Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations, 51829-51830 [E8-20580]

Download as PDF Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices accepted by FDA only through FDMS at https://www.regulations.gov. Dated: August 22, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–20564 Filed 9–4–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0038] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on October 23, 2008, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel telephone number is 301–589– 5200. Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827– 7001, FAX: 301–827–6776, e-mail: Diem.Ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572) in the Washington, DC area), code 3014512543. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. VerDate Aug<31>2005 18:40 Sep 04, 2008 Jkt 214001 Agenda: The Committee will discuss the clinical development of radionuclide imaging products for the detection of amyloid to assist in the diagnosis of Alzheimer’s Disease. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 8, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 30, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 1, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Diem-Kieu Ngo at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 51829 Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 27, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–20577 Filed 9–4–08; 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–0168) Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations 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 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ‘‘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. DATES: Submit written or electronic comments on the draft product-specific BE recommendations listed in this notice by December 4, 2008. 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 https:// www.regulations.gov. See the E:\FR\FM\05SEN1.SGM 05SEN1 51830 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. 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, ‘‘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. Since that notice was published we have published a correction notice concerning Bioequivalence Recommendations for Specific Products on October 25, 2007 (72 FR 60683). This notice includes draft product-specific recommendations either newly posted or updated since the Federal Register notice dated October 25, 2007, through April 30, 2008. mstockstill on PROD1PC66 with NOTICES II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available The following draft BE productspecific recommendations have been newly posted since the FR notice dated October 25, 2007: (1) Abacavir Sulfate; Lamivudine (2) Alendronate Sodium (3) Alfuzosin HCl (4) Alprazolam (5) Amoxicillin; Clavulanate Potassium (multiple RLDs) (6) Amprenavir (7) Aripiprazole (8) Armodafinil (9) Atovaquone (10) Azithromycin (11) Balsalazide Disodium (12) Bupropion HCl (updated) (13) Carbamazepine (multiple dosage forms) (14) Cefdinir (15) Cefixime (16) Cetirizine HCl; Pseudoephedrine HCl (17) Ciprofloxacin; Ciprofloxacin HCl VerDate Aug<31>2005 18:40 Sep 04, 2008 Jkt 214001 (18) Ciprofloxacin HCl (19) Clarithromycin (20) Darunavir Ethanolate (21) Delavirdine Mesylate (22) Dexmethylphenidate (23) Diltiazem HCl (multiple dosage forms; multiple RLDs) (24) Divalproex Sodium (25) Doxycycline (multiple dosage forms) (26) Eprosartan Mesylate; Hydrochlorothiazide (27) Esterified Estrogens (28) Eszopiclone (29) Ethambutol HCl (30) Ethinyl Estradiol; Levonorgestrel (multiple RLDs) (31) Fenofibrate (32) Fluvastatin Sodium (multiple dosage forms) (33) Fosamprenavir Calcium (34) Glimepiride; Rosiglitazone Maleate (35) Lamivudine (36) Linezolid (37) Lisinopril (38) Lopinavir; Ritonavir (39) Memantine HCl (40) Mesalamine (41) Metoprolol Succinate (updated) (42) Minocycline HCl (43) Nelfinavir Mesylate (44) Nevirapine (45) Omeprazole; Sodium Bicarbonate; Magnesium Hydroxide (46) Oxymorphone HCl (multiple dosage forms) (47) Paliperidone (48) Paricalcitol (49) Phenytoin (50) Pimozide (51) Posaconazole (52) Quinine Sulfate (53) Saquinavir Mesylate (multiple dosage forms) (54) Solifenacin Succinate (55) Tenofovir Disoproxil Fumarate (56) Tinidazole (57) Tipranavir (58) Tolterodine Tartrate (59) Tramadol HCl (60) Trospium Chloride (61) Varenicline Tartrate (62) Zafirlukast (63) Zalcitabine (64) Zileuton (65) Zolmitriptan (66) Zonisamide III. Drug Products for Which Updated Draft Product-Specific BE Recommendations Are Available The following five product-specific recommendations previously made available on FDA’s Web site have been updated: 1. Risedronate Sodium 2. Fosinopril Sodium; Hydrochlorothiazide PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 3. Fluoxetine HCl; Olanzapine 4. Erlotinib HCl 5. Morphine Sulfate For a complete history of previous Federal Register notices pertaining to product-specific BE recommendations, please go to https://www.regulations.gov and enter FDA–2007–D–0369. 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. Two copies of mailed comments are to be submitted, except that individuals may submit one 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 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 https://www.regulations.gov. 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: August 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–20580 Filed 9–4–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0450] Science Board to the Food and Drug Administration; Request for Nominations SUBJECT≤ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations to serve on the Science Board to the FDA (Science Board). E:\FR\FM\05SEN1.SGM 05SEN1

Agencies

[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Notices]
[Pages 51829-51830]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369] (formerly Docket No. 2007D-0168)


Publication of Guidances for Industry Describing Product-Specific 
Bioequivalence Recommendations

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 (72 FR 30388), FDA announced the availability of a draft 
guidance for industry, ``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.

