Document ID: FDA-2013-N-0545-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request
Posted Date: 2018-04-09T04:00Z

[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15148-15152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07147]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0545]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 9, 
2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0256. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Infant Formula Requirements--21 CFR parts 106 and 107

OMB Control Number 0910-0256--Extension

    This information collection supports FDA regulations regarding 
infant formula requirements. Statutory requirements for infant formula 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are intended 
to protect the health of infants and include a number of reporting and 
recordkeeping requirements. Among other things, section 412 of the FD&C 
Act (21 U.S.C. 350a) requires manufacturers of infant formula to 
establish and adhere to quality control procedures, notify us when a 
batch of infant formula that has left the manufacturers' control may be 
adulterated or misbranded, and keep records of distribution. We also 
regulate the labeling of infant formula under the authority of section 
403 of the FD&C Act (21 U.S.C. 343). The purpose of the labeling 
requirements is to ensure that consumers have the information they need 
to prepare and use infant formula appropriately. The regulations for 
infant formula requirements are codified in 21 CFR parts 106 and 107.
    To assist respondents with applicable reporting provisions found in 
the regulations, we have developed an electronic Form FDA 3978 that 
allows infant formula manufacturers to electronically submit reports 
and notifications in a standardized format. Form FDA 3978 prompts 
respondents to include information in a standardized format and helps 
respondents organize submissions to include only the information needed 
for our review. Draft screenshots of Form FDA 3978 and instructions are 
available at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/InfantFormula/default.htm. Form FDA 3978 was 
deployed in 2017 as a pilot by FDA and, while informal feedback 
regarding its use has been favorable, we continue to invite comment. If 
manufacturers prefer, however, FDA continues to accept paper 
submissions.

[[Page 15149]]

    In the Federal Register of November 15, 2017, we published a notice 
inviting public comment on the proposed collection of information. No 
comments were received. We therefore retain our original burden 
estimate for the information collection, which is as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of        Total
         FD&C act or 21 CFR section             Number of      responses per      annual            Average burden  per response            Total hours
                                               respondents      respondent      responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports; Section 412(d) of the FD&C Act....               5                13           65  10                                                       650
Notifications; Sec.   106.120(b)...........               1                 1            1  4                                                          4
Reports for Exempt Infant Formula; Sec.                   3                 2            6  4                                                         24
 107.50(b)(3) and (4).
Notifications for Exempt Infant                           1                 1            1  4                                                          4
 Formula;Sec.   107.50(e)(2).
Requirements for Quality Factors Growth                   4                 9           36  20                                                       720
 Monitoring Study Exemption; Sec.
 106.96(c).
Requirements for Quality Factors--PER                     1                34           34  12                                                       408
 Exemption; Sec.   106.96(g).
New Infant Formula Registration; Sec.                     4                 9           36  0.50 (30 minutes)                                         18
 106.110.
New Infant Formula Submission; Sec.                       4                 9           36  10                                                       360
 106.120.
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ..............  ................  ...........  ............................................           2,188
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.

