[Federal Register: March 18, 2008 (Volume 73, Number 53)]
[Proposed Rules]
[Page 14411-14417]
[DOCID:fr18mr08-23]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 516

[Docket No. 2008N-0011]
RIN 0910-AG03

Defining Small Number of Animals for Minor Use Designation

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The designation provision of the Minor Use and Minor Species
Animal Health Act of 2004 (MUMS act) provides incentives to animal drug
sponsors to encourage drug development and approval for minor species
and for minor uses in major animal species. Congress provided a
statutory definition of ``minor use'' that relied on the phrase ``small
number of animals'' to characterize such use. At this time, FDA is
proposing to amend the implementing regulations of the MUMS act. In
response to Congress' charge to the agency to further define minor use,
this amendment proposes a specific ``small number of animals'' for each
of the seven major animal species to be used in determining whether any
particular intended use in a major species is a minor use.

DATES: Submit written or electronic comments on the proposed rule by
July 16, 2008. Submit comments regarding information collection by
April 17, 2008 to OMB (see ADDRESSES).

ADDRESSES: You may submit comments, identified by Docket No. 2008N-0011
and RIN number 0910-AG03, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to  http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to  http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
    Information Collection Provisions: Submit written comments on the
information collection provisions to the Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB).To ensure
that comments on the information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Margaret Oeller, Center for Veterinary
Medicine (HFV-50), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. The Definition of Minor Use

    The MUMS act (Public Law 108-282) amended the Federal Food, Drug,
and Cosmetic Act (the act) to provide incentives for the development of
new animal drugs for use in minor animal species and for minor uses in
major animal species. The MUMS act defines ``minor use'' as ``the
intended use of a drug in a major species for an indication that occurs
infrequently and in only a small number of animals or in limited
geographical areas and in only a small number of animals annually''
(section 201(pp) of the act (21 U.S.C. 321(pp)). The major species are
cattle, horses, swine, chickens, turkeys, dogs, and cats (21 U.S.C.
321(nn)).
    Prior to enactment of the MUMS act, FDA defined minor use by
regulation to

mean, ``the use of: * * * (b) new animal drugs in any animal species
for the control of a disease that (1) occurs infrequently or (2) occurs
in limited geographical areas'' (48 FR 1922; January 14, 1983 (former
Sec.  514.1(d)(1) (21 CFR 514.1(d)(1))). The MUMS act narrowed this
definition by restricting it to uses ``in only a small number of
animals annually'' (21 U.S.C. 321(pp)).
    The legislative history of the MUMS act indicates that Congress
intended that FDA further define minor use in a major species by
regulation and that it do so ``by evaluating, in the context of the
drug development process, whether the incidence of a disease or
condition occurs so infrequently that the sponsor of a drug intended
for such use has no reasonable expectation of its sales generating
sufficient revenues to offset the cost of development'' (S. Rpt. 108-
226 at 12-13). The legislative history also notes that the new
statutory definition for minor use ``incorporates the existing
definition in the Code of Federal Regulations (21 CFR 514.1(d)(1)) with
a further limitation to small numbers to assure that such intended uses
will not be extended to a wider use'' (S. Rept. 108-226 at 12-13).
    Therefore, while the MUMS act establishes incentives for animal
drug development for minor uses, it also limits the availability of
those incentives in order to prevent them from stimulating ``wider
use'' of new animal drugs marketed under the MUMS act provisions.
    Consistent with these dual aims of stimulating animal drug
development for minor uses in major species and at the same time
preventing ``wider use'' of such new animal drugs, the agency is
proposing to define the term ``small number of animals'' for each major
species that would constitute the upper limit of a ``minor use'' under
the MUMS act. In keeping with the goal of creating a drug development
incentive, the proposed definition would establish the number of
animals eligible to be treated annually based on the number of animals
that represents a drug market value that (relative to drug development
costs) would not be likely to be pursued in the absence of the MUMS act
incentives. Furthermore, as explained in the following section I.B of
this document, FDA believes it is necessary to establish ``small number
of animals'' differently for companion animals than for food-producing
animals.

B. Companion Animals vs. Food-Producing Animals

    The issue of considering companion animals and food-producing
animals separately in the context of establishing small numbers of
animals was raised in comments on the MUMS designation proposed rule
(70 FR 56394; September 27, 2005).
    One of the comments stated that the agency and sponsors would be
best served by separating requirements for companion and food-producing
animals because ``this separation would provide information clearly
focused on the information necessary for each group'' (Ref. 1).
    A second comment requested that the agency ``consider separation of
the requirements for companion animals from that for food-producing
animals, as it is difficult to generalize across the two categories''
(Ref. 2).
    A third comment urged FDA to establish different sets of criteria
for major species of food-producing animals and companion animals
because ``economic criteria play differently into decisions to
administer drugs to these two types of animals'' (Ref. 3).
    The agency generally agrees that food-producing and companion
animals should be considered separately with respect to establishing
small numbers, and notes that one of the principal reasons for
considering food-producing and companion animals differently is that
the decision to treat food-producing animals is almost exclusively
based on an assessment of the economic value of the animals at the time
treatment is needed. In addition, very often this decision involves
administering a drug to all animals in a herd or flock, not just those
showing signs of disease. Because the decision to administer a drug may
be made more conservatively than for companion animals but, once made,
often involves the exposure of more animals, there is no clear basis
for estimating the likelihood of drug administration to individual
food-producing animals.
    Other factors to consider are that there are much larger absolute
numbers of food-producing animals than companion animals (in the case
of chickens, approximately 9 billion) (Ref. 4), and that food-producing
animals tend to be geographically concentrated to a greater extent than
companion animals (Ref. 5). Each of these factors supports establishing
``small numbers of animals'' for companion animals differently than
``small numbers of animals'' for food-producing animals.
    When FDA proposed regulations to implement the designation
provision of the MUMS act, the preamble contained considerable
discussion regarding the definition of ``minor use,'' including the
issues surrounding the use of the phrase ``small number of animals'' in
the statutory definition of minor use. (See section II.A.2 Minor Use of
70 FR 56394 at 56395.) Ultimately, the agency indicated that it did not
have enough information to propose a ``small number of animals'' for
each major species at that time, but indicated its intention to do so
in the future, and requested information to facilitate that process.
    In response to this request, FDA received four comments concerning
``small numbers of animals'' and minor use which the agency responded
to in the preamble of the MUMS designation final rule. (See section
III.B of 72 FR 41010 at 41013.) These comments were general in nature.
This may be attributed, in part, to animal drug sponsors considering
specific information regarding the cost of drug development, and the
process by which they make decisions to pursue drug development, to be,
``for the most part, confidential'' (Ref. 2). However, the agency was
able to obtain information regarding average animal drug development
costs as well as typical drug treatment costs for the seven major
species. This information was obtained by contracting with a source
with significant knowledge of the animal pharmaceutical industry that
was also capable of collecting information from a large number of other
sources (Ref. 6). From this source, the agency was also able to obtain
general information regarding the incidence or prevalence of a large
number of diseases and conditions of dogs, cats, and horses. Similar
information regarding disease incidence or prevalence was not readily
available for major food-producing species.
    In fact, in spite of repeated agency requests to the animal health
industry to identify potential conditions of food-producing animals
that might qualify as minor uses, very few conditions have been
suggested; for example babesiosis in cattle.
    Therefore, following a careful analysis of the information noted
previously, and based on early experience making designation
determinations on a case-by-case basis, the agency is now proposing the
establishment of a ``small number of animals'' for each of the seven
major animal species.

