Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products, 43200-43202 [E6-12159]
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43200
Federal Register / Vol. 71, No. 146 / Monday, July 31, 2006 / Notices
quickly and efficiently respond to the
request:
•Questions to the agency concerning
specific issues regarding the protocol;
and
•All data, assumptions, and
information needed to permit an
adequate evaluation of the protocol,
including: (1) The role of the study in
the overall development of the drug; (2)
information supporting the proposed
trial, including power calculations, the
choice of study endpoints, and other
critical design features; (3) regulatory
outcomes that could be supported by
the results of the study; (4) final labeling
that could be supported by the results
of the study; and (5) for a stability
protocol, product characterization and
relevant manufacturing data.
Description of Respondents: A
sponsor, applicant, or manufacturer of a
drug or biologic product regulated by
the agency under the act or section 351
of the Public Health Service Act (42
U.S.C. 262) who requests special
protocol assessment.
Burden Estimate: Table 1 of this
document provides an estimate of the
annual reporting burden for requests for
special protocol assessment.
Notification for a Carcinogenicity
Protocol. Based on data collected from
the review divisions and offices within
CDER and CBER, including the number
of notifications for carcinogenicity
protocols and the number of
carcinogenicity protocols submitted in
fiscal years (FY) 2004 and 2005, CDER
estimates that it will receive
approximately 45 notifications of an
intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately 20
sponsors. CBER estimates that it will
receive approximately one notification
of an intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately one
sponsor. The hours per response, which
is the estimated number of hours that a
sponsor would spend preparing the
notification and background
information to be submitted in
accordance with the guidance, is
estimated to be approximately 8 hours.
Requests for Special Protocol
Assessment. Based on data collected
from the review divisions and offices
within CDER and CBER, including the
number of requests for special protocol
assessment submitted in FY 2004 and
FY 2005, CDER estimates that it will
receive approximately 364 requests for
special protocol assessment per year
from approximately 143 sponsors. CBER
estimates that it will receive
approximately 10 requests from
approximately 8 sponsors. The hours
per response is the estimated number of
hours that a respondent would spend
preparing the information to be
submitted with a request for special
protocol assessment, including the time
it takes to gather and copy questions to
be posed to the agency regarding the
protocol and data, assumptions, and
information needed to permit an
adequate evaluation of the protocol.
Based on the agency’s experience with
these submissions, FDA estimates
approximately 15 hours on average
would be needed per response.
FDA estimates the burden of this
collection as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Notification for Carcinogenicity
Protocols
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
21
2.19
46
8
368
151
Requests for Special Protocol Assessment
2.48
374
15
5,610
Total
5,978
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–12158 Filed 7–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sroberts on PROD1PC70 with NOTICES
[Docket No. 2006N–0283]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; FDA Survey of
Physicians’ Perceptions of the Impact
of Early Risk Communication About
Medical Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Total Hours
Notice.
VerDate Aug<31>2005
17:34 Jul 28, 2006
Jkt 208001
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 a 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
a proposed survey of physicians’
perceptions of the impact of early risk
communication about medical products.
The purpose of the proposed survey is
to improve FDA’s understanding of how
and when physicians get, and would
like to get, information about the risk of
medical products, and what factors
might influence the likelihood of
reporting their patients’ adverse
experiences. Together with other
information, the data from this survey
will be used to assess FDA’s
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
communication efforts concerning early
risk communication about medical
products, and inform any potential
communication-related changes.
DATES: Submit written or electronic
comments on the collection of
information by September 29, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
E:\FR\FM\31JYN1.SGM
31JYN1
43201
Federal Register / Vol. 71, No. 146 / Monday, July 31, 2006 / Notices
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:
FDA Survey of Physicians’ Perceptions
of the Impact of Early Risk
Communication About Medical
Products
The authority for FDA to collect the
information derives from the FDA
Commissioner’s authority, as specified
in section 903(d)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)).
FDA engages in a number of
communication activities to inform
health care providers about new risks of
regulated medical products, including
prescription drugs, biologics, and
medical devices (for example,
pacemakers, implantable cardiac
defibrillators, contact lenses, infusion
pumps). More recently, FDA’s
communication activities have also
included the general public. Activities
include, but are not limited to,
communications in medical journals,
through the press (press releases, public
health advisories), letters to health care
providers sent out in cooperation with
product manufacturers, and
notifications and information sheets
about recalls, withdrawals, and new
product safety information on FDA’s
Internet site.
Extensive publicity regarding serious
side effects from certain commonly used
prescription drugs, as well as certain
implantable medical devices, has
spurred public pressure to make risk
information available sooner. In
opposition to such public pressures,
however, at least some prescribers and
medical societies have suggested that
early disclosure of potential side effects
(emerging risks) may have unintended
negative effects on patient care. For FDA
to plan informed programmatic
communication activities we need better
empirical data about the impact of
disseminating emerging risk information
on providers and patient care. In
addition, only limited research
addresses specific barriers to physicians
reporting patient adverse events either
to FDA or product manufacturers.
