Notice of Availability of Final Policy Document, 12553-12554 [2010-5671]
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12553
Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices
required to appear in advertising and
packaging. FDA is required to review
each plan submitted and approve the
plan if it provides for rotation, display,
and distribution of warnings in
compliance with the requirements of the
Smokeless Tobacco Act. To the best of
FDA’s knowledge, all of the affected
companies have previously submitted
similar plans to the Federal Trade
Commission (FTC), which had authority
to implement the requirements of the
Smokeless Tobacco Act prior to the
Tobacco Control Act’s amendments.
However, since the requirements of the
Smokeless Tobacco Act have been
revised and since FDA now has
authority to implement the Smokeless
Tobacco Act, each affected company
will be required to submit a new plan
to FDA instead of FTC. The Tobacco
Control Act’s amendments to the
Smokeless Tobacco Act are effective on
June 22, 2010.
In the Federal Register of August 7,
2007 (72 FR 44138), FTC published a
30-day notice announcing an
opportunity for public comment and
that the information collection would be
sent to OMB for review. Based on FTC’s
previous experience with the
submission of rotational plans and
FDA’s experience with smokeless
tobacco companies (e.g.,
correspondence associated with user
fees under section 919 of the Federal
Food, Drug, and Cosmetic Act, as
amended by the Tobacco Control Act),
FDA estimates that there are 14
companies affected by this information
collection. To account for the entry of
new smokeless tobacco companies who
may be affected by this information
collection, FDA is estimating the total
number of respondents to be 20.
When FTC originally implemented
the rotational plan requirements in
1986, the Smokeless Tobacco Council,
Inc. indicated that the 6 companies it
represented would require 700 to 800
hours in total (133 hours each) to
complete an initial rotational plan,
involving multiple brands, multiple
brand varieties, and multiple forms of
both packaging and advertising. When
FTC requested an extension of their
PRA clearance in 2007, FTC decreased
the estimate for submitting an initial
plan from 143 hours to 60 hours,
accounting for increased
computerization and improvements in
electronic communication over the
subsequent 20 years since the
Smokeless Tobacco Act was enacted.
FDA believes the estimate of 60 hours
to complete an initial rotational plan
continues to be reasonable. However,
since the requirements of the new
Smokeless Tobacco Act are unfamiliar
to industry, FDA is increasing the time
estimate for submitting initial plans to
100 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Submission of rotational plans for
health warning label statements
1 There
20
Total Annual
Responses
1
Hours per
Response
20
Total Hours
100
2,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
and/or for Federally Qualified Health
Center Look-Alike designation. The PIN,
‘‘Confirming Public Agency Status under
the Health Center Program and FQHC
Look-Alike Program,’’ and the Agency’s
‘‘Response to Public Comments’’ are
available on the Internet at https://
bphc.hrsa.gov/policy/pin1001/and
https://bphc.hrsa.gov/policy/pin1001/
PublcCommentsPIN2010–01.pdf,
respectively.
[FR Doc. 2010–5654 Filed 3–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Availability of Final Policy
Document
AGENCY: Health Resources and Services
Administration (HRSA), HHS.
ACTION: Final agency guidance and
response to public comments.
sroberts on DSKD5P82C1PROD with NOTICES
Annual Frequency
per Response
SUMMARY: HRSA is publishing a Final
Agency Guidance (‘‘Policy Information
Notice’’ (PIN) 2010–01) to describe the
documentation that will be considered
by the Health Resources and Services
Administration (HRSA) in confirming
public agency status for organizations
that self-identify as public agencies (also
referred to in previous PINs as ‘‘public
entities’’ or ‘‘public applicants’’) for
Health Center Program grant funding
authorized under section 330 of the
Public Health Service Act, as amended,
VerDate Nov<24>2008
16:33 Mar 15, 2010
Jkt 220001
DATES: The effective date of this final
Agency guidance is February 5, 2010.
Background: HRSA administers the
Health Center Program, which supports
more than 1,100 organizations operating
more than 7,500 health care delivery
sites, including community health
centers, migrant health centers, health
care for the homeless centers, and
public housing primary care centers.
Health centers serve medically
underserved communities delivering
preventive and primary care services to
patients regardless of their ability to
pay. The Health Center Program’s
authorizing statute and implementing
regulations (Section 330 of the PHS Act,
as amended, 42 CFR part 51c, and 42
CFR part 56) state that any public or
non-profit private entity is eligible to
apply for a grant under the Health
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Center Program. The term ‘‘public
agency’’ is not defined in section 330 of
the PHS Act, as amended, or in the
Health Center Program’s regulations;
however, reference is made to public
agencies in section 330 of the PHS Act,
as amended, in the context of defining
a public center as ‘‘a health center
funded (or to be funded) through a grant
under this section to a public agency.’’
