78252 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31381 Filed 12–14–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0418] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Institutional 

Review Boards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 14, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0130. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850,. 301– 

796–3792. 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Institutional Review Boards—OMB 

Control Number 0910–0130—Extension 

When reviewing clinical research 

studies regulated by FDA, institutional 

review boards (IRBs) are required to 

create and maintain records describing 

their operations, and make the records 

available for FDA inspection when 

requested. These records include: 

Written procedures describing the 

structure and membership of the IRB 

and the methods that the IRB will use 

in performing its functions; the research 

protocols, informed consent documents, 

progress reports, and reports of injuries 

to subjects submitted by investigators to 

the IRB; minutes of meetings showing 

attendance, votes and decisions made 

by the IRB, the number of votes on each 

decision for, against, and abstaining, the 

basis for requiring changes in or 

disapproving research; records of 

continuing review activities; copies of 

all correspondence between 

investigators and the IRB; statement of 

significant new findings provided to 

subjects of the research; and a list of IRB 

members by name, showing each 

member’s earned degrees, representative 

capacity, and experience in sufficient 

detail to describe each member’s 

contributions to the IRB’s deliberations, 

and any employment relationship 

between each member and the IRB’s 

institution. This information is used by 

FDA in conducting audit inspections of 

IRBs to determine whether IRBs and 

clinical investigators are providing 

adequate protections to human subjects 

participating in clinical research. 

In the Federal Register of August 17, 

2010 (75 FR 50766), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received regarding the information 

collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

recordkeeper Total hours 

56.115 ........................................................................ 2,500 14.6 36,500 100 3,650,000 

Total .................................................................... .......................... .......................... .......................... .......................... 3,650,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The recordkeeping requirement 

burden is based on the following: The 

burden for each of the paragraphs under 

21 CFR 56.115 has been considered as 

one estimated burden. FDA estimates 

that there are approximately 2,500 IRBs. 

The IRBs meet on an average of 14.6 

times annually. The agency estimates 

that approximately 100 hours of persontime per meeting are required to meet 

the requirements of the regulation. 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant, Commissioner for Policy. 

[FR Doc. 2010–31389 Filed 12–14–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0184] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study of Patient Information 

Prototypes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 14, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–new and 

title ‘‘Experimental Study of Patient 

Information Prototypes.’’ Also include 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78253 

1Public Law 104–180, August 6, 1996, Title VI, 

Effective Medication Guides. 

2Part 208 (21 CFR part 208). 

3 21 CFR 310.501 and 310.515. 

4Aikin, K.J., ‘‘Consumer Comprehension and 

Preference for Variations in the Proposed Over-TheCounter Drug Labeling Format, Final Report,’’ 1998; 

Vigilante, W.J., M.S. Wogalter, ‘‘The Preferred Order 

of Over-the-Counter (OTC) Pharmaceutical Label 

Components,’’ Drug Information Journal, 31, 973– 

988, 1997. 

5Levy, A.S., S.B. Fein, R.E. Schucker, ‘‘More 

Effective Nutrition Label Formats Are Not 

Necessarily More Preferred,’’ Journal of the 

American Dietetic Association, 92(10), 1230–1234, 

1992. 

6Lorch, R., E. Lorch, ‘‘Effects of Organizational 

Signals on Text-Processing Strategies,’’ Journal of 

Educational Psychology, 87(4), 537–544, 1995; 

Lorch, R., E. Lorch, ‘‘Effects of Organizational 

Signals on Free Recall of Expository Text,’’ Journal 

of Educational Psychology, 88(1), 38–48, 1996; 

Lorch, R., E. Lorch, W. Inman, ‘‘Effects of Signaling 

Topic Structure on Text Recall,’’ Journal of 

Educational Psychology, 85(2), 281–290, 1993. 

