Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices 23413 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

ORR–9 Annual Survey of Refugees ............................................................................... 2,000 1 0.63 1,253.20 

Request for Participation Letter ....................................................................................... 2,000 1 0.04 80 

Estimated Total Annual Burden 

Hours: 1,333.20 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7245, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: May 14, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–11606 Filed 5–18–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0075] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Reporting: Manufacturer, Importer, 

User Facility, and Distributor Reporting 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by June 18, 

2009. 

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: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0437. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Medical Device Reporting: 

Manufacturer, Importer, User Facility, 

and Distributor Reporting—21 CFR Part 

803 (OMB Control Number 0910– 

0437)—Extension 

Section 519(a)(1) of Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360i(a)(1)) requires every 

manufacturer or importer to report 

‘‘whenever the manufacturer or 

importer receives or otherwise becomes 

aware of information that reasonably 

suggests that one of its marketed 

devices: (A) May have caused or 

contributed to a death or serious injury, 

or (B) has malfunctioned and that such 

device or a similar device marketed by 

the manufacturer or importer would be 

likely to cause or contribute to a death 

or serious injury if the malfunction were 

to recur * * *.’’ 

Section 519(b)(1)(A) of the act 

requires ‘‘whenever a device user 

facility receives or otherwise becomes 

aware of information that reasonably 

suggests that a device has or may have 

caused or contributed to the death of a 

patient of the facility, the facility shall, 

as soon as practicable but not later than 

10 working days after becoming aware 

of the information, report the 

information to the Secretary and, if the 

identity of the manufacturer is known, 

to the manufacturer of the device.’’ 

Section 519(b)(1)(B) of the act requires 

‘‘whenever a device user facility 

receives or otherwise becomes aware of: 

(i) information that reasonably suggests 

that a device has or may have caused or 

contributed to the serious illness of, or 

serious injury to, a patient of the facility 

* * *, shall, as soon as practicable but 

not later than 10 working days after 

becoming aware of the information, 

report the information to the 

manufacturer of the device or to the 

Secretary if the identity of the 

manufacturer is not known.’’ 

Complete, accurate, and timely 

adverse event information is necessary 

for the identification of emerging device 

problems. Information from these 

reports will be used to evaluate risks 

associated with medical devices which 

will enable FDA to take appropriate 

regulatory measures in protection of the 

public health under section 519 of the 

act. Thus FDA is requesting approval for 

these information collection 

requirements which are being 

implemented under part 803 (21 CFR 

part 803). 

Respondents to this collection of 

information are businesses or other for 

profit and nonprofit organizations 

including user facilities, manufacturers, 

and importers of medical devices. 

In the Federal Register of February 

25, 2009 (74 FR 8547), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. FDA received one nonrelated PRA comment that did not 

require a response. 

FDA estimates the burden of this 

collection of information as follows: 

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23414 Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR 

Section FDA Form No. No. of Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

803.19 57 4 228 3.0 684 

803.30 and 

803.32 393 2 777 1.0 777 

803.33 3,419 393 1 393 1 393 

803.40 and 

803.42 73 37 2,682 1.0 2,682 

803.50 and 

803.52 1,601 104 166,271 1.0 166,271 

803.56 1,200 63 76,186 1.0 76,186 

Total 246,537 246,993 

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 No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

803.17 220 1 220 10 2,200 

803.18(a) through (d) 30,000 1 30,000 1.5 45,000 

Total 47,200 

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

Part 803 requires user facilities to 

report to the device manufacturer and to 

FDA in case of a death, incidents where 

a medical device caused or contributed 

to a death or serious injury. 

Additionally, user facilities are required 

to annually submit the number and 

summary of adverse events reported 

during the calendar year, using FDA 

Form 3419. Manufacturers of medical 

devices are required to report to FDA 

when they become aware of information 

indicating that one of their devices may 

have caused or contributed to death or 

serious injury or has malfunctioned in 

such a way that should the malfunction 

recur it would be likely to cause or 

contribute to a death or serious injury. 

Device importers report deaths and 

serious injuries to the manufacturers 

and FDA. Importers report malfunctions 

only to the manufacturers, unless they 

are unknown, then the reports are sent 

to FDA. 

The number of respondents for each 

Code of Federal Regulations (CFR) 

section in table 1 of this document is 

based upon the number of respondents 

entered into FDA’s internal databases. 

FDA estimates, based on its experience 

and interaction with the medical device 

community, that all reporting CFR 

sections are expected to take 1 hour to 

complete, with the exception of 

§ 803.19. Section 803.19 is expected to 

take approximately 3 hours to complete, 

but is only required for reporting the 

summarized data quarterly to FDA. By 

summarizing events, the total time used 

to report for this section is reduced 

because the respondents do not submit 

a full report for each event they report 

in a quarterly summary report. 

The agency believes that the majority 

of manufacturers, user facilities, and 

importers have already established 

written procedures to document 

complaints and information to meet the 

medical device reporting (MDR) 

requirements as part of their internal 

quality control system. There are an 

estimated 30,000 medical device 

distributors. Although they do not 

submit MDR reports, they must 

maintain records of complaints, under 

§ 803.18(d). 

The agency has estimated that on 

average 220 user facilities, importers, 

and manufacturers would annually be 

required to establish new procedures, or 

revise existing procedures, in order to 

comply with this provision. 

Therefore, FDA estimates the onetime burden to respondents for 

establishing or revising procedures 

under § 803.17 to be 2,200 hours (220 

respondents x 10 hours). For those 

entities, a one-time burden of 10 hours 

is estimated for establishing written 

MDR procedures. The remaining 

manufacturers, user facilities, and 

importers, not required to revise their 

written procedures to comply with this 

provision, are excluded from the burden 

because the recordkeeping activities 

needed to comply with this provision 

are considered ‘‘usual and customary’’ 

under 5 CFR 1320.3(b)(2). 

Under § 803.18, 30,000 respondents 

represent distributors, importers, and 

other respondents to this information 

collection. FDA estimates that it should 

take them approximately 1.5 hours to 

complete the recordkeeping requirement 

for this section. Total hours for this 

section equal 45,000 hours. 

Dated: May 13, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–11625 Filed 5–18–09; 8:45 am] 

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