Federal Register / Vol. 73, No. 161 / Tuesday, August 19, 2008 / Notices 48383 

schedules L–NT1, L–FPT1, L–NFPT1, 

L–AS1, L–AS2, L–AS4, L–AS5, L–AS6 

and L–AS7 through February 28, 2011. 

Dated: August 12, 2008. 

Jeff Kupfer, 

Acting Deputy Secretary. 

Department of Energy 

Deputy Secretary 

Rate Order No. WAPA–141. 

In the Matter of: Western Area Power 

Administration Rate Extension for Loveland 

Area Projects Transmission and Ancillary 

Services Formula Rates. 

Order Confirming and Approving an 

Extension of the Loveland Area Projects 

Transmission and Ancillary Services 

Formula Rates 

The Loveland Area Projects (LAP) 

transmission and ancillary services rate 

formulae were established following section 

302(a) of the Department of Energy (DOE) 

Organization Act (42 U.S.C. 7152). This act 

transferred to and vested in the Secretary of 

Energy the power marketing functions of the 

Secretary of the Department of the Interior 

and the Bureau of Reclamation under the 

Reclamation Act of 1902 (ch. 1093, 32 Stat. 

388), as amended and supplemented by 

subsequent laws, particularly section 9(c) of 

the Reclamation Project Act of 1939 (43 

U.S.C. 485h(c)), and other Acts that 

specifically apply to the project system 

involved. 

By Delegation Order No. 00–037.00 

effective December 6, 2001, the Secretary of 

Energy delegated: (1) The authority to 

develop power and transmission rates to the 

Administrator of the Western Area Power 

Administration (Western); (2) the authority to 

confirm, approve, and place such rates into 

effect on an interim basis to the Deputy 

Secretary of Energy; and (3) the authority to 

confirm, approve, and place into effect on a 

final basis, to remand, or to disapprove such 

rates to the Federal Energy Regulatory 

Commission (FERC). This rate extension is 

issued pursuant to the Delegation Order and 

the DOE rate extension procedures at 10 CFR 

part 903.23(b). 

Background 

The existing formula rates, approved under 

Rate Order No. WAPA–106, were approved 

for five (5) years and are effective through 

February 28, 2009. Subsequently, Rate 

Schedule L–AS3, Regulation and Frequency 

Response, was revised and approved for five 

(5) years under Rate Order No. WAPA–118 

and is effective through May 31, 2011. 

Western is not seeking to extend Rate 

Schedule L–AS3 for Regulation and 

Frequency Response service as part of this 

extension. 

Discussion 

On February 28, 2009, Western’s LAP 

transmission and ancillary services formula 

rates will expire, with the exception of 

Regulation and Frequency Response service, 

which will expire May 31, 2011. Western is 

proposing to extend the existing LAP 

transmission and ancillary services formula 

rates pursuant to 10 CFR part 903.23(b). The 

existing LAP rate formulae methodologies 

collect annual revenue sufficient to recover 

annual expenses (including interest) and 

capital requirements, thus ensuring 

repayment of the project within the cost 

recovery criteria set forth in DOE order RA 

6120.2. Western is seeking this extension to 

provide more time for the evaluation of new 

rate requirements for transmission and 

ancillary services mandated under FERC 

Order 890 and the evaluation of adjustments 

to the formulae for ancillary services. For 

these reasons, Western is extending the 

existing rate formulae for transmission and 

ancillary services through February 28, 2011. 

The process will take several months to 

complete because of the complex issues 

Western and its interested parties must 

address. It will also offer opportunities for 

public information and comment forums. For 

these reasons, Western seeks to extend 

existing Rate Schedules L–NT1, L–FPT1, L–

NFPT1, L–AS1, L–AS2, L–AS4, L–AS5, L–

AS6 and L–AS7. Western did not have a 

consultation and comment period and did 

not hold public information and comment 

forums, in accordance with 10 CFR part 

903.23(b). 

Order 

In view of the above and under the 

authority delegated to me, I hereby extend for 

a period effective from March 1, 2009, 

through February 28, 2011, the existing rate 

schedules L–NT1, L–FPT1, L–NFPT1, L–

AS1, L–AS2, L–AS4, L–AS5, L–AS6 and L–

AS7 for LAP transmission and ancillary 

services, excluding L–AS3 for Regulation and 

Frequency Response service. 

Dated: August 12, 2008. 

Jeff Kupfer, 

Acting Deputy Secretary. 

