02-16343. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments on the collection of information by July 29, 2002.

ADDRESSES:

Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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.

Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (OMB Control Number 0910-0374)—Extension

Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA), provides that a food producer may market a food product whose label bears a nutrient content claim or a health claim that is based on an authoritative statement of a scientific body of the U.S. Government or the National Academy of Sciences. Under these sections of the act, a food producer that intends to use such a claim must submit a notification of its intention to use the claim 120 days before it begins marketing the product bearing the claim. In the Federal Register of June 11, 1998 (63 FR 32102), FDA announced the availability of a guidance entitled ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body.'' The guidance provides the agency's interpretation of terms central to the submission of a notification and the agency's views on the information that should be included in the notification. The agency believes that the guidance will enable food producers to meet the criteria for notifications that are established in section 403(r)(2)(G) and (r)(3)(C) of the act. In addition to the information specifically required by the act to be in such notifications, the guidance states that the notifications should also contain information on analytical methodology for the nutrient that is the subject of a claim based on an authoritative statement. FDA intends to review the notifications it receives to ensure that they comply with the criteria established for them by the act.

In the Federal Register of March 26, 2002 (67 FR 13786), the agency requested comments on the proposed information collection. One comment was received that did not pertain to the information collection.

FDA estimates the burden of this collection of information as follows:

Table 1.— Estimated Annual Reporting Burden¹

Basis of Burden	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Section 403(r)(2)(G) nutrient content claims		1	250	250
Section 403(r)(3)(c)	2	1	2	450	900
Guidance for notifications	3	1	3	1	3
Totals					1,153
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on FDA's experience with health claims and nutrient content claims and with other similar notification procedures that fall under its jurisdiction. Because the claims are based on authoritative statements of certain scientific bodies of the Federal Government or the National Academy of Sciences or one of its subdivisions, FDA believes that the information submitted with a notification will either be provided as part of the authoritative statement or readily available as part of the scientific literature to firms wishing to make claims. Presentation of a supporting bibliography and a brief balanced account or analysis of this literature should be fairly straightforward.

Dated: June 21, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.