7Wood, R., A. Bandura, ‘‘Impact of Conceptions 

of Ability on Self-Regulatory Mechanisms and 

Complex Decision Making,’’ Journal of Personality 

and Social Psychology, 56(3), 407–415, 1989. 8Lorch, R., E. Lorch, ‘‘Effects of Organizational 

Signals on Text-Processing Strategies,’’ Journal of 

Educational Psychology, 87(4), 537–544, 1995; 

Lorch, R., E. Lorch, ‘‘Effects of Organizational 

Signals on Free Recall of Expository Text,’’ Journal 

of Educational Psychology, 88(1), 38–48, 1996; 

Lorch, R., E. Lorch, W. Inman, ‘‘Effects of Signaling 

Topic Structure on Text Recall,’’ Journal of 

Educational Psychology, 85(2), 281–290, 1993. 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

792–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Experimental Study of Patient 

Information Prototypes—(OMB Control 

Number 0910–New) 

In order to make informed decisions 

about health care and to use their 

medications correctly, consumers need 

easy access to up-to-date and accurate 

information about the risks, benefits and 

safe use of their prescription drugs. 

Consumers currently receive multiple 

pieces of paper with their prescription 

drugs from the pharmacy, containing 

information that is developed and 

distributed through various sources. 

Written prescription drug information is 

provided through a voluntary effort 

(Consumer Medication Information) 1 as 

well as through FDA mandated use of 

Medication Guides 2 and Patient 

Package Inserts (PPI).3 Patients describe 

a wide range of experiences and varying 

degrees of satisfaction with information 

currently provided at the time 

medicines are received at the pharmacy. 

In some cases, the written documents 

are difficult to read and understand, 

duplicative and overlapping, 

incomplete or contradictory. FDA has 

held multiple public meetings to solicit 

feedback on providing balanced, 

comprehensive, and up-to-date 

prescription drug information to 

consumers. 

Since 1968, FDA regulations have 

required that PPIs written specifically 

for patients be distributed when certain 

prescription drugs or classes of 

prescription drugs are dispensed. PPIs 

are required for estrogens and oral 

contraceptives, are considered part of 

the product labeling, and are to be 

dispensed to the patient with the 

product. In the 1970s, FDA began 

evaluating the general usefulness of 

patient labeling for prescription drugs 

resulting in a series of regulatory steps 

to help ensure the availability of useful 

written consumer information. Other 

PPIs are submitted to FDA voluntarily 

by manufacturers and approved by FDA, 

but their distribution is not mandated 

by regulation. In the Federal Register of 

July 6, 1979 (44 FR 40016), FDA 

proposed regulations that would have 

required written patient information for 

all prescription drugs, and in the 

Federal Register of September 12, 1980 

(45 FR 60754), FDA finalized those 

regulations. In the Federal Register of 

September 7, 1982 (47 FR 39147), the 

regulations were revoked based, in part, 

on assurances that the effort could be 

handled more efficiently within the 

private sector. 

In the Federal Register of August 24, 

1995 (60 FR 44182), FDA proposed the 

‘‘Prescription Drug Product Labeling: 

Medication Guide Requirements,’’ 

designed to set specific distribution and 

quality goals and timeframes for 

distributing written information to 

patients. In the Federal Register of 

December 1, 1998 (63 FR 66378), the 

Agency published a final rule that 

established a program under which 

Medication Guides would be required 

for a small number of drugs considered 

to pose a serious and significant public 

health concern (21 CFR 208.20). 

Evidence suggests that both the 

content (e.g., organization) and format 

(e.g., white space) of a document will 

impact the comprehension of patient 

information. Research on reading 

behavior and document simplification 

suggests that the use of less complex 

terminology presented in shorter 

sentences with a more organized, or 

chunked, structure should improve 

consumer processing for at least three 

reasons. First, it should decrease the 

cognitive load engendered by the 

current physician-directed format. 

Second, a more structured and 

organized patient information document 

should present a less imposing 

processing demand, increasing 

consumers’ willingness and selfperceived ability to read and understand 

the presented material. Research with 

the format of over-the-counter (OTC) 

drug labels,4 the nutrition facts label,5

and other information formats 6

demonstrates that information presented 

with section headings, graphics (such as 

bullets), and other design elements is 

more easily read than information 

presented in paragraph format. 

