[Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Notices]
[Page 33179-33180]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn05-58]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0251]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requests for
Inspection by an Accredited Person Under the Inspection by Accredited
Persons Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 July 7,
2005.
ADDRESSES: The Office of Management and Budget (OMB) is still
experiencing significant delays in the regular mail, including first
class and express mail, and messenger deliveries are not being
accepted. To ensure that comments on the information collection are
received, OMB recommends that comments be faxed to the Office of
Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk
Officer for FDA, FAX: 202-395-6974.
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 compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Requests for Inspection by an Accredited Person under the
Inspection by Accredited Persons Program
Section 201 of the Medical Device User Fee and Modernization Act of
2002 (MDUFMA) (Public Law 107-250) amends section 704 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374) by adding
paragraph (g). This amendment authorizes 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.
Under this new Inspection by Accredited Persons Program (AP program),
such manufacturers may elect to have third parties that have been
accredited by FDA (accredited person or AP) conduct some of their
inspections 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.
The applicant must submit the following information in support of a
request for approval to use an AP:
Information that shows that the applicant ``manufactures,
prepares, propagates, compounds, or processes'' class II or class III
medical devices.
Information that shows that the applicant markets at least
one of the devices in the United States.
Information that shows that the applicant markets or
intends to market at least one of the devices in one or more foreign
countries and one or both of the following two conditions are met as
follows:
1. One of the foreign countries certifies, accredits, or otherwise
recognizes the AP the applicant has selected as a person authorized to
conduct inspections of device establishments; or
2. A statement that the law of a country where the applicant
markets or intends to market the device recognizes an inspection by the
FDA or by the AP.
Information that shows that the applicant's most recent
inspection performed by FDA, or by an AP under this program, was
classified by FDA as either ``No Action Indicated (NAI)'' or
``Voluntary Action Indicated (VAI);'' and
A notice to FDA requesting clearance (approval) to use an
AP, and identifying the AP the applicant selected.
In the Federal Register of June 3, 2004 (69 FR 31397 at 31398), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received one comment concerning the
potential burden associated with the third party inspectional program
application process if related cumulative partial inspections over a 2-
year period were not recognized by FDA as a single comprehensive
inspection. FDA clarified the guidance to state that manufacturers may
rely on a single comprehensive inspection or a serious of partial
inspections that would cumulatively constitute a complete inspection
for the purposes of meeting FDA's biennial inspection requirement.
Reapplication to the FDA AP inspection program will not be necessary to
conduct each related partial inspection that cumulatively constitutes a
single comprehensive inspection of an establishment.
FDA estimates the burden of this collection of information as
follows:
[[Page 33180]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
100 1 100 15 1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 for the AP program. Also
10 to 15 percent of the firms are not eligible due to the results of
their previous inspection. FDA estimates that there are 4,000 domestic
manufacturers and 4,000 foreign manufacturers that are eligible for
inclusion in the AP program. Based on informal communications with
industry, FDA estimates that approximately 100 of these manufacturers
may apply to use an AP in any given year.
Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11264 Filed 6-6-05; 8:45 am]
BILLING CODE 4160-01-S