[Federal Register: May 8, 2009 (Volume 74, Number 88)]
[Notices]
[Page 21688-21689]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08my09-84]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0635]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Emergency Shortages
Data Collection System (formerly ``Emergency Medical Device Shortages
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 review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June 8,
2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0491.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA
published a 30-day notice in the Federal Register of March 16, 2009 (74
FR 11116), that: (1) Responded to comments on the information
collection provisions received in response to a 60-day notice that
published in the Federal Register of December 19, 2008 (73 FR 77718),
and (2) announced submission of the proposed collection of information
to OMB for review and clearance. In response to a request by OMB, FDA
is republishing the 30-day notice of the proposed collection of
information set forth in this document.
[[Page 21689]]
Emergency Shortages Data Collection System (formerly ``Emergency
Medical Device Shortages Program Survey'')--Section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0491)--
Extension
Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 393(d)(2)), the FDA Commissioner is authorized to
implement general powers (including conducting research) to carry out
effectively the mission of FDA. Subsequent to the events of September
11, 2001, and as part of broader counter-terrorism and emergency
preparedness activities, FDA's Center for Devices and Radiological
Health (CDRH) began developing operational plans and interventions that
would enable CDRH to anticipate and respond to medical device shortages
that might arise in the context of federally-declared disasters/
emergencies or regulatory actions. In particular, CDRH identified the
need to acquire and maintain detailed data on domestic inventory,
manufacturing capabilities, distribution plans and raw material
constraints for medical devices that would be in high demand, and/or
would be vulnerable to shortages in specific disaster/emergency
situations, or following specific regulatory actions. Such data could
support prospective risk assessment, help inform risk mitigation
strategies, and support real-time decisionmaking by the Department of
Health and Human Services during actual emergencies or emergency
preparedness exercises.
``The Emergency Medical Device Shortages Program Survey'' was
developed in 2002 to support the acquisition of such data from medical
device manufacturers. In 2004, CDRH changed the process for the data
collection, and the electronic database in which the data were stored
and was formally renamed the ``Emergency Shortages Data Collection
System'' (ESDCS). Recognizing that some of the data collected may be
commercially confidential, access to ESDCS is restricted to members of
the FDA Emergency Shortage Team (EST) and senior management with a
need-to-know. At this time, the need-to-know senior management
personnel are limited to 5 senior managers. Further, the data are used
by this defined group only for decisionmaking and planning in the
context of a federally-declared disaster/emergency, an official
emergency preparedness exercise, or a potential public health risk
posed by non-disaster-related device shortage.
The data procurement process consists of an initial scripted
telephone call to a regulatory officer at a registered manufacturer of
one or more key medical devices being tracked in the emergency
shortages data collection system. In this initial call, the intent and
goals of the data collection effort are described, and the specific
data request is made. After the initial call, one or more additional
followup calls and/or electronic mail correspondence may be required to
verify/validate data sent from the manufacturer, confirm receipt and/or
request additional detail. Although the regulatory officer is the agent
who is initially contacted, they may designate an alternate
representative within their organization to correspond subsequently
with the CDRH EST member who is collecting or verifying/validating the
data.
Because of the dynamic nature of the medical device industry,
particularly with respect to specific product lines, manufacturing
capabilities and raw material/subcomponent sourcing, it is necessary to
update the data in the ESDCS at regular intervals. This is done on a
weekly basis, but efforts are made to limit the frequency of outreach
to a specific manufacturer to no more than every 4 months.
The ESDCS will only include those medical devices for which there
will likely be high demand during a specific emergency/disaster, or for
which there are sufficiently small numbers of manufacturers such that
disruption of manufacture or loss of one or more of these manufacturers
would create a shortage.
In the Federal Register of December 19, 2008 (73 FR 77718), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Section of the No. of Annual Frequency Total Annual Hours per
Act Respondents per Response Responses Response Total Hours
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903(d)(2) 125 3 375 0.5 188
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in Table 1 of this document on past
experience with direct contact with the medical device manufacturers,
and anticipated changes in the medical device manufacturing patterns
for the specific devices being monitored. FDA estimates that
approximately 125 manufacturers would be contacted by telephone and/or
electronic mail 3 times per year to either obtain primary data or to
verify/validate data. Because the data being requested represent data
elements that are monitored or tracked by manufacturers as part of
routine inventory management activities, it is anticipated that for
most manufacturers, the estimated time required of manufacturers to
complete the data request will not exceed 30 minutes per request cycle.
Dated: May 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10816 Filed 5-7-09; 8:45 am]
BILLING CODE 4160-01-S