21688 Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health 

Final Effect of Designation of a Class 

of Employees for Addition to the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice concerning 

the final effect of the HHS decision to 

designate a class of employees at 

Westinghouse Atomic Power 

Development Plant in East Pittsburgh, 

Pennsylvania, as an addition to the 

Special Exposure Cohort (SEC) under 

the Energy Employees Occupational 

Illness Compensation Program Act of 

2000. On March 31, 2009, as provided 

for under 42 U.S.C. 7384q(b), the 

Secretary of HHS designated the 

following class of employees as an 

addition to the SEC: 

All Atomic Weapons Employer employees 

who worked at Westinghouse Atomic Power 

Development Plant in East Pittsburgh, 

Pennsylvania, from August 13, 1942 through 

December 31, 1944, for a number of work 

days aggregating at least 250 work days, 

occurring either solely under this 

employment or in combination with work 

days within the parameters established for 

one or more other classes of employees in the 

SEC. 

This designation became effective on 

April 30, 2009, as provided for under 42 

U.S.C. 7384l(14)(C). Hence, beginning 

on April 30, 2009, members of this class 

of employees, defined as reported in 

this notice, became members of the 

Special Exposure Cohort. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 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. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health. 

[FR Doc. E9–10829 Filed 5–7–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health 

Final Effect of Designation of a Class 

of Employees for Addition to the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice concerning 

the final effect of the HHS decision to 

designate a class of employees at Tyson 

Valley Powder Farm near Eureka, 

Missouri, as an addition to the Special 

Exposure Cohort (SEC) under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000. On 

March 31, 2009, as provided for under 

42 U.S.C. 7384q(b), the Secretary of 

HHS designated the following class of 

employees as an addition to the SEC: 

All Atomic Weapons Employer (AWE) 

employees who worked at Tyson Valley 

Powder Farm near Eureka, Missouri, from 

February 13, 1946 through June 30, 1948, for 

a number of work days aggregating at least 

250 work days, occurring either solely under 

this employment or in combination with 

work days within the parameters established 

for one or more other classes of employees 

in the SEC. 

This designation became effective on 

April 30, 2009, as provided for under 42 

U.S.C. 7384l(14)(C). Hence, beginning 

on April 30, 2009, members of this class 

of employees, defined as reported in 

this notice, became members of the 

Special Exposure Cohort. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 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. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health. 

[FR Doc. E9–10830 Filed 5–7–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0635] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Emergency 

Shortages Data Collection System 

(formerly ‘‘Emergency Medical Device 

Shortages Program Survey’’) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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 June 8, 

2009. 

ADDRESSES: 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: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0491. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

published a 30-day notice in the Federal 

Register of March 16, 2009 (74 FR 

11116), that: (1) Responded to 

comments on the information collection 

provisions received in response to a 60- 

day notice that published in the Federal 

Register of December 19, 2008 (73 FR 

77718), and (2) announced submission 

of the proposed collection of 

information to OMB for review and 

clearance. In response to a request by 

OMB, FDA is republishing the 30-day 

notice of the proposed collection of 

information set forth in this document. 


hsrobinson on PROD1PC76 with NOTICES
Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices 21689 

Emergency Shortages Data Collection 

System (formerly ‘‘Emergency Medical 

Device Shortages Program Survey’’)— 

Section 903(d)(2) of the Federal Food, 

Drug, and Cosmetic Act (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 FDA 

Commissioner is authorized to 

implement general powers (including 

conducting research) to carry out 

effectively the mission of FDA. 

Subsequent to the events of September 

11, 2001, and as part of broader counterterrorism and emergency preparedness 

activities, FDA’s Center for Devices and 

Radiological Health (CDRH) began 

developing operational plans and 

interventions that would enable CDRH 

to anticipate and respond to medical 

device shortages that might arise in the 

context of federally-declared disasters/ 

emergencies or regulatory actions. In 

particular, CDRH identified the need to 

acquire and maintain detailed data on 

domestic inventory, manufacturing 

capabilities, distribution plans and raw 

material constraints for medical devices 

that would be in high demand, and/or 

would be vulnerable to shortages in 

specific disaster/emergency situations, 

or following specific regulatory actions. 

