[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Rules and Regulations]
[Pages 50589-50591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20610]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 20
[Docket No. FDA-2012-N-0205]
Agreements and Memoranda of Understanding Between the Food and
Drug Administration and Other Departments, Agencies, and Organizations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: This final rule makes technical changes that will update a
requirement that many of the written agreements and memoranda of
understanding (MOUs) between the Food and Drug Administration (FDA) and
other departments, Agencies, and organizations be published in the
Federal Register. Because we already post and will continue to post our
ongoing agreements and MOUs with other departments, Agencies, and
organizations on our Web site upon their completion, this requirement
is no longer necessary. This final rule, accordingly, eliminates it. We
are making these technical changes to conserve Agency time and
resources, reduce government paperwork, and eliminate unnecessary
Federal Register printing costs while continuing to afford public
access to these documents.
DATES: This rule is effective October 22, 2012.
FOR FURTHER INFORMATION CONTACT: Daniel W. Sigelman, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 301-796-4706, FAX: 301-847-8616,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Rulemaking Procedure
In the Federal Register of March 23, 2012 (77 FR 16923), FDA
published a direct final rule to eliminate the requirement that many of
our written agreements and MOUs with other departments, Agencies, and
organizations be published in the Federal Register. We explained that
we issued this rule as a direct final rule because we believed it was
noncontroversial and did not anticipate receiving significant adverse
comments. We concurrently published in the Federal Register of March
23, 2012 (77 FR 16971) a companion proposed rule, substantively
identical to the direct final rule, that provided a procedural
framework from which to proceed with standard notice-and-comment
rulemaking in the event we were required to withdraw the direct final
rule because of significant adverse comments. A significant adverse
comment is defined as a comment that explains why the rule would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without change. Any
comments received under the companion proposed rule were treated as
comments regarding the direct final rule and vice versa. A full
description of FDA's policy on direct final rule procedures may be
found in a guidance document published in the Federal Register of
November 21, 1997 (62 FR 62466). This guidance document may be accessed
at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
We received one comment on the proposed rule, which we considered
significantly adverse. Therefore, in the Federal Register of June 27,
2012 (77 FR 38173), we withdrew the direct final rule. This final rule
summarizes and responds to this comment on the direct final rule and
proposed rule. See section IV of this document for a discussion of the
comment and FDA's response.
II. Background
In the Federal Register of October 3, 1974 (39 FR 35697), we
announced that copies of all our MOUs transacted with government
Agencies and nongovernment organizations were available for public
review at our offices during working hours and would be published in
the Federal Register. We subsequently codified this policy in the
Federal Register of December 24, 1974 (39 FR 44602 at 44651) and
recodified it where it currently appears at Sec. 20.108 (21 CFR
20.108) in the Federal Register of March 22, 1977 (42 FR 15616 at
15625).
Consumers, industry, professional groups, associations, educators,
and other government Agencies had manifested widespread interest in the
texts of these MOUs. The intent of Sec. 20.108 was to promote
transparency by providing access to these stakeholders.
III. Summary of the Final Rule
This final rule will eliminate the requirement in current Sec.
20.108(c) that our agreements and MOUs with other departments,
Agencies, and organizations be published in the Federal Register on an
individual basis and instead will require that they be posted on our
Web site as completed. We increasingly rely on Internet-based
communications to ensure and promote transparency in our operations and
activities. So it is with this final rule, which merely recognizes and
codifies our already established practice of making our ongoing
agreements and MOUs with other departments, Agencies, and organizations
publicly available on our Web site. At the time of this writing, each
such publicly disclosable agreement and MOU can be accessed at one of
the following three FDA Web site locations: http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/default.htm; http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/AcademiaMOUs/default.htm; or http://www.fda.gov/AboutFDA/PartnershipsCollaborations/
[[Page 50590]]
MemorandaofUnderstandingMOUs/OtherMOUs/default.htm.
Because all publicly disclosable agreements and MOUs are posted on
our Web site, it is no longer necessary to require, as does current
Sec. 20.108(b), that a permanent file of them be available for public
review during working hours in the Agency's Freedom of Information
Public Reading Room. Accordingly, this rule will revise current Sec.
20.108(b).
The public's access to an FDA Web site that is regularly updated to
include agreements and MOUs as they are completed has already greatly
enhanced the speed, ease, and convenience with which stakeholders can
obtain and review these documents.
