Section 515 of Public Law 106-554

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OFFICE OF MANAGEMENT AND
BUDGET
Guidelines for Ensuring and
Maximizing the Quality, Objectivity,
Utility, and Integrity of Information
Disseminated by Federal Agencies;
Republication
Editorial Note: Due to numerous errors,
this document is being reprinted in its
entirety. It was originally printed in the
Federal Register on Thursday, January 3,
2002 at 67 FR 369–378 and was corrected on
Tuesday, February 5, 2002 at 67 FR 5365.
AGENCY: Office of Management and
Budget, Executive Office of the
President.
ACTION: Final guidelines.
SUMMARY: These final guidelines
implement section 515 of the Treasury
and General Government
Appropriations Act for Fiscal Year 2001
(Public Law 106–554; H.R. 5658).
Section 515 directs the Office of
Management and Budget (OMB) to issue
government-wide guidelines that
‘‘provide policy and procedural
guidance to Federal agencies for
ensuring and maximizing the quality,
objectivity, utility, and integrity of
information (including statistical
information) disseminated by Federal
agencies.’’ By October 1, 2002, agencies
must issue their own implementing
guidelines that include ‘‘administrative
mechanisms allowing affected persons
to seek and obtain correction of
information maintained and
disseminated by the agency’’ that does
not comply with the OMB guidelines.
These final guidelines also reflect the
changes OMB made to the guidelines
issued September 28, 2001, as a result
of receiving additional comment on the
‘‘capable of being substantially
reproduced’’ standard (paragraphs
V.3.B, V.9, and V.10), which OMB
previously issued on September 28,
2001, on an interim final basis.
DATES: Effective Date: January 3, 2002.
FOR FURTHER INFORMATION CONTACT:
Brooke J. Dickson, Office of Information
and Regulatory Affairs, Office of
Management and Budget, Washington,
DC 20503. Telephone (202) 395–3785 or
by e-mail to
[email protected].

In section
515(a) of the Treasury and General
Government Appropriations Act for
Fiscal Year 2001 (Public Law 106–554;
H.R. 5658), Congress directed the Office
of Management and Budget (OMB) to
issue, by September 30, 2001,
government-wide guidelines that
‘‘provide policy and procedural

SUPPLEMENTARY INFORMATION:

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guidance to Federal agencies for
ensuring and maximizing the quality,
objectivity, utility, and integrity of
information (including statistical
information) disseminated by Federal
agencies * * *’’ Section 515(b) goes on
to state that the OMB guidelines shall:
‘‘(1) apply to the sharing by Federal
agencies of, and access to, information
disseminated by Federal agencies; and
‘‘(2) require that each Federal agency
to which the guidelines apply—
‘‘(A) issue guidelines ensuring and
maximizing the quality, objectivity,
utility, and integrity of information
(including statistical information)
disseminated by the agency, by not later
than 1 year after the date of issuance of
the guidelines under subsection (a);
‘‘(B) establish administrative
mechanisms allowing affected persons
to seek and obtain correction of
information maintained and
disseminated by the agency that does
not comply with the guidelines issued
under subsection (a); and
‘‘(C) report periodically to the
Director—
‘‘(i) the number and nature of
complaints received by the agency
regarding the accuracy of information
disseminated by the agency and;
‘‘(ii) how such complaints were
handled by the agency.’’
Proposed guidelines were published
in the Federal Register on June 28, 2001
(66 FR 34489). Final guidelines were
published in the Federal Register on
September 28, 2001 (66 FR 49718). The
Supplementary Information to the final
guidelines published in September 2001
provides background, the underlying
principles OMB followed in issuing the
final guidelines, and statements of
intent concerning detailed provisions in
the final guidelines.
In the final guidelilnes published in
September 2001, OMB also requested
additional comment on the ‘‘capable of
being substantially reproduced’’
standard and the related definition of
‘‘influential scientific or statistical
information’’ (paragraphs V.3.B, V.9,
and V.10), which were issued on an
interim final basis. The final guidelines
published today discuss the public
comments OMB received, the OMB
response, and amendments to the final
guidelines published in September
2001.
In developing agency-specific
guidelines, agencies should refer both to
the Supplementary Information to the
final guidelines published in the
Federal Register on September 28, 2001
(66 FR 49718), and also to the
Supplementary Information published
today. We stress that the three
‘‘Underlying Principles’’ that OMB

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followed in drafting the guidelines that
we published on September 28, 2001
(66 FR 49719), are also applicable to the
amended guidelines that we publish
today.
In accordance with section 515, OMB
has designed the guidelines to help
agencies ensure and maximize the
quality, utility, objectivity and integrity
of the information that they disseminate
(meaning to share with, or give access
to, the public). It is crucial that
information Federal agencies
disseminate meets these guidelines. In
this respect, the fact that the Internet
enables agencies to communicate
information quickly and easily to a wide
audience not only offers great benefits to
society, but also increases the potential
harm that can result from the
dissemination of information that does
not meet basic information quality
guidelines. Recognizing the wide variety
of information Federal agencies
disseminate and the wide variety of
dissemination practices that agencies
have, OMB developed the guidelines
with several principles in mind.
First, OMB designed the guidelines to
apply to a wide variety of government
information dissemination activities
that may range in importance and scope.
OMB also designed the guidelines to be
generic enough to fit all media, be they
printed, electronic, or in other form.
OMB sought to avoid the problems that
would be inherent in developing
detailed, prescriptive, ‘‘one-size-fits-all’’
government-wide guidelines that would
artificially require different types of
dissemination activities to be treated in
the same manner. Through this
flexibility, each agency will be able to
incorporate the requirements of these
OMB guidelines into the agency’s own
information resource management and
administrative practices.
Second, OMB designed the guidelines
so that agencies will meet basic
information quality standards. Given the
administrative mechanisms required by
section 515 as well as the standards set
forth in the Paperwork Reduction Act, it
is clear that agencies should not
disseminate substantive information
that does not meet a basic level of
quality. We recognize that some
government information may need to
meet higher or more specific
information quality standards than
those that would apply to other types of
government information. The more
important the information, the higher
the quality standards to which it should
be held, for example, in those situations
involving ‘‘influential scientific,
financial, or statistical information’’ (a
phrase defined in these guidelines). The
guidelines recognize, however, that

