Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Termination of Acceptance of Nominations and Extending the Duration of the Program, 13343-13344 [2012-5311]
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Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices
TABLE 4—SUMMARY OF ON-SCHEDULE POSTMARKETING COMMITMENTS
[Numbers as of September 30, 2011]
NDA/ANDA
(percent of
total PMC)
On-Schedule open PMCs
BLA (percent
of total PMC) 1
Pending ....................................................................................................................................................................
Ongoing ...................................................................................................................................................................
Submitted .................................................................................................................................................................
141 (38%)
77 (21%)
77 (21%)
81 (29%)
72 (26%)
56 (20%)
Combined total .................................................................................................................................................
295 (80%)
209 (75%)
1 See
note 1 for table 1 of this document.
TABLE 5—SUMMARY OF OFF-SCHEDULE POSTMARKETING COMMITMENTS
[Numbers as of September 30, 2011]
NDA/ANDA
(percent of
total PMC)
Off-Schedule open PMCs
BLA (percent
of total PMC) 1
Delayed ....................................................................................................................................................................
Terminated ...............................................................................................................................................................
69 (19%)
5 (1%)
69 (25%)
2 (0.7%)
Combined total .................................................................................................................................................
74 (20%)
71 (25%)
1 See
note 1 for table 1 of this document.
TABLE 6—SUMMARY OF CONCLUDED POSTMARKETING REQUIREMENTS AND COMMITMENTS
[October 1, 2010 to October 1, 2011]
NDA/ANDA
(percent of
total)
Concluded PMRs:
Requirement met (fulfilled) ...............................................................................................................................
Requirement not met (released and new revised requirement issued) ...........................................................
Requirement no longer feasible or product withdrawn (released) ...................................................................
BLA (percent
of total) 1
55 (70%)
21 (27%)
3 (4%)
16 (84%)
0 (0%)
3 (16%)
Total ...........................................................................................................................................................
Concluded PMCs:
Commitment met (fulfilled) ...............................................................................................................................
Commitment not met (released and new revised requirement/commitment issued) ......................................
Commitment no longer feasible or product withdrawn (released) ...................................................................
79
19
109 (85%)
12 (9%)
7 (5%)
44 (80%)
2 (4%)
9 (16%)
Total ...........................................................................................................................................................
128
55
1 See
note 1 for table 1 of this document.
Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
ACTION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
pmangrum on DSK3VPTVN1PROD with NOTICES
[Docket No. FDA–2011–N–0788]
Pilot Program for Early Feasibility
Study Investigational Device
Exemption Applications; Termination
of Acceptance of Nominations and
Extending the Duration of the Program
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
The Food and Drug
Administration (FDA) is announcing the
termination of the acceptance of
nominations for the Early Feasibility
Study Investigational Device Exemption
(IDE) Applications pilot program. This
program allowed the submission of
nominations from sponsors of
innovative device technologies to
participate in a pilot program for early
feasibility study IDE applications. FDA
is also announcing that the duration of
the pilot program is extended to May 8,
2013, for sponsors that have already
been accepted for the program.
SUMMARY:
[FR Doc. 2012–5302 Filed 3–5–12; 8:45 am]
AGENCY:
Notice.
DATES:
This notice is effective March 6,
2012.
FOR FURTHER INFORMATION CONTACT:
Sheila Brown, Center for Devices and
14:56 Mar 05, 2012
Jkt 226001
PO 00000
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Fmt 4703
Sfmt 4703
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1676, Silver Spring,
MD 20993–0002, 301–796–5640.
In the
Federal Register of November 10, 2011
(76 FR 70150), FDA announced the
availability of a draft guidance entitled
‘‘Investigational Device Exemptions
(IDE) for Early Feasibility Medical
Device Clinical Studies, Including
Certain First in Human (FIH) Studies.’’
This guidance document is intended to
facilitate early feasibility studies of
medical devices, using appropriate risk
mitigation strategies, under the IDE
requirements. Simultaneous with the
publication of the draft guidance, FDA
also announced an Early Feasibility
Study IDE Pilot Program (76 FR 70152,
November 10, 2011) intended to collect
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06MRN1.SGM
06MRN1
Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices
pmangrum on DSK3VPTVN1PROD with NOTICES
information and experience on the
application of the draft guidance in
order to inform the final guidance
document.
FDA began accepting nominations for
the pilot program on December 12,
2011. In the Federal Register notice
announcing the pilot program, FDA
stated its intention to limit the pilot
program to nine candidates. After
review of the nominations received in
response to the pilot program notice,
FDA accepted nine appropriate
candidates for the pilot program.
