Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human Use; Request for Environmental Impact Data and Information, 7606-7608 [2010-3319]
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7606
Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here. Sixty panel members
will take part in a pre-test of the study,
estimated to last 30 minutes (0.5 hours),
for a total of 30 hours. Approximately
15,000 respondents will complete a
screener to determine eligibility for
participation in the study, estimated to
take 1 minute (0.016 hours), for a total
of 125 hours. Fifty-four hundred (5,400)
respondents will complete the full
study, estimated to last 30 minutes (0.5
hours), for a total of 2,700 hours. The
total estimated burden is 2,970 hours.
[FR Doc. 2010–3148 Filed 2–19–10; 8:45 am]
[FR Doc. 2010–3320 Filed 2–19–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC): Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Advisory Committee to the Director,
Centers for Disease Control and
Prevention of the Department of Health
and Human Services, has been renewed
for a 2-year period extending through
February 1, 2012.
Contact Person for More Information:
Anne C. Haddix, PhD, Designated
Federal Officer, ACD, CDC, 1600 Clifton
Road, NE., M/S D14, Atlanta, Georgia
30333. Telephone 404–639–0663.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Jkt 220001
[Docket No. FDA–1996–N–0006] (formerly
Docket No. 1996N–0277)
Safety and Efficacy Review for
Additional Ingredients in Over-theCounter Drug Products for Human
Use; Request for Environmental
Impact Data and Information
AGENCY:
Food and Drug Administration,
HHS.
Disease, Disability, and Injury
Prevention and Control
ACTION: Request for data and
information.
SUMMARY: We (Food and Drug
Administration (FDA)) are requesting
data and information regarding the
potential environmental impact of
amending over-the-counter (OTC) drug
monographs to include certain active
ingredients not previously marketed in
the United States or marketed in the
United States under approved
applications after the OTC drug review
began in 1972. Thirteen active
ingredients have been found eligible for
potential inclusion in OTC drug
monographs based on time and extent
applications (TEAs). We are currently
evaluating the safety and effectiveness
of these ingredients.
DATES: Submit data, information, and
general comments by May 24, 2010.
ADDRESSES: Submit electronic or written
data, information, and general
comments in response to this document.
Submit electronic comments to https://
regulations.gov. Submit written
comments to the Division of Dockets
Management HFA–305), 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Michael L. Koenig, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5411,
Silver Spring, MD 20993–0002, 301–
796–2090.
SUPPLEMENTARY INFORMATION:
Time and Date: 1 p.m.–3 p.m., April 20,
2010 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Healthy Passages Longitudinal
Study of Youth, FOA DP 10–007.’’
Contact Person for More Information:
Michael Dalmat, DRPH., Scientific Review
Officer, National Center for Chronic Disease
and Health Promotion, Office of the Director,
Extramural Research Program Office, 4770
Buford Highway, NE., Mailstop K–92,
Atlanta, GA 30341, Telephone: (770) 488–
6423, E-mail: MED1@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: February 10, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
BILLING CODE 4163–18–P
15:26 Feb 19, 2010
Food and Drug Administration
BILLING CODE 4163–18–P
[FR Doc. 2010–3146 Filed 2–19–10; 8:45 am]
VerDate Nov<24>2008
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Special Emphasis Panel (SEP):
Healthy Passages Longitudinal Study of
Youth, Funding Opportunity
Announcement (FOA) DP 10–007,
Initial Review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Dated: February 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
Dated: February 11, 2010.
Andre Tyler,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
PO 00000
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Fmt 4703
Sfmt 4703
I. Ingredients Affected by This Notice
We are currently evaluating the safety
and effectiveness of 13 active
ingredients found eligible for possible
addition to an OTC drug monograph via
the TEA process described in 21 CFR
330.14. The ingredients under review
are shown in table 1 of this document:
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22FEN1
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Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices
TABLE 1.—LIST OF ACTIVE INGREDIENTS FOUND ELIGIBLE FOR POSSIBLE ADDITION TO AN OTC DRUG MONOGRAPH
Active Ingredient
Monograph
Docket No.
