0381 ss 6-15-2017

FOOD & DRUG ADMINISTRATION:
Food Labeling Regulations
OMB Control No. 0910-0381
SUPPORTING STATEMENT

A. Justification
1. Circumstances Making the Collection of Information Necessary
This information collection request supports food labeling regulations enforced by the
United States Food and Drug Administration (“FDA” or “we”). Specifically, food
labeling regulations require food producers to disclose to consumers and others specific
information about themselves or their products on the label or labeling of their products.
Related regulations require that food producers retain records establishing the basis for
the information contained in the label or labeling of their products and provide those
records to regulatory officials. Finally, certain regulations provide for the submission of
food labeling petitions to FDA. Regulations governing food labeling may be found in
parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105), and are issued under
the authority of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (the FPLA)
(15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and
721 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331,
342, 343, 348, 350, 371, and 379e). Most of the regulations derive from section 403 of
the FD&C Act, which provides that a food product shall be deemed to be misbranded if,
among other things, its label or labeling fails to bear certain required information
concerning the food product, is false or misleading in any particular, or bears certain
types of unauthorized claims. The disclosure requirements and other collections of
information in the regulations in parts 101, 102, 104, and 105 are necessary to ensure that
food products produced or sold in the United States are in compliance with the labeling
provisions of the FD&C Act and the FPLA.
Section 101.3 of our food labeling regulations requires that the label of a food product in
packaged form bear a statement of identity (i.e., the name of the product), including, as
appropriate, the form of the food or the name of the food imitated. Section 101.4
prescribes requirements for the declaration of ingredients on the label or labeling of food
products in packaged form. Section 101.5 requires that the label of a food product in
packaged form specify the name and place of business of the manufacturer, packer, or
distributor and, if the food producer is not the manufacturer of the food product, its
connection with the food product.
On August 29, 2016 (81 FR 59129), the Food and Drug Administration (FDA or we)
issued a final rule entitled, “Food Labeling; Technical Amendments,” revising 21 CFR
Parts 1, 100, 101, and 104. As a result, section 101.105 (21 CFR 101.105) became
section 101.7 (21 CFR 101.7). Section 101.7 specifies requirements for the declaration

of the net quantity of contents on the label of a food in packaged form and prescribes
conditions under which a food whose label does not accurately reflect the actual quantity
of contents may be sold, with appropriate disclosures, to an institution operated by a
Federal, State or local government.
Section 101.108 provides for the submission to us of a written proposal requesting a
temporary exemption from certain requirements of §§ 101.9 and 105.66 for the purpose
of conducting food labeling experiments with our authorization.
Section 101.9 requires that nutrition information be provided for all food products
intended for human consumption and offered for sale, unless an exemption in § 101.9(j)
applies to the product. In particular, § 101.9(c)(2)(ii) requires that the amount of trans
fatty acids present in a food must be declared on the nutrition label on a separate line
immediately under the line for the declaration of saturated fat. Section 101.9(g)(9)
provides that interested parties may submit to us requests for alternative approaches to
nutrition labeling requirements. Finally, § 101.9(j)(18) provides that firms claiming the
small business exemption from nutrition labeling must submit notice to us supporting
their claim exemption. We developed Form FDA 3570 to assist small businesses in
claiming the small business exemption from nutrition labeling. The form contains all the
elements required by § 101.9(j)(18).
Section 101.10 requires that restaurants provide nutrition information, upon request, for
any food or meal for which a nutrient content claim or health claim is made. Section
101.12(b) provides the reference amount that is used for determining the serving sizes for
specific products, including baking powder, baking soda, and pectin. Section 101.12(e)
provides that a manufacturer that adjusts the reference amount customarily consumed
(RACC) of an aerated food for the difference in density of the aerated food relative to the
density of the appropriate nonaerated reference food must be prepared to show us
detailed protocols and records of all data that were used to determine the density-adjusted
RACC. Section 101.12(g) requires that the label or labeling of a food product disclose
the serving size that is the basis for a claim made for the product if the serving size on
which the claim is based differs from the RACC. Section 101.12(h) provides for the
submission of petitions requesting that we change the reference amounts defined by
regulation.
Section 101.13 requires that nutrition information be provided in accordance with § 101.9
for any food product for which a nutrient content claim is made. Under some
circumstances, § 101.13 also requires the disclosure of other types of information as a
condition for the use of a nutrient content claim. For example, under § 101.13(j), if the
claim compares the level of a nutrient in the food with the level of the same nutrient in
another “reference” food, the claim must also disclose the identity of the reference food,
the amount of the nutrient in each food, and the percentage or fractional amount by which
the amount of the nutrient in the labeled food differs from the amount of the nutrient in
the reference food. It also requires that when this comparison is based on an average of
food products, this information must be provided to consumers or regulatory officials
upon request. Section 101.13(q)(5) requires that restaurants document and provide to

