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 P.L. 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 P.L. 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 P.L. 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 (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. 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 (/OMB), under
the heading "Grants Management." Copies of P.L. 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 P.L. 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 P.L. 105-277, OMB published
a Notice of Proposed Revision to the Circular on February 4, 1999.
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 P.L. 105-277 and the proposed revision would have on scientific
research. They sought protection for the privacy of research 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 P.L. 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
P.L. 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 P.L. 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 P.L. 105-277: P.L. 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." P.L. 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.
B.
OMB's Proposed Revision to Circular A-110: In response
to the congressional direction in P.L. 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
P.L. 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
P.L. 105-277 in the form of the proposed revision while 37 percent
opposed the language of P.L. 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 P.L.
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 P.L. 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
P.L. 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.
II.
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 P.L 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 P.L. 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 P.L. 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
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 P.L. 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 P.L. 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 P.L. 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 P.L. 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 P.L. 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 P.L. 105-277 argued for an
interpretation under which "policy or rules" would refer to 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 P.L. 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 P.L. 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, an 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 P.L. 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 P.L. 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 P.L. 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 P.L. 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 P.L. 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 P.L. 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 P.L. 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 P.L. 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 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 P.L. 105-277 beyond the regulatory context.
Accordingly,
in order to advance implementation of the requirements of P.L. 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 P.L. 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 (P.L. 104-4, 2 U.S.C. 1532,
1535) and the Congressional Review Act (P.L. 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 P.L. 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 P.L. 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 P.L. 105-277. OMB intends to publish the final revision
on or before September 30, 1999.
Issued
in Washington, D.C., August 5, 1999.
/s/
Norwood J. Jackson
Acting Controller
Pursuant
to the direction of P.L. 105-277, OMB proposes to amend Section
__.36 of OMB Circular A-110 to read as follows:
(a)
[No change]
(b)
[No change]
(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 subsection
(d):
(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).
(e)
[Re-designation of text currently in section 36(d)]
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