Eligibility
Amiloxate
Sunscreen
FDA–2003–N–0196
July 11, 2003, 68 FR 41386
Bemotrizinol
Sunscreen
FDA–2005–N–0453
December 5, 2005, 70 FR 72449
Bisoctrizole
Sunscreen
FDA–2005–N–0453
December 5, 2005, 70 FR 72449
Climbazole
Dandruff
FDA–2005–N–0021
December 5, 2005, 70 FR 72448
Diethylhexyl butamido triazone
Sunscreen
FDA–2006–O–0314
July 26, 2006, 71 FR 42405
Ecamsule1
Sunscreen
FDA–2008–N–0474
September 12, 2008, 73 FR 53029
Enzacamene
Sunscreen
FDA–2003–N–0196
July 11, 2003, 68 FR 41386
Octyl triazone
Sunscreen
FDA–2003–N–0196
July 11, 2003, 68 FR 41386
Piroctone olamine
Dandruff
FDA–2004–N–0037
February 18, 2004, 69 FR 7652
Sodium picosulfate
Laxative
FDA–2006–O–0057
June 22, 2006, 71 FR 35917
Sodium shale oil sulfonate
Dandruff
FDA–2009–N–0146
April 7, 2009, 74 FR 15741
Triclosan
Acne
FDA–2005–N–0454
December 5, 2005, 70 FR 72447
Triclosan1
Antigingivitis/Antiplaque
FDA–1981–N–0015
July 6, 2004, 69 FR 40640
1 These
ingredients are marketed under approved new drug applications (NDAs).
When our initial assessment of safety
and effectiveness data for any of these
ingredients is complete, we will prepare
a proposed rule describing our
conclusions, which may include a
proposal to add the ingredient to an
OTC drug monograph. Such an action
would be subject to the National
Environmental Policy Act of 1969
(NEPA). In order to comply with NEPA,
we need data and information regarding
the potential environmental impact if
these ingredients are included in an
OTC drug monograph, especially if this
results in their use in drug products
marketed in the United States for the
first time (see section II of this
document). We did not previously
request such data and information for
these 13 active ingredients. Therefore,
we are requesting such data at this time.
We cannot publish proposed rules for
any of these 13 active ingredients until
we receive this data and information.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
II. Data Being Requested
As stated in 21 CFR 25.1, FDA
regulations must comply with NEPA. To
comply with NEPA, an environmental
assessment (EA) of agency actions is
required unless we determine that a
categorical exclusion is warranted.
Many actions on OTC drug monographs
have been categorically excluded from
the NEPA requirement for an EA under
§ 25.31(a) (21 CFR 25.31(a)), because, for
active ingredients already marketed in
the United States, the actions generally
have not resulted in increased use of
VerDate Nov<24>2008
15:26 Feb 19, 2010
Jkt 220001
active ingredient. However, if we amend
a monograph to include a new generally
recognized as safe and effective
(GRASE) active ingredient not
previously marketed in the United
States, this exclusion would not apply
because our action would increase the
use of the active ingredient. This
situation may occur for active
ingredients found eligible for inclusion
in an OTC drug monograph under the
TEA process on the basis of foreign
marketing experience.
Active ingredients found eligible for
potential inclusion in an OTC drug
monograph under the TEA process
might qualify for the categorical
exclusions provided under § 25.31(b) or
(c). These exclusions allow for active
ingredients that will not exceed 1 part
per billion (ppb) (1 microgram per liter)
in the aquatic environment or active
ingredients that naturally occur in the
environment and do not alter
significantly the concentration or
distribution of the ingredient, its
metabolites, or degradation products in
the environment.
In order to determine whether any of
the active ingredients found eligible for
potential inclusion in an OTC
monograph meet the requirements for
any categorical exclusion, including
§ 25.31(b) or (c), or to prepare an EA, we
need additional data and information.
To assist the agency, we are requesting
any information that would support the
application of any categorical exclusion,
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Fmt 4703
Sfmt 4703
or that would support the preparation of
an EA, if necessary.
To estimate the expected introductory
concentration of an ingredient or
ingredients in the aquatic environment
for purposes of § 25.31(b), please refer to
section III of the CDER Guidance on
Environmental Assessment of Human
Drug and Biologic Applications (CDER
EA Guidance Document). This guidance
document can be viewed at https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/ucm070561.pdf.
