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

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Food and Drug Administration/Xavier 

University Global Medical Device 

Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

SUMMARY: 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: 

TABLE 1—REGISTRATION FEES 1

Attendee Fee by 

March 6th 

Fee by 

March 27th 

Industry ................. $995 ........ $1,295 

Small Business 

(<100 employees).

800 ........... 900 

Consultant ............. 500 ........... 600 

Academic .............. 200 ........... 250 

FDA/Government 

Employee.

Free ......... Free 

1The 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 http://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 http://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; 


srobinson on DSK4SPTVN1PROD with NOTICES