SS for Labeling Final Rule for Restaurants and Similar Establishments

SS for Labeling Final Rule for Restaurants and Similar Establishments.pdf

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

OMB: 0910-0783

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Final Rule on Nutrition Labeling of Standard Menu Items in Restaurants
and Similar Retail Food Establishments Under Section 4205 of the
Patient Protection and Affordable Care Act of 2010
OMB Control No. 0910-NEW
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
To implement the nutrition labeling provisions of the Patient Protection and Affordable Care
Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we)
is requiring disclosure of certain nutrition information for standard menu items in certain
restaurants and retail food establishments. The ACA, in part, amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act), among other things, to require restaurants and
similar retail food establishments that are part of a chain with 20 or more locations doing
business under the same name and offering for sale substantially the same menu items to
provide calorie and other nutrition information for standard menu items, including food on
display and self-service food. Under provisions of the ACA, restaurants and similar retail
food establishments not otherwise covered by the law may elect to become subject to these
Federal requirements by registering every other year with FDA. Providing accurate, clear,
and consistent nutrition information, including the calorie content of foods, in restaurants
and similar retail food establishments will make such nutrition information available to
consumers in a direct and accessible manner to enable consumers to make informed and
healthful dietary choices. Thus, under sections 201(n), 403(a)(1), 403(f), 403(q)(5)(H), and
701(a) of the FD&C Act, we have issued a final rule to support this public health objective.
We have revised our labeling regulations by adding new §101.11 to require that covered
establishments provide calorie and other nutrition information for standard menu items,
including food on display and self-service food. Also, we are establishing the terms and
conditions for voluntary registration by establishments that are not otherwise subject to the
requirements of section 4205 of the ACA but elect to become subject to such requirements.

2. Purpose and Use of the Information Collection
The information provided to FDA will help Federal, state or local officials determine which
jurisdiction’s requirements apply to the firm. FDA prefers that the information be submitted
by e-mail by typing complete information into the form (PDF), saving it on the registrant’s
computer, and sending it by e-mail to http:// [email protected] . If email is
not available, the registrant can either fill in the form (PDF) and print it out (or print out the
blank PDF and fill in the information by hand or typewriter), and send it to FDA either by
faxing the completed form to 301–436–2804 or mailing it to the Center for Food Safety and
Applied Nutrition, Compliance Information Branch (HFS–681), 5600 Fishers Lane,
Rockville, MD 20857.

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Information FDA requires on the registration form for restaurants and similar retail food
establishments includes:







The name, address, phone number, e-mail address, and contact information for the
authorized official;
The name, address, and e-mail address of each restaurant or similar retail food
establishment being registered, as well as the name and contact information for an
official onsite, such as the owner or manager, for each specific restaurant or similar
retail food establishment;
All trade names the restaurant or similar retail food establishment uses;
Preferred mailing address (if different from location address for each establishment)
for purposes of receiving correspondence; and
Certification that the information submitted is true and accurate, that the person or
firm submitting it is authorized to do so, and that each registered restaurant or similar
retail food establishment will be subject to the requirements of section 4205.

In addition to the initial registration, the authorized official must register every other year
with FDA, and the registration will automatically expire if not renewed.
Description of Respondents: Respondents to this collection of information will include
restaurants and similar retail food establishments that voluntarily elect to be subject to the
Federal requirements of this rule by registering with FDA. These establishments include
chain retail food establishments and eating and drinking places such as full- and limitedservice restaurants, snack bars (including, for example, ice cream, donut, and bagel shops
and similar establishments), cafeterias and drinking places, managed food service facilities,
grocery stores, supermarkets, convenience stores, general merchandise stores, lodging
facilities, recreational venues, sports venues, performing arts venues, and movie theaters.
3. Use of Improved Information Technology and Burden Reduction
FDA has implemented an interim registration process consisting of a downloadable form
that will indicate the required information and where to fax, send or email the completed
document. FDA estimates that all of the respondents (100%) will electronic means for
reporting under this interim process. FDA will also implement an online registration
process that allows firms to manage their registration information, and that minimizes
burden by allowing firms to re-register by either changing only information elements that
have changed, or by certifying that no information has changed. FDA estimates that all of
the respondents (100%) will use electronic means for reporting once the system is in place.
4. Efforts to Identify Duplication and Use of Similar Information
There are no existing data sources that indicate a small firm’s choice as to whether it wishes
to be covered under existing local and state menu or vending labeling rules, or under Section
4205 of the act.

