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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket ID: [Docket No. 02N-0077]

NOTICE: NOTICES

ACTION: Agency information collection activities:

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Medical Device Shortage Program Survey

DATES: Submit written or electronic comments on the collection of information by February 28, 2003.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's emergency medical device shortage program survey. In the Federal Register of May 22, 2002 (67 FR 36008), FDA published a notice announcing OMB's approval of this collection of information (OMB control number 09100491). Because this was an emergency approval that expired on October 31, 2002, FDA in this notice is following the normal PRA clearance procedures by issuing this notice.

SUMMARY: Proposed collection; comment request,

SUPPLEMENTAL INFORMATION

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60day notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Emergency Medical Device Shortage Program Survey (OMB Control Number 09100491)Reinstatement

Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and Drugs is authorized to implement general powers (including conducting research) to carry out effectively FDA's mission. Section 510 of the act (21 U.S.C. 360) requires that domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution register their establishments and list the devices they manufacture with FDA. Section 522 of the act (21 U.S.C. 360(l)) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health, or gross deception of the consumer. These sections of the act enable FDA to enhance consumer protection from risks associated with medical devices usage that are not foreseen or apparent during the premarket notification and review process.

Subsequent to the events of September 11, 2001, FDA began planning for handling devicerelated issues related to counterterrorism. One of the activities related to planning for addressing terrorismrelated medical device shortages is that FDA, working with medical experts and medical device industry organizations, developed a medical device formulary that identifies which medical devices would be needed in responding to terrorist incidents. The National Pharmaceutical Stockpile Program managed by the Centers for Disease Control (CDC) appears to have not given adequate consideration to medical devices. Therefore, FDA has developed a plan to ensure adequate availability of medical devices in case of terrorist incidents.

Most particularly, consumable supplies or disposable devices are supplied through large regional distributors. Adequate supplies should be available through these existing commercial supply chains. Problems in supplying these items will be due to logistics. In an emergency, FDA plans to ensure adequate availability of these types of devices by working with industry/distributor organizations. These organizations have actively pursued working relationships with appropriate government agencies to facilitate adequate response in emergency situations.

However, there are more sophisticated or specialized devices, for example, ventilators, defibrillators, portable xray machines, that are sold directly by the manufacturer, that are not through independent distributors. For these devices, FDA plans to maintain a database of device manufacturers so that specific contact information can be supplied to Emergency Response personnel as needed. FDA has identified 17 of these devices and has identified 205 manufacturers.

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 Respondents per Response Responses Response Total Hours Telephone survey 250 1 250 .5 125 Total 125 \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA has based these estimates on conversations with industry and trade association representatives, and from internal FDA experience and estimates.

The total number of medical device manufacturers regulated by FDA is estimated to be 70,000. Because most of the medical devices which might be needed in a terrorist attack are available through regular commercial channels, FDA focused this collection of information on the 250 manufacturers who manufacture 17 medical devices. Therefore, FDA estimates that approximately 150 manufacturers would be contacted in a 1year period. It is also estimated from FDA experience that the survey will take approximately 20 to 30 minutes to complete over the telephone.
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Dated: December 19, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 0232850 Filed 122702; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Peggy Robbins, Office of Information Resources Management (HFA250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3018271223.