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Draft

Outline a rulemaking comment the agency can actually adopt

Builds a notice-and-comment filing around evidence and proposed CFR text (the kind that shows up in the final-rule preamble) and keeps your litigation preservation notes out of the public record.

About 30 minadvancedRegulatory, In-house, Government

Your prompt4,980 characters

Still to fill in: The proposed rule, Agency, docket, and deadline, Commenter and position, Evidence you can put your name behind

RoleYou are an administrative lawyer who has filed comments at FDA, FTC, EPA, SEC, and CFPB and watched several turn up in final-rule preambles. You write the proposed regulatory text before you write the argument, because an agency can only adopt language it can paste into the CFR. You will not file anything that reads like a press release.What I needOutline the comment to be filed at Agency, docket, and deadline on the rule below, in the position stated, plus the internal preservation notes that never go into the public record.InputsProposed rule: The proposed rule Commenter and position: Commenter and position Evidence available: Evidence you can put your name behind Arguments to preserve: Legal arguments to preserveHow to work this1. Put the ask in the first sentence: support, oppose, or modify, and the specific change. A reader who stops after one paragraph should know what we want done to the rule. 2. Write a real support section before any objection. A comment that agrees with nothing is discounted before it is read. 3. For each concern produce four things in this order and nothing else: the issue tied to a Federal Register page, evidence from Evidence you can put your name behind with a number and a source, the legal hook, and proposed regulatory text in quotation marks the agency could drop into the CFR. A concern without proposed text is a complaint. 4. Address every alternative the agency raised, including no action, and say why ours beats each. Silence reads as concession. 5. Attack the impact analysis with arithmetic: name the assumption, state what it should be, show the delta and its source. 6. Keep preservation notes in a separate internal section that never enters the filing. Say which section preserves which argument from Legal arguments to preserve, and name the one you did not raise and what raising it would cost.Close with these four sections, every time, without being askedAssumptions I made. That the docket is still open, that the cited studies say what the summary says, that the agency's cost figure comes from the impact analysis rather than the preamble, and which statutory authority the agency actually invoked. Mark each [verify] or [safe]. Where this is weakest. The two or three arguments most likely to be disposed of in a single preamble paragraph, and why. Name the section, not "the comment generally." What only you can decide. Present each as options with tradeoffs. At minimum: filing alone versus anchoring a coalition: alone keeps our specific facts in the record and preserves clean standing but makes us the named objector, while a coalition adds industry breadth and dilutes the record we would want in court. And whether to raise the statutory-authority argument now: raising it preserves the challenge but tells the agency to build a defensive record, while holding it risks a waiver fight later. Agency relationship, litigation appetite, and whether to attach proprietary data are yours. What would make this materially better. Rank by impact: the underlying study PDFs, the agency's impact analysis rather than the preamble summary, any prior agency statement on this question, and whether the trade association is filing.Output formatA filing-ready outline: caption, a three-sentence executive summary carrying the ask, then numbered sections running interest, rule summary, support, concerns, alternatives, impact critique, small-entity impact, timeline, recommendations, conclusion, exhibits, then the separately marked internal preservation section and the four closing sections.Never do this- If the comment would work for any commenter in any docket, it is too generic. Every paragraph should trace to this commenter's numbers or this rule's text. - No hedging filler. Cut "arguably," "it should be noted," and "we respectfully submit" used in place of a position. Do not tell me to consult regulatory counsel. I am signing this filing. - Never invent a Federal Register page, a docket number, a study result, a case citation, or a statistic. Anything not in my inputs gets [UNVERIFIED - confirm before filing]. A fabricated cite in a public docket is permanent. - Where you do not know the agency's stated rationale or what the impact analysis assumed, say you do not know and ask for the document rather than reconstructing it from plausibility. - Do not pad. Two well-evidenced concerns with proposed text beat nine complaints. Length is not value.Before you answer- Does the first sentence state the ask, or introduce the commenter? - Does every concern carry evidence with a source and proposed regulatory text? - Did I address each alternative the agency raised, including no action? - Are the preservation notes marked internal and outside the filing? - Would this comment be useless in a different docket? It should be.

Adds driver's-seat tunes: options instead of answers, questions before work, every citation flagged. Your values come with it.

2

Pressure-test it

Makes the AI switch hats and attack its own answer.

Your outline gets read once and then characterized in a paragraph you do not write. Read it as the agency attorney drafting the response-to-comments section of the final rule, with 4,000 comments to dispose of and a deadline. Name the two arguments that force you to modify the rule, the one you dispose of in a single paragraph and the sentence you would use, and the one you would set aside as outside the scope of this rulemaking. Then rewrite the out-of-scope argument so it is in scope, and add the one point that would have changed your recommendation to the signing official.
3

Go deeper

Pushes the work further once the basics are right.

The comment itself is only part of what goes out the door. Produce the two derivative documents: a one-page coalition version other retailers can co-sign, stripped of our proprietary cost data but keeping the proposed regulatory text intact; and a single-paragraph press statement that describes the position accurately without conceding anything the agency could quote back at us in the final rule.

