National Voluntary Laboratory Accreditation Program-Amendment to the Procedures and Requirements To Accredit Testing and Calibration Laboratories, 60059-60061 [2020-18294]

Download as PDF Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Rules and Regulations program office within ten days of receipt of the notice to request consideration for a prompt settlement of the legal enforcement action. The FAA will send the notification in conjunction with the LOI. Following an individual’s request to be considered for application of this policy, the FAA will determine the individual’s eligibility for the policy. The policy is not available when there is a question about an individual’s qualification to hold a part 61, 63, or 65 certificate other than that presented by the 14 CFR 67.403(a)(1) through (4) violation. It is also not available for individuals who the FAA has found to have previously violated 14 CFR 67.403(a)(1) through (4). If the FAA deems application of the prompt settlement policy is appropriate, AGC–300 enforcement counsel will provide the individual, or his or her legal representative, a formal agreement that sets forth the conditions for prompt settlement. The terms of this settlement agreement will normally include the following provisions. (1) The settlement agreement must be executed by the parties within ten days after the FAA sends the agreement to the individual. (2) The FAA will issue an emergency order revoking all airman, ground instructor, and unexpired medical certificates the individual holds immediately upon receiving the fully executed settlement agreement. (3) The order of revocation will (i) require the immediate surrender of all airman, ground instructor, and unexpired medical certificates the individual holds to enforcement counsel; (ii) notify the individual that the failure to immediately surrender these certificates could subject the individual to further legal enforcement action, including a civil penalty; and (iii) inform the individual that the FAA will not accept an application for any new airman or ground instructor certificate for a period of one year from the date of the issuance of the order of revocation. (4) The individual will waive all appeal rights from the order of revocation. (5) The individual acknowledges that this agreement only concerns this enforcement action brought by the FAA and does not affect any actions that might be brought by State or other Federal agencies (whether civil or criminal), and that this agreement does not prevent the FAA from providing information about this matter to State or other Federal agencies. VerDate Sep<11>2014 16:01 Sep 23, 2020 Jkt 250001 (6) The parties will agree to bear their own costs and attorney fees, if any, in connection with the matter. (7) The individual will agree to not initiate any litigation before any court, tribunal, or administrative entity concerning any costs, damages, or attorney fees, including applications under the Equal Access to Justice Act, incurred as a result of the abovereferenced matter. (8) The individual will agree to waive any and all causes of action against the FAA and its current and/or former officials and employees relating to the above-referenced matter. This policy is expected to allow eligible individuals to more quickly apply for new certificates under 14 CFR parts 61, 63, and 65 following violations of 14 CFR 67.403(a)(1)–(4). It will also reduce uncertainty about the date of issuance of orders of revocation related to such violations, eliminate the unpredictability of litigation, and promote better resource allocation. Issued in Washington, DC, on September 21, 2020. Naomi Tsuda, Assistant Chief Counsel for Enforcement. [FR Doc. 2020–21111 Filed 9–23–20; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF COMMERCE National Institute of Standards and Technology 15 CFR Part 285 [Docket No.: 200128–0034] RIN 0693–AB67 National Voluntary Laboratory Accreditation Program—Amendment to the Procedures and Requirements To Accredit Testing and Calibration Laboratories National Institute of Standards and Technology, Commerce. ACTION: Final rule. AGENCY: The Director of the National Institute of Standards and Technology (NIST) is issuing a final rule amending the regulations pertaining to the operation of the National Voluntary Laboratory Accreditation Program (NVLAP) and the operation of its accreditation programs. The regulations are being revised to include recognition of proficiency testing as an accreditation activity, add or revise terms, and update NVLAP mailing information, in accordance with the applicable international standard. These changes will not impact the public directly, and SUMMARY: PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 60059 will only result in minor changes to NIST’s internal practices. DATES: This rule is effective on September 24, 2020. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of September 24, 2020. ADDRESSES: Dana S. Leaman, Chief, National Voluntary Laboratory Accreditation Program, 100 Bureau Drive, Stop 2140, Gaithersburg, MD 20899–2140 or by sending email to nvlap@nist.gov. FOR FURTHER INFORMATION CONTACT: Dana S. Leaman, Chief, NIST/NVLAP, 100 Bureau Drive, Stop 2140, Gaithersburg, MD 20899–2140, Phone: (301) 975–4016 or email: dana.leaman@ nist.gov. Information regarding NVLAP and the accreditation process can be obtained from http://www.nist.gov/ nvlap. SUPPLEMENTARY INFORMATION: I. Background Title 15, part 285 of the Code of Federal Regulations sets out procedures and general requirements under which NVLAP operates as an unbiased third party to accredit both testing and calibration laboratories. The NVLAP procedures were first published in the Federal Register on February 25, 1976, and have been revised several times. NVLAP currently operates in accordance with ISO/IEC 17011:2004, Conformity assessment—Requirements for accreditation bodies accrediting conformity assessment bodies. The Laboratory Accreditation Programs operated by NVLAP are established based on the criteria in ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. Revisions to ISO/IEC 17011 and ISO/IEC 17025 were published in November 2017 with a three-year implementation period. These revisions include recognition of proficiency testing as an accreditation activity, addition and/or revision of terms, and update of the NVLAP mailing information. The purpose of this amendment is to incorporate these revised requirements into the regulations. II. Incorporation by Reference NIST Handbook 150 presents the basic procedures under which NVLAP operates, and considers the requirements contained in ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025 and NIST Handbook 150 contain the general requirements that testing and calibration E:\FR\FM\24SER1.SGM 24SER1 60060 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Rules and Regulations laboratories must meet if they wish to demonstrate that they operate an appropriate management system, are technically competent, and are able to generate technically valid results. The provisions of NIST Handbook 150 are being incorporated by reference into 15 CFR 285.8 and 285.14, as this will substantially reduce the volume of material published in the Federal Register and the CFR. NIST Handbook 150 is available at no-cost at https:// nvlpubs.nist.gov/nistpubs/hb/2020/ NIST.HB.150-2020.pdf. List of Subjects in 15 CFR Part 285 III. Regulatory Analysis ■ Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment are unnecessary. This final rule makes minor, technical amendments in order to conform the regulations to changes that were made to the applicable international standard. These changes will not impact the public directly, and will only result in minor changes to NIST’s internal practices. None of these changes will have a substantive impact beyond those already considered in previous supporting documents. For the same reasons, there is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date. Executive Order 12866 This final rule was determined to be not significant for purposes of Executive Order 12866. Executive Order 13132 This final rule does not contain policies with Federalism implications as defined in Executive Order 13132. Regulatory Flexibility Act Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., do not apply. Paperwork Reduction Act This final rule contains no new collection of information subject to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. National Environmental Policy Act This final rule will not significantly affect the quality of the human environment. Therefore, an environmental assessment or Environmental Impact Statement is not required to be prepared under the National Environmental Policy Act of 1969. VerDate Sep<11>2014 16:01 Sep 23, 2020 Jkt 250001 Accreditation, Business and industry, Calibration, Commerce, Conformity assessment, Incorporation by reference, Laboratories, Measurement standards, Testing. For the reasons stated in the preamble, NIST amends 15 CFR part 285 as follows: PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM 1. The authority citation for 15 CFR part 285 continues to read as follows: Authority: 15 U.S.C. 272 et seq. ■ 2. Revise § 285.1 to read as follows: § 285.1 Purpose. The purpose of this part is to set out procedures and general requirements under which the National Voluntary Laboratory Accreditation Program (NVLAP) operates as an unbiased third party to accredit both testing and calibration laboratories. Supplementary technical and administrative requirements are provided in supporting handbooks and documents as needed, depending on the criteria established for specific Laboratory Accreditation Programs (LAPs). ■ 3. Revise § 285.6 to read as follows: § 285.6 Application for