DATES: Submit written or electronic comments on the draft product-
specific BE recommendations listed in this notice by December 4, 2008.

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

[[Page 51830]]

SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

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, 
``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 the public to consider and comment on those 
recommendations. Since that notice was published we have published a 
correction notice concerning Bioequivalence Recommendations for 
Specific Products on October 25, 2007 (72 FR 60683). This notice 
includes draft product-specific recommendations either newly posted or 
updated since the Federal Register notice dated October 25, 2007, 
through April 30, 2008.

II. Drug Products for Which New Draft Product-Specific BE 
Recommendations Are Available

    The following draft BE product-specific recommendations have been 
newly posted since the FR notice dated October 25, 2007:
    (1) Abacavir Sulfate; Lamivudine
    (2) Alendronate Sodium
    (3) Alfuzosin HCl
    (4) Alprazolam
    (5) Amoxicillin; Clavulanate Potassium (multiple RLDs)
    (6) Amprenavir
    (7) Aripiprazole
    (8) Armodafinil
    (9) Atovaquone
    (10) Azithromycin
    (11) Balsalazide Disodium
    (12) Bupropion HCl (updated)
    (13) Carbamazepine (multiple dosage forms)
    (14) Cefdinir
    (15) Cefixime
    (16) Cetirizine HCl; Pseudoephedrine HCl
    (17) Ciprofloxacin; Ciprofloxacin HCl
    (18) Ciprofloxacin HCl
    (19) Clarithromycin
    (20) Darunavir Ethanolate
    (21) Delavirdine Mesylate
    (22) Dexmethylphenidate
    (23) Diltiazem HCl (multiple dosage forms; multiple RLDs)
    (24) Divalproex Sodium
    (25) Doxycycline (multiple dosage forms)
    (26) Eprosartan Mesylate; Hydrochlorothiazide
    (27) Esterified Estrogens
    (28) Eszopiclone
    (29) Ethambutol HCl
    (30) Ethinyl Estradiol; Levonorgestrel (multiple RLDs)
    (31) Fenofibrate
    (32) Fluvastatin Sodium (multiple dosage forms)
    (33) Fosamprenavir Calcium
    (34) Glimepiride; Rosiglitazone Maleate
    (35) Lamivudine
    (36) Linezolid
    (37) Lisinopril
    (38) Lopinavir; Ritonavir
    (39) Memantine HCl
    (40) Mesalamine
    (41) Metoprolol Succinate (updated)
    (42) Minocycline HCl
    (43) Nelfinavir Mesylate
    (44) Nevirapine
    (45) Omeprazole; Sodium Bicarbonate; Magnesium Hydroxide
    (46) Oxymorphone HCl (multiple dosage forms)
    (47) Paliperidone
    (48) Paricalcitol
    (49) Phenytoin
    (50) Pimozide
    (51) Posaconazole
    (52) Quinine Sulfate
    (53) Saquinavir Mesylate (multiple dosage forms)
    (54) Solifenacin Succinate
    (55) Tenofovir Disoproxil Fumarate
    (56) Tinidazole
    (57) Tipranavir
    (58) Tolterodine Tartrate
    (59) Tramadol HCl
    (60) Trospium Chloride
    (61) Varenicline Tartrate
    (62) Zafirlukast
    (63) Zalcitabine
    (64) Zileuton
    (65) Zolmitriptan
    (66) Zonisamide

III. Drug Products for Which Updated Draft Product-Specific BE 
Recommendations Are Available

    The following five product-specific recommendations previously made 
available on FDA's Web site have been updated:
    1. Risedronate Sodium
    2. Fosinopril Sodium; Hydrochlorothiazide
    3. Fluoxetine HCl; Olanzapine
    4. Erlotinib HCl
    5. Morphine Sulfate
For a complete history of previous Federal Register notices pertaining 
to product-specific BE recommendations, please go to https://
www.regulations.gov and enter FDA-2007-D-0369.

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. Two copies of mailed 
comments are to be submitted, except that individuals may submit one 
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 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 https://www.regulations.gov.

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: August 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20580 Filed 9-4-08; 8:45 am]
BILLING CODE 4160-01-S
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