Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices 26407 

manufacturer, packer, or distributor of 

the dietary supplement that bears such 

a statement on its label or in its labeling. 

FDA estimates that, each year, 

approximately 2,200 firms will submit 

the information required by section 403 

of the act. We estimate that a firm will 

require 0.75 hours to gather the 

information needed and prepare a 

communication to FDA, for a total of 

1,650 hours (2,200 x 0.75). This estimate 

is based on the average number of 

notification submissions received by the 

agency in the preceding 2 years. 

Dated: May 26, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12797 Filed 6–1–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0232] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Interstate Shellfish 

Dealers Certificate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection provisions of 

the Interstate Shellfish Dealers 

Certificate. 

DATES: Submit written or electronic 

comments on the collection of 

information by August 3, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Interstate Shellfish Dealers Certificate 

(OMB Control Number 0910–0021)— 

Extension 

Under 42 U.S.C. 243, FDA is required 

to cooperate with and aid State and 

local authorities in the enforcement of 

their health regulations and is 

authorized to assist States in the 

prevention and suppression of 

communicable diseases. Under this 

authority, FDA participates with State 

regulatory agencies, some foreign 

nations, and the molluscan shellfish 

industry in the National Shellfish 

Sanitation Program (NSSP). 

NSSP is a voluntary, cooperative 

program to promote the safety of 

molluscan shellfish by providing for the 

classification and patrol of shellfish 

growing waters and for the inspection 

and certification of shellfish processors. 

Each participating State and foreign 

nation monitors its molluscan shellfish 

processors and issues certificates for 

those that meet the State or foreign 

shellfish control authority’s criteria. 

Each participating State and nation 

provides a certificate of its certified 

shellfish processors to FDA on Form 

FDA 3038, ‘‘Interstate Shellfish Dealer’s 

Certificate.’’ FDA uses this information 

to publish the ‘‘Interstate Certified 

Shellfish Shippers List,’’ a monthly 

comprehensive listing of all molluscan 

shellfish processors certified under the 

cooperative program. If FDA did not 

collect the information necessary to 

compile this list, participating States 

would not be able to identify and keep 

out shellfish processed by uncertified 

processors in other States and foreign 

nations. Consequently, NSSP would not 

be able to control the distribution of 

uncertified and possibly unsafe shellfish 

in interstate commerce, and its 

effectiveness would be nullified. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity FDA Form No. No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Submission of 

Interstate 

Shellfish 

Dealer’s 

Certificate 3,038 40 57 2,280 0.10 228 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

26408 Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices 

FDA estimates that 40 respondents 

will submit 2,280 Interstate Shellfish 

Dealer’s Certificates annually, for a total 

burden of 228 hours (2,280 submissions 

x 0.10 hours = 228 hours). This estimate 

is based on FDA’s experience and the 

number of certificates received in the 

past 3 years. 

Dated: May 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12796 Filed 6–1–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0671] 

Cooperative Agreement to Support the 

Illinois Institute of Technology’s 

National Center for Food Safety and 

Technology (U01) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

intention to receive and consider a 

single source application for the award 

of a cooperative agreement in fiscal year 

2009 (FY09) to the Illinois Institute of 

Technology (IIT) to support the National 

Center for Food Safety and Technology 

(NCFST). The estimated amount of 

support in FY09 will be for up to $7 

million (direct plus indirect costs), with 

the possibility of 4 additional years of 

support for up to $28 million, subject to 

the availability of funds. This award 

will improve public health by continued 

support of an applied research, 

education, and outreach program related 

to the safety of food processing 

technologies and processed foods. 

