General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products, 79493-79505 [2015-32024]
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Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Proposed Rules
impact on a substantial number of small
entities. Accordingly, an initial
regulatory flexibility analysis is not
required.
The proposed rule would not affect a
substantial number of small entities.16
Currently only 17 entities are registered
with the FDIC as registered transfer
agents. Additionally, the FDIC has not
received any new registrations for
several years. In fact, over the last 10
years, 18 entities have deregistered as
transfer agents (the most recent
deregistration was in 2014).
Furthermore, if any currently registered
transfer agent does not meet the
threshold requirements, it could
deregister if the proposed rule were
adopted as a final rule. Therefore, the
proposed rule would likely reduce
burden on small entities by increasing
the number of entities that could
deregister with the FDIC. As such, the
proposed rule would not have a
significant economic impact on a
substantial number of small entities.
C. Plain Language
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Section 722 of the Gramm-LeachBliley Act requires the FDIC to use plain
language in all proposed and final rules
published after January 1, 2000. The
FDIC invites comment on how to make
this proposed rule easier to understand.
For example:
• Has the FDIC organized the material
to suit your needs? If not, how could the
FDIC present the rule more clearly?
• Are the requirements in the rule
clearly stated? If not, how could the rule
be more clearly stated?
• Do the regulations contain technical
language or jargon that is not clear? If
so, which language requires
clarification?
• Would a different format (grouping
and order of sections, use of headings,
paragraphing) make the regulation
easier to understand? If so, what
changes would achieve that?
• Is this section format adequate? If
not, which of the sections should be
changed and how?
• What other changes can the FDIC
incorporate to make the regulation
easier to understand?
List of Subjects in 12 CFR Part 341
Banks, banking, Reporting and
recordkeeping requirements, Savings
associations, Securities.
16 In
2010, the OTS estimated that 5 savings
associations would be required to register as
transfer agents. 75 FR 22184 (2010).
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Federal Deposit Insurance Corporation
12 CFR Chapter III
Authority and Issuance
For the reasons stated in the
preamble, the Federal Deposit Insurance
Corporation proposes to amend part 341
of chapter III of title 12, Code of Federal
Regulations as follows:
PART 341—Registration of Securities
Transfer Agents
1. The authority citation for part 341
continues to read as follows:
■
Authority: Secs. 2, 3, 17, 17A and 23(a),
Securities Exchange Act of 1934, as amended
(15 U.S.C. 78b, 78c, 78q, 78q–1 and 78w(a)).
■
2. Revise § 341.1 to read as follows:
§ 341.1
the functions of a transfer agent as
described in § 341.2(a) with respect to
qualifying securities shall register with
the FDIC in the manner indicated in this
section.
*
*
*
*
*
(c) * * * Form TA–1 may be
completed electronically and is
available from the FDIC at www.fdic.gov
or the Federal Financial Institutions
Examination Council at www.ffiec.gov,
or upon request, from the Director,
Division of Risk Management
Supervision (RMS), FDIC, Washington,
DC 20429.
■ 5. Amend § 341.5 by revising the last
sentence in paragraph (b) to read as
follows:
§ 341.5
Scope.
79493
Withdrawal from registration.
This part is issued by the Federal
Deposit Insurance Corporation (the
FDIC) under sections 2, 3(a)(34)(B), 17,
17A and 23(a) of the Securities
Exchange Act of 1934 (the Act), as
amended (15 U.S.C. 78b, 78c(a)(34)(B),
78q, 78q–1 and 78w(a)) and applies to
all insured State nonmember banks,
insured State savings associations, or
subsidiaries of such institutions, that act
as transfer agents for securities
registered under section 12 of the Act
(15 U.S.C. 78l), or for securities exempt
from registration under subsections
(g)(2)(B) or (g)(2)(G) of section 12 (15
U.S.C. 781(g)(2)(B) and (G)) (securities
of investment companies, including
mutual funds, and certain insurance
companies). Such securities are
qualifying securities for purposes of this
part.
■ 3. Amend § 341.2 by revising
paragraphs (h) and (i) to read as follows:
*
§ 341.2
Food and Drug Administration
Definitions.
*
*
*
*
*
(h) The term covered institution
means an insured State nonmember
bank, an insured State savings
association, and any subsidiary of such
institutions.
(i) The term qualifying securities
means:
(1) Securities registered on a national
securities exchange (15 U.S.C. 78l(b)); or
(2) Securities required to be registered
under section 12(g)(1) of the Act (15
U.S.C. 78l(g)(1)), except for securities
exempted from registration with the
SEC by section 12(g)(2) (C, D, E, F, and
H) of the Act.
■ 4. Amend § 341.3 by revising
paragraph (a) and the last sentence in
paragraph (c) to read as follows:
§ 341.3
agent.
Registration as securities transfer
(a) Requirement for registration. Any
covered institution that performs any of
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*
*
*
*
(b) * * * A Request for Deregistration
form is available electronically from
www.fdic.gov or by request from the
Director, Division of Risk Management
Supervision (RMS), FDIC, Washington,
DC 20429.
*
*
*
*
*
§ 341.7
■
[Removed]
6. Remove § 341.7.
By order of the Board of Directors.
Dated at Washington, DC, this 15th day of
December, 2015.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2015–31941 Filed 12–21–15; 8:45 am]
BILLING CODE 6714–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 878
[Docket No. FDA–2015–N–1765]
RIN 0910–AH14
General and Plastic Surgery Devices:
Restricted Sale, Distribution, and Use
of Sunlamp Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA or the Agency) is
proposing to establish device
restrictions for sunlamp products,
which would restrict their use to
individuals age 18 and older, require
prospective users to sign a risk
acknowledgement certification before
use, and require the provision of user
manuals.
SUMMARY:
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Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Proposed Rules
Submit either electronic or
written comments on the proposed rule
by March 21, 2016. Submit comments
on information collection issues under
the Paperwork Reduction Act of 1995 by
February 22, 2016. See Section VIII for
the proposed effective date of a final
rule based on this proposed rule.
ADDRESSES: FDA is explicitly seeking
comment on the risks to health that
should be included in the risk
acknowledgement certification. You
may submit comments as follows:
DATES:
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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–1765 for ‘‘General and Plastic
Surgery Devices: Restricted Sale,
Distribution, and Use of Sunlamp
Products.’’ Received comments will be
placed in the docket and, except for
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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.
Submit comments on information
collection issues to the Office of
Management and Budget in the
following ways:
• Fax to the Office of Information and
Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202–395–7285, or
email to oira_submission@omb.eop.gov.
All comments should be identified with
the title ‘‘Restricted Sale, Distribution,
and Use of Sunlamp Products.’’
FOR FURTHER INFORMATION CONTACT: Neil
R.P. Ogden, Center for Devices and
Radiological Health, Food and Drug
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Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1438, Silver Spring,
MD 20993–0002, 301–796–6397.
SUPPLEMENTARY INFORMATION:
I. Background and Legal Authority
Sunlamp products are both ‘‘devices’’
under section 201(h) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 321(h)), and
‘‘electronic products’’ under section
531(2) of the FD&C Act (21 U.S.C.
360hh(2)). They are designed to
incorporate one or more ultraviolet (UV)
lamps intended for irradiation of any
part of the living human body, by UV
radiation with wavelengths in air
between 200 and 400 nanometers, to
induce skin tanning (see §§ 878.4635(a)
and 1040.20(b)(9) (21 CFR 878.4635(a)
and 1040.20(b)(9))). Sunlamp products
include tanning beds and tanning
booths. Sunlamp products, as defined in
proposed § 878.4635, do not include—
and this proposed rulemaking does not
address—ultraviolet lamps for
dermatological disorders regulated
under 21 CFR 878.4630.1
The FD&C Act establishes a
comprehensive system for the regulation
of medical devices intended for human
use. Section 513 of the FD&C Act (21
U.S.C. 360c) defines three categories
(classes) of devices, reflecting the
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
FDA regulates electronic products
under chapter 5, subchapter C, of the
FD&C Act (21 U.S.C. 360hh et seq.).
Under these provisions, FDA
administers an electronic product
radiation control program to protect the
public health and safety. This authority
provides for developing, amending, and
administering radiation safety
performance standards for electronic
products, including sunlamp products.
FDA is undertaking three initiatives to
address the risks associated with
sunlamp products. First, in a final
reclassification order that issued June 2,
2014 (79 FR 31205 at 31213), FDA
reclassified sunlamp products and UV
lamps intended for use in sunlamp
products from class I to class II, and
established special controls and
1 UV emitting lamps that are medical devices and
have different intended uses than devices classified
under 21 CFR 878.4635 (intended to tan skin)
would not fall under that regulation. Manufacturers
of such devices would have to obtain approval,
clearance or authorization to market their device
under the premarket approval, 510(k) or de novo
pathway. The use of such devices in a pediatric
population is beyond the scope of this document.
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Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Proposed Rules
premarket notification (510(k))
requirements under the medical device
authorities of the FD&C Act. The special
controls include performance testing
and labeling requirements, including a
warning that sunlamp products are not
to be used on persons under the age of
18 years.
Second, and simultaneously with this
proposed rule, FDA is proposing
amendments to the sunlamp products
and UV lamps performance standard at
§ 1040.20, which includes technical and
labeling requirements issued under the
radiological health provisions of the
FD&C Act. As explained elsewhere in
this issue of the Federal Register, FDA
is taking this action to reflect current
scientific knowledge related to sunlamp
product use, harmonize it more closely
with International Electrotechnical
Commission (IEC) International
Standard 60335–2–27, Ed. 5.0: 2009–12,
and strengthen the warning statement
required by § 1040.20(d)(1)(i) in
accordance with the results of the study
FDA conducted under section 230 of the
Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85).
Finally, in this action, FDA is
proposing device restrictions under
section 520(e) of the FD&C Act (21
U.S.C. 360j(e)), which authorizes FDA to
issue regulations imposing restrictions
on the sale, distribution, or use of a
device, if, because of its potentiality for
harmful effects or the collateral
measures necessary to its use, FDA
determines that absent such restrictions,
there cannot be a reasonable assurance
of its safety and effectiveness. The
proposed device restrictions would
require that:
1. Tanning facility operators permit
use of sunlamp products only if the
prospective user is age 18 or older;
2. Tanning facility operators, upon
request by the user or prospective user,
provide a copy of the sunlamp product
user manual or name and address of the
manufacture or distributor from whom a
user manual may be obtained;
3. 510(k) holders assure that a user
manual accompanies each sunlamp
product and, upon request, provide a
copy of the user manual to any tanning
facility operator, user or prospective
user; and
4. Tanning facility operators obtain
each prospective user’s signature on a
risk acknowledgement certification.
These device restrictions would
primarily apply to tanning facility
operators, and to a lesser extent, device
manufacturers and distributors. FDA
considers a tanning facility operator to
be any person offering for sale the use
of sunlamp products. FDA would not
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consider people who use their own
tanning beds (home users) to be tanning
facility operators.
Certain provisions of the FD&C Act
relate specifically to FDA’s authority
over restricted devices. For example,
sections 502(q) and (r) of the FD&C Act
(21 U.S.C. 352(q) and (r)) provide that a
restricted device distributed or offered
for sale in any state shall be deemed to
be misbranded if its advertising is false
or misleading or fails to include certain
information regarding the device, or it is
sold, distributed, or used in violation of
regulations prescribed under section
520(e), and section 704(a) of the FD&C
Act (21 U.S.C. 374(a)) authorizes FDA to
inspect certain records relating to
restricted devices.
If this proposed rule becomes final, it
may be enforced by means of seizure of
the sunlamp product, under section 304
of the FD&C Act (21 U.S.C. 334); a suit
for injunction, under section 302 of the
FD&C Act (21 U.S.C. 332); imposition of
civil money penalties, under section 303
of the FD&C Act (21 U.S.C. 333); or
criminal prosecution, under section 303
of the FD&C Act. FDA expects to
cooperate with counterpart agencies at
the state level in enforcing the proposed
requirements, if they become final.
Consumer complaints to FDA and State
Agencies would be important in
identifying entities that violate the
conditions for sale or use of these
devices.
II. Risks Posed by the Device
The General and Plastic Surgery
Devices Panel of the Medical Devices
Advisory Committee (2010 Advisory
Panel) met on March 25, 2010, to review
and discuss recent information
regarding the risks to the general public
from exposure to sunlamp products, and
identified the following risks to health
for sunlamp products.2 These risks are
well documented and discussed in
published literature.
A. Increased Skin Cancer Risk From
Cumulative, Repeated UV Radiation
Exposure
UV radiation exposure can lead to
permanent damage to DNA in the skin,
which has been shown to lead to an
increased risk of skin cancer (Refs. 1–3).
Skin cancers that have been associated
with cumulative repeated UV radiation
exposure include melanoma and nonmelanoma skin cancers (NMSC) such as
basal cell carcinoma and squamous cell
carcinoma (Ref. 4). One study suggests
that doses of UV–A radiation emitted by
2 See https://www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/Generaland
PlasticSurgeryDevicesPanel/ucm205684.htm.
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high power sunlamp products may be
up to 10 to 15 times higher than that of
the midday sun, resulting in an intense
amount of exposure that does not exist
in nature (Ref. 5). Users with a personal
history of melanoma have an increased
risk of skin cancer, as do users with
familial melanoma—having one firstdegree relative with melanoma doubles
one’s risk of developing melanoma
(Refs. 6, 7). There is also evidence
suggesting that individuals who begin
indoor tanning at ages younger than 18
years are particularly vulnerable to the
carcinogenic impact of indoor tanning
(see section III.A for further discussion).