accreditation. A laboratory may apply for accreditation in any of the established LAPs. The applicant laboratory shall provide a completed application to NVLAP, pay all required fees and agree to certain conditions as set forth in the NVLAP Application for Accreditation, and provide management system documentation to NVLAP (or a designated NVLAP assessor) prior to the assessment process. specified for each LAP in the NVLAP program handbooks. (b) Analysis and reporting. Proficiency testing results are analyzed by NVLAP and results of the analysis are made known to the participants. Any result not meeting the criteria specified in the NVLAP LAP program handbook is identified as a nonconformity. (c) Proficiency testing nonconformities. (1) Unsatisfactory participation in any proficiency testing program is a technical nonconformity which must be resolved in order to obtain initial accreditation or maintain accreditation. (2) Proficiency testing nonconformities are defined as, but not limited to, one or more of the following: (i) Failure to meet specified proficiency testing performance requirements prescribed by NVLAP; (ii) Failure to participate in a regularly scheduled ‘‘round’’ of proficiency testing for which the laboratory has received instructions and/or materials; (iii) Failure to submit laboratory control data as required; or (iv) Failure to produce acceptable test or calibration results when using NIST Standard Reference Materials or special artifacts whose properties are wellcharacterized and known to NIST/ NVLAP. (3) NVLAP will notify the laboratory of proficiency testing nonconformities and actions to be taken to resolve the nonconformities. Denial or suspension of accreditation will result from failure to resolve nonconformities. ■ 6. Revise § 285.10(b) to read as follows: § 285.10 Renewal of accreditation. 4. In § 285.7, remove the word ‘‘deficiencies’’ wherever it occurs and add in its place the word ‘‘nonconformities.’’ ■ 5. Revise § 285.8 to read as follows: * * * * (b) On-site assessments of currently accredited laboratories are performed in accordance with the procedures in § 285.7. If nonconformities are found during the assessment of an accredited laboratory, the laboratory must follow the procedures set forth in § 285.7(e)(2) or face possible suspension or revocation of accreditation. ■ 7. Revise § 285.12 to read as follows: § 285.8 § 285.12 § 285.7 [Amended] ■ Proficiency testing. (a) Proficiency testing requirements. Proficiency testing undertaken to meet the criteria for NVLAP accreditation shall be consistent with the provisions contained in NIST Handbook 150, NVLAP Procedures and General Requirements (incorporated by reference, see § 285.16), where applicable, including revisions from time to time. Laboratories must participate in proficiency testing as PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 * Monitoring visits. (a) In addition to regularly scheduled assessments, monitoring visits may be conducted by NVLAP at any time during the accreditation period. They may occur for cause or on a random selection basis. While most monitoring visits will be scheduled in advance with the laboratory, NVLAP may conduct unannounced monitoring visits. (b) The scope of a monitoring visit may range from checking a few E:\FR\FM\24SER1.SGM 24SER1 Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Rules and Regulations designated items to a complete review. The assessors may review nonconformity resolutions, verify reported changes in the laboratory’s personnel, facilities or operations, or evaluate proficiency testing activities, when appropriate. ■ 8. Revise § 285.14 to read as follows: § 285.14 Criteria for accreditation. The requirements for laboratories to be recognized by the National Voluntary Laboratory Accreditation Program as competent to carry out tests and/or calibrations are contained in NIST Handbook 150, NVLAP Procedures and General Requirements (incorporated by reference, see § 285.16). ■ 9. Revise § 285.15(b) to read as follows: § 285.15 Kevin A. Kimball, Chief of Staff. [FR Doc. 2020–18294 Filed 9–23–20; 8:45 am] BILLING CODE 3510–13–P Obtaining documents. * * * * * (b) Copies of all ISO/IEC documents are available for purchase from the American National Standards Institute’s eStandards Store at http:// webstore.ansi.org. You may inspect copies of all applicable ISO/IEC documents at the National Voluntary Laboratory Accreditation Program, National Institute of Standards and Technology, 100 Bureau Drive, Room B119, Gaithersburg, MD. For access to the NIST campus, please contact NVLAP by phone at 301–975–4016 or by email at NVLAP@nist.gov to obtain instructions for visitor registration. ■ 10. Add § 285.16 to read as follows: § 285.16 B119, Gaithersburg, MD, 301–975–4016 NVLAP@nist.gov, www.nist.gov/ publications/. (1) NIST Handbook 150, National Voluntary Laboratory Accreditation Program