DATES: The application due date is June 

28, 2009. The anticipated start date is 

September 2009. The opening date was 

May 28, 2009. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: For 

more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at http:// 

www.cfsan.fda.gov/list.html. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

Request for Application Number: RFA– 

FD–09–004 

Catalog of Federal Domestic Assistance: 

93.103 

A. Background 

FDA has supported the NCFST under 

five previously awarded cooperative 

agreements (53 FR 15736; 56 FR 46189; 

59 FR 24703; 64 FR 39512; and 69 FR 

25405). NCFST was established by IIT to 

bring together the food safety and 

technology expertise of academia, 

industry and FDA for the purpose of 

enhancing the safety of the food supply 

in the common goal of enhancing and 

improving the safety of the food for U.S. 

consumers. NCFST is structured so that 

representatives of participating 

organizations play a role in establishing 

policy and administrative procedures as 

well as identifying long- and short-term 

research needs. With this organizational 

structure, NCFST is able to build 

cooperative food safety programs on a 

foundation of knowledge about current 

industrial trends in food processing and 

packaging technologies, regulatory 

perspectives from public health 

organizations, and fundamental 

scientific expertise from academia. 

B. Research Objectives 

The FDA recognizes that food 

production and processing technology is 

rapidly changing, that globalization of 

the food supply is increasing, and that 

the number and nature of the hazards 

associated with foods are rapidly 

evolving. FDA intends to maintain and 

facilitate the further development of 

NCFST for the purpose of enhancing 

food safety to benefit the public. NCFST 

is uniquely positioned as a key 

component of FDA’s food protection 

program. Specifically, through the 

center’s science platforms, the research 

at NCFST focuses on the development 

and validation of food processing and 

packaging technologies for safety and 

quality; investigation and development 

of preventive technologies targeted to 

reduce or eliminate harmful chemical 

and microbial contamination of foods; 

and the effects of processing on the 

stability and safety of bioactive 

ingredients added to or naturally 

occurring in foods. Additionally, the 

development of an integrated 

collaborative food protection research/ 

education/outreach program will 

provide fundamental food safety 

information, in the public domain, for 

use by all segments of the food science 

community in product and process 

development, regulatory activities, 

academic programs and consumer 

programs. 

C. Eligibility Information 

Competition is limited to the IIT. FDA 

believes that continued support of 

NCFST at IIT is appropriate because IIT 

is uniquely qualified to fulfill the 

objectives of the proposed cooperative 

agreement. IIT’s Moffet Center, where 

NCFST is located, is a unique research 

facility which includes an industrialsize pilot plant and smaller pilot plants 

for food processing and packaging 

equipment, a pathogen containment 

pilot plant, a packaging laboratory, 

analytical laboratories, offices, 

containment facilities, classrooms, and 

support facilities which permit research 

from bench-top to industrial-scale. The 

industrial-size pilot plant is built to 

accommodate routine food processing 

and packaging research in a commercial 

atmosphere. The physical layout of the 

facility provides maximum versatility in 

the use and arrangement of equipment 

of both commercial and pilot size, and 

in the capability to simultaneously 

operate several different pieces of 

equipment without interference with 

each other. Additionally, NCFST has a 

BL3 pilot plant and laboratory as well 

as a select agent laboratory to conduct 

studies with C. botulinum and other 

selected agents. NCFST researchers have 

access to nutritional clinical facilities on 

the IIT campus for validating in humans 

how processing may impact the 

availability of bioactive ingredients 

added to or naturally occurring in foods. 

II. Award Information/Funds Available 

A. Award Amount 

The estimated amount of funds 

available for support in FY 2009 will be 

for up to $7 million (direct plus indirect 

costs), with the possibility of 4 

additional years of support for up to $28 

million, subject to the availability of 

funds. Future year amounts will depend 

on annual appropriations and successful 

performance. 

This award will be funded based on 

the quality (e.g., how well the grantee 

responds to the RFA (request for 

application) requirements) of the 

application received and is subject to 

availability of Federal funds to support 

the project. In addition, if a cooperative 

agreement is awarded, the grantee will 

be informed of any additional 

documentation that should be submitted 

to FDA. This cooperative agreement 

program requires that the applicant 

substantially share in the project costs if 

an award is made. 

FDA grants policies as described in 

the DHHS (Department of Health and 

Human Services) Policy Statement, 

http://www.hhs.gov/grantsnet/adminis/ 

gpd/index.htm, will apply to the 

applications submitted and awards 

made in response to this FOA.