Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices 58383 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Determination Concerning a Petition 

To Add a Class of Employees to the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice of a 

determination concerning a petition to 

add a class of employees from Titanium 

Alloys Manufacturing in Niagara Falls, 

New York, to the Special Exposure 

Cohort (SEC) under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000 

(EEOICPA), 42 U.S.C. 7384q. On August 

23, 2012, the Secretary of HHS 

determined that the following class of 

employees does not meet the statutory 

criteria for addition to the SEC as 

authorized under EEOICPA: 

All employees who worked in any area or 

building at Titanium Alloys Manufacturing 

from January 1, 1955, through December 31, 

1956. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 1– 

877–222–7570. Information requests can 

also be submitted by email to 

DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2012–23276 Filed 9–19–12; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Secretary’s Advisory Committee on 

Human Research Protections 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: Pursuant to Section 10(a) of 

the Federal Advisory Committee Act, 

U.S.C. Appendix 2, notice is hereby 

given that the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) will hold its 

twenty-ninth meeting. The meeting will 

be open to the public. Information about 

SACHRP and the full meeting agenda 

will be posted on the SACHRP Web site 

at: http://www.hhs.gov/ohrp/sachrp/ 

mtgings/index.html. 

DATES: The meeting will be held on 

Tuesday, October 9, 2012 from 8:30 a.m. 

until 5:00 p.m. and Wednesday, October 

10, 2012 from 8:30 a.m. until 4:30 p.m. 

ADDRESSES: U.S. Department of Health 

and Human Services, 200 Independence 

Avenue SW., Room 705A, Washington, 

DC 20201. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Menikoff, M.D., J.D., Director, Office for 

Human Research Protections (OHRP), or 

Julia Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; 240–453–8141; fax: 

240–453–6909; email address: 

Julia.Gorey@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, Section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services and the 

Assistant Secretary for Health on issues 

and topics pertaining to or associated 

with the protection of human research 

subjects. 

The meeting will open Tuesday, 

October 9, with remarks from SACHRP 

Chair Dr. Barbara Bierer and OHRP 

Director Dr. Jerry Menikoff, followed by 

a report from the Subpart A 

Subcommittee (SAS). SAS will discuss 

their recent work, including 

considerations for revisions to the 

expedited review list, principal 

investigator responsibilities, and 

informed consent waiver criteria. SAS is 

charged with developing 

recommendations for consideration by 

SACHRP regarding the application of 

subpart A of 45 CFR part 46 in the 

current research environment; this 

subcommittee was established by 

SACHRP in October 2006. Tuesday 

afternoon will be a discussion of 

informed consent issues in cluster 

randomized trials, featuring Dr. Andrew 

McRae, Research Director of the 

Division of Emergency Medicine, 

University of Calgary. 

On the morning of October 10, the 

Subcommittee on Harmonization (SOH) 

will give a report and discuss their 

recent work, including local context 

guidance recommendations. SOH was 

established by SACHRP at its July 2009 

meeting, and is charged with identifying 

and prioritizing areas in which 

regulations and/or guidelines for human 

subjects research adopted by various 

agencies or offices within HHS would 

benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. Wednesday afternoon 

SACHRP will discuss a revised 

document on the issue of the use of the 

Internet in human subjects research, 

drafted by Drs. Elizabeth Buchanan and 

Dean Gallant. Public Comment will be 

heard on both days. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend the meeting and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the designated contact persons. 

Members of the public will have the 

opportunity to provide comments on 

both days of the meeting. Public 

comment will be limited to five minutes 

per speaker. Any members of the public 

who wish to have printed materials 

distributed to SACHRP members for this 

scheduled meeting should submit 

materials to the Executive Director, 

SACHRP, prior to the close of business 

October 1, 2012. 

Dated: September 13, 2012. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections, Executive Secretary, Secretary’s 

Advisory Committee on Human Research 

Protections. 

[FR Doc. 2012–23143 Filed 9–19–12; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: ‘‘Online 

Application Order Form for Products 

from the Healthcare Cost and Utilization 

Project (HCUP).’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously published in the Federal 

Register on June 27th, 2012 and allowed 

60 days for public comment. Several 

comments were received. The purpose 

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58384 Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices 

of this notice is to allow an additional 

30 days for public comment. 

