Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements, 77469-77472 [2020-26537]
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Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices
final rule for any proposal to amend the
standard of identity for canned Pacific
salmon that may result from the
National Food Processors Association’s
petition, submitted on behalf of Bumble
Bee Seafoods, Inc., and other salmon
packers holding temporary permits, or
30 days after termination of such
proposal.
In the Federal Register of April 24,
2020 (85 FR 23047), we issued a notice
announcing that we amended the
temporary permit to allow for the
canned skinless and boneless chunk
salmon packed in water with or without
sodium tripolyphosphate and to allow
the test product to be manufactured
only at one plant, Pataya Food
Industries Ltd., located at 90/6 Moo 7,
Settakit Road, Tambol Tarsai, Amphur
Maung, Samutsakorn 74000, Thailand.
Under our regulations at 21 CFR
130.17(f), we are amending the
temporary permit issued to Bumble Bee
Seafoods, Inc., to allow the test product
to be manufactured at an additional
plant, RS Cannery Company Limited,
located at 255/1 Industrial Soi 3,
Bangpoo Industrial Estate,
Samutprakarn 10280, Thailand. All
other conditions and terms of this
permit remain the same.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26533 Filed 12–1–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–1119; FDA–
2010–N–0622; FDA–2011–N–0016; FDA–
2009–N–0501; and FDA–2019–N–6098]
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
SUMMARY:
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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, PRAStaff@
fda.hhs.gov.
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:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods .........................................................................................................................................
Color Additive Certification Requests and Recordkeeping .....................................................................................
Recordkeeping and Records Access Requirements for Food Facilities .................................................................
Reporting and Recordkeeping Requirements for Reportable Food ........................................................................
Focus Groups as Used by the Food and Drug Administration ...............................................................................
Dated: November 25, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26571 Filed 12–1–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0190]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
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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
solicits 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 electronic Form
FDA 3978 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 February 1, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
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0910–0037
0910–0216
0910–0560
0910–0643
0910–0497
Date approval
expires
10/31/2023
10/31/2023
10/31/2023
10/31/2023
11/30/2023
considered. Electronic comments must
be submitted on or before February 1,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 1, 2021.
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
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Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices
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–
2010–N–0190 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, 240–402–7500.
• 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
https://www.regulations.gov. Submit
both copies to the Dockets Management
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17:39 Dec 01, 2020
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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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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: Under the
PRA (44 U.S.C. 3501–3521), 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, FDA invites
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
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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 (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 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.
Failure to comply with any of the
applicable labeling regulations will
render an infant formula misbranded
under section 403 of the FD&C Act. The
purpose of these labeling requirements
is to ensure that consumers have the
information they need to prepare and
use infant formula appropriately.
While the infant formula regulations
help ensure the consistent production of
safe and nutritionally adequate infant
formulas for healthy term infants, they
apply with one narrow exception.
Section 412(h)(1) of the FD&C Act
exempts an infant formula represented
and labeled for use by an infant with an
inborn error of metabolism, low birth
weight, or who otherwise has an
unusual medical or dietary problem
from the requirements of subsections
412(a), (b), and (c) of the FD&C Act.
These formulas are customarily referred
to as ‘‘exempt infant formulas.’’ Section
412(h)(2) of the FD&C Act authorizes us
to establish terms and conditions for the
exemption of an infant formula from the
requirements of subsections 412(a), (b),
and (c) of the FD&C Act.
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In support of exempt infant formulas,
we have issued the agency guidance
document entitled, ‘‘Exempt Infant
Formula Production: Current Good
Manufacturing Practices (CGMPs),
Quality Control Procedures, Conduct of
Audits, and Records and Reports.’’ The
guidance document includes our
recommendation that manufacturers of
exempt infant formulas follow, to the
extent practicable, subparts A, B, C, D,
and F of 21 CFR part 106, and is
available at https://www.fda.gov/
regulatory-information/search-fda-
guidance-documents/guidanceindustry-exempt-infant-formulaproduction.
