Attachment G - Federal Register Notice

Federal Register / Vol. 75, No. 222 / Thursday, November 18, 2010 / Notices
Estimated total average annual hours
burden: 1,043,961 hours.
Based, in part, on industry data
regarding the number of businesses
under various industry codes, staff
estimates that 1,101,780 non-GLBA
entities under FTC jurisdiction have
affiliates and would be affected by the
Rule.5 Staff further estimates that there
are an average of 5 businesses per family
or affiliated relationship, and that the
affiliated entities will choose to send a
joint notice, as permitted by the Rule.
Thus, an estimated 220,356 non-GLBA
business families may send the affiliate
marketing notice. Staff also estimates
that non-GLBA entities under the
jurisdiction of the FTC would each
incur 14 hours of burden during the
prospective requested three-year PRA
clearance period, comprised of a
projected 7 hours of managerial time, 2
hours of technical time, and 5 hours of
clerical assistance.
Based on the above, total burden for
non-GLBA entities during the
prospective three-year clearance period
would be approximately 3,084,984
hours. Associated labor cost would total
$101,874,986.6 These estimates include
the start-up burden and attendant costs,

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5 This

estimate is derived from an analysis of a
database of U.S. businesses based on SIC codes for
businesses that market goods or services to
consumers, which included the following
industries: Transportation services; communication;
electric, gas, and sanitary services; retail trade;
finance, insurance, and real estate; and services
(excluding business services and engineering,
management services). See http://www.naics.com/
search.htm. This estimate excludes businesses not
subject to the FTC’s jurisdiction and businesses that
do not use data or information subject to the rule.
To the resulting sub-total (6,677,796), staff applies
a continuing assumed rate of affiliation of 16.75
percent, see 69 FR 33324, 33334 (June 15, 2004),
reduced by a continuing estimate of 100,000 entities
subject to the Commission’s GLBA privacy notice
regulations, see id., applied to the same assumed
rate of affiliation. The net total is 1,101,780.
6 The associated labor cost is based on the labor
cost burden per notice by adding the hourly mean
private sector wages for managerial, technical, and
clerical work and multiplying that sum by the
estimated number of hours. The classifications used
are ‘‘Management Occupations’’ for managerial
employees, ‘‘Computer and Mathematical Science
Occupations’’ for technical staff, and ‘‘Office and
Administrative Support’’ for clerical workers. See
National Compensation Survey: Occupational
Earnings in the United States 2009, U.S.
Department of Labor, released August 2010,
Bulletin 2738, Table 3 (‘‘Summary: Full-time
civilian workers: Mean and median hourly, weekly,
and annual earnings and mean weekly and annual
hours’’) http://www.bls.gov/ncs/ocs/sp/
nctb1346.pdf. The respective private sector hourly
wages for these classifications are $43.99, $36.07,
and $16.45. Estimated hours spent for each labor
category are 7, 2, and 5, respectively. Multiplying
each occupation’s hourly wage by the associated
time estimate, labor cost burden per notice equals
$462.32. This subtotal is then multiplied by the
estimated number of non-GLB business families
projected to send the affiliate marketing notice
(220,356) to determine cumulative labor cost
burden for non-GLBA entities ($101,874,986).

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such as determining compliance
obligations. Non-GLBA entities,
however, will give notice only once
during the clearance period ahead.
Thus, averaged over that three-year
period, the estimated annual burden for
non-GLBA entities is 1,028,328 hours
and $33,958,329 in labor costs.7
Entities that are subject to the
Commission’s GLBA privacy notice
regulation already provide privacy
notices to their customers.8 Because the
FACT Act and the Rule contemplate
that the affiliate marketing notice can be
included in the GLBA notices, the
burden on GLBA regulated entities
would be greatly reduced. Accordingly,
the GLBA entities would incur 6 hours
of burden during the first year of the
clearance period, comprised of a
projected 5 hours of managerial time
and 1 hour of technical time to execute
the notice, given that the Rule provides
a model.9 Staff further estimates that
3,350 GLBA entities under the FTC’s
jurisdiction would be affected,10 so that
the total burden for GLBA entities
during the first year of the clearance
period would approximate 20,100 hours
and $857,667 in associated labor
costs.11 Allowing for increased
familiarity with procedure, the PRA
burden in ensuing years would decline,
with GLBA entities each incurring an
estimated 4 hours of annual burden (3
hours of managerial time and 1 hour of
technical time) during the remaining
two years of the clearance, amounting to
13,400 hours and $562,934 in labor
costs in each of the ensuing two years.12
Thus, averaged over the three-year
clearance period, the estimated annual
burden for GLBA entities is 15,633
hours and $661,178 in labor costs.

