Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations, 16971-16973 [2012-6969]
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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules
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:
Proposed rule.
We are publishing this
companion proposed rule to the direct
final rule on ‘‘Agreements and
Memoranda of Understanding Between
the Food and Drug Administration and
Other Departments, Agencies, and
Organizations,’’ which makes technical
changes intended to update a
requirement that many of these
agreements and memoranda of
understanding (MOUs) 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 proposed rule,
accordingly, would eliminate it. We are
proposing 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: Submit either electronic or
written comments on or before June 6,
2012. If we receive any significant
adverse comments, we will publish a
document withdrawing the direct final
rule within 30 days after the comment
period ends. We will then proceed to
respond to comments under this
proposed rule using the usual notice
and comment procedures.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2012–N–
0205 by any of the following methods:
SUMMARY:
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
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• Mail/Hand delivery/Courier (for
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2012–N–0205 for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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: daniel.sigelman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. 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 in § 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.
This proposed rule would 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. We increasingly
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16971
rely on Internet-based communications
to ensure and promote transparency in
our operations and activities. So it is
with this proposed rule, which would
merely recognize and codify 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 Food and
Drug Administration (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/
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 Room. Accordingly, the proposed
rule would 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.
Our proposed technical changes
would 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
would 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
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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
(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
proposed rule would end such disparate
treatment. Proposed § 20.108(b) would
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
would be revised and redesignated as
§ 20.108(c).
This proposed rule would not amend
§ 20.108(a) (stating that our written
agreements and MOUs are available for
public disclosure).
II. Companion Document to Direct
Final Rulemaking
This proposed rule is a companion to
the direct final rule published elsewhere
in this issue of the Federal Register. The
direct final rule and this companion
proposed rule are substantively
identical. This companion proposed
rule provides the procedural framework
within which the rule may be finalized
in the event that any significant adverse
comment is received in response to the
direct final rule and it is withdrawn.
FDA is publishing the direct final rule
because we believe the rule is
noncontroversial, and we do not
anticipate receiving any significant
adverse comments. If no significant
adverse comment is received in
response to the direct final rule, no
further action will be taken related to
this proposed rule. Instead we will
publish a document confirming the
effective date within 30 days after the
comment period ends, confirming when
the direct final rule will go into effect.
If we receive any significant adverse
comment regarding the direct final rule,
we will withdraw the direct final rule
within 30 days after the comment
period ends and proceed to respond to
all of the comments under this
companion proposed rule using usual
notice-and-comment rulemaking
procedures under the Administrative
Procedures Act (APA) (5 U.S.C. 552a et
seq.). The comment period for this
companion proposed rule runs
concurrently with the comment period
for the direct final rule. Any comments
received under this companion
proposed rule will also be considered as
comments regarding the direct final
rule, and vice versa. We will not
provide additional opportunity for
comment. A significant adverse
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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 a change. In
determining whether an adverse
comment is significant and warrants
withdrawing a direct final rule, we will
consider whether the comment raises an
issue serious enough to warrant a
substantive response in a notice-andcomment process in accordance with
section 553 of the APA (5 U.S.C. 553).
Comments that are frivolous,
insubstantial, or outside the scope of the
rule will not be considered adverse
under this procedure. For example, a
comment recommending an additional
change to the rule will not be
considered a significant comment
unless the comment states why the rule
would be ineffective without the
additional change. In addition, if a
significant adverse comment applies to
part of a rule and that part can be
severed from the remainder of the rule,
we may adopt as final those parts of the
rule that are not the subject of a
significant adverse comment.
In the Federal Register of November
21, 1997 (62 FR 62466), we announced
the availability of the guidance
document entitled ‘‘Guidance for FDA
and Industry: Direct Final Rule
Procedures.’’ This guidance document
may be accessed at https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm125166.htm.
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 $136
million, using the most current (2010)
Implicit Price Deflator for the Gross
Domestic Product. We do not expect
this proposed rule to result in any 1year expenditure that would meet or
exceed this amount.
