Document ID: FDA-2010-N-0033-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Postmarket Surveillance
Posted Date: 2010-04-20T04:00Z

[Federal Register: April 20, 2010 (Volume 75, Number 75)]
[Notices]               
[Page 20604-20606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap10-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0033]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Postmarket 
Surveillance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 May 20, 
2010.

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@eop.gov. All 
comments should be identified with the OMB control number 0910-0449. 
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, email: 
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.

[[Page 20605]]

Postmarket Surveillance--21 CFR Part 822 (OMB Control Number 0910-
0449)--Extension

    Section 522(a) of the Federal Food, Drug, and Cosmetic 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 Sec. Sec.  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 
Sec.  822.38. Respondents to this collection of information are those 
manufacturers who require postmarket surveillance of their products.

Explanation of Reporting Burden Estimate

    The burden captured in table 1 of 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.
    In the Federal Register of February 5, 2010 (75 FR 6036), 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:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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822.9 and 822.10                                                       21                     1                 21                120              2,520
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822.21                                                                  5                     1                  5                 40                200
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822.28                                                                  5                     1                  5                  8                 40
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822.29                                                                  1                     1                  1                 40                 40
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822.30                                                                  1                     1                  1                 40                 40
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822.38                                                                 40                     1                 40                 40              1,600
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Total                                                                                                                                              4,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                        Recordkeepers      per Recordkeeping         Record            Records          Total Hours
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822.31                                                                 21                     1                 21                 20                420
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822.32                                                                 63                     1                 63                  5                315
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Total                                                                                                                                                735
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 20606]]

    Dated: April 14, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8977 Filed 4-19-10; 8:45 am]
BILLING CODE 4160-01-S