Administrative Actions for Noncompliance; Lesser Administrative Actions, 19066-19069 [2016-07524]
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Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules
approved inspection site. Each
consignment of fruit would have to be
accompanied by a phytosanitary
certificate with an additional
declaration stating that the fruit had
been found free of B. chilensis based on
field and packinghouse inspections.
This proposed rule would allow for the
safe importation of lemons from Chile
using mitigation measures other than
fumigation with methyl bromide.
Implementing this rule will require
permits, production site registration
with low-prevalence level certification
option, phytosanitary inspections,
phytosanitary certificates, and chemical
treatment procedures.
We are soliciting comments from the
public (as well as affected agencies)
concerning our proposed information
collection and recordkeeping
requirements. These comments will
help us:
(1) Evaluate whether the proposed
information collection is necessary for
the proper performance of our agency’s
functions, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the proposed
information collection, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
information collection on those who are
to respond (such as through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology; e.g., permitting
electronic submission of responses).
Estimate of burden: Public reporting
burden for this collection of information
is estimated to average 0.6917 hours per
response.
Respondents: Producers and
importers of lemons, and the NPPO of
Chile.
Estimated annual number of
respondents: 198.
Estimated annual number of
responses per respondent: 6.71.
Estimated annual number of
responses: 1,330.
Estimated total annual burden on
respondents: 920 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
Copies of this information collection
can be obtained from Ms. Kimberly
Hardy, APHIS’ Information Collection
Coordinator, at (301) 851–2727.
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E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E-Government Act
to promote the use of the Internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this proposed rule, please contact Ms.
Kimberly Hardy, APHIS’ Information
Collection Coordinator, at (301) 851–
2727.
List of Subjects in 7 CFR Part 319
Coffee, Cotton, Fruits, Imports, Logs,
Nursery stock, Plant diseases and pests,
Quarantine, Reporting and
recordkeeping requirements, Rice,
Vegetables.
Accordingly, we propose to amend 7
CFR part 319 as follows:
PART 319—FOREIGN QUARANTINE
NOTICES
1. The authority citation for part 319
continues to read as follows:
■
Authority: 7 U.S.C. 450, 7701–7772, and
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3.
§ 319.56–38
[Amended]
2. Section 319.56–38 is amended as
follows:
■ a. In the introductory text, by adding
the words ‘‘, lemons (Citrus limon (L.)
Burm. f.),’’ between the words ‘‘(Citrus
paradisi Macfad.)’’ and ‘‘and sweet
oranges’’.
■ b. In paragraph (e), by adding the
word ‘‘lemons,’’ between the words
‘‘grapefruit,’’ and ‘‘mandarins,’’.
■ c. In paragraph (f), by adding the word
‘‘lemons,’’ between the words
‘‘grapefruit,’’ and ‘‘mandarins,’’.
■
Done in Washington, DC, this 29th day of
March 2016.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2016–07673 Filed 4–1–16; 8:45 am]
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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:
Proposed rule.
The Food and Drug
Administration (FDA) is proposing to
amend 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: Submit electronic or written
comments on this proposed rule or its
companion direct final rule by June 20,
2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
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manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper comments 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
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.
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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 proposing to amend the text of
§ 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. FDA is
proposing this revision to clarify the
language and improve the accuracy of
the regulations. Specifically, this
proposed rule would propose to amend
§ 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 proposes to
renumber 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).
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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
drugs 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
§ 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 proposed rule would amend
§ 56.120(b) to read that, 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
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its noncompliance. We believe revising
§ 56.120(b) will improve the clarity and
accuracy of the regulations. We are also
proposing to redesignate § 56.120(b)(4)
as § 56.120(c), and § 56.120(c) as
§ 56.120(d).
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. Why is FDA publishing this
proposed rule?
This proposed rule is a companion to
a direct final rule affirming FDA’s
longstanding interpretation of
§ 56.120(b), i.e., that FDA may impose
these restrictions on a noncompliant
IRB until the IRB takes appropriate
corrective action. The direct final rule is
published in the final rules section of
this issue of the Federal Register. The
direct final rule and this companion
proposed rule are substantively
identical. This companion proposed
rule will serve the purpose of issuing a
proposed rule under usual notice-andcomment procedures in the event we
withdraw the direct final rule because
we receive significant adverse comment.
We are publishing the direct final rule
because we believe it is
noncontroversial, and we do not
anticipate any significant adverse
comments. If we do not receive any
significant adverse comments in
response to the direct final rule, we will
not take any further action on this
proposed rule. Instead, within 30 days
after the comment period ends, we
intend to publish a notice that confirms
the effective date of the direct final rule.
If FDA receives any significant
adverse comment regarding the direct
final rule, we will publish a notice of
significant adverse comment and
withdraw the direct final rule within 30
days after the comment period ends. We
will then proceed to final rulemaking
using our usual notice-and-comment
rulemaking procedures under the
Administrative Procedure Act (APA).
The comment period for this companion
proposed rule runs concurrently with
the direct final rule’s comment period.
We will consider any comments that we
receive in response to this companion
proposed rule to be comments also
regarding the direct final rule and vice
versa. We do not intend to provide
additional opportunity for comment.
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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-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. 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.
You can find additional information
about FDA’s direct final rulemaking
procedures in the guidance document
entitled ‘‘Guidance for FDA and
Industry: Direct Final Rule
Procedures,’’ 1 announced in the
Federal Register of November 21, 1997
(62 FR 62466).
