Notice of Establishment, 36098-36099 [2010-15293]
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36098
Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices
collection of information to OMB for
review and clearance.
Adoption of the FDA Food Code by
Local, State, and Tribal Governments—
42 U.S.C. 243(a) (OMB Control Number
0910–0448)—Extension
FDA has developed its model Food
Code to assist and promote consistent
implementation of national food safety
regulatory policy among the local, State,
and tribal governmental agencies that
have primary responsibility for the
regulation or oversight of retail level
food operations. The FDA Food Code
provides a scientifically sound technical
and legal basis for regulating the retail
segment of the food industry. Authority
for providing such assistance is derived
from section 311(a) of the Public Health
Service Act (42 U.S.C. 243(a)). Under 31
U.S.C. 1535, FDA provides assistance to
other Federal agencies such as the
Indian Health Service (IHS).
Nationwide adoption of the model
FDA Food Code is an important step
toward the agency’s goal for consistent,
scientifically sound, and risk-based food
safety standards and practices. A
current, comprehensive, and accurate
inventory of food code adoptions by
States and U.S. territories, local, and
tribal governments is necessary to
determine the status of up-to-date
protection of the U.S. population and to
identify areas where assistance to these
governments may promote the adoption
of regulations based on the FDA Food
Code.
This collection effort, which began in
2001, has had remarkable success with
97 percent participation from State and
territorial governmental agencies. FDA
contracted with the Association of Food
and Drug Officials (AFDO) to conduct
the initial survey using the OMB
approved survey form. The rulemaking
process that local, State, territorial, and
tribal governmental agencies must
follow to adopt the model FDA Food
Code is often a long and complicated
process that can extend for several
years. For this reason, many agencies
have reported that they are still in the
rulemaking process to adopt or update
their food codes. Thus, FDA believes
that extension of OMB approval of the
survey is needed in order to keep the
current database accurate and up-todate. The contractor will collect the
information electronically and/or
telephonically and will be able to
provide respondents with previous
survey responses already in the
database. Respondents to this
information collection are States and
U.S. territories, local, and tribal
governmental agencies.
In the Federal Register of April 14,
2010 (71 FR 19405), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Food Code Survey
Respondents
1 There
75
Total Annual
Responses
4
Hours per
Response
300
Total Hours
1
300
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA’s
experience and the number of updates
received in the past 3 years. FDA
estimates that 75 respondents will
provide four quarterly updates each,
resulting in an estimated 300 total
annual responses. The agency estimates
that each quarterly update will take
about 1 hour. Of the 75 respondents,
those who amend their regulations with
changes unrelated to the risk factors and
interventions, and those who are not
adopting model FDA Food Code
provisions, but are incorporating certain
Conference for Food Protection
recommendations only, will likely need
only annual contact.
Dated: June 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–15337 Filed 6–23–10; 8:45 am]
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Annual Frequency per
Response
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Establishment
Pursuant to Section 10413, Part V of
the Patient Protection and Affordable
Care Act (which established Section
399NN of the Public Health Service Act,
as amended); Public Law 111–48, the
Director, Centers for Disease Control
and Prevention (CDC), announces the
establishment of the Advisory
Committee on Breast Cancer in Young
Women.
This committee is established to assist
in creating a national evidence-based
public education and media campaign
to provide age-appropriate messages and
materials to: (1) Increase awareness of
good breast health habits; (2) identify
risk factors based on familial, racial
ethnic and cultural backgrounds; (3)
encourage young women and healthcare
professionals to increase early detection
of breast cancers; and (4) increase the
availability of health information and
other resources for young women
diagnosed with breast cancer.
The Advisory Committee on Breast
Cancer in Young Women will advise the
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Secretary, HHS, the Assistant Secretary
for Health, and the Director, CDC
regarding the formative research,
development, implementation and
evaluation of evidence-based activities
designed to prevent breast cancer
(particularly among those at heightened
risk) and promote the early detection
and support of young women who
develop the disease. The advice
provided by the Committee will assist in
ensuring scientific quality, timeliness,
utility, and dissemination of credible
appropriate messages and resource
materials.
For more information, contact Ena
Wanliss, M.S., Lead Public Health
Advisor, CDC, National Center for
Chronic Disease Prevention and Health
Promotion, Division of Cancer
Prevention and Control, 4770 Buford
Highway, Mailstop K–57, Chamblee,
Georgia 30316, Telephone: 770–488–
4225.
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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Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices
Dated: June 18, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–15293 Filed 6–23–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Legislative Changes to Primary Care
Loan Program Authorized Under Title
VII of the Public Health Service Act
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice.
On March 23, 2010, President
Obama signed into law the Affordable
Care Act (ACA), Public Law 111–148.
