[Federal Register: November 15, 2005 (Volume 70, Number 219)]
[Page 69344-69345]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0317]

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.


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 
December 15, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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.

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)(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 (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. 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

[[Page 69345]]

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 data bases 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 August 23, 2005 (70 FR 49295), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. One comment was received that was not related to 
the information collection.
    FDA estimates the burden of the collection of information as 

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
                                                                     Annual frequency
              21 CFR section                 Number of respondents     per response    Total annual responses    Hours per response       Total hours
101.82(c)(2)(ii)(B)                                          25                  1                      25                       1                 25
\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/coronary heart disease 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 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: November 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22636 Filed 11-14-05; 8:45 am]