We have also developed electronic
Form FDA 3978 (Infant Formula
Tracking System (IFTRACK)) so that
infant formula manufacturers may
electronically submit reports and
notifications in a standardized format to
FDA. However, manufacturers that
prefer to submit paper submissions in a
format of their own choosing will still
have the option to do so. 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. Screenshots of Form FDA
3978 and instructions are available at
https://www.fda.gov/Food/Guidance
Regulation/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
responses per
respondent
Number of
respondents
FD&C act or 21 CFR
Average
burden per
response
Total annual
responses
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
13
1
2
65
1
6
10 .........................
4 ...........................
4 ...........................
650
4
24
1
4
1
9
1
36
4 ...........................
20 .........................
4
720
1
34
34
12 .........................
408
4
4
9
9
36
36
0.50 (30 mins.) .....
10 .........................
18
360
Total .......................................................................
........................
........................
........................
..............................
2,188
1 There
are no capital or operating and maintenance costs associated with the information collection.
Based on a review of the information
collection, we have adjusted our burden
estimate to correct a nominal
calculation error. This reflects a
decrease of 62 annual responses and a
corresponding decrease of 308 annual
hours.
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.
The total estimated annual reporting
burden is 2,188 hours, as shown in table
1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
FD&C act or 21 CFR part
Number of
records per
recordkeeper
Total annual
records
Burden per
record
Total hours
Part 106—SUBPART B: CGMP Requirements ...................
Part 106—SUBPARTS C–G: Quality control; audits; quality factors; records and reports ........................................
Part 107—SUBPART C; Exempt infant formulas ................
Exempt infant formula production; GMP; audits, recordkeeping, & reports ............................................................
5
429.8
2,149
4.4
9,414
5
3
726.8
10
3,634
30
6
300
21,818
9,000
3
634
1,902
45
85,590
Total ..............................................................................
........................
........................
........................
........................
125,822
1 There
are no capital costs or operating and maintenance costs associated with the information.
have been rounded.
2 Numbers
The total estimated annual
recordkeeping burden is 125,822 hours,
as shown in table 2.
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Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity; 21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Nutrient labeling; §§ 107.10(a) and 107.20 .........................
5
13
65
8
520
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
the past decade—and people with HIV
in care and treatment are living longer,
healthier lives. In 2018 the estimated
number of new HIV infections was
36,400. A robust prevention toolbox that
Dated: November 23, 2020.
includes pre-exposure prophylaxis
Lauren K. Roth,
(PrEP), post-exposure prophylaxis
Acting Principal Associate Commissioner for
(PEP), and syringe services programs
Policy.
(SSPs) has lowered a person’s risk of
[FR Doc. 2020–26537 Filed 12–1–20; 8:45 am]
acquiring HIV. Research in recent years
BILLING CODE 4164–01–P
has proven that people with HIV who
take antiretroviral therapy achieve and
maintain an undetectable viral load, not
DEPARTMENT OF HEALTH AND
protect their health but also have
HUMAN SERVICES
effectively no risk of transmitting HIV
through sex.
Request for Information: HIV National
This stability in the annual number of
Strategic Plan 2021–2025 Available for
new infections, though, has further
Public Comment
illuminated opportunities for focused
efforts. According to the most recent
AGENCY: Office of the Secretary,
available data, less than one-half
Department of Health and Human
(38.9%) of the U.S. population have
Services.
ever been tested for HIV 1 and an
ACTION: Notice.
estimated 161,800 (14%) people with
SUMMARY: The Department of Health and HIV are unaware of their status.2 Only
63% of people diagnosed with HIV are
Human Services’ (HHS) Office of
Infectious Disease and HIV/AIDS Policy virally suppressed.3 Approximately
80% of new HIV infections are due to
(OIDP) in the Office of the Assistant
Secretary for Health (OASH) announces people who do not know they have HIV
or are not receiving regular care,4 and
the draft HIV National Strategic Plan: A
only 18% of the approximately 1.2
Roadmap to End the HIV Epidemic
million people indicated for PrEP are
(2021–2025) (HIV Plan) available for
receiving it.5 6
public comment. The draft HIV Plan
may be reviewed at www.hiv.gov.
