[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]


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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.

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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 http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/InfantFormula/default.htm.
    Description of Respondents: Respondents to this information 
collection are manufacturers of infant formula.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                   Number of
              FD&C act or 21 CFR                   Number of     responses per   Total annual         Average  burden per  response         Total hours
                                                  respondents     respondent       responses
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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
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    Total.....................................  ..............  ..............  ..............  ........................................           2,188
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\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\
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                                                     Number of
     FD&C act or 21 CFR part         Number of      records per    Total annual     Burden per      Total hours
                                   recordkeepers   recordkeeper       records         record
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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
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\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\
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                                                                                         Number of
                      Activity; 21 CFR section                          Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Nutrient labeling; Sec.  Sec.   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 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