Further, we have no data evaluating
FDA’s efforts to improve reporting.
Given differing perspectives on the
value and timing of providing risk
information to medical experts and the
public at large, FDA believes it is
important to assess how well it is
communicating with physicians — the
health care provider group with primary
responsibility for deciding whether to
use medical products to address patient
problems. This information is critical
both to plan programmatic
communication activities and to
improve the effectiveness of our
reporting systems. Therefore, FDA plans
to conduct a survey of a nationally
representative group of physicians about
these issues.
The survey will collect information
from respondents through computerassisted telephone interviews conducted
by experienced interviewers. FDA
expects to have a final sample of 895
physicians, broken down approximately
half and half between primary care
practitioners (general practice, family
practice, general internal medicine, and
pediatricians) and specialists. We
expect to identify physician specialty
groups that are most likely to have been
affected by recent publicity over risks of
prescription drugs or medical devices.
Such groups may include neurologists,
psychiatrists, cardiologists,
gastroenterologists, dermatologists,
allergists, urologists, obstetricians/
gynecologists, and geriatricians.
Procedures will be used to ensure
production of a sample of physicians
that is reasonably representative of the
population within the United States.
The design of the interview questions
will be guided by the results of a series
of physician focus groups that have
recently been completed. The interview
will take approximately 15 minutes to
administer.
Key information to be collected
includes the following topics:
• The impact on physicians, their
patients, and their practices of the
disclosure of still uncertain, emerging
risks associated with medical products.
• How physicians currently receive
and ideally would like to receive new
risk and benefit information about
medical products (for example, at what
level of certainty regarding causality
and through what communication
channels).
• How physicians perceive the
credibility of FDA and other potential
sources of risk and benefit information,
including product sponsors, medical
societies, and the media.
• What FDA might do to increase the
likelihood that respondents will report
to FDA or to manufacturers serious
patient reactions that might be side
effects of using medical products.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
sroberts on PROD1PC70 with NOTICES
27 (Pretests)
1
27
.25
6.75
995 (Screener)
1
995
.025
24.88
895 (Survey)
1
895
.25
223.75
VerDate Aug<31>2005
17:34 Jul 28, 2006
Jkt 208001
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
E:\FR\FM\31JYN1.SGM
31JYN1
43202
Federal Register / Vol. 71, No. 146 / Monday, July 31, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
255.38
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA’s
and the contractor’s experience with
previous surveys. The respondents are
divided into two groups: Primary care
physicians and specialist physicians.
We are basing this estimate on 90
percent of the screened physicians being
eligible to participate in the survey.
Prior to administering the survey with
the entire sample, FDA plans to conduct
pretests with up to 27 physicians; these
are meant to evaluate the clarity and
consistency of the survey questionnaire
and interview protocol.
Dated: July 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–12159 Filed 7–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0274]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining a List of United States
Dairy Product Manufacturers/
Processors With Interest in Exporting
to Chile
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Total Hours
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
the information collection provisions
associated with the guidance document
entitled ‘‘Establishing and Maintaining a
List of U.S. Dairy Product
Manufacturers/Processors With Interest
in Exporting to Chile.’’
VerDate Aug<31>2005
17:34 Jul 28, 2006
Jkt 208001
Submit written or electronic
comments on the collection of
information by September 29, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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
DATES:
PO 00000
Frm 00109
Fmt 4703
Sfmt 4703
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/
Processors With Interest in Exporting to
Chile (OMB Control Number 0910–
0509)—Extension
As a direct result of discussions that
have been adjunct to the U.S./Chile Free
Trade Agreement, Chile has recognized
FDA as the competent U.S. food safety
authority and has accepted the U.S.
regulatory system for dairy inspections.
Chile has concluded that it will not
require individual inspections of U.S.
firms by Chile as a prerequisite for
trade, but will accept firms identified by
FDA as eligible to export to Chile.
Therefore, in the Federal Register of
June 22, 2005 (70 FR 36190), FDA
announced the availability of a revised
guidance document entitled
‘‘Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/
Processors With Interest in Exporting to
Chile.’’ The guidance can be found at
https://www.cfsan.fda.gov/
guidance.html. The guidance document
explains that FDA has established a list
that is provided to the government of
Chile and posted on FDA’s Internet site,
which identifies U.S. dairy product
manufacturers/processors that have
expressed interest to FDA in exporting
dairy products to Chile, are subject to
FDA jurisdiction, and are not the subject
of a pending judicial enforcement action
(i.e., an injunction or seizure) or a
pending warning letter. The term ‘‘dairy
products,’’ for purposes of this list, is
not intended to cover the raw
agricultural commodity raw milk.
