26964 Federal Register / Vol. 75, No. 92 / Thursday, May 13, 2010 / Notices 

The number of respondents in table 1 

of this document is the number of 

sponsors registered to make electronic 

submissions (40). The number of total 

annual responses is based on a review 

of the actual number of such 

submissions made between January 1, 

2008, and December 31, 2008 (96 x 

hours per response (.08) = 7.7 total 

hours). 

Dated: May 10, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–11453 Filed 5–12–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0088] 

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 June 14, 

2010. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0025. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, email: 

Daniel.Gittleson@fda.hhs.gov. 

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 title 21 of the 

Code of Federal Regulations, chapter I, 

subpart J, parts 1000 through 1050 (parts 

1002 through 1050). 

Section 532 of the act directs the 

Secretary of the Department 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 information 

to determine whether the manufacturer 

has acted in compliance. 

The regulations under 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. 

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 (ARO)’’ 

• 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’’ 


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Federal Register / Vol. 75, No. 92 / Thursday, May 13, 2010 / Notices 26965 

• 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’’ 

• FDA Form 3659 ‘‘Reporting and 

Compliance Guide for Television 

Products’’ 

• FDA Form 3660 ‘‘Guidance for 

Preparing Reports on Radiation Safety of 

Microwave Ovens’’ 

• FDA Form 3661 ‘‘Guide for the 

Submission of an Abbreviated Report on 

X-Ray Tables, Cradles, Film Changers, 

or Cassette Holders Intended for 

Diagnostic Use’’ 

• FDA Form 3662 ‘‘Guide for 

Submission of an Abbreviated Radiation 

Safety Report on Cephalometric Devices 

Intended for Diagnostic Use’’ 

• FDA Form 3663 ‘‘Abbreviated 

Reports on Radiation Safety for 

Microwave Products (Other than 

Microwave Ovens)’’ 

• FDA Form 3801 ‘‘Guide for 

Preparing Initial Reports and Model 

Change Reports on Medical Ultraviolet 

Lamps and Products Containing Such 

Lamps’’ 

The most likely respondents to this 

information collection will be electronic 

product and x-ray manufacturers, 

importers, and assemblers. 

In the Federal Register of February 

26, 2010 (75 FR 8963), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1 –ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/ 

Part 

FDA Form 

No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1002.3 N/A 10 1 10 12 120 

1002.10 3626—Diagnostic X-Ray 

3627—CT X-Ray 

3639—Cabinet X-Ray 

3632—Laser 

3640—Laser Light Show 

3630—Sunlamp 

3646—Mercury Vapor Lamp 

3644—Ultrasonic Therapy 

3659—TV 

3660—Microwave Oven 

3801—UV Lamps 

1,000 1.2 1,200 24 28,800 

1002.11 N/A 400 0.6 240 0.5 120 

1002.12 3629—General Abbreviated Report 

3661—X-Ray Tables, etc. 

3662—Cephalometric Device 

3663—non-Oven Microwave Product 

50 1 50 5 250 

1002.13 3628—General 

3634—TV 

3638—Diagnostic X-Ray 

3641—Cabinet X-Ray 

3643—Microwave Oven 

3636—Laser 

3631—Sunlamp 

3647—Mercury Vapor Lamp 

3645—Ultrasonic Therapy 

1,000 1 1,000 18 18,000 

1002.13(c) N/A 100 2.4 240 0.5 120 

1002.20 3649—ARO 25 1 25 2 50 

1002.41(a) N/A 1 1 1 1 1 

1002.50(a) and 

1002.51 

3642—General Correspondence 10 0.5 5 1 5 

1005.10 2767—Sample Product 50 1 50 0.1 5 

1005.25(b) N/A 1 1 1 1 1 

1005 2877—Imports Declaration 600 32 19,200 0.2 3,840 


sroberts on DSKD5P82C1PROD with NOTICES
26966 Federal Register / Vol. 75, No. 92 / Thursday, May 13, 2010 / Notices 

TABLE 1 –ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section/ 

Part 

FDA Form 

No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1010.2 N/A 1 1 1 5 5 

1010.4(b) 3633—General Variance Request 

3147—Laser Show Variance Request 

3635—Laser Show Notification 

160 0.3 48 1.2 58 

1010.5(c) and (d) N/A 4 1 4 22 88 

1010.13 N/A 1 1 1 10 10 

1020.20(c)(4) N/A 1 1 1 1 1 

1020.30(d), (d)(1), 

and (d)(2) 

2579—Assembler Report 1,150 10.7 12,305 0.30 3,692 

1020.30(g) N/A 200 1.33 266 35 9,310 

1020.30(h)(1) 

through (h)(4), 

1020.32(a)(1) and 

(g) 