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appropriate regulatory officials, upon request, the basis for any nutrient content claims
they have made for the foods they sell.
Section 101.14(d)(2) and (d)(3) provides for the disclosure of nutrition information in
accordance with § 101.9 and, under some circumstances, certain other information as a
condition for making a health claim for a food product. Section 101.15 provides that, if
the label of a food product contains any representation in a foreign language, all words,
statements, and other information required by or under authority of the FD&C Act to
appear on the label must appear in both the foreign language and in English. Section
101.22 contains labeling requirements for the disclosure of spices, flavorings, colorings,
and chemical preservatives in food products. Section 101.22(i)(4) sets forth disclosure
and recordkeeping requirements pertaining to certifications for flavors designated as
containing no artificial flavors. Section 101.30 specifies the conditions under which a
beverage that purports to contain any fruit or vegetable juice must declare the percentage
of juice present in the beverage and the manner in which the declaration is to be made.
Section 101.36 requires that nutrition information be provided for dietary supplements
offered for sale, unless an exemption in § 101.36(h) applies. In particular, § 101.36(b)(2)
requires that the amount of trans fatty acids present in dietary supplements must be
declared on the nutrition label on a separate line immediately under the line for the
declaration of saturated fat. Section 101.36(e) permits the voluntary declaration of the
quantitative amount and the percent of Daily Value of a dietary ingredient on a “per day”
basis in addition to the required “per serving” basis, if a dietary supplement label
recommends that the dietary supplement be consumed more than once per day. Section
101.36(f)(2) cross-references the provisions in § 101.9(g)(9) for the submission to us of
requests for alternative approaches to nutrition labeling requirements. Also, §
101.36(h)(2) cross-references the provisions in § 101.9(j)(18) for the submission of small
business exemption notices. As noted above, we developed Form FDA 3570 to assist
small businesses in claiming the small business exemption from nutrition labeling. The
form contains all the elements required by § 101.36(h)(2). Section 101.36(e) permits the
voluntary declaration of the quantitative amount and the percent of Daily Value of a
dietary ingredient on a “per day” basis in addition to the required “per serving” basis, if a
dietary supplement label recommends that the dietary supplement be consumed more
than once per day.
Section 101.42 requests that food retailers voluntarily provide nutrition information for
raw fruits, vegetables, and fish at the point of purchase, and § 101.45 contains guidelines
for providing such information. Also, § 101.45(c) provides for the submission to us of
nutrient databases and proposed nutrition labeling values for raw fruit, vegetables, and
fish for review and approval.
Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify information that must be
disclosed as a condition for making particular nutrient content claims. Section 101.67
provides for the use of nutrient content claims for butter, and cross-references
requirements in other regulations for information declaration (§ 101.4) and disclosure of
information concerning performance characteristics (§ 101.13(d)). Section 101.69

