80 FR 18410 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 65 (April 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 65 (April 6, 2015)
| Page Range | 18410-18411 | |
| FR Document | 2015-07817 |
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)] [Notices] [Pages 18410-18411] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07817] ----------------------------------------------------------------------- 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 [[Page 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 ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Average Total hours Capital Type of respondent respondents per annual burden per \1\ costs respondent responses response ---------------------------------------------------------------------------------------------------------------- Screener.......................... 60 1 60 0.08 5 ........... Health care professionals 24 1 24 1.5 36 ........... participating at a hospital...... Health care professionals 12 1 12 3.5 42 $240 participating at FDA............. ----------------------------------------------------------------------------- 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
![18410 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices
Dated: March 31, 2015. and format of the same labeling that labeling. They will not be interacting
Leslie Kux, FDA researchers will develop using the with the device and this will be a
Associate Commissioner for Policy. existing labeling as their source of the usability test; they will be responding to
[FR Doc. 2015–07818 Filed 4–3–15; 8:45 am] information. scenarios to search for information.
BILLING CODE 4164–01–P
Building upon the research (Comment 3) One comment stated
methodology and success of the that FDA should ask the question,
approach FDA used to evaluate drug particularly to physicians, whether the
DEPARTMENT OF HEALTH AND labeling, we propose to measure the standard of care requires them to read
HUMAN SERVICES usability and usefulness of a draft the user instructions and understand the
standard content and format of device product’s warning.
Food and Drug Administration labeling against existing manufacturer (Response) This study is the third part
labeling of the same device. This will of a three-part study. FDA performed
[Docket No. FDA–2014–N–1219] focus groups of health care practitioners
support our research that has already
Agency Information Collection been done to assess whether health care asking them what they want in labeling,
practitioners (HCPs) find the format and where do they find labeling, what are
Activities; Submission for Office of
content of device labeling to be clear, the most important sections of labeling,
Management and Budget Review;
understandable, useful, and user and whether they even look at labeling.
Comment Request; Survey of Health
friendly (OMB control number 0910– Their responses indicated that they do
Care Practitioners for Device Labeling
0715). Findings will provide evidence to not look at labeling because it is
Format and Content
inform FDA’s planned regulatory complicated and they typically cannot
AGENCY: Food and Drug Administration, approach to standardizing medical find the information they want in one
HHS. device labeling across the United States. section. They stated they would like an
ACTION: Notice. In the Federal Register of September abbreviated version of labeling in order
12, 2014 (79 FR 54727), FDA published to find use information more easily,
SUMMARY: The Food and Drug a 60-day notice requesting public they would like a standard content of
Administration (FDA) is announcing comment on the proposed collection of labeling, and they also would like to
that a proposed collection of information. FDA used comments from find it electronically and in one place if
information has been submitted to the the medical device industry, health care possible.
Office of Management and Budget professionals, caregivers, and patients to FDA does not regulate the practice of
(OMB) for review and clearance under help formulate the objectives and define medicine; we do, however, regulate
the Paperwork Reduction Act of 1995. the scope of this study. The received labeling that accompanies a device.
DATES: Fax written comments on the comments are followed by FDA’s Based on the previous phases of the
collection of information by May 6, responses as follows: studies already done, we now want to
2015. (Comment 1) One comment stated test a standard content of labeling
that FDA should coordinate with the against an existing piece of the same
ADDRESSES: To ensure that comments on
American Society for Testing and labeling to see if health care
the information collection are received,
Materials (ASTM) as they already have practitioners can find what they need in
OMB recommends that written
published a consensus standard (F2943) a consistent and easy way. This is a
comments be faxed to the Office of
on this topic. This standard resulted cognitive testing of a standard content of
Information and Regulatory Affairs,
from the work of a multi-stakeholder labeling and does not include questions
OMB, Attn: FDA Desk Officer, FAX:
working group. regarding whether or not someone is
202–395–7285, or emailed to oira_ (Response) FDA reviewed the required to read the labeling before
submission@omb.eop.gov. All consensus standard (F2943) when we using the device.
