45858 Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 

1 Institute of Medicine, ‘‘The Future of Drug 

Safety—Promoting and Protecting the Health of the 

Public,’’ September 22, 2006, http://www.iom.edu/ 

. (FDA has verified the Web site address, but FDA 

is not responsible for any subsequent changes to the 

Web site after this document publishes in the 

Federal Register.) 

2Food and Drug Administration Amendments 

Act of 2007, Public Law 110–85, was signed into 

law in September 2007. See Title IX, Section 905. 

regulations, ACF requests extension of 

the ACF–800. With this extension, ACF 

is proposing several changes and 

clarifications to the reporting 

requirements and instructions. 

Respondents: States, the District of 

Columbia, and Territories including 

Puerto Rico, Guam, the Virgin Islands, 

American Samoa, and the Northern 

Marianna Islands. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ACF–800 .......................................................................................................... 56 1 40 2,240 

Estimated Total Annual Burden Hours: 2,240 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7245, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: September 1, 2009. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. E9–21410 Filed 9–3–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0098] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Evaluation of 

Potential Data Sources for the Sentinel 

Initiative 

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 October 5, 

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–NEW and 

title, ‘‘Evaluation of Potential Data 

Sources for the Sentinel Initiative.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794, 

JonnaLynn.Capezzuto@fda.hhs.gov. 

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. 

Evaluation of Potential Data Sources for 

the Sentinel Initiative 

In September 2005, the Secretary of 

Health and Human Services (the 

Secretary) asked FDA to expand its 

current system for monitoring medical 

product performance. The Secretary 

asked FDA to explore the possibility of 

working in collaboration with multiple 

healthcare data systems to augment 

FDA’s capability of identifying and 

evaluating product safety information 

beyond its existing voluntary reporting 

systems. Such a step would strengthen 

FDA’s ability, ultimately, to monitor the 

performance of a product after 

marketing approval. The Secretary 

recommended that FDA explore creating 

a public-private collaboration as a 

framework for such an effort leveraging 

increasingly available large, electronic 

healthcare databases and taking 

advantage of emerging technologies and 

building on existing systems and efforts, 

rather than creating new systems. 

In 2006, the Institute of Medicine 

(IOM) issued a report entitled ‘‘The 

Future of Drug Safety—Promoting and 

Protecting the Health of the Public.’’1

Among other suggestions, this IOM 

report recommended FDA identify ways 

to access other health-related databases 

and create a public-private partnership 

to support safety and efficacy studies. 

In 2007, Congress enacted the Food 

and Drug Administration Amendments 

Act of 20072 (FDAAA). Section 905 of 

FDAAA calls for the Secretary to 

develop methods to obtain access to 

disparate data sources and to establish 

an active postmarket risk identification 

and analysis system that links and 

analyzes healthcare data from multiple 

sources. The law sets a goal of access to 

data from 25 million patients by July 1, 

2010, and 100 million patients by July 

1, 2012. The law also requires FDA to 

work closely with partners from public, 

academic, and private entities. FDA 

views the Sentinel Initiative as a 

mechanism through which this mandate 

can be carried out. 

Consistent with FDA’s mission to 

protect and promote the public health, 

FDA is embarking on the Sentinel 

Initiative to create a national, electronic 

distributed system, strengthening FDA’s 

ability to monitor the post-market 

performance of a product. As currently 

envisioned, the Sentinel Initiative will 

enable FDA to capitalize on the 

capabilities of multiple, existing data 

systems (e.g. electronic health record 

systems and medical claims databases) 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45859 

to augment the agency’s current 

surveillance capabilities. The proposed 

system will enable queries of distributed 

data sources quickly and securely for 

relevant product safety information. 

Data will continue to be managed by its 

owners, and only data of organizations 

who agree to participate in this system 

will be included. Operations will adhere 

to strict privacy and security safeguards. 

