Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Recruitment and Retention of Pregnant Women into an Asthma Pregnancy Registry, 42901-42903 [E9-20407]
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Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—(OMB Control
Number 0523)—Extension
This regulation relates to agency
management and organization and has
two purposes. The first is to implement
section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)), as
added by the Safe Medical Devices Act
of 1990 (Public Law 101–629), and
amended by the Medical Device User
Fee and Modernization Act of 2002
(Public Law 107–250), by specifying
how FDA will determine the
organizational component within FDA
assigned to have primary jurisdiction for
the premarket review and regulation of
products that are comprised of any
combination of the following products:
(1) A drug and a device; (2) a device and
a biological product; (3) a biological
product and a drug; or (4) a drug, a
device, and a biological product. The
second purpose of this regulation is to
enhance the efficiency of agency
management and operations by
providing procedures for classifying and
determining which agency component
is designated to have primary
jurisdiction for any drug, device, or
biological product where such
jurisdiction is unclear or in dispute.
The regulation establishes a
procedure by which an applicant may
obtain an assignment or designation
determination. The regulation requires
42901
that the request include the identity of
the applicant, a comprehensive
description of the product and its
proposed use, and the applicant’s
recommendation as to which agency
component should have primary
jurisdiction, with an accompanying
statement of reasons. The information
submitted would be used by FDA as the
basis for making the assignment or
designation decision. Most information
required by the regulation is already
required for premarket applications
affecting drugs, devices, biological
products, and combination products.
The respondents will be businesses or
other for-profit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Part 3
43
1 There
Dated: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy
[FR Doc. E9–20409 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0373]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Mental Models
Study of Recruitment and Retention of
Pregnant Women into an Asthma
Pregnancy Registry
AGENCY:
Food and Drug Administration,
HHS.
pwalker on DSK8KYBLC1PROD with NOTICES
Total Annual
Responses
1
Hours per
Response
43
Total Hours
24
1,032
are no capital costs or operating and maintenance costs associated with this collection of information.
These burden estimates are based on
the number of applications FDA
received over the past 2 fiscal years.
ACTION:
Annual Frequency
per
Response
No. of
Respondents
21 CFR Section
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
VerDate Nov<24>2008
22:52 Aug 24, 2009
Jkt 217001
the information collection provisions of
the Mental Models Study of
Recruitment and Retention of Pregnant
Women into an Asthma Pregnancy
Registry. Pregnancy registries are a
common source of safety information
about medications used during
pregnancy. Together with other
information being collected, FDA will
use the results from this study to better
understand how pregnant women and
their health care providers make
decisions about participation in
pregnancy exposure registries. FDA will
use this new knowledge to develop and
recommend effective ways to support
the involvement of health care providers
and pregnant women in pregnancy
registries. Ultimately, greater
involvement of health care providers
and pregnant women in pregnancy
registries will improve the quality of
safety information gathered through the
registries. Better safety information will
support informed treatment decisions
by health care providers and women
who need prescription medications
while pregnant.
DATES: Submit written or electronic
comments on the collection of
information by October 26, 2009.
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.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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: Liz
Berbakos, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,
Elizabeth.Berbakos@fda.hhs.gov, 301–
796–3792.
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
E:\FR\FM\25AUN1.SGM
25AUN1
42902
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
pwalker on DSK8KYBLC1PROD with NOTICES
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.
Mental Models Study of Recruitment
and Retention into an Asthma
Pregnancy Registry
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 priorities, perceptions and
communication needs about how
pregnant women and their health care
providers make decisions about
participation in a pregnancy registry.
Understanding these priorities,
perceptions and communication needs
will foster more effective approaches to
recruitment of pregnant women into
pregnancy registries and full retention
of those women until the end of the
registry study period. Ultimately, early
enrollment and complete follow up of
women in pregnancy registries will
strengthen the quality of safety data
about use of needed medications during
pregnancy.
Before a medication is approved by
FDA for sale in the United States,
pregnant women are rarely included in
experimental research studies of the
medication because of concerns that the
experimental treatment may harm the
developing fetus and/or the pregnant
woman. As a result, when a medication
is approved for marketing in the United
States, little systematically collected
human data are available to define the
chance of serious side effects in
pregnant women and/or their
developing fetuses from use of the
medication during pregnancy.
