Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations, 50589-50591 [2012-20610]
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Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations
The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends chapter III of Title 14, Code of
Federal Regulations as follows:
PART 400—BASIS AND SCOPE
1. The authority citation for part 400
continues to read as follows:
■
Authority: 51 U.S.C. 50901–50923.
■
2. Revise § 400.2 to read as follows:
§ 400.2
Scope.
These regulations set forth the
procedures and requirements applicable
to the authorization and supervision
under 51 U.S.C. Subtitle V, chapter 509,
of commercial space transportation
activities conducted in the United States
or by a U.S. citizen. The regulations in
this chapter do not apply to—
(a) Space activities carried out by the
United States Government on behalf of
the United States Government; or
(b) The launch of an amateur rocket
as defined in § 1.1 of chapter I unless—
(1) The rocket is a Class 3 advanced
high-power rocket as defined in § 101.22
of chapter I; and
(2) The operator of the Class 3
advanced high-power rocket voluntarily
submits an application for a license or
a permit.
Issued in Washington, DC, on July 31,
2012.
Michael P. Huerta,
Acting Administrator.
[FR Doc. 2012–20671 Filed 8–21–12; 8:45 am]
BILLING CODE 4910–13–P
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.
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ACTION:
Final rule.
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
SUMMARY:
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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,
daniel.sigelman@fda.hhs.gov.
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 https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm125166.htm.
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50589
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 § 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
§ 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 § 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: https://
www.fda.gov/AboutFDA/
PartnershipsCollaborations/
MemorandaofUnderstandingMOUs/
DomesticMOUs/default.htm; https://
www.fda.gov/AboutFDA/
PartnershipsCollaborations/
MemorandaofUnderstandingMOUs/
AcademiaMOUs/default.htm; or https://
www.fda.gov/AboutFDA/
PartnershipsCollaborations/
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50590
Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations
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 § 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 § 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 § 20.108, the
accessibility of records of widespread
interest to consumers, industry,
professional groups, associations,
educators, and other government
Agencies.
Currently, § 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 § 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
§ 20.108(d), which will be revised and
redesignated as § 20.108(c).
This final rule does not amend
§ 20.108(a) (stating that our written
agreements and MOUs are available for
public disclosure).
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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
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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.
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Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations
List of Subjects in 21 CFR Part 20
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Confidential business information,
Courts, Freedom of information,
Government employees.
Food and Drug Administration
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
2. Section 20.108 is amended as
follows:
■ a. Revise paragraph (b);
■ b. Remove paragraph (c);
■ c. Redesignate paragraph (d) as
paragraph (c);
■ d. Revise newly redesignated
paragraph (c).
The revisions read as follows:
■
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*
*
*
*
(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 https://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.
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Food and Drug Administration,
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending its
regulations regarding compounds of
carcinogenic concern used in foodproducing animals. Specifically, the
Agency is clarifying the definition of
‘‘So’’ and revising the definition of ‘‘Sm’’
so that it conforms to the clarified
definition of So. Other clarifying and
conforming changes are also being
made.
SUMMARY:
This rule is effective September
21, 2012.
FOR FURTHER INFORMATION CONTACT:
Kevin Greenlees, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8214,
email: kevin.greenlees@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
§ 20.108 Agreements between the Food
and Drug Administration and other
departments, agencies, and organizations.
[FR Doc. 2012–20610 Filed 8–21–12; 8:45 am]
Animal Drugs, Feeds, and Related
Products; Regulation of Carcinogenic
Compounds in Food-Producing
Animals
HHS.
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.
Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[Docket No. FDA–2010–N–0612]
AGENCY:
1. The authority citation for 21 CFR
part 20 continues to read as follows:
■
*
21 CFR Part 500
I. Background
On December 20, 2010, FDA issued a
proposed rule (75 FR 79320) to amend
its regulations regarding compounds of
carcinogenic concern used in foodproducing animals. Specifically, the
Agency clarified the definition of ‘‘So’’
and revised the definition of ‘‘Sm’’ so
that it would conform to the clarified
definition of So. The Agency also
proposed a number of clarifying and
conforming changes.
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) contains three
anticancer, or Delaney, clauses: Sections
409(c)(3)(A), 512(d)(1)(I), and
721(b)(5)(B)(i) (21 U.S.C. 348(c)(3)(A),
360b(d)(1)(I), and 379e(b)(5)(B)(i)),
pertaining to food additives, new animal
drugs, and color additives, respectively.
These clauses prohibit approval of
substances that have been shown to
induce cancer in man or animals.
However, each clause contains an
exception, termed the
‘‘Diethylstilbestrol (DES) Proviso,’’ that
permits administration of such
substances to food-producing animals
where: (1) The food additive, color
additive, or new animal drug will not
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50591
adversely affect the animal and (2) no
residue of the food additive, color
additive, or new animal drug will be
found in any edible portion of that
animal by a method of examination
prescribed or approved by the Secretary
of Health and Human Services by
regulation. The regulations under part
500 (21 CFR part 500), subpart E
entitled ‘‘Regulation of Carcinogenic
Compounds Used in Food-Producing
Animals’’ (§§ 500.80 through 500.92),
implement the DES Proviso. To
elaborate on how to determine that there
is no residue, and thus demonstrate that
the second prong of the DES Proviso has
been satisfied, the regulations define
several terms, including So and Sm.
So is currently defined as the
concentration of the compound of
carcinogenic concern in the total diet of
test animals that corresponds to a
maximum lifetime risk of cancer to the
test animals of 1 in 1 million, and is
calculated from tumor data of the cancer
bioassays using a statistical
extrapolation procedure. The definition
of So also provides that FDA will
assume that the So corresponds to the
concentration of residue of carcinogenic
concern in the total human diet that
represents no significant increase in the
risk of cancer to people. The
concentration, derived from the So, of
residues of carcinogenic concern in a
specific edible tissue is termed the Sm.
This rule changes the definition of So
so that it is primarily defined as ‘‘the
concentration of a residue of
carcinogenic concern in the total human
diet that represents no significant
increase in the risk of cancer to the
human consumer * * *’’ and
secondarily as ‘‘the concentration of test
compound in the total diet of test
animals that corresponds to a maximum
lifetime risk of cancer in the test
animals of 1 in 1 million.’’ The change
in this rule to the definition of So is
intended to enable the Center for
Veterinary Medicine to consider
allowing the use of alternative
procedures to satisfy the DES Proviso
(See 75 FR 79320 at 79321) without
requiring the development of a second,
alternative, set of terminology. FDA
believes that the original intent of 21
CFR part 500, Subpart E, as reflected in
the preamble to the final rule
establishing that regulation, was to
place an emphasis on no significant
increase in the risk of cancer to the
human consumer, rather than on the
specific 1 in 1 million risk of cancer to
the test animals approach (See e.g., 52
FR 49572 at 49575 and 49582).
Therefore, FDA has concluded that the
redefinition of So is consistent with this
original intent of the regulation.
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]]>Agencies
[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Rules and Regulations]
[Pages 50589-50591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20610]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
daniel.sigelman@fda.hhs.gov.
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 https://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: https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/default.htm; https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/AcademiaMOUs/default.htm; or https://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);
0
b. Remove paragraph (c);
0
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 https://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]
BILLING CODE 4160-01-P
