0428 ss 6-6-2018 final

U.S. Food and Drug Administration
Record Retention Requirements for the Soy Protein/CHD Health Claim
21 CFR 101.82
OMB Control No. 0910-0428
SUPPORTING STATEMENT Part A: Justification
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 of Health and Human
Services to authorize the use of such a health claim. Section 101.82 (21 CFR 101.82) of
our regulations authorizes a health claim for food labels about soy protein and the risk of
coronary heart disease (CHD). Accordingly, we established this ICR in support of the
regulation. While we are currently proposing to revoke the regulation (RIN 0910-AH43)
as announced in the Federal Register of October 31, 2017 (82 FR 50324), the regulation
remains in effect.
Accordingly, we request extension of OMB approval for the information collection
provisions found in 21 CFR 101.82: Health claims: Soy protein and risk of coronary
heart disease (CHD).
2. Purpose and Use of the Information Collection
The information collection enables FDA to review food labeling to determine the basis of
soy protein/CHD health claims. Respondents are required to retain records for FDA
inspection regarding 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. Respondents to the
information collection 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. We estimate ninety-five percent (95%) of the
recordkeeping will be maintained electronically.

4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
We estimate ten percent (10%) of recordkeepers are small businesses, however we do not
believe the information collection imposes undue burden on small entities. We assist
small businesses in complying with our regulations through Regional Small Business
Representatives and through scientific and administrative staffs within the agency. We
also provide a Small Business Guide on our 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 programs or
policy activities if the information is not collected or is collected less frequently.
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 March 8, 2018 (83 FR 9856). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are provided to respondents to the information collection.
10. Assurance of Confidentiality Provided to Respondents
Company records such as nutrient databases or analyses, recipes or formulations, and
purchase orders for ingredients, which may be consulted or copied during FDA
inspections, often contain trade secret and confidential commercial information. This
information is safeguarded by section 301(j) of the FD&C Act and would be protected
from disclosure under the Freedom of Information Act (FOIA) under sections 552(a) and
(b) (5 U.S.C. 552(a) and (b)) and by part 20 of our regulations (21 CFR part 20).
11. Justification for Sensitive Questions
This information collection does not involve any questions that are of a personally
sensitive nature.

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12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1
21 CFR 101.82

Health claims: Soy
protein and risk of
coronary heart disease
(CHD)
1

No. of
Recordkeepers

No. of Records
per
Recordkeeper

25

1

Total
Annual
Records
25

Avg. Burden
per
Recordkeeping

Total
Hours

1

25

There are no capital costs or operating and maintenance costs associated with this collection of information.

Based upon our experience with the use of health claims, we estimate 25 firms market
products bearing a soy protein/CHD health claim and that, 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 limited to in assembling and retaining the
records, which we estimate will take 1 hour annually.
12b. Annualized Cost Burden Estimate
We estimate the annualized cost burden for assembling and retaining the required records
is $2,176. This estimate assumes 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 2018, which makes the annual wage cost for assembling and
retaining the required records approximately $1,162 (25 hours x $46.46 per hour). To
account for overhead, this cost is increased by 100%, making the total estimated burden
hour cost to the recordkeepers $2,324.
Activity
Assembling and
retaining required
records

Total Burden
Hours
25

Hourly Wage Rate
$92.92 ($46.46 x 2 for
overhead)

Total Respondent
Costs
$2,324

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection.

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14. Annualized Cost to the Federal Government
FDA review of the retained records occurs as part of scheduled firm inspections.
Assuming it takes one hour per product record review (25 products x one hour = 25
hours), we estimate the annual cost to the Federal government is 25 hours at the rate of
$46.46/hour (the GS-13/Step-1 rate for the Washington-Baltimore locality pay area for
the year 2018) (25 hours x $46.46/hour = $1,162). To account for overhead, we
multiplied this cost by 100%, making the total estimated annual cost to the Federal
government $2,324.
15. Explanation for Program Changes or Adjustments
We retain the currently approved burden for the information collection.
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.

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