B. Ocular Injury
UV and visible radiation from
sunlamp products can be harmful to the
eyes if proper protective eyewear is not
worn. The UV radiation from sunlamp
products can cause keratitis and corneal
burns, which can be painful and affect
vision (Ref. 8). The intense visible light
from some sunlamp products can
damage the retina and permanently
affect vision (Ref. 8). Artificial UV
radiation has also been linked to ocular
melanoma, which can cause vision loss
and often spreads to other parts of the
body (Ref. 9).
C. Discomfort, Pain, and Tenderness on
the Skin Resulting From Burns to the
Skin Due to Acute Overexposure to UV
Radiation
A recent study showed that, despite
protective properties touted by
commercial tanning facilities such as
claims that indoor tanning limits
exposure time and intensity, 66 percent
of female college-age users reported skin
erythema (or redness due to sunburn)
from indoor tanning, and these users
reported one episode of sunburn out of
every five tanning sessions (Ref. 10).
Those findings are in line with a
previous report that found that 58
percent of sunlamp product users ages
11 years to 18 years had experienced
sunburns from exposure to sunlamp
products (Ref. 11).
In certain individuals who are
photosensitive, skin exposure to UV
radiation may induce unexpected
reactions such as rash, severe burns, and
hypersensitivity (Ref. 12). Various drugs
may cause a photosensitivity reaction in
the skin. Some drugs may cause a
phototoxic reaction when they absorb
UV–A radiation and cause cellular
damage. These drugs include antiinfective drugs such as tetracyclines and
fluoroquinolones, cardiovascular drugs
like hydrochlorothiazide and
amiodarone, psychiatric drugs such as
phenothiazines, and retinoids such as
isotretinoin (Ref. 13). Some dietary
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supplements may also cause
photosensitivity (Ref. 13).
Sunlamp products, like most light
sources, generate heat that can cause
thermal skin burns, similar to any hot
surface. Individuals with open wounds
or lesions are particularly susceptible to
burns from UV radiation because these
individuals lack the protective
epidermal layer of the skin that provides
the body’s greatest protection from UV
irradiation (Ref. 14).
D. Skin Damage
Cumulative, repeated exposure to UV
radiation emitted by sunlamp products
may lead to accelerated aging of skin
due in part to DNA and skin cell
damage (Ref. 15). UV irradiation inhibits
the production of collagen precursor
molecules such as type I and type III
procollagen (Ref. 16). UV irradiation
stimulates skin metalloproteinases,
which break down skin proteins that
then lead to photoaging (Ref. 17). On a
cellular level, UV radiation has been
known to cause DNA damage (Ref. 1).
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III. Proposed Device Restrictions
FDA is proposing the following
restrictions which, because of the
potential for harmful effects from the
device, are necessary for a reasonable
assurance of safety and effectiveness of
sunlamp products:
A. Use Would Be Restricted to
Individuals Age 18 and Older
Although the risks associated with
sunlamp products are applicable to all
persons, FDA is proposing to restrict the
use of this device to persons age 18 and
older because children and adolescents
who are exposed to UV radiation may be
at higher risk of developing certain
types of skin cancer than persons who
begin exposure later in life as adults
(Ref. 18). In the final reclassification
order for this device, FDA established
special controls labeling regarding
minors’ use of sunlamp products and
UV lamps intended for use in sunlamp
products (see § 878.4635(b)(6)). Based
on the increased risk of developing skin
cancer and minors’ difficulty in
appreciating the risks posed by the
devices (see Refs. 19 to 24), FDA has
determined that use of sunlamp
products by minors is not appropriate
and is therefore establishing a proposed
restriction in this rulemaking action to
complement the special controls
labeling.
Published medical evidence
demonstrates that there is a direct
correlation between sunlamp product
use among youths and their developing
melanoma skin cancer, as well as other
skin cancers (Refs. 25, 26). Melanoma is
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a leading cause of cancer death in
women ages 15 years to 29 years and
there is some evidence that suggests use
of sunlamp products is an underlying
cause (Refs. 27, 28).
There is increasing epidemiological
evidence that shows that tanning at ages
younger than 18 years increases the risk
of developing melanoma (Refs. 25, 29 to
32). Melanoma (of the types of skin
cancer, this is the more concerning type
due to greater potential for fatality) is
currently the second leading type of
cancer in persons age 20 years to 39
years, and many experts believe that at
least one cause for this is the increasing
use of sunlamp products (Refs. 30, 33).
A 2009 International Agency for
Research in Cancer (IARC) report linked
UV exposure (including from indoor
tanning devices) by individuals under
age 35 to higher rates of melanoma as
compared to a similar cohort of
individuals who had not used sunlamp
products, and recommended that
minors not use sunlamp products.
Similarly, a meta-analysis by Gallagher
et al. that evaluated metrics of sunlamp
product exposure, including in young
adults, indicated a significantly
increased risk of cutaneous melanoma
subsequent to sunlamp product
exposure (Ref. 34). In particular, the
analysis showed a positive association
between first exposure as a young adult
and subsequent melanoma. Further, a
case control study in Connecticut found
a relative risk of 1.4 for melanoma
diagnosis when individuals are exposed
to sunlamp products before the age of 25
(Ref. 35).
In addition, there is increasing
epidemiological evidence that shows
that tanning at ages younger than 18
years increases the risk of developing
NMSC. For example, recent studies
found a significantly higher risk for
basal cell carcinoma for individuals
who used sunlamp products during
high school and college as compared to
those who used sunlamp products
between the ages of 25 and 35 (Refs. 36,
37).
Individuals under 18 who are exposed
to UV radiation are at an increased risk
of developing skin cancer because (1)
there is evidence suggesting that they
are particularly vulnerable to the
damaging effects of UV radiation and (2)
the cumulative effects of exposure have
been linked to higher incidence of skin
cancer. First, evidence suggests that
minors exposed to UV radiation are
particularly vulnerable to developing
skin cancer (Ref. 38). In particular,
migration studies compare people who
moved from less UV-intense
environments to more UV-intense
environments at a young age, for
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example, children who moved from the
United Kingdom to Australia. A number
of biological factors, such as skin
development and formation of nevi at a
young age, are identified as potentially
causing the increase in the risk of
developing melanoma from exposure to
UV radiation, like that from sunlamps
(Refs. 18, 39). Second, as with other
radiation exposure, increased
cumulative lifetime UV exposure results
in increased skin cancer risk (Ref. 40).
The age restriction also is necessary
because individuals under 18 often fail
to appropriately evaluate the significant
health risks associated with indoor
tanning. For example, a study has
shown that college age students often
use sunlamp products despite
awareness of the long-term risks (Refs.
41 to 43). Rather, persons under age 18
years appear to be discounting whatever
risk information they are receiving or
may have difficulty incorporating the
information into their decisionmaking.
For example, a recent study links indoor
tanning by high school students to other
risk-taking behaviors, including bingedrinking, unhealthy weight control,
sexual intercourse, and illegal drug or
steroid use (Ref. 20). This linkage
suggests that, like other risk-taking
behaviors, adolescents use sunlamp
products for self-esteem or sensation
seeking reasons, irrespective of known
health risks (Ref. 20). Similarly, another
recent study showed that psychosocial
and demographic characteristics
strongly correlated with adolescent
indoor tanning (Ref. 22). By restricting
sunlamp product use to individuals 18
and older, we would be protecting a
subpopulation that generally tends to
discount risk information and favor risk
taking.
Based on the scientific evidence
available at the time, some members of
the 2010 Advisory Panel recommended
an age restriction to preclude use by
persons under 18 years of age to reduce
the unintended health effects of these
devices (Ref. 44). The scientific
literature published since that meeting,
as described in this document, offers
further support for an age restriction
(Refs. 20, 22, 41).
Various professional organizations
also support an age restriction on
sunlamp product use. The World Health
Organization (WHO) has classified UV
radiation from sunlamp products as a
class I carcinogen based on the 2009
IARC report that linked sunlamp
product use by individuals under age 35
to higher rates of melanoma and
strongly urged consideration of
restricting minors from using sunlamp
products (Ref. 45). Accordingly, the
WHO recommends that persons under
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age 18 not use sunlamp products (Ref.
46).
The American Academy of
Dermatology (AAD) recognizes WHO’s
declaration that sunlamp products are
cancer-causing agents and are in the
same risk category as tobacco, and
supports the position that minors
should not use sunlamp products (Ref.
47). In 2011, the American Academy of
Pediatrics published a policy statement
similar to that of the AAD calling for a
restriction on sunlamp product use by
minors (Refs. 48, 49).
Experts in pediatrics, public health,
and dermatology also support a
legislative age restriction on sunlamp
product use. For example, recent studies
cited other peer reviewed articles to
examine the effects of legislation on
indoor tanning use (Refs. 22, 50, 51).
They concluded that an age restriction
or ban would be far more effective at
reducing youth indoor tanning than
other potential actions such as parental
consent (Refs. 22, 50, 51).
This scientific evidence also has led
many State and foreign governments to
institute age restrictions in the last few
years on the use of sunlamp products by
minors (Ref. 50). To date, more than 40
states have age restrictions on sunlamp
product use (Ref. 52). These restrictions
have age limits ranging from ages 14 to
18. At least 11 countries have restricted
the use of sunlamp products to adults
age 18 and older, including Great
Britain and France (Refs. 52 to 54).
Restricting use of these devices to
individuals 18 and over should reduce
future morbidity and mortality from
melanoma and other skin cancers and
would help to protect the public health,
according to both expert advisory
opinion and findings from current
scientific, medical, and public health
policy literature (Ref. 54). In the journal
Health Policy in 2009, Hirst et al.
estimated that preventing minors from
indoor tanning has the potential to
reduce the incidence of skin cancers
and related medical costs (Ref. 54).
This restriction is particularly
important because, as previously
discussed, it has been shown that
increased knowledge of the risks of UV
exposure among adolescents and young
adults does not appreciably alter their
tanning behavior and attitudes (Refs. 19,
41, 42, 55). The use of sunlamp
products has been suggested to have
both a psychological reinforcing effect
in minors due to feedback from others
on minors’ cosmetic appearance or selfperceptions that leads to continued or
increased use, in addition to the
physical reinforcing effect that has been
linked to high rates of use (Refs. 19, 56).
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This age restriction is also important
because parental awareness of the risks,
educational campaigns, and parental
consent to the risks, on their own, have
been shown to be insufficient in
reducing indoor tanning in young age
groups (Refs. 21, 22, 41).
The risks associated with use of
sunlamp products by individuals under
18 are particularly concerning given the
widespread use of these devices among
high school students. The Centers for
Disease Control and Prevention has
documented high rates of use in U.S.
high school students from its 2011
Behavioral Risk Survey: 13 percent of
all high school students report indoor
tanning, and 29 percent of white female
high school students report usage in the
last year (Ref. 53). There are a number
of collaborative studies that have
demonstrated that young women, in
particular, use sunlamp products at
increasingly high rates (Refs. 22 to 24,
57). For example, one study found that
indoor tanning usage (defined as
tanning during the previous 12 months)
progressively increased in adolescents
(age 14–17) from 5.5 percent at age 14
to 16.5 percent at age 17, which suggests
that adolescents use indoor tanning
more often as they get older (Ref. 22).
Another study analyzed the results of a
survey of over 10,000 U.S. individuals
age 12 years to 18 years and found
nearly 10 percent of respondents used a
sunlamp product during the previous
year and rates increased to 35 percent
for females by age 17, highlighting that
teenage girls are more likely than their
male counterparts to use indoor tanning
facilities (Ref. 24).
FDA seeks comments on its proposal
to restrict use of these devices to
individuals 18 years of age and over as
well as data and information in support
of any comments. In addition, although
FDA has strong reservations about a
parent-consent process in this setting,
we recognize parents’ decision-making
role. We welcome comment on parental
consent and its potential scope,
including comments on experiences in
jurisdictions that have a parental
consent provision for use of sunlamp
products.
B. Sunlamp Product User Manuals
Would Have To Be Provided to Users,
Prospective Users, and Tanning Facility
Operators Upon Request
User manuals provide valuable
information to operators and users.
Sunlamp product user manuals can
include vital information such as
instructions for use, exposure
schedules, maintenance guidance, and
device warnings. In order to help ensure
the dissemination of this important
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information to sunlamp product users,
FDA is proposing that tanning facility
operators be required to provide a copy
of the user manual or the name and
address of the manufacturer or
distributor that can provide a copy of
the user manual to any user or
prospective user that requests one.
Similarly, FDA is also proposing that
510(k) holders be required to provide
user manuals to any tanning facility
operator, user, or prospective user that
requests one. The electronic product
performance standard currently requires
manufacturers to provide manuals to
purchasers and, upon request, to others
for the life of the sunlamp product (see
§ 1040.20(e)). FDA believes that access
to the information contained in the user
manual would help prospective users
make informed decisions when
considering whether to use the device
and would also inform tanning facility
operators and users on how to use the
device properly.
C. Prospective Users Would Have To
Sign a Risk Acknowledgement
Certification Before Sunlamp Product
Use
FDA is proposing that tanning facility
operators would have to provide, and
sunlamp product prospective users 18
and older would have to sign, the
certification set forth in proposed
§ 878.4635(c)(4) prior to use of any
sunlamp product, unless the
prospective user has previously signed
the risk acknowledgement certification
within the preceding 6 months. The
certification provides warnings
regarding sunlamp products as well as
information regarding the proper use of
the devices. By making this information
available to users in a direct and
accessible manner, the certification
would better enable consumers to make
informed decisions about their use of
sunlamp products. Moreover, and as
discussed more fully in this section
III.C, the information could counteract
any false or misleading information that
sunlamp product users may have
received regarding the risks of indoor
tanning.
Compliance with this proposed
requirement would not be unduly
burdensome for tanning facilities. The
certification has already been drafted by
FDA and, as discussed in the economic
analysis in Docket FDA–2015–N–1765
and at https://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses/default.htm (Ref.
