Federal Register / Vol. 72, No. 210 / Wednesday, October 31, 2007 / Notices 61657 

addresses the use of resistance testing in 

clinical phases of drug development and 

recommends the type of information 

that should be collected and the types 

of analyses that should be conducted to 

characterize an antiretroviral’s 

resistance profile. This guidance also is 

intended to serve as a focus for 

continued discussions among the 

Division of Antiviral Products, 

pharmaceutical sponsors, the academic 

community, and the public. 

This guidance is based on a 2-day 

session of the Antiviral Drug Product 

Advisory Committee convened on 

November 2 and 3, 1999, to address 

issues relating to HIV resistance testing, 

the division’s experience with 

reviewing resistance data for 

antiretroviral drugs, and input from 

pharmaceutical sponsors and the HIV 

community. 

This guidance has been updated to 

address public comments on the draft 

version. The following significant 

changes were made to the guidance: (1) 

The inclusion of more details and 

clarification on the recommendations 

about the amount and type of 

nonclinical studies that should be 

conducted before phase 1 clinical 

studies, (2) the inclusion of more details 

and clarification regarding data 

collection and types of analyses for 

treatment-naı ̈ve and treatmentexperienced patients, (3) the inclusion 

of additional details regarding exposureresponse analyses, and (4) updated 

guidance for submitting HIV resistance 

data. 

The guidance reviews the role of 

resistance testing in initial activity and 

dose-finding studies, for study 

enrollment criteria, and background 

regimen selection. The guidance also 

reviews the use of resistance data to 

establish an indication. This guidance 

includes an appendix that provides 

recommendations on how to submit HIV 

resistance data to FDA. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the role of HIV 

resistance testing in antiretroviral drug 

development. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 312 have been approved 

under OMB control number 0910–0014. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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 brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: October 24, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–21403 Filed 10–30–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2002D–0049 (formerly Docket 

No. 02D–0049)] 

Draft Guidance for the Public, Food 

and Drug Administration Advisory 

Committee Members, and Food and 

Drug Administration Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest 

Information and Waivers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance 

document for the public, FDA advisory 

committee members, and FDA staff 

entitled ‘‘Guidance for the Public, FDA 

Advisory Committee Members, and FDA 

Staff: Public Availability of Advisory 

Committee Members’ Financial Interest 

Information and Waivers.’’ This 

guidance is intended to help the public, 

FDA advisory committee members, and 

FDA staff to understand and implement 

FDA procedures regarding public 

availability of information regarding 

certain financial interests and waivers 

granted by FDA to permit individuals to 

participate in an advisory committee 

meeting. The draft guidance announced 

in this notice supersedes FDA’s ‘‘Draft 

Guidance on Disclosure of Conflicts of 

Interest for Special Government 

Employees Participating in FDA Product 

Specific Advisory Committees,’’ dated 

January 2002. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115 (g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by December 31, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Policy (HF–11), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit telephone requests to 800–835– 

4709 or 301–827–1800. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to either http:// 

www.fda.gov/dockets/ecomments or 

http://www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Jill 

Hartzler Warner, Office of Policy and 

Planning (HF–11), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3370. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Guidance for 

the Public, FDA Advisory Committee 

Members, and FDA Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers,’’ dated October 2007. 

FDA’s advisory committees provide 

independent and expert advice on 

scientific, technical, and policy matters 

related to the development and 

evaluation of products regulated by 

FDA. FDA implements a rigorous 

process for soliciting and vetting 

candidates for advisory committee 

meetings to minimize any potential for 

financial conflicts of interest. The 

agency is authorized by statute to grant 

waivers to allow individuals with 

potentially conflicting financial 


rwilkins on PROD1PC63 with NOTICES
61658 Federal Register / Vol. 72, No. 210 / Wednesday, October 31, 2007 / Notices 

interests to participate in meetings 

where we conclude, after close scrutiny, 

that certain criteria are met. (See 18 

U.S.C. 208(b)(1) and (b)(3) and section 

712(c)(2)(B) of the Federal Food, Drug, 

and Cosmetic Act (the act) (added by the 

Food and Drug Administration 

Amendments Act of 2007 (Public Law 

No. 110–85), section 701 (effective 

October 1, 2007).) 