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5. Impact on Small Businesses or Other Small Entities
FDA estimates that no small businesses (0%) will be affected by the information collection.
To the extent that a small business may be impacted, the registration process is specifically
designed to minimize burden by giving a choice as to which rules the small business wishes
to follow. The registration process is voluntary, and is the minimal amount of burden that
FDA can impose in order to give firms this choice and to give regulatory authorities the
information they need to enforce applicable statutes. If a small business chooses to register,
FDA can aid small businesses in complying with nutrition labeling requirements through its
Regional Small Business Representatives and through the administrative and scientific 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
The act mandates a twice yearly registration. FDA has no authority to collect the
information 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 the Federal Register of April 6, 2011, (76 FR 19191[2]) FDA published a proposed rule
that included a section entitled, “Paperwork Reduction Act of 1995.” One comment
regarding our analysis of the burdens was received. We discussed the comment in the
publication of our final rule in the Federal Register of December 1, 2015 (79 FR 71155[6],
at 71245) and discuss it again here. The comment stated that the recordkeeping burdens of
the proposed rule would impose millions of dollars in cost per year and that these burdens
are needless. The agency disagrees. Providing accurate, clear, and consistent nutrition
information, including the calorie content of foods, in restaurants and similar retail food
establishments will make such nutrition information available to consumers in a direct and
accessible manner and enable them to make informed and healthful dietary choices.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any gifts or payments to respondents.
10. Assurance of Confidentiality Provided to Respondents
The information collected is limited to addresses and contact information for authorized
individuals at firms volunteering to be covered under section 4205. The purpose of the
information collection is to give regulatory authorities the information they need to enforce
the appropriate statutes. Therefore, some or all of this information cannot be confidential.

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11. Justification for Sensitive Questions
This information does not contain questions pertaining to sexual behavior and attitudes,
religious beliefs, or any other matter commonly considered private or of a 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:
Reporting Burden
Table 1.--Estimated Reporting Burden1
21 CFR Part 101

No. of
Respondents

No. of Responses
per Respondent per
year

Initial Burden (annualized over 3 years)
§ 101.11(d) Initial
3,559
Registration
Annual Burden
§ 101.11(d)
Registration
Renewal

5,340

Total Annual
Responses

Average Burden
per Response (in
hours)

Total
Hours

1

3,559

2

7,118

1

5,340

0.5
(30 minutes)

2,670
9,788

Total Burden Hours
1

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

At this time, we lack data on the number of restaurants and similar retail food establishments that
might voluntarily register to comply with this final rule. We do not expect the net benefit for
voluntary registration for many non-covered establishments to be positive and in the RIA (Ref. 42
of the final rule) we indicate that as of the conducting of this analysis, no establishments have
voluntarily registered with FDA. Therefore we did not estimate a significant burden in the RIA.
However, in the event that a few register anyway, or find positive incentive to do so, for the
purposes of this PRA analysis, we estimate the burden such establishments will face. We believe
that implementation of the final rule, and the resulting attention to the nutrition content of standard
menu items, may give non-covered establishments an incentive to voluntarily disclose calorie and
other nutrition information. We believe that the only types of establishments that would likely face
a positive incentive to voluntarily register are some restaurants and some grocery, convenience, and
general merchandise stores that do not already provide this information in some form or another at
the point of purchase. We estimate that 5 percent of these establishments may register, or 10,678
[(5% volunteer x 47% no nutrition info x 348,200 non-covered restaurants) + (5% volunteer x
49,900 non-covered grocery, convenience, and general merchandise stores)] (Refs. 44 and 45 of the
final rule). We estimate it will require approximately 2 hours per initial registration. Given 10,678
establishments and one initial registration per establishment at 2 hours per registration, we estimate
the initial hourly burden for these establishments is 21,356 hours (10,678 establishments x 1 initial
registration per establishment x 2 hours per registration). Annualizing this value over 3 years yields
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7,118 hours per year (10,678 establishments / 3 years x 1 initial registration per establishment x 2
hours per registration). (10,678 establishments / 3 years = 3,559 establishments per year.)
We expect that renewal registrations will require substantially less time because
establishments are expected to be able to affirm or update the existing information in an online
account in a way similar to other FDA firm registration systems. We estimate that re-registration
will take 30 minutes (0.5 hours) for each registrant. This would indicate that biennial registration
would impose a burden of 5,340 hours (10,678 establishments x 0.5 hours) every 2 years, or 2,670
hours every year (10,678 establishments / 2 years x 0.5 hours).
Recordkeeping Burden
Table 2.--Estimated Recordkeeping Burden1
21 CFR Part 101

