Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions, 82129-82131 [2011-33588]
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Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Rules and Regulations
date of injury is the date on which the
individual was hurt.
(2) Occupational disease or infection.
Occupational illnesses and infections
generally involve delayed onset of
symptoms following exposure to a
harmful workplace substance or
condition. If the individual claims
compensation for an occupational
illness or infection, the date of injury is
the date the individual was exposed to
the substance or condition.
(3) Hearing loss. If the individual
claims compensation for hearing loss,
the date of injury is the date the
individual was exposed to harmful
workplace noise or other stimulus that
is capable of causing hearing loss.
(4) Death-benefit claims. If the
individual claims compensation for an
employee’s death, the date of injury is
the date of the workplace event or
incident that caused, hastened, or
contributed to the death.
(5) Cumulative trauma. If the
individual claims compensation for
cumulative trauma, in which multiple
traumas contribute to an overall medical
condition, such as a neck condition
resulting from repetitive motion, the
date of injury is any date on which a
workplace trauma worsened the
individual’s condition. A workplace
event will not be deemed a contributing
trauma if a corresponding worsening of
the condition is due solely to its natural
progression, rather than the workplace
event.
(b) If the date of injury is before
February 17, 2009, the individual’s
entitlement is governed by section
2(3)(F) as it existed prior to the 2009
amendment.
(c) If the date of injury is on or after
February 17, 2009, the individual’s
entitlement is governed by the 2009
amendment to section 2(3)(F).
■ 8. Add § 701.505 to read as follows:
§ 701.505 May an employer stop paying
benefits awarded before February 17, 2009
if the employee would now fall within the
exclusion?
tkelley on DSK3SPTVN1PROD with RULES
No. If an individual was awarded
compensation for an injury occurring
before February 17, 2009, the employer
must still pay all benefits awarded,
including disability compensation and
medical benefits, even if the employee
would be excluded from coverage under
the amended exclusion.
Signed at Washington, DC, this 19th day of
December 2011.
Gary A. Steinberg,
Acting Director, Office of Workers’
Compensation Programs.
[FR Doc. 2011–32880 Filed 12–29–11; 8:45 am]
BILLING CODE 4510–CF–P
VerDate Mar<15>2010
17:50 Dec 29, 2011
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2011–D–0028]
Medical Devices; Ovarian Adnexal
Mass Assessment Score Test System;
Labeling; Black Box Restrictions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
regulation classifying ovarian adnexal
mass assessment score test systems to
restrict these devices so that a
prescribed warning statement that
addresses a risk identified in the special
controls guidance document must be in
a black box and must appear in all
labeling, advertising, and promotional
material. The black box warning
mitigates the risk to health associated
with off-label use as a screening test,
stand-alone diagnostic test, or as a test
to determine whether or not to proceed
with surgery.
DATES: Effective Date: January 30, 2012.
FOR FURTHER INFORMATION CONTACT:
Scott McFarland, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5543, Silver Spring,
MD 20993–0002, (301) 796–6217.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. What is the background of this final
rule?
A. Ovarian Adnexal Mass Assessment
Score Test System
An ovarian adnexal mass assessment
score test system is a device that
measures one or more proteins in serum
or plasma. It yields a single result for
the likelihood that an adnexal pelvic
mass in a woman for whom surgery is
planned, is malignant. The test is for
adjunctive use, in the context of a
negative primary clinical and
radiological evaluation, to augment the
identification of patients whose
gynecologic surgery requires oncology
expertise and resources.
B. Identified Risk to Health
The ovarian adnexal mass assessment
score test system is not indicated for use
as a screening or diagnostic test for
ovarian cancer. Off-label use of the test
(e.g., in patients who are not already
identified as needing surgery for pelvic
mass or without reference to an
PO 00000
Frm 00055
Fmt 4700
Sfmt 4700
82129
independent clinical/radiological
evaluation of the patient), may lead to
a high frequency of unnecessary further
testing and surgery due to false positive
results, or to delay in tumor diagnosis
due to false negative results.
II. Why is FDA requiring black box
warnings on ovarian adnexal mass
assessment score test system labeling,
advertising, and promotional material?
