27146 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 

Amendments Act of 2007 (Public Law 

110–85), FDA has the authority to assess 

and collect user fees for certain drug 

and biologics license applications and 

supplements. Under this authority, 

pharmaceutical companies pay a fee for 

certain new human drug applications, 

biologics license applications, or 

supplements submitted to the agency for 

review. Because the submission of user 

fees concurrently with applications and 

supplements is required, review of an 

application by FDA cannot begin until 

the fee is submitted. Form FDA 3397, 

the user fee cover sheet, is designed to 

provide the minimum necessary 

information to determine whether a fee 

is required for review of an application, 

to determine the amount of the fee 

required, and to account for and track 

user fees. The form provides a crossreference of the fee submitted for an 

application by using a unique number 

tracking system. The information 

collected is used by FDA’s Center for 

Drug Evaluation and Research (CDER) 

and Center for Biologics Evaluation and 

Research (CBER) to initiate the 

administrative screening of new drug 

applications, biologics license 

applications, and supplemental 

applications. 

Respondents to this collection of 

information are new drug and biologics 

manufacturers. Based on FDA’s database 

system for fiscal year (FY) 2008, there 

are an estimated 255 manufacturers of 

products subject to the user fee 

provisions of PDUFA. However, not all 

manufacturers will have any 

submissions, and some may have 

multiple submissions in a given year. 

The total number of annual responses is 

based on the number of submissions 

received by FDA in FY 2008. CDER 

received 3,107 annual responses that 

include the following submissions: 147 

new drug applications; 13 biologics 

license applications; 1,813 

manufacturing supplements; 987 

labeling supplements; and 147 efficacy 

supplements. CBER received 810 annual 

responses that include the following 

submissions: 9 biologics license 

applications; 743 manufacturing 

supplements; 48 labeling supplements; 

and 10 efficacy supplements. Based on 

the previous submissions that were 

received, the rate of these submissions 

is not expected to change significantly 

in the next few years. The estimated 

hours per response are based on past 

FDA experience with the various 

submissions, and the average is 30 

minutes. 

FDA is revising Form FDA 3397 in the 

following ways: (1) By including an 

additional question regarding 

redemption of a priority review 

voucher; (2) by deleting the exclusion 

for certain applications submitted under 

section 505(b)(2) of the FD&C Act (21 

U.S.C. 355(b)(2)); and (3) by making 

several minor editorial changes. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Form No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

FDA 3397 255 15.36 3,917 0.5 1,959 

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

Dated: June 1, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–13276 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) 

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 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 final product-specific 

BE recommendations. 

DATES: Submit written or electronic 

comments on the draft and revised draft 

product-specific BE recommendations 

listed in this notice by September 8, 

2009. 

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 draft 

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 


cprice-sewell on PRODPC61 with NOTICES
Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 27147 

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. 

Recommendations were last announced 

in the Federal Register of September 5, 

2008 (73 FR 51829). This notice 

announces draft product-specific 

recommendations, either new or 

revised, that have been posted on FDA’s 

Web site in the period from May 1, 

2008, through October 31, 2008. Final 

product-specific recommendations are 

being announced elsewhere in this issue 

of the Federal Register. 

II. Drug Products for Which Draft 

Product-Specific BE Recommendations 

Are Available 

FDA is announcing draft BE productspecific recommendations for drug 

products containing the following active 

ingredients: 

A 

Acetazolamide 

Adefovir Dipivoxil 

Albuterol Sulfate 

Aliskiren Hemifumarate 

Alprazolam 

Aminosalicylic Acid 

Amlodipine Besylate; Olmesartan 

Medoxomil 

Amlodipine Besylate; Valsartan 

Amprenavir 

Atovaquone; Proguanil 

Azacitidine 

Azithromycin 

B 

Baclofen 

Bethanechol Chloride 

Bismuth Subcitrate Potassium; 