N/A 200 1.33 266 35 9,310 

1020.30(h)(5) and 

(h)(6) and 

1020.32(j)(4) 

N/A 20 5 100 18 1,800 

1020.32(g), 

1020.33(c), (d), 

(g)(4), (j)(3), and 

(j)(4) 

N/A 9 1 9 40 360 

1020.40(c)(9)(i) and 

(c)(9)(ii) 

N/A 8 1 8 40 320 

1030.10(c)(4) N/A 41 1.6 66 20 1,320 

1030.10(c)(5)(i) 

through (c)(5)(iv) 

N/A 41 1.6 66 20 1,320 

1030.10(c)(6)(iii) 

and (c)(6)(iv) 

N/A 1 1 1 1 1 

1040.10(a)(3)(i) 3637—OEM Report 40 1 40 3 120 

1040.10(h)(1)(i) 

through (h)(1)(vi) 

N/A 805 1 805 8 6,440 

1040.10(h)(2)(i) and 

(h)(2)(ii) 

N/A 100 1 100 8 800 

1040.11(a)(2) N/A 50 1 50 10 500 

1040.20(d)(1)(ii) 

through (d)(1)(vi), 

(e)(1), and (e)(2) 

N/A 110 1 110 10 1,100 

1040.30(c)(1)(ii) N/A 1 1 1 1 1 

1040.30(c)(2) N/A 7 1 7 1 7 

1050.10(d)(1) 

through (d)(4) 

and (f)(1) through 

(f)(2)(iii) 

N/A 10 1 10 56 560 

Total Annual Reporting Burden 88,435 

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


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Federal Register / Vol. 75, No. 92 / Thursday, May 13, 2010 / Notices 26967 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

of Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1002.30 and 1002.31(a) 1,150 1,655.5 1,903,825 0.12 228,459 

1002.40 and 1002.41 2,950 49.2 145,140 0.05 7,257 

1020.30(g) 22 1 22 0.5 11 

1040.10(a)(3)(ii) 40 1 40 1.0 40 

Totals 235,767 

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

The burden estimates were derived by 

consultation with FDA and industry 

personnel, and are based on 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. 

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 (5 CFR 

1320.3(c)(2)): Sections 1020.10(c)(4), 

1030.10(c)(6), 1040.10(g), 1040.30(c)(1), 

and 1050.10(d)(1). 

Dated: May 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–11396 Filed 5–12–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0236] 

Guidance for Industry: Use of Water by 

Food Manufacturers in Areas Subject 

to a Boil-Water Advisory; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Guidance for Industry: Use of Water by 

Food Manufacturers in Areas Subject to 

a Boil-Water Advisory.’’ This guidance 

is intended to advise food 

manufacturers that once a boil-water 

advisory has been issued they should 

stop using the water subject to the 

advisory until the water again meets the 

applicable Federal and State drinking 

water quality standards. Further, this 

guidance is intended to assist food 

manufacturers in evaluating food that 

already was produced with water 

subject to the advisory. The guidance is 

in response to the recent major water 

pipe break in Massachusetts that 

interrupted service to 30 Massachusetts 

Water Resources Authority (MWRA) 

customer communities (serving 

approximately 2 million residents). 

DATES: Submit electronic or written 

comments on the guidance at any time. 

ADDRESSES: Submit electronic 

comments on the guidance to http:// 

www.regulations.gov. Submit written 

comments on the guidance to the 

Division of Dockets Management 

(HFA—305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

written requests for single copies of the 

guidance to the Office of Food Safety, 

Center for Food Safety and Applied 

Nutrition (HFS–300), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Jenny Scott, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1700 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Guidance for 

Industry: Use of Water by Food 

Manufacturers in Areas Subject to a 

Boil-Water Advisory.’’ This guidance is 

intended to advise food manufacturers 

that once a boil-water advisory has been 

issued they should stop using the water 

subject to the advisory until the water 

again meets the applicable Federal and 

State drinking water quality standards. 

Further, this guidance is intended to 

assist food manufacturers in evaluating 

food that already was produced with 

water subject the advisory. 

FDA is issuing this guidance as Level 

1 guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). Consistent with FDA’s good 

guidance practices regulation, the 

agency will accept comment, but is 

implementing the guidance document 

immediately in accordance with 21 CFR 

10.115(g)(2) because the agency has 

determined that prior public 

participation is not feasible or 

appropriate in light of the need to 

respond expeditiously to the recent 

major water pipe break in Massachusetts 

that interrupted service to 30 MWRA 

customer communities (serving 

approximately 2 million residents). The 

guidance represents the agency’s current 

thinking on the use of water by food 

manufacturers in areas subject to a 

‘‘Boil-Water Advisory.’’ It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternate approach may be 


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