Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 10536-10537 [2012-4035]

Download as PDF 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 https://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/CDER/GUIDANCE/ bioequivalence/default.htm or https:// 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. 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 srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:37 Feb 21, 2012 Jkt 226001 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 https://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: 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 https:// 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. 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 https://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 C PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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: 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 E:\FR\FM\22FEN1.SGM 22FEN1 Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices Dated: February 14, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing revised draft product-specific BE recommendations for drug products containing the following active ingredients: A DEPARTMENT OF HEALTH AND HUMAN SERVICES Alendronate Sodium Alendronate Sodium; Cholecalciferol Food and Drug Administration B [Docket No. FDA–2012–N–0001] Benzoyl Peroxide; Erythromycin (multiple RLDs) Food and Drug Administration/Xavier University Global Medical Device Conference M Milnacipran HCl Mupirocin Calcium AGENCY: N Niacin; Simvastatin ACTION: Food and Drug Administration, HHS. Notice of public conference. S IV. Drug Products for Which Draft Product-Specific BE Recommendations Have Been Withdrawn FDA is announcing the withdrawal of the product-specific BE recommendations for drug products containing the following ingredients: Acetaminophen; Propoxyphene Napsylate. FDA has requested that products containing propoxyphene be withdrawn from sale for reasons of safety or efficacy. The product-specific BE recommendations for Acetaminophen; Propoxyphene Napsylate that previously were published on the ‘‘Bioequivalence Recommendations for Specific Products’’ Web page have been deleted. V. Comments srobinson on DSK4SPTVN1PROD with NOTICES 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 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. VI. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. VerDate Mar<15>2010 The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ‘‘FDA/Xavier University Global Medical Device Conference.’’ This 3-day public conference includes presentations from key FDA officials and industry experts, and has two separate tracks of interest. The conference is intended for companies of all sizes and employees at all levels. Dates and Times: The public conference will be held on May 2, 2012, from 8:30 a.m. to 5 p.m.; May 3, 2012, from 8:30 a.m. to 5 p.m.; and May 4, 2012, from 8:30 a.m. to 1 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073 or 513–745–3396. Contact Persons: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513–679– 2700, ext. 2167, FAX: 513–679–2771, email: gina.brackett@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073, email: phillipsm4@ xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 3 days of the conference. Early registration ends March 6, 2012. Standard registration ends March 27, 2012. There will be onsite registration. The cost of registration is as follows: SUMMARY: Sevelamer HCl 16:37 Feb 21, 2012 Jkt 226001 TABLE 1—REGISTRATION FEES 1 Attendee Fee by March 6th Fee by March 27th Industry ................. Small Business (<100 employees). Consultant ............. Academic .............. FDA/Government Employee. $995 ........ 800 ........... $1,295 900 500 ........... 200 ........... Free ......... 600 250 Free [FR Doc. 2012–4035 Filed 2–21–12; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 10537 1 The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks. To register online for the public conference, please visit the ‘‘Registration’’ link on the conference Web site at https://www.XavierMedCon. com. FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register. To register by mail, please send your name, title, firm name, address, telephone and fax numbers, email, and payment information for the fee to Xavier University, Attention: Sue Bensman, 3800 Victory Pkwy., Cincinnati, OH 45207. An email will be sent confirming your registration. Attendees are responsible for their own accommodations. The conference headquarters hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West 5th St., Cincinnati, OH, 45202, 513–421–9100. Special conference block rates are available through April 11, 2012. To make reservations online, please visit the ‘‘Venue & Logistics’’ link at https://www.XavierMedCon.com. If you need special accommodations due to a disability, please contact Marla Phillips (see Contact Persons) at least 7 days in advance of the conference. SUPPLEMENTARY INFORMATION: The public conference helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect the public health. The conference will provide those engaged in FDA-regulated medical devices (for humans) with information on the following topics: • CDRH Medical Device Innovation Initiative Keynote Address; • 510(k)—Office of Device Evaluation Perspective; • The Purchasing Control Subsystem—Requirements and Implementation; • Draft 510(k) Guidance—Deciding When to Submit a 510(k) for a Change or Modification; • Challenges of Design Controls; • FDA 483s and Regulatory Action— Response Workshop; E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10536-10537]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4035]


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

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 
product-specific 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 self-addressed 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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/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, 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 
https://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

[[Page 10537]]

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

    FDA is announcing revised draft product-specific BE recommendations 
for drug products containing the following active ingredients:

A

Alendronate Sodium
Alendronate Sodium; Cholecalciferol

B

Benzoyl Peroxide; Erythromycin (multiple RLDs)

M

Milnacipran HCl
Mupirocin Calcium

N

Niacin; Simvastatin

S

Sevelamer HCl

IV. Drug Products for Which Draft Product-Specific BE Recommendations 
Have Been Withdrawn

    FDA is announcing the withdrawal of the product-specific BE 
recommendations for drug products containing the following ingredients: 
Acetaminophen; Propoxyphene Napsylate. FDA has requested that products 
containing propoxyphene be withdrawn from sale for reasons of safety or 
efficacy. The product-specific BE recommendations for Acetaminophen; 
Propoxyphene Napsylate that previously were published on the 
``Bioequivalence Recommendations for Specific Products'' Web page have 
been deleted.

V. 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 
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.

VI. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4035 Filed 2-21-12; 8:45 am]
BILLING CODE 4160-01-P
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