1 National HIV Testing Day—June 27, 2019.
DATES: All comments must be received
MMWR. 2019;68:561. doi: https://dx.doi.org/
by 5:00 p.m. ET on December 14, 2020
10.15585/mmwr.mm6825a1.
2 Centers for Disease Control and Prevention.
to be considered.
Estimated HIV incidence and prevalence in the
ADDRESSES: All comments must be
United States, 2014–2018. HIV Surveillance
submitted electronically to
Supplemental Report 2020;25(1). Accessed
HIVPlanComments@hhs.gov to be
September 28, 2020. https://www.cdc.gov/hiv/
library/reports/hiv-surveillance.html.
considered.
We estimate compliance with our
infant formula labeling requirements in
§§ 107.10(a) and 107.20 requires 520
hours annually.
FOR FURTHER INFORMATION CONTACT:
Harold J. Phillips, OIDP,
Harold.Phillips@hhs.gov, 202–725–
8872.
The
National HIV/AIDS Strategy, first
released in 2010 and updated in 2015,
changed the way that Americans talk
about HIV and the ways that
stakeholders prioritize and coordinate
resources and deliver prevention and
care services that support people with
HIV or at risk for HIV. As a result, the
nation’s new HIV infections have
declined from their peak in the mid1980s—although remaining stable over
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:39 Dec 01, 2020
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3 Harris NS, Johnson AS, Huang YLA, et al. Vital
Signs: status of human immunodeficiency virus
testing, viral suppression, and HIV preexposure
prophylaxis—United States, 2013–2018. MMWR.
2019;68:1117–1123. doi: https://dx.doi.org/
10.15585/mmwr.mm6848e1.
4 Li Z, Purcell DW, Sansom SL, et al. Vital Signs:
HIV transmission along the continuum of care—
United States, 2016. MMWR. 2019;68:267–272.
Figure 1. doi: https://dx.doi.org/10.15585/
mmwr.mm6811e1.
5 Harris NS, Johnson AS, Huang YLA, et al. Vital
Signs: status of human immunodeficiency virus
testing, viral suppression, and HIV preexposure
prophylaxis—United States, 2013–2018. MMWR.
2019;68:1117–1123. doi: https://dx.doi.org/
10.15585/mmwr.mm6848e1.
6 Centers for Disease Control and Prevention. HIV
Surveillance Data Tables (early release): Core
indicators for monitoring the Ending the HIV
Epidemic initiative (preliminary data): HIV
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To respond and address the HIV
public health epidemic, OASH through
OIDP, in collaboration with a steering
committee composed of a wide array of
federal partners, has led and
coordinated development of the HIV
Plan. Opportunities for public input
were provided, and public comments
received were reviewed and analyzed,
to help inform development of the
components of the HIV Plan. The HIV
Plan covers the entire country, provides
a roadmap across the federal
government, non-federal partners and
stakeholders in all sectors of society,
and encourages integration of several
key components that are vital to our
collective work.
The HIV Plan is the nation’s third
consecutive national HIV strategy. It sets
forth bold targets for ending the HIV
epidemic in the United States by 2030,
including a 75% reduction in new HIV
infections by 2025 and a 90% reduction
by 2030. The HIV Plan articulates goals,
objectives, and strategies to prevent new
infections, treat people with HIV to
improve health outcomes, reduce HIVrelated disparities, and better integrate
and coordinate the efforts of all partners
to end the HIV epidemic in the United
States. The HIV Plan also establishes
indicators to measure progress, with
quantitative targets for each indicator,
and designates populations
disproportionately impacted by and at
risk for HIV as well as key areas of
focus.
The order of goals, objectives, and
strategies does not indicate any
prioritization, and many are
intertwined. The following are the HIV
Plan’s vision and four goals:
Vision: The United States will be a
place where new HIV infections are
prevented, every person knows their
status, and every person with HIV has
high-quality care and treatment and
lives free from stigma and
discrimination. This vision includes all
people, regardless of age, sex, gender
identity, sexual orientation, race,
diagnoses and linkage to HIV medical care, 2019
(reported through December 2019); and preexposure
prophylaxis (PrEP)—2018, updated. HIV
Surveillance Data Tables 2020;1(2). Accessed
October 16, 2020. https://www.cdc.gov/hiv/library/
reports/surveillance-data-tables/.