The rule's technical changes will lessen demands on the time of our
staff and reduce the government paperwork and printing costs associated
with Federal Register publication of newly completed agreements and
MOUs with other departments, Agencies, and organizations. At the same
time, it will continue to ensure, consistent with the underlying intent
of Sec. 20.108, the accessibility of records of widespread interest to
consumers, industry, professional groups, associations, educators, and
other government Agencies.
Currently, Sec. 20.108(c) treats our cooperative work-sharing
agreements with State or local government Agencies differently from our
agreements and MOUs with other Agencies and organizations. Because
these cooperative work-sharing agreements rarely vary significantly
from one another, we decided against publishing their full texts in the
Federal Register (51 FR 19851; June 3, 1986). Instead, since 1993, we
have merely required them to be listed at least once every 2 years in
the Federal Register (58 FR 48794; September 20, 1993). This final rule
will end such disparate treatment. Revised Sec. 20.108(b) will apply
to all of our written agreements and MOUs with other departments,
Agencies, and organizations, including cooperative work-sharing
agreements with State or local government Agencies, except for signed
agreements and MOUs relating to activities of our Office of Criminal
Investigations, which are addressed in Sec. 20.108(d), which will be
revised and redesignated as Sec. 20.108(c).
This final rule does not amend Sec. 20.108(a) (stating that our
written agreements and MOUs are available for public disclosure).
IV. Comment on the Proposed Rule and FDA's Response
We received one comment on the proposed rule. A summary of that
comment and FDA's response follow.
(Comment 1) While acknowledging ``FDA's efforts to reduce printing
costs associated with publication of newly completed'' agreements and
MOUs, the comment urged that such documents be published in full in the
Federal Register, as they constitute ``vital aspects of FDA's
mission,'' and the Federal Register has been designated as the one
place where important governmental actions can be found. The comment
maintained that the Federal Register embodies a permanently available
historical record providing potentially necessary details for
recreating Agency thinking or policy at a given time. By contrast, the
comment continued, FDA removes obsolete documents from its Web site as
it continuously updates it, thereby rendering that Web site unreliable
as an Agency historical record. It additionally contended that on
numerous occasions when FDA has updated its Web site, information has
become difficult to find or links no longer connect to appropriate Web
site pages.
(Response) We believe that the burden and costs imposed by Federal
Register publication of agreements and MOUs, which include not only the
printing costs acknowledged by the comment, but also the time of FDA
staff and associated government paperwork, outweigh any arguable
interest in reproducing these documents in their entirety in the
Federal Register. To the extent that any of these documents are
eventually no longer accessible on FDA's Web site, they, like numerous
other significant documents that are not reprinted in the Federal
Register, constitute permanent Agency records required to be archived
and made available to the public on request.
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule does not impose any significant
costs, we certify that it will not have a significant economic impact
on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
rule to result in any 1-year expenditure that would meet or exceed this
amount.
VI. Paperwork Reduction Act of 1995
We have concluded that this final rule contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520)
is not required.
VII. Environmental Impact
We have determined under 21 CFR 25.33 that this final rule is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that this final
rule does not contain policies that have substantial direct effects on
the States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we have concluded that this
final rule does not contain policies that have federalism implications
as defined in the Executive order and, consequently, a federalism
summary impact statement is not required.
[[Page 50591]]
List of Subjects in 21 CFR Part 20
Confidential business information, Courts, Freedom of information,
Government employees.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
20 is amended as follows:
PART 20--PUBLIC INFORMATION
0
1. The authority citation for 21 CFR part 20 continues to read as
follows:
Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21
U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.
0
2. Section 20.108 is amended as follows:
0
a. Revise paragraph (b);
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b. Remove paragraph (c);
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c. Redesignate paragraph (d) as paragraph (c);
0
d. Revise newly redesignated paragraph (c).
The revisions read as follows:
Sec. 20.108 Agreements between the Food and Drug Administration and
other departments, agencies, and organizations.
* * * * *
(b) All written agreements and memoranda of understanding between
FDA and any entity, including, but not limited to other departments,
Agencies, and organizations will be made available through the Food and
Drug Administration Web site at http://www.fda.gov once finalized.
(c) Agreements and understandings signed by officials of FDA with
respect to activities of the Office of Criminal Investigations are
exempt from the requirements set forth in paragraph (b) of this
section. Although such agreements and understandings will not be made
available through the FDA Web site, these agreements will be available
for disclosure in response to a request from the public after deletion
of information that would disclose confidential investigative
techniques or procedures, or information that would disclose guidelines
for law enforcement investigations if such disclosure could reasonably
be expected to risk circumvention of the law.
Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20610 Filed 8-21-12; 8:45 am]
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