36238 Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs (OMB NO. 0930–0158)— 

Extension 

SAMHSA’s Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs will request OMB approval for 

the Federal Drug Testing Custody and 

Control Form for Federal agency and 

federally regulated drug testing 

programs which must comply with the 

HHS Mandatory Guidelines for Federal 

Workplace Drug Testing Programs (69 

FR 19644) dated April 13, 2004, and for 

the information provided by laboratories 

for the National Laboratory Certification 

Program (NLCP). 

The Federal Drug Testing Custody 

and Control Form is used by all Federal 

agencies and employers regulated by the 

Department of Transportation to 

document the collection and chain of 

custody of urine specimens at the 

collection site, for laboratories to report 

results, and for Medical Review Officers 

to make a determination. The Federal 

Drug Testing Custody and Control Form 

approved by OMB three years ago is 

being resubmitted for OMB approval 

without any revision. 

Prior to an inspection, a laboratory is 

required to submit specific information 

regarding its laboratory procedures. 

Collecting this information prior to an 

inspection allows the inspectors to 

thoroughly review and understand the 

laboratory’s testing procedures before 

arriving at the laboratory. 

The NLCP application form has not 

been revised compared to the previous 

form. 

The annual total burden estimates for 

the Federal Drug Testing Custody and 

Control Form, the NLCP application, the 

NLCP inspection checklist, and NLCP 

recordkeeping requirements are shown 

in the following table. 

Form/respondent 

Burden/ 

response 

(hrs.) 

Number of 

responses 

Total annual 

burden (hrs.) 

Custody and Control Form 

Donor .................................................................................................................................... .08 7,096,000 567,680 

Collector ................................................................................................................................ .07 7,096,000 496,720 

Laboratory ............................................................................................................................. .05 7,096,000 354,800 

Medical Review Officer ......................................................................................................... .05 7,096,000 354,800 

Laboratory Application ................................................................................................................. 3.00 3 9 

Laboratory Inspection Checklist .................................................................................................. 3.00 100 300 

Laboratory Recordkeeping .......................................................................................................... 250.00 50 12,500 

Total ...................................................................................................................................... ........................ ........................ 1,786,809 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by August 21, 2009 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 

Dated: July 15, 2009. 

Dennis O. Romero, 

Deputy Executive Officer and Deputy 

Director, Office of Program Services. 

[FR Doc. E9–17377 Filed 7–21–09; 8:45 am] 

BILLING CODE 4162–20–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. 

High Diversity/High Affinity Domain 

Antibody Library 

Description of Invention: Available for 

licensing and commercial development 

is a highly diverse domain antibody 

(dAb) library providing antibodies that 

bind with high affinity to a variety of 

antigen targets. Antibody diversity is 

inherently limited by using only three 

CDRs of either light chain variable 

domain (LCDRs) or heavy chain variable 

domain (HCDRs). This novel dAb 

library is designed using light chain 

variable domain 3 (LCDR3) and heavy 

chain variable domain (HCDR3), which 

are of primary importance for creating 

binding site diversity in the human 

immune system. The library contains 

2.5 × 10 10 dAbs. Human naturally 

occurring LCDR3s were grafted onto 

HCDR1 of m0. These antibodies are of 

very small size (15–17 kDa), high 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices 36239 

stability and can be expressed at high 

levels as monomers. The library can be 

used for the selection of antibodies to 

any antigen including cancer and viral 

antigens and exhibit such properties as 

good penetration, stability, solubility, 

high levels of expression (at potentially 

low cost), and low level of 

immunogenicity or toxicity. 

Applications: Cancer; Infectious 

disease; Therapeutics; Diagnostics; 

Research reagents; Research tools; 

Library panning. 

Inventors: Dimiter S. Dimitrov and 

Weizao Chen (NCI). 

Relevant Publications: 

1. P Jirholt et al. Exploiting sequence 

space: shuffling in vivo formed 

complementarity determining regions 

into a master framework. Gene 1998 Jul 

30;215(2):471–476. 

2. Y Reiter et al. An antibody singledomain phage display library of a native 

heavy chain variable region: isolation of 

functional single-domain VH molecules 

with a unique interface. J Mol Biol. 1999 

Jul 16;290(3):685–698. 

3. L Riechmann and S Muyldermans. 

Single domain antibodies: comparison 

of camel VH and camelised human VH 

domains. J Immunol Methods 1999 Dec 

10;231(1–2):25–38. 

4. E So ̈derlind et al. Recombining 

germline-derived CDR sequences for 

creating diverse single-framework 

antibody libraries. Nat Biotechnol. 2000 

Aug;18(8): 852–856. 

5. LJ Holt et al. Domain antibodies: 

proteins for therapy. Trends Biotechnol. 

2003 Nov;21(11): 484–490. 

6. W Chen et al. Construction of a 

large phage-displayed human antibody 

domain library with a scaffold based on 

a newly identified highly soluble, stable 

heavy chain variable domain. J Mol 

Biol. 2008 Oct 10;382(3):779–789. 

