the FAA website
at: http://www.faa.gov/about/office_org/headquarters_offices/ast/advisory_committee/.

    Signed in Washington, DC, on June 11, 2021.
Peter Paul Montgomery Buttigieg,
Secretary of Transportation.
[FR Doc. 2021-13359 Filed 6-23-21; 8:45 am]
BILLING CODE 4910-13-P