Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application, 36543-36545 [2015-15638]
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Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices
reporting on the overall performance of
these grant programs.
Data will be collected from all 60
Community-Centered Healthy Marriage,
54 Pathways to Responsible Fatherhood
and 5 Community-Centered Responsible
Fatherhood Ex-Prisoner Reentry
grantees in the OFA programs. Grantees
will report on program and participant
outcomes in such areas as participants’
improvement in knowledge skills,
attitudes, and behaviors related to
healthy marriage and responsible
fatherhood. Grantees will be asked to
input data for selected outcomes for
activities funded under the grants.
Grantees will extract data from program
records and will report the data twice
yearly through an on-line data
collection tool. Training and assistance
will be provided to grantees to support
this data collection process.
Respondents: Office of Family
Assistance Funded CommunityCentered Healthy Marriage, Pathways to
Responsible Fatherhood and
Community-Centered Responsible
Fatherhood Ex-Prisoner Reentry
Grantees.
ANNUAL BURDEN ESTIMATES
Performance measure reporting form (for private sector affected public) ........................................................................
Performance measure reporting form (for State, local, and
tribal government affected public) ........................................
Estimated Total Annual Burden
Hours: 190
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
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Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total annual
burden hours
110
2
0.8
176
9
2
0.8
14
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
document, under Instructions, ‘‘Docket
No. FDA–2013–N–1524’’ is corrected to
read ‘‘Docket No. FDA–2015–N–1196’’.
Dated: June 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[Docket No. FDA–2015–N–1196]
List of Bulk Drug Substances That May
Be Used by an Outsourcing Facility To
Compound Drugs for Use in Animals;
Request for Nominations; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The Food and Drug
Administration is correcting a notice
entitled ‘‘List of Bulk Drug Substances
That May Be Used by an Outsourcing
Facility to Compound Drugs for Use in
Animals; Request for Nominations’’ that
appeared in the Federal Register of May
19, 2015 (80 FR 28622). The document
announced the intention to develop a
list of bulk drug substances that may be
used by outsourcing facilities registered
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to
compound animal drugs, in accordance
with FDA’s draft guidance for industry
#230, ‘‘Compounding Animal Drugs
from Bulk Drug Substances.’’ The
document was published with an
incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
3330, Silver Spring, MD 20993–0002,
301–796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Tuesday, May 19,
2015, in FR Doc. 2015–11983, the
following correction is made:
1. On page 28622, in the second
column, in the ADDRESSES section of the
SUMMARY:
[FR Doc. 2015–15558 Filed 6–24–15; 8:45 am]
[Docket No. FDA–2011–N–0915]
Agency Information Collection
Activities; Proposed Collection;
Submission for Office of Management
and Budget Review; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Nonprescription
Human Drug Products Marketed
Without an Approved Application
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 July 27,
2015.
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:
202–395–7285, or emailed to oira_
SUMMARY:
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Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0636. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an
Approved Application (OMB Control
Number 0910–0636)—Extension
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (under
section 502(b)(1) (21 U.S.C. 352(b)(1)) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act)) appears on the label
of a nonprescription drug marketed in
the United States. FDA is requesting
public comment on estimates of annual
submissions from these respondents, as
required by the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (Pub. L. 109–462) and
described in the guidance. The guidance
document discusses what should be
included in a serious adverse drug event
report submitted under section 760(b)(1)
(21 U.S.C. 379aa(b)(1)) of the FD&C Act,
including follow-up reports under
760(c)(2) (21 U.S.C. 379aa(c)(2)) of the
FD&C Act, and how to submit these
reports. The estimates for the annual
reporting and recordkeeping burdens
are based on FDA data on the number
of adverse drug experience reports
submitted for nonprescription drug
products marketed without an approved
application, including FDA’s knowledge
about the time needed to prepare the
reports and to maintain records.
