Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 36099-36100 [2010-15259]
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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.
emcdonald on DSK2BSOYB1PROD with NOTICES
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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36100
Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from July 1, 2009, through
September 30, 2009, and from October
1, 2009, through December 31, 2009.
There were no denial actions during
either period. The list provides the
manufacturer’s name, the product’s
generic name or the trade name, and the
approval date.
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2009, THROUGH DECEMBER 31, 2009.
PMA No.
Docket No.
Applicant
Trade Name
Approval Date
P070022
FDA–2009–M–0317
Hologic, Inc.
ADIANA PERMANENT CONTRACEPTION SYSTEM
July 6, 2009
P060008/S11
FDA–2009–M–0369
Boston Scientific Corp.
TAXUS LIBERTE LONG PACLITAXEL ELUING
STENT SYSTEM
July 13, 2009
P030050/S2
FDA–2009–M–0370
Sanofi Aventis, LLC
SCULPTRA AESTHETIC
July 28, 2009
P080013
FDA–2009–M–0485
Confluent Surgical, Inc.
DURASEAL XACT SEALANT SYSTEM
September 4, 2009
P080008
FDA–2009–M–0536
bioMerieux, Inc.
VIDAS FREE PSA RT (fPSA) ASSAY
October 8, 2009
P030042
FDA–2009–M–0540
Wright Medical Technology,
Inc.
CONSERVE PLUS TOTAL RESURFACING HIP
SYSTEM
November 3, 2009
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: June 17, 2010.
Nancy Stade,
Acting Associate Director for Regulations and
Policy, Center for Devices and Radiological
Health.
[FR Doc. 2010–15259 Filed 6–23–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
emcdonald on DSK2BSOYB1PROD with NOTICES
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The contract proposals and
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the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Dated: June 18, 2010.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel National Childrens
Study.
Date: July 12, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Sathasiva B. Kandasamy,
PhD, Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, 6100 Executive Boulevard,
Room 5B01, Bethesda, MD 20892–9304, (301)
435–6680, skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
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[FR Doc. 2010–15311 Filed 6–23–10; 8:45 am]
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National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
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]]>Agencies
[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Notices]
[Pages 36099-36100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15259]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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]
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
[[Page 36100]]
Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification
of an order approving, denying, or withdrawing approval of a PMA will
continue to include a notice of opportunity to request review of the
order under section 515(g) of the act. The 30-day period for requesting
reconsideration of an FDA action under Sec. 10.33(b) (21 CFR 10.33(b))
for notices announcing approval of a PMA begins on the day the notice
is placed on the Internet. Section 10.33(b) provides that FDA may, for
good cause, extend this 30-day period. Reconsideration of a denial or
withdrawal of approval of a PMA may be sought only by the applicant; in
these cases, the 30-day period will begin when the applicant is
notified by FDA in writing of its decision.
The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from July 1, 2009, through September 30,
2009, and from October 1, 2009, through December 31, 2009. There were
no denial actions during either period. The list provides the
manufacturer's name, the product's generic name or the trade name, and
the approval date.
Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From July 1, 2009, through December 31, 2009.
------------------------------------------------------------------------
PMA No. Docket Approval
No. Applicant Trade Name Date
------------------------------------------------------------------------
P070022 Hologic, Inc. ADIANA PERMANENT July 6,
FDA-2009-M-0317 CONTRACEPTION SYSTEM 2009
------------------------------------------------------------------------
P060008/S11 Boston TAXUS LIBERTE LONG July 13,
FDA-2009-M-0369 Scientific PACLITAXEL ELUING STENT 2009
Corp. SYSTEM
------------------------------------------------------------------------
P030050/S2 Sanofi SCULPTRA AESTHETIC July 28,
FDA-2009-M-0370 Aventis, LLC 2009
------------------------------------------------------------------------
P080013 Confluent DURASEAL XACT SEALANT September
FDA-2009-M-0485 Surgical, SYSTEM 4, 2009
Inc.
------------------------------------------------------------------------
P080008 bioMerieux, VIDAS FREE PSA RT (fPSA) October 8,
FDA-2009-M-0536 Inc. ASSAY 2009
------------------------------------------------------------------------
P030042 Wright Medical CONSERVE PLUS TOTAL November
FDA-2009-M-0540 Technology, RESURFACING HIP SYSTEM 3, 2009
Inc.
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: June 17, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for
Devices and Radiological Health.
[FR Doc. 2010-15259 Filed 6-23-10; 8:45 am]
BILLING CODE 4160-01-S
