Notice: Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Mental Models Study 
of Recruitment and Retention of Pregnant Women Into An Asthma Pregnancy 
Registry

Federal Register: February 26, 2010 (Volume 75, Number 38)              
                  Page 8957-8959

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 March 
29, 2010.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title Mental Models Study of Recruitment and Retention of Pregnant 
Women Into An Asthma Pregnancy Registry. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

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 Recruitment and Retention of Pregnant Women Into 
An Asthma Pregnancy Registry--(OMB Control Number 0910)--NEW

    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 
followup 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 
followup of all enrolled pregnancies to the end of the registry study 
period. Ultimately, high quality human

[[Page 8958]]

pregnancy data gathered through a pregnancy registry and incorporated 
into medical product labeling will provide patients and their health 
care providers 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 a 
guidance document 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. FDA's 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. In the Federal 
Register of May 29, 2008 (73 FR 30831), FDA published a proposed rule 
to amend the agency's regulations for required labeling for drugs and 
biologics when they are used during pregnancy or breastfeeding. When 
finalized, these revised regulations will improve labeling information 
about the effects of medicines used during pregnancy and breastfeeding. 
Enactment of the Food and Drug Administration Amendments Act of 2007 
gave FDA new legal authority to require postapproval 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 decisionmaking processes of a group or groups 
to a model of the same priorities, perceptions, communication needs, 
and decisionmaking 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. Once developed, that decision model will 
be 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. These critical areas can 
then 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 1-on-1 telephone 
discussions with a total of 60 individuals (20 individuals per cohort) 
from the 3 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 
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.
    In the Federal Register of August 25, 2009 (74 FR 42901), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received stating that the 
stakeholder agreed that the proposed study was valid and could provide 
information to support development of a clinically useful pregnancy 
registry. The stakeholder requested information about how physicians 
would be chosen for study participation and which subspecialties would 
be represented in the cohort. Noting that diversity would be 
beneficial, the comment suggested inclusion of physicians practicing in 
the following areas: Allergy/immunology, pulmonology, obstetrics and 
gynecology, and primary care.
    FDA's response is, the Health Care Providers (HCPs) cohort for this 
mental models study will include a mix of targeted or known HCPs who 
have participated in pregnancy registries, a variety of specialists who 
may or may not have participated in pregnancy registries, and Ob/Gyn 
and primary care providers who may or may not have participated in 
pregnancy registries. Various resources may be used to identify a 
diverse sample of prospective primary care and subspecialty HCPs who 
practice in a variety of clinical settings. Examples might include 
physicians with privileges at or who refer/transfer patient care to 
tertiary care hospitals and HCPs who have contacted the Organization 
for Teratology Information Specialists regarding drug exposures during 
pregnancy or about pregnancy registry enrollment. The cohort of 20 HCPs 
will be interviewed by trained interviewers in 1-on-1 in-depth 
telephone interviews. The telephone interactions will take 
approximately 60 minutes and will include approximately 45 minutes of 
structured interview.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 8959]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
      No. of         Annual Frequency      Total Annual
    Respondents        per Response          Responses         Hours per  Response            Total Hours
----------------------------------------------------------------------------------------------------------------
60                                   1                  60                        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: February 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3912 Filed 2-25-10; 8:45 am]
BILLING CODE 4160-01-S