(Sentence following Section
330(k)(3)(M) of the PHS Act, as
amended) HRSA is issuing this PIN to
describe the documentation that will be
considered by HRSA in confirming
public agency status for organizations
that self-identify as public agencies (also
referred to in previous PINs as ‘‘public
entities’’ or ‘‘public applicants’’) for
Health Center Program grant funding
authorized under section 330 of the
Public Health Service Act, as amended,
and/or for Federally Qualified Health
Center Look-Alike designation.
On August 14, 2009, the Health
Resources and Services Administration
(HRSA) made the draft Program
Information Notice (PIN), ‘‘Confirming
Public Agency Status under the Health
Center Program and FQHC Look-Alike
Program,’’ available for public comment.
HRSA also published a notice in the
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12554
Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices
Federal Register of August 28, 2009,
requesting comments on this draft PIN.
Sixteen parties, including both
individuals and groups, submitted a
total of 31 comments regarding the draft
PIN. After review and careful
consideration of all comments received,
HRSA has amended the PIN to
incorporate certain recommendations
from the public. The final PIN reflects
these changes.
In addition to making the final PIN
available on HRSA’s Web site, HRSA is
also posting the Agency’s ‘‘Response to
Public Comments.’’ The purpose of that
document is to summarize the major
comments received and describe the
Agency’s response, including any
corresponding changes made to the PIN.
Where comments did not result in a
revision to the PIN, explanations are
provided.
FOR FURTHER INFORMATION CONTACT: For
questions regarding this notice, please
contact the Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, at OPPDGeneral@hrsa.gov.
Dated: March 8, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–5671 Filed 3–15–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
sroberts on DSKD5P82C1PROD with NOTICES
Clinical Laboratory Improvement
Advisory Committee: Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Clinical
Laboratory Improvement Advisory
Committee, Centers for Disease Control
and Prevention, Department of Health
and Human Services, has been renewed
for a 2-year period through February 19,
2012.
For information, contact Thomas
Hearn, PhD, Designated Federal Officer,
Clinical Laboratory Improvement
Advisory Committee, Centers for
Disease Control and Prevention,
Department of Health and Human
Services, 1600 Clifton Road, NE.,
Mailstop C12, Atlanta, Georgia 30333,
telephone (404) 718–1048 or fax (404)
639–3039.
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 CDC
VerDate Nov<24>2008
16:33 Mar 15, 2010
Jkt 220001
and the Agency for Toxic Substances
and Disease Registry.
Dated: March 9, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Dated: March 9, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–5628 Filed 3–15–10; 8:45 am]
BILLING CODE 4163–18–P
[FR Doc. 2010–5633 Filed 3–15–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Centers for Disease Control and
Prevention
National Advisory Council on Nurse
Education and Practice; Notice of
Meeting
Mine Safety and Health Research
Advisory Committee, National Institute
for Occupational Safety and Health
(MSHRAC, NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meetings:
Name: National Advisory Council on
Nurse Education and Practice
(NACNEP).
Dates and Times: April 22, 2010, 8:30
a.m.–4:30 p.m.
April 23, 2010, 8:30 a.m.–4 p.m.
Place: Doubletree Bethesda Hotel &
Executive Meeting Center, 8120
Wisconsin Avenue, Bethesda, MD
20814.
Status: The meeting will be open to
the public.
Agenda: Agency and Bureau
administrative updates will be
provided.
Purpose: The purpose of this meeting
is to address issues relating to the role
of nursing in primary care and
implications for workforce. The
objectives of the meeting are to: (1)
Delineate the variety of roles nurses
play in primary care including health
promotion, screening, public education,
illness prevention, primary care and
management of stable chronic
conditions; (2) review and evaluate the
data related to education preparation
and supply of primary care nurses and
advanced practice registered nurses; (3)
describe factors that facilitate and
sustain primary care practice by
qualified, competent advanced practice
registered nurses; (4) identify the
financial and regulatory barriers to
effective, accessible primary care
delivered by nurses and recommended
strategies for resolution; and (5) review
and recommend community-based,
nurse-directed models for primary care
delivery that are cost effective and
produce quality outcomes. This meeting
is a continuation of the meeting that was
held November 2009. Experts from
professional nursing, public and private
organizations will make presentations
on primary care delivery models. During
this meeting, the NACNEP council
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 following meeting for the
aforementioned committee:
Time and Date: 8:15 a.m.–5 p.m., March
30, 2010; 8 a.m.–11:30 a.m., March 31, 2010.