Patent Status: HHS Reference No. E– 

216–2009/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Michael A. 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, CCR, 

CCRNP is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this domain antibody 

library. Please contact John D. Hewes, 

PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Mouse Monoclonal Antibody Targeting 

Tetanus Toxin Heavy Chain Fragment C 

Description of Invention: The FDA is 

pleased to announce as available for 

licensing a murine monoclonal antibody 

that specifically binds to Fragment C of 

tetanus toxin. Tetanus toxin is one of 

the most potent neurotoxins known. It 

is a complex molecule, composed of a 

linked heavy chain and light chain, each 

having different domains serving 

different functions. One domain of the 

heavy chain, known as ‘‘Fragment C,’’ is 

known to bind the toxin to neurons. 

Fragment C is the focus of much 

research, including: analysis of the 

subtle differences between neuronal 

uptake of tetanus toxin and the related 

botulinum toxin, the design of 

compounds that block the uptake of 

tetanus toxin, and design of drugs that 

target the same cellular mechanism to 

enhance uptake. 

Applications: Cell-based imaging 

agents; New drug development, 

including antitoxins. 

Advantages: Toxin specific-site 

antibodies. 

Development Status: Cell line (mousespleen hybridoma) established to 

produce antibodies. 

Inventors: Marjorie A. Shapiro, PhD, 

and Sean P. Fitzsimmons, PhD (FDA). 

Relevant Publication: SP 

Fitzsimmons, KJ Clark, R Wilkerson, 

MA Shapiro. Inhibition of tetanus toxin 

fragment C binding to ganglioside 

G(T1b) by monoclonal antibodies 

recognizing different fragment C 

epitopes. Vaccine 2000 Aug 

15;19(1):114–121. 

Patent Status: HHS Reference No. E– 

061–2009/0—Research Materials. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for nonexclusive Biological Materials 

Licensing. 

Licensing Contact: Bruce Goldstein, 

J.D., M.S.; 301–435–5470; 

goldsteb@mail.nih.gov. 

Collaborative Research Opportunity: 

The FDA’s Office of Biotechnology 

Products in the Center for Drug 

Evaluation and Research is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize antibodies directed 

against tetanus toxin. Please contact 

Alice Welch, PhD at (301) 827–0359 or 

Alice.Welch@fda.hhs.gov for more 

information. 

Membrane Proximal Region of HIV 

gp41 Anchored to the Lipid Layer of a 

Virus-Like Particle Vaccine 

Description of Invention: The HIV–1 

envelope glycoproteins (gp120–gp41), 

which mediate receptor binding and 

entry, are the major targets for 

neutralizing antibodies. Although the 

envelope glycoproteins are 

immunogenic and induce a variety of 

antibodies, the neutralizing antibodies 

that are induced are strain-specific and 

the majority of the immune response is 

diverted to non-neutralizing 

determinants. Broadly neutralizing 

antibodies have been isolated only from 

natural HIV infection, and rarely, as 

only five broadly-neutralizing 

antibodies have been identified to date. 

Three are gp41-directed (2F5, 4E10 and 

Z13) and the other two (b12 and 2G12) 

are gp120-directed. The three gp41 

neutralizing antibodies recognize the 

membrane proximal region (MPR) of the 

HIV–1 gp41 glycoprotein. The MPR 

region includes a series of amino acids 

that lie on the HIV virus surface, just 

before gp41 crosses the viral membrane. 

The MPR is highly hydrophobic (fifty 

percent of its residues are hydrophobic) 

and is highly conserved across many 

HIV clades. Recently, the hydrophobic 

context of MPR and the presence of 

lipid membrane were shown to be 

important for the optimal binding of 2F5 

and 4E10 antibodies. To date, 

immunization with conserved 

membrane proximal elements or the 

core 2F5 epitope in a number of 

contexts has failed to elicit broadly 

neutralizing antibodies. 

Available for licensing is a technology 

that uses the immunogenic hepatitis B 

surface antigen (HBsAg) platform to 

array epitopes from the conserved, 

neutralization-sensitive MPR of HIV–1, 

and use of these constructs to induce an 

immune response to HIV–1. The 

replacement of a membrane spanning 

domain of HBsAg with a membrane 

spanning domain of gp41 anchors gp41 

into HBsAg in virtually the identical 

orientation as on HIV virions and 

correctly orients the nearby MPR on the 

lipid layer. More specifically, HBsAg 

variant compositions with one or more 

transmembrane domains of the HBsAg 

replaced with a gp41 transmembrane 

domain and one or more gp41 MPRs are 

available for licensing. 

Application: Development of Human 

Immunodeficiency Virus (HIV) 

vaccines, therapeutics and diagnostics. 

Development Status: Vaccine 

candidates have been synthesized and 

preclinical studies have been 

performed. 

Inventors: Ira Berkower (FDA). 

Patent Status: U.S. Provisional 

Application No. 61/086,098 filed 04 

Aug 2008 (HHS Reference No. E–291– 

2008/0–US–01). 

Licensing Status: Available for 

licensing. 


jlentini on DSKJ8SOYB1PROD with NOTICES
36240 Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; 

soukasp@mail.nih.gov. 

