[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Pages 42901-42903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20407]


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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.

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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 http://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, [email protected], 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 http://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 
http://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\
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                                       Annual Frequency     Total Annual        Hours per
         No. of  Respondents            per  Response        Responses           Response        Total Hours
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60                                                    1                  1                1.0             60.0
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Total                                 .................  .................  .................             60.0
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\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