14022 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 

ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued 

Respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

per response 

(in hours) 

CDI Surveillance Case Report Form—Partial ........................................................... 10 438 15/60 

CDI Surveillance Health Interview ............................................................................. 10 50 45/60 

Dated: March 9, 2011. 

Carol Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–5919 Filed 3–14–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Withdrawl of Publication 

This is to serve notice that the 

following Federal Register notice 

published on March 1, 2011, page 

11250, is being rescinded: 

Submission for OMB Review: Comment 

Request 

Title: Child Care and Development 

Fund Tribal Plan Preprint—ACF–118– 

A. 

OMB No.: 0970–0198. 

The original notice published on 

February 9, 2011, pages 7218–7219 is 

still in effect. 

Dated: March 9, 2011. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–5845 Filed 3–14–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0554] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Reports of Corrections and Removals 

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 April 14, 

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 0910–0359. 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. 

Medical Devices; Reports of Corrections 

and Removals—(OMB Control Number 

0910–0359)—(Extension) 

The collection of information required 

under the reports of corrections and 

removals, part 806 (21 CFR part 806), 

implements section 519(g) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 360i(g)), as 

amended by the Food and Drug 

Administration Modernization Act of 

1997 (21 U.S.C. 301) (Pub. L. 105–115). 

Each device manufacturer or importer 

under § 806.10 shall submit a written 

report to FDA of any action initiated to 

correct or remove a device to reduce a 

risk to health posed by the device, or to 

remedy a violation of the FD&C Act 

caused by the device that may present 

a risk to health, within 10 working days 

of initiating such correction or removal. 

Each device manufacturer or importer of 

a device who initiates a correction or 

removal of a device that is not required 

to be reported to FDA under § 806.20 

shall keep a record of such correction or 

removal. 

The information collected in the 

reports of corrections and removals will 

be used by FDA to identify marketed 

devices that have serious problems and 

to ensure that defective devices are 

removed from the market. This will 

assure that FDA has current and 

complete information regarding these 

corrections and removals and to 

determine whether recall action is 

adequate. 

Respondents to this collection of 

information are manufacturers and 

importers of medical devices. FDA 

reviewed reports of device corrections 

and removals submitted to the Agency 

for the previous 3 years as part of 

responding to the current request for 

approval of the information collection 

requirements for §§ 806.10 and 806.20. 

This information was obtained through 

the Agency’s voluntary recall provisions 

(i.e., 21 CFR part 7). The specific 

information requested was the total 

number of class I, II, and III recalls for 

the last 3 years. This information was 

obtained from the Agency’s Recall 

Enterprise System—a database of all 

recalls submitted to the Agency. 

This information is relevant since a 

§ 806.10 report is required for all class 

I and II recalls. Although class III recalls 

are not required to be submitted to FDA 

(by § 806.10), a record must be kept in 

the firm’s § 806.20 file. Therefore, the 

number of class I and II recalls can be 

used to estimate the maximum number 

of reports that are required to be 

submitted under § 806.10. Also, the 

recordkeeping burden can be estimated 

based upon the number of class III 

recalls, which are not required to be 

reported, but must be retained in a 

§ 806.20 file. 

FDA has determined that estimates of 

the reporting burden for § 806.10 should 

be revised to reflect a projected 7.3 

percent increase (from the last PRA 

numbers) in reports submitted to FDA 

as class I and II. FDA also estimates the 

recordkeeping burden in § 806.20 

should be revised to reflect a reduction 

of 6.8 percent (from the last PRA 

numbers) in records filed and 

maintained under § 806.20. The 

estimates of time needed to collect part 

806 information have not changed. 

In the Federal Register of November 

23, 2010 (75 FR 71446), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 


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