[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Rules and Regulations]
[Page 40736-40741]
[DOCID:fr14jy10-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0561;FRL-8833-8]

Acetic Acid; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the existing tolerance exemption for
acetic acid by establishing an exemption from the requirement of a
tolerance for residues of acetic acid, also known as vinegar in or on
all food crops resulting from unintentional spray and drift to non-
target vegetation including non-food, food and feed crops when used as
a non-selective contact herbicide spray. SummerSet Products c/o SciReg,
Inc. submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of acetic acid, also known as vinegar.

DATES: This regulation is effective July 14, 2010. Objections and
requests for hearings must be received on or before September 13, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0561. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Cheryl Greene, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a(g), any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2010-0561 in the subject line on the first page of
your submission. All objections and requests for a hearing must be in
writing, and must be received by the Hearing Clerk on or before
September 13, 2010. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2010-0561, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

     In the Federal Register of November 19, 2008, (FR 69635) (FRL-
8389-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F7319) by SummerSet Products c/o SciReg, Inc., 130
Columbia Court, Chaska, MN 55318. The petition requested that 40 CFR
part 180 be amended by establishing an exemption from the requirement
of a tolerance for residues of acetic acid. This notice referenced a
summary of the petition prepared by the petitioner SummerSet Products,
which is available in the docket, http://www.regulations.gov. One
anonymous comment was received on the notice of filing. However, EPA
was unable to address the comment because it was not specific to this
action, focusing instead on the registration of pesticides generally,
and therefore was not a significant comment.

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' Additionally, section 408(b)(2)(D) of FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues and other substances that
have a common mechanism of toxicity's.
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    Acetic acid is a substance found or produced naturally in most
plants and animals, including primates and humans. It is also naturally
produced during the fermentation process in a wide range of foods. In
plants and animals, it is generally produced biologically by bacteria
from the genus Acetobacter. Acetic acid has a fundamental role in
cellular metabolism, particularly in the tricarboxylic acid cycle, also
known as the citric acid (Ref. 1.) or krebs cycle (Ref. 2.), which is
the chemical activity in all cells that utilize oxygen as part of their
respiration process. The krebs cycle is carried out in the mitochondria
of the cells of plants and animals including humans. Acetic acid plays
a key role in the production of carbon dioxide and is a chemical rich
in adenosine triphosphate (ATP). Acetic acid occurs naturally in many
commonly consumed food items such as coffee, chick peas, edible plants,
brown sugar, fruits, and vegetables where it forms during post-harvest
fermentation. As an organic chemical, acetic acid is readily
metabolized by the tissues of the body and is used in plants and
animals to synthesize proteins, carbohydrates and fatty acids. In
animals, including humans, acetic acid is produced naturally as
consumed sugars and alcohol containing foods or liquids such as
alcoholic beverage undergo fermentation.
    Acetic acid has been used as a food additive in most cultures
throughout recorded history. Historical reports suggest that the first
dietary consumption of acetic acid was in wine, beer and similar brewed
beverages and fermented food items such as sauerkraut. Acetic acid also
has a long history of use as a food additive. Acetic acid is a
component of white distilled vinegar at 4%. In the form of vinegar, it
is historically consumed in a wide range of commonly used condiments
such as food seasonings, pickled food items, dried, preserved, canned
and processed fruits and vegetables. It is also added to or found
naturally in many dairy based foods including yogurt, chocolate milk
and eggnog. It is included as an additive in many contemporary common
foods including breakfast cereals, processed meats, prepared table top
sweeteners, sports and energy drinks (CODEX GSFA, 2009) (Ref. 3.) and
is used in pharmaceutical products such as antibiotics, antibacterials
and antimicrobials. Acetic acid is also the main acid in vinegars, and
it is the acid in vinegar that gives vinegar its characteristic odor.
In commonly consumed vinegars such as white (distilled), cider,
balsamic, malt, red wine, white wine, rice and sherry the percentage of
acetic acid generally ranges between 3% and 8%. The Food and Drug
Administration (FDA) classifies acetic acid as ``Generally Recognized
as Safe (GRAS)'' under 21 CFR 184.1005 as a direct food substance and
under 21 CFR 582.1005 as a general purpose food additive.
    As a pesticide, acetic acid is registered for use as a non-
selective contact herbicide for combating a wide range of weeds and
some grasses. Upon contact with targeted weed and weed grasses, acetic
acid destroys or damages the cell membrane of the plants which causes
rapid dehydration of the plant tissues. This process is called
``burnout'' or ``burndown'' and can result in the death of the targeted
plant or injury sufficient to slow the growth and reproduction of the
targeted plant.
    In a final rule dated August 3, 2005, (70 FR 44483) (FRL-7717-2),
EPA established an exemption from the requirement of a tolerance for
residues of acetic acid when used as an active ingredient as a
preservative on post-harvest agricultural commodities intended for
animal feed, including alfalfa, barley grain, bermuda grass; bluegrass,
brome grass, clover, corn grain, cowpea hay, fescue, lespedeza,
lupines, oat grain, orchard grass, peanut grass, Timothy, vetch, and
wheat grain, or commodities described as grain or hay. Acetic acid is
also approved for use on growing crops or raw agricultural commodities
after harvest as an inert ingredient in pesticide products under 40 CFR
180.1258.
    In support of the request to amend the existing exemption from the
requirement of a tolerance, the Agency has reviewed all information
submitted in support of this action. This petition is supported by
information from open scientific literature and cited studies which are
discussed in detail in this unit. When used as an indirect spray to
control weeds and weed grasses according to the required label
instructions, significant dietary residues of acetic acid are unlikely
because direct exposure to food plants would be accidental or due to
spray drift. Additionally, acetic acid rapidly biodegrades in the
environment; it is non-toxic at pesticidal use concentrations; it is
readily metabolized in the body; it is ubiquitous in food and the
environment. Moreover, pesticidal uses of acetic acid are not expected
to contribute significantly to the overall exposure of the general
population, and information from the open literature indicates that
acetic acid has little or no toxicity from an acute oral perspective
(toxicity category III; median lethal dose (LD50 3,310
milligrams/kilogram (mg/kg). (Ref. 4.)