Metronidazole; Tetracycline HCl 

Brimonidine Tartrate 

Bumetanide 

Busulfan 

C 

Calcitriol 

Capecitabine 

Citalopram HBr (multiple dosage forms) 

Clotrimazole 

Colesevelam HCl 

Cyclobenzaprine HCl 

D 

Demeclocycline HCl 

Desogestrel; Ethinyl Estradiol 

Diflunisal 

Disopyramide Phosphate (multiple 

dosage forms) 

Doxercalciferol 

Doxycycline 

Doxycycline Hyclate 

E 

Efavirenz; Emtricitabine; Tenofovir 

Disoproxil Fumarate 

Enalapril Maleate 

Eprosartan Mesylate 

Escitalopram Oxalate 

Ethinyl Estradiol; Levonorgestrel 

Ethinyl Estradiol; Norethindrone 

Acetate (multiple reference listed drugs 

(RLDs)) 

Ethosuximide 

Ezetimibe; Simvastatin 

Ezetimibe 

F 

Famciclovir 

Fenofibrate (multiple dosage forms) 

Fexofenadine HCl 

Frovatriptan Succinate 

G 

Gatifloxacin 

Glipizide 

Goserelin Acetate 

Griseofulvin, Ultramicrocrystalline 

H 

Hydrochlorothiazide; Telmisartan 

Hydrochlorothiazide; Triamterene 

Hydralazine HCl 

Hydroxyurea 

I 

Ibuprofen (multiple dosage forms) 

Indapamide 

Isoniazid 

Isotretinoin 

K 

Ketoconazole 

Ketorolac Tromethamine 

L 

Lansoprazole 

Latanoprost 

Letrozole 

Leucovorin Calcium 

Leuprolide Acetate 

Levocetirizine Dihydrochloride 

Levofloxacin 

Lisdexamfetamine Dimesylate 

Lithium Carbonate 

Lopinavir; Ritonavir 

Loratadine 

M 

Mebendazole 

Melphalan 

Metformin HCl 

Methadone HCl 

Midodrine HCl 

Minocycline HCl 

Montelukast 

Montelukast Sodium 

Moxifloxacin HCl 

N 

Nabilone 

Naltrexone HCl 

Naproxen Sodium (multiple RLDs) 

Naratriptan HCl 

Nicardipine HCl 

O 

Olanzapine 

Olopatadine HCl 

Omeprazole; Sodium Bicarbonate 

P 

Paroxetine HCl 

Penicillamine 

Phenoxybenzamine HCl 

Prednisolone Sodium Phosphate 

Q 

Quetiapine Fumarate 

R 

Ramipril 

Repaglinide 

S 

Sapropterin Dihydrochloride 

Selegiline HCl 

Sevelamer Carbonate 

Sevelamer HCl 

Simvastatin 

Sitagliptin Phosphate; Metformin HCl 

Sodium Iodide 

Stavudine 

Sulfadiazine 

Sulfamethoxazole; Trimethoprim 

T 

Theophylline 

Tiagabine HCl 

Triptorelin Pamoate 

Trospium Cl 

U 

Ursodiol 

V 

Valganciclovir HCl 

Verapamil HCl 

Vorinostat 

Z 

Zileuton 

Ziprasidone HCl 

III. Drug Products for Which Revised 

Draft Product-Specific BE 

Recommendations Are Available 

FDA is announcing revised draft BE 

product-specific recommendations for 

drug products containing the following 

active ingredients. These 

recommendations were previously 

posted on FDA’s Web site. 

A 

Alprazolam 

C 

Candesartan Cilexetil; 

Hydrochlorothiazide 

Carbidopa; Entacapone; Levodopa 

Clopidogrel Bisulfate 

F 

Fexofenadine HCl (multiple dosage 

forms) 

Fosinopril Sodium; 

Hydrochlorothiazide 


cprice-sewell on PRODPC61 with NOTICES
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