Manual of Standard Operating Procedures and Policies

General Information

Procedures for the Preparation, Routing, and Issuance of Regulations

SOPP 8014

Version #1

Date: October 30, 2008

1. Purpose

This SOPP serves as a guide for Center for Biologics Evaluation and Research (CBER) staff for the development of CBER regulations. This document provides guidance on the procedures for developing regulations from the concept stage to preparing, routing, and publishing regulations developed by CBER.

2. Definitions

See Appendix 1 for definitions of terms used in this SOPP.

3. Background and Policy

Under the Federal Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.), FDA has authority to publish substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency that are necessary to implement and enforce legislative acts. (5 U.S.C. § 552(a)(1)(D)). The Federal Food, Drug, and Cosmetic Act and the Public Health Service Act also provide FDA with rulemaking authority. CBER regulates biological products under the Public Health Service Act (42 U.S.C. 262 and 264) and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Under these authorities, FDA issues implementing regulations that further inform industry and the public how the provisions of Congressional statutes and legislative acts affecting products regulated by CBER will be applied. Rules on FDA’s promulgation of regulations for the efficient enforcement of the law are located in 21 CFR 10.40. FDA also issues regulations when the agency determines policy decisions directly affect the public or regulated industry. The rulemaking process set out in section 553 of the APA (5 U.S.C. 553) requires that every regulation, with certain exceptions (e.g., procedural regulations), must publish as a proposal in the Federal Register (FR) for public review and comment before promulgation in final form. FDA ordinarily allows a minimum 75 day comment period during which the public and regulated industry can review the proposal and submit comments to the agency. Comments are received by submission to the Division of Dockets Management (DDM) under the appropriate docket number. When the proposed rule’s comment period closes, FDA must analyze all comments to the Docket and prepare a detailed preamble to the final rule stating the nature of each type of comment and FDA’s response. Once a final rule is in effect, the regulation is enforceable in the courts. Comment period length for a proposed rule may vary depending on the nature and complexity of the proposal and can be extended, via publication of a notice in the FR, if FDA deems it appropriate. Also, any interested person may request the Commissioner to extend the comment period for an additional specified period by submitting a written request to the DDM stating the grounds for the request (21 CFR 10.40(b)(3)).

The following actions can begin the rulemaking process for CBER-regulated products:

  • A CBER Office identifies the need for rulemaking (e.g., new technologies not addressed in existing regulations).
  • Enactment of a new law requiring regulations or for which new regulations are needed for smooth implementation.
  • Review of industry practices or other events by FDA’s Office of the Commissioner (e.g., Office of Policy, Office of Legislative Affairs) or by other FDA Centers with assessment of the need for regulations.
  • A request from FDA’s Office of the Commissioner. Such a request usually occurs in the context of inter-center rulemaking. Inter-center regulations affect and are drafted by more than one FDA Center. One Center takes the lead for processing the regulation for publication in the FR.
  • A request from the public.

4. Steps in Regulation Development

This section provides a brief overview of the 10 major steps that comprise regulation development and clearance. Although the details of the process may vary given the specifics of a particular rulemaking, this basic framework is used for most of the regulations CBER develops.

The roles, responsibilities, and procedures associated with each of these steps are detailed in the next section of this SOPP.

 I. The Concept Paper

 When a CBER Office wishes to initiate a rulemaking, the Office fully develops the regulation’s core concepts through the development of a Concept Paper. The Concept Paper provides the foundation of the regulation by including the relevant policy decisions and rationales for why a regulation is needed. Generally no more than two pages in length, the Concept Paper identifies the objective(s) of a proposed rulemaking and analyzes all issues relevant to the rulemaking.

A thorough and concise Concept Paper:

  • Identifies the ISSUE(S) to be addressed, the policy decisions and rationales for why CBER recommends addressing the issue(s) with rulemaking, and any deadlines.
  • Discusses a SUMMARY OF PROPOSED ACTION outlining the key elements of the proposal, what other options were considered and why they were rejected, any expected obstacles, the legal authority for the rulemaking, and how the proposed action supports the agency’s Strategic Action Plan.
  • Discusses the PRELIMINARY COST/BENEFIT ANALYSIS and PAPERWORK BURDEN ANALYSIS including a brief assessment of costs and benefits to industry, FDA, and the impact on small entities.
  • Identifies any STAKEHOLDER INTEREST, i.e., anticipated reaction from interested parties as well as a description of comments already received, if any.
  • Identifies the Champion, other affected Offices, and/or Centers.
  • Identifies the target publication date, and any Congressionally mandated deadlines.

