Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request, 15148-15152 [2018-07147]
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15148
Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
as well as the name, address, and phone
number of its U.S. agent (§ 607.40(d)).
This information assists FDA in its
inspections of facilities, among other
uses, and its collection is essential to
the overall regulatory scheme designed
to ensure the safety of the Nation’s
blood supply.
Respondents to this collection of
information are human blood and
plasma donor centers, blood banks,
certain transfusion services, other blood
product manufacturers, and
independent laboratories that engage in
quality control and testing for registered
blood product establishments.
FDA estimates the burden of this
collection of information based upon
information obtained from the database
of FDA’s Center for Biologics Evaluation
and Research and FDA experience with
the blood establishment registration and
product listing requirements.
In the Federal Register of December
26, 2017 (82 FR 61013), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. We received no comments.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Activity/form FDA
2830
607.20(a), 607.21, 607.22, 607.25,
and 607.40.
607.21, 607.22, 607.25, 607.26,
607.31, and 607.40.
607.21, 607.25, 607.30(a), 607.31,
and 607.40.
607.22(b) .........................................
Initial Registration.
Annual Registration.
Product Listing
Update.
Waiver Requests
Total .........................................
............................
1There
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07145 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice.
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.
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
Average burden
per
response
Total annual
responses
Total hours
115
1
115
1 .........................
115
2,612
1
2,612
1,306
200
1
200
25
........................
25
0.5 ......................
(30 minutes) .......
0.25 ....................
(15 minutes) .......
1 .........................
........................
........................
........................
............................
1,496
50
25
are no capital costs of operating and maintenance costs associated with this collection of information.
The burden for this information
collection has changed since the last
OMB approval. Because of a slight
increase in the number of initial
registrations and product listing updates
FDA has received during the past 3
years, we have increased our reporting
burden estimate.
ACTION:
Number of
respondents
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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 oira_
submission@omb.eop.gov. 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, PRAStaff@
fda.hhs.gov.
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.
ADDRESSES:
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.
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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.
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Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
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
15149
information collection, which is as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
FD&C act or 21 CFR section
Total
annual
responses
Average burden
per response
Total hours
Reports; Section 412(d) of the FD&C Act ......................................
Notifications; § 106.120(b) ..............................................................
Reports for Exempt Infant Formula; § 107.50(b)(3) and (4) ...........
Notifications for Exempt Infant Formula;§ 107.50(e)(2) ..................
Requirements for Quality Factors Growth Monitoring Study Exemption; § 106.96(c).
Requirements for Quality Factors—PER Exemption; § 106.96(g)
New Infant Formula Registration; § 106.110 ..................................
New Infant Formula Submission; § 106.120 ...................................
5
1
3
1
4
13
1
2
1
9
65
1
6
1
36
10
4
4
4
20
650
4
24
4
720
1
4
4
34
9
9
34
36
36
12
0.50 (30 minutes)
10
408
18
360
Total .........................................................................................
........................
............................
....................
1 There
..............................................
2,188
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 § 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 § 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
§ 107.50(e)(2) and that it takes 4 hours
to prepare.
