[Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Page 33179-33180]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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, 

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 
    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 
    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 

[[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]