# Regulatory & Administrative — United States

Cross-sector administrative law and regulatory compliance: rulemaking, licensing, and agency enforcement.

Jurisdiction: `us` · Practice: `regulatory` · Skill language: en

## Skills (66)

| Skill | What it does |
|---|---|
| [`FDA 510(k) Premarket Notification`](skills/510k-premarket-notification/) | Drafts FDA 510(k) Premarket Notification submissions demonstrating substantial equivalence under 21 CFR Part 807. |
| [`Adverse Event Reporting Policy`](skills/adverse-event-reporting-policy/) | Drafts an Adverse Event Reporting Policy compliant with 21 CFR 312.32 (IND safety reporting), 21 CFR 314.80… |
| [`Client Advisory Summary`](skills/advisory-summary/) | Drafts U.S. regulatory client advisory summaries translating legal developments into actionable risk and compliance… |
| [`AML Compliance Program`](skills/aml-compliance-program/) | Drafts board-ready Anti-Money Laundering compliance programs for U.S. |
| [`Annual Report for State Charity Bureau`](skills/annual-report-charity-bureau/) | Generates a cross-referenced U.S. nonprofit annual filing package for state charity-bureau registration. |
| [`Legal Audit Summary`](skills/audit-summary/) | Produces structured U.S. legal audit summaries that distill compliance findings into executive-ready risk… |
| [`Aviation Law Summary`](skills/aviation-summary/) | Generates structured U.S. aviation-law summaries by synthesizing FAA, DOT, and TSA rules, treaties, and precedent into… |
| [`AWA Compliance Audit (USDA/APHIS)`](skills/awa-compliance-audit/) | Produces an enforcement-aware Animal Welfare Act compliance audit for USDA/APHIS-regulated facilities. |
| [`Legislative Bill Summary`](skills/bill-summary/) | Produces neutral, section-pinned U.S. legislative bill summaries translating statutory language into plain terms with… |
| [`BSA/AML Risk Assessment`](skills/bsa-risk-assessment/) | Drafts a BSA/AML Risk Assessment for U.S. financial institutions per FinCEN, FFIEC, and OCC standards. |
| [`C-TPAT Security Profile`](skills/c-tpat-security-profile/) | Drafts a U.S. C-TPAT Security Profile for CBP submission covering physical, personnel, procedural, conveyance, and IT… |
| [`CBP Binding Ruling Request (19 CFR Part 177)`](skills/cbp-binding-ruling/) | Drafts U.S. Customs and Border Protection binding ruling requests under 19 CFR Part 177 for tariff classification,… |
| [`USMCA/NAFTA Certificate of Origin`](skills/certificate-of-origin/) | Drafts USMCA/NAFTA Certificates of Origin for preferential tariff treatment on US-Mexico-Canada goods. |
| [`Charitable Solicitation Registration`](skills/charitable-solicitation-registration/) | Prepares jurisdiction-specific charitable solicitation registration packages for U.S. nonprofits. |
| [`Annual Report for State Charity Bureau`](skills/charity-annual-report/) | Drafts filing-ready Annual Reports for State Charity Bureaus with certified financials, governance disclosures, and… |
| [`State Charity Filing Threshold Research`](skills/charity-filing-thresholds/) | Researches state-specific charitable solicitation filing requirements keyed to gross revenue, producing a… |
| [`Client Advisory Summary`](skills/client-advisory-summary/) | Produces client-ready U.S. regulatory advisory summaries translating legal developments into actionable impacts with… |
| [`Congressional Testimony Preparation`](skills/congressional-testimony-preparation/) | Prepares witnesses for U.S. congressional hearings with committee member profiling, predicted question matrices, mock… |
| [`Corporate Compliance Checklist`](skills/corporate-compliance-checklist/) | Drafts a U.S. corporate compliance program checklist anchored in DOJ ECCP, Federal Sentencing Guidelines Chapter 8, and… |
| [`C-TPAT Security Profile`](skills/ctpat-security-profile/) | Drafts a submission-ready C-TPAT Security Profile from verified company records for U.S. |
| [`Customs Power of Attorney`](skills/customs-power-of-attorney/) | Drafts a U.S. Customs Power of Attorney authorizing a licensed customs broker to transact customs business on behalf of… |
| [`CBP Form 19 — Protest of Customs Decision`](skills/customs-protest-form19/) | Drafts CBP Form 19 protests under 19 U.S.C. § 1514 and 19 C.F.R. |