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]]>Agencies
[Federal Register Volume 85, Number 232 (Wednesday, December 2, 2020)]
[Notices]
[Pages 77469-77472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26537]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0190]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Infant Formula Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 solicits 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 electronic Form FDA
3978 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 February 1, 2021.
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 February 1, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 1, 2021. 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
[[Page 77470]]
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-2010-N-0190 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, 240-402-7500.
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 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.govinfo.gov/content/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, 240-402-7500.
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: Under the PRA (44 U.S.C. 3501-3521), 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, FDA
invites 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 (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 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. Failure to comply with any
of the applicable labeling regulations will render an infant formula
misbranded under section 403 of the FD&C Act. The purpose of these
labeling requirements is to ensure that consumers have the information
they need to prepare and use infant formula appropriately.
While the infant formula regulations help ensure the consistent
production of safe and nutritionally adequate infant formulas for
healthy term infants, they apply with one narrow exception. Section
412(h)(1) of the FD&C Act exempts an infant formula represented and
labeled for use by an infant with an inborn error of metabolism, low
birth weight, or who otherwise has an unusual medical or dietary
problem from the requirements of subsections 412(a), (b), and (c) of
the FD&C Act. These formulas are customarily referred to as ``exempt
infant formulas.'' Section 412(h)(2) of the FD&C Act authorizes us to
establish terms and conditions for the exemption of an infant formula
from the requirements of subsections 412(a), (b), and (c) of the FD&C
Act.
[[Page 77471]]
In support of exempt infant formulas, we have issued the agency
guidance document entitled, ``Exempt Infant Formula Production: Current
Good Manufacturing Practices (CGMPs), Quality Control Procedures,
Conduct of Audits, and Records and Reports.'' The guidance document
includes our recommendation that manufacturers of exempt infant
formulas follow, to the extent practicable, subparts A, B, C, D, and F
of 21 CFR part 106, and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exempt-infant-formula-production.
We have also developed electronic Form FDA 3978 (Infant Formula
Tracking System (IFTRACK)) so that infant formula manufacturers may
electronically submit reports and notifications in a standardized
format to FDA. However, manufacturers that prefer to submit paper
submissions in a format of their own choosing will still have the
option to do so. 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. Screenshots of Form FDA 3978 and instructions
are available at https://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
FD&C act or 21 CFR Number of responses per Total 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 formula; Sec. 1 1 1 4....................................... 4
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 mins.)......................... 18
106.110.
New infant formula submission; Sec. 106.120. 4 9 36 10...................................... 360
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 2,188
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
Based on a review of the information collection, we have adjusted
our burden estimate to correct a nominal calculation error. This
reflects a decrease of 62 annual responses and a corresponding decrease
of 308 annual hours.
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.
The total estimated annual reporting burden is 2,188 hours, as
shown in table 1.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of
FD&C act or 21 CFR part Number of records per Total annual Burden per Total hours
recordkeepers recordkeeper records record
----------------------------------------------------------------------------------------------------------------
Part 106--SUBPART B: CGMP 5 429.8 2,149 4.4 9,414
Requirements...................
Part 106--SUBPARTS C-G: Quality 5 726.8 3,634 6 21,818
control; audits; quality
factors; records and reports...
Part 107--SUBPART C; Exempt 3 10 30 300 9,000
infant formulas................
Exempt infant formula 3 634 1,902 45 85,590
production; GMP; audits,
recordkeeping, & reports.......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 125,822
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information.
\2\ Numbers have been rounded.
The total estimated annual recordkeeping burden is 125,822 hours,
as shown in table 2.
[[Page 77472]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nutrient labeling; Sec. Sec. 107.10(a) and 107.20............... 5 13 65 8 520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
We estimate compliance with our infant formula labeling
requirements in Sec. Sec. 107.10(a) and 107.20 requires 520 hours
annually.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26537 Filed 12-1-20; 8:45 am]
BILLING CODE 4164-01-P