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information quality comes at a cost.
Accordingly, the agencies should weigh
the costs (for example, including costs
attributable to agency processing effort,
respondent burden, maintenance of
needed privacy, and assurances of
suitable confidentiality) and the benefits
of higher information quality in the
development of information, and the
level of quality to which the information
disseminated will be held.
Third, OMB designed the guidelines
so that agencies can apply them in a
common-sense and workable manner. It
is important that these guidelines do not
impose unnecessary administrative
burdens that would inhibit agencies
from continuing to take advantage of the
Internet and other technologies to
disseminate information that can be of
great benefit and value to the public. In
this regard, OMB encourages agencies to
incorporate the standards and
procedures required by these guidelines
into their existing information resources
management and administrative
practices rather than create new and
potentially duplicative or contradictory
processes. The primary example of this
is that the guidelines recognize that, in
accordance with OMB Circular A–130,
agencies already have in place wellestablished information quality
standards and administrative
mechanisms that allow persons to seek
and obtain correction of information
that is maintained and disseminated by
the agency. Under the OMB guidelines,
agencies need only ensure that their
own guidelines are consistent with
these OMB guidelines, and then ensure
that their administrative mechanisms
satisfy the standards and procedural
requirements in the new agency
guidelines. Similarly, agencies may rely
on their implementation of the Federal
Government’s computer security laws
(formerly, the Computer Security Act,
and now the computer security
provisions of the Paperwork Reduction
Act) to establish appropriate security
safeguards for ensuring the ‘‘integrity’’
of the information that the agencies
disseminate.
In addition, in response to concerns
expressed by some of the agencies, we
want to emphasize that OMB recognizes
that Federal agencies provide a wide
variety of data and information.
Accordingly, OMB understands that the
guidelines discussed below cannot be
implemented in the same way by each
agency. In some cases, for example, the
data disseminated by an agency are not
collected by that agency; rather, the
information the agency must provide in
a timely manner is compiled from a
variety of sources that are constantly
updated and revised and may be

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confidential. In such cases, while
agencies’ implementation of the
guidelines may differ, the essence of the
guidelines will apply. That is, these
agencies must make their methods
transparent by providing
documentation, ensure quality by
reviewing the underlying methods used
in developing the data and consulting
(as appropriate) with experts and users,
and keep users informed about
corrections and revisions.
Summary of OMB Guidelines
These guidelines apply to Federal
agencies subject to the Paperwork
Reduction Act (44 U.S.C. chapter 35).
Agencies are directed to develop
information resources management
procedures for reviewing and
substantiating (by documentation or
other means selected by the agency) the
quality (including the objectivity,
utility, and integrity) of information
before it is disseminated. In addition,
agencies are to establish administrative
mechanisms allowing affected persons
to seek and obtain, where appropriate,
correction of information disseminated
by the agency that does not comply with
the OMB or agency guidelines.
Consistent with the underlying
principles described above, these
guidelines stress the importance of
having agencies apply these standards
and develop their administrative
mechanisms so they can be
implemented in a common sense and
workable manner. Moreover, agencies
must apply these standards flexibly, and
in a manner appropriate to the nature
and timeliness of the information to be
disseminated, and incorporate them into
existing agency information resources
management and administrative
practices.
Section 515 denotes four substantive
terms regarding information
disseminated by Federal agencies:
quality, utility, objectivity, and
integrity. It is not always clear how each
substantive term relates—or how the
four terms in aggregate relate—to the
widely divergent types of information
that agencies disseminate. The
guidelines provide definitions that
attempt to establish a clear meaning so
that both the agency and the public can
readily judge whether a particular type
of information to be disseminated does
or does not meet these attributes.
In the guidelines, OMB defines
‘‘quality’’ as the encompassing term, of
which ‘‘utility,’’ ‘‘objectivity,’’ and
‘‘integrity’’ are the constituents.
‘‘Utility’’ refers to the usefulness of the
information to the intended users.
‘‘Objectivity’’ focuses on whether the
disseminated information is being

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presented in an accurate, clear,
complete, and unbiased manner, and as
a matter of substance, is accurate,
reliable, and unbiased. ‘‘Integrity’’ refers
to security—the protection of
information from unauthorized access
or revision, to ensure that the
information is not compromised
through corruption or falsification. OMB
modeled the definitions of
‘‘information,’’ ‘‘government
information,’’ ‘‘information
dissemination product,’’ and
‘‘dissemination’’ on the longstanding
definitions of those terms in OMB
Circular A–130, but tailored them to fit
into the context of these guidelines.
In addition, Section 515 imposes two
reporting requirements on the agencies.
The first report, to be promulgated no
later than October 1, 2002, must provide
the agency’s information quality
guidelines that describe administrative
mechanisms allowing affected persons
to seek and obtain, where appropriate,
correction of disseminated information
that does not comply with the OMB and
agency guidelines. The second report is
an annual fiscal year report to OMB (to
be first submitted on January 1, 2004)
providing information (both quantitative
and qualitative, where appropriate) on
the number, nature, and resolution of
complaints received by the agency
regarding its perceived or confirmed
failure to comply with these OMB and
agency guidelines.
Public Comments and OMB Response
Applicability of Guidelines. Some
comments raised concerns about the
applicability of these guidelines,
particularly in the context of scientific
research conducted by Federally
employed scientists or Federal grantees
who publish and communicate their
research findings in the same manner as
their academic colleagues. OMB
believes that information generated and
disseminated in these contexts is not
covered by these guidelines unless the
agency represents the information as, or
uses the information in support of, an
official position of the agency.
As a general matter, these guidelines
apply to ‘‘information’’ that is
‘‘disseminated’’ by agencies subject to
the Paperwork Reduction Act (44 U.S.C.
3502(1)). See paragraphs II, V.5 and V.8.
The definitions of ‘‘information’’ and
‘‘dissemination’’ establish the scope of
the applicability of these guidelines.
‘‘Information’’ means ‘‘any
communication or representation of
knowledge such as facts or data * * *’’
This definition of information in
paragraph V.5 does ‘‘not include
opinions, where the agency’s
presentation makes it clear that what is

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being offered is someone’s opinion
rather than fact or the agency’s views.’’
‘‘Dissemination’’ is defined to mean
‘‘agency initiated or sponsored
distribution of information to the
public.’’ As used in paragraph V.8,
‘‘agency INITIATED * * * distribution
of information to the public’’ refers to
information that the agency
disseminates, e.g., a risk assessment
prepared by the agency to inform the
agency’s formulation of possible
regulatory or other action. In addition,
if an agency, as an institution,
disseminates information prepared by
an outside party in a manner that
reasonably suggests that the agency
agrees with the information, this
appearance of having the information
represent agency views makes agency
dissemination of the information subject
to these guidelines. By contrast, an
agency does not ‘‘initiate’’ the
dissemination of information when a
Federally employed scientist or Federal
grantee or contractor publishes and
communicates his or her research
findings in the same manner as his or
her academic colleagues, even if the
Federal agency retains ownership or
other intellectual property rights
because the Federal government paid for
the research. To avoid confusion
regarding whether the agency agrees
with the information (and is therefore
disseminating it through the employee
or grantee), the researcher should
include an appropriate disclaimer in the
publication or speech to the effect that
the ‘‘views are mine, and do not
necessarily reflect the view’’ of the
agency.
Similarly, as used in paragraph V.8.,
‘‘agency * * * SPONSORED
distribution of information to the
public’’ refers to situations where an
agency has directed a third-party to
disseminate information, or where the
agency has the authority to review and
approve the information before release.
Therefore, for example, if an agency
through a procurement contract or a
grant provides for a person to conduct
research, and then the agency directs
the person to disseminate the results (or
the agency reviews and approves the
results before they may be
disseminated), then the agency has
‘‘sponsored’’ the dissemination of this
information. By contrast, if the agency
simply provides funding to support
research, and it the researcher (not the
agency) who decides whether to
disseminate the results and—if the
results are to be released—who
determines the content and presentation
of the dissemination, then the agency
has not ‘‘sponsored’’ the dissemination
even though it has funded the research

