Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices 22497 

2 In particular, the written request for confidential 

treatment that accompanies the comment must 

include the factual and legal basis for the request, 

and must identify the specific portions of the 

comment to be withheld from the public record. See 

FTC Rule 4.9(c), 16 CFR 4.9(c). 

before May 22, 2014. Write ‘‘FTC 

Generic Clearance ICR, Project No. 

P035201’’ 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 http://

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 doesn’t 

include any sensitive personal 

information, like anyone’s 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 

doesn’t include any sensitive health 

information, like medical records or 

other individually identifiable health 

information. In addition, don’t include 

any ‘‘[t]rade secret or any commercial or 

financial information which is obtained 

from any person and which is privileged 

or confidential . . ., ’’ as provided 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). 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 have to follow the 

procedure explained in FTC Rule 4.9(c), 

16 CFR 4.9(c).2 Your comment will be 

kept confidential only if the FTC 

General Counsel 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, we encourage you to submit your 

comments online, or to send them to the 

Commission by courier or overnight 

service. To make sure that the 

Commission considers your online 

comment, you must file it at https://

ftcpublic.commentworks.com/ftc/

genericclearancepra2 by following the 

instructions on the web-based form. If 

this Notice appears at http://

www.regulations.gov/#!home, you also 

may file a comment through that Web 

site. 

If you file your comment on paper, 

write ‘‘FTC Generic Clearance ICR, 

Project No. P035201’’ on your comment 

and on the envelope, and mail or deliver 

it to the following address: Federal 

Trade Commission, Office of the 

Secretary, Room H–113 (Annex J), 600 

Pennsylvania Avenue NW., Washington, 

DC 20580. If possible, submit your 

paper comment to the Commission by 

courier or overnight service. 

Comments on any proposed 

information collection requirements 

subject to review under the PRA should 

additionally be submitted to OMB. If 

sent by U.S. mail, they should be 

addressed to Office of Information and 

Regulatory Affairs, Office of 

Management and Budget, Attention: 

Desk Officer for the Federal Trade 

Commission, New Executive Office 

Building, Docket Library, Room 10102, 

725 17th Street NW., Washington, DC 

20503. Comments sent to OMB by U.S. 

postal mail, however, are subject to 

delays due to heightened security 

precautions. Thus, comments instead 

should be sent by facsimile to (202) 

395–5167. 

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 May 22, 2014. You can find more 

information, including routine uses 

permitted by the Privacy Act, in the 

Commission’s privacy policy, at http:// 

www.ftc.gov/ftc/privacy.htm. 

David C. Shonka, 

Principal Deputy General Counsel. 

[FR Doc. 2014–09173 Filed 4–21–14; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration; 

Delegation of Authorities 

Notice is hereby given that I have 

delegated to the Commissioner, Food 

and Drug Administration (FDA), with 

authority to re-delegate, the authorities 

vested in the Secretary of the 

Department of Health and Human 

Services under the Drug Quality and 

Security Act (DQSA), Public Law 113– 

54, insofar as these authorities pertain to 

the functions and operations of FDA. 

This delegation includes, but is not 

limited to, authority to communicate 

with state Boards of Pharmacy under 

Section 105 of the DQSA. 

This delegation shall be exercised in 

accordance with the Department’s 

applicable policies, procedures, and 

guidelines. 

I hereby affirm and ratify any actions 

taken by the Commissioner, FDA, or 

other FDA officials that involved the 

exercise of these authorities prior to the 

effective date of this delegation. 

This delegation of authorities is 

effective upon date of signature. 

Authority: 44 U.S.C. 3101. 

Dated: April 11, 2014. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2014–09033 Filed 4–21–14; 8:45 am] 

BILLING CODE 4160–01–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: 

‘‘SelectMD 2.0 Clinician Choice 

Experiment.’’ In accordance with the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3506(c)(2)(A), AHRQ invites the 

public to comment on this proposed 

information collection. 

This proposed information collection 

was previously published in the Federal 


tkelley on DSK3SPTVN1PROD with NOTICES
22498 Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices 

Register on January, 29th 2014 and 

allowed 60 days for public comment. 

