[Federal Register: October 8, 2003 (Volume 68, Number 195)]
[Page 58113-58114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0066]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.


SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
November 7, 2003.

ADDRESSES: 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 written 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.

[[Page 58114]]

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 
    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 the April 28, 2003, 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 
    In the Federal Register of July 10, 2003 (68 FR 41160), 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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
              Item                    No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
Request for Accreditation (First              25               1              25              80           2,000
Request for Accreditation                     10               1              10              15             150
 (Second Year)
Request for Accreditation (Third               5               1               5              80             400
Total                             ..............  ..............  ..............  ..............           2,550
\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 (FDA) 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: September 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25444 Filed 10-7-03; 8:45 am]