Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 43043 

■ 2. In § 14.100, add paragraph (a)(5) to 

read as follows: 

§ 14.100 List of standing advisory 

committees. 

* * * * * 

(a) * * * 

(5) Tobacco Products Scientific 

Advisory Committee. 

(i) Date Established: August 12, 2009. 

(ii) Function: The committee reviews 

and evaluates safety, dependence, and 

health issues relating to tobacco 

products and provides appropriate 

advice, information, and 

recommendations to the Commissioner 

of Food and Drugs. Specifically, the 

committee will submit reports and 

recommendations on tobacco-related 

topics, including: The impact of the use 

of menthol in cigarettes on the public 

health, including such use among 

children, African Americans, Hispanics 

and other racial and ethnic minorities; 

the nature and impact of the use of 

dissolvable tobacco products on the 

public health, including such use on 

children; the effects of the alteration of 

nicotine yields from tobacco products 

and whether there is a threshold level 

below which nicotine yields do not 

produce dependence on the tobacco 

product involved; and any application 

submitted by a manufacturer for a 

modified risk tobacco product. The 

committee may provide 

recommendations to the Secretary of 

Health and Human Services regarding 

any regulations to be issued under the 

Federal Food, Drug, and Cosmetic Act 

and may review any applications for 

new tobacco products or petitions for 

exemption under section 906(e) of the 

Family Smoking Prevention and 

Tobacco Control Act. The committee 

may consider and provide 

recommendations on any other matter 

as provided in the Family Smoking 

Prevention and Tobacco Control Act. 

* * * * * 

Dated: August 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20485 Filed 8–26–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 516 

[Docket No. FDA–2008–N–0176; Formerly 

Docket No. 2008N–0011] 

RIN 0910–AG03 

Defining ‘‘Small Number of Animals’’ 

for Minor Use Designation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

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, the Food and Drug 

Administration (FDA) is amending the 

implementing regulations of the MUMS 

Act. In response to Congress’ charge to 

the agency to further define minor use, 

this amendment establishes 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: This rule is effective November 

9, 2009. 

FOR FURTHER INFORMATION CONTACT: Meg 

Oeller, Center for Veterinary Medicine 

(HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9005, email: Margaret.Oeller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 18, 

2008 (73 FR 14411), FDA issued a 

proposed rule (the March 2008 

proposed rule) intended to define the 

term ‘‘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. As noted in that 

proposed rule, the MUMS Act (Public 

Law 108–282) amended the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C 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 FD&C Act (21 U.S.C. 321(pp))). The 

major species are cattle, horses, swine, 

chickens, turkeys, dogs, and cats 

(section 201(nn) of the FD&C Act (21 

U.S.C. 321(nn))). 

Prior to enactment of the MUMS Act, 

FDA defined by regulation minor use 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’’ (formerly 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’’ (section 201(pp) of the FD&C 

Act). 

The legislative history of the MUMS 

Act indicates that Congress intended 

that FDA further define by regulation 

minor use in a major species 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’’ (see S. Rept. 

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’’ (see 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 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 

now defining the term ‘‘small number of 

animals’’ by establishing for each major 

species a number 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, this definition establishes 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 

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43044 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

in the absence of the MUMS Act 

incentives. 

II. Comments 

The agency received comments from 

seven organizations or individuals on 

the March 2008 proposed rule. 

Comments were received from a trade 

organization representing new animal 

drug manufacturers, a trade organization 

representing turkey producers, a 

professional association representing 

veterinarians, an organization 

concerned with the ethical treatment of 

animals, an animal pharmaceutical 

manufacturer, a law firm representing 

an unidentified client, and a consumer. 

(Comment 1) One comment indicated 

unqualified support for the March 2008 

proposed rule and three additional 

comments stated appreciation for the 

agency’s attempt to establish what was 

variously described as a ‘‘quantitative,’’ 

‘‘reasonable,’’ ‘‘bright-line,’’ 

‘‘understandable,’’ or ‘‘easy to use’’ 

approach for determining whether an 

intended use of an animal drug in a 

major species is a minor use. However, 

all of the latter comments went on to 

note various concerns with the 

proposed approach which are addressed 

in the following paragraphs. 

(Response) FDA appreciates the 

characterization of its attempted 

approach as ‘‘quantitative,’’ 

‘‘reasonable,’’ ‘‘bright-line,’’ 

‘‘understandable,’’ and ‘‘easy to use.’’ 

(Comment 2) Three comments 

indicated that the agency should not 

establish ‘‘fixed’’ or ‘‘static’’ small 

numbers, but instead should establish 

the small numbers as a percentage of 

each major species population. Also, 

three comments stated that, if the 

agency did elect to use fixed or static 

numbers, the small numbers (or the 

entire approach) should be reevaluated 

at least every 5 years—preferably, more 

frequently. The comments stated or 

implied that the suggested reevaluation 

was associated with the potential for 

increasing populations of a major 

species. An additional comment 

suggested periodic reevaluation of the 

small numbers based on the potential 

for an increase in the cost of drug 

development. 

(Response) FDA agrees that there is a 

need to periodically reevaluate the 

definition of ‘‘small number of 

animals.’’ Because Congress did not 

establish by statute what a ‘‘small 

number’’ is, it affords FDA the 

opportunity to periodically reevaluate 

and update the definition of ‘‘small 

number of animals’’ as necessary. We 

further agree that such a reevaluation 

should take into account the potential 

for increases in the development cost of 

new animal drugs, but note that it also 

should take into account potential 

increases in the cost that animal owners 

are willing to pay to treat affected 

animals as well as other factors involved 

in establishing ‘‘small numbers,’’ such 

as changes in the total population of 

major animal species. 

