[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31692-31693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12297]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0313]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Requests for Inspection Under the Inspection by 
Accredited Persons Program

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 eligibility criteria and 
the process to be followed by establishments when requesting FDA's 
approval to have an accredited third party conduct a quality systems 
regulation inspection of their establishment instead of FDA, under the 
new inspections by the Accredited Persons Program.

DATES:  Submit written or electronic comments on the collection of 
information by August 4, 2008.

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, M20852. 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 the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301 827-1472.

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.

Requests for Inspection Under the Inspection by Accredited Persons 
Program--21 U.S.C. 374(g) (OMB Control Number 0910-0569)--Extension

    Section 201 of the Medical Device User Fee and Modernization Act of 
2002, (Public Law 107-250), amended section 704 of the Federal Food, 
Drug,

[[Page 31693]]

and Cosmetic Act by adding subsection (g) (21 U.S.C. 374 (g)). This 
amendment authorized FDA to establish a voluntary third party 
inspection program applicable to manufacturers of class II or class III 
medical devices who meet certain eligibility criteria. On September 15, 
2005, FDA issued a guidance entitled, ``Requests for Inspection by an 
Accredited Person under the Inspection by Accredited Persons Program 
Authorized by Section 201 of the Medical Device User Fee and 
Modernization Act 2002,'' http://www.fda.gov/cdrh/comp/guidance/1532.html. This guidance describes the eligibility criteria and the 
process for establishments to follow when requesting FDA's approval to 
have an accredited person (AP) conduct a quality system regulation 
inspection of their establishment under the new inspection by the 
Accredited Persons Program (AP program) instead of FDA. The AP program 
applies to manufacturers who currently market their medical devices in 
the United States and who also market or plan to market their devices 
in foreign countries. Such manufacturers may need current inspections 
of their establishments to operate in global commerce.
    In order to meet the eligibility criteria for requesting FDA 
approval to have an AP conduct a quality system regulations inspection 
of their establishment instead of FDA, applicants must submit a request 
with certain information. The following information must be submitted, 
which shows that the applicant:
    (1) ``Manufactures, prepares, propagates, compounds, or processes'' 
class II or class III medical devices,
    (2) Markets at least one of the devices in the United States,
    (3) Markets or intends to market at least one of the devices in one 
or more foreign countries when one or both of the following two 
conditions are met:
    (a) One of the foreign countries certifies, accredits, or otherwise 
recognizes the selected AP applicant as a person authorized to conduct 
inspections of device establishments, or
    (b) A statement that the law of a country where the applicant 
markets or intends to market the device recognizes an inspection 
conducted by FDA or an AP.
    (4) Provided the most recent inspection performed by FDA, or by an 
AP under the AP program and inspection was classified by FDA as either 
``No Action Indicated'' or ``Voluntary Action Indicated'' and,
    (5) Provided notice advising FDA of their intent to use an AP, and 
identifying the AP applicant selected.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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   21 U.S.C.          No. of         Annual Frequency       Total Annual        Hours per
   Section:        Respondents         per Response          Responses           Response         Total Hours
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374(g)                        100                     1                100                 15              1,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    There are approximately 8,000 foreign and 10,000 domestic 
manufacturers of medical devices. Approximately 5,000 of these firms 
only manufacture class I devices and are, therefore, not eligible for 
the AP program. In addition, 40 percent of the domestic firms do not 
export devices and therefore are not eligible to participate in the AP 
program. Further, 10 to 15 percent of the firms are not eligible due to 
the results of their previous inspection. FDA estimates there are 4,000 
domestic manufacturers and 4,000 foreign manufacturers that are 
eligible for inclusion under the AP program. Based on communications 
with industry, FDA estimates that on an annual basis approximately 100 
of these manufacturers may submit a request to use an AP in any given 
year.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12297 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S