Cumulatively for both GLBA and nonGLBA entities, the average annual
burden over the prospective three-year
clearance period is 1,043,961 burden
hours and $34,619,507 in labor costs.
GLBA entities are already providing
notices to their customers so there are
no new capital or non-labor costs, as
this notice may be consolidated into
their current notices. For non-GLBA
entities, the Rule provides for simple
and concise model forms that
institutions may use to comply. Entities
that already have on-line capabilities
will offer consumers the choice to
receive notices via electronic format
(e.g., computer equipment and
software), and covered entities are
already equipped to provide disclosures
(e.g., computers with word processing
programs, copying machines, mailing
capabilities). Thus, any capital or nonlabor costs associated with compliance
for these entities are negligible.
Willard K. Tom,
General Counsel.
[FR Doc. 2010–29048 Filed 11–17–10; 8:45 am]
BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Evaluation of the National Guideline
ClearinghouseTM.’’ In accordance with
the Paperwork Reduction Act, 44 U.S.C.
3501–3520, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on September 17th, 2010 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by December 20, 2010.
ADDRESSES: Written comments should
be submitted to: AHRQs OMB Desk
Officer by fax at (202) 395–6974
SUMMARY:

hours ÷ 3 = 1,028,328; $101,874,986
÷ 3 = $33,958,329.
8 Financial institutions must provide a privacy
notice at the time the customer relationship is
established and then annually so long as the
relationship continues. Staff’s estimates assume that
the affiliate marketing opt-out will be incorporated
in the institution’s initial and annual notices.
9 As stated above, no clerical time is included in
the estimate because the notice likely would be
combined with existing GLBA notices.
10 Based on the previously stated estimates of
100,000 GLBA business entities (see supra note 5)
at an assumed rate of affiliation of 16.75 percent
(16,750), divided by the presumed ratio of 5
businesses per family, this yields a total of 3,350
GLBA business families subject to the Rule. For
simplicity, staff assumes that all of these entities are
new establishments and/or newly integrating the
affiliated opt-out notice with the GLBA notice in
the first year of the prospective three-year clearance
period; thus, the higher estimate of hours assigned
to the first year. This, too, then, would effectively
overstate actual burden.
11 3,350 GLBA entities × [($43.99 × 5 hours) +
($36.07 × 1 hour)] = $857,667.
12 3,350 GLBA entities × [($43.99 × 3 hours) +
($36.07 × 1 hour)] = $562,934.
7 3,084,984

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Federal Register / Vol. 75, No. 222 / Thursday, November 18, 2010 / Notices

(attention: AHRQ’s desk officer) or by email at [email protected]
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AURO Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Evaluation of the National Guideline
ClearinghouseTM
The mission of the Agency for
Healthcare Research and Quality
(AHRQ) is to enhance the quality,
appropriateness, and effectiveness of
health services, and access to such
services, through the establishment of a
broad base of scientific research and
through the promotion of improvements
in clinical and health system practices,
including the prevention of diseases and
other health conditions. 42 U.S.C.
299(b). AHRQ supports the
dissemination of evidence-based
guidelines through its National
Guideline ClearinghouseTM (NGC).
The NGC serves as a publicly
accessible Web-based database of
evidence-based clinical practice
guidelines meeting explicit criteria. The
NGC also supports AHRQ’s strategic
goal on effectiveness: To improve health
care outcomes by encouraging the use of
evidence to make informed health care
decisions. The NGC is a vehicle for such
encouragement. The mission of the NGC
is to provide physicians, nurses, and
other health professionals, health care
providers, health plans, integrated
delivery systems, purchasers and others
an accessible mechanism for obtaining
objective, detailed information on
clinical practice guidelines and to

further their dissemination,
implementation and use.
AHRQ proposes to conduct a
comprehensive evaluation of the NGC.
This evaluation will build on the site
trends AHRQ has already identified,
including growth from 70,000 to
700,000 visits per month, 600 to
approximately 40,000 e-mail
subscribers, 250 to 2,370 guidelines
represented, and 50 to nearly 300
participating guideline developer
organizations from July 1999 to July
2009.
The objectives of the NGC evaluation
are to gain a better understanding of
how:
• The NGC is used.
• The NGC supports dissemination of
evidence-based clinical practice
guidelines and related documents.
• The NGC has influenced efforts in
guideline development and guideline
implementation and use.
• The NGC can be improved.
This study is being conducted by
AHRQ through its contractor, AFYA,
Inc. and The Lewin Group (AFYA/
Lewin), pursuant to AHRQ’s statutory
authority to conduct and support
research and disseminate information
on healthcare and on systems for the
delivery of such care, including
activities with respect to clinical
practice. 42 U.S.C. 299a(a)(4).
Method of Collection
To achieve the objectives of this
project the following data collections
will be implemented:
(1) NGC evaluation survey—a Webbased survey administered to a
convenience sample of both users and
non-users of the NGC,
(2) Focus groups—conducted with
guideline developers, medical
librarians, informatics specialists,
clinicians, and students, and
(3) Key informant interviews—inperson interviews conducted with
influential individuals in medical