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provides for the submission of a petition requesting that we authorize a particular nutrient
content claim by regulation. Section 101.70 provides for the submission of a petition
requesting that we authorize a particular health claim by regulation. Section
101.77(c)(2)(ii)(D) requires the disclosure of soluble fiber per serving in the nutrition
labeling of a food bearing a health claim about the relationship between soluble fiber and
a reduced risk of coronary heart disease. Section 101.79(c)(2)(iv) requires the disclosure
of the amount of folate in the nutrition label of a food bearing a health claim about the
relationship between folate and a reduced risk of neural tube defects.
Section 101.100(d) provides that any agreement that forms the basis for an exemption
from the labeling requirements of section 403(c), (e), (g), (h), (i), (k), and (q) of the
FD&C Act be in writing and that a copy of the agreement be made available to us upon
request. Section 101.100 also contains reporting and disclosure requirements as
conditions for claiming certain labeling exemptions (e.g., 101.100(h)).
Regulations in part 102 define the information that must be included as part of the
statement of identity for particular foods and prescribe related labeling requirements for
some of these foods. For example, § 102.22 requires that the name of a protein
hydrolysate will include the identity of the food source from which the protein was
derived.
Part 104, which pertains to nutritional quality guidelines for foods, cross-references
several labeling provisions found in part 101.
Part 105 contains special labeling requirements for hypoallergenic foods, infant foods,
and certain foods represented as useful in reducing or maintaining body weight.
We therefore request OMB approval of the information collection provisions found or
referenced in 21 CFR Parts 101, 102, 104, and 105; Form FDA 3570, Model Small
Business Nutrition Labeling Exemption Notice; and discussed in this supporting
statement.
2. Purpose and Use of the Information Collection
The purpose of our food labeling requirements is to allow consumers to be
knowledgeable about the foods they purchase. Nutrition labeling provides information
for use by consumers in selecting a nutritious diet. Other information enables a consumer
to comparison shop. Ingredient information also enables consumers to avoid substances
to which they may be sensitive. Petitions or other requests submitted to us provide the
basis for us to permit new labeling statements or to grant exemptions from certain
labeling requirements. Recordkeeping requirements enable us to monitor the basis upon
which certain label statements are made for food products and whether those statements
are in compliance with the requirements of the FD&C Act or the FPLA.
The primary user of the information to be disclosed on the label or labeling of food
products is the consumer that purchases the food product. Consumers will use the

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information to assist them in making choices concerning their purchase of a food product,
including choices related to substances that the consumer must avoid to prevent adverse
reactions. This information also enables the consumer to determine the role of the food
product in a healthful diet. Additionally, FDA intends to use the information to
determine whether a manufacturer or other supplier of food products is meeting its
statutory and regulatory obligations. Failure of a manufacturer or other supplier of food
products to label its products in compliance with section 403 of the FD&C Act and parts
101, 102, 104, and 105 of FDA’s food labeling regulations may result in a product being
misbranded under the FD&C Act and the firm and the product subject to regulatory
action.
The information submitted to FDA as a nutrient content claim or health claim petition
will be used by the agency in reaching a finding as to whether the petition meets the
requirements of the regulations for the issuance of regulations pertaining to nutrient
content or health claims and thereby ensuring that the public health is safeguarded. The
requirements in §§ 101.69 and 101.70 are those that FDA believes are necessary to fulfill
the requirements of the FD&C Act. The consequences of not collecting the information
required under these sections would be the inability of the agency to determine whether
the petition meets the requirements of the regulation and whether the proposed claims are
justified.
The information submitted to FDA for a nutrient content claim or health claim under the
notification process will be used by FDA to assure that a Scientific Body of the United
States Government or the National Academy of Sciences has published an authoritative
statement which is currently in effect about the level of the nutrient to which the nutrient
content claim refers or about the relationship between the nutrient and the disease or
health related condition to which the health claim refers, and that the claim is an accurate
representation of that statement.
The information collections that will be reported to FDA under the provisions of
§§ 101.9(j)(18) and 101.36(h)(2) will be from small businesses for the purpose of
claiming an exemption from nutrition labeling for low-volume food products. Under
section 403(q)(5)(E) of the FD&C Act, a low-volume food product is exempt from the
requirements for nutrition labeling if it is the subject of a notice from a small business
claiming the exemption provided by the Nutrition Labeling and Education Act
Amendments of 1993. Those food products that are not the subject of such a notice are
not exempt from the mandatory nutrition labeling requirements of section 403 (q) of the
FD&C Act unless the food qualifies for another exemption. Section 403(q)(5)(E) of the
FD&C Act does not require that the information in a notice claiming exemption be
reviewed by FDA for the exemption to be in effect. However, FDA does review the
information in each notice to determine whether it meets the requirements for the notice
established in section 403(q)(5)(E)(iii) of the FD&C Act. FDA provides the information
on the identity of firms submitting notices claiming exemption to its field personnel and
to State enforcement agencies by posting the names and addresses of the firms on a
website maintained by the agency.