In the Federal Register of January 12, 

2002 (67 FR 6545), FDA issued ‘‘Draft 

Guidance on Disclosure of Conflicts of 

Interest for Special Government 

Employees Participating in FDA Product 

Specific Advisory Committees,’’ and 

requested comments on the draft 

guidance (Docket No. 02D–0049). The 

draft guidance was limited in 

application to special government 

employees (SGEs) participating in 

advisory committee meetings at which 

particular matters relating to particular 

products were discussed. 

FDA has recently undertaken an 

internal assessment of its advisory 

committee process. As a result of this 

review, and based on the comments 

submitted to the docket for the January 

2002 draft guidance, FDA is revising 

this draft guidance to broaden its 

applicability, bring as much 

transparency as possible to FDA’s 

waiver process, and increase the 

consistency and clarity of the process. 

The draft guidance proposes revised 

procedures, consistent with section 

712(c)(3) of the act, to make publicly 

available relevant information regarding 

financial interests and waivers granted 

by the agency for SGEs and regular 

Government employees invited to 

participate in FDA advisory committee 

meetings. 

The draft guidance also includes a 

template for disclosing to the public the 

disqualifying financial interests for 

which waivers are sought and a 

template for all waivers that FDA grants. 

The guidance further describes FDA’s 

process for making these documents 

available on its Web site in advance of 

each advisory committee meeting. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

agency’s current thinking on public 

availability of information regarding 

advisory committee members’ financial 

interests and waivers granted by FDA to 

permit participation in advisory 

committee meetings. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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 brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 24, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–5408 Filed 10–29–07; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

Immunostimulatory Combinations of 

TLR Ligands and Methods of Use 

Description of Technology: New drugs 

or therapies that act by stimulating the 

immune system, or alternatively 

inhibiting certain aspects of the immune 

system, may be useful for treating 

various diseases or disorders, for 

example viral diseases, neoplasias, and/ 

or allergies, and may also have use as 

vaccine adjuvants. However, although 

adjuvants have been suggested for use in 

vaccine compositions, there is an unmet 

need for adjuvants that can effectively 

enhance immune response. 

Development of innate and adaptive 

immunity critically depends on the 

engagement of pattern recognition 

receptors (PRRs), which specifically 

detect microbial components named 

pathogen- or microbe-associated 

molecular patterns (PAMPs or MAMPs) 

(1–4). Toll-like receptors (TLRs) 

represent an important group of PRRs 

that can sense PAMPs or MAMPs once 

in the body. TLRs are widely expressed 

by many types of cells, for example cells 

in the blood, spleen, lung, muscle and 

intestines. 

The present invention claims 

immunostimulatory combinations of 

TLR ligands and therapeutic and/or 

prophylactic methods that include 

administering an immunostimulatory 

combination to a subject. In general, the 

immunostimulatory combinations can 

provide an increased immune response 

compared to other immunostimulatory 

combinations and/or compositions. 

More specifically, combinations of TLR 

2, 3 and 9 are claimed. The application 

also describes a novel mechanism for 

TLR synergy in terms of both signaling 

pathways and cytokine combinations. 

Application: Development of 

improved adjuvants and/or synergistic 

combinations of adjuvants for vaccines. 

Developmental Status: Compositions 

have been synthesized and preclinical 

studies have been performed. 

Inventors: Jay Berzofsky and Qing Zhu 

(NCI). 

Patent Status: U.S. Provisional 

Application filed 24 Sep 2007 (HHS 

Reference No. E–298–2007/0–US–01). 

Licensing Status: Available for 

exclusive or nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute’s Vaccine 

Branch is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this invention of 

synergistic combinations of TLR 

ligands. Please contact John D. Hewes, 

PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 


rwilkins on PROD1PC63 with NOTICES