[Federal Register Volume 74, Number 9 (Wednesday, January 14, 2009)]
[Notices]
[Pages 2079-2080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0544]


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.

DATES: Fax written comments on the collection of information by 
February 13, 2009.

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: 202-395-6974, or e-mailed to [email protected]. 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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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.

[[Page 2080]]

Record Retention Requirements for the Soy Protein and Risk of Coronary 
Heart Disease Health Claim--(OMB Control Number 0910-0428--Extension)

    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. Section 
101.82 (Sec.  101.82) of FDA's regulations authorizes a health claim 
for food labels about soy protein and the risk of coronary heart 
disease. To bear the soy protein/coronary heart disease 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 foods 
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 October 23, 2008 (73 FR 63157), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. 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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                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
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101.82(c)(2)(ii)(                 25                  1                 25                  1                 25
 B)
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\1\ There are no capital costs or operating and maintenance costsassociated 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 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: January 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-573 Filed 1-13-09; 8:45 am]
BILLING CODE 4160-01-S