To complete an EA, we need
information similar to that specified in
section IV of the CDER EA Guidance
Document (pages 9–27). We request that
a submitter segregate any data or
information that the submitter believes
is protected from disclosure by 18
U.S.C. 1905 or 21 U.S.C. 331(j) or
360j(c). If such data or information is
included in the submission, we request
that the submitter summarize the
information, to the extent possible, for
public disclosure (see 21 CFR 25.50 and
25.51(a)).
III. Submission of Data
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic data,
information, and general comments.
Submit a single copy of electronic data,
information, and general comments or
two paper copies of any mailed data,
information, and general comments,
except that individuals may submit one
paper copy. Data, information, and
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22FEN1
7608
Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices
general comments are to be identified
with the docket number found in
brackets in the heading of this
document. Received data, information,
and general comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
(2) Office of Planning and Evaluation
(RA51);
(3) Office of Health Information
Technology & Quality (RA52);
(4) Office of Policy Analysis (RA53);
and
(5) Office of Data Management and
Research (RA54).
Dated: February 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Section RA5–20, Functions
(1) Delete the functional statement for
the Office of Planning, Analysis and
Evaluation (RA5) and replace in its
entirety; (2) establish the Office Policy
Analysis (RS53); (3) establish the Office
of Data Management and Research
(RA54); and renames the Division of
Health Information Technology and
Quality (RA52) as the Office of Health
Information Technology and Quality
(RA52).
[FR Doc. 2010–3319 Filed 2–19–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 75 FR 391–404 dated
January 5, 2010).
This notice reflects organizational
changes in the Health Resources and
Services Administration. Specifically,
this notice establishes the Office of
Policy Analysis (RA53) and the Office of
Data Management and Research (RA54)
within the Office of Planning, Analysis
and Evaluation (RA5); renames the
Division of Health Information
Technology and Quality (RA52) as the
Office of Health Information Technology
and Quality (RA52); establishes the
Division of Workforce Development
(RB44) within the Office of Management
(RB4); and renames the Division of
Policy Review and Coordination as the
Division of Policy and Information
Coordination (RB41) within the Office
of Management (RB4).
cprice-sewell on DSK2BSOYB1PROD with NOTICES
Chapter RA5—Office of Planning,
Analysis and Evaluation
Section RA5–10, Organization
Delete in its entirety and replace with
the following:
The Office of Planning, Analysis and
Evaluation (RA5) is headed by the
Director, Office of Planning, Analysis
and Evaluation, within the Office of the
Administrator, Health Resources and
Services Administration, who reports
directly to the Administrator. The Office
of Planning, Analysis and Evaluation
includes the following components:
(1) Immediate Office of the Director
(RA5);
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15:26 Feb 19, 2010
Jkt 220001
budgetary data with regard to planning
guidelines; (7) develops and produces
performance reports required under the
Government Performance and
Accountability Report and OMB; (8)
conducts the public use reports
clearance function; and (9) conducts,
guides, and/or participates in
evaluations studies and prepares reports
on HRSA program efficiencies.
Office of Planning, Analysis and
Evaluation (RA5)
(1) Provides Agency-wide leadership
for policy development, data collection
and management, major analytic
activities, research, and evaluation: (2)
develops HRSA-wide policies; (3)
coordinates the Agency’s strategic
planning process; (4) conducts and
coordinates analyses, evaluation and
research; (5) coordinates the Agency’s
intergovernmental activities; (6)
maintains liaison between the
Administrator, other OPDIVs, Office of
the Secretary staff components, and
other Departments on critical matters
involving analysis of program policy
undertaken in the Agency; (7) prepares
policy analysis papers and planning
documents as required; (8) analyzes
budgetary data with regard to planning
guidelines; (9) collaborates with the
Office of Operations in the development
of budgets, performance plans, and
other administration reporting
requirements; (10) conducts and/or
guides the Agency’s research and
program evaluation; (11) provides
leadership in the development of
policies on health information
technology and quality; and (12)
provides support for the Department’s
Medical Claims Review Panel.
