OMB Circular A-110, ``Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations''

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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