Federal Register / Vol. 75, No. 238 / Monday, December 13, 2010 / Notices 77647 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

80.22 .................................................................................... 32 185 5,920 0.05 296 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,302 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section Number of 

recordkeepers 

Annual 

frequency of 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

80.39 .................................................................................... 32 185 5,920 0.25 1,480 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,480 

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

FDA bases its estimate on its review 

of the certification requests received 

over the past 3 fiscal years (FY). The 

annual burden estimate for this 

information collection is 2,782 hours. 

The estimated reporting burden for this 

information collection is 1,302 hours 

and the estimated recordkeeping burden 

for this information collection is 1,480 

hours. From FY 2008 to FY 2010, FDA 

processed an average of 5,932 responses 

(requests for certification of batches of 

color additives) per year. There were 32 

different respondents, corresponding to 

an average of approximately 185 

responses from each respondent per 

year. Using information from industry 

personnel, FDA estimates that an 

average of 0.22 hour per response is 

required for reporting (preparing 

certification requests and accompanying 

samples) and an average of 0.25 hour 

per response is required for 

recordkeeping. 

FDA’s Web-based color certification 

information system allows certifiers to 

request color certification online, follow 

their submissions through the process, 

and obtain information on account 

status. The system sends back the 

certification results electronically, 

allowing certifiers to sell their certified 

color before receiving hard copy 

certificates. Any delays in the system 

result only from shipment of color 

additive samples to FDA’s Office of 

Cosmetics and Colors for analysis. FDA 

has estimated a reduction in the hour 

burden for reporting from use of the 

Web-based system. 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31195 Filed 12–10–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0389] 

Medical Device User Fee Program; 

Meetings on Reauthorization; Request 

for Notification of Patient and 

Consumer Advocacy Group Intention 

to Participate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for notification 

of participation. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

notice to request that patient and 

consumer advocacy groups notify FDA 

of their intent to participate in periodic 

consultation meetings on 

reauthorization of the Medical Device 

User Fee Amendments of 2007 

(MDUFA) (the Food and Drug 

Administration Amendments Act of 

2007). The statutory authority for 

MDUFA expires September 30, 2012. At 

that time, new legislation will be 

required for FDA to continue collecting 

user fees for the medical device 

program. The Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) requires 

that FDA consult with a range of 

stakeholders in developing 

recommendations for the next MDUFA 

program. The FD&C Act also requires 

that FDA hold continued discussions 

with representatives of patient and 

consumer advocacy groups at least 

monthly during FDA’s negotiations with 

the regulated industry. The purpose of 

this request for notification is to ensure 

continuity and progress in these 

discussions by establishing consistent 

patient and consumer advocacy group 

representation. 

DATES: Submit notification of intention 

to participate by January 6, 2011. The 

first patient and consumer advocacy 

group meeting will be held on January 

13, 2011, from 9 a.m. to 11 a.m. 

Meetings will continue at least monthly 

during reauthorization negotiations with 

the regulated industry. 

ADDRESSES: Submit notification of 

intention to participate in monthly 

patient and consumer advocacy group 

meetings by e-mail to 

MDUFAReauthorization@fda.hhs.gov. 

The first meeting will be held at the 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 31, rm. 

1503 B and C, Silver Spring, MD 20993– 

0002. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Garris, Food and Drug 

Administration, Center for Devices and 

Radiological Health 10903 New 

Hampshire Ave., Bldg. 66, rm. 4610, 

Silver Spring, MD 20993–0002, 301– 

796–5861, FAX: 301–847–8149. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

The authority for MDUFA (Pub. L. 

110–85) expires September 30, 2012. 

Without new legislation to reauthorize 

the program, FDA will no longer be able 

to collect user fees to fund the medical 

device program. Section 738A(b)(1) (21 

U.S.C. 379j–1(b)(1)) of the FD&C Act 

requires that FDA consult with a range 

of groups in developing 

recommendations for the next MDUFA 

program, including scientific and 

academic experts, health care 

professionals, and representatives from 

patient and consumer advocacy groups. 

FDA initiated this process of 

consultation on September 14, 2010, by 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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