[Federal Register: August 11, 1999 (Volume 64, Number 154)]
[Notices]
[Page 43786-43791]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au99-152]
-----------------------------------------------------------------------
OFFICE OF MANAGEMENT AND BUDGET
OMB Circular A-110, ``Uniform Administrative Requirements for
Grants and Agreements With Institutions of Higher Education, Hospitals,
and Other Non-Profit Organizations''
AGENCY: Office of Management and Budget, Executive Office of the
President.
ACTION: Request for Comments on Clarifying Changes to Proposed Revision
on Public Access to Research Data.
-----------------------------------------------------------------------
SUMMARY: This notice offers interested parties an opportunity to
comment on clarifying changes to a proposed revision to OMB Circular A-
110, ``Uniform Administrative Requirements for Grants and Agreements
with Institutions of Higher Education, Hospitals, and Other Non-Profit
Organizations.'' Public Law 105-277 directs OMB to amend Section __.36
of the Circular ``to require Federal awarding agencies to ensure that
all data produced under an award will be made available to the public
through the procedures established under the Freedom of Information
Act'' (FOIA). Pursuant to the direction of Public Law 105-277, OMB
published a Notice of Proposed Revision on February 4, 1999.
OMB received over 9,000 comments on the proposed revision. Many of
these comments raised serious concerns about the impact Public Law 105-
277 and the proposed revision would have on the conduct of scientific
research. In part, these concerns arose from questions as to how
expansively or narrowly the proposed revision would be interpreted and
applied. In raising these questions, commenters on both sides of the
debate sought clarification of four concepts found in the proposed
revision: ``data,'' ``published,'' ``used by the Federal Government in
developing policy or rules,'' and cost reimbursement.
In response to these comments, and in order to advance
implementation of the requirements of Public Law 105-277, OMB has
developed proposed clarifying definitions for the first three of these
concepts and is providing additional background discussion regarding
the fourth. In framing these definitions, OMB has used its discretion
to balance the need for public access to research data with protections
of the research process. Specifically, OMB seeks to further the
interest of the public in obtaining the information needed to validate
Federally-funded research findings, ensure that research can continue
to be conducted in accordance with the traditional scientific process,
and implement a public-access process that will be workable in
practice. OMB will consider all comments received in response to this
notice, and the comments received in response to the prior notice, in
its development of the final revision to the Circular. OMB intends to
publish the final revision on or before September 30, 1999. It is not
necessary to re-submit comments already provided to OMB.
DATES: Comments must be received by September 10, 1999.
ADDRESSES: Comments on this proposed revision should be addressed to:
F. James Charney, Policy Analyst, Office of Management and Budget, Room
6025, New Executive Office Building, Washington, DC 20503. Comments may
be submitted via E-mail (grants@omb.eop.gov), but must be made in the
text of the message and not as an attachment. Since OMB will consider
all comments that it receives, it is not necessary to send multiple
copies of a comment letter to different officials in the Executive
Branch. The full text of Circular A-110, the text of this notice, and
the text of the February 4, 1999, Notice of Proposed Revision, may be
obtained by accessing OMB's home page (http://www.whitehouse.gov/OMB),
under the heading ``Grants Management.'' Copies of Public Law 105-277
can be obtained by accessing the Library of Congress's home page
(http://thomas.loc.gov).
FOR FURTHER INFORMATION CONTACT: F. James Charney, Policy Analyst,
Office of Management and Budget, at (202) 395-3993. Press inquiries
must be directed to OMB's Communications Office, at (202) 395-7254.
SUPPLEMENTARY INFORMATION:
I. Approach to Implementation
Congress included a two-sentence provision in Public Law 105-277
that directs OMB to amend Circular A-110 ``to require Federal awarding
agencies to ensure that all data produced under an award will be made
available to the public through the procedures established under the
Freedom of Information Act.'' The provision also provides for a
reasonable fee to cover the costs incurred in responding to the
request. The Circular applies to grants and other financial assistance
provided to institutions of higher education, hospitals, and non-profit
institutions, from all Federal agencies. Therefore, the proposed
revision will affect the full range of research activities funded by
the Federal Government.