DATES: Comments on this notice must be 

received by October 22, 2012. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Online Application Order Form for 

Products From the Healthcare Cost and 

Utilization Project (HCUP) 

The Healthcare Cost and Utilization 

Project (HCUP, pronounced ‘‘H-Cup’’) is 

a vital resource helping AHRQ achieve 

its research agenda, thereby furthering 

its goal of improving the delivery of 

health care in the United States. HCUP 

is a family of health care databases and 

related software tools and products 

developed through a Federal-StateIndustry partnership and sponsored by 

AHRQ. HCUP includes the largest 

collection of longitudinal hospital care 

data in the United States, with all-payer, 

encounter-level information beginning 

in 1988. The HCUP databases are annual 

files that contain anonymous 

information from hospital discharge 

records for inpatient care and certain 

components of outpatient care, such as 

emergency care and ambulatory 

surgeries. The project currently releases 

a variety of databases created for 

research use on a broad range of health 

issues, including cost and quality of 

health services, medical practice 

patterns, access to health care programs, 

and outcomes of treatments at the 

national, State, and local market levels. 

HCUP also produces a large number of 

software tools to enhance the use of 

administrative health care data for 

research and public health use. Software 

tools use information available from a 

variety of sources to create new data 

elements, often through sophisticated 

algorithms, for use with the HCUP 

databases. 

HCUP’s objectives are to: 

• Create and enhance a powerful 

source of national, state, and all-payer 

health care data. 

• Produce a broad set of software 

tools and products to facilitate the use 

of HCUP and other administrative data. 

• Enrich a collaborative partnership 

with statewide data organizations (that 

voluntarily participate in the project) 

aimed at increasing the quality and use 

of health care data. 

• Conduct and translate research to 

inform decision making and improve 

health care delivery. 

The HCUP releases six types of 

databases for public research use: 

(1) The Nationwide Inpatient Sample 

(NIS) is the largest all-payer inpatient 

care database in the United States, 

containing data from approximately 8 

million hospital stays from roughly 

1,000 hospitals; this approximates a 20- 

percent stratified sample of U.S. 

community hospitals. NIS data releases 

are available for purchase from the 

HCUP Central Distributor for data years 

beginning in 1988. 

(2) The Kids’ Inpatient Database (KID) 

is the only all-payer inpatient care 

database for children in the United 

States. The KID was specifically 

designed to permit researchers to study 

a broad range of conditions and 

procedures related to child health 

issues. The KID contains a sample of 

over 3 million discharges for children 

age 20 and younger from more than 

3,500 U.S. community hospitals. 

(3) The Nationwide Emergency 

Department Sample (NEDS) is the 

largest all-payer ED database in the 

United States. It is constructed to 

capture information both on ED visits 

that do not result in an admission and 

on ED visits that result in an admission 

to the same hospital. The NEDS 

contains more than 25 million 

unweighted records for ED visits at 

about 1,000 U.S. community hospitals 

and approximates a 20-percent stratified 

sample of U.S. hospital-based EDs. Files 

are available beginning with data year 

2006. 

(4) The State Inpatient Databases (SID) 

contain the universe of inpatient 

discharge abstracts from data 

organizations in 46 States that currently 

participate in the SID. Together, the SID 

encompasses approximately 97 percent 

of all U.S. community hospital 

discharges. Most States that participate 

in the SID make their data available for 

purchase through the HCUP Central 

Distributor. Files are available beginning 

with data year 1990. 

(5) The State Ambulatory Surgery 

Databases (SASD) contain data from 

ambulatory care encounters in hospitalaffiliated (and sometimes freestanding) 

ambulatory surgery sites. Currently, 29 

States participate in the SASD. Files are 

available beginning with data year 1997. 

(6) The State Emergency Department 

Databases (SEDD) contain data from 

hospital-affiliated emergency 

department (ED) abstracts for visits that 

do not result in a hospitalization. 

Currently, 29 States participate in the 

SEDD. Files are available beginning 

with data year 1999. 

To support AHRQ’s mission to 

improve health care through scientific 

research, HCUP databases and software 

tools are disseminated to users outside 

of the Agency through a mechanism 

known as the HCUP Central Distributor. 

The HCUP Central Distributor assists 

qualified researchers to access uniform 

research data across multiple states with 

the use of one application process. The 

HCUP databases disseminated through 

the Central distributor are referred to as 

‘‘restricted access public release files;’’ 

that is, they are publicly available, but 

only under restricted conditions. 

