Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 8747 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual 

Frequency per Recordkeeping 

Total Annual 

Records 

Hours per 

Record 

Total 

Hours 

101.13(q)(5) 300,000 1 .5 450,000 0 .75 337,500 

101.14(d)(2) 300,000 1 .5 450,000 0 .75 337,500 

101.22(i)(4) 25 1 25 1 25 

101.100(d)(2) 1,000 1 1,000 1 1,000 

101.105(t) 100 1 100 1 100 

Total 676,150 

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

The estimated annual reporting and 

recordkeeping burdens are based on 

agency communications with industry 

and FDA’s knowledge of and experience 

with food labeling and the submission 

of petitions and requests to the agency. 

Where an agency regulation implements 

an information collection requirement 

in the act or the FPLA, only any 

additional burden attributable to the 

regulation has been included in FDA’s 

burden estimate. 

No burden has been estimated for 

those requirements where the 

information to be disclosed is 

information that has been supplied by 

FDA. Also, no burden has been 

estimated for information that is 

disclosed to third parties as a usual and 

customary part of a food producer’s 

normal business activities. 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. Under 

5 CFR 1320.3(b)(2), the time, effort, and 

financial resources necessary to comply 

with a collection of information are 

excluded from the burden estimate if 

the reporting, recordkeeping, or 

disclosure activities needed to comply 

are usual and customary because they 

would occur in the normal course of 

activities. 

Dated: February 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3257 Filed 2–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0427] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reporting and 

Recordkeeping Requirements and 

Availability of Sample Electronic 

Products for Manufacturers and 

Distributors of Electronic Products 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by March 29, 

2007. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

1472. 

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: 

Reporting and Recordkeeping 

Requirements and Availability of 

Sample Electronic Products for 

Manufacturers and Distributors of 

Electronic Products (OMB Control 

Number 0910–0025)—Extension 

Under sections 532 through 542 of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360ii through 360ss), 

FDA has the responsibility to protect the 

public from unnecessary exposure of 

radiation from electronic products. The 

regulations issued under these 

authorities are listed in the Code of 

Federal Regulations, title 21, chapter I, 

subpart J. Specifically, 1410.10 of the 

FDA Staff Manual Guide delegates 

administrative authorities to FDA. 

Section 532 of the act directs the 

Secretary of Health and Human Services 

(the Secretary), to establish and carry 

out an electronic product radiation 

control program, including the 

development, issuance, and 

administration of performance 

standards to control the emission of 

electronic product radiation from 

electronic products. The program is 

designed to protect the public health 

and safety from electronic radiation, and 

the act authorizes the Secretary to 

procure (by negotiation or otherwise) 

electronic products for research and 

testing purposes and to sell or otherwise 

dispose of such products. 

Section 534(g) of the act directs the 

Secretary to review and evaluate 

industry testing programs on a 

continuing basis; and section 535(e) and 

(f) of the act directs the Secretary to 

immediately notify manufacturers of, 

and ensure correction of, radiation 

defects or noncompliances with 

performance standards. 

Section 537(b) of the act contains the 

authority to require manufacturers of 

electronic products to establish and 

maintain records (including testing 

records), make reports, and provide 


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8748 Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 

information to determine whether the 

manufacturer has acted in compliance. 

Parts 1002 through 1010 (21 CFR parts 

1002 through 1010) specify reports to be 

provided by manufacturers and 

distributors to FDA and records to be 

maintained in the event of an 

investigation of a safety concern or a 

product recall. 

FDA conducts laboratory compliance 

testing of products covered by 

regulations for product standards in 

parts 1020, 1030, 1040, and 1050 (21 

CFR parts 1020, 1030, 1040, and 1050). 

FDA details product-specific 

performance standards that specify 

information to be supplied with the 

product or require specific reports. The 

information collections are either 

specifically called for in the act or were 

developed to aid the agency in 

performing its obligations under the act. 

The data reported to FDA and the 

records maintained are used by FDA 

and the industry to make decisions and 

take actions that protect the public from 

radiation hazards presented by 

electronic products. This information 

refers to the identification of, location 

of, operational characteristics of, quality 

assurance programs for, and problem 

identification and correction of 

electronic products. The data provided 

to users and others are intended to 

encourage actions to reduce or eliminate 

radiation exposures. 