Appendix 2 includes a Concept Paper template. Refer to Section 5.I. of this SOPP for the approval process of a Concept Paper.

II. The Work Plan

 Once a Concept Paper is approved by the appropriate parties in CBER, CBER’s Regulations and Policy Staff (RPS) Project Officer will develop a Work Plan for the regulation. A Work Plan is a step-by-step breakdown that describes management of the regulation’s development. A Work Plan serves to clarify the expectations for each participant group in the regulation development process and provides those responsible for the rule’s review and clearance with estimated distribution and due dates.

The Work Plan includes the following items, including any other appropriate step(s) given the specific rulemaking:

Actual completion dates for:

  • Drafting of the Concept Paper
  • Clearance of the Concept Paper at all appropriate level(s)

Target completion dates for:

  • Drafting of the Codified Language
  • Clearance of the Codified Language at all appropriate level(s)
  • Drafting of the Paperwork and Economic Sections
  • Drafting of the Preamble
  • Clearance of the Preamble at all appropriate level(s)
  • Completion of the Full Document
  • Final clearance of the regulation at all appropriate level(s) prior to publication

Appendix 3 includes a Work Plan template.

III. The Codified Language

 The Codified Language is the section of a rulemaking that has a binding effect and sets out FDA’s additions and/or changes to the Code of Federal Regulations (CFR). It is important to remember that regulations are enforceable as law and bind industry and FDA. Although a detailed background of issues pertaining to a regulation is included in its Preamble, this background information does not publish in the CFR. Accordingly, the regulation published in the CFR must be understandable as a “stand alone” provision.

IV. Codified Language Review Cycle

Once a draft of the Codified Language is complete, the appropriate parties within CBER will review and provide input on the Codified Language. Appropriate parties include the RPS Project Officer, RPS Director, Champion, Lead Office (including the Lead Office Associate Director for Policy (ADP)), other Office ADPs if those Offices will clear the document, all members of the Working Group, if applicable, and all other key players, as appropriate. Depending on the complexity of the regulation, additional review cycles for the Codified Language may be necessary.

V. The Preamble

The Preamble describes the regulation, explains why the regulation is necessary, how it will be implemented, and provides further explanation of the various provisions of the regulation. It also cites the legal authority for the rulemaking.

The Preamble comprises several components, with some distinctions between proposed rules and final rules.

  • Agency Caption –The agency caption states that FDA is issuing the rulemaking.
  • Action Caption – The action caption identifies the type of rulemaking that FDA is issuing (e.g., Proposed Rule, Interim Final Rule, Direct Final Rule, Final Rule, etc.).
  • Summary Paragraph – The summary paragraph identifies what action FDA is taking, why the action is necessary, and the intended effect of the action.
  • Dates Caption –The dates caption presents the dates that are essential to the rulemaking (e.g., deadlines for public comment period, the effective date of the rulemaking, etc.).
  • Addresses Caption – The addresses caption contains any addresses the public needs to be aware of (e.g., address for the mailing of public comments).
  • For Further Information Caption – The further information caption identifies a point person within FDA who is the primary contact for questions about the rulemaking. This point person is usually the RPS Project Officer.
  • Supplementary Information for Proposed Rules –The supplementary information for a proposed rule includes: a section on the background and history of the regulation, a discussion of any major issues, a section-by-section highlight of the proposed rule, a request for comments, and all appropriate assessment statements (i.e., Economic, Paperwork Burden, Environmental, Federalism, etc.).
  • Supplementary Information for Final Rules – The supplementary information for a final rule includes: all applicable portions of the proposed rule’s supplementary information, a section-by-section highlight of the final rule, a summary of the comments received on the proposed rule and FDA’s corresponding responses, and all appropriate assessment statements (i.e., Economic, Paperwork Burden, Environmental, Federalism, etc.).

Special Note for Interim and Direct Final Rules: The supplementary information of an interim final rule includes a good cause statement as to why prior notice and comment on the rulemaking is not warranted (21 CFR 10.40(e)(1)). The supplementary information of a direct final rule includes a justification for why direct final rulemaking is appropriate.

VI. Preamble Review Cycle

Once a draft of the Preamble is complete, the appropriate parties within CBER will review and provide input on the Preamble language. Appropriate parties include the RPS Project Officer, RPS Director, Champion, the Lead Office (including the Lead Office ADP), other Office ADPs if those Offices will clear the document, all members of the Working Group, if applicable, and other key players, as appropriate. Depending on the complexity of the regulation, additional review cycles for the Preamble may be necessary.