In response to the provision contained in Public Law 105-277, OMB
published a Notice of Proposed Revision to the Circular on February 4,
1999 (64 FR 5684). OMB received over 9,000 comments on the proposed
revision. Many of these comments (including many of those from the
scientific community) raised serious concerns about the effect the
provision contained in Public Law 105-277 and the proposed revision
would have on scientific research. They sought protection for the
privacy of research
[[Page 43787]]
subjects and the proprietary interests of scientists and their research
partners. They also emphasized that scientists must be able to pursue
their research efforts to their conclusion, without the premature
release of their research data.
Science and technology are the principal agents of change and
progress, with over half of the Nation's economic productivity in the
last 50 years attributable to technological innovation and the science
that supports it. Although the private sector makes many investments in
technology development, the Federal Government has an important role to
play--particularly when risks are too great or the return to companies
too speculative. Its support of cutting-edge science contributes to new
knowledge and greater understanding, ranging from the edge of the
universe to the smallest imaginable particles.
In implementing the provision contained in Public Law 105-277, OMB
seeks to (1) Further the interest of the public in obtaining the
information needed to validate Federally-funded research findings, (2)
ensure that research can continue to be conducted in accordance with
the traditional scientific process, and (3) implement a public-access
process that will be workable in practice.
To this end, OMB earlier proposed to require public access to
``data relating to published research findings produced under an award
that were used by the Federal Government in developing policy or
rules.'' It intended these clarifications to ensure public access to
data supporting the Federally-funded research findings upon which
agencies rely, without upsetting the traditional scientific process by
requiring researchers to release their data prematurely.
As in many other fields of endeavor, scientists need a private
setting where they are free to deliberate over, develop, and pursue
alternative approaches. When a scientist completes research, he or she
publishes the results for the scrutiny of other scientists and the
community at large. In light of this traditional scientific process,
OMB does not construe the statute as requiring scientists to make
research data publicly available while the research is still ongoing,
because that would force scientists to ``operate in fishbowl'' and to
release information prematurely. Cf. Wolfe v. Department of Health and
Human Services, 839 F.2d 768, 773 (D.C. Cir. 1988) (en banc) (Congress
in enacting the FOIA did not force government officials to ``operate in
a fishbowl''); Montrose Chemical Corp. of Calif. v. Train, 491 F.2d 63,
66 (D.C. Cir. 1974) (same). OMB also understands the need of
researchers to assure confidentiality to those who voluntarily agree to
participate in Federally-funded research. Accordingly, OMB's proposed
revision would allow agencies to withhold personal privacy and
confidential business information pursuant to the FOIA ``exemptions''
in 5 U.S.C. 552(b). For example, under FOIA exemption 6, 5 U.S.C.
552(b)(6), an agency is not required to release ``personnel and medical
files and similar files the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy.'' As the Supreme
Court explained in U.S. Dep't of Justice v. Reporters Committee of the
Freedom of the Press, 489 U.S. 749 (1989), certain types of privacy
information can be protected as a categorical matter, without regard to
individual circumstances. Id at 776-780. Moreover, in accord with
exemption 6's express protection for their medical records, courts have
found that individuals have a strong privacy interest in medical
records. See McDonnell v. United States, 4 F.3d 1227, 1251-1254 (3rd
Cir. 1993); Plain Dealer Pub. Co. v. U.S. Dep't of Labor, 471 F. Supp.
1023, 1027-29 (D.D.C. 1979). In addition, courts have held that,
although the redaction of names or other individual identifiers may be
sufficient in some cases to protect privacy, an entire record may be
withheld if necessary to ensure privacy (e.g., in a case where,
notwithstanding the redaction of names or other personal identifiers,
an individual's identity could still be inferred from other
information). See Alirez v. NLRB, 676 F.2d 423, 428 (10th Cir. 1982);
Whitehouse v. U.S. Dep't of Labor, 997 F. Supp. 172, 175 (D. Mass.
1998).