A. Acute Toxicity

    Acute toxicity information submitted to support the exemption from
the requirement of a tolerance for acetic

acid confirms a low toxicity profile and reflects the Agency's findings
that acetic acid poses no significant human health risk with regard to
food commodities. As a biochemical pesticide, products containing
acetic acid would be used to control herbaceous broadleaf weeds and
weed grasses that may damage or otherwise compromise the production of
food crops. Products containing acetic acid are not intended for direct
use on food crops. Moreover, any food crops exposed to acetic acid when
used as a biochemical pesticide would be destroyed or significantly
damaged. Such exposure would most likely be accidental or from spray
drift and would render the plant unsuitable or less suitable for
marketing. The low toxicological profile of acetic acid when used as an
herbicide provides additional justification for this exemption from the
requirement of a tolerance. Further, published literature (discussed in
this unit) concerning low toxicity and the extensive history of acetic
acid used in foods supports this exemption from the requirement of a
tolerance.
    The primary routes of exposure to the general population have been
determined to be through consumption of food and inhalation of air in
workplaces. (Ref. 5.)
    1. Acute oral toxicity. The acute oral median LD50 for
acetic acid in rats was greater than 3,310 mg/kg in rats and 4,960 mg/
kg in mice, which confirmed negligible toxicity through oral exposure.
(Ref. 6.) The lowest observed adverse effect level (LOAEL) was
determined to be 390 mg/kg and the no observed adverse effect level
(NOAEL) was determined to be 195 mg/kg (Ref. 7.) Acedic acid is a
toxicity category III for acute oral toxicity.
    2. Acute dermal toxicity.The acute dermal LD50 for
acetic acid in rats was 1,060 mg/kg, (MRID 47330503) which confirmed
moderate dermal toxicity, (MRID 47330503) the requirement of sub-acute
toxicity data was waived because the use pattern and personal
protection equipment (PPE) requirements of products containing acetic
acid mitigate any risk from dermal exposure. Specifically, acetic acid
as a biopesticide is only intended for use in spray products formulated
for use as contact herbicides on broadleaf weeds and grasses; the
Agency requires appropriate signal word (DANGER) and corresponding
precautionary language on all labels containing acetic acid as a
biochemical pesticide; and the Agency requires all applicators and
handlers of such products to wear PPE that includes protective eyewear,
long-sleeved shirt, long pants, socks and shoes. Given these
considerations, the Agency believes that repeated dermal and inhalation
exposure is not expected to occur. Acetic acid is a toxicity category
II for acute dermal toxicity.
    3. Acute inhalation toxicity. The acute inhalation median
LC50 was greater than 11.4 milligrams per liter (mg/L) in
rats and showed little to no inhalation toxicity or irritation (MRID
47330503). Acetic acid is toxicity category IV for acute inhalation
toxicity.
    4. Primary eye irritation. A primary eye study showed significant
potential for eye irritation. Eye corneal damage can occur from
exposure to acetic acid and clarity of vision is not reversed within
seven days (MRID 47330503). As such, the Agency has determined that
acetic acid is Toxicity Category I for acute eye irritation. (PPE
requirements of products containing acetic acid will mitigate any risk
associated with the products).
    5. Acute dermal/skin sensitization. An acute dermal irritation/skin
sensitization study showed that acetic acid is corrosive at very high
(60%) concentrations (MRIDs 47330503) and (47330504). However, due to
the use pattern and PPE requirements of biopesticidal products
containing acetic acid (see Unit III.A.2., in this unit, regarding the
use pattern and PPE requirements), and a required default restricted-
entry interval (REI) of 48 hours following application of products
containing acetic acid, exposure risks associated with products
containing acetic acid will be mitigated. Acetic acid is a Toxicity
category I for acute dermal irritation/skin sensitization.

B. Subchronic Toxicity

    Based on its acute toxicity profile, use pattern and biodegradation
properties, residues of acetic acid are not expected to result in
significant dietary exposure beyond the levels expected in background
dietary exposures. Nonetheless, a subchronic oral, dermal and
inhalation toxicity study satisfied the data requirements for
subchronic toxicity and indicated that acetic acid has no subchronic
toxicological effect.
    1. 90-day oral toxicity. A 90-day oral toxicity study (Ref. 8.)
found no toxicological effects regarding mortality, clinical
observations, neurotoxicity assessment, hematology, clinical chemistry,
organ weights, and macroscopic or microscopic observations. Weight loss
was observed in test subjects administered up to 390 mg/kg body weight
(bw/day) acetic acid in drinking water for 2-4 months. The reduction in
weight gain is likely attributed to reduced appetite and food
consumption observed in the study. No other effects were reported. The
LOAEL was determined to be 390 mg/kg bw/day, and the NOAEL was
determined to be 195 mg/kg bw/day.
    2. 90-day dermal toxicity. Requirement of a 90-day dermal toxicity
study has been waived. Considering the use pattern and PPE requirements
of pesticide products containing acetic acid (see Unit III.A.2., in
this unit, regarding the use pattern and PPE requirements), repeated
dermal and inhalation exposure is not expected to occur. Additionally,
the Agency does not expect significant dermal exposure since uses of
acetic acid as a contact biopesticide will not involve purposeful
application to the skin, nor will it result in prolonged dermal
exposure to the product when label directions are followed. Moreover,
acute toxicity testing of the two proposed end-use products in which
acetic acid will be used as an herbicide have indicated that the
products are non-irritating to slightly-irritating to the skin.
Applicators are required to wear protective eye-wear, long-sleeved
shirts, long pants, socks and shoes. Additionally, a REI of 48 hours
has been added to these labels.
    3. 90-day inhalation toxicity. Requirements for a 90-day inhalation
toxicity study have also been waived. Herbicide products containing
acetic acid are liquids and it is therefore, unlikely that significant
levels of repeated inhalation will occur from the use of these
products. Based on the results of toxicity testing cited above,
proposed herbicide products containing acetic acid are placed into
Toxicity Category IV for acute inhalation toxicity and to further
mitigate exposure, a REI of 48 hours has been added to these labels.

C. Developmental Toxicity

    Developmental toxicity data submitted to the Agency demonstrate a
clear lack of developmental toxicity for acetic acid and supports the
Agency's conclusion that there is no risk of developmental toxicity
associated with new food uses for acetic acid.
    A prenatal developmental toxicity study (MRID 47330503) found no
significant treatment-related reproductive effects. The study showed
abnormalities of soft or skeletal tissue of the test group, but the
abnormalities did not differ from those found in the control group. The
study established a LOAEL of 1,600 mg/kg bw/day. The NOAEL is equal to
1,600 mg/kg bw/day. A second prenatal developmental toxicity study
(MRID 47330503) also, found no significant treatment related to
reproductive effects or fetal abnormalities. Based on this

information, the Agency believes that there is no risk of developmental
toxicity associated with new food uses for acetic acid.

