Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Notices 17657 

registrations and listings for additional 

information is estimated to be 12,375 

hours, and the annual respondent 

recordkeeping burden is estimated to be 

45,000 hours. Therefore, the total 

burden hours for this collection are 

estimated to be 57,375. The estimates 

cited in tables 1 and 2 of this document 

are based primarily on fiscal year 2010 

data from current systems and on 

conversations with industry and trade 

association representatives. 

In the Federal Register of December 7, 

2010 (75 FR 76008), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

respondents 

Average 

burden per 

response 

(in hours) 

Total hours 

807.31(d)(2) ......................................................................... 2,250 1 2,250 0.5 1,125 

807.31(e) .............................................................................. 22,500 1 22,500 0.5 11,250 

Total .............................................................................. ........................ ........................ ........................ ........................ 12,375 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section No. of recordkeepers 

No. of records 

per recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total hours 

807.31(a) to (c) .................................................................... 22,500 4 90,000 0.5 45,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 45,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: March 24, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7389 Filed 3–29–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Medical Device Epidemiology Network 

2011: Second Annual Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Medical Device Epidemiology 

Network (MDEpiNet) 2011: Second 

Annual Public Workshop.’’ The purpose 

of the public workshop is to provide a 

public update on the development of 

MDEpiNet and to facilitate discussion 

among FDA and all stakeholders with 

expertise in epidemiology and health 

services research on issues related to the 

methodology for studying medical 

device performance. 

DATE AND TIME: The public workshop 

will be held on April 25, 2011 from 8 

a.m. to 5 p.m. Participants are 

encouraged to arrive early to ensure 

time for parking and security screening 

before the meeting. Registration will 

begin at 7 a.m. 

LOCATION: The public workshop will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Rm. 1503 (the Great Room), Silver 

Spring, MD 20993. 

CONTACTS: Mary Beth Ritchey, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993, 301–796–6638, e-mail: 

MaryElizabeth.Ritchey@fda.hhs.gov; or 

Ellen Pinnow, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–6066, e-mail: 

Ellen.Pinnow@fda.hhs.gov. 

Registration: Registration is available 

through April 15, 2011, at the following 

Web site: http://fda-ws.s-3.net/ 

EpiNetWSApr11/. There is no fee to 

attend the workshop, but attendees must 

register in advance. Registration will be 

on a first-come, first-served basis and 

we ask that one person per institution 

be selected to represent the entity at the 

workshop. Non-U.S. citizens are subject 

to additional security screening, and 

they should register as soon as possible. 

If you need special accommodations 

because of a disability, please contact 

Mary Beth Ritchey (see CONTACTS) at 

least 7 days before the public workshop. 

SUPPLEMENTARY INFORMATION: 

I. Why are we holding this public 

workshop? 

The purpose of the public workshop 

is to facilitate continuing discussion 

among FDA, the academic epidemiology 

and health services research 

community, and all stakeholders on 

issues related to the methodology of 

studies for medical device performance. 

We aim to describe and solicit feedback 

on the establishment of a network that 

works with FDA experts to determine 

the evidence gaps and questions, 

datasets and approaches for conducting 

robust analytic studies and improve our 

understanding of the performance of 

medical devices (including comparative 

effectiveness studies). We also aim to 

reach out to stakeholders to initiate 

development of scientific, methodology, 

and device-area priorities for MDEpiNet. 

II. Who is the target audience for this 

public workshop? Who should attend 

this public workshop? 

This workshop is open to all 

interested parties. The target audience is 

comprised of academic researchers with 

experience in epidemiology or health 

services research with an interest in 

medical device outcome and 

epidemiologic study methodology. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

17658 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Notices 

III. What are the topics we intend to 

address at the public workshop? 

We intend to discuss a large number 

of issues at the workshop, including, but 

not limited to the following: 

• Establishment of the MDEpiNet 

infrastructure, 

• Gaps and challenges in medical 

device outcomes and epidemiologic 

studies, 

• Opportunities for medical device 

epidemiologic research and 

partnerships between the Center for 

Devices and Radiological Health and 

academia. 

IV. Where can I find out more about 

this public workshop? 

Background information on the public 

workshop, registration information, the 

agenda, information about lodging, and 

other relevant information will be 

posted, as it becomes available, on the 

Internet at http://fda-ws.s-3.net/ 

EpiNetWSApr11/. 

Dated: March 25, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7434 Filed 3–29–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Forum for State and Territorial 

Chief Executives (National Forum) 

Program Cooperative Agreement 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of Non-competitive OneYear Extension With Funds for the 

National Forum for State and Territorial 

Chief Executives (National Forum) 

Program Cooperative Agreement. 

SUMMARY: HRSA will be providing a 

one-year extension with funds in the 

amount authorized in fiscal year (FY) 

2010 to support activities that focus on 

cross-cutting publicly-funded health 

program integration and health access 

issues identified by the State and 

Territory governors and their senior 

health policy advisors, including 

addressing the needs of uninsured, 

underinsured and special needs 

populations, oral health, border health 

and health information technology as 

well as HRSA’s overall strategic goals. 

SUPPLEMENTARY INFORMATION: 

Cooperative Agreement Recipient of 

Record: National Governors Association 

Center for Best Practices (NGA), 

Washington, DC. 

Original Period of Support: April 1, 

2008, to March 31, 2011. 

Amount of Supplement Award: 

$160,000. 

Authority: Sections 241 and 301 of the 

Public Health Service Act, as amended 

(42 U.S.C. 238J and 241 respectively). 

CFDA Number: 93.224. 

Justification for the Exception to 

Competition: The National Forum 

cooperative agreement provides a 

unique vehicle for HRSA to collaborate 

with the Nation’s governors on their 

shared priorities, and provides 

opportunities through which governors 

can build on lessons others states have 

learned in addressing similar health 

policy challenges. A 1-year extension 

with funds will allow the National 

Forum to facilitate ongoing 

communication on emerging strategies 

addressing common priorities, public 

health policy, and governance issues 

affecting States and Territories thereby 

allowing HRSA to reevaluate the focus 

and implementation of this Program 

prior to the FY 2012 competition for the 

next 3-year project period. Further 

funding beyond March 31, 2012, will be 

competitively awarded in FY 2012. 

FOR FURTHER INFORMATION CONTACT: 

Mark Pincus, Director, Office of Policy 

Analysis, HRSA, via e-mail: 

mpincus@hrsa.gov or via telephone: 

301–443–5911. 

Dated: March 23, 2011. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2011–7444 Filed 3–29–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney 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 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK Central 

Repositories Non-Renewable Sample Access 

(X01)-Hepatitis C. 

Date: April 26, 2011. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call) 

Contact Person: Najma Begum, PhD, 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 749, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8894, 

begumn@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 24, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–7500 Filed 3–29–11; 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 

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; ‘‘Mouse Resource’’. 

Date: April 20, 2011. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817, 

(Telephone Conference Call) 

Contact Person: Gregory P. Jarosik, PhD, 

Scientific Review Administrator, Scientific 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES