[Federal Register Volume 64, Number 154 (Wednesday, August 11, 1999)]
[Notices]
[Pages 43786-43791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20683]


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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.

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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 ([email protected]), 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]
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