Notwithstanding these clarifications in the earlier proposal,
commenters from the scientific community expressed serious concerns
about the impact Public Law 105-277 would have on their research
activities. In part, these concerns arose from questions as to how
expansively or narrowly the statute and the proposed revision would be
interpreted and applied. In raising these questions, commenters on both
sides of the debate sought clarification of four concepts found in the
proposed revision: ``data,'' ``published,'' ``used by the Federal
Government in developing policy or rules,'' and cost reimbursement.
In order to advance implementation of the requirements of Public
Law 105-277, and to provide the greater clarification that the
commenters requested, OMB seeks public comment on proposed clarifying
definitions for the first three concepts, and its additional background
discussion regarding the fourth.
II. Background
A. Data Access Provision Contained in Public Law 105-277
Public Law 105-277 includes a provision that directs OMB to amend
Section __.36 of the Circular ``to require Federal awarding agencies to
ensure that all data produced under an award will be made available to
the public through the procedures established under the Freedom of
Information Act.'' Public Law 105-277 further provides that ``if the
agency obtaining the data does so solely at the request of a private
party, the agency may authorize a reasonable user fee equaling the
incremental cost of obtaining the data.''
According to congressional floor statements made in support of the
provision, its aim is to ``provide the public with access to federally
funded research data'' that are ``used by the Federal Government in
developing policy and rules.'' 144 Cong. Rec. S12134 (October 9, 1998)
(Statement of Sen. Lott); see id. (Statement of Sen. Shelby) (the
provision ``represents a first step in ensuring that the public has
access to all studies used by the Federal Government to develop Federal
policy''). The congressional proponents further explained that the
provision requires OMB ``to amend OMB Circular A-110 to require Federal
awarding agencies to ensure that all research results, including
underlying research data, funded by the Federal Government are made
available to the public through the procedures established under the
Freedom of Information Act.'' Id. (Statement of Sen. Lott). The
proponents stated that ``the amended Circular shall apply to all
Federally funded research, regardless of the level of funding or
whether the award recipient is also using non-Federal funds.'' Id.
(Statement of Sen. Campbell). They also noted that ``[t]he Conferees
recognize that this language covers research data not currently covered
by the Freedom of Information Act. The provision applies to all
Federally funded research data regardless of whether the awarding
agency has the data at the time the request is made'' under the FOIA.
Id. Under the Supreme Court's decision in Forsham v. Harris, 445 U.S.
169, 179-80 (1980), data that are in the files of a recipient of a
Federal award, but not in the files of a Federal agency, would not
otherwise be available under FOIA.
[[Page 43788]]
B. OMB's Proposed Revision to Circular A-110
In response to the congressional direction in Public Law 105-277,
OMB published a Notice of Proposed Revision to the Circular on February
4, 1999 (64 FR 5684) to amend Section ____.36(c) of the Circular to
read as follows:
(c) The Federal Government has the right to (1) Obtain,
reproduce, publish or otherwise use the data first produced under an
award, and (2) authorize others to receive, reproduce, publish, or
otherwise use such data for Federal purposes. In addition, in
response to a Freedom of Information Act (FOIA) request for data
relating to published research findings produced under an award that
were used by the Federal Government in developing policy or rules,
the Federal awarding agency shall, within a reasonable time, obtain
the requested data so that they can be made available to the public
through the procedures established under the FOIA. If the Federal
awarding agency obtains the data solely in response to a FOIA
request, the agency may charge the requester a reasonable fee
equaling the full incremental cost of obtaining the data. This fee
should reflect costs incurred by the agency, the recipient, and
applicable subrecipients. This fee is in addition to any fees the
agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).
In the preamble to the notice, OMB provided an explanation of the
proposed revision. As the notice outlined, the proposed revision
implements Public Law 105-277 by providing that, after publication of
research findings used by the Federal Government in developing policy
or rules, the research results and underlying data would be available
to the public in accordance with the FOIA. The proposed revision
requires Federal awarding agencies, in response to a FOIA request, to
obtain the requested data from the recipient of the Federal award.
Since the agency must take steps to obtain the data, the agency is
afforded a reasonable time to do so. Once the agency has obtained the
data, the agency will then process the FOIA request in accordance with
the standard FOIA procedural and substantive rules. The agency will
therefore have to determine whether any of the FOIA exemptions, which
permit an agency to withhold requested records, would apply to some or
all of the data. If the Federal awarding agency obtained the data
solely in response to a FOIA request, the agency may charge the
requester a reasonable fee equaling the full incremental cost of
obtaining the data. This fee should reflect costs incurred by the
agency, the recipient, and applicable subrecipients. This fee is in
addition to any fees the agency may assess under the FOIA.
