Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, 19357-19360 [2012-7602]
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Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices
to shares of Common Stock should be
passed through to the accounts of
Participants.
29. The Applicant states that the
requested exemption is protective of the
rights of Participants and beneficiaries
because they had the opportunity, at
their own discretion, to participate in
the Offering on the same terms as every
other Shareholder. The Applicant
stresses that Participants and their
beneficiaries had no obligation to
exercise their Rights, and in fact could
not exercise their Rights if the
Subscription Price was below the
Closing Price on January 14, 2011 (any
Rights not exercised by the Participants
simply expired). The Applicant states
that the terms of the Offering were
described to the Participants in clearly
written communications, namely the
401(k) Participant Instructions and the
401(k) Participant Election Form, and
that the decision by Participants to
exercise Rights held in their Plan
Accounts of the Participants in the
Offering was strictly voluntary. Finally,
the Applicant notes that neither TIB nor
any of the Plan fiduciaries placed any
pressure on Participants to exercise
their Rights in the Offering or otherwise
attempted to influence their decision,
and the Offering was conducted in a
manner which did not prejudice the
Participants.
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Summary
30. In summary, the Applicant
represents that the covered transactions
satisfied the statutory requirements for
an exemption under section 408(a) of
the Act because:
(a) The receipt of the Rights by the
Plan occurred pursuant to Plan
provisions for individually directed
investments of such accounts, in
connection with the Offering, and was
made available by TIB on the same
terms to all Shareholders of Common
Stock as of the Record Date;
(b) The acquisition of the Rights by
the Plan resulted from an independent
act of TIB as a corporate entity, and all
holders of the Rights, including the
Plan, were treated in the same manner
with respect to such acquisition;
(c) All Shareholders of Common
Stock, including the Plan, received the
same proportionate number of Rights
based on the number of shares of
Common Stock held by such
Shareholders;
(d) All decisions regarding the Rights
held by the Plan were made by the
Participants whose accounts in the Plan
received the Rights pursuant to the
Offering, in accordance with the
provisions under the Plan for
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individually-directed investment of
such account; and
(e) The Plan did not pay any fees or
commissions in connection with the
acquisition and or holding of the Rights.
Notice to Interested Persons
Notice of the proposed exemption
will be given to all Participants who
received Rights within 20 days of the
publication of the notice of proposed
exemption in the Federal Register, by
first class U.S. mail to the last known
address of all such Participants. Such
notice will contain a copy of the notice
of proposed exemption, as published in
the Federal Register, and a
supplemental statement, as required
pursuant to 29 CFR 2570.43(b)(2). The
supplemental statement will inform
interested persons of their right to
comment on and to request a hearing
with respect to the pending exemption.
Written comments and hearing requests
are due within 50 days of the
publication of the notice of proposed
exemption in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Warren Blinder of the Department,
telephone (202) 693–8553. (This is not
a toll-free number.)
General Information
The attention of interested persons is
directed to the following:
(1) The fact that a transaction is the
subject of an exemption under section
408(a) of the Act and/or section
4975(c)(2) of the Code does not relieve
a fiduciary or other party in interest or
disqualified person from certain other
provisions of the Act and/or the Code,
including any prohibited transaction
provisions to which the exemption does
not apply and the general fiduciary
responsibility provisions of section 404
of the Act, which, among other things,
require a fiduciary to discharge his
duties respecting the plan solely in the
interest of the participants and
beneficiaries of the plan and in a
prudent fashion in accordance with
section 404(a)(1)(b) of the Act; nor does
it affect the requirement of section
401(a) of the Code that the plan must
operate for the exclusive benefit of the
employees of the employer maintaining
the plan and their beneficiaries;
(2) Before an exemption may be
granted under section 408(a) of the Act
and/or section 4975(c)(2) of the Code,
the Department must find that the
exemption is administratively feasible,
in the interests of the plan and of its
participants and beneficiaries, and
protective of the rights of participants
and beneficiaries of the plan;
(3) The proposed exemptions, if
granted, will be supplemental to, and
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19357
not in derogation of, any other
provisions of the Act and/or the Code,
including statutory or administrative
exemptions and transitional rules.
Furthermore, the fact that a transaction
is subject to an administrative or
statutory exemption is not dispositive of
whether the transaction is in fact a
prohibited transaction; and
(4) The proposed exemptions, if
granted, will be subject to the express
condition that the material facts and
representations contained in each
application are true and complete, and
that each application accurately
describes all material terms of the
transaction which is the subject of the
exemption.
Signed at Washington, DC, this 27th day of
March 2012.
Lyssa E. Hall,
Acting Director of Exemption Determinations,
Employee Benefits Security Administration,
U.S. Department of Labor.
[FR Doc. 2012–7706 Filed 3–29–12; 8:45 am]
BILLING CODE 4510–29–P
OFFICE OF MANAGEMENT AND
BUDGET
Federal Participation in the
Development and Use of Voluntary
Consensus Standards and in
Conformity Assessment Activities
Request for Information and
Notice of public workshop.