FDA uses the following forms to aid 

respondents in the submission of 

information for this information 

collection: 

FDA Form 2579 ‘‘Report of Assembly 

of a Diagnostic X-ray System’’

FDA Form 2767 ‘‘Notice of 

Availability of Sample Electronic 

Product’’

FDA Form 2877 ‘‘Declaration for 

Imported Electronic Products Subject To 

Radiation Control Standards’’

FDA Form 3649 ‘‘Accidental 

Radiation Occurrence’’

FDA Form 3626 ‘‘A Guide for the 

Submission of Initial Reports on 

Diagnostic X-Ray Systems and Their 

Major Components’’

FDA Form 3627 ‘‘Diagnostic X-ray CT 

Products Radiation Safety Report’’

FDA Form 3628 ‘‘General Annual 

Report (Includes Medical, Analytical, 

and Industrial X-ray Products Annual 

Report)’’

FDA Form 3629 ‘‘Abbreviated Report’’

FDA Form 3630 ‘‘Guide for Preparing 

Product Reports on Sunlamps and 

Sunlamp Products’’

FDA Form 3631 ‘‘Guide for Preparing 

Annual Reports on Radiation Safety 

Testing of Sunlamps and Sunlamp 

Products’’

FDA Form 3632 ‘‘Guide for Preparing 

Product Reports on Lasers and Products 

Containing Lasers’’

FDA Form 3633 ‘‘General Variance 

Request’’

FDA Form 3634 ‘‘Television Products 

Annual Report’’

FDA Form 3635 ‘‘Laser Light Show 

Notification’’

FDA Form 3636 ‘‘Guide for Preparing 

Annual Reports on Radiation Safety 

Testing of Laser and Laser Light Show 

Products’’

FDA Form 3637 ‘‘Laser Original 

Equipment Manufacturer (OEM) 

Report’’

FDA Form 3638 ‘‘Guide for Filing 

Annual Reports for X-ray Components 

and Systems’’

FDA Form 3639 ‘‘Guidance for the 

Submission of Cabinet X-ray System 

Reports Pursuant to 21 CFR 1020.40’’

FDA Form 3640 ‘‘Reporting Guide for 

Laser Light Shows and Displays’’

FDA Form 3147 ‘‘Application for a 

Variance From 21 CFR 1040.11(c) for a 

Laser Light Show, Display, or Device’’

FDA Form 3641 ‘‘Cabinet X-ray 

Annual Report’’

FDA Form 3642 ‘‘General 

Correspondence’’

FDA Form 3643 ‘‘Microwave Oven 

Products Annual Report’’

FDA Form 3644 ‘‘Guide for Preparing 

Product Reports for Ultrasonic Therapy 

Products’’

FDA Form 3645 ‘‘Guide for Preparing 

Annual Reports for Ultrasonic Therapy 

Products’’

FDA Form 3646 ‘‘Mercury Vapor 

Lamp Products Radiation Safety Report’’

FDA Form 3647 ‘‘Guide for Preparing 

Annual Reports on Radiation Safety 

Testing of Mercury Vapor Lamps’’

In the Federal Register of November 

3, 2006 (71 FR 64714), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

The most likely respondents to this 

information collection will be electronic 

product and X-ray manufacturers, 

importers, and assemblers. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section FDA Form Number No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1002.3 10 1 10 12 120 

1002.10 3626—Diagnostic Xray 540 1 .6 850 24 20,400 

3627—CT X-ray 

3639—Cabinet X-ray 

3632—Laser 

3640—Laser Light 

Show 

3630—Sunlamp 

3646—Mercury 

Vapor Lamp 

3644—Ultrasonic 

Therapy 

1002.11 1,000 1 .5 1,500 0.5 750 

1002.12 3629—Abbreviated 

Report 

150 1 150 5 750 

1002.13 3628—General 900 1 900 26 23,400 

3634—TV 

3638—Diagnostic Xray 


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Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 8749 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section FDA Form Number No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

3641—Cabinet X-ray 

3643—Microwave 

Oven 

3636—Laser 

3631—Sunlamp 

3647—Mercury 

Vapor Lamp 

3645—Ultrasonic 

Therapy 

1002.13 250 2 .4 600 0.5 300 

1002.20 3649—ARO 40 1 40 2 80 

1002.41(a) 1 1 1 1 1 

1002.50(a) and 1002.51 3642—General Correspondence 10 1 .5 15 1 15 

1005.10 2767—Sample Product 145 11 .03 1,600 0.09 144 

1005.25(b) 1 1 1 1 1 

2877—Imports Declaration 600 32 19,200 0.2 3,840 

1010.2 and 1010.3 1 1 1 5 5 

1010.4(b) 3633—General Variance Request 1 1 1 120 120 

3147—Laser Show 

Variance Request 

3635—Laser Show 

Notification 

1010.5(c) and (d) 2 1 2 22 44 

1010.13 1 1 1 10 10 

1020.20(c)(4) 1 1 1 1 1 

1020.30(d), (d)(1), and (d)(2) 2579—Assembler 

Report 

2,345 8 .96 21,000 0.30 6,300 

1020.30(g) 200 1 .33 265 35 9,275 

1020.30(h)(1) through (h)(4) and 

1020.32(a)(1) and (g) 