58), tanning facility operators would
need only a brief amount of time to
explain to the user the purpose of the
certification and to process or file the
signed certification. Reading and
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signing the certification would not be
overly burdensome for prospective
users—the user would need only a brief
amount of time to read and sign the
form, if they choose to proceed (Ref. 58).
FDA proposes that the text of the risk
acknowledgement certification would
have to be at least 10-point font and that
the tanning facility operator would have
to provide a copy of the signed
acknowledgement certification to the
prospective user and retain a copy of the
signed acknowledgement certification
for 1 year or until the prospective user
signs a new risk acknowledgement
certification, whichever is sooner. The
statements in the certification are
intended to inform prospective users of
the risks they may be exposing
themselves to by using the device and
the inherent risks posed by UV
radiation, as well as provide
information regarding the proper use of
the device.
When developing the certification,
FDA aimed to inform readers of the
most serious risks in a clear and
succinct manner in order to promote
rapid comprehension and not take more
time than necessary for the key
information to be conveyed and
understood. Readability analysis,
human participants’ usability testing,
and human factors/risk communication
analysis were conducted on the
certification to ensure the certification
achieved its intended goals clearly and
succinctly (Refs. 58 and 59). After
obtaining feedback from the testing, the
certification was revised consistent with
recommendations made in the testing
and is presented in this proposed rule
with its refined content and format.
FDA welcomes comment on the
proposed certification form.
Unlike a label that must be affixed to
a device (see § 878.4635(b)(6)(i)(A)), a
risk acknowledgement certification can
include more comprehensive warnings
to ensure that users are aware of the
risks associated with the use of the
devices (Refs. 50 and 59). FDA expects
that users will consider the risks
carefully when signing the certification.
If users were provided the certification
but not required to sign it, they would
be less likely to read the risk
information in the certification, and
they may even opt not to read the
certification, mistakenly thinking that it
was promotional material provided by
the tanning facility.
Members of the 2010 Advisory Panel
recommended that sunlamp product
users be required to read and sign an
acknowledgement of risks related to
sunlamp products before using the
device. Since this meeting, FDA has
become aware of additional information
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regarding the use of sunlamp products
that further supports the need for risk
acknowledgement certifications.
There are reports in the literature that
document tanning facility operators
failing to inform patrons of certain risks,
causing various groups to call for
‘‘informed consent’’ or better informing
users at indoor tanning facilities (Ref.
60).
In keeping with the literature, on
February 1, 2012, staff of the U.S. House
of Representatives Committee on Energy
and Commerce released a report
summarizing their findings regarding
false and misleading information
provided to patrons of indoor tanning
salons, especially teenage women. They
found, for example, that 90 percent of
operators responded that indoor tanning
presented no risks (Ref. 61). When
pressed about skin cancer specifically,
more than half of the operators claimed
indoor tanning would not increase the
risk (Ref. 61). Some operators who did
inform their patrons of skin cancer risks
nevertheless mischaracterized the
magnitude and the vulnerable
subpopulations (Ref. 60). Other
operators provided misleading benefit
information, including claims that
indoor tanning would protect patrons
from cancer or beneficially create
vitamin D (Ref. 61).
These reported practices support the
need for risk acknowledgement
certifications, which could counteract
any false or misleading information
communicated to prospective users.
This risk acknowledgment will provide
prospective users with accurate
information about the risks and proper
use of the devices so that they can make
informed decisions about their use of
these devices.
IV. Environmental Impact
The Agency has determined that
under 21 CFR 25.34(f) this proposed
action will not result in increases in the
existing levels of use or changes in the
intended uses of the product or its
substitutes. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
V. Analysis of Economic Impacts
FDA has examined the impacts of the
proposed rule under Executive Order
12866, Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
Executive Orders 12866 and 13563
direct Agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
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approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). OMB has
determined that this proposed rule is a
significant regulatory action as defined
by 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. We believe this proposed rule
would result in a significant impact on
a substantial number of small entities,
but the impacts are uncertain.
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 $144
million, using the most current (2014)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this proposed rule to result in any 1year expenditure that would meet or
exceed this amount.
The proposed rule would restrict the
use of sunlamp products to individuals
aged 18 years and over and require all
prospective users to read and sign a risk
acknowledgement certification before
use (unless the prospective user has
previously signed the form within the
preceding 6 months). The social benefits
from this proposed rule stem from a
potential reduction in the incidence of
skin cancer. The social costs of the
proposed rule are associated with the
value of time spent by users and tanning
facility operators on the risk
acknowledgement certifications and
verifying proof of age, as well as other
compliance costs. As discussed more
fully in the complete assessment,
analyzing the impact of the proposed
rule is difficult because of the
uncertainty of how users would be
affected by reading and signing the risk
acknowledgment certification and how
nonuse when under 18 years of age
would affect later adult use. Because of
this uncertainty, we use a 1 to 10
percent range in the response rate to the
risk information and age restriction,
assuming that the age restriction
reduces future tanning. Under these
scenarios, assuming a discount rate of 7
percent the annualized cost over 10
years would range from $104 million to
$114 million; annualized benefits would
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million to $820 million at a 7 percent
discount rate over 10 years and from
about $500 million to $825 million at a
3 percent discount rate.
In addition to the social costs, the
proposed rule would likely generate
distribution effects from the reduced
demand for tanning services. The
annualized reduction in indoor tanning
revenues would range from about $500
range from $70 to $115 million. With a
3 percent discount rate the annualized
cost over 10 years would range from
$122 million to $144 million;
annualized benefits would range from
$151 to $248 million.
TABLE 1—SUMMARY OF THE IMPACT OF THE PROPOSED RULE
[$ millions]
7% Discount
rate, 5%
impact
7% Discount
rate, 1%
impact
7% Discount
rate, 10%
impact
3% Discount
rate, 5%
impact
3% Discount
rate, 1%
impact
3% Discount
rate, 10%
impact
Present Value over 10 Years
Benefits ....................................................
Costs ........................................................
Net Benefits .............................................
Lost Revenue ...........................................
632.9
763.4
¥130.5
4,532.9
491.7
732.2
¥240.5
3,527.2
806.8
801.7
5.1
5,770.4
1,657.3
1,126.4
530.9
5222.4
1,284.4
1,043.3
241.1
4287.4
2,115.7
1,228.6
887.1
7040.7
194.3
132.1
62.2
647.4
150.6
122.3
28.3
502.6
248.0
144.0
104.0
825.4
Annualized Value over 10 Years
Benefits ....................................................
Costs ........................................................
Net Benefits .............................................
Revenue Loss ..........................................
90.1
107.2
¥18.6
645.4
70.0
104.2
¥34.2
502.2
114.9
114.1
0.7
821.6
Note: The impacts are tied to the acknowledgement certification and changing habits, which we interpret as the effect of age restrictions in disrupting the development of a habit for indoor tanning.
Tanning salons and most of the other
establishments who offer commercial
tanning services are classified as Other
Personal Care Services under the North
American Industry Classification
System (NAICS 812199). We do not
have information on the size
distribution of this industry but most, if
not all, entities are small businesses.
There are 18,000 to 19,000 indoor
tanning salons and 15,000 to 20,000
other facilities that offer indoor tanning
services. The proposed rule would have
a significant impact on a substantial
number of small entities chiefly due to
the loss of revenue.
The full assessment of the economic
analysis is available in Docket FDA–
2015–N–1765 and at https://www.fda.
gov/AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm
(Ref. 62). Table 2 summarizes the
analysis.
TABLE 2—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE
Units
Primary
estimate
Low estimate
$90.10
194.30
........................
........................
........................
$70.00
150.60
........................
........................
........................
107.20
132.10
........................
........................
........................
........................
........................
Category
Benefits:
Annualized Monetized $millions/year ....
Annualized Quantified ............................
Qualitative ..............................................
Costs:
Annualized .............................................
Monetized $millions/year .......................
Annualized .............................................
Quantified ...............................................
Qualitative ..............................................
Transfers:
Federal Annualized ................................
Monetized $millions/year .......................
High estimate
Year dollars
Discount rate
(%)
Period
covered
(years)
$114.90
248.00
........................
........................
........................
2014
2014
2014
2014
........................
7
3
7
3
........................
10
10
10
10
........................
104.20
122.30
........................
........................
........................
114.10
144.00
........................
........................
........................
2014
2014
2014
2014
........................
7
3
7
3
........................
10
10
10
10
........................
........................
........................
........................
........................
2014
2014
7
3
20
20
2014
2014
7
3
10
10
From:
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Other Annualized ...................................
Monetized $millions/year .......................
To:
645.4
647.4
502.2
502.6
821.6
825.4
From: Industry
Effects ...........................................................
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Notes
To: Consumer
This will have a significant impact on a substantial number of small entities.
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VI. Federalism
FDA has analyzed this proposed 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 proposed rule creates a
requirement under 21 U.S.C. 360k.
At the time of publication of this
proposed rule, most States and some
localities have acted to impose some
form or restriction on tanning for
minors.3 Section 521(b) of the FD&C Act
(21 U.S.C. 360k(b)) provides that the
Commissioner of Food and Drugs may,
upon application of a State or local
government, exempt a requirement from
preemption, if the State or local
requirement for the device is more
stringent than the requirement under
the FD&C Act, or if the requirement is
necessitated by compelling local
conditions and compliance with it
would not cause the device to be in
violation of a requirement under the
FD&C Act. Following this process, and
if this rule becomes final, a State or
local government may request an
exemption from preemption for those
State or local requirements pertaining to
sunlamp products that are preempted by
the Agency’s final rule. FDA’s rules that
detail the content of such requests and
the process for considering them are
contained within 21 CFR part 808.
VII. Paperwork Reduction Act of 1995
This proposed rule contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The title,
description, and respondent description
of the information collection provisions
are shown in this section VII with an
estimate of the annual recordkeeping.
Included in the estimate is the time for
maintaining documentation and
disclosing materials.
FDA invites comments on these
topics: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Restricted sale, distribution, and
use of sunlamp products.
Description: FDA is requesting OMB
approval of the requirements set forth in
this proposed rule, which would: (1)
Restrict the use of sunlamp products to
individuals age 18 years and over
(§ 878.4635(c)(1)); (2) require that
tanning facility operators provide a user
manual to users and prospective users
that request one, or the name and
address of the manufacturer or
distributor from who a user manual may
be obtained (21 CFR 878.4635(c)(2)); (3)
require that sunlamp product 510(k)
holders accompany each product with a
user manual and provide a user manual
to users and tanning facility operators
that request one (§ 878.4635(c)(3)); and
(4) require all prospective users to read
and sign a risk acknowledgement
certification before use (unless the
prospective user has previously signed
the certification within the preceding 6
months) (§ 878.4635(c)(4)).
Description of Respondents: The
requirements apply to manufacturers
and distributors of sunlamp products,
sunlamp product users and prospective
users, as well as tanning facility
operators.
Burden: FDA estimates the burden of
this collection of information to be as
follows:
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Facility maintains signed certification (878.4635(c)(4)(iii)) ...
36,000
594
21,384,000
0.004 (0.25
minutes,
i.e., 15 seconds).
85,536
Total hours
Total capital
costs
1 There
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity/21 CFR section
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
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One-Time Burden
Facility explains certification on user’s first
visit.
Manufacturer/Distributor provides user
manual with device; provides copy of
manual upon request (878.4635(c)(3)).
36,000
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10,692,000
20
3 National Conference of State Legislators, Indoor
Tanning Restrictions for Minors—A State-by-State
297
1
20
Comparison, https://www.ncsl.org/research/health/
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0.008 (30
seconds).
15 ................
85,536
$2,000,000
300
27,800
indoor-tanning-restrictions.aspx (last updated July
1, 2015).
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79501
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Activity/21 CFR section
Total one-time burden .........................
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
........................
........................
........................
.....................
85,836
0.004 (0.25
minutes,
i.e., 15
seconds).
42,768
Total hours
Total capital
costs
2,027,800
Annual Burden
Facility provides user manual upon request (878.4635(c)(2)).
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1 There
36,000
297
10,692,000
are no operating and maintenance costs associated with this collection of information.
The economic analysis for this
rulemaking provides a range of 33,000
to 39,000 for the number of tanning
facilities (18,000 to 19,000 indoor
tanning salons and 15,000 to 20,000
other facilities that offer indoor tanning
services). In the PRA analysis we use
the mean, 36,000 facilities, for the
estimated number of facilityrespondents. The economic analysis
also provides a range for the number of
sunlamp product users (after accounting
for the impact of the age restriction and
the communication of the risk
information) of 10.2 to 11.2 million. We
used the mean, 10.7 million, to calculate
the average number of users per facility
(10.7 million users divided by 36,000
facilities equals an average of 297 users
per facility).
Proposed § 878.4635(c)(2) of the
proposed rule would require, upon
request by a user, tanning facility
operators to supply a copy of the user
manual for their sunlamp products; or
the tanning facility could supply the
name and address where the user could
request a copy of the manual. We
believe the incremental compliance
costs to tanning facilities would be
negligible because facilities receive the
user manual with the equipment and
likely already use the information to
train their employees. Requests from
users would not be frequent and the
tanning facility need only supply the
name and address, which could be an
email address, of the 510(k) holder. We
expect it will take approximately 15
seconds for the facility to provide the
address.