ACTION:
The Office of Management
and Budget (OMB) invites interested
parties to provide input on current
issues regarding Federal agencies’
standards and conformity assessment
related activities. Input is being sought
to inform OMB’s consideration of
whether and how to supplement
Circular A–119 (Federal Participation in
the Development and Use of Voluntary
Consensus Standards and in Conformity
Assessment Activities). In addition,
OMB is announcing a public workshop
at the Department of Commerce’s
National Institute of Standards and
Technology (NIST) on May 15, 2012. A
complementary NIST workshop,
‘‘Conformity Assessment: Approaches
and Best Practices,’’ will take place on
April 11, 2012 to seek input from
individuals on the planned update of
Guidance on Federal Conformity
Assessment Activities, issued by NIST
in 2000. The NIST workshop was
announced separately by NIST at
https://www.nist.gov/director/sco/caworkshop-2012.cfm (see also 77 FR
15719; March 16, 2012).
DATES: Comments: Comments are due
on or before April 30, 2012.
SUMMARY:
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Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices
Public workshop: In addition to
providing written comments, interested
parties are invited to attend the public
workshop on May 15th. The workshop
will include presentations from key
government officials, industry, and
experts on standards and conformity
assessment issues, and time will be
allotted for participant input and
discussions. There is no registration fee
for the workshop.
Registration: To gain access to the
NIST campus, located at 100 Bureau
Drive in Gaithersburg, MD 20899, all
participants must register in advance no
later than 5 p.m. EST on May 8, 2012.
Non-U.S. citizens must register no later
than May 1, 2012. There will be no
onsite registration. To register online,
visit the ‘‘Register Now’’ link on the
conference web site at https://wwws.nist.gov/CRS/
conf_disclosure.cfm?conf_id=5262.
All comments should be
submitted via https://
www.regulations.gov or faxed at
202–395–5167. Please submit comments
only and include your name, company
name (if any), and cite ‘‘Federal
Participation in the Development and
Use of Voluntary Consensus Standards
and in Conformity Assessment
Activities’’ in all correspondence. All
comments received will be posted,
without change or redaction, to
www.regulations.gov, so commenters
should not include information they do
not wish to be posted (e.g., personal or
confidential business information).
FOR FURTHER INFORMATION CONTACT:
Jasmeet Seehra, Office of Information
and Regulatory Affairs, at
jseehra@omb.eop.gov.
ADDRESSES:
In the
‘‘National Technology Transfer and
Advancement Act of 1995’’ (Pub L. 104–
113; hereinafter ‘‘the NTTAA’’),
Congress stated that Federal agencies
‘‘shall use technical standards that are
developed or adopted by voluntary
consensus standards bodies, using such
technical standards as a means to carry
out policy objectives or activities,’’
except when an agency determines that
such use ‘‘is inconsistent with
applicable law or otherwise
impractical.’’ As amended by Section
1115 of Public Law 107–107, Section
12(d) provides that:
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SUPPLEMENTARY INFORMATION:
(d) UTILIZATION OF CONSENSUS
TECHNICAL STANDARDS BY FEDERAL
AGENCIES; REPORTS.—
(1) IN GENERAL.—Except as provided in
paragraph (3) of this subsection, all Federal
agencies and departments shall use technical
standards that are developed or adopted by
voluntary consensus standards bodies, using
such technical standards as a means to carry
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out policy objectives or activities determined
by the agencies and departments.
(2) CONSULTATION; PARTICIPATION.—
In carrying out paragraph (1) of this
subsection, Federal agencies and
departments shall consult with voluntary,
private sector, consensus standards bodies
and shall, when such participation is in the
public interest and is compatible with agency
and departmental missions, authorities,
priorities, and budget resources, participate
with such bodies in the development of
technical standards.
(3) EXCEPTION.—If compliance with
paragraph (1) of this subsection is
inconsistent with applicable law or otherwise
impractical, a Federal agency or department
may elect to use technical standards that are
not developed or adopted by voluntary
consensus standards bodies if the head of
each such agency or department transmits to
the Office of Management and Budget an
explanation of the reasons for using such
standards. Each year, beginning with fiscal
year 1997, the Office of Management and
Budget shall transmit to Congress and its
committees a report summarizing all
explanations received in the preceding year
under this paragraph.
(4) EXPENSES OF GOVERNMENT
PERSONNEL.—Section 5946 of title 5,
United States Code, shall not apply with
respect to any activity of an employee of a
Federal agency or department that is
determined by the head of that agency or
department as being an activity undertaken
in carrying out this subsection.
(5) DEFINITION OF TECHNICAL
STANDARDS.—As used in this subsection,
the term ‘‘technical standards’’ means
performance based or design-specific
technical specifications and related
management systems practices.
Section 12(d) is found as a ‘‘note’’ to 15
U.S.C. 272.
In response to the enactment of the
NTTAA, OMB prepared a proposed set
of revisions to Circular A–119 (entitled
‘‘Federal Participation in the
Development and Use of Voluntary
Consensus Standards and in Conformity
Assessment Activities’’) and issued a
Federal Register notice seeking public
comment on the proposed revisions. 61
FR 68312 (December 27, 1996). After
consideration of the comments, OMB
issued the final revision of the Circular.
63 FR 8546 (February 19, 1998). In the
preamble to the final notice, OMB
responded to the public comments and
provided explanatory background
regarding the revised Circular. A copy of
the Circular is on OMB’s Web site at
https://www.whitehouse.gov/omb/
circulars_a119/.
