12312 Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 

a packet containing beads—it is 

important to have reasonable assurance 

that the patient will be able to swallow 

the beads (uncrushed) with the food 

with which the beads are mixed without 

stimulating the urge to chew. Additional 

assurances may be needed when the 

label also includes specific language 

concerning alternate administration via 

an enteral feeding tube. 

The recommendations in this 

guidance are based on literature on 

chewing and swallowing particle size 

and on Agency experience with NDAs 

and ANDAs submitted for these dosage 

forms. This guidance provides the 

following information related to drug 

products labeled for sprinkle: 

Appropriate maximum size for the 

beads, special considerations for 

sprinkle drug products that include 

language in labeling concerning 

alternate administration via an enteral 

feeding tube, and bioavailability (BA) or 

bioequivalence (BE) recommendations. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on the size of beads in 

drug products labeled for sprinkle. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments 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. 

III. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). Information submitted in an 

NDA, ANDA, or BLA supporting the 

appropriate size for beads in drug 

products that are labeled to be 

administered via sprinkling, including 

related BA and BE studies, is approved 

by OMB under control number 0910– 

0001 for NDAs and ANDAs and control 

number 0910–0338 for BLAs. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4784 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0130] 

Electronic Submission of Nonclinical 

Study Data; Notice of Pilot Project 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) Center for 

Biologics Evaluation and Research 

(CBER) is announcing an invitation to 

participate in a pilot evaluation program 

to test the electronic submission of 

nonclinical study data using the 

Standard for Exchange of Nonclinical 

Data (SEND), a new electronic data 

standard format, which can be used to 

support review activity. Participation in 

the pilot program is open to all 

sponsors. The pilot program is intended 

to provide industry and CBER 

regulatory review staff the opportunity 

to evaluate SEND and determine if it 

facilitates the submission process of 

nonclinical study data related to 

investigational new drug applications 

(INDs). 

DATES: Submit either electronic or 

written requests for participation in this 

pilot program by May 29, 2012. 

ADDRESSES: Submit electronic requests 

to participate in the pilot and comments 

regarding the project to http:// 

www.regulations.gov. Submit written 

requests and comments to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

FOR FURTHER INFORMATION CONTACT: 

Amy Malla, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448, 301–827–6085, email: 

Amy.Malla@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products and is committed to advancing 

the public health through innovative 

activities that help ensure the safety, 

effectiveness and timely delivery of 

these products to patients. Further, 

CBER seeks to continuously enhance 

and update review efficiency and 

quality, and the quality of its regulatory 

efforts and interactions, by providing 

CBER staff and industry with improved 

processes. In support of this goal, CBER 

has participated in the development of 

the Clinical Data Interchange Standards 

Consortium (CDISC) SEND, a data 

model initially developed for 

nonclinical data from animal studies 

submitted in support of applications for 

approval of human drugs. This pilot is 

designed to test the ability of SEND to 

support the review of nonclinical study 

data submitted to CBER. The ultimate 

goal of the pilot is to replace the existing 

paper and portable document format 

(PDF)-based listings of nonclinical study 

data. 

SEND was developed by the CDISC 

SEND Team. 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). 

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 format for nonclinical 

studies. 

Recently, CBER has adopted a 

standard for clinical study data based on 

the CDISC SDTM standard. FDA 

believes the use of standardized SEND 

datasets, together with new and better 

analysis tools, will enhance CBER’s 

review and evaluation of nonclinical 

data. 

The Center for Drug Evaluation and 

Research (CDER) completed a pilot 

project (phase 1) using the SEND format 

in sample nonclinical datasets, that is 

outside of a regulatory setting (68 FR 

3885, January 27, 2003). The phase 1 

CDER 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 

display and evaluate data efficiently 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 12313 

from animal studies submitted in the 

SEND format. The pilot resulted in the 

development of a SEND Implementation 

Guide (SENDIG) describing the process 

for formatting data from single- and 

repeat-dose animal toxicity and 

carcinogenicity studies for submission 

purposes. Following the phase 1 pilot, 

CDER announced a second pilot (phase 

2) to test SEND formatted datasets in a 

regulatory setting (72 FR 56363, October 

3, 2007). The phase 2 pilot was aimed 

at evaluating 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. 

CBER currently receives nonclinical 

study data in paper, PDF, and other 

electronic formats. The lack of 

uniformity in the formats used by 

sponsors to submit data, in addition to 

the inconsistent use of terminology 

across submissions, complicates CBER’s 

efforts to validate, display, and 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, CBER is planning to 

transition to an electronic data format 

for submission of study data for 

regulatory review. 

