Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions, 61872-61873 [2014-24365]
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Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices
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[FR Doc. 2014–24442 Filed 10–14–14; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4163–18–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1491]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Survey of
Pharmacists and Patients; Variations
in the Physical Characteristics of
Generic Drug Pills and Patients’
Perceptions
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
the information collection associated
with a survey of pharmacists and
patients about their experiences
resulting from changes in generic drug
pill appearance.
DATES: Submit either electronic or
written comments on the collection of
information by December 15, 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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.
SUMMARY:
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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.
Survey of Pharmacists and Patients:
Variations in the Physical
Characteristics of Generic Drug Pills
and Patients’ Perceptions—(OMB
Control Number 0910–NEW)
Generic drugs make up approximately
85 percent of all human prescription
drugs prescribed in the United States.
While generic drugs are required to be
pharmaceutically equivalent and
bioequivalent to their brand-name
counterparts, generics made by different
manufacturers may differ substantially
from their brand-name therapeutic
equivalents and from each other in their
physical appearance (e.g., color, shape,
or size of pills). When pharmacists
switch generic drug suppliers, patients
refilling their generic prescriptions may
therefore experience changes in their
drugs’ appearances. These changes may
result in patient confusion and concerns
about the safety and effectiveness of the
generic drug products. Studies indicate
that patients are more likely to stop
taking their generic medications when
they experience a change in their drugs’
physical appearances, leading to
harmful clinical and public health
consequences as well as increased
health care costs from avoidable
morbidity and mortality.
To provide additional information
that may help guide regulatory policy or
pharmacy business practices, we intend
to conduct surveys of pharmacists and
patients about their perceptions about
and experiences with generic drug
E:\FR\FM\15OCN1.SGM
15OCN1
Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices
product pill appearance change. These
surveys are intended to further our
understanding of the relationship
between changes in pill appearance and
non-adherence to prescribed therapeutic
regimens. The surveys may enable us to
investigate factors that may explain the
association between changes in pill
appearance and non-adherence,
including which factors could be
modified to improve the safe and
effective use of generic drugs.
We intend to survey a national cohort
of pharmacists about their experiences
with dispensing generic drug pills that
differ in appearance from previous
refills of the same medication and
dosage level (e.g., when pharmacies
switch generic suppliers). A stratified,
random sample of U.S.-licensed
pharmacists will be obtained based on
a master list from KM Lists. The target
sample includes pharmacists with
active licenses who practice in
traditional community pharmacy
settings and will be proportionally
allocated across the United States in
relation to the number of pharmacists in
each state. Based on an 11 percent
undeliverable rate and a 52 percent
response rate, 2,161 questionnaires will
be mailed to pharmacists to obtain the
1,000 responses required for adequate
statistical power. The pharmacists’
survey will consist of a mailed
questionnaire rather than a telephone
survey or an email survey. Prior
experience conducting surveys has
shown that it is easier to guarantee
respondent anonymity using an
impersonal, mailed questionnaire with
no individual identifying information.
The pharmacists will be asked about the
frequency with which their pharmacy
changes suppliers that lead to variations
in the appearance of the generic drugs
that they dispense, as well as strategies
they use with patients to address the
transition to pills that have a different
appearance (e.g., alert stickers on pill
bottles, verbal warnings, and other
strategies). They will also be asked
about patient responses to changes in
pill appearance, including what types of
appearance changes seem to affect
patients most often (shape/color/size),
how often patients report confusion
about pill appearance, and how often
patients ultimately refuse to accept the
new product. Participation is expected
to take approximately 20 minutes.
We also intend to survey two different
patient samples using two
methodologies. The first is a telephone
survey of patients who are 50 years and
older and who take one or more generic
medications for at least one of the
following chronic conditions: Epilepsy,
diabetes, hypertension, hyperlipidemia,
depression, and HIV. The telephone
61873
survey will be generalizable and will
consist of well-defined methods to
minimize sampling bias such as use of
random phone numbers for both
landlines and mobile phones, as well as
small-batch sampling to ensure a high
response rate that meets demographic
diversity goals. For the second patient
survey, patients will be selected from a
proprietary research database of
commercially insured patients
containing medical and pharmacy
claims linked to health insurance
enrollment information. A nationally
representative sample of patients with at
least one chronic condition and who
experienced a change in physical
appearance of a generic pill will be
identified by the research team using
medical and pharmacy claims data.
Both patient surveys will consist of
questions covering topics similar to
those asked in the survey of pharmacists
and is intended to provide answers to
the same topic areas from patients’
perspectives. As before, topic areas will
include beliefs about generic drugs,
outcomes related to changes in generic
drug pill appearance, and strategies
used by pharmacists or doctors to alert
patients to the possibility of changes in
appearance. Participation is expected to
take approximately 20 minutes.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Surveys of pharmacists and patients on variations in the
physical characteristics of generic drug pills and patients’
perceptions
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Survey of Pharmacists .........................................................
1,000
1
1,000
Survey of Patients #1 ..........................................................
1,000
1
1,000
Survey of Patients #2 ..........................................................
1,000
1
1,000
Total ..............................................................................
........................
........................
........................
1 There
Total hours
0.333
(20 minutes)
0.333
(20 minutes)
0.333
(20 minutes)
333
........................
