E8-19653. 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 ...

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: [phone], or e-mailed to [e-mail]. 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:

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
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.