Administrative Actions for Noncompliance; Lesser Administrative Actions, 19033-19036 [2016-07523]
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Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations
Regulatory Flexibility Act
We certify that this final rule will not
have a significant economic impact on
a substantial number of small entities
because it applies to individuals only.
Thus, a regulatory flexibility analysis is
not required under the Regulatory
Flexibility Act, as amended.
Paperwork Reduction Act
These rules do not create any new or
affect any existing collections and,
therefore, do not require Office of
Management and Budget approval
under the Paperwork Reduction Act.
(Catalog of Federal Domestic Assistance
Program No. 96.006, Supplemental Security
Income.)
List of Subjects in 20 CFR Part 404
Administrative practice and
procedure; Blind; Disability benefits;
Government employees; Old-age,
Survivors and Disability Insurance;
Reporting and recordkeeping
requirements; Social security.
4. In § 404.401, revise paragraph (a)(4)
to read as follows:
ADDRESSES:
§ 404.401 Deduction, reduction, and
nonpayment of monthly benefits or lumpsum death payments.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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(a) * * *
(4) An individual under full
retirement age (see § 404.409) is
concurrently entitled to disability
insurance benefits and to certain public
disability benefits (see § 404.408);
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■ 5. In § 404.408, revise paragraph
(a)(2)(ii) to read as follows:
§ 404.408 Reduction of benefits based on
disability on account of receipt of certain
other disability benefits provided under
Federal, State, or local laws or plans.
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(a) * * *
(2) * * *
(ii) The individual has not attained
full retirement age as defined in
§ 404.409.
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Dated: March 25, 2016.
Carolyn W. Colvin,
Acting Commissioner of Social Security.
[FR Doc. 2016–07602 Filed 4–1–16; 8:45 am]
BILLING CODE 4191–02–P
For the reasons set forth in the
preamble, we amend subparts D and E
of part 404 of title 20 of the Code of
Federal Regulations as set forth below:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950– ).
21 CFR Part 56
[Docket No. FDA–2015–N–5052]
Subpart D—[Amended]
1. The authority citation for subpart D
of part 404 continues to read as follows:
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Authority: Secs. 202, 203(a) and (b), 205(a),
216, 223, 225, 228(a)–(e), and 702(a)(5) of the
Social Security Act (42 U.S.C. 402, 403(a)
and (b), 405(a), 416, 423, 425, 428(a)–(e), and
902(a)(5)).
2. Amend § 404.317 by revising the
fourth sentence to read as follows:
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§ 404.317 How is the amount of my
disability benefit calculated?
* * * Your monthly benefit amount
may be reduced if you receive workers’
compensation or public disability
payments before you attain full
retirement age (as defined in § 404.409)
(see § 404.408). * * *
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Subpart E—[Amended]
3. The authority citation for subpart E
of part 404 continues to read as follows:
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Authority: Secs. 202, 203, 204(a) and (e),
205(a) and (c), 216(l), 222(c), 223(e), 224, 225,
702(a)(5), and 1129A of the Social Security
Act (42 U.S.C. 402, 403, 404(a) and (e), 405(a)
and (c), 416(l), 422(c), 423(e), 424a, 425,
902(a)(5), and 1320a–8a); 48 U.S.C. 1801.
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Administrative Actions for
Noncompliance; Lesser Administrative
Actions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Direct final rule.
The Food and Drug
Administration (FDA) is amending the
regulation describing lesser
administrative actions that may be
imposed on an Institutional Review
Board (IRB) that has failed to comply
with FDA’s IRB regulations. We are
clarifying that FDA may require the IRB
to withhold approval of new FDAregulated studies, stop the enrollment of
new subjects in ongoing studies, and
terminate ongoing studies, or any
combination of these actions until the
noncompliance with FDA’s IRB
regulations is corrected. We are taking
this action to ensure clarity and improve
the accuracy of the regulations.
DATES: This rule is effective August 17,
2016. Submit electronic or written
comments on this direct final rule or its
companion proposed rule by June 20,
2016.
