[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63157-63158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25336]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

-----------------------------------------------------------------------

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 
requirement of the soy protein/coronary heart disease health claim.

DATES: Submit written or electronic comments on the collection of 
information by December 22, 2008.

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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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)(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

[[Page 63158]]

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. 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 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 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                    No. of  Record-    Annual Frequency     Total Annual        Hours per
   21 CFR Part          keepers        of Recordkeeping       Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
101.82(c)(2)(ii)(                 25                  1                 25                  1                 25
 B)
----------------------------------------------------------------------------------------------------------------
\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 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25336 Filed 10-22-08; 8:45 am]
BILLING CODE 4160-01-S