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:
Final Revision
SUMMARY:
This notice finalizes the revision to OMB Circular A-110, required
by a provision of OMB's appropriation for fiscal year (FY) 1999,
contained in Public Law 105-277. The provision directs OMB to amend
Section ___.36, Intangible property, 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 the provision contained in Public Law 105-277,
OMB published a Notice of Proposed Revision on February 4, 1999
(64 FR 5684), and a request for comments on clarifying changes to
the proposed revision on August 11, 1999 (64 FR 43786). We received
over 9,000 comments on the proposed revision and over 3,000 comments
on the clarifying changes.
After
a review of the comments on the clarifying changes, as well as the
comments on the proposed revision, OMB is issuing this final revision
to the Circular, as required by the provision contained in Public
Law 105-277.
DATES:
The revised Circular is effective November 6, 1999.
ADDRESSES:
You may obtain the full text of the Circular, the text of this notice,
and the text of the February 4th and August 11th
notices on OMB's home page (/OMB), under the heading "Grants Management."
You many obtain copies of Public Law 105-277 on 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. Please direct
press inquiries to OMB's Communications Office, at (202) 395-7254.
SUPPLEMENTARY
INFORMATION:
I.
Background
A.
The Statutory Direction to Amend Circular A-110
Congress
included a two-sentence provision in OMB's appropriation for FY
1999, contained in Public Law 105-277, directing 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." The provision also provides for a reasonable
fee to cover the costs incurred in responding to a 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.
In
directing OMB to revise the Circular, Congress entrusted OMB with
the authority to resolve statutory ambiguities, the obligation
to address implementation issues the statute did not address,
and the discretion to balance the need for public access to research
data with protections of the research process. In developing this
revision to the Circular, OMB seeks to implement the statutory
language fairly, in the context of its legislative history. This
requires a balanced approach that (1) furthers the interest of
the public in obtaining the information needed to validate Federally-funded
research findings, (2) ensures that research can continue to be
conducted in accordance with the traditional scientific process,
and (3) implements a public access process that will be workable
in practice.
OMB
recognizes the importance of ensuring that the revised Circular
does not interfere with the traditional scientific process. Science
and technology are the principal agents of change and progress,
with over half of the Nation's labor productivity growth 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 appear
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. When the Federal Government changes the
requirements that apply to researchers whom it funds, it needs
to ensure that the changes do not interfere with cutting-edge
science and the benefits that such science provides to the American
people.
During
the revision process, many commenters expressed concern that the
statute would compel Federally-funded researchers to work in a
"fishbowl" in which they would be required to reveal the results
of their research, and their research methods, prematurely. They
argued that this could prevent researchers from operating under
the traditional scientific process. As in many other fields of
endeavor, scientists need to deliberate over, develop, and pursue
alternative approaches in their research before making results
public. When a scientist is sufficiently confident of their results,
they publish them for the scrutiny of other scientists and the
community at large. Accordingly, in light of this traditional
scientific process, we have not construed the statute as requiring
scientists to make research data publicly available while the
research is still ongoing.
B.
OMB's Two Requests for Public Comment on the Proposed Revision
To
address implementation issues, OMB published two notices in the
Federal Register requesting public comment on the proposed revision
to the Circular. Interested parties can consult these notices,
which provide extensive background information, for a more complete
understanding of the final revision. The original proposal appeared
on February 4, 1999 (64 FR 5684). It would have revised Section
___.36 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))."
OMB
received over 9,000 comments in response to the proposed revision.
Commenters offered strongly differing views on the provision contained
in P.L. 105-277. Those 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. They acknowledged 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. However, 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.
Many
commenters on the original proposal 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 agreed that clarification was needed
for these concepts. On August 11, 1999, OMB published a second
notice (64 FR 43786), requesting public comment on clarifications
to the proposed revision:
"(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).
