Agency Information Collection Activities; Proposed Collection; Comment Request, 62530-62533 [2015-26362]
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providing the dates and pertinent
details of any maintenance performed
on station equipment, along with the
name and address of the service
technician who did the work. If all
maintenance is performed by the same
technician or service company, the
name and address need be entered only
once in the station records.
Section 90.443(c) requires that at least
one licensee participating in the cost
arrangement must maintain cost sharing
records.
Federal Communications Commission.
Marlene H. Dortch,
Secretary, Office of the Secretary.
[FR Doc. 2015–26304 Filed 10–15–15; 8:45 am]
BILLING CODE 6712–01–P
FEDERAL MARITIME COMMISSION
Sunshine Act Meeting
Federal Maritime Commission.
October 21, 2015; 10 a.m.
PLACE: 800 N. Capitol Street NW., First
Floor Hearing Room, Washington, DC.
STATUS: The first portion of the meeting
will be held in Open Session; the
second in Closed Session.
AGENCY:
TIME AND DATE:
Matters To Be Considered
Open Session
1. Docket No. 13–05: Amendments to
Regulations Governing Ocean
Transportation Intermediary
Licensing and Financial
Responsibility Requirements, and
General Duties
2. Briefing on FMC Information
Technology Modernization
3. Briefing on FMC Continuity of
Operations Plan
4. Briefing on U.S.-Japan Maritime
Discussions
Closed Session
1. Service Contracts and Non-VesselOperating Common Carrier Service
Arrangements—Regulatory Review
CONTACT PERSON FOR MORE INFORMATION:
Karen V. Gregory, Secretary, (202) 523
5725.
Karen V. Gregory,
Secretary.
[FR Doc. 2015–26474 Filed 10–14–15; 4:15 pm]
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BILLING CODE 6731–AA–P
FEDERAL TRADE COMMISSION
Agency Information Collection
Activities; Proposed Collection;
Comment Request
Federal Trade Commission
(FTC or Commission).
AGENCY:
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ACTION:
Notice.
The information collection
requirements described below will be
submitted to the Office of Management
and Budget (OMB) for review, as
required by the Paperwork Reduction
Act (PRA). The FTC seeks public
comments on its proposal to extend, for
three years, the current PRA clearance
for information collection requirements
contained in the rules and regulations
under the Health Breach Notification
Rule. This clearance expires on March
31, 2016.
DATES: Comments must be received on
or before December 15, 2015.
ADDRESSES: Interested parties may file a
comment online or on paper by
following the instructions in the
Request for Comments part of the
SUPPLEMENTARY INFORMATION section
below. Write ‘‘Health Breach
Notification Rule, PRA Comments, P–
125402’’ on your comment, and file
your comment online at https://
ftcpublic.commentworks.com/ftc/
healthbreachnotificationpra by
following the instructions on the webbased form. If you prefer to file your
comment on paper, mail or deliver your
comment to the following address:
Federal Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue
NW., Suite CC–5610 (Annex J),
Washington, DC 20580, or deliver your
comment to the following address:
Federal Trade Commission, Office of the
Secretary, Constitution Center, 400 7th
Street SW., 5th Floor, Suite 5610
(Annex J), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT:
Requests for copies of the collection of
information and supporting
documentation should be addressed to
Cora Tung Han, 202–326–2441,
Attorney, Privacy & Identity Protection,
Bureau of Consumer Protection, 600
Pennsylvania Ave. NW., Washington,
DC 20580.
SUPPLEMENTARY INFORMATION: On
February 17, 2009, President Obama
signed the American Recovery and
Reinvestment Act of 2009 (the Recovery
Act or the Act) into law. The Act
included provisions to advance the use
of health information technology and, at
the same time, strengthen privacy and
security protections for health
information. The Act required the FTC
to adopt a rule implementing the breach
notification requirements applicable to
vendors of personal health records,
‘‘PHR related entities,’’ 1 and third party
SUMMARY:
1 ‘‘PHR related entity’’ means an entity, other than
a HIPAA-covered entity or an entity to the extent
that it engages in activities as a business associate
of a HIPAA-covered entity, that: (1) Offers products
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service providers, and the Commission
issued a final rule on August 25, 2009.
74 FR 42962.
The Health Breach Notification Rule
(Rule), 16 CFR part 318, requires
vendors of personal health records and
PHR related entities to provide: (1)
Notice to consumers whose unsecured
personally identifiable health
information has been breached; and (2)
notice to the Commission. The Rule
only applies to electronic health records
and does not include recordkeeping
requirements. The Rule requires third
party service providers (i.e., those
companies that provide services such as
billing or data storage) to vendors of
personal health records and PHR related
entities to provide notification to such
vendors and PHR related entities
following the discovery of a breach. To
notify the FTC of a breach, the
Commission developed a form, which is
posted at www.ftc.gov/healthbreach, for
entities subject to the rule to complete
and return to the agency.
These notification requirements are
subject to the provisions of the PRA, 44
U.S.C. Chapter 35. Under the PRA,
federal agencies must get OMB approval
for each collection of information they
conduct, sponsor, or require.
