0256 Supporting Statement for Selenium in Labeling of Infant Formula 2015

Infant Formula Requirements:
Third-Party Disclosure of Selenium
OMB Control No. 0910-0256
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 412(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
350a(i)) establishes requirements for the nutrient content of infant formulas. Under
section 412(i)(2) (21 U.S.C. 350a(i)(2)), the Secretary of Health and Human Services is
authorized to revise the list of required nutrients and the required level for any required
nutrient, which authority has been delegated to the Commissioner of Food and Drugs.
The table in section 412(i) and FDA regulations, 21 CFR 107.100, specify that infant
formulas must contain 29 nutrients; minimum levels for each nutrient and maximum
levels for nine of the nutrients are also specified.
At the time FDA established nutrient specifications for infant formula; selenium was not
recognized as an essential nutrient and was not one of the nutrients required by statute in
infant formula. As explained in detail below, selenium has subsequently been recognized
as an essential nutrient. Therefore, we are amending the nutrient specifications for infant
formula in § 107.100 to include selenium as a required nutrient and to establish minimum
and maximum values for selenium. The final rule revises §107.10(a) to require that
selenium be listed in the nutrient list on the label for all infant formulas. In particular, in
the nutrient list, selenium would be required to be listed between iodine and sodium and
the amount per 100 calories declared; and, because selenium would be a required
ingredient in infant formula, selenium would also be required to be declared in the
formula’s ingredient statement by its common or usual name and positioned according to
the descending order of its predominance in the formula, under § 101.4. The present
version of § 107.10(a) is approved by OMB in accordance with the PRA and has been
assigned OMB control number 0910-0256. This final rule modifies the information
collection associated with the present version of § 107.10(a) by adding 23 hours to the
burden associated with the collection at IC number 7, “Infant Formula: Labeling (3rd
Party) Requirements.”
FDA requests the revision of OMB approval of the information collection provisions in
the following citation:
21 CFR 107.10(a) - Third Party Disclosure
Requires specific nutrient information be included in the labeling of infant formula.

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2. Purpose and Use of the Information Collection
The nutrient information disclosed by manufacturers on the infant formula label is
necessary to inform purchasers of the value of the infant formula. This information is
used by consumers when purchasing, storing and preparing infant formulas. The
information is also used by firms and FDA to confirm that the nutrient requirements of
the FD&C Act have been met.
Description of Respondents: Respondents to this information collection are
manufacturers of infant formula. Respondents are from the private sector (for-profit
businesses).
3. Use of Improved Information Technology and Burden Reduction
FDA estimates that 100% of the respondents will use electronic means to fulfill the
agency’s requirement or request.
4. Efforts to Identify Duplication and Use of Similar Information
This data collection does not duplicate any other information that is already available to
FDA.
5. Impact on Small Businesses or Other Small Entities
FDA finds that, under the Regulatory Flexibility Act (5 U.S.C. 605(b)), this final rule will
not have a significant impact on a substantial number of small entities, as only one firm is
affected by this rule and it is considered large by Small Business Administration
standards.
6. Consequences of Collecting the Information Less Frequently
Respondents will respond on an occasional basis, as prescribed by the final rule.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
FDA published a proposed rule on April 16, 2013 (78 FR 22442) requesting public
comment on the affected information collection provision. Comments received to the
proposed rule are addressed in the preamble of the agency’s final rule, although no
comments specifically addressed the four information collection topics solicited under the
PRA.

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9. Explanation of Any Payment or Gift to Respondents
There are no payments or gifts to respondents associated with this collection of
information.
10. Assurance of Confidentiality Provided to Respondents
There is no assurance of confidentiality associated with the requirement that selenium be
listed in the nutrient list on the label for all infant formulas. Information submitted to
FDA under the infant formula regulations may contain trade secret and commercial
confidential information. Only information that is releasable under the agency’s
regulations in 21 CFR part 20 would be released to the public. This information is also
safeguarded by Section 301(j) of the 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)).
11. Justification for Sensitive Questions
This collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate

FDA estimates the burden of the revision to the collection of information as follows:

21 CFR
Section
§107.10
Nutrient
labeling for
infant formula
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Table 1.--Estimated Annual Third-Party Disclosure Burden1
No. of
No. of
Total
Avg.
Total
Total
Respondents
Disclosures per Annual
Burden per
Hours Capital
Respondent
Disclosures Disclosure
Cost
1
46
46
0.5
23 $765,439
(30 mins.)

