[Federal Register Volume 68, Number 122 (Wednesday, June 25, 2003)]
[Notices]
[Pages 37846-37847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15995]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0075]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below 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 July 
25, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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)), to detain 
during establishment inspections devices that are believed to be 
adulterated or misbranded. FDA issued a final rule that published in 
the Federal Register of March 9, 1979 (44 FR 13234 at 13239), on 
administrative detention procedures, which includes, among other 
things, certain reporting requirements under Sec.  800.55(g) and (k) 
(21 CFR 800.55(g) and (k)) and recordkeeping requirements. Under Sec.  
800.55(g), an applicant of a detention order must show documentation of 
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 
an unreasonable and substantial risk of illness or injury. The final 
rule for banned devices that published in the Federal Register of May 
18, 1979 (44 FR 29214 at 29221), contained certain reporting 
requirements under Sec. Sec.  895.21(d) and 895.22 (21 CFR 895.21(d) 
and 895.22). Section 895.21(d) states that if the Commissioner of Food 
and Drugs (the Commissioner) decides to initiate a proceeding to make a 
device a banned device, a notice of proposed rulemaking will be 
published in the Federal Register and this document will contain the 
finding that the substantial risk of illness or injury exists. The 
document will also contain the reasons why the proceeding was 
initiated, an evaluation of data and information obtained under other 
provisions of the act, any consultations with the panel, and a 
determination as to whether the device could be corrected by labeling 
or change of labeling, or change of advertising, and if that labeling 
or change of advertising has been made. Under Sec.  895.21(d), any 
interested person may request an informal hearing and submit written 
comments. Under Sec.  895.22, a manufacturer, distributor, or importer 
of a device may be required to submit to FDA all relevant and available 
data and information to enable the Commissioner to determine whether 
the device presents substantial deception, unreasonable and substantial 
risk of illness or injury, or unreasonable, direct, and substantial 
danger to the health of individuals.
    Respondents to this collection of information are those 
manufacturers, distributors, or importers whose products FDA seeks to 
detain or ban. As previously stated, the collection of data and 
information under these regulations is conducted on a very infrequent 
basis and only as necessary.
    In the Federal Register of March 17, 2003 (68 FR 12706), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR                          Annual Frequency      Total Annual       Total Hours per
   Section    No. of Respondents     per Response          Responses           Response           Total Hours
----------------------------------------------------------------------------------------------------------------
800.55(g)             1                   1                   1                  25                  25
----------------------------------------------------------------------------------------------------------------
895.21(d)            26                   1                  26                  16                 416
 and 895.22
----------------------------------------------------------------------------------------------------------------
Total         ..................  ..................  ..................  ..................        441
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 37847]]


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR           No. of         Annual Frequency      Total Annual
   Section       Recordkeepers        per Record            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.

    Over the past several years, there has been an average of less than 
one new administrative detention action per year. Each administrative 
detention will have varying amounts of data and information that must 
be maintained. Historically, the Center for Devices and Radiological 
Health has had very few or no annual responses for this information 
collection and normally reports one response per year.
    FDA's estimate of the burden under the administrative detention 
provision is based on FDA's discussion with one of the three firms 
whose devices had been detained.

    Dated: June 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15995 Filed 6-24-03; 8:45 am]
BILLING CODE 4160-01-S