‘‘Collection of information’’ means
agency requests or requirements to
submit reports, keep records, or provide
information to a third party. 44 U.S.C.
3502(3); 5 CFR 1320.3(c). As required by
Section 3506(c)(2)(A) of the PRA, the
FTC is providing this opportunity for
public comment before requesting that
OMB extend the existing PRA clearance
for the information collection
requirements associated with the
Commission’s rules and regulations
under the Health Breach Notification
Rule (or Rule), 16 CFR part 318 (OMB
Control Number 3084–0150).
The FTC invites comments on: (1)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the agency’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 those who are to respond. All
or services through the Web site of a vendor of
personal health records; (2) offers products or
services through the Web sites of HIPAA-covered
entities that offer individuals personal health
records; or (3) accesses information in a personal
health record or sends information to a personal
health record. 16 CFR 318.2(f).
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comments must be received on or before
December 15, 2015.
In the Commission’s view, it has
maximized the practical utility of the
breach notification requirements in the
Rule, consistent with the requirements
of the Recovery Act. Under the Rule,
consumers whose information has been
affected by a breach of security receive
notice of it ‘‘without unreasonable delay
and in no case later than 60 calendar
days’’ after discovery of the breach.
Among other information, the notices
must provide consumers with steps they
can take to protect themselves from
harm. Moreover, the breach notice
requirements encourage entities to
safeguard the information of their
customers, thereby potentially reducing
the incidence of harm.
The form entities must use to inform
the Commission of a security breach
requests minimal information, mostly as
replies to check boxes; thus, entities do
not require extensive time to complete
it. For breaches involving the health
information of 500 or more individuals,
entities must notify the Commission as
soon as possible, and in any event no
later than ten business days after
discovering the breach. Breaches
involving the information of fewer than
500 individuals may be reported in an
annual submission that includes all
breaches within the calendar year that
fall within this category. The form
serves the Commission by providing the
agency with information about breaches
occurring in the PHR industry.
The Commission inputs the
information it receives from entities into
a database that the Commission updates
periodically. The Commission makes
certain information about these breaches
available to the public. This publiclyavailable information serves businesses
and the public. It provides businesses
with information about potential causes
of data breaches, which is particularly
helpful to those setting up data security
procedures. It also provides the public
with information about the extent of
data breaches. Thus, in the
Commission’s view, the Rule and form
have significant practical utility.
Pursuant to § 318.5 of the Rule,
entities must notify the FTC ‘‘according
to instructions at the Federal Trade
Commission’s Web site.’’ In 2009, the
Commission indicated that ‘‘[d]ue to
security concerns associated with email
transmission, the Commission will not
accept emailed forms at this time.’’ 2
The Commission now offers a secure
online method for receiving these
notices, and instructions are on the form
entities should use for notification,
2 74
FR at 42975.
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which is available on the FTC’s Web
site. Alternatively entities may continue
to print and send the form to a
designated FTC official by courier or
overnight mail.
Burden Estimates
The PRA burden of the Rule’s
requirements depends on a variety of
factors, including the number of covered
firms; the percentage of such firms that
will experience a breach requiring
further investigation and, if necessary,
the sending of breach notices; and the
number of consumers notified. The
annual hours and cost estimates below
likely overstate the burden because,
among other things, they assume,
though it is not necessarily so, that all
breaches subject to the Rule’s
notification requirements will be
required to take all of the steps
described below.
At the time the Rule was issued,
insufficient data was available about the
incidence of breaches in the PHR
industry. Accordingly, staff based its
burden estimate on data pertaining to
private sector breaches across multiple
industries. Staff estimated that there
would be 11 breaches per year requiring
notification of 232,000 consumers.3
As described above, the Rule requires
covered entities that have suffered a
breach to notify the Commission. Since
the Rule has now been in effect for over
five years,4 staff is now able to base the
burden estimate on the actual
notifications received from covered
entities, which include the number of
consumers notified. Accordingly, staff
has used this information to update its
burden estimate.
On average, about 2,500 consumers
per year received notifications over the
years 2010 and 2011. In 2012 and 2013,
between 4,000 and 5,000 consumers
received notifications each year. In
2014, approximately 17,993 consumers
received notifications. In light of this
upwards trend, staff bases its current
burden estimate on an assumed two
breach incidents per year that, together,
require the notification of
approximately 40,000 consumers. This
estimate will likely overstate the
burden; however, as consumers
increasingly download their information
into personal health records,5 staff
anticipates that the number of affected
consumers will increase.
Estimated Annual Hours Burden:
3,267.
3 74
FR at 42977.
rule became effective on September 24,
2009. Full compliance was required by February 22,
2010.
5 See e.g., https://www.va.gov/bluebutton/.
4 The
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As explained in more detail within
the next section, FTC staff projects that
covered firms will require on average,
per breach, 100 hours of employee labor
to determine what information has been
breached, identify the affected
customers, prepare the breach notice,
and make the required report to the
Commission. Based on an estimated 2
breaches per year, yearly hourly burden
would be 200 hours. Additionally, staff
expects covered firms will require 3,067
annual hours (1,067 hours of telephone
operator time + 2000 hours of
information processor time) to process
calls they may receive in the event of a
data breach. See footnote 8 infra.
