
[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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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\
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    \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.
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    \2\ See http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm205684.htm.
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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

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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 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 http://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 http://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, http://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 http://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 
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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 
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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 
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7. Niendorf, K.B. and H. Tsao, ``Cutaneous Melanoma: Family 
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9. Vajdic, C.M., A. Kricker, M. Giblin, et al., ``Artificial 
Ultraviolet Radiation and Ocular Melanoma in Australia.'' 
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115:190-198, 2009.
12. Wolff, K. L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's 
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Letter 20:200509, May 2004.
14. Wolff, K. L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's 
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Photoaging and Chronological Skin Aging.'' Archives of Dermatology, 
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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.
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Swedish Urban Adolescents Related to Behavioral Characteristics.'' 
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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-
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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.
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Tanning: A Cancer Prevention Opportunity for Pediatricians.'' 
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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 
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Age (National Cancer Institute, NIH Pub. No. 06-5767, chapt. 5, pp. 
53-63) 2007. Bethesda, MD: U.S. Department of Health and Human 
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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.'' 
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 Population-Based 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

[[Page 79503]]

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 
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44. FDA, 2010 Meeting materials, including presentations, a meeting 
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Cancer: ``The Association of Use of Sunbeds With Cutaneous Malignant 
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Public Health, 104(4):e69-e74, 2014.
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Exposure Is a Reinforcing Stimulus in Frequent Indoor Tanners.'' 
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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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[GRAPHIC] [TIFF OMITTED] TP22DE15.004


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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


