11370 Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 

presentations may depend on the 

number of persons who wish to speak. 

If you require special 

accommodations due to a disability, 

please contact Aleta Sindelar at least 7 

days in advance of the meeting. 

Comments: Interested persons may 

submit to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, written or 

electronic comments. Electronic 

comments may be submitted to the 

docket at the following site: http:// 

www.fda.gov/dockets/ecomments. 

Submit a single copy of electronic 

comments or two paper copies of 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. The docket 

will remain open for written or 

electronic comments through May 24, 

2007. 

SUPPLEMENTARY INFORMATION: 

I. Background 

ADUFA amended the Federal Food, 

Drug, and Cosmetic Act (the act) and 

authorized FDA to collect fees for 

certain animal drug applications, 

establishments, products and sponsors 

in support of the review of animal 

drugs. These additional resources 

support FDA’s responsibilities under 

the act to provide greater public health 

protection by ensuring that animal drug 

products that are approved to be safe 

and effective are readily available for 

both companion animals and animals 

intended for food consumption. 

The FDA animal drug user fee 

program was authorized in 2003 and 

implemented in 2004. A significant part 

of the preparations for the program 

included determining the fee levels for 

fiscal year (FY) 2004. ADUFA provides 

for four fees: (1) A sponsor fee, (2) an 

establishment fee, (3) a product fee, and 

(4) an application fee. ADUFA also 

provides for specific waivers and 

exemptions from fees. FDA prepared 

guidance for the industry regarding the 

fees, billings and submission of fees, as 

well as waivers and exemptions (http:// 

www.fda.gov/cvm/adufa.htm). 

The total amounts authorized for 

collection were: $5 million for FY 2004; 

$8 million in FY 2005; and $10 million 

in each FY 2006 through 2008, subject 

to annual inflation and workload 

adjustments after 2004. ADUFA 

provided for four types of fees to be 

assessed each fiscal year, with each fee 

type expected to raise 25 percent of the 

annual amount collected. Thus, in FY 

2004, we expected to receive $1.25 

million from sponsor fees, 

establishment fees, product fees, and 

application fees, for a total of $5 million 

dollars. The user fees are used to 

achieve shorter, more predictable 

review times by increasing the review 

staff at FDA and building better 

management systems. As a result, we 

anticipate substantial savings to the 

industry in regulatory review and 

developmental expenses. 

FDA’s animal drug premarket review 

program is making continual and 

substantial improvements in the animal 

drug review process as a result of user 

fees. This helps ensure an adequate 

supply of safe and effective therapeutic 

and production animal drugs. 

II. Agenda 

In the language authorizing ADUFA, 

Congress directed the Secretary of 

Health and Human Services (the 

Secretary) to consult with the 

Committee on Energy and Commerce of 

the House of Representatives; the 

Committee on Health, Education, Labor 

and Pensions of the Senate; appropriate 

scientific and academic experts; 

veterinary professionals; representatives 

of consumer advocacy groups; and the 

regulated industry in developing 

recommendations to Congress for the 

reauthorization of ADUFA and for the 

goals and plans for meeting the goals 

associated with the process for review of 

animal drug applications. As directed 

by Congress, FDA is holding a public 

meeting to gather information on what 

we should consider to include in the 

reauthorization of ADUFA (http:// 

www.fda.gov/cvm/adufa.htm) and hear 

stakeholder views on this subject. 

We are offering the following two 

general questions for consideration, and 

we are interested in responses to these 

questions and any other pertinent 

information stakeholders would like to 

share. 

1. What is your assessment of the 

overall performance of the ADUFA 

program thus far? 

2. What suggestions or changes would 

you make relative to the reauthorization 

of ADUFA? 

We have published a number of 

reports that may help inform the public 

about the ADUFA program. Key 

documents such as, ADUFA-related 

guidance, legislation, performance 

reports, and financial reports, can be 

found at http://www.fda.gov/cvm/ 

adufa.htm. 

III. Meeting Format 

In general, the meeting format will 

include presentations by FDA followed 

by the open public comment period. 

Registered speakers for the open public 

comments will be grouped and invited 

to speak in the order of their affiliation 

and time of registration (scientific and 

academic experts/veterinary 

professionals, representatives of 

consumer advocacy groups, and the 

regulated industry). FDA presentations 

are planned from 9 a.m. until 10:30 a.m. 

The open public comment portion of the 

meeting for registered speakers is 

planned to begin at 10:30 a.m. An 

opportunity for public comments from 

meeting attendees will commence 

following the registered presentations, if 

time permits. The docket will remain 

open for written or electronic comments 

through May 24, 2007. 

IV. Transcripts 

Meeting transcripts will be made 

available on the CVM Website (http:// 

www.fda.gov/cvm/adufa.htm) 

approximately 30 working days after the 

meeting. The transcript will also be 

available for public examination at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m. Monday 

through Friday. 