One comment was 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 May 22, 2014. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email at doris.lefkowitz@ahrq.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

SelectMD 2.0 Clinician Choice 

Experiment 

This study builds on previous 

research conducted as part of the 

Consumer Assessment of Healthcare 

Providers and Systems (CAHPS) 

program to explore new ways of 

integrating patient comments with other 

performance metrics in web-based 

quality reports for consumers to support 

their choice of physicians. Our previous 

consumer choice study, referred to as 

SelectMD 1.0 (approved by OMB on 3/ 

8/10 under OMB Control Number 0935– 

0161), revealed important risks and 

opportunities of using patient comments 

that require additional research in order 

to develop effective guidance for report 

sponsors. Sponsors of performance 

reports in both the public and private 

sectors, including Federal agencies such 

as the Centers for Medicare & Medicaid 

Services (CMS), have indicated strong 

interest in receiving such guidance on 

strategies for effectively incorporating 

patient comments to increase 

consumers’ use of public reports and to 

enhance their ability to interpret CAHPS 

and other performance measures. 

This follow-on study (referred to as 

SelectMD 2.0) will use an experimental 

design to test different methods of 

incorporating patient comments along 

with CAHPS survey results, the 

Healthcare Effectiveness Data and 

Information Set (HEDIS)-like measures 

of effective clinical treatments, and 

indicators of patient safety in web-based 

physician quality reports. The study 

will help AHRQ understand how people 

choose a doctor as their regular source 

of medical care and advice. 

The study has three stages. In the first 

stage, respondents will be asked some 

questions about their health care 

experiences and how they go about 

choosing a doctor. In the second stage 

the respondents will log onto an 

experimental Web site that has 

information about a fictitious set of 

doctors from which to choose. 

Respondents will be asked to use the 

information on the Web site to select a 

doctor who they think would be the best 

for their health care needs. Although 

they will not really be selecting a 

doctor, they will be asked to consider 

the choice as carefully as if they were 

making it for themselves. In the third 

stage, following their selection of a 

doctor, respondents will answer a set of 

questions about how they made their 

choice of doctor, how useful they found 

the Web site, and how confident they 

were in the choice they made. 

This research has the following goals: 

(1) to expand on the findings from 

AHRQ’s previous choice experiment 

regarding how including narrative 

patient comments in web-based 

physician quality reports influences the 

ways in which consumers learn about 

and select among clinicians, and 

(2) to assess whether and how patient 

comments can be presented in a way 

that promotes learning about physician 

quality and complements rather than 

detracts from standardized measures of 

quality. 

This study is being conducted by 

AHRQ through its contractors, RAND 

and Yale University, pursuant to 

AHRQ’s statutory authority to conduct 

and support research on healthcare and 

on systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness and value of healthcare 

services and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented over the three stages of the 

experiment: 

(1) Pre-Choice Survey—The purpose 

of this survey is to measure the 

respondents’ previous exposure to 

information on health care provider 

performance and how they go about 

choosing a physician. 

(2) Experimental Web site—The 

purpose of this site is to present 

different combinations and displays of 

performance information that 

respondents will use to select a doctor. 

Respondents will be randomly assigned 

to one of eight different versions of the 

experimental SelectMD Web site that 

will vary according to the level of detail 

presented, how patient comments are 

grouped and labeled, whether 

respondents can choose which and how 

much information to review, and 

whether respondents have access to live 

telephone assistance when making their 

choices. 

(3) Post-Choice Survey—The purpose 

of the post-choice survey is to assess 

how respondents made their doctor 

selection, how useful the Web site 

version assigned to them was in helping 

to make their choice, and how confident 

they are in the choice they made. 

Responses to the post-choice survey will 

provide insights into which of the 

experimental Web site versions are more 

effective in supporting consumer choice 

of doctors and why. 