[FR Doc. E8–19161 Filed 8–18–08; 8:45 am] 

BILLING CODE 6450–01–P 

EQUAL EMPLOYMENT OPPORTUNITY 

COMMISSION 

Sunshine Act Meeting 

DATE AND TIME: Friday, August 22, 2008, 

1 p.m. Eastern Time. 

PLACE: Clarence M. Mitchell, Jr. 

Conference Room on the Ninth Floor of 

the EEOC Office Building, 1801 ‘‘L’’

Street, NW., Washington, DC 20507. 

STATUS: The meeting will be open to the 

public. 

MATTERS TO BE CONSIDERED: 

Open Session 

1. Announcement of Notation Votes, 

2. Obligation of Funds for eGovernment Application Hosting/ 

Managed Services and Extension of 

DOI/NBC Hosting, and 

3. Obligation of Funds for 

Competitive Revolving Fund Online 

Registration and Payment Collection 

System Contract, and Sole Source 

Extension of Current Contract for 

Transition Period. 

Note: In accordance with the Sunshine Act, 

the meeting will be open to public 

observation of the Commission’s 

deliberations and voting. (In addition to 

publishing notices on EEOC Commission 

meetings in the Federal Register, the 

Commission also provides a recorded 

announcement a full week in advance on 

future Commission sessions.) 

Please telephone (202) 663–7100 

(voice) and (202) 663–4074 (TTY) at any 

time for information on these meetings. 

The EEOC provides sign language 

interpretation at Commission meetings 

for the hearing impaired. Requests for 

other reasonable accommodations may 

be made by using the voice and TTY 

numbers listed above. 

CONTACT PERSON FOR MORE INFORMATION: 

Stephen Llewellyn, Executive Officer on 

(202) 663–4070. 

Dated: August 15, 2008. 

Stephen Llewellyn, 

Executive Officer, Executive Secretariat. 

[FR Doc. E8–19279 Filed 8–15–08; 4:15 pm] 

BILLING CODE 6570–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0428] 

Electronic Study Data Submission for 

Phase 3 Janus Operational Pilot; 

Notice of Pilot Project 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Center for Drug 

Evaluation and Research (CDER) is 

seeking sponsors interested in 

participating in a pilot project to test the 

submission and processing of clinical 

study data provided electronically in a 

standardized format. This pilot will test 

the data extract, validation, and load 

procedures developed to populate 

‘‘Janus,’’ the study data repository 

component of a common, standardsbased infrastructure that is being 

developed jointly by the Food and Drug 

Administration (FDA) and the National 

Cancer Institute (NCI) to support the 

exchange of clinical research data. The 

pilot also will test a new XML 

(extensible markup language)-based 

submission format for standardized 

clinical study data. We anticipate that a 

successful pilot will enable CDER to 

routinely receive, process, and store all 

standardized clinical study data in a 


ebenthall on PRODPC60 with NOTICES
48384 Federal Register / Vol. 73, No. 161 / Tuesday, August 19, 2008 / Notices 

1See http://www.fda.gov/bbs/topics/news/2004/ 

NEW01095.html. 

2See http://www.reginfo.gov/public/do/ 

eAgendaViewRule?ruleID=279292. (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.) 

3See SDTM Validation Specification 1.0, Nov. 

2007 at http://www.fda.gov/oc/datacouncil/janus_

operational_pilot.html. 

data warehouse environment that will 

enhance the center’s capability to 

manage and review standardized study 

data. 

DATES: Submit written or electronic 

requests to participate in the pilot 

project by November 17, 2008. General 

comments on the Janus operational pilot 

project are welcome at any time. 

ADDRESSES: Submit written requests to 

participate and comments regarding this 

pilot project to the Division of Drug 

Information, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Bobbie Witczak, Food and Drug 

Administration, 5600 Fishers Lane 

(HFD–070), Rockville, MD 20857, 301–

796–4126. 

For specific questions regarding 

Voluntary Genomic Data Submissions, 

please contact: Federico Goodsaid, Food 

and Drug Administration, 10903 New 

Hampshire Ave, Bldg. 51, rm. 2148 

Silver Spring, MD 20903, 301–796–1535 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing an opportunity to 

participate in a pilot project that 

involves the ongoing development and 

testing of a repository for standardized 

clinical study data (the Janus study data 

warehouse). This pilot will test the 

electronic receipt, processing, and 

storage of standardized clinical study 

data, including the successful validation 

and loading of data into the Janus study 

repository and subsequent access of that 

data by reviewers using a combination 

of analytical and visualization tools. 