The
August 11th notice explained these clarifications were
intended to implement the statute in a manner that (1) furthers
the interest of the public in obtaining the information needed
to validate Federally-funded research findings, (2) ensures that
research can continue to be conducted in accordance with the traditional
scientific process, and (3) implements a public access process
that will be workable in practice. OMB received over 3,000 comments
in response to the clarifying changes.
After
considering the views and concerns of all the commenters, OMB
now issues a final revision to the Circular. Although the final
revision resembles the clarifying changes proposed on August 11,
1999, it reflects additional changes in response to the public
comments.
Issuance
of this final revision meets the statutory requirement imposed
by OMB's appropriation for FY 1999 within the time in which it
has legal effect. As OMB and the agencies develop experience with
the revised Circular, changes to the data access process may be
considered. These could range from technical and clarifying changes
to substantive revision or rescission. OMB also endeavors to review
each of its Circulars every three years.
II.
Comments on the Clarifying Changes to the Proposed Revision
A.
Research Data
A
number of commenters objected that the proposed definition of
"research data" would transfer authority to determine which records
are exempt from mandatory disclosure under FOIA from Federal agencies
to recipients. It was not OMB's intent to transfer the agency's
FOIA exemption authority to recipients. Rather, we were providing
a definition for what constitutes research "data," a term that
is not defined in the provision contained in Public Law 105-277.
We have always understood that it would be the recipient, not
Federal agency staff, who would identify the research data in
the recipient's files which are responsive to a FOIA request.
In the over 12,000 comments OMB received on the proposed revision,
we are not aware of any suggestion that Federal agency staff should
perform the search of a recipient's offices to identify responsive
research data. The fact that the recipient is responsible for
searching for, and identifying, the research data does not mean
the Circular has transferred the agencies' responsibility to recipients.
When the recipient searches files for responsive research data,
pursuant to Section .___36(d), and in so doing applies the definition
of "research data," the recipient is not exercising the agencies'
authority under FOIA to determine exemptions. Rather, the recipient
is simply identifying the research data that must be provided
to the agency. The Federal awarding agency would retain its right
to ask the recipient for additional information, if it believed
the recipient's submission was not complete.
Several
commenters expressed concern because the proposed definition of
"research data" excluded "information which may be copyrighted
or patented." These commenters believed the proposed language
was too broad. They argued that, under copyright law, a wide range
of materials "may be" copyrighted, and therefore that such a test
could have unintended consequences for the scope of the public
access process. In reviewing this language, we note that the protections
available in the other parts of the definition (in particular,
those protecting "trade secrets" and "commercial information")
broadly protect the intellectual property rights of researchers.
The proposed definition was not intended to create additional
protections for intellectual property, but rather to ensure that
existing protections continue to be respected. To avoid unintended
consequences, and to avoid having to sort out the complexities
of copyright law (and how it might apply in various areas of Federally-funded
research), the final revision substitutes "similar information
which is protected under law" for "information which may be copyrighted
or patented." This language is intended to ensure that the public
access process will not upset intellectual property rights that
are elsewhere recognized and protected under the law.
Many
commenters suggested a change to the definition of "research data"
to ensure that appropriate data were protected from disclosure,
no matter what the format. Their suggestion was to replace the
word "files" with the word "information" in the phrase "[p]ersonnel
and medical files and similar files the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy."
Examples of research data that might not be considered to be in
the form of a "file" include video or audio tapes of research
subjects. We agree with this technical change and have included
it in the final revision to the Circular.
Several
commenters noted that the definition of "research data" excluded
"materials necessary to be held confidential until publication
of their results in a peer-reviewed journal." However, since this
language is not exactly the same as that used in the definition
of "published," ("either when: (A) Research findings are published
in a peer-reviewed scientific or technical journal; or (B) A Federal
agency publicly and officially cites the research findings in
support of an agency action that has the force and effect of law")
it appeared that the two might be in conflict. We have revised
the definition of "research data" to avoid any conflict between
the two definitions.