The policies in the Circular are
intended to reduce to a minimum the
reliance by agencies on governmentunique standards. In accordance with
Section 12(d) of the NTTAA, Circular
A–119 directs Federal agencies to use
voluntary consensus standards in lieu of
government-unique standards except
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where inconsistent with law or
otherwise impractical. The Circular also
provides guidance for agencies
participating in the work of bodies that
develop voluntary consensus standards
and describes procedures for satisfying
the NTTAA’s agency-reporting
requirements. In addition, consistent
with Section 12(b) of the NTTAA, the
Circular directs the Secretary of
Commerce to issue guidance to agencies
in order to coordinate conformity
assessment activities.
On January 17, 2012, the Office of
Information and Regulatory Affairs, the
Office of Science and Technology
Policy, and the United States Trade
Representative built on the Circular and
issued guidance on Federal engagement
in standards activities to address
national priorities.1 We note more
generally the requirements of Executive
Order 13563, which emphasizes that our
regulatory system ‘‘must protect public
health, welfare, safety, and our
environment while promoting economic
growth, innovation, competitiveness,
and job creation’’ (emphasis added),
and which stresses the importance of
public participation and of careful
consideration of both benefits and costs.
Purpose: The purpose of this Request
for Information (RFI) and related public
workshop on May 15, 2012, is to allow
interested stakeholders to provide input
to OMB, NIST, Federal regulators and
other relevant agencies on how the
Federal government should address
issues in standards and conformity
assessment that have emerged or moved
to the forefront since the Circular was
promulgated in 1998. Such input could
help improve U.S. agencies’
implementation of the NTTAA and the
Circular.
In addition, input received through
the RFI and during the workshop could
be used to inform OMB’s consideration
of whether and how to supplement
Circular A–119 to provide additional or
more specific guidance on standards
and conformity assessment to agencies
engaged in rulemaking, procurement,
and other activities. Any such
supplemental guidance would be
developed in conjunction with NIST’s
effort to update its conformity
assessment guidelines, in order to
ensure consistency between the two
documents. The NIST conformity
assessment guidelines are available at
https://gsi.nist.gov/global/docs/
FR_FedGuidanceCA.pdf. Additional
information on the conformity
assessment workshop objectives was
provided by NIST in a separate Federal
1 See https://www.whitehouse.gov/sites/default/
files/omb/memoranda/2012/m-12-08_1.pdf.
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Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices
Register notice published on March 16,
2012 (77 FR 15719).
If OMB determines, based on the
responses to the RFI, discussions at the
workshops, and further consideration of
the issues, that it would be useful to
develop supplemental guidance for the
Circular to address some or all of the
issues raised, then OMB will publish a
draft notice in the Federal Register at a
subsequent date and request public
comment.
In response to this RFI and at the
workshop, OMB is interested in
receiving input from interested
stakeholders pertaining to one or more
of the following issues relating to
standards and conformity assessment,
specifically with respect to how these
issues may affect agencies engaged in
rulemaking, procurement, and other
activities.
Agency Implementation of Circular
A–119 in Rulemakings. Are Federal
agencies generally following the
guidance set out in the Circular and
providing an adequate explanation of
how they considered standards and
conformity assessment-related issues in
the preambles to rulemakings?
Standardization Activities. OMB
A–119 does not establish a preference
between consensus and non-consensus
standards developed in the private
sector. A limited set of foundational
attributes of standardization activities
are identified in the Circular, focusing
on voluntary consensus standard
activities. It may also be important to
recognize the contributions of
standardization activities that take place
outside of the voluntary consensus
process, in particular certain activities
in emerging technology areas.
• What factors should agencies use in
evaluating whether to use voluntary
non-consensus standards in regulation,
procurement solicitations, or other nonregulatory uses? OMB also invites
comments on the respective roles of
voluntary consensus standards vs.
voluntary non-consensus standards for
agency responsibilities in rulemaking,
procurement, and other activities.
Conformity Assessment. Circular
A–119 directs the Secretary of
Commerce to issue guidance to Federal
agencies on conformity assessment.
NIST issued such guidance in 2000 and
plans to update the guidance.
In conjunction with NIST’s efforts to
update its conformity assessment
guidance, should a supplement to
Circular A–119 be issued to set out
relevant principles on conformity
assessment? If so, what issues should be
addressed in such a supplement? The
following are among the topics that
could be considered:
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• Factors agencies should use in
selecting the appropriate conformity
assessment procedure, including
product/sector specific issues and the
level of risk of non-fulfillment of
legitimate regulatory, procurement, or
other mission-related objectives;
• Guidance for regulatory agencies on
compliance with relevant international
obligations pertaining to conformity
assessment and accreditation activities;
• Factors agencies should consider in
determining whether to recognize the
results of conformity assessment and
accreditation activities conducted by
private sector bodies in support of
regulation;
• Non-regulatory uses of standards
(including vendor conformity for
purposes of response to procurement
solicitations); and
• Ensuring that agencies consider
how to minimize conformity assessment
costs and delays for businesses,
especially small and medium sized
enterprises, subject to statutory and
budgetary constraints and the ability of
agencies to fulfill their legitimate
regulatory, procurement, or other
mission-related objectives.
Protection of Copyright Associated
With Standards. Standards themselves
are considered to be intellectual
property and are typically copyrighted
by the standards developing bodies that
administer the process by which
specific standards are developed and
maintained. The rights of copyright
holders are protected under U.S. law,
and standards developers typically
charge fees to access their copyrighted
materials. Some parties have raised
transparency concerns with respect to
the availability of copyrighted materials
in instances where standards are
referenced or incorporated in regulation
and compliance with such standards is
mandatory.