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and even if the Federal agency retains
ownership or other intellectual property
rights because the Federal government
paid for the research. To avoid
confusion regarding whether the agency
is sponsoring the dissemination, the
researcher should include an
appropriate disclaimer in the
publication or speech to the effect that
the ‘‘views are mine, and do not
necessarily reflect the view’’ of the
agency. On the other hand, subsequent
agency dissemination of such
information requires that the
information adhere to the agency’s
information quality guidelines. In sum,
these guidelines govern an agency’s
dissemination of information, but
generally do not govern a third-party’s
dissemination of information (the
exception being where the agency is
essentially using the third-party to
disseminate information on the agency’s
behalf). Agencies, particularly those that
fund scientific research, are encouraged
to clarify the applicability of these
guidelines to the various types of
information they and their employees
and grantees disseminate.
Paragraph V.8 also states that the
definition of ‘‘dissemination’’ does not
include ‘‘* * * distribution limited to
correspondence with individuals or
persons, press releases, archival records,
public filings, subpoenas or adjudicative
processes.’’ The exemption from the
definition of ‘‘dissemination’’ for
‘‘adjudicative processes’’ is intended to
exclude, from the scope of these
guidelines, the findings and
determinations that an agency makes in
the course of adjudications involving
specific parties. There are wellestablished procedural safeguards and
rights to address the quality of
adjudicatory decisions and to provide
persons with an opportunity to contest
decisions. These guidelines do not
impose any additional requirements on
agencies during adjudicative
proceedings and do not provide parties
to such adjudicative proceedings any
additional rights of challenge or appeal.
The Presumption Favoring PeerReviewed Information.As a general
matter, in the scientific and research
context, we regard technical information
that has been subjected to formal,
independent, external peer review as
presumptively objective. As the
guidelines state in paragraph V.3.b.i: ‘‘If
data and analytic results have been
subjected to formal, independent,
external peer review, the information
may generally be presumed to be of
acceptable objectivity.’’ An example of a
formal, independent, external peer
review is the review process used by
scientific journals.

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Most comments approved of the
prominent role that peer review plays in
the OMB guidelines. Some comments
contended that peer review was not
accepted as a universal standard that
incorporates an established, practiced,
and sufficient level of objectivity. Other
comments stated that the guidelines
would be better clarified by making peer
review one of several factors that an
agency should consider in assessing the
objectivity (and quality in general) of
original research. In addition, several
comments noted that peer review does
not establish whether analytic results
are capable of being substantially
reproduced. In light of the comments,
the final guidelines in new paragraph
V.3.b.i qualify the presumption in favor
of peer-reviewed information as follows:
‘‘However, this presumption is
rebuttable based on a persuasive
showing by the petitioner in a particular
instance.’’
We believe that transparency is
important for peer review, and these
guidelines set minimum standards for
the transparency of agency-sponsored
peer review. As we state in new
paragraph V.3.b.i: ‘‘If data and analytic
results have been subjected to formal,
independent, external peer review, the
information may generally be presumed
to be of acceptable objectivity. However,
this presumption is rebuttable based on
a persuasive showing by the petitioner
in a particular instance. If agencysponsored peer review is employed to
help satisfy the objectivity standard, the
review process employed shall meet the
general criteria for competent and
credible peer review recommended by
OMB–OIRA to the President’s
Management Council (9/20/01) (http://
www.whitehouse.gov/omb/inforeg/
oira_review-process.html), namely, ‘that
(a) peer reviewers be selected primarily
on the basis of necessary technical
expertise, (b) peer reviewers be expected
to disclose to agencies prior technical/
policy positions they may have taken on
the issues at hand, (c) peer reviewers be
expected to disclose to agencies their
sources of personal and institutional
funding (private or public sector), and
(d) peer reviews be conducted in an
open and rigorous manner.’ ’’
The importance of these general
criteria for competent and credible peer
review has been supported by a number
of expert bodies. For example, ‘‘the
work of fully competent peer-review
panels can be undermined by
allegations of conflict of interest and
bias. Therefore, the best interests of the
Board are served by effective policies
and procedures regarding potential
conflicts of interest, impartiality, and
panel balance.’’ (EPA’s Science Advisory

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Board Panels: Improved Policies and
Procedures Needed to Ensure
Independence and Balance, GAO–01–
536, General Accounting Office,
Washington, DC, June 2001, page 19.)
As another example, ‘‘risk analyses
should be peer-reviewed and
accessible—both physically and
intellectually—so that decision-makers
at all levels will be able to respond
critically to risk characterizations. The
intensity of the peer reviews should be
commensurate with the significance of
the risk or its management
implications.’’ (Setting Priorities,
Getting Results: A New Direction for
EPA, Summary Report, National
Academy of Public Administration,
Washington, DC, April 1995, page 23.)
These criteria for peer reviewers are
generally consistent with the practices
now followed by the National Research
Council of the National Academy of
Sciences. In considering these criteria
for peer reviewers, we note that there
are many types of peer reviews and that
agency guidelines concerning the use of
peer review should tailor the rigor of
peer review to the importance of the
information involved. More generally,
agencies should define their peer-review
standards in appropriate ways, given the
nature and importance of the
information they disseminate.
Is Journal Peer Review Always
Sufficient? Some comments argued that
journal peer review should be adequate
to demonstrate quality, even for
influential information that can be
expected to have major effects on public
policy. OMB believes that this position
overstates the effectiveness of journal
peer review as a quality-control
mechanism.
Although journal peer review is
clearly valuable, there are cases where
flawed science has been published in
respected journals. For example, the
NIH Office of Research Integrity recently
reported the following case regarding
environmental health research:
‘‘Based on the report of an investigation
conducted by [XX] University, dated July 16,
1999, and additional analysis conducted by
ORI in its oversight review, the US Public
Health Service found that Dr. [X] engaged in
scientific misconduct. Dr. [X] committed
scientific misconduct by intentionally
falsifying the research results published in
the journal SCIENCE and by providing
falsified and fabricated materials to
investigating officials at [XX] University in
response to a request for original data to
support the research results and conclusions
report in the SCIENCE paper. In addition,
PHS finds that there is no original data or
other corroborating evidence to support the
research results and conclusions reported in
the SCIENCE paper as a whole.’’ (66 FR
52137, October 12, 2001).

