[Federal Register Volume 65, Number 17 (Wednesday, January 26, 2000)]
[Notices]
[Pages 4229-4230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1744]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

[Docket No. 000106008-0008-01]
RIN: 0693-XX49


National Voluntary Conformity Assessment System Evaluation 
(NVCASE) Program

AGENCY:  National Institute of Standards and Technology, Commerce.

ACTION:  Notice.

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SUMMARY:  The National Institute of Standards and Technology (NIST) 
hereby announces the establishment of a sub-program under the National 
Voluntary Conformity Assessment System Evaluation (NVCASE) program to 
recognize bodies that accredit quality

[[Page 4230]]

system registrars that register organizations that produce medical 
devices. This sub-program is being established in accordance with 
NVCASE regulations in response to a request from a Federal Agency, the 
Food and Drug Administration (FDA). Accreditation bodies recognized by 
NIST may then accredit quality system registrars to register applicable 
organizations that demonstrate that they satisfy designated foreign or 
domestic mandated regulatory requirements.
    The action taken under this notice addresses both generic and 
specific NVCASE requirements to allow NIST to support the FDA in 
fulfilling its obligations as designating authority under the current 
United States (U.S.)/European Union (EU) Mutual Recognition Agreement 
(MRA) medical devices sectoral annex. If additional MRAs covering 
medical devices are negotiated between the United States and another 
country or region, additional specific requirements may also be 
included under this NVCASE activity.
    Sub-program requirements have been developed in accordance with 
NVCASE regulations and with public consultation. Public input was 
obtained at an open meeting on April 15, 1999, and from comments 
received through May 15, 1999.

DATES:  Applications will be received beginning February 1, 2000.

ADDRESSES:  Applications for recognition may be obtained from, and 
returned to, Robert L. Gladhill, NVCASE Program Manager, NIST, 100 
Bureau Drive, Mail stop 2100, Gaithersburg, MD 20899-2100, by fax (301) 
975-5414, or E-mail at robert. [email protected].

FOR FURTHER INFORMATION CONTACT:  Robert L. Gladhill, NVCASE Program 
Manager, at NIST, 100 Bureau Drive, Mail stop 2100, Gaithersburg, MD 
20899-2100, telefax: (301) 975-5414, or E-mail: 
robert.[email protected].

SUPPLEMENTARY INFORMATION:  This NVCASE sub-program to recognize 
accreditation bodies that accredit quality system registrars is being 
established in accordance with the NVCASE Regulations (15 CFR part 
286.2(b)(3)(ii)). The generic requirements and specific criteria for 
this NVCASE sub-program have been established in accordance with NVCASE 
regulations (15 CFR Part 286.5). Public input on the establishment of 
both generic requirements and specific criteria for the medical devices 
sector was received during an open workshop held at the Department of 
Commerce on April 15, 1999. This workshop was announced in the Federal 
Register vol. 64, No. 42/Thursday, March 4, 1999. Follow-up comments 
were accepted from the public through May 15, 1999.
    NIST will apply the generic requirements contained in the 
International Organization for Standardization/International 
Electrotechnical Commission (ISO/IEC) Guide 61--``General Requirements 
for Assessment and Accreditation of Certification/Registration Bodies'' 
to all applicant accreditation bodies. Quality system registrars 
applying to recognized accreditors shall be assessed against the 
requirements of ISO/IEC Guide 62--``General Requirements for Bodies 
Operating Assessment and Certification/Registration of Quality 
Systems.'' These generic requirements will be supplemented by specific 
sectoral criteria contained in individual supplements to the NVCASE 
Program Handbook, for example, European Commission document MEDDEV 
2.10/2 ``Designation and Monitoring of Notified Bodies within the 
framework of the directives on medical devices.'' Such specific 
sectoral criteria are developed through consultation with the public 
and appropriate experts.
    As stated in the NVCASE regulations (15 CFR Part 286.4), the NVCASE 
program is operated on a cost reimbursement basis. It is open for 
voluntary participation by any U.S. based body that conducts activities 
relating to conformity assessment falling within the program's scope. 
Pursuant to this notice, NIST will accept applications from interested 
accreditation bodies for recognition to accredit quality system 
registrars under the U.S./EU MRA medical devices sectoral annex. 
Prospective accreditation bodies must submit a complete application and 
required fees by March 15, 2000 in order to be included in the initial 
group to be evaluated.
    The evaluation of the first group of accreditation bodies applying 
for NVCASE recognition will begin on or about April 3, 2000. All 
accreditation bodies that have submitted a complete application and 
required fees to NIST by March 15, 2000, will be included in this 
initial group. Applications received subsequently will be considered on 
an as-received basis for evaluation after the initial group of 
applicants has been considered.
    NIST expects to announce recognition of qualified accreditation 
bodies in the initial applicant group on or about June 1, 2000. On or 
about the same time, NIST also expects to identify and list an initial 
group of qualified registrars. Each registrar listed under the 
provisions of the U.S./EA MRA will be designated by NIST as a 
conformity assessment body (CAB).
    This notice contains a collection of information requirement 
subject to the Paperwork Reduction Act. The collection of information 
has been approved by OMB under the following control Number : 0693-
0019.
    Notwithstanding any other provision of law, no person is required 
to respond nor shall a person be subject to a penalty for failure to 
comply with a collection of information subject to the requirements of 
the Paperwork Reduction Act unless that collection of information 
displays a currently valid Office of Management and Budget Control 
Number.

    Dated: January 18, 2000.
Karen H. Brown,
Deputy Director.
[FR Doc. 00-1744 Filed 1-25-00; 8:45 am]
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