Document ID: FDA-2010-N-0033-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2010-02-05T05:00Z

[Federal Register: February 5, 2010 (Volume 75, Number 24)]
[Notices]               
[Page 6036-6037]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe10-85]                         

[[Page 6036]]

-----------------------------------------------------------------------

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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.9,                                                                 21                     1                 21                120              2,520
822.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 6037]]

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                        Recordkeepers      per Recordkeeping         Record            Records          Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.31                                                                 21                     1                 21                 20                420
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.32                                                                 63                     1                 63                 10                630
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                              1,050
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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