D. Mutagenicity

    A mutagenicity study using acetic acid as the test substance was
conducted. The reverse mutation assays performed (MRID 47330503) were
negative for mutagenicity to bacteria exposed to concentrations of
acetic acid from 0 micrograms per plate to 10,000 micrograms per plate
with and without metabolic activation. In the in-vitro Chinese hamster
tests (MRID 47330503), results were also negative for mutagenicity.
Results showed that acetic acid is not mutagenic at levels less than or
equal to 16 micromoles. The Agency has determined that these data are
sufficient to confirm that there are no expected dietary or non-
occupational risks of mutagenicity with regard to new food uses of
acetic acid.

E. Endocrine Effects

    There is no available evidence demonstrating that acetic acid is an
endocrine disruptor in humans. As a result, the Agency is not requiring
information on the endocrine effects of acetic acid at this time.
However, the Endocrine Disruption Screening Program (EDSP) has
established a protocol, which guides the Agency in selecting suspect
ingredients for review, and the Agency reserves the right to require
new information should the program require it. Presently, based on the
lack of exposure and the negligible toxicity profile of acetic acid, no
adverse effects to the endocrine system are known or expected. Overall,
the lack of evidence of endocrine disruption is consistent with the low
toxicity profile of acetic acid and supports this exemption from the
requirement of a tolerance.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses). The Agency has determined that
there is reasonable certainty that no harm to the U.S. population will
result from aggregate exposure to residues of acetic acid. This
includes all exposures for which there is reliable information. The
Agency arrived at this conclusion based on the low level of toxicity of
the chemical, low anticipated dietary and non-dietary exposures, worker
protection requirements on the label (PPE and REI requirements) and the
already widespread exposure without any reported adverse effects on
human health. The risks from aggregate exposure via oral, dermal and
inhalation exposure are negligible.

A. Dietary Exposure

    The use of acetic acid as a pesticide is not intended as a direct
spray to food commodities and will not be directly applied to food
commodities intended for human consumption. Therefore, the Agency
anticipates negligible to no residues present at the time of
consumption.
    1. Food. The Agency expects that food commodities will only be
exposed to acetic acid by accidental application or spray drift. The
Agency believes that any unintentional application or drift of products
containing acetic acid would kill or substantially damage food crops,
making them undesirable for human consumption. However, even in the
event of indirect spray to food crops, the Agency is not concerned with
potential residues due to low toxicity of acetic acid and the fact that
acetic acid is a weak acid that rapidly degrades into a base composed
of an acetate ion and hydrogen. Finally, the Agency believes that
because acetic acid biodegrades rapidly under both anaerobic and
aerobic conditions in the environment, residues of toxicological
concern are not expected.
    2. Drinking water exposure. Pesticide products containing acetic
acid are not applied directly to water; applications are made directly
to terrestrial non food crops, and as such, drinking water exposure of
humans to acetic acid from pesticidal use is unlikely. Moreover, the
Agency believes that any potential exposure to surface water would be
negligible because of the low application rates and rapid
biodegradation of acetic acid. Therefore, drinking water exposure is
not expected to pose any quantifiable risk due to a lack of residues of
toxicological concern.

B. Other Non-Occupational Exposure--Non-Dietary Exposure-Dermal and
Inhalation Exposure

    The potential for non-dietary exposure of the general population,
including infants and children, is limited based on the use patterns of
acetic acid (see Unit III.A.2., in this unit, regarding the use pattern
and PPE requirements) and REI requirements (48 hours) on product
labels, and the lack of anticipated residues of toxicological concern.
Non-dietary exposures would not be expected to pose any quantifiable
risk to the general population.
    1. Dermal exposure. Non-occupational dermal exposures to acetic
acid when used as an indirect non-selective herbicide are expected to
be negligible based on the use patterns of acetic acid (see Unit
III.A.2., in this unit, regarding the use patterns).
    2. Inhalation exposure. Non occupational exposures to acetic acid
when used as a selective herbicide are expected to be negligible
because acetic acid products are limited to targeted weeds and grasses
in proximity to food crops.

V. Cumulative Effects from Substances with a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found acetic acid to share a common mechanism of
toxicity with any other substances, and acetic acid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
acetic acid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    The Agency has considered acetic acid in light of the relevant
safety factors in FQPA and FIFRA. A determination has been made that no
unreasonable adverse effects to the U.S. population in general, and to
infants and children in particular, will result from the use of acetic
acid when label instructions are followed.

A. U.S. Population

    A determination has been made that no unreasonable adverse effects
to the U.S. population in general will result from the use of acetic
acid when used as an indirect spray to control weeds and weed grasses
when label instructions are followed. This conclusion is based on the
unlikelihood of significant dietary residues of acetic acid because
direct exposure to food

plants would be accidental or due to spray drift. Additionally, acetic
acid rapidly biodegrades in the environment; it is non-toxic at
pesticidal use concentrations; it is readily metabolized in the body;
and, it is ubiquitous in food and the environment. Moreover, pesticidal
uses of acetic acid are not expected to contribute significantly to the
overall exposure of the general population, and information from the
open literature indicates that acetic acid has little or no toxicity
from an acute oral perspective (toxicity category III; median
LD50 3,310 mg/kg).
    The Agency is reasonably certain that there will be no harm to
residential and/or commercial workers and applicators using herbicide
products containing acetic acid based on the low application rates of
end-use products, the low toxicity of acetic acid, and the rapid
biodegradation of acetic acid in the environment. Precautionary
labeling language, personal protective equipment and a 48 hour rentry
interval for contact herbicides containing acetic acid adds an
additional level of assurance of no harm to residential and commercial
workers using such pesticide products.