In this respect, we take note of three
recent developments relevant to this
issue:
At its Plenary Session on December 8,
2011, the Administrative Conference of
the United States (ACUS) considered
and adopted a Recommendation on
Incorporation by Reference, specifically
addressing the place of voluntary
consensus standards in that process and
how to determine ‘‘reasonable
availability.’’ https://www.acus.gov/wpcontent/uploads/downloads/2011/12/
Recommendation-2011-5-Incorporationby-Reference.pdf.
Second, the Pipeline Safety,
Regulatory Certainty, and Job Creation
Act of 2011 (the Act) was signed into
law on January 3, 2012 (Pub. L. 112–90).
Section 24 of the Act created a new
subsection (p) of Section 60102 of Title
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19359
49 of the U.S. Code. Section 60102(p)
prohibits the Secretary of
Transportation from issuing ‘‘guidance
or a regulation’’ pursuant to Title 49 of
the U.S. Code, Chapter 601 (pipeline
safety) ‘‘that incorporates by reference
any documents or portions thereof
unless those documents or portions
thereof are made available to the public,
free of charge, on an Internet Web site.’’
Section 60102(p) takes effect one year
from the date of its enactment, i.e.,
January 3, 2013.
Third, the National Archives and
Records Administration, Office of the
Federal Register, recently published a
petition for rulemaking received on
February 13, 2012, to amend its
regulations governing the approval of
agency requests to incorporate material
by reference into the Code of Federal
Regulations, and requested public
comment. 77 FR 11414 (February 27,
2012). OMB notes that the petition
raises issues that are closely related to
some of the issues discussed in this RFI
and encourages interested stakeholders
to provide comments in response to the
petition.
Circular A–119 specifically
contemplates incorporation by reference
of voluntary consensus standards by
Federal agencies, defining agency ‘‘use’’
of a voluntary consensus standard as
‘‘incorporation of a standard in whole,
in part, or by reference for procurement
purposes, and the inclusion of a
standard in whole, in part, or by
reference in regulation(s).’’ Circular
A–119 also directs agencies to respect
intellectual property rights that may
exist in voluntary consensus standards
that are incorporated into regulation by
reference: ‘‘If a voluntary standard is
used and published in an agency
document, your agency must observe
and protect the rights of the copyright
holder and any other similar
obligations.’’
Since passage of the NTTAA, major
strides have been made by Federal
agencies in their use of voluntary
consensus standards. The NIST
‘‘Standards Incorporated by Reference
Database’’ includes thousands of such
standards incorporated by reference in
the CFR—https://standards.gov/sibr/
query/index.cfm?fuseaction=rsibr.total
_regulatory_sibr.
• Is lack of access to standards
incorporated by reference in regulation
an issue for commenters responding to
a request for public comment in
rulemaking or for stakeholders that
require access to such standards? Please
provide specific examples.
• What are the best practices for
providing access to standards
incorporated by reference in regulation
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19360
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during rulemaking and during the
effective period of the regulation while
respecting the copyright associated with
the standard?
• What are the best practices for
incorporating standards by reference in
regulation while respecting the
copyright associated with the standard?
Voluntary Consensus Standards and
Cost-Benefit Analysis. Standards
developing bodies, including not-forprofit organizations, use a variety of
cost-recovery models as part of their
overall way of doing business. OMB
believes that it may be helpful for the
purposes of the Circular and for the
evaluation of costs and benefits of
significant regulatory actions pursuant
to Executive Orders 12866 and 13563
for Federal agencies to have a basic
understanding of the costs associated
with the development of private sector
standards, in addition to the purchase
costs of standards. Similarly, agencies
and the public should have an
understanding of the overall resources
and costs that would be involved if
Federal agencies were to develop
government-unique standards. Both of
these can be elements in determining
when it is practical or impractical to
incorporate a voluntary standard into
regulation or otherwise adopt a standard
in the course of carrying out an agency’s
mission, as compared to developing a
government-unique standard.
• What resource and other costs are
involved in the development and
revision of voluntary standards?
• What economic and other factors
should agencies take into consideration
when determining that the use of a
voluntary standard is practical for
regulatory or other mission purposes?
• How often do standards-developing
bodies review and subsequently update
standards? If standards are already
incorporated by reference in regulations,
do such bodies have mechanisms in
place for alerting the relevant agencies
and the public, especially in regard to
the significance of the changes in the
standards?
Using and Updating Standards in
Regulation. Federal agencies have
adopted various methods of using
standards as a basis for regulation. They
have also developed different
approaches to updating standards that
have been referenced or incorporated in
regulations.
• Should OMB set out best practices
on how to reference/incorporate
standards (or the relevant parts) in
regulation? If so, what are the best
means for doing so? Are the best means
of reference/incorporation contextspecific? Are there instances where
incorporating a standard or part thereof
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into a regulation is preferable to
referencing a standard in regulation (or
vice versa)?
• Should an OMB supplement to the
Circular set out best practices for
updating standards referenced in
regulation as standards are revised? If
so, what updating practices have
worked well and which ones have not?