Proposed § 878.4635(c)(3) of the
proposed rule would require the 510(k)
holders of sunlamp products to, upon
request, supply tanning facility
operators, users, and potential users
copies of their user manuals. The 510(k)
holders would have to develop standard
operating procedures (SOPs) for
responding to requests. In our
experience, it would take a company
about 5 hours of management time to
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develop the SOPs and set up a system
for response. We believe most of the
approximately 20 510(k) holders would
satisfy this proposed requirement by
making the manuals available on the
Internet so recurring costs to satisfy
requests for the user manual should be
negligible. Many companies already
make user manuals available online but
for those who do not, it may take up to
10 hours of a computer programmer’s
time to modify the company’s Web site
and to upload the manuals for both
current and past models that could still
be in use. About 20 firms manufacture
and distribute sunlamp products that
could be affected by these proposed
requirements. Because we do not know
how many of them have user manuals
online and all would have to modify
their Web pages so product users could
find the manuals, we are assuming all
firms will incur one-time costs of 5
hours for SOPs and 10 hours to modify
their Web pages. We include an estimate
of $27,800 for one-time capital costs to
account for the wage rate for a manager
and computer programmer.
Proposed § 878.4365(c)(4)(iii) would
require tanning facilities to maintain
signed risk acknowledgement
certifications for at least 1 year or until
the user signs a new risk
acknowledgement certification,
whichever is earlier. The 10.7 million
users divided among the 36,000 tanning
facilities yields an average of 297 users
per facility and since users must sign
the certification twice per year, this is
594 certifications to be maintained by
each tanning facility per year.
Multiplying the 594 certifications by the
36,000 facilities yields 21,384,000 total
certifications to be filed per year. FDA
expects that filing the certification,
either paper or electronic, will take the
facility 15 seconds or 0.004 hours and
this multiplied by the 21,384,000 total
certifications yields a burden estimate of
85,536 hours for this recordkeeping
requirement. As mentioned previously,
the number of facilities and users is an
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average based on the range of facilities
and users stated in the economic
analysis of this rulemaking. Therefore,
the resulting hour burden is consistent
with, but not identical to, the hours
stated in the economic analysis.
We also assume that the first time a
user visits a tanning facility after the
date the proposed requirements become
effective, a tanning facility operator
would take an extra 30 seconds to
explain to the prospective user the
purpose of the certification and the
facility’s policy regarding its
implementation. We have therefore
included a one-time burden estimate for
facilities to explain the certification to
users. As mentioned previously, the
numbers of facilities and users are
averages based on the ranges of facilities
and users stated in the economic
analysis of this rulemaking. Therefore,
the resulting hour-burden is consistent
with, but not identical to, the hours
stated in the economic analysis. We
estimate the one-time cost burden will
be $2 million, the mean of the range
($1.9 to 2.1 million) stated in the
economic analysis.
In addition, FDA concludes that the
user’s proof of age in § 878.4635(c)(1)
and the risk acknowledgement
certification in § 878.4635(c)(4) do not
constitute information but are rather
‘‘Affidavits, oaths, affirmations,
certifications, receipts, changes of
address, consents, or acknowledgments
. . .’’ (5 CFR 1320.3(h)(1)).
In compliance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the
information collection provisions of this
proposed rule to OMB for review. To
ensure that comments on information
collection are received, OMB
recommends that written comments be
faxed or emailed (see ADDRESSES). These
requirements will not be effective until
FDA obtains OMB approval. FDA will
publish a notice concerning OMB
approval of these requirements in the
Federal Register.
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VIII. Proposed Effective Date
FDA proposes that any final rule
based on this proposal become effective
90 days after its date of publication in
the Federal Register.
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IX. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and online at https://
www.regulations.gov (FDA has verified
all the Web site addresses in this
reference section, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Cadet, J., E. Sage, and T. Douki,
‘‘Ultraviolet Radiation-Mediated Damage
to Cellular DNA.’’ Mutation Research/
Fundamental and Molecular
Mechanisms of Mutagenesis, 571(1–2):3–
17, 2005.
2. Wolff, K. ,L.A. Goldsmith, S.I. Katz, et al.,
Fitzpatrick’s Dermatology in General
Medicine, 7th ed., p. 999, 2006.
3. Lazovich, D., R.I. Vogel, M. Berwick, et al.,
‘‘Indoor Tanning and Risk of Melanoma:
A Case-Control Study in a Highly
Exposed Population.’’ Cancer
Epidemiology, Biomarkers & Prevention,
19(6):1557–1568, 2010.
4. Wolff, K., L.A. Goldsmith, S.I. Katz, et al.,
Fitzpatrick’s Dermatology in General
Medicine, 7th ed., p. 814, 2006.
5. Gerber, B., P. Mathys, M. Moser, et al.,
‘‘Ultraviolet Emission Spectra of
Sunbeds.’’ Photochemistry and
Photobiology, 76:664–668, 2002.
6. Salama, A.K., N. deRosa, R.P. Scheri, et al.
‘‘Hazard-Rate Analysis and Patterns of
Recurrence in Early Stage Melanoma:
Moving Towards a Rationally Designed
Surveillance Strategy.’’ PLoS One,
8(3):e57665, 2013.
7. Niendorf, K.B. and H. Tsao, ‘‘Cutaneous
Melanoma: Family Screening and
Genetic Testing.’’ Dermatologic Therapy,
19:1, 2006.
8. Walters, B.L. and T.M. Kelley,
‘‘Commercial Tanning Facilities: A New
Source of Eye Injury.’’ The American
Journal of Emergency Medicine,
5(5):386–389, 1987.
9. Vajdic, C.M., A. Kricker, M. Giblin, et al.,
‘‘Artificial Ultraviolet Radiation and
Ocular Melanoma in Australia.’’
International Journal of Cancer,
112(5):896–900, 2004.
10. Stapleton, J.L., J. Hillhouse, R. Turrisi, et
al., ‘‘Erythema and Ultraviolet Indoor
Tanning: Findings From a Diary Study.’’
Translational Behavioral Medicine,
3(10):10–16, 2013.
11. Cokkinides, V., M. Weinstock, D.
Lazovich, et al., ‘‘Indoor Tanning Use
Among Adolescents in the U.S., 1998–
2004.’’ Cancer, 115:190–198, 2009.
12. Wolff, K. L.A. Goldsmith, S.I. Katz, et al.,
Fitzpatrick’s Dermatology in General
Medicine, 7th ed., p. 828, 2006.
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13. Shields, KM, ‘‘Drug-Induced
Photosensitivity.’’ Pharmacist’s Letter
20:200509, May 2004.
14. Wolff, K. L.A. Goldsmith, S.I. Katz, et al.,
Fitzpatrick’s Dermatology in General
Medicine, 7th ed., p. 57, 2006.
15. Wolff, K. L.A. Goldsmith, S.I. Katz, et al.,
Fitzpatrick’s Dermatology in General
Medicine, 7th ed., p. 815, 2006.
16. Fisher, G.J., S. Kang, J. Varani, et al.,
‘‘Mechanisms of Photoaging and
Chronological Skin Aging.’’ Archives of
Dermatology, 138(11):1462–1470, 2002.
17. Quan, T., Z. Qin, W. Xia, et al., ‘‘MatrixDegrading Metalloproteinases in
Photoaging.’’ Journal of Investigative
Dermatology Symposium Proceedings,
14(1);20–24, 2009.
18. Autier, P. and P. Boyle, ‘‘Artificial
Ultraviolet Sources and Skin Cancers:
Rationale for Restricting Access to
Sunbed Use Before 18 years of Age.’’
Nature Clinical Practice. Oncology,
5(4):178–179, 2008.
19. Boldeman, C., B. Jansson, B. Nilsson, et
al., ‘‘Sunbed Use in Swedish Urban
Adolescents Related to Behavioral
Characteristics.’’ Preventive Medicine,
26:114–119, 1997.
20. Guy, G.P., Z. Berkowitz, E. Tai, et al.,
‘‘Indoor Tanning Among High School
Students in the United States, 2009 and
2011.’’ Journal of the American Medical
Association Dermatology, 150(5):501–
511, 2014.
21. Demko, C.A., E.A. Borawski, S.M.
Debanne, et al., ‘‘Use of Indoor Tanning
Facilities by White Adolescents in the
United States.’’ Archives of Pediatrics &
Adolescent Medicine, 157(9):854–860,
2003.
22. Mayer, J.A., S.I. Woodruff, D.J. Slymen,
et al., ‘‘Adolescents’ Use of Indoor
Tanning: A Large-Scale Evaluation of
Psychosocial, Environmental, and
Policy-Level Correlates.’’ American
Journal of Public Health, 101(5):930–938,
2011.
23. Paul, C.L., A. Girgis, F. Tzelepis, et al.,
‘‘Solaria Use by Minors in Australia: Is
There a Cause for Concern?’’ Australian
and New Zealand Journal of Public
Health, 28:90, 2004.
24. Geller, A.C., G. Colditz, S. Oliveria, et al.,
‘‘Use of Sunscreen, Sunburning Rates,
and Tanning Bed Use Among More Than
10,000 U.S. Children and Adolescents.’’
Pediatrics, 109(6):1009–1014, June 2002.
25. Cust, A.E., B.K. Armstrong, C. Goumas, et
al., ‘‘Sunbed Use During Adolescence
and Early Adulthood Is Associated With
Increased Risk of Early-Onset
Melanoma.’’ International Journal of
Cancer, 128:2425–2435, 2011.
26. Balk, S.J., D.E. Fisher, and A.C. Geller,
‘‘Teens and Indoor Tanning: A Cancer
Prevention Opportunity for
Pediatricians.’’ Pediatrics, 131:772–785,
2013.
27. Diffey, B., ‘‘Sunbeds, Beauty and
Melanoma.’’ British Journal of
Dermatology, 157(2): 215–216, 2007.
28. Herzog, C., A.S. Pappo, M.L. Bondy, et
al., ‘‘Malignant Melanoma.’’ In: A.
Bleyer, M. O’Leary and L.A.G. Ries
(Eds.), Cancer Epidemiology in Older
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
Adolescents and Young Adults 15 to 29
Years of Age (National Cancer Institute,
NIH Pub. No. 06–5767, chapt. 5, pp. 53–
63) 2007. Bethesda, MD: U.S.
Department of Health and Human
Services.
29. Reed, K.B., J.D. Brewer, C.M. Lohse, et al.,
‘‘Increasing Incidence of Melanoma
Among Young Adults: An
Epidemiological Study in Olmsted
County, Minnesota.’’ Mayo Clinic
Proceedings, 87(4):328–334, 2012.
30. Boniol, M., P. Autier, P. Boyle, et al.,
‘‘Cutaneous Melanoma Attributable to
Sunbed Use: Systematic Review and
Meta-Analysis.’’ BMJ, 345:e4757, 2012.
31. Colantonio, S., M.B. Bracken, and J.
Beecker, ‘‘The Association of Indoor
Tanning and Melanoma in Adults:
Systematic Review and Meta-Analysis.’’
Journal of the American Academy of
Dermatology, 70(5):847–857, 2014.
32. Wehner, M.R., M.L. Shive, M.M. Chren,
et al., ‘‘Indoor Tanning and NonMelanoma Skin Cancer: Systematic
Review and Meta-Analysis.’’ BMJ,
345:e5909, 2012.
33. Bleyer, R.B., ‘‘Cancer in Young Adults 20
to 39 Years of Age: Overview.’’ Seminars
in Oncology, 36(3):194–206, 2009.
34. Gallagher, R.P., J.J. Spinelli, and T.K. Lee,
‘‘Tanning Beds, Sunlamps, and Risk of
Cutaneous Malignant Melanoma.’’
Cancer Epidemiology, Biomarkers &
Prevention, 14(3):562–566, 2005.
35. Chen, Y.T., R. Dubrow, T. Zheng, et al.,
‘‘Sunlamp Use and the Risk of Cutaneous
Malignant Melanoma: A PopulationBased Case-Control Study in
Connecticut, USA.’’ International
Journal of Epidemiology, 27:758–765,
1998.
36. Zhang, M., A.A. Qureshi, A.C. Geller, et
al., ‘‘Use of Tanning Beds and Incidence
of Skin Cancer.’’ Journal of Clinical
Oncology, 30(14):1588–1593, 2012.
37. Karagas, M.R., M.S. Zens, Z. Li, et al.,
‘‘Early-Onset Basal Cell Carcinoma and
Indoor Tanning: A Population-Based
Study.’’ Pediatrics, 134:e4–e12, 2014.
38. Whiteman, D.C., C.A. Whiteman, and
A.C. Green, ‘‘Childhood Sun Exposure as
a Risk Factor for Melanoma: A
Systematic Review of Epidemiological
Studies.’’ Cancer Causes and Control,
12:69–82, 2001.
39. Gandini, S., F. Sera, M.S. Cattaruzza, et
al., ‘‘Meta-Analysis of Risk Factors for
Cutaneous Melanoma: I. Common and
Atypical Naevi.’’ European Journal of
Cancer, 41:28–44, 2005.
40. Chang, Y.M., J.H. Barret, D.T. Bishop, et
al., ‘‘Sun Exposure and Melanoma Risk
at Different Latitudes: A Pooled Analysis
of 5,700 Cases and 7,216 Controls.’’
International Journal of Epidemiology,
38:814–830, 2009.
41. Knight, J.M., A.N. Kirincich, E.R. Farmer,
et al., ‘‘Awareness of the Risks of
Tanning Lamps Does Not Influence
Behavior Among College Students,’’
Archives of Dermatology, 138:1311–
1315, 2002.
42. Poorsatter, S.P. and R.L. Hornung, ‘‘UV
Light Abuse and High-Risk Tanning
Behavior Among Undergraduate College
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Students.’’ Journal of the American
Academy of Dermatology, 56:375–379,
2007.
43. Jerkegren, E., L. Sandrieser, Y. Brandberg,
et al., ‘‘Sun-Related Behaviour and
Melanoma Awareness Among Swedish
University Students.’’ European Journal
of Cancer Prevention, 8:27–34, 1999.