II. Proposed Regulation

A. ``Small Numbers'' for Major Species of Companion Animals

1. The Value of Exclusivity
    There are three drug development incentives established by the
Orphan Drug Act (Public Law 97-414) that are associated with human
orphan product development: Seven years of exclusive marketing, an
approximately 50 percent

reduction in development costs via tax reductions, and eligibility for
grants to support development costs. Designated MUMS drugs are
currently eligible for 7 years of exclusive marketing (section 573(c)
of the act) (21 U.S.C. 360ccc-2(c)), and eventually will be eligible
for grants (section 102(b)(8) of the MUMS act). A tax incentive for
animal drug development was not included in this legislation. The
designation provisions of the MUMS act went into effect upon enactment.
Therefore, FDA must define ``small numbers'' as soon as possible.
    Consistent with the intent and the language of the MUMS act,
``small number'' for each major companion animal species (horses, dogs,
and cats) should represent a drug market value that (relative to drug
development costs) would not be likely to be pursued in the absence of
the MUMS act incentives. While incentives in addition to marketing
exclusivity, such as the MUMS grant provisions, should they become
available, would be expected to increase the likelihood of developing
drugs for markets smaller than the proposed small number thresholds,
the increase in incentives would not alter the small numbers
themselves.
    To estimate the value of 7 years of exclusive marketing rights, we
have examined the marketing exclusivity established by the Generic
Animal Drug and Patent Term Restoration Act (GADPTRA) (Public Law 100-
670) as a benchmark for MUMS exclusivity. GADPTRA provides 5 years of
exclusivity for the first-time approval of a drug in animals (section
512(c)(2)(F) of the act) (21 U.S.C. 360b(c)(2)(F)). In enacting
GADPTRA, Congress indicated that it viewed this term of exclusivity as
a sufficient return on investment prior to generic competition to
provide an incentive for the pioneer sponsor to develop a drug.
Together with information regarding average animal drug development
costs obtained by the agency (Ref. 6), we can calculate the relative
value of the 5-year GADPTRA incentive. A basic principle of animal drug
product development embedded in these data is that a sponsor will
generally need to perceive a market potential in the third year of
marketing equal to the development cost of the product in order to
pursue development (Ref. 6). This third year market is apparently
considered the mature market for the drug or, in industry parlance, the
``going'' market (Ref. 6) and can serve as a basis for calculating the
entire market potential of a drug prior to generic competition.
    As a hypothetical example, for a drug with a $15,000,000 ($15M)
development cost for a particular intended use, the third year market
would need to be perceived to be $15M in order to support product
development. In this example, we project a ramp up to this ``going''
market value of $5M in the first year of marketing and $10M in the
second. This means that under the 5-year term of exclusivity provided
by GADPTRA, for a first-time approval of a drug in animals, a market
prior to generic competition sufficient to justify pioneer sponsor
investment relative to a $15M investment is $60M (i.e., $5M in year 1 +
10M in year 2 + 15M in year 3 + 15M in year 4 + $15M in year 5).
    There may be a number of ways of interpreting the value of the
additional 2 years of exclusivity provided to MUMS drugs; but, the most
useful interpretation of the value of this extended marketing
exclusivity is that it provides a sponsor an opportunity to lower its
perception of an acceptable ``going'' market value to support drug
development because the sponsor has longer to recoup development costs
without competition. In the previous example, this would mean that the
$60M fair and reasonable market value prior to competition established
under GADPTRA could be spread over 7 years instead of 5 with the result
that the ``going'' market value (third year market value) for a drug
with development costs of $15M would only need to be $10M in order to
support drug development (i.e., $3.5M + 6.5M + 10M + 10M + 10M + 10M +
10M). Therefore, assuming for the purposes of a general estimate that
the ramp-up to a going market is roughly linear as shown in the
example, in a practical sense, the economic value of the 7 years of
exclusive marketing rights for MUMS drugs is to lower the ``going''
market value needed to support drug development by about one-third. It
should be noted that MUMS exclusive marketing rights provide protection
from competition from all products with the same drug, same dosage
form, and same intended use rather than just from generics under
GADPTRA and this provides additional value to this incentive.
    Having estimated the market value of this MUMS incentive as a one
third reduction in the ``going'' market value, in order to define
``small number,'' the agency's task is then to estimate the number of
animals of each major companion animal species the drug treatment of
which represents a drug market value, that is about two-thirds of the
estimated cost of drug development for each of these species.
    The agency is well aware of the enormous variability that will be
encompassed by one estimate of drug development cost for each major
companion animal species. For companion animals, an estimated range of
drug development costs for first-time approval of an animal drug is $10
to $20 million, with additional estimates as low as $5 million (Ref.
6). Based on these estimates, the agency believes $15 million
represents the average drug development cost.
2. Additional Factors Unique to Companion Animals
    The number of major species companion animals eligible for
treatment on an annual basis that represents a drug market value
roughly equivalent to two-thirds of the estimated drug development cost
for these major species depends on a large number of factors affecting
the drug treatment value of individual animals. For purposes of this
discussion, drug treatment value means the portion of the cost of
treating an animal with a given drug that is returned to the sponsor of
the drug. Again, the agency acknowledges the great variability that
will be encompassed in one estimate of drug treatment value for
individual animals of each major companion animal species. The drug
treatment value of individual animals is a portion of the cost that
animal owners are willing to pay to have animals treated for a given
condition. The sum of the drug treatment values of all of the animals
treated with a given drug over the course of a year represents the
sponsor's annual market value of that drug.
    Two of the most basic factors affecting drug market value are the
species involved, which significantly affects the amount that people
are willing to pay to treat an individual animal, and the percentage of
the eligible population of animals that is actually treated under
typical circumstances.
    Drug treatment values must be considered in the context of the cost
of ancillary veterinary services associated with diagnosis and
subsequent treatment. Clearly, costs ancillary to drug costs may
decrease the likelihood of a decision to treat a given animal. For a
given drug, the drug treatment value, the ancillary cost of treatment,
the practitioner's decision to markup the drug cost to the client, and
the decision of the client to accept the total cost of treating an
animal are all inter-related. As the drug treatment value increases,
other costs may decrease in order for the total cost of treatment to be
made acceptable to a given client. Available information regarding the
amount that people are willing to pay to treat representative
conditions in the three

