Federal Register / Vol. 73, No. 161 / Tuesday, August 19, 2008 / Notices 48385 

4See http://www.fda.gov/cder/genomics/ 

VGDS.htm. 

5Health Level Seven in an American Standards 

Institute (ANSI)-accredited standards development 

organization operating in the health care arena. See 

http://www.hl7.org. (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.) 

6See http://www.fda.gov/oc/datacouncil/ 

janus_operational_pilot.html. 

messages, see below) currently under 

development; 

• Extend the Janus logical data model 

and service-oriented architecture to 

support submission of CDISC-HL7 

messages; 

• Integrate with NCI’s Enterprise 

Vocabulary Service (EVS); 

• Test the integration and analysis of 

clinical study data stored in Janus with 

pharmacogenomic data currently being 

received through the Voluntary 

Genomic Data Submissions (VGDS) 

program.4

A desired outcome of the phase 3 

pilot is a production environment that 

supports the routine processing and 

management of all structured clinical 

study data provided in regulatory 

submissions. 

The phase 3 operational pilot will 

also test a new submission format. 

Currently, SDTM datasets are provided 

in SAS transport format. FDA 

recognizes the limitations of the 

outdated SAS transport format and 

intends to transition towards a new, 

more robust XML-based submission 

format. FDA is currently sponsoring a 

project within HL75 to develop a 

standard XML exchange format (called 

‘‘messages’’) for standardized clinical 

study data content as defined by CDISC. 

This ‘‘CDISC Content to HL7 Message 

Project’’ will enable the exchange of 

clinical study data in a standardized 

HL7–XML-based format. We believe this 

will facilitate loading study data into 

Janus and provide additional benefits. A 

successful phase 3 pilot will also enable 

FDA to routinely accept HL7–XMLbased clinical study data submissions. 

Concurrent with the phase 3 pilot, 

CDER also will be exploring ways to 

integrate related data standards 

initiatives with the Janus effort. These 

related initiatives include the 

enhancement of the current Janus 

logical model to incorporate preclinical 

and pharmacogenomics data and 

product safety data. Future efforts will 

continue to focus on business 

information requirements for managing 

product life-cycle data across all FDA 

regulated products. 

II. Pilot Project Description 

This pilot project is part of an ongoing 

effort to improve the efficiency of the 

review of study data within CDER. As 

we gain additional experience from this 

pilot, CDER expects to update its study 

data submission technical specifications 

as part of a continuing process to 

improve the quality of clinical study 

data provided electronically. 

A. Approach 

CDER is seeking applicants who have 

submitted or are planning to submit in 

the near future (i.e., within 6 months of 

publication of this notice) SDTM files in 

a regulatory submission in accordance 

with existing guidance and technical 

specifications. Our experience during 

phase 2 has shown that SDTM files 

routinely fail the Janus validation 

procedures and cannot be loaded into 

Janus automatically. Pilot participants 

should agree to work closely with Janus 

technical staff to review the validation 

errors, correct them, and resubmit the 

files. The ability to successfully load 

data into the Janus repository is an 

important pilot milestone. Experience 

gained as a result of working with 

participating sponsors during this pilot 

will help us improve the validation 

criteria, which subsequently will help 

improve the quality of future study data 

submissions. Pilot participants will also 

gain valuable experience in creating and 

submitting quality standardized data 

submissions. Of particular interest are 

pilot participants who are also able to 

provide pharmacogenomic data (i.e., 

VGDS) with the CDISC data. This will 

enable us to test the integration of 

clinical data stored in Janus with 

pharmacogenomic data. Although a 

VGDS is not required to participate in 

this pilot, it is a desirable component of 

the pilot and is encouraged whenever 

possible. 

From this pool of pilot participants, 

we are also seeking five to eight 

companies willing to supply study data 

in the new HL7 XML format (in addition 

to SDTM datasets) for testing, 

processing, and loading into Janus. FDA 

will provide some technical support 

with the new HL7 XML format, such as 

help in understanding and interpreting 

the new specifications. Those who 

participate in this part of the pilot also 

will be provided secure access to their 

data in Janus so they can test the 

integrity of their data within the Janus 

environment. Although the SDTM files 

are part of a regulatory submission, all 

of the activities involved in this pilot 

will be conducted outside of a 

regulatory setting. That is, the SDTM 

datasets will be reviewed according to 

current review practices for any 

electronic dataset submission, and pilot 

activities will not impact the regulatory 

review clock, will not affect or delay 

reviewability assessments, filability 

decisions, or any regulatory actions. 

B. How to Participate 

Requests to participate in the pilot 

project should be submitted to the 

Division of Dockets Management (see 

ADDRESSES). Requests are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The pilot enrollment period 

will last 6 months following publication 

of this notice. The pilot is expected to 

last approximately 1 year, but this 

duration will be subject to change as the 

pilot progresses. Updates to the pilot 

will be publicly posted on the FDA 

Janus Operational Pilot Web page.6

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this pilot project. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: August 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19197 Filed 8–18–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 30-Day 

Proposed Information Collection: 

Behavioral Health Preventive Care 

Assessment Focus Group 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 which requires 

30 days for public comment on 

proposed information collection 

projects, the Indian Health Service (IHS) 

has submitted to the Office of 

Management and Budget (OMB) a 

request to review and approve the 

information collection listed below. 