    In compiling these estimates, we consulted our records of the 
number of infant formula submissions we received under the information 
collection. All infant formula submissions may be provided to us in 
electronic format. Our estimate of the time needed per response is 
based on our experience with similar programs and informal feedback we 
have received from industry.
    We assume that we will receive 13 reports from 5 manufacturers 
under section 412(d) of the FD&C Act, for a total of 65 reports 
annually. We assume each report takes 10 hours to compile for a total 
of 650 hours annually. We also assume that we will receive one 
notification under Sec.  106.120(b) and 4 hours is needed per response, 
for a total of 4 hours annually.
    For exempt infant formula, we assume we will receive two reports 
from three manufacturers under Sec.  107.50(b)(3) and (4), for a total 
of six reports annually. We assume each report takes 4 hours to compile 
for a total burden of 24 hours annually. We also assume we will receive 
one notification annually under Sec.  107.50(e)(2) and that it takes 4 
hours to prepare.
    We assume that 4 firms will submit 36 exemptions under Sec.  
106.96(c) and that each exemption will take 20 hours to assemble for a 
total burden of 720 hours annually, as reflected in row 5 of table 1.
    We assume that the infant formula industry annually submits 35 
protein efficiency ratio (PER) submissions. For the submission of the 
PER exemption, we estimate that the infant formula industry submits 34 
exemptions per year and that each exemption takes supporting staff 12 
hours to prepare. Therefore, we calculate 34 exemptions x 12 hours per 
exemption = 408 hours to fulfill the requirements of Sec.  106.96(g), 
as shown in row 6 of table 1.
    We estimate that four firms each use one senior scientist or 
regulatory affairs professional who needs 30 minutes to gather and 
record the required information for an infant formula registration 
under Sec.  106.110. We estimate that the industry annually registers 
35 new infant formulas, or an average of 9 registrations per firm. 
Therefore, we calculate the annual burden as 36 registrations x 0.5 
hour per registration = 17.5 (rounded to 18) hours, as shown in row 7 
of table 1.
    We estimate that four firms each use one senior scientist or 
regulatory affairs professional who needs 10 hours to gather and record 
information needed for infant formula submissions under Sec.  106.120. 
This estimate includes the time needed to gather and record the 
information the manufacturer uses to request an exemption under Sec.  
106.91(b)(1)(ii), which provides that the manufacturer includes the 
scientific evidence that the manufacturer is relying on to demonstrate 
that the stability of the new infant formula will likely not differ 
from the stability of formula with similar composition, processing, and 
packaging for which there are extensive stability data. We estimate 
that 4 firms make submissions for 36 new infant formulas, or an average 
of 9 submissions per firm. Therefore, to comply with Sec.  106.120, we 
calculate the annual burden as 36 submissions x 10 hours per submission 
= 360 hours, as shown in row 8 of table 1. Thus, the total annual 
reporting burden is 2,188 hours.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
         Activity; 21 CFR section              Number of      records per    Total  annual        Average burden  per recordkeeping        Total  hours
                                             recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Controls to prevent adulteration caused by              21               1              21  1.5 (90 minutes)                                          32
 facilities--testing for radiological
 contaminants; \3\ Sec.   106.20(f)(3)
Controls to prevent adulteration caused by              21               1              21  0.08 (5 minutes)                                           2
 facilities--recordkeeping of testing for
 radiological contaminants; \2\ Sec.  Sec.
   106.20(f)(4) and 106.100(f)(1)
Controls to prevent adulteration caused by               5              52             260  0.08 (5 minutes)                                          21
 facilities--testing for bacteriological
 contaminants Sec.   106.20(f)(3)
Controls to prevent adulteration caused by               5              52             260  0.08 (5 minutes)                                          21
 facilities--recordkeeping of testing for
 bacteriological contaminants Sec.  Sec.
 106.20(f)(4) and 106.100(f)(1)
Controls to prevent adulteration by                      5              52             260  0.22 (13 minutes)                                         57
 equipment or utensils; Sec.  Sec.
 106.30(d) and 106.100(f)(2)
Controls to prevent adulteration by                      5              52             260  0.22 (13 minutes)                                         57
 equipment or utensils; Sec.  Sec.
 106.30(e)(3)(iii) and 106.100(f)(3)

[[Page 15150]]