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Although such cases of falsification
are presumably rare, there is a
significant scholarly literature
documenting quality problems with
articles published in peer-reviewed
research. ‘‘In a [peer-reviewed] metaanalysis that surprised many—and some
doubt—researchers found little evidence
that peer review actually improves the
quality of research papers.’’ (See, e.g.,
Science, Vol. 293, page 2187 (September
21, 2001.)) In part for this reason, many
agencies have already adopted peer
review and science advisory practices
that go beyond journal peer review. See,
e.g., Sheila Jasanoff, The Fifth Branch:
Science Advisers as Policy Makers,
Cambridge, MA, Harvard University
Press, 1990; Mark R. Powell, Science at
EPA: Information in the Regulatory
Process. Resources for the Future,
Washington, DC., 1999, pages 138–139;
151–153; Implementation of the
Environmental Protection Agency’s Peer
Review Program: An SAB Evaluation of
Three Reviews, EPA–SAB–RSAC–01–
009, A Review of the Research Strategies
Advisory Committee (RSAC) of the EPA
Science Advisory Board (SAB),
Washington, DC., September 26, 2001.
For information likely to have an
important public policy or private sector
impact, OMB believes that additional
quality checks beyond peer review are
appropriate.
Definition of ‘‘Influential’’. OMB
guidelines apply stricter quality
standards to the dissemination of
information that is considered
‘‘influential.’’ Comments noted that the
breadth of the definition of ‘‘influential’’
in interim final paragraph V.9 requires
much speculation on the part of
agencies.
We believe that this criticism has
merit and have therefore narrowed the
definition. In this narrower definition,
‘‘influential’’, when used in the phrase
‘‘influential scientific, financial, or
statistical information’’, is amended to
mean that ‘‘the agency can reasonably
determine that dissemination of the
information will have or does have a
clear and substantial impact on
important public policies or important
private sector decisions.’’ The intent of
the new phrase ‘‘clear and substantial’’
is to reduce the need for speculation on
the part of agencies. We added the
present tense—‘‘or does have’’—to this
narrower definition because on
occasion, an information dissemination
may occur simultaneously with a
particular policy change. In response to
a public comment, we added an explicit
reference to ‘‘financial’’ information as
consistent with our original intent.
Given the differences in the many
Federal agencies covered by these

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guidelines, and the differences in the
nature of the information they
disseminate, we also believe it will be
helpful if agencies elaborate on this
definition of ‘‘influential’’ in the context
of their missions and duties, with due
consideration of the nature of the
information they disseminate. As we
state in amended paragraph V.9, ‘‘Each
agency is authorized to define
‘influential’ in ways appropriate for it
given the nature and multiplicity of
issues for which the agency is
responsible.’’
Reproducibility. As we state in new
paragraph V.3.b.ii: ‘‘If an agency is
responsible for disseminating influential
scientific, financial, or statistical
information, agency guidelines shall
include a high degree of transparency
about data and methods to facilitate the
reproducibility of such information by
qualified third parties.’’ OMB believes
that a reproducibility standard is
practical and appropriate for
information that is considered
‘‘influential’’, as defined in paragraph
V.9—that ‘‘will have or does have a
clear and substantial impact on
important public policies or important
private sector decisions.’’ The
reproducibility standard applicable to
influential scientific, financial, or
statistical information is intended to
ensure that information disseminated by
agencies is sufficiently transparent in
terms of data and methods of analysis
that it would be feasible for a replication
to be conducted. The fact that the use
of original and supporting data and
analytic results have been deemed
‘‘defensible’’ by peer-review procedures
does not necessarily imply that the
results are transparent and replicable.
Reproducibility of Original and
Supporting Data. Several of the
comments objected to the exclusion of
original and supporting data from the
reproducibility requirements.
Comments instead suggested that OMB
should apply the reproducibility
standard to original data, and that OMB
should provide flexibility to the
agencies in determining what
constitutes ‘‘original and supporting’’
data. OMB agrees and asks that agencies
consider, in developing their own
guidelines, which categories of original
and supporting data should be subject to
the reproducibility standard and which
should not. To help in resolving this
issue, we also ask agencies to consult
directly with relevant scientific and
technical communities on the feasibility
of having the selected categories of
original and supporting data subject to
the reproducibility standard. Agencies
are encouraged to address ethical,
feasibility, and confidentiality issues

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with care. As we state in new paragraph
V.3.b.ii.A, ‘‘Agencies may identify, in
consultation with the relevant scientific
and technical communities, those
particular types of data that can
practicably be subjected to a
reproducibility requirement, given
ethical, feasibility, or confidentiality
constraints.’’ Further, as we state in our
expanded definition of
‘‘reproducibility’’ in paragraph V.10, ‘‘If
agencies apply the reproducibility test
to specific types of original or
supporting data, the associated
guidelines shall provide relevant
definitions of reproducibility (e.g.,
standards for replication of laboratory
data).’’ OMB urges caution in the
treatment of original and supporting
data because it may often be impractical
or even impermissible or unethical to
apply the reproducibility standard to
such data. For example, it may not be
ethical to repeat a ‘‘negative’’
(ineffective) clinical (therapeutic)
experiment and it may not be feasible to
replicate the radiation exposures
studied after the Chernobyl accident.
When agencies submit their draft agency
guidelines for OMB review, agencies
should include a description of the
extent to which the reproducibility
standard is applicable and reflect
consultations with relevant scientific
and technical communities that were
used in developing guidelines related to
applicability of the reproducibility
standard to original and supporting
data.
It is also important to emphasize that
the reproducibility standard does not
apply to all original and supporting data
disseminated by agencies. As we state in
new paragraph V.3.b.ii.A, ‘‘With regard
to original and supporting data related
[to influential scientific, financial, or
statistical information], agency
guidelines shall not require that all
disseminated data be subjected to a
reproducibility requirement.’’ In
addition, we encourage agencies to
address how greater transparency can be
achieved regarding original and
supporting data. As we also state in new
paragraph V.3.b.ii.A, ‘‘It is understood
that reproducibility of data is an
indication of transparency about
research design and methods and thus
a replication exercise (i.e., a new
experiment, test, or sample) shall not be
required prior to each dissemination.’’
Agency guidelines need to achieve a
high degree of transparency about data
even when reproducibility is not
required.
Reproducibility of Analytic Results.
Many public comments were critical of
the reproducibility standard and
expressed concern that agencies would

