10228 Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices 

Final regulations at 45 CFR part 60 set 

forth these criteria and procedures for 

information to be reported to and 

disclosed by the NPDB. Section 60.3 of 

these regulations defines the terms used 

in this announcement. 

In determining any changes in the 

amount of the user fee, the Department 

uses the criteria set forth in section 

60.12(b) of the regulations. The 

Department must recover the full costs 

of operating the Data Bank through user 

fees. Paragraph (b) of the regulations 

states: 

‘‘The amount of each fee will be 

determined based on the following 

criteria: 

a. Use of electronic data processing 

equipment to obtain information—the 

actual cost for the service, including 

computer search time, runs, printouts, 

and time of computer programmers and 

operators, or other employees, 

b. Photocopying or other forms of 

reproduction, such as magnetic tapes—

actual cost of the operator’s time, plus 

the cost of the machine time and the 

materials used, 

c. Postage—actual cost, and 

d. Sending information by special 

methods requested by the applicant, 

such as express mail or electronic 

transfer—the actual cost of the special 

service.’’

An annual subscription fee of $3.25 

per practitioner will be charged upon 

enrollment. This fee includes the cost of 

an initial query, which automatically 

occurs when a practitioner is first 

enrolled, and all reports received on the 

enrolled practitioner over the course of 

the subscription period of 1 year. The 

fee was determined through economic 

analysis of the average annual rate of 

queries performed by health care 

entities in relationship to the current 

query fee that is based on the actual cost 

for services. The Department will accept 

payment for the subscription fee from 

entities via credit card or electronic 

funds transfer. When the prototype 

period concludes, the Department may 

change the subscription fee. Any 

changes will be announced through 

notice in the Federal Register. 

The periodic query fee remains at 

$4.75 per name. The practitioner selfquery fee remains at $8.00. Currently 

when a periodic query is on one or more 

physicians, dentists or other health care 

practitioners, the appropriate fee will be 

$4.75 multiplied by the number of 

individuals about whom the 

information is requested. Similarly, 

when a PDS prototype participating 

entity enrolls one or more physicians, 

dentists or other health care 

practitioners, the appropriate fee will be 

$3.25 multiplied by the number of 

individuals whom are enrolled. An 

individual practitioner may not enroll 

in PDS. For examples, see the tables 

below. 

Periodic query method 

Fee per 

name in 

query 

Examples 

Entity query (via) internet with electronic payment ....................................................................................... $4.75 10 names in query. 

10 x $4.75 = $47.50. 

Practitioner Self-query ................................................................................................................................... 8.00 One self-query = 

$8.00. 

Proactive disclosure service (PDS) query method 

Fee per 

name enrolled Examples 

Entity query (via) internet with electronic payment ....................................................................................... $3.25 10 names in query. 

10 x $3.25 = $32.50. 

Dated: March 1, 2007. 

Elizabeth M. Duke, 

Administrator. 

[FR Doc. E7–3974 Filed 3–6–07; 8:45 am] 

BILLING CODE 4165–15–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. 

Novel System for HIV–1 Vaccine 

Development 

Description of Technology: The 

available technologies describe specific 

immunogenic peptides, peptide 

modifications and methods for 

identifying additional immunogens 

against HIV–1 surface proteins, gp120 

and gp41. Additionally, detailed 

methods for use of the described 

immunogenic peptides in the 

development of vaccines and 

diagnostics for HIV–1 are disclosed. The 

current technologies further include a 

comprehensive system for immunogen 

design, comprising in silico design 

coupled to feedback from X-ray 

crystallography, antigenic analysis, and 

immunization. 

The described methodology 

demonstrates how to transplant a given 

HIV–1 epitope recognized by broadly 

neutralizing antibodies into an 

appropriate scaffold, while preserving 

its structure and antigenicity. 

Conservation of the three dimensional 

structure may lead to the generation of 

antibodies with broadly neutralizing 

characteristics, similar to the template 

antibody. Such epitope-transplant 

scaffolds may serve as valuable 

diagnostics to identify specific serum 

reactivity against the target HIV–1 

epitopes. The subject scaffolding 

technology may be applied to any virus 

for which a broadly neutralizing 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices 10229 

antibody and its respective epitope has 

been characterized at the atomic-level. 

Applications: 

1. Immunogens that elicit immune 

responses to HIV–1. 

2. Efficient development of vaccines 

against HIV–1. 

3. Screening tool to isolate antibodies 

with activities similar to identified 

template antibody. 

Inventors: Peter D. Kwong et al. 

(NIAID) 

Publications: 

1. G Ofek, W Schief, J Guenaga, et al. 

Epitope-transplant scaffolds: Automated 

design, structural analysis, and 

antigenic characteristics. Manuscript in 

preparation (2007). 

2. T Zhou, L Xu, B Dey, AJ Hessell, 

DV Ryk, SH Xiang, X Yang, MY Zhang, 

MB Zwick, J Arthos, DR Burton, DS 

Dimitrov, J Sodroski, R Wyatt, GJ Nabel, 

PD Kwong. Structural definition of a 

conserved neutralization epitope on 

HIV–1 gp120. Nature. 2007 Feb 

15;445(7129):732–737. 

3. DC Douek, PD Kwong, GJ Nabel. 

The rational design of an AIDS vaccine. 

Cell. 2006 Feb 24;124(4):677–681. 