III. Analysis of Impacts
VI. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. We
have determined that the proposed rule,
if finalized, would not contain policies
that would 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 tentatively conclude
that the proposed 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.
FDA has examined the impacts of the
proposed 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 proposed 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 the proposed rule
would not impose any significant costs,
we propose to certify that the final rule
will not have a significant economic
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IV. Paperwork Reduction Act of 1995
We have concluded that this proposed
rule contains no ‘‘collections 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.
V. Environmental Impact
We have determined under 21 CFR
25.33 that this proposed rule is of a type
that would not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
VII. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules
heading of this document and they may
be accompanied by a supporting
memorandum or brief. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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, it is proposed that
21 CFR part 20 be amended as follows:
Dated: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6969 Filed 3–22–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 202
[Docket No. FDA–2009–N–0582]
RIN 0910–AG27
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.
Direct-to-Consumer Prescription Drug
Advertisements; Presentation of the
Major Statement in Television and
Radio Advertisements in a Clear,
Conspicuous, and Neutral Manner;
Reopening of the Comment Period
AGENCY:
PART 20—PUBLIC INFORMATION
2. Amend section 20.108 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 and redesignations read
as follows:
§ 20.108 Agreements between the Food
and Drug Administration and other
departments, Agencies, and organizations.
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
*
*
*
*
*
(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 the Food and Drug
Administration 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 Food and Drug
Administration 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,
HHS.
Proposed rule; reopening of
comment period on specific data.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period on specific data related
to a proposed rule published in the
Federal Register of March 29,, to
establish standards that would be
considered in determining whether the
major statement in direct-to-consumer
(DTC) television and radio
advertisements relating to the side
effects and contraindications of an
advertised prescription drug intended
for use by humans is presented in a
clear, conspicuous, and neutral manner.
In the Federal Register of January 27,
2012, FDA announced that it had added
a document to the docket for the
proposed rulemaking concerning a
study entitled ‘‘Experimental Evaluation
of the Impact of Distraction on
Consumer Understanding of Risk and
Benefit Information in Direct-toConsumer Prescription Drug Television
Advertisements’’ (Distraction Study)
and the public was given until February
27, 2012, to comment on this study as
it relates to the proposed standards.
FDA is reopening the comment period
for the rulemaking proceeding in
response to a request for more time to
submit comments to the Agency.
DATES: Submit either electronic or
written comments on the Distraction
Study report as it relates to the proposed
standards by April 9, 2012.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2009–N–
0582 and/or Regulatory Information
Number (RIN) 0910–AG27, by any of the
following methods.
SUMMARY:
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16973
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (For
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name, docket
number, and RIN for this rulemaking.
All comments received may be posted
without change to https://www.
regulations.gov, including any personal
information provided. For additional
information on submitting comments,
see the ‘‘Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://www.
regulations.gov and insert the docket
number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
For information concerning human
drug products: Ernest S. Voyard, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 3276,
Silver Spring, MD 20993–0002, 301–
796–3832.
For information concerning human
biological drug products: Stephen
Ripley, Center for Biologics Evaluation
and Research (HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 29,
2010 (75 FR 15376), FDA published a
proposed rule entitled ‘‘Direct-toConsumer Prescription Drug
Advertisements; Presentation of the
Major Statement in Television and
Radio Advertisements in a Clear,
Conspicuous, and Neutral Manner,’’ to
amend its regulations concerning DTC
advertisements of prescription drugs.