FDA has determined that in order to
provide reasonable assurance of safety
and effectiveness, it is necessary to
restrict the ovarian adnexal mass
assessment score test system to sale,
distribution, and use with labeling,
advertising, and promotional material
that bears a warning statement in a
black box that alerts users to the risk
associated with off-label use as a
screening test, stand-alone diagnostic
test, or as a test to determine whether or
not to proceed with surgery. In the
Federal Register of March 23, 2011 (76
FR 16292 at 12694), FDA published a
final rule that classified this device into
class II and established as a special
control the guidance entitled ‘‘Class II
Special Controls Guidance Document:
Ovarian Adnexal Mass Assessment
Score Test System’’ that recommends a
black box warning to address the risk of
off-label use. In the Federal Register of
March 23, 2011 (76 FR 16425), FDA
published a notice of availability of this
special controls guidance document.
However, FDA believes it is necessary to
require this warning in labeling and
advertising by restricting the device
under section 520(e) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360j(e)). In the Federal
Register of March 23, 2011 (76 FR 16350
at 16352), FDA published a proposed
rule to require the black box warning.
For devices that have significant risks
that would make the devices unsafe if
used inappropriately, FDA may require
that the risks be explained in warning
statements placed in a black box that is
displayed prominently in the labeling,
advertising, and promotional material to
ensure awareness by the end user.
Awareness of these important risks by
the end user enables these devices to be
used safely. In this case, a prominent
black box warning, which alerts the user
to the limitations of this device, is
necessary in all labeling, advertising,
and promotional materials to allow
ovarian adnexal mass assessment score
test system devices to be used safely.
The prominent black box warning must
read as follows:
E:\FR\FM\30DER1.SGM
30DER1
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Rules and Regulations
III. What comments did FDA receive on
this rule?
In the Federal Register of March 23,
2011 (76 FR 16350 at 16352), FDA
announced the proposed rule to require
the black box warning. Comments on
the proposed rule were due by May 23,
2011. FDA received one comment in the
docket for the proposed rule from a
consumer. The comment supported the
proposed rule.
IV. What is the legal authority for this
final rule?
FDA is issuing this final rule under
the authority of section 520(e) of the
FD&C Act, which authorizes FDA to
restrict sale, distribution, and use of
devices upon certain conditions. FDA is
also issuing this final rule under general
device and administrative provisions of
the FD&C Act (sections 501, 510, 513,
515, 520, and 701 (21 U.S.C. 351, 360,
360c, 360e, 360j, and 371, respectively)).
tkelley on DSK3SPTVN1PROD with RULES
V. What is the environmental impact of
this final rule?
FDA has determined under 21 CFR
25.34(b) and (f) 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.
VI. What is the economic impact of this
final rule?
FDA has examined the impacts of the
final rule under Executive Order 12866,
Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct Agencies to
assess all costs and benefits of available
regulatory alternatives and, when
regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
Agency believes that this final rule is
VerDate Mar<15>2010
17:50 Dec 29, 2011
Jkt 226001
not a significant regulatory action under
Executive Order 12866.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because this final rule
strengthens existing cautions against
misuse of a product, the Agency
certifies that the final rule will not have
a significant economic impact on a
substantial number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that Agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $136
million, using the most current (2010)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
An ovarian adnexal mass assessment
test system is a device that measures
one or more proteins in serum to yield
a single result for the likelihood that an
adnexal pelvic mass in a woman is
malignant. Such a test would identify
women whose planned gynecologic
surgery would benefit from referral to a
gynecological oncologist, despite
negative results from other clinical and
radiographic tests for ovarian cancer.
In considering the appropriate level of
regulatory oversight for this device, FDA
concluded in classifying the device that
general and special controls to minimize
the risk of false positive and false
negative results, and risks associated
with improper off-label use would
provide a reasonable assurance of safety
and effectiveness of the ovarian adnexal
mass assessment test system. The
special controls guidance recommends
use of a black box warning to minimize
PO 00000
Frm 00056
Fmt 4700
Sfmt 4700
these risks. Without such a strong
warning, ovarian adnexal mass
assessment test systems might be used
as a screening test, stand-alone
diagnostic test, or as a test to determine
whether or not to proceed with surgery.
Off-label use of the test or the use of test
results without consideration of other
diagnostic testing and clinical
assessment could pose a risk for
morbidity and mortality due to
nonreferral for oncologic evaluation and
treatment.
In order to require the specific black
box warning on labeling and on all
advertising and promotional materials
for the device, FDA is issuing this final
rule under section 520(e) of the FD&C
Act. Through this action, the Agency
requires a black box warning on product
labeling, advertising, and promotional
materials for ovarian adnexal mass
assessment test systems. This warning
will make users aware of the limitations
of this device and the serious risks
associated with its misuse. With the
addition of this black box warning to
product labeling, advertising, and
marketing materials, the Agency
concludes there will be a reasonable
assurance of the safety and effectiveness
of ovarian adnexal mass assessment test
systems.
