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Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements

This document has a comment period that ends in 16 days. (02/01/2021) Submit a formal comment

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Food and Drug Administration, HHS.




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.


Submit either electronic or written comments on the collection of information by February 1, 2021.


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 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: Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 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 Start Printed Page 77470confidential 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
  • 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 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 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:​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 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.

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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,

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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.Start Printed 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​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​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

FD&C act or 21 CFRNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
Reports; Section 412(d) of the FD&C Act5136510650
Notifications; § 106.120(b)11144
Reports for exempt infant formula; § 107.50(b)(3) and (4)326424
Notifications for exempt infant formula; § 107.50(e)(2)11144
Requirements for quality factors— growth monitoring study exemption; § 106.96(c)493620720
Requirements for quality factors—PER exemption; § 106.96(g)1343412408
New infant formula registration; § 106.11049360.50 (30 mins.)18
New infant formula submission; § 106.120493610360
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 12

FD&C act or 21 CFR partNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsBurden per recordTotal hours
Part 106—SUBPART B: CGMP Requirements5429.82,1494.49,414
Part 106—SUBPARTS C-G: Quality control; audits; quality factors; records and reports5726.83,634621,818
Part 107—SUBPART C; Exempt infant formulas310303009,000
Exempt infant formula production; GMP; audits, recordkeeping, & reports36341,9024585,590
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.Start Printed Page 77472

Table 3—Estimated Annual Third-Party Disclosure Burden 1

Activity; 21 CFR sectionNumber of respondentsNumber of disclosures per respondentTotal annual disclosuresAverage burden per disclosureTotal hours
Nutrient labeling; §§ 107.10(a) and 107.20513658520
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 §§ 107.10(a) and 107.20 requires 520 hours annually.

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Dated: November 23, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

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[FR Doc. 2020-26537 Filed 12-1-20; 8:45 am]