Section 5201 of the ACA changes the
Primary Care Loan (PCL) program by: (1)
Reducing the number of years for the
primary health care service requirement;
(2) lowering the interest rate for service
default; and (3) eliminating the HHS
requirement that parental financial
information be submitted for
independent students.
SUPPLEMENTARY INFORMATION: The PCL
program was created through the Health
Professions Education Extension
Amendments of 1992 (Pub. L. 102–408),
which established a new requirement
for the use of the Health Professions
Student Loan funds for allopathic and
osteopathic schools. The PCL program
strives to increase the number of
primary care physicians by providing
long-term, low interest rate loans to fulltime students with financial need
pursuing a degree in allopathic or
osteopathic medicine. Below are details
on how the ACA changes Section 723 of
the Public Health Service Act (PHSA)
regarding administration of the PCL
program.
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SUMMARY:
Primary Health Care Service
Requirement
Under the PCL program, students
were required to enter and complete a
residency training program in primary
health care and practice in primary
health care until the PCL borrower’s
loan was repaid in full. The ACA
change requires that for any new PCLs
made on or after March 23, 2010, the
PCL borrowers are to enter and
complete residency training in primary
health care and practice in primary
health care for either 10 years (including
the years spent in residency training) or
through the date on which the loan is
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repaid in full, whichever occurs first.
(Section 5201(a)(1)(B) of the ACA).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Service Default Interest Rate
Food and Drug Administration
In the past, PCL borrowers who did
not fulfill the service requirements and
began practicing in a discipline or
specialty other than primary health care
were penalized by having their interest
rate on the PCL recalculated at 18
percent. The ACA change requires that
borrowers who receive a PCL on or after
March 23, 2010, and fail to comply with
the service requirements of the program
will have their loans begin to accrue
interest at an annual rate of 2 percent
greater than the rate the student would
pay if compliant. (Section 5201(a)(3) of
the ACA.)
[Docket Nos. FDA–2009–M–0317, FDA–
2009–M–0369, FDA–2009–M–0370, FDA–
2009–M–0485, FDA–2009–M–0536, FDA–
2009–M–0540]
Parental Financial Information
Requirement for Independent Students
Prior to enactment of the new law,
independent students were required to
provide parental financial information
to the school’s financial aid office so
that the school could consider all
financial resources available to the
independent student for a PCL. The
ACA change eliminates the HHS
requirement for independent students to
provide parental financial information
to determine financial need. At its
discretion, a school may still require
parental financial information for
independent students seeking a PCL.
(Section 5201(b) of the ACA.) For this
program, an independent student is a
student who is at least 24 years of age
and has been independent for a
minimum of 3 years. Dependent
students are still required to submit
parental financial information.
The ACA changes to the PCL program
will require a participating school to
revise its PCL master promissory note
for new loans made on or after March
23, 2010, to be consistent with the ACA.
Dated: June 21, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–15354 Filed 6–23–10; 8:45 am]
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Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
agency’s Division of Dockets
Management.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1650, Silver Spring,
MD 20993, 301–796–6570.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
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Agencies
[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Notices]
[Pages 36098-36099]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15293]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Establishment
Pursuant to Section 10413, Part V of the Patient Protection and
Affordable Care Act (which established Section 399NN of the Public
Health Service Act, as amended); Public Law 111-48, the Director,
Centers for Disease Control and Prevention (CDC), announces the
establishment of the Advisory Committee on Breast Cancer in Young
Women.
This committee is established to assist in creating a national
evidence-based public education and media campaign to provide age-
appropriate messages and materials to: (1) Increase awareness of good
breast health habits; (2) identify risk factors based on familial,
racial ethnic and cultural backgrounds; (3) encourage young women and
healthcare professionals to increase early detection of breast cancers;
and (4) increase the availability of health information and other
resources for young women diagnosed with breast cancer.
The Advisory Committee on Breast Cancer in Young Women will advise
the Secretary, HHS, the Assistant Secretary for Health, and the
Director, CDC regarding the formative research, development,
implementation and evaluation of evidence-based activities designed to
prevent breast cancer (particularly among those at heightened risk) and
promote the early detection and support of young women who develop the
disease. The advice provided by the Committee will assist in ensuring
scientific quality, timeliness, utility, and dissemination of credible
appropriate messages and resource materials.
For more information, contact Ena Wanliss, M.S., Lead Public Health
Advisor, CDC, National Center for Chronic Disease Prevention and Health
Promotion, Division of Cancer Prevention and Control, 4770 Buford
Highway, Mailstop K-57, Chamblee, Georgia 30316, Telephone: 770-488-
4225.
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.
[[Page 36099]]
Dated: June 18, 2010.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2010-15293 Filed 6-23-10; 8:45 am]
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