Federal Register / Vol. 74, No. 125 / Wednesday, July 1, 2009 / Notices 31457 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Fellowships 

in Language and Communication. 

Date: July 6, 2009. 

Time: 3 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Chicago, 151 East 

Wacker Drive, Chicago, IL 60601. 

Contact Person: Dana Jeffrey Plude, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3176, 

MSC 7848, Bethesda, MD 20892. 301–435– 

2309. pluded@csr.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. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: June 22, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–15584 Filed 6–30–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Pain Control by Selective 

Ablation of Pain-Sensing Neurons by 

Administration of Resiniferatoxin 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(l) and 37 CFR Part 

404.7(a)(l)(i), that the National Institutes 

of Health, Department of Health and 

Human Services, is contemplating the 

grant of an exclusive patent license to 

practice the inventions embodied in 

PCT Patent Application PCT/US2001/ 

09425 [HHS Ref. E–109–2000/0–PCT– 

01], US Patent Application 10/472,874 

[HHS Ref. E–109–2000/0–US–02], both 

entitled ‘‘Molecular Neurochirurgerie 

for Pain Control Administering Locally 

Capsaicin or Resiniferatoxin’’, and 

Canadian Patent Application 2442049 

[HHS Ref. E–109–2000/0–CA–03] 

entitled ‘‘Selective Ablation of PainSensing Neurons by Administration of a 

Vanilloid Receptor Agonist’’, and all 

continuing applications and foreign 

counterparts, to Sherrington 

Pharmaceuticals, which has offices in 

New York, N.Y. The patent rights in 

these inventions have been assigned to 

and/or exclusively licensed to the 

Government of the United States of 

America. 

The prospective exclusive license 

territory may be worldwide, and the 

field of use may be limited to: 

All fields of use, both human and 

veterinary, covered under the above listed 

patents, for the life of these patents; the 

selective ablation of pain-sensing neurons 

using vanilloid receptor agonists including 

resiniferatoxin and capsaicin using localized 

delivery, including intrathecal and 

intraganglionic injection. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

August 31, 2009 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: Norbert Pontzer, Senior 

Licensing and Patenting Manager, Office 

of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, MD 

20852–3804; Telephone: (301) 435– 

5502; Facsimile: (301) 402–0220; E-mail: 

pontzern@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: Pain 

pathways, including those mediating 

severe pain associated with chronic and 

terminal diseases, have unique receptors 

(termed vanilloid or more recently 

TRPV1) that mediate the transmission of 

nociceptive sensory signals from the 

periphery through the spinal cord to the 

brain. Compounds such as capsaicin 

from hot peppers activate pain neurons 

by opening cation channels linked to 

TRPV1 receptors on nerve terminals and 

cell bodies. NIH inventors discovered 

that resiniferatoxin (RTX) is an 

extremely potent TRPV1 receptor 

agonist that produces a calcium 

overload and selectively degeneration of 

pain neurons when cell body TRPV1 

receptors are activated by RTX. 

Intrathecal or intraganglionic 

administration of RTX can thus cause 

the permanent and selective destruction 

of the pain neurons in the CNS 

displaying TRPV1 receptors. This 

invention allows pain control in human 

and other animals with intractable pain 

through selective ablation of pain 

pathway neurons. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR Part 404.7. The 

prospective exclusive license may be 

granted unless within sixty (60) days 

from the date of this published notice, 

the NIH receives written evidence and 

argument that establishes that the grant 

of the license would not be consistent 

with the requirements of 35 U.S.C. 209 

and 37 CFR Part 404.7. 

Applications for a license in the field 

of use filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive license. 

Comments and objections submitted to 

this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: June 19, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–15576 Filed 6–30–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0294] 

Regulation of Tobacco Products; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is establishing a 

public docket to obtain information on 

the implementation of the Family 

Smoking Prevention and Tobacco 

Control Act. FDA is establishing this 

docket in order to provide an 

opportunity for all interested parties to 

provide information and share views on 

the implementation of the new law. 

DATES: Submit written or electronic 

comments by September 29, 2009. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Erik 

Mettler, Office of Policy, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO1, rm. 4300, Silver Spring, MD 

20993, 301–796–4830, FAX: 301–847– 

3541, Erik.Mettler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Tobacco products are responsible for 

more than 430,000 deaths each year. 

The Centers for Disease Control and 

Prevention (CDC) report an estimated 60 

31458 Federal Register / Vol. 74, No. 125 / Wednesday, July 1, 2009 / Notices 

million adults smoke cigarettes in the 

United States, even though this behavior 

will result in death or disability for half 

of all regular users. Paralleling this 

enormous health burden is the 

economic burden of tobacco use, which 

is estimated to total $193 billion 

annually in medical expenditures and 

lost productivity. Curbing the 

significant adverse consequences of 

tobacco use is one of the most important 

public health goals of our time. 

