Document ID: FDA-2008-N-0635-0003
Agency: fda
Document Type: Notice
Title: 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") - Notices
Posted Date: 2009-05-08T04:00Z

[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