[Federal Register: December 30, 2002 (Volume 67, Number 250)]
[Notices]
[Page 79637-79639]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de02-101]
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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