| [`DD Form 254 — Contract Security Classification Specification`](skills/dd-form-254/) | Drafts DD Form 254 Contract Security Classification Specifications for classified government contracts. |
| [`Export Compliance Program (ECP) Manual`](skills/ecp-manual/) | Drafts an audit-ready Export Compliance Program manual covering EAR, ITAR, and OFAC requirements. |
| [`Energy Regulation Summary`](skills/energy-regulation-summaries/) | Generates structured summaries of U.S. energy sector regulations and landmark cases with compliance-focused analysis. |
| [`Exporter of Record (EOR) Agreement`](skills/eor-agreement/) | Drafts a U.S.-compliant Exporter of Record (EOR) Agreement appointing a third party as USPPI for international export… |
| [`FCPA Compliance Policy`](skills/fcpa-compliance-policy/) | Drafts an implementable Foreign Corrupt Practices Act (FCPA) Compliance Policy for U.S.-jurisdictional corporations… |
| [`FDA Establishment Registration & Device Listing`](skills/fda-device-registration/) | Drafts FDA Establishment Registration and Device Listing documents compliant with 21 CFR Part 807. |
| [`FERC Market-Based Rate Tariff`](skills/ferc-market-based-rate-tariff/) | Drafts eTariff-ready FERC Market-Based Rate Tariffs for wholesale electric energy, capacity, and ancillary services… |
| [`Fintech Regulatory Summaries`](skills/fintech-regulatory-summaries/) | Generates structured regulatory summaries for fintech compliance covering crypto, payments, lending, mobile banking,… |
| [`FDA Food Facility Registration`](skills/food-facility-registration/) | Drafts an FDA Food Facility Registration under FSMA and 21 CFR Part 1, Subpart H (21 U.S.C. 350d). |
| [`Professional Fundraiser Contract Compliance Check`](skills/fundraiser-contract-compliance/) | Audits professional solicitor, fundraising counsel, and commercial co-venturer contracts for state charitable… |
| [`Gambling Law Regulatory Summary`](skills/gambling-law-summary/) | Produces jurisdiction-specific U.S. gambling law regulatory summaries covering legal status, licensing, taxes,… |
| [`Gas Gathering Agreement`](skills/gas-gathering-agreement/) | Drafts a Gas Gathering Agreement for receipt, compression, dehydration, and transportation of natural gas from wellhead… |
| [`GMP Standard Operating Procedure`](skills/gmp-sop/) | Drafts inspection-ready GMP standard operating procedures for regulated manufacturing. |
| [`GSA Schedule Contract`](skills/gsa-schedule-contract/) | Drafts FAR/GSAR-compliant GSA Schedule (MAS/FSS) contracts with clause matrices, SIN scope, pricing/PRC/EPA mechanics,… |
| [`HACCP Plan`](skills/haccp-plan/) | Drafts U.S. HACCP plans for food production under FDA or USDA regimes. |
| [`Historic Preservation Law Summary`](skills/historic-preservation-law-summary/) | Produces a structured U.S. historic preservation law summary covering federal, state, and local authorities, key cases,… |
| [`Import Compliance Manual`](skills/import-compliance-manual/) | Drafts a U.S. import compliance manual demonstrating reasonable care under 19 U.S.C. § 1484. |
| [`IND Application`](skills/ind-application/) | Drafts FDA Investigational New Drug (IND) applications under 21 CFR Part 312, including Form 1571, Investigator's… |
| [`Interconnection Agreement`](skills/interconnection-agreement/) | Drafts U.S. telecommunications Interconnection Agreements (ICAs) under 47 U.S.C. |
| [`ITAR Technology Control Plan (TCP)`](skills/itar-tcp/) | Drafts ITAR Technology Control Plans (TCPs) for managing USML defense articles and technical data under 22 CFR Parts… |
| [`ITAR Technology Control Plan`](skills/itar-technology-control-plan/) | Drafts an ITAR Technology Control Plan (TCP) for U.S. export control compliance under 22 CFR 120-130. |
| [`FDA Labeling Compliance Review`](skills/labeling-compliance-review/) | Conducts FDA labeling compliance reviews for drugs, foods, dietary supplements, and medical devices. |
| [`New Drug Application (NDA)`](skills/nda-drug-application/) | Drafts an eCTD-compliant New Drug Application (NDA) for FDA submission under 21 CFR Part 314. |