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be required to reproduce each analytical
result before it is disseminated. While
several comments commended OMB for
establishing an appropriate balance in
the ‘‘capable of being substantially
reproduced’’ standard, others
considered this standard to be
inherently subjective. There were also
comments that suggested the standard
would cause more burden for agencies.
It is not OMB’s intent that each
agency must reproduce each analytic
result before it is disseminated. The
purpose of the reproducibility standard
is to cultivate a consistent agency
commitment to transparency about how
analytic results are generated: the
specific data used, the various
assumptions employed, the specific
analytic methods applied, and the
statistical procedures employed. If
sufficient transparency is achieved on
each of these matters, then an analytic
result should meet the ‘‘capable of being
substantially reproduced’’ standard.
While there is much variation in types
of analytic results, OMB believes that
reproducibility is a practical standard to
apply to most types of analytic results.
As we state in new paragraph V.3.b.ii.B,
‘‘With regard to analytic results related
[to influential scientific, financial, or
statistical information], agency
guidelines shall generally require
sufficient transparency about data and
methods that an independent reanalysis
could be undertaken by a qualified
member of the public. These
transparency standards apply to agency
analysis of data from a single study as
well as to analyses that combine
information from multiple studies.’’ We
elaborate upon this principle in our
expanded definition of
‘‘reproducibility’’ in paragraph V.10:
‘‘With respect to analytic results,
‘capable of being substantially
reproduced’ means that independent
analysis of the original or supporting
data using identical methods would
generate similar analytic results, subject
to an acceptable degree of imprecision
or error.’’
Even in a situation where the original
and supporting data are protected by
confidentiality concerns, or the analytic
computer models or other research
methods may be kept confidential to
protect intellectual property, it may still
be feasible to have the analytic results
subject to the reproducibility standard.
For example, a qualified party,
operating under the same
confidentiality protections as the
original analysts, may be asked to use
the same data, computer model or
statistical methods to replicate the
analytic results reported in the original
study. See, e.g., ‘‘Reanalysis of the

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Harvard Six Cities Study and the
American Cancer Society Study of
Particulate Air Pollution and Mortality,’’
A Special Report of the Health Effects
Institute’s Particle Epidemiology
Reanalysis Project, Cambridge, MA,
2000.
The primary benefit of public
transparency is not necessarily that
errors in analytic results will be
detected, although error correction is
clearly valuable. The more important
benefit of transparency is that the public
will be able to assess how much an
agency’s analytic result hinges on the
specific analytic choices made by the
agency. Concreteness about analytic
choices allows, for example, the
implications of alternative technical
choices to be readily assessed. This type
of sensitivity analysis is widely
regarded as an essential feature of highquality analysis, yet sensitivity analysis
cannot be undertaken by outside parties
unless a high degree of transparency is
achieved. The OMB guidelines do not
compel such sensitivity analysis as a
necessary dimension of quality, but the
transparency achieved by
reproducibility will allow the public to
undertake sensitivity studies of interest.
We acknowledge that confidentiality
concerns will sometimes preclude
public access as an approach to
reproducibility. In response to public
comment, we have clarified that such
concerns do include interests in
‘‘intellectual property.’’ To ensure that
the OMB guidelines have sufficient
flexibility with regard to analytic
transparency, OMB has, in new
paragraph V.3.b.ii.B.i, provided agencies
an alternative approach for classes or
types of analytic results that cannot
practically be subject to the
reproducibility standard. ‘‘[In those
situations involving influential
scientific, financial, or statistical
information * * * ] making the data and
methods publicly available will assist in
determining whether analytic results are
reproducible. However, the objectivity
standard does not override other
compelling interests such as privacy,
trade secrets, intellectual property, and
other confidentiality protections. ’’
Specifically, in cases where
reproducibility will not occur due to
other compelling interests, we expect
agencies (1) to perform robustness
checks appropriate to the importance of
the information involved, e.g.,
determining whether a specific statistic
is sensitive to the choice of analytic
method, and, accompanying the
information disseminated, to document
their efforts to assure the needed
robustness in information quality, and
(2) address in their guidelines the

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degree to which they anticipate the
opportunity for reproducibility to be
limited by the confidentiality of
underlying data. As we state in new
paragraph V.3.b.ii.B.ii, ‘‘In situations
where public access to data and
methods will not occur due to other
compelling interests, agencies shall
apply especially rigorous robustness
checks to analytic results and document
what checks were undertaken. Agency
guidelines shall, however, in all cases,
require a disclosure of the specific data
sources that have been used and the
specific quantitative methods and
assumptions that have been employed.’’
Given the differences in the many
Federal agencies covered by these
guidelines, and the differences in
robustness checks and the level of detail
for documentation thereof that might be
appropriate for different agencies, we
also believe it will be helpful if agencies
elaborate on these matters in the context
of their missions and duties, with due
consideration of the nature of the
information they disseminate. As we
state in new paragraph V.3.b.ii.B.ii,
‘‘Each agency is authorized to define the
type of robustness checks, and the level
of detail for documentation thereof, in
ways appropriate for it given the nature
and multiplicity of issues for which the
agency is responsible.’’
We leave the determination of the
appropriate degree of rigor to the
discretion of agencies and the relevant
scientific and technical communities
that work with the agencies. We do,
however, establish a general standard
for the appropriate degree of rigor in our
expanded definition of
‘‘reproducibility’’ in paragraph V.10:
‘‘ ‘Reproducibility’ means that the
information is capable of being
substantially reproduced, subject to an
acceptable degree of imprecision. For
information judged to have more (less)
important impacts, the degree of
imprecision that is tolerated is reduced
(increased).’’ OMB will review each
agency’s treatment of this issue when
reviewing the agency guidelines as a
whole.
Comments also expressed concerns
regarding interim final paragraph
V.3.B.iii, ‘‘making the data and models
publicly available will assist in
determining whether analytic results are
capable of being substantially
reproduced,’’ and whether it could be
interpreted to constitute public
dissemination of these materials,
rendering moot the reproducibility test.
(For the equivalent provision, see new
paragraph V.3.b.ii.B.i.) The OMB
guidelines do not require agencies to
reproduce each disseminated analytic
result by independent reanalysis. Thus,

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public dissemination of data and
models per se does not mean that the
analytic result has been reproduced. It
means only that the result should be
CAPABLE of being reproduced. The
transparency associated with this
capability of reproduction is what the
OMB guidelines are designed to
achieve.
We also want to build on a general
observation that we made in our final
guidelines published in September
2001. In those guidelines we stated: ‘‘...
in those situations involving influential
scientific[, financial,] or statistical
information, the substantial
reproducibility standard is added as a
quality standard above and beyond
some peer review quality standards’’ (66
FR 49722 (September 28, 2001)). A
hypothetical example may serve to
illustrate this point. Assume that two
Federal agencies initiated or sponsored
the dissemination of five scientific
studies after October 1, 2002 (see
paragraph III.4) that were, before
dissemination, subjected to formal,
independent, external peer review, i.e.,
that met the presumptive standard for
‘‘objectivity’’ under paragraph V.3.b.i.
Further assume, at the time of
dissemination, that neither agency
reasonably expected that the
dissemination of any of these studies
would have ‘‘a clear and substantial
impact’’ on important public policies,
i.e., that these studies were not
considered ‘‘influential’’ under
paragraph V.9, and thus not subject to
the reproducibility standards in
paragraphs V.3.b.ii.A or B. Then
assume, two years later, in 2005, that
one of the agencies decides to issue an
important and far-reaching regulation
based clearly and substantially on the
agency’s evaluation of the analytic
results set forth in these five studies and
that such agency reliance on these five
studies as published in the agency’s
notice of proposed rulemaking would
constitute dissemination of these five
studies. These guidelines would require
the rulemaking agency, prior to
publishing the notice of proposed
rulemaking, to evaluate these five
studies to determine if the analytic
results stated therein would meet the
‘‘capable of being substantially
reproduced’’ standards in paragraph
V.3.b.ii.B and, if necessary, related
standards governing original and
supporting data in paragraph V.3.b.ii.A.
If the agency were to decide that any of
the five studies would not meet the
reproducibility standard, the agency
may still rely on them but only if they
satisfy the transparency standard and—
as applicable—the disclosure of

