Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration, 19096-19097 [2014-07705]
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19096
Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Notices
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07708 Filed 4–4–14; 8:45 am]
BILLING CODE 4160–01–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:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
FOR FURTHER INFORMATION CONTACT:
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
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 June 6, 2014.
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.
SUMMARY:
Data To Support Drug Product
Communications as Used by the Food
and Drug Administration—(OMB
Control Number 0910–0695)—Extension
Testing of communication messages
in advance of a communication
campaign provides an important role in
improving FDA communications as they
allow for an in-depth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. 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 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.
FDA will use these methods to test
and refine its 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 redirecting significant resources to
support these policies.
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-toconsumer 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 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
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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.
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17:49 Apr 04, 2014
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E:\FR\FM\07APN1.SGM
07APN1
Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Notices
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07705 Filed 4–4–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0231]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
AGENCY:
Food and Drug Administration,
HHS.
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
the proposed extension of the collection
of information concerning requirements
relating to FDA’s Adverse Experience
Reporting System (AERS) for licensed
biological products, and general records
associated with the manufacture and
distribution of biological products.
DATES: Submit either electronic or
written comments on the collection of
information by June 6, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:49 Apr 04, 2014
Jkt 232001
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.
Adverse Experience Reporting for
Licensed Biological Products; and
General Records—21 CFR Part 600—
(OMB Control Number 0910–0308)—
Extension
Under the Public Health Service Act
(42 U.S.C. 262), FDA may only approve
a biologics license application for a
biological product that is safe, pure, and
potent. When a biological product is
approved and enters the market, the
product is introduced to a larger patient
population in settings different from
clinical trials. New information
generated during the postmarketing
period offers further insight into the
benefits and risks of the product, and
evaluation of this information is
important to insure its safe use. FDA
issued the Adverse Experience
Reporting (AER) requirements in part
600 (21 CFR part 600) to enable FDA to
take actions necessary for the protection
of the public health in response to
reports of adverse experiences related to
licensed biological products. The
primary purpose of FDA’s AER system
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
19097
is to identify potentially serious safety
problems with licensed biological
products. Although premarket testing
discloses a general safety profile of a
biological product’s comparatively
common adverse effects, the larger and
more diverse patient populations
exposed to the licensed biological
product provides the opportunity to
collect information on rare, latent, and
long-term effects. In addition,
production and/or distribution
problems have contaminated biological
products in the past. AER reports are
obtained from a variety of sources,
including manufacturers, patients,
physicians, foreign regulatory agencies,
and clinical investigators. Identification
of new and unexpected safety issues
through the analysis of the data in AERS
contributes directly to increased public
health protection. For example,
evaluation of these safety issues enables
FDA to take focused regulatory action.
Such action may include, but is not
limited to, important changes to the
product’s labeling (such as adding a
new warning), coordination with
manufacturers to ensure adequate
corrective action is taken, and removal
of a biological product from the market
when necessary.
Section 600.80(c)(1) requires licensed
manufacturers or any person whose
name appears on the label of a licensed
biological product to report each
adverse experience that is both serious
and unexpected, whether foreign or
domestic, as soon as possible but in no
case later than 15 calendar days of
initial receipt of the information by the
licensed manufacturer. These reports
are known as postmarketing 15-day
Alert reports. This section also requires
licensed manufacturers to submit any
followup reports within 15 calendar
days of receipt of new information or as
requested by FDA, and if additional
information is not obtainable, to
maintain records of the unsuccessful
steps taken to seek additional
information. In addition, this section
requires a person who submits an
adverse action report to the licensed
manufacturer, rather than FDA, to
maintain a record of this action. Section
600.80(e) requires licensed
manufacturers to submit a 15-day Alert
report for an adverse experience
obtained from a postmarketing clinical
study only if the licensed manufacturer
concludes that there is a reasonable
possibility that the product caused the
adverse experience. Section 600.80(c)(2)
requires licensed manufacturers to
report each adverse experience not
reported in a postmarketing 15-day
Alert report at quarterly intervals, for 3
E:\FR\FM\07APN1.SGM
07APN1
]]>Agencies
[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19096-19097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07705]
-----------------------------------------------------------------------
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) 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 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 June 6, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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 communication messages in advance of a communication
campaign provides an important role in improving FDA communications as
they allow for an in-depth 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. 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.
FDA will use these methods to test and refine its 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 redirecting significant resources to
support these policies.
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 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
Number of responses Total annual Average
Activity respondents per responses burden per Total hours
respondent response
----------------------------------------------------------------------------------------------------------------
Interviews/Surveys........................ 19,822 1 19,822 0.24 (14 4,757
minutes)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 19097]]
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07705 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P
