Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 52669 

Date and Time: The meeting will be 

held on September 20, 2011, from 1 

p.m. to approximately 4 p.m. 

Location: National Institutes of Health 

(NIH), 9000 Rockville Pike, Building 

29B, Conference Room C, Bethesda, MD 

20892. The public is welcome to attend 

the meeting at the specified location 

where a speakerphone will be provided. 

Public participation in the meeting is 

limited to the use of the speakerphone 

in the conference room. Important 

information about transportation and 

directions to the NIH campus, parking, 

and security procedures is available on 

the Internet at http://www.nih.gov/ 

about/visitor/index.htm. (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) Visitors must show two forms 

of identification, one of which must be 

a government-issued photo 

identification such as a Federal 

employee badge, driver’s license, 

passport, green card, etc. Detailed 

information about security procedures is 

located at http://www.nih.gov/about/ 

visitorsecurity.htm. Due to the limited 

available parking visitors are 

encouraged to use public transportation. 

Agenda: On September 20, 2011, the 

committee will meet in open session to 

hear updates of the research programs in 

the Laboratory of Enteric and Sexually 

Transmitted Diseases, Division of 

Bacterial, Parasitic, and Allergenic 

Products, Office of Vaccines Research 

and Review, Center for Biologics 

Evaluation and Research, FDA. 

Procedure: On September 20, 2011, 

from 1 p.m. to approximately 3:30 p.m., 

the meeting is open to the public. 

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 

September 13, 2011. Oral presentations 

from the public will be scheduled 

between approximately 2:30 p.m. and 

3:30 p.m. Those individuals interested 

in making 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 9, 2011. 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 

September 10, 2011. 

Closed Committee Deliberations: On 

September 20, 2011, from 

approximately 3:30 p.m. to 

approximately 4 p.m., the meeting will 

be closed to permit discussion where 

disclosure would constitute a clearly 

unwarranted invasion of personal 

privacy (5 U.S.C. 552b(c)(6)). The 

committee will discuss the report of the 

intramural research programs and make 

recommendations regarding personnel 

staffing decisions. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: August 18, 2011. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2011–21535 Filed 8–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0332] 

Report on the Performance of Drug 

and Biologics Firms in Conducting 

Postmarketing Requirements and 

Commitments; Availability; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; 

correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice of availability that appeared in 

the Federal Register of August 4, 2011 

(76 FR 47211). The Agency is required 

to report annually in the Federal 

Register on the status of postmarketing 

requirements and commitments 

required of, or agreed upon by, holders 

of approved drug and biological 

products. The August 4, 2011, notice is 

the Agency’s report on the status of the 

studies and clinical trials that 

applicants have agreed to, or are 

required to, conduct. The document was 

published with an error. This document 

corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Joyce A. Strong, Office of Policy and 

Planning, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 3208, Silver Spring, 

MD 20993–0002, 301–796–9148. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2011–19806, appearing on page 47211 

in the Federal Register of August 4, 

2011, the following correction is made: 

On page 47214, table 1 is corrected to 

read as follows: 

TABLE 1—SUMMARY OF POSTMARKETING REQUIREMENTS AND COMMITMENTS

[Numbers as of September 30, 2010] 

NDA/ANDA (% of Total PMR or 

% of total PMC) 

BLA (% of Total PMR or % of 

total PMC) 1

Number of open PMRs ............................................................................. 526 149. 

On-schedule open PMRs (see table 2 of this document) ................. 477 (91%) 131 (88%). 

Off-schedule open PMRs (see table 3 of this document) ................. 49 (9%) 18 (12%). 

Number of open PMCs 2 ........................................................................... 473 307. 

On-schedule open PMCs (see table 4 of this document) ................. 399 (84%) 236 (77%). 

Off-schedule open PMCs (see table 5 of this document) ................. 74 (16%) 71 (23%). 

1On October 1, 2003, FDA completed a consolidation of certain therapeutic products formerly regulated by CBER into CDER. Consequently, 

CDER now reviews many BLAs. Fiscal year statistics for postmarketing requirements and commitments for BLAs reviewed by CDER are included in BLA totals in this table. 2The number of PMCs reported as open as of September 30, 2009, in the ‘‘Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments’’ notice published in the Federal Register on November 9, 2010 (75 FR 68802), inadvertently also included open PMRs. That error has been corrected for the current reporting period. 

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52670 Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 

Dated: August 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21487 Filed 8–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

2011 Technology Transfer Summit 

North America Conference 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice of Conference. 

