
[Federal Register Volume 77, Number 108 (Tuesday, June 5, 2012)]
[Notices]
[Pages 33223-33224]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0197]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Emergency Shortages 
Data Collection System

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 July 5, 
2012.

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: 202-395-7285, or emailed 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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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--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 FD&C Act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and 
Drugs is authorized to implement general powers

[[Page 33224]]

(including conducting research) to carry out effectively the mission of 
FDA. Subsequent to the events of September 11, 2001, and as part of 
broader counterterrorism 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 decision-making by the Department of Health and 
Human Services during actual emergencies or emergency preparedness 
exercises.
    FDA developed ``The Emergency Medical Device Shortages Program 
Survey'' 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 
was formally renamed the ``Emergency Shortages Data Collection System'' 
(ESDCS). Recognizing that some of the data collected may be 
commercially confidential, access to the ESDCS is restricted to members 
of the CDRH 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 two 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 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 tracked in the ESDCS. In this initial 
call, the EST member describes the intent and goals of the data 
collection effort and makes the specific data request. 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 the EST member 
initially contacts, regulatory officers 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. The EST makes 
such updates on a regular basis, but makes efforts 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 March 8, 2012 (77 FR 14020), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of                      Average  burden
                          FD&C Act Section                              Number of      responses per     Total annual    per  response     Total hours
                                                                       respondents        response        responses         (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 either to obtain primary data or to 
verify/validate data. Because the requested data 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 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13524 Filed 6-4-12; 8:45 am]
BILLING CODE 4160-01-P


