[Federal Register Volume 74, Number 203 (Thursday, October 22, 2009)]
[Notices]
[Pages 54570-54571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25395]
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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.
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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\
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FD&C Act No. of Annual Frequency Total Annual Hours per
Section : Respondents per Response Responses Response Total Hours
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704(g) 3 1 3 80 240
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\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]
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