[Federal Register Volume 67, Number 250 (Monday, December 30, 2002)]
[Notices]
[Pages 79637-79639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32850]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0077]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 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 0910-0491). 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.

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

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/

[[Page 79638]]

dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

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

SUPPLEMENTARY 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 60-day 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 
0910-0491)--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 device-related issues related to counter-terrorism. One of 
the activities related to planning for addressing terrorism-related 
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 x-ray 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\
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                         No. of        Annual Frequency     Total Annual        Hours per
                      Respondents        per Response        Responses           Response         Total  Hours
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Telephone survey                 250                  1                250                 .5                125
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Total                                                                                                        125
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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 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 
1-year period. It is also estimated from FDA experience that the survey 
will take approximately 20 to 30 minutes to complete over the 
telephone.


[[Page 79639]]


    Dated: December 19, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32850 Filed 12-27-02; 8:45 am]
BILLING CODE 4160-01-S