Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 57801 

about both risks and benefits, and no 

additional information) in three 

different promotional offers (money 

back guarantee and two others) in a 

medium prevalence medical condition 

(defined previously). This supplemental 

study will be conducted online. One 

type of offer examined will be money 

back guarantee; we will choose the other 

two types of promotional offers based 

on the results of the main study. The 

exact wording of the qualifying context 

to be examined will be determined 

through pretesting. This study is 

experimental in method: Participants 

will be randomly assigned to condition. 

Supplementary Study Design 

Type of Offer 

Type of Context 

(examples) 

Money Back 

Guarantee 

Offer 2 

To be determined 

Offer 3 

To be determined 

Additional information about risk 

Additional information about efficacy 

Additional information about efficacy and risk 

Control: No Context 

Interviews are expected to last no 

more than 20 minutes. A total of 10,000 

participants will be involved in the 

pretesting and two phases of the study. 

This will be a one time (rather than 

annual) collection of information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Pretests 1,000 1 1,000 .33 330 

Main study: online 3,750 1 3,750 .33 1,238 

Main study: mall intercept 2,250 1 2,250 .33 743 

Supplementary study 3,000 1 3,000 .33 990 

Total 10,000 3,301 

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

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23632 Filed 9–21–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0447] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices 

Third-Party Review Under the Food 

and Drug Administration 

Modernization Act 

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 

the information collection in ‘‘Medical 

Devices Third-Party Review under the 

Food and Drug Administration 

Modernization Act of 1997.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 22, 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., 

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 


emcdonald on DSK2BSOYB1PROD with NOTICES
57802 Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 

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. 

Medical Devices Third-Party Review 

Under the Food and Drug 

Administration Modernization Act— 

Section 523 of the Federal Food, Drug, 

and Cosmetic Act (OMB Control 

Number 0910–0375)—Extension 

Section 210 of the Food and Drug 

Administration Modernization Act 

(FDAMA) established section 523 of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360m), directing 

FDA to accredit persons in the private 

sector to review certain premarket 

notifications [510(k)s]. Participation in 

this third-party review program by 

accredited persons is entirely voluntary. 

A third party wishing to participate will 

submit a request for accreditation to 

FDA. Accredited third-party reviewers 

have the ability to review a 

manufacturer’s 510(k) of the act (21 

U.S.C. 360) submission for selected 

devices. After reviewing a submission, 

the reviewer will forward a copy of the 

510(k) submission, along with the 

reviewer’s documented review and 

recommendation to FDA. Third-party 

reviewers should maintain records of 

their 510(k) reviews and a copy of the 

510(k) for a reasonable period of time, 

usually a period of 3 years. 

This information collection will allow 

FDA to continue to implement the 

accredited person review program 

established by FDAMA and improve the 

efficiency of 510(k) review for low- to 

moderate-risk devices. 

Respondents to this information 

collection are businesses or other forprofit organizations. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section 523 of the Act No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Respondents 

Hours per 

Response Total Hours 

Requests for Accreditation 1 1 1 24 24 

510(k) reviews conducted by accredited third parties 10 26 260 40 10,400 

Totals 10,424 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Section 523 of the Act No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

510(k) reviews 10 26 260 10 2,600 

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

I. Reporting 

510(k) reviews conducted by accredited 

third parties 

According to FDA’s data in 2009, the 

agency has experienced that the number 

of 510(k)’s submitted for third-party 

review is approximately 260 annually, 

which is 26 annual reviews per each of 

the 10 accredited reviewers. 

II. Recordkeeping 

Third party reviewers are required to 

keep records of their review of each 

submission. According to FDA’s in 

2009, the agency anticipates 

approximately 260 submissions of 

510(k)’s for third-party review per year. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23633 Filed 9–21–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Income Withholding for 

Support (IWO). 

OMB No.: 0970–0154. 

Description 

Use of the OMB-approved Income 

Withholding for Support form falls 

under the authority of section 466 of the 

Act, 42 U.S.C. 666. Section 

466(b)(6)(A)(ii) of the Act requires that 

the notice given to the employer for 

income withholding in IV–D cases shall 

be in a standard format prescribed by 

the Secretary, and contain only such 

information as may be necessary for the 

employer to comply with the 

withholding order for all IV–D cases. 

Section 466(a)(8)(B)(iii) of the Act 

requires that section 466(b)(6)(A)(ii) of 

the Act be applicable also to non-IV–D 

income withholding orders. These 

provisions clearly require all 

individuals and entities to use a form 

developed by the Secretary of HHS to 

notify employers of the income 

withholding order for child support in 

all IV–D and non-IV–D cases. 

OCSE requires States’ automated 

systems to be able to automatically 

generate and download data to the OMB 

approved income withholding form. If 

child support orders are established by 

the child support agency, necessary 

information is already contained within 

the automated system for downloading 

into income withholding orders. If a 

court or other tribunal has issued a 

child support order, then agency staff 


emcdonald on DSK2BSOYB1PROD with NOTICES