Estimated Annual Labor Costs:
$61,764.
FTC staff projects that covered firms
will require on average, per breach, 100
hours of employee labor to determine
what information has been breached,
identify the affected customers, prepare
the breach notice, and make the
required report to the Commission, at an
estimated cost of $5,732 6 (staff assumes
that outside services of a forensic expert
will also be required and those services
are separately accounted for under
‘‘Estimated Annual Non-Labor Costs’’
below). Based on an estimated 2
breaches per year, the annual employee
labor cost burden for affected entities to
perform these tasks is $11,464.7
Additionally, covered entities will
incur labor costs associated with
processing calls they may receive in the
event of a data breach. The rule requires
that covered entities that fail to contact
10 or more consumers because of
insufficient or out-of-date contact
information must provide substitute
6 Hourly wages throughout this document are
based on mean hourly wages found at https://
www.bls.gov/news.release/ocwage.htm
(‘‘Occupational Employment and Wages–May
2014,’’ U.S. Department of Labor, released March
2015, Table 1 (‘‘National employment and wage
data from the Occupational Employment Statistics
survey by occupation, May 2014’’).
The breakdown of labor hours and costs is as
follows: 50 hours of computer and information
systems managerial time at approximately $66 per
hour; 12 hours of marketing manager time at $66
per hour; 33 hours of computer programmer time
at $40 per hour; and 5 hours of legal staff time at
$64 per hour.
7 Labor hours and costs pertaining to reporting to
the Commission are subsumed within this total.
Specifically, staff estimates that covered firms will
require per breach, on average, 1 hour of employee
labor at an approximate cost of $65 to complete the
required form. This is composed of 30 minutes of
marketing managerial time at $66 per hour, and 30
minutes of legal staff time at $64 per hour, with the
hourly rates based on the above-referenced
Department of Labor table. See note 6, supra. Thus,
based on 2 breaches per year for which notification
may be required, the cumulative annual-hours
burden for covered entities to complete the
notification to the Commission is 2 hours and the
annual labor cost is approximately $130.00.
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notice through either a clear and
conspicuous posting on their Web site
or media notice. Such substitute notice
must include a toll-free number for the
purpose of allowing a consumer to learn
whether or not his/her information was
affected by the breach.
Individuals contacted directly will
have already received this information.
Staff estimates that no more than 10
percent of affected consumers will
utilize the offered toll-free number.
Thus, of the 40,000 consumers affected
by a breach annually, staff estimates that
4,000 may call the companies over the
90 days they are required to provide
such access. Staff additionally projects
that 4,000 additional consumers who
are not affected by the breach will also
call the companies during this period.
Staff estimates that processing all 8,000
calls will require an average of 3,067
hours of employee labor at a cost of
$50,300.8
Accordingly, estimated cumulative
annual labor costs, excluding outside
forensic services, is $62,000.
Estimated Annual Capital and other
Non-Labor Costs: $49,960.
Commission staff anticipates that
capital and other non-labor costs
associated with the Rule will consist of
the following:
1. The services of a forensic expert in
investigating the breach;
2. notification of consumers via email,
mail, web posting, or media; and
3. the cost of setting up a toll-free
number, if needed.
Staff estimates that covered firms
(breached entities) will require 30 hours
of a forensic expert’s time, at a
cumulative cost of $3,960 for each
breach. This is the product of hourly
wages of an information security analyst
($44), tripled to reflect profits and
overhead for an outside consultant
($132), and multiplied by 30 hours.
Based on the estimate that there will be
2 breaches per year, the annual cost
associated with the services of an
outside forensic expert is $7,920.
As explained above, staff estimates
that an average of 40,000 consumers per
year will receive a breach notification.
Given the online relationship between
consumers and vendors of personal
health records and PHR related entities,
most notifications will be made by
8 This
assumes telephone operator time of 8
minutes per call and information processor time of
15 minutes per call. The cost estimate above is
arrived at as follows: 1,067 hours of telephone
operator time (8 minutes per call × 8,000 calls) at
$19 per hour, and 2000 hours of information
processor time (15 minutes per call × 8,000 calls)
at $15 per hour.
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email and the cost of such notifications
will be minimal.9
In some cases, however, vendors of
personal health records and PHR related
entities will need to notify individuals
by postal mail, either because these
individuals have asked for such
notification, or because the email
addresses of these individuals are not
current or not working. Staff estimates
that the cost of a mailed notice is $0.06
for the paper and envelope, and $0.49
for a first class stamp. Assuming that
vendors of personal health records and
PHR related entities will need to notify
by postal mail 10 percent of the 40,000
customers whose information is
breached, the estimated cost of this
notification will be $2,200 per year.10
In addition, vendors of personal
health records and PHR related entities
sometimes may need to notify
consumers by posting a message on
their home page, or by providing media
notice. Based on a recent study on data
breach costs, staff estimates the cost of
providing notice via Web site posting to
be $0.06 per breached record, and the
cost of providing notice via published
media to be $0.03 per breached
record.11 Applied to the above-stated
estimate of 40,000 affected consumers,
the estimated total annual cost of Web
site notice will be $2,400, and the
estimated total annual cost of media
notice will be $1,200, yielding an
estimated total annual cost for all forms
of notice to consumers of $5,800.
