E7-5046. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information That They Provide to Pregnant Women

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 April 19, 2007.

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].

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Survey of Health Care Professionals on the Food Safety and Nutrition Information That They Provide to Pregnant Women

Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the nation's food supply. FDA is planning to conduct a survey of health care professionals to determine what information, advice, and recommendations they are offering to pregnant women about the following topics: (1) Methyl mercury and seafood consumption, (2) Listeriosis prevention, (3) weight control and nutrition, (4) dietary supplement usage, (5) food allergies, (6) Toxoplasmosis prevention, and (7) infant feeding practices. FDA is interested in obtaining this data since FDA has recently issued advice for pregnant women about food safety risks and diet risks such as mercury in seafood, Listeriosis, and Toxoplamosis. (“Food Safety for Moms-to-Be,” 2005 and “What You Need to Know about Mercury in Fish and Shellfish,” 2004). Data from this survey will be used to evaluate whether health care professionals are aware of this advice and if they are educating their patients about information in the FDA advisories.

FDA will also use this survey to get a better understanding of what resources health care professionals use to stay abreast of current practices for caring for pregnant women. This will help FDA provide timely recommendations to health care professionals that will reach the largest audience.

A sample of 400 obstetrician/gynecologists, 200 nurse practitioners, 200 nurse midwives, 200 physician assistants, and 200 dietitians from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) will be included in this survey. The sample of nurse practitioners, nurse midwives, and physician assistants will be drawn from those specializing in obstetrics. The samples will be randomly selected from lists obtained from national associations. The survey will be conducted using a mailed questionnaire. Cognitive interviews and a pretest will be conducted prior to fielding the survey.

In the Federal Register of June 2, 2006 (71 FR 32095), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received one comment responsive to the comment request.

(Comment) The comment suggests that FDA should expand the respondent universe of the survey to include all categories of health care providers that care for pregnant women.

(Response) FDA agrees that the survey universe should include samples drawn from all categories of health care providers that provide care for pregnant women. The current sampling plan calls for samples of 400 obstetrician/gynecologists, 200 nurse practitioners, 200 certified nurse midwives, 200 physician assistants, and 200 WIC nutrition educators.

Table 1.—Estimated Annual Reporting Burden¹

No. of Respondents	Annual Frequency Per Response	Total Annual Responses	Hours Per Response	Total Hours
1,200—Survey	1	1,200	.167	200.4
75—Pretest	1	75	.167	12.5
16—Cognitive Interview	1	16	.75	12
Total	1	1,291		224.9
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimate is based on FDA's experience with previous surveys.

Dated: March 15, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.