| [`NYDFS Information Security Program (23 NYCRR 500)`](skills/nydfs-infosec-program/) | Drafts a comprehensive Information Security Program compliant with NYDFS Cybersecurity Regulation (23 NYCRR 500). |
| [`OCI Mitigation Plan`](skills/oci-mitigation-plan/) | Drafts FAR 9.5-compliant Organizational Conflict of Interest mitigation plans for federal government contractors. |
| [`Past Performance Questionnaire`](skills/past-performance-questionnaire/) | Drafts a Past Performance Questionnaire for evaluating legal service providers or contractors in government contract… |
| [`Pharmaceutical Regulation Compliance Summary`](skills/pharma-reg-summary/) | Generates structured pharmaceutical regulatory compliance summaries covering FDA approval pathways, patent/IP… |
| [`Promotional Materials Review Policy`](skills/promo-materials-review-policy/) | Drafts an internal Promotional Materials Review Policy for life sciences and pharmaceutical companies under FDA… |
| [`Notice of Intent to Protest Award`](skills/protest-notice/) | Drafts a formal Notice of Intent to Protest Award for federal contracts under FAR 33.103, 33.104, and 4 C.F.R. Part 21. |
| [`Quality Agreement for Contract Manufacturing`](skills/quality-agreement/) | Drafts Quality Agreements for pharmaceutical contract manufacturing. |
| [`Request for Equitable Adjustment (REA)`](skills/rea-request/) | Drafts a Request for Equitable Adjustment (REA) for U.S. federal government contracts under FAR provisions. |
| [`Recall Plan and Procedure`](skills/recall-plan/) | Drafts FDA product recall plans compliant with 21 CFR Part 7, covering Recall Committee governance, health hazard… |
| [`Regulatory Submission Summary`](skills/regulatory-submission-summary/) | Produces structured summaries of regulatory submission packages (FDA NDAs, 510(k)s, BLAs, ANDAs, environmental permits,… |
| [`Regulatory Practice`](skills/regulatory/) | Navigates regulatory compliance, government relations, and administrative law across financial services, healthcare,… |
| [`RFP Response`](skills/rfp-response/) | Drafts evaluation-ready U.S. federal RFP responses across all standard proposal volumes (cover letter, technical,… |
| [`SAM.gov Representations and Certifications`](skills/sam-reps-certs/) | Drafts Representations and Certifications documents for SAM.gov federal contractor registration. |
| [`SAR Filing`](skills/sar-filing/) | Drafts FinCEN Suspicious Activity Reports (Form 111) for BSA/AML regulatory filing. |
| [`Shipper's Letter of Instruction (SLI)`](skills/shippers-letter-of-instruction/) | Drafts a U.S.-focused Shipper's Letter of Instruction (SLI) authorizing a freight forwarder, capturing EEI/AES filing… |
| [`Space Law Case Summary`](skills/space-law-case-summary/) | Generates structured summaries of space law cases involving satellite deployment, space debris, orbital conflicts,… |
| [`State Charity Bureau Annual Report`](skills/state-charity-annual-report/) | Drafts U.S. state charity bureau annual report packages for nonprofit charitable solicitation compliance. |
| [`Small Business Subcontracting Plan`](skills/subcontracting-plan/) | Drafts a FAR 52.219-9-compliant Small Business Subcontracting Plan for federal prime contractors. |
| [`Telecommunications Law Summary`](skills/telecom-law-summary/) | Generates executive-level summaries of recent US telecommunications law developments covering spectrum rights, network… |
| [`International Trade Law Summary`](skills/trade-law-summary/) | Produces structured U.S.-focused international trade law summaries covering tariffs, customs, export controls,… |
| [`Escheatment and Unclaimed Property Policy`](skills/unclaimed-property-policy/) | Drafts an enterprise Escheatment and Unclaimed Property Policy covering property identification, dormancy matrices, due… |

## Cold-start context

See [`CLAUDE.md`](CLAUDE.md) — scope, forums, sources of law, citation discipline, and when this plugin does NOT apply.

## Provenance & license

Skills imported from open sources ([CaseMark/skills](https://github.com/CaseMark/skills), Apache-2.0). See each `SKILL.md` `author`/`author_url` for provenance. Plugin license: Apache-2.0.

## Disclaimer

These skills produce informational drafts and analyses, not legal advice. Verify against current law before use.