200 1 .33 265 35 9,275 

1020.30(h)(5) and (h)(6) and 

1020.32(j)(4) 

20 5 100 180 18,000 

1020.32(g) and 1020.33(c), (d), 

and (g)(4) 

9 1 .00 9 40 360 

1020.40(c)(9)(i) and (c)(9)(ii) 8 1 .00 8 40 320 

1030.10(c)(4) 41 1 .61 66 20 1,320 

1030.10(c)(5)(i) through 

(c)(5)(iv) 

41 1 .61 66 20 1,320 

1030.10(c)(6)(iii) and (c)(6)(iv) 1 1 1 1 1 

1040.10(a)(3)(i) 3637—OEM Report 83 1 83 3 249 

1040.10(h)(1)(i) through 

(h)(1)(vi) 

805 1 .00 805 8 6,440 

1040.10(h)(2)(i) and (h)(2)(ii) 100 1 .00 100 8 800 


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8750 Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section FDA Form Number No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1040.11(a)(2) 190 1 .00 190 10 1,900 

1040.20(d)(1)(ii) through 

(d)(1)(vi) and (e)(1) and (e)(2) 

110 1 .00 110 10 1,100 

1040.30(c)(1)(ii) 1 1 .00 1 1 1 

1040.30(c)(2) 7 1 .00 7 1 7 

1050.10(d)(1) through (d)(4) and 

(f)(1) through (f)(2)(iii) 

10 1 .00 10 56 560 

Total 107,209 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1002.30 and 1002.31(a) 1,150 1,655 .5 1,903,825 198 .7 228,505 

1002.40 and 1002.41 2,950 49 .2 145,140 2 .4 7,080 

1020.30(g) 22 1 22 0 .5 11 

1040.10(a)(3)(ii) 83 1 83 1 .0 83 

Totals 235,679 

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

The information collection 

requirements under OMB control 

number 0910–0564 and Form FDA 

3626, the data collection instrument for 

this collection, have been consolidated 

under the information collection 

activity of OMB control number 0910–

0025, thus resulting in an adjustment 

(increase) in the current burden 

estimate. 

The burden estimates were derived by 

consultation with FDA and industry 

personnel and actual data collected 

from industry. An evaluation of the type 

and scope of information requested was 

also used to derive some time estimates. 

For example, disclosure information 

primarily requires time only to update 

and maintain existing manuals. Initial 

development of manuals has been 

performed except for new firms entering 

the industry. When information is 

generally provided to users, assemblers, 

or dealers in the same manual, they 

have been grouped together in the 

‘‘Estimated Annual Reporting Burden’’

table (table 1 of this document). 

The following information collection 

requirements are not subject to review 

by OMB because they do not constitute 

a ‘‘collection of information’’ under the 

PRA: Sections 1002.31(c); 1003.10(a), 

(b), and (c); 1003.11(a)(3) and (b); 

1003.20(a) through (h); 1003.21(a) 

through (d); 1003.22(a) and (b); 

1003.30(a) and (b); 1003.31(a) and (b); 

1004.2(a) through (i); 1004.3(a) through 

(i); 1004.4(a) through (h); 1005.21(a) 

through (c); and 1005.22(b). These 

requirements ‘‘apply to the collection of 

information during the conduct of 

general investigations or audits’’ (5 CFR 

1320.4(b)). The following labeling 

requirements are also not subject to 

review under the PRA because they are 

a public disclosure of information 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public 

(1410.10 of the FDA Staff Manual Guide 

and §§ 1020.10(c)(4), 1030.10(c)(6), 

1040.10(g), 1040.30(c)(1), and 

1050.10(d)(1)). 

Dated: February 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3258 Filed 2–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0051] 

Safety of Fresh Produce; Public 

Hearings; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearings; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

two public hearings concerning the 

safety of fresh produce. The purpose of 

the hearings is for FDA to share 

information about recent outbreaks of 

foodborne illness associated with 

microbial contamination of fresh 

produce, and to solicit comments, data, 

and other scientific information about 

current agricultural and manufacturing 

practices used to produce, harvest, pack, 

cool, process, and transport fresh 

produce; risk factors for contamination 

of fresh produce associated with these 

practices; and possible measures by 

FDA to enhance the safety of fresh 

produce. 

DATES: The first public hearing will be 

held on March 20, 2007, from 9 a.m. to 


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