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
12314 Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 

compliance policies. This workshop is 

also consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Pub. L. 104–121), as outreach 

activities by government agencies to 

small businesses. 

The goal of this public workshop is to 

present information that will enable 

manufacturers and regulated industry to 

better comply with labeling 

requirements, especially in light of 

growing concerns about obesity and 

food allergens. Information presented 

will be based on Agency position as 

articulated through regulation, 

compliance policy guides, and 

information previously made available 

to the public. Topics to be discussed at 

the workshop include: (1) Mandatory 

label elements, (2) the Food Allergen 

Labeling and Consumer Protection Act 

of 2004, (3) nutrition labeling 

requirements, (4) health and nutrition 

claims, and (5) special labeling issues, 

such as exemptions. FDA expects that 

participation in this public workshop 

will provide regulated industry with 

greater understanding of the Agency’s 

regulatory and policy perspectives on 

food labeling and increase voluntary 

compliance with labeling requirements. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4782 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, email 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1984. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the Agency; (b) the accuracy of the 

Agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Maternal, Infant and 

Early Childhood Home Visiting 

Program FY 2012 Competitive Funding 

Opportunity Announcement (OMB No. 

0915–xxxx)—[New] 

On March 23, 2010, the President 

signed into law the Patient Protection 

and Affordable Care Act (the Act). 

Section 2951 of the Act amended Title 

V of the Social Security Act by adding 

a new section, 511, which authorized 

the creation of the Maternal, Infant, and 

Early Childhood Home Visiting 

Program, (http://frwebgate.access.gpo.

gov/cgi-bin/getdoc.cgi?dbname=111_

cong_bills&docid=f:h3590enr.txt.pdf, 

pages 216–225). The Act responds to the 

diverse needs of children and families 

in communities at risk and provides an 

unprecedented opportunity for 

collaboration and partnership at the 

Federal, State, and community levels to 

improve health and development 

outcomes for at risk children through 

evidence-based home visiting programs. 

Under this program, a funding 

opportunity announcement for formulabased funding for States was issued in 

June 2011. The same level of funding, 

$125,000,000, was made available to 

States according to the same formula as 

in FY 2010. These two-year grants were 

awarded to support States in 

implementing their Updated State Plans 

that were submitted during the summer 

of 2011. 

Additionally, a competitive Funding 

Opportunity Announcement (FOA) was 

issued in June 2011 to allow interested 

States to apply for one of two possible 

grants: Development Grants and 

Expansion Grants. Development Grants 

were intended to support States and 

jurisdictions with modest evidencebased home visiting programs to expand 

the depth and scope of these efforts, 

with the intent to develop the 

infrastructure and capacity needed to 

seek an Expansion Grant in the future. 

Expansion Grants were intended to 

recognize states and jurisdictions that 

had already made significant progress 

towards a high-quality home visiting 

program or embedding their home 

visiting program into a comprehensive, 

high-quality early childhood system. 

Among eligible applicants to the 

competitive grant program, 13 States 

were awarded Development Grants and 

nine States were awarded Expansion 

Grants. Currently, the 54 States and 

eligible jurisdictions participating in the 

formula-funded program have begun 

implementing their State Home Visiting 

Plans. Because the FY 2011 grants were 

for two-years, no additional FOA will be 

issued this year for the formula 

program, but the State grantees will be 

completing non-competing progress 

reports in order to secure the release of 

their FY 2012 allocations. The 22 States 

that received competitive grant funding 

have also begun to carry out their 

proposed programs, integrating them 

with their formula-based programming. 

These competitive grants are for two 

years (Development Grants) and four 

years (Expansion Grants) respectively, 

and those grantees will also be 

completing non-competitive progress 

reports for FY 2012. 

The Maternal, Infant, and Early 

Childhood Home Visiting Program 

intends to make an additional 

$84,484,397 available for Development 

and Expansion Grants in FY 2012. With 

the concurrence of the Secretary, ten 

more Expansion Grants, totaling 

$71,359,043, will be awarded (by rank 

order) from among high-ranking 

applicants under the FY 2011 

announcement. The FY 2012 

competitive FOA will announce 

approximately $12,000,000 for new 

Development Grants. The intent of these 

Development Grants is identical to that 

announced in FY 2011, which is to 

support States and jurisdictions with 

modest evidence-based home visiting 

programs to expand the depth and scope 

of these efforts, with the intent to 

develop the infrastructure and capacity 

needed to seek an Expansion Grant in 

the future. It is anticipated that there 

will be awarded between four and eight 

Development Grants. The total grant 

award may range between $1 million to 

$3 million annually. Applicants may 

apply for a ceiling amount of up to $3 

million per year. The project period is 

two (2) years. 

The annual estimate of burden is as 

follows: 


tkelley on DSK3SPTVN1PROD with NOTICES