[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Notices]
[Pages 13603-13604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0422]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 April 
17, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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 (Formerly the Emergency 
Medical Device Shortage Program Survey)--(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 Food and Drugs 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 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 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 FDA's 
Emergency Shortage Team (EST) and senior management with a need-to-
know. The need-to-know personnel include five EST members, the EST 
leader, the EST data entry technician, and five 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

[[Page 13604]]

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).
    In the Federal Register of November 4, 2005 (70 FR 67177), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                   Annual Frequency per     Total Annual        Hours per
        No. of Respondents                Response           Responses           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 facilities. 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: March 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3820 Filed 3-15-06; 8:45 am]
BILLING CODE 4160-01-S