SUMMARY:
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You may submit comments
as follows:
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–5052 for ‘‘Subpart E—
Administrative Actions for
Noncompliance; Lesser Administrative
Actions.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
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Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper 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:
Sheila Brown, Office of Good Clinical
Practice, Office of Special Medical
Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,
MD 20993–0002, 301–796–6563.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is amending § 56.120(b) (21 CFR
56.120(b)), which describes lesser
administrative actions that the Agency
may impose on an IRB until the IRB
takes appropriate action to correct the
IRB’s noncompliance. We are
publishing this direct final rule because
it is intended to clarify an existing
regulation, and we do not anticipate any
significant adverse comment regarding
this amendment to § 56.120(b).
Specifically, this direct final rule would
amend § 56.120(b) by clarifying that
FDA has authority to require the IRB to
withhold approval of new FDA-
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regulated studies conducted at the
institution or reviewed by the IRB,
direct that no new subjects be added to
ongoing studies, and terminate ongoing
studies provided that doing so would
not endanger study subjects.
This amendment also renumbers
current paragraphs (b)(4) and (c) as
paragraphs (c) and (d), respectively, and
inserts ‘‘FDA may’’ into newly
designated paragraph (c) so that it is a
complete sentence.
FDA first proposed requirements for
the composition and operations of
institutional review committees in the
‘‘Proposed Investigational Device
Exemptions,’’ published in the Federal
Register of August 20, 1976 (41 FR
35282; ‘‘Proposed IDE Rule’’). In that
document, FDA proposed
disqualification procedures for
institutional review committees and
requested comments on the proposed
procedures and other possible
administrative actions that FDA might
take against a committee that is not in
compliance with the regulations (41 FR
35282 at 35293). FDA also stated its
intention to publish uniform, Agencywide regulations governing clinical
investigations at a later date, including
requirements governing institutional
review committees (41 FR 35282 at
35283).
Subsequently, FDA published
‘‘Standards for Institutional Review
Boards for Clinical Investigations’’ on
August 8, 1978 (43 FR 35186; ‘‘Proposed
IRB Standards’’). Comments on
implementing institutional review
requirements received in response to the
Proposed IDE Rule were reviewed and
utilized in preparing the Proposed IRB
Standards (43 FR 35186 at 35187). In the
Proposed IRB Standards, FDA proposed
that disqualification would be used only
if the Commissioner of Food and Drugs
finds that: (1) The IRB failed to comply
with one or more of the standards for
IRBs in part 56 or other supplemental
requirements in the investigational new
drug or investigational device
exemptions (IDE) regulations; (2) the
noncompliance adversely affects the
validity of the data or the rights or safety
of the human subjects; and (3) other
lesser regulatory actions (e.g., warnings
or rejection of data from individual
clinical investigations) have not been or
probably will not be adequate in
achieving compliance (43 FR 35186 at
35195).
FDA received numerous comments to
the Proposed IRB Standards, and
addressed those comments in the
Federal Register of January 27, 1981 (46
FR 8958), ‘‘Protection of Human
Subjects: Standards for Institutional
Review Boards for Clinical
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Investigations, Final Rule.’’ Specifically,
several comments suggested that any
lesser regulatory actions should be
listed (46 FR 8958 at 8973). FDA
accepted these comments and revised
§ 56.120(b) to set forth the lesser
administrative actions that the Agency
may take if FDA finds deficiencies in
the operation of an IRB and to describe
the circumstances in which these lesser
administrative actions may be used by
the Agency. FDA’s longstanding
interpretation of § 56.120(b) is that FDA
may impose these restrictions on a
noncompliant IRB until the IRB takes
appropriate corrective action. The text
of the regulation, however, suggests that
it is the Agency that would withhold
approval of studies that have been
reviewed by a noncompliant IRB, rather
than authorizing FDA to direct the IRB
to stop approving new studies until the
IRB comes back into compliance.