Consumers are more likely to engage in 

behavior they believe they can 

successfully complete.7 Third, a patient 

information document that provides 

readers with clearer ‘‘signals’’ regarding 

the most important information should 

help readers prioritize the importance of 

the presented information. This should 

increase the probability that the set of 

information identified as important is 

subjected to more complete mental 

processing, thereby increasing the 

communication of that information.8

As part of FDA’s efforts to improve 

the patient information received with 

prescription drugs, a Risk 

Communications Advisory Committee 

meeting was held on February 26 and 

27, 2009. At this meeting, committee 

members discussed issues such as the 

ones described previously in this 

document and listened to stakeholder 

problems regarding the design and 

distribution of patient information. 

Following the advisory committee 

meeting, the working group created four 

prototypes to aid discussion at a public 

workshop to be held later in the year. 

This public workshop was held on 

September 24 and 25, 2009. During the 

workshop stakeholders from industry, 

consumer advocacy, and academia 

converged to discuss desirable features 

for a single-document patient leaflet, if 

that were to be developed, consumer 

tested, and distributed. Participants 

were divided into six groups to address 

the pros and cons of the four prototypes 

with the goal of deciding which features 

participants appreciated and did not 

appreciate. For additional information 

on the September 24 and 25, 2009, 

public workshop, go to http:// 

www.fda.gov/Drugs/′NewsEvents/ 

ucm168106.htm. 

Given the information obtained from 

workshop participants, the working 


hsrobinson on DSK69SOYB1PROD with NOTICES
78254 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

9Cotunga N., C.E. Vickery, K.M. CarpenterHaefele, ‘‘Evaluation of Literacy Level of Patient 

Education Pages in Health-Related Journals,’’ 

Journal of Community Health, 30(3), 213–219, 2005. 

10Andrus, M.R., M.T. Roth, ‘‘Health Literacy: A 

Review,’’ Pharmacotherapy, 22(3), 282–302, 2002. 

group refined several prototypes and 

designed a study to investigate the 

usefulness of three possible patient 

information formats from a user 

perspective. The results of this study 

will inform FDA as to the usefulness 

and parameters of various format 

options for the patient information 

documents. 

Description of the Project 

This project is designed to test 

different ways of presenting information 

about prescription drugs to patients who 

have obtained a prescription. The 

information used will be based on a 

fictitious medication for the treatment of 

rheumatoid arthritis, ankylosing 

spondylitis, and plaque psoriasis. Data 

collection will occur via computer at 

training and testing facilities with 

orientation and debriefing conducted by 

interviewers. Participants will include 

adults who have been diagnosed with 

one of the conditions the fictitious drug 

treats. Participants will be prescreened 

to obtain a reasonable representation of 

health literacy, including those who 

score at the lower end of the scale. 

Questionnaire measures will include 

open- and closed-ended questions. 

Extensive pretesting of materials and 

stimuli will be conducted to refine the 

experimental stimuli and dependent 

measures and to ensure the stimuli meet 

minimum communication requirements 

and are delivering expected messages. 

Proposed Study Design and Protocol 

The study is experimental and will 

have two independent variables in a 3x2 

design. The independent variables are 

Format (3 levels: Drug Facts, Minimal 

Column, and Column Plus) and Order (2 

levels: Warning first and Indication 

first). 

FORMAT

Order Drug facts Minimal 

column Column plus 

Warning first.

Indication first.

The Order manipulation will vary the 

primacy of the boxed warning 

information versus the paragraph about 

the uses to the drug. In terms of Format, 

the Drug Facts format will follow the 

conventions of the existing OTC 

labeling. The Minimal Column 

condition will contain information in 

two columns with only basic 

information in the sections regarding 

information patients should tell their 

doctors. The Column Plus condition 

will also present information in two 

columns, but will include additional 

contextual information in the sections 

about what information patients should 

report to their doctors. 

Participants with relevant medical 

conditions will be randomly assigned to 

one of the six experimental conditions 

and each participant will see only one 

version of the patient information. 

