Submission for OMB Review; Comment Request, 57802-57803 [2010-23562]

Download as PDF 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 No. of Respondents Section 523 of the Act Annual Frequency per Response Requests for Accreditation Total Annual Respondents Hours per Response Total Hours 1 1 24 24 10 510(k) reviews conducted by accredited third parties 1 26 260 40 10,400 Totals 10,424 1 There 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 510(k) reviews 1 There 10 Total Annual Records 26 Hours per Record 260 Total Hours 10 2,600 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. emcdonald on DSK2BSOYB1PROD with NOTICES Annual Frequency per Recordkeeping 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 VerDate Mar<15>2010 17:32 Sep 21, 2010 Jkt 220001 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 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22SEN1.SGM 22SEN1 57803 Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 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 Number of respondents Instrument Income Withholding for Support (Form) .................................................. e-IWO Record Layouts ............................................................................ 58 58 Estimated Total Annual Burden Hours: 0. DEPARTMENT OF HEALTH AND HUMAN SERVICES Additional Information Food and Drug Administration 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 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 VerDate Mar<15>2010 17:32 Sep 21, 2010 [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. 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. SUMMARY: OMB Comment emcdonald on DSK2BSOYB1PROD with NOTICES Number of responses per respondent Jkt 220001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Average burden hours per response 0 0 0 0 Total burden hours 0 0 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 E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[Federal Register Volume 75, Number 183 (Wednesday, September 22, 2010)]
[Notices]
[Pages 57802-57803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23562]


-----------------------------------------------------------------------

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

[[Page 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 (e-IWO) 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
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          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
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