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Have Been Withdrawn 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withdrawn from sale for reasons of 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
10538 Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices 

• Recalls—Globally; 

• GHTF Document on CAPA— 

Workshop; 

• 510(k)—An Industry Perspective; 

• Interdependency of Postmarket 

Surveillance, Risk, and CAPA; 

• Promotional Practices—Global; 

• Office of Compliance Initiatives; 

• U.S. Senate HELP Committee 

Keynote Dinner; 

• Risk Management Across the 

Quality Systems—FDA Expectations 

and Implementation; 

• Global Regulatory Strategy; and 

• FDA Inspectional Approach—Panel 

With Current FDA Investigators. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The conference helps to achieve 

objectives set forth in section 406 of the 

Food and Drug Administration 

Modernization Act of 1997 (Pub. L. 105– 

115) (21 U.S.C. 393), which includes 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The conference also is consistent 

with the Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121) by providing outreach 

activities by Government Agencies to 

small businesses. 

Dated: February 15, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4036 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–0093] 

Training Program for Regulatory 

Project Managers; Information 

Available to Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA) Center for Drug 

Evaluation and Research (CDER) is 

announcing the continuation of the 

Regulatory Project Management Site 

Tours and Regulatory Interaction 

Program (the Site Tours Program). The 

purpose of this document is to invite 

pharmaceutical companies interested in 

participating in this program to contact 

CDER. 

DATES: Pharmaceutical companies may 

submit proposed agendas to the Agency 

by April 23, 2012. 

FOR FURTHER INFORMATION CONTACT: Dan 

Brum, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 4160, Silver Spring, 

MD 20993–0002, 301–796–0578, email: 

dan.brum@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

An important part of CDER’s 

commitment to make safe and effective 

drugs available to all Americans is 

optimizing the efficiency and quality of 

the drug review process. To support this 

primary goal, CDER has initiated 

various training and development 

programs to promote high performance 

in its regulatory project management 

staff. CDER seeks to significantly 

enhance review efficiency and review 

quality by providing the staff with a 

better understanding of the 

pharmaceutical industry and its 

operations. To this end, CDER is 

continuing its training program to give 

regulatory project managers the 

opportunity to tour pharmaceutical 

facilities. The goals are to provide the 

following: (1) Firsthand exposure to 

industry’s drug development processes 

and (2) a venue for sharing information 

about project management procedures 

(but not drug-specific information) with 

industry representatives. 

II. The Site Tours Program 

In this program, over a 2- to 3-day 

period, small groups (five or less) of 

regulatory project managers, including a 

senior level regulatory project manager, 

can observe operations of 

pharmaceutical manufacturing and/or 

packaging facilities, pathology/ 

toxicology laboratories, and regulatory 

affairs operations. Neither this tour nor 

any part of the program is intended as 

a mechanism to inspect, assess, judge, 

or perform a regulatory function, but is 

meant rather to improve mutual 

understanding and to provide an avenue 

for open dialogue. During the Site Tours 

Program, regulatory project managers 

will also participate in daily workshops 

with their industry counterparts, 

focusing on selective regulatory issues 

important to both CDER staff and 

industry. The primary objective of the 

daily workshops is to learn about the 

team approach to drug development, 

including drug discovery, preclinical 

evaluation, tracking mechanisms, and 

regulatory submission operations. The 

overall benefit to regulatory project 

managers will be exposure to project 

management, team techniques, and 

processes employed by the 

pharmaceutical industry. By 

participating in this program, the 

regulatory project manager will grow 

professionally by gaining a better 

understanding of industry processes and 

procedures. 

III. Site Selection 

All travel expenses associated with 

the site tours will be the responsibility 

of CDER; therefore, selection will be 

based on the availability of funds and 

resources for each fiscal year. Selection 

will also be based on firms having a 

favorable facility status as determined 

by FDA’s Office of Regulatory Affairs 

District Offices in the firms’ respective 

regions. Firms interested in offering a 

site tour or learning more about this 

training opportunity should respond by 

submitting a proposed agenda to Dan 

Brum (see DATES and FOR FURTHER

INFORMATION CONTACT). 

Dated: February 14, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4034 Filed 2–21–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Cardiothoracic Surgery Program. 

Date: March 12, 2012. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Chang Sook Kim, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7179, Bethesda, MD 20892–7924, 301–435– 

0287, carolko@mail.nih.gov. 


srobinson on DSK4SPTVN1PROD with NOTICES