E9-20407. 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 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, [e-mail], 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 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 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 Burden¹

No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per 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.