Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8329 

at least 21 days in advance of the 

conference. 

Registration Instructions: To register, 

please complete and submit an AFDO 

Conference Registration Form, along 

with a check or money order payable to 

‘‘AFDO’’. Please mail your completed 

registration form and payment to: 

AFDO, 2550 Kingston Rd., suite 311, 

York, PA 17402. To register online, 

please visit http://indy.afdo.org/

register.html. (FDA has verified the Web 

site address but is not responsible for 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

The registrar will also accept payment 

through Visa and MasterCard credit 

cards. For more information on the 

conference, or for questions about 

registration, please contact AFDO at 

717–757–2888, FAX: 717–650–3650, or 

email: afdo@afdo.org. 

SUPPLEMENTARY INFORMATION: The 

conference helps fulfill the Department 

of Health and Human Services’ and 

FDA’s important mission to protect the 

public health. The conference will 

provide FDA-regulated drug and device 

entities with information on a number 

of topics concerning FDA requirements 

related to the production and marketing 

of drugs and/or devices. Topics for 

discussion include, but are not limited 

to, the following: 

• Medical Device Single Audit Program 

• Contract Manufacturing 

Arrangements for Drugs: Quality 

Agreements 

• Compliance Question and Answer 

Panel 

• Draft Guidance: Distinguishing 

Medical Device Recalls from Product 

Enhancements and Associated 

Reporting Requirements 

• Compounding Pharmacies 

• Overview of Global Device/Drug 

Requirements v. U.S. System 

• Case for Quality Initiative Update 

• Unique Device Identifier (UDI) 

Implementation Update 

• Metric, Data, and Analysis; Biometrics 

• Pharmaceutical Inspection 

Cooperation Scheme 

• Biosimilar Regulations 

FDA has made education of the food, 

feed, drug, and device manufacturing 

community a high priority to help 

ensure the quality of FDA-regulated 

products. The conference helps to 

achieve objectives set forth in section 

406 of the Food and Drug 

Administration Modernization Act of 

1997 (21 U.S.C. 393), which includes 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The conference also is consistent 

with the Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121), as outreach activities by 

government agencies to small 

businesses. 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03115 Filed 2–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0824] 

Regulatory Site Visit Training Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Biologics Evaluation and Research 

(CBER) is announcing an invitation for 

participation in its Regulatory Site Visit 

Training Program (RSVP). This training 

program is intended to give CBER 

regulatory review, compliance, and 

other relevant staff an opportunity to 

visit biologics facilities. These visits are 

intended to allow CBER staff to directly 

observe routine manufacturing practices 

and to give CBER staff a better 

understanding of the biologics industry, 

including its challenges and operations. 

The purpose of this document is to 

invite biologics facilities to contact 

CBER for more information if they are 

interested in participating in this 

program. 

DATES: Submit either an electronic or 

written request for participation in this 

program by March 19, 2015. The request 

should include a description of your 

facility relative to products regulated by 

CBER. Please specify the physical 

address(es) of the site(s) you are 

offering. 

ADDRESSES: If your biologics facility is 

interested in offering a site visit, submit 

either an electronic request to http://

www.regulations.gov or a written 

request to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. If you 

previously responded to earlier requests 

to participate in this program and you 

continue to be interested in 

participating, please renew your request 

through a submission to the Division of 

Dockets Management. 

FOR FURTHER INFORMATION CONTACT: Loni 

Warren Henderson, Division of 

Manufacturers Assistance and Training, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. G112, Silver Spring, 

MD 20993–0002, 240–402–7800, FAX: 

301–595–1243, Industry.Biologics@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products including blood and blood 

products, vaccines, and cellular, tissue, 

and gene therapies. CBER is committed 

to advancing the public health through 

innovative activities that help ensure 

the safety, effectiveness, and availability 

of biological products to patients. To 

support this primary goal, CBER has 

initiated various training and 

development programs, including 

programs to further enhance 

performance of its compliance staff, 

regulatory review staff, and other 

relevant staff. CBER seeks to 

continuously enhance and update 

review efficiency and quality, and the 

quality of its regulatory efforts and 

interactions, by providing CBER staff 

with a better understanding of the 

biologics industry and its operations. 

Further, CBER seeks to enhance: (1) Its 

understanding of current industry 

practices and regulatory impacts and 

needs and (2) communication between 

CBER staff and industry. CBER initiated 

its RSVP in 2005. Through these annual 

notices, CBER is requesting that those 

firms that have previously applied and 

are still interested in participating 

reaffirm their interest. CBER is also 

requesting that new interested parties 

apply. 

II. RSVP 

A. Regulatory Site Visits 

In this program, over a period of time 

to be agreed upon with the facility, 

small groups of CBER staff may observe 

operations of biologics establishments, 

including for example, blood and tissue 

establishments. The visits may include 

the following: (1) Packaging facilities, 

(2) quality control and pathology/

toxicology laboratories, and (3) 

regulatory affairs operations. These 

visits, or any part of the program, are 

not intended as a mechanism to inspect, 

assess, judge, or perform a regulatory 

function, but are meant to improve 

mutual understanding and to provide an 

avenue for open dialogue between the 

biologics industry and CBER. 

