80 FR 36824 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 123 (June 26, 2015)

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.

[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36824-36825]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15641]


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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 
27, 2015.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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--(OMB Control Number 0910-
0491)--Extension

    Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic 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 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 18, 2015 (80 FR 14138), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. 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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                                                                           Number of
           Activity/FD&C act section                  Number of          responses per         Total annual     Average burden  per      Total hours
                                                     respondents           respondent           responses             response
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Emergency Shortages Data Collection System                      125                    3                  375     0.5 (30 minutes)                  188
 (903(d)(2))...................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 36825]]

    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: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15641 Filed 6-25-15; 8:45 am]
 BILLING CODE 4164-01-P