As Congress noted in the legislative 

history of the MUMS Act, it is the 

relationship between the development 

cost of an animal drug and the potential 

market value of an animal drug that 

determines the need for the minor use 

drug development incentives provided 

by the MUMS Act (see S. Rept. 108–226 

at 12–13). If the number of animals 

affected by a given disease is great 

enough to produce a market potential 

sufficient to support the development 

cost of an animal drug in the absence of 

the minor use incentives of the MUMS 

Act, then the incentives should not be 

provided. The incentives should be 

reserved for cases in which the number 

of animals affected by a disease is not 

great enough to produce a market 

potential sufficient to support the 

development costs of an animal drug in 

the absence of the minor use incentives 

of the MUMS Act. 

With respect to population increase as 

a basis for reevaluation of ‘‘small 

numbers,’’ if the number of animals 

affected by a disease increases over time 

due to increasing rate of occurrence of 

the disease in the population, or simply 

due to an increase in the total 

population of animals with a steady rate 

of disease occurrence, the market value 

of a drug intended to treat the disease 

would also tend to increase and the 

need for minor use incentives to support 

drug development for that disease 

would tend to decrease—unless animal 

drug development cost or other factors 

change to a greater extent over the same 

period of time. Therefore, the effects of 

population change need to be evaluated 

in the context of periodically 

reevaluating other factors affecting the 

establishment of ‘‘small numbers.’’ 

If the relationship between drug 

development cost and drug market 

value changes sufficiently over time, the 

‘‘small number of animals’’ should 

change as well. Note, however, that 

once a particular new animal drug has 

been designated for a particular 

intended use that has been determined 

to be a minor use, the designation and 

associated incentives will not be 

affected by subsequent changes in drug 

market value or published ‘‘small 

numbers’’ (see § 516.29(h) (21 CFR 

516.29(h))). 

Further reason for periodic 

reevaluation of the ‘‘small numbers’’ is 

that either the agency may have 

misperceived the current relationship 

between development cost, market 

value, and the value of the MUMS 

minor use incentives, or the animal 

pharmaceutical industry’s perception of 

the relationship between these factors 

sufficient to support drug development 

could change over time. 

In any event, as noted previously, 

FDA agrees that the ‘‘small numbers’’ 

should be periodically reevaluated and 

intends to do so. FDA will update the 

numbers through proposed rulemaking, 

as warranted, based on the results of the 

reevaluation. 

(Comment 3) Two comments 

suggested that FDA not implement the 

proposal at all and that the agency make 

minor use determinations on a case-bycase basis. 

(Response) The agency began making 

minor use determinations ‘‘on a case-bycase basis’’ in the absence of published 

‘‘small numbers’’ over 3 years ago, but 

found that it could not equitably do so 

without establishing a standard against 

which to assess the individual cases. 

The agency had no reasonable basis to 

establish different small numbers for the 

same intended use depending upon the 

relative efficiency of each sponsor’s 

drug development processes. Nor could 

it determine any practical basis to 

equitably establish a different small 

number for every intended use based on 

perceived potential drug market value 

for each of those uses. 

As explained in the preamble to the 

March 2008 proposed rule, the agency 

determined that the most equitable 

means of establishing the small number 

for each major companion animal 

species was to use the best available 

information regarding the relationships 

between the number of animals eligible 

to be treated, the potential value of drug 

treatment for those animals, and the cost 

of animal drug development to establish 

a single small number for each major 

species that would apply for all new 

animal drugs. Evaluating the 

relationship between these factors on a 

case-by-case basis would require 

sponsors to divulge, and the agency to 

assess, information regarding the cost of 

development of specific animal drugs. 

Sponsors are reluctant to share such 

information with the agency. 

Small numbers for major food animal 

species were established on a different 

basis and this process is discussed in 

response to comment 11 of this 

document. 

Additionally, making one small 

number for each major species publicly 

available permits sponsors to 

independently assess, early in the drug 

development process, the likelihood 

that particular potential intended uses 

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Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 43045 

will qualify as minor uses and plan drug 

development accordingly. 

(Comment 4) Two comments 

indicated that obtaining epidemiological 

data on animal disease prevalence is 

‘‘difficult to impossible’’ or ‘‘almost 

impossible’’ to obtain. One comment 

was apparently made as a basis for 

arguing against the establishment of 

small numbers, and the other for the 

purpose of requesting information 

regarding how such information might 

be obtained. 

(Response) The agency indicated in 

the preamble to the 2005 proposed 

designation regulation that, in order to 

document minor use status, sponsors 

needed to provide an estimate of the 

number of animals eligible to be treated 

for a particular intended use per year 

(70 FR 56394 at 56400, September 27, 

2005). We acknowledged at that time 

that such information ‘‘is not readily 

available for uncommon animal diseases 

or conditions.’’ Nevertheless, there is 

clearly no way to determine whether the 

population of animals eligible to be 

treated for a given disease or condition 

meets the statutory standard of a small 

number of animals without determining 

the number of animals eligible to be 

treated in the first place. 

Whether the agency determines that 

the population of animals eligible to be 

treated is a small number by means of 

applying the objective standard used in 

this regulation, or by means of some 

undefined subjective process applied on 

a case-by-case basis, it does not alter the 

need to know, in the first place, the 

number of animals subject to the 

intended use under consideration. 

