[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Pages 54926-54930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26264]
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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: Final Revision
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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 8, 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 (http://www.whitehouse.gov/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
[[Page 54927]]
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 Public Law 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 Public Law
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
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.
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
[[Page 54928]]
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
[[Page 54929]]
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
[[Page 54930]]
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.
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.
[FR Doc. 99-26264 Filed 10-7-99; 8:45 am]
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