We assume that 4 firms will submit 36
exemptions under § 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 ×
12 hours per exemption = 408 hours to
fulfill the requirements of § 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 § 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 × 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
§ 106.120. This estimate includes the
time needed to gather and record the
information the manufacturer uses to
request an exemption under
§ 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 § 106.120, we
calculate the annual burden as 36
submissions × 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
recordkeepers
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Activity; 21 CFR section
Controls to prevent adulteration caused by facilities—testing for
radiological contaminants; 3 § 106.20(f)(3)
Controls to prevent adulteration caused by facilities—recordkeeping
of
testing
for
radiological
contaminants; 2
§§ 106.20(f)(4) and 106.100(f)(1)
Controls to prevent adulteration caused by facilities—testing for
bacteriological contaminants § 106.20(f)(3)
Controls to prevent adulteration caused by facilities—recordkeeping
of
testing
for
bacteriological
contaminants
§§ 106.20(f)(4) and 106.100(f)(1)
Controls to prevent adulteration by equipment or utensils;
§§ 106.30(d) and 106.100(f)(2)
Controls to prevent adulteration by equipment or utensils;
§§ 106.30(e)(3)(iii) and 106.100(f)(3)
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Number of
records per
recordkeeper
Total
annual
records
Average burden
per recordkeeping
Total
hours
21
1
21
1.5 (90 minutes)
32
21
1
21
0.08 (5 minutes)
2
5
52
260
0.08 (5 minutes)
21
5
52
260
0.08 (5 minutes)
21
5
52
260
0.22 (13 minutes)
57
5
52
260
0.22 (13 minutes)
57
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Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Activity; 21 CFR section
Controls to prevent adulteration by equipment or utensils;
§§ 106.30(f) and 106.100(f)(4)
Controls to prevent adulteration due to automatic (mechanical or
electronic) equipment; §§ 106.35(c) and 106.100(f)(5)
Controls to prevent adulteration due to automatic (mechanical or
electronic) equipment §§ 106.35(c) and 106.100(f)(5)
Controls to prevent adulteration caused by ingredients, containers, and closures; §§ 106.40(d) and 106.100(f)(6)
Controls to prevent adulteration during manufacturing;
§§ 106.50(a)(1) and 106.100(e)
Controls to prevent adulteration from microorganisms;
§§ 106.55(d) and 106.100(e)(5)(ii) and (f)(7)
Controls to prevent adulteration during packaging and labeling of
infant formula; § 106.60(c)
General quality control—testing; § 106.91(b)(1), (2), and (3)
General
quality
control;
§§ 106.91(b)(1)
and(d),
and
106.100(e)(5)(i)
General quality control; §§ 106.91(b)(2) and (d), and
106.100(e)(5)(i)
General quality control; §§ 106.91(b)(3) and (d), and
106.100(e)(5)(i)
Audit plans and procedures; ongoing review and updating of audits; § 106.94
Audit plans and procedures —regular audits; § 106.94
Requirements for quality factors for infant formulas—written study
report; §§ 106.96(b) and (d), 106.100(p)(1) and (q)(1), and
106.121
Requirements for quality factors for infant formulas—anthropometric data; §§ 106.96(b)(2) and (d), and 106.100(p)(1)
Requirements for quality factors for infant formulas—formula intake §§ 106.96(b)(3) and (d), and 106.100(p)(1)
Requirements for quality factors for infant formulas—data plotting; §§ 106.96(b)(4) and (d), and 106.100(p)(1)
Requirements for quality factors for infant formulas—data comparison; §§ 106.96(b)(5) and (d), and 106.100(p)(1)
Requirements for quality factors—per data collection; § 106.96(f)
Requirements for quality factors—per written report; § 106.96(f)
Records; § 106.100
Records for Exempt Infant Formula; § 107.50(c)(3)
Total .........................................................................................
Number of
records per
recordkeeper
Total
annual
records
Average burden
per recordkeeping
0.20 (12 minutes)
Total
hours
5
52
260
52
5
1
5
520
2,600
5
2
10
640
6,400
5
52
260
0.17 (10 minutes)
44
5
52
260
0.23 (14 minutes)
60
5
52
260
0.25 (15 minutes)
65
1
12
12
0.25 (15 minutes)
3
4
4
1
52
4
208
2
0.15 (9 minutes)
8
31
4
52
208
0.15 (9 minutes)
31
4
52
208
0.15 (9 minutes)
31
5
1
5
8
40
5
1
52
1
260
1
4
16
112
6
672
0.50 (30 minutes)
336
112
6
672
0.25 (15 minutes)
168
112
6
672
0.08 (5 minutes)
54
112
6
672
0.08 (5 minutes)
54
1
1
5
3
1
1
10
10
1
1
50
30
........................
........................
........................
1,040
16
8
1
400
300
8
1
20,000
9,000
..............................................