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Information in petitions submitted under the provisions of § 101.12(h) will be used by the
agency in reaching a conclusion as to whether a new reference amount should be
established or an existing reference amount should be amended. The consequence of not
having this information is that FDA would be restricted in obtaining the information
necessary to amend or add to the regulation on reference amounts.
Information submitted to FDA in response to the provisions for alternative approaches
contained in §§ 101.9(g)(9) and 101.36(f)(2) is used by FDA to determine whether such
alternative approaches would be consistent with the requirements for nutrition labeling in
section 403(q) of the FD&C Act. The consequences of not having this information
would be a reduced flexibility of the manufacturer to use alternative approaches for
complying with the requirements of section 403(q) of the FD&C Act for the nutrition
labeling of food products.
Data generated by the food labeling experiments permitted under § 101.108 may form the
basis for a citizen’s petition to amend the existing food labeling regulations. The data
could also be useful to FDA for evaluating whether changes in current food labeling
requirements are warranted, and for developing alternative labeling formats that may be
useful to consumers and manufacturers. The extent of the collection of information is
determined by the firm proposing the labeling experiment, and is of benefit to this firm.
However, the labeling changes proposed by a firm could not be implemented without
supporting information favoring the proposed changes.
Description of Respondents: Respondents to this information collection are
manufacturers, packers, and distributors of food products. Because of the existence of
exemptions and exceptions, not all of the requirements apply to all food producers or to
all of their products. Some of the regulations affect food retailers, such as supermarkets
and restaurants. Respondents include the private sector (including for-profit businesses,
not-for-profit institutions and farms).
3. Use of Improved Information Technology and Burden Reduction
The regulations in parts 101, 102, 104, and 105 do 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 developing
notifications or meeting labeling requirements for food. FDA has developed a web-based
data entry system so small businesses may electronically claim exemption from the
requirements for nutrition labeling. FDA estimates that ninety percent (90%) of the
respondents will use electronic means to submit the request for exemption.

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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
FDA estimates that approximately ten percent (10%) of the respondents are small
businesses. The requirements are the minimum requirements for complying with the
provisions of the FD&C Act. In most cases, the information that is required to be
disclosed or submitted to the agency is information that is available to a firm, including a
small business, as a normal course of its doing business. Small businesses may claim
exemption from the requirements for nutrition labeling under the provisions of 21 CFR
101.9(j)(18) and 101.36(h)(2). 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 collected less frequently. As noted above, failure of
a firm to comply with the requirements for disclosure of the information on the labels or
labeling of its food products may result in those products being misbranded under section
403 of the FD&C Act and the products and the firm subject to regulatory action.
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), in the Federal Register of December 30, 2016 (81
FR 96462), we published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments. One comment was not related
to the Paperwork Reduction Act and is therefore not discussed. The second comment
underscored the importance of food labeling and offered general support of the
information collection.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payments or gifts to respondents.

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10. Assurance of Confidentiality Provided to Respondents
Information submitted to FDA under the food labeling 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 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)).
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive
nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1 – Estimated Annual Reporting Burden
21 CFR Section; Activity

101.9(j)(18) and 101.36(h)(2);
procedure for small business
nutrition labeling exemption
notice using Form FDA 3570
101.12(h); petitions to
establish or amend a RACC
101.69; petitions for nutrient
content claims
101.70; petitions for health
claims
101.108; written proposal for
requesting temporary
exemptions from certain
regulations for the purpose of
conducting food labeling
experiments
TOTAL

No. of
Respondents

No. of
Responses
per
Respondent

Total Annual
Responses

Average
Burden per
Response

Total
Hours

10,000

1

10,000

8

80,000

5

1

5

80

400

3

1

3

25

75

5

1

5

80

400

1

1

1

40

40

10,014

8

80,915

Table 2 – Estimated Annual Recordkeeping Burden
21 CFR Section; Activity

101.7(t); recordkeeping pertaining to
disclosure requirements for food not
accurately labeled for quantity of
contents
101.12(e); recordkeeping to document
the basis for density-adjusted RACC
101.13(q)(5); recordkeeping to
document the basis for nutrient
content claims
101.14(d)(2); recordkeeping to
document nutrition information
related to health claims for food
products
101.22(i)(4); recordkeeping to
document supplier certifications for
flavors designated as containing no
artificial flavors
101.100(d)(2); recordkeeping
pertaining to agreements that form the
basis for an exemption from the
labeling requirements of section
403(c), (e), (g), (h), (i), (k), and (q) of
the FD&C Act
TOTAL

