[Federal Register Volume 82, Number 219 (Wednesday, November 15, 2017)]
[Notices]
[Pages 52927-52933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24688]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Infant Formula Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice invites comments on the information collection provisions of our 
infant formula regulations, including infant formula labeling, quality 
control procedures, notification requirements, and recordkeeping. The 
notice also invites comment on a pilot electronic form that allows 
manufacturers of infant formula to submit reports and notifications in 
a standardized format.

DATES: Submit either electronic or written comments on the collection 
of information by January 16, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 16, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0545 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Infant Formula Requirements.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on

[[Page 52928]]

https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
<a href="/cdn-cgi/l/email-protection#9cccceddcfe8fdfafadcfaf8fdb2f4f4efb2fbf3ea"><span class="__cf_email__" data-cfemail="530301120027323535133537327d3b3b207d343c25">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
Infant Formula Requirements--21 CFR parts 106 and 107
OMB Control Number 0910-0256--Extension
    Statutory requirements for infant formula under the Federal Food, 
Drug, and Cosmetic Act (the 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 have issued 
regulations to implement the FD&C Act's requirements for infant formula 
in parts 106 and 107 (21 CFR parts 106 and 107). We also regulate the 
labeling of infant formula under the authority of section 403 of the 
FD&C Act (21 U.S.C. 343). Under our labeling regulations for infant 
formula in part 107, the label of an infant formula must include 
nutrient information and directions for use. The purpose of these 
labeling requirements is to ensure that consumers have the information 
they need to prepare and use infant formula appropriately.
    We have developed an electronic form (Form FDA 3978) that infant 
formula manufacturers will be able to use to electronically submit 
reports and notifications in a standardized format to FDA. 
Manufacturers that prefer to submit paper submissions in a format of 
their own choosing will still have the option to do so, however. Form 
FDA 3978 prompts a respondent to include reports and notifications in a 
standard electronic format and helps the respondent organize their 
submission to include only the information needed for our review. Draft 
screenshots of Form FDA 3978 and instructions are available for comment 
at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/InfantFormula/default.htm.
    Description of Respondents: Respondents to this information 
collection are manufacturers of infant formula.
    We estimate the burden of this collection of information as 
follows:

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


[[Page 52929]]

    In compiling these estimates, we consulted our records of the 
number of infant formula submissions received in the past. All infant 
formula submissions may be provided to us in electronic format. The 
hours per response reporting estimates are based on our experience with 
similar programs and information received from industry.
    We estimate that we will receive 13 reports from 5 manufacturers 
annually under section 412(d) of the FD&C Act, for a total annual 
response of 65 reports. Each report is estimated to take 10 hours per 
response for a total of 650 hours. We also estimate that we receive one 
notification under Sec.  106.120(b). The notification is expected to 
take 4 hours per response, for a total of 4 hours.
    For exempt infant formula, we estimate that we receive two reports 
from three manufacturers annually under Sec.  107.50(b)(3) and (4), for 
a total annual response of six reports. Each report is estimated to 
take 4 hours per response for a total of 24 hours. We also estimate 
that we receive one notification annually under Sec.  107.50(e)(2) and 
that the notification takes 4 hours to prepare.
    We estimate that 4 firms submit 36 exemptions annually and that 
each exemption will take 20 hours to assemble. Therefore, we calculate 
36 exemptions x 20 hours = 720 hours as the estimated burden for Sec.  
106.96(c), as presented in row 5 of table 1.
    We estimate 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 
pursuant to 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 pursuant to 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\ \2\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
   Row No.    Activity; 21 CFR     Number of      records per    Total annual          per          Total hours
                   section       recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
1...........  Controls to                   21               1              21  1.5 (90 minutes)              32
               prevent
               adulteration
               caused by
               facilities--tes
               ting for
               radiological
               contaminants
               \3\; Sec.
               106.20(f)(3).
2...........  Controls to                   21               1              21  0.08 (5 minutes)               2
               prevent
               adulteration
               caused by
               facilities--rec
               ordkeeping of
               testing for
               radiological
               contaminants\2\
               ; Sec.  Sec.
               106.20(f)(4)
               and
               106.100(f)(1).
3...........  Controls to                    5              52             260  0.08 (5 minutes)              21
               prevent
               adulteration
               caused by
               facilities--tes
               ting for
               bacteriological
               contaminants
               Sec.
               106.20(f)(3).
4...........  Controls to                    5              52             260  0.08 (5 minutes)              21
               prevent
               adulteration
               caused by
               facilities--rec
               ordkeeping of
               testing for
               bacteriological
               contaminants
               Sec.  Sec.
               106.20(f)(4)
               and 106.100(f).
5...........  Controls to                    5              52             260  0.22 (13                      57
               prevent                                                           minutes).
               adulteration by
               equipment or
               utensils; Sec.
               Sec.
               106.30(d) and
               106.100(f)(2).
6...........  Controls to                    5              52             260  0.22 (13                      57
               prevent                                                           minutes).
               adulteration by
               equipment or
               utensils; Sec.
               Sec.
               106.30(e)(3)(ii
               i) and
               106.100(f)(3).
7...........  Controls to                    5              52             260  0.20 (12                      52
               prevent                                                           minutes).
               adulteration by
               equipment or
               utensils; Sec.
               Sec.
               106.30(f) and
               106.100(f)(4).

