[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]
[Page 77718-77719]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de08-105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0635]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Emergency Shortages Data Collection System (formerly
``Emergency Medical Device Shortages Program Survey'')
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 written or electronic comments on the collection of
information by February 17, 2009.
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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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 (formerly ``Emergency
Medical Device Shortages Program Survey'')--Federal Food, Drug, and
Cosmetic Act, Section 903(d)(2) (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 Commissioner of FDA 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 the ESDCS is restricted to members
of the FDA Emergency Shortage Team (EST) and senior management with a
need-to-
[[Page 77719]]
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
nondisaster-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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
Section of the Act Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30155 Filed 12-18-08; 8:45 am]
BILLING CODE 4160-01-S