Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13343 

TABLE 4—SUMMARY OF ON-SCHEDULE POSTMARKETING COMMITMENTS

[Numbers as of September 30, 2011] 

On-Schedule open PMCs 

NDA/ANDA 

(percent of 

total PMC) 

BLA (percent 

of total PMC) 1

Pending .................................................................................................................................................................... 141 (38%) 81 (29%) 

Ongoing ................................................................................................................................................................... 77 (21%) 72 (26%) 

Submitted ................................................................................................................................................................. 77 (21%) 56 (20%) 

Combined total ................................................................................................................................................. 295 (80%) 209 (75%) 

1See note 1 for table 1 of this document. 

TABLE 5—SUMMARY OF OFF-SCHEDULE POSTMARKETING COMMITMENTS

[Numbers as of September 30, 2011] 

Off-Schedule open PMCs 

NDA/ANDA 

(percent of 

total PMC) 

BLA (percent 

of total PMC) 1

Delayed .................................................................................................................................................................... 69 (19%) 69 (25%) 

Terminated ............................................................................................................................................................... 5 (1%) 2 (0.7%) 

Combined total ................................................................................................................................................. 74 (20%) 71 (25%) 

1See 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) 

BLA (percent 

of total) 1

Concluded PMRs: 

Requirement met (fulfilled) ............................................................................................................................... 55 (70%) 16 (84%) 

Requirement not met (released and new revised requirement issued) ........................................................... 21 (27%) 0 (0%) 

Requirement no longer feasible or product withdrawn (released) ................................................................... 3 (4%) 3 (16%) 

Total ........................................................................................................................................................... 79 19 

Concluded PMCs: 

Commitment met (fulfilled) ............................................................................................................................... 109 (85%) 44 (80%) 

Commitment not met (released and new revised requirement/commitment issued) ...................................... 12 (9%) 2 (4%)

Commitment no longer feasible or product withdrawn (released) ................................................................... 7 (5%) 9 (16%) 

Total ........................................................................................................................................................... 128 55 

1See note 1 for table 1 of this document. 

Dated: February 28, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5302 Filed 3–5–12; 8:45 am] 

BILLING CODE 4160–01–P 

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 


pmangrum on DSK3VPTVN1PROD with NOTICES
13344 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / 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 

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 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: 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 

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. 

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: 

• 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 

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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