The economic impact of this final rule
is expected to be very small. We are
aware of a single manufacturer
producing a single product that will be
affected by this black box warning. The
manufacturer should be able to
incorporate the warning in the course of
developing its product labeling. The
admonition against off-label use for this
device already exists, so the addition of
this type of warning is not expected to
have a significant effect on the market
for this product. The expected impact of
this final rule on the market for this
product would be a reduction in offlabel use among the small number of
users who would be undeterred by a
less visible warning.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
E:\FR\FM\30DER1.SGM
30DER1
ER30DE11.007</GPH>
82130
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Rules and Regulations
VII. How does the Paperwork
Reduction Act of 1995 apply to this
final rule?
FDA concludes that labeling
provisions of this final rule are not
subject to review by the Office of
Management and Budget because they
do not constitute a ‘‘collection of
information’’ under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). Rather, the black box warning on
all labeling, advertising, and
promotional materials for ovarian
adnexal mass assessment score test
system devices is a ‘‘public disclosure of
information originally supplied by the
Federal Government to the recipient for
the purpose of disclosure to the public.’’
(see 5 CFR 1320.3(c)(2)).
Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
NATIONAL LABOR RELATIONS
BOARD
tkelley on DSK3SPTVN1PROD with RULES
29 CFR Part 102
Special Procedural Rules With Respect
to Representation Cases Governing
Periods When the National Labor
Relations Board Lacks a Quorum of
Members
National Labor Relations
VerDate Mar<15>2010
17:50 Dec 29, 2011
Jkt 226001
Final rule.
The National Labor Relations
Board (the Board or the NLRB) is
revising its rules governing the
processing of representation cases
during periods when the Board lacks a
quorum of Members. This revision is
being adopted to facilitate, insofar as it
is possible, the normal functioning of
the Agency when the number of Board
Members falls below three, the number
required to establish a quorum of the
Board. See 29 U.S.C. 153(b); New
Process Steel v. NLRB, 130 S.Ct. 2635
(2010). The effect of the revision is to
enable the Agency to process some
representation cases to the certification
of a representative or the certification of
the results of the election, while
SUMMARY:
BILLING CODE 4160–01–P
Board.
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. Section 4(a)
of the Executive order requires Agencies
to ‘‘construe * * * a Federal statute to
preempt State law only where the
statute contains an express preemption
provision or there is some other clear
evidence that the Congress intended
preemption of State law, or where the
exercise of State authority conflicts with
the exercise of Federal authority under
the Federal statute.’’ Federal law
includes an express preemption
provision that preempts certain State
requirements ‘‘different from or in
addition to’’ certain Federal
requirements applicable to devices (21
U.S.C. 360k; See Medtronic, Inc. v. Lohr,
518 U.S. 470 (1996); Riegel v.
Medtronic, Inc., 552 U.S. 312 (2008)).
This final rule creates a requirement
under 21 U.S.C. 360k for a black box
warning statement that must appear in
all advertising, labeling, and
promotional material for ovarian
adnexal mass assessment score test
systems.
ACTION:
[FR Doc. 2011–33588 Filed 12–29–11; 8:45 am]
AGENCY:
VIII. What are the federalism impacts
of this final rule?
PO 00000
Frm 00057
Fmt 4700
Sfmt 4700
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, FDA amends 21 CFR
part 866 as follows.
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for 21 CFR
part 866 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. In § 866.6050 of subpart G, add new
paragraph (c) to read as follows:
■
§ 866.6050 Ovarian adnexal mass
assessment score test system.
*
*
*
*
*
(c) Black box warning. Under section
520(e) of the Federal Food, Drug, and
Cosmetic Act these devices are subject
to the following restriction: A warning
statement must be placed in a black box
and must appear in all advertising,
labeling, and promotional material for
these devices. That warning statement
must read:
deferring Board consideration of parties’
requests for review until a quorum has
been restored.
DATES: Effective December 30, 2011.
FOR FURTHER INFORMATION CONTACT:
Lester A. Heltzer, Executive Secretary,
National Labor Relations Board, 1099
14th Street NW., Room 11600,
Washington, DC 20570. Telephone (202)
273–1067 (this is not a toll-free
number), 1–866–315–6572 (TTY/TDD).
