73600 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

requesting that the Agency determine 

whether PFIZERPEN (penicillin G 

potassium) Injection, 1 units/vial, and 

penicillin G potassium injection, 1 

million units/vial, had been withdrawn 

from sale for reasons of safety or 

effectiveness. Penicillin G potassium 

Injection, 1 million units/vial, is the 

subject of ANDA 65–079, held by 

Sandoz, and approved on August 30, 

2002. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that PFIZERPEN (penicillin G 

potassium) Injection, 1 million units/

vial, was not withdrawn for reasons of 

safety or effectiveness (this 

determination also applies to penicillin 

G potassium injection, 1 million units/ 

vial, ANDA 65–079). The petitioner 

believes that PFIZERPEN (penicillin G 

potassium) Injection, 1 million units/

vial, was not withdrawn for reasons of 

safety or effectiveness because it was 

discontinued due to commercial 

reasons. We have carefully reviewed our 

files for records concerning the 

withdrawal of PFIZERPEN (penicillin G 

potassium) Injection, 1 million units/

vial, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this product was not 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list PFIZERPEN (penicillin 

G potassium) Injection, 1 million units/ 

vial, in the ‘‘Discontinued Drug Product 

List’’ section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to PFIZERPEN (penicillin G potassium) 

Injection, 1 million units/vial, may be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: December 5, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29034 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Bioequivalence Recommendations for 

Budesonide Extended-Release 

Tablets; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Bioequivalence 

Recommendations for Budesonide 

Extended-Release Tablets.’’ The 

guidance provides specific 

recommendations on the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for budesonide extendedrelease tablets. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 9, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft 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. 

FOR FURTHER INFORMATION CONTACT: Kris 

Andre ́, Center for Drug Evaluation and 

Research (HFD–600), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1615, Silver Spring, 

MD 20993–0002, 240–402–7290. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site at 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm. As described in 

that guidance, FDA adopted this process 

as a means to develop and disseminate 

product-specific BE recommendations 

and to provide a meaningful 

opportunity for the public to consider 

and comment on those 

recommendations. This notice 

announces the availability of draft BE 

recommendations for budesonide 

extended-release tablets. 

New drug application 203634 for 

UCERIS (budesonide) extended-release 

tablets, 9 milligrams (mg), was initially 

approved by FDA in January 2013. FDA 

is now issuing a draft guidance for 

industry on BE recommendations for 

generic budesonide extended-release 

tablets. 

In February 2013, Santarus, Inc., 

submitted a citizen petition requesting 

that FDA: (1) Issue an individual BE 

guidance for budesonide extendedrelease tablets and (2) refrain from 

approving any ANDA that identifies 

UCERIS (budesonide) extended-release 

tablets as the reference listed drug 

unless the generic product is shown to 

be bioequivalent based on appropriate 

data from a clinical efficacy endpoint 

study, comparative pharmacokinetic 

testing, in vitro dissolution testing, and 

pharmacoscintigraphy studies (Docket 

No. FDA 2013–P–0127). FDA reviewed 

the issues raised in the petition and is 

responding to the petition today in a 

letter that will be included in the citizen 

petition docket. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the design of BE studies to support 

ANDAs for budesonide extended-release 

tablets. 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 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73601 

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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: December 5, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29035 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of a Start-Up 

Exclusive Patent License Agreement: 

Use of Compounds Covered by Patent 

Rights for Diagnosis of Human Thyroid 

Cancer Requiring FDA Premarket 

Approval or an Equivalent Authority 

Outside of the United States, and 

Treatment of Human Thyroid Cancer 

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 of a 

Start-Up Exclusive Patent License to 

Nova Therapeutics LLC, a company 

having a place of business in Delaware, 

to practice the inventions embodied in 

the following patent applications: 

(a) PCT Patent Application No. PCT/

US2008/11958, Filed: October 20, 

2008, HHS Ref. No.: E–284–2008/0– 

PCT–01 

(b) Australian Patent No. 2008–363295, 

Filed: October 20, 2008, HHS Ref No.: 

E–284–2008/0–AU–02 

(c) Canadian Patent Application No. 

