[Federal Register: October 8, 2003 (Volume 68, Number 195)]
[Notices]
[Page 58113-58114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc03-57]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
act).
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
organizations.
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
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
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
Year)
Request for Accreditation 10 1 10 15 150
(Second Year)
Request for Accreditation (Third 5 1 5 80 400
Year)
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]
BILLING CODE 4160-01-S