 VII. CBER Clearance of a Regulation

 Once the regulation is fully developed (i.e., all review cycles for the Codified Language and the Preamble are complete and agreed upon versions of the Codified Language and the Preamble are combined into a Full Document), the appropriate CBER Offices and other FDA Centers/Offices will review and comment on the regulation as appropriate.

Appendix 4 provides a sample CBER Clearance Record, used to document the Offices and individuals responsible for review of and comment on the regulation at this stage in development.

 VIII. Final Agency Clearance of a Regulation

Once CBER Clearance is complete and there is a revised regulation incorporating all agreed upon comments, the RPS Project Officer circulates the regulation for final clearance across FDA.

Appendix 5 provides a sample Blue Sheet (Final Clearance Record), used to obtain final clearance of the regulation across the Agency.

 IX. Publication in the Federal Register

 Once the regulation clears FDA, and the Department of Health and Human Services (DHHS) and/or the Office of Management and Budget (OMB), as necessary, the regulation will be forwarded to the Office of the Federal Register (OFR) for publication. The OFR will schedule a publication date.

 X. The Administrative Record

 The Administrative Record includes information FDA considered or relied on directly or indirectly when making a decision, including the existence of contrary evidence to FDA’s position and FDA’s handling of contrary evidence. The Administrative Record is often reviewed to understand why a decision was made on the matter. FDA, the Courts, Congress, the Office of the Inspector General, the General Accountability Office, the general public, and the press might review the Administrative Record.

FDA retains the Administrative Record indefinitely. It is not subject to other records retention policies within CBER or FDA. If a regulation’s Administrative Record is flawed, the regulation, if challenged, may be invalidated and discovery and testimony may be needed to supplement the record. Therefore, compiling an accurate and thorough Administrative Record is a critical part of developing the regulation.

5. Responsibilities and Procedures for the Major Steps of Regulation Development

I. The Concept Paper

A. The Lead Office, generally:

  • Designates a knowledgeable staff person as the Champion, who is responsible for developing the Concept Paper.
  • Establishes a Working Group of key individuals, as appropriate, to assist in developing the rulemaking concepts and implementation strategy.
  • Identifies other affected CBER Offices and FDA Centers.
  • Conducts an analysis of all issues relevant to the rulemaking.
  • Identifies any issues that need to be resolved before the process can proceed further, and the decision-making authority needed to resolve those issues.
  • Identifies the individuals who will ultimately sign-off on the regulation and ensures that their comments are solicited during development of the Concept Paper.
  • Works with the Center’s Policy Coordinating Committee to identify which CBER Offices and FDA Centers need to review and approve the Concept Paper, and which Offices should receive an “FYI” copy, with an option to comment.

A.1. The Champion:

  • Solicits comments from any individual within the agency who is knowledgeable on the subject or who may have relevant information.
  • Develops the Concept Paper for approval by the Lead Office Director.
A.2. The Lead Office Director:
  • Reviews and clears the Concept Paper after completion by the Champion.
  • Submits the Concept Paper to the RPS Director and to the CBER Associate Director for Policy (ADP) for approval.

B. RPS Director:

  • Circulates the Concept Paper to the identified CBER Offices/FDA Centers.
  • Provides recommendations on the Concept Paper to the CBER ADP.

CBER ADP

  • Approves the Concept Paper, so the rulemaking can go forward.
  • Consults with other CBER/FDA parties for their input on the Concept Paper, as appropriate.

II. The Work Plan

 A. The RPS Project Officer (assigned by the RPS Director):

  • Drafts the Work Plan after the Concept Paper is cleared at all appropriate level(s).
  • In developing the Work Plan, the RPS Project Officer:
    • Reviews the scope and specifics of the regulation to ensure their understanding of the end product and a timeframe for completion.
    • Identifies all tasks needed for publication of the regulation in the FR.
    • Identifies the key player(s), both individual(s) and Office(s), that must provide approval and clearance at each step.
    • Estimates a reasonable timeframe for completion of each task.
    • Obtains agreement on the Work Plan from the key players.
    • Shares a copy of the Work Plan with the key players.
    • Sets reasonable timeframes allowing for timely and sufficient completion of each step. Often, the Lead Office provides the RPS Project Officer with suggested timeframes for the project.
    • Updates and reports any deviations from the Work Plan to the RPS Director and/or the RPS Team Leader. The RPS Project Officer should also update the Lead Office ADP (if overseeing the Champion), the Champion, and/or the Working Group, as applicable.
    • For those projects experiencing delays, promptly discusses with the RPS Director the need for a meeting to address delays and sets up such meeting if needed.

