[Federal Register: March 17, 2003 (Volume 68, Number 51)]
[Page 12705-12706]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 02N-0077]

Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Emergency Medical Device Shortage Program 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES:  Submit written comments on the collection of information by 
April 16, 2003.

ADDRESSES: Fax written comments on the collection of information to the 
Office of Information and Regulatory Affairs, OMB, Attn: Stuart 
Shapiro, Desk Officer for FDA, FAX 202-395-6974, or electronically mail 
comments to sshapiro@omb.eop.gov.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

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 Medical Device Shortage Program Survey (OMB Control Number 

    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 FDA's mission. 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. 360l) 
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 devices usage that are not foreseen or apparent during the 
premarket notification and review process.
    Subsequent to the events of September 11, 2001, FDA began planning 
for handling device-related issues related to counterterrorism. One of 
the activities related to planning for addressing terrorism-related 
medical device shortages is that FDA, working with medical experts and 
medical device industry organizations, developed a medical device 
formulary that identifies which medical devices would be needed in 
responding to terrorist incidents. The National Pharmaceutical 
Stockpile Program managed by the Centers for Disease Control appears to 
have not given adequate consideration to medical devices. Therefore, 
FDA has developed a plan to ensure adequate availability of medical 
devices in case of terrorist incidents.
    Most particularly, consumable supplies or disposable devices are 
supplied through large regional distributors. Adequate supplies should 
be available through these existing commercial supply chains. Problems 
in supplying these items will be due to logistics. In an emergency, FDA 
plans to ensure adequate availability of these types of devices by 
working with industry/distributor organizations. These organizations 
have actively pursued working relationships with appropriate government 
agencies to facilitate adequate response in emergency situations.
    However, there are more sophisticated or specialized devices, for 
example, ventilators, defibrillators, and portable x-ray machines are 
sold directly by the manufacturer but are not sold through independent 
distributors. For these devices, FDA plans to maintain a database of 
device manufacturers so that specific contact information can be 
supplied to emergency response personnel as needed. FDA has identified 
17 of these devices and has identified 205 manufacturers.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                Annual Frequency per       Total Annual
                                           No. of Respondents         Response              Responses          Hours per Response        Total Hours
Telephone Survey                                 250                     1                    250                       .5                 125
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 12706]]

    FDA has based these estimates on conversations with industry and 
trade association representatives and from internal FDA experience and 
    The total number of medical device manufacturers regulated by FDA 
is estimated to be 70,000. Because most of the medical devices which 
might be needed in a terrorist attack are available through regular 
commercial channels, FDA focused this collection of information on the 
250 manufacturers who manufacture 17 medical devices. Therefore, FDA 
estimates that approximately 150 manufacturers would be contacted in a 
1-year period. It is also estimated from FDA experience that the survey 
will take approximately 20 to 30 minutes to complete over the 

    Dated: March 7, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-6229 Filed 3-14-03; 8:45 am]