The Janus study data repository is the 

data warehouse component of a 

common, standards-based infrastructure 

that is being developed jointly by FDA 

and the NCI to support the exchange of 

clinical research data. Janus is designed 

to enhance the agency’s capability to 

manage and review standardized study 

data. 

CDER has been accepting voluntary 

electronic submissions of standardized 

clinical study data since July 2004.1

Applicants wishing to provide clinical 

study data in standardized format are 

advised to follow the Study Data 

Tabulation Model (SDTM) defined by 

the Clinical Data Interchange Standards 

Consortium (CDISC). CDISC is an open, 

multidisciplinary, nonprofit 

organization that has established 

worldwide industry standards to 

support the electronic acquisition, 

exchange, submission, and archiving of 

clinical trial data and metadata for 

medical and biopharmaceutical product 

development (http://www.cdisc.org). 

Under current regulations, applicants 

are required to provide case report 

tabulations (i.e., study data) for certain 

studies included in a marketing 

application (see 21 CFR 314.50). In 

guidance for industry titled ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Human Pharmaceutical 

Product Application and Related 

Submissions Using the eCTD 

Specifications,’’ FDA makes 

recommendations about how to submit 

documents in electronic format for 

investigational new drug (IND) 

applications, biologic license 

applications (BLAs), and new drug 

applications (NDAs) using the electronic 

common technical document (eCTD) 

specifications. In Section III.E.4 of that 

guidance, FDA refers to the CDISC 

SDTM as the Study Data Specification 

for voluntary electronic submission of 

clinical study data. 

In addition, FDA is planning to 

amend the regulations governing the 

format in which clinical study data and 

bioequivalence data are required to be 

submitted for NDAs, BLAs, and 

abbreviated new drug applications 

(ANDAs).2 This proposal would revise 

FDA’s regulations to require that 

clinical data submitted for NDAs, BLAs, 

and ANDAs, and their supplements and 

amendments: (1) Be provided in 

electronic format and (2) use a 

standardized data structure, 

terminology, and code sets as referenced 

in FDA guidance to enable efficient and 

comprehensive data review. 

The Janus study data repository is 

being developed by FDA and NCI 

through the Interagency Oncology Task 

Force (IOTF), which was established in 

2003 to enable the two organizations to 

share knowledge and resources to 

facilitate the development of new cancer 

drugs and speed the development and 

their delivery to patients. As part of the 

IOTF agreement, FDA is working with 

NCI to build tools and an environment 

that facilitates and streamlines 

electronic interaction and collaboration 

among FDA and its stakeholders in the 

regulatory review process. The Janus 

initiative is part of a larger effort to 

implement a common, standards-based 

electronic infrastructure that supports 

the submission, validation, data 

warehousing, access, and analysis of 

structured scientific data to support 

regulatory review. 

Phase 1 of the Janus implementation 

effort was a proof of concept pilot that 

successfully demonstrated the ability to 

load SDTM data into Janus, extract data 

from Janus using commercial-off-theshelf (COTS) query tools, and produce 

data from Janus in SDTM format. Phase 

2 of this initiative involved 

development of an operational pilot that 

includes a data import and validation 

facility, the integration of reviewer tools 

with the Janus repository, and provision 

of reviewer access to the data via 

selected analytical and visualization 

tools. Validation criteria for processing 

SDTM submissions were developed for 

use in that pilot based on the SDTM 

implementation guide and FDA 

business requirements. The SDTM 

validation specification for Janus 

established the business rules for errorchecking functions that determine 

whether SDTM submission data can be 

loaded successfully into the Janus 

repository.3

CDER has received a limited number 

of SDTM submissions since it began 

accepting these standardized datasets. 

Our experience with these submissions 

during the phase 2 pilot has shown that 

additional collaboration with sponsors 

will be needed on the preparation, 

submission, and analysis of SDTM 

datasets to facilitate a common 

understanding of the data quality 

requirements that are necessary to 

realize long-term benefits of an 

integrated clinical trials data repository. 

As a result, FDA is now announcing 

the start of phase 3 of the Janus 

operational pilot, which will enable a 

wider stakeholder community to 

participate in the Janus development 

initiative. The goals of the phase 3 pilot 

are as follows: 

• Transition the phase 2 pilot to 

operational production; 

• Test the electronic processing of 

standardized clinical study data, 

including the successful validation and 

loading of data into the Janus study 

repository and subsequent access to that 

data by reviewers using a combination 

of analytical and visualization tools; 

• Test a new XML-based submission 

format for CDISC content (CDISC–HL7 


ebenthall on PRODPC60 with NOTICES
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