76010 Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 

OMB control number 0910–0025. The 

approval expires on October 31, 2013. A 

copy of the supporting statement for this 

information collection is available on 

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

public/do/PRAMain. 

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30555 Filed 12–6–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0316] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adverse Event 

Pilot Program for Medical Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 6, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0471. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Adverse Event Pilot Program for 

Medical Products—(OMB Control 

Number 0910–0471)—Extension 

Under section 519 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 360i), FDA is 

authorized to require: Manufacturers to 

report medical device-related deaths, 

serious injuries, and malfunctions; and 

user facilities to report device-related 

deaths directly to manufacturers and 

FDA, and to report serious injuries to 

the manufacturer. Section 213 of the 

FDA Modernization Act of 1997 

(FDAMA) amended section 519(b) of the 

FD&C Act relating to mandatory 

reporting by user facilities of deaths and 

serious injuries and serious illnesses 

associated with the use of medical 

devices. This amendment legislated the 

replacement of universal user facility 

reporting by a system that is limited to 

a ‘‘* * * subset of user facilities that 

constitutes a representative profile of 

user reports’’ for device-related deaths 

and serious injuries. This amendment is 

reflected in section 519(b)(5)(A) of the 

FD&C Act. The current universal 

reporting system remains in place 

during the pilot stages of the new 

program and until FDA implements the 

new national system by regulation. This 

legislation provides FDA with the 

opportunity to design and implement a 

national surveillance network, 

composed of well-trained clinical 

facilities, to provide high-quality data 

on medical devices in clinical use. This 

system is called the Medical Product 

Safety Network (MedSun). 

FDA is continuing to conduct a pilot 

of the MedSun system before the 

Agency issues regulation to change from 

universal mandatory reporting for 

medical device user facilities to 

reporting by a representative sample of 

facilities. This data collection has been 

ongoing since February 20, 2002, and 

this notice is for continuation of this 

data collection. 

FDA is seeking OMB clearance to 

continue to use electronic data 

collection to obtain the information on 

the 3500A Form related to medical 

devices and tissue products from the 

user facilities participating in MedSun, 

to obtain a demographic profile of the 

facilities, and to pilot additional 

questions, which will permit FDA to 

better understand the cause of reported 

adverse events. During the pilot 

program, participants will be asked to 

complete an annual outcome measures 

form, as a Customer/Partner Service 

Survey (approved under OMB control 

number 0910–0360) to aid FDA in 

evaluating the effectiveness of the 

program. Participation in this pilot is 

voluntary and currently includes 400 

facilities. The use of an interactive 

electronic data collection system is 

easier and more efficient for the 

participating user facilities to use than 

the alternative paper system. 

In addition to collecting data on the 

electronic adverse event report form, 

MedSun is proposing to collect 

additional information from 

participating sites about reported 

problems emerging from the MedSun 

hospitals. This data collection is also 

voluntary and will be collected on the 

same Web site as the report information. 

This will replace the Device-Safety 

Exchange (DS–X). The burden to 

respond to these questions will take the 

same time as that used for DS–X: 30 

minutes. 

The total burden hours for MedSun 

and emerging signal questions equals 

6,000 hours (4,500 for MedSun and 

1,500 for emerging signals). The burden 

estimate for the electronic reporting of 

adverse events is based on the number 

of facilities currently participating in 

MedSun (400). FDA estimates an 

average of 15 reports per site annually. 

This estimate is based on MedSun 

working to promote reporting in general 

from the sites, as well as promoting 

reporting from specific parts of the 

hospitals, such as the pediatric 

intensive care units, electrophysiology 

laboratories, and the hospital 

laboratories. The burden estimate for the 

emerging signal portion of MedSun is 

based on the assumption that not all 

sites will use this part of the software 

each time questions are asked because 

not all sites will use the device in 

question. 

In the Federal Register of July 9, 2010 

(75 FR 39535), 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: 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 76011 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Item Nunber of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

MedSun facilities participating in the electronic reporting of 

adverse events program .................................................. 400 15 6,000 0.75 4,500 

MedSun facilities’ electronic responses to Public Health 

Questions (PHQs) ............................................................ 400 10 4,000 0.5 2,000 

Total hours .................................................................... ........................ ........................ ........................ ........................ 6,500 

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

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30583 Filed 12–6–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0083] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Substances Prohibited From Use in 

Animal Food or Feed; Animal Proteins 

Prohibited in Ruminant Feed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Substances Prohibited From Use in 

Animal Food or Feed; Animal Proteins 

Prohibited in Ruminant Feed’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 18, 2010 (75 FR 

34744), the Agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0339. The 

approval expires on November 30, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30556 Filed 12–6–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0056] (formerly 

2004N–0234) 

Annual Guidance Agenda 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing its 

annual guidance document agenda. This 

list is being published under FDA’s 

good guidance practices (GGPs) 

regulations. It is intended to seek public 

comment on possible topics for future 

guidance document development or 

revisions of existing ones. 

DATES: Submit either electronic or 

written comments on this list and on 

any agency guidance document at any 

time. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: For 

general information regarding FDA’s 

GGP policy contact: Lisa Helmanis, 

Office of Policy, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO32, rm. 3216, Silver Spring, 

MD 20993–0002, 301–796–9135. 

For information regarding specific 

topics or guidances, please see contact 

persons or specific offices listed in the 

table in the SUPPLEMENTARY INFORMATION

section of this document. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

19, 2000 (65 FR 56468), FDA issued its 

final rule on GGPs (21 CFR 10.115). 

GGPs are intended to ensure 

involvement of the public in the 

development of guidance documents 

and to enhance understanding of the 

availability, nature, and legal effect of 

such guidance documents. 

As part of FDA’s effort to ensure 

meaningful interaction with the public 

regarding guidance documents, the 

Agency committed to publishing an 

annual guidance document agenda of 

possible guidance topics or documents 

for development or revision during the 

coming year. The Agency also 

committed to soliciting public input 

regarding these and additional ideas for 

new topics or revisions to existing 

guidance documents (65 FR 56468 at 

56477; 21 CFR 10.115(f)(5)). 

The Agency is neither bound by this 

list of possible topics nor required to 

issue every guidance document on this 

list or precluded from issuing guidance 

documents not on the list set forth in 

this document. 

The following list of guidance topics 

or documents represents possible new 

topics or revisions to existing guidance 

documents that the Agency is 

considering. The Agency solicits 

comments on the topics listed in this 

document and also seeks additional 

ideas from the public. 

The guidance documents are 

organized by the issuing Center or 

Office within FDA, and in some cases 

are further grouped within the issuing 

Center or Office by topic categories. 

II. Center for Biologics Evaluation and 

Research (CBER) 


emcdonald on DSK2BSOYB1PROD with NOTICES