SUPPORTING STATEMENT
Terms of Clearance: None.
1. Circumstances
Making the Collection of Information Necessary
Section
403(r)(3)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C
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 promulgated by the Secretary 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/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.
We request OMB approval for extension of the following information collection requirements contained in § 101.82:
21 CFR 101.82 -- Recordkeeping
Requires food manufacturers to retain, and make available to regulatory officials, records concerning the ratio of soy protein to other sources of protein in a food product bearing a soy protein/CHD health claim.
2. Purpose
and Use of the Information Collection
The
information is used by FDA during inspection review of firms’
label claims to determine the basis of soy protein/CHD health claims.
The purpose of the information collection is to permit calculation
of the ratio of soy protein to other sources of protein in a food
when that food bears a soy protein/CHD health claim. The agency
believes that requiring records retention in this circumstance for
soy protein/CHD health claims is necessary for the efficient
enforcement of the FD&C
Act. Without access to
this information, FDA would be unable to ensure that food products
that contain non-soy proteins comply with the requirements for the
soy protein/CHD health claim.
Description of Recordkeepers: Recordkeepers include businesses engaged in the manufacture of foods containing soy and other proteins that bear soy protein/CHD health claims. Respondents are from the private sector (for-profit businesses).
3. Use
of Improved Information Technology and Burden Reduction
The regulation does not specifically prescribe the use of automated, electronic, mechanical, or other technological techniques or other forms of information technology as necessary for use by firms. Companies are free to use whatever forms of information technology may best assist them in retaining the appropriate records and making them available to regulatory officials.
The
agency estimates that about ninety-five percent (95%) of the
recordkeeping will be maintained electronically in the next three
years.
4. Efforts
to Identify Duplication and Use of Similar Information
No
duplication of Federal regulations concerning the regulation for a
health claim for soy protein/CHD is likely because of the clear
Congressional authorization that FDA promulgate regulations
pertaining to health claims for foods as opposed to the jurisdiction
of the U.S. Department of Agriculture (meats and poultry) and the
Federal Trade Commission (advertising).
5. Impact
on Small Businesses or Other Small Entities
FDA
estimates that ten percent (10%) of recordkeepers are small
businesses. The notification procedures are no more burdensome for
small businesses than for large. The requirements are the minimum
requirements for the health claim for soy protein and CHD.
FDA aids small businesses in complying with its requirements through
the agency’s Regional Small Business Representatives and
through the scientific and administrative staffs within the agency.
FDA has provided a Small Business Guide on the agency’s website
at http://www.fda.gov/oc/industry/.
6. Consequences
of Collecting the Information Less Frequently
Data
collection occurs occasionally. There
are no consequences to Federal program or policy activities if the
information is not collected or is collected less frequently. Under
the regulations, a food manufacturer could not use a soy protein/CHD
health claim on a food product containing non-soy sources of protein
if it did not retain the appropriate records for possible review by
regulatory officials.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments
in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the Federal Register of November 16, 2011 (76 FR 71040). No comments were received.
9. Explanation
of Any Payment or Gift to Respondents
FDA does not provide any
payments or gifts
to respondents.
10. Assurance
of Confidentiality Provided to Respondents
Information
that is trade secret or confidential is subject to FDA's regulations
on the release of information, 21 CFR Part 20.
12. Estimates of Annualized Burden Hours and Costs
12
a. Annualized Hour Burden Estimate
Description
of Recordkeepers:
Recordkeepers include businesses engaged in the manufacture of foods
containing soy and other proteins that bear soy protein/CHD health
claims. Respondents
are from the private sector (for-profit businesses).
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1 |
|||||
21 CFR Section |
No. of Recordkeepers |
No. of Records per Recordkeeper |
Total Annual Records |
Average Burden per Recordkeeping |
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/CHD 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 § 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.
12 b. Annualized Cost Burden Estimate
Estimated Annualized Cost for the Burden Hours
FDA estimates the annualized burden hour cost to a respondent for retention and disclosure of the required records to be approximately $2,133. FDA estimates a recordkeeper’s average wage to be that of a Federal government employee at the GS-13/Step-1 rate for the Washington-Baltimore locality pay area for the year 2012, which makes the annual wage cost for retention and disclosure approximately $1,066.50 (25 hours x $42.66 per hour). To account for overhead, this cost is increased by 100%, making the total estimated burden hour cost to the recordkeepers $2,133.
13. Estimates
of Other Total Annual Cost Burden to Recordkeepers
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized
Cost to Federal
Government
FDA’s
review of the retained records would generally occur as part of its
scheduled inspection of a food firm. FDA estimates that its review
of the retained records would take one hour per product (25 products
x one hour = 25 hours). Thus, FDA estimates the annual cost to the
Federal Government to be 25 hours at rate of $42.66/hour,
the GS-13/Step-1
rate for the Washington-Baltimore locality pay area for the year 2012
(25 hours x $42.66/hour
= $1,066.50).
To account for overhead, this cost is increased by 100%, making the
total estimated annual cost to the Federal Government $2,133.
15. Explanation
for Program Changes or Adjustments
There is no change in the burden estimate.
16. Plans for Tabulation and Publication and Project Time Schedule
The information obtained from this information collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There
are no reasons why display of the expiration date for OMB approval of
the information collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | dhc |
| File Modified | 2012-04-18 |
| File Created | 2012-04-18 |