major companion animal species is quite variable (Ref. 6). However,
based on available information, the agency concludes that companion
animal owners generally will pay more to treat a horse than a dog, and
more to treat a dog than a cat (Ref. 6). Based on available
information, the agency further concludes that a reasonable annual drug
treatment value for conditions significantly affecting the health of
individual animals of these species is about $500 for horses, about
$350 for dogs, and about $200 for cats (Ref. 6).
    For any given condition, many animals that are eligible to be
treated will not actually be treated and the decision to treat will
depend to a large extent on the nature of the condition and the cost of
treatment. While an estimate of the likelihood of treatment must be
very general to represent the large variability encompassed by that
estimate, based on the factors described previously and currently
available information (Ref. 7), the agency believes that it is
reasonable to estimate a 50 percent non-treatment rate across all major
companion animal species.
    Defining small numbers for companion animal species must take into
account the uncertainty inherent in the estimates of prevalence or
incidence of diseases or conditions that occur in relatively small
numbers of animals. Therefore, a disease prevalence or incidence
estimate submitted with a request for minor use designation will be
considered relative to its degree of uncertainty to enable the agency
to be 90 percent confident that the actual prevalence or incidence of
the disease at issue is at or below the estimate, and that the
resulting estimate is below the small number threshold.
    Even reasonably good estimates, such as those based on published
articles involving actual tabulation of a number of cases of the
disease or condition at issue gathered at multiple sites or over an
extended time, or results of surveys involving about a hundred
respondents, appear to present uncertainties on the order of +/- 10
percent around the estimate. Since at least +/- 10 percent uncertainty
is likely to exist for most estimates, based on an assumption of normal
distribution, the agency has also increased the proposed small numbers
for companion animals by approximately 13 percent to account for this.
The practical effect of this approach is that an estimated prevalence
or incidence that is on the order of 12 percent below the proposed
threshold could be accepted as a small number with 90 percent
confidence that it is truly below the threshold when the uncertainty
associated with the estimate is on the order of +/- 10 percent or less,
but could be rejected as a small number if the uncertainty associated
with the estimate is sufficiently above 10 percent.
    Finally, proposed thresholds were somewhat increased to achieve
``round'' numbers. Given the variability associated with several of its
assumptions, the agency believes that this is acceptable.
    In summary, the following assumptions underlie the proposed ``small
numbers'' definition for companion animals:
    (1) A reasonably representative development cost for a new
companion animal drug is about $15 million.
    (2) Without incentives, a sponsor will generally need to perceive a
market potential in the third year of marketing equal to the
development cost of the product in order to pursue development.
    (3) Due to the extended exclusive marketing rights, the ``going
market'' for a MUMS product can be about one-third less than the market
normally required for a sponsor to pursue drug development.
    (4) Although the amount individual animal owners spend on companion
animals is highly variable, companion animal owners generally will pay
more for the treatment of a horse than for a dog and more for a dog
than a cat.
    (5) Treatment costs ancillary to drug treatment value decrease the
likelihood of a decision to treat a given animal and provide no return
on investment to sponsors.
    (6) The drug treatment value for a horse is about $500, for a dog
about $350, and for a cat about $200.
    (7) There is about a 50 percent non-treatment rate across all major
companion animal species.
    (8) There is about 10 percent uncertainty in even the best
published estimates of disease incidence or prevalence in companion
animals.
    A ``small number of animals'' for each of the three major companion
animal species can be calculated by incorporating these assumptions
into the following formula:
[average companion animal drug development cost in dollars] - 1/3 =
[minor use ``going market'' in dollars] / [average drug treatment value
in dollars for each species] = [a preliminary small number of animals]
x 2 (untreated factor) + 13% (uncertainty factor) + (increase to
``round'' number) = [species specific ``small number of animals'']
    The agency recognizes that there is considerable variability within
each of these assumptions. However, in order to consistently and fairly
implement the designation provision of the MUMS act, FDA believes it is
vital to establish one ``small number'' for each major species. The
agency's task is to set these numbers so that they can be applied to a
wide variety of requests for minor use designation. This is the same
task that Congress undertook when it established by statute a threshold
number of 200,000 for human orphan drugs (section 526(a)(2) of the act)
(21 U.S.C. 360bb(a)(2)).
    Following this approach, the agency proposes defining ``small
numbers'' for the major companion animal species as: 50,000 horses,
70,000 dogs, and 120,000 cats affected annually.

B. ``Small Numbers'' for Major Species of Food-Producing Animals

    For the reasons discussed in Background section I.B. of this
document, FDA is proposing to establish ``small numbers'' in a
different manner for food-producing animals than for companion animals.
    Just as it did with respect to establishing ``small numbers'' for
companion animals, the agency looked for a benchmark to serve as a
basis for quantifying a threshold small number for each food-producing
major species. Consistent with comments received on the MUMS
designation proposed rule (Refs. 1 and 3), the benchmark that the
agency found to be most appropriate for food-producing animals is based
on a comparison between major and minor food-producing species, and the
minor food-producing species most directly comparable to major food-
producing species with respect to drug development costs, animal
husbandry, and the nature and scope of drug use is sheep.
    The market for new animal drug sales represented by that portion of
the U.S. sheep population that could reasonably be treated on an annual
basis qualifies for the incentives of MUMS designation because sheep
are a minor species. The market for sheep drugs thus represents a
market for food-producing animal species that Congress determined
merited MUMS act incentives in order to stimulate drug development.
Therefore, it is reasonable that an intended use in a major food-
producing species that represents a similar size market should also
qualify for these incentives.
    To serve as a reasonable estimate of the size of the drug market
for sheep, and to permit an equitable comparison across all major food-
producing species, the agency used the biomass of sheep presented to
slaughter facilities in the United States in 2004 (the year of

passage of the MUMS act) as the basis for extrapolation to establish
small numbers for major food-producing species. Because new animal
drugs are usually dosed by weight, biomass serves as a reasonable basis
for extrapolation because the amount of drug sold to treat a particular
food-producing species over the course of a year roughly correlates to
the total weight, or biomass, of the animal species being treated
during that year.
    The biomass of sheep going to slaughter in 2004 represents slightly
less than 50 percent of the total biomass of sheep existing in that
year and, therefore, represents an assumption that 50 percent of sheep
existing in 2004 might have been treated with a given drug during that
year. Given the limited amount of information available regarding
disease prevalence or incidence in food-producing animals, treatment of
50 percent of the sheep population by a given drug is considered by the
agency to be a reasonable estimate of the maximum drug market for the
species. As previously noted, this estimate also represents a food-
producing species drug market that Congress established as eligible for
MUMS act incentives.
    The amount of biomass from sheep (including lambs) arriving at
slaughter facilities in 2004 (the total live weight of animals
presented for slaughter) is reported by the U.S. Department of
Agriculture (USDA) (Ref. 8) to be 380,000,000 (380M) pounds (lbs).
Therefore, we propose to define the ``small number'' that represents
``minor use'' for each major food-producing animal species as the
number of animals going to slaughter in 2004 that produced a cumulative
biomass equivalent to 380M lbs/year.
    Following this approach, based on USDA statistics for 2004 for
cattle, pigs, turkeys and chickens (Refs. 4 and 8), 380M pounds of
biomass (live weight at slaughter) roughly equates to 310,000 cattle
(at 1,240 lbs/animal); 1,450,000 pigs (at 266 lbs/animal); 14,000,000
turkeys (at 27 lbs/bird); and 72,000,000 chickens (at 5.3 lbs/bird).

C. Small Numbers as a Limitation to ``Wider Use''

    As noted previously, the legislative history of the MUMS act states
that the statutory definition for minor use ``incorporates the existing
definition in the Code of Federal Regulations (21 CFR 514.1(d)(1)) with
a further limitation to small numbers to assure that such intended uses
will not be extended to a wider use'' (S. Rept. 108-226 at 12 13). The
agency believes that the ``small number of animals'' of each major
species being proposed to clarify the definition of ``minor use'' meets
the dual goals that Congress established in the legislative history of
the MUMS act to provide added incentives for animal drug development
while assuring that the proposed ``small numbers'' will not result in
minor uses being ``extended to a wider use'' in major animal species.