 
Controls to prevent adulteration by                      5              52             260  0.20 (12 minutes)                                         52
 equipment or utensils; Sec.  Sec.
 106.30(f) and 106.100(f)(4)
Controls to prevent adulteration due to                  5               1               5  520                                                    2,600
 automatic (mechanical or electronic)
 equipment; Sec.  Sec.   106.35(c) and
 106.100(f)(5)
Controls to prevent adulteration due to                  5               2              10  640                                                    6,400
 automatic (mechanical or electronic)
 equipment Sec.  Sec.   106.35(c) and
 106.100(f)(5)
Controls to prevent adulteration caused by               5              52             260  0.17 (10 minutes)                                         44
 ingredients, containers, and closures;
 Sec.  Sec.   106.40(d) and 106.100(f)(6)
Controls to prevent adulteration during                  5              52             260  0.23 (14 minutes)                                         60
 manufacturing; Sec.  Sec.   106.50(a)(1)
 and 106.100(e)
Controls to prevent adulteration from                    5              52             260  0.25 (15 minutes)                                         65
 microorganisms; Sec.  Sec.   106.55(d)
 and 106.100(e)(5)(ii) and (f)(7)
Controls to prevent adulteration during                  1              12              12  0.25 (15 minutes)                                          3
 packaging and labeling of infant formula;
 Sec.   106.60(c)
General quality control--testing; Sec.                   4               1               4  2                                                          8
 106.91(b)(1), (2), and (3)
General quality control; Sec.  Sec.                      4              52             208  0.15 (9 minutes)                                          31
 106.91(b)(1) and(d), and 106.100(e)(5)(i)
General quality control; Sec.  Sec.                      4              52             208  0.15 (9 minutes)                                          31
 106.91(b)(2) and (d), and
 106.100(e)(5)(i)
General quality control; Sec.  Sec.                      4              52             208  0.15 (9 minutes)                                          31
 106.91(b)(3) and (d), and
 106.100(e)(5)(i)
Audit plans and procedures; ongoing review               5               1               5  8                                                         40
 and updating of audits; Sec.   106.94
Audit plans and procedures --regular                     5              52             260  4                                                      1,040
 audits; Sec.   106.94
Requirements for quality factors for                     1               1               1  16                                                        16
 infant formulas--written study report;
 Sec.  Sec.   106.96(b) and (d),
 106.100(p)(1) and (q)(1), and 106.121
Requirements for quality factors for                   112               6             672  0.50 (30 minutes)                                        336
 infant formulas--anthropometric data;
 Sec.  Sec.   106.96(b)(2) and (d), and
 106.100(p)(1)
Requirements for quality factors for                   112               6             672  0.25 (15 minutes)                                        168
 infant formulas--formula intake Sec.
 Sec.   106.96(b)(3) and (d), and
 106.100(p)(1)
Requirements for quality factors for                   112               6             672  0.08 (5 minutes)                                          54
 infant formulas--data plotting; Sec.
 Sec.   106.96(b)(4) and (d), and
 106.100(p)(1)
Requirements for quality factors for                   112               6             672  0.08 (5 minutes)                                          54
 infant formulas--data comparison; Sec.
 Sec.   106.96(b)(5) and (d), and
 106.100(p)(1)
Requirements for quality factors--per data               1               1               1  8                                                          8
 collection; Sec.   106.96(f)
Requirements for quality factors--per                    1               1               1  1                                                          1
 written report; Sec.   106.96(f)
Records; Sec.   106.100                                  5              10              50  400                                                   20,000
Records for Exempt Infant Formula; Sec.                  3              10              30  300                                                    9,000
 107.50(c)(3)
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................................          40,232
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Where necessary, numbers have been rounded to the nearest whole number.
\3\ This testing only occurs every 4 years.

