10768 Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in Guidance for Industry #170. 

These collections of information are 

subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520) and have been 

approved under OMB Control No. 0910–

0540. 

IV. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in the 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either CVM 

home page (http://www.fda.gov/cvm) or 

the Division of Dockets Management 

Web site http://www.fda.gov/ohrms/ 

dockets/default.htm. 

Dated: March 1, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4322 Filed 3–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submissions for OMB Review; 

Comment Request; Evaluation of the 

Impact of the New Conflicts of Interest 

Regulations on the National Institutes 

of Health’s Ability to Recruit and 

Retain Staff 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of 

Human Resources (OHR), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. The purpose of this notice 

is to allow 30 days for public comment. 

The NIH may not conduct or sponsor, 

and the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection 

Title: Evaluation of the Impact of the 

New Conflicts of Interest regulations on 

the National Institutes of Health’s 

Ability To Recruit and Retain Staff. 

Type of Information Collection 

Request: NEW. 

Need and Use of Information 

Collection: To assess the impact of new 

Department of Health and Human 

Services (HHS) conflicts of interest 

regulations on the NIH’s ability to 

continue to attract and recruit highly 

qualified scientific personnel. Gauging 

both the immediate and long-term 

impact of these new rules is crucial to 

NIH’s ability to develop and maintain a 

world-class staff. This project will 

produce data that will help NIH and 

HHS leaders determine the impact of 

the regulations and how to minimize the 

effect of the regulations on NIH’s ability 

to recruit and retain staff. NIH intends 

to survey potential applications for NIH 

employment from scientific 

organizations from which NIH has 

traditionally drawn leading scientific 

personnel, and those senior scientists 

and administrators who have 

voluntarily left NIH since February 

2005. This will allow NIH to determine 

whether the regulations impact 

individuals’ attitudes about 

employment at NIH and the likelihood 

of their joining and/or leaving the 

agency. This proposed one-time survey 

is part of a larger study that will provide 

OHR with the high-quality data needed 

to evaluate the impact of the new rules. 

Data will be collected on respondents’

understanding of the new regulations, 

how they believe the regulations could 

impact them, and on their feelings about 

working at NIH in light of the 

regulations. Data will also be collected 

from current NIH employees and the 

combined data will be used in the 

review of the rules. The survey is 

planned to launch in early 2007 and to 

be in the field for eight weeks. 

Frequency of Response: Once. 

Affected Public: Individuals or 

households. 

Type of Respondents: Potential 

applicants for NIH positions and senior 

scientists and administrators who have 

voluntarily left NIH since February 

2005. 

The annual reporting burden is as 

follows: 

Type of respondent Number of respondents 

Frequency of 

response 

Average time 

per response 

(minutes) 

Estimated total 

annual hour 

burden 

(hours) 

Potential Applicants ......................................................................................... 400 1 15 100 

Former NIH Employees ................................................................................... 100 1 10 16.67 

TOTAL ...................................................................................................... 500 ........................ ........................ 116.67 

Total Number of Respondents: 500. 

Total Number of Responses: 500. 

Total Hours: 116.67 hours. 

The annualized cost to respondents is 

estimated at: $3,850. 

There are no capital costs, operating 

costs, and/or maintenance costs to 

report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comment to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, New Executive 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 10769 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Mr. 

Richard M. Taffet, Director, Client 

Services Division; Office of Human 

Resources, Office of the Director, 

National Institutes of Health, Room 2–

D234, East Jefferson Street, Bethesda, 

MD 20892–8503, or call the non-toll-free 

number 301–402–6627, or e-mail your 

comments or request, including your 

address, to: Taffetr@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of this 

publication. 

Dated: February 26, 2007. 

Richard M. Taffet, 

Director, Client Services Division, OHR, OD, 

National Institutes of Health. 

[FR Doc. 07–1087 Filed 3–8–07; 8:45 am] 

BILLING CODE 4140–10–M 

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. 

Methods of Treating Conditions 

Characterized by Unwanted or 

Excessive Presynaptic Neuronal 

Activity or Secretion 

Description of Technology: Botulinum 

toxins are highly potent neurotoxins 

produced by the spore-forming 

bacterium, Clostridium botulinum. 