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Average
Burden per
Recordkeeping

100

1

100

1

100

25

1

25

1

25

300,000

1.5

450,000

0.75

337,500

300,000

1.5

450,000

0.75

337,500

25

1

25

1

25

1,000

1

1,000

1

1,000

901,150

Total
Hours

676,150

Table 3– Estimated Annual Third Party Disclosure Burden
21 CFR Section; Activity

101.3, 101.22, 102 and 104;
statement of identity labeling
requirements
101.4, 101.22, 101.100, 102, 104
and 105; ingredient labeling
requirements
101.5; requirement to specify the
name and place of business of the
manufacturer, packer, or distributor
and, if the food producer is not the
manufacturer of the food product,
its connection with the food product
101.9, 101.13(n), 101.14(d)(3),
101.62, and 104; labeling
requirements for disclosure of
nutrition information
101.9(g)(9) and 101.36(f)(2);
alternative means of compliance
permitted

No. of
Respondents

No. of
Disclosures per
Respondent

Total Annual
Disclosures

Avg.
Burden per
Disclosure

25,000

1.03

25,750

.5

12,875

25,000

1.03

25,750

1

25,750

25,000

1.03

25,750

0.25

6,438

25,000

1.03

25,750

40

103,000

12

1

12

4

48

9

Total
Hours

21 CFR Section; Activity

101.10; requirements for nutrition
labeling of restaurant foods
101.12(b); RACC for baking
powder, baking soda and pectin
101.12(e); adjustment to the RACC
of an aerated food permitted
101.12(g); requirement to disclose
the serving size that is the basis for
a claim made for the product if the
serving size on which the claim is
based differs from the RACC
101.13(d)(1) and 101.67;
requirements to disclose nutrition
information for any food product for
which a nutrient content claim is
made
101.13(j)(2), 101.13(k), 101.54,
101.56, 101.60, 101.61, and 101.62;
additional disclosure required if the
nutrient content claim compares the
level of a nutrient in one food with
the level of the same nutrient in
another food
101.13(q)(5); requirement that
restaurants disclose the basis for
nutrient content claims made for
their food
101.14(d)(2); general requirements
for disclosure of nutrition
information related to health claims
for food products
101.15; requirements pertaining to
prominence of required statements
and use of foreign language
101.22(i)(4); supplier certifications
for flavors designated as containing
no artificial flavors
101.30 and 102.33; labeling
requirements for fruit or vegetable
juice beverages
101.36; nutrition labeling of dietary
supplements
101.42 and 101.45; nutrition
labeling of raw fruits, vegetables,
and fish
101.45(c); databases of nutrient
values for raw fruits, vegetables,
and fish
101.79(c)(2)(i)(D); disclosure
requirements for food labels that
contain a folate/neural tube defect
health claim

No. of
Respondents

No. of
Disclosures per
Respondent

Total Annual
Disclosures

Avg.
Burden per
Disclosure

300,000

1.5

450,000

0.25

112,500

29

2.3

67

1

67

25

1

25

1

25

5,000

1

5,000

1

5,000

200

1

200

1

200

5,000

1

5,000

1

5,000

300,000

1.5

450,000

0.75

337,500

300,000

1.5

450,000

0.75

337,500

160

10

1,600

8

12,800

25

1

25

1

25

1,500

5

7,500

1

7,500

300

40

12,000

4.025

48,300

1,000

1

1,000

0.5

500

5

4

20

4

80

1,000

1

1,000

0.25

250

10

Total
Hours

21 CFR Section; Activity

No. of
Respondents

101.79(c)(2)(iv); disclosure of
amount of folate for food labels that
contain a folate/neural tube defect
health claim
101.100(d); disclosure of
agreements that form the basis for
exemption from the labeling
requirements of section 403(c), (e),
(g), (h), (i), (k), and (q) of the
FD&C Act
101.7 and 101.100(h); disclosure
requirements for food not accurately
labeled for quantity of contents and
for claiming certain labeling
exemptions
TOTAL