[[Page 52930]]

 
8...........  Controls to                    5               1               5  520.............           2,600
               prevent
               adulteration
               due to
               automatic
               (mechanical or
               electronic)
               equipment; Sec.
                Sec.
               106.35(c) and
               106.100(f)(5).
9...........  Controls to                    5               2              10  640.............           6,400
               prevent
               adulteration
               due to
               automatic
               (mechanical or
               electronic)
               equipment Sec.
               Sec.
               106.35(c) and
               106.100(f)(5).
10..........  Controls to                    5              52             260  0.17 (10                      44
               prevent                                                           minutes).
               adulteration
               caused by
               ingredients,
               containers, and
               closures; Sec.
               Sec.
               106.40(d) and
               106.100(f)(6).
11..........  Controls to                    5              52             260  0.23 (14                      60
               prevent                                                           minutes).
               adulteration
               during
               manufacturing;
               Sec.  Sec.
               106.50(a)(1)
               and 106.100(e).
12..........  Controls to                    5              52             260  0.25 (15                      65
               prevent                                                           minutes).
               adulteration
               from
               microorganisms;
               Sec.  Sec.
               106.55(d) and
               106.100(e)(5)(i
               i) and (f)(7).
13..........  Controls to                    1              12              12  0.25 (15                       3
               prevent                                                           minutes).
               adulteration
               during
               packaging and
               labeling of
               infant formula;
               Sec.
               106.60(c).
14..........  General quality                4               1               4  2...............               8
               control--testin
               g; Sec.
               106.91(b)(1),
               (2), and (3).
15..........  General quality                4              52             208  0.15 (9 minutes)              31
               control; Sec.
               Sec.
               106.91(b)(1)
               and(d), and
               106.100(e)(5)(i
               ).
16..........  General quality                4              52             208  0.15 (9 minutes)              31
               control; Sec.
               Sec.
               106.91(b)(2)
               and (d), and
               106.100(e)(5)(i
               ).
17..........  General quality                4              52             208  0.15 (9 minutes)              31
               control; Sec.
               Sec.
               106.91(b)(3)
               and (d), and
               106.100(e)(5)(i
               ).
18..........  Audit plans and                5               1               5  8...............              40
               procedures;
               ongoing review
               and updating of
               audits; Sec.
               106.94.
19..........  Audit plans and                5              52             260  4...............           1,040
               procedures --
               regular audits;
               Sec.   106.94.
20..........  Requirements for               1               1               1  16..............              16
               quality factors
               for infant
               formulas--writt
               en study
               report; Sec.
               Sec.
               106.96(b) and
               (d),
               106.100(p)(1)
               and (q)(1), and
               106.121.
21..........  Requirements for             112               6             672  0.50 (30                     336
               quality factors                                                   minutes).
               for infant
               formulas--anthr
               opometric data;
               Sec.  Sec.
               106.96(b)(2)
               and (d), and
               106.100(p)(1).
22..........  Requirements for             112               6             672  0.25 (15                     168
               quality factors                                                   minutes).
               for infant
               formulas--formu
               la intake Sec.
               Sec.
               106.96(b)(3)
               and (d), and
               106.100(p)(1).
23..........  Requirements for             112               6             672  0.08 (5 minutes)              54
               quality factors
               for infant
               formulas--data
               plotting; Sec.
               Sec.
               106.96(b)(4)
               and (d), and
               106.100(p)(1).
24..........  Requirements for             112               6             672  0.08 (5 minutes)              54
               quality factors
               for infant
               formulas--data
               comparison;
               Sec.  Sec.
               106.96(b)(5)
               and (d), and
               106.100(p)(1).

[[Page 52931]]

 
25..........  Requirements for               1               1               1  8...............               8
               quality
               factors--per
               data
               collection;
               Sec.
               106.96(f).
26..........  Requirements for               1               1               1  1...............               1
               quality
               factors--per
               written report;
               Sec.
               106.96(f).
27..........  Records; Sec.                  5              10              50  400.............          20,000
               106.100.
28..........  Records for                    3              10              30  300.............           9,000
               Exempt Infant
               Formula; Sec.
               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 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.

[[Page 52932]]

    Section 106.60 establishes requirements for the recordkeeping and 
labeling of mixed-lot packages of infant formula. Section 106.60(c) 
requires infant formula diverters 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-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 
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.

[[Page 52933]]



                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual   Average burden
         21 CFR section             respondents         per         disclosures   per disclosure    Total hours
                                                    respondent
----------------------------------------------------------------------------------------------------------------
Nutrient labeling; 21 CFR                      5              13              65               8             520
 107.10(a) and 107.20...........
----------------------------------------------------------------------------------------------------------------
\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: November 8, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24688 Filed 11-14-17; 8:45 am]
 BILLING CODE 4164-01-P


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