Poisoning by any of the seven known 

botulinum toxin serotypes, designated A 

to G, results in impaired communication 

between nerve and muscle that causes 

paralysis in patients and possible death 

by respiratory failure. Injections of 

botulinum toxins A and B have been 

approved for treating disorders 

associated with uncontrollable muscle 

contractions. However, the use of 

approved botulinum toxins is limited by 

their temporary duration of action, the 

development of neutralizing antibodies 

after repeated injections, and crossreactivity with autonomic neurons. 

Thus, an interest exists in finding new 

ways to achieve longer-lasting effects 

using botulinum toxins. 

This technology describes a novel 

method for treating diseases by 

combining two botulinum toxins, 

botulinum toxin A and B. Researchers at 

the FDA have shown that the 

combination of the A and B toxins is 

synergistic, improves muscle paralysis 

characteristics compared to individually 

administered serotypes, and produces a 

longer duration of action and a faster 

onset of paralysis. The synergistic effect 

allows lower doses compared to single 

use of either toxin and should help 

reduce resistance after repeated use. 

This technology is beneficial for the 

treatment of diseases already known to 

be treatable with botulinum toxins, such 

as facial wrinkles, headaches, muscle 

spasms, and cervical dystonia. This 

technology is also suitable to treat other 

diseases, such as strabismus, hemifacial 

spasms, facial nerve damage, and 

hyperhidrosis (excessive sweating). 

Available for licensing are methods 

and pharmaceutical compositions for 

administering a combination of 

botulinum toxin A and B to treat 

unwanted or excessive presynaptic 

neuronal activity or secretion. 

Application: Alternative therapy for 

diseases treatable with individual 

botulinum toxins; such therapies 

include Botox, Botox Cosmetic, and 

Myobloc. 

Market: Patients who are currently 

prescribed individual toxins for 

treatment of diseases such as 

strabismus, blepharospasm, cervical 

dystonia, and cosmetic wrinkle 

reduction. 

Development Status: Pre-clinical data 

is available. 

Inventors: James E. Keller (CBER/ 

FDA). 

Publications: JE Keller. Recovery from 

botulinum neurotoxin poisoning in 

vivo. Neuroscience 2006 May 

12;139(2):629–637. 

Patent Status: U.S. Provisional 

Application No. 60/773,412 filed 15 Feb 

2006 (HHS Reference No. E–172–2005/ 

0–US–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Norbert Pontzer, 

PhD, J.D.; 301/435–5502; 

pontzern@mail.nih.gov. 

Collaborative Research Opportunity: 

The FDA Center for Biologics 

Evaluation and Research, Laboratory of 

Respiratory and Special Pathogens, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Please contact James E. 

Keller, PhD, at 301/ for more 

information. 

Synergistic Effect of TGF-Beta Blockade 

and Immunogenic Agents on Tumors 

Description of Technology: 

Overcoming immune suppression in 

cancer patients is a major challenge for 

the success of cancer immunotherapy. 

TGF–b and its receptors are expressed 

in essentially all tissues, and they have 

been found to be important in many 

cellular processes including cell growth 

inhibition. The inhibition of TGF–b 

signaling has been shown to have an 

inhibitory effect on tumor growth. 

However, TGF–b also has 

immunosuppressive properties. 

Cancer vaccines are one of many 

therapies available for treatment and 

prevention. In particular, vaccines that 

elicit immune responses have been used 

to treat or control tumor growth that has 

evaded immunosurveillance. However, 

these vaccines have demonstrated 

limited success. 

Available for licensing is a method for 

synergistically affecting tumor growth 

involving the administration of an agent 

that blocks the TGF–b signaling 

pathway, in combination with an 

immunogenic agent. The agent that 

blocks the TGF–b signaling pathway 

may inhibit the immunosuppressive 

effects of TGF–b, while the 

immunogenic agent is believed to 

enhance an immune response. 

Surprisingly, the combination of such 

elements produces a synergistic effect. 

The administration of the 1D11.16 antiTGF–b antibody in combination with 

the human papilloma virus E7(49–57) 

peptide enhances tumor regression in an 

animal model. The administration of the 

1D11.16 anti-TGF–b antibody in 


jlentini on PROD1PC65 with NOTICES