OMB recognizes that changes in
technology and the need for innovation
can result in the updating of private
sector standards in a turn-around time
of two years or even less. Where such
standards are already incorporated into
regulations, these changes can suggest a
need to update the relevant regulations
as well and, in some cases, can result in
a need for regulated entities to purchase
the newly updated standards on a fairly
routine basis. In addition to the costs
associated with the continuing purchase
of such standards, rapid update cycles
may make it difficult for the regulated
public to understand the nature and
significance of the changing regulations.
• Is there a role for OMB in providing
guidance on how Federal agencies can
best manage the need for relevant
regulations in the face of changing
standards?
• How should agencies determine the
cost-effectiveness of issuing updated
regulations in response to updated
standards?
• Do agencies consult sufficiently
with private sector standards bodies
when considering the update of
regulations that incorporate voluntary
standards, especially when such
standards may be updated on a regular
basis?
Use of More Than One Standard or
Conformity Assessment Procedure in a
Regulation or Procurement Solicitation.
OMB recognizes that, in some instances,
it may be best, in terms of economic
activity, if a regulation or procurement
solicitation sets out a requirement that
can be met by more than one standard
and more than one conformity
assessment procedure. In some cases,
however, allowing the use of more than
one standard or conformity assessment
procedure may not be possible or meet
the regulatory or procurement objective.
For example, doing so may be precluded
by statute, and an alternate standard or
conformity assessment procedure may
not provide an equivalent level of
protection as the standard or conformity
assessment procedure selected by the
regulator.
• Should OMB provide guidance to
agencies on when it is appropriate to
allow the use of more than one standard
or more than one conformity assessment
procedure to demonstrate conformity
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with regulatory requirements or
solicitation provisions?
• Where an agency is requested by
stakeholders to consider allowing the
demonstration of conformity to another
country’s standard or the use of an
alternate conformity assessment
procedure as adequate to fulfilling U.S.
requirements, should OMB provide
guidance to agencies on how to consider
such requests?
Other Developments
• Have there been any developments
internationally—including but not
limited to U.S. regulatory cooperation
initiatives—since the publication of
Circular A–119 that OMB should take
into account in developing a possible
supplement to the Circular?
• Does the significant role played by
consortia today in standards
development in some technology areas
have any bearing on (or specific
implications for) Federal participation?
• Are there other issues not set out
above that OMB might usefully seek to
address in a supplement?
Cass Sunstein,
Administrator, Office of Information and
Regulatory Affairs, Office of Management and
Budget.
[FR Doc. 2012–7602 Filed 3–29–12; 8:45 am]
BILLING CODE P
MILLENNIUM CHALLENGE
CORPORATION
[MCC 12–04]
Report on Countries That Are
Candidates for Millennium Challenge
Account Eligibility in Fiscal Year 2012
and Countries That Would Be
Candidates but for Legal Prohibitions
Millennium Challenge
Corporation.
ACTION: Notice.
AGENCY:
Section 608(d) of the
Millennium Challenge Act of 2003 (the
‘‘Act’’) requires the Millennium
Challenge Corporation to publish a
report that identifies countries that are
‘‘candidate countries’’ for Millennium
Challenge Account assistance during FY
2012. In December 2011, Congress
enacted changes in MCC’s FY 2012
appropriation that redefined candidate
countries for FY 2012 as part of the
Consolidated Appropriations Act, 2012
(Pub. L. 112–74) (the ‘‘Appropriations
Act’’).1 While this does not affect the
SUMMARY:
1 The changes to the Act enacted in the
Appropriations Act only apply to the FY 2012
selection process. The relevant language would
need to be included in next year’s appropriations
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Agencies
[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Pages 19357-19360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7602]
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OFFICE OF MANAGEMENT AND BUDGET
Federal Participation in the Development and Use of Voluntary
Consensus Standards and in Conformity Assessment Activities
ACTION: Request for Information and Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Office of Management and Budget (OMB) invites interested
parties to provide input on current issues regarding Federal agencies'
standards and conformity assessment related activities. Input is being
sought to inform OMB's consideration of whether and how to supplement
Circular A-119 (Federal Participation in the Development and Use of
Voluntary Consensus Standards and in Conformity Assessment Activities).
In addition, OMB is announcing a public workshop at the Department of
Commerce's National Institute of Standards and Technology (NIST) on May
15, 2012. A complementary NIST workshop, ``Conformity Assessment:
Approaches and Best Practices,'' will take place on April 11, 2012 to
seek input from individuals on the planned update of Guidance on
Federal Conformity Assessment Activities, issued by NIST in 2000. The
NIST workshop was announced separately by NIST at https://www.nist.gov/director/sco/ca-workshop-2012.cfm (see also 77 FR 15719; March 16,
2012).
DATES: Comments: Comments are due on or before April 30, 2012.
[[Page 19358]]
Public workshop: In addition to providing written comments,
interested parties are invited to attend the public workshop on May
15th. The workshop will include presentations from key government
officials, industry, and experts on standards and conformity assessment
issues, and time will be allotted for participant input and
discussions. There is no registration fee for the workshop.
Registration: To gain access to the NIST campus, located at 100
Bureau Drive in Gaithersburg, MD 20899, all participants must register
in advance no later than 5 p.m. EST on May 8, 2012. Non-U.S. citizens
must register no later than May 1, 2012. There will be no onsite
registration. To register online, visit the ``Register Now'' link on
the conference web site at https://www-s.nist.gov/CRS/conf_disclosure.cfm?conf_id=5262.
