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Docket FDA-2026-N-2886

The FDA is reopening a comment period that closed on 6 July, on a rule that takes the word gender out of 34 provisions of its regulations

Money & World
The Editorial Team ·
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The comment period that reopens on Monday closed on 6 July.

That is the substance of a notice the Food and Drug Administration filed for public inspection on Friday morning. It reopens, for a further 60 days, comment on a proposed rule published on 6 May at 91 FR 24380, which would remove the word gender wherever it appears in Title 21 of the Code of Federal Regulations and either replace it with sex or delete the reference. The original period ran to 6 July. The notice was filed 25 days after that, and the reason it gives for reopening is that the agency wants to allow interested persons additional time to submit comments. It reports no comment count and names nobody who asked. It is signed by Robert F. Kennedy, Jr., as Secretary of Health and Human Services, rather than by the Commissioner of Food and Drugs.

FDA states that it is acting to comply with Executive Order 14168, issued on 20 January 2025, whose section 3(c) directs that when administering or enforcing sex-based distinctions every agency and every federal employee acting officially shall use the term sex and not gender in all applicable federal policies and documents. Section 2(a) of the order defines sex as an individual's immutable biological classification as either male or female.

Thirty-four provisions, and where they sit

The proposed rule lists them in a table. They run across 16 parts of Title 21 and they are more specific than a terminology change usually is.

Two are institutional review board rules at 21 CFR 56.107, one of which is the requirement that no board consist entirely of men or entirely of women. One is an infant formula records provision. Three are clinical hold provisions at 312.42, covering the hold that applies when a study of a drug for a life-threatening condition excludes men or women of reproductive potential, together with its exceptions for studies pertinent only to one sex and for studies run alongside a second study that excludes nobody. Six are adverse event reporting rules for drugs, biologics and devices. Two are new drug application content requirements. Two cover premarket tobacco product applications.

Eleven are device classification regulations, and they name products. A total 25-hydroxyvitamin D mass spectrometry test system. A device to detect non-microbial analytes to aid assessment of patients with suspected sepsis. A genetic health risk assessment system, five cardiovascular indicators including coronary vascular physiologic simulation software, an eye movement assessment aid for traumatic brain injury, and a computerized cognitive assessment aid for concussion.

What the amended text does

Read against the current regulations, the edits are narrow. The revised meeting rule at 10.65(d)(3) bars an agency representative from knowingly joining a meeting closed on the basis of sex, race, or religion. The revised board membership rule keeps the substance intact: no board entirely of one sex, the institution to consider qualified persons of both sexes, and no selection made on that basis. The clinical hold text keeps its trigger, its examples, which are studies of the excretion of a drug in semen and of effects on menstrual function, and its concurrent-study exception.

The number FDA puts on it

Zero.

Annualized benefits are given as $0 at both a 3 and a 7 percent discount rate. Annualized costs are given as 0 at both. Present value of costs, of cost savings and of net costs over a perpetual horizon are each $0. The rows for state, local or tribal government, for small business, for wages and for growth each read none. FDA writes that the rule reflects editorial changes that affect FDA rather than industry practice, that it anticipates no measurable change in industry, and that it expects no loss of public health benefits. The Office of Information and Regulatory Affairs determined the proposal is not a significant regulatory action.

Any final rule would take effect 30 days after it publishes. Comments close 60 days after Monday.

