Federal Register / Vol. 75, No. 222 / Thursday, November 18, 2010 / Notices 70677 

5This 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. 

6The 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). 

7 3,084,984 hours ÷ 3 = 1,028,328; $101,874,986 

÷ 3 = $33,958,329. 

8Financial 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. 

9As stated above, no clerical time is included in 

the estimate because the notice likely would be 

combined with existing GLBA notices. 

10Based 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. 

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, 

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: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: 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 

mstockstill on DSKH9S0YB1PROD with NOTICES

70678 Federal Register / Vol. 75, No. 222 / Thursday, November 18, 2010 / Notices 

(attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov 

(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 

doris.lefkowitz@AHRQ.hhs.gov. 

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

Data collection method Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

NGC Evaluation Survey ................................................................... 40,220 1 8/60 5,363 

Focus Groups .................................................................................. 99 1 1.5 149 

Key Informant Interviews ................................................................. 30 1 1 30 

Total .......................................................................................... 40,349 NA NA 5,542 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection method Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate* Total cost burden 

NGC Evaluation Survey ................................................................... 40,220 5,363 $33.51 $179,714 

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Federal Register / Vol. 75, No. 222 / Thursday, November 18, 2010 / Notices 70679 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Data collection method Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate* Total cost burden 

Focus Groups .................................................................................. 99 149 33.51 4,993 

Key Informant Interviews ................................................................. 30 30 33.51 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 

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, 

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 

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

Cost component Total cost Annualized cost 

Project Development and Management .......................................................................................................... $70,000 $70,000 

Data Collection Activities ................................................................................................................................. 105,000 105,000 

Data Processing and Analysis ......................................................................................................................... 70,000 70,000 

Administrative Support and Reporting ............................................................................................................. 105,000 105,000 

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] 

BILLING CODE 4160–90–M 

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. 

SUMMARY: 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, Daniel.Gittleson@fda.hhs.gov. 

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 

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] 

BILLING CODE 4160–01–P 

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., 

mstockstill on DSKH9S0YB1PROD with NOTICES