B. Site Selection 

CBER will be responsible for all travel 

expenses associated with the site visits. 


tkelley on DSK3SPTVN1PROD with NOTICES
8330 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 

Therefore, selection of potential 

facilities will be based on the 

coordination of CBER’s priorities for 

staff training as well as the limited 

available resources for this program. In 

addition to logistical and other resource 

factors to consider, a key element of site 

selection is a successful compliance 

record with FDA or another Agency 

with which we have a memorandum of 

understanding. If a site visit involves a 

visit to a separate physical location of 

another firm under contract to the 

applicant, the other firm also needs to 

agree to participate in the program, as 

well as have a satisfactory compliance 

history. 

III. Requests for Participation 

Identify requests for participation 

with the docket number found in 

brackets in the heading of this 

document. Received requests are 

available for public examination in the 

Division of Dockets Management (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03117 Filed 2–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Start-up Evaluation License 

for the Development of Theranostic 

Kits for Taxane-based Chemotherapy 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209 and 37 CFR part 404, 

that the National Institutes of Health, 

Department of Health and Human 

Services, is contemplating the grant to 

Taxor Diagnostics, LLC of an exclusive 

evaluation option license to practice the 

inventions embodied in the following 

US Patent, US Patent Application, and 

International Patent Application (and all 

foreign counterparts): US Patent No. 

8,546,091, issued 01 October 2013, 

entitled, ‘‘Akt Phosphorylation at 

SER473 as an Indicator for Taxanebased Chemotherapy’’ [HHS Ref. E–191– 

2009/0–US–07]; US Patent Application 

serial no. 14/031,699, of the same name, 

filed 19 September 2013 [HHS Ref. E– 

191–2009/0–US–08]; and International 

(PCT) Patent Application no. PCT/

US2010/035816, of the same name, filed 

21 May 2010 [HHS Ref. E–191–2009/0– 

PCT–02]. The patent rights in this 

invention have been assigned to the 

Government of the United States of 

America. 

The prospective exclusive evaluation 

option license territory may be 

worldwide, and the field of use may be 

limited to: 

1. Exclusive use of the Licensed Patent 

Rights to develop a test kit approved by the 

FDA as a Class III medical device under the 

Premarket approval (PMA) process, such test 

kit to be distributed in commerce for the 

purpose of identifying subgroups of breast 

cancer, colorectal cancer, and non-small cell 

lung cancer patients that may benefit from 

treatment with a taxane therapy; and 

2. Non-exclusive use of the Licensed Patent 

Rights to develop a test kit for which the FDA 

issues an order, in the form of a letter, which 

finds Licensee’s device to be substantially 

equivalent to one or more similar legally 

marketed devices, and states that the 

Licensee’s device can be marketed in the U.S. 

(i.e., 510(k) cleared), such test kit to be 

distributed in commerce for the purpose of 

identifying subgroups of breast cancer, 

colorectal cancer, and non-small cell lung 

cancer patients that may benefit from 

treatment with a taxane therapy. 

Upon the expiration or termination of 

the exclusive evaluation option license, 

Taxor Diagnostics, LLC will have the 

exclusive right to execute an exclusive 

commercialization license which will 

supersede and replace the exclusive 

evaluation option license with no 

greater field of use and territory than 

granted in the exclusive evaluation 

option license. 

DATES: Only written comments or 

applications for a license (or both) 

which are received by the NIH Office of 

Technology Transfer on or before March 

4, 2015 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive evaluation 

option license should be directed to: 

Patrick McCue, Ph.D., Licensing and 

Patenting Manager, Office of 

Technology Transfer, National Institutes 

of Health, 6011 Executive Boulevard, 

Suite 325, Rockville, MD 20852–3804; 

Telephone: (301) 435–5560; Facsimile: 

(301) 402–0220; Email: mccuepat@

mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

technology describes a method of 

identifying cancer patients that will 

respond favorably to and benefit from 

treatment with taxane-based therapy 

depending on the phosphorylation 

status of protein Akt-Serine 473 in 

patient’s tumor biopsy sample. 

The prospective exclusive evaluation 

license is being considered under the 

small business initiative launched on 1 

October 2011, and will comply with the 

terms and conditions of 35 U.S.C. 209 

and 37 CFR part 404. The prospective 

exclusive evaluation option license, and 

a subsequent exclusive 

commercialization license, may be 

granted unless 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 

within fifteen (15) days from the date of 

this published notice. 

Complete 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 

evaluation option 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: February 9, 2015. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2015–03088 Filed 2–13–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel; Worker Health and Safety 

Training Review. 

Date: March 9–10, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Chapel Hill Hotel, One 

Europa Drive, Chapel Hill, NC 27517. 


tkelley on DSK3SPTVN1PROD with NOTICES