Procedures (NVLAP) and General Requirements, authored by Dana S. Leaman and Bethany Hackett, 2020 Edition, August 2020, 2020 (NVLAP Procedures and General Requirements) https://nvlpubs.nist.gov/ nistpubs/hb/2020/NIST.HB.1502020.pdf; into §§ 285.8(a) and § 285.14. (2) [Reserved] (b) [Reserved] Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at National Institute of Standards and Technology, National Voluntary Laboratory Accreditation Program (NVLAP), National Institute of Standards and Technology, 100 Bureau Drive, Room B119, Gaithersburg, MD and is available from the source(s) listed in the following paragraph(s). It is also available for inspection at the National Archives and Records Administration (NARA). For access to the NIST campus, please contact NVLAP by phone at 301– 975–4016 or by email at NVLAP@ nist.gov to obtain instructions for visitor registration. For information on the availability of this material at NARA, email fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ ibr-locations.html. (a) National Institute of Standards and Technology (NIST), U.S. Department of Commerce, 100 Bureau Drive, Room VerDate Sep<11>2014 16:01 Sep 23, 2020 Jkt 250001 DEPARTMENT OF COMMERCE 15 CFR Chapter VII [Docket Number 200917–0247] RIN 0605–XD009 Identification of Prohibited Transactions To Implement Executive Order 13942 and Address the Threat Posed by TikTok and the National Emergency With Respect to the Information and Communications Technology and Services Supply Chain Office of the Secretary, U.S. Department of Commerce. ACTION: Identification of prohibited transactions. AGENCY: Pursuant to Executive Order 13942, the Secretary of Commerce is publishing the list of prohibited transactions by any person, or with respect to any property, subject to the jurisdiction of the United States, with ByteDance Ltd. (a.k.a. Zı`jie´ Tia`odo`ng), Beijing, China, or its subsidiaries, including TikTok Inc., in which any such company has any interest, to address the national emergency with respect to the information and communications technology and services supply chain declared in Executive Order 13873, May 15, 2019 (Securing the Information and Communications Technology and Services Supply Chain), and particularly to address the threat identified in Executive Order 13942 posed by mobile application TikTok. DATES: Transactions identified in paragraph 1 below will be prohibited at 11:59 p.m. eastern standard time on September 27, 2020; transactions identified in paragraphs 2, 3, 4, and 5 below will be prohibited at 11:59 p.m. SUMMARY: PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 60061 eastern standard time on November 12, 2020. FOR FURTHER INFORMATION CONTACT: Kathy Smith, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482–1859. For media inquiries: Meghan Burris, Director, Office of Public Affairs, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482–4883. SUPPLEMENTARY INFORMATION: In Executive Order 13873 of May 15, 2019 (Securing the Information and Communications Technology and Services Supply Chain), the President found that foreign adversaries are increasingly creating and exploiting vulnerabilities in information and communications technology and services (ICTS), which store and communicate vast amounts of sensitive information, facilitate the digital economy, and support critical infrastructure and vital emergency services, in order to commit malicious cyber-enabled actions, including economic and industrial espionage against the United States and its people. The President further found that the unrestricted acquisition or use in the United States of ICTS designed, developed, manufactured, or supplied by persons owned by, controlled by, or subject to the jurisdiction or direction of foreign adversaries augments the ability of foreign adversaries to create and exploit vulnerabilities in ICTS, with potentially catastrophic effects, and thereby constitutes an unusual and extraordinary threat to the national security, foreign policy, and economy of the United States, and declared a national emergency with respect to this threat. The President directed that additional steps are required to protect the security, integrity, and reliability of ICTS provided and used in the United States. On August 6, 2020, in Executive Order 13942 (Addressing the Threat Posed by TikTok, and Taking Additional Steps To Address the National Emergency With Respect to the Information and Communications Technology and Services Supply Chain), the President further found that the spread in the United States of mobile applications developed and owned by companies in the People’s Republic of China (China) continues to threaten the national security, foreign policy, and economy of the United States. The President directed that action must be taken to address the threat posed by the mobile application TikTok. E:\FR\FM\24SER1.SGM 24SER1

