Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products, 41066-41068 [2013-16401]
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41066
Federal Register / Vol. 78, No. 131 / Tuesday, July 9, 2013 / Notices
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Devices; Third-Party Review
Under FDAMA—21 U.S.C. 360m (OMB
Control Number 0910–0375)—Extension
Section 210 of the Food and Drug
Administration Modernization Act
(FDAMA) established section 523 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360m),
directing FDA to accredit persons in the
private sector to review certain
premarket notifications (510(k)s).
Participation in this third-party review
program by accredited persons is
entirely voluntary. A third party
wishing to participate will submit a
request for accreditation to FDA.
Accredited third-party reviewers have
the ability to review a manufacturer’s
510(k) submission for selected devices.
After reviewing a submission, the
reviewer will forward a copy of the
510(k) submission, along with the
reviewer’s documented review and
recommendation to FDA. Third-party
reviewers should maintain records of
their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually a period of 3 years.
This information collection will allow
FDA to continue to implement the
accredited person review program
established by FDAMA and improve the
efficiency of 510(k) review for low- to
moderate-risk devices.
Respondents to this information
collection are businesses or other forprofit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Activity
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Requests for accreditation ...................................................
510(k) reviews conducted by accredited third parties .........
1
10
1
26
1
260
24
40
24
10,400
Total ..............................................................................
........................
........................
........................
........................
10,424
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual records
Average
burden per
recordkeeping
Total hours
510(k) reviews ......................................................................
10
26
260
10
2,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Reporting
510(k) Reviews Conducted by
Accredited Third Parties
According to FDA’s data, the number
of 510(k)s submitted for third-party
review is approximately 260 annually,
which is 26 annual reviews per each of
the 10 accredited reviewers.
the Agency anticipates approximately
260 submissions of 510(k)s for thirdparty review per year.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[Docket No. FDA–2013–N–0796]
[FR Doc. 2013–16402 Filed 7–8–13; 8:45 am]
BILLING CODE 4160–01–P
II. Recordkeeping
Third-party reviewers are required to
keep records of their review of each
submission. According to FDA’s data,
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Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications on Medical Devices
and Radiation-Emitting Products
AGENCY:
Food and Drug Administration,
HHS.
Frm 00042
Fmt 4703
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09JYN1
Federal Register / Vol. 78, No. 131 / Tuesday, July 9, 2013 / Notices
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
communication studies involving
medical devices and radiation-emitting
products regulated by FDA. This
information will be used to explore
concepts of interest and assist in the
development and modification of
communication messages and
campaigns to fulfill the Agency’s
mission to protect the public health.
DATES: Submit either electronic or
written comments on the collection of
information by September 9, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
SUMMARY:
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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 radiationemitting products will involve many
research methods, including individual
indepth interviews, mall-intercept
interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys.
41067
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.
FDA estimates the burden of this
collection of information as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Individual indepth interviews ................................
General public focus group interviews .................
Intercept interviews: Central location ...................
Intercept interviews: Telephone ...........................
Self-administered surveys ....................................
Gatekeeper reviews .............................................
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Number of
responses per
respondent
360
144
200
4,000
2,400
400
Frm 00043
Fmt 4703
Total
annual
responses
1
1
1
1
1
1
Sfmt 4703
360
144
200
4,000
2,400
400
E:\FR\FM\09JYN1.SGM
Average
burden per
response
0.75
1.50
0.25
0.08
0.25
0.50
(45 minutes) ..........
hours .....................
(15 minutes) ..........
(5 minutes) ............
(15 minutes) ..........
(30 minutes) ..........
09JYN1
Total hours
270
216
50
320
600
200
41068
Federal Register / Vol. 78, No. 131 / Tuesday, July 9, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
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: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16401 Filed 7–8–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0370]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Medical
Devices; Foreign Letters of Approval
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 August 8,
2013.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
SUMMARY:
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 0910–0264. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@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.
Export of Medical Devices; Foreign
Letters of Approval—(OMB Control
Number 0910–0264)—Extension
Section 801(e)(2) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 381(e)(2)) provides for the
exportation of an unapproved device
under certain circumstances if the
exportation is not contrary to the public
health and safety and it has the approval
of the foreign country to which it is
intended for export. Requesters
communicate (either directly or through
a business associate in the foreign
country) with a representative of the
foreign government to which they seek
exportation, and written authorization
must be obtained from the appropriate
office within the foreign government
approving the importation of the
medical device. An alternative to
obtaining written authorization from the
foreign government is to accept a
notarized certification from a
responsible company official in the
United States that the product is not in
conflict with the foreign country’s laws.
This certification must include a
statement acknowledging that the
responsible company official making the
certification is subject to the provisions
of 18 U.S.C. 1001. This statutory
provision makes it a criminal offense to
knowingly and willingly make a false or
fraudulent statement, or make or use a
false document, in any manner within
the jurisdiction of a department or
agency of the United States. The
respondents to this collection of
information are companies that seek to
export medical devices. FDA’s estimate
of the reporting burden is based on the
experience of FDA’s medical device
program personnel.
In the Federal Register of April 5,
2013 (78 FR 20660), 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
mstockstill on DSK4VPTVN1PROD with NOTICES
Activity/section of FD&C Act
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total operating
& maintenance
costs
Foreign letter of approval—§ 801(e)(2) ....
38
1
38
3
114
$9,500
1 There
are no capital costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41066-41068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16401]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0796]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications on Medical Devices and
Radiation-Emitting Products
AGENCY: Food and Drug Administration, HHS.
[[Page 41067]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on communication studies
involving medical devices and radiation-emitting products regulated by
FDA. This information will be used to explore concepts of interest and
assist in the development and modification of communication messages
and campaigns to fulfill the Agency's mission to protect the public
health.
DATES: Submit either electronic or written comments on the collection
of information by September 9, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
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 1.50 hours...... 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 0.50 (30 200
minutes).
[[Page 41068]]
Omnibus surveys............... 1,200 1 1,200 0.17 (10 204
minutes).
---------------------------------------------------------------------------------
Total (general public).... 8,704 .............. .............. ................ 1,860
----------------------------------------------------------------------------------------------------------------
Physician focus group 144 1 144 1.50 hours...... 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.
Dated: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16401 Filed 7-8-13; 8:45 am]
BILLING CODE 4160-01-P
