18410 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 

Dated: March 31, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07818 Filed 4–3–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1219] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Survey of Health 

Care Practitioners for Device Labeling 

Format and Content 

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 May 6, 

2015. 

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 emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

title Survey of Health Care Practitioners 

for Device Labeling Format and Content. 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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. 

Survey of Health Care Practitioners for 

Device Labeling Format and Content— 

21 CFR Part 801 (OMB Control Number 

0910–NEW) 

The purpose of this study is to 

compare existing device labeling from 

approximately six different types of 

medical devices with a standard content 

and format of the same labeling that 

FDA researchers will develop using the 

existing labeling as their source of the 

information. 

Building upon the research 

methodology and success of the 

approach FDA used to evaluate drug 

labeling, we propose to measure the 

usability and usefulness of a draft 

standard content and format of device 

labeling against existing manufacturer 

labeling of the same device. This will 

support our research that has already 

been done to assess whether health care 

practitioners (HCPs) find the format and 

content of device labeling to be clear, 

understandable, useful, and user 

friendly (OMB control number 0910– 

0715). Findings will provide evidence to 

inform FDA’s planned regulatory 

approach to standardizing medical 

device labeling across the United States. 

In the Federal Register of September 

12, 2014 (79 FR 54727), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA used comments from 

the medical device industry, health care 

professionals, caregivers, and patients to 

help formulate the objectives and define 

the scope of this study. The received 

comments are followed by FDA’s 

responses as follows: 

(Comment 1) One comment stated 

that FDA should coordinate with the 

American Society for Testing and 

Materials (ASTM) as they already have 

published a consensus standard (F2943) 

on this topic. This standard resulted 

from the work of a multi-stakeholder 

working group. 

(Response) FDA reviewed the 

consensus standard (F2943) when we 

drafted the outline for this study. We 

consulted with a member of the ASTM 

committee. We also requested a member 

of the committee to be on our strategic 

planning committee for this study. 

(Comment 2) A comment stated that 

FDA does not follow the guidance on 

formative human factors and usability 

studies. The guidance provides good 

direction on appropriately choosing 

representative end users, replicating the 

intended user environment, and 

evaluating the user-product interface 

(see FDA draft guidance ‘‘Applying 

Human Factors and Usability 

Engineering to Optimize Medical Device 

Design’’ issued on June 22, 2011). 

(Response) FDA had designed the 

protocol for this study with a human 

factors expert and a social scientist. In 

this particular study, we will be doing 

a cognitive test of the health care 

practitioners. They will be asked to find 

a piece of information in the draft 

outline of standard content of labeling, 

or in the manufacturer’s existing 

labeling. They will not be interacting 

with the device and this will be a 

usability test; they will be responding to 

scenarios to search for information. 

(Comment 3) One comment stated 

that FDA should ask the question, 

particularly to physicians, whether the 

standard of care requires them to read 

the user instructions and understand the 

product’s warning. 

(Response) This study is the third part 

of a three-part study. FDA performed 

focus groups of health care practitioners 

asking them what they want in labeling, 

where do they find labeling, what are 

the most important sections of labeling, 

and whether they even look at labeling. 

Their responses indicated that they do 

not look at labeling because it is 

complicated and they typically cannot 

find the information they want in one 

section. They stated they would like an 

abbreviated version of labeling in order 

to find use information more easily, 

they would like a standard content of 

labeling, and they also would like to 

find it electronically and in one place if 

possible. 

FDA does not regulate the practice of 

medicine; we do, however, regulate 

labeling that accompanies a device. 

Based on the previous phases of the 

studies already done, we now want to 

test a standard content of labeling 

against an existing piece of the same 

labeling to see if health care 

practitioners can find what they need in 

a consistent and easy way. This is a 

cognitive testing of a standard content of 

labeling and does not include questions 

regarding whether or not someone is 

required to read the labeling before 

using the device. 

