Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Notices 23865 

impractical or when in-depth responses 

are required. 

The evaluation information will be 

used to determine whether DHDSP 

activities and products are reaching the 

intended audiences, whether they are 

deemed to be useful by those audiences, 

and whether DHDSP efforts improve 

public health practices. Finally, the 

generic clearance format will allow the 

DHDSP to identify new programmatic 

opportunities and to respond to 

partners’ concerns. 

There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

491. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Data collection mechanism Number of 

respondents 

Average 

burden per 

response 

(in hours) 

State and Local Health Departments ........................... Web-based survey ........................................................ 250 30/60 

Interview ....................................................................... 30 1 

Focus group .................................................................. 32 1 

Private Sector Partners ................................................ Web-based survey ........................................................ 180 30/60 

Interview ....................................................................... 90 1 

Focus group .................................................................. 48 1 

Academic Institutions .................................................... Web-based survey ........................................................ 60 30/60 

Interview ....................................................................... 30 1 

Focus group .................................................................. 16 1 

Dated: May 14, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–11895 Filed 5–20–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0043] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Irradiation in the 

Production, Processing, and Handling 

of Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 22, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0186. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Irradiation in the Production, 

Processing, and Handling of Food— 

(OMB Control Number 0910–0186)— 

Extension 

Under sections 201(s) and 409 of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 321(s) and 348), food 

irradiation is subject to regulation under 

the food additive premarket approval 

provisions of the act. The regulations 

providing for uses of irradiation in the 

production, processing, and handling of 

food are found in part 179 (21 CFR part 

179). To ensure safe use of a radiation 

source, § 179.21(b)(1) requires that the 

label of sources bear appropriate and 

accurate information identifying the 

source of radiation and the maximum 

(or minimum and maximum) energy of 

radiation emitted by x-ray tube sources. 

Section 179.21(b)(2) requires that the 

label or accompanying labeling bear 

adequate directions for installation and 

use and a statement supplied by FDA 

that indicates maximum dose of 

radiation allowed. Section 179.26(c) 

requires that the label or accompanying 

labeling bear a logo and a radiation 

disclosure statement. Section 179.25(e) 

requires that food processors who treat 

food with radiation make and retain, for 

1 year past the expected shelf life of the 

products up to a maximum of 3 years, 

specified records relating to the 

irradiation process (e.g., the food 

treated, lot identification, scheduled 

process, etc.). The records required by 

§ 179.25(e) are used by FDA inspectors 

to assess compliance with the regulation 

that establishes limits within which 

radiation may be safely used to treat 

food. The agency cannot ensure safe use 

without a method to assess compliance 

with the dose limits, and there are no 

practicable methods for analyzing most 

foods to determine whether they have 

been treated with ionizing radiation and 

are within the limitations set forth in 

part 179. Records inspection is the only 

way to determine whether firms are 

complying with the regulations for 

treatment of foods with ionizing 

radiation. 

In this request for extension of OMB 

approval, FDA proposes to include and 

consolidate into the subject collection of 

information (OMB control number 

0910–0186) the collection of 

information and associated burden 

hours from OMB control number 0910– 

0549. This inclusion is reflected in the 

estimated burden reported in table 1 of 

this document, which has increased by 

the addition of one recordkeeper in the 

large processors line, increasing the 

number of estimated recordkeepers from 

two to three. 

Description of Respondents: 

Respondents are businesses engaged in 

the irradiation of food. 

In the Federal Register of February 

13, 2009 (74 FR 7236), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 


dwashington3 on PROD1PC60 with NOTICES
23866 Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Notices 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

179.25(e), large processors 3 300 900 1 900 

179.25(e), small processors 4 30 120 1 120 

Total 1,020 

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

FDA bases its estimate of burden for 

the recordkeeping provisions of 

§ 179.25(e) on the agency’s experience 

regulating the safe use of radiation as a 

direct food additive. The number of 

firms who process food using irradiation 

is extremely limited. FDA estimates that 

there are 3 irradiation plants whose 

business is devoted primarily (i.e., 

approximately 100 percent) to 

irradiation of food and other agricultural 

products. Four other firms also irradiate 

small quantities of food. FDA estimates 

that this irradiation accounts for no 

more than 10 percent of the business for 

each of these firms. Therefore, the 

average estimated burden is based on: 

Three facilities devoting 100 percent of 

their business to food irradiation (3 × 

300 hours = 900 hours for recordkeeping 

annually); four facilities devoting 10 

percent of their business to food 

irradiation (4 × 30 hours = 120 hours for 

recordkeeping annually). 