C. Public Comments Called for Clarification
OMB received approximately 8,350 comments during the 60-day public
comment period. Additionally, OMB received approximately 800 comments
after the close of the comment period. OMB will consider the comments
received in response to the prior notice, and the comments received in
response to this notice, in developing the final revision to the
Circular.
Of the comments received, 55 percent were submitted by individual
members of the public, without any organizational identification.
Individual researchers working at institutions of higher education
accounted for 36 percent of the comments. The remainder of the comments
came from other non-profit research organizations (three percent),
professional associations (two percent), commercial research
organizations (one percent), and official comments from institutions of
higher education (one percent). OMB also received comments from Members
of Congress, Federal agencies, employees of State governments, and law
firms.
Of those comments received, 55 percent supported implementation of
Public Law 105-277 in the form of the proposed revision while 37
percent opposed the language of Public Law 105-277 and the proposed
revision. The remaining eight percent of those commenting had serious
concerns about the proposed revision, suggesting that it be modified in
some substantial way.
Commenters offered strongly differing views on the provision
contained in Public Law 105-277. Commenters who supported the statutory
provision stated that the public has a right to obtain research data
that have been funded with tax dollars, particularly when the research
findings were used by the Federal Government in developing policy or
rules. These commenters also expressed the view that making this data
available for public review and validation would improve the scientific
process. Commenters who opposed the provision contained in Public Law
105-277 stated that they support the concepts of full disclosure and
open access to information. In their comments, they explained that the
traditional scientific process operates by requiring researchers to
subject their findings to the scrutiny of the scientific community and
the general public, so that those findings may be validated, corrected,
or rejected. They expressed concern that the approach required by
Public Law 105-277 would significantly impair scientific research. In
their view, individuals and businesses would be reluctant to agree to
participate in research, since the participants' personal privacy and
proprietary information could not be assured of confidential treatment.
III. Proposed Clarification of Concepts
Many commenters asked OMB to clarify four concepts found in the
proposed revision: ``data,'' ``published,'' ``used by the Federal
Government in developing policy or rules,'' and cost reimbursement. OMB
agrees that clarification is needed for these concepts and believes
development of the final revision, pursuant to the direction of Public
Law 105-277, will be advanced by requesting additional public comment.
A. ``Data''
A large number of comments addressed the fact that the term
``data'' is not defined in either the provision contained in Public Law
105-277 or in the proposed revision to the Circular.
Commenters from the scientific community expressed concern that
``data'' might be interpreted expansively to include such things as lab
specimens (e.g., cell cultures, tissue or plant samples), a
researcher's lab notebooks, working papers, phone logs and electronic
mail, or a researcher's financial records. These commenters stated that
requiring researchers to turn over such materials would be extremely
burdensome and would harm the scientific process. Commenters from the
scientific community raised the additional concern that requiring
public access to research ``data'' would result in the public
disclosure of highly private information about individuals (e.g.,
information about the medical condition or treatment of research
subjects) and the proprietary business information (e.g., intellectual
property) of their research partners. In this regard, these commenters
were not reassured by the fact that the Federal awarding agency would
be able to withhold information that falls within the existing FOIA
exemptions that permit agencies to withhold personal and confidential
business information. See 5 U.S.C. 552(b). Notwithstanding the
applicability of these FOIA exemptions, the commenters from the
scientific community asserted that they would no longer be able to
promise confidentiality to persons who agree to participate in research
studies.
Commenters supporting the provision contained in Public Law 105-277
agreed that the term ``data'' needs to be defined. One argued for a
broad interpretation of ``data,'' but agreed that ``[f]inancial records
and other personal
[[Page 43789]]
data of individual researchers should be excluded from the definition
of data in the revised Circular.'' A comment letter from Senators
Shelby, Lott, and Campbell, who support the provision contained in
Public Law 105-277, stated that ``data'' should be defined ``based on
how the term is commonly used in the scientific community and the
ultimate goal of this provision. At a minimum, data should include all
information necessary to replicate and verify the original results and
assure that the results are consistent with the data collected and
evaluated under the award.''
