[Federal Register Volume 67, Number 36 (Friday, February 22, 2002)]
[Notices]
[Pages 8452-8460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: R2-59]



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Part IX





Office of Management and Budget





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Guidelines for Ensuring and Maximizing the Quality, Objectivity, 
Utility, and Integrity of Information Disseminated by Federal Agencies; 
Notice; Republication

Federal Register / Vol. 67, No. 36 / Friday, February 22, 2002 / 
Notices

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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.

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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 
<a href="/cdn-cgi/l/email-protection#432a2d252c312e22372a2c2d3236222f2a373a032c2e216d262c336d242c35"><span class="__cf_email__" data-cfemail="f59c9b939a879894819c9a9b848094999c818cb59a9897db909a85db929a83">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 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 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 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

[[Page 8453]]

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 well-established 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 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 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

[[Page 8454]]

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 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 well-established 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 Peer-Reviewed 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.
    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 agency-sponsored 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).

    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] 
meta-analysis 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 
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

[[Page 8456]]

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 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 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 high-quality 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

[[Page 8457]]

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, 
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 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

[[Page 8458]]

risk for the specific populations [affected]; (iii) each appropriate 
upper-bound 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 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.''
    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 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 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

[[Page 8459]]

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 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 
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 agency-sponsored 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

[[Page 8460]]

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 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 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 inter-agency 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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