Agencies

[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Rules and Regulations]
[Pages 60059-60061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18294]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 285

[Docket No.: 200128-0034]
RIN 0693-AB67


National Voluntary Laboratory Accreditation Program--Amendment to 
the Procedures and Requirements To Accredit Testing and Calibration 
Laboratories

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Director of the National Institute of Standards and 
Technology (NIST) is issuing a final rule amending the regulations 
pertaining to the operation of the National Voluntary Laboratory 
Accreditation Program (NVLAP) and the operation of its accreditation 
programs. The regulations are being revised to include recognition of 
proficiency testing as an accreditation activity, add or revise terms, 
and update NVLAP mailing information, in accordance with the applicable 
international standard. These changes will not impact the public 
directly, and will only result in minor changes to NIST's internal 
practices.

DATES: This rule is effective on September 24, 2020. The incorporation 
by reference of certain publications listed in the rule is approved by 
the Director of the Federal Register as of September 24, 2020.

ADDRESSES: Dana S. Leaman, Chief, National Voluntary Laboratory 
Accreditation Program, 100 Bureau Drive, Stop 2140, Gaithersburg, MD 
20899-2140 or by sending email to [email protected].

FOR FURTHER INFORMATION CONTACT: Dana S. Leaman, Chief, NIST/NVLAP, 100 
Bureau Drive, Stop 2140, Gaithersburg, MD 20899-2140, Phone: (301) 975-
4016 or email: [email protected]. Information regarding NVLAP and 
the accreditation process can be obtained from http://www.nist.gov/nvlap.

SUPPLEMENTARY INFORMATION:

I. Background

    Title 15, part 285 of the Code of Federal Regulations sets out 
procedures and general requirements under which NVLAP operates as an 
unbiased third party to accredit both testing and calibration 
laboratories. The NVLAP procedures were first published in the Federal 
Register on February 25, 1976, and have been revised several times.
    NVLAP currently operates in accordance with ISO/IEC 17011:2004, 
Conformity assessment--Requirements for accreditation bodies 
accrediting conformity assessment bodies. The Laboratory Accreditation 
Programs operated by NVLAP are established based on the criteria in 
ISO/IEC 17025, General requirements for the competence of testing and 
calibration laboratories. Revisions to ISO/IEC 17011 and ISO/IEC 17025 
were published in November 2017 with a three-year implementation 
period. These revisions include recognition of proficiency testing as 
an accreditation activity, addition and/or revision of terms, and 
update of the NVLAP mailing information. The purpose of this amendment 
is to incorporate these revised requirements into the regulations.

II. Incorporation by Reference

    NIST Handbook 150 presents the basic procedures under which NVLAP 
operates, and considers the requirements contained in ISO/IEC 17025, 
General requirements for the competence of testing and calibration 
laboratories. ISO/IEC 17025 and NIST Handbook 150 contain the general 
requirements that testing and calibration

[[Page 60060]]

laboratories must meet if they wish to demonstrate that they operate an 
appropriate management system, are technically competent, and are able 
to generate technically valid results.
    The provisions of NIST Handbook 150 are being incorporated by 
reference into 15 CFR 285.8 and 285.14, as this will substantially 
reduce the volume of material published in the Federal Register and the 
CFR. NIST Handbook 150 is available at no-cost at https://nvlpubs.nist.gov/nistpubs/hb/2020/NIST.HB.150-2020.pdf.

