[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14138-14139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06118]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 18, 2015.
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.
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: 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,
[[Page 14139]]
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)--
(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 (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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of Average
Number of responses Total annual burden per
Activity/FD&C act section respondents per responses response Total hours
respondent (hours)
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Emergency Shortages Data Collection System 125 3 375 0.5 188
(903(d)(2))..............................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06118 Filed 3-17-15; 8:45 am]
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