This direct final rule amends
§ 56.120(b) to read, in addition, until the
IRB or the parent institution takes
appropriate corrective action, the
Agency may require the IRB to withhold
approval of new studies, direct that no
new subjects be added to ongoing
studies, or terminate ongoing studies.
This will ensure that those activities are
suspended until the IRB takes
appropriate corrective action to address
its noncompliance. We believe revising
§ 56.120(b) as described in this
document will improve the clarity and
accuracy of the regulations. We are also
renumbering § 56.120(b)(4) as
§ 56.120(c), and § 56.120(c) as
§ 56.120(d). We are inserting ‘‘FDA
may’’ into newly designated § 56.120(c)
so that it is a complete sentence.
FDA may notify relevant State and
Federal regulatory Agencies when
warranted to assure that organizations
with a need to know about the IRB’s
apparent noncompliance are
appropriately informed. The revision
would eliminate confusion by stating
clearly that FDA is authorized to notify
others about the IRB’s noncompliance.
We believe these changes will ensure
clarity and improve the accuracy of the
regulations.
II. Procedures for Issuing a Direct Final
Rule
In the Federal Register of November
21, 1997 (62 FR 62466), FDA announced
the availability of the guidance
document entitled ‘‘Guidance for FDA
and Industry: Direct Final Rule
Procedures’’ 1 that described when and
how we will employ direct final
rulemaking. We believe that this rule is
1 https://www.fda.gov/regulatoryinformation/
guidances/ucm125166.htm.
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Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Rules and Regulations
appropriate for direct final rulemaking
because it is intended to clarify an
existing regulation. We anticipate no
significant adverse comment.
Consistent with FDA’s direct final
rulemaking procedures, we are
publishing a companion proposed rule
elsewhere in this issue of the Federal
Register. That proposed rule is identical
in substance to this direct final rule. The
companion proposed rule will serve the
purpose of issuing a proposed rule
under usual notice-and-comment
procedures in the event we withdraw
this direct final rule because we receive
significant adverse comment. The
comment period for this direct final rule
runs concurrently with the comment
period of the companion proposed rule.
We will consider any comments that we
receive in response to the companion
proposed rule to be comments also
regarding this direct final rule and vice
versa.
If FDA receives any significant
adverse comment, we will withdraw
this direct final rule before its effective
date by publishing a notice in the
Federal Register within 30 days after
the comment period ends. A significant
adverse comment is one 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 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 Administrative Procedure Act
(APA) (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the
scope of the rule would not be
considered adverse. A comment
recommending a rule change in addition
to the rule would not be considered a
significant adverse 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.
If we withdraw this direct final rule,
FDA will consider all comments that we
received regarding the companion
proposed rule as we develop a final rule
through the usual notice-and-comment
procedures of the APA. If we receive no
significant adverse comment during the
specified comment period regarding this
direct final rule, we intend to publish a
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confirmation notice in the Federal
Register within 30 days after the
comment period ends.
III. Legal Authority
This rule, if finalized, would amend
§ 56.120(b). FDA’s authority to modify
§ 56.120(b) arises from the same
authority under which FDA initially
issued this regulation, the IRB
regulations, and general administrative
provisions of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 343,
346, 346a, 348, 350a, 350b, 351, 352,
353, 355, 360, 360c–360f, 360h, 360i,
360j, 360hh–360ss, 371, 379e, 381; 42
U.S.C. 216, 241, 262).
IV. Analysis of Environmental Impact
We have determined under 21 CFR
25.30(h) and 25.34(a) that this action 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.
V. Economic Analysis of Impact
We have 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 us 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). We believe that
this final rule is not a significant
regulatory action as defined by
Executive Order 12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because this rule does not add any
additional regulatory burdens, we
certify that this 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
us to prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before issuing ‘‘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 $144 million, using the
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19035
most current (2014) Implicit Price
Deflator for the Gross Domestic Product.
This final rule would not result in an
expenditure in any year that meets or
exceeds this amount.
The purpose of this final rule is to
affirm FDA’s longstanding
interpretation of § 56.120(b), that FDA
may impose these administrative
actions on a noncompliant IRB until the
IRB takes appropriate corrective action.
