Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration, 27840-27841 [2017-12601]
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27840
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total hours
11.10 ....................................................................................
11.30 ....................................................................................
11.50 ....................................................................................
11.300 ..................................................................................
2,500
2,500
4,500
4,500
1
1
1
1
2,500
2,500
4,500
4,500
20
20
20
20
50,000
50,000
90,000
90,000
Total ..............................................................................
........................
........................
........................
........................
280,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
at the end of August 18, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
[FR Doc. 2017–12619 Filed 6–16–17; 8:45 am]
BILLING CODE 4164–01–P
Electronic Submissions
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 18, 2017.
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 18,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:09 Jun 16, 2017
Jkt 241001
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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–0345 for ‘‘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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
E:\FR\FM\19JNN1.SGM
19JNN1
Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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
Testing of messages in advance of a
communication campaign provides an
important role in improving FDA
communications. The methods to be
employed include individual indepth
interviews, general public focus group
interviews, intercept interviews, selfadministered surveys, gatekeeper
surveys, and professional clinician
focus group interviews. The qualitative
27841
methods to be used serve the narrowly
defined need for direct and informal
opinion on a specific topic and have
two major purposes: To obtain
information that is useful in formulating
policies and regulatory decisions and
for developing variables and measures
for formulating the basic objectives of
risk communication campaigns, and to
assess the potential effectiveness of
messages and materials in reaching and
successfully communicating with their
intended audiences.
FDA will use these methods to test
and help refine messages and other
communications but will generally
conduct further research before making
important decisions. FDA 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, FDA
projects about 45 communication
studies using the variety of test methods
listed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Interviews/Surveys ....................................................
1 There
Number of
responses per
respondent
19,822
1
19,822
0.24 (14 minutes) .....
Total hours
4,757
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–12601 Filed 6–16–17; 8:45 am]
[Docket No. FDA–2010–N–0536]
BILLING CODE 4164–01–P
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Average burden
per response
(in hours)
Total annual
responses
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Pharmacogenomic Data
Submission
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
SUMMARY:
VerDate Sep<11>2014
17:09 Jun 16, 2017
Jkt 241001
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by July 19,
2017.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0557. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
E:\FR\FM\19JNN1.SGM
19JNN1
Agencies
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27840-27841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12601]
-----------------------------------------------------------------------
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 18, 2017.
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 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 18, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely 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 ``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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the
[[Page 27841]]
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@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.
Data To Support Drug Product Communications as Used by the Food and
Drug Administration; OMB Control Number 0910-0695--Extension
Testing of messages in advance of a communication campaign provides
an important role in improving FDA communications. The methods to be
employed include individual indepth interviews, general public focus
group interviews, intercept interviews, self-administered surveys,
gatekeeper surveys, and professional clinician focus group interviews.
The qualitative methods to be used serve the narrowly defined need for
direct and informal opinion on a specific topic and have two major
purposes: To obtain information that is useful in formulating policies
and regulatory decisions and for developing variables and measures for
formulating the basic objectives of risk communication campaigns, and
to assess the potential effectiveness of messages and materials in
reaching and successfully communicating with their intended audiences.
FDA will use these methods to test and help refine messages and
other communications but will generally conduct further research before
making important decisions. FDA 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,
FDA projects about 45 communication studies using the variety of test
methods listed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total annual Average burden per response (in hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys.......................... 19,822 1 19,822 0.24 (14 minutes)......................... 4,757
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12601 Filed 6-16-17; 8:45 am]
BILLING CODE 4164-01-P