[Federal Register: January 14, 2009 (Volume 74, Number 9)]
[Notices]
[Page 2079-2080]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja09-71]
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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 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: 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