Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions, 50030-50031 [E8-19653]
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<![CDATA[
50030
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Reporting Activity
Total
118
1There
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0087] (formerly
Docket No. 2007N–0461)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Mental Models
Study of Communicating With Health
Care Providers About the Risks and
Benefits of Prescription Drug Use for
Pregnant and Nursing Women With
Chronic Conditions
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PRODPC60 with NOTICES
Total Annual
Responses
2.39
Hours per
Response
142
Total Hours
160
10,915
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19626 Filed 8–22–08; 8:45 am]
ACTION:
Annual Frequency
per Response
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 September
24, 2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–NEW and title,
‘‘Mental Models Study of
Communicating with Health Care
Providers about the Risks and Benefits
of Prescription Drug Use for Pregnant
and Nursing Women with Chronic
Conditions.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
VerDate Aug<31>2005
15:18 Aug 22, 2008
Jkt 214001
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
Mental Models Study of
Communicating With Health Care
Providers About the Risks and Benefits
of Prescription Drug Use for Pregnant
and Nursing Women With Chronic
Conditions
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)).
The proposed information collection
will help FDA advance public health by
identifying misperceptions and
knowledge gaps about how health care
providers use information to make
decisions about the use of prescription
drugs for the targeted patient groups.
Knowledge of these misperceptions and
gaps provides opportunities for FDA to
target its communications more
precisely to such gaps and areas of
misperception in health care providers’
mental models regarding treatment
decisions.
FDA engages in various
communication activities to ensure that
patients and health care providers have
the information they need to make
informed decisions about treatment
options, including the use of
prescription drugs. FDA regulations (21
CFR 201.57) describe the content of
required product labeling, and FDA
reviewers ensure that labeling contains
accurate and complete information
about the known risks and benefits of
each drug. This data collection and
analysis is designed to identify
knowledge gaps that FDA could then
address, which would ultimately
improve decision making and
potentially improve health outcomes.
The project will use ‘‘mental
modeling,’’ a qualitative research
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
method that compares a model of the
decision-making processes of a group or
groups to an ‘‘expert model’’ of the same
decision-making processes developed
from expert knowledge and experience.
In this study, the decision models of
certain health care providers concerning
treatment options for pregnant and
nursing women will be compared to an
expert model concerning such treatment
options that was derived from the
knowledge and experience of FDA
reviewers responsible for product
labeling. FDA will use telephone
interviews to determine from the health
care providers the factors that influence
their treatment decisions for pregnant
and nursing women with chronic
conditions. A comparison between
expert and health care provider models
based on the collected information may
identify consequential knowledge gaps
that can be redressed through messages
or information campaigns designed by
FDA.
Using a protocol derived from the
research that resulted in the ‘‘expert
model,’’ trained interviewers will
conduct one-on-one telephone
discussions with 24 to 30 members of
each of 2 categories of health care
providers (described in the following
paragraph) who provide health care
services to pregnant and nursing
women.
The two categories of health care
providers are:
(1) Those who directly care for
pregnant and nursing women, including
obstetricians, OB/GYNs (obstetrician/
gynecologists), nurse midwives, and
primary care practitioners.
(2) Selected specialties of healthcare
providers who directly care for women
of reproductive age who have chronic
health conditions (allergists,
psychiatrists, neurologists, and
cardiologists).
In the Federal Register of December
11, 2007 (72 FR 70328), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\25AUN1.SGM
25AUN1
50031
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
60
1
1 There
Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19653 Filed 8–22–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0453]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations Under
the Federal Import Milk Act
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PRODPC60 with NOTICES
Hours per
Response
1
Total Hours
1.0
60.0
are no capital costs or operating and maintenance costs for this information collection.
The study will involve about 60
respondents and take approximately 1
hour each to complete. These estimates
are based on the contractor’s extensive
experience with mental models
research. FDA conducted pretests of the
mental models protocol with six health
care providers. These resulted in the
current protocol.
ACTION:
Total Annual
Responses
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 reporting and recordkeeping
requirements of FDA’s regulations
implementing the Federal Import Milk
Act (FIMA).
DATES: Submit written or electronic
comments on the collection of
information by October 24, 2008.
ADDRESSES: Submit electronic
comments on the collection of
VerDate Aug<31>2005
15:18 Aug 22, 2008
Jkt 214001
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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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
PO 00000
Frm 00050
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.
Regulations Under the Federal Import
Milk Act—21 CFR Part 1210 (OMB
Control Number 0910–0212)—Extension
Under FIMA (21 U.S.C. 141–149),
milk or cream may be imported into the
United States only by the holder of a
valid import milk permit (21 U.S.C.