comments should be identified with the drafted the outline for this study. We We will be using outside experts to
title Survey of Health Care Practitioners consulted with a member of the ASTM develop the protocol, develop the
for Device Labeling Format and Content. committee. We also requested a member scenarios, develop the draft
Also include the FDA docket number of the committee to be on our strategic standardized labeling, perform the
found in brackets in the heading of this planning committee for this study. testing, and provide a summary of the
document. (Comment 2) A comment stated that study. This is being done through the
FOR FURTHER INFORMATION CONTACT: FDA FDA does not follow the guidance on Entrepreneurs in Residence program
PRA Staff, Office of Operations, Food formative human factors and usability that is funded by the White House to
and Drug Administration, 8455 studies. The guidance provides good use outside experts and their special
Colesville Rd., COLE–14526, Silver direction on appropriately choosing knowledge and skills to work on an
Spring, MD 20993–0002, PRAStaff@ representative end users, replicating the innovative idea that helps the
fda.hhs.gov. intended user environment, and government when faced with a unique
SUPPLEMENTARY INFORMATION: In evaluating the user-product interface problem. Dr. Daryle Gardner-Bonneau is
compliance with 44 U.S.C. 3507, FDA (see FDA draft guidance ‘‘Applying a renowned social scientist and human
has submitted the following proposed Human Factors and Usability factors specialist who has worked with
collection of information to OMB for Engineering to Optimize Medical Device the device industry, standards
review and clearance. Design’’ issued on June 22, 2011). organizations, and the National
(Response) FDA had designed the Research Council on issues with
Survey of Health Care Practitioners for protocol for this study with a human medical device labeling. Patricia
Device Labeling Format and Content—
tkelley on DSK4VPTVN1PROD with NOTICES
factors expert and a social scientist. In Kingsley is a former FDA employee who
21 CFR Part 801 (OMB Control Number this particular study, we will be doing worked on medical device labeling
0910–NEW) a cognitive test of the health care issues. Nancy Ostrove is a former FDA
The purpose of this study is to practitioners. They will be asked to find employee who worked on surveys and
compare existing device labeling from a piece of information in the draft studies with drug community when the
approximately six different types of outline of standard content of labeling, Center for Drug Evaluation and Research
medical devices with a standard content or in the manufacturer’s existing was developing standardized labeling
VerDate Sep<11>2014 18:14 Apr 03, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\06APN1.SGM 06APN1](https://thefederalregister.org/doc/80_FR_18475/page/1.svg)
![Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18411
for drugs. Dr. Ruth Day, a social a visual language developer for Health to determine if visual language
scientist researcher at Duke University, instructions for use. His company could be used in lieu of words on
has worked as a special government worked on a Cooperative Research and certain portions of device labeling.
employee on the labeling for drugs. Ron Development Agreement with the FDA estimates the burden of this
Charnock is CEO of Kwikpoint, which is Center for Devices and Radiological collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of Average
Number of responses Total annual Total Capital
Type of respondent burden per
respondents per responses hours 1 costs
response
respondent
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 the discussions could disclose Dated: March 31, 2015.
potential respondents prior to being confidential trade secrets or commercial Michelle Trout,
included in the study. The screener will property such as patentable material, Program Analyst, Office of Federal Advisory
be done using email. We estimate that and personal information concerning Committee Policy.
the screener will only take individuals associated with the grant [FR Doc. 2015–07740 Filed 4–3–15; 8:45 am]
approximately 5 minutes per person. applications, the disclosure of which BILLING CODE 4140–01–P
We will conduct the studies at three would constitute a clearly unwarranted
different sites including two area invasion of personal privacy.
hospitals using their devices, existing DEPARTMENT OF HEALTH AND
labeling, and HCPs. We expect that the Name of Committee: Center for Scientific HUMAN SERVICES
maximum time for testing will be 1.5 Review Special Emphasis Panel; RFA–OD–
hours. Given a sample of 6 devices with 15–001: Building Interdisciplinary Research National Institutes of Health
2 different labeling types, there will be Careers in Women’s Health K12s.