Dated: March 6, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4452 Filed 3–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0064] 

Electronic Case Report Form 

Submission; Notice of Pilot Project 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Center for Drug 

Evaluation and Research (CDER) and the 

Center for Biologics Evaluation and 

Research (CBER) in the Food and Drug 

Administration (FDA) are seeking 

sponsors interested in participating in a 

pilot project to test the submission of 

case report form (CRF) data provided 

electronically in extensible markup 

language (XML) based on the 

Operational Data Model (ODM) 

developed by the Clinical Data 

Interchange Standards Consortium 

(CDISC). This pilot will test the ability 

of a new data format to support all 


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Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 11371 

review activity, which our current 

submission format is incapable of doing. 

Data supplied in ODM format by 

sponsors during the pilot project will 

not replace any regulatory requirements 

for submitting CRFs. We anticipate that 

a successful pilot will allow CDER and 

CBER to routinely accept CRFs from 

studies employing electronic data 

capture (EDC) in ODM format in 

marketing applications provided in 

electronic format. 

DATES: Submit written or electronic 

requests to participate in the pilot 

project by September 10, 2007. General 

comments on the pilot project are 

welcome at any time. 

ADDRESSES: Submit written requests to 

participate and comments regarding this 

pilot project 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.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Armando Oliva, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 6310, Silver Spring, 

MD 20993–0002, 301–796–0514. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the opportunity to 

participate in a pilot project being 

conducted by CDER and CBER 

involving the testing of the ODM 

standard developed by the CDISC, with 

the goal of replacing the existing 

portable document format (PDF)-based 

CRFs derived from clinical trials that 

use EDC and, therefore, lack paper 

CRFs. 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 existing Federal regulations (21 

CFR 314.50), applicants must provide 

CRFs with a marketing application. 

Since November 1997, under 21 CFR 

part 11, we have accepted CRFs in 

electronic format instead of paper. FDA 

has issued several guidances that 

provide recommendations concerning 

electronic submissions. In the Federal 

Register of October 19, 2005 (70 FR 

60842), FDA announced the availability 

of a guidance entitled ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Human Pharmaceutical 

Product Applications and Related 

Submissions Using the eCTD 

Specifications’’ (http://www.fda.gov/ 

cder/guidance/index.htm or http:// 

www.fda.gov/cber/gdlns/esubapp.htm). 

In section III.E.3. of that guidance, FDA 

recommends that applicants submit an 

individual subject’s complete CRF as a 

single, PDF file. The guidance 

recommends that if a paper CRF was 

used in the clinical trial, the submitted 

CRF should be a scanned image of the 

paper CRF, including all original entries 

with modifications, addenda, 

corrections, comments, annotations, and 

any extemporaneous additions (i.e., 

audit trail). The guidance further 

recommends that if EDC was used in the 

clinical trial, the applicant should 

submit a PDF-generated form or other 

PDF representation of the information 

(e.g., subject profile). 

Based on our experience, PDF-based 

CRFs from clinical trials that employ 

EDC are not ideal to support all review 

activity. Although the PDF-based CRFs 

for trials that use EDC can provide a 

record of the observations collected 

during the trial (i.e., the data) and 

additional information about what was 

collected (metadata), they typically do 

not provide an audit trail. CDER and 

CBER are interested in adopting a new, 

standard format that can replace the 

PDF-based CRF and that can reliably 

provide all three components of the CRF 

in an electronic format: Data, metadata, 

and audit trail. 

The ODM is an XML-based standard 

that facilitates the electronic exchange 

of clinical trial data, metadata, and audit 

trail. We are working with CDISC to 

develop the capabilities within CDER 

and CBER to review CRFs using ODM. 

CDISC employed the current production 

version (Version 1.2) of the ODM on the 

CDISC Web site, and we performed 

some initial testing of limited CRF data 

in ODM. To help in this development, 

we are launching this pilot project and 

seeking sponsors willing to provide 

CRFs in ODM format to test our 

capabilities to review these files. 

However, data supplied during the pilot 

project will not replace any regulatory 

requirements for submitting CRFs. 

The purpose of this pilot project is to 

obtain additional experience with ODMbased CRFs. We anticipate that a 

successful pilot will allow CDER and 

CBER to routinely accept CRFs from 

studies that employ EDC in ODM format 

in marketing applications submitted in 

electronic format. 

II. Pilot Project Description 

This pilot project is part of an effort 

to improve the quality of CRFs provided 

to CDER and CBER in electronic format 

and to improve the centers’ capability to 

review these files. Eventually, CDER 

and CBER expect to recommend new 

technical specifications for the 

submission of CRFs that are derived 

from clinical trials that employ EDC 

and, therefore, lack paper CRFs. 

A. Initial Approach 

Because only a limited number of 

sponsors are needed (i.e., approximately 

five), CDER and CBER will use their 

discretion in choosing participants, 

based on participants’ previous 

experience submitting CRFs in 

accordance with existing guidance. 

Participants should be willing to 

provide the same CRFs in two formats: 

PDF, in accordance with existing 

guidance, and ODM. If PDF-based CRFs 

have already been submitted as part of 

an existing new drug application or 

biologics license application on file 

with the agency, then participants need 

only provide the ODM-based CRFs with 

the same information. Having the same 

information available in both PDF and 

ODM provides the best opportunity to 

compare the two formats. 

B. How to Participate 

Written 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. 

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: March 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4451 Filed 3–12–07; 8:45 am] 

BILLING CODE 4160–01–S 


cprice-sewell on PROD1PC66 with NOTICES