
[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71040-71041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29478]



[[Page 71040]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0781]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 record retention 
requirements for the soy protein and coronary heart disease health 
claim.

DATES: Submit either electronic or written comments on the collection 
of information by January 17, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-3793.

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 these topics: (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.

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

    Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 343(r)(3)(A)) 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 promulgated by the Secretary of Health and Human 
Services to authorize the use of such a health claim. Section 101.82 
(21 CFR 101.82) of FDA's regulations authorizes a health claim for food 
labels about soy protein and the risk of coronary heart disease (CHD). 
To bear the soy protein and CHD health claim, foods must contain at 
least 6.25 grams of 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. However, 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 requirement that the food 
contain 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:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                       No. of records                   Average  burden
                           21 CFR section                                 No. of            per          Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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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 the Agency's experience with the use of health claims, 
FDA estimates that only about 25 firms would be likely to market 
products bearing a soy protein/coronary heart disease 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 Sec.  101.82(c)(2)(ii)(B) are the records, e.g., the 
formulation or recipe, that a

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manufacturer has and maintains as a normal course of its doing 
business. Thus, the burden to the food manufacturer is limited to 
assembling and retaining the records, which FDA estimates will take 1 
hour annually.

    Dated: November 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29478 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P