Taking into account the concerns that commenters expressed, and in
order to advance implementation of the requirements of Public Law 105-
277, OMB has developed and seeks comment on a proposed definition of
``research data''. In framing this definition, OMB has sought to ensure
that members of the public can obtain the information needed to
validate Federally-funded research findings, while ensuring the privacy
of research subjects and proprietary interests of scientists and their
research partners. OMB proposes to define ``research data'' in a way
that does not require recipients to transmit information which, in
their judgment, includes ``trade secrets, commercial information,'' or
``personnel and medical files and similar files the disclosure of which
would constitute a clearly unwarranted invasion of personal privacy.''
The Federal awarding agency would retain its right to ask the recipient
for additional information, if it believed the recipient's application
of these principles was improper.
Accordingly, OMB proposes to define ``research data'' as ``the
recorded factual material commonly accepted in the scientific community
as necessary to validate researching findings, but not any of the
following: preliminary analyses, drafts of scientific papers, plans for
future research, peer reviews, or communications with colleagues.''
This excludes physical objects such as laboratory samples. Moreover,
under the proposed definition, ``research data'' would exclude ``(A)
trade secrets, commercial information, materials necessary to be held
confidential by a researcher until publication of their results in a
peer-reviewed journal, or information which may be copyrighted or
patented; and (B) personnel and medical files and similar files the
disclosure or which would constitute a clearly unwarranted invasion of
personal privacy, such as information that could be used to identify a
particular research subject in a research study.''
B. ``Published''
Commenters generally supported OMB's clarification that public
access pertains to ``published'' research findings. For example, a
comment letter from Senators Shelby, Lott, and Campbell, who support
the provision contained in Public Law 105-277, stated that ``the OMB
reference to published findings is not inconsistent with the underlying
statute'' and that ``this limitation to data related to published
research findings will ensure that the provision does not disrupt the
research process by forcing the premature release of data before the
study is completed.''
Notwithstanding the general support for a publication requirement,
a significant number of commenters raised questions regarding when
research findings have been ``published.'' While there was a general
consensus that research findings are ``published'' when they appear in
a peer-reviewed scientific or technical journal, commenters asked
whether research findings could be considered to be ``published'' at an
earlier time. Examples of earlier definitions of ``published'' include:
(1) When data are distributed as part of the journal's peer-review
process; (2) when a researcher makes a presentation at a scientific
meeting open to the public; or (3) when data have been otherwise made
available to the public (e.g., through a press release or a
presentation to the media). In particular, commenters from the
scientific community expressed the concern that defining ``published''
expansively could lead to premature release of data as well as
misunderstandings and false claims about what research proves. These
commenters also noted that requiring researchers to make their data
publicly available prematurely could also prevent future publication in
some peer-reviewed journals, and may limit a researcher's patent
rights. Additionally, commenters argued that the willingness of private
sector organizations to enter into partnerships would be reduced unless
their proprietary data can be protected. Other researchers feared
harassment from groups that do not support certain scientific methods
or those that do not support certain areas of research.
Commenters who support the provision contained in Public Law 105-
277 were generally sympathetic to these concerns. However, many
expressed the concern that, if ``published'' meant only publication in
a peer-reviewed journal, Federal agencies would be able to rely on
research findings that have been released to the agency (while not
having yet been published in a peer-review journal), but interested
members of the public would not be able to obtain the data that are
necessary to validate these findings. As one commenter stated, under
that scenario ``award recipients would be able to avoid disclosure of
data otherwise available to the public merely by failing to submit the
data to a formal peer review publication.'' This concern was also
raised in the comment letter from Senators Shelby, Lott, and Campbell,
which stated that ``[if] federally-funded pre-published data or
findings are used to support a federal policy or rule, then the final
revision should ensure that such data would also be made publicly
available under FOIA. If the data are sufficiently sound to support a
federal policy or rule, then they should be able to bear public
scrutiny and disclosure * * *. This point is critical to ensuring that
our federal rules and policies are based on good science and research
findings.''