II. Pilot Project Description 

This pilot is intended to help CBER 

evaluate the adequacy of the current 

SEND format (SAS transport files, XPT 

version 5) in accommodating 

nonclinical study data submitted to the 

center. As part of this evaluation and in 

anticipation of FDA receiving datasets 

for regulatory review, the CDISC SEND 

team, in collaboration with FDA and 

available pilot participants, will update 

the SENDIG as needed to include 

biologic-specific data elements and 

terms. 

III. Requests for Participation 

Requests to participate in the SEND 

pilot are to be identified with the docket 

number found in brackets in the 

heading of this document. You should 

include the following information in 

your request: Contact name, contact 

phone number, email address, name of 

the establishment, address, and license 

number. Once requests for participation 

are received, FDA will contact 

interested establishments to discuss the 

pilot program. CBER is seeking a limited 

number of sponsors (approximately 

three to five, but no more than six) to 

participate in this pilot. The duration of 

the pilot is expected to be 

approximately 12 months but may be 

extended as needed. A familiarity with 

SEND would benefit participants but is 

not required for participation in the 

project. Participants should be willing 

to provide the same nonclinical study 

data in both paper format and SEND 

electronic format using SAS transport 

files (XPT version 5). Participation in 

this pilot will be outside the regulatory 

pathway and as such will not be used 

to make regulatory decisions. 

We anticipate that a successful pilot 

program, including the implementation 

of any needed changes to the SENDIG 

and/or data validation, viewing and 

analysis tools, will allow CBER to 

accept specific types of nonclinical 

study data electronically based on the 

SEND format. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4785 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Food Labeling Workshop; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA), Office of Regulatory Affairs 

(ORA), Dallas District Office (DALDO), 

in collaboration with Oklahoma State 

University (OSU), Robert M. Kerr Food 

& Agricultural Products Center (FAPC), 

is announcing a public workshop 

entitled ‘‘Food Labeling Workshop.’’ 

This public workshop is intended to 

provide information about FDA food 

labeling regulations and other related 

subjects to the regulated industry, 

particularly small businesses and 

startups. 

Date and Time: This public workshop 

will be held on April 24 and 25, 2012, 

from 8 a.m. to 5 p.m. 

Location: This public workshop will 

be held at FAPC, OSU, 148 FAPC, 

Stillwater, OK 74078–6055. 

Contact: David Arvelo, Office of 

Regulatory Affairs, Food and Drug 

Administration, Southwest Regional 

Office, 4040 North Central Expressway, 

Suite 900, Dallas, TX 75204, 214–253– 

4952, FAX: 214–253–4970, email: 

david.arvelo@fda.hhs.gov. 

For information on accommodation 

options, contact conference coordinators 

Karen Smith or Andrea Graves at FAPC, 

OSU, 148 FAPC, Stillwater, OK 74078– 

6055, 405–744–6071, FAX: 405–744– 

6313, or email: 

karenl.smith@okstate.edu or 

andrea.graves@okstate.edu. More 

information is also available online at 

http://www.fapc.biz/foodlabeling.html. 

(FDA has verified the Web site address, 

but we are not responsible for any 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

Registration: You are encouraged to 

register by April 10, 2012. The 

workshop has a $400 registration fee to 

cover the cost of facilities, materials, 

lunch, and breaks. Seats are limited; 

please submit your registration as soon 

as possible. Workshop space will be 

filled in order of receipt of registration. 

Those accepted into the workshop will 

receive confirmation. Registration will 

close after the workshop is filled. 

Registration at the site is not guaranteed 

but may be possible on a space available 

basis on the day of the public workshop 

beginning at 8 a.m. The cost of 

registration at the site is $400 payable to 

FAPC. There are no registration fees for 

FDA employees. 

If you need special accommodations 

due to a disability, please contact Karen 

Smith (see Contact) at least 7 days in 

advance. 

Registration Form Instructions: To 

register, please complete the online 

registration form at http://www.fapc.biz/ 

forms/foodlabeling.htm. 

Transcripts: Transcripts of the public 

workshop will not be available due to 

the format of this workshop. Course 

handouts may be requested after the 

date of the public workshop through the 

contact persons (see Contact) at cost 

plus shipping. 

SUPPLEMENTARY INFORMATION: This 

public workshop is being held in 

response to the large volume of food 

labeling inquiries from small food 

manufacturers and startups originating 

from the area covered by the FDA 

DALDO. FDA DALDO presents this 

workshop to help achieve objectives set 

forth in section 406 of the Food and 

Drug Administration Modernization Act 

of 1997 (21 U.S.C. 393), which include 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. This is consistent with the 

purposes of ORA’s Small Business 

Representative Program, which are in 

part to respond to industry inquiries, 

develop educational materials, and 

sponsor workshops and conferences to 

provide firms, particularly small 

businesses, with firsthand working 

knowledge of FDA’s requirements and 


tkelley on DSK3SPTVN1PROD with NOTICES