44. FDA, 2010 Meeting materials, including
presentations, a meeting transcript, and
meeting summary. Available at: https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Medical
Devices/MedicalDevicesAdvisory
Committee/GeneralandPlasticSurgery
DevicesPanel/ucm205684.htm.
45. IARC Working Group on Artificial
Ultraviolet Light (UV) and Skin Cancer:
‘‘The Association of Use of Sunbeds
With Cutaneous Malignant Melanoma
and Other Skin Cancers: A Systematic
Review.’’ International Journal of
Cancer, 120:1116–1122, 2009.
46. WHO, ‘‘The World Health Organization
Recommends That No Person Under 18
Should Use a Sunbed.’’ Available at:
https://www.who.int/mediacentre/news/
notes/2005/np07/en/.
47. AAD, ‘‘Dangers of Indoor Tanning.’’
Available at: https://www.aad.org/
media-resources/stats-and-facts/
prevention-and-care/dangers-of-indoortanning.
48. Skin Cancer Foundation, ‘‘American
Academy of Pediatrics Calls for Ban on
Youth Tanning.’’ Available at: https://
www.skincancer.org/news/tanning/
american-academy-of-pediatrics-callsfor-ban-on-youth-tanning.
49. American Academy of Pediatrics, ‘‘Policy
Statement—Ultraviolet Radiation: A
Hazard to Children and Adolescents.’’
Pediatrics, 127(3):588–597, 2011.
Available at: https://pediatrics.
aappublications.org/content/early/2011/
02/28/peds.2010-3501.full.pdf+html.
50. Pawlak, M.T., M. Bui, M. Amir, et al.,
‘‘Legislation Restricting Access to Indoor
Tanning Throughout the World.’’
Archives of Dermatology, 148:1006–
1012, 2012.
51. Guy, G.P., Z. Berkowitz, S.E. Jones, et al.,
‘‘State Indoor Tanning Laws and
Adolescent Indoor Tanning.’’ American
Journal of Public Health, 104(4):e69–e74,
2014.
52. National Conference of State Legislatures,
‘‘Indoor Tanning Restrictions for
Minors—A State-by-State Comparison.’’
Washington, DC and Denver, CO:
National Conference of State
Legislatures. Available at: https://www.
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15:12 Dec 21, 2015
Jkt 238001
ncsl.org/issues-research/health/indoortanning-restrictions-for-minors.aspx.
53. Centers for Disease Control and
Prevention (CDC), ‘‘Skin Cancer: Indoor
Tanning.’’ Available at: https://www.cdc.
gov/cancer/skin/basic_info/indoor_
tanning.htm.
54. Hirst, N., L. Gordon, P. Gies, et al.,
‘‘Estimation of Avoidable Skin Cancers
and Cost-Savings to Government
Associated With Regulation of the
Solarium Industry in Australia.’’ Health
Policy, 89(3):303–311, 2009.
55. Beasley, M.T. and B.S. Kittel, ‘‘Factors
That Influence Health Risk Behaviors
Among Tanning Salon Patrons.’’
Evaluation & the Health Professions,
20(4):371–388, 1997.
56. Feldman, S.R., A. Liguori, M. Kucenic, et
al., ‘‘Ultraviolet Exposure Is a
Reinforcing Stimulus in Frequent Indoor
Tanners.’’ Journal of the American
Academy of Dermatology, 51(1):45–51,
July 2004.
¨
57. Schneider, S. and H. Kramer, ‘‘Who Uses
Sunbeds? A Systematic Literature
Review of Risk Groups in Developed
Countries.’’ Journal of the European
Academy of Dermatology and
Venereology, 24:639–648, 2010.
58. https://www.fda.gov/AboutFDA/Reports
ManualsForms/Reports/Economic
Analyses/default.htm.
59. Huntley-Fenner Advisors, ‘‘HFA Review
of Risks of Indoor UV Tanning Devices
Form,’’ submitted to FDA, August 9,
2013.
60. Heilig, L.F., R. D’Ambrosia, A.L. Drake,
et al., ‘‘A Case for Informed Consent?
Indoor UV Tanning Facility Operator’s
Provision of Health Risks Information
(United States).’’ Cancer Causes and
Control, 16(5):557–560, 2005.
61. https://democrats.energycommerce.house.
gov/sites/default/files/documents/FalseHealth-Info-by-Indoor-Tanning-Industry2012-2-1.pdf.
List of Subjects in 21 CFR Part 878
Medical devices.
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 878 be amended as follows:
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for part 878
continues to read as follows:
■
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79503
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Section 878.4635 is amended as
follows:
■ a. Redesignate paragraph (c) as
paragraph (d);
■ b. Add new paragraph (c);
■ c. Revise the heading of newly
designated paragraph (d).
The revisions and additions read as
follows:
■
§ 878.4635 Sunlamp products and
ultraviolet lamps intended for use in
sunlamp products.
*
*
*
*
*
(c) Restrictions on sale, distribution,
and use of sunlamp products. (1) A
tanning facility operator must not
permit the use of a sunlamp product
unless the prospective user is at least 18
years of age and has signed the risk
acknowledgement certification
described in paragraph (c)(4) of this
section.
(2) A tanning facility operator must,
upon request by a sunlamp product user
or prospective user, with respect to any
sunlamp product that the operator
operates, provide a copy of the sunlamp
product user manual or the name and
address of the manufacturer or
distributor from whom a user manual
may be obtained.
(3) In addition to assuring that a user
manual accompanies each sunlamp
product, a 510(k) holder must provide,
upon request, a copy of the sunlamp
product user manual to any tanning
facility operator, sunlamp product user,
or prospective user with respect to any
sunlamp product it manufactures/
manufactured or distributes/distributed.
(4) Risk acknowledgement
certification. (i) The tanning facility
operator must not permit the use of a
sunlamp product unless it obtains each
prospective user’s signature on a risk
acknowledgement certification that
contains the following statement prior
to use of the sunlamp product, unless
the prospective user has previously
signed the risk acknowledgement
certification within the preceding 6
months:
BILLING CODE 4164–01–P
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RISKS OJ.' INUOOR UV TANNING
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(ii) The text of the risk
acknowledgement certification shall be
at least 10-point font.
(iii) The tanning facility operator shall
provide a copy of the signed
acknowledgement certification to the
prospective user and the tanning facility
shall retain a copy of the signed risk
acknowledgement certification for 1
year or until the prospective user signs
a new risk acknowledgement
certification, whichever is earlier.
(d) Electronic product performance
standard. * * *
Dated: December 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32024 Filed 12–18–15; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1002 and 1040
[Docket No. FDA–1998–N–0880 (Formerly
1998N–1170)]
RIN 0910–AG30
Sunlamp Products; Proposed
Amendment to Performance Standard
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA or Agency) is
proposing to amend the performance
standard for sunlamp products and
ultraviolet (UV) lamps intended for use
in these products. This standard was
last amended in 1985. The current
amendments seek to improve consumer
safety by requiring more effective
communication regarding the risks
posed by these products. They also
would reduce risks to consumers by
updating technical requirements to
reflect current science, and by adopting
and incorporating by reference certain
elements from the International
Electrotechnical Commission (IEC)
International Standard 60335–2–27, Ed.
5.0: 2009–12.
DATES: Submit either electronic or
written comments on the proposed rule
by March 21, 2016. Submit comments
on information collection issues under
the Paperwork Reduction Act of 1995 by
January 21, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
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SUMMARY:
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• 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–
1998–N–0880 for ‘‘Sunlamp Products;
Proposed Amendment to Performance
Standard.’’ 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
PO 00000
Frm 00019
Fmt 4702
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79505
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.
Submit comments on information
collection issues to the Office of
Management and Budget (OMB) in the
following ways:
• Fax to the Office of Information and
Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202–395–7285, or
email to oira_submission@omb.eop.gov.
All comments should be identified with
the title, ‘‘Sunlamp Products; Proposed
Amendment to Performance Standard.’’
FOR FURTHER INFORMATION CONTACT:
Sharon Miller, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4234, Silver Spring,
MD 20993–0002, 301–796–2471.
SUPPLEMENTARY INFORMATION:
Executive Summary
Purpose of the Regulatory Action
The Safe Medical Devices Act of 1990
(Pub. L. 101–629), enacted on November
28, 1990, transferred the provisions of
the Radiation Control for Health and
Safety Act of 1968 (Pub. L. 90–602) from
Title III of the Public Health Service Act
to Chapter V, subchapter C of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360hh et
seq.). Under these provisions, FDA
administers an electronic product
E:\FR\FM\22DEP1.SGM
22DEP1
]]>Agencies
[Federal Register Volume 80, Number 245 (Tuesday, December 22, 2015)]
[Proposed Rules]
[Pages 79493-79505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32024]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2015-N-1765]
RIN 0910-AH14
General and Plastic Surgery Devices: Restricted Sale,
Distribution, and Use of Sunlamp Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
proposing to establish device restrictions for sunlamp products, which
would restrict their use to individuals age 18 and older, require
prospective users to sign a risk acknowledgement certification before
use, and require the provision of user manuals.
[[Page 79494]]
DATES: Submit either electronic or written comments on the proposed
rule by March 21, 2016. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by February 22, 2016.
See Section VIII for the proposed effective date of a final rule based
on this proposed rule.
ADDRESSES: FDA is explicitly seeking comment on the risks to health
that should be included in the risk acknowledgement certification. 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-1765 for ``General and Plastic Surgery Devices: Restricted
Sale, Distribution, and Use of Sunlamp Products.'' 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.
Submit comments on information collection issues to the Office of
Management and Budget in the following ways:
Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
oira_submission@omb.eop.gov. All comments should be identified with the
title ``Restricted Sale, Distribution, and Use of Sunlamp Products.''
FOR FURTHER INFORMATION CONTACT: Neil R.P. Ogden, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1438, Silver Spring, MD 20993-0002, 301-
796-6397.
SUPPLEMENTARY INFORMATION:
I. Background and Legal Authority
Sunlamp products are both ``devices'' under section 201(h) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)),
and ``electronic products'' under section 531(2) of the FD&C Act (21
U.S.C. 360hh(2)). They are designed to incorporate one or more
ultraviolet (UV) lamps intended for irradiation of any part of the
living human body, by UV radiation with wavelengths in air between 200
and 400 nanometers, to induce skin tanning (see Sec. Sec. 878.4635(a)
and 1040.20(b)(9) (21 CFR 878.4635(a) and 1040.20(b)(9))). Sunlamp
products include tanning beds and tanning booths. Sunlamp products, as
defined in proposed Sec. 878.4635, do not include--and this proposed
rulemaking does not address--ultraviolet lamps for dermatological
disorders regulated under 21 CFR 878.4630.\1\
---------------------------------------------------------------------------
\1\ UV emitting lamps that are medical devices and have
different intended uses than devices classified under 21 CFR
878.4635 (intended to tan skin) would not fall under that
regulation. Manufacturers of such devices would have to obtain
approval, clearance or authorization to market their device under
the premarket approval, 510(k) or de novo pathway. The use of such
devices in a pediatric population is beyond the scope of this
document.
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The FD&C Act establishes a comprehensive system for the regulation
of medical devices intended for human use. Section 513 of the FD&C Act
(21 U.S.C. 360c) defines three categories (classes) of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
FDA regulates electronic products under chapter 5, subchapter C, of
the FD&C Act (21 U.S.C. 360hh et seq.). Under these provisions, FDA
administers an electronic product radiation control program to protect
the public health and safety. This authority provides for developing,
amending, and administering radiation safety performance standards for
electronic products, including sunlamp products.
FDA is undertaking three initiatives to address the risks
associated with sunlamp products. First, in a final reclassification
order that issued June 2, 2014 (79 FR 31205 at 31213), FDA reclassified
sunlamp products and UV lamps intended for use in sunlamp products from
class I to class II, and established special controls and
[[Page 79495]]
premarket notification (510(k)) requirements under the medical device
authorities of the FD&C Act. The special controls include performance
testing and labeling requirements, including a warning that sunlamp
products are not to be used on persons under the age of 18 years.
Second, and simultaneously with this proposed rule, FDA is
proposing amendments to the sunlamp products and UV lamps performance
standard at Sec. 1040.20, which includes technical and labeling
requirements issued under the radiological health provisions of the
FD&C Act. As explained elsewhere in this issue of the Federal Register,
FDA is taking this action to reflect current scientific knowledge
related to sunlamp product use, harmonize it more closely with
International Electrotechnical Commission (IEC) International Standard
60335-2-27, Ed. 5.0: 2009-12, and strengthen the warning statement
required by Sec. 1040.20(d)(1)(i) in accordance with the results of
the study FDA conducted under section 230 of the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85).
Finally, in this action, FDA is proposing device restrictions under
section 520(e) of the FD&C Act (21 U.S.C. 360j(e)), which authorizes
FDA to issue regulations imposing restrictions on the sale,
distribution, or use of a device, if, because of its potentiality for
harmful effects or the collateral measures necessary to its use, FDA
determines that absent such restrictions, there cannot be a reasonable
assurance of its safety and effectiveness. The proposed device
restrictions would require that:
1. Tanning facility operators permit use of sunlamp products only
if the prospective user is age 18 or older;
2. Tanning facility operators, upon request by the user or
prospective user, provide a copy of the sunlamp product user manual or
name and address of the manufacture or distributor from whom a user
manual may be obtained;
3. 510(k) holders assure that a user manual accompanies each
sunlamp product and, upon request, provide a copy of the user manual to
any tanning facility operator, user or prospective user; and
4. Tanning facility operators obtain each prospective user's
signature on a risk acknowledgement certification.
