18830 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 24, 2012, from 8 a.m. to 6 

p.m. 

Location: Hilton Washington, DC 

North/Gaithersburg, Montgomery Rm., 

620 Perry Pkwy., Gaithersburg, MD 

20877. The hotel telephone number is 

301–977–8900. 

Contact Person: Jamie Waterhouse, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 1611, Silver Spring, MD 20993– 

0002, 301–796–3063, 

Jamie.Waterhouse@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On May 24, 2012, the 

committee will discuss current 

knowledge about the safety and 

effectiveness of the AMPLATZER ASO 

Device & Gore HELEX ASD Occluder as 

transcatheter Atrial Septal Defect (ASD) 

occluders used for the closure of 

secundum atrial septal defects. The 

AMPLATZER Septal Occluder (ASO) 

Device was the first device introduced 

to the US market in 2001 followed by 

the Gore HELEX device in 2006. With 

more widespread use of these devices, 

more information has become available 

regarding adverse events. These events 

range from rare life-threatening events 

to more common events that are 

perceived to have less severe clinical 

sequelae. Many of these events were 

evident in the premarket studies; 

however, rare events such as erosion 

were not seen. The purpose of 

discussion of these events is: (1) To 

discuss the significance of these events 

in the overall context of the disease and 

existing treatment options; (2) to discuss 

whether additional measures should be 

taken to improve protection of the 

public health (e.g., additional study 

and/or data analyses, labeling changes); 

and (3) to communicate to patients and 

physicians what is and is not known 

about device treatment options. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before May 16, 2012. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before May 9, 

2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by May 11, 2012. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams, Conference Management Staff 

at AnnMarie.Williams@fda.hhs.gov, 

301–796–5966, at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7407 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0121] 

Small Entity Compliance Guide: 

Further Amendments to General 

Regulations of the Food and Drug 

Administration To Incorporate 

Tobacco Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Further Amendments to 

General Regulations of the Food and 

Drug Administration to Incorporate 

Tobacco Products—Small Entity 

Compliance Guide’’ for a final rule 

published in the Federal Register of 

February 2, 2012. This small entity 

compliance guide (SECG) is intended to 

set forth in plain language the 

requirements of the regulation and to 

help small businesses understand and 

comply with the regulation. 

DATES: Submit either electronic or 

written comments on the SECG at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the SECG entitled 

‘‘Further Amendments to General 

Regulations of the Food and Drug 

Administration to Incorporate Tobacco 

Products—Small Entity Compliance 

Guide’’ to the Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

guidance document may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance 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. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 18831 

FOR FURTHER INFORMATION CONTACT: 

Gerie Voss, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 877–287– 

1373, gerie.voss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 2, 

2012 (77 FR 5171), FDA issued a final 

rule regarding further amendments to 

the general regulations of the FDA to 

incorporate tobacco products. FDA 

examined the economic implications of 

the final rule as required by the 

Regulatory Flexibility Act (5 U.S.C. 

601–612) and determined that the rule 

would have a significant economic 

impact on a substantial number of small 

entities. In compliance with section 212 

of the Small Business Regulatory 

Enforcement Fairness Act (Pub. L. 104– 

121), FDA is making available this SECG 

stating in plain language the legal 

requirements of the February 2, 2012, 

final rule, set forth in 21 CFR parts 1, 

7, and 16, amending the FDA’s general 

regulations to ensure that tobacco 

products are subject to the same general 

requirements that apply to other FDAregulated products. 

FDA is issuing this SECG as level 2 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115(c)(2)). The SECG represents the 

Agency’s current thinking on this topic. 

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) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://www.

fda.gov/TobaccoProducts/ 

GuidanceCompliance

RegulatoryInformation/default.htm or 

http://www.regulation.gov. 

Dated: March 23, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7455 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–01–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. 

Lenalidomide Analogs for the 

Treatment of Neurodegenerative 

Disorders and Cancer 

Description of Technology: 

Inflammatory processes associated with 

the over-production of tumor necrosisalpha (TNF-a), a potent activator of the 

immune system accompany numerous 

neurodegenerative diseases. TNF-a has 

been validated as a drug target with the 

development of the inhibitors Enbrel 

and Remicade (fusion antibodies) as 

prescription medications. Both, 

however, are large macromolecules that 

require direct injection and have limited 

brain access. The classical drug, 

thalidomide is being increasingly used 

in the clinical management of a wide 

spectrum of immunologically-mediated 

and infectious diseases, and cancers. 

The NIA inventors developed and 

assessed novel thio analogs of 

lenalidomide (Celegene’s Revlimid and 

an analog of thalidomide) as 

immunomodulatory agents, with the 

potential to reduce chronic systemic 

and central nervous system 

inflammation. These compounds were 

synthesized and evaluated for their 

TNF-a inhibitory activity. This 

invention was extended from the 

inventors’ prior work to develop potent 

compounds to reduce 

neuroinflammation as a treatment 

strategy for neurodegenerative 

disorders. The current studies focus the 

compounds activity in classical models 

of neurodegeneration as well as cancer. 

Potential Commercial Applications: 

• Treatment for blood disorders 

(myelodysplastic syndrome), cancer 

(multiple myeloma), inflammatory 

processes and erythema 

• Immunomodulatory agents 

• Reduce chronic systemic and 

central nervous system inflammation 

Competitive Advantages: 

• Effective smaller molecular weight 

compound that can enter brain among 

current agents 

• Experimental therapeutic to reduce 

inflammation systematically and within 

the brain 

• Effective in reducing 

proinflammatory cytokines than existing 

agents 

Development Stage: 

• Prototype 

• Clinical 

• In vitro data available 

• In vivo data available (animal) 

Inventors: Nigel H. Greig, Weiming 

Luo, David Tweedie, Harold W. 

Holloway, Qian-sheng Yu (all of NIA). 

Publication: Luo W, et al. Design, 

synthesis and biological assessment of 

novel N-substituted 3-(phthalimidin-2- 

yl)-2,6-dioxopiperidines and 3- 

substituted 2,6-dioxopiperidines for 

TNF-alpha inhibitory activity. Bioorg 

Med Chem. 2011 Jul 1;19(13):3965– 

3972. [PMID 21658960] 

Intellectual Property: HHS Reference 

No. E–045–2012/0—U.S. Patent 

Application No. 13/310,242 filed 02 Dec 

2011. 

Related Technologies: HHS Reference 

No. E–189–2003/0— 

• U.S. Patent No. 7,973,057 issued 05 

Jul 2011 

• U.S. Application No. 13/153,355 

filed 03 Jun 2011 

• and related international patents/ 

patent applications 

Licensing Contact: Whitney Hastings, 

Ph.D.; 301–451–7337; 

hastingw@mail.nih.gov. 

Use of Englerin A, a Small Molecule 

HSF1 Activator, for the Treatment of 

Diabetes, Obesity, and Other Diseases 

Associated With Insulin Resistance 

Description of Technology: Insulin 

resistance is a causative factor for type 


tkelley on DSK3SPTVN1PROD with NOTICES