[Federal Register: August 29, 2008 (Volume 73, Number 169)]
[Notices]
[Page 50976-50977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au08-84]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0313]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Request 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 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
September 29, 2008.
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, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0569. Also
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 50977]]
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, 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 the 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.
In the Federal Register of June 3, 2008 (73 FR 31692), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual Hours per
21 U.S.C. Section No. of Respondents 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.
Dated: August 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20113 Filed 8-28-08; 8:45 am]
BILLING CODE 4160-01-S