B. Infants and Children

    In examining exposures to sensitive subpopulations, FFDCA section
408 directs EPA to apply an additional tenfold margin of exposure (MOE)
(safety) for infants and children in the case of threshold effects to
account for pre- and post-natal toxicity and the completeness of the
database, unless EPA determines that a different MOE will be protective
for infants and children. MOE are often referred to as uncertainty or
safety factors. For the proposed pesticidal uses, based on all the
available information, the Agency concludes that acetic acid is
practically non-toxic (with the exception of severe eye irritation) to
mammals, including infants and children. Acetic acid is found in many
foods already consumed by infants and children, and there is no
information available indicating an appreciable difference in risk
between adults and infants and children from exposure to acetic acid
when used as a contact herbicide. As a result, EPA has not used a MOE
approach to assess the safety of acetic acid. When used as proposed,
EPA expects that the contact herbicides containing acetic acid as an
active ingredient would not result in residue levels that are of
toxicological concern. Thus, there are no threshold effects of concern.
As such, an additional margin of safety is not necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

     In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with internal standards whenever possible, consistent with
U.S. food safety standards and agricultural practices. EPA considers
the international maximum residue limits (MRLs) established by the
Codex Alimentarius Commission (Codes), as required by FFDCA section
408(b)(4). The Codex is a joint U.N. Food and Agriculture Organization/
World Health Organization food standards program, and it is recognized
as an international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain the reasons for departing from the
Codex Level. The Codex has not established a MRL for acetic acid.

VIII. Conclusions

     The Agency concludes that there is a reasonable certainty that no
harm will result to the U.S. population, including infants and
children, from aggregate exposure to residues of acetic acid when used
as an herbicide to control broadleaf weeds and grasses. Therefore, an
exemption is established for residues of the biochemical acetic acid
when used as a non selective, indirect contact herbicide spray for
broadleaf weeds and weed grasses on all food crops.

IX. References

    1. MRIDs 47350604 through 47350609).
    2. MRIDs 47330501, 47330505, 47330510-47330512 and 47775901).
    3. ``Acetic Acid''. Codex General Standards for Food Additives
Online Database. 2010. GSFA Online. January 13, 2010  http://
www.codexalimentarius.net/gsfaonline/additives/details.html?id=170.
    4. MRIDs 47350601 through 47350603 and 47776001.
     5. ``Acetic Acid''. Hazardous Substances Data Base. 2010. National
Library of Medicine January 13, 2010 http://www.toxnet.nlm.nih.gov/
cgibin/sis/search/f?./temp/~SWRBRt:1.
    6. MRIDs 47330503, 47330504, 47330507, 47330508 and 47330513-
47330518).
    7. Joint FAO/WHO Expert Committee on Food Additives.
``Toxicological Evaluation of Some Microbials, Antioxidants,
Emulsifiers, Stabilizers, Flour-Treatment Agents, Acids and Bases.''
1967. WHO/Food Add. January 13, 2010 http://www.inchem.org/documents/
jecfa/jecmono/40abcj37.htm.
    8. EPA Memorandum R.S. Jones to D. Benmhend. ``Science Review in
Support of the Registration of Eastman Acetic Acid[reg] P Grain and Hay
Preservative. . . .''. April 12, 2004.

 X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of

power and responsibilities among the various levels of government or
between the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 30, 2010.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In subpart D, revise Sec. 180.1258 to read as follows:

Sec.  180.1258  Acetic acid; exemption from the requirement of a
tolerance.

    (a) An exemption from the requirement of a tolerance is established
for residues of the biochemical pesticide acetic acid when used as a
preservative on post-harvest agricultural commodities intended for
animal feed, including Alfalfa, seed; alfalfa, hay; barley, grain;
bermudagrass, hay; bluegrass, hay; bromegrass, hay; clover, hay; corn,
field, grain; corn, pop, grain; cowpea, hay; fescue, hay; lespedeza,
hay; lupin; oat, grain; orchardgrass, hay; peanut, hay; timothy, hay;
vetch, hay; and wheat, grain, or commodities described as grain or hay.
    (b) An exemption from the requirement of a tolerance is established
for residues of acetic acid in or on all food crops resulting from
unintentional spray and drift to non-target vegetation including non-
food, food and feed crops when used as a non-selective contact
herbicide spray.
[FR Doc. 2010-17163 Filed 7-13-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 84 (Tuesday, May 1, 2012)]
[Rules and Regulations]
[Pages 25610-25611]
[FR Doc No: 2012-10487]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Chapter II

[Docket No. FRA-2009-0057, Notice No. 3]

Statement of Agency Policy and Interpretation on the Hours of
Service Laws as Amended; Delay of Effective Date of One Specific
Interpretation

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

ACTION: Statement of agency policy and interpretation; delay of
effective date.

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

SUMMARY: This document delays the effective date of a section of FRA's
statement of agency policy and interpretation on the hours of service
laws that was published in the Federal Register on February 29, 2012,
and that is scheduled to take effect on May 29, 2012. In response to
the document, several issues were brought to FRA's attention with
regard to the feasibility of implementing one of the interpretations by
the May 29, 2012 effective date. In response to those concerns, the
present document delays the effective date of that specific
interpretation until January 1, 2013. However, a railroad may choose to
comply with the interpretation on or after May 29, 2012, and in advance
of its new January 1, 2013, effective date. The effective date of all
other interpretations contained in the February 29, 2012, statement
remains May 29, 2012.

DATES: The effective date for section IV.B.1 of the statement of agency
policy and interpretation published February 29, 2012, at 77 FR 12408,
and originally effective on May 29, 2012, is delayed until January 1,
2013. All other sections of the statement of agency policy and
interpretation published February 29, 2012, remain effective on May 29,
2012.

FOR FURTHER INFORMATION CONTACT: Colleen A. Brennan, Trial Attorney,
Office of Chief Counsel, FRA, 1200 New Jersey Avenue SE., RCC-12, Mail
Stop 10, Washington, DC 20590 (telephone<PHONE_NUMBER> or<PHONE_NUMBER>);
Matthew T. Prince, Trial Attorney, Office of Chief Counsel, FRA, 1200
New Jersey Avenue SE., RCC-12, Mail Stop 10, Washington, DC 20590
(telephone<PHONE_NUMBER> or<PHONE_NUMBER>); or Richard Connor, Operating
Practices Specialist, Operating Practices Division, Office of Safety
Assurance and Compliance, FRA, 1200 New Jersey Avenue SE., RRS-11, Mail
Stop 25, Washington, DC 20590 (telephone<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: On February 29, 2012, FRA published its
statement of agency policy and interpretation on the hours of service
laws as amended (Final Interpretations), responding to public comments
on FRA's earlier interim statement of policy, 74 FR 30665 (June 26,
2009), and clarifying additional questions concerning the hours of
service laws. 77 FR 12408. In the Final Interpretations, FRA construed
the word ``day'' for purposes of the statutory limitation on the number
of consecutive days on which certain employees may initiate an on-duty
period before being required to receive a certain rest period (i.e., 49
U.S.C. 21103(a)(4) (sec. 21103(a)(4)). In the Final Interpretations,
FRA interpreted the word ``day'' for purposes of sec. 21103(a)(4) to
refer to the 24-hour period ending when an employee is finally released
from duty, and any new initiation of an on-duty period at any point
during the 24-hour period following the employee's prior final release
will have been initiated on a day consecutive to the prior duty tour.
This interpretation differed from the interpretation of what
constitutes a ``day'' that was articulated in the interim statement of
policy, which construed a ``day'' for the purposes of section
21103(a)(4) as a calendar day. FRA's interim interpretations went into
effect on July 16, 2009, and they have remained in effect. The Final
Interpretations are scheduled to go into effect on May 29, 2012.
    In response to the Final Interpretations, the Association of
American Railroads (AAR) requested a meeting with FRA. The meeting took
place on April 4, 2012, and included the AAR as well as several
railroads in teleconference. At the meeting, FRA