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robustness checks required by these
guidelines. Otherwise, the agency
should not disseminate any of the
studies that did not meet the applicable
standards in the guidelines at the time
it publishes the notice of proposed
rulemaking.
Some comments suggested that OMB
consider replacing the reproducibility
standard with a standard concerning
‘‘confirmation’’ of results for influential
scientific and statistical information.
Although we encourage agencies to
consider ‘‘confirmation’’ as a relevant
standard—at least in some cases—for
assessing the objectivity of original and
supporting data, we believe that
‘‘confirmation’’ is too stringent a
standard to apply to analytic results.
Often the regulatory impact analysis
prepared by an agency for a major rule,
for example, will be the only formal
analysis of an important subject. It
would be unlikely that the results of the
regulatory impact analysis had already
been confirmed by other analyses. The
‘‘capable of being substantially
reproduced’’ standard is less stringent
than a ‘‘confirmation’’ standard because
it simply requires that an agency’s
analysis be sufficiently transparent that
another qualified party could replicate it
through reanalysis.
Health, Safety, and Environmental
Information. We note, in the scientific
context, that in 1996 the Congress, for
health decisions under the Safe
Drinking Water Act, adopted a basic
standard of quality for the use of science
in agency decisionmaking. Under 42
U.S.C. 300g–1(b)(3)(A), an agency is
directed, ‘‘to the degree that an Agency
action is based on science,’’ to use ‘‘(i)
the best available, peer-reviewed
science and supporting studies
conducted in accordance with sound
and objective scientific practices; and
(ii) data collected by accepted methods
or best available methods (if the
reliability of the method and the nature
of the decision justifies use of the
data).’’
We further note that in the 1996
amendments to the Safe Drinking Water
Act, Congress adopted a basic quality
standard for the dissemination of public
information about risks of adverse
health effects. Under 42 U.S.C. 300g–
1(b)(3)(B), the agency is directed, ‘‘to
ensure that the presentation of
information [risk] effects is
comprehensive, informative, and
understandable.’’ The agency is further
directed, ‘‘in a document made available
to the public in support of a regulation
[to] specify, to the extent practicable—
(i) each population addressed by any
estimate [of applicable risk effects]; (ii)
the expected risk or central estimate of

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risk for the specific populations
[affected]; (iii) each appropriate upperbound or lower-bound estimate of risk;
(iv) each significant uncertainty
identified in the process of the
assessment of [risk] effects and the
studies that would assist in resolving
the uncertainty; and (v) peer-reviewed
studies known to the [agency] that
support, are directly relevant to, or fail
to support any estimate of [risk] effects
and the methodology used to reconcile
inconsistencies in the scientific data.’’
As suggested in several comments, we
have included these congressional
standards directly in new paragraph
V.3.b.ii.C, and made them applicable to
the information disseminated by all the
agencies subject to these guidelines:
‘‘With regard to analysis of risks to
human health, safety and the
environment maintained or
disseminated by the agencies, agencies
shall either adopt or adapt the quality
principles applied by Congress to risk
information used and disseminated
pursuant to the Safe Drinking Water Act
Amendments of 1996 (42 U.S.C. 300g–
1(b)(3)(A) & (B)).’’ The word ‘‘adapt’’ is
intended to provide agencies flexibility
in applying these principles to various
types of risk assessment.
Comments also argued that the
continued flow of vital information from
agencies responsible for disseminating
health and medical information to
medical providers, patients, and the
public may be disrupted due to these
peer review and reproducibility
standards. OMB responded by adding to
new paragraph V.3.b.ii.C: ‘‘Agencies
responsible for dissemination of vital
health and medical information shall
interpret the reproducibility and peerreview standards in a manner
appropriate to assuring the timely flow
of vital information from agencies to
medical providers, patients, health
agencies, and the public. Information
quality standards may be waived
temporarily by agencies under urgent
situations (e.g., imminent threats to
public health or homeland security) in
accordance with the latitude specified
in agency-specific guidelines.’’
Administrative Correction
Mechanisms. In addition to commenting
on the substantive standards in these
guidelines, many of the comments noted
that the OMB guidelines on the
administrative correction of information
do not specify a time period in which
the agency investigation and response
must be made. OMB has added the
following new paragraph III.3.i to direct
agencies to specify appropriate time
periods in which the investigation and
response need to be made. ‘‘Agencies
shall specify appropriate time periods

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for agency decisions on whether and
how to correct the information, and
agencies shall notify the affected
persons of the corrections made.’’
Several comments stated that the
OMB guidelines needed to direct
agencies to consider incorporating an
administrative appeal process into their
administrative mechanisms for the
correction of information. OMB agreed,
and added the following new paragraph
III.3.ii: ‘‘If the person who requested the
correction does not agree with the
agency’s decision (including the
corrective action, if any), the person
may file for reconsideration within the
agency. The agency shall establish an
administrative appeal process to review
the agency’s initial decision, and specify
appropriate time limits in which to
resolve such requests for
reconsideration.’’ Recognizing that
many agencies already have a process in
place to respond to public concerns, it
is not necessarily OMB’s intent to
require these agencies to establish a new
or different process. Rather, our intent is
to ensure that agency guidelines specify
an objective administrative appeal
process that, upon furthercomplaint by
the affected person, reviews an agency’s
decision to disagree with the correction
request. An objective process will
ensure that the office that originally
disseminates the information does not
have responsibility for both the initial
response and resolution of a
disagreement. In addition, the agency
guidelines should specify that if the
agency believes other agencies may have
an interest in the resolution of any
administrative appeal, the agency
should consult with those other
agencies about their possible interest.
Overall, OMB does not envision
administrative mechanisms that would
burden agencies with frivolous claims.
Instead, the correction process should
serve to address the genuine and valid
needs of the agency and its constituents
without disrupting agency processes.
Agencies, in making their determination
of whether or not to correct information,
may reject claims made in bad faith or
without justification, and are required to
undertake only the degree of correction
that they conclude is appropriate for the
nature and timeliness of the information
involved, and explain such practices in
their annual fiscal year reports to OMB.
OMB’s issuance of these final
guidelines is the beginning of an
evolutionary process that will include
draft agency guidelines, public
comment, final agency guidelines,
development of experience with OMB
and agency guidelines, and continued
refinement of both OMB and agency
guidelines. Just as OMB requested

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public comment before issuing these
final guidelines, OMB will refine these
guidelines as experience develops and
further public comment is obtained.
Dated: December 21, 2001.
John D. Graham,
Administrator, Office of Information and
Regulatory Affairs.