In the pilot program notice, FDA
stated its intention to accept
nominations to participate in the pilot
program until May 8, 2012. Because
FDA has already accepted nine sponsors
to participate in the program, FDA will
no longer accept nominations to
participate in the program and will
conduct the pilot program for the nine
sponsors that have already been
accepted.
In the pilot program notice, FDA also
stated that the pilot program will
terminate on May 8, 2012. Instead, the
pilot program will be extended for the
Potential Commercial Applications:
• Real-time monitoring of tissue
damage from primary blast pressure
• Real-time monitoring of tissue
damage from secondary effects of blast
pressure, such as tissue shearing against
surfaces
• Can monitor tissue through both
live imaging and assaying cell viability
• Can measure pressure effects on
various tissues
Competitive Advantages:
VerDate Mar<15>2010
14:56 Mar 05, 2012
Jkt 226001
nine accepted sponsors until May 8,
2013.
Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–5311 Filed 3–5–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
SUMMARY:
• Allows differentiation of primary
and secondary blast pressure effects on
tissue damage
• Employs multiple methods to assess
cell viability
• Possesses high temporal resolution
Development Stage: Prototype.
Inventors: Rea Ravin, Paul Blank,
Alex Steinkamp, Joshua Zimmerberg,
Sergey Bezrukov, and Kim Lee Mcafee
(all of NICHD).
Intellectual Property: HHS Reference
No E–068–2012/0—U.S. Provisional
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Device for Simulating Explosive Blast
Trauma
Description of Technology: NIH
scientists have developed a novel device
to simulate the effects of pressure waves
resulting from explosions or blasts on
biological tissue. This methodology
allows real-time monitoring of tissue
damage while it is occurring and can
track the secondary effects of pressure
damage after tissue insult. This tool is
well-adapted for investigating traumatic
brain injury and organ damage resulting
from explosion pressure waves, such as
in military combat.
Application No. 61/590,209 filed 24 Jan
2012.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019; mish@
codon.nih.gov.
Small-Molecule Inhibitors of Human
Galactokinase for the Treatment of
Galactosemia and Cancers
Description of Technology: Lactose,
found in dairy products and other foods,
is comprised of two simple sugars,
glucose and galactose. In galactosemia,
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EN06MR12.002</GPH>
13344
]]>Agencies
[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13343-13344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5311]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0788]
Pilot Program for Early Feasibility Study Investigational Device
Exemption Applications; Termination of Acceptance of Nominations and
Extending the Duration of the Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
termination of the acceptance of nominations for the Early Feasibility
Study Investigational Device Exemption (IDE) Applications pilot
program. This program allowed the submission of nominations from
sponsors of innovative device technologies to participate in a pilot
program for early feasibility study IDE applications. FDA is also
announcing that the duration of the pilot program is extended to May 8,
2013, for sponsors that have already been accepted for the program.
DATES: This notice is effective March 6, 2012.
FOR FURTHER INFORMATION CONTACT: Sheila Brown, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1676, Silver Spring, MD 20993-0002, 301-796-5640.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 10, 2011
(76 FR 70150), FDA announced the availability of a draft guidance
entitled ``Investigational Device Exemptions (IDE) for Early
Feasibility Medical Device Clinical Studies, Including Certain First in
Human (FIH) Studies.'' This guidance document is intended to facilitate
early feasibility studies of medical devices, using appropriate risk
mitigation strategies, under the IDE requirements. Simultaneous with
the publication of the draft guidance, FDA also announced an Early
Feasibility Study IDE Pilot Program (76 FR 70152, November 10, 2011)
intended to collect
[[Page 13344]]
information and experience on the application of the draft guidance in
order to inform the final guidance document.
FDA began accepting nominations for the pilot program on December
12, 2011. In the Federal Register notice announcing the pilot program,
FDA stated its intention to limit the pilot program to nine candidates.
After review of the nominations received in response to the pilot
program notice, FDA accepted nine appropriate candidates for the pilot
program.
In the pilot program notice, FDA stated its intention to accept
nominations to participate in the pilot program until May 8, 2012.
Because FDA has already accepted nine sponsors to participate in the
program, FDA will no longer accept nominations to participate in the
program and will conduct the pilot program for the nine sponsors that
have already been accepted.
In the pilot program notice, FDA also stated that the pilot program
will terminate on May 8, 2012. Instead, the pilot program will be
extended for the nine accepted sponsors until May 8, 2013.
Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5311 Filed 3-5-12; 8:45 am]
BILLING CODE 4160-01-P
