43042 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

S66286, not including the stainless steel 

designated as 303Pb (UNS S30360). 

(2) Precious metals: Gold (at least 10 

karat); sterling silver (at least 925/1000); 

platinum; palladium; rhodium; osmium; 

iridium; ruthenium, titanium. 

Dated: August 19, 2009. 

Alberta E. Mills, 

Acting Secretary, Consumer Product Safety 

Commission. 

[FR Doc. E9–20589 Filed 8–25–09; 8:45 am] 

BILLING CODE 6335–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 14 

[Docket No. FDA–2009–N–0381] 

Advisory Committee; Tobacco 

Products Scientific Advisory 

Committee; Establishment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

Establishment of the Tobacco Products 

Scientific Advisory Committee. These 

actions are needed to implement the 

Federal Food, Drug, and Cosmetic Act, 

as amended by the Family Smoking 

Prevention and Tobacco Control Act. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing two 

separate documents requesting 

nominations for voting and non-voting 

membership on this committee. This 

document also amends the agency’s 

regulations to add the Tobacco Products 

Scientific Advisory Committee (the 

committee) to the agency’s list of 

standing advisory committees. 

DATES: This rule is effective August 26, 

2009. The committee is being 

established and this charter will remain 

in effect until amended or terminated by 

the Commissioner of Food and Drugs 

(the Commissioner). 

FOR FURTHER INFORMATION CONTACT: Erik 

P. Mettler, Office of Policy, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 4324, 

Silver Spring, MD 20993–0002, 301– 

796–4711, FAX: 301–847–3541, e-mail: 

erik.mettler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

committee was established under 21 

U.S.C. 387q, as added by section 917 of 

the Family Smoking Prevention and 

Tobacco Control Act (Public Law 111– 

31). The committee is also governed by 

part 14 (21 CFR part 14), Public Law 92– 

463 (5 U.S.C. app.), and the Federal 

Advisory Committee Act, which sets 

forth standards for the formation and 

use of advisory committees. The 

committee advises the Commissioner or 

designee in discharging responsibilities 

as they relate to the regulation of 

tobacco products. 

The committee reviews and evaluates 

safety, dependence, and health issues 

relating to tobacco products and 

provides appropriate advice, 

information, and recommendations to 

the Commissioner. 

Specifically, the committee will 

submit reports and recommendations on 

tobacco-related topics, including the 

following: 

• 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 

product 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. 

The committee shall consist of 12 

members including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

individuals knowledgeable in the fields 

of medicine, medical ethics, science, or 

technology involving the manufacture, 

evaluation, or use of tobacco products. 

Members will be invited to serve for 

overlapping terms of up to 4 years. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. The committee shall 

include nine technically qualified 

voting members, selected by the 

Commissioner or designee. The nine 

voting members shall be physicians, 

dentists, scientists, or health care 

professionals practicing in the area of 

oncology, pulmonology, cardiology, 

toxicology, pharmacology, addiction, or 

any other relevant specialty. One 

member shall be an officer or employee 

of a State or local government or of the 

Federal Government. The final voting 

member shall be a representative of the 

general public. In addition to the voting 

members, the committee shall include 

three nonvoting members who are 

identified with industry interests. These 

members shall include one 

representative of the tobacco 

manufacturing industry, one 

representative of the interests of tobacco 

growers, and one representative of the 

interests of the small business tobacco 

manufacturing industry. This final 

position can be filled on a rotating, 

sequential basis by representatives of 

different small business tobacco 

manufacturers based on areas of 

expertise relevant to the topics being 

considered by the committee. 

The Commissioner or designee shall 

designate one of the voting members of 

the committee to serve as chairperson. 

As added by section 917 of the Family 

Smoking Prevention and Tobacco 

Control Act, 21 U.S.C. 387q(d)(3) 

provides that section 14 of the Federal 

Advisory Committee Act does not apply 

to this committee. 

Under 5 U.S.C. 553(b)(3)(B) and (d) 

and 21 CFR 10.40(d) and (e), the agency 

finds good cause to dispense with notice 

and public comment procedures and to 

proceed to an immediate effective date 

on this rule. Notice and public comment 

and a delayed effective date are 

unnecessary and are not in the public 

interest as this final rule merely amends 

the information in § 14.100 to reflect the 

establishment of the committee. 

Therefore the agency is amending 

§ 14.100(a) as set forth in the regulatory 

text of this document. 

List of Subjects in 21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 14 is 

amended to read as follows: 

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE 

■ 1. The authority citation for 21 CFR 

part 14 continues to read as follows: 

Authority: 5 U.S.C. App. 2; 15 U.S.C. 

1451–1461, 21 U.S.C. 41–50, 141–149, 321– 

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; 

Pub. L. 108–155. 

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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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