The amendment will improve the clarity
and accuracy of the regulations. Because
this final rule is a clarification and
would impose no additional regulatory
burdens, this regulation is not
anticipated to result in any compliance
costs, and the economic impact is
expected to be minimal.
VI. Paperwork Reduction Act of 1995
This direct final rule contains no
collection of information. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 is not required.
VII. Federalism
We have analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the 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, the
Agency has concluded that the 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.
List of Subjects in 21 CFR Part 56
Human research subjects, Reporting
and recordkeeping requirements, Safety.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 56 is
amended as follows:
PART 56—INSTITUTIONAL REVIEW
BOARDS
1. The authority citation for 21 CFR
part 56 is revised to read as follows:
■
Authority: 21 U.S.C. 321, 343, 346, 346a,
348, 350a, 350b, 351, 352, 353, 355, 360,
360c–360f, 360h, 360i, 360j, 360hh–360ss,
371, 379e, 381; 42 U.S.C. 216, 241, 262.
2. In § 56.120, redesignate paragraphs
(b)(4) and (c) as paragraphs (c) and (d),
respectively, and revise paragraph (b)
and newly designated paragraph (c) to
read as follows:
■
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§ 56.120
Lesser administrative actions.
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(b) On the basis of the IRB’s or the
institution’s response, FDA may
schedule a reinspection to confirm the
adequacy of corrective actions. In
addition, until the IRB or the parent
institution takes appropriate corrective
action, the Agency may require the IRB
to:
(1) Withhold approval of new studies
subject to the requirements of this part
that are conducted at the institution or
reviewed by the IRB;
(2) Direct that no new subjects be
added to ongoing studies subject to this
part; or
(3) Terminate ongoing studies subject
to this part when doing so would not
endanger the subjects.
(c) When the apparent noncompliance
creates a significant threat to the rights
and welfare of human subjects, FDA
may notify relevant State and Federal
regulatory agencies and other parties
with a direct interest in the Agency’s
action of the deficiencies in the
operation of the IRB.
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Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07523 Filed 4–1–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG–2015–1055]
RIN 1625–AA08
Special Local Regulation; Charleston
Race Week, Charleston Harbor,
Charleston, SC
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a special local regulation on
the waters of Charleston Harbor in
Charleston, SC during the Charleston
Race Week from April 15, 2016 through
April 17, 2016. This special local
regulation is necessary to ensure the
safety of participants, spectators, and
the general public during the event.
This regulation prohibits persons and
vessels from being in the regulated area
unless authorized by the Captain of the
Port Charleston or a designated
representative.
DATES: This rule is effective from April
15, 2016 through April 17, 2016.
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SUMMARY:
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To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2015–
1055 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this rule, call
or email Lieutenant John Downing,
Sector Charleston Office of Waterways
Management, Coast Guard;
telephone(843)740–3184, email
John.Z.Downing@uscg.mil.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
*
I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
On November 18, 2015, the
Charleston Ocean Racing Association
notified the Coast Guard that it will
sponsor a series of sailboat races in the
Charleston Harbor, Charleston, SC. from
8:30 a.m. to 5 p.m. April 15, 2016
through April 17, 2016. In response, on
February 5, 2016, the Coast Guard
published a notice of proposed
rulemaking titled Charleston Race
Week. There we stated why we issued
the NPRM and invited comments on our
proposed regulatory action related to
this special local regulation. During the
comment period that ended March 7,
2016, we received no comments.
Under good cause provisions in 5
U.S.C. 553(d)(3), we are making this rule
effective less than 30 days after its
publication in the Federal Register. The
Coast Guard finds that good cause exists
for making this rule effective starting
April 15, 2016 because this special local
regulation is necessary to ensure the
safety of life and property during this
high speed boat race and it would be
contrary to public interest not to make
this rule effective by April 15, 2016.
Also, this regulation will have a limited
impact on the waterway for a limited
time and designated representatives will
be on scene to assist the public with
compliance.
