Food and Drug Administration, HHS.
Notice.
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
Submit written or electronic comments on the collection of information by February 11, 2008.
Submit electronic comments on the collection of information to:
Jonna Capezutto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659.
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
With respect to the following collection of information, FDA invites comments on: (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.
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 a model of the same decision-
Using a protocol derived from the research that resulted in the “expert model,” trained interviewers will conduct one-on-one telephone discussions with about 25 members of 2 categories of health care providers (described below) who provide health care services to pregnant or 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 general practitioners.
(2) Those who directly care for women of reproductive age with significant chronic health conditions (e.g., allergists, psychiatrists, or cardiologists).
FDA estimates the burden of this collection of information as follows:
The study will involve about 54 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 three health care providers. These resulted in the current protocol.