requested that the AAR put its concerns in writing. FRA received a
letter from the AAR, dated April 9, 2012, requesting that FRA delay the
effective date of the interpretation relating to the meaning of ``day''
in section 21103(a)(4), section IV.B.1 of the Final Interpretations,
until January 1, 2013, and raising other concerns. FRA has posted the
letter to the docket, Docket No. FRA-2009-0057. The letter argues that
it is infeasible for railroads to comply with the interpretation by May
29, 2012, for three reasons:

    First, the change to a 24-hour day requires significant
programming changes for railroad information technology (IT)
systems. These programming changes, which will require significant
testing before they can be implemented, cannot be accomplished by
May 29 or even shortly thereafter. Second, the change to a 24-hour
day will require some railroads to hire additional employees * * *.
Those railroads cannot hire and train employees by May 29. Third,
the railroads need to update their training materials and train all
affected employees on the new interpretation.

    Recognizing that it may not be possible for some railroads to
comply with the new interpretation by May 29, 2012, FRA is issuing this
document, which delays the effective date of section IV.B.1, ``What
constitutes a `Day' for the purpose of sec. 21103(a)(4)?'' until
January 1, 2013. All other sections of the Final Interpretations remain
effective on May 29, 2012.
    In its April 9, 2012, letter, the AAR also requests a transition
period from December 1, 2012 until the requested January 1, 2013,
effective date in order to allow railroads to comply with the new
interpretation of ``day'' for purposes of section 21103(a)(4) in
advance of the effective date, rather than requiring compliance with
the interim interpretation until the effective date of the new
interpretation. To provide flexibility, rather than establish a static
transition date, FRA will allow a railroad to choose to comply with the
new interpretation on any date on or after May 29, 2012, and prior to
January 1, 2013. FRA suggests that railroads choosing to transition to
the new interpretation prior to January 1, 2013, inform the appropriate
FRA regional offices, to reduce confusion and avoid redundant
information requests from FRA inspectors.
    Transition to the new interpretation must be by a railroad in its
entirety, rather than on an employee-by-employee or subdivision-by-
subdivision basis. Were a railroad to try to transition piecemeal,
employees would likely be forced to move frequently between the interim
interpretation and the new interpretation as they moved between
subdivisions of the railroad. The AAR noted the complexity of moving
employees from the interim interpretation to the new interpretation in
the context of a single transition date; allowing multiple transition
dates for a single railroad would exacerbate these concerns.
    FRA requests that Class I railroads provide monthly status reports
to Richard Connor, FRA Operating Practices Specialist, at
<EMAIL_ADDRESS>or at the street address listed above, starting
July 1, 2012 and ending for each railroad after its transition to the
new interpretation, to update FRA on the progress of each railroad
toward resolving technological, training, and hiring issues, and any
other issues that present an obstacle to compliance with the new
interpretation. Such reports will allow FRA to ensure that railroads
are working toward full compliance with the new interpretation no later
than January 1, 2013. If FRA determines that railroads are not
progressing toward implementation of the new interpretation, or if FRA
is unable to gather the information necessary to make such a
determination, FRA may publish an additional notice expediting the
transition period.

    Issued in Washington, DC, on April 25, 2012.
Joseph C. Szabo,
Administrator.
[FR Doc. 2012-10487 Filed 4-30-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Notices]
[Pages 69840-69841]
[FR Doc No: 2016-24340]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0007]

Public Assistance Program Minimum Standards

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of availability.

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

SUMMARY: This document provides notice of the availability of the final
policy Public Assistance Program Minimum Standards. The Federal
Emergency Management Agency (FEMA) published a notice of

availability and request for comment on the proposed policy in the
April 21, 2016 Federal Register (81 FR 23503), and requested public
comments no later than May 23, 2016. The comment period was then
reopened on June 8, 2016 (81 FR 36940) and public comments were
requested no later than July 8, 2016.

DATES: This policy is effective September 30, 2016.

ADDRESSES: The final policy is available online at http://www.regulations.gov and on FEMA's Web site at http://www.fema.gov. The
proposed and final policy, all related Federal Register notices, and
all public comments received during the comment period are available at
http://www.regulations.gov under Docket ID FEMA-2016-0007. Hard copies
of the final policy are available at the Office of Chief Counsel,
Federal Emergency Management Agency, 8NE, 500 C St. SW., Washington, DC
20472.

FOR FURTHER INFORMATION CONTACT: Christopher Logan, Acting Director,
Public Assistance Division, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The purpose of the policy is to establish
minimum standards for Public Assistance projects in order to promote
resiliency and achieve risk reduction under the authority of the
Stafford Act Sec. Sec.  323 and 406(e) (42 U.S.C. 5165a and 5172) and
44 CFR part 206, subpart M. When using Public Assistance funds to
repair, replace, or construct buildings located in hazard-prone areas,
applicants will use, at a minimum, the hazard-resistant design
standards in or referenced in the International Building Code (IBC),
the International Existing Building Code (IEBC), and/or the
International Residential Code (IRC). Costs associated with meeting
these standards are eligible for Public Assistance funding.
    FEMA revised the policy content in response to public comments
received as follows:
     To clarify that FEMA will evaluate more stringent, locally
adopted codes or standards as described in 44 CFR part 206.226(d),
     To clarify that the most recent edition of the IBC, IEBC,
or IRC as of the disaster declaration date will be used as the new
Federal minimum design standard,
     To clarify that the policy only applies to the standards
of the IBC, IEBC, and IRC related to hazard-resistant designs, and
     To provide information regarding how the policy will
interact with floodplain management minimization standards as described
in 44 CFR part 9.11(d) as well as with the calculation for repair
versus replacement described in 44 CFR part 206.226(f).
    The final policy does not have the force or effect of law.