Finally, staff estimates that the cost of
providing a toll-free number will
depend on the costs associated with T1
lines sufficient to handle the projected
call volume and the cost of obtaining a
toll-free telephone number.12 Based on
industry research, staff projects that
affected entities may need two T1 lines
9 See National Do Not Email Registry, A Report
to Congress, June 2004 n.93, available at
www.ftc.gov/reports/dneregistry/report.pdf.
10 As mentioned above, covered entities will also
need to notify the Commission either through an
online process or via mail. Staff estimates the nonlabor costs for this notification to be negligible.
11 Ponemon Institute, 2006 Annual Study: Cost of
a Data Breach, Understanding Financial Impact,
Customer Turnover, and Preventative Solutions,
Table 2. In studies conducted for subsequent years,
the Ponemon Institute does not report this level of
detail.
12 Staff included costs associated with obtaining
a T1 line (a specific type of telephone line that can
carry more data than traditional telephone lines) in
its initial estimate in 2009, but did not include
these costs in its most recent estimate based on the
low number of consumers notified pursuant to the
Rule in 2010 and 2011. Since staff’s current
estimate includes larger projected call volumes,
however, staff has again included these costs. Staff
recognizes that this likely overstates the burden
because entities may already have these services in
place and/or they may not all be necessary
depending on how many consumers are affected.
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at a cost of $9,000 for the 90 day
period.13 In addition, staff estimates the
cost of obtaining a dedicated toll-free
line to be $4,540 per month.
Accordingly, staff projects that the cost
of obtaining two toll-free lines for 90
days will be $27,240,14 and the total
annual cost for providing a toll-free
number will be $36,240.
In sum, the total estimate for nonlabor costs is $49,960: $7,920 (services
of a forensic expert) + $5,800 (costs of
notifying consumers) + $36,240 (cost of
providing a toll-free number).
The total estimated PRA annual cost
burden is $61,764 (labor costs) +
$49,960 (non-labor costs) =
approximately $112,000 (rounded to the
nearest thousand).
Request for Comments
You can file a comment online or on
paper. Write ‘‘Health Breach
Notification Rule, PRA Comments, P–
125402’’ on your comment. Your
comment—including your name and
your state—will be placed on the public
record of this proceeding, including, to
the extent practicable, on the public
Commission Web site, at https://
www.ftc.gov/os/publiccomments.shtm.
As a matter of discretion, the
Commission tries to remove individuals’
home contact information from
comments before placing them on the
Commission Web site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, such as a Social Security
number, date of birth, driver’s license
number or other state identification
number or foreign country equivalent,
passport number, financial account
number, or credit or debit card number.
You are also solely responsible for
making sure that your comment does
not include any sensitive health
information, such as medical records or
other individually identifiable health
information. In addition, do not include
any ‘‘[t]rade secret or any commercial or
financial information which is . . .
privileged or confidential,’’ as discussed
in Section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR
4.10(a)(2). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
13 According to industry research, the cost of a
single T1 line is $1,500 per month.
14 Staff estimates a monthly charge of $15 along
with an activation charge of $15 for each toll-free
line, as well as a per minute charge of $.07. Since
staff estimates each breach will require 1067 hours
of telephone operator time (see note 10, infra), staff
estimates the cost/month of each toll-free line to be
$4,540.
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inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you must follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c). Your comment will be kept
confidential only if the FTC General
Counsel, in his or her sole discretion,
grants your request in accordance with
the law and the public interest. Postal
mail addressed to the Commission is
subject to delay due to heightened
security screening. As a result, the
Commission encourages you to submit
your comments online. To make sure
that the Commission considers your
online comment, you must file it at
https://ftcpublic.commentworks.com/
ftc/healthbreachnotificationpra by
following the instructions on the webbased form. If this Notice appears at
https://www.regulations.gov, you also
may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘Health Breach Notification Rule,
PRA Comments, P–125402’’ on your
comment and on the envelope, and mail
it to the following address: Federal
Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue
NW., Suite CC–5610, (Annex J),
Washington, DC 20580, or deliver your
comment to the following address:
Federal Trade Commission, Office of the
Secretary, Constitution Center, 400 7th
Street SW., 5th Floor, Suite 5610,
(Annex J), Washington, DC 20024. If
possible, submit your paper comment to
the Commission by courier or overnight
service.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before December 15, 2015. You can find
more information, including routine
uses permitted by the Privacy Act, in
the Commission’s privacy policy, at
https://www.ftc.gov/ftc/privacy.htm.
David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2015–26362 Filed 10–15–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ).
ACTION: Notice of public meeting.
AGENCY:
In accordance with section
10(a) of the Federal Advisory Committee
Act, 5 U.S.C. App. 2, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality.
DATES: The meeting will be held on
Tuesday, November 3, 2015, from 8:30
a.m. to 2:45 p.m.