    We estimate that 21 infant formula plants will test at least every 
4 years for radiological contaminants. In addition, we estimate that 
collecting water for all testing in Sec.  106.20(f)(3) takes between 1 
and 2 hours. We estimate that water collection takes an average of 1.5 
hours and that water collection occurs separately for each type of 
testing. We estimate that performing the test will take 1.5 hours per 
test, every 4 years. Therefore, 1.5 hours per plant x 21 plants = 31.5 
(rounded to 32) total hours, every 4 years, as seen in row 1 of table 
2. Furthermore, Sec. Sec.  106.20(f)(4) and 106.100(f)(1) require firms 
to make and retain records of the frequency and results of water 
testing. For the 21 plants that are estimated not to currently test for 
radiological contaminants, this burden is estimated to be 5 minutes per 
record every 4 years. Therefore, 0.08 hour per record x 21 plants = 
1.68 (rounded to 2) hours, every 4 years for the maintenance of records 
of radiological testing, as seen on row 2 of table 2.
    We estimate that five infant formula plants will test weekly for 
bacteriological contaminants. We estimate that performing the test will 
take 5 minutes per test once a week. Annually, this burden is 0.08 
hours x 52 weeks = 4.16 hours per year, per plant, and 4.16 hours per 
plant x 5 plants = 20.8 (rounded to 21) total annual hours, as seen on 
row 3 of table 2. Furthermore, for the five plants that are estimated 
to not currently test weekly for bacteriological contaminants, this 
burden is estimated to be 5 minutes per record, every week. Therefore, 
0.08 hour per record x 52 weeks = 4.16 hours per plant for the 
maintenance of records of bacteriological testing. Accordingly, 4.16 
hours x 5 plants = 20.8 (rounded to 21) annual hours, as seen on row 4 
of table 2.
    Sections 106.30(d) and 106.100(f)(2) require that records of 
calibrating certain instruments be made and retained. We estimate that 
one senior validation engineer for each of the five plants will need to 
spend about 13 minutes per week to satisfy the ongoing calibration 
recordkeeping requirements. Therefore, 5 recordkeepers x 52 weeks = 260 
records; 260 records x 0.22 hour per record = 57 hours as the annual 
burden, as presented in row 5 of table 2.
    Sections 106.30(e)(3)(iii) and 106.100(f)(3)) require the 
recordkeeping of the temperatures of each cold storage compartment. We 
estimate that five plants will each require one senior validation 
engineer about 13 minutes per week of recordkeeping. Therefore, 5 
recordkeepers x 52 weeks = 260 records; 260 records x 0.22 hours per 
record = 57 hours as the annual burden, as presented in row 6 of table 
2.
    Sections 106.30(f) and 106.100(f)(4) require the recordkeeping of 
ongoing sanitation efforts. We estimate that five plants will each 
require one senior validation engineer about 12 minutes

[[Page 15151]]

