Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 27146-27148 [E9-13272]

Download as PDF 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 No. of Respondents Form FDA 3397 1 There 255 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 Food and Drug Administration, HHS. cprice-sewell on PRODPC61 with NOTICES ACTION: Total Annual Responses 15.36 Hours per Response 3,917 Total Hours 0.5 1,959 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] AGENCY: Annual Frequency per Response 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 VerDate Nov<24>2008 15:15 Jun 05, 2009 Jkt 217001 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. 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 ADDRESSES: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// 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 https://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 E:\FR\FM\08JNN1.SGM 08JNN1 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 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 cprice-sewell on PRODPC61 with NOTICES 15:15 Jun 05, 2009 Jkt 217001 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 L Lansoprazole Latanoprost Letrozole Leucovorin Calcium Leuprolide Acetate Levocetirizine Dihydrochloride Levofloxacin Lisdexamfetamine Dimesylate Lithium Carbonate Lopinavir; Ritonavir Loratadine C Calcitriol Capecitabine Citalopram HBr (multiple dosage forms) Clotrimazole Colesevelam HCl Cyclobenzaprine HCl VerDate Nov<24>2008 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 K Ketoconazole Ketorolac Tromethamine B Baclofen Bethanechol Chloride Bismuth Subcitrate Potassium; Metronidazole; Tetracycline HCl Brimonidine Tartrate Bumetanide Busulfan D Demeclocycline HCl Desogestrel; Ethinyl Estradiol Diflunisal Disopyramide Phosphate (multiple dosage forms) Naratriptan HCl Nicardipine HCl Doxercalciferol Doxycycline Doxycycline Hyclate I Ibuprofen (multiple dosage forms) Indapamide Isoniazid Isotretinoin Amlodipine Besylate; Valsartan Amprenavir Atovaquone; Proguanil Azacitidine Azithromycin Fmt 4703 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. C Candesartan Cilexetil; Hydrochlorothiazide Carbidopa; Entacapone; Levodopa Clopidogrel Bisulfate N Nabilone Naltrexone HCl Naproxen Sodium (multiple RLDs) Frm 00060 O Olanzapine Olopatadine HCl Omeprazole; Sodium Bicarbonate A Alprazolam M Mebendazole Melphalan Metformin HCl Methadone HCl Midodrine HCl Minocycline HCl Montelukast Montelukast Sodium Moxifloxacin HCl PO 00000 27147 Sfmt 4703 F Fexofenadine HCl (multiple dosage forms) Fosinopril Sodium; Hydrochlorothiazide E:\FR\FM\08JNN1.SGM 08JNN1 27148 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices H Hydrochlorothiazide; Valsartan DEPARTMENT OF HEALTH AND HUMAN SERVICES M Minoxidil Montelukast Sodium Morphine Sulfate 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 S Sirolimus Z Zolmitriptan For a complete history of previously published Federal Register notices, please go to https://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 cprice-sewell on PRODPC61 with NOTICES Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https:// 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 VerDate Nov<24>2008 15:15 Jun 05, 2009 Jkt 217001 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 https:// 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 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 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 https://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 E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 74, Number 108 (Monday, June 8, 2009)]
[Notices]
[Pages 27146-27148]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13272]


-----------------------------------------------------------------------

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 
product-specific 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 self-addressed 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 https://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 product-specific BE 
recommendations available to the public on FDA's Web site at https://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 product-specific BE recommendations and provide a 
meaningful opportunity for

[[Page 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 product-specific 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


[[Page 27148]]


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 https://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 https://www.fda.gov/cder/guidance/index.htm or https://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
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