ADDRESSES: All comments should be submitted via https://www.regulations.gov or faxed at 202-395-5167. Please submit comments
only and include your name, company name (if any), and cite ``Federal
Participation in the Development and Use of Voluntary Consensus
Standards and in Conformity Assessment Activities'' in all
correspondence. All comments received will be posted, without change or
redaction, to www.regulations.gov, so commenters should not include
information they do not wish to be posted (e.g., personal or
confidential business information).
FOR FURTHER INFORMATION CONTACT: Jasmeet Seehra, Office of Information
and Regulatory Affairs, at jseehra@omb.eop.gov.
SUPPLEMENTARY INFORMATION: In the ``National Technology Transfer and
Advancement Act of 1995'' (Pub L. 104-113; hereinafter ``the NTTAA''),
Congress stated that Federal agencies ``shall use technical standards
that are developed or adopted by voluntary consensus standards bodies,
using such technical standards as a means to carry out policy
objectives or activities,'' except when an agency determines that such
use ``is inconsistent with applicable law or otherwise impractical.''
As amended by Section 1115 of Public Law 107-107, Section 12(d)
provides that:
(d) UTILIZATION OF CONSENSUS TECHNICAL STANDARDS BY FEDERAL
AGENCIES; REPORTS.--
(1) IN GENERAL.--Except as provided in paragraph (3) of this
subsection, all Federal agencies and departments shall use technical
standards that are developed or adopted by voluntary consensus
standards bodies, using such technical standards as a means to carry
out policy objectives or activities determined by the agencies and
departments.
(2) CONSULTATION; PARTICIPATION.--In carrying out paragraph (1)
of this subsection, Federal agencies and departments shall consult
with voluntary, private sector, consensus standards bodies and
shall, when such participation is in the public interest and is
compatible with agency and departmental missions, authorities,
priorities, and budget resources, participate with such bodies in
the development of technical standards.
(3) EXCEPTION.--If compliance with paragraph (1) of this
subsection is inconsistent with applicable law or otherwise
impractical, a Federal agency or department may elect to use
technical standards that are not developed or adopted by voluntary
consensus standards bodies if the head of each such agency or
department transmits to the Office of Management and Budget an
explanation of the reasons for using such standards. Each year,
beginning with fiscal year 1997, the Office of Management and Budget
shall transmit to Congress and its committees a report summarizing
all explanations received in the preceding year under this
paragraph.
(4) EXPENSES OF GOVERNMENT PERSONNEL.--Section 5946 of title 5,
United States Code, shall not apply with respect to any activity of
an employee of a Federal agency or department that is determined by
the head of that agency or department as being an activity
undertaken in carrying out this subsection.
(5) DEFINITION OF TECHNICAL STANDARDS.--As used in this
subsection, the term ``technical standards'' means performance based
or design-specific technical specifications and related management
systems practices.
Section 12(d) is found as a ``note'' to 15 U.S.C. 272.
In response to the enactment of the NTTAA, OMB prepared a proposed
set of revisions to Circular A-119 (entitled ``Federal Participation in
the Development and Use of Voluntary Consensus Standards and in
Conformity Assessment Activities'') and issued a Federal Register
notice seeking public comment on the proposed revisions. 61 FR 68312
(December 27, 1996). After consideration of the comments, OMB issued
the final revision of the Circular. 63 FR 8546 (February 19, 1998). In
the preamble to the final notice, OMB responded to the public comments
and provided explanatory background regarding the revised Circular. A
copy of the Circular is on OMB's Web site at https://www.whitehouse.gov/omb/circulars_a119/.
The policies in the Circular are intended to reduce to a minimum
the reliance by agencies on government-unique standards. In accordance
with Section 12(d) of the NTTAA, Circular A-119 directs Federal
agencies to use voluntary consensus standards in lieu of government-
unique standards except where inconsistent with law or otherwise
impractical. The Circular also provides guidance for agencies
participating in the work of bodies that develop voluntary consensus
standards and describes procedures for satisfying the NTTAA's agency-
reporting requirements. In addition, consistent with Section 12(b) of
the NTTAA, the Circular directs the Secretary of Commerce to issue
guidance to agencies in order to coordinate conformity assessment
activities.
On January 17, 2012, the Office of Information and Regulatory
Affairs, the Office of Science and Technology Policy, and the United
States Trade Representative built on the Circular and issued guidance
on Federal engagement in standards activities to address national
priorities.\1\ We note more generally the requirements of Executive
Order 13563, which emphasizes that our regulatory system ``must protect
public health, welfare, safety, and our environment while promoting
economic growth, innovation, competitiveness, and job creation''
(emphasis added), and which stresses the importance of public
participation and of careful consideration of both benefits and costs.
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\1\ See https://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-08_1.pdf.
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Purpose: The purpose of this Request for Information (RFI) and
related public workshop on May 15, 2012, is to allow interested
stakeholders to provide input to OMB, NIST, Federal regulators and
other relevant agencies on how the Federal government should address
issues in standards and conformity assessment that have emerged or
moved to the forefront since the Circular was promulgated in 1998. Such
input could help improve U.S. agencies' implementation of the NTTAA and
the Circular.
In addition, input received through the RFI and during the workshop
could be used to inform OMB's consideration of whether and how to
supplement Circular A-119 to provide additional or more specific
guidance on standards and conformity assessment to agencies engaged in
rulemaking, procurement, and other activities. Any such supplemental
guidance would be developed in conjunction with NIST's effort to update
its conformity assessment guidelines, in order to ensure consistency
between the two documents. The NIST conformity assessment guidelines
are available at https://gsi.nist.gov/global/docs/FR_FedGuidanceCA.pdf.