HCUP databases are released to 

researchers outside of AHRQ after the 

completion of required training and 

submission of an application that 

includes a signed FICUP Data Use 

Agreement (DUA). In addition, before 

restricted access public release statelevel databases are released, the user is 

asked for a brief description of their 

research to ensure that the planned use 

is consistent with HCUP policies and 

with the FICUP data use requirements. 

Fees are set for databases released 

through the HCUP Central Distributor 

depending on the type of database. The 

fee for sale of state-level data is 

determined by each participating 

Statewide Data Organization and 

reimbursed to those organizations. This 

project is being conducted by AHRQ 

through its contractor and 

subcontractor, Thomson Reuters and 

Social & Scientific Systems, Inc., 

pursuant to AHRQ’s statutory authority 

to conduct and support research on 

healthcare and on systems for the 

delivery of such care, including 

activities with respect to the outcomes, 

cost, cost-effectiveness, and use of 

health care services and access to such 

services. (42 U.S.C. 299a(a)(3).) 

Method of Collection 

This information collection request is 

for the activities associated with 

completing an online application form 

to request HCUP data, not the collection 

of health care data for HCUP databases. 

The activities associated with the HCUP 

online application include: 

(1) HCUP Application Form. All 

persons wanting access to the HCUP 

databases must complete an application 

package. Each unique database has a 

unique application package. All 

application packages are available for 

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Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices 58385 

downloading at http://www.hcupus.ahrq.gov/tech_assist/centdist.jsp. 

(2) HCUP Data Use Agreement 

Training. All persons wanting access to 

the HCUP databases must complete this 

online training course. The purpose of 

the training is to emphasize the 

importance of data protection, reduce 

the risk of inadvertent violations, and 

describe the individual’s responsibility 

when using HCUP data. The training 

course can be accessed and completed 

online at http://www.hcup-us.ahrq.gov/ 

tech_assist/dua.jsp. 

(3) HCUP Data Use Agreement (DUA). 

All persons wanting access to the HCUP 

databases must sign a data use 

agreement. Each database has a unique 

DUA; an example DUA for the 

Nationwide Inpatient Sample database 

is available at http://www.hcupus.ahrq.gov/team/NISDUA.jsp. 

Information collected in the HCUP 

Application Order Form will be used for 

two purposes only: 

1. Business Transaction: HCUP 

databases and software are currently 

delivered on disk and shipped to users 

who have completed the application 

process. Contact information is used for 

shipping the data on disk (or any other 

media used in the future). AHRQ policy 

and current agreements with Statewide 

Data Organizations contributing data to 

HCUP prohibit providing access to the 

data via the Internet or email. 

2. Enforcement of the HCUP Data Use 

Agreement (DUA): The HCUP DUA 

contains several restrictions on use of 

the data. Most of these restrictions have 

been put in place to safeguard the 

privacy of individuals and 

establishments represented in the data. 

For example, data users can only use the 

data for research, analysis, and aggregate 

statistical reporting and are prohibited 

from attempting to identify any persons 

in the data. Contact information on 

HCUP Data Use Agreements is retained 

in the event that a violation of the DUA 

takes place. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden associated with the 

applicants’ time to order any of the 

HCUP databases. An estimated 1,200 

persons will order HCUP data annually. 

Each of these persons will complete an 

application (10 minutes), the DUA 

training (15 minutes) and a DUA (5 

minutes). The total burden is estimated 

to be 600 hours annually. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the applicants’ time to order HCUP data. 

The total cost burden is estimated to be 

$21,408 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

HCUP Application Form .................................................................................. 1,200 1 10/60 200 

HCUP DUA Training ........................................................................................ 1,200 1 15/60 300 

HCUP DUA ...................................................................................................... 1,200 1 5/60 100 

Total .......................................................................................................... 3,600 na na 600 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average hourly wage rate * Total cost 

burden 

HCUP Application Form .................................................................................. 1,200 200 $35.68 $7,136 

HCUP DUA Training ........................................................................................ 1,200 300 35.68 10,704

HCUP DUA ...................................................................................................... 1,200 100 35.68 3,568 

Total .......................................................................................................... 3,600 600 na 21,408 

* Based upon the mean of the average wages for Life Scientists, All Other (19–1099), National Compensation Survey: Occupational wages in 

the United States May 2011, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost to process HCUP 

database applications and maintain the 

ordering system over the 3 years 

covered by this information collection 

request. It is estimated to cost $17,237 

annually to operate and maintain the 

ordering system. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Order Review ........................................................................................................................................................... $14,493 $4,831 