SUPPLEMENTARY INFORMATION: The
National Labor Relations Board is
revising its rule requiring the automatic
impoundment of ballots in
representation cases when a party files
a request for review. This rules revision
is an addendum to the Board’s
December 14, 2011 rules revisions,
E:\FR\FM\30DER1.SGM
30DER1
ER30DE11.007</GPH>
significant impact of a rule on small
entities. This final rule would impose
almost no cost on manufacturers. The
black box warning will strengthen an
existing admonition against off-label use
and will not significantly affect usage.
Impacts on any entities will be so small
as to be difficult to quantify. For these
reasons, the Agency certifies that this
rule will not have a significant
economic impact on a substantial
number of small entities.
82131
]]>Agencies
[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Rules and Regulations]
[Pages 82129-82131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33588]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2011-D-0028]
Medical Devices; Ovarian Adnexal Mass Assessment Score Test
System; Labeling; Black Box Restrictions
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation classifying ovarian adnexal mass assessment score test
systems to restrict these devices so that a prescribed warning
statement that addresses a risk identified in the special controls
guidance document must be in a black box and must appear in all
labeling, advertising, and promotional material. The black box warning
mitigates the risk to health associated with off-label use as a
screening test, stand-alone diagnostic test, or as a test to determine
whether or not to proceed with surgery.
DATES: Effective Date: January 30, 2012.
FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5543, Silver Spring, MD 20993-0002, (301)
796-6217.
SUPPLEMENTARY INFORMATION:
I. What is the background of this final rule?
A. Ovarian Adnexal Mass Assessment Score Test System
An ovarian adnexal mass assessment score test system is a device
that measures one or more proteins in serum or plasma. It yields a
single result for the likelihood that an adnexal pelvic mass in a woman
for whom surgery is planned, is malignant. The test is for adjunctive
use, in the context of a negative primary clinical and radiological
evaluation, to augment the identification of patients whose gynecologic
surgery requires oncology expertise and resources.
B. Identified Risk to Health
The ovarian adnexal mass assessment score test system is not
indicated for use as a screening or diagnostic test for ovarian cancer.
Off-label use of the test (e.g., in patients who are not already
identified as needing surgery for pelvic mass or without reference to
an independent clinical/radiological evaluation of the patient), may
lead to a high frequency of unnecessary further testing and surgery due
to false positive results, or to delay in tumor diagnosis due to false
negative results.
II. Why is FDA requiring black box warnings on ovarian adnexal mass
assessment score test system labeling, advertising, and promotional
material?
FDA has determined that in order to provide reasonable assurance of
safety and effectiveness, it is necessary to restrict the ovarian
adnexal mass assessment score test system to sale, distribution, and
use with labeling, advertising, and promotional material that bears a
warning statement in a black box that alerts users to the risk
associated with off-label use as a screening test, stand-alone
diagnostic test, or as a test to determine whether or not to proceed
with surgery. In the Federal Register of March 23, 2011 (76 FR 16292 at
12694), FDA published a final rule that classified this device into
class II and established as a special control the guidance entitled
``Class II Special Controls Guidance Document: Ovarian Adnexal Mass
Assessment Score Test System'' that recommends a black box warning to
address the risk of off-label use. In the Federal Register of March 23,
2011 (76 FR 16425), FDA published a notice of availability of this
special controls guidance document. However, FDA believes it is
necessary to require this warning in labeling and advertising by
restricting the device under section 520(e) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(e)). In the Federal
Register of March 23, 2011 (76 FR 16350 at 16352), FDA published a
proposed rule to require the black box warning.
For devices that have significant risks that would make the devices
unsafe if used inappropriately, FDA may require that the risks be
explained in warning statements placed in a black box that is displayed
prominently in the labeling, advertising, and promotional material to
ensure awareness by the end user. Awareness of these important risks by
the end user enables these devices to be used safely. In this case, a
prominent black box warning, which alerts the user to the limitations
of this device, is necessary in all labeling, advertising, and
promotional materials to allow ovarian adnexal mass assessment score
test system devices to be used safely. The prominent black box warning
must read as follows:
[[Page 82130]]
[GRAPHIC] [TIFF OMITTED] TR30DE11.007
III. What comments did FDA receive on this rule?
In the Federal Register of March 23, 2011 (76 FR 16350 at 16352),
FDA announced the proposed rule to require the black box warning.
Comments on the proposed rule were due by May 23, 2011. FDA received
one comment in the docket for the proposed rule from a consumer. The
comment supported the proposed rule.