Guidelines for Ensuring and
Maximizing the Quality, Objectivity,
Utility, and Integrity of Information
Disseminated by Federal Agencies
I. OMB Responsibilities
Section 515 of the Treasury and
General Government Appropriations
Act for FY2001 (Public Law 106–554)
directs the Office of Management and
Budget to issue government-wide
guidelines that provide policy and
procedural guidance to Federal agencies
for ensuring and maximizing the
quality, objectivity, utility, and integrity
of information, including statistical
information, disseminated by Federal
agencies.
II. Agency Responsibilities
Section 515 directs agencies subject to
the Paperwork Reduction Act (44 U.S.C.
3502(1)) to—
1. Issue their own information quality
guidelines ensuring and maximizing the
quality, objectivity, utility, and integrity
of information, including statistical
information, disseminated by the agency
no later than one year after the date of
issuance of the OMB guidelines;
2. Establish administrative
mechanisms allowing affected persons
to seek and obtain correction of
information maintained and
disseminated by the agency that does
not comply with these OMB guidelines;
and
3. Report to the Director of OMB the
number and nature of complaints
received by the agency regarding agency
compliance with these OMB guidelines
concerning the quality, objectivity,
utility, and integrity of information and
how such complaints were resolved.
III. Guidelines for Ensuring and
Maximizing the Quality, Objectivity,
Utility, and Integrity of Information
Disseminated by Federal Agencies
1. Overall, agencies shall adopt a
basic standard of quality (including
objectivity, utility, and integrity) as a
performance goal and should take
appropriate steps to incorporate
information quality criteria into agency
information dissemination practices.
Quality is to be ensured and established
at levels appropriate to the nature and
timeliness of the information to be
disseminated. Agencies shall adopt

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specific standards of quality that are
appropriate for the various categories of
information they disseminate.
2. As a matter of good and effective
agency information resources
management, agencies shall develop a
process for reviewing the quality
(including the objectivity, utility, and
integrity) of information before it is
disseminated. Agencies shall treat
information quality as integral to every
step of an agency’s development of
information, including creation,
collection, maintenance, and
dissemination. This process shall enable
the agency to substantiate the quality of
the information it has disseminated
through documentation or other means
appropriate to the information.
3. To facilitate public review, agencies
shall establish administrative
mechanisms allowing affected persons
to seek and obtain, where appropriate,
timely correction of information
maintained and disseminated by the
agency that does not comply with OMB
or agency guidelines. These
administrative mechanisms shall be
flexible, appropriate to the nature and
timeliness of the disseminated
information, and incorporated into
agency information resources
management and administrative
practices.
i. Agencies shall specify appropriate
time periods for agency decisions on
whether and how to correct the
information, and agencies shall notify
the affected persons of the corrections
made.
ii. If the person who requested the
correction does not agree with the
agency’s decision (including the
corrective action, if any), the person
may file for reconsideration within the
agency. The agency shall establish an
administrative appeal process to review
the agency’s initial decision, and specify
appropriate time limits in which to
resolve such requests for
reconsideration.
4. The agency’s pre-dissemination
review, under paragraph III.2, shall
apply to information that the agency
first disseminates on or after October 1,
2002. The agency’s administrative
mechanisms, under paragraph III.3.,
shall apply to information that the
agency disseminates on or after October
1, 2002, regardless of when the agency
first disseminated the information.
IV. Agency Reporting Requirements
1. Agencies must designate the Chief
Information Officer or another official to
be responsible for agency compliance
with these guidelines.
2. The agency shall respond to
complaints in a manner appropriate to

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the nature and extent of the complaint.
Examples of appropriate responses
include personal contacts via letter or
telephone, form letters, press releases or
mass mailings that correct a widely
disseminated error or address a
frequently raised complaint.
3. Each agency must prepare a draft
report, no later than April 1, 2002,
providing the agency’s information
quality guidelines and explaining how
such guidelines will ensure and
maximize the quality, objectivity,
utility, and integrity of information,
including statistical information,
disseminated by the agency. This report
must also detail the administrative
mechanisms developed by that agency
to allow affected persons to seek and
obtain appropriate correction of
information maintained and
disseminated by the agency that does
not comply with the OMB or the agency
guidelines.
4. The agency must publish a notice
of availability of this draft report in the
Federal Register, and post this report on
the agency’s website, to provide an
opportunity for public comment.
5. Upon consideration of public
comment and after appropriate revision,
the agency must submit this draft report
to OMB for review regarding
consistency with these OMB guidelines
no later than July 1, 2002. Upon
completion of that OMB review and
completion of this report, agencies must
publish notice of the availability of this
report in its final form in the Federal
Register, and post this report on the
agency’s web site no later than October
1, 2002.
6. On an annual fiscal-year basis, each
agency must submit a report to the
Director of OMB providing information
(both quantitative and qualitative,
where appropriate) on the number and
nature of complaints received by the
agency regarding agency compliance
with these OMB guidelines and how
such complaints were resolved.
Agencies must submit these reports no
later than January 1 of each following
year, with the first report due January 1,
2004.
V. Definitions
1. ‘‘Quality’’ is an encompassing term
comprising utility, objectivity, and
integrity. Therefore, the guidelines
sometimes refer to these four statutory
terms, collectively, as ‘‘quality.’’
2. ‘‘Utility’’ refers to the usefulness of
the information to its intended users,
including the public. In assessing the
usefulness of information that the
agency disseminates to the public, the
agency needs to consider the uses of the
information not only from the

