Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79383 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0528] 

Unapproved Animal Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency) is 

soliciting comments from stakeholders 

on strategies to address the prevalence 

of animal drug products marketed in the 

United States without approval or other 

legal marketing status. FDA is 

concerned that the safety and 

effectiveness of these actively-marketed 

products has not been demonstrated. 

Therefore, the Agency is requesting 

comments on approaches for increasing 

the number of legally-marketed animal 

drug products, as well as on the use of 

enforcement discretion for some 

unapproved animal drug products in 

certain limited circumstances. 

DATES: Submit either electronic or 

written comments by February 18, 2011. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Tracey H. Forfa, Center for Veterinary 

Medicine (HFV–1), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9000. 

e-mail: tracey.forfa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Purpose 

FDA is soliciting comments from all 

stakeholders, including the regulated 

industry, veterinary professionals, and 

the public on strategies to address the 

prevalence of animal drug products 

marketed in the United States without 

approval or other legal marketing status. 

The Agency is concerned that the safety 

and effectiveness of these marketed 

products has not been demonstrated. 

FDA recognizes that the continued 

availability of a number of these 

products is important to meet the health 

needs of animals. FDA is requesting 

comments on approaches for increasing 

the number of currently marketed 

animal drug products that have legal 

marketing status. Our focus at this time 

is not on revising the current new 

animal drug approval process. Instead, 

we wish to explore additional 

mechanisms that utilize FDA’s existing 

regulatory framework as well as novel 

strategies not currently employed by the 

agency to increase the number of 

approved or otherwise legally marketed 

animal drugs. Furthermore, we are 

requesting comment on the use of 

limited enforcement discretion as an 

element of the overall strategy. 

II. Background 

New animal drugs cannot be legally 

marketed unless they have been 

reviewed and approved, conditionally 

approved, or index-listed by FDA. The 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) defines the term ‘‘drug’’ 

to include articles intended for use in 

the diagnosis, cure, mitigation, 

treatment, or prevention of disease in 

man or other animals, and articles (other 

than food) intended to affect the 

structure or any function of the body of 

man or other animals (section 201(g)(1) 

of the FD&C Act (21 U.S.C. 321(g)(1)). 

The FD&C Act also defines the term 

‘‘new animal drug.’’ A ‘‘new animal 

drug’’ includes any drug intended for 

use for animals that is not generally 

recognized as safe and effective for use 

under the conditions listed in the drug’s 

labeling (section 201(v) of the FD&C 

Act). 

Under the FD&C Act, a new animal 

drug may not be legally introduced into 

interstate commerce unless it is the 

subject of an approved new animal drug 

application (NADA) or abbreviated new 

animal drug application (ANADA) 

under section 512 of the FD&C Act (21 

U.S.C. 360b), a conditional approval 

(CNADA) under section 571 of the 

FD&C Act (21 U.S.C. 360ccc), an index 

listing under section 572 of the FD&C 

Act (21 U.S.C. 360ccc–1), or an 

investigational new animal drug 

exemption (INAD) under section 512(j) 

of the FD&C Act (21 U.S.C. 360b(j)). 

When this notice refers to an 

‘‘unapproved animal drug,’’ we mean an 

animal drug that does not have a 

necessary approval, conditional 

approval, index listing, or INAD 

exemption. 

The FD&C Act’s new animal drug 

approval requirements provide 

important protection for humans and 

animals. Animal drugs that are 

marketed without required FDA review 

and approval may not meet 

requirements and standards for, among 

other things, safety and effectiveness. 

The FDA drug approval process ensures, 

through an evaluation of scientific 

evidence, that animal drugs are safe and 

effective. The approval process also 

provides a review of product-specific 

information that is critical to ensuring 

the safety and effectiveness of the 

finished animal drug product. For 

instance, the sponsor of an NADA must 

demonstrate that the manufacturing 

processes can reliably produce drug 

products of expected identity, strength, 

quality, and purity. Furthermore, FDA’s 

review of the applicant’s labeling 

assures that veterinarians, animal 

owners and other consumers have the 

information necessary to understand a 

drug product’s risks. In addition, firms 

marketing approved animal drug 

products must report adverse events 

associated with their product’s use, 

which helps FDA continuously assess 

the risks associated with a particular 

product. Although the conditional 

approval and indexing requirements 

differ in some ways from the animal 

drug approval process, they all provide 

for a science-based review to assure the 

drug will be safe for its intended use. 

FDA employs these standards in the 

new animal drug approval process to 

protect both human and animal health. 

For many years, FDA has been aware 

that a wide variety of animal drug 

products are being marketed that meet 

the definition of ‘‘drug’’ and ‘‘new 

animal drug’’ as defined in the FD&C 

Act, but are not approved, conditionally 

approved, or indexed. Many of these 

unapproved animal drugs were, and 

some continue to be, the standard of 

care in treating animals, and some are 

essential to protecting animal health 

and ensuring an adequate food supply. 