IV. What is the legal authority for this final rule?
FDA is issuing this final rule under the authority of section
520(e) of the FD&C Act, which authorizes FDA to restrict sale,
distribution, and use of devices upon certain conditions. FDA is also
issuing this final rule under general device and administrative
provisions of the FD&C Act (sections 501, 510, 513, 515, 520, and 701
(21 U.S.C. 351, 360, 360c, 360e, 360j, and 371, respectively)).
V. What is the environmental impact of this final rule?
FDA has determined under 21 CFR 25.34(b) and (f) 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.
VI. What is the economic impact of this final rule?
FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule strengthens existing
cautions against misuse of a product, the Agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
An ovarian adnexal mass assessment test system is a device that
measures one or more proteins in serum to yield a single result for the
likelihood that an adnexal pelvic mass in a woman is malignant. Such a
test would identify women whose planned gynecologic surgery would
benefit from referral to a gynecological oncologist, despite negative
results from other clinical and radiographic tests for ovarian cancer.
In considering the appropriate level of regulatory oversight for
this device, FDA concluded in classifying the device that general and
special controls to minimize the risk of false positive and false
negative results, and risks associated with improper off-label use
would provide a reasonable assurance of safety and effectiveness of the
ovarian adnexal mass assessment test system. The special controls
guidance recommends use of a black box warning to minimize these risks.
Without such a strong warning, ovarian adnexal mass assessment test
systems might be used as a screening test, stand-alone diagnostic test,
or as a test to determine whether or not to proceed with surgery. Off-
label use of the test or the use of test results without consideration
of other diagnostic testing and clinical assessment could pose a risk
for morbidity and mortality due to nonreferral for oncologic evaluation
and treatment.
In order to require the specific black box warning on labeling and
on all advertising and promotional materials for the device, FDA is
issuing this final rule under section 520(e) of the FD&C Act. Through
this action, the Agency requires a black box warning on product
labeling, advertising, and promotional materials for ovarian adnexal
mass assessment test systems. This warning will make users aware of the
limitations of this device and the serious risks associated with its
misuse. With the addition of this black box warning to product
labeling, advertising, and marketing materials, the Agency concludes
there will be a reasonable assurance of the safety and effectiveness of
ovarian adnexal mass assessment test systems.
The economic impact of this final rule is expected to be very
small. We are aware of a single manufacturer producing a single product
that will be affected by this black box warning. The manufacturer
should be able to incorporate the warning in the course of developing
its product labeling. The admonition against off-label use for this
device already exists, so the addition of this type of warning is not
expected to have a significant effect on the market for this product.
The expected impact of this final rule on the market for this product
would be a reduction in off-label use among the small number of users
who would be undeterred by a less visible warning.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any
[[Page 82131]]
significant impact of a rule on small entities. This final rule would
impose almost no cost on manufacturers. The black box warning will
strengthen an existing admonition against off-label use and will not
significantly affect usage. Impacts on any entities will be so small as
to be difficult to quantify. For these reasons, the Agency certifies
that this rule will not have a significant economic impact on a
substantial number of small entities.
VII. How does the Paperwork Reduction Act of 1995 apply to this final
rule?
FDA concludes that labeling provisions of this final rule are not
subject to review by the Office of Management and Budget because they
do not constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the black box
warning on all labeling, advertising, and promotional materials for
ovarian adnexal mass assessment score test system devices is a ``public
disclosure of information originally supplied by the Federal Government
to the recipient for the purpose of disclosure to the public.'' (see 5
CFR 1320.3(c)(2)).
VIII. What are the federalism impacts of this final rule?
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain State requirements ``different from or in
addition to'' certain Federal requirements applicable to devices (21
U.S.C. 360k; See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel
v. Medtronic, Inc., 552 U.S. 312 (2008)). This final rule creates a
requirement under 21 U.S.C. 360k for a black box warning statement that
must appear in all advertising, labeling, and promotional material for
ovarian adnexal mass assessment score test systems.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA amends
21 CFR part 866 as follows.
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for 21 CFR part 866 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. In Sec. 866.6050 of subpart G, add new paragraph (c) to read as
follows:
Sec. 866.6050 Ovarian adnexal mass assessment score test system.
* * * * *
(c) Black box warning. Under section 520(e) of the Federal Food,
Drug, and Cosmetic Act these devices are subject to the following
restriction: A warning statement must be placed in a black box and must
appear in all advertising, labeling, and promotional material for these
devices. That warning statement must read:
[GRAPHIC] [TIFF OMITTED] TR30DE11.007
Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33588 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P
