[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Notices]
[Pages 63764-63765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18190]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0220]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Administrative 
Detention and Banned Medical Devices

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 
November 30, 2006.

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, 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.

Administrative Detention and Banned Medical Devices--(OMB Control 
Number 0910-0114)--Extension

    FDA has the statutory authority under section 304(g) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 334(g)), where 
officers or employees (FDA investigators), duly designated by the 
Secretary of Health and Human Services, may detain during establishment 
inspections devices that are believed to be adulterated or misbranded. 
In the Federal Register of March 9, 1979 (44 FR 13234), FDA issued, 
under Sec.  800.55 (21 CFR 800.55), a final regulation on 
administrative detention procedures, under section 304(g) of the act, 
which includes certain reporting requirements (Sec.  800.55(g)(1) and 
(g)(2)) and recordkeeping requirements (Sec.  800.55(k)). Under Sec.  
800.55(g), an appellant of a detention order must show documentation of

[[Page 63765]]

ownership if devices are detained at a place other than that of the 
appellant. Under Sec.  800.55(k), the owner or other responsible person 
must supply records about how the devices may have become adulterated 
or misbranded, as well as records of distribution of the detained 
devices. These recordkeeping requirements for administrative detentions 
allow FDA to trace devices for which the detention period expired 
before a seizure is accomplished or injunctive relief is obtained.
    FDA also has the statutory authority under section 516 of the act 
(21 U.S.C. 360f), to ban devices that present substantial deception, or 
unreasonable and substantial risk of illness or injury, or 
unreasonable, direct, and substantial danger to the health of 
individuals. The final regulation for banned devices (part 895 (21 CFR 
part 895)), issued in the Federal Register of May 18, 1979 (44 FR 
29214), contained certain reporting requirements (Sec. Sec.  895.21(d) 
and 895.22(a)).
    In the Federal Register of June 7, 2006 (71 FR 32987), FDA 
published a 60-day notice requesting public comments 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(g)                                                               1                     1                  1                 25                 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
895.21(d) and 895.22(a)                                                26                     1                 26                 16                416
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                441
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeper         Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.55(k)                                                               1                     1                  1                 20                 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of the burden under the administrative detention 
provision is based on FDA's discussion with the last firm whose devices 
had been detained. Historically, FDA has had very few or no annual 
responses for this information collection.

    Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18190 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S