Federal Register / Vol. 70, No. 213 / Friday, November 4, 2005 / Notices 67177 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) gives notice as 

required by 42 CFR 83.12(e) of a 

decision to evaluate a petition to 

designate a class of employees at the 

Oak Ridge Institute for Nuclear Studies, 

Oak Ridge, Tennessee, to be included in 

the Special Exposure Cohort under the 

Energy Employees Occupational Illness 

Compensation Program Act of 2000. The 

initial proposed definition for the class 

being evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: Oak Ridge Institute for 

Nuclear Studies. 

Location: Oak Ridge, Tennessee. 

Job Titles and/or Job Duties: All 

medical division employees. 

Period of Employment: June 1, 1950 

through June 25, 1956. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS C–46, Cincinnati, OH 

45226, Telephone 513–533–6800 (this is 

not a toll-free number). Information 

requests can also be submitted by e-mail 

to OCAS@CDC.GOV. 

Dated: October 31, 2005. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 05–22030 Filed 11–3–05; 8:45 am] 

BILLING CODE 4163–19–P 

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. 

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 

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.