66104 Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0163] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Draft Guidance, Emergency Use 

Authorization of Medical Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Draft Guidance, Emergency Use 

Authorization of Medical Products’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, e-mail: 

Jonnalynn.capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 6, 2009 (74 

FR 51285), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0595. The 

approval expires on January 31, 2013. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: October 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27160 Filed 10–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0121] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

The Mammography Quality Standards 

Act Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘The Mammography Quality Standards 

Act Requirements’’ has been approved 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, e-mail: 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 15, 2010 (75 FR 

33811), the Agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0309. The 

approval expires on October 31, 2013. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: October 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27159 Filed 10–26–10; 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. 

Immunotoxin for the Treatment of 

Neuroblastoma Relapse 

Description of Technology: 

Immunotoxins are proteins which have 

two distinct domains: (1) An antibody 

or antibody binding fragment which is 

capable of recognizing a single specific 

cell surface protein and (2) a toxin 

domain which is capable of inducing 

cell death. Immunotoxins are currently 

being pursued as therapeutics because 

they specifically kill diseased cells 

while leaving essential, healthy cells 

alone. This increases the effectiveness of 

the therapy while reducing the 

appearance of side-effects. A particular 

immunotoxin that is being studied in 

clinical trials consists of an anti-CD22 

antibody binding fragment and a 

mutated Pseudomonas exotoxin A. 

Although this immunotoxin is being 

explored primarily as a treatment for 

hematological malignancies, it can be 

used to treat any condition where CD22 

is overexpressed on the cell membrane 

of diseased cells. 

Neuroblastomas are malignant cancers 

that start in nerve tissue and primarily 

affect infants and children. Although 

frontline treatments for neuroblastoma 

are often effective, relapse frequently 

occurs in high risk cases. The most 

common form of relapse in 

neuroblastoma patients is caused by 

Neuroblastoma tumor initiating cells 

(NB–TIC). Therefore, if NB–TIC could 

be eliminated, high risk neuroblastoma 

patients could have a therapeutic option 

for preventing a relapse. 

This invention concerns the discovery 

that NB–TIC expresses CD22. As a 

result, NB–TIC are susceptible to 

treatment with an anti-CD22 

immunotoxin. By combining frontline 


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