These device restrictions would primarily apply to tanning facility
operators, and to a lesser extent, device manufacturers and
distributors. FDA considers a tanning facility operator to be any
person offering for sale the use of sunlamp products. FDA would not
consider people who use their own tanning beds (home users) to be
tanning facility operators.
Certain provisions of the FD&C Act relate specifically to FDA's
authority over restricted devices. For example, sections 502(q) and (r)
of the FD&C Act (21 U.S.C. 352(q) and (r)) provide that a restricted
device distributed or offered for sale in any state shall be deemed to
be misbranded if its advertising is false or misleading or fails to
include certain information regarding the device, or it is sold,
distributed, or used in violation of regulations prescribed under
section 520(e), and section 704(a) of the FD&C Act (21 U.S.C. 374(a))
authorizes FDA to inspect certain records relating to restricted
devices.
If this proposed rule becomes final, it may be enforced by means of
seizure of the sunlamp product, under section 304 of the FD&C Act (21
U.S.C. 334); a suit for injunction, under section 302 of the FD&C Act
(21 U.S.C. 332); imposition of civil money penalties, under section 303
of the FD&C Act (21 U.S.C. 333); or criminal prosecution, under section
303 of the FD&C Act. FDA expects to cooperate with counterpart agencies
at the state level in enforcing the proposed requirements, if they
become final. Consumer complaints to FDA and State Agencies would be
important in identifying entities that violate the conditions for sale
or use of these devices.
II. Risks Posed by the Device
The General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee (2010 Advisory Panel) met on March 25, 2010,
to review and discuss recent information regarding the risks to the
general public from exposure to sunlamp products, and identified the
following risks to health for sunlamp products.\2\ These risks are well
documented and discussed in published literature.
---------------------------------------------------------------------------
\2\ See https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm205684.htm.
---------------------------------------------------------------------------
A. Increased Skin Cancer Risk From Cumulative, Repeated UV Radiation
Exposure
UV radiation exposure can lead to permanent damage to DNA in the
skin, which has been shown to lead to an increased risk of skin cancer
(Refs. 1-3). Skin cancers that have been associated with cumulative
repeated UV radiation exposure include melanoma and non-melanoma skin
cancers (NMSC) such as basal cell carcinoma and squamous cell carcinoma
(Ref. 4). One study suggests that doses of UV-A radiation emitted by
high power sunlamp products may be up to 10 to 15 times higher than
that of the midday sun, resulting in an intense amount of exposure that
does not exist in nature (Ref. 5). Users with a personal history of
melanoma have an increased risk of skin cancer, as do users with
familial melanoma--having one first-degree relative with melanoma
doubles one's risk of developing melanoma (Refs. 6, 7). There is also
evidence suggesting that individuals who begin indoor tanning at ages
younger than 18 years are particularly vulnerable to the carcinogenic
impact of indoor tanning (see section III.A for further discussion).
B. Ocular Injury
UV and visible radiation from sunlamp products can be harmful to
the eyes if proper protective eyewear is not worn. The UV radiation
from sunlamp products can cause keratitis and corneal burns, which can
be painful and affect vision (Ref. 8). The intense visible light from
some sunlamp products can damage the retina and permanently affect
vision (Ref. 8). Artificial UV radiation has also been linked to ocular
melanoma, which can cause vision loss and often spreads to other parts
of the body (Ref. 9).
C. Discomfort, Pain, and Tenderness on the Skin Resulting From Burns to
the Skin Due to Acute Overexposure to UV Radiation
A recent study showed that, despite protective properties touted by
commercial tanning facilities such as claims that indoor tanning limits
exposure time and intensity, 66 percent of female college-age users
reported skin erythema (or redness due to sunburn) from indoor tanning,
and these users reported one episode of sunburn out of every five
tanning sessions (Ref. 10). Those findings are in line with a previous
report that found that 58 percent of sunlamp product users ages 11
years to 18 years had experienced sunburns from exposure to sunlamp
products (Ref. 11).
In certain individuals who are photosensitive, skin exposure to UV
radiation may induce unexpected reactions such as rash, severe burns,
and hypersensitivity (Ref. 12). Various drugs may cause a
photosensitivity reaction in the skin. Some drugs may cause a
phototoxic reaction when they absorb UV-A radiation and cause cellular
damage. These drugs include anti-infective drugs such as tetracyclines
and fluoroquinolones, cardiovascular drugs like hydrochlorothiazide and
amiodarone, psychiatric drugs such as phenothiazines, and retinoids
such as isotretinoin (Ref. 13). Some dietary
[[Page 79496]]
supplements may also cause photosensitivity (Ref. 13).
Sunlamp products, like most light sources, generate heat that can
cause thermal skin burns, similar to any hot surface. Individuals with
open wounds or lesions are particularly susceptible to burns from UV
radiation because these individuals lack the protective epidermal layer
of the skin that provides the body's greatest protection from UV
irradiation (Ref. 14).
D. Skin Damage
Cumulative, repeated exposure to UV radiation emitted by sunlamp
products may lead to accelerated aging of skin due in part to DNA and
skin cell damage (Ref. 15). UV irradiation inhibits the production of
collagen precursor molecules such as type I and type III procollagen
(Ref. 16). UV irradiation stimulates skin metalloproteinases, which
break down skin proteins that then lead to photoaging (Ref. 17). On a
cellular level, UV radiation has been known to cause DNA damage (Ref.
1).
III. Proposed Device Restrictions
FDA is proposing the following restrictions which, because of the
potential for harmful effects from the device, are necessary for a
reasonable assurance of safety and effectiveness of sunlamp products:
A. Use Would Be Restricted to Individuals Age 18 and Older
Although the risks associated with sunlamp products are applicable
to all persons, FDA is proposing to restrict the use of this device to
persons age 18 and older because children and adolescents who are
exposed to UV radiation may be at higher risk of developing certain
types of skin cancer than persons who begin exposure later in life as
adults (Ref. 18). In the final reclassification order for this device,
FDA established special controls labeling regarding minors' use of
sunlamp products and UV lamps intended for use in sunlamp products (see
Sec. 878.4635(b)(6)). Based on the increased risk of developing skin
cancer and minors' difficulty in appreciating the risks posed by the
devices (see Refs. 19 to 24), FDA has determined that use of sunlamp
products by minors is not appropriate and is therefore establishing a
proposed restriction in this rulemaking action to complement the
special controls labeling.
Published medical evidence demonstrates that there is a direct
correlation between sunlamp product use among youths and their
developing melanoma skin cancer, as well as other skin cancers (Refs.
25, 26). Melanoma is a leading cause of cancer death in women ages 15
years to 29 years and there is some evidence that suggests use of
sunlamp products is an underlying cause (Refs. 27, 28).
There is increasing epidemiological evidence that shows that
tanning at ages younger than 18 years increases the risk of developing
melanoma (Refs. 25, 29 to 32). Melanoma (of the types of skin cancer,
this is the more concerning type due to greater potential for fatality)
is currently the second leading type of cancer in persons age 20 years
to 39 years, and many experts believe that at least one cause for this
is the increasing use of sunlamp products (Refs. 30, 33). A 2009
International Agency for Research in Cancer (IARC) report linked UV
exposure (including from indoor tanning devices) by individuals under
age 35 to higher rates of melanoma as compared to a similar cohort of
individuals who had not used sunlamp products, and recommended that
minors not use sunlamp products. Similarly, a meta-analysis by
Gallagher et al. that evaluated metrics of sunlamp product exposure,
including in young adults, indicated a significantly increased risk of
cutaneous melanoma subsequent to sunlamp product exposure (Ref. 34). In
particular, the analysis showed a positive association between first
exposure as a young adult and subsequent melanoma. Further, a case
control study in Connecticut found a relative risk of 1.4 for melanoma
diagnosis when individuals are exposed to sunlamp products before the
age of 25 (Ref. 35).
In addition, there is increasing epidemiological evidence that
shows that tanning at ages younger than 18 years increases the risk of
developing NMSC. For example, recent studies found a significantly
higher risk for basal cell carcinoma for individuals who used sunlamp
products during high school and college as compared to those who used
sunlamp products between the ages of 25 and 35 (Refs. 36, 37).
Individuals under 18 who are exposed to UV radiation are at an
increased risk of developing skin cancer because (1) there is evidence
suggesting that they are particularly vulnerable to the damaging
effects of UV radiation and (2) the cumulative effects of exposure have
been linked to higher incidence of skin cancer. First, evidence
suggests that minors exposed to UV radiation are particularly
vulnerable to developing skin cancer (Ref. 38). In particular,
migration studies compare people who moved from less UV-intense
environments to more UV-intense environments at a young age, for
example, children who moved from the United Kingdom to Australia. A
number of biological factors, such as skin development and formation of
nevi at a young age, are identified as potentially causing the increase
in the risk of developing melanoma from exposure to UV radiation, like
that from sunlamps (Refs. 18, 39). Second, as with other radiation
exposure, increased cumulative lifetime UV exposure results in
increased skin cancer risk (Ref. 40).
The age restriction also is necessary because individuals under 18
often fail to appropriately evaluate the significant health risks
associated with indoor tanning. For example, a study has shown that
college age students often use sunlamp products despite awareness of
the long-term risks (Refs. 41 to 43). Rather, persons under age 18
years appear to be discounting whatever risk information they are
receiving or may have difficulty incorporating the information into
their decisionmaking. For example, a recent study links indoor tanning
by high school students to other risk-taking behaviors, including
binge-drinking, unhealthy weight control, sexual intercourse, and
illegal drug or steroid use (Ref. 20). This linkage suggests that, like
other risk-taking behaviors, adolescents use sunlamp products for self-
esteem or sensation seeking reasons, irrespective of known health risks
(Ref. 20). Similarly, another recent study showed that psychosocial and
demographic characteristics strongly correlated with adolescent indoor
tanning (Ref. 22). By restricting sunlamp product use to individuals 18
and older, we would be protecting a subpopulation that generally tends
to discount risk information and favor risk taking.
Based on the scientific evidence available at the time, some
members of the 2010 Advisory Panel recommended an age restriction to
preclude use by persons under 18 years of age to reduce the unintended
health effects of these devices (Ref. 44). The scientific literature
published since that meeting, as described in this document, offers
further support for an age restriction (Refs. 20, 22, 41).
Various professional organizations also support an age restriction
on sunlamp product use. The World Health Organization (WHO) has
classified UV radiation from sunlamp products as a class I carcinogen
based on the 2009 IARC report that linked sunlamp product use by
individuals under age 35 to higher rates of melanoma and strongly urged
consideration of restricting minors from using sunlamp products (Ref.
45). Accordingly, the WHO recommends that persons under
[[Page 79497]]
age 18 not use sunlamp products (Ref. 46).
The American Academy of Dermatology (AAD) recognizes WHO's
declaration that sunlamp products are cancer-causing agents and are in
the same risk category as tobacco, and supports the position that
minors should not use sunlamp products (Ref. 47). In 2011, the American
Academy of Pediatrics published a policy statement similar to that of
the AAD calling for a restriction on sunlamp product use by minors
(Refs. 48, 49).
Experts in pediatrics, public health, and dermatology also support
a legislative age restriction on sunlamp product use. For example,
recent studies cited other peer reviewed articles to examine the
effects of legislation on indoor tanning use (Refs. 22, 50, 51). They
concluded that an age restriction or ban would be far more effective at
reducing youth indoor tanning than other potential actions such as
parental consent (Refs. 22, 50, 51).
This scientific evidence also has led many State and foreign
governments to institute age restrictions in the last few years on the
use of sunlamp products by minors (Ref. 50). To date, more than 40
states have age restrictions on sunlamp product use (Ref. 52). These
restrictions have age limits ranging from ages 14 to 18. At least 11
countries have restricted the use of sunlamp products to adults age 18
and older, including Great Britain and France (Refs. 52 to 54).
Restricting use of these devices to individuals 18 and over should
reduce future morbidity and mortality from melanoma and other skin
cancers and would help to protect the public health, according to both
expert advisory opinion and findings from current scientific, medical,
and public health policy literature (Ref. 54). In the journal Health
Policy in 2009, Hirst et al. estimated that preventing minors from
indoor tanning has the potential to reduce the incidence of skin
cancers and related medical costs (Ref. 54).
This restriction is particularly important because, as previously
discussed, it has been shown that increased knowledge of the risks of
UV exposure among adolescents and young adults does not appreciably
alter their tanning behavior and attitudes (Refs. 19, 41, 42, 55). The
use of sunlamp products has been suggested to have both a psychological
reinforcing effect in minors due to feedback from others on minors'
cosmetic appearance or self-perceptions that leads to continued or
increased use, in addition to the physical reinforcing effect that has
been linked to high rates of use (Refs. 19, 56).
This age restriction is also important because parental awareness
of the risks, educational campaigns, and parental consent to the risks,
on their own, have been shown to be insufficient in reducing indoor
tanning in young age groups (Refs. 21, 22, 41).
The risks associated with use of sunlamp products by individuals
under 18 are particularly concerning given the widespread use of these
devices among high school students. The Centers for Disease Control and
Prevention has documented high rates of use in U.S. high school
students from its 2011 Behavioral Risk Survey: 13 percent of all high
school students report indoor tanning, and 29 percent of white female
high school students report usage in the last year (Ref. 53). There are
a number of collaborative studies that have demonstrated that young
women, in particular, use sunlamp products at increasingly high rates
(Refs. 22 to 24, 57). For example, one study found that indoor tanning
usage (defined as tanning during the previous 12 months) progressively
increased in adolescents (age 14-17) from 5.5 percent at age 14 to 16.5
percent at age 17, which suggests that adolescents use indoor tanning
more often as they get older (Ref. 22). Another study analyzed the
results of a survey of over 10,000 U.S. individuals age 12 years to 18
years and found nearly 10 percent of respondents used a sunlamp product
during the previous year and rates increased to 35 percent for females
by age 17, highlighting that teenage girls are more likely than their
male counterparts to use indoor tanning facilities (Ref. 24).