No burden has been estimated for the 

labeling requirements in § 179.21(b)(1) 

and (b)(2) and § 179.26(c) because the 

information to be disclosed is 

information that has been supplied by 

FDA. Under 5 CFR 1320.3(c)(2), the 

public disclosure of information 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public is 

not a collection of information. 

Dated: May 14, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–11931 Filed 5–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

Diabetes Mellitus Interagency 

Coordinating Committee; Notice of 

Meeting 

The National Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK), 

on behalf of the National Institutes of 

Health (NIH), the Centers for Disease 

Control and Prevention (CDC), and the 

Diabetes Mellitus Interagency 

Coordinating Committee (DMICC), is 

convening an ad hoc planning and 

evaluation meeting to provide a midcourse assessment of ongoing preclinical research efforts supported by 

the Special Statutory Funding Program 

for Type 1 Diabetes Research and to 

discuss possible future directions for 

these efforts. 

Sessions of the meeting will be open 

to the public as indicated below, with 

attendance limited to space available. 

Certain sessions, during which 

confidential information will be 

discussed, will be closed to the public. 

Members of the public planning to 

attend the meeting must register online 

at: http://www.scgcorp.com/ 

Type1Diabetes09/registration.asp. This 

is not a meeting to solicit public 

comment. Therefore, members of the 

public are permitted to attend the open 

sessions as observers only. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should inform the 

Contact Person listed below at least 10 

days in advance of the meeting. 

Name: Meeting on Pre-Clinical 

Research Supported by the Special 

Statutory Funding Program for Type 1 

Diabetes Research. 

Place: National Institutes of Health, 

Neuroscience Building, 6001 Executive 

Blvd., Conference Room C, Bethesda, 

MD 20852. 

Date: June 17, 2009. 

Open: 8 a.m. to 8:45 a.m. 

Agenda: Meeting introduction; 

overview of the Type 1 Diabetes—Rapid 

Access to Intervention Development 

(T1D–RAID) research program. 

Closed: 8:45 a.m. to 9:30 a.m. 

Agenda: Mid-course assessment of 

T1D–RAID. 

Open: 9:30 a.m. to 10 a.m. 

Agenda: Overview of the Type 1 

Diabetes Preclinical Testing Program 

(T1D–PTP)—Prevention or Reversal of 

Type 1 Diabetes in Rodent Models. 

Closed: 10 a.m. to 10:30 a.m. 

Agenda: Mid-course assessment of the 

T1D–PTP—Prevention or Reversal of 

Type 1 Diabetes in Rodent Models. 

Open: 10:45 a.m. to 11:15 a.m. 

Agenda: Overview of the T1D–PTP— 

Prevention or Reversal of Diabetic 

Complications in Rodent Models. 

Closed: 11:15 a.m. to 11:45 a.m. 

Agenda: Mid-course assessment of the 

T1D–PTP—Prevention or Reversal of 

Diabetic Complications in Rodent 

Models. 

Open: 12:30 p.m. to 1 p.m. 

Agenda: Overview of the Animal 

Models of Diabetic Complications 

Consortium (AMDCC) research program. 

Closed: 1 p.m. to 2 p.m. 

Agenda: Mid-course assessment of the 

AMDCC. 

Open: 2 p.m. to 2:30 p.m. 

Agenda: Overview of the Type 1 

Diabetes Resource. 

Closed: 2:30 p.m. to 3:15 p.m. 

Agenda: Mid-course assessment of the 

Type 1 Diabetes Resource. 

Open: 3:30 p.m. to 4 p.m. 

Agenda: Overview of Beta Cell 

Biology Consortium (BCBC). 

Closed: 4 p.m. to 5 p.m. 

Agenda: Mid-course assessment of the 

BCBC. 

Contact Person: Julie Wallace, PhD, 

Health Science Policy Analyst, Office of 

Scientific Program and Policy Analysis, 

National Institute of Diabetes and 

Digestive and Kidney Diseases, 9000 

Rockville Pike, Building 31, Room 

9A05, Bethesda, MD 20892, (301) 496– 

6623, wallaceja@niddk.nih.gov. 


dwashington3 on PROD1PC60 with NOTICES