Before you run it

What to gather first

  • The agency, docket number, Federal Register citation, and the comment deadline
  • Who is commenting and their concrete stake in the outcome
  • Quantified impact data you can put your name behind
  • Third-party studies or surveys you can attach as exhibits
  • Whether litigation is realistically on the table if the rule finalizes as proposed

Watch for

  • Everything filed becomes part of the administrative record and is public and permanent. Do not include a position, a concession, or a cost figure you would not want quoted in litigation against you.
  • Verify every Federal Register page, docket number, and study result before filing. The model will produce plausible-looking citations that do not exist.
  • Late comments may be excluded entirely. Confirm the closing date and the submission method, and keep the regulations.gov receipt.
  • A comment that objects without proposing text rarely moves a rule, and a bare objection may not preserve the issue for judicial review.
  • Major questions and statutory-authority arguments cut both ways. Raising one signals the agency to build a defensive record in the final rule. Decide deliberately, not reflexively.

What comes back

A filing-ready outline: caption with docket, Federal Register citation, and date; a three-sentence executive summary containing the ask; interest of the commenter; summary of the rule; areas of support; areas of concern, each carrying issue, evidence, legal hook, and proposed regulatory text; alternatives; impact-analysis critique with arithmetic; small-entity impact; timeline; recommendations; conclusion; exhibits list; a separately marked internal preservation section; and the four collaboration sections.

See an example of what you’ll get
COMMENT OF NORTHSHORE WELLNESS · Docket No. FDA-2025-N-1234 · 91 Fed. Reg. 12,345 (Feb. 18, 2026) · Submitted via regulations.gov, April 27, 2026 Executive summary. Northshore supports the rule's supply-chain integrity objective and supports the annual supplier-verification requirement without change. Northshore opposes the flat five-year audit-trail retention in proposed § X.205(b)(2) and proposes a 24-month standard with a 60-month retention for categories the agency designates as higher-risk. The agency's own evidence base supports 24 months; the five-year figure is unexplained and the impact analysis omits the capital cost that drives it. III. Areas of support. Annual supplier verification (91 Fed. Reg. at 12,352): industry already runs 12- to 18-month cadences and codification levels the field. Risk-based prioritization for botanicals and imported cosmetics: supported as drafted. IV.A. The five-year retention period is unexplained. - *Issue.* The preamble states a supply-chain integrity rationale (91 Fed. Reg. at 12,358) but never explains why integrity requires five years rather than two. - *Evidence.* Carnegie Mellon (2024) finds marginal integrity benefit beyond 24 months is small outside high-risk categories (Ex. A). Berkeley (2023) is consistent (Ex. B). Northshore's own incident data shows 92% of supplier-integrity issues surface within 14 months (Ex. C). - *Legal hook.* The agency must articulate a rational connection between the record and the duration chosen. *Motor Vehicle Mfrs. Ass'n v. State Farm*, 463 U.S. 29, 43 (1983). - *Proposed text.* Replace § X.205(b)(2) with: "Retailers shall maintain audit trails for twenty-four (24) months, except that audit trails for product categories designated as higher-risk under § X.205(c) shall be retained for sixty (60) months." VI. Impact analysis. The RIA's $90M assumes retailers repurpose existing document-management systems. Northshore has none; the build is $4.5M in capex plus $1.2M annually. The NRF survey of 240 mid-market retailers (Ex. D) projects industry cost at $140M annually plus roughly $720M of capital inside the 18-month window: a 55% understatement on the operating side and a category the RIA omits entirely. INTERNAL - NOT FILED. Preservation notes. § IV.A preserves the State Farm reasoned-decisionmaking challenge to the five-year duration. § VI preserves the cost-benefit challenge. § VII preserves the RFA § 603 small-entity analysis challenge. Not raised: the FDCA § 701(a) statutory-authority argument. Raising it here would invite the agency to build an authority record in the final-rule preamble, and it sits badly next to our support for the verification requirement, which rests on the same authority. --- Assumptions I made. The Carnegie Mellon and Berkeley studies say what the summary describes [verify - I have not read them]. The $90M figure appears in the RIA and not only the preamble [verify]. The docket remains open through May 19 [safe]. Where this is weakest. Section VI. Extrapolating from a 240-respondent trade survey to the whole industry is the move the agency economist will attack first, and "55% understatement" is a single-point estimate where a range would survive better. What only you can decide. File alone or anchor a coalition: alone keeps our incident data in the record and preserves clean standing, but makes Northshore the named objector on a safety rule, which is a headline risk. A coalition adds breadth and cover but the association will not attach our proprietary cost study, and that study is the strongest thing we have. Separately: whether to attach Exhibit C at all: it is the best evidence in the filing and also a public admission of our supplier-issue rate. What would make this materially better. (1) The RIA itself rather than the preamble summary: it decides whether Section VI is right. (2) The two study PDFs. (3) Any prior FDA statement on retention duration in an adjacent rule. (4) Whether the trade association is filing and on what timeline.
Why this prompt is built the way it is
## Framework 1. **Ask first.** Support, oppose, or modify (and the specific text change) in the opening paragraph. 2. **Earn the disagreement.** A real support section before any objection. A comment that agrees with nothing gets read as an industry filing. 3. **Four elements per concern, in order.** Issue with a Federal Register page cite, evidence with a number and a source, legal hook, proposed regulatory text in quotation marks. 4. **Answer every alternative the agency raised**, including no action. Silence reads as concession. 5. **Attack the impact analysis with arithmetic.** Name the assumption, show what it should be, show the delta. 6. **Length discipline.** Match length to substantive load. Eighty pages is a press release with footnotes. 7. **Preservation lives internally.** The public comment never carries the litigation strategy. Note separately what each section preserves, and what you chose not to raise.