No. Recordkeepers

Initial Burden (Annualized over 3 years)
§ 101.8(c)(2)(i)(A)
Initial
69,017
Nutrition Analysis
Records
Annual Burden
§ 101.8(c)(2)(i)(A)
Recurring
30,059
Nutrition Analysis
Records

Annual Frequency
per Recordkeeper

Total Annual
Records

Hours per
Record

Total Hours

1

69,017

0.25
(15 minutes)

17,254

1

30,059

0.25
(15 minutes)

7,515

Total Burden Hours
1

24,769

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

Initial Nutrition Analysis
We estimate the annual number of the largest restaurant chains that will need to produce
substantiation of their standard menu items to be 541 (503 covered restaurant chains + 38 voluntary
restaurant chains) with an average of 117 unique menu items that will require an initial nutrition
analysis. This leads to 63,297 (541 chains x 117 items) individual chains-specific restaurant
records. In addition to chain-level nutrition analysis, each individual restaurant establishment will
likely have a small variety of standard menu items that are unique to the individual establishment.
We estimate there are 11,684 restaurants establishments (10,866 covered + 818 voluntary) with
establishment-specific items. Each of these restaurant establishments has an average of five
establishment-specific menu items. This leads to 58,420 (11,684 establishments x 5 items)
individual establishment-specific restaurant records.
In addition to restaurants, other similar retail food establishments have both chain-specific
and establishment-specific menu items. Other covered retail food establishments include: Grocery
stores, supermarkets, convenience stores, general merchandise stores, lodging facilities, recreational
venues, sports venues, performing arts venues, and movie theaters. We estimate there are 691
grocery, convenience, and general merchandise (GCGM) store chains (660 covered + 31 voluntary)
with an average of 40 menu items each (= 27,640 records); 5,309 GCGM establishments (5,060
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covered + 249 voluntary) with an average of 5 establishment-specific menu items each (= 26,545
records); 50 managed food service (MFS) chains with an average of 80 menu items (= 4,000
records); 450 MFS establishments with an average of 5 establishment-specific menu items (= 2,250
records); 100 lodging chains with an average of 40 menu items (= 4,000 records); 620 lodging
establishments with an average of 5 establishment-specific menu items (= 3,100 records); 250
sports, recreation and entertainment (SRE) chains with an average of 59 menu items (= 14,750
records); and 610 SRE establishments with an average of 5 establishment-specific menu times
(= 3,050 records). In total, we estimate there are 207,052 records (63,297 restaurant chain-level +
58,420 restaurant establishment-level + 27,640 GCGM chain-level + 26,545 GCGM establishmentlevel + 4,000 MFS chain-level + 2,250 MFS establishment-level + 4,000 lodging chain-level +
3,100 lodging establishment-level + 14,750 SRE chain-level + 3,050 SRE establishment-level).
Annualized over 3 years, this value yields 69,017 (= 207,052 records / 3 years) per year. We
estimate that each nutrition analysis will require a burden of 15 minutes to produce each record. We
estimate the total recordkeeping burden for the initial nutrition analysis to be 17,254.25 hours
(= 69,017 records x 0.25 hours per record).
Recurring Nutrition Analysis
From Mintel Menu Insights data, we estimate that restaurant chains introduced, on average,
24 new menu items in 2009 (Ref. 47 of the final rule). Because the final requirements do not apply
to temporary menu items, daily specials, and foods that are part of a customary market test, only a
fraction of these items will need nutrition analysis. We estimate that existing restaurant chains or
individual establishments would need new nutrition analysis for 25 percent of new standard menu
items, or six new standard menu items per year. If in addition to these new standard menu items,
chains need nutrition analysis on 6 reformulated standard menu items, there would be a total of 12
nutrition analyses per chain needed on an annual basis. Thus we estimate there will be 26,904
annual records associated with new or reformulated items of covered chains [= (1,151 restaurant
chains + 691 GCGM chains + 50 MFS chains + 100 lodging chains + 250 SRE chains) x 12 menus
items].
In addition we estimate that each year there will be the number of covered chains to increase
in each category as companies expand. As discussed in the final RIA, each year there will be some
existing non-covered chains that, through expansion of their business, will become subject to the
rule’s requirements (for example, a chain expanding from 19 to 20 locations). We estimate there
will be 20 new restaurant chains, each with an average of 117 menu items; 5 new GCGM chains
each with an average of 40 menu items; 3 new MFS chains each with an average of 80 menu items;
2 new lodging chains each with an average of 40 menu items; 5 new SRE chains each with an
average of 59 menu items. Thus we estimate there will be 3,155 annual records [= (20 restaurants x
117 items) + (5 GCGM x 40 items) + (3 MFS x 80 items) + (2 lodging x 40 items) + (5 SRE x 59
items] associated with nutrition analysis for new covered chains.
Based on data from FDA’s Recordkeeping Cost Model, we estimate that it will take
approximately 15 minutes per standard menu item for providing the information of nutrition
analysis to FDA (Ref. 48 of the final rule). We estimate the total recurring recordkeeping burden
for the nutrition analysis to be 7,515 hours [(26,899 records for new/reformulated standard menu
items under existing chains + 3,155 records for items under new chains) x 0.25 hours per record)].