A pregnancy registry is a research
study conducted after a medication has
been approved, during which pregnant
women being treated with the
medication are observed to identify
possible harms to the woman and/or to
her developing fetus. Pregnant women
voluntarily enroll in a pregnancy
registry; data about the pregnancy,
labor, delivery and newborn are
collected and analyzed to identify any
VerDate Nov<24>2008
22:52 Aug 24, 2009
Jkt 217001
serious adverse outcomes and consider
whether use of the medication may be
linked to any observed harm. The
quality of pregnancy registry data is
enhanced by enrollment of women early
in their pregnancy and by complete
follow up of all enrolled pregnancies to
the end of the registry study period.
Ultimately, high quality human
pregnancy data gathered through a
pregnancy registry and incorporated
into medical product labeling will
provide patients and their health care
provider’s useful information so they
may make informed medical treatment
decisions during pregnancy. Data
collected from this mental models study
will be incorporated into
recommendations for improvement of
the quality of pregnancy registries,
ultimately improving medical treatment
decisions, and potentially improving
pregnancy outcomes.
FDA engages in various regulatory
and communication activities to
support, and at times, require collection
of safety data through establishment of
a pregnancy registry. Pregnancy
exposure registries are a major source of
human pregnancy data for product
labeling; therefore, FDA is committed to
fostering ongoing improvements in the
design and conduct of pregnancy
registries. In 2002 FDA issued Guidance
for Industry entitled ‘‘Establishing
Pregnancy Exposure Registries’’ (see
https://www.fda.gov/downloads/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
ucm071639.pdf ). This guidance
provides an overview of pregnancy
exposure registries, describing when
and how to conduct a pregnancy
registry about treatment of a disease in
pregnancy or use of a specific
medication or group of medications
during pregnancy. The FDA Office of
Women’s Health maintains a list of
current pregnancy registries on its Web
site, see https://www.fda.gov/
ScienceResearch/SpecialTopics/
WomensHealthResearch/
ucm134844.htm. FDA regulations (21
CFR 201.57) describe the content of
required product labeling for
prescription drugs. On May 28, 2008,
FDA proposed major revisions to
required product labeling to provide
better information about the effects of
medicines used during pregnancy.
Enactment of the Food, Drug and
Cosmetics Amendments Act of 2007
gave FDA new legal authority to require
post-approval studies to assess certain
safety concerns, including, in certain
situations, establishment of a pregnancy
registry. Through this data collection
and analysis, FDA will identify and
address the perceptions and
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
communication needs of pregnant
women and health care providers to
support their participation in pregnancy
registries.
The project will use ‘‘mental
modeling,’’ a qualitative research
method that compares a model of the
priorities, perceptions, communication
needs, and decision-making processes of
a group or groups to a model of the same
priorities, perceptions, communication
needs, and decision-making processes
developed from expert knowledge and
experience. In this study, the decision
models of women who are current or
potential participants in a pregnancy
registry and of health care providers
who have participated or might
participate in a pregnancy registry will
be derived through qualitative
structured interviews. The project
focuses on an asthma disease-based
pregnancy registry; the three cohorts to
be interviewed are described in detail in
the following paragraphs.
Using information gathered from the
interviews, the decision model about
pregnancy registry involvement for
pregnant women and health care
providers will be developed and then
compared to decision models about
pregnancy registry involvement that
were derived from experts in the fields
of obstetrical and asthma treatment
during pregnancy, design and conduct
of pregnancy registries, FDA medication
regulation, and biomedical ethics. FDA
will use telephone interviews with the
three cohorts to determine the priorities,
perceptions, communication needs and
other factors that influence decisions
about participation in a pregnancy
registry by pregnant women and health
care providers. A comparison between
an expert model and models based on
the information collected directly from
women and health care providers may
identify consequential perception,
priority and communication gaps that
can be redressed through strategic
efforts to foster involvement in
pregnancy registries designed by FDA or
others.
Using a protocol derived from the
research that resulted in the ‘‘expert
model,’’ trained interviewers will
conduct one-on-one telephone
discussions with a total of 60
individuals (20 individuals per cohort)
from the three cohorts described here:
(1) Potential Pregnancy Registry
Participants: women older than 18 years
who are currently being treated for
asthma and are pregnant or have been
pregnant within the past 18 months, and
who may or may not currently be
participating in a pregnancy registry;
(2) Current Pregnancy Registry
Participants: pregnant women older
E:\FR\FM\25AUN1.SGM
25AUN1
42903
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
than 18 years who are current
participants in any pregnancy registry
for a chronic condition; and
(3) Health Care Providers: to include
a mix of health care providers
(including specialists, obstetriciangynecologists, and primary care
providers) some who have participated
in a pregnancy registry and some who
have not participated in a pregnancy
registry.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency
per
Response
No. of
Respondents
60
Total Annual
Responses
1
Hours per
Response
1
Total Hours
1.0
Total
60.0
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
Dated: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20407 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
pwalker on DSK8KYBLC1PROD with NOTICES
60.0
Name of Committee: Peripheral and
Central Nervous System Drugs Advisory
Committee.
