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
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 57803 

enter the terms of the order into the 

automated system for use in issuing 

income withholding orders. Copies of 

the income withholding order are made 

for all necessary parties, and copies are 

transmitted to the employer/income 

withholder by mail or through the OCSE 

electronic income withholding order (eIWO) portal. 

The Income Withholding for Support 

form and instructions were updated for 

consistency and clarity in light of 

numerous comments suggesting 

changes, based on comments received 

during the 60-day comment period of 

the 1st Federal Register Notice 

publication. 

Respondents: State Child Support 

Agencies and Tribes. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Income Withholding for Support (Form) .................................................. 58 0 0 0 

e-IWO Record Layouts ............................................................................ 58 0 0 0 

Estimated Total Annual Burden 

Hours: 0. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project. Fax: 202– 

395–6974. Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: September 15, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–23562 Filed 9–21–10; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0490] 

Preparation for International 

Conference on Harmonisation Steering 

Committee and Expert Working Group 

Meetings in Fukuoka, Japan; Regional 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH Steering Committee and Expert 

Working Group Meetings in Fukuoka, 

Japan’’ to provide information and 

receive comments on the International 

Conference on Harmonisation (ICH) as 

well as the upcoming meetings in 

Fukuoka, Japan. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Group meetings in 

Fukuoka, Japan, November 6 through 

11, 2010, at which discussion of the 

topics underway and the future of ICH 

will continue. 

Date and Time: The public meeting 

will be held on October 13, 2010, from 

2:30 p.m. to 4:30 p.m. 

Location: The public meeting will be 

held at the Washington Theater at the 

Hilton Washington DC/Rockville Hotel 

& Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: All participants must 

register with Jennifer Haggerty, Office of 

the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

email: jennifer.haggerty@fda.hhs.gov, or 

FAX: 301–595–7937. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material, and requests 

to make oral presentations to Jennifer 

Haggerty (see Contact Person) by 5 p.m. 

e.s.t. on October 11, 2010. 

If you need special accommodations 

due to a disability, please contact 

Jennifer Haggerty (see Contact Person) at 

least 7 days in advance. 

Transcripts: Please be advised that as 

soon as a transcript is available, it can 

be obtained in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The ICH 

was established in 1990 as a joint 

regulatory/industry project to improve, 

through harmonization, the efficiency of 

the process for developing and 

registering new medicinal products in 

Europe, Japan, and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 


emcdonald on DSK2BSOYB1PROD with NOTICES