ADDRESSES: The meeting will be held at
the Hubert H. Humphrey Building,
Room 800, 200 Independence Avenue
SW., Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Jaime Zimmerman, Designated
Management Official, at the Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland,
20850, (301) 427–1456. For press-related
information, please contact Alison Hunt
at (301) 427–1244.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact the
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than Friday,
October 23, 2015. The agenda, roster,
and minutes are available from Ms.
Bonnie Campbell, Committee
Management Officer, Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland,
20850. Ms. Campbell’s phone number is
(301) 427–1554.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Purpose
The National Advisory Council for
Healthcare Research and Quality is
authorized by Section 941 of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to AHRQ’s
conduct of its mission including
providing guidance on (A) priorities for
health care research, (B) the field of
health care research including training
needs and information dissemination on
health care quality and (C) the role of
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the Agency in light of private sector
activity and opportunities for public
private partnerships.
The Council is composed of members
of the public, appointed by the
Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
II. Agenda
On Tuesday, November 3, 2015, there
will be a subcommittee meeting for the
National Healthcare Quality and
Disparities Report scheduled to begin at
7:30 a.m. The subcommittee meeting is
open the public. The Council meeting
will convene at 8:30 a.m., with the call
to order by the Council Chair and
approval of previous Council summary
notes. The meeting is open to the public
and will be available via webcast at
www.webconferences.com/ahrq. The
meeting will begin with the AHRQ
director presenting an update on current
research, programs, and initiatives.
Following the Director’s update, the
agenda will include discussion of
AHRQ’s work on health information
technology (Health IT), a presentation
on the Medical Expenditure Panel
Survey (MEPS), and discussion on the
recent IOM report on diagnostic errors.
The final agenda will be available on the
AHRQ Web site at www.AHRQ.gov no
later than Friday, October 23, 2015.
Sharon B. Arnold,
Deputy.
[FR Doc. 2015–26319 Filed 10–15–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[Docket No. ATSDR–2015–0002]
Availability of Draft Toxicological
Profile; Set 27 Toxicological Profiles
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice of availability and
request for comment.
AGENCY:
The Agency for Toxic
Substances and Disease Registry
(ATSDR), located within the
Department of Health and Human
Services (HHS) announces the
availability of Set 27 Toxicological
Profiles for review and comment. The
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA), as amended by
SUMMARY:
E:\FR\FM\16OCN1.SGM
16OCN1
Agencies
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62530-62533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26362]
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FEDERAL TRADE COMMISSION
Agency Information Collection Activities; Proposed Collection;
Comment Request
AGENCY: Federal Trade Commission (FTC or Commission).
ACTION: Notice.
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SUMMARY: The information collection requirements described below will
be submitted to the Office of Management and Budget (OMB) for review,
as required by the Paperwork Reduction Act (PRA). The FTC seeks public
comments on its proposal to extend, for three years, the current PRA
clearance for information collection requirements contained in the
rules and regulations under the Health Breach Notification Rule. This
clearance expires on March 31, 2016.
DATES: Comments must be received on or before December 15, 2015.
ADDRESSES: Interested parties may file a comment online or on paper by
following the instructions in the Request for Comments part of the
SUPPLEMENTARY INFORMATION section below. Write ``Health Breach
Notification Rule, PRA Comments, P-125402'' on your comment, and file
your comment online at https://ftcpublic.commentworks.com/ftc/healthbreachnotificationpra by following the instructions on the web-
based form. If you prefer to file your comment on paper, mail or
deliver your comment to the following address: Federal Trade
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite
CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex
J), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Requests for copies of the collection
of information and supporting documentation should be addressed to Cora
Tung Han, 202-326-2441, Attorney, Privacy & Identity Protection, Bureau
of Consumer Protection, 600 Pennsylvania Ave. NW., Washington, DC
20580.
SUPPLEMENTARY INFORMATION: On February 17, 2009, President Obama signed
the American Recovery and Reinvestment Act of 2009 (the Recovery Act or
the Act) into law. The Act included provisions to advance the use of
health information technology and, at the same time, strengthen privacy
and security protections for health information. The Act required the
FTC to adopt a rule implementing the breach notification requirements
applicable to vendors of personal health records, ``PHR related
entities,'' \1\ and third party service providers, and the Commission
issued a final rule on August 25, 2009. 74 FR 42962.
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\1\ ``PHR related entity'' means an entity, other than a HIPAA-
covered entity or an entity to the extent that it engages in
activities as a business associate of a HIPAA-covered entity, that:
(1) Offers products or services through the Web site of a vendor of
personal health records; (2) offers products or services through the
Web sites of HIPAA-covered entities that offer individuals personal
health records; or (3) accesses information in a personal health
record or sends information to a personal health record. 16 CFR
318.2(f).