Office of Health Information
Technology & Quality (RA52)
(1) Provides support, policy direction,
and leadership for HRSA’s health
quality efforts; (2) serves as the focal
point for developing policy to promote
the coordination and advancement of
health information technology,
including telehealth, to HRSA’s
programs, including the use of
electronic health record systems; (3)
develops an Agency-wide health
information technology and telehealth
strategy for HRSA; (4) assists HRSA
components in program-level health
information technology and health
quality efforts; (5) ensures successful
dissemination of appropriate
information technology advances, such
as electronic health records systems, to
HRSA programs; (6) works
collaboratively with States, foundations,
national organizations, private sector
providers, as well as departmental
agencies and other Federal departments
in order to promote the adoption of
health information technology and
health quality policy; (7) ensures the
health information technology policy
and activities of HRSA are coordinated
with those of other HHS components;
(8) assesses the impact of health
information technology and quality
initiatives in the community, especially
for the uninsured, underserved, and
special needs populations; (9) translates
technological advances in health
information technology to HRSA’s
programs; (10) provides guidance in
using the results of the medical claims
review process to HRSA programs to
improve quality; and (11) provides
support for the Department’s Medical
Claims Review Panel.
Office of Planning and Evaluation
(RA51)
(1) Provides leadership in the
development of the long-term Agencywide strategic plan; (2) participates with
HRSA organizations in developing
strategic plans for their component; (3)
conducts major program evaluation
efforts; (4) provides advice and
assistance to program-level HRSA
components in the design and conduct
of evaluations; (5) develops annual
performance plans; (6) analyzes
Office of Policy Analysis (RA53)
(1) Serves as the principal Agency
resource for policy analysis; (2) analyzes
issues arising from legislation, budget
proposals, regulatory actions, and other
program or policy actions; (3) serves as
focal point within HRSA for analysis of
healthcare payment systems and
financing issues; (4) collaborates with
HHS Agencies to examine the impact of
Medicare, Medicaid, and Children’s
Health Insurance Program (CHIP) on
HRSA grantees and safety net providers;
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]]>Agencies
[Federal Register Volume 75, Number 34 (Monday, February 22, 2010)]
[Notices]
[Pages 7606-7608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3319]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1996-N-0006] (formerly Docket No. 1996N-0277)
Safety and Efficacy Review for Additional Ingredients in Over-
the-Counter Drug Products for Human Use; Request for Environmental
Impact Data and Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Request for data and information.
-----------------------------------------------------------------------
SUMMARY: We (Food and Drug Administration (FDA)) are requesting data
and information regarding the potential environmental impact of
amending over-the-counter (OTC) drug monographs to include certain
active ingredients not previously marketed in the United States or
marketed in the United States under approved applications after the OTC
drug review began in 1972. Thirteen active ingredients have been found
eligible for potential inclusion in OTC drug monographs based on time
and extent applications (TEAs). We are currently evaluating the safety
and effectiveness of these ingredients.
DATES: Submit data, information, and general comments by May 24, 2010.
ADDRESSES: Submit electronic or written data, information, and general
comments in response to this document. Submit electronic comments to
https://regulations.gov. Submit written comments to the Division of
Dockets Management HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.
SUPPLEMENTARY INFORMATION:
I. Ingredients Affected by This Notice
We are currently evaluating the safety and effectiveness of 13
active ingredients found eligible for possible addition to an OTC drug
monograph via the TEA process described in 21 CFR 330.14. The
ingredients under review are shown in table 1 of this document:
[[Page 7607]]
Table 1.--List of active ingredients found eligible for possible
addition to an OTC drug monograph
------------------------------------------------------------------------
Active Ingredient Monograph Docket No. Eligibility
------------------------------------------------------------------------
Amiloxate Sunscreen FDA-2003-N-019 July 11, 2003, 68
6 FR 41386
------------------------------------------------------------------------
Bemotrizinol Sunscreen FDA-2005-N-045 December 5, 2005,
3 70 FR 72449
------------------------------------------------------------------------
Bisoctrizole Sunscreen FDA-2005-N-045 December 5, 2005,
3 70 FR 72449
------------------------------------------------------------------------
Climbazole Dandruff FDA-2005-N-002 December 5, 2005,
1 70 FR 72448
------------------------------------------------------------------------
Diethylhexyl Sunscreen FDA-2006-O-031 July 26, 2006, 71
butamido triazone 4 FR 42405
------------------------------------------------------------------------
Ecamsule\1\ Sunscreen FDA-2008-N-047 September 12,
4 2008, 73 FR
53029
------------------------------------------------------------------------
Enzacamene Sunscreen FDA-2003-N-019 July 11, 2003, 68
6 FR 41386
------------------------------------------------------------------------
Octyl triazone Sunscreen FDA-2003-N-019 July 11, 2003, 68
6 FR 41386
------------------------------------------------------------------------
Piroctone olamine Dandruff FDA-2004-N-003 February 18,
7 2004, 69 FR 7652
------------------------------------------------------------------------
Sodium picosulfate Laxative FDA-2006-O-005 June 22, 2006, 71
7 FR 35917
------------------------------------------------------------------------
Sodium shale oil Dandruff FDA-2009-N-014 April 7, 2009, 74
sulfonate 6 FR 15741
------------------------------------------------------------------------
Triclosan Acne FDA-2005-N-045 December 5, 2005,
4 70 FR 72447
------------------------------------------------------------------------
Triclosan\1\ Antigingivitis/ FDA-1981-N-001 July 6, 2004, 69
Antiplaque 5 FR 40640
------------------------------------------------------------------------
\1\ These ingredients are marketed under approved new drug applications
(NDAs).
