6036 Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0033] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Postmarket 

Surveillance 

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 

information collection requirements for 

Postmarket Surveillance. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 6, 2010. 

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 (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–5156, 

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. 

Postmarket Surveillance—21 CFR Part 

822 (OMB Control Number 0910– 

0449)—Extension 

Section 522(a) of the Federal Food, 

Drug and Cosmetic Act (the act) (21 

U.S.C. 360l) authorizes FDA to require 

manufacturers to conduct postmarket 

surveillance (PS) of any device that 

meets the criteria set forth in the statute. 

The PS regulation establishes 

procedures that FDA uses to approve 

and disapprove PS plans. The regulation 

provides instructions to manufacturers 

so they know what information is 

required in a PS plan submission. FDA 

reviews PS plan submissions in 

accordance with part 822 (21 CFR part 

822) in §§ 822.15 to 822.19 of the 

regulation, which describe the grounds 

for approving or disapproving a PS plan. 

In addition, the PS regulation provides 

instructions to manufacturers to submit 

interim and final reports in accordance 

with § 822.38. 

Respondents to this collection of 

information are those manufacturers 

who require postmarket surveillance of 

their products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

822.9, 

822.10 21 1 21 120 2,520 

822.21 (supplements) 5 1 5 40 200 

822.28 (stop marketing) 5 1 5 8 40 

822.29 (request waiver) 1 1 1 40 40 

822.30 (request exemption) 1 1 1 40 40 

822.38 (reports) 40 1 40 40 1,600 

Total 4,440 

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


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Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices 6037 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Record 

Hours per 

Records Total Hours 

822.31 21 1 21 20 420 

822.32 63 1 63 10 630 

Total 1,050 

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

Explanation of Reporting Burden 

Estimate 

The burden captured in table 1 for 

this document for each of these 

responses is based on the data available 

in FDA’s internal tracking system for 

2009. There was not an internal tracking 

system prior to 2009. 

Sections 822.26, 822.27, and 822.34 

do not constitute information collection 

subject to review under the PRA 

because ‘‘it entails no burden other than 

that necessary to identify the 

respondent, the date, the respondent’s 

address, and the nature of the 

instrument.’’ (5 CFR 1320.3(h)(1)). 

Explanation of Recordkeeping Burden 

Estimate 

FDA expects that at least some of the 

manufacturers will be able to satisfy the 

PS requirement using information or 

data they already have. For purposes of 

calculating burden, however, FDA has 

assumed that each PS order can only be 

satisfied by a 3-year clinically-based 

surveillance plan, using three 

investigators. These estimates are based 

on FDA’s knowledge and experience 

with limited implementation of section 

522 under the Safe Medical Devices Act. 

Therefore, FDA would expect that the 

recordkeeping requirements would 

apply to a maximum of 21 

manufacturers (3 to 4 added each year) 

and 30 investigators (3 per surveillance 

plan). After 3 years, FDA would expect 

these numbers to remain level as the 

surveillance plans conducted under the 

earliest orders reach completion and 

new orders are issued. 

Dated: January 27, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–2458 Filed 2–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0034] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on How to Submit a Notice of 

Final Disposition of Investigational 

Animals Not Intended for Immediate 

Slaughter in Electronic Format to the 

Center for Veterinary Medicine 

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 reporting requirements for the 

information collection activity ‘‘How to 

Submit a Notice of Final Disposition of 

Investigational Animals Not Intended 

for Immediate Slaughter In Electronic 

Format to the Center for Veterinary 

Medicine.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by April 6, 2010. 

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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 


srobinson on DSKHWCL6B1PROD with NOTICES