General Function of the Committee: To
provide advice and recommendations to the
agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on October 14, 2009, from 8 a.m. to 5 p.m.
Location: The Inn and Conference Center,
University of Maryland University College
(UMUC), Marriott Conference Centers, 3501
University Blvd. East, Adelphi, MD. The
hotel telephone number is 301–985–7300.
Contact Person: Diem-Kieu Ngo, Center for
Drug Evaluation and Research (HFD–21),
Food and Drug Administration, 5600 Fishers
Lane (for express delivery, 5630 Fishers
Lane, rm. 1093), Rockville, MD 20857, 301–
827–7001, FAX: 301–827–6776, e-mail:
diem.ngo@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
VerDate Nov<24>2008
00:41 Aug 25, 2009
Jkt 217001
8138 (301–443–0572 in the Washington, DC
area), code 3014512543. Please call the
Information Line for up-to-date information
on this meeting. A notice in the Federal
Register about last minute modifications that
impact a previously announced advisory
committee meeting cannot always be
published quickly enough to provide timely
notice. Therefore, you should always check
the agency’s Web site and call the
appropriate advisory committee hot line/
phone line to learn about possible
modifications before coming to the meeting.
Agenda: The committee will discuss new
drug application (NDA) 22–250, with the
proposed trade name AMAYA (fampridine)
10 milligram (mg) tablets, manufactured by
Acorda Therapeutics, Inc. The proposed
indication for this new drug product is to
improve walking ability in individuals with
multiple sclerosis (MS). MS is a neurological
disease that may cause a wide variety of
possible symptoms, including in some
patients difficulty in walking.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. If FDA is
unable to post the background material on its
Web site prior to the meeting, the background
material will be made publicly available at
the location of the advisory committee
meeting, and the background material will be
posted on FDA’s Web site after the meeting.
Background material is available at https://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate
advisory committee link.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
September 29, 2009. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those
desiring to make formal oral presentations
should notify the contact person and submit
a brief statement of the general nature of the
evidence or arguments they wish to present,
the names and addresses of proposed
participants, and an indication of the
approximate time requested to make their
presentation on or before September 21,
2009. Time allotted for each presentation
may be limited. If the number of registrants
requesting to speak is greater than can be
reasonably accommodated during the
scheduled open public hearing session, FDA
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
may conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by September 22, 2009.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Diem-Kieu
Ngo at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20380 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Pages 42901-42903]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20407]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0373]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Mental Models Study of Recruitment and Retention of
Pregnant Women into an Asthma Pregnancy Registry
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 provisions of
the Mental Models Study of Recruitment and Retention of Pregnant Women
into an Asthma Pregnancy Registry. Pregnancy registries are a common
source of safety information about medications used during pregnancy.
Together with other information being collected, FDA will use the
results from this study to better understand how pregnant women and
their health care providers make decisions about participation in
pregnancy exposure registries. FDA will use this new knowledge to
develop and recommend effective ways to support the involvement of
health care providers and pregnant women in pregnancy registries.
Ultimately, greater involvement of health care providers and pregnant
women in pregnancy registries will improve the quality of safety
information gathered through the registries. Better safety information
will support informed treatment decisions by health care providers and
women who need prescription medications while pregnant.
DATES: Submit written or electronic comments on the collection of
information by October 26, 2009.
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: Liz Berbakos, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, Elizabeth.Berbakos@fda.hhs.gov, 301-796-3792.
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
[[Page 42902]]
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.
Mental Models Study of Recruitment and Retention into an Asthma
Pregnancy Registry
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 priorities, perceptions and communication needs
about how pregnant women and their health care providers make decisions
about participation in a pregnancy registry. Understanding these
priorities, perceptions and communication needs will foster more
effective approaches to recruitment of pregnant women into pregnancy
registries and full retention of those women until the end of the
registry study period. Ultimately, early enrollment and complete follow
up of women in pregnancy registries will strengthen the quality of
safety data about use of needed medications during pregnancy.
Before a medication is approved by FDA for sale in the United
States, pregnant women are rarely included in experimental research
studies of the medication because of concerns that the experimental
treatment may harm the developing fetus and/or the pregnant woman. As a
result, when a medication is approved for marketing in the United
States, little systematically collected human data are available to
define the chance of serious side effects in pregnant women and/or
their developing fetuses from use of the medication during pregnancy.
