Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment, 43042-43043 [E9-20485]
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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.
mstockstill on DSKH9S0YB1PROD with RULES
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–
VerDate Nov<24>2008
16:32 Aug 25, 2009
Jkt 217001
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
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Fmt 4700
Sfmt 4700
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.
E:\FR\FM\26AUR1.SGM
26AUR1
Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations
■
2. In § 14.100, add paragraph (a)(5) to
read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§ 14.100 List of standing advisory
committees.
Food and Drug Administration
*
21 CFR Part 516
*
*
*
*
(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]
mstockstill on DSKH9S0YB1PROD with RULES
BILLING CODE 4160–01–S
VerDate Nov<24>2008
16:32 Aug 25, 2009
Jkt 217001
[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
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Fmt 4700
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43043
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
E:\FR\FM\26AUR1.SGM
26AUR1
]]>Agencies
[Federal Register Volume 74, Number 164 (Wednesday, August 26, 2009)]
[Rules and Regulations]
[Pages 43042-43043]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20485]
=======================================================================
-----------------------------------------------------------------------
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 Sec. 14.100 to reflect the establishment of the
committee.
Therefore the agency is amending Sec. 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.
0
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
0
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.
[[Page 43043]]
0
2. In Sec. 14.100, add paragraph (a)(5) to read as follows:
Sec. 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