Such data could support prospective 

risk assessment, help inform risk 

mitigation strategies, and support realtime decisionmaking by the Department 

of Health and Human Services during 

actual emergencies or emergency 

preparedness exercises. 

‘‘The Emergency Medical Device 

Shortages Program Survey’’ was 

developed in 2002 to support the 

acquisition of such data from medical 

device manufacturers. In 2004, CDRH 

changed the process for the data 

collection, and the electronic database 

in which the data were stored and was 

formally renamed the ‘‘Emergency 

Shortages Data Collection System’’ 

(ESDCS). Recognizing that some of the 

data collected may be commercially 

confidential, access to ESDCS is 

restricted to members of the FDA 

Emergency Shortage Team (EST) and 

senior management with a need-toknow. At this time, the need-to-know 

senior management personnel are 

limited to 5 senior managers. Further, 

the data are used by this defined group 

only for decisionmaking and planning 

in the context of a federally-declared 

disaster/emergency, an official 

emergency preparedness exercise, or a 

potential public health risk posed by 

non-disaster-related device shortage. 

The data procurement process 

consists of an initial scripted telephone 

call to a regulatory officer at a registered 

manufacturer of one or more key 

medical devices being tracked in the 

emergency shortages data collection 

system. In this initial call, the intent and 

goals of the data collection effort are 

described, and the specific data request 

is made. After the initial call, one or 

more additional followup calls and/or 

electronic mail correspondence may be 

required to verify/validate data sent 

from the manufacturer, confirm receipt 

and/or request additional detail. 

Although the regulatory officer is the 

agent who is initially contacted, they 

may designate an alternate 

representative within their organization 

to correspond subsequently with the 

CDRH EST member who is collecting or 

verifying/validating the data. 

Because of the dynamic nature of the 

medical device industry, particularly 

with respect to specific product lines, 

manufacturing capabilities and raw 

material/subcomponent sourcing, it is 

necessary to update the data in the 

ESDCS at regular intervals. This is done 

on a weekly basis, but efforts are made 

to limit the frequency of outreach to a 

specific manufacturer to no more than 

every 4 months. 

The ESDCS will only include those 

medical devices for which there will 

likely be high demand during a specific 

emergency/disaster, or for which there 

are sufficiently small numbers of 

manufacturers such that disruption of 

manufacture or loss of one or more of 

these manufacturers would create a 

shortage. 

In the Federal Register of December 

19, 2008 (73 FR 77718), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Act No. of 

Respondents 

Annual Frequency 

per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

903(d)(2) 125 3 375 0.5 188 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA based the burden estimates in 

Table 1 of this document on past 

experience with direct contact with the 

medical device manufacturers, and 

anticipated changes in the medical 

device manufacturing patterns for the 

specific devices being monitored. FDA 

estimates that approximately 125 

manufacturers would be contacted by 

telephone and/or electronic mail 3 times 

per year to either obtain primary data or 

to verify/validate data. Because the data 

being requested represent data elements 

that are monitored or tracked by 

manufacturers as part of routine 

inventory management activities, it is 

anticipated that for most manufacturers, 

the estimated time required of 

manufacturers to complete the data 

request will not exceed 30 minutes per 

request cycle. 

Dated: May 4, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–10816 Filed 5–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Title IV–E Foster Care Eligibility 

Review and Child and Family Service 

Reviews; Final Rule. 

OMB No.: 0970–0214. 

Description: The following five 

separate activities are associated with 

this information collection: Foster Care 

Eligibility Review (FCER) Program 

Improvement Plan; Child and Family 

Services Reviews (CFSR) State agency 


hsrobinson on PROD1PC76 with NOTICES