In the Federal Register of January 23,
2015 (80 FR 3608), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received one
comment. The comment requested that
we increase the reporting burden
estimates from 2 hours to 6 hours and
the recordkeeping burden estimates
from 5 hours to 8 hours. The comment
said although there may be
circumstances where FDA’s estimates
for reporting and recordkeeping may be
accurate, the comment contended that,
in its experience, the approximations
are underestimated. The comment said
that as many as 6 hours may be required
to complete a single serious adverse
event report, especially when the
sponsor’s medical and quality review
teams are involved, and that as many as
8 hours may be required to maintain all
relevant records for a single adverse
event report as stipulated by statute.
FDA Response: We have reconsidered
our estimates, and agree with the
comment that there may be
circumstances where 6 hours would be
needed to prepare and submit a report
to us and 8 hours may be needed for
recordkeeping. We have revised our
reporting and recordkeeping burden
estimates accordingly.
Based on FDA data, we estimate
between 10,000 and 15,000 (i.e.,
approximately 12,500) total annual
responses from approximately 50
respondents for nonprescription drugs
marketed without an approved
application, and we also estimate that
each submission will take
approximately 6 hours to prepare and
submit.
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
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................
50
250
12,500
6
75,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) (21 U.S.C. 379aa(e) of
the FD&C Act also requires that
responsible persons maintain records of
nonprescription adverse event reports,
whether or not the event is serious, for
a period of 6 years. The guidance
document recommends that
respondents maintain records of efforts
to obtain the minimum data elements
for a report of a serious adverse drug
event and any follow-up reports. We
estimate that there are approximately
20,000 records per year maintained by
approximately 200 respondents, and
that it takes approximately 8 hours to
maintain each record.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping (21 U.S.C. 379aa(e)(1)) ..............................
200
100
20,000
8
160,000
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices
Therefore, the estimated annual
reporting burden for this information is
25,000 hours and the estimated annual
recordkeeping burden is 100,000 hours.
Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15638 Filed 6–24–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2163]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Hearing, Aging,
and Direct-to-Consumer Television
Advertisements
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Hearing, Aging, and
Direct-to-Consumer Television
Advertisements’’. This study will
examine how changes to hearing across
the lifespan affect the comprehension of
direct-to-consumer (DTC) television
advertisements for prescription drugs.
DATES: Submit either electronic or
written comments on the collection of
information by August 24, 2015.
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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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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.
SUPPLEMENTARY INFORMATION:
Hearing, Aging, and Direct-toConsumer Television Advertisements—
(OMB Control Number 0910–NEW)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(b)(2)(c)) authorizes FDA
to conduct research relating to drugs
and other FDA regulated products in
carrying out the provisions of the FD&C
Act.
Older adults use a disproportionate
number of prescription drugs (Ref. 1)
and watch more television than other
age groups (Ref. 2). Age-related changes
in hearing are common (Ref. 3, 4, and
5) and, depending on their severity,
influence the understanding of speech.
DTC television advertisements (ads)
contain large amounts of complex
information about prescription drug
treatments that may be particularly
relevant to a population that is
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36545
experiencing some level of hearing loss.
Moreover, much of the information in
these ads is conveyed by voiceover,
meaning that the audio channel is the
only way to receive the information.
Although people with serious hearing
loss may compensate by using closed
captioning (which may or may not be
available for ads) or hearing aids, some
individuals experience the effects of
hearing loss without realizing that it is
the cause and others choose not to use
external compensatory aids (Ref. 6). For
these reasons, FDA is proposing
research to investigate how people at
various ages and levels of hearing ability
comprehend DTC ads.
Sponsors of DTC ads cannot control
the hearing abilities of their audiences.
Nonetheless, researchers have identified
several aspects of DTC ads within their
control that influence the understanding
of speech in individuals who experience
aging-related hearing loss. First,
frequency thresholds differ as people
age; older adults are not able to hear
higher frequencies as well (Ref. 7 and 8).
Second, DTC television ads contain a
risk statement of the most serious and
most common side effects, called ‘‘the
major statement’’. FDA regulations
require that the major statement must be
included in at least the audio portion of
the ad (Ref. 9). The risks of a medical
product often include highly technical
medical terms that must be transformed
into consumer-friendly language to
convey the risks appropriately. This is
easier in some cases than in others. In
addition, there are techniques to help
reduce the complexity of the major
statement, such as maintaining active
voice, reducing instances where words
need clarification from other later words
in the broadcast, and using shorter
sentences. Third, television ad spots are
typically bought in increments of 15
seconds, leading to many 30- and 60second ads, and some 75-second ads
when risk information is especially
dense. In order to fit the required
information into this time frame, the
audio presentation speed may be
adjusted to be faster or slower. Research
has shown that fast speech is more
difficult to understand than slower
speech, even for healthy young adults
(Ref. 10).
