Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration, 36591-36593 [2020-13079]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
August 17, 2020.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number_Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:44 Jun 16, 2020
Jkt 250001
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10525 PACE Quality Data
Monitoring and Reporting
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title:
PACE Quality Data Monitoring and
Reporting; Use: The Programs of AllInclusive Care for the Elderly (PACE)
program is a unique model of managed
care service delivery for the frail elderly,
most of whom are dually-eligible for
Medicare and Medicaid benefits. To be
eligible to enroll in PACE, an individual
must: Be 55 or older, live in the service
area of a PACE organization (PO), need
a nursing home-level of care (as certified
by the state in which he or she lives),
and be able to live safely in the
community with assistance from PACE.
PACE organizations are responsible
for providing all required Medicare and
Medicaid covered services, and any
other service that the interdisciplinary
team (IDT) determines necessary to
improve and maintain a participant’s
overall health condition (42 CFR
460.92). POs must also comply with the
quality monitoring and reporting
requirements outlined in §§ 460.140,
460.200(b)(1), 460.200(c) and 460.202.
POs are also required to report certain
unusual incidents to other Federal and
State agencies consistent with
applicable statutory or regulatory
requirements (see 42 CFR 460.136(a)(5)).
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
36591
Form Number: CMS–10525 (OMB
control number: 0938–1264); Frequency:
Annual; Affected Public: Private Sector:
Business or other for-profits; Number of
Respondents: 131; Total Annual
Responses: 1,143; Total Annual Hours:
156,414. (For policy questions regarding
this collection contact Donna
Williamson at 410–786–4647.)
Dated: June 11, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–12993 Filed 6–16–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0345]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Drug Product Communications as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 a generic
clearance to collect information to
support communications used by FDA
about drug products.
DATES: Submit either electronic or
written comments on the collection of
information by August 17, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 17,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 17, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
SUMMARY:
E:\FR\FM\17JNN1.SGM
17JNN1
36592
Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
khammond on DSKJM1Z7X2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–0345 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Data To
Support Drug Product Communications
as Used by the Food and Drug
Administration.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
VerDate Sep<11>2014
16:44 Jun 16, 2020
Jkt 250001
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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.
Data To Support Drug Product
Communications as Used by the Food
and Drug Administration
OMB Control Number 0910–0695—
Extension
This information collection supports
Agency outreach efforts. Testing of
communication messages in advance of
a communication campaign provides an
important role in improving FDA
communications as they allow for an
indepth understanding of individuals’
attitudes, beliefs, motivations, and
feelings. The methods to be employed
include individual in-depth interviews,
general public focus group interviews,
intercept interviews, self-administered
surveys, gatekeeper surveys, and
professional clinician focus group
interviews, all on a voluntary basis. The
methods to be used serve the narrowly
defined need for direct and informal
opinion on a specific topic and, as a
qualitative research tool, have two major
purposes: (1) To obtain information that
is useful for developing variables and
measures for formulating the basic
objectives of risk communication
campaigns; and (2) to assess the
potential effectiveness of messages and
materials in reaching and successfully
communicating with their intended
audiences. We will use these methods to
test and refine our ideas and to help
develop messages and other
communications but will generally
conduct further research before making
important decisions, such as adopting
new policies and allocating or
E:\FR\FM\17JNN1.SGM
17JNN1
Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
redirecting significant resources to
support these policies. We will use this
mechanism to test messages about
regulated drug products on a variety of
subjects related to consumer, patient, or
health care professional perceptions and
about use of drug products and related
materials, including but not limited to,
direct-to-consumer prescription drug
promotion, physician labeling of
prescription drugs, medication guides,
over-the-counter drug labeling,
emerging risk communications, patient
labeling, online sale of medical
products, and consumer and
professional education. Annually, we
project about 45 communication studies
using the variety of test methods listed
36593
in this document. We are requesting an
extension of these burden hours so as
not to restrict our ability to gather
information on public sentiment for its
proposals in its regulatory and
communications programs.
We estimate 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
Interviews/Surveys ............................
43,875
1
43,875
0.21925 (12 minutes) .......................
9,620
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection has not changed
since the last OMB approval.
Dated: June 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13079 Filed 6–16–20; 8:45 am]
BILLING CODE 4164–01–P
guidance of the same title dated January
2020, and supersedes the document
entitled ‘‘Revised Preventive Measures
to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products,
Guidance for Industry,’’ dated May
2010, and updated January 2016.
The announcement of the
guidance is published in the Federal
Register on June 17, 2020.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2012–D–0307]
Recommendations To Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant
Creutzfeldt Jakob Disease by Blood
and Blood Components; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Recommendations to
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt Jakob
Disease by Blood and Blood
Components.’’ The guidance provides
blood establishments that collect blood
and blood components with revised
recommendations intended to reduce
the possible risk of transmission of
Creutzfeldt-Jakob disease (CJD) and
variant Creutzfeldt-Jakob disease (vCJD)
by blood and blood components. The
recommendations in the guidance apply
to the collection of Whole Blood and
blood components intended for
transfusion or for use in further
manufacturing, including Source
Plasma. The guidance finalizes the draft
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:44 Jun 16, 2020
Jkt 250001
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
Food and Drug Administration
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–D–0307 for ‘‘Recommendations to
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt Jakob
Disease by Blood and Blood
Components.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36591-36593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0345]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Drug Product Communications as Used by
the Food and Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 a generic clearance to collect information
to support communications used by FDA about drug products.
DATES: Submit either electronic or written comments on the collection
of information by August 17, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 17, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 17, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely
[[Page 36592]]
if they are postmarked or the delivery service acceptance receipt is on
or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-0345 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Data To Support Drug Product
Communications as Used by the Food and Drug Administration.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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: Under the PRA (44 U.S.C. 3501-3521), 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.
Data To Support Drug Product Communications as Used by the Food and
Drug Administration
OMB Control Number 0910-0695--Extension
This information collection supports Agency outreach efforts.
Testing of communication messages in advance of a communication
campaign provides an important role in improving FDA communications as
they allow for an indepth understanding of individuals' attitudes,
beliefs, motivations, and feelings. The methods to be employed include
individual in-depth interviews, general public focus group interviews,
intercept interviews, self-administered surveys, gatekeeper surveys,
and professional clinician focus group interviews, all on a voluntary
basis. The methods to be used serve the narrowly defined need for
direct and informal opinion on a specific topic and, as a qualitative
research tool, have two major purposes: (1) To obtain information that
is useful for developing variables and measures for formulating the
basic objectives of risk communication campaigns; and (2) to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. We will use
these methods to test and refine our ideas and to help develop messages
and other communications but will generally conduct further research
before making important decisions, such as adopting new policies and
allocating or
[[Page 36593]]
redirecting significant resources to support these policies. We will
use this mechanism to test messages about regulated drug products on a
variety of subjects related to consumer, patient, or health care
professional perceptions and about use of drug products and related
materials, including but not limited to, direct-to-consumer
prescription drug promotion, physician labeling of prescription drugs,
medication guides, over-the-counter drug labeling, emerging risk
communications, patient labeling, online sale of medical products, and
consumer and professional education. Annually, we project about 45
communication studies using the variety of test methods listed in this
document. We are requesting an extension of these burden hours so as
not to restrict our ability to gather information on public sentiment
for its proposals in its regulatory and communications programs.
We estimate 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 per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys.............................. 43,875 1 43,875 0.21925 (12 minutes).............. 9,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection has not changed
since the last OMB approval.
Dated: June 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13079 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P