SUMMARY: The NIH Office of Technology 

Transfer extends invitations to attend 

the 2011 Technology Transfer Summit 

North America Conference. 

DATES: October 3–4, 2011. 

ADDRESSES: NIH campus, 9000 

Rockville Pike, Bethesda MD, NIH 

Clinical Center (Building 10), Masur 

Auditorium. 

SUPPLEMENTARY INFORMATION: The NIH 

campus in Bethesda, MD will be the site 

for the 2011 Tech Transfer Summit 

North America (TTSNA), the leading 

early-stage biotech partnering, licensing, 

venture and innovation platform, cohosted and co-sponsored by the NIH 

Office of Technology Transfer, TTS Ltd. 

and regional host partners such as BIO 

Maryland. 

TTSNA is one of a series of summits 

held within the Global Tech Transfer 

Initiative and is designed specifically to 

put innovators, early-stage SMEs and 

technology managers from leading 

universities and research institutes 

together with biotech & pharma 

licensing & business development 

executives, VCs, serial entrepreneurs, 

and leading IP specialists for interactive 

sessions relating to partnering, licensing 

& business development. 

Conference speakers for the 2011 

include: 

—Kathy Hudson, Deputy Director, 

National Institutes of Health (NIH) 

—James C. Greenwood, President & 

CEO, BIO 

—Shiv Krishnan, Director, Scouting & 

Partnering, Sanofi, USA 

—Sanjeev Munshi, Director, Licensing 

and External Research, Merck & Co 

—David Kaslow, Head of Vaccines 

Project & Pipeline Leadership, Merck 

& Co 

—Ed Mascioli, Head of Orphan & 

Genetic Diseases Research Unit, Pfizer 

—Arthur Tzianabos, Vice President of 

Research, HGT Division, Shire 

—Steve Groft, Director, Office of Rare 

Diseases Research, NIH 

—Phil Ross, Managing Director, 

Healthcare, JPMorgan 

—Maarten deJong, Managing Director, 

Barclays Capital 

—Andrew Robertson, Chief Policy 

Officer, BIO Ventures for Global 

Health 

—Orin Herskowitz, Executive Director & 

Vice President, Intellectual Property 

Technology Transfer, Columbia 

Technology Ventures 

—Erik Lium, Assistant Vice Chancellor 

of Research, UCSF 

—Brian Kelly, Director, Technology, 

Enterprise & Commercialisation, Weill 

Cornell Medical College 

—Daniel Perez, Partner, Bay City Capital 

—Hubert Birner, Partner, TVM Capital 

—Glen Steinbach, COO, Johns Hopkins 

Technology Transfer 

—Markus Goebel, Managing Director, 

Novartis Venture Fund 

The Summit will strive to induce 

interactive debate, deliberation and 

discussion, networking and business 

over the 2-day period with the leaders 

in the sector. The Summit conference 

will be further enhanced by the TTS 

Initiative Business Social Network, an 

online business-networking platform 

powered by JuJaMa. The Network is a 

communication tool for business that 

will allow the posting of profiles and 

technology offers; the searching of other 

participants by category, by technology 

or licensing offer; and the setting up of 

meetings prior to, during and after the 

Summit. Total participation numbers for 

this conference will be strictly limited 

to ensure the ideal environment for real 

discussion and business. 

FOR FURTHER INFORMATION CONTACT: 

More details about the conference 

including registration information and 

the conference agenda can be found by 

contacting Tech Transfer Summit North 

America (http:// 

www.techtransfersummit.com/ 

northamerica2011). Attendees may also 

enter the Partner Code ‘‘NIH11’’ to 

register with a 10% reduction. For 

information about sign language 

interpretation or accommodation for 

disabilities, please contact Sharon 

Fields at telephone 301–594–7700 or 

fieldssh@od.nih.gov. 

Dated: August 16, 2011. 

Steven M. Ferguson, 

Deputy Director, Licensing & 

Entrepreneurship, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2011–21514 Filed 8–22–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases Notice of Closed 

Meeting 

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 meeting. 

The meeting 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 Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Targeting Resistance in 

Select Gram-Negative Pathogens. 

Date: September 22–23, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Silver Spring, 8727 Colesville 

Road, Chesapeake Room, Silver Spring, MD 

20910. 

Contact Person: Nancy Lewis Ernst, PhD, 

Scientific Review Official, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–451–7383, 

nancy.ernst@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: August 17, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–21512 Filed 8–22–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

mstockstill on DSK4VPTVN1PROD with NOTICES