The results of this study will be used 

to develop recommendations for helping 

consumers to better understand and 

more effectively use complex 

information to select health care 

providers, with the aim of making 

performance information less 

burdensome and more accessible, 

useful, and transparent to the public. In 

particular, the study findings will 

inform the design and content of the 

growing number of web-based reports 

on provider performance incorporating 

patient comments along with other 

measures of quality. By adding to the 

evidence base on the types and 

combination of information that are 

most salient and useful to consumers in 

choosing among provider options, the 

study will make a significant 

contribution to improving current 

reporting initiatives. In addition, the 

simulated web-based reports will be 

made available as examples for other 

report developers to use. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

experiment. The portion of the 

experiment involving respondent 

participation will take place over a 

period of approximately two months, 

once OMB approval has been received. 

All participants will complete the prechoice survey, which is estimated to 

take 10 minutes. To assess the impact of 

their exposure to the SelectMD Web 

site, several questions on the initial prechoice survey are replicated on the postchoice questionnaire. To reduce the 

likelihood that respondents will simply 

repeat the answers that they provided 

on the pre-choice survey (in an effort to 

appear consistent), it is essential to 

allow some time to elapse between the 

two surveys. Consequently, participants 

will not have access to the SelectMD 

Web site until one week after 

completing the pre-choice survey. Since 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices 22499 

we expect that about 5% of participants 

taking the pre-choice survey will not 

return to participate in the experiment 

one week later, the number of 

respondents initially required is 5% 

higher (1,575) than the full sample of 

1,500 required for the experiment. We 

estimate based on our previous 

experience with the SelectMD 1.0 

experiment that participants will 

require about 10 minutes to review the 

information on the Web site and select 

their preferred physician from the set of 

doctors available. The average time 

required to complete the post-choice 

survey is estimated to be 20 minutes. 

Consequently, respondents will average 

about 40 minutes completing all three 

phases of the study. 

Exhibit 2 shows the respondents’ cost 

burden for their time to participate in 

this experiment. The total cost burden is 

estimated to be $22,297. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hour per 

response 

(min/60) 

Total burden 

hours 

Pre-Choice Survey ........................................................................................... 1575 1 10/60 263 

Time on Website (Choosing MD) .................................................................... 1500 1 10/60 250 

Post-Choice Survey ......................................................................................... 1500 1 20/60 500 

Total Hours ............................................................................................... 4,575 na na 1,013 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Pre-Choice Survey ........................................................................................... 1575 263 $22.01 $5,789 

Time on Website (Choosing MD) .................................................................... 1500 250 22.01 5,503 

Post-Choice Survey ......................................................................................... 1500 500 22.01 11,005 

Total Cost ................................................................................................. ........................ ........................ ........................ 22,297 

* Based upon the national mean hourly wage for all occupations from the ‘‘May 2012 Occupational Employment and Wage Estimates’’, U.S. 

Department of Labor, Bureau of Labor Statistics. 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

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 health care 

research and 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: April 9, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–09168 Filed 4–21–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0374] 

Postmarketing Requirements for the 

Class-Wide Extended-Release/LongActing Opioid Analgesics; Public 

Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to obtain stakeholder 

input on the design and conduct of the 

postmarketing requirements (PMRs) for 

the class-wide extended-release/longacting (ER/LA) opioid analgesic drug 

products to further assess the serious 

risks of misuse, abuse, hyperalgesia, 

addiction, overdose, and death 

associated with their long-term use. 

FDA is seeking input on these issues 

from stakeholders, including patients, 

academia, researchers, State and other 

Federal regulators, health care 

organizations, health care providers, the 

pharmaceutical industry, and others 

from the general public. 

DATES: The public meeting will be held 

on May 19 and 20, 2014, from 8 a.m. to 

5 p.m. Individuals who wish to present 

at the meeting must register by May 9, 

2014. See section III under the 

SUPPLEMENTARY INFORMATION section for 

information on how to register to speak 

at the meeting. 

ADDRESSES: The public meeting will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Participants must enter through 

Building 1 and undergo security 

screening. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Submit either electronic or written 

comments by June 19, 2014. Submit 

electronic comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify all 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Janelle Derbis, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 20 North 

Michigan Ave., Suite 510, Chicago, IL 

60602, 312–596–6516, FAX: 312–886– 


tkelley on DSK3SPTVN1PROD with NOTICES