[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45627-45628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22928]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology
[Docket No. 970620147-7147-01]


National Voluntary Conformity Assessment System Evaluation 
(NVCASE) Program

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Notice: Proposal To Establish Recognition Program.

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SUMMARY: NIST hereby proposes to establish a recognition program under 
NVCASE that will recognize accreditors of Quality System Registrars. 
NIST recognized accreditors may then accredit companies (Registrars) 
which in turn may register organizations that operate under applicable 
quality system standards that satisfy specific foreign regulatory 
requirements. The resulting recognition program will allow NIST to 
designate qualified U.S. conformity assessment bodies and assure their 
competence to other governments.
    The action being taken under this notice only addresses development 
of generic program requirements. Once a generic program is established, 
applicants will be required to specify the specific mandated foreign 
regulation(s) covered by the application. In cases where a Mutual 
Recognition Agreement (MRA) covering the mutual recognition of 
conformity assessment has been negotiated between the United States and 
another country, the sectors which may be included in an application 
may be limited to those covered by the MRA.
    NIST proposes to apply the requirements contained in the *ISO/IEC 
Guide 61--``General requirements for assessment and accreditation of 
certification/registration bodies'' to all applicant accreditation 
bodies. If further proposes that registrars applying for accreditation 
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 with specific sectoral requirements as necessary. Such 
specific sectoral requirements will be developed through consultation 
with appropriate experts in the affected sector. Organizations needing 
to be registered shall be registered to a quality management system 
standard appropriate for the regulation/sector involved.
    *ISO documents available from: International Organization for 
Standardization, Casa postale 56, CH-1211, Geneve 20, Switzerland.

DATES: Comments on this notice must be received by September 29, 1997.

ADDRESSES: Comments should be submitted in writing to Robert L. 
Gladhill, NVCASE Program Manager, NIST, Bldg. 820, Room 282, 
Gaithersburg, MD 20899, by fax 301-963-2871 or E-mail at 
[email protected].

FOR FURTHER INFORMATION CONTACT:
Robert L. Gladhill, NVCASE Program Manager, at NIST, Bldg. 820, Room 
282, Gaithersburg, MD 20899, by telephone at 301-975-4273 or by telefax 
at 301-963-2871.


[[Page 45628]]


SUPPLEMENTARY INFORMATION: The National Institute of Standards and 
Technology received letters dated May 10, 1994, and October 31, 1994, 
from the American National Standards Institute requesting to have the 
ANSI-RAB American National Accreditation Program for Registrars of 
Quality Systems recognized under NVCASE. The request seeks U.S. 
Government assurance of the competency of the ANSI-RAB program to 
accredit registrars so that they can in turn register organizations in 
satisfaction of foreign mandatory regulatory requirements.
    The NVCASE procedures at 15 CFR Part 286 require NIST to seek 
public consultation when it receives requests for evaluation. The 
original request was published in the Federal Register at Vol. 60, No. 
20/Tuesday, January 31, 1995, page 5901. A 30-day public comment period 
ended on March 2, 1995. The comments received are discussed below.
    No action was taken on the request until now, pending conclusion of 
U.S.-EU MRA negotiations. The MRA was initiated on June 20, 1997. NIST 
is now proceeding with establishment of criteria and initiation of the 
application process.
    NIST received responses from 15 different organizations during the 
public comment period on the original ANSI request and also considered 
an additional letter received after the official period closed.
    Of the 16 letters considered, nine indicated general support, five 
opposed specific sectoral areas included in the request, one indicated 
general non-support and one provided only a general comment. The 
specific sectors to which the five commenters voiced opposition are not 
planned for inclusion under the proposed NVCASE program. The pressure 
vessel sector is not presently part of the U.S.-EU negotiations (three 
opponents), and the medical device sector is under the jurisdiction of 
the Food and Drug Administration (FDA); NIST will not take action in 
that sector without full agreement from FDA (two opponents). Further, 
NIST will not accept any application for recognition in these two 
sectors without notifying the opposing entities and other members of 
the sectoral community.
    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 OMB Control Number.

    Dated: August 22, 1997.
Elaine Bunten-Mines,
Director, Program Office.
[FR Doc. 97-22928 Filed 8-27-97; 8:45 am]
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