Federal Register / Vol. 76, No. 55 / Tuesday, March 22, 2011 / Notices 15985 

delivery of educational activities and 

training; (5) maintains knowledge of 

information technology and learning 

standards as they apply to education 

and training to demonstrate and 

promote compliance and best practices 

by CDC programs; (6) applies the 

principles of instructional systems 

design and learning theory to design, 

develop, deliver, and evaluate 

informational and instructional 

products; (7) implements and maintains 

the CDC Training and Continuing 

Education Online web-based 

accreditation and registration system; 

(8) adapts information systems and 

processes to reflect current best 

practices and adherence to accreditation 

requirements; and (9) provides technical 

assistance and guidance to learners to 

ensure accreditation and learner 

support. 

Delete in its entirety the title and 

functional statement for the Division of 

Training Development and Services 

(CPLD) within the Scientific Education 

and Professional Development Program 

Office (CPL), Office of Surveillance, 

Epidemiology and Laboratory Services 

(CP) 

Dated: March 10, 2011. 

James D. Seligman, 

Acting Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–6515 Filed 3–21–11; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1991–F–0203] (Formerly 

Docket No. 91F–0111) 

Hartech Corporation; Denial Without 

Prejudice of Food Additive Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying a food 

additive petition (FAP 1M4246) 

proposing that the food additive 

regulations be amended to provide for 

the safe use of a source of ionizing 

radiation to treat shellfish, including 

crustaceans. 

DATES: This order is effective June 20, 

2011; except as to any provisions that 

may be stayed by the filing of proper 

objections. Submit either electronic or 

written objections and requests for a 

hearing by April 21, 2011. 

ADDRESSES: You may submit either 

electronic or written objections and 

requests for a hearing identified by 

Docket No. FDA–1991–F–0203, by any 

of the following methods: 

Electronic Submissions 

Submit electronic objections in the 

following way: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written objections in the 

following ways: 

Fax: 301–827–6870. 

Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Richard E. Bonnette, Center for Food 

Safety and Applied Nutrition (HFS– 

255), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1235. 

SUPPLEMENTARY INFORMATION: In a notice 

published in the Federal Register of 

April 16, 1991 (56 FR 15373), FDA 

announced that a food additive petition 

(FAP 1M4246) had been filed by 

Hartech Corp. (formerly United States 

Harvest Technologies, Inc., One East 

Chase St., suites 1112 and 1113, 

Baltimore, MD). The petition proposed 

to amend the food additive regulations 

in § 179.26 Ionizing radiation for the 

treatment of food (21 CFR 179.26) to 

provide for the safe use of a source of 

ionizing radiation to treat shellfish, 

including crustaceans. 

For any food additive petition, the 

burden is on the petitioner to submit to 

FDA data and information that are 

adequate for the Agency to determine 

that the proposed use of the additive 

under the specified conditions of use is 

safe (21 U.S.C. 348(c)(3)(A), 21 CFR 

171.1). Hartech Corp. was notified of 

significant deficiencies in the 

information supporting its petition by 

letters from the Agency dated May 28, 

1992, February 5, 1999, December 15, 

2004, March 19, 2009, and May 22, 

2009. The deficiencies related primarily 

to concerns about the possibility of 

Clostridium botulinum outgrowth in 

irradiated products, especially where 

the normal growth pattern of typical 

spoilage organisms could be changed by 

irradiation, thus reducing perception of 

spoilage. FDA had therefore requested 

information on typical spoilage and 

pathogenic microbial populations of 

shellfish irradiated at the maximum 

dose requested. FDA also requested 

additional data on the efficacy of the 

proposed doses of irradiation in 

reducing pathogens in crustaceans 

because the petition only included data 

on the efficacy of irradiation in reducing 

the levels of Vibrio species in oysters. 

Hartech Corp. has not provided 

information to address these 

deficiencies, and the Agency’s most 

recent letters to Hartech Corp.’s last 

known address were returned as 

undeliverable. Additional efforts to 

contact this petitioner have been 

unsuccessful. The petitioner has not 

provided sufficient data and 

information for the Agency to conclude 

that the proposed use of the food 

additive is safe in accordance with 

section 409 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 348). FDA 

is therefore denying the petition without 

prejudice to a future filing (21 U.S.C. 

348(c)(1)(B), 21 CFR 171.100(a)). 

This order is effective as shown in the 

DATES section of this document; except 

as to any provisions that may be stayed 

by the filing of proper objections. Any 

person who will be adversely affected 

by this order may file with the Division 

of Dockets Management (see ADDRESSES) 

either electronic or written objections. 

Each objection shall be separately 

numbered, and each numbered 

objection shall specify with particularity 

the provisions of the regulation to 

which objection is made and the 

grounds for the objection. Each 

numbered objection on which a hearing 

is requested shall specifically so state. 

Failure to request a hearing for any 

particular objection shall constitute a 

waiver of the right to a hearing on that 

objection. Each numbered objection for 

which a hearing is requested shall 

include a detailed description and 

analysis of the specific factual 

information intended to be presented in 

support of the objection in the event 

that a hearing is held. Failure to include 

such a description and analysis for any 

particular objection shall constitute a 

waiver of the right to a hearing on the 

objection. It is only necessary to send 

one set of documents. It is no longer 

necessary to send three copies of all 

documents. Identify documents with the 

docket number found in brackets in the 

heading of this document. Any 

objections received in response to the 

order may be seen in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

FDA will publish notice of the 

objections that the Agency has received 

or lack thereof in the Federal Register. 

Dated: March 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6624 Filed 3–21–11; 8:45 am] 

BILLING CODE 4160–01–P 


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