# Agency Emergency Processing Request Under OMB Review > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A98-15484 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** June 11, 1998 - **Citation:** 63 FR 32102 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-0320] Agency Emergency Processing Request Under OMB Review 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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the submission of notifications of health claims or nutrient content claims based on authoritative statements of scientific bodies. This action is in response to provisions of the FDA Modernization Act of 1997 (FDAMA). DATES: Submit written comments on the collection of information by June 22, 1998. 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: Desk Officer for FDA. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223. SUPPLEMENTARY INFORMATION: 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 [[Page 32103]] 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. Notification of a Health Claim or a Nutrient Content Claim Based on an Authoritative Statement 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 FDAMA, provides that a food producer may market a food product whose label bears a nutrient claim or a health claim that is based on an authoritative statement of a scientific body of the Federal 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. Elsewhere in this issue of the Federal Register, FDA is announcing 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 a notification. 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 estimates the burden of this collection of information as follows: Table 1.--Estimated Annual Reporting Burden1 ---------------------------------------------------------------------------------------------------------------- No. of No. of Responses per Total Annual Hours per Total Annual Respondents Respondent Responses Response Hours ---------------------------------------------------------------------------------------------------------------- Guidance for Notifications 12 5 60 1 60 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The agency believes that this guidance will enable food producers to meet the criteria for notifications that are established in sections 403(r)(2)(G) and 403(r)(3)(C) of the act during the interim period while the agency is initiating notice-and-comment rulemaking in this matter. FDA intends to review the notifications it receives to ensure that they comply with the criteria established for them by the act. 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 be either provided as part of the authoritative statement or readily available to firms wishing to make claims. The hour burden estimates contained in Table 1 of this document are for the information collection requests in the guidance only and do not include statutory requirements specifically mandated by the act. FDA has requested emergency processing of this proposed collection of information under section 3507(j) of the PRA and 5 CFR 1320.13. The information is needed immediately to implement FDAMA, and it is essential to the agency's mission of protecting and promoting the public health. The use of normal clearance procedures would be likely to result in the prevention or disruption of this collection of information. Dated: June 3, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-15484 Filed 6-10-98; 8:45 am] BILLING CODE 4160-01-F --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-15484. Public record. Not legal advice.