A pregnancy registry is a research study conducted after a
medication has been approved, during which pregnant women being treated
with the medication are observed to identify possible harms to the
woman and/or to her developing fetus. Pregnant women voluntarily enroll
in a pregnancy registry; data about the pregnancy, labor, delivery and
newborn are collected and analyzed to identify any serious adverse
outcomes and consider whether use of the medication may be linked to
any observed harm. The quality of pregnancy registry data is enhanced
by enrollment of women early in their pregnancy and by complete follow
up of all enrolled pregnancies to the end of the registry study period.
Ultimately, high quality human pregnancy data gathered through a
pregnancy registry and incorporated into medical product labeling will
provide patients and their health care provider's useful information so
they may make informed medical treatment decisions during pregnancy.
Data collected from this mental models study will be incorporated into
recommendations for improvement of the quality of pregnancy registries,
ultimately improving medical treatment decisions, and potentially
improving pregnancy outcomes.
FDA engages in various regulatory and communication activities to
support, and at times, require collection of safety data through
establishment of a pregnancy registry. Pregnancy exposure registries
are a major source of human pregnancy data for product labeling;
therefore, FDA is committed to fostering ongoing improvements in the
design and conduct of pregnancy registries. In 2002 FDA issued Guidance
for Industry entitled ``Establishing Pregnancy Exposure Registries''
(see https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071639.pdf ). This
guidance provides an overview of pregnancy exposure registries,
describing when and how to conduct a pregnancy registry about treatment
of a disease in pregnancy or use of a specific medication or group of
medications during pregnancy. The FDA Office of Women's Health
maintains a list of current pregnancy registries on its Web site, see
https://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134844.htm. FDA regulations (21 CFR 201.57) describe the content of
required product labeling for prescription drugs. On May 28, 2008, FDA
proposed major revisions to required product labeling to provide better
information about the effects of medicines used during pregnancy.
Enactment of the Food, Drug and Cosmetics Amendments Act of 2007 gave
FDA new legal authority to require post-approval studies to assess
certain safety concerns, including, in certain situations,
establishment of a pregnancy registry. Through this data collection and
analysis, FDA will identify and address the perceptions and
communication needs of pregnant women and health care providers to
support their participation in pregnancy registries.
The project will use ``mental modeling,'' a qualitative research
method that compares a model of the priorities, perceptions,
communication needs, and decision-making processes of a group or groups
to a model of the same priorities, perceptions, communication needs,
and decision-making processes developed from expert knowledge and
experience. In this study, the decision models of women who are current
or potential participants in a pregnancy registry and of health care
providers who have participated or might participate in a pregnancy
registry will be derived through qualitative structured interviews. The
project focuses on an asthma disease-based pregnancy registry; the
three cohorts to be interviewed are described in detail in the
following paragraphs.
Using information gathered from the interviews, the decision model
about pregnancy registry involvement for pregnant women and health care
providers will be developed and then compared to decision models about
pregnancy registry involvement that were derived from experts in the
fields of obstetrical and asthma treatment during pregnancy, design and
conduct of pregnancy registries, FDA medication regulation, and
biomedical ethics. FDA will use telephone interviews with the three
cohorts to determine the priorities, perceptions, communication needs
and other factors that influence decisions about participation in a
pregnancy registry by pregnant women and health care providers. A
comparison between an expert model and models based on the information
collected directly from women and health care providers may identify
consequential perception, priority and communication gaps that can be
redressed through strategic efforts to foster involvement in pregnancy
registries designed by FDA or others.
Using a protocol derived from the research that resulted in the
``expert model,'' trained interviewers will conduct one-on-one
telephone discussions with a total of 60 individuals (20 individuals
per cohort) from the three cohorts described here:
(1) Potential Pregnancy Registry Participants: women older than 18
years who are currently being treated for asthma and are pregnant or
have been pregnant within the past 18 months, and who may or may not
currently be participating in a pregnancy registry;
(2) Current Pregnancy Registry Participants: pregnant women older
[[Page 42903]]
than 18 years who are current participants in any pregnancy registry
for a chronic condition; and
(3) Health Care Providers: to include a mix of health care
providers (including specialists, obstetrician-gynecologists, and
primary care providers) some who have participated in a pregnancy
registry and some who have not participated in a pregnancy registry.
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
---------------------------------------------------------------------------------------------------------------
60 1 1 1.0 60.0
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. 60.0
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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.
Dated: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20407 Filed 8-24-09; 8:45 am]
BILLING CODE 4160-01-S
