Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Communications To Educate Consumers on How To Safely Purchase Drugs Online, 40920-40921 [2011-17415]
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40920
Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Notices
Catina Conner,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–17410 Filed 7–11–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0360. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2011–N–0019]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Customer/Partner
Service Surveys
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
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 11,
2011.
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:
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Customer/Partner Service Surveys
(OMB Control Number 0910–0360)–
Extension
Under section 903 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393), FDA is authorized to conduct
research and public information
programs about regulated products and
responsibilities of the agency. Executive
Order 12862, entitled, ‘‘Setting
Customer Service Standard,’’ directs
Federal agencies that ‘‘provide
significant services directly to the
public’’ to ‘‘survey customers to
determine the kind and quality of
services they want and their level of
satisfaction with existing services.’’ FDA
is seeking OMB clearance to conduct a
series of surveys to implement
Executive Order 12862. Participation in
the surveys is voluntary. This request
covers customer/partner service surveys
of regulated entities, such as food
processors; cosmetic drug, biologic and
medical device manufacturers;
consumers; and health professionals.
The request also covers ‘‘partner’’ (State
and local governments) customer
service surveys.
FDA will use the information from
these surveys to identify strengths and
weaknesses in service to customers/
partners and to make improvements.
The surveys will measure timeliness,
appropriateness and accuracy of
information, courtesy and problem
resolution in the context of individual
programs.
FDA estimates conducting 15
customer/partner service surveys per
year, each requiring an average of 15
minutes for review and completion. We
estimate respondents to these surveys to
be between 100 and 10,000 customers.
Some of these surveys will be repeats of
earlier surveys for purposes of
monitoring customer/partner service
and developing long-term data.
In the Federal Register of January 13,
2011 (76 FR 2395), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of survey
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Mail, telephone, web-based .................................................
20,000
1
20,000
0.25 (15 min.)
5,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17416 Filed 7–11–11; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2011–N–0494]
BILLING CODE 4160–01–P
emcdonald on DSK2BSOYB1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Communications To Educate
Consumers on How To Safely
Purchase Drugs Online
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
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16:14 Jul 11, 2011
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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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a generic clearance on ‘‘Data to Support
Communications to Educate Consumers
on How to Safely Purchase Drugs
Online.’’ This data collection will obtain
baseline knowledge of the Internet
users’ knowledge, attitudes, and
practices with regard to online
pharmacies, and then will collect
ongoing data for tracking changes in
knowledge, attitudes, and practices as a
E:\FR\FM\12JYN1.SGM
12JYN1
Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Notices
function of an integrated public
outreach campaign FDA will roll out to
educate consumers on how to safely
purchase drugs online.
DATES: Submit either electronic or
written comments on the collection of
information by September 12, 2011.
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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, 301–796–3792,
Elizabeth.Berbakos@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
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.
Data To Support Communications To
Educate Consumers on How To Safely
Purchase Drugs Online—(OMB Control
Number 0910—New)
FDA has planned an integrated public
outreach campaign to improve the safe
use of online pharmacies for drug
purchases. In order to effectively
40921
evaluate this campaign, FDA must
understand individuals’ knowledge,
attitudes, and practices with regard to
online pharmacies both at the start of
the campaign and on an ongoing basis.
This will enable FDA to gauge progress
toward educating the public on safely
purchasing from online pharmacies. An
online survey panel will be employed to
collect this information, which serves
the need for direct and quantitative
measurement of our target population,
and which, as a quantitative research
tool has some major benefits:
• To focus on our target population of
adults who use the Internet.
• To collect data quickly and
efficiently with minimal cost to the
government.
• To reduce burden to the public by
providing a means to complete the
survey at a time and place of their
choosing.
FDA will use online data collection to
establish a baseline and evaluate the
success of its messages and distribution
methods for its outreach campaign,
which educates consumers about how to
safely purchase drugs online.
Additionally, FDA will use this method
to help tailor messages and
communications vehicles to have both a
more powerful and desired impact on
target audiences. The data will not be
used for the purposes of making policy
or regulatory decisions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Survey Study ........................................................................
5,000
1
5,000
.33 (20 min.)
1,650
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Annually, FDA projects one survey
study. FDA is requesting this data
collection 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.
emcdonald on DSK2BSOYB1PROD with NOTICES
Dated: July 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17415 Filed 7–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0476]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Enforcement Policy for Premarket
Notification Requirements for Certain
In Vitro Diagnostic and Radiology
Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
SUMMARY:
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16:14 Jul 11, 2011
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entitled ‘‘Enforcement Policy for
Premarket Notification Requirements for
Certain In Vitro Diagnostic and
Radiology Devices.’’ This document
describes FDA’s intent with regard to
enforcement of premarket notification
(510(k)) requirements for certain in vitro
diagnostic and radiology devices under
the regulations. This draft guidance is
not final nor is it in effect at this time.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 11,
2011.
DATES:
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]]>Agencies
[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Notices]
[Pages 40920-40921]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17415]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0494]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Communications To Educate Consumers on
How To Safely Purchase Drugs Online
AGENCY: Food and Drug Administration, HHS.
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a generic clearance on ``Data to Support
Communications to Educate Consumers on How to Safely Purchase Drugs
Online.'' This data collection will obtain baseline knowledge of the
Internet users' knowledge, attitudes, and practices with regard to
online pharmacies, and then will collect ongoing data for tracking
changes in knowledge, attitudes, and practices as a
[[Page 40921]]
function of an integrated public outreach campaign FDA will roll out to
educate consumers on how to safely purchase drugs online.
DATES: Submit either electronic or written comments on the collection
of information by September 12, 2011.
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: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, 301-796-3792, Elizabeth.Berbakos@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 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.
Data To Support Communications To Educate Consumers on How To Safely
Purchase Drugs Online--(OMB Control Number 0910--New)
FDA has planned an integrated public outreach campaign to improve
the safe use of online pharmacies for drug purchases. In order to
effectively evaluate this campaign, FDA must understand individuals'
knowledge, attitudes, and practices with regard to online pharmacies
both at the start of the campaign and on an ongoing basis. This will
enable FDA to gauge progress toward educating the public on safely
purchasing from online pharmacies. An online survey panel will be
employed to collect this information, which serves the need for direct
and quantitative measurement of our target population, and which, as a
quantitative research tool has some major benefits:
To focus on our target population of adults who use the
Internet.
To collect data quickly and efficiently with minimal cost
to the government.
To reduce burden to the public by providing a means to
complete the survey at a time and place of their choosing.
FDA will use online data collection to establish a baseline and
evaluate the success of its messages and distribution methods for its
outreach campaign, which educates consumers about how to safely
purchase drugs online. Additionally, FDA will use this method to help
tailor messages and communications vehicles to have both a more
powerful and desired impact on target audiences. The data will not be
used for the purposes of making policy or regulatory decisions.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey Study....................................................... 5,000 1 5,000 .33 (20 min.) 1,650
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Annually, FDA projects one survey study. FDA is requesting this
data collection 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.
Dated: July 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17415 Filed 7-11-11; 8:45 am]
BILLING CODE 4160-01-P
