70 FR 67 pgs. 18031-18032 - Agency Information Collection Activities; Proposed Collection;Comment Request; Guidance for Industry: Notification of a Health Claim orNutrient Content Claim Based on an Authoritative Statement of a ScientificBody
Type: NOTICEVolume: 70Number: 67Pages: 18031 - 18032
Docket number: [Docket No. 2005N-0124]
FR document: [FR Doc. 05-7024 Filed 4-7-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0124]
Agency Information Collection Activities; Proposed Collection;Comment Request; Guidance for Industry: Notification of a Health Claim orNutrient Content Claim Based on an Authoritative Statement of a ScientificBody
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing an opportunity for public comment on the proposed collection ofcertain information by the agency. Under the Paperwork Reduction Act of1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection ofinformation, including each proposed extension of an existing collection ofinformation, and to allow 60 days for public comment in response to thenotice. This notice solicits comments on the collection of informationassociated with the submission of notifications of health claims ornutrient content claims based on authoritative statements of scientificbodies of the U.S. Government.
DATES:
Submit written or electronic comments on thecollection of information by June 7, 2005.
ADDRESSES:
Submit electronic comments on the collectionof information to: http://www.fda.gov/dockets/ecomments .Submit written comments on the collection of information to the Division ofDockets Management (HFA-305), Food and Drug Administration, 5630Fishers Lane, rm 1061, Rockville, MD 20852. All comments should beidentified with the docket number found in brackets in the heading of thisdocument.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins,Office of Management Programs (HFA-250), Food and DrugAdministration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION:
Under the PRA (44U.S.C. 3501-3520), Federal agencies must obtain approval from theOffice of Management and Budget (OMB) for each collection of informationthey conduct or sponsor. "Collection of information" isdefined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agencyrequests or requirement that members of the public submit reports, keeprecords, or provide information to a third party. Section 3506(c)(2)(A) ofthe PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a60-day notice in the Federal Register concerning eachproposed collection of information, including each proposed extension of anexisting collection of information, before submitting the collection to OMBfor approval. To comply with this requirement, FDA is publishing notice ofthe proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invitescomments on these topics: (1) Whether the proposed collection ofinformation is necessary for the proper performance of FDA's functions,including whether the information will have practical utility; (2) theaccuracy of FDA's estimate of the burden of the proposed collection ofinformation, including the validity of the methodology and assumptionsused; (3) ways to enhance the quality, utility, and clarity of theinformation to be collected; and (4) ways to minimize the burden of thecollection of information on respondents, including through the use ofautomated collection techniques, when appropriate, and other forms ofinformation technology.
Guidance for Industry: Notification of a Health Claim or NutrientContent Claim Based on an Authoritative Statement of a Scientific Body (OMBControl Number 0910-0374)-Extension
Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug andCosmetic Act (the act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as amendedby the FDA Modernization Act of 1997 (FDAMA), provides that a food producermay market a food product whose label bears a nutrient content claim or ahealth claim that is based on an authoritative statement of a scientificbody of the U.S. Government or the National Academy of Sciences. Underthis section of the act, a food producer that intends to use such a claimmust submit a notification of its intention to use the claim 120 daysbefore it begins marketing the product bearing the claim. In the Federal Register of June 11, 1998 (63 FR 32102), FDA announcedthe availability of a guidance entitled "Guidance for Industry:Notification of a Health Claim or Nutrient Content Claim Based on anAuthoritative Statement of a Scientific Body." The guidance providesthe agency's interpretation of terms central to the submission of anotification and the agency's views on the information that should beincluded in the notification. The agency believes that the guidance willenable food producers to meet the criteria for notifications that areestablished in section 403(r)(2)(G) and (r)(3)(C) of the act. In additionto the information specifically required by the act to be in suchnotifications, the guidance states that the notifications should alsocontain information on analytical methodology for the nutrient that is thesubject of a claim based on an authoritative statement. FDA intends toreview the notifications the agency receives to ensure that they complywith the criteria established by the act.
FDA estimates the burden of this collection of information asfollows:
| Section of the Act/Basis of Burden | No. of Respondents | No. of Responses per Respondent | Total Annual Responses | Hours per Response | Total Hours | ||||
|---|---|---|---|---|---|---|---|---|---|
| 403(r)(2)(G) (nutrient contentclaims) | 1 | 1 | 1 | 250 | 250 | ||||
| 403(r)(3)(C) (health claims) | 2 | 1 | 2 | 450 | 900 | ||||
| Guidance for notifications | 3 | 1 | 3 | 1 | 3 | ||||
| Total | 1,153 | ||||||||
| 1 There are no capital costs or operating andmaintenance costs associated with this collection of information. | |||||||||
These estimates are based on FDA's experience with health claims,nutrient content claims, and other similar notification procedures thatfall under our jurisdiction. Because the claims are based on anauthoritative statement of certain scientific bodies of the FederalGovernment or the National Academy of Sciences or one of its subdivisions,FDA believes that the information submitted with a notification will eitherbe provided as part of the authoritative statement, or readily available aspart of the scientific literature to firms wishing to make claims.Presentation of a supporting bibliography and a brief balanced account oranalysis of this literature should be fairly straightforward.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7024 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S