✍️ Writing
Regulations.gov Public Comment Writer: Substantive Comments on a Federal Register Proposed Rule with Section Citations, Evidence, Alternatives, and Answers to the Agency's Questions
Draft a public comment on a Federal Register proposed rule that an agency analyst can actually use: a comment map tying each rule section to your position and evidence, an opening that names the docket and RIN, one numbered section per issue with a concrete alternative, direct answers to the agency's numbered questions, a small entity paragraph, and a Regulations.gov submission checklist that protects confidential business information.
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Prompt
Act as a regulatory affairs writer who drafts public comments on Federal Register proposed rules for small businesses, trade groups, and individuals. Agencies must consider significant comments before a final rule, so you write comments an agency analyst can cite and answer, not petitions or form letters. Inputs: - Docket ID, RIN, agency, and comment deadline from the Federal Register notice: [DocketInfo] - The proposed rule sections or preamble pages the commenter cares about, pasted or cited: [RuleSections] - Who is commenting and how the rule affects them (operations, costs, size, location): [CommenterProfile] - Facts, records, or figures the commenter can personally stand behind: [Evidence] - The numbered questions in the notice's request for comment section that apply: [AgencyQuestions] - The commenter's position on each section (support, oppose, support with changes): [Positions] - Any confidential business information the commenter wants to protect: [ConfidentialInfo] - Output format: [Format] Generate: 1. A comment map table: each item in RuleSections, the position from Positions, the concrete effect on CommenterProfile, the Evidence item that supports it, and the AgencyQuestions number it answers. 2. An opening paragraph that names the docket ID and RIN from DocketInfo, identifies the commenter and their stake in two or three sentences, and states the overall position. 3. One numbered comment section per issue. Each heading cites the proposed regulatory text or preamble page. Each section gives the problem in plain words, the supporting evidence, and a specific alternative written as revised regulatory language, a threshold, a phase in date, or an exemption. 4. Direct answers to each relevant AgencyQuestions item, labeled with the agency's own numbering so the analyst can sort them. 5. A small entity paragraph when CommenterProfile is a small business, pointing to the Regulatory Flexibility Act analysis in the preamble and the cost or burden that analysis missed. 6. A Regulations.gov submission checklist: saving the comment tracking number, attachment format, the warning that everything submitted is public, and how to mark and separately handle ConfidentialInfo if the notice allows it. Constraints: - Use only facts in Evidence. Where a figure is missing, write NEEDS FIGURE instead of estimating. - No form letter language, no insults, no slogans, no claims about agency motives. - Quote regulatory text exactly as pasted. Do not invent section numbers, page numbers, or case law. - This is drafting help, not legal advice. No em dashes.
Instructions
Replace every [bracket] with your details before running. Works on ChatGPT, Claude, and Gemini.
Generated Output
This image was generated using the prompt above.
Examples
Example Input
DocketInfo: FDA sample docket FDA-2026-N-0000 (illustration only), RIN 0910-AA00, proposed rule on precautionary allergen labeling, comments due December 1 RuleSections: proposed section 101.XX(b): 'Each precautionary allergen statement shall be supported by a written cross-contact risk assessment updated at least every 6 months.' Preamble page 41 estimates 8 hours of burden per facility per year. Proposed compliance date: 12 months after the final rule. CommenterProfile: family owned wholesale bakery in Dayton, Ohio, 14 employees, 38 SKUs, one shared production line, sells to 6 regional grocers Evidence: our last full allergen review took our QA manager 26 hours; we reformulate seasonal items 4 times a year; we print about 210,000 labels a year and a reprint costs us $0.04 per label AgencyQuestions: Q3 asks whether a 6 month update interval is appropriate; Q7 asks about burden on small facilities Positions: support a standardized statement; oppose the fixed 6 month interval; support the 12 month compliance date only with a label sell through allowance ConfidentialInfo: names of our grocer customers Format: comment map, full comment, checklist
Example Output
Comment map | Section | Position | Effect on us | Evidence | Answers | | 101.XX(b) standardized statement | Support | Ends guesswork on wording | None needed | n/a | | 101.XX(b) 6 month update | Oppose as written | Up to 6 full reviews a year with 4 reformulations | 26 hours per review | Q3, Q7 | | Preamble p. 41 burden estimate | Disagree | Burden understated for multi SKU lines | 26 hours vs 8 hours | Q7 | | 12 month compliance date | Support with changes | Unused label stock | 210,000 labels a year at $0.04 | Q7 | Comment on Docket FDA-2026-N-0000, RIN 0910-AA00 We are a family owned wholesale bakery in Dayton, Ohio, with 14 employees and 38 products made on one shared line. Precautionary allergen labeling is central to how we protect customers. We support a standardized precautionary statement and ask FDA to change the update interval and the compliance date as described below. 1. Proposed 101.XX(b): fixed 6 month update interval The proposed text requires a written risk assessment "updated at least every 6 months." For a facility that also reformulates, this stacks with change driven reviews. With two scheduled updates and four seasonal reformulations, we could complete up to six reviews a year. Our last full review took 26 hours. Proposed alternative: "...updated at least every 12 months, and whenever an ingredient, supplier, or line change could introduce a new allergen." This keeps reviews tied to actual risk changes. 2. Preamble page 41: burden estimate The preamble estimates 8 hours per facility per year. One review of our 38 SKUs took 26 hours. Six reviews would be about 156 hours. We ask FDA to scale the estimate by SKU count and shared line use. Industry wide cost data: NEEDS FIGURE (we do not have it). 3. Compliance date We print about 210,000 labels a year. Discarding a year of stock at $0.04 per label would cost us about $8,400. We support 12 months if FDA allows existing labels to be used until depleted or for an added 6 months, whichever is first. Responses to FDA questions Q3: No. A fixed 6 month interval is less tied to risk than change triggered review with an annual minimum. Q7: Yes, the burden falls harder on small multi SKU facilities. See sections 2 and 3. Small entity impact As a small business under the Regulatory Flexibility Act, we ask FDA to revisit its small entity analysis using per SKU review time rather than a flat per facility estimate. Submission checklist - Submit on Regulations.gov before 11:59 PM Eastern on December 1 and save the comment tracking number. - Paste the comment in the text box and attach a PDF copy with the docket ID in the file name. - Everything you submit is public, including your name if you enter it. - Grocer names are left out. If they matter, follow the notice's instructions for confidential submissions and mark a separate copy; do not upload them to the public docket.