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

The final rule modifies the information collection associated with the present version of
§ 107.10(a) by adding 23 hours to the burden associated with the collection. A
manufacturer not in compliance with the new minimum and maximum levels for
selenium in infant formula would be required to make a one-time change to the nutrient
list information disclosed to consumers on the label of its infant formula, to account for
the required change in the amount of selenium in its products.
FDA has concluded that the additional burden to disclose selenium in the ingredient
statement resulting from the revision to §107.10 is negligible because all U.S. infant

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formula manufacturers currently add selenium as an ingredient to their infant formula
products, and all manufacturers currently disclose the selenium in the ingredient
statement, as specified by §101.4. Additionally, all manufacturers currently disclose
selenium in the nutrient list, as required by §107.10(b)(5). Only one manufacturer
produces infant formula that would not meet the requirements of the rule and would thus
need to be reformulated. Under §107.10(a)(2), this one manufacturer would need to
make a one-time labeling change to modify its nutrient list to account for the addition of
more selenium to its infant formula.
The third-party disclosure burden consists of the setup time required to design a revised
label and incorporate it into the manufacturing process. Based upon its knowledge of
food and dietary supplement labeling, FDA estimates that the affected manufacturer
would require less than 0.5 hour per product to modify the label’s nutrient list to reflect
the addition of more selenium to the product. The one-time third-party disclosure burden
for the final rule is estimated in table 1 of this document.
Additionally, because of the change in formulation of its products required by the rule, a
manufacturer would need to determine whether it is required to make a one-time
submission to FDA before the first processing of its formulas, as required by section
412(d)(3) of the FD&C Act. This reporting requirement is approved by OMB under
OMB control number 0910-0256. The current hour burden approved by OMB for section
412(d) of the FD&C Act is 10 hours per report. Based on the agency’s experience with
infant formula submissions, FDA estimates that the affected manufacturer will submit
one report that will cover all 46 reformulated infant formulas. In a future request for
extension of the 0910-0256 information collection, FDA will include and consolidate this
estimate into the existing collection.
b. Annualized Cost Burden Estimate
We measure costs based on the best available information from government, industry,
and academic sources. We list some common conventions used throughout the cost
analysis here. All wage rates used come from the Bureau of Labor Statistics,
Occupational Employment Statistics, May 2012, National Industry-Specific Occupational
Employment and Wage Estimates (available at:
http://www.bls.gov/oes/current/oes191012.htm).
Wages are increased by 50 percent to account for overhead. Food Scientist and
Technologist: Our estimate for the mean hourly wage rate for a farm operator or
manager is $46.26 including fringe benefits and other overhead.

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First Year Cost
Type of
Respondent
Line Worker—
Food Scientist

Total Burden
Hours

Hourly Wage Rate

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$46.26

Total
Respondent
Costs
$1,064

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
The final column of Table 1 (Annualized Hour Burden Estimate; question 12a. above)
shows an estimated capital cost of $765,439. This figure represents the cost we attribute
to designing a revised label and incorporating it into the manufacturing process. This
figure assumes that, over a longer period of time, any additional labeling changes will be
coordinated, thus minimizing the cost.
14. Annualized Cost to the Federal Government
These activities will be covered by existing resource allocations. In the 2010 supporting
statement, FDA estimated the annualized cost to the Federal government associated with
the entire 0910-0256 information collection to be as follows. FDA consumer safety
officers review submitted notifications with input from technical reviewers. The dollar
estimate for FDA consumer safety officer wages corresponds roughly to GS level 13, step
6, which is $95,459 annually per the 2010 GS Salary Table. These costs are estimated at
3.3 person years (PY) or an approximate total of $315,014.70 ($95,459 X 3.3 PY =
$315,014.70).
FDA investigators currently inspect each manufacturing site annually and collect product
labels for review. The dollar estimate for FDA investigator wages corresponds roughly
to GS level 12, step 3, which is $73,396 annually per the 2010 GS Salary Table. It is
estimated that the agency expends approximately 1.3 PY on each firm for a total of 5.2
PY (1.3 PY X 4 = 5.2 PY) on enforcement activities associated with violations of these
regulations. The costs are estimated at a total of $381,592 ($73,396 X 5.2 PY =
$381,592). Thus, the total cost to the Federal government is $696,673.90.
15. Explanation for Program Changes or Adjustments
The final rule modifies the information collection 0910-0256 associated with the present
version of § 107.10(a) by adding 23 hours to the burden associated with the collection at
IC number 7, “Infant Formula: Labeling (3rd Party) Requirements.”
16. Plans for Tabulation and Publication and Project Time Schedule
These information collection requirements will not be published, tabulated or
manipulated.
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17. Reason(s) Display of OMB Expiration Date is Inappropriate
Approval to not display the expiration date of OMB approval is not being sought.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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