Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products, 7566-7567 [2020-02531]
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7566
Federal Register / Vol. 85, No. 27 / Monday, February 10, 2020 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0796]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Testing
Communications on Medical Devices
and Radiation-Emitting Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 March 11,
2020.
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
OMB control number 0910–0678. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
Testing Communications on Medical
Devices and Radiation-Emitting
Products
OMB Control Number 0910–0678—
Extension
FDA is authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)) to conduct educational
and public information programs
relating to the safety of regulated
medical devices and radiation-emitting
products. FDA must conduct needed
research to ensure that such programs
have the highest likelihood of being
effective. Improving communications
about medical devices and radiation
emitting products will involve many
research methods, including individual
indepth interviews, mall-intercept
interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about medical device and
radiation-emitting product use.
Knowledge of consumer and healthcare
professional decision-making processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using medical devices and
radiation-emitting products by
providing users with a better context in
which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
Annually, FDA projects conducting
about 30 studies using a variety of
research methods and lasting an average
of 0.17 hours each (varying from 0.08 to
1.5 hours). FDA estimates the burden of
this collection of information based on
prior experience with the various types
of data collection methods described
earlier. FDA is requesting this burden so
as not to restrict the Agency’s ability to
gather information on public sentiment
for its proposals in its regulatory and
communications programs.
In the Federal Register of November
15, 2019 (84 FR 62541), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
jbell on DSKJLSW7X2PROD with NOTICES
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Individual Indepth Interviews ................................
General Public Focus Group Interviews ..............
Intercept Interviews: Central Location .................
Intercept Interviews: Telephone ...........................
Self-Administered Surveys ...................................
Gatekeeper Reviews ............................................
Omnibus Surveys .................................................
360
144
200
4,000
2,400
400
1,200
1
1
1
1
1
1
1
360
144
200
4,000
2,400
400
1,200
0.75 (45 minutes) ..........
1.5 .................................
0.25 (15 minutes) ..........
0.08 (5 minutes) ............
0.25 (15 minutes) ..........
0.5 (30 minutes) ............
0.17 (10 minutes) ..........
270
216
50
320
600
200
204
Total (General Public) ...................................
Physician Focus Group Interviews ......................
8,704
144
........................
1
8,702
144
.......................................
1.5 .................................
1,860
216
Total (Physician) ...........................................
144
........................
........................
.......................................
216
Total (Overall) ...............................................
8,848
........................
........................
.......................................
2,076
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 85, No. 27 / Monday, February 10, 2020 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Center for Scientific Review; Notice of
Closed Meetings
[FR Doc. 2020–02531 Filed 2–7–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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.
jbell on DSKJLSW7X2PROD with NOTICES
Name of Committee: National Institute on
Aging Special Emphasis Panel; Aging and
Dementia Assessment via Driving Skills.
Date: February 24, 2020.
Time: 10:30 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Maurizio Grimaldi, MD,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, 7201 Wisconsin
Avenue, Gateway Building, Suite 2W200,
Bethesda, MD 20892, (301) 496–9374,
grimaldim2@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: February 4, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–02518 Filed 2–7–20; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
16:58 Feb 07, 2020
Jkt 250001
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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; Eukaryotic
Parasites and Vectors.
Date: March 9–10, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Fouad A. El-Zaatari, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3186,
MSC 7808, Bethesda, MD 20892, (301) 435–
1149, elzaataf@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Disease Prevention and
Management, Risk Reduction and Health
Behavior Change.
Date: March 9–10, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Menger Hotel, 204 Alamo Plaza, San
Antonio, TX 78205.
Contact Person: Michael J. McQuestion,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
Bethesda, MD 20892, (301) 480–1276,
mike.mcquestion@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Health
Services Organization and Delivery.
Date: March 9, 2020.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Lauren Fordyce, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
7567
Bethesda, MD 20892, (301) 827–8269,
fordycelm@mail.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: February 4, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–02517 Filed 2–7–20; 8:45 am]
BILLING CODE 4140–01–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, 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;
Fellowships: Genes, Genomes and Genetics.
Date: March 4, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Handlery Union Square Hotel, 351
Geary Street, San Francisco, CA 94102.
Contact Person: Alexander Gubin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4196,
MSC 7812, Bethesda, MD 20892, (301) 435–
2902, gubina@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Biochemistry and Biophysics of Biological
Macromolecules Fellowship Applications.
Date: March 5–6, 2020.
Time: 11:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: David R. Jollie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4166,
MSC 7806, Bethesda, MD 20892, (301) 408–
9072, jollieda@csr.nih.gov.
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 85, Number 27 (Monday, February 10, 2020)]
[Notices]
[Pages 7566-7567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02531]
[[Page 7566]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0796]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Testing
Communications on Medical Devices and Radiation-Emitting Products
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 March
11, 2020.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0678.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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.
Testing Communications on Medical Devices and Radiation-Emitting
Products
OMB Control Number 0910-0678--Extension
FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational
and public information programs relating to the safety of regulated
medical devices and radiation-emitting products. FDA must conduct
needed research to ensure that such programs have the highest
likelihood of being effective. Improving communications about medical
devices and radiation emitting products will involve many research
methods, including individual indepth interviews, mall-intercept
interviews, focus groups, self-administered surveys, gatekeeper
reviews, and omnibus telephone surveys.
The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about medical device
and radiation-emitting product use. Knowledge of consumer and
healthcare professional decision-making processes will provide the
better understanding of target audiences that FDA needs to design
effective communication strategies, messages, and labels. These
communications will aim to improve public understanding of the risks
and benefits of using medical devices and radiation-emitting products
by providing users with a better context in which to place risk
information more completely.
Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the developmental stage. Respondents will be
asked to give their reaction to the messages in either individual or
group settings.
Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
Annually, FDA projects conducting about 30 studies using a variety
of research methods and lasting an average of 0.17 hours each (varying
from 0.08 to 1.5 hours). FDA estimates the burden of this collection of
information based on prior experience with the various types of data
collection methods described earlier. FDA is requesting this burden so
as not to restrict the Agency's ability to gather information on public
sentiment for its proposals in its regulatory and communications
programs.
In the Federal Register of November 15, 2019 (84 FR 62541), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Individual Indepth Interviews. 360 1 360 0.75 (45 270
minutes).
General Public Focus Group 144 1 144 1.5............. 216
Interviews.
Intercept Interviews: Central 200 1 200 0.25 (15 50
Location. minutes).
Intercept Interviews: 4,000 1 4,000 0.08 (5 minutes) 320
Telephone.
Self-Administered Surveys..... 2,400 1 2,400 0.25 (15 600
minutes).
Gatekeeper Reviews............ 400 1 400 0.5 (30 minutes) 200
Omnibus Surveys............... 1,200 1 1,200 0.17 (10 204
minutes).
---------------------------------------------------------------------------------
Total (General Public).... 8,704 .............. 8,702 ................ 1,860
Physician Focus Group 144 1 144 1.5............. 216
Interviews.
---------------------------------------------------------------------------------
Total (Physician)......... 144 .............. .............. ................ 216
---------------------------------------------------------------------------------
Total (Overall)........... 8,848 .............. .............. ................ 2,076
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 7567]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: February 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02531 Filed 2-7-20; 8:45 am]
BILLING CODE 4164-01-P