This proposed information collection 

project was previously published in the 


ebenthall on PRODPC60 with NOTICES
48386 Federal Register / Vol. 73, No. 161 / Tuesday, August 19, 2008 / Notices 

Federal Register (73 FR 23254) on April 

29, 2008 and allowed 60 days for public 

comment. No public comment was 

received in response to the notice. The 

purpose of this notice is to allow 30 

days for public comment to be 

submitted directly to OMB. 

Proposed Collection: Title: 0917–

NEW, ‘‘Behavioral Health Preventative 

Care Assessment Focus Group.’’ Type of 

Information Collection Request: Three 

year approval for this new information 

collection, 0917–NEW, ‘‘Behavioral 

Health Preventive Care Assessment 

Focus Group Guide.’’ Form Number(s): 

None. Need and Use of Information 

Collection: The IHS goal is to raise the 

health status of the American Indian 

and Alaska Native people to the highest 

possible level by providing 

comprehensive health care and 

preventive health services. To support 

the IHS mission, IHS uses the 

Government Performance Act (GPRA) to 

assess quality of care among its Federal, 

urban, and Tribal health programs. The 

IHS has been largely successful in 

meeting GPRA targets for selected 

clinical performance measures at the 

national level. However, there is 

significant variability in performance 

among IHS and Tribal service units. 

Until this time, IHS has not 

undertaken any comprehensive studies 

to evaluate the reasons for that 

variability or the factors that contribute 

to high quality care at the local level. 

The IHS has three GPRA measures 

relating to behavioral health, a high 

priority for the Agency and one of the 

IHS Director’s Initiatives. This study 

will focus on these three GPRA 

behavioral health measures: Depression 

Screening in adults age 18 and over, 

Domestic/Intimate Partner Violence 

screening in women ages 15–40 and 

Alcohol Screening (to prevent Fetal 

Alcohol Syndrome) in women ages 

15–44. 

Tribal programs voluntarily report 

their GPRA results quarterly and 

annually for national reporting. GPRA 

data collected for these three behavioral 

health measures includes: The number 

of patients eligible for a screening 

(denominator), number of eligible 

patients who receive a screening 

(numerator), and the resulting screening 

rate (percentage). IHS has developed 

methodology to identify superior and 

poor performers on these measures in 

both Tribal and Federal sites using fiscal 

year 2005, 2006, and 2007 GPRA 

performance results. 

IHS will convene focus groups with 

employees at 17 of these programs 

(7 IHS and 10 Tribal) in order to identify 

the factors contributing to (and when 

appropriate, the barriers preventing) the 

provision of high quality behavioral 

health care at the local level. These 

focus groups will allow employees to 

provide detailed data regarding program 

practices, screening and documentation 

procedures, initiatives, resources, and 

other factors relating to the provision of 

behavioral health preventive care at 

their health program. A total of two to 

three focus groups, organized by 

occupational specialty, will be 

convened at each program. 

Using the Chronic Care Model and 

Institute of Medicine recommendations, 

IHS will analyze the information 

collected during these site visits, along 

with background information that is 

publicly available (e.g., information 

found on clinic Web pages) on other 

qualitative and quantitative features of 

individual programs, such as staffing 

and funding levels, community 

demographics, and organizational 

structure, to develop a behavioral health 

preventive care model relevant to the 

unique system of IHS delivery. Affected 

Public: Individuals. Type of 

Respondents: Tribal employees at Tribal 

health programs. 

The table below provides: Types of 

data collection instruments, Estimated 

number of respondents, Number of 

responses per respondent, Number of 

total annual responses, Average burden 

hour per response, and Total annual 

burden hour(s). 

Data collection instrument(s) Number of 

respondents 

Responses 

per 

respondent 

Total annual 

response 

Burden hour 

per response 

Annual burden 

hours 

Administrators/Supervisor Focus Group Guide ................... 30 1 30 2 60 

Provider Focus Group Guide ............................................... 30 1 30 2 60 

Behavioral Health Provider Focus Group Guide ................. 15 1 15 2 30 

Data Entry Focus Group Guide ........................................... 15 1 15 2 30 

Total .............................................................................. 90 ........................ ........................ ........................ 180 

There are no Capital Costs, Operating 

Costs, and/or Maintenance Costs to 

report. 

Request for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

agency processes the information 

collected in a useful and timely fashion; 

(c) the accuracy of public burden 

estimate (the estimated amount of time 

needed for individual respondents to 

provide the requested information); (d) 

whether the methodology and 

assumptions used to determine the 

estimates are logical; (e) ways to 

enhance the quality, utility, and clarity 

of the information being collected; and 

(f) ways to minimize the public burden 

through the use of automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Send your 

written comments and suggestions 

regarding the proposed information 

collection contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time to: Office of Management and 

Budget, Office of Regulatory Affairs, 

New Executive Office Building, Room 

10235, Washington, DC 20503, 

Attention: Desk Officer for IHS. 

To request more information on the 

proposed collection or to obtain a copy 

of the data collection instrument(s) and/ 

or instruction(s) contact: Ms. Janet 

Ingersoll, Acting IHS Reports Clearance 

Officer, 12300 Twinbrook Parkway, 

Suite 450, Rockville, MD 20852–1601; 

call non-toll-free (301) 443–1116; send 

via facsimile to (301) 443–2316; or send 

your e-mail requests, comments, and 

return address to: 

JanetIngersoll@ihs.gov. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 11, 2008. 

Robert G. McSwain, 

Director, Indian Health Service. 

[FR Doc. E8–19050 Filed 8–18–08; 8:45 am] 

BILLING CODE 4165–16–M 


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