D. Proposed ``Small Numbers''

    Based on an assessment of all of the factors noted previously, and
for the purpose of further defining ``minor use'' under the Minor Use
and Minor Species Animal Health Act of 2004 and 21 CFR 516.3, the
agency proposes to define ``small numbers'' for each major species as
equal to or less than each of the following numbers:

         Table 1.--Proposed Small Numbers for Each Major Species
------------------------------------------------------------------------
             Species                            Small Number
------------------------------------------------------------------------
Horses                             50,000
------------------------------------------------------------------------
Dogs                               70,000
------------------------------------------------------------------------
Cats                               120,000
------------------------------------------------------------------------
Cattle                             310,000
------------------------------------------------------------------------
Pigs                               1,450,000
------------------------------------------------------------------------
Turkeys                            14,000,000
------------------------------------------------------------------------
Chickens                           72,000,000
------------------------------------------------------------------------

    Finally, as noted in the response to comments on the proposed MUMS
designation rule (see 72 FR 41010 at 41012), paragraph (c) of Sec.
516.21 (21 CFR 516.21) (Documentation of minor use status) is
unnecessary once small numbers of animals have been established.
Because the agency is proposing to establish small numbers of animals
at this time, the agency is also proposing to remove Sec.  516.21(c)
and its associated burden on the animal pharmaceutical industry.

III. Legal Authority

    FDA's authority for issuing this proposed rule is provided by the
Minor Use and Minor Species Animal Health Act of 2004 (section 571 of
the act) (21 U.S.C. 360ccc et seq.). When Congress passed the MUMS act,
it directed FDA to publish implementing regulations (see 21 U.S.C.
360ccc note). In the context of the MUMS act, the statutory
requirements of section 573 of the act, along with section 701(a) of
the act (21 U.S.C. 371(a)) provide authority for this proposed rule.
Section 701(a) authorizes the agency to issue regulations for the
efficient enforcement of the act.

IV. Analysis of Economic Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act (Public Law 104-4). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; and distributive impacts and equity). The agency believes
that this proposed rule is not a significant regulatory action as
defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule is only expected to
slightly reduce the administrative effort of ``minor use'' requestors
while imposing no additional costs, the agency does not believe that
this proposed rule would have a significant economic impact on a
substantial number of small entities. FDA requests comment on this
issue.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceeded this amount.
    FDA previously published both a proposed rule and final rule on the
MUMS designation system. Each of these publications included analyses
of the expected economic impacts of the creation and administration of
the MUMS designation system as required by the Executive order and two
statutes mentioned in the previous paragraphs. The final rule presented
estimates of the annual costs of the MUMS designation system of about
$65,000 annually. Additionally, the final rule provided some discussion
of, but was not able to quantify, the expected benefits of the rule.
    The final rule included a statement that it would address the issue
of

establishing a definition of ``small number'' of animals in a future
rulemaking. This proposed rule proposes that definition of ``small
number'' of animals for each of the seven major animal species as
defined by the MUMS act, based on the data and analysis as described
previously in this preamble.
    This proposed rule would set an upper limit on the number of
animals of each of the seven major animal species for which a request
for designation could be made under the ``minor use'' provisions of the
MUMS designation final rule. FDA does not have any additional
information to show that these proposed threshold numbers would
significantly affect the expected number of MUMS designation requests
that are received by the agency each year (estimated at 75 requests per
year in the MUMS designation final rule). The proposed definition of a
``small number'' of each of the seven major species reduces the
ambiguity for ``minor use'' requestors. Additionally, this proposed
rule would provide for a small reduction in administrative effort by
``minor use'' requestors who would no longer be required to provide
additional information on potential markets and drug development costs
due to the proposed deletion of Sec.  516.21(c). As such, FDA has
determined that the proposed rule would not impose any additional costs
or provide any further health benefits beyond those contained in the
MUMS designation final rule.

V. Paperwork Reduction Act of 1995

    This proposed rule does not contain new information collection
provisions that would be subject to review by OMB, under the Paperwork
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
    Title: Setting ``Small Numbers of Animals'' for Determining Minor
Use
    Description: This proposed rule is intended to revise the minor use
provisions of 21 CFR part 516, subpart B. Part 516 contains the
implementing regulations for the Minor Use and Minor Species Animal
Health Act of 2004, and subpart B contains the designation provisions
for minor use and minor species new animal drugs. Currently, requests
for minor use designation are considered case-by-case by the agency
based on product-specific financial information supporting minor use
status included in the request. In order to further define minor use,
this rule proposes seven threshold ``small numbers of animals,'' one
for each major species, based on industry-wide economic or animal
production data. With these numbers in place, drug sponsors requesting
minor use designation will no longer be required to submit confidential
product-specific financial information, as currently required in Sec.
516.21(c), thus lowering their reporting burden somewhat. However, we
anticipate that most requests for designation will be for minor
species, not minor use, and furthermore, the current requirement for
financial information is only one part of a request for designation,
therefore, the paperwork burden currently assigned to 21 CFR 516.20
will not be affected significantly.
    Information collection requirements in this section were approved
by OMB and assigned OMB control number 0910-0605.

VI. Environmental Impact

    We have carefully determined under 21 CFR 25.30(h) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VII. Federalism

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

VIII. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Public comment to Docket No. 2005N-0329, comment EC3,
received February 2, 2006, submitted by American Veterinary Medical
Association (AVMA), signed by Elizabeth Curry-Galvin.
    2. Public comment to Docket No. 2005N-0329, comment C5, received
January 26, 2006, submitted by Animal Health Institute, signed by
Richard Carnevale.
    3. Public comment to Docket No. 2005N-0329, comment EMC3,
received December 12, 2005, submitted by Keep Antibiotics Working,
signed by Rebecca Goldburg and Steve Roach.
    4. USDA/National Agricultural Statistics Service, ``Poultry
Slaughter 2004 Annual Summary,'' February 2005.
    5. USDA/Animal and Plant Health Inspection Service, ``2004
United States Animal Health Report,'' August 2005.
    6. Brakke Consulting, Inc., ``Disease Incidence Rates, Drug
Development and Treatment Costs,'' September 2005.
    7. AVMA, ``U.S. Pet Ownership & Demographics Sourcebook,'' 2002.
    8. USDA/National Agricultural Statistics Service, ``2004
Livestock Slaughter Report,'' March 2005.

List of Subjects in 21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 516 be amended as follows:

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

    1. The authority citation for 21 CFR part 516 continues to read as
follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
    2. Amend Sec.  516.3 by adding a new definition in alphabetical
order to paragraph (b) as follows:

Sec.  516.3  Definitions.