Taking into account the concerns that commenters expressed, and in
order to advance implementation of the requirements of Public Law 105-
277, OMB has developed and seeks comment on a proposed definition of
``published.'' In framing this definition, OMB has sought to ensure
that members of the public can obtain the information needed to
validate Federally-funded research findings, while at the same time
ensuring that researchers will continue to be able to engage in the
traditional scientific process without fear that they could be forced
to release their research prematurely. OMB has also framed this
definition based on the understanding that Federal agencies generally
rely on research findings that have been peer-reviewed, because until
they have been peer-reviewed, research findings may be inherently
unreliable. OMB solicits comments on these issues.
Accordingly, OMB proposes to define ``published'' research findings
as ``either when (A) research findings are published in a peer-reviewed
scientific or technical journal, or (B) a Federal agency publicly and
officially cites to the research findings in support of'' an agency
action.
C. ``Used by the Federal Government in Developing Policy or Rules''
Many commenters requested clarification on what is meant by ``used
by the Federal Government in developing policy or rules.'' Commenters
who oppose the provision contained in Public Law 105-277 argued for an
interpretation under which ``policy or rules'' would refer to
[[Page 43790]]
agency regulations, and ``used'' would refer to the agency's public and
official citation of the research findings in support of the agency
action. Commenters who support the provision contained in Public Law
105-277 argued for a more expansive interpretation, under which
``policy or rules'' would include such things as agency guidance,
surveys, risk assessments and reports, and ``used'' would refer to when
the agency first relies internally on the findings--or perhaps even
earlier. Referring to situations where ``studies are funded, performed,
and published with a clear anticipation that the data in the study will
be useful in connection with future government rulemaking or policy
development,'' one commenter argued that, in some regulatory
situations, such data ``clearly should be available for public scrutiny
before the formal regulatory proceedings begin.'' This commenter,
though, went on to state that ``OMB should also define a meaningful
carve-out for activities that do not influence the development of
regulations or policy.'' In explaining this ``carve-out'' approach, the
commenter stated that, in contrast to situations where a published
study is cited by an agency, ``[w]here materials are merely submitted
by the public and not cited by the government decision makers, however,
the issue is less clear. In such cases it is often difficult or
impossible to determine what studies the government has ``used'' in
shaping policy.'' Based on this commenter's view that ``all data
adverse to the position of a party impacted by regulatory action should
be susceptible of honest scrutiny,'' the commenter addressed the
problem of how to identify when research findings are ``used''--when
they have not been cited--by concluding that ``if materials are
submitted in the course of rulemaking or other government policy
formulation, those data should be made available to the public.''
OMB believes that the provision contained in Public Law 105-277
should be implemented in a manner that respects the general framework
of the traditional scientific process, and is workable in practice. In
this regard, the operating principles that OMB adopts in its revisions
to section ____.36 of the Circular should be relatively easy to
administer (by the public, Federal agencies, and recipients), should
rely on existing processes whenever possible, and should not result in
uncertainties and disagreements when they are applied to the facts in
individual cases. Based on our review of the comments, OMB believes
that the provision contained in Public Law 105-277 can be implemented
in the context of the agencies' promulgation of regulations, but that
considerable implementation problems would arise if the scope of the
provision contained in Public Law 105-277 extended to such agency
actions as guidance, surveys, assessments, and reports.
When an agency promulgates a regulation, it does so through the
well-established rulemaking process. Through notices in the Federal
Register (typically proposed and final rulemaking notices), an agency
explains regulations and seeks and reacts to public comments. As was
pointed out by commenters who support the provision contained in Public
Law 105-277, agencies generally cite the sources that support their
regulations, often including findings from Federally-funded research in
their rulemaking notices published in the Federal Register. In so
doing, the agency relies on the research findings--in an official and
public manner--to explain and justify the agency's regulatory actions
to the public, to Congress, and to the courts. Many commenters argued
that members of the public should be able to obtain the data that
underlies these research findings. This allows the public to seek to
validate the findings, evaluate the regulation, submit comments to the
agency on the proposed regulations, or seek judicial review of the
final regulations.
