Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices 10535 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

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 June 11, 2010 (75 FR 33311), 

FDA announced the availability of a 

guidance for industry, ‘‘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. The BE 

recommendations identified in this 

notice were developed using the process 

described in that guidance. 

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. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the 

recommendations. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments on product-specific 

BE recommendations to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

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– 

276–8608. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010, 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 

product-specific 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 

guidance, FDA adopted this process as 

a means to develop and disseminate 

product-specific BE recommendations 

and provide a meaningful opportunity 

for the public to consider and comment 

on those recommendations. Under that 

process, 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 60 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 final product-specific 

recommendations that were posted on 

FDA’s Web site in October 2011. 

For a complete history of previous 

Federal Register notices relating to 

product-specific BE recommendations, 

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. 

II. Drug Products for Which Final 

Product-Specific BE Recommendations 

are Available 

FDA is announcing final productspecific BE recommendations for drug 

products containing the following active 

ingredients: 

A 

Acetaminophen; Caffeine; Dihydrocodeine 

Bitartrate 

C 

Cephalexin 

Ciprofloxacin 

D 

Desmopressin Acetate 

E 

Eletriptan HBr 

F 

Fenoprofen Calcium 

Fludrocortisone Acetate 

G 

Glimepiride; Pioglitazone 

H 

Hydroxyzine Pamoate (multiple RLDs) 

I 

Imatinib Mesylate 

L 

Lansoprazole 

Levetiracetam 

Linezolid 

M 

Meprobamate 

Methotrexate Sodium (multiple RLDs) 

Methylprednisolone Acetate 

Metoclopramide HCl 

N 

Nadolol 

Nifedipine 

Nilutamide 

Nisoldipine 

Nitazoxanide 

Nitrofurantoin 

Nitrofurantoin Macrocrystalline 

O 

Oxybutynin Chloride 

P 

Phendimetrazine Tartrate (multiple RLDs) 

Phentermine HCl (multiple RLDs) 

Phytonadione 

Pregabalin 

Propafenone HCl 

Pyridostigmine Bromide 

R 

Raltegravir Potassium 

Ramelteon 

S 

Scopolamine 

Selegiline 

Sorafenib Tosylate 

T 

Tamoxifen Citrate 

Telbivudine 

Temazepam 

Terbinafine HCl 

Toremifene Citrate 

V 

Voriconazole 

Z 

Zolpidem 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments on any of the specific BE 

recommendations posted on FDA’s Web 

site. 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. The 


srobinson on DSK4SPTVN1PROD with NOTICES
10536 Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices 

guidance, notices, and received 

comments are available for public 

examination in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA through FDMS only at 

http://www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/CDER/GUIDANCE/ 

bioequivalence/default.htm or http:// 

www.regulations.gov. 

Dated: February 14, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4037 Filed 2–21–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Draft and Revised Draft 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 additional draft and 

revised draft 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 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 

product-specific BE recommendations 

available to the public on FDA’s Web 

site. The BE recommendations 

identified in this document were 

developed using the process described 

in that guidance. 

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 these draft 

and revised draft guidances before it 

begins work on the final versions of the 

guidances, submit either electronic or 

written comments on the draft and 

revised draft product-specific BE 

recommendations listed in this notice 

by April 23, 2012. 

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. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance recommendations. 

Submit electronic comments on the 

draft product-specific BE 

recommendations 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: 

Doan T. Nguyen, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855, 240– 

276–8608. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010, 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 

product-specific BE recommendations 

available to the public on FDA’s Web 

site at http://www.fda.gov/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/default.htm. As 

described in that 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 the FDA’s Web site and 

announced periodically in the Federal 

Register. The public is encouraged to 

submit comments on those 

recommendations within 60 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. 

Recommendations were last announced 

in the Federal Register of January 25, 

2012 (77 FR 3777). This notice 

announces draft product-specific 

recommendations, either new or 

revised, that have been posted on the 

FDA’s Web site in the period from July 

1, 2011, through November 30, 2011. 

For a complete history of previously 

published Federal Register notices 

relating to product-specific BE 

recommendations, please go to http://

www.regulations.gov and enter docket 

number FDA–2007–D–0369. 

These draft and revised draft 

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. 

II. Drug Products for Which New Draft 

Product-Specific BE Recommendations 

Are Available 

FDA is announcing new draft 

product-specific BE recommendations 

for drug products containing the 

following active ingredients: 

C 

Carbamazepine 

Cholestyramine 

Clindamycin HCl 

D 

Dinoprostone (multiple RLDs) 

E 

Enoxaparin 

Ethinyl Estradiol Norethindrone 

Etravirine 

F 

Fingolimod 

I 

Ibuprofen; Phenlyephrine HCl 

Imiquimod 

L 

Lanthanum Carbonate 

Loteprednol; Tobramycin 

M 

Methylphenidate HCl 

P 

Paliperidone Palmitate 

Podofilox 

Potassium Chloride (multiple RLDs) 

Pyridostigmine Bromide 

T 

Testosterone 


srobinson on DSK4SPTVN1PROD with NOTICES