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Third Party Disclosure Burden
Table 3.--Estimated Third Party Disclosure Burden
No. of
Total
Average
No.
Disclosures
21 CFR Part 101
Annual Burden per
Respondents
per
Disclosures Disclosure
Respondent
Initial Burden (Annualized over 3 years)
§101.8(c)(2)(i)(A)
Initial
Nutrition Analysis

69,017

1

Total
Hours

69,017

4

276,068

53,084

Total Operating
and
Maintenance
Costs

-

§101.8(c)(2)(i)(A)
Initial
Menu Replacement

106,168

1

106,168

0.5
(30
minutes)

§101.8(c)(2)(i)(A)
Written Nutrition
Information
Chain-level

1,632

1

1,632

3

4,896

-

18,673

1

18,673

0.5
(30
minutes)

9,337

-

30,054

1

30,054

4

120,216

-

700

1

700

0.5
(30
minutes)

350

§101.8(c)(2)(i)(A)
Written Nutrition
Information
Establishment-level
Annual Burden
§101.8(c)(2)(i)(A)
Recurring
Nutrition Analysis
§101.8(c)(2)(i)(A)
Recurring
Menu Replacement
Total

463,951

$248,767,000

$529,000
$249,296,000

Initial Nutrition Analysis
The first burden is the time and effort expended by restaurants and other retail food establishments
to determine the nutrition content of their covered menu items, which we refer to as “Nutrition
Analysis.” A nutrition analysis entails the burden of determining nutrition content for covered and
voluntary establishment menus by analyzing the food product and summarizing the nutritional
information results. Note that the recordkeeping portion of this burden was estimated in the
previous subsection.
Our estimate for the annual number of the restaurant and similar retail food chains and individual
establishments that will be burdened with initial nutrition analysis is identical to our estimate for the
chains and establishments under the recordkeeping subsection. The total number of respondents
estimated for the third-party disclosure burden of initial nutrition analysis is 207,052. Annualized
over 3 years, this value becomes 69,017. We estimate that each nutrition analysis will require a
burden of 4 hours (this estimate of 4 hours was used in the final RIA (Ref. 42 of the final rule)),
7

