[Federal Register Volume 67, Number 140 (Monday, July 22, 2002)]
[Notices]
[Pages 47819-47820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18464]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0284]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection of 
the record retention requirement of the soy protein/coronary heart 
disease health claim.

DATES: Submit written or electronic comments on the collection of 
information by September 20, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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: Under the PRA (44 U.S.C. 3501-3520) Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    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 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.

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

[[Page 47820]]

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:

           Table 1.--Estimated Annual Recordkeeping Burden\1\
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                               Annual      Total
  21 CFR        No. of      Frequency of   Annual    Hours per    Total
  Section   Recordkeepers  Recordkeeping  Records  Recordkeeper   Hours
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101.82(c)(         25              1          25           1         25
 2)(ii)(B)
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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 non-soy 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: July 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18464 Filed 7-19-02; 8:45 am]
BILLING CODE 4160-01-S