27148 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 

H 

Hydrochlorothiazide; Valsartan 

M 

Minoxidil 

Montelukast Sodium 

Morphine Sulfate 

S 

Sirolimus 

Z 

Zolmitriptan 

For a complete history of previously 

published Federal Register notices, 

please go to http://www.regulations.gov 

and enter docket number FDA–2007–D– 

0369. 

These guidances are being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidances represent the agency’s 

current thinking on product-specific 

design of BE studies to support ANDAs. 

They do not create or confer any rights 

for or on any person and do 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. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on any of the specific BE 

recommendations posted on FDA’s Web 

site. Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The 

guidance, notices, and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: May 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–13272 Filed 6–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] (formerly 

Docket No. 2007D–0169) 

Final Guidances for Industry 

Describing Product-Specific 

Bioequivalence Recommendations; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of final product-specific 

bioequivalence (BE) recommendations. 

The recommendations provide productspecific guidance on the design of BE 

studies to support abbreviated new drug 

applications (ANDAs). In the Federal 

Register of May 31, 2007, FDA 

announced the availability of a draft 

guidance for industry entitled 

‘‘Bioequivalence Recommendations for 

Specific Products’’ explaining the 

process that would be used to make 

product-specific BE recommendations 

available to the public on FDA’s Web 

site. The BE recommendations 

identified in this notice were developed 

using the process described in that 

guidance. Elsewhere in this issue of the 

Federal Register, FDA is announcing 

the availability of additional draft and 

revised draft product-specific BE 

recommendations. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the individual BE 

guidances 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 selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

product-specific BE recommendations 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the 

recommendations. 

FOR FURTHER INFORMATION CONTACT: 

Doan T. Nguyen, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855, 240– 

276–9314. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of May 31, 

2007 (72 FR 30388), FDA announced the 

availability of a draft guidance for 

industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that 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/cder/guidance/ 

bioequivalence/default.htm. As 

described in that draft guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific BE recommendations and 

provide a meaningful opportunity for 

the public to consider and comment on 

those recommendations. Under that 

process, draft recommendations are 

posted on FDA’s Web site and 

announced periodically in the Federal 

Register. The public is encouraged to 

submit comments on those 

recommendations within 90 days of 

their announcement in the Federal 

Register. FDA considers any comments 

received and either publishes final 

recommendations, or publishes revised 

draft recommendations for comment. 

Once finalized, the recommendations 

are posted on FDA’s Web site and 

announced in the Federal Register. This 

notice announces product-specific 

recommendations that have been posted 

on FDA’s Web site from May 1, 2008, 

through October 31, 2008. Additional 

draft and revised draft product-specific 

BE recommendations are being 

announced elsewhere in this issue of 

the Federal Register. 

II. Drug Products for Which Final 

Product-Specific BE Recommendations 

Are Available 

FDA is announcing final BE productspecific recommendations for drug 

products containing the following active 

ingredients: 

A 

Abacavir Sulfate 

Abacavir Sulfate; Lamivudine; 

Zidovudine 

Acamprosate Calcium 

Acyclovir 

Almotriptan Malate 

Alosetron HCl 

Amlodipine Besylate 

Amlodipine Besylate; Benazepril HCl 

Amoxicillin; Clavulanate Potassium 

Anagrelide HCl 

Anastrozole 

Aprepitant 


cprice-sewell on PRODPC61 with NOTICES
Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 27149 

Atazanavir Sulfate 

Atomoxetine HCl 

Atorvastatin Calcium 

B 

Benzonatate 

Benzphetamine HCl 

Bicalutamide 

Bisoprolol Fumarate 

Bisoprolol Fumarate; 

Hydrochlorothiazide 

C 

Candesartan Cilexetil 

Carbamazepine 

Carvedilol 

Cefditoren Pivoxil 

Cetirizine HCl 

Cevimeline HCl 

Cilostazol 

Cinacalcet HCl 

Clarithromycin 

Clonidine HCl 

D 

Danazol 

Darifenacin HBr 

Deferasirox 

Desloratadine (multiple dosage forms) 

Dextromethorphan Polistirex 

Diclofenac Sodium; Misoprostol 

Dicloxacillin Sodium 

Didanosine (multiple dosage forms) 

Digoxin 

Dipyridamole 

Divalproex Sodium 

Dofetilide 

Donepezil HCl (multiple dosage forms) 

