Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products, 76841-76842 [2013-30149]
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Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
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
[FR Doc. 2013–30147 Filed 12–18–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
Food and Drug Administration,
HHS.
Notice.
[Docket No. FDA–2008–D–0150]
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims
SUMMARY:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
September 10, 2013, the Agency
submitted a proposed collection of
information entitled ‘‘Guidance for
Industry on Hypertension Indication:
Drug Labeling for Cardiovascular
Outcome Claims’’ to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0670. The
approval expires on December 31, 2016.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
Dated: December 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30146 Filed 12–18–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
16:41 Dec 18, 2013
Jkt 232001
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 21,
2014.
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.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
FOR FURTHER INFORMATION CONTACT:
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-
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
76841
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 health care
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 about 30
studies using a variety of research
methods and lasting an average of 0.17
hours each (varying from 0.08–1.5
hours). FDA estimates the burden of this
collection of information based on prior
recent 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 July 9, 2013
(78 FR 41066), 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:
E:\FR\FM\19DEN1.SGM
19DEN1
76842
Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
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
Total (general public) ........................................
8,704
........................
Physician focus group interviews ............................
144
Total (physician) ...............................................
Total (overall) ....................................................
1 There
[FR Doc. 2013–30149 Filed 12–18–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Food and Drug Administration/
American Academy of Ophthalmology
Workshop on Developing Novel
Endpoints for Premium Intraocular
Lenses; Public Workshop
Food and Drug Administration,
HHS.
emcdonald on DSK67QTVN1PROD with NOTICES
ACTION:
0.75
1.50
0.25
0.08
0.25
0.50
0.17
Total hours
(45 minutes) ......
hours .................
(15 minutes) ......
(5 minutes) ........
(15 minutes) ......
(30 minutes) ......
(10 minutes) ......
270
216
50
320
600
200
204
........................
....................................
1,860
1
144
1.50 hours .................
216
144
........................
........................
....................................
216
8,848
........................
........................
....................................
2,076
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Average burden per
response
Notice.
The Food and Drug Administration
(FDA) is announcing the following
public workshop entitled ‘‘FDA/
American Academy of Ophthalmology
(AAO) Workshop on Developing Novel
Endpoints for Premium Intraocular
Lenses.’’ The main topic of this
workshop is the current challenges in
the assessment of innovative intraocular
lens (IOL) designs with a focus on
endpoint methodologies used in
evaluating IOL safety and effectiveness.
Experts in subjects ranging from patient
reported outcomes to objective measures
of accommodation will give talks on the
latest developments in the field.
Participants will then engage in indepth discussions of the pros and cons
of various methods used to assess
premium IOLs, and work to devise a
plan to further promote innovation in
this device area. The primary goal of the
workshop is to improve the regulatory
science for evaluating premium IOLs,
VerDate Mar<15>2010
16:41 Dec 18, 2013
Jkt 232001
which in turn may enhance the
efficiency with which safe and effective
premium IOLs get to the market. This
public workshop is being rescheduled
due to the government shutdown.
Date and Time: The public workshop
will be held on March 28, 2014, from
8:30 a.m. to 5:30 p.m. Materials may be
picked up starting at 7:30 a.m.
Location: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Contact: Michelle Tarver, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–5620, FAX: 301–847–
8126, email: michelle.tarver@
fda.hhs.gov.
Registration: AAO will charge a
registration fee to cover its share of the
expenses associated with the workshop.
The registration fee is $250 for Academy
members and $400 for non-members.
Registration is available on a first-come,
first-served basis. Persons interested in
attending this public workshop must
register online. The deadline for online
registration is March 27, 2014, at 5 p.m.
EDT. There will be no onsite registration
on the day of the public workshop.
Early registration is recommended
because facilities are limited and,
therefore, FDA may limit the number of
participants from each organization. To
register for the public workshop, please
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
visit the AAO Web site (https://
www.aao.org/meetings/iol_
workshop.cfm). Those interested in
attending but unable to access the
electronic registration site should fax
the PDF form on the AAO Web site
(https://www.aao.org/meetings/upload/
FDA_iol_workshop_reg.pdf) to 415–
561–8575. Those without Internet
access should contact AAO Customer
Service to register at 415–561–8540 or
866–561–8558 (toll free). Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone number. If there are any
questions with registration, please
contact the AAO administrative offices
at 415–561–8540. Registrants will
receive confirmation after they have
been accepted. You will be notified if
you are on a waiting list.
This public workshop is being
rescheduled due to the government
shutdown. It was originally scheduled
for October 11, 2013. Those who
registered for the original workshop date
were contacted by AAO individually
and offered either a complete refund or
the option to have those monies applied
to the rescheduled date registration.
Any questions about this process should
be addressed to AAO Customer Service
at 415–561–8540 or 866–561–8558 (toll
free).
Food and beverages will be available
for purchase by participants during the
workshop breaks.
If you need special accommodations
due to a disability, please contact Ms.
Susan Monahan at susan.monahan@
fda.hhs.gov or 301–796–5661 no later
than March 14, 2014.
For more information on the
workshop, please see FDA’s Medical
Devices News & Events—Workshops &
Conferences calendar at https://
E:\FR\FM\19DEN1.SGM
19DEN1
]]>Agencies
[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Pages 76841-76842]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30149]
-----------------------------------------------------------------------
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 January
21, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
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 health
care 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 about 30 studies using a variety of research
methods and lasting an average of 0.17 hours each (varying from 0.08-
1.5 hours). FDA estimates the burden of this collection of information
based on prior recent 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 July 9, 2013 (78 FR 41066), 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:
[[Page 76842]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individual indepth interviews............... 360 1 360 0.75 (45 minutes)......................... 270
General public focus group interviews....... 144 1 144 1.50 hours................................ 216
Intercept interviews: Central location...... 200 1 200 0.25 (15 minutes)......................... 50
Intercept interviews: Telephone............. 4,000 1 4,000 0.08 (5 minutes).......................... 320
Self-Administered surveys................... 2,400 1 2,400 0.25 (15 minutes)......................... 600
Gatekeeper reviews.......................... 400 1 400 0.50 (30 minutes)......................... 200
Omnibus surveys............................. 1,200 1 1,200 0.17 (10 minutes)......................... 204
-----------------------------------------------------------------------------------------------------------
Total (general public).................. 8,704 .............. .............. .......................................... 1,860
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physician focus group interviews............ 144 1 144 1.50 hours................................ 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.
Dated: December 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30149 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P