4. G Ofek, M Tang, A Sambor, H 

Katinger, JR Mascola, R Wyatt, PD 

Kwong. Structure and mechanistic 

analysis of the anti-HIV–1 antibody 2F5 

in complex with its gp41 epitope. J 

Virol. 2004 Oct;78(19):10724–10737. 

Patent Status: 

1. PCT Application No. PCT/US2005/ 

016633 filed 13 May 2005, which 

published as WO 2005/111079 on 24 

Nov 2005 (HHS Reference No. E–218–

2004/0–PCT–02), and National Stage 

filed in the U.S. on 26 Nov 2006 (HHS 

Reference No. E–218–2004/0–US–03), 

entitled ‘‘HIV Vaccine Immunogens and 

Immunization Strategies to Elicit 

Broadly-Neutralizing Anti-HIV–1 

Antibodies Against the Membrane 

Proximal of HIV gp41’’. 

2. PCT Application No. PCT/US2006/ 

034681 filed 06 Sep 2006 (HHS 

Reference No. E–324–2005/3–PCT–01), 

entitled ‘‘Conformationally Stabilized 

HIV Envelope Immunogens and 

Triggering HIV-1 Envelope to Reveal 

Cryptic V3-Loop Epitopes’’

3. PCT Application No. PCT/US2006/ 

034882 filed 06 Sep 2006 (HHS 

Reference No. E–280–2006/1–PCT–01), 

entitled ‘‘HIV gp120 Crystal Structure 

and Its Use to Identify Immunogens’’

4. U.S. Provisional Application No. 

60/840,119 filed 25 Aug 2006 (HHS 

Reference No. E–302–2006/0–US–01), 

entitled ‘‘Epitope-Transplant Scaffolds 

and Their Use’’

Licensing Availability: Available for 

non-exclusive or exclusive licensing. 

Licensing Contact: Susan Ano, Ph.D.; 

301/435–5515; anos@mail.nih.gov 

CCR5-Specific Human Monoclonal 

Antibodies 

Description of Technology: The 

subject invention provides the 

composition claims related to anti-CCR5 

monoclonal antibodies, their fusion 

protein, conjugates, derivatives, or 

fragments, DNA sequences encoding 

such antibodies, host cells containing 

such DNA sequences, as well as the 

methods to produce them 

recombinantly and their 

pharmacological composition. 

It has been demonstrated that the HIV 

co-receptor CCR5 plays an important 

role in virus entry. The subject 

antibodies exhibited neutralization 

activity against HIV–1 infection by 

binding to cell associated CCR5 in vitro. 

Moreover, subject antibodies have 

potentially lower immunogenicity and 

toxicity, because they are fully human 

antibodies. Therefore, subject anti-CCR5 

antibodies have a potential as a 

therapeutic and/or prophylactic in 

combination with other HIV–1 

neutralizing antibodies and antiretroviral drugs. 

Applications: HIV treatment and 

prevention. 

Development Status: In vitro data is 

available at this time. 

Inventors: Dimiter S. Dimitrov and 

Mei-Yun Zhang (NCI). 

Related Publications: 

1. C Pastori et al. Long-lasting CCR5 

internalization by antibodies in a subset 

of long-term nonprogressors: A possible 

protective effect against disease 

progression. Blood. 2006 Jun 

15;107(12):4825–4833. 

2. MY Zhang, B Vu, CC Huang, I 

Sidirov, V Choudhly, PD Kwong, DS 

Dimitrov. Identification of human 

monoclonal antibodies specific for 

CCR5 from an antibody library derived 

from HIV-infected long-term nonprogressors. Retrovirology. 2006 Dec 

21;3 Suppl 1:S61. 

3. DS Dimitrov. Virus entry: 

molecular mechanisms and biomedical 

applications. Nat Rev Microbiol. 2004 

Feb;2(2):109–122. 

Patent Status: U.S. Provisional 

Application No. 60/859,401 filed 15 

Nov 2006 (HHS Reference No. E–297–

2006/0–US–01) 

Licensing Availability: Available for 

exclusive and non-exclusive licensing. 

Licensing Contact: Sally Hu, Ph.D.; 

301/435–5606; HuS@mail.nih.gov. 

Collaborative Research Opportunity: 

The NCI CCR Nanobiology Program is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

monoclonal antibodies. Please contact 

John D. Hewes, Ph.D. at 301–435–3121 

or hewesj@mail.nih.gov for more 

information. 

Dated: February 28, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer 

National Institutes of Health. 

[FR Doc. E7–3959 Filed 3–6–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

Advisory Committee on Research on 

Women’s Health. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Advisory Committee 

on Research on Women’s Health. 

Date: March 29–30, 2007. 

Time: March 29, 2007, 9 a.m. to 5 p.m. 

Agenda: Provide advice to the Office of 

Research on Women’s Health (ORWH) on 

appropriate research activities with respect to 

women’s health and related studies to be 

undertaken by the National Research 

Institutes; to provide recommendations 

regarding ORWH activities; to meet the 

mandates of the office; and for discussion of 

scientific issues. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, 6C/10, 

Bethesda, MD 20892. 

Time: March 30, 2007, 9 a.m. to 1 p.m. 

Agenda: Same as above. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, 6C/10, 

Bethesda, MD 20892. 

Contact Person: Joyce Rudick, Director, 

Programs & Management, Office of Research 

on Women’s Health, Office of the Director, 

National Institutes of Health, Building 1, 

Room 201, Bethesda, MD 20892, 301/402–

1770. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www4.od.nih.gov/orwh/, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 


sroberts on PROD1PC70 with NOTICES