per week of recordkeeping. Therefore, 5 recordkeepers x 52 weeks = 260 
records; 260 records x 0.20 hours per record = 52 hours as the annual 
burden, as presented in row 7 of table 2.
    For Sec. Sec.  106.35(c) and 106.100(f)(5), we estimate that one 
senior validation engineer per plant needs 10 hours per week of 
recordkeeping, with the annual burden for this provision being 520 
hours per plant x 5 plants = 2,600 annual hours, as shown in row 8 of 
table 2. In addition, an infant formula manufacturer revalidates its 
systems when it makes changes to automatic equipment. We estimate that 
such changes occur twice a year, and that on each of the two occasions, 
a team of four senior validation engineers per plant needs to work full 
time for 4 weeks (4 weeks x 40 hours per week = 160 work hours per 
person) to provide revalidation of the plant's automated systems 
sufficient to comply with this section. The annual burden for four 
senior validation engineers each working 160 hours twice a year is 
1,280 hours ((160 hours x 2 revalidations) x 4 engineers = 1,280 total 
work hours) per plant. Therefore, 640 hours x 5 plants x 2 times per 
year = 6,400 hours as the annual burden, as shown on row 9 of table 2.
    Sections 106.40(d) and 106.100(f)(6) require written specifications 
for ingredients, containers, and closures. We estimate that one senior 
validation engineer per plant needs about 10 minutes a week to fulfill 
the recordkeeping requirements. Therefore, 5 recordkeepers x 52 weeks = 
260 records and 260 records x 0.17 hour = 44 hours as the annual 
burden, as shown in row 10 of table 2.
    We estimate that five plants will change a master manufacturing 
order and that one senior validation engineer for each of the five 
plants spends about 14 minutes per week on recordkeeping pertaining to 
the master manufacturing order, as required by Sec. Sec.  106.50(a)(1) 
and 106.100(e). Thus, 5 recordkeepers x 52 weeks = 260 records; 260 
records x 0.23 hour = 60 hours as the annual burden, as shown in row 11 
of table 2.
    Sections 106.55(d), 106.100(e)(5)(ii), and 106.100(f)(7)) require 
recordkeeping of the testing of infant formula for microorganisms. We 
estimate that five plants each need one senior validation engineer to 
spend 15 minutes per week on recordkeeping pertaining to 
microbiological testing. Thus, 5 recordkeepers x 52 weeks = 260 
records; 260 records x 0.25 hour per record = 65 hours as the annual 
burden, as shown in row 12 of table 2.
    Section 106.60 establishes requirements for the recordkeeping and 
labeling of mixed-lot packages of infant formula. Section 106.60(c) 
requires infant formula distributors to label infant formula packaging 
(such as packing cases) to facilitate product tracing and to keep 
specific records of the distribution of these mixed lot cases. We 
estimate that one worker needs 15 minutes, once a month (0.25 x 12 
months) to accomplish this, for an annual burden of 3 hours, as shown 
in row 13 of table 2.
    Sections 106.91(b)(1), (2), and (3) provide ongoing stability 
testing requirements. We estimate that the stability testing 
requirements has a burden of 2 hours per plant. Therefore, 2 hours x 4 
plants = 8 hours as the annual burden to fulfill the testing 
requirements, as shown in row 14 of table 2.
    Sections 106.91(d) and 106.100(e)(5)(i) provide for recordkeeping 
of tests required under Sec.  106.91(b)(1), (2), and (3). We estimate 
that one senior validation engineer per plant will spend about 9 
minutes per week of recordkeeping to be in compliance. Thus, 4 
recordkeepers x 52 weeks = 208 records; 208 records x 0.15 hour per 
record = 31.2 (rounded to 31) hours for the annual burden, as shown in 
rows 15, 16, and 17 of table 2.
    We estimate that the ongoing review and updating of audit plans 
requires a senior validation engineer 8 hours per year, per plant. 
Therefore, 8 hours x 5 plants = 40 hours for the annual burden, as 
shown in row 18 of table 2.
    We estimate that a manufacturer chooses to audit once per week. We 
estimate each weekly audit requires a senior validation engineer 4 
hours, or 52 weeks x 4 hours = 208 hours per plant. Therefore, burden 
for updating audit plans is calculated as 208 hours x 5 plants = 1,040 
hours for the annual burden, as shown in row 19 of table 2.
    We estimate that, as a result of the regulations, the industry as a 
whole performs one additional growth study per year, in accordance with 
Sec.  106.96. The regulations require that several pieces of data be 
collected and maintained for each infant in the growth study. We 
estimate that the data collection associated with the growth study is 
assembled into a written report and kept as a record in compliance with 
Sec. Sec.  106.96(d) and 106.100(p)(1). Thus, we estimate that one 
additional growth study report is generated, and that this report 
requires one senior scientist to work 16 hours to compile the data into 
a study report. Therefore, one growth study report x 16 hours = 16 
hours for the annual burden for compliance with Sec. Sec.  106.96(b) 
and (d), 106.100(p)(1) and (q)(1), and 106.121 as shown in row 20 of 
table 2.
    A study conducted according to the requirements of Sec.  
106.96(b)(2) must include the collection of anthropometric measurements 
of physical growth and information on formula intake, and Sec. Sec.  
106.96(d) and 106.100(p)(1) require that the anthropometric 
measurements be made six times during the growth study. We estimate 
that in a growth study of 112 infants, 2 nurses or other health 
professionals with similar experience need 15 minutes per infant at 
each of the required 6 times to collect and record the required 
anthropometric measurements. Therefore, 2 nurses x 0.25 hours = 0.50 
hour per infant, per visit, and 0.50 hour x 6 visits = 3 hours per 
infant. For 112 infants in the study, 3 hours x 112 infants = 336 hours 
for the annual burden, as shown in row 21 of table 2. In addition, we 
estimate that one nurse needs 15 minutes per infant to collect and 
record the formula intake information. That is, 0.25 hour x 6 visits = 
1.5 hour per infant, and 1.5 hour per infant x 112 infants = 168 hours 
for the annual burden, as shown in row 22 of table 2.
    Section 106.96(b)(4) requires plotting each infant's anthropometric 
measurements on the Centers for Disease Control and Prevention-
recommended World Health Organization Child Growth Standards. We 
estimate that it takes 5 minutes per infant to record the 
anthropometric data on the growth chart at each study visit. Therefore, 
112 infants x 6 data plots = 672 data plots, and 672 data plots x 0.08 
hour per comparison = 53.75 hours (rounded to 54) for the annual 
burden, as shown in row 23 of table 2.
    Section 106.96(b)(5) requires that data on formula intake by the 
test group be compared to the intake of a concurrent control group. We 
estimate that one nurse or other health care professional with similar 
experience needs 5 minutes per infant for each of the six times 
anthropometric data are collected. Therefore, 6 comparisons of data x 
112 infants = 672 data comparisons and 672 data comparisons x 0.08 hour 
per comparison = 53.75 hours (rounded to 54) for the annual burden, as 
shown in row 24 of table 2.
    Section 106.96(f) provides that a manufacturer meets the quality 
factor of sufficient biological quality of the protein by establishing 
the biological quality of the protein in the infant formula when fed as 
the sole source of nutrition using an appropriate modification of the 
PER rat bioassay. Under Sec.  106.96(g)(1), a manufacturer of infant 
formula may be exempt from this requirement if the manufacturer

