Scope
Defines the document types and technical topics covered by this volume, including boundaries of applicability and any cross-references to other NUREG guidance used during review.
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NUREG-0750 Volume 16 Book II of II
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What NUREG-0750 Volume 16 Book II of II covers
Why this volume matters for reviewers and licensees
NUREG-0750 Volume 16 Book II of II reduces ambiguity by documenting review expectations, evidence requirements, and acceptable methods. Using it aligns submissions with NRC practice, shortens review cycles by reducing iterative questions, and provides defensible criteria for technical decisions and compliance judgments.
Primary users and contributors
The document is used by multiple practitioner groups involved in nuclear regulatory review and compliance.
- NRC reviewers and technical staff who apply the volume's acceptance criteria during licensing and inspection activities.
- Licensee engineering teams and safety analysts who prepare technical reports, calculations, and response packages for NRC review.
- Consulting firms and subject-matter experts retained to produce or peer-review technical sections of licensing documents.
Key roles who sign or approve content
NRC Licensing Reviewer
An NRC licensing reviewer assesses conformity to NUREG acceptance criteria, documents review findings, and signs official review records. They are responsible for recording technical conclusions and any requests for additional information in the regulatory record.
Plant Licensing Engineer
A licensee engineering lead compiles technical inputs, certifies correctness, and approves final submission packages. Their signature or approval indicates organizational responsibility for the accuracy of technical content.
Core components to expect in this volume
Acceptance Criteria
Lists the measurable conditions, performance metrics, or evidence that reviewers will use to determine whether an element of a submission is acceptable for regulatory purposes.
Review Procedures
Stepwise procedures for reviewers, including information to request, evaluation methods, and typical analytical checks used to validate licensee claims.
Data and Documentation Requirements
Specifies the technical data, calculation deliverables, and document formats expected with submissions to allow reproducible review and traceability.
Change Control and Revision History
Guidance for documenting changes, version control expectations, and how to present redlines or deviation notices when an existing submission is revised.
References and Templates
Compiled normative references, regulatory citations, and sample templates or checklists that streamline preparing and checking submission packages.
Step-by-step: preparing a compliant submission package
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01Collect Materials: Gather all referenced calculations, drawings, and source data before authoring the cover checklist.
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02Match Acceptance Criteria: Cross-check each section against the volume's acceptance criteria and document where each criterion is satisfied.
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03Internal Review: Obtain peer and management review comments, address findings, and record resolutions prior to submission.
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04Archive and Submit: Create a final PDF/A package, preserve revision history, and submit through the authorized channel or repository.
Configuring an online review workflow
| Field | Configuration |
|---|---|
| Authentication Level | Choose email, SMS code, or higher-assurance methods depending on document criticality. |
| Routing Order | Define sequential or parallel reviewer roles so approvals occur in the required order. |
| Audit Trail | Enable full timestamps, IP capture, and action history for each signer and reviewer. |
| Retention Policy | Set automatic archival and retention rules aligned with institutional and regulatory requirements. |
Where to send or file completed packages
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NRC Docketing: File packages through the NRC-designated electronic docket or the channel specified in the request.
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Internal Repository: Store an archival copy in your records management system with version metadata and access controls.
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Reviewer Routing: Send working drafts to assigned reviewers using the established workflow and keep a change log.
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Public Disclosure: Redact proprietary details when preparing documents for public release consistent with agency policy.
Technical formats, integrations, and authentication notes
Verify that the chosen platform can export a tamper-evident signed PDF and a complete audit trail to satisfy review and retention requirements.
- Supported Formats: PDF/A, PDF, DOCX, Excel for tables and attachments.
- Integrations: Connectors for document management and cloud storage reduce manual steps.
- Signer Authentication: Email or SMS code suffice for many documents; stronger authentication recommended for high-assurance items.
Typical timelines and processing expectations
Initial internal review:
30–45 days typical for a complete, high-quality package.
External reviewer cycle:
30–90 days depending on technical depth and supplementary information needs.
Revision turnaround:
15–60 days typical after receiving consolidated reviewer comments.
Final acceptance:
Variable; may require multiple cycles if new data is requested.
Record retention start:
Retention period begins on the submission or acceptance date as defined by policy.
Common preparation mistakes to avoid
- Omitting cross-references to supporting calculations, which forces reviewers to request additional information and delays the review process.
- Inconsistent versioning between figures, tables, and text, causing confusion about which set of data is authoritative.
- Failure to provide raw data or source files for key analyses, making it impossible for reviewers to validate results efficiently.
- Using non-standard file formats or poorly structured attachments that prevent automated indexing and lengthen intake processing.
Consequences of incomplete or incorrect submissions
Regulatory Delay:
Submission may be placed on hold, delaying licensing actions.
Rework Costs:
Additional engineering and review effort increases program cost.
Inspection Findings:
Poor documentation can lead to formal findings or enforcement.
Safety Risk:
Unclear analyses may mask technical issues affecting safety margins.
Public Records Exposure:
Improper redaction may expose proprietary or sensitive information.
Legal Liability:
Misrepresentations can increase contractual and regulatory liability.
eSignature vendor pricing and capability snapshot
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Trial | 7-day free trial | Varies | Varies | Varies | Varies |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
Practical tips for accurate and efficient completion
Use consistent identifiers
Apply the same document title, revision ID, and cover metadata across all files to eliminate confusion during intake and reviewer cross-reference.
Attach source data
Include raw data sets, calculation spreadsheets, and model inputs so reviewers can validate results without repeated clarification requests.
Enable comprehensive audit trails
Capture signer identity, timestamps, and IP addresses when using electronic signatures to support attribution and to comply with ESIGN/UETA legal tests.
Plan for retention early
Decide retention labels, access controls, and archival formats up front to ensure records meet federal and state retention obligations.
Frequently asked questions and troubleshooting
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Can I submit materials electronically?
Yes. Electronic submissions are generally accepted when routed through the NRC-mandated channels or as instructed. Ensure file formats are preserved (PDF/A recommended) and that metadata matches cover pages to avoid intake delays.
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Are electronic signatures legally valid?
Electronic signatures are legally enforceable in interstate transactions under the ESIGN Act (15 U.S.C. ch. 96) and under state UETA laws where adopted. Verify exceptions such as certain wills or court orders before relying on eSign.
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What level of signer authentication is required?
Authentication should match document sensitivity. Email or SMS code can suffice for many approvals; high-assurance items may require multi-factor or certificate-based methods consistent with agency policy.
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How should I handle proprietary attachments?
Identify proprietary sections, provide redacted public versions, and supply unredacted versions under non-public handling instructions. Follow agency guidance on safeguarding privileged information.
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When is notarization required?
Notarization depends on the document and jurisdiction. If a notarized attestation is required, use in-person notarization or RON only where permitted by state law and agency acceptance.
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Which signNow plan supports high-volume needs?
signNow offers Site License pricing at $1.50 per signature invite for high-volume usage; Business, Business Premium, and Enterprise tiers handle differing feature needs and integrations.
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