40,232
1 There
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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 § 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 × 21
plants = 31.5 (rounded to 32) total
hours, every 4 years, as seen in row 1
of table 2. Furthermore, §§ 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 × 21
plants = 1.68 (rounded to 2) hours,
every 4 years for the maintenance of
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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 × 52
weeks = 4.16 hours per year, per plant,
and 4.16 hours per plant × 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 × 52 weeks = 4.16 hours per
plant for the maintenance of records of
bacteriological testing. Accordingly,
4.16 hours × 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
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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 × 52 weeks
= 260 records; 260 records × 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 × 52 weeks = 260 records;
260 records × 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
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per week of recordkeeping. Therefore, 5
recordkeepers × 52 weeks = 260 records;
260 records × 0.20 hours per record = 52
hours as the annual burden, as
presented in row 7 of table 2.
For §§ 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 × 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 × 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 × 2 revalidations) × 4
engineers = 1,280 total work hours) per
plant. Therefore, 640 hours × 5 plants ×
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 × 52 weeks = 260
records and 260 records × 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 §§ 106.50(a)(1) and
106.100(e). Thus, 5 recordkeepers × 52
weeks = 260 records; 260 records × 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 × 52 weeks = 260 records;
260 records × 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
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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 × 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 × 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
§ 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 × 52
weeks = 208 records; 208 records × 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 × 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 × 4 hours = 208 hours per plant.
Therefore, burden for updating audit
plans is calculated as 208 hours × 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 § 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
§§ 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 × 16 hours = 16 hours for
the annual burden for compliance with
§§ 106.96(b) and (d), 106.100(p)(1) and
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15151
(q)(1), and 106.121 as shown in row 20
of table 2.
A study conducted according to the
requirements of § 106.96(b)(2) must
include the collection of anthropometric
measurements of physical growth and
information on formula intake, and
§§ 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 ×
0.25 hours = 0.50 hour per infant, per
visit, and 0.50 hour × 6 visits = 3 hours
per infant. For 112 infants in the study,
3 hours × 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 × 6 visits
= 1.5 hour per infant, and 1.5 hour per
infant × 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 Preventionrecommended 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 × 6 data plots =
672 data plots, and 672 data plots × 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 × 112
infants = 672 data comparisons and 672
data comparisons × 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 § 106.96(g)(1), a manufacturer of
infant formula may be exempt from this
requirement if the manufacturer
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requests an exemption and provides
assurances, as required under § 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 § 106.100(g)(2),
if the manufacturer requests an
exemption and provides assurances, as
required under § 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 § 106.96(g)(3) if the
manufacturer requests an exemption
and provides assurances, as required
under § 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 ×
5 records = 100 records; 100 records ×
0.08 hour minutes per record = 8 hours
to fulfill the requirements of § 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 § 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 § 106.100 and that three
firms will expend approximately 9,000
hours per year to fully satisfy the
recordkeeping requirements in
§ 107.50(c)(3). Thus, the total
recordkeeping burden is 40,232 hours.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
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 §§ 107.10(a)
and 107.20 requires 520 hours annually
by five manufacturers.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[Docket Nos. FDA–2014–N–0075; FDA–
2011–N–0015; FDA–2011–N–0076; FDA–
2017–N–0932; FDA–2016–N–4487; FDA–
2014–N–0345; FDA–2013–N–0523; FDA–
2017–N–2428; FDA–2008–N–0312; and
FDA–2014–N–1072]
[FR Doc. 2018–07147 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
Control No.
Title of collection
Good Laboratory Practice Regulations for Nonclinical Studies ..............................................................................
Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation .............................................................................
Electronic Records: Electronic Signatures ..............................................................................................................
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings ...........................................
VerDate Sep<11>2014
18:06 Apr 06, 2018
Jkt 244001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
E:\FR\FM\09APN1.SGM
09APN1
Date
approval
expires
0910–0119
1/31/2021
0910–0167
0910–0303
0910–0848
1/31/2021
1/31/2021
1/31/2021
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
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Number of
21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
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Nutrient labeling; 21 CFR 107.10(a) and 107.20..................... 5 13 65 8 520
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\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