FDA seeks comments on its proposal to restrict use of these devices
to individuals 18 years of age and over as well as data and information
in support of any comments. In addition, although FDA has strong
reservations about a parent-consent process in this setting, we
recognize parents' decision-making role. We welcome comment on parental
consent and its potential scope, including comments on experiences in
jurisdictions that have a parental consent provision for use of sunlamp
products.
B. Sunlamp Product User Manuals Would Have To Be Provided to Users,
Prospective Users, and Tanning Facility Operators Upon Request
User manuals provide valuable information to operators and users.
Sunlamp product user manuals can include vital information such as
instructions for use, exposure schedules, maintenance guidance, and
device warnings. In order to help ensure the dissemination of this
important information to sunlamp product users, FDA is proposing that
tanning facility operators be required to provide a copy of the user
manual or the name and address of the manufacturer or distributor that
can provide a copy of the user manual to any user or prospective user
that requests one. Similarly, FDA is also proposing that 510(k) holders
be required to provide user manuals to any tanning facility operator,
user, or prospective user that requests one. The electronic product
performance standard currently requires manufacturers to provide
manuals to purchasers and, upon request, to others for the life of the
sunlamp product (see Sec. 1040.20(e)). FDA believes that access to the
information contained in the user manual would help prospective users
make informed decisions when considering whether to use the device and
would also inform tanning facility operators and users on how to use
the device properly.
C. Prospective Users Would Have To Sign a Risk Acknowledgement
Certification Before Sunlamp Product Use
FDA is proposing that tanning facility operators would have to
provide, and sunlamp product prospective users 18 and older would have
to sign, the certification set forth in proposed Sec. 878.4635(c)(4)
prior to use of any sunlamp product, unless the prospective user has
previously signed the risk acknowledgement certification within the
preceding 6 months. The certification provides warnings regarding
sunlamp products as well as information regarding the proper use of the
devices. By making this information available to users in a direct and
accessible manner, the certification would better enable consumers to
make informed decisions about their use of sunlamp products. Moreover,
and as discussed more fully in this section III.C, the information
could counteract any false or misleading information that sunlamp
product users may have received regarding the risks of indoor tanning.
Compliance with this proposed requirement would not be unduly
burdensome for tanning facilities. The certification has already been
drafted by FDA and, as discussed in the economic analysis in Docket
FDA-2015-N-1765 and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 58), tanning facility
operators would need only a brief amount of time to explain to the user
the purpose of the certification and to process or file the signed
certification. Reading and
[[Page 79498]]
signing the certification would not be overly burdensome for
prospective users--the user would need only a brief amount of time to
read and sign the form, if they choose to proceed (Ref. 58).
FDA proposes that the text of the risk acknowledgement
certification would have to be at least 10-point font and that the
tanning facility operator would have to provide a copy of the signed
acknowledgement certification to the prospective user and retain a copy
of the signed acknowledgement certification for 1 year or until the
prospective user signs a new risk acknowledgement certification,
whichever is sooner. The statements in the certification are intended
to inform prospective users of the risks they may be exposing
themselves to by using the device and the inherent risks posed by UV
radiation, as well as provide information regarding the proper use of
the device.
When developing the certification, FDA aimed to inform readers of
the most serious risks in a clear and succinct manner in order to
promote rapid comprehension and not take more time than necessary for
the key information to be conveyed and understood. Readability
analysis, human participants' usability testing, and human factors/risk
communication analysis were conducted on the certification to ensure
the certification achieved its intended goals clearly and succinctly
(Refs. 58 and 59). After obtaining feedback from the testing, the
certification was revised consistent with recommendations made in the
testing and is presented in this proposed rule with its refined content
and format. FDA welcomes comment on the proposed certification form.
Unlike a label that must be affixed to a device (see Sec.
878.4635(b)(6)(i)(A)), a risk acknowledgement certification can include
more comprehensive warnings to ensure that users are aware of the risks
associated with the use of the devices (Refs. 50 and 59). FDA expects
that users will consider the risks carefully when signing the
certification. If users were provided the certification but not
required to sign it, they would be less likely to read the risk
information in the certification, and they may even opt not to read the
certification, mistakenly thinking that it was promotional material
provided by the tanning facility.
Members of the 2010 Advisory Panel recommended that sunlamp product
users be required to read and sign an acknowledgement of risks related
to sunlamp products before using the device. Since this meeting, FDA
has become aware of additional information regarding the use of sunlamp
products that further supports the need for risk acknowledgement
certifications.
There are reports in the literature that document tanning facility
operators failing to inform patrons of certain risks, causing various
groups to call for ``informed consent'' or better informing users at
indoor tanning facilities (Ref. 60).
In keeping with the literature, on February 1, 2012, staff of the
U.S. House of Representatives Committee on Energy and Commerce released
a report summarizing their findings regarding false and misleading
information provided to patrons of indoor tanning salons, especially
teenage women. They found, for example, that 90 percent of operators
responded that indoor tanning presented no risks (Ref. 61). When
pressed about skin cancer specifically, more than half of the operators
claimed indoor tanning would not increase the risk (Ref. 61). Some
operators who did inform their patrons of skin cancer risks
nevertheless mischaracterized the magnitude and the vulnerable
subpopulations (Ref. 60). Other operators provided misleading benefit
information, including claims that indoor tanning would protect patrons
from cancer or beneficially create vitamin D (Ref. 61).
These reported practices support the need for risk acknowledgement
certifications, which could counteract any false or misleading
information communicated to prospective users. This risk acknowledgment
will provide prospective users with accurate information about the
risks and proper use of the devices so that they can make informed
decisions about their use of these devices.
IV. Environmental Impact
The Agency has determined that under 21 CFR 25.34(f) this proposed
action will not result in increases in the existing levels of use or
changes in the intended uses of the product or its substitutes.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
V. Analysis of Economic Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). OMB has determined that this proposed rule is a significant
regulatory action as defined by 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. We believe this proposed rule would result in a
significant impact on a substantial number of small entities, but the
impacts are uncertain.
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 $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
The proposed rule would restrict the use of sunlamp products to
individuals aged 18 years and over and require all prospective users to
read and sign a risk acknowledgement certification before use (unless
the prospective user has previously signed the form within the
preceding 6 months). The social benefits from this proposed rule stem
from a potential reduction in the incidence of skin cancer. The social
costs of the proposed rule are associated with the value of time spent
by users and tanning facility operators on the risk acknowledgement
certifications and verifying proof of age, as well as other compliance
costs. As discussed more fully in the complete assessment, analyzing
the impact of the proposed rule is difficult because of the uncertainty
of how users would be affected by reading and signing the risk
acknowledgment certification and how nonuse when under 18 years of age
would affect later adult use. Because of this uncertainty, we use a 1
to 10 percent range in the response rate to the risk information and
age restriction, assuming that the age restriction reduces future
tanning. Under these scenarios, assuming a discount rate of 7 percent
the annualized cost over 10 years would range from $104 million to $114
million; annualized benefits would
[[Page 79499]]
range from $70 to $115 million. With a 3 percent discount rate the
annualized cost over 10 years would range from $122 million to $144
million; annualized benefits would range from $151 to $248 million.
In addition to the social costs, the proposed rule would likely
generate distribution effects from the reduced demand for tanning
services. The annualized reduction in indoor tanning revenues would
range from about $500 million to $820 million at a 7 percent discount
rate over 10 years and from about $500 million to $825 million at a 3
percent discount rate.
Table 1--Summary of the Impact of the Proposed Rule
[$ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
7% Discount 7% Discount 7% Discount 3% Discount 3% Discount 3% Discount
rate, 5% rate, 1% rate, 10% rate, 5% rate, 1% rate, 10%
impact impact impact impact impact impact
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value over 10 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits................................................ 632.9 491.7 806.8 1,657.3 1,284.4 2,115.7
Costs................................................... 763.4 732.2 801.7 1,126.4 1,043.3 1,228.6
Net Benefits............................................ -130.5 -240.5 5.1 530.9 241.1 887.1
Lost Revenue............................................ 4,532.9 3,527.2 5,770.4 5222.4 4287.4 7040.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Value over 10 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits................................................ 90.1 70.0 114.9 194.3 150.6 248.0
Costs................................................... 107.2 104.2 114.1 132.1 122.3 144.0
Net Benefits............................................ -18.6 -34.2 0.7 62.2 28.3 104.0
Revenue Loss............................................ 645.4 502.2 821.6 647.4 502.6 825.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The impacts are tied to the acknowledgement certification and changing habits, which we interpret as the effect of age restrictions in disrupting
the development of a habit for indoor tanning.
Tanning salons and most of the other establishments who offer
commercial tanning services are classified as Other Personal Care
Services under the North American Industry Classification System (NAICS
812199). We do not have information on the size distribution of this
industry but most, if not all, entities are small businesses. There are
18,000 to 19,000 indoor tanning salons and 15,000 to 20,000 other
facilities that offer indoor tanning services. The proposed rule would
have a significant impact on a substantial number of small entities
chiefly due to the loss of revenue.
The full assessment of the economic analysis is available in Docket
FDA-2015-N-1765 and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 62). Table 2 summarizes the
analysis.
Table 2--Summary of Benefits, Costs and Distributional Effects of the Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------------------
Category Primary Low estimate High estimate Period Notes
estimate Year dollars Discount rate covered
(%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year. $90.10 $70.00 $114.90 2014 7 10
194.30 150.60 248.00 2014 3 10
Annualized Quantified............... .............. .............. .............. 2014 7 10
.............. .............. .............. 2014 3 10
Qualitative......................... .............. .............. .............. .............. .............. ..............
Costs:
Annualized.......................... 107.20 104.20 114.10 2014 7 10
Monetized $millions/year............ 132.10 122.30 144.00 2014 3 10
Annualized.......................... .............. .............. .............. 2014 7 10
Quantified.......................... .............. .............. .............. 2014 3 10
Qualitative......................... .............. .............. .............. .............. .............. ..............
Transfers:
Federal Annualized.................. .............. .............. .............. 2014 7 20
Monetized $millions/year............ .............. .............. .............. 2014 3 20
---------------------------------------------------------------------------------------------------------------
From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized.................... 645.4 502.2 821.6 2014 7 10
Monetized $millions/year............ 647.4 502.6 825.4 2014 3 10
---------------------------------------------------------------------------------------------------------------
From: Industry
To: Consumer
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects................................. This will have a significant impact on a substantial number of small entities.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 79500]]
VI. Federalism
FDA has analyzed this proposed 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 proposed rule creates a
requirement under 21 U.S.C. 360k.
At the time of publication of this proposed rule, most States and
some localities have acted to impose some form or restriction on
tanning for minors.\3\ Section 521(b) of the FD&C Act (21 U.S.C.
360k(b)) provides that the Commissioner of Food and Drugs may, upon
application of a State or local government, exempt a requirement from
preemption, if the State or local requirement for the device is more
stringent than the requirement under the FD&C Act, or if the
requirement is necessitated by compelling local conditions and
compliance with it would not cause the device to be in violation of a
requirement under the FD&C Act. Following this process, and if this
rule becomes final, a State or local government may request an
exemption from preemption for those State or local requirements
pertaining to sunlamp products that are preempted by the Agency's final
rule. FDA's rules that detail the content of such requests and the
process for considering them are contained within 21 CFR part 808.
---------------------------------------------------------------------------
\3\ National Conference of State Legislators, Indoor Tanning
Restrictions for Minors--A State-by-State Comparison, https://www.ncsl.org/research/health/indoor-tanning-restrictions.aspx (last
updated July 1, 2015).
---------------------------------------------------------------------------
VII. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown in this section VII with an estimate of
the annual recordkeeping. Included in the estimate is the time for
maintaining documentation and disclosing materials.
FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Restricted sale, distribution, and use of sunlamp products.
Description: FDA is requesting OMB approval of the requirements set
forth in this proposed rule, which would: (1) Restrict the use of
sunlamp products to individuals age 18 years and over (Sec.
878.4635(c)(1)); (2) require that tanning facility operators provide a
user manual to users and prospective users that request one, or the
name and address of the manufacturer or distributor from who a user
manual may be obtained (21 CFR 878.4635(c)(2)); (3) require that
sunlamp product 510(k) holders accompany each product with a user
manual and provide a user manual to users and tanning facility
operators that request one (Sec. 878.4635(c)(3)); and (4) require all
prospective users to read and sign a risk acknowledgement certification
before use (unless the prospective user has previously signed the
certification within the preceding 6 months) (Sec. 878.4635(c)(4)).
Description of Respondents: The requirements apply to manufacturers
and distributors of sunlamp products, sunlamp product users and
prospective users, as well as tanning facility operators.
Burden: FDA estimates the burden of this collection of information
to be as follows:
Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facility maintains signed certification 36,000 594 21,384,000 0.004 (0.25 minutes, i.e., 15 85,536
(878.4635(c)(4)(iii)). seconds).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 4--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures Total annual Average burden per disclosure Total hours Total capital
respondents per respondent disclosures costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facility explains certification on user's 36,000 297 10,692,000 0.008 (30 seconds)........... 85,536 $2,000,000
first visit.
Manufacturer/Distributor provides user 20 1 20 15........................... 300 27,800
manual with device; provides copy of
manual upon request (878.4635(c)(3)).