12 different labeling types to be tested. Date: April 28, 2015. National Institute of Dental &
Time: 11:00 a.m. to 5:00 p.m. Craniofacial Research; Notice of
We plan to have 24 people test each
Agenda: To review and evaluate grant Closed Meetings
type of the labeling.
applications.
We will also conduct the studies on
FDA’s campus using medical devices Place: National Institutes of Health; 6701 Pursuant to section 10(d) of the
received from medical device industry
Rockledge Drive; Bethesda, MD 20892; Federal Advisory Committee Act, as
representatives through a material
(Virtual Meeting). amended (5 U.S.C. App.), notice is
Contact Person: Suzanne Ryan, Ph.D.; hereby given of the following meetings.
transfer agreement. To account for travel
Scientific Review Officer; Center for The meetings will be closed to the
time we have included 2 additional
Scientific Review; National Institutes of
hours per response in the burden public in accordance with the
Health; 6701 Rockledge Drive, Room 3139,
estimate for the 12 health care provisions set forth in sections
MSC 7770; Bethesda, MD 20892; (301) 435–
professionals participating at FDA. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
1712; ryansj@csr.nih.gov.
Dated: March 31, 2015.
as amended. The grant applications and
Name of Committee: Center for Scientific the discussions could disclose
Leslie Kux, Review Special Emphasis Panel; Conference confidential trade secrets or commercial
Associate Commissioner for Policy. and Meetings: Office of Research property such as patentable material,
[FR Doc. 2015–07817 Filed 4–3–15; 8:45 am] Infrastructure Programs (ORIP). and personal information concerning
BILLING CODE 4164–01–P Date: April 29, 2015. individuals associated with the grant
Time: 3:00 p.m. to 4:40 p.m. applications, the disclosure of which
Agenda: To review and evaluate grant
would constitute a clearly unwarranted
DEPARTMENT OF HEALTH AND applications.
invasion of personal privacy.
HUMAN SERVICES Place: National Institutes of Health; 6701
Rockledge Drive; Bethesda, MD 20892; Name of Committee: National Institute of
National Institutes of Health (Telephone Conference Call). Dental and Craniofacial Research Special
Contact Person: Cathleen L Cooper, Ph.D.; Emphasis Panel Review of UH2 grant
Center for Scientific Review; Notice of applications.
Scientific Review Officer; Center for
Closed Meetings Date: May 5–6, 2015.
Scientific Review; National Institutes of Time: 8:00 a.m. to 2:00 p.m.
Pursuant to section 10(d) of the Health; 6701 Rockledge Drive, Room 4208, Agenda: To review and evaluate grant
MSC 7812; Bethesda, MD 20892; 301–443– applications.
Federal Advisory Committee Act, as
4512; cooperc@csr.nih.gov. Place: Crowne Plaza Washington National
tkelley on DSK4VPTVN1PROD with NOTICES
amended (5 U.S.C. App.), notice is
(Catalogue of Federal Domestic Assistance Airport, 1489 Jefferson Davis Hwy, Arlington,
hereby given of the following meetings.
Program Nos. 93.306, Comparative Medicine; VA 20220.
The meetings will be closed to the Contact Person: Savvas C Makrides, Ph.D.,
public in accordance with the 93.333, Clinical Research, 93.306, 93.333,
Scientific Review Officer, Scientific Review
provisions set forth in sections 93.337, 93.393–93.396, 93.837–93.844,
Branch, National Institute of Dental and
552b(c)(4) and 552b(c)(6), title 5 U.S.C., 93.846–93.878, 93.892, 93.893, National
Craniofacial Research, National Institutes of
as amended. The grant applications and Institutes of Health, HHS) Health, 6701 Democracy Boulevard, Suite
VerDate Sep<11>2014 18:14 Apr 03, 2015 Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\06APN1.SGM 06APN1](https://thefederalregister.org/doc/80_FR_18475/page/2.svg)
Document Created: 2015-12-18 11:17:58
Document Modified: 2015-12-18 11:17:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 6, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 18410 |
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