Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8963 

Dated: February 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4003 Filed 2–25–10; 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; Proposed Collection; 

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 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 

information collection requirements for 

reporting and recordkeeping, general 

and specific requirements, and the 

availability of sample electronic 

products for manufacturers and 

distributors of electronic products. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 27, 2010. 

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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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. 

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. 

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. 

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)’’ 


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8964 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 

• 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’’ 

• 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 Reports on Cephalometric 

Devices Intended for Diagnostic Use’’ 

• FDA Form 3663 ‘‘Abbreviated 

Reports on Radiation Safety for 

Microwave Products (Other than 

Microwave Ovens)’’ 

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 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 

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 

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 

3663—Non-Oven Microwave Product 

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 


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Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8965 

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 

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 

1005.3 2877—Imports Declaration 600 32 19,200 0 .2 3,840 

1010.2 and 1010.3 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) and 

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) and 

1020.33(c), (d), 

(g)(4), (j)(1), and 

(j)(2) 

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) 

and (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 


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8966 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / 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 

1040.30(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 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 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 

Total 235,767 

1There are no 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: February 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4002 Filed 2–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Discretionary Grant Program 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of Noncompetitive 

Program Extension Supplemental 

Awards. 

SUMMARY: HRSA will be providing 

extensions with funds ranging from 5 to 

10 months to program grantees for the 

following programs in order to bring 

these programs into alignment with 

changes resulting from HRSA’s Maternal 

and Child Health Bureau’s developing 

strategic plan and the Early Learning 

and Development Initiative of the HHS 

and Department of Education. The 

programs are: 

• Alliance for Information in Maternal 

and Child Health (AIM) 

Æ Improving Understanding of 

MCH—10 grants 

Æ Partnerships to Promote MCH—5 

grants 

• AIM Policy Center—1 grant 

• Mental Health and Schools Resource 

Centers—2 grants 

• Public Policy Analysis and Education 

Center for Early Childhood—1 grant 

• National Healthy Child Care America 

Program 

Æ National Training Institute for 

Health Consultants—1 grant 

Æ Child Care Health Partnership 

Program—1 grant 

Æ Resource Center for Childcare 

Health and Safety—1 grant 

• National Sudden and Unexpected 

Infant/Child Death and Pregnancy 

Loss Centers—3 grants 

SUPPLEMENTARY INFORMATION: 

Intended Recipients of the Award 

The intended recipients are the 

incumbent grantees. They are either 

national membership organizations 

whose members impact maternal and 

child health programming or 

institutions of higher learning. They 

share a common purpose of providing 

education and technical assistance to 

either their individual members or State 

and community Maternal and Child 

Health programs. 

Authority: Section 501(a) (3) of the Social 

Security Act, as amended 

CFDA Number: 93.110. 

Project Period: The period of 

supplemental support is from the 

grantee’s original project end date 


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