Finally,
several commenters asked for a clarification to the revision pertaining
to research data already available to the public. They suggested
that if a request is made for research data the recipient has
already made available to the public, through a data archive or
other means, further action should not be necessary. Since this
principle is used when a Federal agency responds to FOIA requests,
it makes sense to apply it in this case as well. However, the
Federal awarding agency should respond to the FOIA request with
directions on how the requester can access the publicly available
research data.
B.
Used by the Federal Government in Developing a Regulation
A
number of commenters objected to the definition which applied
the revision to research data that are used by the Federal Government
in developing a "regulation." These commenters had generally been
satisfied with the language found in the proposed revision ("used
by the Federal Government in developing policy or rules"), because
it had been used by congressional sponsors during the legislative
consideration of Public Law 105-277. However, these commenters
believed that the clarifying changes significantly narrowed the
scope of the revision.
As
we explained in the August 11th notice, its clarification was
intended "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" (64 FR 43791).
We sought to refer to agency actions that have "the force and
effect of law" when it included "a regulation (for which notice
and comment is required under 5 U.S.C. 553)" in the proposed definitions.
While it is true that agencies also take actions that have "the
force and effect of law" when they issue administrative orders
(e.g., decisions issued by administrative law judges), we think
that agencies rarely rely on Federally-funded research in the
context of their administrative orders. Nevertheless, in response
to the comments, we have changed the revision to refer to "an
agency action that has the force and effect of law" rather than
to "a regulation."
We
believe this change addresses the concerns of most commenters.
We note that a comment letter from Senators Shelby, Lott, Campbell,
and Gramm stated that the revision should not be limited to regulations,
but should apply generally to "federal actions that can dramatically
impact the public." Agency actions that have "the force and effect
of law" certainly represent "federal actions that can dramatically
impact the public." Indeed, it is through actions that have the
force and effect of law that an agency (in the words of one business
association) "imposes costs, mandates, restrictions, obligations
and responsibilities on the regulated community." However, as
stated in the August 11th notice, we have decided not
to extend the scope of the revision to agency guidance documents
and other issuances that do not have the force and effect of law.
We continue to believe that the public interest in such access
is less than where the agency is taking action that has the force
and effect of law, and that the revision would not be workable
in those circumstances. Some commenters, who argued for a broader
application, nevertheless were sympathetic to OMB's desire that
the public access provision be workable. For example, one commenter
stated that "the reproposal may be a workable first step
in implementation. OMB could start with its August position and
see how the system works."
A
number of commenters raised a concern about whether requesters
would be able to obtain the research data sufficiently in advance
of when public comments are due on proposed regulations. These
commenters offered various suggestions for how the Circular might
be revised to address this concern. In the prior two notices,
OMB has proposed a "reasonable time" standard for the response
to a request for research data. Since OMB and the agencies do
not yet have experience with implementing the public access process,
we believe the "reasonable time" standard, which allows consideration
of the circumstances of a particular case, is appropriate. As
OMB and the agencies gain experience with the public access process,
we may be able to develop further clarification on this point.
Finally,
in the August 11th notice, OMB also requested comment
"on whether limiting the scope of the proposed revision to regulations
that meet [a] $100 million [impact] threshold would be appropriate"
(64 FR 43791). Such a limitation received strong support, as well
as strong opposition from commenters. For now, we have decided
not to limit the scope of the revision to agency actions that
have an impact in excess of $100 million. As OMB and the agencies
develop experience from implementing the revision, we may revisit
this issue.
C.
Published
Commenters
generally supported the proposed definition of "published." Some
in the research community were more supportive of the first part
of the definition (when "[r]esearch findings are published in
a peer-reviewed scientific or technical journal") rather than
the second part (when "[a] Federal agency publicly and officially
cites the research findings in support of" an agency action).
However, those who support the provision in Public Law 105-277
argued that the second part is necessary to ensure that the public
can have access to the data that underlies Federally-funded research
findings on which agencies rely to support their actions. We continue
to believe that both parts of the definition are important to
successful implementation of a data access provision that furthers
the interest of the public in obtaining information while ensuring
that research can continue to be conducted in accordance with
the traditional scientific process. The only change that has been
made to the definition of "published" is to make conforming revisions
to reflect the previously-discussed change from "used by the Federal
Government in developing a regulation" to "used by the Federal
Government in developing an agency action that has the force and
effect of law."