On June 22, 2009, the President 

signed H.R. 1256, the Family Smoking 

Prevention and Tobacco Control Act, 

into law. The Family Smoking 

Prevention and Tobacco Control Act 

grants FDA important new authority to 

regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. The 

Family Smoking Prevention and 

Tobacco Control Act authorizes FDA to 

require disclosure of tobacco product 

ingredients and additives; regulate 

‘‘modified risk’’ tobacco products; create 

standards for tobacco products, 

including standards for the reduction or 

elimination of certain constituents; 

restrict sales, distribution, advertising, 

and promotion of tobacco products; and 

require stronger health warnings on 

packaging. The Family Smoking 

Prevention and Tobacco Control Act 

also requires FDA to issue its 1996 final 

regulation restricting the sale and 

distribution of nicotine-containing 

cigarettes and smokeless tobacco 

products. The rule contains provisions 

designed to limit young people’s access 

to tobacco products, as well as 

restrictions on marketing to curb the 

appeal of these products to minors. 

We are requesting comments that will 

inform strategies to protect the public 

health as we implement this new 

authority. A copy of the Family 

Smoking Prevention and Tobacco 

Control Act is available on the agency’s 

Web site at http://www.fda.gov/tobacco. 

II. Request for Comments and 

Information 

We are particularly interested in 

comments on the approaches and 

actions the agency should consider 

initially to increase the likelihood of 

reducing the incidence and prevalence 

of tobacco product use and protecting 

the public health. Although the agency 

will not respond to specific suggestions, 

we will consider them in establishing 

the new Center for Tobacco Products 

and in implementing the Family 

Smoking Prevention and Tobacco 

Control Act. In the future, we intend to 

solicit public input on specific issues. 

Please organize any comments you have 

in response to this notice using these 

general categories: 

Federal, State, and local government 

collaboration; 

New product submission and 

approval; 

Product ingredient disclosure; 

Prevention; 

Tobacco use by specific groups 

including minors, women, and 

racial and ethnic minority 

populations; 

Tobacco addiction; 

Smoking cessation; 

Data collection; 

Products with ‘‘reduced harm/risk’’ 

claims; 

Enforcement; 

Research and testing; 

Advertising and marketing of tobacco 

products; 

Label statements and warnings 

(including graphic warnings); 

Tobacco product standards (including 

flavors, ingredients, etc.); 

Sale and distribution of tobacco 

products; 

Manufacturing restrictions and 

facilities controls; and 

Other. 

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. 

Dated: June 25, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–15549 Filed 6–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2009–0035] 

National Protection and Programs 

Directorate, Office of Infrastructure 

Protection; Submission for Chemical 

Facility Anti-Terrorism Standards 

Information Collection 1670–NEW. 

AGENCY: National Protection and 

Programs Directorate, Office of 

Infrastructure Protection, Infrastructure 

Security Compliance Division, DHS. 

ACTION: 60-Day Notice and request for 

comments: New information collection 

request 1670–NEW. 

SUMMARY: The Department of Homeland 

Security, National Protection and 

Programs Directorate, Office of 

Infrastructure Protection, Infrastructure 

Security Compliance Division (ISCD) 

will be submitting the following 

information collection request (ICR) to 

the Office of Management and Budget 

(OMB) for review and clearance in 

accordance with the Paperwork 

Reduction Act of 1995. The information 

collection is a new information 

collection. The purpose of this notice is 

to solicit comments during a 60-day 

public comment period prior to the 

submission of this collection to OMB. 

The submission describes the nature of 

the information collection, the 

categories of respondents, the estimated 

burden and cost. 

DATES: Comments are encouraged and 

will be accepted until August 31, 2009. 

This process is conducted in accordance 

with 5 CFR 1320.8. 

ADDRESSES: Interested persons are 

invited to submit comments on the 

proposed information collection 

through Federal Rulemaking Portal at 

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

instructions for submitting comments. 

Comments must be identified by docket 

number DHS–2009–0035. 

FOR FURTHER INFORMATION CONTACT: A 

copy of this ICR, with applicable 

supporting documentation, may be 

obtained through Federal Rulemaking 

Portal at http://www.regulations.gov. 

SUPPLEMENTARY INFORMATION: 

Program Description 

The Chemical Facility Anti-Terrorism 

Standards (CFATS), 6 CFR Part 27, are 

the Department’s regulations under 

Section 550 governing security at highrisk chemical facilities. CFATS 

represents a national-level effort to 

minimize terrorism risk to such 

facilities. Its design and implementation 

balance maintaining economic vitality 

with securing facilities and their 

surrounding communities. The 

regulations were designed, in 

collaboration with the private sector and 

other stakeholders, to take advantage of 

protective measures already in place 

and to allow facilities to employ a wide 

range of tailored measures to satisfy the 

regulations’ Risk-Based Performance 

Standards (RBPS). 

The instruments within this 

collection will be used to manage the 

CFATS program.