In general, the types of unapproved 

animal drugs being marketed include, 

but are not limited to, injectable 

vitamins, various topical solutions, 

shampoos, and liniments, electrolyte 

and glucose solutions, and antidotes. In 

addition, there are a variety of antiinfective and other animal drug 

products marketed for use in a variety 

of animal species. The Agency 

determined, based on available 

information, that some of these animal 

drug products or categories of products 

did not raise safety concerns. With 

respect to those products, the Agency 

historically exercised its enforcement 

discretion, even though such products 

lacked the required FDA marketing 

approval. This approach has been 

important for setting enforcement 

priorities and for making decisions as to 

whether to take action against an 

illegally marketed unapproved drug or 

class of drugs under particular 

circumstances. 

Some of these unapproved drugs 

which did not raise safety concerns 

have been marketed under an FDA letter 

of ‘‘no objection,’’ issued in response to 

a firm’s request, stating that FDA did 

not at the time object to the marketing 

of a particular unapproved new animal 


jlentini on DSKJ8SOYB1PROD with NOTICES
79384 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 

drug. In addition, some unapproved 

drugs have been marketed under the 

auspices of Compliance Policy Guides 

issued by FDA to let its staff, the public, 

and industry know the conditions under 

which FDA would consider 

enforcement action with respect to these 

unapproved drugs. This practice of 

proactively announcing the Agency’s 

intent to exercise enforcement 

discretion with respect to particular 

types of unapproved drugs under 

specified conditions has been used in 

certain circumstances because of the 

relatively limited number of approved 

animal drugs available to meet the 

animal health needs of a diverse number 

of animal species. 

FDA recognizes that it will be 

necessary to continue to exercise 

enforcement discretion in limited 

circumstances for certain essential 

unapproved animal drug products or 

categories of products as the Agency 

works to develop new ways to increase 

the availability of products that are 

approved or otherwise legally marketed. 

However, it is the Agency’s general 

expectation that new animal drugs must 

be approved or otherwise legally 

marketed as required by the FD&C Act. 

Therefore, any exercise of the Agency’s 

enforcement discretion with respect to 

unapproved animal drugs should be 

limited to the greatest extent possible. 

To that end, the Agency is seeking 

comment on strategies for increasing the 

number of animal drug products that are 

legally marketed, and thus decreasing 

the number of currently marketed 

products that lack approval or other 

legal marketing status. Such strategies 

may include alternative pathways to 

achieve legal marketing status that 

assure animal drug products meet safety 

and effectiveness standards, including 

human food safety standards. However, 

even after alternative pathways to legal 

marketing are established, some drugs 

may not be well-suited to such 

alternatives and may be required to go 

through the new animal drug approval 

process, especially in cases where there 

are safety or effectiveness concerns. For 

example, certain drug products 

intended for use in food-producing 

animals may only be able to achieve 

legal marketing status through the 

traditional new animal drug approval 

process because of concerns about drug 

residues appearing in edible tissues. 

III. Agency Request for Comments 

FDA is soliciting public comment on 

potential actions the Agency can take to 

help achieve the goal of obtaining legal 

marketing status, as appropriate, for 

unapproved animal drugs that are 

currently being marketed in the United 

States. We are interested in comments 

on strategies that utilize FDA’s existing 

regulatory framework for addressing this 

issue as well as comments on novel 

strategies not currently employed by the 

Agency. In conjunction with pursuing 

this goal, the Agency recognizes the 

need for maintaining the availability of 

essential animal drugs for pet owners, 

veterinarians, and animal producers. 

FDA is also specifically requesting 

comments and information on the 

questions and subjects below. This list 

is not all-inclusive, however, and is not 

intended to limit the range of options 

available for public comment. The 

Agency asks that comments be as 

detailed as possible, with explanations 

and information to assist FDA in 

evaluating whether the approaches will 

help accomplish the goal of increasing 

the number of currently marketed 

animal drug products that have 

approval or other legal marketing status. 

FDA’s intent is that of inquiry and not 

for anyone to read this list as any 

indication of the Agency’s position on a 

particular approach or a determination 

that the Agency has the resources to 

implement such an approach. 

A. Increasing the Availability of Legally 

Marketed Animal Drug Products 

In general, the types of unapproved 

animal drugs being marketed include, 

but are not limited to: Injectable 

vitamins; various topical solutions, 

shampoos, and liniments; electrolyte 

and glucose solutions; and antidotes. In 

addition, there are a variety of antiinfective and other animal drug 

products marketed for use in a variety 

of animal species. Given the broad array 

of animal drug products that are 

important for meeting the health needs 

of a diverse number of animal species, 

FDA is interested in exploring 

alternative approaches (i.e., alternatives 

to the existing new animal drug 

approval process) by which those 

products could be legally marketed. 

Some examples of alternative 

approaches are discussed in sections 

III.A.1 and III.A.2 of this document. 

1. Monographs 

Certain over-the-counter (OTC) drugs 

for humans are marketed under 

monographs that establish the 

conditions under which these drugs are 

generally recognized as safe and 

effective and not misbranded. The 

monographs specify active ingredients, 

dosage forms, product strengths, 

indications for use, labeling, and other 

conditions. Human OTC drug products 

that comply with all of a monograph’s 

conditions and the provisions in 21 CFR 

part 330 may be manufactured and 

distributed without applications or any 

other premarket review. Monographs are 

developed after review of available 

information about safety and 

effectiveness, including published and 

unpublished data and information 

submitted to the Agency, and must be 

supported by adequate and wellcontrolled studies. 