III. Legal Authority and Need for Rule
The legal basis for the rule is the
Coast Guard’s authority to establish
special local regulations: 33 U.S.C.
1233. The purpose of the rule is to
insure safety of life on navigable waters
of the United States during three
Charleston Race Week sailboat races. It
was determined that potential hazards
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are associated with the areas used in the
Charleston Race Week sailboat races
that can be alleviated by prohibiting
access to the regulated areas.
IV. Discussion of Comments, Changes,
and the Rule
As noted above, we received no
comments on our NPRM published
February 5, 2016. There are no changes
in the regulatory text of this rule from
the proposed rule in the NPRM.
From April 15, 2016 through April 17,
2016, Charleston Ocean Racing
Association will host three sailboat
races on Charleston Harbor in
Charleston, South Carolina during
Charleston Race Week. Approximately
300 sailboats will participate in the
three races. This rule establishes a
special local regulation on certain
waters of Charleston Harbor in
Charleston, South Carolina. The special
local regulation will be enforced daily
from 8:30 a.m. until 5 p.m. on April 15,
2016 through April 17, 2016. The
special local regulation consists of the
following three race areas.
1. Race Area #1. All waters
encompassed within a 700 yard radius
of position 32°46′10″ N. 79°55′15″ W.
2. Race Area #2. All waters
encompassed within a 700 yard radius
of position 32°46′02″ N. 79°54′15″ W.
3. Race Area #3. All waters
encompassed within a 700 yard radius
of position 32°45′55″ N. 79°53′39″ W.
Except for those persons and vessels
participating in the sailboat races,
persons and vessels are prohibited from
entering, transiting through, anchoring
in, or remaining within any of the race
areas unless specifically authorized by
the Captain of the Port Charleston or a
designated representative. Persons and
vessels desiring to enter, transit through,
anchor in, or remain within any of the
race areas may contact the Captain of
the Port Charleston by telephone at
(843) 740–7050, or a designated
representative via VHF radio on channel
16, to request authorization. If
authorization to enter, transit through,
anchor in, or remain within the race
areas is granted by the Captain of the
Port Charleston or a designated
representative, all persons and vessels
receiving such authorization must
comply with the instructions of the
Captain of the Port Charleston or a
designated representative. The Coast
Guard will provide notice of the
regulated areas by Local Notice to
Mariners, Broadcast Notice to Mariners,
and on-scene designated
representatives.
E:\FR\FM\04APR1.SGM
04APR1
Agencies
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Rules and Regulations]
[Pages 19033-19036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07523]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 56
[Docket No. FDA-2015-N-5052]
Administrative Actions for Noncompliance; Lesser Administrative
Actions
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation describing lesser administrative actions that may be imposed
on an Institutional Review Board (IRB) that has failed to comply with
FDA's IRB regulations. We are clarifying that FDA may require the IRB
to withhold approval of new FDA-regulated studies, stop the enrollment
of new subjects in ongoing studies, and terminate ongoing studies, or
any combination of these actions until the noncompliance with FDA's IRB
regulations is corrected. We are taking this action to ensure clarity
and improve the accuracy of the regulations.
DATES: This rule is effective August 17, 2016. Submit electronic or
written comments on this direct final rule or its companion proposed
rule by June 20, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-5052 for ``Subpart E--Administrative Actions for
Noncompliance; Lesser Administrative Actions.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper
[[Page 19034]]
submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper 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: Sheila Brown, Office of Good Clinical
Practice, Office of Special Medical Programs, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20993-0002, 301-796-6563.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is amending Sec. 56.120(b) (21 CFR 56.120(b)), which describes
lesser administrative actions that the Agency may impose on an IRB
until the IRB takes appropriate action to correct the IRB's
noncompliance. We are publishing this direct final rule because it is
intended to clarify an existing regulation, and we do not anticipate
any significant adverse comment regarding this amendment to Sec.
56.120(b). Specifically, this direct final rule would amend Sec.
