[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Pages 14020-14021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5633]



Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Emergency Shortages Data Collection System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the Emergency Shortages Data 
Collection System.

DATES: Submit either electronic or written comments on the collection 
of information by May 7, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Emergency Shortages Data Collection System--Section 903(d)(2) of the 
Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0491)--

    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 (including conducting 
research) to carry out effectively the mission of FDA. Subsequent to 
the events of September 11, 2001, and as part of broader

[[Page 14021]]

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 decisionmaking by HHS 
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 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 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 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 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 
    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.
    FDA estimates the burden of this collection of information as 

                                 Table 1--Estimated Annual Reporting Burden \1\
                                                     Number of
     Section of the FD&C Act         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
903(d)(2).......................             125               3             375             0.5             188
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    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: March 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5633 Filed 3-7-12; 8:45 am]