Doxazosin Mesylate 

Drospirenone; Estradiol 

Duloxetine HCl 

Dutasteride 

E 

Efavirenz (multiple dosage forms) 

Emtricitabine 

Entacapone 

Entecavir 

Eplerenone 

Erlotinib HCl 

Escitalopram Oxalate 

Esomeprazole Magnesium 

Etidronate Disodium 

Exemestane 

F 

Famotidine (multiple dosage forms) 

Fenofibrate (multiple dosage forms) 

Fluconazole 

Fluoxetine HCl; Olanzapine 

Fosamprenavir Calcium 

Fosinopril Sodium 

G 

Gabapentin 

Gemifloxacin Mesylate 

Glimepiride 

Glipizide; Metformin HCl 

Glyburide; Metformin HCl 

Granisetron HCl 

H 

Hydrochlorothiazide 

Hydrochlorothiazide; Irbesartan 

Hydrochlorothiazide; Lisinopril 

Hydrochlorothiazide; Losartan 

Potassium 

Hydrochlorothiazide; Olmesartan 

Medoxomil 

I 

Ibandronate Sodium 

Indinavir Sulfate 

Irbesartan 

Isosorbide Mononitrate 

Isradipine (multiple dosage forms) 

L 

Lamivudine 

Lamivudine; Zidovudine 

Lamotrigine (multiple dosage forms) 

Levonorgestrel 

Liothyronine Sodium 

Loratadine 

Losartan Potassium 

M 

Mefloquine HCl 

Meloxicam (multiple dosage forms) 

Mercaptopurine 

Metformin HCl 

Metformin HCl; Pioglitazone HCl 

Miglustat 

Mirtazapine 

Modafinil 

Moexipril HCl 

N 

Nabumetone 

Nateglinide 

Nelfinavir Mesylate 

Nevirapine 

O 

Olanzapine 

Olmesartan Medoxomil 

Olsalazine Sodium 

Omeprazole 

Omeprazole Magnesium 

Omeprazole; Sodium Bicarbonate 

Ondansetron 

Ondansetron HCl 

Oxcarbazepine (multiple dosage forms) 

P 

Pantoprazole Sodium 

Perindopril Erbumine 

Phenytoin 

Phenytoin Sodium (multiple dosage 

forms) 

Pilocarpine HCl 

Pravastatin Sodium 

Q 

Quetiapine Fumarate 

Quinapril HCl 

R 

Raloxifene HCI 

Ramipril 

Ribavirin (multiple dosage forms) 

Rifampin 

Riluzole 

Risedronate Sodium; Calcium Carbonate 

Ritonavir 

Rizatriptan Benzoate 

Rosiglitazone Maleate 

Rosuvastatin Calcium 

S 

Sertraline HCl 

Sibutramine HCl 

Sildenafil Citrate 

Simvastatin 

Stavudine 

Sulfamethoxazole; Trimethoprim 

Sumatriptan Succinate 

T 

Tamsulosin HCl 

Telithromycin 

Telmisartan 

Terazosin HCl 

Terbinafine HCl 

Testosterone 

Ticlopidine HCl 

Tizanidine HCl 

Tolterodine Tartrate 

Torsemide 

Tramadol HCl 

Tramadol HCl; Acetaminophen 

Trandolapril 

Triamterene 

V 

Valacyclovir HCl 

Valsartan 

Vardenafil HCl 

Verapamil HCl (multiple reference 

listed drug (RLDs)) 

Voriconazole 

Z 

Zaleplon 

Zidovudine (multiple dosage forms) 

Ziprasidone HCl 

For a complete history of previously 

published Federal Register notices, 

please go to http://www.regulations.gov 

and enter docket number FDA–2007–D– 

0369. 

These guidances are being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidances represent the agency’s 

current thinking on product-specific 

design of BE studies to support ANDAs. 

