Submission for OMB Review; 30-Day Comment Request: A Generic Submission for Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI), 14558-14559 [2013-05164]
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14558
Federal Register / Vol. 78, No. 44 / Wednesday, March 6, 2013 / Notices
pmangrum on DSK3VPTVN1PROD with NOTICES
Ethan D. Cohen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 62, rm. 1204,
Silver Spring, MD 20993–0002, 301–
796–2485;
For clinical concerns:
Bernard P. Lepri, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 2404,
Silver Spring, MD 20993–0002, 301–
796–6501.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance addresses the
investigation of medical devices
intended to manage permanent vision
impairment resulting from ocular
pathology such as retinitis pigmentosa.
Vision impairment, or low vision, is
vision that is not correctable to normal
levels by spectacles, contact lenses,
medications, surgery, or other
techniques and devices. It is irreversible
loss of vision due to disease, not
refractive errors (myopia, astigmatism,
presbyopia). This guidance is intended
to assist device manufacturers who plan
to conduct clinical investigations of
devices indicated for the treatment of
vision impairment in support of
premarket approval (PMA) applications,
humanitarian device exemptions, or
premarket notification (510(k))
submissions. The guidance describes
FDA’s recommendations for human
clinical trials that involve the use of any
type of retinal prosthesis device,
including, but not limited to, visual
prosthetic devices implanted on or
beneath the retina, and those on or
beneath the outer surface of the globe
that use electrical stimulation to provide
some level of visual perception for
persons suffering from degenerative
retinal conditions. This document does
not apply to prostheses that stimulate
the optic nerve or other higher brain
areas such as the visual cortex or the
lateral geniculate nucleus.
In the Federal Register of April 17,
2009 (74 FR 17872), FDA announced the
availability of the draft guidance.
Comments on the draft guidance were
due by July 16, 2009. Six comments
were received with each comment
making multiple recommendations on
changes to the content of the guidance
document. The comments included
recommended changes to primary,
secondary, and functional vision
endpoints and changes to the
recommended clinical study design. In
response to these comments, FDA has
clarified the appropriate context for
recommended endpoints and a
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sponsor’s options with respect to use of
a given endpoint. FDA also revised and
clarified the recommendation regarding
use of sham controls.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on IDE applications for
retinal prostheses. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Investigational Device
Exemption (IDE) Guidance for Retinal
Prostheses,’’ you may either send an
email request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1809 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 812 have been approved
under OMB control number 0910–0078;
collections of information in part 814
(21 CFR part 814), subpart H, have been
approved under OMB control number
0910–0332; collections of information in
21 CFR 56.115 have been approved
under OMB control number 0910–0130;
and collections of information in part
814, subpart E, have been approved
under OMB control number 0910–0231.
V. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES), or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
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Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: February 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05125 Filed 3–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: A Generic
Submission for Formative Research,
Pretesting, and Customer Satisfaction
of NCI’s Communication and
Education Resources (NCI)
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on January 2, 2013
(Volume 78, Page 105) and allowed 60days for public comment. Two public
comments were received and responded
to. The purpose of this notice is to allow
an additional 30 days for public
comment. The National Cancer Institute
(NCI), the National Institutes of Health
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
E:\FR\FM\06MRN1.SGM
06MRN1
14559
Federal Register / Vol. 78, No. 44 / Wednesday, March 6, 2013 / Notices
plans and instruments, contact: Nina
Goodman, Public Health Advisor, Office
of Communications and Education
(OCE), NCI, NIH, 6116 Executive Blvd.,
Suite 400, Rockville, MD 20892, call
non-toll-free number (301) 435–7789 or
email your request, including your
address to: goodmann@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: A Generic
Submission For Formative Research,
Pretesting, and Customer Satisfaction of
NCI’s Communication and Education
Resources, 0925–0046, Expiration Date
2/28/2013, Reinstatement without
Change, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: In order to carry out NCI’s
legislative mandate to educate and
disseminate information about cancer
prevention, detection, diagnosis, and
treatment to a wide variety of audiences
and organizations, it is beneficial for
NCI through its Office of
Communications and Education (OCE),
to pretest NCI communications
strategies, concepts, and messages while
they are under development. This
pretesting, or formative evaluation,
helps ensure that the messages,
communication materials, and
information services created by NCI
have the greatest capacity of being
received, understood, and accepted by
their target audiences. Since NCI’s OCE
is also responsible for the design,
implementation, and evaluation of
education programs over the entire
cancer continuum, and management of
NCI initiatives that address specific
challenges in cancer research and
treatment, it is also necessary to ensure
that customers are satisfied with
programs. This customer satisfaction
research helps ensure the relevance,
utility, and appropriateness of the many
educational programs and products that
OCE and NCI produce. OCE will use a
variety of qualitative (focus groups,
interviews) and quantitative (paper,
phone, in-person, and web surveys)
methodologies to conduct this formative
and customer satisfaction research,
allowing NCI to: (1) Understand
characteristics (attitudes, beliefs, and
behaviors) of the intended target
audience and use this information in the
development of effective
communication tools and strategies; (2)
use a feedback loop to help refine,
revise, and enhance messages, materials,
products, and programs—ensuring that
they have the greatest relevance, utility,
appropriateness, and impact for/to
target audiences; and (3) expend limited
program resource dollars wisely and
effectively. The participants may
include, but are not limited to, cancer
patients, their families, the general
public, health providers, the media,
voluntary groups, scientific and medical
organizations (affected public could
include individuals or households;
businesses or other for profit; not-forprofit institutions; and Federal
Government; State, Local, or Tribal
Government).