141). Before such permit is issued: (1)
All cows from which import milk or
cream is produced must be physically
examined and found healthy; (2) if the
milk or cream is imported raw, all such
cows must pass a tuberculin test; (3) the
dairy farm and each plant in which the
milk or cream is processed or handled
must be inspected and found to meet
certain sanitary requirements; (4)
bacterial counts of the milk at the time
of importation must not exceed
specified limits; and (5) the temperature
of the milk or cream at time of
importation must not exceed 50° F (21
U.S.C. 142).
FDA’s regulations in part 1210 (21
CFR part 1210) implement the
provisions of FIMA. Sections 1210.11
and 1210.14 require reports on the
sanitary conditions of, respectively,
dairy farms and plants producing milk
and/or cream to be shipped to the
United States. Section 1210.12 requires
reports on the physical examination of
herds, while § 1210.13 requires the
reporting of tuberculin testing of the
herds. In addition, the regulations in
part 1210 require that dairy farmers and
plants maintain pasteurization records
(§ 1210.15) and that each container of
milk or cream imported into the United
States bear a tag with the product type,
permit number, and shipper’s name and
address (§ 1210.22). Section 1210.20
requires that an application for a permit
to ship or transport milk or cream into
the United States be made by the actual
shipper. Section 1210.23 allows permits
to be granted based on certificates from
accredited officials.
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 73, Number 165 (Monday, August 25, 2008)]
[Notices]
[Pages 50030-50031]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19653]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0087] (formerly Docket No. 2007N-0461)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Mental Models Study
of Communicating With Health Care Providers About the Risks and
Benefits of Prescription Drug Use for Pregnant and Nursing Women With
Chronic Conditions
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
September 24, 2008.
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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-NEW and title,
``Mental Models Study of Communicating with Health Care Providers about
the Risks and Benefits of Prescription Drug Use for Pregnant and
Nursing Women with Chronic Conditions.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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.
Mental Models Study of Communicating With Health Care Providers About
the Risks and Benefits of Prescription Drug Use for Pregnant and
Nursing Women With Chronic Conditions
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)).
The proposed information collection will help FDA advance public
health by identifying misperceptions and knowledge gaps about how
health care providers use information to make decisions about the use
of prescription drugs for the targeted patient groups. Knowledge of
these misperceptions and gaps provides opportunities for FDA to target
its communications more precisely to such gaps and areas of
misperception in health care providers' mental models regarding
treatment decisions.
FDA engages in various communication activities to ensure that
patients and health care providers have the information they need to
make informed decisions about treatment options, including the use of
prescription drugs. FDA regulations (21 CFR 201.57) describe the
content of required product labeling, and FDA reviewers ensure that
labeling contains accurate and complete information about the known
risks and benefits of each drug. This data collection and analysis is
designed to identify knowledge gaps that FDA could then address, which
would ultimately improve decision making and potentially improve health
outcomes.
The project will use ``mental modeling,'' a qualitative research
method that compares a model of the decision-making processes of a
group or groups to an ``expert model'' of the same decision-making
processes developed from expert knowledge and experience. In this
study, the decision models of certain health care providers concerning
treatment options for pregnant and nursing women will be compared to an
expert model concerning such treatment options that was derived from
the knowledge and experience of FDA reviewers responsible for product
labeling. FDA will use telephone interviews to determine from the
health care providers the factors that influence their treatment
decisions for pregnant and nursing women with chronic conditions. A
comparison between expert and health care provider models based on the
collected information may identify consequential knowledge gaps that
can be redressed through messages or information campaigns designed by
FDA.
Using a protocol derived from the research that resulted in the
``expert model,'' trained interviewers will conduct one-on-one
telephone discussions with 24 to 30 members of each of 2 categories of
health care providers (described in the following paragraph) who
provide health care services to pregnant and nursing women.
The two categories of health care providers are:
(1) Those who directly care for pregnant and nursing women,
including obstetricians, OB/GYNs (obstetrician/gynecologists), nurse
midwives, and primary care practitioners.
(2) Selected specialties of healthcare providers who directly care
for women of reproductive age who have chronic health conditions
(allergists, psychiatrists, neurologists, and cardiologists).
In the Federal Register of December 11, 2007 (72 FR 70328), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 50031]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
60 1 1 1.0 60.0
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs for this information collection.
The study will involve about 60 respondents and take approximately
1 hour each to complete. These estimates are based on the contractor's
extensive experience with mental models research. FDA conducted
pretests of the mental models protocol with six health care providers.
These resulted in the current protocol.
Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19653 Filed 8-22-08; 8:45 am]
BILLING CODE 4160-01-S