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The Health Breach Notification Rule (Rule), 16 CFR part 318,
requires vendors of personal health records and PHR related entities to
provide: (1) Notice to consumers whose unsecured personally
identifiable health information has been breached; and (2) notice to
the Commission. The Rule only applies to electronic health records and
does not include recordkeeping requirements. The Rule requires third
party service providers (i.e., those companies that provide services
such as billing or data storage) to vendors of personal health records
and PHR related entities to provide notification to such vendors and
PHR related entities following the discovery of a breach. To notify the
FTC of a breach, the Commission developed a form, which is posted at
www.ftc.gov/healthbreach, for entities subject to the rule to complete
and return to the agency.
These notification requirements are subject to the provisions of
the PRA, 44 U.S.C. Chapter 35. Under the PRA, federal agencies must get
OMB approval for each collection of information they conduct, sponsor,
or require. ``Collection of information'' means agency requests or
requirements to submit reports, keep records, or provide information to
a third party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). As required by
Section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity
for public comment before requesting that OMB extend the existing PRA
clearance for the information collection requirements associated with
the Commission's rules and regulations under the Health Breach
Notification Rule (or Rule), 16 CFR part 318 (OMB Control Number 3084-
0150).
The FTC invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (2) the accuracy of the agency'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 those who
are to respond. All
[[Page 62531]]
comments must be received on or before December 15, 2015.
In the Commission's view, it has maximized the practical utility of
the breach notification requirements in the Rule, consistent with the
requirements of the Recovery Act. Under the Rule, consumers whose
information has been affected by a breach of security receive notice of
it ``without unreasonable delay and in no case later than 60 calendar
days'' after discovery of the breach. Among other information, the
notices must provide consumers with steps they can take to protect
themselves from harm. Moreover, the breach notice requirements
encourage entities to safeguard the information of their customers,
thereby potentially reducing the incidence of harm.
The form entities must use to inform the Commission of a security
breach requests minimal information, mostly as replies to check boxes;
thus, entities do not require extensive time to complete it. For
breaches involving the health information of 500 or more individuals,
entities must notify the Commission as soon as possible, and in any
event no later than ten business days after discovering the breach.
Breaches involving the information of fewer than 500 individuals may be
reported in an annual submission that includes all breaches within the
calendar year that fall within this category. The form serves the
Commission by providing the agency with information about breaches
occurring in the PHR industry.
The Commission inputs the information it receives from entities
into a database that the Commission updates periodically. The
Commission makes certain information about these breaches available to
the public. This publicly-available information serves businesses and
the public. It provides businesses with information about potential
causes of data breaches, which is particularly helpful to those setting
up data security procedures. It also provides the public with
information about the extent of data breaches. Thus, in the
Commission's view, the Rule and form have significant practical
utility.
Pursuant to Sec. 318.5 of the Rule, entities must notify the FTC
``according to instructions at the Federal Trade Commission's Web
site.'' In 2009, the Commission indicated that ``[d]ue to security
concerns associated with email transmission, the Commission will not
accept emailed forms at this time.'' \2\ The Commission now offers a
secure online method for receiving these notices, and instructions are
on the form entities should use for notification, which is available on
the FTC's Web site. Alternatively entities may continue to print and
send the form to a designated FTC official by courier or overnight
mail.
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\2\ 74 FR at 42975.
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Burden Estimates
The PRA burden of the Rule's requirements depends on a variety of
factors, including the number of covered firms; the percentage of such
firms that will experience a breach requiring further investigation
and, if necessary, the sending of breach notices; and the number of
consumers notified. The annual hours and cost estimates below likely
overstate the burden because, among other things, they assume, though
it is not necessarily so, that all breaches subject to the Rule's
notification requirements will be required to take all of the steps
described below.
At the time the Rule was issued, insufficient data was available
about the incidence of breaches in the PHR industry. Accordingly, staff
based its burden estimate on data pertaining to private sector breaches
across multiple industries. Staff estimated that there would be 11
breaches per year requiring notification of 232,000 consumers.\3\
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\3\ 74 FR at 42977.
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As described above, the Rule requires covered entities that have
suffered a breach to notify the Commission. Since the Rule has now been
in effect for over five years,\4\ staff is now able to base the burden
estimate on the actual notifications received from covered entities,
which include the number of consumers notified. Accordingly, staff has
used this information to update its burden estimate.
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\4\ The rule became effective on September 24, 2009. Full
compliance was required by February 22, 2010.
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On average, about 2,500 consumers per year received notifications
over the years 2010 and 2011. In 2012 and 2013, between 4,000 and 5,000
consumers received notifications each year. In 2014, approximately
17,993 consumers received notifications. In light of this upwards
trend, staff bases its current burden estimate on an assumed two breach
incidents per year that, together, require the notification of
approximately 40,000 consumers. This estimate will likely overstate the
burden; however, as consumers increasingly download their information
into personal health records,\5\ staff anticipates that the number of
affected consumers will increase.
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\5\ See e.g., https://www.va.gov/bluebutton/.
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Estimated Annual Hours Burden: 3,267.
As explained in more detail within the next section, FTC staff
projects that covered firms will require on average, per breach, 100
hours of employee labor to determine what information has been
breached, identify the affected customers, prepare the breach notice,
and make the required report to the Commission. Based on an estimated 2
breaches per year, yearly hourly burden would be 200 hours.
