Document ID: FDA-2010-N-0190-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of 
Management and Budget Review; Comment Request; Infant Formula 
Requirements
Posted Date: 2021-04-23T04:00Z

[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21754-21756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08470]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0190]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Infant Formula 
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
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: Submit written comments (including recommendations) on the 
collection of information by May 24, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 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.

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.
    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

[[Page 21755]]

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.
    In the Federal Register of December 2, 2020 (85 FR 77469), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received providing general 
comment regarding requirements for infant formula labeling; however, 
neither comment requested revision to the burden estimates.
    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 Section       Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Reports; Section 412(d) of the               5              13              65  10..............             650
 FD&C Act.
Notifications; Sec.                          1               1               1  4...............               4
 106.120(b).
Reports for exempt infant                    3               2               6  4...............              24
 formula; Sec.   107.50(b)(3)
 and (4).
Notifications for exempt                     1               1               1  4...............               4
 infant formula; Sec.
 107.50(e)(2).
Requirements for quality                     4               9              36  20..............             720
 factors--growth monitoring
 study exemption; Sec.
 106.96(c).
Requirements for quality                     1              34              34  12..............             408
 factors--Protein Efficiency
 Ratio exemption; Sec.
 106.96(g).
New infant formula                           4               9              36  0.50............              18
 registration; Sec.   106.110.                                                  (30 minutes)....
New infant formula submission;               4               9              36  10..............             360
 Sec.   106.120.
                               ---------------------------------------------------------------------------------
    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                    Average burden
     FD&C Act or 21 CFR Part         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Part 106--subpart B:............               5           429.8           2,149             4.4           9,414
CGMP Requirements...............
Part 106--subparts C through G:                5           726.8           3,634               6          21,818
 Quality 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, and 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 21756]]

                                               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; 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 21 CFR 107.10(a) and 107.20 requires 520 hours 
annually.

    Dated: April 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08470 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P