Additional information on the conformity assessment workshop objectives
was provided by NIST in a separate Federal
[[Page 19359]]
Register notice published on March 16, 2012 (77 FR 15719).
If OMB determines, based on the responses to the RFI, discussions
at the workshops, and further consideration of the issues, that it
would be useful to develop supplemental guidance for the Circular to
address some or all of the issues raised, then OMB will publish a draft
notice in the Federal Register at a subsequent date and request public
comment.
In response to this RFI and at the workshop, OMB is interested in
receiving input from interested stakeholders pertaining to one or more
of the following issues relating to standards and conformity
assessment, specifically with respect to how these issues may affect
agencies engaged in rulemaking, procurement, and other activities.
Agency Implementation of Circular A-119 in Rulemakings. Are Federal
agencies generally following the guidance set out in the Circular and
providing an adequate explanation of how they considered standards and
conformity assessment-related issues in the preambles to rulemakings?
Standardization Activities. OMB A-119 does not establish a
preference between consensus and non-consensus standards developed in
the private sector. A limited set of foundational attributes of
standardization activities are identified in the Circular, focusing on
voluntary consensus standard activities. It may also be important to
recognize the contributions of standardization activities that take
place outside of the voluntary consensus process, in particular certain
activities in emerging technology areas.
What factors should agencies use in evaluating whether to
use voluntary non-consensus standards in regulation, procurement
solicitations, or other non-regulatory uses? OMB also invites comments
on the respective roles of voluntary consensus standards vs. voluntary
non-consensus standards for agency responsibilities in rulemaking,
procurement, and other activities.
Conformity Assessment. Circular A-119 directs the Secretary of
Commerce to issue guidance to Federal agencies on conformity
assessment. NIST issued such guidance in 2000 and plans to update the
guidance.
In conjunction with NIST's efforts to update its conformity
assessment guidance, should a supplement to Circular A-119 be issued to
set out relevant principles on conformity assessment? If so, what
issues should be addressed in such a supplement? The following are
among the topics that could be considered:
Factors agencies should use in selecting the appropriate
conformity assessment procedure, including product/sector specific
issues and the level of risk of non-fulfillment of legitimate
regulatory, procurement, or other mission-related objectives;
Guidance for regulatory agencies on compliance with
relevant international obligations pertaining to conformity assessment
and accreditation activities;
Factors agencies should consider in determining whether to
recognize the results of conformity assessment and accreditation
activities conducted by private sector bodies in support of regulation;
Non-regulatory uses of standards (including vendor
conformity for purposes of response to procurement solicitations); and
Ensuring that agencies consider how to minimize conformity
assessment costs and delays for businesses, especially small and medium
sized enterprises, subject to statutory and budgetary constraints and
the ability of agencies to fulfill their legitimate regulatory,
procurement, or other mission-related objectives.
Protection of Copyright Associated With Standards. Standards
themselves are considered to be intellectual property and are typically
copyrighted by the standards developing bodies that administer the
process by which specific standards are developed and maintained. The
rights of copyright holders are protected under U.S. law, and standards
developers typically charge fees to access their copyrighted materials.
Some parties have raised transparency concerns with respect to the
availability of copyrighted materials in instances where standards are
referenced or incorporated in regulation and compliance with such
standards is mandatory.
In this respect, we take note of three recent developments relevant
to this issue:
At its Plenary Session on December 8, 2011, the Administrative
Conference of the United States (ACUS) considered and adopted a
Recommendation on Incorporation by Reference, specifically addressing
the place of voluntary consensus standards in that process and how to
determine ``reasonable availability.'' https://www.acus.gov/wp-content/uploads/downloads/2011/12/Recommendation-2011-5-Incorporation-by-Reference.pdf.
Second, the Pipeline Safety, Regulatory Certainty, and Job Creation
Act of 2011 (the Act) was signed into law on January 3, 2012 (Pub. L.
112-90). Section 24 of the Act created a new subsection (p) of Section
60102 of Title 49 of the U.S. Code. Section 60102(p) prohibits the
Secretary of Transportation from issuing ``guidance or a regulation''
pursuant to Title 49 of the U.S. Code, Chapter 601 (pipeline safety)
``that incorporates by reference any documents or portions thereof
unless those documents or portions thereof are made available to the
public, free of charge, on an Internet Web site.'' Section 60102(p)
takes effect one year from the date of its enactment, i.e., January 3,
2013.
Third, the National Archives and Records Administration, Office of
the Federal Register, recently published a petition for rulemaking
received on February 13, 2012, to amend its regulations governing the
approval of agency requests to incorporate material by reference into
the Code of Federal Regulations, and requested public comment. 77 FR
11414 (February 27, 2012). OMB notes that the petition raises issues
that are closely related to some of the issues discussed in this RFI
and encourages interested stakeholders to provide comments in response
to the petition.
