[Federal Register Volume 68, Number 81 (Monday, April 28, 2003)]
[Notices]
[Pages 22388-22389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10414]



[[Page 22388]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0066]


Agency Emergency Processing Under OMB Review; Inspection by 
Accredited Persons Program Under the Medical Device User Fee and 
Modernization Act of 2002

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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information will be used by FDA to publish the criteria FDA intends to 
use to accredit third parties to conduct inspections of eligible 
manufacturers of class II and class III medical devices.

DATES: Fax written comments on the information collection provisions by 
May 28, 2003. FDA is requesting approval of this emergency processing 
by June 12, 2003, under the PRA of 1995 to implement the statutory 
provision under section 201 of the Medical Device User Fee and 
Modernization Act of 2002 (MDUFMA).

ADDRESSES: Submit written comments on the collection of information to 
OMB. 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 
electronically mailed to [email protected] or faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk 
Officer for FDA, FAX: 202-395-6974. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). This information is needed 
immediately so that the agency can publish the criteria required to 
implement an Inspection by Accredited Persons Program to accredit 
persons that wish to conduct inspections of eligible manufacturers of 
class II and class III medical devices. FDA is requesting this 
emergency processing to implement the statutory provision under section 
201 of the Medical Device User Fee and Modernization Act of 2002 
(MDUFMA) directing FDA to publish criteria for accrediting third 
parties within 180 days of enactment of MDUFMA. In addition, FDA must 
accredit persons under the published criteria no later than 1 year 
after enactment of MDUFMA. MDUFMA was signed into law on October 26, 
2002. The use of normal clearance procedure would likely result in the 
prevention or disruption of this collection of information. Therefore, 
FDA has requested approval of emergency processing of this proposed 
collection of information by June 12, 2003.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Inspection by Accredited Persons Program Under MDUFMA

    MDUFMA, Public Law 107-250, amends section 704 (21 U.S.C. 374) of 
the Federal Food, Drug and Cosmetic Act. MDUFMA was signed into law on 
October 26, 2002.
    New section 704(g)(1) of the act (21 U.S.C. 374(g)(1)) directs FDA 
to accredit persons to inspect eligible manufacturers of class II and 
class III medical devices in lieu of an FDA inspection. Under section 
704(g)(2) (21 U.S.C. 374(g)(2)) of the act, FDA must publish, within 
180 days of enactment of MDUFMA, criteria for the accreditation of 
third parties to conduct inspections of eligible manufacturers of class 
II and class III medical devices. Within 60 days of receiving a request 
for accreditation, FDA must inform the requestor whether the request 
for accreditation is adequate for review. Under section 704(g)(4) of 
the act (21 U.S.C. 374(g)(4)), FDA must publish, on the Internet, a 
complete list of accredited persons and the activities for which they 
are accredited. These sections of the act will enable FDA to implement 
an ``Inspection by Accredited Persons Program'' under MDUFMA.
    Participation in the program is voluntary. Manufacturers may 
continue to have FDA perform inspections or, if eligible, they may 
utilize an accredited person. FDA will serve as the accreditation body. 
FDA will began accepting applications immediately following approval by 
OMB of the proposed collection of information. Because the statute 
requires the agency to make accreditation decisions no later than 1 
year after MDUFMA's enactment (October 26, 2003), FDA intends to stop 
accepting applications on August 25, 2003.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
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.'' The guidance further describes the criteria FDA will 
use to accredit persons that wish to conduct inspections of eligible 
manufacturers of class II and class III medical devices. The guidance 
also addresses the format and content of accreditation applications and 
the evaluation process FDA will use in qualifying firms to participate 
in this program.
    Respondents to the proposed collection of information will likely 
be businesses or other for-profit organizations.
    FDA estimates the burden of this information collection as follows:

[[Page 22389]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                            Annual
                                            No. of        Frequency    Total Annual       Hours per       Total
                Item                  [chyph]Respondents     per     [chyph]Responses  [chyph]Response    Hours
                                                           Response
----------------------------------------------------------------------------------------------------------------
Request for Accreditation (1st Year)            25               1            25                80         2000
----------------------------------------------------------------------------------------------------------------
Request for Accreditation (2nd Year)            10               1            10                15          150
----------------------------------------------------------------------------------------------------------------
Request for Accreditation (3rd Year)             5               1             5                80          400
----------------------------------------------------------------------------------------------------------------
Total Hours                                                                                               2,550
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\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 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: April 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10414 Filed 4-23-03; 5:03 pm]
BILLING CODE 4160-01-S