[Federal Register Volume 67, Number 200 (Wednesday, October 16, 2002)]
[Notices]
[Pages 63931-63932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26327]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0284]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Food Labeling: Health Claims; Record Retention 
Requirements for the Soy Protein and Risk of Coronary Heart Disease 
Health Claim

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
November 15, 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.

Food Labeling: Health Claims; Record Retention Requirements for the Soy 
Protein and Risk of Coronary Heart Disease Health Claim--21 CFR 
101.82(c)(2)(ii)(B) (OMB Control Number 0910-0428)--Extension

    This regulation authorizes a health claim for food labels about soy 
protein and coronary heart disease (CHD). Section 403(r)(3)(A)(i) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(3)(A)(i)) 
provides for the use of food label statements characterizing a 
relationship of any nutrient of the type required to be in the label or 
labeling of the food to a disease or a health related condition only 
where that statement meets the requirements of the regulations issued 
by the Secretary of Health and Human Services to authorize the use of 
such a health claim. To bear the soy protein and CHD health claim, 
foods must contain at least 6.25-gram soy protein per reference amount 
customarily consumed. Analytical methods for measuring total protein 
can be used to quantify the amount of soy protein in foods that contain 
soy as the sole source of protein. At the present time, there is no 
validated analytical methodology available to quantify the amount of 
soy protein in foods that contain other sources of protein. For these 
latter foods, FDA must rely on information known only to the 
manufacturer to assess compliance with the qualifying amount of soy 
protein. Thus, FDA requires manufacturers to have and keep records to 
substantiate the amount of soy protein in a food that bears the health 
claim and contains sources of protein other than soy, and to make such 
records available to appropriate regulatory officials upon written 
request. The information collected includes nutrient databases or 
analyses, recipes or formulations, purchase orders for ingredients, or 
any other information that reasonably substantiates the ratio of soy 
protein to total protein.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 63932]]



                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                   Annual Frequency    Total Annual     Hours per
      21 CFR Section        No. of Recordkeepers   of Recordkeepers       Records     Recordkeeper   Total Hours
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101.82(c)(2)(ii)(B)                 25                    1                25              1            25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based upon its experience with the use of health claims, FDA 
estimates that only about 25 firms would be likely to market products 
bearing a soy protein/CHD health claim and that only, perhaps, one of 
each firm's products might contain nonsoy sources of protein along with 
soy protein. The records required to be retained by 21 CFR 
101.82(c)(2)(ii)(B) are the records, e.g., the formulation or recipe, 
that a manufacturer has and maintains as a normal course of its doing 
business. Thus, the burden to the food manufacturer is that involved in 
assembling and providing the records to appropriate regulatory 
officials for review or copying.

    Dated: October 9, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26327 Filed 10-15-02; 8:45 am]
BILLING CODE 4160-01-S