    Authority: 42 U.S.C. 5165a, 5172; 44 CFR 206.226, 206.400.

Matthew Payne,
Director, Policy Division, Office of Policy and Program Analysis,
Federal Emergency Management Agency.
[FR Doc. 2016-24340 Filed 10-6-16; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 10 (Friday, January 14, 2022)]
[Notices]
[Page 2427]
[FR Doc No: 2022-00680]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER12-1400-008; ER11-46-016; ER11-47-013; ER12-1540-
011; ER21-136-002; ER17-1932-005; ER17-1931-005; ER17-1930-005; ER16-
323-010; ER14-868-002; ER14-594-015; ER13-1896-017; ER12-2343-011;
ER12-1544-011; ER12-1542-011; ER12-1541-011.
    Applicants: Kentucky Power Company, Kingsport Power Company,
Wheeling Power Company, AEP Energy, Inc., AEP Generation Resources
Inc., Ohio Power Company, AEP Retail Energy Partners, Ohio Valley
Electric Corporation, Public Service Company of Oklahoma, AEP Texas
Inc., Southwestern Electric Power Company, Flat Ridge 3 Wind Energy,
LLC, Indiana Michigan Power Company, Indiana Michigan Power Company,
Appalachian Power Company, Ohio Power Company, Kingsport Power Company,
Columbus Southern Power Company, Kentucky Power Company, Wheeling Power
Company, AEP ENERGY PARTNERS, INC, Flat Ridge 2 Wind Energy LLC.
    Description: Supplement to June 30, 2021 Triennial Market Power
Analysis for Southwest Power Pool, Inc. Region of AEP Energy Partners,
Inc., et al.
    Filed Date: 1/7/22.
    Accession Number: 20220107-5125.
    Comment Date: 5 p.m. ET 1/28/22.

    Docket Numbers: ER20-1742-003.
    Applicants: San Diego Gas & Electric Company.
    Description: Compliance filing: Order No. 864 Compliance Filing to
be effective 1/27/2020.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5126.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-452-001.
    Applicants: Wheeling Power Company.
    Description: Tariff Amendment: Amend Filing: New Mitchell Plant
Agreements: Ownership; O&M to be effective 3/18/2022.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5140.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-453-001.
    Applicants: Kentucky Power Company.
    Description: Tariff Amendment: Amend Concurrence Filing: New
Mitchell Plant Agreements: Ownership; O&M to be effective 1/19/2022.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5159.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-793-000.
    Applicants: Arlington Solar, LLC.
    Description: Baseline eTariff Filing: Arlington Solar, LLC SFA with
Arlington Solar II and Arlington Solar III to be effective 1/11/2022.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5077.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-794-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: First Revised ISA No. 5859;
Queue No. AD1-081 to be effective 12/10/2021.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5080.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-795-000.
    Applicants: New York Independent System Operator, Inc., Niagara
Mohawk Power Corporation.
    Description: Sec.  205(d) Rate Filing: New York Independent System
Operator, Inc. submits tariff filing per 35.13(a)(2)(iii: Joint 205:
SGIA among NYISO, NMPC, Bakerstand Amended Restated SA2572 to be
effective 12/29/2021.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5086.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-796-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 30 2nd
Amended TFA PacifiCorp to be effective 3/12/2022.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5088.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-797-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Auction Revenue Rights and
Financial Transmission Rights Tariff and OA Revisions to be effective
3/11/2022.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5111.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-798-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: Calpine NITSA Rev 15 to be
effective 1/1/2022.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5139.
    Comment Date: 5 p.m. ET 1/31/22.

    Docket Numbers: ER22-799-000.
    Applicants: Lancaster Area Battery Storage, LLC.
    Description: Baseline eTariff Filing: Lancaster Area Battery
Storage, LLC MBR Tariff to be effective 1/11/2022.
    Filed Date: 1/10/22.
    Accession Number: 20220110-5157.
    Comment Date: 5 p.m. ET 1/31/22.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 10, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-00680 Filed 1-13-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Proposed Rules]
[Pages 32783-32784]
[FR Doc No: 2017-14946]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 80

[EPA-HQ-OAR-2017-0091; FRL-9965-00-OAR]
RIN 2060-AT04

Public Hearing for Standards for 2018 and Biomass-Based Diesel
Volume for 2019 Under the Renewable Fuel Standard Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Announcement of public hearing.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing a
public hearing to be held in Washington, DC on August 1, 2017 for the
proposed rule ``Renewable Fuel Standard Program: Standards for 2018 and
Biomass-Based Diesel Volume for 2019.'' This proposed rule will be
published separately in the Federal Register. The pre-publication
version of this proposal can be found at https://www.epa.gov/renewable-fuel-standard-program/regulations-and-volume-standards-under-renewable-fuel-standard. In the separate notice of proposed rulemaking, EPA has
proposed amendments to the renewable fuel standard program regulations
that would establish annual percentage standards for cellulosic
biofuel, biomass-based diesel, advanced biofuel, and renewable fuels
that would apply to all gasoline and diesel produced in the U.S. or
imported in the year 2018. In addition, the separate proposal includes
a proposed biomass-based diesel applicable volume for 2019.

DATES: The public hearing will be held on August 1, 2017, at the
location noted below under ADDRESSES. The hearing will begin at 9 a.m.
and end when all parties present who wish to speak have had an
opportunity to do so. Parties wishing to testify at the hearing should
notify the contact person listed under FOR FURTHER INFORMATION CONTACT
by July 25, 2017. Additional information regarding the hearing appears
below under SUPPLEMENTARY INFORMATION.