Place: Hilton Garden Inn Pittsburgh/
Southpointe, 1000 Corporate Drive,
Canonsburg, Pennsylvania 15317, telephone
(724) 743–5000, fax (724) 743–5010.
Status: Open to public, limited only by the
space available. The meeting room
accommodates approximately 50 people.
Purpose: This committee is charged with
providing advice to the Secretary,
Department of Health and Human Services;
the Director, CDC; and the Director, NIOSH,
on priorities in mine safety and health
research, including grants and contracts for
such research, 30 U.S.C. 812(b)(2), Section
102(b)(2).
Matters To Be Discussed: The meeting will
focus on deep cover retreat mining research,
mine illumination research, mine escape and
rescue, human factors research, coal dust
particle size surveys, and updates on
proximity detection, a mine escape vehicle,
robotics research, and results of broad agency
announcements for mining research.
Agenda items are subject to change as
priorities dictate.
For More Information Contact: Jeffery L.
Kohler, PhD, Designated Federal Officer,
MSHRAC, NIOSH, CDC, 626 Cochrans Mill
Road, telephone (412) 386–5301, fax (412)
386–5300.
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.
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]]>Agencies
[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12553-12554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5671]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Availability of Final Policy Document
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Final agency guidance and response to public comments.
-----------------------------------------------------------------------
SUMMARY: HRSA is publishing a Final Agency Guidance (``Policy
Information Notice'' (PIN) 2010-01) to describe the documentation that
will be considered by the Health Resources and Services Administration
(HRSA) in confirming public agency status for organizations that self-
identify as public agencies (also referred to in previous PINs as
``public entities'' or ``public applicants'') for Health Center Program
grant funding authorized under section 330 of the Public Health Service
Act, as amended, and/or for Federally Qualified Health Center Look-
Alike designation. The PIN, ``Confirming Public Agency Status under the
Health Center Program and FQHC Look-Alike Program,'' and the Agency's
``Response to Public Comments'' are available on the Internet at http:/
/bphc.hrsa.gov/policy/pin1001/and https://bphc.hrsa.gov/policy/pin1001/PublcCommentsPIN2010-01.pdf, respectively.
DATES: The effective date of this final Agency guidance is February 5,
2010.
Background: HRSA administers the Health Center Program, which
supports more than 1,100 organizations operating more than 7,500 health
care delivery sites, including community health centers, migrant health
centers, health care for the homeless centers, and public housing
primary care centers. Health centers serve medically underserved
communities delivering preventive and primary care services to patients
regardless of their ability to pay. The Health Center Program's
authorizing statute and implementing regulations (Section 330 of the
PHS Act, as amended, 42 CFR part 51c, and 42 CFR part 56) state that
any public or non-profit private entity is eligible to apply for a
grant under the Health Center Program. The term ``public agency'' is
not defined in section 330 of the PHS Act, as amended, or in the Health
Center Program's regulations; however, reference is made to public
agencies in section 330 of the PHS Act, as amended, in the context of
defining a public center as ``a health center funded (or to be funded)
through a grant under this section to a public agency.'' (Sentence
following Section 330(k)(3)(M) of the PHS Act, as amended) HRSA is
issuing this PIN to describe the documentation that will be considered
by HRSA in confirming public agency status for organizations that self-
identify as public agencies (also referred to in previous PINs as
``public entities'' or ``public applicants'') for Health Center Program
grant funding authorized under section 330 of the Public Health Service
Act, as amended, and/or for Federally Qualified Health Center Look-
Alike designation.
On August 14, 2009, the Health Resources and Services
Administration (HRSA) made the draft Program Information Notice (PIN),
``Confirming Public Agency Status under the Health Center Program and
FQHC Look-Alike Program,'' available for public comment. HRSA also
published a notice in the
[[Page 12554]]
Federal Register of August 28, 2009, requesting comments on this draft
PIN.
Sixteen parties, including both individuals and groups, submitted a
total of 31 comments regarding the draft PIN. After review and careful
consideration of all comments received, HRSA has amended the PIN to
incorporate certain recommendations from the public. The final PIN
reflects these changes.
In addition to making the final PIN available on HRSA's Web site,
HRSA is also posting the Agency's ``Response to Public Comments.'' The
purpose of that document is to summarize the major comments received
and describe the Agency's response, including any corresponding changes
made to the PIN. Where comments did not result in a revision to the
PIN, explanations are provided.
FOR FURTHER INFORMATION CONTACT: For questions regarding this notice,
please contact the Office of Policy and Program Development, Bureau of
Primary Health Care, HRSA, at OPPDGeneral@hrsa.gov.
Dated: March 8, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010-5671 Filed 3-15-10; 8:45 am]
BILLING CODE 4165-15-P