They do not create or confer any rights 

for or on any person and do 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. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on any of the specific BE 

recommendations posted on FDA’s Web 


cprice-sewell on PRODPC61 with NOTICES
27150 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 

site. Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The 

guidance, notices, and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: May 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–13261 Filed 6–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

Interactive Venn Diagram Software 

Designed for Microarray Analysis 

Description of Technology: Multiple 

conditions from any source, but 

designed for experiments involving 

microarrays, will produce (significant 

gene lists for arrays) lists from each 

condition, thus multiple lists. This 

Java® based software provides 

investigators with a method of 

displaying multiple conditions in a 

single graphic along with producing a 

text output of genes that are the product 

of these conditional intersections along 

with each conditions unique list. A 

standard Venn diagram is limited to 

only display three (3) comparisons; this 

software can display any number of 

comparisons and will automatically 

create lists from all intersections even if 

not able to be displayed along with each 

conditions unique list. 

Applications: 

• Microarray analysis. 

• Genomics. 

• Bioinformatics. 

• Any environment creating multiple 

lists (Business, Accounting, Inventory 

Control, etc.). 

Inventor: Daniel E. Sturdevant 

(NIAID). 

Patent Status: HHS Reference No. E– 

189–2009/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Michael A. 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@mail.nih.gov. 

Axenically-Produced Coxiella 

burnetii and Methods for Producing 

Axenic Coxiella burnetii 

Description of Technology: Coxiella 

burnetii is the causative agent of Q 

(Query) fever. Currently, there is a need 

for a safe Q fever vaccine. It is 

anticipated that axenically-produced C. 

burnetii, which is free of host cell 

related impurities, could provide either 

the basis for a whole-cell Q fever 

vaccine or advance the development of 

a safe recombinant Q fever vaccine. 

Currently, there are no licensed Q-fever 

vaccines except for a whole-cell, 

formalin inactivated, vaccine which is 

available in Australia (Q–Vax). 

Individuals with a previous exposure to 

C. burnetii may, however, have a severe 

allergic reaction to this vaccine and 

other individuals may experience a 

headache or flu-like symptoms after 

vaccination. It is anticipated that 

axenically-produced C. burnetii could 

provide the basis for a less reactogenic 

whole-cell vaccine or facilitate the 

development of a recombinant vaccine 

that does not cause an allergic reaction. 

Additionally, the inability to propagate 

obligate intracellular pathogens under 

axenic (host cell-free) culture conditions 

imposes severe experimental constraints 

that have negatively impacted progress 

in understanding pathogen virulence 

and disease mechanisms. 

Q fever is a zoonotic disease and farm 

animals, pets, and rodents are 

significant reservoirs for C. burnetii. C. 

burnetii persists in the soil for a long 

time and typically humans are exposed 

to Q fever by the inhalation of the 

bacterium deposited with animal waste 

such as urine, feces, and amniotic fluid. 

The epidemiology of Q fever is diverse 

and the disease does not discriminate 

between developed and developing 

countries. Additionally, urban outbreaks 

have been known to occur due to 

windborne C. burnetii. C. burnetii is 

listed as a select agent by the 

Department of Health and Human 

Services (HHS) because of its potential 

as an agent of bioterrorism. Deployed 

military personnel are also at risk of 

contracting Q fever and thousands of 

cases of Q fever have been reported 

among military personnel since the 

disease was first reported in the 1930s. 

Advantages: 

• The ability to propagate, previously 

unpropagatable, C. burnetii without a 

hostcell. 

• The ability to study C. burnetii 

virulence using axenic conditions or 

conditions free of host cell-related 

impurities. 

• This technology is ready for use in 

drug/vaccine discovery, production, and 

development. 

• Potential licensees of this invention 

include companies that are: 1) seeking 

vaccine production platforms based on 

host cell-free (axenic) media, 2) seeking 

to develop recombinant vaccines for 

obligate, intracellular, bacteria; or 3) 

seeking to lower costs and ease scale-up 

would be potential licensees of this 

technology. 

Development Status: This technology 

has been demonstrated with C. burnetii. 

Currently, the inventors are testing this 

technology for support of axenic growth 

of other obligate, intracellular, bacteria 

of public health significance. 

Inventors: Robert A. Heinzen, Anders 

Omsland, Diane C. Cockrell, Dale Howe 

(NIAID). 

Publication: A Omsland et al. Host 

cell-free growth of the Q fever bacterium 

Coxiella burnetii. Proc Natl Acad Sci 

USA. 2009 Mar 17;106(11):4430–4434. 

Patent Status: U.S. Provisional 

Application No. 61/154,330 filed 20 Feb 

2009 (HHS Reference No. E–114–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; 

soukasp@mail.nih.gov. 


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