Does published literature of sufficient 

quality exist for some currently 

marketed unapproved animal drugs 

such that monographs might be a 

feasible approach? For which drugs 

might this be feasible? What are the 

attributes that make the published 

literature suitable for this purpose? 

What criteria should be used to 

determine whether an animal drug is 

potentially suitable for a monograph to 

ensure that quality, safety and 

effectiveness would not be 

compromised in the absence of 

premarket review? 

2. Use of Publicly Available Information 

In some cases, human prescription 

drugs have been approved and marketed 

after FDA reviewed the existing 

literature and data regarding a particular 

drug or class of drugs. Examples of 

drugs for which FDA has used this 

approach include the following: 

• Prussian Blue (see ‘‘Guidance for 

Industry on Prussian Blue for Treatment 

of Internal Contamination With 

Thallium or Radioactive Cesium; 

Availability’’ (68 FR 5645, February 4, 

2003)) and 

• Pancreatic Enzymes (see ‘‘Exocrine 

Pancreatic Insufficiency Drug Products’’ 

(69 FR 23410, April 28, 2004), ‘‘Exocrine 

Pancreatic Insufficiency Drug Products 

for Over-the-Counter Human Use’’ (56 

FR 32282, July 15, 1991), and ‘‘Guidance 

for Industry: Exocrine Pancreatic 

Insufficiency Drug Products— 

Submitting NDAs,’’ issued in April 2006 

and available online at 

http://www.fda.gov/downloads/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/ 

ucm071651.pdf). 

For each of these drugs, FDA 

reviewed the publicly available 

information and published in the 

Federal Register a discussion regarding 

the drug’s safety and effectiveness, and 

any conclusions reached by the Agency 

based on that review. Firms then 

submitted drug applications referencing 

the public information and/or the 

Federal Register notice to address 

certain information requirements 

needed for an application. 

Does published literature of sufficient 

quality exist for some animal drugs that 

could be used to support safety and 

effectiveness evaluations for these 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79385 

currently unapproved marketed drugs? 

For which drugs might this be feasible? 

What attributes make published 

literature of sufficient quality to 

contribute to such an evaluation? 

B. Limiting the Use of Enforcement 

Discretion 

As stated previously, the Agency 

acknowledges that the practice of 

exercising enforcement discretion in 

certain circumstances is necessary to 

ensure the availability of some essential 

animal drug products. This practice of 

exercising enforcement discretion (i.e., a 

decision on the part of the Agency to 

not take enforcement action in certain 

circumstances) is not only important for 

managing limited Agency resources 

related to compliance activities but is 

also important for assuring that certain 

animal drug products remain available 

for addressing the health needs of 

animals. However, FDA’s goal is to 

limit, to the extent possible, its use of 

enforcement discretion for unapproved 

animal drugs. 

What factors should the Agency 

consider when determining which 

unapproved animal drug products or 

categories of products should be the 

subject of enforcement discretion? 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

Dated: December 15, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31889 Filed 12–17–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB; Comment 

Request; National Epidemiologic 

Survey on Alcohol and Related 

Conditions—III 

SUMMARY: In compliance with the 

requirement of Section 3507(a)(1)(D) of 

the Paperwork Reduction Act of 1995, 

the National Institute on Alcohol Abuse 

and Alcoholism (NIAAA), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on October 15, 

2010, and allowed 60-days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: National 

Epidemiologic Survey on Alcohol and 

Related Conditions—III. Type of 

Information Collection Request: NEW. 

Need and Use of Information Collection: 

This study will determine the 

prevalence of alcohol use patterns and 

alcohol use disorders and their 

associated disabilities in a 

representative sample of adults in the 

United States population. The primary 

objectives of this study are to: (1) 

Understand the relationships between 

alcohol use patterns and alcohol use 

disorders and their related 

psychological and medical disabilities 

with a view toward designing more 

effective treatment, prevention and 

intervention programs; (2) identify 

subgroups at high risk for alcohol use 

disorders that are complicated by 

associated disabilities; (3) understand 

treatment utilization, unmet treatment 

need, barriers to treatment, health 

disparities, and economic costs of 

alcohol use disorders and their 

associated disabilities; and (4) identify 

environmental and genetic risk factors 

and their interactions that are associated 

with harmful consumption patterns and 

alcohol use disorders and their 

associated disabilities. Frequency of 

Response: On occasion. Affected Public: 

Individuals. Type of Respondents: 

Adults. 

ESTIMATED TOTAL ANNUAL BURDEN

Type of 

respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

requested 

Adults ............................................................................................................... 44,900 1 1.0 44,900 

Adults ............................................................................................................... 1,700 2 1.7 2,890 

Total .......................................................................................................... ........................ ........................ ........................ 47,790 

The annualized cost to respondents is 

estimated to be $936,684.00. There are 

no Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) 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; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. 


jlentini on DSKJ8SOYB1PROD with NOTICES