Fortunately, based on our experience 

in reviewing requests for minor use 

determination up to this point, it has 

not been as difficult as expected to 

obtain sufficient information to 

determine whether an indication 

qualifies as a minor use. In fact, of the 

designation requests involving nonaquatic species, most have involved 

minor use in major species. Of these 

designation requests, more have been 

granted for minor use in major species 

than for minor species. Thus, it has 

routinely proven possible to gather the 

needed information regarding animal 

disease occurrence, and this information 

has been sufficient to support 

determinations that an intended use 

actually is a minor use. FDA, therefore, 

does not agree with the comments that 

it is ‘‘almost impossible’’ to obtain such 

information. 

With respect to the comment that 

requested information on how to obtain 

such information, most of the 

determinations of minor use made by 

FDA to this point have been based on 

a compilation of information available 

in the veterinary literature. In some 

cases, this information was augmented 

with unpublished information available 

from databases containing information 

on the rate of occurrence of animal 

diseases, or the results of surveys of 

appropriate veterinary experts 

conducted by sponsors or other (third) 

parties. In at least one case, the 

determination was based almost 

exclusively on a sponsor-initiated 

survey of veterinary experts conducted 

in accordance with sound statistical 

practices. 

(Comment 5) One comment suggested 

that FDA should support conditional 

approval and exclusivity to the greatest 

extent possible even when the number 

of animals involved exceeds a small 

number. 

(Response) While we appreciate the 

commenter’s position with respect to 

the maximization of the minor use 

incentives, the MUMS Act limits the 

incentives associated with the 

development of drugs intended for 

minor use in major species to intended 

uses involving a ‘‘small number of 

animals.’’ This statutory restriction 

prevents FDA from extending MUMS 

Act provisions to indications in major 

species that exceed the ‘‘small number’’ 

restriction. 

(Comment 6) One comment stated 

that FDA should not provide an 

incentive to develop any animal drug 

product intended for use in industrial 

aquaculture or agribusiness. 

(Response) The MUMS Act does not 

contain any language excluding 

‘‘agribusiness’’ from the incentives of 

the MUMS Act. The incentives are 

available to all minor uses in major 

species, including food-producing 

animals, with the exception of 

genetically engineered animals. 

Industrial aquaculture, referred to by the 

commenter, deals entirely with minor 

species and minor species are outside 

the scope of this regulation. 

Just as the agency could not ignore a 

statutory restriction in response to the 

previous comment, FDA cannot exclude 

‘‘agribusiness’’ from the MUMS Act 

provisions in response to this comment 

when such a restriction does not appear 

in the statutory language. 

(Comment 7) One comment stated 

that the preamble to the March 2008 

proposed rule implies that the purpose 

of the limitation of minor use to a small 

number of animals is to prevent wider 

use and that this contradicts a statement 

made in the response to a comment on 

the 2005 proposed designation 

regulation, which the commenter 

summarized as ‘‘the purpose (of 

defining a subset of a major species 

which may have a particular disease or 

condition) is not to prevent a drug with 

MUMS approval for disease A from 

being used in disease B or C.’’ 

(Response) When Congress expressed 

concern regarding the prevention of 

‘‘wider use’’ of minor use animal drugs 

it was in the context of defining the 

‘‘small number of animals’’ for which a 

minor use new animal drug may be 

intended if such drug were to qualify for 

MUMS Act incentives (see S. Rept. 108– 

226 at 12–13). The intended use of a 

new animal drug is the particular use 

for which an animal drug sponsor 

intends that it be used as determined 

through various means, including 

statements in the labels and labeling. 

The cited response to a comment on the 

2005 proposed designation regulation 

dealt with the provision to permit 

sponsors to decrease the number of 

animals eligible to be treated by a given 

drug by the subset of animals for which 

treatment would be medically 

inappropriate. In trying to clarify this 

provision, the agency stated what the 

provision did not do. FDA did not 

intend to require a sponsor to 

demonstrate that the drug at issue could 

not be administered for a use other than 

the intended use for which a minor use 

determination was being sought. FDA’s 

intent was for the MUMS incentives to 

be available for drug products for 

labeled intended uses involving a small 

number of animals. 

In the agency’s judgment, because 

neither the ‘‘wider use’’ concept 

articulated by Congress nor the specific 

provision of the 2005 proposed 

designation regulation just discussed 

were intended to involve any use of an 

animal drug beyond the scope of its 

intended use, the agency’s statements in 

the recent preamble to the March 2008 

proposed rule and in the cited response 

to a comment on the 2005 proposed 

designation regulation are consistent. 

(Comment 8) One comment noted that 

the 2007 final designation regulation (72 

FR 41010, July 26, 2007) uses the phrase 

‘‘* * * total number of animals to 

which the drug could potentially be 

administered on an annual basis’’ 

whereas the preamble to the March 2008 

proposed rule on ‘‘small numbers’’ uses 

the phrase ‘‘* * * eligible to be treated 

on an annual basis.’’ The comment 

requested clarification of the meaning of 

the phrases and suggested that 

something along the lines of ‘‘* * * 

number of cases * * *’’ rather than 

‘‘* * * number of animals likely to be 

treated * * *’’ would be more 

appropriate. 

(Response) FDA did not intend any 

difference in meaning between the 

phrases ‘‘* * * eligible to be treated on 

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43046 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

an annual basis’’ and ‘‘total number of 

animals to which the drug could 

potentially be administered on an 

annual basis.’’ 