* * * * *
    (b) * * *
    Small number of animals means equal to or less than 50,000 horses,
70,000 dogs, 120,000 cats, 310,000 cattle,

1,450,000 pigs, 14,000,000 turkeys, and 72,000,000 chickens.
* * * * *

Sec.  516.21  [Amended]

    3. Amend Sec.  516.21 by removing paragraph (c).

    Dated: January 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. E8-5385 Filed 3-17-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Notices]
[Page 67464]
[FR Doc No: 2022-24336]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Exempt Wholesale Generator Status

------------------------------------------------------------------------
                                                      Docket Nos.
------------------------------------------------------------------------
Kawailoa Solar, LLC..........................  EG22-199-000
Sunflower Energy Center, LLC.................  EG22-200-000
Chaparral Springs, LLC.......................  EG22-201-000
Appaloosa Run Wind, LLC......................  EG22-202-000
Young Wind, LLC..............................  EG22-203-000
Lacy Creek Wind, LLC.........................  EG22-204-000
Inertia Wind Project, LLC....................  EG22-205-000
AES Energy Storage, LLC......................  EG22-206-000
MTSun LLC....................................  EG22-207-000
Hunt Energy Network Land Company, L.L.C......  EG22-208-000
HEN Infrastructure, L.L.C....................  EG22-209-000
Eight Point Wind, LLC........................  EG22-210-000
Clearwater Energy Resources LLC..............  EG22-211-000
Sun Valley Solar LLC.........................  EG22-212-000
BT Cunningham Storage, LLC...................  EG22-213-000
CPV Three Rivers, LLC........................  EG22-214-000
------------------------------------------------------------------------

    Take notice that during the month of October 2022, the status of
the above-captioned entities as Exempt Wholesale Generators Companies
became effective by operation of the Commission's regulations. 18 CFR
366.7(a) (2021).

    Dated: November 2, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-24336 Filed 11-7-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Proposed Rules]
[Pages 11913-11915]
[FR Doc No: 2021-02758]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2020-0343; FRL-10016-31-Region 6]

Air Plan Approval; Texas; Clean Air Act Requirements for Enhanced
Vehicle Inspection and Maintenance and Nonattainment New Source Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is proposing to approve portions
of two State Implementation Plan (SIP) revisions submitted by the State
of Texas for the 2008 8-hour ozone National Ambient Air Quality
Standard (NAAQS). The SIP revisions proposed for approval describe how
CAA requirements for vehicle Inspection and Maintenance (I/M) and
Nonattainment New Source Review (NNSR) are met in the Dallas-Fort Worth
(DFW) and Houston-Galveston-Brazoria (HGB) serious ozone nonattainment
areas.

DATES: Written comments must be received on or before March 31, 2021.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2020-0343, at https://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact Carrie Paige, 214-665-
6521<EMAIL_ADDRESS>For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov. While all documents in the
docket are listed in the index, some information may not be publicly
available due to docket file size restrictions or content (e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Ms. Carrie Paige, EPA Region 6 Office,
Infrastructure and Ozone Section,<PHONE_NUMBER><EMAIL_ADDRESS>
Out of an abundance of caution for members of the public and our staff,
the EPA Region 6 office may be closed to the public to reduce the risk
of transmitting COVID-19. We encourage the public to submit comments
via https://www.regulations.gov, as there will be a delay in processing
mail and no courier or hand deliveries will be accepted. Please call or
email the contact listed above if you need alternative access to
material indexed but not provided in the docket.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

    On March 12, 2008, the EPA revised both the primary and secondary
NAAQS for ozone to a level of 0.075 parts per million (ppm) to provide
increased protection of public health and the environment (73 FR 16436,
March 27, 2008).\1\ The 2008 ozone NAAQS retains the same general form
and averaging time as the 0.08 ppm NAAQS set in 1997 but is set at a
more protective level. Specifically, the 2008 ozone NAAQS is attained
when the 3-year average of the annual fourth-highest daily maximum 8-
hour average ambient air quality ozone concentrations is less

than or equal to 0.075 ppm. See 40 CFR 50.15.\2\
---------------------------------------------------------------------------

    \1\ For a history of the ozone NAAQS, please visit https://www.epa.gov/ground-level-ozone-pollution/table-historical-ozone-national-ambient-air-quality-standards-naaqs. For information on
EPA's periodic review of the ozone NAAQS, please visit https://www.epa.gov/naaqs/ozone-o3-air-quality-standards.
    \2\ The current NAAQS for ozone is an 8-hour standard of 0.070
ppm, finalized in 2015 (October 26, 2015, 80 FR 65292). This action
does not address the 2015 ozone NAAQS.
---------------------------------------------------------------------------

    Both the DFW and HGB areas were designated as nonattainment for the
2008 ozone NAAQS (77 FR 30088, May 21, 2012). The DFW area consists of
Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Rockwall,
Tarrant and Wise counties. The HGB area consists of Brazoria, Chambers,
Fort Bend, Galveston, Harris, Liberty, Montgomery and Waller counties.
    On December 23, 2014, the D.C. Circuit Court issued a decision
rejecting, among other things, our attainment deadlines for the 2008
ozone nonattainment areas, finding that we did not have statutory
authority under the CAA to extend those deadlines to the end of the
calendar year. NRDC v. EPA, 777 F.3d 456, 464-69 (D.C. Cir. 2014).
Consistent with the court's decision we modified the attainment
deadlines for all nonattainment areas for the 2008 ozone NAAQS, and set
the attainment deadline for all 2008 moderate ozone nonattainment
areas, including the DFW area as July 20, 2018, and the HGB area
(initially classified as marginal) as July 20, 2015 (80 FR 12264, March
6, 2015). The HGB area qualified for a 1-year extension of the
attainment deadline and we revised the attainment deadline to July 20,
2016 (81 FR 26697, May 4, 2016). The HGB area did not meet the revised
attainment deadline of July 20, 2016, and we reclassified the area to
moderate (81 FR 90207, December 14, 2016). The DFW and HGB areas did
not meet the moderate area attainment deadline and were accordingly
reclassified as serious (84 FR 44238, August 23, 2019).\3\ Section 182
of the CAA outlines SIP requirements applicable to ozone nonattainment
areas in each classification category. The serious area classification
triggers additional requirements, including NNSR and enhanced vehicle
I/M. See CAA section 182(c) and 40 CFR 51.350.
---------------------------------------------------------------------------

    \3\ The attainment deadline for a serious area classification is
9 years after the initial designation as nonattainment, which in
this case is July 20, 2021. See 40 CFR 51.1103 and 84 FR 44238.
---------------------------------------------------------------------------

    On May 13, 2020, the Texas Commission on Environment Quality (TCEQ
or State) submitted to EPA a SIP revision for each of the DFW and HGB
serious ozone nonattainment areas. In those SIP revisions, the State
describes how the DFW and HGB areas meet the enhanced vehicle I/M
program and NNSR requirements for serious ozone nonattainment areas
using existing measures already approved into the SIP. These two SIP
revisions are available in the docket for this action, at
www.regulations.gov, docket number EPA-R06-OAR-2020-0343.

II. The TCEQ Submittals and EPA's Evaluation

    The two Texas SIP revisions include a statement certifying that the
DFW and HGB areas meet the serious area requirements for enhanced I/M
and nonattainment NSR for the 2008 eight-hour ozone NAAQS. In addition,
the SIP revisions provide a brief history of the enhanced I/M and NNSR
programs in the Texas SIP. The SIP revisions also state that, (1) the
vehicle I/M program in the DFW and HGB ozone nonattainment areas meet
the federal requirements for areas classified as serious or above; and
(2) because the Texas SIP includes nonattainment NSR requirements, the
requirements for nonattainment NSR are met for the DFW and HGB serious
ozone nonattainment areas.

