Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Animal Drug User Fee Cover Sheet, 61873-61874 [2014-24444]
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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.
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61874
Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0539. The
approval expires on August 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24444 Filed 10–14–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1414]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Class II Special
Controls Guidance Document:
Labeling of Natural Rubber Latex
Condoms
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 information collection for the
labeling of natural rubber latex
condoms.
SUMMARY:
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
tkelley on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:00 Oct 14, 2014
Jkt 235001
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:
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.
SUPPLEMENTARY INFORMATION:
Class II Special Controls Guidance
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21
CFR 884.5300—(OMB Control Number
0910–0633)—Extension
Under the Medical Device
Amendments of 1976 (Pub. L. 94–295),
class II devices were defined as those
devices for which there was insufficient
information to show that general
controls themselves would provide a
reasonable assurance of safety and
effectiveness but for which there was
sufficient information to establish
PO 00000
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performance standards to provide such
assurance.
Condoms without spermicidal
lubricant containing nonoxynol 9 are
classified in class II. They were
originally classified before the
enactment of provisions of the Safe
Medical Devices Act of 1990 (Pub. L.
101–629), which broadened the
definition of class II devices and now
permit FDA to establish special controls
beyond performance standards,
including guidance documents, to help
provide reasonable assurance of the
safety and effectiveness of such devices.
In December 2000 Congress enacted
Public Law 106–554, which, among
other provisions, directed FDA to
‘‘reexamine existing condom labels’’
and ‘‘determine whether the labels are
medically accurate regarding the overall
effectiveness or lack of effectiveness in
preventing sexually transmitted diseases
* * *.’’ In response, FDA recommended
labeling intended to provide important
information for condom users, including
the extent of protection provided by
condoms against various types of
sexually transmitted diseases.
Respondents to this collection of
information are manufacturers and
repackagers of male condoms made of
natural rubber latex without spermicidal
lubricant. FDA expects approximately 5
new manufacturers or repackagers to
enter the market yearly and to
collectively have a third-party
disclosure burden of 60 hours. The
number of respondents cited in table 1
of this document is based on FDA’s
database of premarket submissions and
the electronic registration and listing
database. The average burden per
disclosure was derived from a study
performed for FDA by Eastern Research
Group, Inc., an economic consulting
firm, to estimate the impact of the 1999
over-the-counter (OTC) human drug
labeling requirements final rule (64 FR
13254, March 17, 1999). Because the
packaging requirements for condoms are
similar to those of many OTC drugs, we
believe the burden to design the labeling
for OTC drugs is an appropriate proxy
for the estimated burden to design
condom labeling.
The special controls guidance
document also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR 807
subpart E have been approved under
OMB control number 0910–0120; and
the collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073.
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[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61873-61874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24444]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0078]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Animal Drug User Fee Cover Sheet
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing 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.
SUPPLEMENTARY INFORMATION: 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
[[Page 61874]]
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0539.
The approval expires on August 31, 2017. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24444 Filed 10-14-14; 8:45 am]
BILLING CODE 4164-01-P