ADDRESSES: The hearing will be held at the following location: Hyatt
Regency Washington on Capitol Hill, 400 New Jersey Avenue NW.,
Washington, DC, USA, 20001 (phone number<PHONE_NUMBER>). A complete set
of documents related to the proposal will be available for public
inspection through the Federal eRulemaking Portal: https://www.regulations.gov, Docket ID No. EPA-HQ-OAR-2017-0091. Documents can
also be viewed at the EPA Docket Center, located at 1301 Constitution
Avenue NW., Room 3334, Washington, DC between 8:30 a.m. and 4:30 p.m.,
Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Julia MacAllister, Office of
Transportation and Air Quality, Assessment and Standards Division,
Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI
48105; telephone number:<PHONE_NUMBER>; Fax number:<PHONE_NUMBER>;
Email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The proposal for which EPA is holding the
public hearing will be published separately in the Federal Register.
The pre-publication version can be found at https://www.epa.gov/renewable-fuel-standard-program/regulations-and-volume-standards-under-renewable-fuel-standard.
    Public Hearing: The public hearing will provide interested parties
the opportunity to present data, views, or arguments concerning the
proposal (which can be found at https://www.epa.gov/renewable-fuel-standard-program/regulations-and-volume-standards-under-renewable-fuel-standard). The EPA may ask clarifying questions during the oral
presentations but will not respond to the presentations at that time.
Written statements and supporting information submitted during the
comment period will be considered with the same weight as any oral
comments and supporting information presented at the public hearing.
Written comments must be received by the last day of the comment
period, as specified in the notice of proposed rulemaking.

How can I get copies of this document, the proposed rule, and other
related information?

    The EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2017-0091. The EPA has also

developed a Web site for the Renewable Fuel Standard (RFS) program,
including the notice of proposed rulemaking, at the address given
above. Please refer to the notice of proposed rulemaking for detailed
information on accessing information related to the proposal.

    Dated: July 10, 2017.
Christopher Grundler,
Director, Office of Transportation and Air Quality, Office of Air and
Radiation.
[FR Doc. 2017-14946 Filed 7-17-17; 8:45 am]
 BILLING CODE 6560-50-M


P-19-0064 Sanitized Support Documents Index:
 P-19-0064 Sanitized Determination Document (linked)
 P-19-0064 Sanitized CHEM Report (attached)
 P-19-0064 Sanitized ECO Report (attached)
 P-19-0064 Sanitized ENG Report (attached)
 P-19-0064 Sanitized EXP Report (attached)
 P-19-0064 Sanitized Fate Report (attached)
 P-19-0064 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61003-61006]
[FR Doc No: 2017-27712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2294]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Evaluation of the
Food and Drug Administration's `Fresh Empire' Multicultural Youth
Tobacco Prevention Campaign

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on an extension of the time period for the
outcome evaluation of FDA's multicultural youth tobacco public
education campaign, the addition of two rounds of data collection with
the original youth surveyed for the outcome evaluation, and recruitment
of new youth to participate in those two additional surveys.

DATES: Submit either electronic or written comments on the collection
of information by February 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-N-2294 for ``Evaluation of the Food and Drug Administration's
`Fresh Empire' Multicultural Youth Tobacco Prevention Campaign''
Received comments, those filed in a timely manner (see ADDRESSES), 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.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Evaluation of the Food and Drug Administration's `Fresh Empire'
Multicultural Youth Tobacco Prevention Campaign (OMB Control Number
0910-0788--Extension)

    The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
public health and to reduce tobacco use by minors. Section
1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the
development and implementation of FDA public education campaigns
related to tobacco use. Accordingly, FDA is currently developing and
implementing a youth-targeted public education campaign (`Fresh
Empire') to help prevent tobacco use among multicultural youth and
thereby reduce the public health burden of tobacco. The campaign
features events, advertisements on television and radio and in print,
digital communications including social media, and other forms of
media.
    Evaluation is an essential organizational practice in public health
and a systematic way to account for and improve public health actions.
Comprehensive evaluation of FDA's multicultural public education
campaign will be used to document whether the intended audience is
aware of and understands campaign messages, and whether campaign
exposure influences specific cognitive outcomes related to tobacco use
that are targeted by the campaign.