Additionally, staff expects covered firms will require 3,067 annual
hours (1,067 hours of telephone operator time + 2000 hours of
information processor time) to process calls they may receive in the
event of a data breach. See footnote 8 infra.
Estimated Annual Labor Costs: $61,764.
FTC staff projects that covered firms will require on average, per
breach, 100 hours of employee labor to determine what information has
been breached, identify the affected customers, prepare the breach
notice, and make the required report to the Commission, at an estimated
cost of $5,732 \6\ (staff assumes that outside services of a forensic
expert will also be required and those services are separately
accounted for under ``Estimated Annual Non-Labor Costs'' below). Based
on an estimated 2 breaches per year, the annual employee labor cost
burden for affected entities to perform these tasks is $11,464.\7\
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\6\ Hourly wages throughout this document are based on mean
hourly wages found at https://www.bls.gov/news.release/ocwage.htm
(``Occupational Employment and Wages-May 2014,'' U.S. Department of
Labor, released March 2015, Table 1 (``National employment and wage
data from the Occupational Employment Statistics survey by
occupation, May 2014'').
The breakdown of labor hours and costs is as follows: 50 hours
of computer and information systems managerial time at approximately
$66 per hour; 12 hours of marketing manager time at $66 per hour; 33
hours of computer programmer time at $40 per hour; and 5 hours of
legal staff time at $64 per hour.
\7\ Labor hours and costs pertaining to reporting to the
Commission are subsumed within this total. Specifically, staff
estimates that covered firms will require per breach, on average, 1
hour of employee labor at an approximate cost of $65 to complete the
required form. This is composed of 30 minutes of marketing
managerial time at $66 per hour, and 30 minutes of legal staff time
at $64 per hour, with the hourly rates based on the above-referenced
Department of Labor table. See note 6, supra. Thus, based on 2
breaches per year for which notification may be required, the
cumulative annual-hours burden for covered entities to complete the
notification to the Commission is 2 hours and the annual labor cost
is approximately $130.00.
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Additionally, covered entities will incur labor costs associated
with processing calls they may receive in the event of a data breach.
The rule requires that covered entities that fail to contact 10 or more
consumers because of insufficient or out-of-date contact information
must provide substitute
[[Page 62532]]
notice through either a clear and conspicuous posting on their Web site
or media notice. Such substitute notice must include a toll-free number
for the purpose of allowing a consumer to learn whether or not his/her
information was affected by the breach.
Individuals contacted directly will have already received this
information. Staff estimates that no more than 10 percent of affected
consumers will utilize the offered toll-free number. Thus, of the
40,000 consumers affected by a breach annually, staff estimates that
4,000 may call the companies over the 90 days they are required to
provide such access. Staff additionally projects that 4,000 additional
consumers who are not affected by the breach will also call the
companies during this period. Staff estimates that processing all 8,000
calls will require an average of 3,067 hours of employee labor at a
cost of $50,300.\8\
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\8\ This assumes telephone operator time of 8 minutes per call
and information processor time of 15 minutes per call. The cost
estimate above is arrived at as follows: 1,067 hours of telephone
operator time (8 minutes per call x 8,000 calls) at $19 per hour,
and 2000 hours of information processor time (15 minutes per call x
8,000 calls) at $15 per hour.
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Accordingly, estimated cumulative annual labor costs, excluding
outside forensic services, is $62,000.
Estimated Annual Capital and other Non-Labor Costs: $49,960.
Commission staff anticipates that capital and other non-labor costs
associated with the Rule will consist of the following:
1. The services of a forensic expert in investigating the breach;
2. notification of consumers via email, mail, web posting, or
media; and
3. the cost of setting up a toll-free number, if needed.
Staff estimates that covered firms (breached entities) will require
30 hours of a forensic expert's time, at a cumulative cost of $3,960
for each breach. This is the product of hourly wages of an information
security analyst ($44), tripled to reflect profits and overhead for an
outside consultant ($132), and multiplied by 30 hours. Based on the
estimate that there will be 2 breaches per year, the annual cost
associated with the services of an outside forensic expert is $7,920.
As explained above, staff estimates that an average of 40,000
consumers per year will receive a breach notification. Given the online
relationship between consumers and vendors of personal health records
and PHR related entities, most notifications will be made by email and
the cost of such notifications will be minimal.\9\
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\9\ See National Do Not Email Registry, A Report to Congress,
June 2004 n.93, available at www.ftc.gov/reports/dneregistry/report.pdf.
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In some cases, however, vendors of personal health records and PHR
related entities will need to notify individuals by postal mail, either
because these individuals have asked for such notification, or because
the email addresses of these individuals are not current or not
working. Staff estimates that the cost of a mailed notice is $0.06 for
the paper and envelope, and $0.49 for a first class stamp. Assuming
that vendors of personal health records and PHR related entities will
need to notify by postal mail 10 percent of the 40,000 customers whose
information is breached, the estimated cost of this notification will
be $2,200 per year.\10\
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\10\ As mentioned above, covered entities will also need to
notify the Commission either through an online process or via mail.
Staff estimates the non-labor costs for this notification to be
negligible.