As noted in the preamble to the 2005 

proposed designation regulation, there 

is a special circumstance involving drug 

use in food-producing major species in 

which drugs are administered on a herd 

or flock basis so that the drug is 

administered to animals that do not 

have the disease or condition. The 2005 

proposed designation regulation takes 

note of this special circumstance, 

because the phrase ‘‘* * * number of 

animals to which the drug could 

potentially be administered on an 

annual basis * * *’’ is followed by the 

phrase ‘‘* * * including animals 

administered the drug as part of herd or 

flock treatment * * *.’’ 

The 2005 proposed designation 

regulation needed to capture the special 

case of herd or flock treatment as well 

as the general principle involved in 

establishing the population of animals 

to which a drug might be administered 

for a particular intended use. As 

previously noted, it is this total 

population of animals that the agency 

relied upon to establish the market 

potential on an annual basis for the drug 

under consideration and this market 

potential, in turn, was a primary factor 

in establishing the ‘‘small numbers’’ in 

this final rule. 

(Comment 9) A related comment 

requested clarification of the phrase ‘‘on 

an annual basis’’ and suggested that the 

phrase should be interpreted to mean 

that the small number of animals would 

include only new cases of a disease or 

condition appearing each year, that is, 

what is typically referred to as the 

‘‘incidence’’ of a disease or condition in 

any given year rather than the total 

number of cases of the disease or 

condition existing during the year, that 

is, what is typically referred to as the 

‘‘prevalence’’ of the disease or condition 

over the course of the year. 

(Response) The agency devoted 

considerable discussion to this issue in 

the preamble to the 2005 proposed 

designation regulation. We concluded 

that it is the total number of animals, on 

an annual basis, eligible to be treated or, 

in some circumstances (in accordance 

with the previous discussion), the total 

number of animals that could 

potentially be administered a drug for a 

particular intended use (i.e., including 

whole herds or flocks that might be 

treated) that represents the annual 

market potential for an animal drug and, 

therefore, it is this population of 

animals that is of concern to the agency. 

Also, as noted in the preamble to the 

2005 proposed designation regulation, 

because of the variability in the time 

course of diseases and the variability in 

life-span of the seven major species of 

animals, general application of either of 

the terms ‘‘prevalence’’ or ‘‘incidence’’ 

would not be particularly helpful (70 FR 

56394 at 56397). 

Experience gained in reviewing the 

veterinary literature in support of 

requests for minor use determination 

has led to the understanding that there 

is considerable inconsistency in how 

the terms ‘‘incidence’’ and ‘‘prevalence’’ 

are used with respect to the reporting of 

estimates of animal disease occurrence. 

Therefore, the agency is less concerned 

with the formal definitions of 

‘‘incidence’’ and ‘‘prevalence’’ relative 

to the way the terms are used in the 

context of describing any particular 

study or body of information, and more 

concerned with the manner in which a 

study is performed or information is 

captured relative to its ability to 

contribute to an estimate of the total 

population of animals eligible to be 

treated for a given disease or condition 

over the course of a year. As a result, 

FDA relied upon the total number of 

animals ‘‘eligible to be treated on an 

annual basis’’ to define ‘‘small 

numbers’’ rather than relying on 

‘‘incidence’’ or ‘‘prevalence’’ of disease. 

(Comment 10) Another related 

comment requested clarification of 

whether the ‘‘small numbers’’ refer to 

the number of ‘‘animals’’ or the number 

of ‘‘treatments’’ on an annual basis. 

(Response) The small numbers refer to 

the number of animals, not the number 

of treatments, on an annual basis. 

Depending on the nature of the 

disease or condition involved, the 

treatment of a given animal could 

consist of a single short course of 

treatment or could require repeated 

administration of a drug over a 

significant period of time, potentially 

for the entire life of the animal 

subsequent to the initiation of 

treatment. Each year that an animal with 

such a disease or condition lives after 

the initiation of treatment, it constitutes 

part of the population of animals 

eligible for treatment in that year and, 

therefore, it is part of the market 

potential for the drug (or drugs) with 

which it is being treated for that year. 

(Comment 11) One comment stated 

that the agency should consider turkeys 

to be a quasi-minor species, and that in 

setting the small number for turkeys the 

agency should consider that a much 

higher percentage of turkeys are treated 

by feed or water on a flock basis than 

sheep, which are more commonly 

treated on an individual animal basis. 

(Response) The MUMS Act defines 

turkeys as a major species (section 

201(nn) of the FD&C Act). FDA cannot 

change that definition without a 

statutory change. 

With respect to factoring the method 

of drug administration into the 

comparison between turkeys and sheep 

that was utilized to establish the small 

number for turkeys, we note that the 

agency operated on the assumption that 

all of the sheep existing in the United 

States in 2004 were eligible to be treated 

and further assumed that all of the 

sheep going to slaughter in that year had 

been treated. Because the assumption 

was that 100 percent of sheep going to 

slaughter were treated that year, 

regardless of the method of drug 

administration, the treatment rate could 

not have been any higher if the sheep 

were treated on a flock basis rather than 

an individual basis. As a result, the 

method of drug administration does not 

affect the small number FDA established 

for turkeys. 

(Comment 12) One comment stated 

that many compounds that could be 

developed for a small number of 

companion animals are likely to be 

‘‘specialty compounds’’ and/or new 

classes of drugs that are likely to have 

substantially higher development costs 

than the estimate provided in the March 

2008 proposed rule, and that, therefore, 

the agency should utilize an estimated 

development cost for minor use new 

animal drugs of $25 million rather than 

$15 million. 