The success of this Initiative will 

depend largely on the content, quality, 

searchability, and responsiveness of 

participating data sources and/or data 

environments. It is essential that FDA 

understand the strengths and limitations 

of potential data sources that might be 

included in the Sentinel Initiative. This 

survey will be used to collect 

information from potentially 

participating data sources and/or 

environments. The data we are seeking 

will describe the characteristics of the 

data available, not personally 

identifiable information. The findings 

will help FDA plan for this proposed 

system and for future work related to 

the Sentinel Initiative. 

This survey will collect information 

on the scope, content, structure, quality, 

and timeliness of data; patient 

population(s), duration of followup, and 

capture of care across all settings; 

availability, experience, and interest of 

investigators with knowledge of the data 

in using it for post-market product 

safety surveillance as well as plans for 

further data source enhancements; 

availability, experience, and interest of 

investigators with knowledge of the data 

in participating in a distributed data 

system; and barriers that exist to 

including each data source in the 

Sentinel Initiative. 

In the Federal Register of March 9, 

2009 (74 FR 10053), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions to which one comment was 

received but was outside the scope of 

the PRA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Data Source and/or Environment 

Survey 250 1 250 24.5 6,125 

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

FDA estimates that approximately 250 

respondents will participate in this 

voluntary survey. These respondents 

will consist mostly of other Federal 

agencies, health plan data sources, 

health information exchanges, large 

multi-specialty medical groups and 

academic medical centers, large hospital 

systems, pharmacies, medical societies, 

consumer-oriented Web sites, 

commercial data sets, research 

networks, lab data, and registries. 

Each respondent will extend 

approximately 24.5 hours to complete 

one survey for a total of 6,125 hours 

(250 x 1 x 24.5 = 6,125). 

Dated: August 27, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21364 Filed 9–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–09BW] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an 

e-mail to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Postural Analysis in Low-Seam 

Mines—Existing collection without an 

OMB control number—National 

Institute for Occupational Safety and 

Health (NIOSH), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

NIOSH, under Public Law 91–596, 

sections 20 and 22 (section 20–22, 

Occupational Safety and Health Act of 

1970) has the responsibility to conduct 

research relating to innovative methods, 

techniques, and approaches dealing 

with occupational safety and health 

problems. 

According to the Mining Safety and 

Health Administration (MSHA) injury 

database, 227 knee injuries were 

reported in underground coal mining in 

2007. With data from the National 

Institute for Occupational Safety and 

Health (NIOSH), it can be estimated that 

the financial burden of knee injuries 

was nearly three million dollars in 2007. 

Typically, mine workers utilize 

kneepads to better distribute the 

pressures at the knee. The effectiveness 

of these kneepads is to be investigated 

in a study by NIOSH. Thus, NIOSH will 

be determining the forces, stresses, and 

moments at the knee while in postures 

associated with low-seam mining. At 

this time, the postures utilized by lowseam mine workers and their frequency 

of use are unknown. Therefore, before 

conducting this larger, experimental 

study, the existing collection without an 

OMB control number was required. 

The aim of the field study described 

in this document was to determine the 

postures predominantly used by lowseam mine workers such that they may 

complete the various tasks associated 

with their job duties. A questionnaire 

was developed for each of the major job 

types seen in low-seam mines with 

continuous miners (continuous miner 

operator, roof bolter operator, shuttle car 

operator, mobile bridge operator, 

mechanic, beltman, maintenance shift 

worker, foreman). The questionnaire 

asked basic demographic information 

(e.g., time in job type, years in mining, 

age). Additionally, a series of questions 

were asked such that it could be 

determined if a mine worker is likely to 

have a knee injury, even if it is 

undiagnosed. These questions were 

developed with the help of a physical 

therapist. A schematic of possible 

postures was then presented to the mine 

workers and they were asked to identify 

the primary two postures they utilize to 

complete their job duties. The 

questionnaire then asked mine workers 

to identify the primary postures they 

utilize to complete specific tasks (e.g., 

hanging curtain, building stoppings) 

that are part of their job duties. Finally, 


srobinson on DSKHWCL6B1PROD with NOTICES