Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices 11731 

The public consultation draft report is 

the result of work that began in 2004, 

when SACGHS identified the effect of 

gene patents and licensing practices on 

patient and clinical access to genetic 

tests as a high-priority issue that 

warranted further study. SACGHS 

activities in this area were deferred until 

the completion of a National Academy 

of Sciences (NAS) study on the granting 

and licensing of intellectual property 

rights to genetic and proteomic 

discoveries and the effects of these 

practices on research and innovation. In 

the fall of 2005, NAS released that 

study’s report, Reaping the Benefits of 

Genomic and Proteomic Research: 

Intellectual Property Rights, Innovation, 

and Public Health. After reviewing the 

report, SACGHS decided that more 

information was needed regarding the 

effects of gene patents and licenses on 

patient and clinical access to genetic 

tests. In 2006, a task force was formed 

by SACGHS to guide its work in this 

area. The task force commissioned case 

studies, compiled relevant information 

through a review of the literature, and 

consulted with national and 

international experts and stakeholders. 

At the outset of its work, the task 

force decided to limit the scope of its 

inquiry to those genetic tests, whether 

used for diagnostic, predictive, or other 

clinical purposes, that rely on analysis 

of nucleic acid molecules to determine 

human genotype. As such, the kinds of 

patent claims that the Committee 

evaluated were nucleic acid-related 

patent claims associated with genetic 

tests for human genotype. This report 

does not address protein-based genetic 

tests or protein-related patent claims 

associated with tests designed to infer 

genotype. 

The public consultation draft report 

presents the Committee’s preliminary 

findings. The draft report also includes 

policy options. These options do not 

necessarily correlate with any particular 

preliminary finding, but rather provide 

a framework within which to gather 

public input. The Committee developed 

these options to present a broad range 

of possible actions, but has not yet 

decided which, if any, of these policy 

options to support. 

Before SACGHS can develop specific 

recommendations for the Secretary, the 

Committee needs public input on 

several issues, including whether 

changes are needed in patenting and 

licensing practices that affect genetic 

testing, and the appropriateness, 

feasibility, and implications of the 

report’s policy options. Members of the 

public are also invited to recommend 

specific policy options not included in 

the presented options and any needed 

modifications to existing options. 

SACGHS also encourages the public to 

provide any additional information and 

data regarding the positive or negative 

effects gene patenting or licensing 

practices have had, are having, or may 

have on patient and clinical access to 

genetic tests. 

The Committee will carefully 

consider public input in finalizing its 

report and developing any 

recommendations to the Secretary. 

Comments received by May 15, 2009, 

will be considered by SACGHS in 

preparing its final report. The public 

comments and revised report will be 

discussed during a future SACGHS 

meeting. 

Comments will be available for public 

inspection at the NIH Office of 

Biotechnology Activities Monday 

through Friday between the hours of 

8:30 a.m. and 5 p.m. 

Dated: March 11, 2009. 

Sarah Carr, 

Executive Secretary, SACGHS. 

[FR Doc. E9–5936 Filed 3–18–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Advisory Board on Radiation and 

Worker Health (ABRWH or Advisory 

Board), National Institute for 

Occupational Safety and Health 

(NIOSH) 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC announces the 

following meeting of the 

aforementioned committee: 

Time and Date: 11 a.m.–5 p.m., Thursday, 

March 31, 2009. 

Place: Audio Conference Call via FTS 

Conferencing. The USA toll free dial in 

number is 1–866–659–0537 with a pass code 

of 9933701. 

Status: Open to the public, but without a 

public oral comment period. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation Program 

Act of 2000 to advise the President on a 

variety of policy and technical functions 

required to implement and effectively 

manage the new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines which 

have been promulgated by the Department of 

Health and Human Services (HHS) as a final 

rule, advice on methods of dose 

reconstruction which have also been 

promulgated by HHS as a final rule, advice 

on the scientific validity and quality of dose 

estimation and reconstruction efforts being 

performed for purposes of the compensation 

program, and advice on petitions to add 

classes of workers to the Special Exposure 

Cohort (SEC). 

In December 2000, the President delegated 

responsibility for funding, staffing, and 

operating the Advisory Board to HHS, which 

subsequently delegated this authority to the 

CDC. NIOSH implements this responsibility 

for CDC. The charter was issued on August 

3, 2001, renewed at appropriate intervals, 

most recently, August 3, 2007, and will 

expire on August 3, 2009. 

Purpose: This Advisory Board is charged 

with (a) providing advice to the Secretary, 

HHS, on the development of guidelines 

under Executive Order 13179; (b) providing 

advice to the Secretary, HHS, on the 

scientific validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, advising the Secretary on 

whether there is a class of employees at any 

Department of Energy facility who were 

exposed to radiation but for whom it is not 

feasible to estimate their radiation dose, and 

on whether there is reasonable likelihood 

that such radiation doses may have 

endangered the health of members of this 

class. 

Matters To Be Discussed: The agenda for 

the conference call includes: Dose 

Reconstruction Interview Scripts and 

Procedures; Special Exposure Cohort Petition 

Status Updates; Board Subcommittee and 

Work Group Updates; Update on Board 

Technical Support Contractor Activities; 

Future Plans. 

Due to administrative matters, this Federal 

Register Notice is being published on less 

than 15 calendar days notice to the public (41 

CFR 102–3.150(b)). 

The agenda is subject to change as 

priorities dictate. 

Because there is no public comment 

period, written comments may be submitted. 

Any written comments received will be 

included in the official record of the meeting 

and should be submitted to the contact 

person below in advance of the meeting. 

Contact Person for More Information: 

Theodore M. Katz, M.P.A., Executive 

Secretary, NIOSH, CDC, 1600 Clifton Rd. NE., 

Mailstop: E–20, Atlanta, GA 30333, 

Telephone (513) 533–6800, Toll Free 1–800– 

CDC–INFO, E-mail ocas@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 12, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–5977 Filed 3–18–09; 8:45 am] 

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