Enhanced Vehicle Inspection and Maintenance

    Section 182(c)(3) of the CAA requires states with ozone
nonattainment areas classified as serious or worse to implement an
enhanced program to reduce hydrocarbon emissions and nitrogen oxides
(NOX) \4\ emissions from in-use motor vehicles registered in
each urbanized area in the nonattainment area. The Federal rules
addressing I/M program requirements are provided at 40 CFR part 51,
subpart S and further defined at 40 CFR 51.350 (Applicability). Under
these requirements, serious ozone nonattainment areas in urbanized
areas with 1980 Census-defined urbanized populations of 200,000 or more
are required to adopt enhanced I/M programs (40 CFR 51.350(a)(2) and
(4)).
---------------------------------------------------------------------------

    \4\ NOX and Volatile Organic Compounds (VOC) are
precursors to ozone formation.
---------------------------------------------------------------------------

    The Texas SIP includes 30 TAC Section 114.2 (Inspection and
Maintenance Definitions) and 30 TAC Section 114.50 (Vehicle Emissions
Inspection Requirements) except for 30 TAC Section 114.50(b)(2).\5\
Under these provisions Brazoria, Fort Bend, Galveston, Harris, and
Montgomery counties in the HGB area are included in the I/M program,
and Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Rockwall,
and Tarrant counties in the DFW area are included in the I/M program.
The program requires that gasoline powered light-duty vehicles, and
light and heavy-duty trucks between two and twenty-four years old, that
are registered or required to be registered in the I/M program area,
including fleets, are subject to annual inspection and testing. These
programs were adopted and approved as meeting the applicable
requirements of the I/M rules in response to the area designations
under the one-hour ozone standard and later the 1997 8-hour standard.
The size of the HGB nonattainment area did not change with the
implementation of the 2008 ozone standard. As a result, EPA's previous
finding that the program covers the necessary vehicle population is
still appropriate. See 70 FR 58119, 58132 (October 5, 2005) and 71 FR
52670 (September 6, 2006). Wise County was added to the DFW
nonattainment area under the 2008 standard. Wise County, however, is
not required to be included in the I/M program as the current I/M
program in the DFW area sufficiently covers a non-urbanized area
population greater than the urbanized area in Wise County. To verify,
we evaluate the extent of area coverage for I/M, as defined at 40 CFR
51.350(b)(2): ``Outside of ozone transport regions, programs shall
nominally cover at least the entire urbanized area, based on the 1990
census.\6\ Exclusion of some urban population is allowed as long as an
equal number of non-urban residents of the MSA containing the subject
urbanized area are included to compensate for the exclusion.'' Based on
the 1990 census, the urban population of the DFW area covered by the I/
M program (which consisted of 9 counties: Collin, Dallas, Denton,
Ellis, Johnson, Kaufman, Parker, Rockwall and Tarrant) was 3,198,259
and the urban population of Wise County was 8,735. Thus, the population
of the entire urbanized area was 3,206,994 (3,198,259 + 8,735). The
urban and non-urban population of the 9-county DFW area was 3,885,415.
By subtracting the population of the entire urbanized area (3,206,994)
from the urban and non-urban populations of the 9-county DFW I/M area
(3,885,415-3,206,994 = 678,421), more than an equal number of non-urban
residents in the 9-county DFW area are included in the I/M

program to compensate for the exclusion of the urbanized population of
8,735 in Wise County.\7\ Thus, Wise County need not implement an I/M
program.
---------------------------------------------------------------------------

    \5\ We did not approve 30 TAC Section 114.50(b)(2) as part of
the Texas SIP as (1) it placed an additional reporting burden upon
commanders at Federal facilities regarding affected Federal vehicles
that is not imposed upon any other affected non-federal vehicle; and
(2) the additional reporting requirement is not an essential element
for an approvable I/M program, since affected Federal vehicles are
also subject to the same reporting requirements as other affected
non-federal vehicles. See 66 FR 57261, 57262 (November 14, 2001).
    \6\ Texas is not included in the Ozone Transport Region (OTR),
which is defined at CAA section 184(a).
    \7\ All population data in this paragraph are from the 1990
Census. The 1990 Census report for Texas is in the docket for this
rulemaking.
---------------------------------------------------------------------------

    Therefore, since the provisions in the Texas SIP already include
the I/M requirements specified by the CAA for serious ozone
nonattainment areas, we are proposing to approve this portion of the
two SIP revisions.

Nonattainment NSR

    The applicable NNSR requirements for the various ozone
nonattainment classifications are described in CAA section 182 and
further defined in 40 CFR part 51, subpart I (Review of New Sources and
Modifications). Under these requirements new major sources or major
modifications at existing sources in an ozone nonattainment area must
comply with the lowest achievable emission rate and obtain sufficient
emission offsets.\8\ For serious ozone nonattainment areas, major
sources are defined as any stationary source or group of sources
located within a contiguous area and under common control that emits,
or has the potential to emit, at least 50 tons per year (tpy) of
NOX or VOC (see CAA sections 182(c) and 182(f), and 40 CFR
51.165). The emission offset ratio required for serious ozone
nonattainment areas is 1.2 to 1 (see CAA section 182(c)(10).
---------------------------------------------------------------------------

    \8\ Offsets are the ratio of total emissions reductions of
NOX or VOC to the emissions increase of such air
pollutant.
---------------------------------------------------------------------------

    The EPA-approved Texas SIP already includes 30 TAC Section 116.12
(Nonattainment and Prevention of Significant Deterioration Review
Definitions) and 30 TAC Section 116.150 (New Major Source or Major
Modification in Ozone Nonattainment Area).\9\ These provisions require
new major sources or major modifications at existing sources in the DFW
and HGB areas to comply with the lowest achievable emission rate and
obtain emission offsets at the serious classification ratio of 1.2 to
1.
---------------------------------------------------------------------------

    \9\ See 60 FR 49781, September 27, 1995 and subsequent revisions
at 77 FR 65119, October 25, 2012 and 79 FR 66626, November 10, 2014.
---------------------------------------------------------------------------

    Therefore, since the provisions in the Texas SIP already include
the NNSR requirements specified by the CAA for serious ozone
nonattainment areas, we are proposing to approve this portion of the
two SIP revisions.

III. Proposed Action

    We are proposing to approve portions of two revisions to the Texas
SIP submitted on May 13, 2020, that describe how CAA requirements for
vehicle I/M and NNSR are met in the DFW and HGB serious ozone
nonattainment areas for the 2008 ozone NAAQS.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: February 5, 2021.
David Gray,
Acting Regional Administrator, Region 6.
[FR Doc. 2021-02758 Filed 2-26-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30704-30705]
[FR Doc No: 2019-13722]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR19-28-000]

Medallion Delaware Express, LLC, Medallion Pipeline Company, LLC;
Notice of Petition for Declaratory Order

    Take notice that on June 13, 2019, pursuant to Rule 207(a)(2) of
the Federal

Energy Regulatory Commission's (Commission) Rules of Practice and
Procedure, 18 CFR 385.207(a)(2) (2018), Medallion Delaware Express, LLC
(Delaware Express) and Medallion Pipeline Company, LLC (Medallion)
(collectively, the Carriers) filed a declaratory order petition seeking
approval of the overall tariff rate structure and terms of service,
open season procedures, and proposed joint tariff service, for an
expansion of the Carriers' facilities and existing integrated joint
crude-oil transportation services. The expansion consists of new
gathering facilities in Reeves County, Texas, to connect to the
Delaware Express mainline; an expansion of the Delaware Express
mainline; and an expansion of segments of the Medallion pipeline system
along the existing joint tariff route, all as more fully explained in
the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on July 8, 2019.