(Response) While development costs 

for some minor use new animal drugs 

could exceed the $15 million estimate 

utilized by the agency in the process of 

establishing small numbers, we note 

that the estimates of development costs 

for companion animal drugs provided 

by the animal pharmaceutical industry 

itself generally fall in the range of $10 

million to $20 million with a number of 

estimates as low as $5 million (Ref. 1). 

There is no evidence to show that the 

development of ‘‘specialty compounds 

and/or new classes of drugs’’ is unique 

to minor uses. Moreover, the industry’s 

estimate of its development costs for 

companion animal drugs did not 

capture an estimate as high as $25 

million even in its overall range of 

development costs. This indicates that a 

development cost for a companion 

animal drug as high as $25 million 

would be unusual. 

In addition, we note that drugs that 

could be developed for relatively rare 

conditions in animals are often also 

under development, or have already 

been developed, for similar or related 

conditions in humans so that the 

relative infrequency of an intended drug 

use in animals may not correlate with a 

higher than usual development cost. 

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Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 43047 

Therefore, the agency determines that 

there is currently no convincing 

information available to support 

increasing its estimate of companion 

animal drug development cost, but will 

periodically reexamine this estimate 

along with others supporting the 

establishment of small numbers for 

major companion animal species to 

determine whether the small numbers 

need to be revised. 

(Comment 13) One comment stated 

that the agency’s estimate of $10 million 

for third-year sales of a companion 

animal drug was too high for a minor 

use drug, and that the figure should be 

lowered to $3 million. 

(Response) The agency determined 

the $10 million figure on the basis of 

animal drug marketing principles 

provided by outside experts in the 

development of animal drugs (Ref. 1). 

As noted in the preamble to the March 

2008 proposed rule, one of those basic 

principles was that, taking into 

consideration the current animal drug 

development incentives associated with 

exclusivity under the Generic Animal 

Drug and Patent Term Restoration Act, 

a sponsor would need to perceive a 

potential third-year market value for an 

animal drug equivalent to the 

development cost of the drug in order to 

pursue development (73 FR 14411 at 

14413). The agency received no 

comments that contradicted the validity 

of this basic principle. 

The agency also relied on the 

principle that the 7 years of exclusive 

marketing rights provided to MUMS 

drugs ‘‘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’’ (73 FR 14411 at 14413). 

Again, the agency received no 

comments opposing the validity of this 

basic principle. 

The agency then applied these two 

principles to estimate that the 

quantitative effect of the additional 2 

years of exclusivity associated with the 

approval of a designated minor use drug 

was to lower the perceived third-year 

drug market value needed to support a 

decision to develop a drug by about onethird (73 FR 14411 at 14413). The 

agency received no comments opposing 

the validity of the general conclusion 

drawn from the application of the basic 

principles noted in the previous 

paragraphs. 

The figure of $10 million as the 

perceived third-year market necessary to 

support the development of a drug with 

a $15 million development cost is 

simply the result of applying the general 

conclusion to a reasonable estimate of 

the development cost of a companion 

animal drug. 

The implication in the comment that 

many companion animal drugs have 

been developed in the past for intended 

uses whose third-year market values 

were less than the agency’s $10 million 

estimate could be interpreted in a 

number of ways, including the 

following: That the development cost 

for the drugs was less than $10 million; 

that the sponsors involved were willing 

to accept a return on investment lower 

than a third-year market equal to 

development costs when they made the 

decision to develop the drugs; and/or 

that actual market values routinely fail 

to achieve the potential market value 

perceived by sponsors, on the basis of 

which sponsors decide to develop 

drugs. 

Of these possible interpretations, the 

latter appears the most improbable, 

because it is unlikely that animal drug 

sponsors could survive the economic 

consequences of routinely failing to 

accurately predict potential markets. 

The other two possibilities appear to 

support a conclusion that the agency 

may have overestimated drug 

development cost and/or the perceived 

return on investment needed to support 

animal drug development. 

Therefore, the implication that thirdyear market values less than $10 million 

have routinely supported animal drug 

development in the past (in the absence 

of the MUMS incentives), argues in 

favor of decreasing estimated drug 

development cost or decreasing the 

estimated 1:1 relationship between 

development cost and perceived thirdyear market value (absent the value of 

MUMS exclusivity) that the agency 

assumed was needed to support animal 

drug development. This would lead to 

a decrease in the estimated size of the 

population of animals eligible to be 

treated that is needed in order to 

provide a market value sufficient to 

support drug development. 

The agency notes in passing that the 

comment stating that the agency’s 

estimate of third-year market value 

needed to support companion animal 

drug development was too high tends to 

contradict the preceding comment 

(comment 12 of this document) which 

argued that the agency’s proposed 

estimate of companion animal drug 

development cost for a minor use was 

too low. More significantly, no 

comments provided evidence to support 

decreasing either the proposed estimate 

of companion animal drug development 

cost or of the 1:1 relationship between 

development cost and perceived market 

value (absent the value of MUMS 

exclusivity) that the agency assumed 

was needed to support animal drug 

development. However, the agency will 

periodically reexamine these estimates 

along with others supporting the 

establishment of small numbers for 

major companion animal species based 

on newly available information 

regarding drug development costs and 

other factors to determine whether the 

small numbers need to be revised. 

(Comment 14) One comment stated 

that production costs would be 

relatively higher for drugs intended for 

the small number of animals associated 

with minor use because such drugs lack 

the economy of scale associated with 

the production of drugs intended for 

larger numbers of animals. 