Application for inclusion on the list is
voluntary. However, Chile has advised
that dairy products from firms not on
this list could be delayed or prevented
by Chilean authorities from entering
commerce in Chile.The revised
guidance explains what information
firms should submit to FDA in order to
be considered for inclusion on the list
and what criteria FDA intends to use to
determine eligibility for placement on
the list. The document also explains
how FDA intends to update the list and
how FDA intends to communicate any
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[Federal Register Volume 71, Number 146 (Monday, July 31, 2006)]
[Notices]
[Pages 43200-43202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0283]
Agency Information Collection Activities; Proposed Collection;
Comment Request; FDA Survey of Physicians' Perceptions of the Impact of
Early Risk Communication About Medical Products
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 a 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 a proposed survey of physicians'
perceptions of the impact of early risk communication about medical
products. The purpose of the proposed survey is to improve FDA's
understanding of how and when physicians get, and would like to get,
information about the risk of medical products, and what factors might
influence the likelihood of reporting their patients' adverse
experiences. Together with other information, the data from this survey
will be used to assess FDA's communication efforts concerning early
risk communication about medical products, and inform any potential
communication-related changes.
DATES: Submit written or electronic comments on the collection of
information by September 29, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
[[Page 43201]]
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.
FDA Survey of Physicians' Perceptions of the Impact of Early Risk
Communication About Medical Products
The authority for FDA to collect the information derives from the
FDA Commissioner's authority, as specified in section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).
FDA engages in a number of communication activities to inform
health care providers about new risks of regulated medical products,
including prescription drugs, biologics, and medical devices (for
example, pacemakers, implantable cardiac defibrillators, contact
lenses, infusion pumps). More recently, FDA's communication activities
have also included the general public. Activities include, but are not
limited to, communications in medical journals, through the press
(press releases, public health advisories), letters to health care
providers sent out in cooperation with product manufacturers, and
notifications and information sheets about recalls, withdrawals, and
new product safety information on FDA's Internet site.
Extensive publicity regarding serious side effects from certain
commonly used prescription drugs, as well as certain implantable
medical devices, has spurred public pressure to make risk information
available sooner. In opposition to such public pressures, however, at
least some prescribers and medical societies have suggested that early
disclosure of potential side effects (emerging risks) may have
unintended negative effects on patient care. For FDA to plan informed
programmatic communication activities we need better empirical data
about the impact of disseminating emerging risk information on
providers and patient care. In addition, only limited research
addresses specific barriers to physicians reporting patient adverse
events either to FDA or product manufacturers. Further, we have no data
evaluating FDA's efforts to improve reporting.
Given differing perspectives on the value and timing of providing
risk information to medical experts and the public at large, FDA
believes it is important to assess how well it is communicating with
physicians -- the health care provider group with primary
responsibility for deciding whether to use medical products to address
patient problems. This information is critical both to plan
programmatic communication activities and to improve the effectiveness
of our reporting systems. Therefore, FDA plans to conduct a survey of a
nationally representative group of physicians about these issues.
The survey will collect information from respondents through
computer-assisted telephone interviews conducted by experienced
interviewers. FDA expects to have a final sample of 895 physicians,
broken down approximately half and half between primary care
practitioners (general practice, family practice, general internal
medicine, and pediatricians) and specialists. We expect to identify
physician specialty groups that are most likely to have been affected
by recent publicity over risks of prescription drugs or medical
devices. Such groups may include neurologists, psychiatrists,
cardiologists, gastroenterologists, dermatologists, allergists,
urologists, obstetricians/gynecologists, and geriatricians. Procedures
will be used to ensure production of a sample of physicians that is
reasonably representative of the population within the United States.
The design of the interview questions will be guided by the results of
a series of physician focus groups that have recently been completed.
The interview will take approximately 15 minutes to administer.
Key information to be collected includes the following topics:
The impact on physicians, their patients, and their
practices of the disclosure of still uncertain, emerging risks
associated with medical products.
How physicians currently receive and ideally would like to
receive new risk and benefit information about medical products (for
example, at what level of certainty regarding causality and through
what communication channels).
How physicians perceive the credibility of FDA and other
potential sources of risk and benefit information, including product
sponsors, medical societies, and the media.
What FDA might do to increase the likelihood that
respondents will report to FDA or to manufacturers serious patient
reactions that might be side effects of using medical products.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
27 (Pretests) 1 27 .25 6.75
----------------------------------------------------------------------------------------------------------------
995 (Screener) 1 995 .025 24.88
----------------------------------------------------------------------------------------------------------------
895 (Survey) 1 895 .25 223.75
----------------------------------------------------------------------------------------------------------------
[[Page 43202]]
Total ................. .................... ................. 255.38
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA's and the contractor's experience
with previous surveys. The respondents are divided into two groups:
Primary care physicians and specialist physicians. We are basing this
estimate on 90 percent of the screened physicians being eligible to
participate in the survey.
Prior to administering the survey with the entire sample, FDA plans
to conduct pretests with up to 27 physicians; these are meant to
evaluate the clarity and consistency of the survey questionnaire and
interview protocol.
Dated: July 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12159 Filed 7-28-06; 8:45 am]
BILLING CODE 4160-01-S