Thus, we propose to examine the
effects of three aspects of DTC ads
(voice frequency, complexity of major
statement, speed of major statement) on
the comprehension of the ads among
four different age groups of individuals.
Because hearing losses begin to occur as
people age, we will examine a group of
middle-aged adults (40–50 years),
young-old adults (60–75 years), and oldold adults (75+ years), and a group of
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]]>Agencies
[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Pages 36543-36545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15638]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0915]
Agency Information Collection Activities; Proposed Collection;
Submission for Office of Management and Budget Review; Guidance for
Industry on Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 July
27, 2015.
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: 202-395-7285, or emailed to oira_
[[Page 36544]]
submission@omb.eop.gov. All comments should be identified with the OMB
control number 0910-0636. Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed Without an Approved
Application (OMB Control Number 0910-0636)--Extension
Respondents to this collection of information are manufacturers,
packers, and distributors whose name (under section 502(b)(1) (21
U.S.C. 352(b)(1)) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act)) appears on the label of a nonprescription drug marketed in the
United States. FDA is requesting public comment on estimates of annual
submissions from these respondents, as required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Pub. L.
109-462) and described in the guidance. The guidance document discusses
what should be included in a serious adverse drug event report
submitted under section 760(b)(1) (21 U.S.C. 379aa(b)(1)) of the FD&C
Act, including follow-up reports under 760(c)(2) (21 U.S.C.
379aa(c)(2)) of the FD&C Act, and how to submit these reports. The
estimates for the annual reporting and recordkeeping burdens are based
on FDA data on the number of adverse drug experience reports submitted
for nonprescription drug products marketed without an approved
application, including FDA's knowledge about the time needed to prepare
the reports and to maintain records.
In the Federal Register of January 23, 2015 (80 FR 3608), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment. The comment
requested that we increase the reporting burden estimates from 2 hours
to 6 hours and the recordkeeping burden estimates from 5 hours to 8
hours. The comment said although there may be circumstances where FDA's
estimates for reporting and recordkeeping may be accurate, the comment
contended that, in its experience, the approximations are
underestimated. The comment said that as many as 6 hours may be
required to complete a single serious adverse event report, especially
when the sponsor's medical and quality review teams are involved, and
that as many as 8 hours may be required to maintain all relevant
records for a single adverse event report as stipulated by statute.
FDA Response: We have reconsidered our estimates, and agree with
the comment that there may be circumstances where 6 hours would be
needed to prepare and submit a report to us and 8 hours may be needed
for recordkeeping. We have revised our reporting and recordkeeping
burden estimates accordingly.
Based on FDA data, we estimate between 10,000 and 15,000 (i.e.,
approximately 12,500) total annual responses from approximately 50
respondents for nonprescription drugs marketed without an approved
application, and we also estimate that each submission will take
approximately 6 hours to prepare and submit.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports of serious adverse drug events (21 U.S.C. 379aa((b) and 50 250 12,500 6 75,000
(c))..............................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) (21 U.S.C. 379aa(e) of the FD&C Act also requires
that responsible persons maintain records of nonprescription adverse
event reports, whether or not the event is serious, for a period of 6
years. The guidance document recommends that respondents maintain
records of efforts to obtain the minimum data elements for a report of
a serious adverse drug event and any follow-up reports. We estimate
that there are approximately 20,000 records per year maintained by
approximately 200 respondents, and that it takes approximately 8 hours
to maintain each record.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping (21 U.S.C. 379aa(e)(1)).............................. 200 100 20,000 8 160,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 36545]]
Therefore, the estimated annual reporting burden for this
information is 25,000 hours and the estimated annual recordkeeping
burden is 100,000 hours.
Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15638 Filed 6-24-15; 8:45 am]
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