    Dated: June 19, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-13722 Filed 6-26-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Pages 12167-12170]
[FR Doc No: 2017-03930]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules
and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 529, and 558

[Docket No. FDA-2016-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of a New Animal Drug Application; Change of
Sponsor; Change of Sponsor's Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during November and December 2016. FDA is also
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to reflect the change of
sponsorship of an application and a change of a sponsor's name.

DATES: This rule is effective March 1, 2017, except for amendments 2.a
and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and
529.1186, which are effective March 13, 2017.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during November and December 2016, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act and, for
actions requiring review of safety or effectiveness data, summaries of
the basis of approval (FOI Summaries) under the Freedom of Information
Act (FOIA). These public documents may be seen in the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with access to the Internet may obtain
these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                             Table 1--Original and Supplemental NADAs and ANADAs Approved During November and December 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Effect of the
         Approval date              File No.            Sponsor            Product name          Species              action          Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
November 10, 2016..............         141-474  Elanco US, Inc.,      ITRAFUNGOL           Cats.............  Original approval    FOI Summary.
                                                  2500 Innovation       (itraconazole oral                      for the treatment
                                                  Way, Greenfield, IN   solution).                              of dermatophytosis
                                                  46140.                                                        caused by
                                                                                Microsporum canis
                                                                                in cats.
November 16, 2016..............         141-443  Elanco US Inc., 2500  ONSIOR               Dogs.............  Supplemental         FOI Summary.
                                                  Innovation Way,       (robenacoxib)                           approval for the
                                                  Greenfield, IN        Injection.                              control of
                                                  46140.                                                        postoperative pain
                                                                                and inflammation
                                                                                associated with
                                                                                soft tissue
                                                                                surgery in dogs by
                                                                                subcutaneous
                                                                                injection; and for
                                                                                the use of oral
                                                                                tablets to
                                                                                complete the
                                                                                dosing regimen of
                                                                                a maximum of 3
                                                                                days.
December 12, 2016..............         141-452  Zoetis Inc., 333      SIMPARICA            Dogs.............  Supplemental         FOI Summary.
                                                  Portage St.,          (sarolaner)                             approval for the
                                                  Kalamazoo, MI 49007.  Chewables.                              treatment and
                                                                                control of
                                                                                infestations of
                                                                                Ixodes scapularis
                                                                                (black-legged
                                                                                tick) in dogs.

December 16, 2016..............         141-473  Huvepharma AD, 5th    LINCOMIX             Chickens.........  Original approval    FOI Summary.
                                                  Floor, 3A Nikolay     (lincomycin                             for use in two-
                                                  Haytov Str., 1113     phosphate) plus                         way, combination
                                                  Sophia, Bulgaria.     STENOROL                                drug Type C
                                                                        (halofuginone                           medicated broiler
                                                                        hydrobromide) Type                      feeds for control
                                                                        C medicated feeds.                      of necrotic
                                                                                enteritis and
                                                                                prevention of
                                                                                coccidiosis in
                                                                                broiler chickens.
December 21, 2016..............         200-589  Med-Pharmex, Inc.,    FLORCON              Swine............  Original approval    FOI Summary.
                                                  2727 Thompson Creek   (florfenicol) 2.3%                      of a generic copy
                                                  Rd., Pomona, CA       Concentrate                             of NADA 141-206.
                                                  91767-1861.           Solution.
December 29, 2016..............         141-475  VetDC, Inc., 320 E.   TANOVEA-CA1          Dogs.............  Conditional          FOI Summary.
                                                  Vine Dr., Suite       (rabacfosadine for                      approval for the
                                                  218, Fort Collins,    injection).                             treatment of
                                                  CO 80524.                                                     lymphoma in dogs.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Following the conditional approval of NADA 141-175, VetDC, Inc.
will now be included in the list of sponsors of approved applications
in Sec.  510.600(c) (21 CFR 510.600(c)).

II. Change of Sponsorship

    ECO LLC, 344 Nassau St., Princeton, NJ 08540 has informed FDA that
it has transferred ownership of, and all rights and interest in, ANADA
200-600 for WORMX (pyrantel pamoate) Flavored Tablets to Sergeant's Pet
Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. The
regulations will be amended to reflect this change of sponsorship.

III. Withdrawals of Approval

    During November and December 2016, the following sponsors requested
that FDA withdraw approval of the NADAs listed in the following table
because the products are no longer manufactured or marketed:

----------------------------------------------------------------------------------------------------------------
                                                                                21 CFR
                File No.                            Sponsor                  Product name             section
----------------------------------------------------------------------------------------------------------------
135-773.................................  Baxter Healthcare Corp.,    AERRANE (isoflurane USP)..        529.1186
                                           One Baxter Pkwy.,
                                           Deerfield, IL 60015.
200-421.................................  Hospira, Inc., 275 North    Ceftiofur (ceftiofur              522.313c
                                           Field Dr., Lake Forest,     sodium) for Injection.
                                           IL 60045.
----------------------------------------------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 135-773 and ANADA 200-524, and all supplements
and amendments thereto, is withdrawn, effective March 13, 2017. As
provided in the regulatory text of this document, the animal drug
regulations are amended to reflect this voluntary withdrawal of
approval. Following this withdrawal of approval, neither Baxter
Healthcare Corp. nor Hospira, Inc. is the sponsor of an approved
application.
    IV. Technical Amendments
    iVaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155
has informed FDA that it has changed its name to Ivaoes Animal Health.
Accordingly, we are amending Sec.  510.600 (c) to reflect this change
of sponsor name. We are also making several technical amendments to
improve the accuracy of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
516, 520, 522, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. Amend Sec.  510.600 as follows:
0
a. Effective March 13, 2017, in the table in paragraph (c)(1), remove
the entries for ``Baxter Healthcare Corp.'' and ``Hospira, Inc.'';
0
b. Effective March 1, 2017, in the table in paragraph (c)(1), revise
the entry for ``iVaoes Animal Health'' and alphabetically add an entry
for ``VetDC, Inc.'';
0
c. Effective March 13, 2017, in the table in paragraph (c)(2), remove
the entries for ``000409'' and ``010019''; and
0
d. Effective March 1, 2017, in the table in paragraph (c)(2), revise
the entry for ``086064'' and numerically add an entry for ``086072''.

    The revisions and additions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110,               086064
 Miami, FL 33155........................................

                              * * * * * * *
VetDC, Inc., 320 E. Vine Dr., Suite 218, Fort Collins,            086072
 CO 80524...............................................

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
086064......................  Ivaoes Animal Health, 4300 SW 73rd Ave.,
                               Suite 110, Miami, FL 33155.

                              * * * * * * *
086072......................  VetDC, Inc., 320 E Vine Dr., Suite 218,
                               Fort Collins, CO 80524.

                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for part 516 continues to read as follows:

    Authority: 360ccc, 360ccc-2, 371.

0
4. Add Sec.  516.2065 to read as follows:

Sec.  516.2065  Rabacfosadine.

    (a) Specifications. Each vial of powder contains 16.4 milligrams
(mg) rabacfosadine. Each milliliter of constituted solution contains
8.2 mg rabacfosadine.
    (b) Sponsor. See No. 086072 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer rabacfosadine
at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once
every 3 weeks, for up to 5 doses.
    (2) Indications for use. For the treatment of lymphoma in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for part 520 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.370  [Amended]

0
6. In Sec.  520.370, in paragraph (c)(2), remove ``(group G, -
hemolytic)'' and in its place add ``(group G, beta-hemolytic)''.

