Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002, 64718 [E6-18603]

Download as PDF 64718 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices 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 21 CFR 1020.10(c)(4), 1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and 1050.10(d)(1). Dated: October 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–18559 Filed 11–2–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0326] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 4, 2006. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Devices: Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (OMB Control Number 0910–0510)—Extension The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107–250) was signed into law on October 26, 2002. Section 201 of MDUFMA adds a new paragraph ‘‘g’’ to section 704 of the Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons or APs) to conduct inspections of eligible manufacturers of class II or class III devices. This is a voluntary program. FDA has a guidance document that provides information for those interested in participating in this program. The guidance is entitled ‘‘Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria.’’ In the Federal Register of August 24, 2006 (71 FR 50067), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Respondents are expected to be businesses or other for profit organizations. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Information Collection No. of Respondents Request for Accreditation Annual Frequency per Response 3 Total Annual Responses 1 Hours per Response 3 80 Total Hours 1There 240 240 are no capital costs or operating and maintenance costs associated with this collection of information. FDA based these estimates on conversations with industry, trade association representatives, and internal FDA estimates. Once an organization is accredited, it will not be required to reapply. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–18603 Filed 11–2–06; 8:45 am] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 016 BILLING CODE 4160–01–S AGENCY: Food and Drug Administration [Docket No. 2004N–0226] Food and Drug Administration, HHS. ACTION: mstockstill on PROD1PC68 with NOTICES Total Hours Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 016’’ (Recognition List Number: 016), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 016’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological E:\FR\FM\03NON1.SGM 03NON1

Agencies

[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Page 64718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0326]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Inspection by 
Accredited Persons Program Under the Medical Device User Fee and 
Modernization Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 4, 2006.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Devices: Inspection by Accredited Persons Program Under the 
Medical Device User Fee and Modernization Act of 2002 (OMB Control 
Number 0910-0510)--Extension

    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
(Public Law 107-250) was signed into law on October 26, 2002. Section 
201 of MDUFMA adds a new paragraph ``g'' to section 704 of the Federal, 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), directing FDA 
to accredit third parties (accredited persons or APs) to conduct 
inspections of eligible manufacturers of class II or class III devices. 
This is a voluntary program.
    FDA has a guidance document that provides information for those 
interested in participating in this program. The guidance is entitled 
``Implementation of the Inspection by Accredited Persons Program Under 
the Medical Device User Fee and Modernization Act of 2002; 
Accreditation Criteria.''
    In the Federal Register of August 24, 2006 (71 FR 50067), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    Respondents are expected to be businesses or other for profit 
organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                Information Collection                     Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for Accreditation                                               3                     1                  3                 80                240
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours                                                                                                                                          240
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based these estimates on conversations with industry, trade 
association representatives, and internal FDA estimates. Once an 
organization is accredited, it will not be required to reapply.

    Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18603 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S
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