Specifically, the proposed rule would
implement a new requirement of the
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]]>Agencies
[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Proposed Rules]
[Pages 16971-16973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6969]
[[Page 16971]]
=======================================================================
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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: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are publishing this companion proposed rule to the direct
final rule on ``Agreements and Memoranda of Understanding Between the
Food and Drug Administration and Other Departments, Agencies, and
Organizations,'' which makes technical changes intended to update a
requirement that many of these agreements and memoranda of
understanding (MOUs) 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
proposed rule, accordingly, would eliminate it. We are proposing 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: Submit either electronic or written comments on or before June
6, 2012. If we receive any significant adverse comments, we will
publish a document withdrawing the direct final rule within 30 days
after the comment period ends. We will then proceed to respond to
comments under this proposed rule using the usual notice and comment
procedures.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0205 by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-0205 for this rulemaking. All comments
received may be posted without change to https://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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:
daniel.sigelman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. 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 in 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.
This proposed rule would 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. We increasingly rely on Internet-based communications to
ensure and promote transparency in our operations and activities. So it
is with this proposed rule, which would merely recognize and codify 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 Food and Drug Administration (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/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 Room. Accordingly, the proposed rule would 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.
Our proposed technical changes would 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 would 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
[[Page 16972]]
(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 proposed rule would
end such disparate treatment. Proposed Sec. 20.108(b) would 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 would be
revised and redesignated as Sec. 20.108(c).
This proposed rule would not amend Sec. 20.108(a) (stating that
our written agreements and MOUs are available for public disclosure).
II. Companion Document to Direct Final Rulemaking
This proposed rule is a companion to the direct final rule
published elsewhere in this issue of the Federal Register. The direct
final rule and this companion proposed rule are substantively
identical. This companion proposed rule provides the procedural
framework within which the rule may be finalized in the event that any
significant adverse comment is received in response to the direct final
rule and it is withdrawn. FDA is publishing the direct final rule
because we believe the rule is noncontroversial, and we do not
anticipate receiving any significant adverse comments. If no
significant adverse comment is received in response to the direct final
rule, no further action will be taken related to this proposed rule.
Instead we will publish a document confirming the effective date within
30 days after the comment period ends, confirming when the direct final
rule will go into effect.
If we receive any significant adverse comment regarding the direct
final rule, we will withdraw the direct final rule within 30 days after
the comment period ends and proceed to respond to all of the comments
under this companion proposed rule using usual notice-and-comment
rulemaking procedures under the Administrative Procedures Act (APA) (5
U.S.C. 552a et seq.). The comment period for this companion proposed
rule runs concurrently with the comment period for the direct final
rule. Any comments received under this companion proposed rule will
also be considered as comments regarding the direct final rule, and
vice versa. We will not provide additional opportunity for comment. 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 a change. In determining whether an adverse comment is
significant and warrants withdrawing a direct final rule, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the APA (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered adverse under this procedure. For example, a comment
recommending an additional change to the rule will not be considered a
significant comment unless the comment states why the rule would be
ineffective without the additional change. In addition, if a
significant adverse comment applies to part of a rule and that part can
be severed from the remainder of the rule, we may adopt as final those
parts of the rule that are not the subject of a significant adverse
comment.
In the Federal Register of November 21, 1997 (62 FR 62466), we
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures.'' This guidance
document may be accessed at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
III. Analysis of Impacts
FDA has examined the impacts of the proposed 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 proposed 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 the proposed rule would not impose any
significant costs, we propose to certify that the final rule 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 $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
IV. Paperwork Reduction Act of 1995
We have concluded that this proposed rule contains no ``collections
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.
V. Environmental Impact
We have determined under 21 CFR 25.33 that this proposed rule is of
a type that would not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule, if finalized, would not contain policies that would
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 tentatively conclude that the proposed 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.
VII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the
[[Page 16973]]
heading of this document and they may be accompanied by a supporting
memorandum or brief. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
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, it is
proposed that 21 CFR part 20 be amended as follows:
PART 20--PUBLIC INFORMATION
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.
2. Amend section 20.108 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 and redesignations 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 the Food
and Drug Administration 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 Food and Drug
Administration 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: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6969 Filed 3-22-12; 8:45 am]
BILLING CODE 4160-01-P