0
7. In Sec.  520.955, revise paragraph (b) to read as follows:

Sec.  520.955  Florfenicol.

* * * * *
    (b) Sponsors. See Nos. 000061, 054925, and 058198 in Sec.
510.600(c) of this chapter.
* * * * *

0
8. Add Sec.  520.1189 to read as follows:

Sec.  520.1189  Itraconazole.

    (a) Specifications. Each milliliter (mL) of solution contains 10
milligrams (mg) of itraconazole.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 5 mg/kilogram (kg)
(0.5 mL/kg) of body weight once daily on alternating weeks for 3
treatment cycles.
    (2) Indications for use. For the treatment of dermatophytosis
caused by Microsporum canis in cats.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec.  520.2041  [Amended]

0
9. In Sec.  520.2041, in paragraph (b), remove ``017135, 051311, and
066916'' and in its place add ``066916, 017135, and 051311''.

0
10. In Sec.  520.2086, revise paragraph (c)(2) to read as follows:

Sec.  520.2086  Sarolaner.

* * * * *
    (c) * * *
    (2) Indications for use. Kills adult fleas, and for the treatment
and prevention of flea infestations (Ctenocephalides felis), and the
treatment and control of tick infestations [Amblyomma americanum (lone
star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor
variabilis (American dog tick), Ixodes scapularis (black-legged tick),
and Rhipicephalus sanguineus (brown dog tick)] for 1 month in dogs 6
months of age or older and weighing 2.8 pounds or greater.
* * * * *

Sec.  520.2325b  [Amended]

0
11. In Sec.  520.2325b, in paragraph (b), remove ``050749'' and in its
place add ``016592''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
12. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.313c  [Amended]

0
13. Effective March 13, 2017, in Sec.  522.313c, in paragraph (b),
remove

``000409, 054771, and 068330'' and in its place add ``054771 and
068330''.

0
14. In Sec.  522.2075, revise paragraph (c) to read as follows:

Sec.  522.2075  Robenacoxib.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg per
pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a
maximum of 3 days. After the initial subcutaneous dose, subsequent
doses can be given by subcutaneous injection or as the oral tablet in
dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of
age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose
per day. See Sec.  520.2075(c)(1) of this chapter.
    (ii) Indications for use. For the control of postoperative pain and
inflammation associated with soft tissue surgery in dogs at least 4
months of age for a maximum of 3 days.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.91 mg per pound (2 mg/kg) by
subcutaneous injection, once daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and
inflammation associated with orthopedic surgery, ovariohysterectomy,
and castration in cats at least 4 months of age for a maximum of 3
days.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
15. The authority citation for part 529 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  529.1186  [Amended]

0
16. Effective March 13, 2017, in Sec.  529.1186, in paragraph (b),
remove ``010019,''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
17. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
18. In Sec.  558.325, revise paragraph (e)(1)(ii) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination  in
     Lincomycin  grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(ii) 2........................  Halofuginone 2.72  Broiler chickens: For   Feed continuously as           016592
                                                    the control of          sole ration.
                                                    necrotic enteritis      Withdraw 4 days
                                                    caused or complicated   before slaughter. Do
                                                    by Clostridium spp.     not feed to laying
                                                    or other organisms      chickens or
                                                    susceptible to          waterfowl.
                                                    lincomycin; and the     Halofuginone
                                                    prevention of           hydrobromide as
                                                    coccidiosis caused by   provided by No.
                                                    Eimeria tenella, E.     016592 in Sec.
                                                    necatrix, E.            510.600 of this
                                                    acervulina, E.          chapter.
                                                    brunetti, E. mivati,
                                                    and E. maxima.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03930 Filed 2-28-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Pages 56625-56626]
[FR Doc No: 2020-20191]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2020-0030; OMB No. 1660-0002]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Disaster Assistance Registration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: 60-Day notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on a revision of
a currently approved information collection. In accordance with the
Paperwork Reduction Act of 1995, this notice seeks comments concerning
Disaster Assistance Registration.

DATES: Comments must be submitted on or before November 13, 2020.

ADDRESSES: To avoid duplicate submissions to the docket, please use the
following means to submit comments:
    Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2020-0030 Follow the instructions for submitting comments.
    All submissions received must include the agency name and Docket
ID. All submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy and
Security Notice that is available via a link on the homepage of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Brian Thompson, Supervisory Program
Specialist, FEMA, Recovery Directorate<EMAIL_ADDRESS>
540-686-3602. You may contact the Information Management Division for
copies of the proposed collection of information at email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Pub. L. 93-288, 42 U.S.C. 5121, et seq.) (the
Stafford Act), as amended, is the legal basis for the Federal Emergency
Management Agency (FEMA) to provide financial assistance and services
to individuals who apply for disaster assistance benefits in the event
of a federally-declared disaster. Title 44 CFR, Part 206, Subpart D,
``Federal Assistance to Individuals and Households,'' provides the
regulatory framework implementing the policy and procedures set forth
in Sec.  408 of the Stafford Act. This program provides financial
assistance and, if necessary, direct assistance to eligible individuals
and households who, as a direct result of a major disaster, have
necessary expenses and serious needs that are unable to be met through
other means. Individuals and households may apply for assistance
(Registration Intake) under the Individuals and Households program in
person, via telephone, or internet.

Collection of Information

    Title: Disaster Assistance Registration.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0002.
    FEMA Forms: FEMA Form 009-0-1T (English) Tele-Registration,
Disaster Assistance Registration; FEMA Form 009-0-1Int (English)
internet, Disaster Assistance Registration; FEMA Form 009-0-2Int
(Spanish) internet, Registro Para Asistencia De Desastre; FEMA Form
009-0-1 (English) Paper Application, Disaster Assistance Registration;
FEMA Form 009-0-2 (Spanish), Solicitud en Papel, Registro Para
Asistencia De Desastre; FEMA Form 009-0-3 (English), Declaration and
Release; FEMA Form 009-0-4 (Spanish), Declaraci[oacute]n Y
Autorizaci[oacute]n; FEMA Form 009-0-5 (English), Manufactured Housing
Unit Revocable License and Receipt for Government Property; FEMA Form
009-0-6 (Spanish), Las Casas Manufacturadas Unidad Licencia Revocable y
Recibo de la Propiedad del Gobierno; Request for Information.
    Abstract: The forms in this collection are used to obtain pertinent
information to provide financial assistance, and if necessary, direct
assistance to eligible individuals and households who, as a direct
result of a disaster or emergency, have uninsured or under-insured,
necessary or serious expenses they are unable to meet. To provide
meaningful access to individuals with disabilities throughout FEMA
programs, the revision to the collection will obtain pertinent
disability-related information.
    Affected Public: Individuals or Households.
    Estimated Number of Respondents: 1,004,488.

    Estimated Number of Responses: 1,004,488.
    Estimated Total Annual Burden Hours: 356,007.
    Estimated Total Annual Respondent Cost: $13,368,063.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $32,192,627.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Maile Arthur,
Deputy Director of Information Management, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2020-20191 Filed 9-11-20; 8:45 am]
BILLING CODE 9111-23-P