(Response) While it is possible that 

production costs could be a determining 

factor in the decision to develop a 

particular drug product for a particular 

minor use, it appears that many other 

factors are considerably more important 

in determining the price of a drug 

product and, therefore, its market value, 

and that differences in cost associated 

with scale of production would rarely 

be the determining factor in the decision 

to develop a drug for a minor use (Ref. 

2). 

Thus far, sponsors seeking minor use 

determinations have not expressed 

concern to FDA regarding the effect of 

limited market size on the cost of drug 

production. 

Therefore, the agency is not 

convinced that, in general, the potential 

impact of this factor is sufficient in itself 

to prevent the development of animal 

drugs for minor uses in accordance with 

the small numbers of animals 

established by this regulation. 

(Comment 15) One comment stated 

that, for a variety of reasons, the agency 

should consider the drug treatment rate 

for minor uses in companion animals to 

be 25 percent rather than 50 percent. 

(Response) A number of independent 

sources appear to agree that a reasonable 

estimation of the treatment rate for 

companion animals is on the order of 50 

percent (Ref. 3). The comment does not 

appear to take exception to this as a 

general estimate of companion animal 

treatment rate, but argues that it is too 

high for ‘‘a rare condition * * * 

especially in the first years of a new 

drug’s availability’’ because ‘‘many of 

these conditions have a poor prognosis 

or occur in older pets for which the 

owner is more likely to do nothing or 

consider euthanasia’’ and that the 

utilization of a drug for a minor use is 

‘‘likely to be slower due to higher cost, 

limited distribution, and less 

promotion’’ than for a major use. 

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43048 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

The agency believes that a companion 

animal owner’s decision to treat has a 

great deal to do with the seriousness of 

the disease or condition involved, the 

cost of treatment, and the emotional 

value of a pet, and has relatively little 

to do with the rarity of the disease or 

condition warranting treatment. There is 

no reliable information to conclude that 

the treatment rate of a rare disease 

would be routinely lower than the 

treatment rate of a common disease, 

simply on the basis that it is rare. 

Based on FDA’s experience with 

minor use determinations thus far, the 

agency believes that a primary 

characteristic of the drugs pursued for 

minor uses in animals under the 

incentives provided by the MUMS Act 

will be for uses where there is a longestablished need for treatment and no 

legally available, practical, or affordable 

treatment option. Because these 

intended uses most often involve 

diseases or conditions that are relatively 

serious and that result in considerable 

animal suffering, in the absence of legal, 

practical, safe and effective treatment 

options an animal owner might turn to 

euthanasia. However, if an effective 

treatment were available these are the 

kinds of diseases and conditions that 

animal owners would be inclined to 

treat once a definitive diagnosis was 

made, irrespective of the frequency of 

occurrence of the disease or condition 

in the population (see the results of the 

surveys cited in the following 

paragraphs). 

Under these circumstances, the 

factors most likely to affect an animal 

owner’s decision to treat are the pet’s 

perceived value, the cost of treatment, 

and the potential effects, positive and 

negative, of treatment. In any particular 

case in which a veterinarian concludes 

that the risks associated with treatment 

outweigh the benefits, the appropriate 

course of action would be a 

recommendation of no treatment or 

euthanasia (depending on the prognosis 

for an untreated animal). This would be 

true regardless of the cost of the 

treatment or whether the disease or 

condition is rare or common. When a 

veterinarian concludes that the benefits 

of treatment outweigh the risks, 

depending upon the nature of the 

treatment recommended, the animal 

owner is faced with a decision that 

could very well depend upon the cost 

of treatment relative to the prognosis. 

Therefore, the agency gathered 

considerable information relating to the 

willingness of companion animal 

owners to treat serious (significantly 

debilitating or life-threatening, if 

untreated) diseases or conditions in 

their pets in the process of estimating 

both practical drug treatment values and 

the likelihood of treatment. The agency 

found the following: 

A 1999 report commissioned by the 

American Veterinary Medical 

Association, the American Animal 

Hospital Association, and the 

Association of American Veterinary 

Medical Colleges (Ref. 4) states that: 

• Pet owners say they would pay 

$688 for a 75 percent chance of 

successfully treating their pet and $356 

for only a 10 percent chance of a 

successful treatment. 

• Pet owners say they would pay an 

average of $1,042 to keep their favorite 

pet (dog) from dying and $657 to keep 

their favorite pet (cat) from dying. 

• Horse owners would pay an average 

of $1,827 for a 75 percent chance of 

successfully treating their horse and 

$828 for a 10 percent chance. 

• Horse owners say they would pay 

an average of $3,314 to keep their 

favorite horse from dying and $2,010 for 

their least favorite horse. 

A 2002 survey of pet owners by the 

American Animal Hospital Association 

found that 73 percent of pet owners 

would go into debt to provide for their 

pet’s well-being and 73 percent would 

spend from $1,000 up to any amount in 

a life-threatening situation (Ref. 1). 

A 2003 survey of veterinarians by 

DVM Magazine found that, among 

companion animal practitioners, the 

cost at which a majority of pet owners 

would refuse treatment was just under 

$1,100, and that 26 percent of pet 

owners would treat regardless of price 

and an additional 34 percent would 

treat in accordance with all of the 

veterinarian’s recommendations (Ref. 5). 

A 2005 survey of pet owners by Hartz 

Mountain found that 32 percent said 

that money was no object when it came 

to their pet’s health (Ref. 6). 

These surveys demonstrate that 

companion animal owner willingness to 

care for their animals regardless of cost 

has increased over time, and may have 

continued to increase since the surveys 

noted in the previous paragraphs. Given 

this information, it is difficult to 

conclude that cost alone would decrease 

treatment rates for serious diseases or 

conditions below the estimate of 50 

percent proposed by the agency. 