III. Legal Authority
This proposed 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 Impacts
We have examined the impacts of the
proposed rule under Executive Order
1 https://www.fda.gov/regulatoryinformation/
guidances/ucm125166.htm.
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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 proposed 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 proposed rule would not
add any additional regulatory burdens,
we propose to certify that this proposed
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 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 $144 million,
using the most current (2014) Implicit
Price Deflator for the Gross Domestic
Product. This proposed rule would not
result in an expenditure in any year that
meets or exceeds this amount.
The purpose of this proposed rule is
to affirm FDA’s longstanding
interpretation of § 56.120(b), that FDA
may impose these restrictions on a
noncompliant IRB until the IRB takes
appropriate corrective action. The
amendment will improve the clarity and
accuracy of the regulations. Because this
proposed 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
FDA tentatively concludes that this
proposed 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.
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VII. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. We
have 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, we
conclude 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, it is proposed that
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:
■
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
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Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07524 Filed 4–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 330
[Docket No. FDA–2016–N–0543]
RIN 0910–AH30
Food and Drug Administration Review
and Action on Over-the-Counter Time
and Extent Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA or Agency) is
proposing to amend its nonprescription
(over-the-counter or OTC) drug
regulations. The proposed rule, if
finalized as proposed, would
supplement the time and extent
application (TEA) process for OTC
drugs by establishing timelines and
performance metrics for FDA’s review of
non-sunscreen TEAs, as required by the
Sunscreen Innovation Act (SIA). We are
also proposing other changes to make
the TEA process more efficient.
DATES: Submit either electronic or
written comments on the proposed rule
by June 3, 2016. Submit comments on
information collection issues under the
Paperwork Reduction Act of 1995 by
June 3, 2016, (see the ‘‘Paperwork
Reduction Act of 1995’’ section of this
document).
ADDRESSES: You may submit comments
as follows:
SUMMARY:
■
§ 56.120
with a direct interest in the Agency’s
action of the deficiencies in the
operation of the IRB.
*
*
*
*
*
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
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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–
2016–N–0543 for ‘‘Food and Drug
Administration Review and Action on
Over-the-Counter Time and Extent
Applications.’’ 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
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
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Agencies
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Proposed Rules]
[Pages 19066-19069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07524]
=======================================================================
-----------------------------------------------------------------------
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: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
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: Submit electronic or written comments on this proposed rule or
its companion direct final 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
[[Page 19067]]
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').
Written/Paper Submissions
Submit written/paper comments 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 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 proposing to amend the text of 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. FDA is proposing this revision to
clarify the language and improve the accuracy of the regulations.
Specifically, this proposed rule would propose to 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 proposes to renumber 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 drugs 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 proposed rule would amend Sec. 56.120(b) to read that, 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
[[Page 19068]]
its noncompliance. We believe revising Sec. 56.120(b) will improve the
clarity and accuracy of the regulations. We are also proposing to
redesignate Sec. 56.120(b)(4) as Sec. 56.120(c), and Sec. 56.120(c)
as Sec. 56.120(d).
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. Why is FDA publishing this proposed rule?
This proposed rule is a companion to a direct final rule affirming
FDA's longstanding interpretation of Sec. 56.120(b), i.e., that FDA
may impose these restrictions on a noncompliant IRB until the IRB takes
appropriate corrective action. The direct final rule is published in
the final rules section of this issue of the Federal Register. The
direct final rule and this companion proposed rule are substantively
identical. This companion proposed rule will serve the purpose of
issuing a proposed rule under usual notice-and-comment procedures in
the event we withdraw the direct final rule because we receive
significant adverse comment. We are publishing the direct final rule
because we believe it is noncontroversial, and we do not anticipate any
significant adverse comments. If we do not receive any significant
adverse comments in response to the direct final rule, we will not take
any further action on this proposed rule. Instead, within 30 days after
the comment period ends, we intend to publish a notice that confirms
the effective date of the direct final rule.
If FDA receives any significant adverse comment regarding the
direct final rule, we will publish a notice of significant adverse
comment and withdraw the direct final rule within 30 days after the
comment period ends. We will then proceed to final rulemaking using our
usual notice-and-comment rulemaking procedures under the Administrative
Procedure Act (APA). The comment period for this companion proposed
rule runs concurrently with the direct final rule's comment period. We
will consider any comments that we receive in response to this
companion proposed rule to be comments also regarding the direct final
rule and vice versa. We do not intend to provide additional opportunity
for comment.
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 APA (5 U.S.C. 553). Comments that are frivolous, insubstantial,
or outside the scope of the rule will 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.
You can find additional information about FDA's direct final
rulemaking procedures in the guidance document entitled ``Guidance for
FDA and Industry: Direct Final Rule Procedures,'' \1\ announced in the
Federal Register of November 21, 1997 (62 FR 62466).
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\1\ https://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.
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III. Legal Authority
This proposed 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 Impacts
We have 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 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 proposed 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 proposed rule would not add any additional
regulatory burdens, we propose to certify that this proposed 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 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 $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
The purpose of this proposed rule is to affirm FDA's longstanding
interpretation of Sec. 56.120(b), that FDA may impose these
restrictions on a noncompliant IRB until the IRB takes appropriate
corrective action. The amendment will improve the clarity and accuracy
of the regulations. Because this proposed 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
FDA tentatively concludes that this proposed 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.
[[Page 19069]]
VII. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have 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, we conclude 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, it is
proposed that 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:
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. 2016-07524 Filed 4-1-16; 8:45 am]
BILLING CODE 4164-01-P