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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.
Submit written comments (including recommendations) on the collection of information by July 20, 2026.
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 0910-0606. Also include the FDA docket number found in brackets in the heading of this document.
Christopher Colburn, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8758, PRAStaff@fda.hhs.gov.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Dietary Supplement Health and Education Act (DSHEA) (Pub. L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practice for dietary supplements. Section 402(g) of the FD&C Act also stipulates that such regulations will be modeled after current good manufacturing practice (CGMP) regulations for food and may not impose standards for which there are no current, and generally available, analytical methodology. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if “it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.”
Accordingly, we have promulgated regulations in part 111 (21 CFR part 111) establishing minimum CGMP requirements pertaining to the manufacturing, packaging, labeling, or holding of dietary supplements to ensure their quality. Included among the requirements is recordkeeping, documenting, planning, control, and improvement processes of a quality control system. Implementation of these processes in a manufacturing operation serves as the backbone to CGMP. The records must show what is being manufactured and whether the controls in place ensure the product's identity, purity, strength, and composition, and that limits on contaminants and measures to prevent adulteration are effective. Further, records must show whether and what deviations from control processes occurred, facilitate evaluation and corrective action concerning these deviations (including, where necessary, whether associated batches of product should be recalled from the marketplace), and enable a manufacturer to assure that the corrective action was effective. We believe the regulations in part 111 establish the minimum manufacturing practices necessary to ensure that dietary supplements are manufactured, packaged, labeled, or held in a manner that will ensure the quality of the dietary supplements during manufacturing, packaging, labeling or holding operations.
Specifically, the recordkeeping requirements of the regulations in part 111 include establishing written procedures and maintaining records pertaining to: (1) personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning, and sanitizing equipment and utensils and other contact surfaces; (6) water used that may become a component of the dietary supplement; (7) production and process controls; (8) quality control; (9) components, packaging, labels and product received for packaging and labeling; (10) master manufacturing and batch production; (11) laboratory operations; (12) manufacturing operations; (13) packaging and labeling operations; (14) holding and distributing operations; (15) returned dietary supplements; and (16) product complaints.
Section 111.75(a)(1) (21 CFR 111.75) reflects FDA's determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient. However, we recognize that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. Section 111.75(a)(1) provides an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency. Section 111.75(a)(1) also sets forth the information a manufacturer is required to submit for an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the Agency for such an exemption to 100 percent identity testing under 21 CFR 10.30 and the Agency grants such exemption.
Description of Respondents: Respondents to this collection of information include manufacturers, packagers and repackagers, labelers and re-labelers, holders, distributors, warehousers, exporters, importers, large businesses, and small businesses engaged in the dietary supplement industry. Respondents are from the private sector.
In the Federal Register of February 24, 2026 (91 FR 8886), FDA published a 60-day notice requesting public comment on the proposed collection of information. One stakeholder provided multiple comments. Although the commenter supports this collection of information, the commenter has concern that the burden estimate may not fully capture the range of compliance costs across firms of different sizes and operational complexities. Another comment related to enhancing the quality and utility of collected information, further suggesting flexibility in how records are maintained and reported. ( printed page 36862)
We estimate that a substantial proportion of firms subject to the regulations in part 111 are small businesses. We are aware that burden may vary depending on the size and complexity of the operation. We do not provide a burden estimate for various operation types or their various complexities but instead provide an average of the burden estimate.
We believe the regulations in part 111 establish the minimum manufacturing practices necessary to ensure that dietary supplements are manufactured, packaged, labeled, or held in a manner that will ensure the quality of the dietary supplements during manufacturing, packaging, labeling, or holding operations. Regarding flexibility in how records are maintained and reported, the regulations in part 111 do not specifically prescribe the use of automated, electronic, mechanical, or other technological techniques or other forms of information technology as necessary for use by firms. Companies are free to use whatever forms of information technology may best assist them in recordkeeping and reporting.
We estimate the burden of this collection of information as follows:
| 21 CFR section; activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 111.14; records of personnel practices, including documentation of training | 15,000 | 4 | 60,000 | 1 | 60,000 |
| 111.23; records of physical plant sanitation practices, including pest control and water quality | 15,000 | 1 | 15,000 | 0.2 (12 minutes) | 3,000 |
| 111.35; records regarding equipment and utensils, including calibration and sanitation practices | 400 | 1 | 400 | 12.5 | 5,000 |
| 111.95; records of production and process control systems | 250 | 1 | 250 | 45 | 11,250 |
| 111.140; records that quality control personnel must make and keep | 240 | 1,163 | 279,120 | 1 | 279,120 |
| 111.180; records associated with components, packaging, labels, and product received for packaging and labeling as a dietary supplement | 240 | 1,163 | 279,120 | 1 | 279,120 |
| 111.210; requirements for what the master manufacturing record must include | 240 | 1 | 240 | 2.5 | 600 |
| 111.260; requirements for what the batch production record must include | 145 | 1,408 | 204,160 | 1 | 204,160 |
| 111.325; records that quality control personnel must make and keep for laboratory operations | 120 | 1 | 120 | 15 | 1,800 |
| 111.375; records of the written procedures established for manufacturing operations | 260 | 1 | 260 | 2 | 520 |
| 111.430; records of the written procedures for packaging and labeling operations | 50 | 1 | 50 | 12.6 | 630 |
| 111.475; records of product distribution and procedures for holding and distributing operations | 15,000 | 1 | 15,000 | 0.4 (24 minutes) | 6,000 |
| 111.535; records for returned dietary supplements | 110 | 4 | 440 | 13.5 | 5,940 |
| 111.570; records regarding product complaints | 240 | 600 | 144,000 | 0.5 (30 minutes) | 72,000 |
| Total | 929,140 | ||||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 21 CFR section; activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| 111.75; petition for exemption from 100 percent identity testing | 1 | 1 | 1 | 8 | 8 |
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Based on a review of the information collection since its last OMB approval, we have made no adjustments to our burden estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-12238 Filed 6-17-26; 8:45 am]
BILLING CODE 4164-01-P
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