Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices 48171 

proposed by FDA, and information on 

reference databases; an open public 

comment session; and an open 

discussion on selected topics raised by 

the presentations (see section III of this 

document.) During the discussions, the 

participants will not be asked to 

develop consensus opinions but rather 

to provide their individual perspectives. 

Additional information, including a 

meeting agenda, will be available on the 

Internet, immediately after publication 

of this document in the Federal 

Register. The evaluation approach 

proposed by FDA is expected to be 

available at a later date. This 

information will be placed on file in the 

public docket (docket number found in 

brackets in the heading of this 

document), which is available at 

http://www.regulations.gov. This 

information will also be available at 

http://www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm (select the appropriate 

meeting from the list). 

III. Topics for Input 

FDA will seek input on its proposed 

performance evaluation approach, 

which will include the following topics: 

1. Clinical Application of Highly 

Multiplexed Microbiology Devices: Their 

clinical application and public health/ 

clinical needs; inclusion of MCMrelated pathogens that are expected to 

be rarely present in the tested 

specimens; the composition of clinically 

relevant panels of pathogens; the 

interpretation of the test results taking 

into consideration the possible 

detection of microorganisms that are not 

clinically relevant, and what is known 

and unknown about co-infections. 

2. Device Evaluation: How to evaluate 

the analytical and clinical performance 

of highly multiplexed microbiology 

devices; approaches to device validation 

when positive specimens are not easily 

available, which is the case for many 

MCM pathogens; sufficiency, feasibility, 

and practicality of the proposed FDA 

evaluation approach to establish device 

performance. 

3. Reference Databases: Quality 

criteria for establishing the accuracy of 

reference databases; methods for 

curating, maintaining, and updating 

these databases; what is the current 

practice for creating and maintaining 

reference databases. 

IV. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. A transcript 

will also be available in either hardcopy 

or on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (ELEM–1029), 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg., rm. 1050, 

Rockville, MD 20857. 

Dated: August 2, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–19996 Filed 8–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency; (b) the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: National Health 

Service Corps Site Application (OMB 

No. 0915–0230)—Revision 

The National Health Service Corps 

(NHSC) of the Bureau of Clinician 

Recruitment and Service (BCRS), Health 

Resources and Services Administration, 

is committed to improving the health of 

the Nation’s underserved by uniting 

communities in need with caring health 

professionals, and by supporting their 

efforts to build better systems of care. 

The NHSC Site Application, which 

renames and revises the previous 

Recruitment and Retention Assistance 

Application, requests information on 

the clinical service site, sponsoring 

agency, recruitment contact, staffing 

levels, service users, charges for 

services, employment policies, and 

fiscal management capabilities. 

Assistance in completing the 

application may be obtained through the 

appropriate State Primary Care Offices, 

State Primary Care Associations and the 

NHSC. The information on the 

application is used for determining the 

eligibility of sites for assignment of 

NHSC-obligated health professionals 

and to verify the need for NHSC 

clinicians. Approval as an NHSC service 

site is good for 3 years; sites wishing to 

remain eligible for assignment of NHSC 

providers must submit a new Site 

Application every 3 years. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

NHSC Site Application ......................................................... 3000 1 3000 0.5 1500 

mstockstill on DSK4VPTVN1PROD with NOTICES

48172 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices 

E-mail comments to 

paperwork@hrsa.gov or mail to the 

HRSA Reports Clearance Officer, Room 

10–33, Parklawn Building, 5600 Fishers 

Lane, Rockville, MD 20857. Written 

comments should be received within 30 

days of this notice. 

Dated: August 2, 2011. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2011–20077 Filed 8–5–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the Agency; (b) the accuracy of the 

Agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: National Sample 

Survey of Nurse Practitioners (OMB No. 

0915–xxxx)–[NEW] 

The number of Nurse Practitioners 

(NP) in the United States has been 

growing rapidly over the past decade 

and continued growth is expected as the 

annual number of graduates of NP 

programs is at an all time high. 

Furthermore, over the past 20 years, 

many regulatory and financial barriers 

to using NPs have been removed. The 

expansion of health insurance under the 

Patient Protection and Affordable Care 

Act of 2010 (Pub. L. 111–148) will also 

increase the demand for services. With 

increasing numbers, NPs are poised to 

play a critical role in the nation’s efforts 

to expand access to health care services. 

Despite the increasing number and 

role of NPs, unfortunately, there is 

currently only limited, inconsistent data 

available to policy makers and the 

health care community. Accordingly, it 

is difficult for these leaders to quantify 

or fully understand the role of NPs in 

the current or future health care system. 

In fact, it is difficult to project with 

confidence the number of NPs 

practicing in the United States today. 

The primary purpose of the Bureau of 

Health Professions’ National Sample 

Survey of Nurse Practitioners data 

collection is to: (1) Improve estimates of 

NPs providing services; (2) describe the 

settings where NPs are working; (3) 

identify the positions/roles in which 

NPs are working; (4) describe the 

activities and services NPs are providing 

in the healthcare workforce; (5) 

determine the specialties in which NPs 

are working; (6) explore NPs’ 

satisfaction with and perception of the 

extent to which they are working to 

their full scope of practice; and (7) 

assess variations in practice settings, 

positions, and practice patterns by 

demographic and educational 

characteristics. 

The statutory provision that 

authorizes this data collection is section 

761 of the Public Health Service Act, 

‘‘Health Professions Workforce 

Information and Analysis,’’ which is 

codified at 42 U.S.C. 294n. The 

information obtained from this survey 

will ultimately lead to more accurate 

and complete national estimates of the 

current NP supply, as well as assist in 

the development of more accurate 

supply and demand projections for NPs. 

This, in turn, is likely to influence 

decisions regarding both the educational 

capacity and the number of NP 

programs at the national level. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

National Sample Survey of Nurse Practitioners .................. 10,000 1 10,000 .33 3,300 

Total .............................................................................. 10,000 ........................ 10,000 ........................ 3,300 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: August 2, 2011. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2011–20000 Filed 8–5–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Use of PKM2 Activators for 

the Treatment of Cancer 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

404.7(a)(1)(i), that the National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of an exclusive 

patent license to practice the inventions 

embodied in U.S. Provisional Patent 

Application No. 61/104,091, entitled 

‘‘Activators of Human Pyruvate Kinase,’’ 

filed October 9, 2008, now abandoned 

[HHS Ref. No. E–326–2008/0–US–01]; 

PCT/US2009/60237 Application 

entitled ‘‘Small Molecule Activators of 

Pyruvate Kinase,’’ filed October 9, 2009, 

now abandoned [HHS Ref. No. E–326– 

2008/0–PCT–02]; EP Application No. 

09740795.1, entitled ‘‘Small Molecule 

Activators of Pyruvate Kinase,’’ filed 

October 9, 2009 [HHS Ref. No. E–326– 

2008/0–EP–05]; U.S. Non-Provisional 

Application No. 13/123,297, entitled 

mstockstill on DSK4VPTVN1PROD with NOTICES