[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:
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.
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:
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.
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.
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,
[email protected].
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.
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Total........ .............. .............. .............. ................. 2,188
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\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).
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Total........ .............. .............. .............. ................ 40,232
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\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