--------------------------------------------------------------------------------------------------------------
[[Page 79501]]
Total one-time burden................ .............. .............. .............. ............................. 85,836 2,027,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facility provides user manual upon 36,000 297 10,692,000 0.004 (0.25 minutes, i.e., 15 42,768
request (878.4635(c)(2)). seconds).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
The economic analysis for this rulemaking provides a range of
33,000 to 39,000 for the number of tanning facilities (18,000 to 19,000
indoor tanning salons and 15,000 to 20,000 other facilities that offer
indoor tanning services). In the PRA analysis we use the mean, 36,000
facilities, for the estimated number of facility-respondents. The
economic analysis also provides a range for the number of sunlamp
product users (after accounting for the impact of the age restriction
and the communication of the risk information) of 10.2 to 11.2 million.
We used the mean, 10.7 million, to calculate the average number of
users per facility (10.7 million users divided by 36,000 facilities
equals an average of 297 users per facility).
Proposed Sec. 878.4635(c)(2) of the proposed rule would require,
upon request by a user, tanning facility operators to supply a copy of
the user manual for their sunlamp products; or the tanning facility
could supply the name and address where the user could request a copy
of the manual. We believe the incremental compliance costs to tanning
facilities would be negligible because facilities receive the user
manual with the equipment and likely already use the information to
train their employees. Requests from users would not be frequent and
the tanning facility need only supply the name and address, which could
be an email address, of the 510(k) holder. We expect it will take
approximately 15 seconds for the facility to provide the address.
Proposed Sec. 878.4635(c)(3) of the proposed rule would require
the 510(k) holders of sunlamp products to, upon request, supply tanning
facility operators, users, and potential users copies of their user
manuals. The 510(k) holders would have to develop standard operating
procedures (SOPs) for responding to requests. In our experience, it
would take a company about 5 hours of management time to develop the
SOPs and set up a system for response. We believe most of the
approximately 20 510(k) holders would satisfy this proposed requirement
by making the manuals available on the Internet so recurring costs to
satisfy requests for the user manual should be negligible. Many
companies already make user manuals available online but for those who
do not, it may take up to 10 hours of a computer programmer's time to
modify the company's Web site and to upload the manuals for both
current and past models that could still be in use. About 20 firms
manufacture and distribute sunlamp products that could be affected by
these proposed requirements. Because we do not know how many of them
have user manuals online and all would have to modify their Web pages
so product users could find the manuals, we are assuming all firms will
incur one-time costs of 5 hours for SOPs and 10 hours to modify their
Web pages. We include an estimate of $27,800 for one-time capital costs
to account for the wage rate for a manager and computer programmer.
Proposed Sec. 878.4365(c)(4)(iii) would require tanning facilities
to maintain signed risk acknowledgement certifications for at least 1
year or until the user signs a new risk acknowledgement certification,
whichever is earlier. The 10.7 million users divided among the 36,000
tanning facilities yields an average of 297 users per facility and
since users must sign the certification twice per year, this is 594
certifications to be maintained by each tanning facility per year.
Multiplying the 594 certifications by the 36,000 facilities yields
21,384,000 total certifications to be filed per year. FDA expects that
filing the certification, either paper or electronic, will take the
facility 15 seconds or 0.004 hours and this multiplied by the
21,384,000 total certifications yields a burden estimate of 85,536
hours for this recordkeeping requirement. As mentioned previously, the
number of facilities and users is an average based on the range of
facilities and users stated in the economic analysis of this
rulemaking. Therefore, the resulting hour burden is consistent with,
but not identical to, the hours stated in the economic analysis.
We also assume that the first time a user visits a tanning facility
after the date the proposed requirements become effective, a tanning
facility operator would take an extra 30 seconds to explain to the
prospective user the purpose of the certification and the facility's
policy regarding its implementation. We have therefore included a one-
time burden estimate for facilities to explain the certification to
users. As mentioned previously, the numbers of facilities and users are
averages based on the ranges of facilities and users stated in the
economic analysis of this rulemaking. Therefore, the resulting hour-
burden is consistent with, but not identical to, the hours stated in
the economic analysis. We estimate the one-time cost burden will be $2
million, the mean of the range ($1.9 to 2.1 million) stated in the
economic analysis.
In addition, FDA concludes that the user's proof of age in Sec.
878.4635(c)(1) and the risk acknowledgement certification in Sec.
878.4635(c)(4) do not constitute information but are rather
``Affidavits, oaths, affirmations, certifications, receipts, changes of
address, consents, or acknowledgments . . .'' (5 CFR 1320.3(h)(1)).
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. To ensure that
comments on information collection are received, OMB recommends that
written comments be faxed or emailed (see ADDRESSES). These
requirements will not be effective until FDA obtains OMB approval. FDA
will publish a notice concerning OMB approval of these requirements in
the Federal Register.
[[Page 79502]]
VIII. Proposed Effective Date
FDA proposes that any final rule based on this proposal become
effective 90 days after its date of publication in the Federal
Register.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and online at https://www.regulations.gov (FDA has verified all the Web
site addresses in this reference section, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
1. Cadet, J., E. Sage, and T. Douki, ``Ultraviolet Radiation-
Mediated Damage to Cellular DNA.'' Mutation Research/Fundamental and
Molecular Mechanisms of Mutagenesis, 571(1-2):3-17, 2005.
2. Wolff, K. ,L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's
Dermatology in General Medicine, 7th ed., p. 999, 2006.
3. Lazovich, D., R.I. Vogel, M. Berwick, et al., ``Indoor Tanning
and Risk of Melanoma: A Case-Control Study in a Highly Exposed
Population.'' Cancer Epidemiology, Biomarkers & Prevention,
19(6):1557-1568, 2010.
4. Wolff, K., L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's
Dermatology in General Medicine, 7th ed., p. 814, 2006.
5. Gerber, B., P. Mathys, M. Moser, et al., ``Ultraviolet Emission
Spectra of Sunbeds.'' Photochemistry and Photobiology, 76:664-668,
2002.
6. Salama, A.K., N. deRosa, R.P. Scheri, et al. ``Hazard-Rate
Analysis and Patterns of Recurrence in Early Stage Melanoma: Moving
Towards a Rationally Designed Surveillance Strategy.'' PLoS One,
8(3):e57665, 2013.
7. Niendorf, K.B. and H. Tsao, ``Cutaneous Melanoma: Family
Screening and Genetic Testing.'' Dermatologic Therapy, 19:1, 2006.
8. Walters, B.L. and T.M. Kelley, ``Commercial Tanning Facilities: A
New Source of Eye Injury.'' The American Journal of Emergency
Medicine, 5(5):386-389, 1987.
9. Vajdic, C.M., A. Kricker, M. Giblin, et al., ``Artificial
Ultraviolet Radiation and Ocular Melanoma in Australia.''
International Journal of Cancer, 112(5):896-900, 2004.
10. Stapleton, J.L., J. Hillhouse, R. Turrisi, et al., ``Erythema
and Ultraviolet Indoor Tanning: Findings From a Diary Study.''
Translational Behavioral Medicine, 3(10):10-16, 2013.
11. Cokkinides, V., M. Weinstock, D. Lazovich, et al., ``Indoor
Tanning Use Among Adolescents in the U.S., 1998-2004.'' Cancer,
115:190-198, 2009.
12. Wolff, K. L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's
Dermatology in General Medicine, 7th ed., p. 828, 2006.
13. Shields, KM, ``Drug-Induced Photosensitivity.'' Pharmacist's
Letter 20:200509, May 2004.
14. Wolff, K. L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's
Dermatology in General Medicine, 7th ed., p. 57, 2006.
15. Wolff, K. L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's
Dermatology in General Medicine, 7th ed., p. 815, 2006.
16. Fisher, G.J., S. Kang, J. Varani, et al., ``Mechanisms of
Photoaging and Chronological Skin Aging.'' Archives of Dermatology,
138(11):1462-1470, 2002.
17. Quan, T., Z. Qin, W. Xia, et al., ``Matrix-Degrading
Metalloproteinases in Photoaging.'' Journal of Investigative
Dermatology Symposium Proceedings, 14(1);20-24, 2009.
18. Autier, P. and P. Boyle, ``Artificial Ultraviolet Sources and
Skin Cancers: Rationale for Restricting Access to Sunbed Use Before
18 years of Age.'' Nature Clinical Practice. Oncology, 5(4):178-179,
2008.
19. Boldeman, C., B. Jansson, B. Nilsson, et al., ``Sunbed Use in
Swedish Urban Adolescents Related to Behavioral Characteristics.''
Preventive Medicine, 26:114-119, 1997.
20. Guy, G.P., Z. Berkowitz, E. Tai, et al., ``Indoor Tanning Among
High School Students in the United States, 2009 and 2011.'' Journal
of the American Medical Association Dermatology, 150(5):501-511,
2014.
21. Demko, C.A., E.A. Borawski, S.M. Debanne, et al., ``Use of
Indoor Tanning Facilities by White Adolescents in the United
States.'' Archives of Pediatrics & Adolescent Medicine, 157(9):854-
860, 2003.
22. Mayer, J.A., S.I. Woodruff, D.J. Slymen, et al., ``Adolescents'
Use of Indoor Tanning: A Large-Scale Evaluation of Psychosocial,
Environmental, and Policy-Level Correlates.'' American Journal of
Public Health, 101(5):930-938, 2011.
23. Paul, C.L., A. Girgis, F. Tzelepis, et al., ``Solaria Use by
Minors in Australia: Is There a Cause for Concern?'' Australian and
New Zealand Journal of Public Health, 28:90, 2004.
24. Geller, A.C., G. Colditz, S. Oliveria, et al., ``Use of
Sunscreen, Sunburning Rates, and Tanning Bed Use Among More Than
10,000 U.S. Children and Adolescents.'' Pediatrics, 109(6):1009-
1014, June 2002.
25. Cust, A.E., B.K. Armstrong, C. Goumas, et al., ``Sunbed Use
During Adolescence and Early Adulthood Is Associated With Increased
Risk of Early-Onset Melanoma.'' International Journal of Cancer,
128:2425-2435, 2011.
26. Balk, S.J., D.E. Fisher, and A.C. Geller, ``Teens and Indoor
Tanning: A Cancer Prevention Opportunity for Pediatricians.''
Pediatrics, 131:772-785, 2013.
27. Diffey, B., ``Sunbeds, Beauty and Melanoma.'' British Journal of
Dermatology, 157(2): 215-216, 2007.
28. Herzog, C., A.S. Pappo, M.L. Bondy, et al., ``Malignant
Melanoma.'' In: A. Bleyer, M. O'Leary and L.A.G. Ries (Eds.), Cancer
Epidemiology in Older Adolescents and Young Adults 15 to 29 Years of
Age (National Cancer Institute, NIH Pub. No. 06-5767, chapt. 5, pp.
53-63) 2007. Bethesda, MD: U.S. Department of Health and Human
Services.
29. Reed, K.B., J.D. Brewer, C.M. Lohse, et al., ``Increasing
Incidence of Melanoma Among Young Adults: An Epidemiological Study
in Olmsted County, Minnesota.'' Mayo Clinic Proceedings, 87(4):328-
334, 2012.
30. Boniol, M., P. Autier, P. Boyle, et al., ``Cutaneous Melanoma
Attributable to Sunbed Use: Systematic Review and Meta-Analysis.''
BMJ, 345:e4757, 2012.
31. Colantonio, S., M.B. Bracken, and J. Beecker, ``The Association
of Indoor Tanning and Melanoma in Adults: Systematic Review and
Meta-Analysis.'' Journal of the American Academy of Dermatology,
70(5):847-857, 2014.
32. Wehner, M.R., M.L. Shive, M.M. Chren, et al., ``Indoor Tanning
and Non-Melanoma Skin Cancer: Systematic Review and Meta-Analysis.''
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33. Bleyer, R.B., ``Cancer in Young Adults 20 to 39 Years of Age:
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List of Subjects in 21 CFR Part 878
Medical devices.
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 878 be amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for part 878 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Section 878.4635 is amended as follows:
0
a. Redesignate paragraph (c) as paragraph (d);
0
b. Add new paragraph (c);
0
c. Revise the heading of newly designated paragraph (d).
The revisions and additions read as follows:
Sec. 878.4635 Sunlamp products and ultraviolet lamps intended for use
in sunlamp products.
* * * * *
(c) Restrictions on sale, distribution, and use of sunlamp
products. (1) A tanning facility operator must not permit the use of a
sunlamp product unless the prospective user is at least 18 years of age
and has signed the risk acknowledgement certification described in
paragraph (c)(4) of this section.
(2) A tanning facility operator must, upon request by a sunlamp
product user or prospective user, with respect to any sunlamp product
that the operator operates, provide a copy of the sunlamp product user
manual or the name and address of the manufacturer or distributor from
whom a user manual may be obtained.
(3) In addition to assuring that a user manual accompanies each
sunlamp product, a 510(k) holder must provide, upon request, a copy of
the sunlamp product user manual to any tanning facility operator,
sunlamp product user, or prospective user with respect to any sunlamp
product it manufactures/manufactured or distributes/distributed.
(4) Risk acknowledgement certification. (i) The tanning facility
operator must not permit the use of a sunlamp product unless it obtains
each prospective user's signature on a risk acknowledgement
certification that contains the following statement prior to use of the
sunlamp product, unless the prospective user has previously signed the
risk acknowledgement certification within the preceding 6 months:
BILLING CODE 4164-01-P
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(ii) The text of the risk acknowledgement certification shall be at
least 10-point font.
(iii) The tanning facility operator shall provide a copy of the
signed acknowledgement certification to the prospective user and the
tanning facility shall retain a copy of the signed risk acknowledgement
certification for 1 year or until the prospective user signs a new risk
acknowledgement certification, whichever is earlier.
(d) Electronic product performance standard. * * *
Dated: December 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32024 Filed 12-18-15; 8:45 am]
BILLING CODE 4164-01-C