III. Regulatory Analysis

    Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior 
notice and an opportunity for public comment on this action, as notice 
and comment are unnecessary. This final rule makes minor, technical 
amendments in order to conform the regulations to changes that were 
made to the applicable international standard. These changes will not 
impact the public directly, and will only result in minor changes to 
NIST's internal practices. None of these changes will have a 
substantive impact beyond those already considered in previous 
supporting documents. For the same reasons, there is good cause under 5 
U.S.C. 553(d)(3) to waive the 30-day delay in effective date.

Executive Order 12866

    This final rule was determined to be not significant for purposes 
of Executive Order 12866.

Executive Order 13132

    This final rule does not contain policies with Federalism 
implications as defined in Executive Order 13132.

Regulatory Flexibility Act

    Because prior notice and opportunity for public comment are not 
required for this rule by 5 U.S.C. 553, or any other law, the 
analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 
et seq., do not apply.

Paperwork Reduction Act

    This final rule contains no new collection of information subject 
to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

National Environmental Policy Act

    This final rule will not significantly affect the quality of the 
human environment. Therefore, an environmental assessment or 
Environmental Impact Statement is not required to be prepared under the 
National Environmental Policy Act of 1969.

List of Subjects in 15 CFR Part 285

    Accreditation, Business and industry, Calibration, Commerce, 
Conformity assessment, Incorporation by reference, Laboratories, 
Measurement standards, Testing.

    For the reasons stated in the preamble, NIST amends 15 CFR part 285 
as follows:

PART 285--NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM

0
1. The authority citation for 15 CFR part 285 continues to read as 
follows:

    Authority: 15 U.S.C. 272 et seq.


0
2. Revise Sec.  285.1 to read as follows:


Sec.  285.1  Purpose.

    The purpose of this part is to set out procedures and general 
requirements under which the National Voluntary Laboratory 
Accreditation Program (NVLAP) operates as an unbiased third party to 
accredit both testing and calibration laboratories. Supplementary 
technical and administrative requirements are provided in supporting 
handbooks and documents as needed, depending on the criteria 
established for specific Laboratory Accreditation Programs (LAPs).

0
3. Revise Sec.  285.6 to read as follows:


Sec.  285.6  Application for accreditation.

    A laboratory may apply for accreditation in any of the established 
LAPs. The applicant laboratory shall provide a completed application to 
NVLAP, pay all required fees and agree to certain conditions as set 
forth in the NVLAP Application for Accreditation, and provide 
management system documentation to NVLAP (or a designated NVLAP 
assessor) prior to the assessment process.


Sec.  285.7  [Amended]

0
4. In Sec.  285.7, remove the word ``deficiencies'' wherever it occurs 
and add in its place the word ``nonconformities.''

0
5. Revise Sec.  285.8 to read as follows:


Sec.  285.8  Proficiency testing.

    (a) Proficiency testing requirements. Proficiency testing 
undertaken to meet the criteria for NVLAP accreditation shall be 
consistent with the provisions contained in NIST Handbook 150, NVLAP 
Procedures and General Requirements (incorporated by reference, see 
Sec.  285.16), where applicable, including revisions from time to time. 
Laboratories must participate in proficiency testing as specified for 
each LAP in the NVLAP program handbooks.
    (b) Analysis and reporting. Proficiency testing results are 
analyzed by NVLAP and results of the analysis are made known to the 
participants. Any result not meeting the criteria specified in the 
NVLAP LAP program handbook is identified as a nonconformity.
    (c) Proficiency testing nonconformities. (1) Unsatisfactory 
participation in any proficiency testing program is a technical 
nonconformity which must be resolved in order to obtain initial 
accreditation or maintain accreditation.
    (2) Proficiency testing nonconformities are defined as, but not 
limited to, one or more of the following:
    (i) Failure to meet specified proficiency testing performance 
requirements prescribed by NVLAP;
    (ii) Failure to participate in a regularly scheduled ``round'' of 
proficiency testing for which the laboratory has received instructions 
and/or materials;
    (iii) Failure to submit laboratory control data as required; or
    (iv) Failure to produce acceptable test or calibration results when 
using NIST Standard Reference Materials or special artifacts whose 
properties are well-characterized and known to NIST/NVLAP.
    (3) NVLAP will notify the laboratory of proficiency testing 
nonconformities and actions to be taken to resolve the nonconformities. 
Denial or suspension of accreditation will result from failure to 
resolve nonconformities.