Among the commenters who addressed this issue, there was a general
consensus that the case for the public obtaining the underlying
research data is strongest when an agency cites Federally-funded
research findings to support the agency's issuance of a regulation. In
promulgating a regulation, the agency acts with the force and effect of
law. In citing to the research findings to support the agency's
regulatory decision, the agency is relying--publicly and officially--on
those findings. Indeed, that reliance is given legal significance by
the courts during any review of the regulation.
The comments also indicated that an agency's citation to research
findings in support of a regulation allows the process to be
administered most readily and easily. In such cases, the public access
provision should clearly be applicable. Any uncertainty can be resolved
by an inspection of the agency's rulemaking records.
When one moves outside the regulatory context and into other areas
of agency action, the comments provided less of a justification for the
application of the provision contained in Public Law 105-277. It also
becomes less clear how members of the public and the agencies would be
able to determine when public access would be required in individual
cases.
Commenters who support the provision contained in Public Law 105-
277 argued that the public should have access to data used in agency
guidance, surveys, assessments, and reports, when the data comes from
research funded by the Federal taxpayers. Arguably, the need for public
access to data would be less for agency actions that do not have the
force and effect of law or are not subject to judicial review.
OMB is concerned that a broader proposal would be problematic. It
is not clear how the provision contained in Public Law 105-277 would
operate in practice outside the regulatory context. When agencies
undertake less formal agency action they often do not prepare and issue
accompanying explanatory preambles that outline the basis and
underlying factual support for the action. In the absence of a formal
record that explains the agency's action, it would be far more
difficult for the public and the agencies to determine, in individual
cases, whether particular research findings were ``used'' by the agency
in ``developing'' the agency action. For example, from the comments
that we received on the proposed revision, an agency might be viewed as
having ``used'' research findings if those findings: (1) Were relied
upon in an internal agency memorandum sent to a decision maker; (2)
were discussed in an agency staff level communication, such as an email
message; or (3) were simply available for the agency staff to read,
regardless of whether there was any evidence that the staff relied upon
the findings in carrying out their work. In sharp contrast with
identifying agency reliance in the regulatory context, none of these
tests could be applied readily and easily by members of the public and
the agency for determining, in individual cases, whether research data
would be publicly available under the provision contained in Public Law
105-277. Instead of being able to rely on the public record, these
tests would entail a fact-intensive inquiry into the agency's internal
deliberations. This inquiry would be burdensome and time-consuming, and
would intrude into the agency's deliberative process.
In sum, based on the comments that OMB has received, it does not
appear that the provision contained in Public Law 105-277 can be
readily and easily implemented outside of the regulatory context. Given
the considerable implementation difficulties, and the lesser public
interest in obtaining the
[[Page 43791]]
underlying research data when the agency is not taking action that has
the force and effect of law, OMB does not believe that the public
interest would be served by extending the provision contained in Public
Law 105-277 beyond the regulatory context.
Accordingly, in order to advance implementation of the requirements
of Public Law 105-277, OMB seeks comment on a proposal to replace
``used by the Federal Government in developing policy or rules'' with
``used by the Federal Government in developing a regulation.''
``Regulation'' refers to the well-established and long-standing
definition of a regulation for which notice and comment is required
under the Administrative Procedures Act (5 U.S.C. 553). In framing this
proposal, OMB has sought to ensure that members of the public can
obtain the information needed to validate those Federally-funded
research findings on which Federal agencies rely when they take actions
that have the force and effect of law, while at the same time ensuring
that the provision contained in Public Law 105-277 can be administered
in a manner that is workable for members of the public, Federal
agencies and their recipients.
In addition, based on its experience with reviewing agency
regulations, OMB believes the public interest in having access to
research data is likely to be greatest in the case of those regulations
that have the most substantial impact on society. One existing method
for identifying these regulations is whether a regulation meets a $100
million impact threshold. This approach is similar to those required by
the Unfunded Mandates Reform Act (Public Law 104-4, 2 U.S.C. 1532,
1535) and the Congressional Review Act (Public Law 104-121, 8 U.S.C.
