56362 Federal Register / Vol. 72, No. 191 / Wednesday, October 3, 2007 / Notices 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 25, 2007 (72 

FR 20555), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0302. The 

approval expires on August 31, 2010. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: September 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–19457 Filed 10–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Nominations for Membership on the 

Board of Directors of the Reagan-Udall 

Foundation From Consumer Advocacy 

Groups, Professional Scientific and 

Medical Societies, and Industry Trade 

Organizations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

opportunity for patient and consumer 

advocacy groups, professional scientific 

and medical societies, and industry 

trade organizations to nominate 

candidates to serve on the Board of 

Directors (the Board) of a new non-profit 

foundation, the Reagan-Udall 

Foundation for the Food and Drug 

Administration (the Foundation). The 

Foundation will be dedicated to 

modernizing medical, veterinary, food, 

food ingredient, and cosmetic product 

development, accelerating innovation, 

and enhancing product safety. 

DATES: Submit written or electronic 

nominations on or before October 15, 

2007. 

ADDRESSES: Submit written nominations 

either by fax to Lisa Rovin or Nancy 

Stanisic at 301–443–9718 or by e-mail to 

Reagan-Udall-Board@FDA.HHS.GOV. 

FOR FURTHER INFORMATION CONTACT: 

Lisa Rovin, Office of Policy and 

Planning (HF–11), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

1443; or 

Nancy Stanisic, Office of Critical Path 

Programs (HF–18), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

1660. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On September 27, 2007, the President 

signed into law the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA). The law reauthorizes 

the Prescription Drug User Fee Act, the 

Medical Device User Fee Act, the Best 

Pharmaceuticals for Children Act, and 

the Pediatric Research Equity Act of 

2007, and enacts the Pediatric Medical 

Device Safety and Improvement Act of 

2007 as well as additional requirements 

and authorities for FDA. Title VI of 

FDAAA creates the Foundation. The 

purpose of the Foundation is to 

‘‘advance the mission of the Food and 

Drug Administration to modernize 

medical, veterinary, food, food 

ingredient, and cosmetic product 

development, accelerate innovation, and 

enhance product safety.’’

The duties of the Foundation include 

the identification of unmet needs in the 

development, manufacture, and 

evaluation (including postmarket 

evaluation) of the safety and 

effectiveness of FDA-regulated products, 

and the establishment of scientific and 

other projects and programs to meet 

those needs. 

II. Criteria for Board Membership 

The statute mandates a 14-member 

Board of Directors, composed of the 

following: 

• Four representatives of the general 

pharmaceutical, device, food, cosmetic, 

and biotechnology industries; 

• Three representatives of academic 

research organizations; 

• Two representatives of patient or 

consumer advocacy organizations; 

• One representative of health care 

providers; and 

• Four at-large representatives with 

expertise or experience relevant to the 

purpose of the Foundation. 

The Board must include individuals 

with expertise in areas including the 

sciences of developing, manufacturing, 

and evaluating the safety and 

effectiveness of devices, including 

diagnostics, biological products, and 

drugs, and the safety of food, food 

ingredients, and cosmetics. 

The Foundation’s Board will be 

responsible for governing the 

organization and ensuring that it 

succeeds in its mission. To that end, the 

Board members will oversee the mission 

and operations of the Foundation, 

including: Approving programs and 

monitoring their effectiveness, 

coordinating Foundation activities with 

federal research programs, awarding 

grants, and ensuring financial solvency 

and raising resources. 

The initial Board is to be appointed 

no later than 30 days after enactment, 

September 27, 2007, by the ex officio 

board members designated in the 

statute: The Commissioner of Food and 

Drugs, the Director of the National 

Institutes of Health, the Director of the 

Centers for Disease Control and 

Prevention, and the Director of the 

Agency for Healthcare Research and 

Quality. Nine Board members are to be 

appointed from a list of candidates 

provided by the National Academy of 

Sciences. Five Board members are to be 

appointed from lists of candidates 

provided by ‘‘patient and consumer 

advocacy groups, professional scientific 

and medical societies, and industry 

trade organizations.’’

III. Process and Criteria for 

Nominations 

To facilitate nomination of candidates 

from patient and consumer advocacy 

groups, professional scientific and 

medical societies, and industry trade 

organizations, FDA is publishing this 

notice and accepting nominations by fax 

or e-mail submission (see ADDRESSES). 

We welcome nominations from any 

such organization, and are not limiting 

the number of nominations each 

organization may submit. We will 

accept joint nominations from multiple 

organizations. 

Each nomination should include the 

following information: 

(1) Name, affiliation, and contact 

information for each nominating 

organization, and a statement indicating 

to which of the following categories the 

nominating organization belongs: 

Patient and consumer advocacy groups, 

professional scientific and medical 

societies, and industry trade 

organizations. 

(2) Name, title, affiliation (if any), 

resume or curriculum vitae, and contact 

information for each nominee. In 

addition, please include no more than 

one paragraph describing the 

individual’s qualifications in relation to 

the mission of the Foundation and the 

statutory criteria for Board membership, 

described in section II of this document. 

A nominee may qualify in more than 

one of the statutory categories for Board 

membership; please list all categories 

for which each nominee qualifies. 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 191 / Wednesday, October 3, 2007 / Notices 56363 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the FDAAA statute at: 

http://www.fda.gov/oc/initiatives/ 

advance/fdaaa.html. 