With respect to the comment that 

treatment rate would be negatively 

influenced by the lack of awareness of, 

or simply the lack of availability of, a 

drug once it was developed, approved, 

and marketed, due to limited promotion 

or distribution, we note again that many 

minor uses involve conditions or 

diseases for which no practical and legal 

treatment options exist and for which 

effective treatments may have been 

desired by veterinarians for years. 

Under such circumstances, it should not 

take a significant effort to either inform 

veterinarians of the availability of a drug 

for such a disease or condition or to 

convince them of the need for it. 

Therefore, the agency determines that 

there is currently no reliable evidence to 

support decreasing the proposed 

estimate of drug treatment rate for minor 

uses in companion animals, but will 

periodically reexamine this estimate 

along with others supporting the 

establishment of small numbers for 

major companion animal species to 

determine whether the small numbers 

need to be revised. 

(Comment 16) One comment stated 

that a manufacturer receives 

approximately 25 percent of the actual 

cost paid by an animal owner for drug 

treatment, that the rest goes to those 

involved in drug distribution up to the 

point of treatment, and, therefore, that a 

more appropriate drug treatment value 

for dogs would be $100 rather than 

$350. 

(Response) The $350 referenced by 

the comment represents the agency’s 

estimate of the drug treatment value to 

the manufacturer for a product intended 

for use in dogs in order to justify drug 

development for an uncommon, but 

serious condition—with the 

understanding that the price to the 

animal owner would be significantly 

higher. 

While there may be circumstances 

under which a manufacturer would 

receive only 25 percent of the actual 

cost paid by an animal owner for drug 

treatment, the agency does not agree 

that 25 percent represents the typical 

manufacturer share of the cost to an 

animal owner for new animal drugs of 

the kind that are likely to qualify for 

minor use status. 

The manufacturer’s price for a new 

animal drug product and the subsequent 

prices of those involved in the 

distribution of the product to the animal 

owner are significantly affected by a 

number of factors including the nature 

of the drug involved, the significance of 

the intended use of the product, the 

availability of alternative products for 

the intended use, and ultimately by the 

amount that animal owners are willing 

to pay to treat their animals for 

particular intended uses (see the results 

of the surveys cited in the response to 

the previous comment). 

Based on the information available to 

the agency, a more typical example of 

pricing for a product with an intended 

use in dogs that would qualify for minor 

use status would be about $350 from a 

manufacturer to a distributor, $440 from 

a distributor to a veterinarian, and $880 

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Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 43049 

from a veterinarian to an animal owner. 

Thus the manufacturer would receive 

approximately 40 percent of the cost of 

the drug to the animal owner. However, 

for expensive drugs veterinarians may 

be willing to decrease their price from 

the routine 200 percent of their cost to 

something on the order of 135 to 150 

percent which would result in a price to 

the animal owner of about $590 to $660. 

In this case, the manufacturer would 

receive approximately 50 to 60 percent 

of the cost of the drug to the animal 

owner (Ref. 2). 

As explained in response to comment 

15 of this document, even a final drug 

price of $880 would likely be acceptable 

to most dog owners for the treatment of 

a serious condition. 

The information available to the 

agency, as cited previously, does not 

support the comment’s assertion that 

manufacturers receive only 25 percent 

of the final cost to the animal owner of 

a new animal drug. However, FDA will 

periodically reexamine this estimate to 

determine whether the small numbers 

need to be revised. 

III. Legal Authority 

FDA’s authority for issuing this final 

rule is provided by the MUMS Act 

(section 571 of the FD&C Act et seq. (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 FD&C 

Act (21 U.S.C. 360ccc-2), along with 

section 701(a) of the FD&C Act (21 

U.S.C. 371(a)) provide authority for this 

final rule. Section 701(a) authorizes the 

agency to issue regulations for the 

efficient enforcement of the FD&C Act. 

IV. Analysis of Economic Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (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; distributive 

impacts; and equity). The agency 

believes that this final rule is not a 

significant regulatory action under 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 final rule is only 

expected to slightly reduce the 

administrative effort of ‘‘minor use’’ 

requestors while imposing no additional 

costs, the agency certifies that the final 

rule would not have a significant 

economic impact on a substantial 

number of small entities. 

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 $133 

million, using the most current (2008) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

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 2007 final designation regulation 

presented estimates of the annual costs 

of the MUMS designation system of 

about $65,000 annually. Additionally, 

the 2007 final designation regulation 

provided some discussion of, but was 

not able to quantify, the expected 

benefits of the regulation. 

The 2007 final designation regulation 

included a statement that FDA would 

address the issue of establishing a 

definition of ‘‘small number of animals’’ 

in a future rulemaking. In the March 

2008 proposed rule, FDA proposed a 

specific ‘‘small number of animals’’ for 

each of the seven major animal species 

as defined by the MUMS Act, based on 

the data and analysis described in its 

preamble. 

The March 2008 proposed rule, which 

this rule finalizes, sets 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 

2007 final designation regulation. When 

proposing the rule, FDA did not have 

any additional information to show that 

the proposed threshold numbers would 

significantly affect the expected number 

of MUMS designation requests that are 

received by the agency each year. The 

definition of a ‘‘small number’’ of each 

of the seven major species reduces the 

ambiguity for ‘‘minor use’’ requestors. 

Additionally, the rule provides for a 

small reduction in administrative effort 

by ‘‘minor use’’ requestors who are no 

longer required to provide additional 

information on potential markets and 

drug development costs due to the 

proposed removal of § 516.21(c) (21 CFR 

516.21(c)). 