Participants will be prescreened to 

represent a range of health literacy 

levels, including a portion with low 

literacy. Thus, all participants in the 

study will have been diagnosed with 

rheumatoid arthritis, ankylosing 

spondylitis, or plaque psoriasis and at 

least 30 percent of the sample will fall 

in the lower range of literacy. Because 

the average reading level in the United 

States is estimated to be 8th grade 9 and 

it is recommended that consumer 

medication information be written at a 

5th grade reading level,10 the low 

literate cohort will consist of consumers 

who have 5th to 8th grade reading skills. 

Education level is not a reliable 

substitute for literacy testing. At 

screening, the participants will be 

assessed for literacy level using a 

validated instrument. 

An additional small study will be 

conducted via the Internet to determine 

whether electronic prototype 

presentation alters the processing of the 

information in any way. Two-hundred 

individuals with the same 

characteristics of the original sample 

(e.g., medical condition and literacy 

levels) will be recruited over the 

Internet and will complete the same 

questionnaire as original participants. 

FDA is undertaking this study 

because it does not yet have sufficient 

evidence-based research relating to 

patient needs, or whether those needs 

are being effectively met. Research 

related to the functionality and 

effectiveness of written patient 

information consistently identifies the 

importance of performance-based 

testing as well as content based testing, 

which enables the evaluation of 

materials in order to assure their utility 

and identify issues in content format, or 

design. Development of new 

prescription drug patient materials must 

be based on consumer testing that 

focuses on utility to the patient and 

comprehension of material in the 

broadest audience possible. FDA has 

developed three prototypes in order to 

user test prescription drug information 

with consumers in order to achieve this 

goal. For further information, contact 

Elizabeth Berbakos (see FOR FURTHER

INFORMATION CONTACT). 

In the Federal Register of May 4, 2010 

(75 FR 23775), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

FDA received five comments. In the 

following section, we outline the 

observations and suggestions raised in 

the comments and provide our 

responses. Four of the five comments 

expressed support for the conductance 

of the research to explore issues of 

quantitative benefit information. They 

all described the collection of data as a 

worthy endeavor which will provide 

useful information on how best to 

communicate information to patients 

about their prescription drugs. 

(Comment 1) The first comment stated 

that FDA’s approach to examining the 

content and format of the prototypes is 

reasonable. This comment provided 

minor suggestions regarding how to 

improve the study, most of which are 

currently addressed in the 

questionnaire. For example, we have 

included time measurement, questions 

about the safe use of the product, and 

scenario-based questions in the 

questionnaire for the second phase of 

our study. We have incorporated other 

suggestions into the qualitative first 

phase of our project. In this phase, we 

will present participants with all 

versions of the prototypes to assess their 

preferences and will able to probe 

participants more thoroughly about 

their reactions and responses to the 

prototypes. 

(Comment 2) This comment provided 

a statement of support for the approval 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78255 

11See, for example, Day, R.S, PMI: From Concept 

to Compliance, Development and Distribution of 

Patient Medication Information for Prescription Drugs: Part 15 Public Hearing, FDA White Oak 

Campus, Silver Spring, MD, (September 27, 2010). 

of this data collection, claiming the 

study will have practical utility. 

(Comment 3) This comment provided 

support for the research proposed in 

this document and reported that the 

components identified by FDA are 

consistent with those found in their 

own research. The comment suggested 

the inclusion of a visual system for 

identifying drug products and the 

inclusion of a variety of font sizes for 

people with visual impairments. FDA 

fully supports the presentation of 

information for special populations. 

However, the scope of the present study 

is to determine one format out of several 

that works with a range of participants. 

After this step, we can move toward 

incorporating special features, such as 

pictures or large font, to accommodate 

patients with varying needs. 

(Comment 4) Part of comment 4 was 

outside the scope of the proposed data 

collection; i.e., regarding the proper 

channels for distribution of Patient 

Medication Information (PMI). 

Regarding the parts of the comment that 

focused on the proposed research, the 

comment generally discussed omissions 

in the current proposed prototypes. 

These additional pieces of information 

have all been discussed at length at 

various public and expert meetings, 

including the public workshop in 

September 2009, the Brookings Institute 

Expert Workshop in July 2010, and the 

Part 15 hearing in September 2010. 

When improving medication documents 

for patients, there is always a trade-off 

between the desire to keep it simple and 

the desire to provide more information. 