56.120(b) by clarifying that FDA has authority to require the IRB to
withhold approval of new FDA-regulated studies conducted at the
institution or reviewed by the IRB, direct that no new subjects be
added to ongoing studies, and terminate ongoing studies provided that
doing so would not endanger study subjects.
This amendment also renumbers current paragraphs (b)(4) and (c) as
paragraphs (c) and (d), respectively, and inserts ``FDA may'' into
newly designated paragraph (c) so that it is a complete sentence.
FDA first proposed requirements for the composition and operations
of institutional review committees in the ``Proposed Investigational
Device Exemptions,'' published in the Federal Register of August 20,
1976 (41 FR 35282; ``Proposed IDE Rule''). In that document, FDA
proposed disqualification procedures for institutional review
committees and requested comments on the proposed procedures and other
possible administrative actions that FDA might take against a committee
that is not in compliance with the regulations (41 FR 35282 at 35293).
FDA also stated its intention to publish uniform, Agency-wide
regulations governing clinical investigations at a later date,
including requirements governing institutional review committees (41 FR
35282 at 35283).
Subsequently, FDA published ``Standards for Institutional Review
Boards for Clinical Investigations'' on August 8, 1978 (43 FR 35186;
``Proposed IRB Standards''). Comments on implementing institutional
review requirements received in response to the Proposed IDE Rule were
reviewed and utilized in preparing the Proposed IRB Standards (43 FR
35186 at 35187). In the Proposed IRB Standards, FDA proposed that
disqualification would be used only if the Commissioner of Food and
Drugs finds that: (1) The IRB failed to comply with one or more of the
standards for IRBs in part 56 or other supplemental requirements in the
investigational new drug or investigational device exemptions (IDE)
regulations; (2) the noncompliance adversely affects the validity of
the data or the rights or safety of the human subjects; and (3) other
lesser regulatory actions (e.g., warnings or rejection of data from
individual clinical investigations) have not been or probably will not
be adequate in achieving compliance (43 FR 35186 at 35195).
FDA received numerous comments to the Proposed IRB Standards, and
addressed those comments in the Federal Register of January 27, 1981
(46 FR 8958), ``Protection of Human Subjects: Standards for
Institutional Review Boards for Clinical Investigations, Final Rule.''
Specifically, several comments suggested that any lesser regulatory
actions should be listed (46 FR 8958 at 8973). FDA accepted these
comments and revised Sec. 56.120(b) to set forth the lesser
administrative actions that the Agency may take if FDA finds
deficiencies in the operation of an IRB and to describe the
circumstances in which these lesser administrative actions may be used
by the Agency. FDA's longstanding interpretation of Sec. 56.120(b) is
that FDA may impose these restrictions on a noncompliant IRB until the
IRB takes appropriate corrective action. The text of the regulation,
however, suggests that it is the Agency that would withhold approval of
studies that have been reviewed by a noncompliant IRB, rather than
authorizing FDA to direct the IRB to stop approving new studies until
the IRB comes back into compliance.
This direct final rule amends Sec. 56.120(b) to read, in addition,
until the IRB or the parent institution takes appropriate corrective
action, the Agency may require the IRB to withhold approval of new
studies, direct that no new subjects be added to ongoing studies, or
terminate ongoing studies. This will ensure that those activities are
suspended until the IRB takes appropriate corrective action to address
its noncompliance. We believe revising Sec. 56.120(b) as described in
this document will improve the clarity and accuracy of the regulations.
We are also renumbering Sec. 56.120(b)(4) as Sec. 56.120(c), and
Sec. 56.120(c) as Sec. 56.120(d). We are inserting ``FDA may'' into
newly designated Sec. 56.120(c) so that it is a complete sentence.
FDA may notify relevant State and Federal regulatory Agencies when
warranted to assure that organizations with a need to know about the
IRB's apparent noncompliance are appropriately informed. The revision
would eliminate confusion by stating clearly that FDA is authorized to
notify others about the IRB's noncompliance. We believe these changes
will ensure clarity and improve the accuracy of the regulations.
