Document ID: FDA-2009-N-0474-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
Posted Date: 2009-10-22T04:00Z

[Federal Register: October 22, 2009 (Volume 74, Number 203)]
[Notices]               
[Page 54570-54571]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc09-57]                         

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0474]

 
Agency Information Collection Activities; Proposed Collection; 
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 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 the publication of the 
criteria FDA intends to use to accredit third parties to conduct 
inspections of eligible manufacturers of class II or class III medical 
devices.

DATES:  Submit written or electronic comments on the collection of 
information by December 21, 2009.

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:  Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 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.
    Inspection by Accredited Persons Program Under the Medical Device 
User Fee and Modernization Act of 2002; FD&C Act, Section 704(g) (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 FD&C Act) (21 U.S.C. 374), directing 
FDA to accredit third parties (accredited persons (APs) to conduct 
inspections of eligible manufacturers of class II or class III devices. 
This is a voluntary program.

[[Page 54571]]

    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.''
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
   FD&C Act           No. of         Annual Frequency       Total Annual        Hours per
   Section :       Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
704(g)                          3                     1                  3                 80                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 7, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25395 Filed 10-21-09; 8:45 am]

BILLING CODE 4160-01-S