Agency Information Collection Activities; Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0266]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 38096]]

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 (the PRA).

DATES: Submit written comments on the collection of information by

August 15, 1997.

ADDRESSES: Submit written comments on the collection of information to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC, 20503,

Attention: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of

Information Resources Management (HFA-250), Food and Drug

Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,

301-827-1479.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA

(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 (21 CFR 800.55,

800.55(k), 895.21, and 895.22) (OMB Control Number 0910-0114--

Reinstatement)

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. On March 9, 1979, FDA issued a final

regulation on administrative detention procedures, which includes,

among other things, certain reporting requirements (Sec. 800.55(g) (21

CFR 800.55(g))) and recordkeeping requirements (Sec. 800.55(k)). Under

Sec. 800.55(g), an appellant 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

regulation for banned devices contains certain reporting requirements

(Secs. 895.21(d) and 895.22(a) (21 CFR 895.21(d) and 895.22(a))).

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 notice will contain the finding that the

device presents a substantial deception or an unreasonable and

substantial risk of illness or injury. The notice 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.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden\1\

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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800.55(g) 1 1 1 25 25

895.21(d) and 895.22(a)\2\ 0 0 0 0 0

Total .............. .............. .............. .............. 25

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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

\2\No devices were banned during the past 3 years (Secs. 895.21 and 895.22). Therefore, no burden has been

imposed upon industry. When the prosthetic hair fibers were banned, there were no firms in the United States

that were manufacturing or distributing the products. Thus, FDA has put zeroes in the columns estimating

reporting and recordkeeping burdens.

Table 2.--Estimated Annual Recordkeeping Burden

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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800.55(k) 1 1 1 20 20

Total .............. .............. .............. .............. 20

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There are no capital costs or operating and maintenance costs associated with this collection of information.

Over the past 3 years, there has been an average of one new

administrative detention action per year. Each administrative detention

will have varying amounts of data and information that must be

maintained.

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 over the last 3 years.

[[Page 38097]]

Dated: July 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-18592 Filed 7-15-97; 8:45 am]

BILLING CODE 4160-01-F