999
333
333
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24365 Filed 10–14–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0078]
BILLING CODE 4164–01–P
tkelley on DSK3SPTVN1PROD with NOTICES
Average
burden per
response
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Animal Drug User Fee Cover Sheet
AGENCY:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
18:00 Oct 14, 2014
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PO 00000
On July 8,
2014, the Agency submitted a proposed
collection of information entitled
‘‘Animal Drug User Fee Cover Sheet’’ to
OMB for review and clearance under 44
SUPPLEMENTARY INFORMATION:
HHS.
ACTION:
that a collection of information entitled
‘‘Animal Drug User Fee Cover Sheet’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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.
Frm 00028
Fmt 4703
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15OCN1
]]>Agencies
[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61872-61873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24365]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1491]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Survey of Pharmacists and Patients; Variations in the
Physical Characteristics of Generic Drug Pills and Patients'
Perceptions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
a survey of pharmacists and patients about their experiences resulting
from changes in generic drug pill appearance.
DATES: Submit either electronic or written comments on the collection
of information by December 15, 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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 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.
Survey of Pharmacists and Patients: Variations in the Physical
Characteristics of Generic Drug Pills and Patients' Perceptions--(OMB
Control Number 0910-NEW)
Generic drugs make up approximately 85 percent of all human
prescription drugs prescribed in the United States. While generic drugs
are required to be pharmaceutically equivalent and bioequivalent to
their brand-name counterparts, generics made by different manufacturers
may differ substantially from their brand-name therapeutic equivalents
and from each other in their physical appearance (e.g., color, shape,
or size of pills). When pharmacists switch generic drug suppliers,
patients refilling their generic prescriptions may therefore experience
changes in their drugs' appearances. These changes may result in
patient confusion and concerns about the safety and effectiveness of
the generic drug products. Studies indicate that patients are more
likely to stop taking their generic medications when they experience a
change in their drugs' physical appearances, leading to harmful
clinical and public health consequences as well as increased health
care costs from avoidable morbidity and mortality.
To provide additional information that may help guide regulatory
policy or pharmacy business practices, we intend to conduct surveys of
pharmacists and patients about their perceptions about and experiences
with generic drug
[[Page 61873]]
product pill appearance change. These surveys are intended to further
our understanding of the relationship between changes in pill
appearance and non-adherence to prescribed therapeutic regimens. The
surveys may enable us to investigate factors that may explain the
association between changes in pill appearance and non-adherence,
including which factors could be modified to improve the safe and
effective use of generic drugs.
We intend to survey a national cohort of pharmacists about their
experiences with dispensing generic drug pills that differ in
appearance from previous refills of the same medication and dosage
level (e.g., when pharmacies switch generic suppliers). A stratified,
random sample of U.S.-licensed pharmacists will be obtained based on a
master list from KM Lists. The target sample includes pharmacists with
active licenses who practice in traditional community pharmacy settings
and will be proportionally allocated across the United States in
relation to the number of pharmacists in each state. Based on an 11
percent undeliverable rate and a 52 percent response rate, 2,161
questionnaires will be mailed to pharmacists to obtain the 1,000
responses required for adequate statistical power. The pharmacists'
survey will consist of a mailed questionnaire rather than a telephone
survey or an email survey. Prior experience conducting surveys has
shown that it is easier to guarantee respondent anonymity using an
impersonal, mailed questionnaire with no individual identifying
information. The pharmacists will be asked about the frequency with
which their pharmacy changes suppliers that lead to variations in the
appearance of the generic drugs that they dispense, as well as
strategies they use with patients to address the transition to pills
that have a different appearance (e.g., alert stickers on pill bottles,
verbal warnings, and other strategies). They will also be asked about
patient responses to changes in pill appearance, including what types
of appearance changes seem to affect patients most often (shape/color/
size), how often patients report confusion about pill appearance, and
how often patients ultimately refuse to accept the new product.
Participation is expected to take approximately 20 minutes.
We also intend to survey two different patient samples using two
methodologies. The first is a telephone survey of patients who are 50
years and older and who take one or more generic medications for at
least one of the following chronic conditions: Epilepsy, diabetes,
hypertension, hyperlipidemia, depression, and HIV. The telephone survey
will be generalizable and will consist of well-defined methods to
minimize sampling bias such as use of random phone numbers for both
landlines and mobile phones, as well as small-batch sampling to ensure
a high response rate that meets demographic diversity goals. For the
second patient survey, patients will be selected from a proprietary
research database of commercially insured patients containing medical
and pharmacy claims linked to health insurance enrollment information.
A nationally representative sample of patients with at least one
chronic condition and who experienced a change in physical appearance
of a generic pill will be identified by the research team using medical
and pharmacy claims data. Both patient surveys will consist of
questions covering topics similar to those asked in the survey of
pharmacists and is intended to provide answers to the same topic areas
from patients' perspectives. As before, topic areas will include
beliefs about generic drugs, outcomes related to changes in generic
drug pill appearance, and strategies used by pharmacists or doctors to
alert patients to the possibility of changes in appearance.
Participation is expected to take approximately 20 minutes.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Surveys of pharmacists and
patients on variations in the Number of
physical characteristics of Number of responses per Total annual Average burden Total hours
generic drug pills and patients' respondents respondent responses per response
perceptions
----------------------------------------------------------------------------------------------------------------
Survey of Pharmacists........... 1,000 1 1,000 0.333 333
(20 minutes)
Survey of Patients #1........... 1,000 1 1,000 0.333 333
(20 minutes)
Survey of Patients #2........... 1,000 1 1,000 0.333 333
(20 minutes)
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 999
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24365 Filed 10-14-14; 8:45 am]
BILLING CODE 4164-01-P