When our initial assessment of safety and effectiveness data for
any of these ingredients is complete, we will prepare a proposed rule
describing our conclusions, which may include a proposal to add the
ingredient to an OTC drug monograph. Such an action would be subject to
the National Environmental Policy Act of 1969 (NEPA). In order to
comply with NEPA, we need data and information regarding the potential
environmental impact if these ingredients are included in an OTC drug
monograph, especially if this results in their use in drug products
marketed in the United States for the first time (see section II of
this document). We did not previously request such data and information
for these 13 active ingredients. Therefore, we are requesting such data
at this time. We cannot publish proposed rules for any of these 13
active ingredients until we receive this data and information.
II. Data Being Requested
As stated in 21 CFR 25.1, FDA regulations must comply with NEPA. To
comply with NEPA, an environmental assessment (EA) of agency actions is
required unless we determine that a categorical exclusion is warranted.
Many actions on OTC drug monographs have been categorically excluded
from the NEPA requirement for an EA under Sec. 25.31(a) (21 CFR
25.31(a)), because, for active ingredients already marketed in the
United States, the actions generally have not resulted in increased use
of active ingredient. However, if we amend a monograph to include a new
generally recognized as safe and effective (GRASE) active ingredient
not previously marketed in the United States, this exclusion would not
apply because our action would increase the use of the active
ingredient. This situation may occur for active ingredients found
eligible for inclusion in an OTC drug monograph under the TEA process
on the basis of foreign marketing experience.
Active ingredients found eligible for potential inclusion in an OTC
drug monograph under the TEA process might qualify for the categorical
exclusions provided under Sec. 25.31(b) or (c). These exclusions allow
for active ingredients that will not exceed 1 part per billion (ppb) (1
microgram per liter) in the aquatic environment or active ingredients
that naturally occur in the environment and do not alter significantly
the concentration or distribution of the ingredient, its metabolites,
or degradation products in the environment.
In order to determine whether any of the active ingredients found
eligible for potential inclusion in an OTC monograph meet the
requirements for any categorical exclusion, including Sec. 25.31(b) or
(c), or to prepare an EA, we need additional data and information. To
assist the agency, we are requesting any information that would support
the application of any categorical exclusion, or that would support the
preparation of an EA, if necessary.
To estimate the expected introductory concentration of an
ingredient or ingredients in the aquatic environment for purposes of
Sec. 25.31(b), please refer to section III of the CDER Guidance on
Environmental Assessment of Human Drug and Biologic Applications (CDER
EA Guidance Document). This guidance document can be viewed at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070561.pdf.
To complete an EA, we need information similar to that specified in
section IV of the CDER EA Guidance Document (pages 9-27). We request
that a submitter segregate any data or information that the submitter
believes is protected from disclosure by 18 U.S.C. 1905 or 21 U.S.C.
331(j) or 360j(c). If such data or information is included in the
submission, we request that the submitter summarize the information, to
the extent possible, for public disclosure (see 21 CFR 25.50 and
25.51(a)).
III. Submission of Data
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic data, information, and general
comments. Submit a single copy of electronic data, information, and
general comments or two paper copies of any mailed data, information,
and general comments, except that individuals may submit one paper
copy. Data, information, and
[[Page 7608]]
general comments are to be identified with the docket number found in
brackets in the heading of this document. Received data, information,
and general comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3319 Filed 2-19-10; 8:45 am]
BILLING CODE 4160-01-S