FDA did not receive any comments 

pertaining to the analysis of impacts 

section of the March 2008 proposed 

rule. Further, FDA has not made any 

substantive changes to this final rule 

that would require significant changes 

to the assumptions used, and 

conclusions reached, in the impacts 

section of the March 2008 proposed 

rule. As such, FDA retains its impacts 

analysis of the March 2008 proposed 

rule for this final rule. FDA has 

determined that the final rule would not 

impose any additional costs or provide 

any further health benefits beyond those 

contained in the 2007 final designation 

regulation. 

V. Paperwork Reduction Act of 1995 

This final rule does not contain new 

information collection provisions that 

would be subject to review by the Office 

of Management and Budget (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 final rule revises the 

minor use provisions of 21 CFR part 

516, subpart B. Part 516 contains the 

implementing regulations for the MUMS 

Act and subpart B contains the 

designation provisions for minor use 

and minor species new animal drugs. 

Currently, requests for minor use 

designation are considered on a case-bycase basis by the agency under a 

regulation (§ 516.21) requiring that 

product-specific financial information 

supporting minor use status be included 

in the request. In order to further define 

minor use, this rule provides 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 the confidential 

product-specific financial information 

described in § 516.21(c). Therefore, the 

reporting burden for minor use 

designation, as currently required in 

§ 516.20(b)(7), will be somewhat lower. 

However, we anticipate that many 

requests for designation will be for 

minor species, not minor use, and 

furthermore, the current requirement for 

financial information is only one part of 

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43050 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

a request for designation, therefore, the 

total paperwork burden currently 

assigned to § 516.20 will not be affected 

significantly. 

This final rule also refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by OMB under the 

PRA. The collections of information in 

§ 516.20 have been approved under 

OMB control number 0910–0605. 

VI. Environmental Impact 

We have carefully considered the 

potential environmental impacts of this 

final rule and 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 final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the 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 concluded that the 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. References 

The following references have been 

placed on display in the Division of 

Dockets Management, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Brakke Consulting, Inc., ‘‘Disease 

Incidence Rates, Drug Development and 

Treatment Costs,’’ September 2005. 

2. Brakke Consulting, Inc., 

‘‘Pharmaceutical Pricing for Companion 

Animal Products,’’ December 2008. 

3. American Veterinary Medical 

Association, ‘‘U.S. Pet Ownership & 

Demographics Sourcebook,’’ 2002. 

4. Brown, J.P., and J.D. Silverman, ‘‘The 

Current and Future Market for Veterinarians 

and Veterinary Medical Services in the 

United States,’’ Journal of the American 

Veterinary Medical Association, vol. 215, No. 

2, July 15, 1999. 

5. Verdon, D.R., ‘‘Clients Spending More 

Before Stopping Treatment, DVMs Say,’’ 

DVM Newsmagazine, July 1, 2003. 

6. PR Newswire, ‘‘New National Hartz 

Survey on the Human-Animal Bond Finds 

That Pets Are Seen as Part of the Family by 

Three in Four Pet Owners,’’ April 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, 21 CFR part 516 is 

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 § 516.3 by alphabetically 

adding a new definition to paragraph (b) 

as follows: 

§ 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. 

* * * * * 

§ 516.21 [Amended] 

■ 3. Amend § 516.21 by removing 

paragraph (c). 

Dated: August 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20553 Filed 8–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 100, 147, and 165 

[USCG–2009–0777] 

Quarterly Listings; Safety Zones, 

Security Zones and Special Local 

Regulations 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary rules 

issued. 

SUMMARY: This document provides 

required notice of substantive rules 

issued by the Coast Guard and 

temporarily effective between January 

2007 and January 2008, that expired 

before they could be published in the 

Federal Register. This document lists 

temporary safety zones, security zones, 

and local regulations, all of limited 

duration and for which timely 

publication in the Federal Register was 

not possible. 

DATES: This document lists temporary 

Coast Guard rules between 8 January 

2007 and 30 January that became 

effective and were terminated before 

they could be published in the Federal 

Register. 

ADDRESSES: The Docket Management 

Facility maintains the public docket for 

this notice. Documents indicated in this 

notice will be available for inspection or 

copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building, Ground 

Rloor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: For 

questions on this notice contact Yeoman 

First Class Denise Johnson, Office of 

Regulations and Administrative Law, 

telephone (202) 372–3862. For questions 

on viewing, or on submitting material to 

the docket, contact Ms. Angie Ames, 

Docket Operations, telephone 202–366– 

5115. 

SUPPLEMENTARY INFORMATION: Coast 

Guard District Commanders and 

Captains of the Port (COTP) must be 

immediately responsive to the safety 

and security needs within their 

jurisdiction; therefore, District 

Commanders and COTPs have been 

delegated the authority to issue certain 

local regulations. Safety zones may be 

established for safety or environmental 

purposes. A safety zone may be 

stationary and described by fixed limits 

or it may be described as a zone around 

a vessel in motion. Security zones limit 

access to prevent injury or damage to 

vessels, ports, or waterfront facilities 

and may also describe a zone around a 

vessel in motion. Special local 

regulations are issued to enhance the 

safety of participants and spectators at 

regattas and other marine events. 

Timely publication of these rules in the 

Federal Register is often precluded 

when a rule responds to an emergency, 

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sufficient advance notice. The affected 

public is, however, informed of these 

rules through Local Notices to Mariners, 

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Moreover, actual notification is 

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