71446 Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices 

FDA bases its estimates of the number 

of respondents and total annual 

responses on the submissions that the 

Agency has received in the past 3 years 

for each product type. To calculate the 

estimate for the hours per response 

values, we assumed that the information 

requested is readily available to the 

submitter. We expect that the submitter 

will need to gather information from 

appropriate persons in the submitter’s 

company and to prepare this 

information for submission. We believe 

that this effort should take no longer 

than 15 minutes (0.25 hour) per 

response. FDA estimates that it will 

receive 1 submission from 10 shell egg 

producers annually, for a total of 10 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 2.5 hours, rounded to 3. 

FDA estimates that it will receive 1 

submission from 120 dairy product 

producers annually, for a total of 120 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 30 hours. FDA estimates 

that it will receive one submission from 

five game meat and game meat product 

producers annually, for a total of five 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 1.25 hours, rounded to 1 

hour. FDA estimates that it will receive 

one submission from five animal casings 

producers annually, for a total of five 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 1.25 hours, rounded to 1 

hour. FDA estimates that it will receive 

one submission from three gelatin 

producers annually, for a total of three 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 0.75 hour, rounded to 1 

hour. FDA estimates that it will receive 

one submission from three collagen 

producers annually, for a total of three 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 0.75 hour, rounded to 1 

hour. Therefore, the proposed annual 

burden for this information collection is 

37 hours. 

Dated: November 18, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29483 Filed 11–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0554] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Reports of 

Corrections and Removals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection requirements 

for reports of corrections and removal. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 24, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information 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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, e-mail: 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Reports of Corrections and Removals— 

21 CFR Part 806 (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 

(FDAMA) 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices 71447 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

806.10 .................................................................................. 666 1 666 10 6,660 

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

TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

806.20 .................................................................................. 90 1 90 10 900 

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

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 this section. The 

estimates of time needed to collect part 

806 information have not changed. 

Dated: November 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29520 Filed 11–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Application Requirements for 

the Low Income Home Energy 

Assistance Program (LIHEAP) Model 

Plan. 

OMB No.: 0970–0075. 

Description: States, including the 

District of Columbia, Tribes, Tribal 

Organizations and Territories applying 

for LIHEAP block grant funds must 

submit an annual application (Model 

Plan) that meets the LIHEAP statutory 

and regulatory requirements prior to 

receiving Federal funds. A detailed 

application must be submitted every 

three years. Abbreviated applications 

may be submitted in alternate years. 

There have been no changes in the 

Model Plan since the approval of the 

addition of the LIHEAP Program 

Integrity Assessment Supplement by the 

Office of Management and Budget 

earlier this year. 

Respondents: State, Local or Tribal 

Governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

LIHEAP Program Integrity Assessment and Plan ........................................... 216 1 1 216 

Detailed Model Plan ........................................................................................ 72 1 1 72 

Abbreviated Model Plan .................................................................................. 144 1 .33 47.5 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 335.5 

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