[Federal Register Volume 67, Number 58 (Tuesday, March 26, 2002)]
[Notices]
[Page 13788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7146]



[[Page 13788]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0077]


Agency Emergency Processing Under OMB Review; Emergency Medical 
Device Shortage Program Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns a telephone survey used to assist FDA in 
implementing an emergency medical device shortage program so that the 
agency can respond quickly to medical device shortages that might arise 
in the aftermath of a bioterrorist attack.

DATES: Submit written comments on the collection of information by 
April 25, 2002.

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 10503, Attn: 
Stuart Shapiro, Desk Officer for FDA. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). This information is needed 
immediately so that the agency can respond quickly to medical device 
shortages that might arise in the aftermath of a terrorist attack.
    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

    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 FDA is authorized 
to implement general powers (including conducting research) to carry 
out effectively the mission of FDA. 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.
    FDA is compiling a list of medical devices that would be needed to 
treat patients in the event of a biological or chemical weapon attack. 
FDA plans to collect manufacturing and inventory information concerning 
the devices on this list, starting with those devices that are 
considered critical to patient care. This information will allow FDA to 
identify quickly sources and locations of medical devices in the event 
that they are needed in an emergency. It will also help to identify 
logistical problems in the event that borders are closed or 
transportation has been disrupted. In addition, FDA plans to maintain a 
list of telephone contacts for the manufacturers so that communication 
channels with manufacturers will be in place in the event that they are 
needed.
    This telephone survey's primary respondents will be medical device 
manufacturers and wholesalers.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                          Annual
              Activity                    No. of         Frequency     Total Annual      Hours per       Total
                                        Respondents     perResponse      Responses       Response        Hours
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Telephone Survey....................    7,000               1           7,000                .1         700
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\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 estimates.
    The total number of manufacturers is estimated to be 70,000. FDA 
estimates that approximately 10 percent of these manufacturers would be 
contacted in a 1-year period, due to limitations on FDA staff. It is 
estimated also that the survey will take approximately 6 minutes to 
complete over the telephone. Therefore, 7,000 respondents (10 percent 
of the FDA manufacturer base) times 1/10 of an hour (i.e., 6 minutes) 
would equal a total of 700 hours.

    Dated: March 19, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7146 Filed 3-25-02; 8:45 am]
BILLING CODE 4160-01-S