77648 Federal Register / Vol. 75, No. 238 / Monday, December 13, 2010 / Notices 

holding a public meeting where 

stakeholders and other members of the 

public were given an opportunity to 

present their views on reauthorization 

(75 FR 49502, August 13, 2010). This 

meeting and written comments 

submitted to the docket have provided 

critical input as FDA prepares for 

reauthorization discussions. Section 

738A(b)(3) of the FD&C Act further 

requires that FDA meet with patient and 

consumer advocacy groups at least once 

every month during negotiations with 

the regulated industry to continue 

discussions of their views on the 

reauthorization, and their suggestions 

for changes to the MDUFA program. 

FDA is issuing this Federal Register 

notice to request that patient and 

consumer advocacy groups notify FDA 

of their intent to participate in periodic 

consultation meetings on 

reauthorization of MDUFA. FDA 

believes that consistent representation 

at these meetings will be important to 

ensuring progress in these discussions. 

If you wish to participate in this part of 

the reauthorization process, please 

designate one or more representatives 

from your organization who will 

commit to attending these meetings 

regularly and preparing for the 

discussions as needed. Patient and 

consumer advocacy groups who identify 

themselves through this notice will be 

included in all future patient and 

consumer advocacy group meetings 

while FDA negotiates with the regulated 

industry. If a representative of a patient 

and consumer advocacy group decides 

to participate in these monthly meetings 

at a later time, they may still participate 

in remaining monthly meetings by 

notifying FDA (see ADDRESSES). These 

meetings will satisfy the requirement in 

section 738A(b)(3) of the FD&C Act. 

II. Additional Information on MDUFA 

There are several sources of 

information on FDA’s Web site that may 

serve as useful resources for patient and 

consumer advocacy groups participating 

in the periodic consultation meetings: 

• Information on the September 2010 

public meeting on MDUFA 

Reauthorization, the Federal Register 

notice announcing the meeting, and the 

transcript of the meeting are available at 

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

NewsEvents/WorkshopsConferences/

ucm218250.htm. 

• FDA created a Webinar on the 

Medical Device User Fee program, 

medical device development, and FDA’s 

medical device review in MDUFA. 

These presentations are available at 

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

NewsEvents/WorkshopsConferences/

ucm218250.htm. 

• Key Federal Register documents, 

MDUFA-related guidances, legislation, 

performance reports, and financial 

reports and plans are posted at http:// 

www.fda.gov/MDUFA. 

• FDAAA-specific information is 

available at: http://www.fda.gov/

RegulatoryInformation/Legislation/

FederalFoodDrugandCosmeticAct

FDCAct/SignificantAmendmentstothe

FDCAct/FoodandDrugAdministration

AmendmentsActof2007/default.htm. 

III. Notification of Intent To Participate 

in Periodic Patient and Consumer 

Advocacy Group Consultation Meetings 

If you intend to participate in 

continued periodic patient and 

consumer advocacy group consultation 

meetings regarding MDUFA 

Reauthorization, please provide 

notification by e-mail to 

MDUFAReauthorization@fda.hhs.gov by 

January 6, 2011. Your e-mail should 

contain complete contact information, 

including name, title, affiliation, 

address, e-mail address, telephone 

number, and notice of any special 

accommodations required because of 

disability. 

Representatives of patient and 

consumer advocacy groups will receive 

confirmation and additional information 

about the first meeting once FDA 

receives their notification. 

Dated: December 8, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–31160 Filed 12–10–10; 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 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, call the 

HRSA Reports Clearance Officer on 

(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, 

including whether the information shall 

have practical utility; (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: Retention Survey of 

NHSC Clinicians and Alumni/NHSC 

Site Administrators— 

[NEW] The National Health Service 

Corps (NHSC) Loan Repayment and 

Scholarship Programs were established 

to assure an adequate supply of trained 

primary care health care professionals to 

provide services in the neediest Health 

Professional Shortage Areas (HPSAs) of 

the United States. Under these 

programs, the Department of Health and 

Human Services agrees to repay the 

educational loans of, or provide 

scholarships to, primary care health 

professionals. In return, the 

professionals agree to serve for a 

specified period of time in a Federally 

designated HPSA approved by the 

Secretary. The last survey conducted to 

analyze retention of NHSC clinicians is 

more than ten years old. There is a need 

to distribute a survey to reevaluate the 

personal/professional development of 

NHSC clinicians in an effort to retain 

the clinicians in service providing care 

for individuals residing in underserved 

areas. The survey will ask current and 

former NHSC clinicians questions 

regarding professional satisfaction, 

expectations of service in the NHSC, 

and their experiences at NHSC sites. 

The survey will also ask questions of 

NHSC site administrators about their 

locations and the attributes of current 

and former NHSC clinicians at these 

sites. 

The estimated response burden for the 

survey is as follows: 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 238 / Monday, December 13, 2010 / Notices 77649 

SURVEY

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Survey of Site Administrator ................................................ 2,000 1 2,000 .15 300 

Survey of NHSC Clinicians in Service ................................. 6,500 1 6,500 .13 845 

Survey of NHSC ..................................................................

Alumni (Recent) ................................................................... 3,000 1 3,000 .20 600 

Survey of NHSC ..................................................................

Alumni (Remote) .................................................................. 1,143 1 1,143 .15 171 

Total .............................................................................. 12,643 4 12,643 .63 1,916 

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: December 8, 2010. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–31238 Filed 12–10–10; 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: The Division of 

Independent Review Grant Reviewer 

Recruitment Form (OMB No. 0915– 

0295)—[Extension] 

HRSA’s Division of Independent 

Review (DIR) is responsible for carrying 

out the independent and objective 

review of all eligible applications 

submitted to HRSA. DIR ensures that 

the independent review process is 

efficient, effective, economical, and 

complies with statutes, regulations, and 

policies. The review of applications is 

performed by people knowledgeable in 

the field of endeavor for which support 

is requested and is advisory to 

individuals in HRSA responsible for 

making award decisions. 

To streamline the selection and 

assignment of grant reviewers to 

objective review committees, HRSA 

utilizes a Web-based data collection 

form to gather critical reviewer 

information. The Grant Reviewer Form 

standardizes pertinent categories of 

reviewer information, such as: areas of 

expertise; occupations; work settings; 

reviewer experience; and allows 

maximum use of drop-down menus to 

simplify the data collection process. The 

Web-based system also permits 

reviewers to update their information as 

needed. HRSA maintains a pool of 

approximately 5,000 individuals that 

have previously served on HRSA 

objective review committees. 

The estimated annual burden is as 

follows: 

Grant recruitment form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

Response 

Total burden 

hours 

New reviewer ....................................................................... 1,380 1 1,380 45 min. 1,035 

Updating reviewer information ............................................. 4,255 1 4,255 30 min. 1,850 

Total .............................................................................. 4,900 ........................ 4,900 ........................ 2,750 

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: December 8, 2010. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–31236 Filed 12–10–10; 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 Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1