2,741,030, Filed: October 20, 2008, 

HHS Ref. No.: E–284–2008/0–CA–03 

(d) European Patent Application No. 

08876356.0, Filed: October 20, 2008, 

HHS Ref. No.: E–284–2008/0–EP–04 

(e) Indian Patent Application No. 3684/ 

DELNP/2011, Filed: October 20, 2008, 

HHS Ref. No.: E–284–2008/0–IN–05 

(f) Japanese Patent Application No. 

2011–532048, Filed: October 20, 2008, 

HHS Ref. No.: E–284–2008/0–JP–06 

(g) U.S. Patent No. 8,741,259 U.S. Patent 

Application No. 13/125,045, Filed: 

October 20, 2008, HHS Ref. No.: E– 

284–2008/0–US–07 

(h) U.S. Patent Application No. 13/

897,330, Filed: October 20, 2008, HHS 

Ref. No.: E–284–2008/0–US–08 

Current status: pending 

(i) U.S. Patent Application No. 14/

243,821, Filed: October 20, 2008, HHS 

Ref. No.: E–284–2008/0–US–10 

The patent rights in this invention 

have been assigned to the Government 

of the United States of America. The 

territory of the prospective Start-Up 

Exclusive Patent License Agreement 

may be worldwide and the field of use 

may be limited to: Use of compounds 

covered by Patent Rights for diagnosis of 

human thyroid cancer requiring FDA 

premarket approval or an equivalent 

authority outside of the United States, 

and treatment of human thyroid cancer. 

DATES: Only written comments or 

applications for a license (or both) 

which are received by the NIH Office of 

Technology Transfer on or before 

December 26, 2014 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated Start-Up Exclusive Patent 

License Agreement should be directed 

to: Lauren Nguyen-Antczak, Ph.D., J.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– 

4074; Facsimile: (301) 402–0220; Email: 

Lauren.Nguyen-antczak@nih.gov. A 

signed confidentiality nondisclosure 

agreement will be required to receive 

copies of any patent application(s) that 

have not been published or issued by 

the United States Patent and Trademark 

Office of the World Intellectual Property 

Organization. 

SUPPLEMENTARY INFORMATION: This 

invention concerns small molecule 

compounds that agonize the activity of 

the thyroid stimulating hormone 

receptor (‘‘TSHR’’). These TSHR 

agonists enhance or activate the thyroid 

stimulating hormone (‘‘TSH’’) signaling 

pathway by directly binding to the 

transmembrane domain of TSHR. 

Invention compounds may be 

administered alone or in combination 

with radioactive iodine to detect thyroid 

cancer cells. Additionally, invention 

compounds may be administered in 

combination with radioactive iodine to 

treat thyroid cancer, such as to ablate 

thyroid remnants in patients after a 

thyroidectomy. 

The prospective Start-Up Exclusive 

Patent License that is being considered 

can be found at http://www.ott.nih.gov/ 

forms-model-agreements#SUMLA, 

which complies with the terms and 

conditions of 35 U.S.C. 209 and 37 CFR 

part 404. The prospective Start-Up 

Exclusive Patent License is being 

provided under the small business 

initiative launched on 1 October 2011. 

The prospective Start-Up Exclusive 

Patent License may be granted unless 

the NIH receives written evidence and 

argument, within fifteen (15) days from 

the date of this published notice, 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. 

Complete applications for a license in 

the prospective field of use that are filed 

in response to this notice will be treated 

as objections to the grant of the 

contemplated Start-Up Exclusive Patent 

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: December 4, 2014. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2014–29017 Filed 12–10–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of meetings of the National 

Diabetes and Digestive and Kidney 

Diseases Advisory Council. 

The meetings will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meetings 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 

mstockstill on DSK4VPTVN1PROD with NOTICES