[Federal Register Volume 70, Number 213 (Friday, November 4, 2005)]
[Notices]
[Pages 67177-67178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0422]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Emergency Shortages Data Collection System (Formerly 
the Emergency Medical Device Shortage Program Survey)

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 (formerly the Emergency Medical Device Shortage 
Program Survey).

DATES: Submit written or electronic comments on the collection of 
information by January 3, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 the Emergency 
Medical Device Shortage Program Survey)--21 CFR Part 20 (OMB 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. Section 510 of the act (21 U.S.C. 360) 
requires that domestic establishments engaged in the manufacture, 
preparation, propagation, compounding, assembly, or processing of 
medical devices intended for human use and commercial distribution 
register their establishments and list the devices they manufacture 
with the FDA. Section 522 of the act (21 U.S.C. 360(l) authorizes FDA 
to require manufacturers to conduct postmarket surveillance of medical 
devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to 
collect and disseminate information regarding medical products or 
cosmetics in situations involving imminent danger to health, or gross 
deception of the consumer. These sections of the act enable FDA to 
enhance consumer protection from risks associated with medical device 
usage that are not foreseen or apparent during the premarket 
notification and review process.
    Subsequent to the events of September 11, 2001, FDA's Center for 
Devices and Radiological Health (CDRH) began planning for handling 
medical device shortage issues associated with counter-terrorism. One 
of the activities related to the planning was that CDRH would establish 
a data collection system as a supplemental source for available 
product. Because of events on September 11, 2001, local and State 
governments have obtained stockpiles of backup supplies within their 
jurisdiction to cover an emergency for the first 12 hours following a 
terrorist attack. The second 12 hours will have additional medical 
devices supplied by the Centers for Disease Control's Strategic 
National Stockpile and the National Acquisition Center. However, if 
additional supplies are needed in the first 12 hours, the Department of 
Health and Human Services (HHS) will request that FDA provide the 
number of medical devices readily available to meet demands. HHS has an 
established

[[Page 67178]]

transportation and delivery mechanism in place to provide these 
emergent needs to the local and State authorities.
    The Emergency Medical Device Shortage Survey was established in 
1992 to collect data to assist FDA in implementing an emergency medical 
device shortage program that would find resources to supplement the 
needed supplies. In 2004, CDRH changed the process for the data 
collection and the name was changed to the Emergency Shortages Data 
Collection System. Because of the confidentiality aspect of the 
information, the information is only available to those on the FDA 
Emergency Shortage Team (EST) and senior management with a need-to-
know. The need-to-know personnel include 5 EST members, the EST Leader, 
the EST data entry technician, and 5 senior managers.
    The Emergency Shortages Data Collection System will be updated 
every 4 months to keep information current. CDRH learned that medical 
device manufacturers have a high rate of turnover in personnel and in 
corporate structures due to mergers with larger companies. In addition, 
with the constant advances in technology, some of these manufacturers 
are forced to discontinue product lines or add product lines to their 
inventory. This new data collection system process will update 
information on a regular basis ensuring more accurate information in an 
emergency/disaster.
    The process consists of one scripted telephone call to the 
designated shortage person at the four or five largest manufacturers of 
specific medical devices that may be needed by first responders in a 
national emergency. At the current time, the list contains 67 products 
from 65 manufacturers. If other products or new technology are deemed 
necessary to add at a later date, then the EST will conduct the 
appropriate search to find the four or five largest manufacturers of 
that product line and request the manufacturer's voluntary inclusion 
into the program.
    The Emergency Shortages Data Collection System will only include 
those medical devices that are expected to be in demand but in short 
supply in an emergency/disaster. The data collection system includes 
life-saving and life-sustaining products (i.e., mechanically powered 
ventilators) as well as products that would require frequent changes 
resulting in rapidly depleted supplies (i.e., face masks and gloves).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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               No. of Respondents                  Annual Frequency per Response     Total Annual Responses    Hours per Response        Total Hours
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65                                                                              3                        195                    .5                    98
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based these estimates on past experience with direct contact 
with the medical device manufacturers. FDA estimates that approximately 
65 manufacturers would be contacted by electronic mail three times per 
year to get updated information at their facility. Further, it is 
estimated that the manufacturers may require up to 30 minutes to check 
if information received previously is still current and send electronic 
mail back to FDA.

    Dated: October 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21973 Filed 11-3-05; 8:45 am]
BILLING CODE 4160-01-S