Global Harmonization Task Force, Study Group 4; Final Document; Availability, 15759-15760 [E8-5927]

Download as PDF 15759 Federal Register / Vol. 73, No. 58 / Tuesday, March 25, 2008 / Notices Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACE Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: March 19, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–5951 Filed 3–24–08; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Temporary Assistance for Needy Families (TANF) State Plan; Guidance. OMB No.: 0970–0145. Description: The State plan is a mandatory statement submitted to the Secretary of the Department of Health and Human Services by the State. It consists of an outline of how the State’s TANF program will be administered and operated and certain required certifications by the State’s Chief Executive Officer. Its submittal triggers the State’s family assistance grant funding and it is used to provide the public with information about the program. If a State makes changes in its program, it must submit a State plan amendment. Respondents: The 50 States, the District of Columbia, Guam, Puerto Rico and the Virgin Islands. ANNUAL BURDEN ESTIMATES No. of respondents Instrument mstockstill on PROD1PC66 with NOTICES Temporary Assistance for Needy Families (TANF) State Plan Guidance ...... Estimated Total Annual Burden Hours: 891. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded 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. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. VerDate Aug<31>2005 18:33 Mar 24, 2008 Jkt 214001 54 Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: March 19, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–5952 Filed 3–24–08; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0149] (formerly Docket No. 2007D–0031) Global Harmonization Task Force, Study Group 4; Final Document; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final document that has been prepared by Study Group 4 of the Global Harmonization Task Force (GHTF). This document represents a harmonized proposal and recommendation from Study Group 4 of the GHTF that may be used by governments developing and updating their regulatory requirements for medical devices. This document is PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 No. of responses per respondent 0.5 Average burden hours per response 33 Total burden hours 891 intended to provide information only and does not describe current regulatory requirements; elements of this document may not be consistent with current U.S. regulatory requirements. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 240–276–3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this document to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jan Welch, GHTF, Study Group 4, Office of Compliance, Center for Devices and Radiological Health (HFZ–320), Food E:\FR\FM\25MRN1.SGM 25MRN1 15760 Federal Register / Vol. 73, No. 58 / Tuesday, March 25, 2008 / Notices and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240–276– 0115. SUPPLEMENTARY INFORMATION: mstockstill on PROD1PC66 with NOTICES I. Background FDA has participated in a number of activities to promote the international harmonization of regulatory requirements. In September 1992, a meeting was held in Nice, France by senior regulatory officials to evaluate international harmonization. This meeting led to the development of the organization now known as the Global Harmonization Task Force (GHTF) to facilitate harmonization. Subsequent meetings have been held on a yearly basis in various locations throughout the world. The GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific, and North America, each of which actively regulates medical devices using their own unique regulatory framework. The objective of the GHTF is to encourage convergence at the global level of regulatory systems of medical devices to facilitate trade while preserving the right of participating members to address the protection of public health by regulatory means considered most suitable. One of the ways this objective is achieved is by identifying and developing areas of international cooperation to facilitate progressive reduction of technical and regulatory differences in systems established to regulate medical devices. In an effort to accomplish these objectives, the GHTF formed five study groups to draft documents and carry on other activities designed to facilitate global harmonization. This notice is a result of a document that has been developed by one of the Study Groups (4). Study Group 4 was initially tasked with the responsibility of developing guidance documents on quality systems auditing practices. As a result of its efforts, this group has developed document SG4/N33R16:2007. The final document (SG4/N33R16:2007) entitled ‘‘Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers—Part 3: Regulatory Audit Reports’’ provides a structure for audit reports used in multiple jurisdictions, promoting consistency and uniformity and should assist the auditor in preparing a report VerDate Aug<31>2005 18:33 Mar 24, 2008 Jkt 214001 for use by multiple regulators and/or auditing organizations. Having reports that are consistent in content should facilitate the review and exchange of audit reports. Acceptance of audit reports by multiple regulators should eventually reduce the number of audits for manufacturers. This document was announced as available for comment on February 6, 2007 (72 FR 5443). GHTF received several comments on the document proposed on February 6, 2007. In response to the comments, GHTF made changes to clarify the document. of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: March 14, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–5927 Filed 3–24–08; 8:45 am] BILLING CODE 4160–01–S II. Significance of Guidance This document represents recommendations from the GHTF study groups and does not describe regulatory requirements. FDA is making this document available so that industry and other members of the public may express their views and opinions. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. Information on the GHTF may be accessed at http://www.ghtf.org. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. IV. Paperwork Reduction Act of 1995 For this final document, FDA concludes that there are no collection of information requirements under the Paperwork Reduction Act of 1995. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Down Syndrome. Date: April 18, 2008. Time: 1 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, 5B01, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Norman Chang, Ph.D., Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01 Bethesda, MD 20892, (301) 496–1485, changnmaiI.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 73, Number 58 (Tuesday, March 25, 2008)]
[Notices]
[Pages 15759-15760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5927]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0149] (formerly Docket No. 2007D-0031)


