73086 Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 

TABLE 3—SIGNIFICANT DISCIPLINARY ACTION REPORT BURDEN 1—Continued 

Significant disciplinary actions Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

Total hours 

Total ............................................................................... ........................ ........................ ........................ ...................... 26 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 4—OTHER VOLUNTARY REPORTS BURDEN 1

Other voluntary reports Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

Total hours 

Wholesale distributors ........................................................... 5 1 5 0.25 hour (15 

minutes).

1.25 

3PLs ...................................................................................... 1 1 1 0.25 hour (15 

minutes).

0.25 

Total ............................................................................... ........................ ........................ ........................ ...................... 1.50 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

F. Capital Costs 

There are no capital costs associated 

with this collection and reporting of 

information if the FDA-provided Web 

portal is used for reporting. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). 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, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: December 3, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28711 Filed 12–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Endocrinologic 

and Metabolic Drugs Advisory 

Committee. 

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 January 12, 2015, from 8 a.m. 

to 5 p.m. 

Location: College Park Marriott Hotel 

and Conference Center, Potomac 

Ballroom, 3501 University Blvd. East, 

Hyattsville, MD 20783. The conference 

center’s telephone number is 301–985– 

7300. 

Contact Person: Stephanie L. 

Begansky, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: EMDAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). 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 at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will discuss 

the safety and efficacy of new drug 

application (NDA) 022517, proposed 

trade name NOCDURNA (established 

name: desmopressin), orally 

disintegrating sublingual tablets 

submitted by Ferring Pharmaceuticals, 

Inc. The proposed indication is 

treatment of nocturia due to nocturnal 

polyuria in adults who awaken two or 

more times each night to void. 

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 meeting 

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 December 26, 2014. 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 73087 

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 

December 17, 2014. 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 December 18, 2014. 

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 Stephanie L. 

Begansky (see Contact Person) 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/

AdvisoryCommittees/

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: December 2, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–28702 Filed 12–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director Notice of Charter 

Renewal 

In accordance with Title 41 of the 

U.S. Code of Federal Regulations, 

Section 102–3.65(a), notice is hereby 

given that the Charter for the Board of 

Regents of the National Library of 

Medicine (BOR) was renewed for an 

additional two-year period on 

November 20, 2014. 

It is determined that the BOR is in the 

public interest in connection with the 

performance of duties imposed on the 

Department of Health and Human 

Services by law, and that these duties 

can best be performed through the 

advice and counsel of this group. 

Inquires may be directed to Jennifer S. 

Spaeth, Director, Office of Federal 

Advisory Committee Policy, Office of 

the Director, National Institutes of 

Health, 6701 Democracy Boulevard, 

Suite 1000, Bethesda, Maryland 20892 

(Mail Code 4875), Telephone (301) 496– 

2123, or spaethj@od.nih.gov. 

Dated: December 3, 2014. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–28750 Filed 12–8–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

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. 209 and 37 CFR part 404 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. 

FOR FURTHER INFORMATION CONTACT: 

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. 

SUPPLEMENTARY INFORMATION: 

Technology descriptions follow. 

Vaccine for Protection Against 

Shigella sonnei Disease 

Description of Technology: 

Shigellosis is a global human health 

problem. Transmission usually occurs 

by contaminated food and water or 

through person-to-person contact. The 

bacterium is highly infectious by the 

oral route, and ingestion of as few as 10 

organisms can cause an infection in 

volunteers. An estimated 200 million 

people worldwide suffer from 

shigellosis, with more than 650,000 

associated deaths annually. A recent 

CDC estimate indicates the occurrence 

of over 440,000 annual shigellosis cases 

in the United States alone, 

approximately eighty percent (80%) of 

which are caused by Shigella sonnei. 

Shigella sonnei is more active in 

developed countries. Shigella infections 

are typically treated with a course of 

antibiotics. However, due to the 

emergence of multidrug resistant 

Shigella strains, a safe and effective 

vaccine is highly desirable. No vaccines 

against Shigella infection currently 

exist. Immunity to Shigellae is mediated 

largely by immune responses directed 

against the serotype specific Opolysaccharide. Claimed in the 

invention are compositions and 

methods for inducing an 

immunoprotective response against S. 

sonnei. Specifically, an attenuated 

bacteria capable of expressing an S. 

sonnei antigen comprised of the S. 

sonnei form I O-polysaccharide 

expressed from the S. sonnei rfb/rfc 

gene cluster is claimed. The inventors 

have shown that the claimed vaccine 

compositions showed one hundred 

percent (100%) protection against 

parenteral challenge with virulent S. 

sonnei in mice. 

Potential Commercial Applications: 

• Shigella/Typhoid vaccine for 

travelers, military 

• Shigella/Typhoid vaccine for 

developing countries 

• Shigella/Typhoid diagnostics 

Competitive Advantages: 

• Low cost of production 

• Temperature stable formulation 

• Safety/efficacy of Ty21a established 

in humans 

Development Stage: In vivo data 

available (animal) 

Inventors: Dennis J. Kopecko (FDA), 

De Qi Xu (NIDCR), John O. Cisar 

(NICHD) 

Publication: Kopecko DJ, et al. 

Molecular cloning and characterization 

of genes for Shigella sonnei form I O 

polysaccharide: proposed biosynthetic 

pathway and stable expression in a live 

salmonella vaccine vector. Infect 

Immun. 2002 Aug;70(8):4414–23. 

[PMID: 12117952] 


rljohnson on DSK3VPTVN1PROD with NOTICES