
[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Notices]
[Pages 26283-26284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

[[Page 26284]]


DATES: Fax written comments on the collection of information by June 4, 
2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0428. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

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.

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.
    In the Federal Register of November 16, 2011 (76 FR 71040), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
         21 CFR Section              Number of      records 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 on 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 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: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10647 Filed 5-2-12; 8:45 am]
BILLING CODE 4160-01-P


