
[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Notices]               
[Page 11116-11117]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr09-65]                         

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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 April 
15, 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 has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Emergency Shortages Data Collection System (formerly ``Emergency 
Medical Device Shortages Program Survey'')--(Federal Food, Drug, and 
Cosmetic Act, Section 903 (d)(2) (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 the Center 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 decision making by the Department of 
Health and Human Services during actual emergencies or emergency 
preparedness exercises.
    ``The Emergency Medical Device Shortage 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 decision making and planning in the 
context of a federally-declared disaster/emergency, an official 
emergency preparedness exercise, or a potential public health risk 
posed by nondisaster-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 
follow-up 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

[[Page 11117]]

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 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: March 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5545 Filed 3-13-09; 8:45 am]

BILLING CODE 4160-01-S