We will be using outside experts to 

develop the protocol, develop the 

scenarios, develop the draft 

standardized labeling, perform the 

testing, and provide a summary of the 

study. This is being done through the 

Entrepreneurs in Residence program 

that is funded by the White House to 

use outside experts and their special 

knowledge and skills to work on an 

innovative idea that helps the 

government when faced with a unique 

problem. Dr. Daryle Gardner-Bonneau is 

a renowned social scientist and human 

factors specialist who has worked with 

the device industry, standards 

organizations, and the National 

Research Council on issues with 

medical device labeling. Patricia 

Kingsley is a former FDA employee who 

worked on medical device labeling 

issues. Nancy Ostrove is a former FDA 

employee who worked on surveys and 

studies with drug community when the 

Center for Drug Evaluation and Research 

was developing standardized labeling 


tkelley on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18411 

for drugs. Dr. Ruth Day, a social 

scientist researcher at Duke University, 

has worked as a special government 

employee on the labeling for drugs. Ron 

Charnock is CEO of Kwikpoint, which is 

a visual language developer for 

instructions for use. His company 

worked on a Cooperative Research and 

Development Agreement with the 

Center for Devices and Radiological 

Health to determine if visual language 

could be used in lieu of words on 

certain portions of device labeling. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Type of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 1

Capital 

costs 

Screener ........................................................................... 60 1 60 0.08 5 ....................

Health care professionals participating at a hospital ....... 24 1 24 1.5 36 ....................

Health care professionals participating at FDA ............... 12 1 12 3.5 42 $240 

Total .......................................................................... .................... .................... .................... .................... 83 $240 

1 Numbers have been rounded. 

We plan to screen approximately 60 

potential respondents prior to being 

included in the study. The screener will 

be done using email. We estimate that 

the screener will only take 

approximately 5 minutes per person. 

We will conduct the studies at three 

different sites including two area 

hospitals using their devices, existing 

labeling, and HCPs. We expect that the 

maximum time for testing will be 1.5 

hours. Given a sample of 6 devices with 

2 different labeling types, there will be 

12 different labeling types to be tested. 

We plan to have 24 people test each 

type of the labeling. 

We will also conduct the studies on 

FDA’s campus using medical devices 

received from medical device industry 

representatives through a material 

transfer agreement. To account for travel 

time we have included 2 additional 

hours per response in the burden 

estimate for the 12 health care 

professionals participating at FDA. 

Dated: March 31, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07817 Filed 4–3–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA–OD– 

15–001: Building Interdisciplinary Research 

Careers in Women’s Health K12s. 

Date: April 28, 2015. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health; 6701 

Rockledge Drive; Bethesda, MD 20892; 

(Virtual Meeting). 

Contact Person: Suzanne Ryan, Ph.D.; 

Scientific Review Officer; Center for 

Scientific Review; National Institutes of 

Health; 6701 Rockledge Drive, Room 3139, 

MSC 7770; Bethesda, MD 20892; (301) 435– 

1712; ryansj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Conference 

and Meetings: Office of Research 

Infrastructure Programs (ORIP). 

Date: April 29, 2015. 

Time: 3:00 p.m. to 4:40 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health; 6701 

Rockledge Drive; Bethesda, MD 20892; 

(Telephone Conference Call). 

Contact Person: Cathleen L Cooper, Ph.D.; 

Scientific Review Officer; Center for 

Scientific Review; National Institutes of 

Health; 6701 Rockledge Drive, Room 4208, 

MSC 7812; Bethesda, MD 20892; 301–443– 

4512; cooperc@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 31, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07740 Filed 4–3–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; 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., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel Review of UH2 grant 

applications. 

Date: May 5–6, 2015. 

Time: 8:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza Washington National 

Airport, 1489 Jefferson Davis Hwy, Arlington, 

VA 20220. 

Contact Person: Savvas C Makrides, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute of Dental and 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy Boulevard, Suite 


tkelley on DSK4VPTVN1PROD with NOTICES