Global Harmonization Task Force, Study Group 4; Final Document; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final document that has been prepared by Study Group 
4 of the Global Harmonization Task Force (GHTF). This document 
represents a harmonized proposal and recommendation from Study Group 4 
of the GHTF that may be used by governments developing and updating 
their regulatory requirements for medical devices. This document is 
intended to provide information only and does not describe current 
regulatory requirements; elements of this document may not be 
consistent with current U.S. regulatory requirements.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document to the Division of Small Manufacturers, International, and 
Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 240-276-3151. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance. Submit written comments concerning this document to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. Identify 
comments with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Jan Welch, GHTF, Study Group 4, Office 
of Compliance, Center for Devices and Radiological Health (HFZ-320), 
Food

[[Page 15760]]

and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-
276-0115.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has participated in a number of activities to promote the 
international harmonization of regulatory requirements. In September 
1992, a meeting was held in Nice, France by senior regulatory officials 
to evaluate international harmonization. This meeting led to the 
development of the organization now known as the Global Harmonization 
Task Force (GHTF) to facilitate harmonization. Subsequent meetings have 
been held on a yearly basis in various locations throughout the world.
    The GHTF is a voluntary group of representatives from national 
medical device regulatory authorities and the regulated industry. Since 
its inception, the GHTF has been comprised of representatives from five 
founding members grouped into three geographical areas: Europe, Asia-
Pacific, and North America, each of which actively regulates medical 
devices using their own unique regulatory framework.
    The objective of the GHTF is to encourage convergence at the global 
level of regulatory systems of medical devices to facilitate trade 
while preserving the right of participating members to address the 
protection of public health by regulatory means considered most 
suitable. One of the ways this objective is achieved is by identifying 
and developing areas of international cooperation to facilitate 
progressive reduction of technical and regulatory differences in 
systems established to regulate medical devices. In an effort to 
accomplish these objectives, the GHTF formed five study groups to draft 
documents and carry on other activities designed to facilitate global 
harmonization. This notice is a result of a document that has been 
developed by one of the Study Groups (4).
    Study Group 4 was initially tasked with the responsibility of 
developing guidance documents on quality systems auditing practices. As 
a result of its efforts, this group has developed document SG4/
N33R16:2007. The final document (SG4/N33R16:2007) entitled ``Guidelines 
for Regulatory Auditing of Quality Management Systems of Medical Device 
Manufacturers--Part 3: Regulatory Audit Reports'' provides a structure 
for audit reports used in multiple jurisdictions, promoting consistency 
and uniformity and should assist the auditor in preparing a report for 
use by multiple regulators and/or auditing organizations. Having 
reports that are consistent in content should facilitate the review and 
exchange of audit reports. Acceptance of audit reports by multiple 
regulators should eventually reduce the number of audits for 
manufacturers. This document was announced as available for comment on 
February 6, 2007 (72 FR 5443). GHTF received several comments on the 
document proposed on February 6, 2007. In response to the comments, 
GHTF made changes to clarify the document.

II. Significance of Guidance

    This document represents recommendations from the GHTF study groups 
and does not describe regulatory requirements. FDA is making this 
document available so that industry and other members of the public may 
express their views and opinions.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. The Center for Devices and Radiological Health 
(CDRH) maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. Information on the GHTF may be accessed at http://
www.ghtf.org. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh.

IV. Paperwork Reduction Act of 1995

    For this final document, FDA concludes that there are no collection 
of information requirements under the Paperwork Reduction Act of 1995.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: March 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5927 Filed 3-24-08; 8:45 am]
BILLING CODE 4160-01-S