No. of
Disclosures per
Respondent

Total Annual
Disclosures

Avg.
Burden per
Disclosure

100

1

100

0.25

25

1,000

1

1,000

1

1,000

25,000

1.03

25,750

0.5

12,875

1,513,299

Total
Hours

1,029,258

The estimated annual reporting, recordkeeping, and third party disclosure burdens
reflected in Tables 1-3 above are based on our informal communications with industry
and our experience with the information collection. Also, while section 101.108 was
promulgated to provide a petition procedure for certain food labeling exemptions, no
such petitions have been received in the recent past and we therefore provide an estimate
of 1 to reserve approval of any future collection under this part.
12b. Annualized Cost Burden Estimate
FDA estimates that the total annualized cost burden to respondents associated
with the requirements of parts 101 of the regulations to be approximately
$162,269,581.32. FDA estimates a respondent’s average wage to be commensurate to
that of a Federal government employee at the GS-13/Step-1 rate for the year 2017, $45.42
per hour. To account for overhead, this cost is increased by 100 percent, making the
estimated cost burden to the respondent $90.84 per hour. Using these figures, the agency
estimates the cost burden for reporting to be $7,350,318.60 (80,915 hours x $90.84 per
hour), the burden hour cost for recordkeeping to be $61,421,466 (676,150 hours x $90.84
per hour); and, the cost burden for third-party disclosure to be $93,497,796.72 (1,029,258
hours x $90.84 per hour), for a total annualized burden hour cost of $162,269,581.32.
Activity
Reporting
Recordkeeping
Third Party
Disclosure
Total

Total Burden
Hours
80,915
676,150
1,029,258

Hourly Wage Rate
$90.84
$90.84
$90.84

Total Respondent
Costs
$7,350,318.60
$61,421,466.00
$93,497,796.72
$162,269,581.32

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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.
14. Annualized Cost to the Federal Government
FDA estimates that the cost to the Federal government to inspect firms and to collect and
analyze samples to determine compliance with requirements for dietary supplements to
be approximately 14.2 person years. Based on an average person-year cost of
approximately $100,000 and an allowance of $80,000 for overhead, the agency estimates
that this amount of time translates to a cost to the Federal Government of $2,556,000 per
year. FDA further estimates that as much as one person-year at an estimated cost of
$180,000 would be required to respond to violations involving dietary supplements.
Based on its experience, FDA estimates that it will utilize annually 14.7 person years to
inspect firms and collect and analyze samples of conventional foods to determine
compliance with the various food labeling provisions. Using on an average person-year
cost of approximately $100,000 and including an allowance of $80,000 for overhead,
FDA estimates that this amount of time translates to a cost to the Federal government of
approximately $2,646,000 per year. FDA also estimates that an additional one person
year at an estimated cost of $180,000 would be required to respond to violations
involving conventional foods.
Six of the regulations contain provisions for the submission of petitions or notices to
FDA. FDA estimates that a total of over 7,100 hours would be expended in the review of
these submissions. At an estimated rate for a GS-13, Step 1, with overhead estimated to
be equal to the hourly rate, the hourly cost for the review and evaluation of the various
submissions is estimated to be approximately $90.84 per hour for a total estimated cost to
the Federal Government of more than $644,964. FDA estimates that the total cost to the
Federal Government of the provisions contained in this information collection to be
approximately $6,206,964.
15. Explanation for Program Changes or Adjustments
This information collection reflects editorial adjustments only. As previously noted, by
technical amendment on August 29, 2016, 21 CFR part 101.105 became 21 CFR part
101.7, however there was no change in burden to the underlying requirement regarding
declaration of net quantity of product contents. In addition, we have revised the IC list
appearing at www.reginfo.gov by consolidating the previously itemized regulatory
provisions into reporting, recordkeeping, and third party disclosure categories. We
believe this will assist the reader by more easily identifying the summary of cumulative
fluctuations for the collection. At the same time, readers may still view estimated burden
associated with individual provisions by referring to the agency’s 60-day and 30-day

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notices and in the burden tables found in Q.12: Estimates of Annualized Burden Hours
and Costs of this supporting statement.
16. Plans for Tabulation and Publication and Project Time Schedule
The information from this collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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