67178 Federal Register / Vol. 70, No. 213 / Friday, November 4, 2005 / Notices 

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-toknow. 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 BURDEN1

No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 

65 3 195 .5 98 

1There 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0516] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

2005 Food Safety Survey; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

that appeared in the Federal Register of 

October 24, 2005 (70 FR 61455). The 

document announced an approval by 

the Office of Management and Budget. 

The document was published with an 

incorrect expiration date for OMB 

control number 0910–0345. This 

document corrects that error. 

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: In FR Doc. 

05–21157, appearing on page 61455 in 

the Federal Register of Monday, 

October 24, 2005, the following 

correction is made: 

1. On page 61455, in the second 

column, in the SUPPLEMENTARY

INFORMATION section, beginning on line 

13, the sentence ‘‘The approval expires 

on February 30, 2008.’’ is corrected to 

read ‘‘The approval expires on February 

29, 2008.’’

Dated: October 28, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21974 Filed 11–3–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2002E–0020] (formerly Docket 

No. 02E–0020) 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ZOMETA; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of February 28, 2003 (68 FR 

9690). The document announced that 

FDA had determined the regulatory 

review period for ZOMETA. A Request 

for Revision of Regulatory Review 

Period was filed for the product on May 

4, 2005. FDA reviewed its records and 

found that the effective date of the 

investigational new drug application 

(IND) was incorrect due to a clerical 

error. Therefore, FDA is revising the 

determination of the regulatory review 

period to reflect the correct effective 

date for the IND. 

FOR FURTHER INFORMATION CONTACT: 

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–13), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6681.