801(a)(3), 804(2)). Therefore, OMB requests comments on whether
limiting the scope of the proposed revision to regulations that meet
the $100 million threshold would be appropriate. In particular,
commenters should identify current and past regulatory actions that do
not meet the $100 million threshold, but where they believe the public
would have benefitted from having access to the underlying research
data sufficiently to justify burdens on, or risks to, the traditional
scientific process.
D. Cost Reimbursement
Many commenters sought clarification about the ``reasonable fee''
agencies may charge, pursuant to the provision contained in Public Law
105-277. OMB believes the ``reasonable fee,'' which is intended to
cover the cost of obtaining the requested data, is separate from the
FOIA fee an agency could assess under 5 U.S.C. 552(a)(4)(A). In light
of the congressional intent that Federal agencies and researchers be
reimbursed by the requester for the costs that they incur in responding
to the request, OMB has concluded that agencies may retain this new
fee, in order to reimburse themselves, recipients, and applicable
subrecipients, for the costs they incur.
OMB seeks comments on (1) Estimates of potential incremental costs
to be incurred by Federal agencies, their recipients, and applicable
subrecipients in carrying out the proposed revision, and (2) the
mechanisms available to recipients to charge to their awards the costs
that they would incur (e.g., ``direct'' versus ``indirect'' charge, or
by contract).
After receiving comments, OMB will consider revising OMB Circular
A-21, ``Cost Principles for Educational Institutions,'' as necessary to
ensure recipient institutions are reimbursed for the incremental costs
of complying with the provision contained in Public Law 105-277.
OMB encourages interested parties to provide comments on these four
concepts at this time so that any concerns may be addressed in OMB's
development of the final revision to the Circular, pursuant to the
direction of Public Law 105-277. OMB intends to publish the final
revision on or before September 30, 1999.
Issued in Washington, D.C., August 5, 1999.
Norwood J. Jackson,
Acting Controller.
Pursuant to the direction of Public Law 105-277, OMB proposes to
amend Section ____.36 of OMB Circular A-110 by revising paragraph (c),
redesignating paragraph (d) as paragraph (e), and adding new paragraph
(d) to read as follows:
____.36 Intangible property.
* * * * *
(c) The Federal Government has the right to:
(1) Obtain, reproduce, publish or otherwise use the data first
produced under an award; and
(2) Authorize others to receive, reproduce, publish, or otherwise
use such data for Federal purposes.
(d)(1) In addition, in response to a Freedom of Information Act
(FOIA) request for research data relating to published research
findings produced under an award that were used by the Federal
Government in developing a regulation, the Federal awarding agency
shall request, and the recipient shall provide, within a reasonable
time, the research data so that they can be made available to the
public through the procedures established under the FOIA. If the
Federal awarding agency obtains the research data solely in response to
a FOIA request, the agency may charge the requester a reasonable fee
equaling the full incremental cost of obtaining the research data. This
fee should reflect costs incurred by the agency, the recipient, and
applicable subrecipients. This fee is in addition to any fees the
agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).
(2) The following definitions are to be used for purposes of
paragraph (d) of this section:
(i) Research data is defined as the recorded factual material
commonly accepted in the scientific community as necessary to validate
researching findings, but not any of the following: preliminary
analyses, drafts of scientific papers, plans for future research, peer
reviews, or communications with colleagues. This ``recorded'' material
excludes physical objects (e.g., laboratory samples). Research data
also do not include:
(A) Trade secrets, commercial information, materials necessary to
be held confidential by a researcher until publication of their results
in a peer-reviewed journal, or information which may be copyrighted or
patented; and
(B) Personnel and medical files and similar files the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy, such as information that could be used to identify a
particular person in a research study.
(ii) Published is defined as either when:
(A) Research findings are published in a peer-reviewed scientific
or technical journal; or
(B) A Federal agency publicly and officially cites to the research
findings in support of a regulation.
(iii) Used by the Federal Government in developing a regulation is
defined as when an agency publicly and officially cites to the research
findings in support of a regulation (for which notice and comment is
required under 5 U.S.C. 553).
* * * * *
[FR Doc. 99-20683 Filed 8-10-99; 8:45 am]
BILLING CODE 3110-01-P