68454 Federal Register / Vol. 79, No. 221 / Monday, November 17, 2014 / Notices 

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, 

http://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/default.htm, or http:// 

www.regulations.gov. 

Dated: November 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–27022 Filed 11–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1285] 

Smith Miller and Patch, Inc. et al.; 

Withdrawal of Approval of 14 New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 14 new drug applications 

(NDAs) from multiple holders of these 

applications. The basis for the 

withdrawals is that the holders of the 

applications have repeatedly failed to 

file required annual reports for the 

applications. 

DATES: November 17, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6366, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of approved applications to 

market new drugs for human use are 

required to submit annual reports to 

FDA concerning each of their approved 

applications in accordance with 

§ 314.81 (21 CFR 314.81). 

In the Federal Register of November 

6, 2013 (78 FR 66748), FDA published 

a notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of 14 NDAs because 

the firms had failed to submit the 

required annual reports for these 

applications. The holders of these 

applications did not respond to the 

NOOH. Failure to file a written notice 

of participation and request for hearing 

as required by § 314.200 (21 CFR 

314.200) constitutes an election by the 

applicant not to make use of the 

opportunity for a hearing concerning the 

proposal to withdraw approval of the 

applications and a waiver of any 

contentions concerning the legal status 

of the drug products. Therefore, the 

Director, Center for Drug Evaluation and 

Research, is withdrawing approval of 

the 14 applications listed in table 1 of 

this document. 

TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED

Application No. Drug Applicant 

NDA 004979 .............. Multi-Vitamin Tablets ............................................................ Smith Miller and Patch Inc., P.O. Box 367, San German, 

PR 00753. 

NDA 008176 .............. Methostan (methandriol) Tablets ......................................... Do. 

NDA 008326 .............. Methischol (inositol/vitamin B12/racemethionine/choline 

chloride) Injection.

USV Pharmaceutical Corp., 500 Virginia Dr., Fort Washington, PA 19034–2779. 

NDA 008362 .............. Corticotropin Injection .......................................................... Vitarine Pharmaceuticals Inc., 227–15 North Conduit Ave., 

Springfield Gardens, NY 11413. 

NDA 009346 .............. ACTH (corticotropin) Injection .............................................. Parke-Davis, 201 Tabor Rd., Morris Plains, NJ 07950. 

NDA 009515 .............. Hyrye (riboflavin 5′-phosphate sodium) Injection ................. S.F. Durst and Co., Inc., 5317–21 North Third St., Philadelphia, PA 19120. 

NDA 010415 .............. Flamotide (riboflavin 5′-phosphate sodium) Injection .......... Philadelphia Ampoule Laboratories, 400 Green St., Philadelphia, PA 19123. 

NDA 010565 .............. Duracton (corticotropin) Injection ......................................... Nordic Biochemicals Inc., 45 Bay State Rd., Boston, MA 

02215. 

NDA 010791 .............. Rubivite (cyanocobalamin) Injection .................................... Bel Mar Laboratories, Inc., 6–10 Nassau Ave., Inwood, NY 

11696. 

NDA 010831 .............. Corticotropin Injection .......................................................... Organics/LaGrange, Inc., 1935 Techny Rd., suite 14, 

Northbrook, IL 60062. 

NDA 011015 .............. RU–B–12–1000 (cyanocobalamin) Injection ........................ Dow Pharmaceutical Corp., 9550 North Zionsville Rd., Indianapolis, IN 46268. 

NDA 011578 .............. Efacin (niacin) Tablet ........................................................... Person and Covey, Inc., 616 Allen Ave., Glendale, CA 

91201. 

NDA 017861 .............. Acthar Gel Synthetic (seractide acetate) Injection .............. Armour Pharmaceutical Co., P.O. Box 511, Kankakee, IL 

60901. 

NDA 018087 .............. Thyrel TRH (protirelin) Injection ........................................... Ferring Pharmaceuticals, Inc., 400 Rella Blvd., suite 300, 

Suffern, NY 10901. 

The Director, Center for Drug 

Evaluation and Research, under section 

505(e) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(e)), and 

under authority delegated by the 

Commissioner, finds that the holders of 

the applications listed in this document 

have repeatedly failed to submit reports 

required by § 314.81. In addition, under 

§ 314.200, we find that the holders of 

the applications have waived any 

contentions concerning the legal status 

of the drug products. Therefore, under 

these findings, approval of the 

applications listed in this document, 

and all amendments and supplements 

thereto, is hereby withdrawn, effective 

November 17, 2014. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 221 / Monday, November 17, 2014 / Notices 68455 

Dated: November 10, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–27039 Filed 11–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Notice of Meeting 

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

the Federal Advisory Committee Act 

(Public Law 92–463), notice is hereby 

given of the following meeting: 

Name: Advisory Commission on 

Childhood Vaccines (ACCV) 