societies, health plans, and quality
improvement organizations as well as
medical librarians, researchers, and
informatics specialists who produce,
use, and disseminate guidelines.
Questions in the survey, focus group,
and key informant discussion guides
will focus on the effectiveness of NGC
in areas of dissemination,
implementation, and use of evidencebased clinical practice guidelines, and
relative to other available guideline
sources. For example, measures to be
gathered through the instruments
include the level of trust of the NGC, the
use of the NGC relative to other
guideline sources, and the influence of
the NGC on various stakeholder groups.
In addition, the instruments will be
used to measure the use of other
guideline resources which are used by
non-NGC users.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
evaluation. The NGC evaluation
questionnaire will be completed by
approximately 40,220 persons and will
require 10 minutes to complete for users
of the NGC and about 2 minutes for nonusers. For the purpose of calculating
respondent burden an average of 8
minutes is used and reflects a mix of
users and non-users with most
respondents expected to be users.
Eleven different focus groups
consisting of 9 persons each will be
conducted and are expected to last 90
minutes each. Key informant interviews
will be conducted with 30 individuals
and will last about 60 minutes. The total
annual burden hours are estimated to be
5,542 hours.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to participate in this
project. The total annual cost burden is
estimated to be $185,712.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

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Number of
responses per
respondent

Number of
respondents

Data collection method

Hours per
response

Total burden
hours

NGC Evaluation Survey ...................................................................
Focus Groups ..................................................................................
Key Informant Interviews .................................................................

40,220
99
30

1
1
1

8/60
1.5
1

5,363
149
30

Total ..........................................................................................

40,349

NA

NA

5,542

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Data collection method
NGC Evaluation Survey ...................................................................

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Total burden
hours

40,220

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Average hourly
wage rate*

5,363

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$33.51

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Total cost burden
$179,714

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Federal Register / Vol. 75, No. 222 / Thursday, November 18, 2010 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents

Data collection method

Total burden
hours

Average hourly
wage rate*

Total cost burden

Focus Groups ..................................................................................
Key Informant Interviews .................................................................

99
30

149
30

33.51
33.51

4,993
1,005

Total ..........................................................................................

40,349

5542

NA

185,712

* Based upon the mean of the average wages for healthcare practitioner and technical occupations (29–0000) presented in the National Compensation Survey: Occupational wages in the United States, May 2009, U.S. Department of Labor, Bureau of Labor Statistics.

Estimated Annual Costs to the Federal
Government

and 30 key informant interviews and to
analyze and present their results. This
amount is the contract total for AFYA’s
contract with AHRQ to evaluate the
NGC. This amount, includes the costs
for project development and
management ($70,000 or 20% of the
entire contract amount); data collection

Exhibit 3 shows the estimated total
and annualized cost to the government
for this one year project. The total cost
is estimated to be $350,000 to conduct
the one-time survey, 11 focus groups,

activities ($105,000 or 30% of the entire
contract amount); data processing and
analysis ($70,000 or 20% of the entire
contract amount); and administrative
support activities and reporting
($105,000 or 30% of the entire contract
amount).

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

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Cost component

Total cost

Annualized cost

Project Development and Management ..........................................................................................................
Data Collection Activities .................................................................................................................................
Data Processing and Analysis .........................................................................................................................
Administrative Support and Reporting .............................................................................................................

$70,000
105,000
70,000
105,000

$70,000
105,000
70,000
105,000

Total ..........................................................................................................................................................

350,000

350,000

Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQs information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: November 10, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–29010 Filed 11–17–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0554]

Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Manufactured Food Regulatory
Program Standards
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Manufactured Food Regulatory
Program Standards’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, [email protected].
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 3, 2010 (75
FR 9605), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
SUMMARY:

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agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0601. The
approval expires on September 30,
2013. A copy of the supporting
statement for this information collection
is available on the Internet at http://
www.reginfo.gov/public/do/PRAMain.
Dated: November 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–29055 Filed 11–17–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

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