[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Notices]
[Pages 41160-41161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0117]


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 September 8, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 26, 2003 (68 
FR 38065), FDA published a notice announcing the Office of Management 
and Budget's (OMB) approval of this collection of information (OMB 
control number 0910-0510). Since this was an emergency approval that 
expires on September 30, 2003, FDA is following the normal PRA 
clearance procedures by issuing this notice. Under the PRA (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from 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: (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: Inspection by Accredited Persons Program Under MDUFMA 
(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; eligible manufacturers have the option of 
being inspected by an AP or by FDA. The new law requires FDA, within 
180 days from the date of MDUFMA was signed into law, to publish in the 
Federal Register criteria to accredit or deny accreditation to persons 
who request to perform these inspections (section 704(g)(2) of the 
act).
    In the Federal Register of April 28, 2003 (68 FR 22388), FDA 
published a notice announcing that a proposed collection of information 
has been submitted to OMB for emergency processing under the PRA. 
Interested persons were given until May 28, 2003, to comment on the 
notice. Elsewhere in that issue of the Federal Register (68 FR 22400), 
FDA published a document announcing the criteria it will use to 
accredit persons to inspect eligible device manufacturers and the 
availability of a guidance entitled ``Implementation of the Inspection 
by Accredited Persons Program Under the Medical Device User Fee and 
Modernization Act of 2002; Accreditation Criteria: Guidance for 
Industry, FDA Staff, and Third Parties.''
    FDA received a total of three comments from a trade association, an 
industry association, and a consultant. These comments were not 
specifically related to the information collection for the submission 
of applications to become an accredited person. The comments addressed 
the implementation of the third party inspection program. FDA will take 
these comments into consideration in further developing its third party 
inspection program.
    Description of Respondents: Businesses or other for profit 
organizations.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 41161]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                   Annual Frequency      Total Annual
    Item      No. of Respondents     per Response           Records       Hours per Response      Total Hours
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Request for          25                   1                  25                  80               2,000
 Accreditati
 on (First
 Year)
Request for          10                   1                  10                  15                 150
 Accreditati
 on (Second
 Year)
Request for           5                   1                   5                  80                 400
 Accreditati
 on (Third
 Year)
Total Hours   ..................  ..................  ..................  ..................      2,550
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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. Our 
expectation is that 25 bodies will apply and meet the minimum standard 
for being accredited. Under MDUFMA, we can only accredit 15 persons 
during the first year. We expect that the lowest ranking 10 (the ones 
not accredited) will reapply the following year and will submit an 
updated application. Five new applicants may apply the third year. Once 
an organization is accredited, it will not be required to reapply.

    Dated: July 2, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-17411 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S