Although a small number of individuals 

reported the desire for exhaustive 

information, the great majority of the 

feedback FDA has received and the 

literature the Agency has reviewed 

suggests that the information in the 

currently proposed prototypes is a 

reasonable collection of the important 

information that patients need to safely 

use their medications. Moreover, 

research suggests that providing large 

amounts of information will not serve 

patients well, but may instead impede 

their understanding of the 

information.11 Finally, the proposed 

research itself is designed to address the 

issue of whether the information in the 

prototypes is optimal. The first phase of 

the research will involve qualitative 

interviews, wherein participants will 

have ample opportunity to tell us what 

they want and need to know. The 

second phase of the research will 

involve quantitative assessment of the 

comprehension of important 

information in the document. Thus, we 

believe our two-pronged approach will 

address some of the concerns raised in 

this comment and we must defer to the 

volumes of other feedback we have 

received regarding the limiting of 

information in PMI. 

(Comment 5) Comment 5 had five 

main concerns with the study. First, the 

comment suggested that FDA reach out 

to Consumer Medication Information 

(CMI) publishers as early as possible in 

the development of the prototypes. FDA 

concurs with the importance of doing 

this and, in fact, has already done so 

multiple times and in multiple venues. 

Several CMI publishers participated in 

the public workshop held in September 

2009 and spoke at the Part 15 hearing 

in September 2010. 

Second, the comment claims that FDA 

has not used an evidence-based strategy 

to develop the PMI prototypes. We 

disagree. FDA developed the prototypes 

based on the scientific literature. As 

described in the first section of this 

document, the prototypes were based on 

recommendations to include chunks of 

information that would reduce cognitive 

load and facilitate processing by 

including plenty of white space, 

headings, and maintaining a readable 

font size. From this first step, public 

feedback was obtained and 

incorporated, and feedback from 

communications experts was obtained 

and incorporated, resulting in the 

current prototypes. At this stage, we are 

proposing the continuation of the 

gathering of evidence by conducting the 

proposed two-part study to examine the 

PMI prototypes. 

Third, the comment expresses 

concerns that the use of a fictitious drug 

(and only one) may limit the 

generalizability of the findings of the 

study. The use of a fictitious drug 

eliminates the confound of prior 

knowledge when asking participants 

about the information they see. 

Rheutopia was selected to be a very 

close amalgam of an existing class of 

drugs. This class was chosen because it 

has a complicated set of risks, it is given 

by injection (an unusual 

administration), and it has multiple 

indications. FDA’s reasoning is that if 

successful PMI can be developed for 

such a complex drug, PMI for drugs 

with simpler profiles will be attainable. 

It is true we are investigating only one 

drug in the current study; this decision 

was based on resource constraints. One 

research study cannot accomplish all 

goals. Future studies may be used to 

assess the applicability of the results in 

other drug classes. 

Fourth, the comment expresses 

concern that the research will not 

include a variety of different 

populations and that the lack of detail 

provided in the Federal Register notice 

suggests that very little knowledge will 

be gained from the research. Regarding 

the first part, the revised research 

proposed in this document includes low 

literacy individuals with chronic 

disease, general population individuals, 

and individuals with one of the medical 

conditions that Rheutopia treats. FDA 

believes these are the populations most 

relevant to this particular type of drug, 

as well as other chronic diseases. In 

terms of the detail provided, the 

questionnaire, which provided 

extensive detail about the exact 

questions proposed, was available upon 

request during the first comment period 

and will continue to be available during 

the second comment period. 

Fifth and finally, the comment 

suggested that comparing variations of a 

short, one-page document limits the 

findings because there will be no 

comparison to a longer document, 

which may perform better. FDA 

concurs. In the revised research 

currently proposed, we have included a 

control condition. A subset of 

individuals will be randomly assigned 

to see the Medication Guide format for 

Rheutopia. Thus, we will compare two 

proposed one-page prototypes with an 

existing document that would be 

currently required for Rheutopia if it 

were a real drug. 