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated burden, over three years for
this generic request are 6,600 hours.
3-YEAR ESTIMATED BURDEN HOURS (GENERIC REQUEST)
Category of respondents
Form name
Number of
respondents
Frequency of
response per
respondent
Time per
response
(in hours)
Burden hours
Individuals,
Households,
Local,
State, and Federal Governments,
and Private Sector.
Focus Groups, Individual In-Depth
Interviews, Brief Interviews, Surveys, Website Usability Testing.
33,000
1
12/60
6,600
Dated: February 27, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2013–05164 Filed 3–5–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
pmangrum on DSK3VPTVN1PROD with NOTICES
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
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 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,
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15:01 Mar 05, 2013
Jkt 229001
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Multigenic Disease
Models.
Date: March 20, 2013.
Time: 9:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Cathy J. Wedeen, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, OD, Eunice Kennedy
Shriver National Institute of Child Health
and Human Development, NIH, 6100
Executive Blvd., Room 5B01–G, Bethesda,
MD 20892, 301–435–6878,
wedeenc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
PO 00000
Frm 00052
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Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: February 28, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–05109 Filed 3–5–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
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 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
E:\FR\FM\06MRN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Pages 14558-14559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05164]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: A Generic
Submission for Formative Research, Pretesting, and Customer
Satisfaction of NCI's Communication and Education Resources (NCI)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on January 2, 2013 (Volume 78, Page 105) and allowed 60-days
for public comment. Two public comments were received and responded to.
The purpose of this notice is to allow an additional 30 days for public
comment. The National Cancer Institute (NCI), the National Institutes
of Health may not conduct or sponsor, and the respondent is not
required to respond to, an information collection that has been
extended, revised, or implemented on or after October 1, 1995, unless
it displays a currently valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection
[[Page 14559]]
plans and instruments, contact: Nina Goodman, Public Health Advisor,
Office of Communications and Education (OCE), NCI, NIH, 6116 Executive
Blvd., Suite 400, Rockville, MD 20892, call non-toll-free number (301)
435-7789 or email your request, including your address to:
goodmann@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: A Generic Submission For Formative Research,
Pretesting, and Customer Satisfaction of NCI's Communication and
Education Resources, 0925-0046, Expiration Date 2/28/2013,
Reinstatement without Change, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: In order to carry out NCI's
legislative mandate to educate and disseminate information about cancer
prevention, detection, diagnosis, and treatment to a wide variety of
audiences and organizations, it is beneficial for NCI through its
Office of Communications and Education (OCE), to pretest NCI
communications strategies, concepts, and messages while they are under
development. This pretesting, or formative evaluation, helps ensure
that the messages, communication materials, and information services
created by NCI have the greatest capacity of being received,
understood, and accepted by their target audiences. Since NCI's OCE is
also responsible for the design, implementation, and evaluation of
education programs over the entire cancer continuum, and management of
NCI initiatives that address specific challenges in cancer research and
treatment, it is also necessary to ensure that customers are satisfied
with programs. This customer satisfaction research helps ensure the
relevance, utility, and appropriateness of the many educational
programs and products that OCE and NCI produce. OCE will use a variety
of qualitative (focus groups, interviews) and quantitative (paper,
phone, in-person, and web surveys) methodologies to conduct this
formative and customer satisfaction research, allowing NCI to: (1)
Understand characteristics (attitudes, beliefs, and behaviors) of the
intended target audience and use this information in the development of
effective communication tools and strategies; (2) use a feedback loop
to help refine, revise, and enhance messages, materials, products, and
programs--ensuring that they have the greatest relevance, utility,
appropriateness, and impact for/to target audiences; and (3) expend
limited program resource dollars wisely and effectively. The
participants may include, but are not limited to, cancer patients,
their families, the general public, health providers, the media,
voluntary groups, scientific and medical organizations (affected public
could include individuals or households; businesses or other for
profit; not-for-profit institutions; and Federal Government; State,
Local, or Tribal Government).
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated burden, over
three years for this generic request are 6,600 hours.
3-Year Estimated Burden Hours (Generic Request)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Frequency of Time per
Category of respondents Form name Number of response per response (in Burden hours
respondents respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individuals, Households, Local, State, and Focus Groups, Individual In-Depth 33,000 1 12/60 6,600
Federal Governments, and Private Sector. Interviews, Brief Interviews,
Surveys, Website Usability
Testing.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: February 27, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
[FR Doc. 2013-05164 Filed 3-5-13; 8:45 am]
BILLING CODE 4140-01-P