    FDA is in the process of evaluating the effectiveness of its
multicultural youth tobacco prevention campaign through an outcome
evaluation study that follows the multiple, discrete waves of media
advertising planned for the campaign. All information collected is
integral to that evaluation.
    FDA's Fresh Empire youth tobacco public education campaign aims to
reduce tobacco use among youth who affiliate with a hip-hop peer crowd,
predominantly among African American, Hispanic, and Asian/Pacific
Islander youth. The outcome evaluation of the campaign consists of a
pre-test survey of youth aged 12 to 17 before campaign launch followed
by a series of post-test surveys beginning approximately 6 months after
the campaign launch. The post-test surveys are conducted among youth
who participated in one or more surveys (the embedded longitudinal
cohort) and new participants who are recruited to make up for
attrition. Eligible youth were initially 12- to 17-year-old youth who
are influenced by the hip-hop peer crowd. Youth in the embedded
longitudinal cohort may reach the age of 18 over the course of the
evaluation.
    To date, the pre-test and two post-test surveys have been
conducted. A third post-test survey is currently underway. Information
has been collected about youth awareness of and exposure to campaign
events and advertisements and about tobacco-related knowledge,
attitudes, beliefs, intentions, and use. Information has also been
collected on demographic variables including age, sex, race/ethnicity,
grade level, and primary language.
    All information is being collected through in-person and web-based
questionnaires. Youth respondents were recruited from two sources: (1)
A sample drawn from 30 U.S. media markets gathered using an address-
based postal mail sampling of U.S. households for the outcome
evaluation, and (2) targeted social media (e.g., Facebook).
    This study is being conducted in support of the provisions of the
Tobacco Control Act that require FDA to protect the public health and
to educate the population about the risks and potential risks of
tobacco use. The information being collected is necessary to inform
FDA's efforts towards these goals and to measure the effectiveness and
public health impact of the campaign. Data from the outcome evaluation
are being used to estimate awareness of and exposure to the campaign
among youth in target markets where the campaign is active. Data are
also being used to examine statistical associations between exposure to
the campaign and subsequent changes in specific outcomes of interest,
which include knowledge, attitudes, and beliefs related to tobacco use.
    FDA requests OMB approval to extend OMB approval of the evaluation
of FDA's multicultural youth tobacco public education campaign and to
add two additional waves of data collection with existing youth in the
study. To accommodate these two additional surveys, FDA requests
approval to increase the number of burden hours under the existing
control number. The fourth post-test survey will begin in July 2018.
The fifth post-test survey will begin in February 2019. As was done in
earlier post-test surveys, new youth will be recruited to participate
to make up for attrition.
    A total of 2,100 youth will complete questionnaires for the fourth
post-test survey, and the same number will complete questionnaires for
the fifth post-test survey. These respondents will include existing
youth who have participated in one or more surveys previously
(``Longitudinal Cohort'') and new youth recruited via a mail-based
screener or social media ads (``Cross-Sectional Refresher Sample'').
Based on earlier response rates and longitudinal respondents aging out
of the eligibility criteria (over the age of 18), we expect to need to
recruit a larger number of cross-sectional respondents than in previous
waves. We estimate that approximately 600 longitudinal youth and 1,500
cross-sectional youth will participate in each of the fourth and fifth
post-test surveys. With an estimated burden of 45 minutes per
respondent, this adds 450 hours for longitudinal respondents and 1,125
hours for cross-sectional respondents for each of the fourth and fifth
post-test evaluation surveys.
    A mail-based screener was one of the methods used to identify
eligible youth for the pre-test survey. This method will be used during
the fourth post-test survey to recruit new youth to ensure that the
sample composition is similar across rounds of data collection. As was
done during the pre-test survey, parents or guardians will be asked to
provide consent and their contact information on this form. For the
fourth post-test survey, the 5-minute youth screener and the 1-minute
parental consent will be completed by 9,869 households for a total of
822 burden hours for youth and an additional 164 hours for the parents
or guardians. This method will not be used during the fifth post-test
survey, for which new participants will be recruited only via social
media.
    We will continue to recruit new youth through social media (e.g.,
Facebook, Instagram) as a secondary strategy to recruit youth 13 to 17.
An online version of the screener described above will continue to be
used to identify eligible youth. The screener will take 5 minutes and
will be completed by an additional 4,000 youth during each of the
fourth and fifth post-test surveys, for a total of 8,000 additional
youth respondents and 666 total additional burden hours. The new total
number of participants for the youth online post-test screener will be
32,000 and the total burden will be 2,666 hours. This includes the
originally-approved 24,000 participants and 2,000 burden hours.
    As was done previously, eligible youth aged 13 to 14 who complete
the online screener will be asked to provide their parents' or
guardians' contact information to provide parental consent for the main
survey. The process of parents and guardians providing consent for
eligible youth will take approximately 1 minute. For the fourth and
fifth post-test surveys, we estimate that an additional 700 adults will
be contacted to provide consent for eligible youth for a total of 11
additional burden hours. Added to the original 6,000 parents and 100
burden hours, the total number of parental online screener and consents
will be 6,700 and the total burden will be 111 hours.
    With these additions, the estimated number of respondents/responses
for all waves of data collection for the study is 107,743, and the
total burden is estimated at 15,135 hours--an increase of 4,813 hours
from the last approval.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
            Type of respondent                        Activity               Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth aged 12 to 17 in the United States..  Mail Screener and Consent             13,816               1          13,816          0.0833           1,151
                                             Process--Pre-test outcome
                                             survey.
                                            Mail Screener and Consent              9,869               1           9,869          0.0833             822
                                             Process--Post-test outcome
                                             survey.
Adults 18 and older in the United States..  Mail Screener and Consent             13,816               1          13,816          0.0166             229
                                             Process--Pre-test outcome
                                             survey.
                                            Online Screener and Consent              520               1             520          0.0166               9
                                             Process--Pre-test outcome
                                             survey.
                                            Mail Screener and Consent              9,869               1           9,869          0.0166             164
                                             Process--Post-test outcome
                                             survey.
                                            Online Screener and Consent            6,700               1           6,700          0.0166             111
                                             Process--Post-test outcome
                                             survey.
Multicultural Youth aged 12 to 17 in        Pre-test outcome evaluation            2,194               1           2,194             0.5           1,097
 select media markets.                       survey.
Longitudinal Cohort, age 13 to 18 years...  First post-test evaluation             1,722               1           1,722            0.75           1,292
                                             survey.
                                            Second post-test evaluation            1,752               1           1,752            0.75           1,314
                                             survey.
                                            Third post-test evaluation             1,365               1           1,365            0.75           1,024
                                             survey.
                                            Fourth post-test evaluation              600               1             600            0.75             450
                                             survey.
                                            Fifth post-test evaluation               600               1             600            0.75             450
                                             survey.
Cross-Sectional Refresher Sample, age 13    First post-test evaluation               682               1             682            0.75             512
 to 17 years.                                survey.                                 503               1             503            0.75             377
                                            Second post-test evaluation              735               1             735            0.75             551
                                             survey.                               1,500               1           1,500            0.75           1,125
                                            Third post-test evaluation             1,500               1           1,500            0.75           1,125
                                             survey.
                                            Fourth post-test evaluation
                                             survey.
                                            Fifth post-test evaluation
                                             survey.
Multicultural youth aged 13 to 17 in the    Pre-test online screener....           8,000               1           8,000          0.0833             666
 select media markets recruiting through    Post-test online screener...          32,000               1          32,000          0.0833           2,666
 social media and online panels.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................         107,743  ..............  ..............  ..............          15,135
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27712 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 20, 2009 (Volume 74, Number 33)]
[Notices]
[Page 7908]
[DOCID:fr20fe09-71]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0044]

Draft Guidance for Industry on Influenza: Developing Drugs for
Treatment and/or Prophylaxis; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Influenza:
Developing Drugs for Treatment and/or Prophylaxis.'' Recent concerns
about the possibility of pandemic spread of novel influenza strains
have increased interest in influenza drug development for both seasonal
and pandemic settings. The purpose of this guidance is to assist
sponsors in all phases of influenza drug development and to address
questions FDA often receives regarding the potential for emergency use
of influenza drugs for the treatment and/or prophylaxis of influenza.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 21, 2009.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Debra Birnkrant, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6332, Silver Spring, MD 20993-0002, 301-
796-0770.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Influenza: Developing Drugs for Treatment and/or
Prophylaxis.'' Because of the public health implications of both
seasonal and pandemic influenza, the variable nature of the disease,
and the limited therapeutic options and challenges in studying new
options, FDA is developing guidance to assist sponsors in all phases of
influenza drug development. This draft guidance addresses preclinical
development, early phases of clinical development, phase 3 protocol
designs and endpoints for the treatment of both uncomplicated and
serious influenza, and protocol designs for the prophylaxis of
symptomatic influenza. This guidance also addresses the role of animal
data in an influenza drug development program and considerations
relating to the potential for emergency use of influenza drugs
including advance development of protocols for further exploration and
verification of drug effects.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on developing
drugs for the treatment and/or prophylaxis of influenza. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that 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 21 CFR parts 312 and 314 have
been approved under OMB Control Numbers 0910-0014 and 0910-0001,
respectively.

III. Comments

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

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
eitherhttp://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: February 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3554 Filed 2-19-09; 8:45 am]

BILLING CODE 4160-01-S