Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 76009 

unless the Secretary grants a request for 

waiver of the requirement, because the 

use of electronic means is not 

reasonable for the person requesting the 

waiver. The collections of information 

under sections 222, 223, and 224 of 

FDAAA have been approved under 

OMB control number 0910–0625. 

Registration by electronic means for 

device establishments replaced FDA 

Forms 2891 and 2891a, ‘‘Registration of 

Device Establishment,’’ and FDA Form 

2892, ‘‘Medical Device Listing,’’ with 

FDA Form 3673, ‘‘Device Registration 

and Listing Module.’’ The scope of this 

information collection addresses only 

the reporting and recordkeeping 

requirements by non-electronic means 

under § 807.31 (21 CFR 807.31). 

Under § 807.31(a) through (d), each 

owner or operator is required to 

maintain an historical file containing 

the labeling and advertisements in use 

on the date of initial listing, and in use 

after October 10, 1978, but not before 

the date of initial listing. The owner or 

operator must maintain in the historical 

file any labeling or advertisements in 

which a material change has been made 

anytime after initial listing, but may 

discard labeling and advertisements 

from the file 3 years after the date of the 

last shipment of a discontinued device 

by an owner or operator. Section 

807.31(e) requires that the owner or 

operator be prepared to submit to FDA 

copies of: (1) All device labeling, (2) all 

device labeling and representative 

advertising, or (3) only representative 

package inserts, depending upon 

whether the device is subject to the 

regulatory controls under sections 514 

and 515 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360d and 360e), or restrictions imposed 

by 21 CFR 801.109 or otherwise by 

section 520(e) of the FD&C Act. 

The information collected under these 

provisions is used by FDA to identify: 

(1) Firms subject to FDA’s regulations, 

(2) geographic distribution of firms in 

order to effectively allocate FDA’s field 

resources for inspections, and (3) the 

class of the device that determines the 

frequency of inspection. As a result, 

when complications occur with a 

particular device or component, all 

manufacturers of similar or related 

devices can easily be identified. 

The likely respondents to this 

information collection are domestic and 

foreign device establishments who must 

register and submit a device list to FDA, 

e.g., establishments engaged in the 

manufacture, preparation, propagation, 

compounding, assembly, or processing 

of medical devices intended for human 

use and commercial distribution. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual 

frequency of 

response 

Total annual 

responses 

Hours per 

response Total hours 

807.31(d)(2) ......................................................................... 2,250 1 2,250 .5 1,125 

807.31(e) .............................................................................. 22,500 1 22,500 .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 Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

807.31(a–c) .......................................................................... 22,500 4 90,000 0.50 45,000 

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

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

The annual respondent reporting 

burden for device establishment 

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. 

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30582 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–0088] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Electronic Products—General 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Electronic Products—General 

Requirements’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

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 the 

Federal Register of May 13, 2010 (75 FR 

26964), 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 


emcdonald on DSK2BSOYB1PROD with NOTICES
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