[[Page 15152]]

requests an exemption and provides assurances, as required under Sec.  
106.121, that changes made by the manufacturer to an existing infant 
formula are limited to changing the type of packaging. A manufacturer 
may also be exempt from this requirement under Sec.  106.100(g)(2), if 
the manufacturer requests an exemption and provides assurances, as 
required under Sec.  106.121, that demonstrate to FDA's satisfaction 
that the change to an existing formula does not affect the 
bioavailability of the protein. Finally, a manufacturer of infant 
formula may be exempt from this requirement under Sec.  106.96(g)(3) if 
the manufacturer requests an exemption and provides assurances, as 
required under Sec.  106.121(i), that demonstrate that an alternative 
method to the PER that is based on sound scientific principles is 
available to show that the formula supports the quality factor for the 
biological quality of the protein. We estimate that the infant formula 
industry submits a total of 35 PER submissions: 34 exemption requests 
and the results of 1 PER study.
    A PER study conducted according to the Association of Analytical 
Communities Official Method 960.48 is 28 days in duration. We estimate 
that there will be 10 rats in the control and test groups (20 rats 
total) and that food consumption and body weight will be measured at 
day 0 and at 7-day intervals during the 28-day study period (a total of 
5 records per rat). We further estimate that measuring and recording 
food consumption and body weight will take 5 minutes per rat. 
Therefore, 20 rats x 5 records = 100 records; 100 records x 0.08 hour 
minutes per record = 8 hours to fulfill the requirements of Sec.  
106.96(f). Further, we estimate that a report based on the PER study 
will be generated and that this study report will take a senior 
scientist 1 hour to generate. Therefore, a total of 9 hours will be 
required to fulfill the requirements for Sec.  106.96(f): 8 hours for 
the PER study and data collection, and 1 hour for the development of a 
report based on the PER study, as shown in rows 25 and 26 of table 2.
    We estimate that five firms will expend approximately 20,000 hours 
per year to fully satisfy the recordkeeping requirements in Sec.  
106.100 and that three firms will expend approximately 9,000 hours per 
year to fully satisfy the recordkeeping requirements in Sec.  
107.50(c)(3). Thus, the total recordkeeping burden is 40,232 hours.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR section                               Number of       disclosures     Total  annual   Average  burden    Total  hours
                                                                       respondents    per  respondent    disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nutrient labeling; 21 CFR 107.10(a) and 107.20.....................               5               13               65                8              520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate compliance with our labeling requirements in Sec. Sec.  
107.10(a) and 107.20 requires 520 hours annually by five manufacturers.

    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07147 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P