A Unique Infectious Hepatitis C Virus 

Clone, Strain HC–TN (genotype 1a) 

Description of Invention: It is 

anticipated that this infectious clone of 

hepatitis C virus (HCV) strain HC–TN 

(genotype 1a) will be useful for the 

development of vaccines and antiviral 

drugs that target HCV, genotype 1a. The 

HC–TN strain is unique because it has 

been shown to cause fulminant 

hepatitis. To date, only one other HCV 

strain, JFH1 (genotype 1b), has been 

isolated that is known to cause 

fulminant hepatitis. Additionally, little 

is known about the etiology of 

fulminant hepatitis C disease. Therefore, 

the HC–TN strain may be useful as a 

tool for studying the etiology of 

fulminant hepatitis. This invention 

includes the infectious clone, 

nucleotide sequences of the clone, and 

polypeptides encoded by the HC–TN 

clone. Methods are included for 

producing attenuated HCV, and for 

screening therapeutics against HCV and 

developing vaccines and diagnostics. 

Apparently, no companies or other 

laboratories have this HC–TN strain. 

The availability of the pHC–TN clone 

will be highly useful to pharmaceutical 

companies since no further research is 

required for its commercialization into, 

e.g., assays for testing antiviral 

compounds targeting HCV. 

Applications: 

• Production of attenuated viruses 

and polypeptides. 

• HCV vaccines, diagnostics, 

therapeutics and screening tool for antiHCV compounds. 

Advantages: There is no universally 

effective therapy against HCV infection. 

This invention enables development of 

vaccines, diagnostics and therapeutics 

that are specific for the HC–TN strain or 

HCV genotype 1a. 

Development Status: The technology 

is currently in the preclinical stage of 

development. 

Market: More than 80% of the HCV 

infections in North and South America, 

Europe, Russia, China, Japan and 

Australia are genotype 1. The instant 

technology may be transferred through 

biological materials licenses for 

territories in which no patent rights 

exist. 

Inventors: Jens Bukh, Robert H. 

Purcell, Suzanne U. Emerson, Akito 

Sakai, Patrizia Farci (NIAID). 

Publication: A Sakai et al. In vivo 

study of the HC–TN strain of hepatitis 

C virus recovered from a patient with 

fulminant hepatitis: RNA transcripts of 

a molecular clone (pHC–TN) are 

infectious in chimpanzees but not in 

Huh7.5 cells. J Virol. 2007 

July;81(13):7208–7219. 

Patent Status: U.S. Patent Application 

No. 12/061,504 filed 02 April 2008 

(HHS Reference No. E–249–2007/0–US– 

01); No foreign rights available. 

Licensing Status: Available for 

licensing. 

Licensing Contact: RC Tang, JD, LLM; 

301–435–5031; tangrc@mail.nih.gov. 

Dated: July 13, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Transfer, National 

Institutes of Health. 

[FR Doc. E9–17319 Filed 7–21–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel. Formative Children’s Center 

Review 2. 

Date: July 24, 2009. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle, NW., Washington, DC 20005. 

Contact Person: Linda K. Bass, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research and Training, Nat. Institute 

Environmental Health Sciences, P. O. Box 

12233, MD EC–30, Research Triangle Park, 

NC 27709. (919) 541–1307. 

malone@niehs.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: July 14, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–17303 Filed 7–21–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Healthcare Infection Control Practices 

Advisory Committee (HICPAC) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting for the 

aforementioned committee: 

Time and Date: 11 a.m.–12 p.m., July 23, 

2009. 

Place: The teleconference call will 

originate at the CDC. 

Status: Open to the public. Teleconference 

access limited only by availability of 

telephone ports. To participate in the 

teleconference please dial 1 (800) 779–6036 

and enter conference code 6417394. 

Purpose: The Committee is charged with 

providing advice and guidance to the 

Secretary, HHS; the Assistant Secretary for 

Health; the Director, CDC; and the Director, 

National Center for Preparedness, Detection, 

and Control of Infectious Diseases 

(NCPDCID), regarding: (1) The practice of 

hospital infection control; (2) strategies for 

surveillance, prevention, and control of 

infections (e.g., nosocomial infections), 

antimicrobial resistance, and related events 

in settings where healthcare is provided; and 

(3) periodic updating of guidelines and other 

policy statements regarding prevention of 

healthcare-associated infections and 

healthcare-related conditions. 

Matters To Be Discussed: The agenda will 

include a follow up discussion of CDC’s 

Interim Guidance for Infection Control for 

Care of Patients with Confirmed or Suspected 

Novel Influenza A (H1N1) Virus Infection in 

a Healthcare Setting. 

Agenda items are subject to change as 

priorities dictate. This notice is being 

published less than 15 days prior to the 

meeting due to the public health emergency 

declared on April 26, 2009. There is a critical 

need for this committee to deliberate and 

discuss urgent matters related to the H1N1 

virus, and be actively engaged in the national 

preparedness and response efforts as dictated 

by circumstances and events. 


jlentini on DSKJ8SOYB1PROD with NOTICES