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In addition, vendors of personal health records and PHR related
entities sometimes may need to notify consumers by posting a message on
their home page, or by providing media notice. Based on a recent study
on data breach costs, staff estimates the cost of providing notice via
Web site posting to be $0.06 per breached record, and the cost of
providing notice via published media to be $0.03 per breached
record.\11\ Applied to the above-stated estimate of 40,000 affected
consumers, the estimated total annual cost of Web site notice will be
$2,400, and the estimated total annual cost of media notice will be
$1,200, yielding an estimated total annual cost for all forms of notice
to consumers of $5,800.
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\11\ Ponemon Institute, 2006 Annual Study: Cost of a Data
Breach, Understanding Financial Impact, Customer Turnover, and
Preventative Solutions, Table 2. In studies conducted for subsequent
years, the Ponemon Institute does not report this level of detail.
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Finally, staff estimates that the cost of providing a toll-free
number will depend on the costs associated with T1 lines sufficient to
handle the projected call volume and the cost of obtaining a toll-free
telephone number.\12\ Based on industry research, staff projects that
affected entities may need two T1 lines at a cost of $9,000 for the 90
day period.\13\ In addition, staff estimates the cost of obtaining a
dedicated toll-free line to be $4,540 per month. Accordingly, staff
projects that the cost of obtaining two toll-free lines for 90 days
will be $27,240,\14\ and the total annual cost for providing a toll-
free number will be $36,240.
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\12\ Staff included costs associated with obtaining a T1 line (a
specific type of telephone line that can carry more data than
traditional telephone lines) in its initial estimate in 2009, but
did not include these costs in its most recent estimate based on the
low number of consumers notified pursuant to the Rule in 2010 and
2011. Since staff's current estimate includes larger projected call
volumes, however, staff has again included these costs. Staff
recognizes that this likely overstates the burden because entities
may already have these services in place and/or they may not all be
necessary depending on how many consumers are affected.
\13\ According to industry research, the cost of a single T1
line is $1,500 per month.
\14\ Staff estimates a monthly charge of $15 along with an
activation charge of $15 for each toll-free line, as well as a per
minute charge of $.07. Since staff estimates each breach will
require 1067 hours of telephone operator time (see note 10, infra),
staff estimates the cost/month of each toll-free line to be $4,540.
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In sum, the total estimate for non-labor costs is $49,960: $7,920
(services of a forensic expert) + $5,800 (costs of notifying consumers)
+ $36,240 (cost of providing a toll-free number).
The total estimated PRA annual cost burden is $61,764 (labor costs)
+ $49,960 (non-labor costs) = approximately $112,000 (rounded to the
nearest thousand).
Request for Comments
You can file a comment online or on paper. Write ``Health Breach
Notification Rule, PRA Comments, P-125402'' on your comment. Your
comment--including your name and your state--will be placed on the
public record of this proceeding, including, to the extent practicable,
on the public Commission Web site, at https://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to
remove individuals' home contact information from comments before
placing them on the Commission Web site.
Because your comment will be made public, you are solely
responsible for making sure that your comment does not include any
sensitive personal information, such as a Social Security number, date
of birth, driver's license number or other state identification number
or foreign country equivalent, passport number, financial account
number, or credit or debit card number. You are also solely responsible
for making sure that your comment does not include any sensitive health
information, such as medical records or other individually identifiable
health information. In addition, do not include any ``[t]rade secret or
any commercial or financial information which is . . . privileged or
confidential,'' as discussed in Section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do
not include competitively sensitive information such as costs, sales
statistics,
[[Page 62533]]
inventories, formulas, patterns, devices, manufacturing processes, or
customer names.
If you want the Commission to give your comment confidential
treatment, you must file it in paper form, with a request for
confidential treatment, and you must follow the procedure explained in
FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential
only if the FTC General Counsel, in his or her sole discretion, grants
your request in accordance with the law and the public interest. Postal
mail addressed to the Commission is subject to delay due to heightened
security screening. As a result, the Commission encourages you to
submit your comments online. To make sure that the Commission considers
your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/healthbreachnotificationpra by following
the instructions on the web-based form. If this Notice appears at
https://www.regulations.gov, you also may file a comment through that
Web site.
If you file your comment on paper, write ``Health Breach
Notification Rule, PRA Comments, P-125402'' on your comment and on the
envelope, and mail it to the following address: Federal Trade
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite
CC-5610, (Annex J), Washington, DC 20580, or deliver your comment to
the following address: Federal Trade Commission, Office of the
Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite
5610, (Annex J), Washington, DC 20024. If possible, submit your paper
comment to the Commission by courier or overnight service.
The FTC Act and other laws that the Commission administers permit
the collection of public comments to consider and use in this
proceeding as appropriate. The Commission will consider all timely and
responsive public comments that it receives on or before December 15,
2015. You can find more information, including routine uses permitted
by the Privacy Act, in the Commission's privacy policy, at https://www.ftc.gov/ftc/privacy.htm.
David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2015-26362 Filed 10-15-15; 8:45 am]
BILLING CODE 6750-01-P