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perspective of the agency but also from
the perspective of the public. As a
result, when transparency of
information is relevant for assessing the
information’s usefulness from the
public’s perspective, the agency must
take care to ensure that transparency has
been addressed in its review of the
information.
3. ‘‘Objectivity’’ involves two distinct
elements, presentation and substance.
a. ‘‘Objectivity’’ includes whether
disseminated information is being
presented in an accurate, clear,
complete, and unbiased manner. This
involves whether the information is
presented within a proper context.
Sometimes, in disseminating certain
types of information to the public, other
information must also be disseminated
in order to ensure an accurate, clear,
complete, and unbiased presentation.
Also, the agency needs to identify the
sources of the disseminated information
(to the extent possible, consistent with
confidentiality protections) and, in a
scientific, financial, or statistical
context, the supporting data and
models, so that the public can assess for
itself whether there may be some reason
to question the objectivity of the
sources. Where appropriate, data should
have full, accurate, transparent
documentation, and error sources
affecting data quality should be
identified and disclosed to users.
b. In addition, ‘‘objectivity’’ involves
a focus on ensuring accurate, reliable,
and unbiased information. In a
scientific, financial, or statistical
context, the original and supporting
data shall be generated, and the analytic
results shall be developed, using sound
statistical and research methods.
i. If data and analytic results have
been subjected to formal, independent,
external peer review, the information
may generally be presumed to be of
acceptable objectivity. However, this
presumption is rebuttable based on a
persuasive showing by the petitioner in
a particular instance. If agencysponsored peer review is employed to
help satisfy the objectivity standard, the
review process employed shall meet the
general criteria for competent and
credible peer review recommended by
OMB–OIRA to the President’s
Management Council (9/20/01) (http://
www.whitehouse.gov/omb/inforeg/
oira_review-process.html), namely,
‘‘that (a) peer reviewers be selected
primarily on the basis of necessary
technical expertise, (b) peer reviewers
be expected to disclose to agencies prior
technical/policy positions they may
have taken on the issues at hand, (c)
peer reviewers be expected to disclose
to agencies their sources of personal and

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institutional funding (private or public
sector), and (d) peer reviews be
conducted in an open and rigorous
manner.’’
ii. If an agency is responsible for
disseminating influential scientific,
financial, or statistical information,
agency guidelines shall include a high
degree of transparency about data and
methods to facilitate the reproducibility
of such information by qualified third
parties.
A. With regard to original and
supporting data related thereto, agency
guidelines shall not require that all
disseminated data be subjected to a
reproducibility requirement. Agencies
may identify, in consultation with the
relevant scientific and technical
communities, those particular types of
data that can practicable be subjected to
a reproducibility requirement, given
ethical, feasibility, or confidentiality
constraints. It is understood that
reproducibility of data is an indication
of transparency about research design
and methods and thus a replication
exercise (i.e., a new experiment, test, or
sample) shall not be required prior to
each dissemination.
B. With regard to analytic results
related thereto, agency guidelines shall
generally require sufficient transparency
about data and methods that an
independent reanalysis could be
undertaken by a qualified member of the
public. These transparency standards
apply to agency analysis of data from a
single study as well as to analyses that
combine information from multiple
studies.
i. Making the data and methods
publicly available will assist in
determining whether analytic results are
reproducible. However, the objectivity
standard does not override other
compelling interests such as privacy,
trade secrets, intellectual property, and
other confidentiality protections.
ii. In situations where public access to
data and methods will not occur due to
other compelling interests, agencies
shall apply especially rigorous
robustness checks to analytic results
and document what checks were
undertaken. Agency guidelines shall,
however, in all cases, require a
disclosure of the specific data sources
that have been used and the specific
quantitative methods and assumptions
that have been employed. Each agency
is authorized to define the type of
robustness checks, and the level of

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detail for documentation thereof, in
ways appropriate for it given the nature
and multiplicity of issues for which the
agency is responsible.
C. With regard to analysis of risks to
human health, safety and the
environment maintained or
disseminated by the agencies, agencies
shall either adopt or adapt the quality
principles applied by Congress to risk
information used and disseminated
pursuant to the Safe Drinking Water Act
Amendments of 1996 (42 U.S.C. 300g–
1(b)(3)(A) & (B)). Agencies responsible
for dissemination of vital health and
medical information shall interpret the
reproducibility and peer-review
standards in a manner appropriate to
assuring the timely flow of vital
information from agencies to medical
providers, patients, health agencies, and
the public. Information quality
standards may be waived temporarily by
agencies under urgent situations (e.g.,
imminent threats to public health or
homeland security) in accordance with
the latitude specified in agency-specific
guidelines.
4. ‘‘Integrity’’ refers to the security of
information—protection of the
information from unauthorized access
or revision, to ensure that the
information is not compromised
through corruption or falsification.
5. ‘‘Information’’ means any
communication or representation of
knowledge such as facts or data, in any
medium or form, including textual,
numerical, graphic, cartographic,
narrative, or audiovisual forms. This
definition includes information that an
agency disseminates from a web page,
but does not include the provision of
hyperlinks to information that others
disseminate. This definition does not
include opinions, where the agency’s
presentation makes it clear that what is
being offered is someone’s opinion
rather than fact or the agency’s views.
6. ‘‘Government information’’ means
information created, collected,
processed, disseminated, or disposed of
by or for the Federal Government.
7. ‘‘Information dissemination
product’’ means any books, paper, map,
machine-readable material, audiovisual
production, or other documentary
material, regardless of physical form or
characteristic, an agency disseminates to
the public. This definition includes any
electronic document, CD–ROM, or web
page.
8. ‘‘Dissemination’’ means agency
initiated or sponsored distribution of

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information to the public (see 5 CFR
1320.3(d) (definition of ‘‘Conduct or
Sponsor’’)). Dissemination does not
include distribution limited to
government employees or agency
contractors or grantees; intra- or interagency use or sharing of government
information; and responses to requests
for agency records under the Freedom of
Information Act, the Privacy Act, the
Federal Advisory Committee Act or
other similar law. This definition also
does not include distribution limited to
correspondence with individuals or
persons, press releases, archival records,
public filings, subpoenas or adjudicative
processes.
9. ‘‘Influential’’, when used in the
phrase ‘‘influential scientific, financial,
or statistical information’’, means that
the agency can reasonably determine
that dissemination of the information
will have or does have a clear and
substantial impact on important public
policies or important private sector
decisions. Each agency is authorized to
define ‘‘influential’’ in ways appropriate
for it given the nature and multiplicity
of issues for which the agency is
responsible.
10. ‘‘Reproducibility’’ means that the
information is capable of being
substantially reproduced, subject to an
acceptable degree of imprecision. For
information judged to have more (less)
important impacts, the degree of
imprecision that is tolerated is reduced
(increased). If agencies apply the
reproducibility test to specific types of
original or supporting data, the
associated guidelines shall provide
relevant definitions of reproducibility
(e.g., standards for replication of
laboratory data). With respect to
analytic results, ‘‘capable of being
substantially reproduced’’ means that
independent analysis of the original or
supporting data using identical methods
would generate similar analytic results,
subject to an acceptable degree of
imprecision or error.
[FR Doc. 02–59 Filed 1–2–02; 1:36 pm]
BILLING CODE 3110–01–M
Editorial Note: Due to numerous errors,
this document is being reprinted in its
entirety. It was originally printed in the
Federal Register on Thursday, January 3,
2002 at 67 FR 369–378 and was corrected on
Tuesday, February 5, 2002 at 67 FR 5365.
[FR Doc. R2–59 Filed 2–21–02; 8:45 am]
BILLING CODE 1505–01–D

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