thus total burden for the initial nutrition analysis is 276,068 hours (207,052 records /3 years x 4
hours per record).
Recurring Nutrition Analysis
The second burden is the time and effort expended by restaurants and other retail food
establishments in recurring nutrition analysis. As discussed in the recordkeeping subsection of this
PRA, recurring nutrition analysis will be required for new and reformulated standard menu items.
Our estimate for the annual number of the restaurant and similar retail food chains and individual
establishments that will be burdened with recurring nutrition analysis is identical to our estimate for
the chains and establishments under the recordkeeping subsection. The total number of respondents
estimated for the third-party disclosure burden of recurring nutrition analysis is 30,054. We
estimate that each nutrition analysis will require a burden of 4 hours (this estimate of 4 hours was
used in the final RIA (Ref. 42 of the final rule)), thus total third party disclosure burden recurring
nutrition analysis is 120,216 hours (30,054 records x 4 hours per record).
Initial Menu Replacement
The third burden is for the time expended by restaurants and similar retail food establishments to
physically produce and install the menus, menu boards that include the new calorie declarations,
which we refer to as “Calorie Declaration Signs.” As described in the final RIA (Ref. 42 of the final
rule), chain retail food establishments will need to redesign and replace their existing menus and
menu boards in order to comply with the final requirements. For full service restaurants and
drinking places with only personal menus and no menu boards, this burden will be relatively low.
Most menus are replaced frequently anyway as they wear out, are lost, or as prices and menu items
change. For many of these establishments, the burden of updating menus to comply with the final
requirements would be limited to design and associated administrative hours.
The longer lifespan of menu boards in limited-service eating places would likely require the
redesign of menu/menu boards and the replacement of one or more menu boards. In addition, some
chains would need to update self-serve and display signs. The number of menus that an
establishment will keep on hand is highly variable. A full-service restaurant, where each order is
placed using a menu, will need more than a quick-service establishment that uses menus just for
takeout orders. The number of menus is also tied to the seating capacity of the restaurant, and
whether the menu is laminated or paper. Because paper menus are more fragile and cheaper to print
in bulk, an establishment may keep a large reserve in stock, whereas establishments using more
durable and expensive laminated menus may only keep a few extra on hand. Estimates for the
burden of updating menu boards, other major displays that serve as menus, such as electronic
displays, or major materials needed to disclose calories for self-serve or displayed foods to comply
with the final requirements, will vary widely across chains and establishments because of different
menu board and display types.
As described in the RIA, we estimate that the average full-service restaurant establishment must
discard and reprint one menu for each seat, plus 10 extra, for a total of 91 menus per restaurant each
year. We estimate that GCGM stores have an average of two menu boards per establishment based
on public comments that we received. We estimate that MFS and SRE establishments will each
have an average of one menu board. Lodging establishments generally have menus instead of menu
boards, and we estimate the menu replacement burden for establishments in the lodging sector to be
8