The document: Food and Drug Administration, Department of Health and Human Services, Modification of Certain Terminology in Title 21; Reopening of the Comment Period, proposed rule; reopening of the comment period, Docket No. FDA-2026-N-2886, RIN 0910-AJ26, 21 CFR parts 10, 56, 106, 201, 251, 310, 312, 314, 329, 600, 803, 862, 866, 870, 882 and 1114, billing code 4164-01-P, FR document 2026-15671, filed for public inspection on 31 July 2026 at 8:45 a.m. Eastern with a stated publication date of 3 August 2026 and a start page of 48785. BOTH documents were downloaded and read in full here, the reopening notice and the underlying proposed rule; no fetch-tool summary was relied on, and every date, citation, section number and characterisation below was matched against the document text. Identifiers matched on the reopening notice: docket FDA-2026-N-2886; RIN 0910-AJ26; contact Swati Kabaria, Office of Policy, Office of Policy, Legislation, and International Affairs, Office of the Commissioner; signature Robert F. Kennedy, Jr., Secretary, Department of Health and Human Services; foot of document reading [FR Doc. 2026-15671 Filed: 7/31/2026 8:45 am; Publication Date: 8/3/2026]. As verified on the reopening notice: FDA is reopening the comment period on the proposed rule published in the Federal Register of 6 May 2026 at 91 FR 24380 for an additional 60 days, until 60 days after the date of publication of the reopening notice, and states that it is taking this action to allow interested persons additional time to submit comments; the notice gives no other reason and reports no comment count. The underlying proposed rule was separately verified through the Federal Register API: title Modification of Certain Terminology in Title 21, document number 2026-08826, publication date 6 May 2026, start page 24380, comments close date 6 July 2026, agencies Health and Human Services Department and Food and Drug Administration. That gives the gap stated in the copy: the original period closed on 6 July, and the reopening notice was filed for inspection on 31 July, 25 days later. As verified on the underlying proposed rule: it would remove the term gender wherever it appears in Title 21 of the CFR and either replace it with the term sex or delete the reference to gender, as applicable, with other editorial changes for readability, and FDA states it is doing so to comply with Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, issued 20 January 2025 and published at 2025-02090. The proposed rule recites that section 2(a) of that order defines sex as referring to an individual's immutable biological classification as either male or female, and that section 3(c) requires that when administering or enforcing sex-based distinctions every agency and all Federal employees acting in an official capacity shall use the term sex and not gender in all applicable Federal policies and documents. The table at section V of the proposed rule lists 34 numbered provisions to be amended, counted directly from the document: 10.65(d)(3); 56.107(a); 56.107(b); 106.121(a)(2); 201.57(c)(13)(i)(C); 251.18(d)(7)(i)(C); 310.305(d)(1)(iii); 312.33(a)(2); 312.42(b)(1)(v); 312.42(b)(1)(v)(A); 312.42(b)(1)(v)(B); 314.50(d)(5)(v); 314.50(d)(5)(vi); 314.80(f)(1)(iii); 329.100(b)(1)(iii); 600.80(f)(1)(iii); 600.80(g)(1)(iii); 803.32(a)(3); 803.42(a)(3); 803.52(a)(3); 862.1840(b)(3); 866.3215(b)(5); 866.5950(b)(3)(ii)(B); 866.5950(b)(3)(iii)(J)(1)(viii); 870.1415(b)(6)(v); 870.2200(b)(5)(vii); 870.2210(b)(5)(viii); 870.2220(b)(5)(v); 870.5600(b)(5)(ix); 882.1455(b)(6)(ii)(E); 882.1471(b)(3)(i)(D)(5); 1114.3; 1114.41(a)(1)(vi)(C); and 1114.41(a)(1)(xvi). Amendatory text quoted or paraphrased in the copy was read in the proposed rule itself: revised 10.65(d)(3) reads that an agency representative may not knowingly participate in a meeting that is closed on the basis of sex, race, or religion; revised 56.107(a) refers to the diversity of IRB members including consideration of race, sex, cultural backgrounds; revised 56.107(b) reads that every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of sex; revised 312.42(b)(1)(v) concerns an IND for an investigational drug intended to treat a life-threatening disease or condition that affects both sexes, with the carve-outs at (A) for studies pertinent only to one sex, giving as examples studies evaluating the excretion of a drug in semen or the effects on menstrual function, and at (B) for studies conducted only in men or women where a study not excluding members of the other sex with reproductive potential is being conducted concurrently, has been conducted, or will take place within a reasonable time agreed with the agency. The device classification provisions in the list cover, as verified from the table headings: the total 25-hydroxyvitamin D mass spectrometry test system at 862.1840; the device to detect and measure non-microbial analytes in human clinical specimens to aid assessment of patients with suspected sepsis at 866.3215; the genetic health risk assessment system at 866.5950; coronary vascular physiologic simulation software, adjunctive cardiovascular status indicator, adjunctive predictive cardiovascular indicator, adjunctive hemodynamic indicator with decision point and adjunctive open loop fluid therapy recommender in part 870; and the traumatic brain injury eye movement assessment aid and computerized cognitive assessment aid for concussion in part 882. Economic analysis as verified in the proposed rule: OIRA determined the proposed rule is not a significant regulatory action under E.O. 12866; FDA states the rule reflects editorial changes that affect FDA, does not impact industry practices, and will produce no quantifiable savings, costs or transfers, and that it does not expect any loss of public health benefits; Table 1 gives annualized monetized benefits of $0 and annualized monetized costs of 0, each at both 3 and 7 percent discount rates, in millions of 2024 dollars, with the effects rows for State, Local or Tribal Government, Small Business, Wages and Growth each reading none; Table 2 gives $0 for present value of costs, cost savings and net costs and for the annualized equivalents over a perpetual time horizon at 7 percent, and FDA states the rule is not expected to be an E.O. 14192 regulatory action because it is not significant under E.O. 12866. FDA proposes to certify under the Regulatory Flexibility Act that the rule will not have a significant economic impact on a substantial number of small entities, states that the Unfunded Mandates Reform Act threshold after adjustment for inflation is $193 million using the 2025 implicit price deflator for gross domestic product and that the rule would not meet it, and tentatively concludes the proposed rule contains no collection of information requiring clearance under the Paperwork Reduction Act. The proposed effective date is 30 days after publication of any final rule..

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