II. Procedures for Issuing a Direct Final Rule
In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' \1\ that described
when and how we will employ direct final rulemaking. We believe that
this rule is
[[Page 19035]]
appropriate for direct final rulemaking because it is intended to
clarify an existing regulation. We anticipate no significant adverse
comment.
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\1\ https://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.
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Consistent with FDA's direct final rulemaking procedures, we are
publishing a companion proposed rule elsewhere in this issue of the
Federal Register. That proposed rule is identical in substance to this
direct final rule. The companion proposed rule will serve the purpose
of issuing a proposed rule under usual notice-and-comment procedures in
the event we withdraw this direct final rule because we receive
significant adverse comment. The comment period for this direct final
rule runs concurrently with the comment period of the companion
proposed rule. We will consider any comments that we receive in
response to the companion proposed rule to be comments also regarding
this direct final rule and vice versa.
If FDA receives any significant adverse comment, we will withdraw
this direct final rule before its effective date by publishing a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one 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 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
Administrative Procedure Act (APA) (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule would not be
considered adverse. A comment recommending a rule change in addition to
the rule would not be considered a significant adverse 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.
If we withdraw this direct final rule, FDA will consider all
comments that we received regarding the companion proposed rule as we
develop a final rule through the usual notice-and-comment procedures of
the APA. If we receive no significant adverse comment during the
specified comment period regarding this direct final rule, we intend to
publish a confirmation notice in the Federal Register within 30 days
after the comment period ends.
III. Legal Authority
This rule, if finalized, would amend Sec. 56.120(b). FDA's
authority to modify Sec. 56.120(b) arises from the same authority
under which FDA initially issued this regulation, the IRB regulations,
and general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352,
353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e,
381; 42 U.S.C. 216, 241, 262).
IV. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) and 25.34(a) that this
action 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.
V. Economic Analysis of Impact
We have 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 us 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). We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule does not add any additional regulatory
burdens, we certify that this 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
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``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 $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
The purpose of this final rule is to affirm FDA's longstanding
interpretation of Sec. 56.120(b), that FDA may impose these
administrative actions on a noncompliant IRB until the IRB takes
appropriate corrective action. The amendment will improve the clarity
and accuracy of the regulations. Because this final rule is a
clarification and would impose no additional regulatory burdens, this
regulation is not anticipated to result in any compliance costs, and
the economic impact is expected to be minimal.
VI. Paperwork Reduction Act of 1995
This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.
VII. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the 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, the Agency has concluded
that the 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.
List of Subjects in 21 CFR Part 56
Human research subjects, Reporting and recordkeeping requirements,
Safety.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
56 is amended as follows:
PART 56--INSTITUTIONAL REVIEW BOARDS
0
1. The authority citation for 21 CFR part 56 is revised to read as
follows:
Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351,
352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371,
379e, 381; 42 U.S.C. 216, 241, 262.
0
2. In Sec. 56.120, redesignate paragraphs (b)(4) and (c) as paragraphs
(c) and (d), respectively, and revise paragraph (b) and newly
designated paragraph (c) to read as follows:
[[Page 19036]]
Sec. 56.120 Lesser administrative actions.
* * * * *
(b) On the basis of the IRB's or the institution's response, FDA
may schedule a reinspection to confirm the adequacy of corrective
actions. In addition, until the IRB or the parent institution takes
appropriate corrective action, the Agency may require the IRB to:
(1) Withhold approval of new studies subject to the requirements of
this part that are conducted at the institution or reviewed by the IRB;
(2) Direct that no new subjects be added to ongoing studies subject
to this part; or
(3) Terminate ongoing studies subject to this part when doing so
would not endanger the subjects.
(c) When the apparent noncompliance creates a significant threat to
the rights and welfare of human subjects, FDA may notify relevant State
and Federal regulatory agencies and other parties with a direct
interest in the Agency's action of the deficiencies in the operation of
the IRB.
* * * * *
Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07523 Filed 4-1-16; 8:45 am]
BILLING CODE 4164-01-P