87 menu replacements per establishment. Since each covered and voluntarily registered
establishment will need to replace menus and/or menu boards, we estimate this total value to be
318,505 (= 248,610 restaurants + 53,095 GCGM + 4,500 MFS + 6,200 lodging + 6,100 SRE). (In
the previous calculation, 248,610 restaurants = 231,200 covered restaurants + 17,410 voluntary; and
53,095 GCGM = 50,600 covered + 2,495 voluntary.) Annualized over 3 years, this value becomes
106,168 (= 318,505 / 3 years). We estimate the labor burden for ordering new menus and menu
boards to be 30 minutes (0.5 hours) per establishment. Thus the total burden for initial menu
replacement is 53,084 hours per year. At an average wage (which includes an extra 50 percent to
account for overhead costs and employee benefits) of $30 per hour for managers across the covered
industries, the labor burden comes to $1,593,000 (= 53,084 hours x $30 per hour). In the final RIA
(Ref. 42 of the final rule), we estimated the total average costs associated with initial menu
replacement to be $250.36 million. This value takes into consideration costs of menu/menu board
design, printing, and installation. Subtracting the labor costs of ordering new menus, $1,593,000,
from the total costs for initial menu replacement, $250,360,000, yields total initial operating and
maintenance costs of $248,767,000.
Recurring Menu Replacement for New Chains
The fourth burden is for the time expended by new restaurants and similar retail food establishments
to physically replace menus and menu boards that include the new calorie declarations. All
restaurants and similar retail food chains that become covered as the number of their associated
establishments grows beyond the coverage threshold of 20 will need to replace their menus and
menu boards. We estimated in the final RIA (Ref. 42 of the final rule) that the annual number of
new covered restaurants and similar retail food establishments is 700. Again, we estimate the labor
burden for ordering new menus and menu boards to be 30 minutes (0.5 hours) per establishment.
Thus the total annual burden for recurring menu replacement is 350 hours per year. At an average
wage (which includes an extra 50 percent in overhead costs and employee benefits) of $30 per hour
for managers across the covered industries, the recurring labor burden comes to $11,000 (= 350
hours x $30 per hour). In the final RIA, we estimated the total average annual operating and
maintenance costs associated with recurring menu replacement to be $540,000. This value takes
into consideration costs of menu/menu board design, printing, and installation. Subtracting the
recurring labor costs of ordering new menus, $11,000, from the total costs for recurring menu
replacement of $540,000, yields total recurring operating and maintenance costs of $529,000.
Written Nutrition Information
The fifth burden is for the time expended by restaurants and similar retail food establishments to
make written nutrition information available to customers upon request. The number of chains (and
associated establishments) that do not already provide this information was estimated in the
recordkeeping subsection under initial nutrition analysis, or 1,632 chains (503 covered restaurant +
38 voluntary restaurant + 660 covered GCGM + 31 voluntary GCGM + 50 covered MFS + 100
covered lodging + 250 covered SRE) and 18,673 establishments with establishment specific-menu
items (10,866 covered restaurant + 818 voluntary restaurant + 5,060 covered GCGM + 249
voluntary GCGM + 450 covered MFS + 620 covered lodging + 610 covered SRE). We estimate the
time it takes to provide written nutrition information at the chain level to be 3 hours per respondent.
Since the average number of establishment-specific menu items is only five per establishment, we
estimate the time it takes to provide written nutrition information at the establishment level (for
those menu items that are specific only to the establishment) to be 30 minutes per respondent. Thus
9

the total burden hours for chain-level and establishment level written nutrition information
disclosure are 4,896 and 9,336.5 hours, respectively. Therefore the total third party disclosure
burden for the rule is 463,950.5 in annual hours with total operating and maintenance costs of
$249,296,000.

12b. Annualized Cost Burden Estimate
FDA estimates an initial cost burden of $35,590 with a recurring cost burden of $40,050. The
analogous initial cost burden displayed in the third row of Table 2, $75,640, is a result of
dividing by three the burdens that occur only in the first year, to avoid double counting in the
ROCIS system. Hourly burdens are taken from the last column of Table 1. We use average
hourly wage rates based on 2010 BLS Occupational Employment Statistics, we estimate the
hourly wage rate for a non-manager to be $15 (Ref. 9 of the final rule).
Table 2. – Estimated Costs of Hourly Burden1
21 CFR Part 101
Initial Burden (annualized over 3
years)
§ 101.8(d) Initial Registration

Total Hours

Hourly Wage
Rate

Total
Respondent
Costs

7,118

$5.00

$35,590

Annual Burden
§ 101.8(d) Registration Renewal

2,670

$15.00
$40,050
Total Burden Hours
9,788
$75,640
1
Actual first year burden costs have been divided by 3 to avoid double counting in the ROCIS system.

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
Estimated capital, start-up, operating or maintenance costs associated with this collection of
information total $249,296,000, and include the costs of initial and recurring menu replacement
as referenced in rows 3 and 8 of Table 3 (Third Party Disclosure Burden) above.
14.

Annualized Cost to the Federal Government
FDA estimates the initial cost of setting up the registration system to be approximately
$200,000, with recurring maintenance cost of $60,000 per year.

10

15.

Explanation for Program Changes or Adjustments
Because of substantial revisions since issuance of the underlying proposed rule (76 FR
19191[2]) for this collection, FDA discontinued its approval authority for the original provisions
found under OMB Control No. 0910-0665 upon its expiration in 2014. Therefore we are now
submitting the request as a new information collection.

16.

Plans for Tabulation and Publication and Project Time Schedule
There are no plans for tabulation or publication.

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.

11


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