[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Notices]
[Pages 74926-74927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21167]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0382]


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

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 January 
12, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

Postmarket Surveillance--21 CFR Part 822 (OMB No. 0910-0449)--Extension

    Section 522(a) of the Federal Food, Drug and Cosmetic Act (the act) 
(21 U.S.C. 360(l)) 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 specific, clear, and 
flexible instructions to manufacturers so they know what information is 
required in a PS plan submission. FDA reviews submissions in accordance 
with part 822 (21 CFR part 822) in Sec. Sec.  822.15 to 822.18 of the 
regulation, which describe the grounds for approving or disapproving a 
PS plan. If this information is not collected, FDA would not be able to 
ensure that the PS will result in the collection of useful data that 
could reveal unforeseen adverse events or other information necessary 
to protect the public health.
    Respondents to this collection of information are those 
manufacturers who require PS of their products.
    In the Federal Register of October 2, 2006 (71 FR 57973), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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, 822.10                                                           5                     1                  5                120                600
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.21                                                                  3                     1                  3                 40                120
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.26                                                                  1                     1                  1                  8                  8
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.27                                                                  1                     1                  1                 40                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.28                                                                  1                     1                  1                 40                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.29                                                                  1                     1                  1                120                120
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.30                                                                  1                     1                  1                 40                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.34                                                                  1                     1                  1                 20                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.38                                                                 10                     2                 20                120              2,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                              3,338
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 74927]]


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.31                                                                 10                     1                 10                 20                200
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.32                                                                 30                     1                 30                 10                300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that, based on current staffing and resources and 
experience with five actual PS actions over the past 3 years, five PS 
actions will be issued for generic devices, comprised of approximately 
five manufacturers. Each manufacturer will be required to submit a PS 
plan (Sec. Sec.  822.9 and 822.10) and interim and final reports on the 
progress of the PS (Sec.  822.38). FDA anticipates that, on a case-by-
case basis, requests for additional information may be made from a 
manufacturer. FDA expects that a small number of respondents will 
propose changes to their PS plans (Sec.  822.21), request a waiver of a 
specific requirement of this regulation (Sec.  822.29), or request 
exemption from the requirement to conduct PS of their device (Sec.  
822.30). FDA's experience has shown that a few respondents will go out 
of business (Sec.  822.26) or cease marketing the device subject to PS 
(Sec.  822.28) each year. In addition, manufacturers must certify 
transfer of records when ownership changes (Sec.  822.34).
    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 PS plan, 
using three investigators. These estimates are based on FDA's knowledge 
and experience with limited implementation of section 522 under the 
Safe Medical Device Act of 1990. Therefore, FDA would expect that the 
recordkeeping requirements would apply to a maximum of 10 manufacturers 
(3 to 4 added each year) and 30 investigators (3 per PS plan). After 3 
years, FDA would expect these numbers to remain level as the PS plans 
conducted under the earliest orders reach completion and new orders are 
issued.

    Dated: December 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21167 Filed 12-12-06; 8:45 am]
BILLING CODE 4160-01-S