Dated: September 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–4882 Filed 9–28–07; 1:26 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0343] 

Electronic Nonclinical Study Data 

Submission; 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, in 

a regulatory setting, the electronic 

submission of nonclinical study data 

using the Standard for Exchange of 

Nonclinical Data (SEND). The purpose 

of this pilot is to test the ability of a new 

electronic data format to support 

nonclinical review activity. The pilot 

also will involve a collaboration of FDA, 

available pilot participants, and the 

SEND Consortium to update and create 

a new draft SEND implementation 

guide. FDA anticipates that a successful 

pilot will enable CDER to routinely 

accept nonclinical study data 

electronically in SEND format, instead 

of paper or portable document format 

(PDF), in investigational new drug 

applications (INDs), new drug 

applications (NDAs), and biologics 

licensing applications (BLAs). 

DATES: Submit written or electronic 

requests to participate in the pilot 

project by January 2, 2008. 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: 

Bobbie Witczak, Food and Drug 

Administration, 5600 Fishers Lane 

HFD–070, Rockville, MD 20857, 301–

827–3938. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing an opportunity to 

participate in a 3-year pilot project in a 

regulatory setting being conducted by 

CDER involving the ongoing testing of 

SEND, a nonclinical data model 

developed by the Clinical Data 

Interchange Standards Consortium 

(CDISC) . The ultimate goal of the pilot 

is to replace the existing paper/PDFbased listings of nonclinical study data. 

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). 

CDISC is currently facilitating the 

extension of the same standard for 

nonclinical data, termed SEND, through 

the efforts of the SEND Consortium. 

Where possible, the standards 

developed for clinical datasets and 

metadata, as described in the overall 

Study Data Tabulation Model (SDTM), 

are being used to develop a 

standardized dataset format for 

nonclinical studies. 

Under current regulations, applicants 

must provide tabulated nonclinical data 

from animal toxicity studies as part of 

NDA (21 CFR 314.50) and IND (21 CFR 

312.23) applications. In a 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 

to INDs, BLAs, and NDAs using the 

electronic common technical document 

(eCTD) specifications. CDER currently 

receives nonclinical study data either on 

paper or as electronic PDF files. These 

formats do not support the agency’s 

ability to easily receive, validate, 

display, or evaluate the data using 

modern, computer-based review and 

analysis tools. As part of FDA’s effort to 

modernize its information technology 

systems and improve efficiency, the 

agency is planning to transition from the 

traditional paper/PDF formats to a true 

electronic data format for submission of 

nonclinical data for regulatory review. 

Recently, CDER has adopted a 

standard for clinical study data based on 

the CDISC SDTM standard. In addition, 

CDER entered into a CRADA 

(cooperative research and development 

agreement) with PharmQuest 

Corporation, Inc., for the development 

of data validation, viewing, and analysis 

tools to evaluate standardized 

nonclinical datasets based on SEND. 

The FDA believes the use of 

standardized SEND datasets, together 

with new and better analysis tools, will 

increase the efficiency of agency review 

and evaluation of nonclinical data. 

CDER recently completed a related 

pilot project (phase 1) that asked for 

volunteers from industry to submit 

sample nonclinical datasets in the SEND 

format outside of a regulatory setting (68 

FR 3885; January 27, 2003). The phase 

1 pilot also evaluated data validation 

and analysis tools specifically designed 

to validate datasets according to the 

current SEND standard and to enable a 

reviewer to efficiently display and 

evaluate data from animal toxicity 

studies submitted in the SEND format. 

The phase 1 pilot resulted in 

development of a SEND Implementation 

Guide (Version 2.3; November 2005), 

which is available on the CDISC Web 

site (http://www.cdisc.org/models/send/ 

v2.3/SENDV2.3Implementation

Guide.pdf). The SEND Implementation 

Guide describes the process for 

formatting nonclinical data from singleand repeat-dose animal toxicity and 

carcinogenicity studies for submission 

purposes. The pilot also resulted in the 

development of specialized software 

tools for validating, displaying, and 

analyzing SEND-formatted nonclinical 

data. 

As a continuation of this testing 

process, this new pilot (phase 2) will 

enable FDA to evaluate animal toxicity 

data submitted in SEND format in a 

regulatory setting by comparing SENDformatted data provided electronically 

as SAS transport file (XPT version 5) 

datasets with data provided in PDF. 

In addition, in the intervening time 

period between the publication of the 

SEND implementation guide version 2.3 

(November 2005) and now, some 

changes have been made to the SDTM 

for clinical data, making it desirable to 

update the SEND implementation guide 

to ensure harmonized implementation 

of the CDISC study data standard across 

both clinical and nonclinical data. 

There is also a plan to expand the SEND 

implementation guide to include a 

pharmacokinetics domain, more 

detailed implementation examples, and, 

eventually, other nonclinical study 

types. As a result, FDA will not conduct 

the pilot using the existing SEND 

implementation guide version 2.3. 

Instead, phase 2 will include an initial 

collaboration among FDA, available 

pilot participants, and the SEND 

Consortium to update and create a new 

draft SEND implementation guide 

before FDA receives any datasets for 

regulatory review. The current status of 


rwilkins on PROD1PC63 with NOTICES