Circular A-119 specifically contemplates incorporation by reference
of voluntary consensus standards by Federal agencies, defining agency
``use'' of a voluntary consensus standard as ``incorporation of a
standard in whole, in part, or by reference for procurement purposes,
and the inclusion of a standard in whole, in part, or by reference in
regulation(s).'' Circular A-119 also directs agencies to respect
intellectual property rights that may exist in voluntary consensus
standards that are incorporated into regulation by reference: ``If a
voluntary standard is used and published in an agency document, your
agency must observe and protect the rights of the copyright holder and
any other similar obligations.''
Since passage of the NTTAA, major strides have been made by Federal
agencies in their use of voluntary consensus standards. The NIST
``Standards Incorporated by Reference Database'' includes thousands of
such standards incorporated by reference in the CFR--https://standards.gov/sibr/query/index.cfm?fuseaction=rsibr.total_regulatory_sibr.
Is lack of access to standards incorporated by reference
in regulation an issue for commenters responding to a request for
public comment in rulemaking or for stakeholders that require access to
such standards? Please provide specific examples.
What are the best practices for providing access to
standards incorporated by reference in regulation
[[Page 19360]]
during rulemaking and during the effective period of the regulation
while respecting the copyright associated with the standard?
What are the best practices for incorporating standards by
reference in regulation while respecting the copyright associated with
the standard?
Voluntary Consensus Standards and Cost-Benefit Analysis. Standards
developing bodies, including not-for-profit organizations, use a
variety of cost-recovery models as part of their overall way of doing
business. OMB believes that it may be helpful for the purposes of the
Circular and for the evaluation of costs and benefits of significant
regulatory actions pursuant to Executive Orders 12866 and 13563 for
Federal agencies to have a basic understanding of the costs associated
with the development of private sector standards, in addition to the
purchase costs of standards. Similarly, agencies and the public should
have an understanding of the overall resources and costs that would be
involved if Federal agencies were to develop government-unique
standards. Both of these can be elements in determining when it is
practical or impractical to incorporate a voluntary standard into
regulation or otherwise adopt a standard in the course of carrying out
an agency's mission, as compared to developing a government-unique
standard.
What resource and other costs are involved in the
development and revision of voluntary standards?
What economic and other factors should agencies take into
consideration when determining that the use of a voluntary standard is
practical for regulatory or other mission purposes?
How often do standards-developing bodies review and
subsequently update standards? If standards are already incorporated by
reference in regulations, do such bodies have mechanisms in place for
alerting the relevant agencies and the public, especially in regard to
the significance of the changes in the standards?
Using and Updating Standards in Regulation. Federal agencies have
adopted various methods of using standards as a basis for regulation.
They have also developed different approaches to updating standards
that have been referenced or incorporated in regulations.
Should OMB set out best practices on how to reference/
incorporate standards (or the relevant parts) in regulation? If so,
what are the best means for doing so? Are the best means of reference/
incorporation context-specific? Are there instances where incorporating
a standard or part thereof into a regulation is preferable to
referencing a standard in regulation (or vice versa)?
Should an OMB supplement to the Circular set out best
practices for updating standards referenced in regulation as standards
are revised? If so, what updating practices have worked well and which
ones have not?
OMB recognizes that changes in technology and the need for
innovation can result in the updating of private sector standards in a
turn-around time of two years or even less. Where such standards are
already incorporated into regulations, these changes can suggest a need
to update the relevant regulations as well and, in some cases, can
result in a need for regulated entities to purchase the newly updated
standards on a fairly routine basis. In addition to the costs
associated with the continuing purchase of such standards, rapid update
cycles may make it difficult for the regulated public to understand the
nature and significance of the changing regulations.
Is there a role for OMB in providing guidance on how
Federal agencies can best manage the need for relevant regulations in
the face of changing standards?
How should agencies determine the cost-effectiveness of
issuing updated regulations in response to updated standards?
Do agencies consult sufficiently with private sector
standards bodies when considering the update of regulations that
incorporate voluntary standards, especially when such standards may be
updated on a regular basis?
Use of More Than One Standard or Conformity Assessment Procedure in
a Regulation or Procurement Solicitation. OMB recognizes that, in some
instances, it may be best, in terms of economic activity, if a
regulation or procurement solicitation sets out a requirement that can
be met by more than one standard and more than one conformity
assessment procedure. In some cases, however, allowing the use of more
than one standard or conformity assessment procedure may not be
possible or meet the regulatory or procurement objective. For example,
doing so may be precluded by statute, and an alternate standard or
conformity assessment procedure may not provide an equivalent level of
protection as the standard or conformity assessment procedure selected
by the regulator.
Should OMB provide guidance to agencies on when it is
appropriate to allow the use of more than one standard or more than one
conformity assessment procedure to demonstrate conformity with
regulatory requirements or solicitation provisions?
Where an agency is requested by stakeholders to consider
allowing the demonstration of conformity to another country's standard
or the use of an alternate conformity assessment procedure as adequate
to fulfilling U.S. requirements, should OMB provide guidance to
agencies on how to consider such requests?
Other Developments
Have there been any developments internationally--
including but not limited to U.S. regulatory cooperation initiatives--
since the publication of Circular A-119 that OMB should take into
account in developing a possible supplement to the Circular?
Does the significant role played by consortia today in
standards development in some technology areas have any bearing on (or
specific implications for) Federal participation?
Are there other issues not set out above that OMB might
usefully seek to address in a supplement?
Cass Sunstein,
Administrator, Office of Information and Regulatory Affairs, Office of
Management and Budget.
[FR Doc. 2012-7602 Filed 3-29-12; 8:45 am]
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