Federal Register: October 31, 2006 (Volume 71, Number 210)
DOCID: FR Doc E6-18190
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. 2006N-0220]
DOCUMENT ACTION: Notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
DATES: Fax written comments on the collection of information by November 30, 2006.
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.
Agency information collection activities; proposals, submissions, and approvals,
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 09100114)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 60day 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.
Assistant Commissioner for Policy.
[FR Doc. E618190 Filed 103006; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Denver Presley, Office of the Chief Information Officer (HFA250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3018271472.