D.
Cost Reimbursement
Many
commenters, particularly recipients of Federally-funded research
awards, expressed concern about the reimbursement mechanisms available
under the proposed revision. In cases where the award's funding
period expires before a request is made, neither the direct nor
indirect methods of charging would allow reimbursement. Comments
generally focused on the need for a separate agreement between
the Federal awarding agency and the recipient, which would cover
the full incremental cost of responding to the request. The process
for such an agreement could work as follows:
When
a request is received by the Federal awarding agency, it would
pass the request on to the recipient for an assessment of the
costs of complying. Once the recipient has estimated an amount,
the Federal awarding agency can apply its existing standards for
requesting appropriate prepayments from the requester, as with
the FOIA fee. When the recipient transmits the responsive research
data to the agency, it should include an accounting for the associated
costs. The Federal awarding agency will then seek reimbursement
from the FOIA requester and reimburse the recipient.
If
we determine that this mechanism is not adequate, we will consider
revising OMB Circular A-21, "Cost Principles for Educational Institutions,"
as necessary to ensure that recipient institutions are reimbursed
for the incremental costs of complying with the provision contained
in Public Law 105-277.
E.
Record Retention
Some
commenters questioned whether the final revision would impose
additional record retention requirements on recipients. The final
revision only affects Section .___36, which does not discuss recordkeeping
responsibilities. Section .___53, Retention and access requirements
for records, requires that "[f]inancial records, supporting documents,
statistical records, and all other records pertinent to an award
shall be retained for a period of three years from the date of
submission of the final expenditure report." In addition, "[t]he
Federal awarding agency...ha[s] the right of timely and unrestricted
access to any books, documents, papers, or other records of recipients
that are pertinent to the awards...The rights of access in this
paragraph are not limited to the required retention period, but
shall last as long as records are retained." Therefore, if a recipient
chooses to keep records longer than three years, the recipient
must make them available for review in response to requests from
the Federal awarding agency.
F.
Effective Date
Many
commenters sought clarification on the effective date for the
final revision. As stated above, the revised Circular is effective
thirty days after it appears in the Federal Register. The revised
Circular is effective for awards issued after the effective date
and those continuing awards which are renewed after the effective
date.
G.
Projects Funded from Multiple Sources
Some
commenters asked whether the final revision would apply in situations
where research was funded not only by the Federal Government but
also by other entities. As noted in the proposed revision, the
legislative history to the provision contained in Public Law 105-277
indicates 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." 144 Cong. Rec. S12134
(October 9, 1998) (Statement of Sen. Campbell). This statement
is consistent with OMB's longstanding interpretation of the Circular
which holds that it is applicable to all recipients, regardless
of whether they also receive non-Federal funds.
H.
Procurement Contracts
Some
commenters asked whether the final revision would apply to research
that is funded by a Federal agency through a procurement contract.
However, the Circular does not apply to procurement contracts.
Section .___2(e) of the Circular defines "award," and specifically
excludes "contracts which are required to be entered into and
administered under procurement laws and regulations."
Issued
in Washington, DC, September 30, 1999.
/s/
Jacob J. Lew
Director
As
directed by OMB's appropriation for FY 1999, contained in Public
Law 105-277, OMB hereby amends Section ___.36 of OMB Circular A-110
by revising paragraph (c), redesignating paragraph (d) as paragraph
(e), and adding a 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 an agency action that has the force
and effect of law, 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 apply 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 research 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 they are published,
or similar information which is protected under law; and
(B)
Personnel and medical information and similar information
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 the research
findings in support of an agency action that has the force
and effect of law.
(iii)
Used by the Federal Government in developing an agency action
that has the force and effect of law is defined as when an
agency publicly and officially cites the research findings in
support of an agency action that has the force and effect of law.