Date And Time: December 4, 2014, 

10:00 a.m. to 4:00 p.m. EDT 

Place: Audio Conference Call and 

Adobe Connect Pro 

The ACCV will meet on Thursday, 

December 4, 2014, from 10:00 a.m. to 

4:00 p.m. (EDT). The public can join the 

meeting by: 

1. (Audio Portion) Calling the 

conference Phone Number 877–917– 

4913 and providing the following 

information: 

Leader’s Name: Dr. A. Melissa Houston 

Password: ACCV 

2. (Visual Portion) Connecting to the 

ACCV Adobe Connect Pro Meeting 

using the following URL: https://

hrsa.connectsolutions.com/accv/ (copy 

and paste the link into your browser if 

it does not work directly, and enter as 

a guest). Participants should call and 

connect 15 minutes prior to the meeting 

in order for logistics to be set up. If you 

have never attended an Adobe Connect 

meeting, please test your connection 

using the following URL: https://

hrsa.connectsolutions.com/common/

help/en/support/meeting_test.htm and 

get a quick overview by following URL: 

http://www.adobe.com/go/connectpro_

overview. Call (301) 443–6634 or send 

an email to aherzog@hrsa.gov if you are 

having trouble connecting to the 

meeting site. 

Agenda: The agenda items for the 

December 2014 meeting will include, 

but are not limited to: updates from the 

Division of Injury Compensation 

Programs (DICP), Department of Justice 

(DOJ), National Vaccine Program Office 

(NVPO), Immunization Safety Office 

(Centers for Disease Control and 

Prevention), National Institute of 

Allergy and Infectious Diseases 

(National Institutes of Health), and the 

Center for Biologics, Evaluation and 

Research (Food and Drug 

Administration). A draft agenda and 

additional meeting materials will be 

posted on the ACCV Web site (http://

www.hrsa.gov/vaccinecompensation/

accv.htm) prior to the meeting. Agenda 

items are subject to change as priorities 

dictate. 

Public Comment: Persons interested 

in providing an oral presentation should 

submit a written request, along with a 

copy of their presentation to: Annie 

Herzog, DICP, Healthcare Systems 

Bureau (HSB), Health Resources and 

Services Administration (HRSA), Room 

11C–26, 5600 Fishers Lane, Rockville, 

MD 20857 or email: aherzog@hrsa.gov. 

Requests should contain the name, 

address, telephone number, email 

address, and any business or 

professional affiliation of the person 

desiring to make an oral presentation. 

Groups having similar interests are 

requested to combine their comments 

and present them through a single 

representative. The allocation of time 

may be adjusted to accommodate the 

level of expressed interest. DVIC will 

notify each presenter by email, mail, or 

telephone of their assigned presentation 

time. Persons who do not file an 

advance request for a presentation, but 

desire to make an oral statement, may 

announce it at the time of the public 

comment period. Public participation 

and ability to comment will be limited 

to space and time as it permits. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requiring information regarding 

the ACCV should contact Annie Herzog, 

DICP, HSB, HRSA, Room 11C–26, 5600 

Fishers Lane, Rockville, Maryland 

20857, telephone (301) 443–6593, or 

email: aherzog@hrsa.gov. 

Dated: November 7, 2014. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2014–27188 Filed 11–14–14; 8:45 am] 

BILLING CODE 6705–01–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. 

Heterocyclic Compounds for the 

Treatment of Hepatitis C Virus 

Description of Technology: The vast 

majority of people infected with 

Hepatitis C Virus (HCV) will have 

chronic infection. Over decades, this 

can lead to liver disease and liver 

cancer. In fact, HCV infection is the 

leading cause of liver transplants in the 

U.S. Several new drugs have recently 

come into the market that have changed 

the HCV treatment paradigm. However, 

the effectiveness of these new drugs can 

vary depending on the HCV genotype. 

Furthermore, all oral, interferon free 

therapeutic regimens for HCV infection 

will need combinations of drugs that 

target different aspects of the HCV life 

cycle. Thus, there is still the need for 

additional new therapeutics against 

HCV. 

The subject technologies are 

aryloxazole based small molecules that 

are potent inhibitors of HCV infection 

and replication. The compounds exhibit 

synergy with currently available 

therapeutics for HCV and represent a 

new class of anti-HCV compounds. The 

compounds affect the entry step of HCV 

infection, a step not targeted by 

currently available therapeutics against 

HCV. 

Potential Commercial Applications: 

Prevention and treatment of HCV 

infection. 

Competitive Advantages: 

• Potent inhibitors of HCV infection 

and replication. 

• Show synergistic effect with 

currently available HCV therapeutics. 

• Represent new class of HCV 

inhibitors that target the entry step of 

HCV infection. 

Development Stage: 

• Early-stage. 

• In vitro data available. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES