Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 66103 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0544] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

Participation in the Medical Device 

Fellowship Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the application for participation in the 

Medical Device Fellowship Program 

(MDFP). 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 27, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

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, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Application for Participation in the 

Medical Device Fellowship Program—5 

U.S.C. 1104, 1302, 3301, 3304, 3320, 

3361, 3393, and 3394 (OMB Control 

Number 0910–0551)—Extension 

Sections 1104, 1302, 3301, 3304, 

3320, 3361, 3393, and 3394 of Title 5 of 

the United States Code, authorize 

Federal agencies to rate applicants for 

Federal jobs. Collecting applications for 

the MDFP will allow FDA’s Center for 

Devices and Radiological Health (CDRH) 

to easily and efficiently elicit and 

review information from students and 

health care professionals who are 

interested in becoming involved in 

CDRH activities. The process will 

reduce the time and cost of submitting 

written documentation to the Agency 

and lessen the likelihood of applications 

being misrouted within the Agency mail 

system. It will assist the Agency in 

promoting and protecting the public 

health by encouraging outside persons 

to share their expertise with CDRH. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

5 U.S.C. Section FDA form No. Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

1104, 1302, 3301, 3304, 3320, 3361, 

3393, 3394 ........................................... 3608 250 1 250 1 250 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA based these estimates on the 

number of inquiries that have been 

received concerning the program and 

the number of requests for application 

forms over the past 3 years. 

Dated: October 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27158 Filed 10–26–10; 8:45 am] 

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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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