0
6. Revise Sec.  285.10(b) to read as follows:


Sec.  285.10  Renewal of accreditation.

* * * * *
    (b) On-site assessments of currently accredited laboratories are 
performed in accordance with the procedures in Sec.  285.7. If 
nonconformities are found during the assessment of an accredited 
laboratory, the laboratory must follow the procedures set forth in 
Sec.  285.7(e)(2) or face possible suspension or revocation of 
accreditation.

0
7. Revise Sec.  285.12 to read as follows:


Sec.  285.12  Monitoring visits.

    (a) In addition to regularly scheduled assessments, monitoring 
visits may be conducted by NVLAP at any time during the accreditation 
period. They may occur for cause or on a random selection basis. While 
most monitoring visits will be scheduled in advance with the 
laboratory, NVLAP may conduct unannounced monitoring visits.
    (b) The scope of a monitoring visit may range from checking a few

[[Page 60061]]

designated items to a complete review. The assessors may review 
nonconformity resolutions, verify reported changes in the laboratory's 
personnel, facilities or operations, or evaluate proficiency testing 
activities, when appropriate.

0
8. Revise Sec.  285.14 to read as follows:


Sec.  285.14  Criteria for accreditation.

    The requirements for laboratories to be recognized by the National 
Voluntary Laboratory Accreditation Program as competent to carry out 
tests and/or calibrations are contained in NIST Handbook 150, NVLAP 
Procedures and General Requirements (incorporated by reference, see 
Sec.  285.16).

0
9. Revise Sec.  285.15(b) to read as follows:


Sec.  285.15  Obtaining documents.

* * * * *
    (b) Copies of all ISO/IEC documents are available for purchase from 
the American National Standards Institute's eStandards Store at http://webstore.ansi.org. You may inspect copies of all applicable ISO/IEC 
documents at the National Voluntary Laboratory Accreditation Program, 
National Institute of Standards and Technology, 100 Bureau Drive, Room 
B119, Gaithersburg, MD. For access to the NIST campus, please contact 
NVLAP by phone at 301-975-4016 or by email at [email protected] to obtain 
instructions for visitor registration.

0
10. Add Sec.  285.16 to read as follows:


Sec.  285.16  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. All approved material is available for 
inspection at National Institute of Standards and Technology, National 
Voluntary Laboratory Accreditation Program (NVLAP), National Institute 
of Standards and Technology, 100 Bureau Drive, Room B119, Gaithersburg, 
MD and is available from the source(s) listed in the following 
paragraph(s). It is also available for inspection at the National 
Archives and Records Administration (NARA). For access to the NIST 
campus, please contact NVLAP by phone at 301-975-4016 or by email at 
[email protected] to obtain instructions for visitor registration. For 
information on the availability of this material at NARA, email 
[email protected] or go to www.archives.gov/federal-register/cfr/ibr-locations.html.
    (a) National Institute of Standards and Technology (NIST), U.S. 
Department of Commerce, 100 Bureau Drive, Room B119, Gaithersburg, MD, 
301-975-4016 [email protected], www.nist.gov/publications/.
    (1) NIST Handbook 150, National Voluntary Laboratory Accreditation 
Program Procedures (NVLAP) and General Requirements, authored by Dana 
S. Leaman and Bethany Hackett, 2020 Edition, August 2020, 2020 (NVLAP 
Procedures and General Requirements) https://nvlpubs.nist.gov/nistpubs/hb/2020/NIST.HB.150-2020.pdf; into Sec. Sec.  285.8(a) and Sec.  
285.14.
    (2) [Reserved]
    (b) [Reserved]

Kevin A. Kimball,
Chief of Staff.
[FR Doc. 2020-18294 Filed 9-23-20; 8:45 am]
BILLING CODE 3510-13-P