Monthly Updates—Product Catalog ........................................................................................................................ 1,857 619 

System Maintenance ............................................................................................................................................... 13,820 4,607 

Customer Inquiries ................................................................................................................................................... 4,483 1,495 

Management/Troubleshooting ................................................................................................................................. 17,058 5,689 

Total .................................................................................................................................................................. 51,711 17,237 

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58386 Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ healthcare 

research and healthcare information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: September 13, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–23165 Filed 9–19–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: ‘‘Medical 

Expenditure Panel Survey (MEPS) 

Household Component and the MEPS 

Medical Provider Component.’’ In 

accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521, 

AHRQ invites the public to comment on 

this proposed information collection. 

This proposed information collection 

was previously published in the Federal 

Register on June 13th, 2012 and allowed 

60 days for public comment. One 

comment was received. The purpose of 

this notice is to allow an additional 30 

days for public comment. 

DATES: Comments on this notice must be 

received by October 22, 2012. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Medical Expenditure Panel Survey 

(MEPS) Household Component and the 

MEPS Medical Provider Component 

For over thirty years, results from the 

MEPS and its predecessor surveys (the 

1977 National Medical Care 

Expenditure Survey, the 1980 National 

Medical Care Utilization and 

Expenditure Survey and the 1987 

National Medical Expenditure Survey) 

have been used by OMB, DHHS, 

Congress and a wide number of health 

services researchers to analyze health 

care use, expenses, and health policy. 

Major changes continue to take place 

in the health care delivery system. The 

MEPS is needed to provide information 

about the current state of the health care 

system as well as to track changes over 

time. The MEPS permits annual 

estimates of use of health care and 

expenditures and sources of payment 

for that health care. It also permits 

tracking individual change in 

employment, income, health insurance 

and health status over two years. The 

use of the National Health Interview 

Survey (NHIS) as a sampling frame 

expands the MEPS analytic capacity by 

providing another data point for 

comparisons over time. 

Households selected for participation 

in the MEPS Household Component 

(MEPS–HC) are interviewed five times 

in person. These rounds of interviewing 

are spaced about 5 months apart. The 

interview will take place with a family 

respondent who will report for him/ 

herself and for other family members. 

The MEPS–HC has the following goal: 

• To provide nationally 

representative estimates for the U.S. 

civilian noninstitutionalized population 

for health care use, expenditures, 

sources of payment and health 

insurance coverage. 

The MEPS Medical Provider 

Component (MEPS–MPC) will contact 

medical providers (hospitals, 

physicians, home health agencies and 

institutions) identified by household 

respondents in the MEPS–HC as sources 

of medical care for the time period 

covered by the interview, and all 

pharmacies providing prescription 

drugs to household members during the 

covered time period. The MEPS–MPC is 

not designed to yield national estimates. 

The sample is designed to target the 

types of individuals and providers for 

whom household reported expenditure 

data was expected to be insufficient. For 

example, households with one or more 

Medicaid enrollees are targeted for 

inclusion in the MEPSMPC because this 

group is expected to have limited 

information about payments for their 

medical care. 

The MEPS–MPC has the following 

goal: 

• To serve as an imputation source 

for and to supplement/replace 

household reported expenditure and 

source of payment information. This 

data will supplement, replace and verify 

information provided by household 

respondents about the charges, 

payments, and sources of payment 

associated with specific health care 

encounters. 

This study is being conducted by 

AHRQ through its contractors, Westat 

and RTI International, pursuant to 

AHRQ’s statutory authority to conduct 

and support research on healthcare and 

on systems for the delivery of such care, 

including activities with respect to the 

cost and use of health care services and 

with respect to health statistics and 

surveys. 42 U.S.C. 299a(a)(3) and (8); 42 

U.S.C. 299b–2. 

Method of Collection 

To achieve the goals of the MEPS–HC 

the following data collections are 

implemented: 

1. Household Component Core 

Instrument. The core instrument 

collects data about persons in sample 

households. Topical areas asked in each 

round of interviewing include condition 

enumeration, health status, health care 

utilization including prescribed 

medicines, expense and payment, 

employment, and health insurance. 

Other topical areas that are asked only 

once a year include access to care, 

income, assets, satisfaction with health 

plans and providers, children’s health, 

and adult preventive care. While many 

of the questions are asked about the 

entire reporting unit (RU), which is 

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