External Reviewers 

In addition to public comment, FDA’s 

Division of Drug Marketing, 

Advertising, and Communications 

discussed the prototypes and the 

research design and protocol with a 

panel of 19 experts convened by the 

Brookings Institution on July 21, 2010. 

The names of these individuals can be 

found in Appendix A. After the 

workshop, several experts provided 

detailed written feedback to FDA, which 

was incorporated into the design of the 

study. 

FDA estimates the burden of this 

collection of information as follows: 


hsrobinson on DSK69SOYB1PROD with NOTICES
78256 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of respondents 

Annual 

frequency 

per 

response 

Total annual responses Hours per 

response Total hours 

540 ................................................................................................... 1 540 20/60 180 

900 ................................................................................................... 1 900 25/60 375 

200 ................................................................................................... 1 200 25/60 83 

Total .......................................................................................... 638 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden chart reflects up to 3 

pretests of 180 individuals each, 900 

participants in the main study, and 200 

participants in the followup study 

involving electronic administration. 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31388 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0360] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and Drug 

Administration Public Health 

Notification Readership Survey 

(Formerly Known as the Safety Alert/ 

Public Health Advisory Readership 

Survey) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 14, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0341. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850. 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food and Drug Administration Public 

Health Notification Readership Survey 

(Formerly Known as the Safety Alert/ 

Public Health Advisory Readership 

Survey)—(OMB Control Number 0910– 

0341)—Reinstatement 

Section 705(b) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

375(b)) authorizes FDA to disseminate 

information concerning imminent 

danger to public health by any regulated 

product. The Center for Devices and 

Radiological Health (CDRH) 

communicates these risks to user 

communities through two publications: 

(1) The Public Health Notification 

(PHN) and (2) the Preliminary Public 

Health Notification (PPHN). The PHN is 

published when CDRH has information 

or a message to convey to health care 

practitioners in order for them to make 

informed clinical decisions about the 

use of a device or device type when that 

information may not be readily available 

to the affected target audience in the 

health care community. CDRH can make 

recommendations that will help the 

health care practitioner mitigate or 

avoid the risk. 

The PPHN is also published when 

CDRH has information to convey to 

health care practitioners in order for 

them to make informed clinical 

decisions about the use of a device or 

device type. However, two additional 

conditions exist that make use of this 

type of notification preferable: (1) 

CDRH’s understanding of the problem, 

its cause(s), and the scope of the risk; 

the Center believes that health care 

practitioners need the information they 

can provide, however incomplete, as 

soon as possible, and (2) the problem is 

actively being investigated by the 

Center, private industry, another 

Agency, or some other reliable entity, so 

that the Center expects to be able to 

update the PPHN when definitive new 

information becomes available. 

Notifications are sent to organizations 

affected by risks discussed in the 

notification, such as hospitals, nursing 

homes, hospices, home health care 

agencies, retail pharmacies, and other 

health care providers. Through a 

process for identifying and addressing 

postmarket safety issues related to 

regulated products, CDRH determines 

when to publish notifications. 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

FDA seeks to evaluate the clarity, 

timeliness, and impact of safety alerts 

and public health advisories by 

surveying a sample of recipients. 

Subjects will receive a questionnaire 

to be completed and returned to FDA. 

The information to be collected will 

address how clearly notifications for 

reducing risks are explained, the 

timeliness of the information, and 

whether the reader has taken any action 

to eliminate or reduce risks as a result 

of the information in the alert. Subjects 

will also be asked whether they wish to 

receive future notifications 

electronically, as well as how the PHN 

program might be improved. 

The information collected will be 

used to shape FDA’s editorial policy for 

the PHN and PPHN. Understanding how 

target audiences view these publications 

will aid in deciding what changes 

should be considered in their content 

and the format and method of 

dissemination. 

In the Federal Register of August 24, 

2009 (74 FR 42674), FDA published a 

60-day notice requesting comments. No 

comments were received. However, 

FDA is republishing this 30-day notice 

for public comment, due to the amount 

of time that has passed for submission 

of this information collection request to 

OMB. 

FDA estimates the burden of this 

collection of information as follows: 


hsrobinson on DSK69SOYB1PROD with NOTICES