III. The Codified Language

 A. The RPS Project Officer, Champion, and/or Working Group (if applicable):

  • Work together to draft the regulation’s Codified Language. In doing so they:
    • Review the Concept Paper – The Concept Paper is a good resource for drafting the Codified Language. Prior to drafting the Codified Language, the regulation writer(s) must read the Concept Paper and identify the objective(s) of the rulemaking.
    • Organize the Rule – Organization of a rule’s subject matter and its location in the CFR facilitates the writing process. The RPS Project Officer and/or Champion determine what parts and sections of the CFR are affected by the rulemaking and propose a CFR citation for the rule.
    • Adhere to the Standard Format of Regulations – The standard format of proposed rules and final rules are set out in the OFR’s Document Drafting Handbook (DDH). The DDH provides guidance to regulation writers on drafting regulations that comply with OFR’s publication requirements. In accordance with the DDH, regulation writers must use the correct amendatory language when drafting proposed and final rules.
    • Use Plain Language (also known as Plain English) – Regulation writers must write all regulations in “Plain English.” Clarity of a regulation’s text is linked to greater compliance with a regulation. The DDH contains a detailed discussion of “Plain English” in the section entitled “Making Regulations Readable.”

IV. Codified Language Review Cycle

 A. The RPS Project Officer:

  • Circulates the draft of the Codified Language for comment to: the Champion, the Lead Office (including the Lead Office ADP), other Office ADPs if those Offices will clear the document, all members of the Working Group, and other key players, as appropriate. Depending on the complexity of the regulation, more than one review cycle for the Codified Language may be necessary.
  • Consolidates comments on the draft Codified Language and disseminates consolidated comments to the Champion, Lead Office (including the Lead Office ADP), and the Working Group, if applicable, as well as all other appropriate key players.
  • Schedules meetings, as needed, to resolve comments on the draft Codified Language.
  • Revises the draft Codified Language consistent with agreed upon comments.

 B. The Lead Office, including the Champion and ADP:

  • Reviews Codified Language and provides RPS Project Officer with comments by the specified date.

C. Other Office ADPs:

  • Review Codified Language and provide RPS Project Officer with comments by the specified date.

D. Working Group:

  • Reviews Codified Language and provides RPS Project Officer with comments by the specified date.

V. The Preamble

A. The RPS Project Officer, Champion, and/or Working Group (if applicable):

  • Work together to draft the regulation’s general Preamble language.

B. The RPS Project Officer:

  • Determines whether the regulation has any paperwork burden, economic, environmental, and federalism implications that FDA must further discuss.
For Paperwork Burden:
  • The RPS Project Officer prepares a paperwork assessment statement for the regulation in accordance with the Paperwork Reduction Act of 1995 (PRA).
  • Prior to drafting the assessment statement, the RPS Project Officer contacts the liaisons in the Paperwork Reduction and Records Management Staff (PRA Staff) within the Office of the Chief Information Officer, Office of the Commissioner, for specific discussions of a given regulation’s paperwork burden. The RPS Project Officer involves the Champion and other staff, as appropriate, in these discussions.
  • If it is determined that the regulation does not have paperwork burden or that any paperwork burden is covered by current Office of Management and Budget (OMB) packages, the RPS Project Officer includes boiler plate language in the regulation stating that the rule contains no collections of information or includes information on the relevant OMB packages.
  • Any comments received on the paperwork burden of a proposed rule are addressed in the “Paperwork Reduction Act of 1995” section of the final rule.

For Economic Assessment:

  • The RPS Project Officer coordinates development of an economic assessment statement as necessary under Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded Mandates Act.
  • Assistance in preparing economic threshold assessments is available from the Economics Staff within the Office of Planning, Office of the Commissioner.
  • In general, if FDA determines that the regulation does not have a significant economic impact, the RPS Project Officer includes boiler plate language in the regulation stating that an economic assessment statement is not needed. However, in certain circumstances, the Economics Staff may need to include a more detailed response.
  • Any comments received on the economic implications of a proposed rule are addressed in the “Analysis of Impacts” section of the final rule.

For Environmental Impact and Federalism

  • The RPS Project Officer completes the environmental and federalism sections of the Preamble. Template language is normally used for these sections, but further consultation within FDA would be necessary if there is any significant impact on these factors.

C. PRA Staff in the Office of the Chief Information Officer, Office of the Commissioner

  • Available to consult with the RPS Project Officer and other parties interested in the paperwork burden of a regulation.

D. Economics Staff in the Office of Planning, Office of the Commissioner

  • Available to consult with the RPS Project Officer and other parties interested in the economic implications of a regulation.

VI. Preamble Review Cycle

A. The RPS Project Officer:

  • Circulates the draft of the Preamble for comment to: the Champion, the Lead Office (including the Lead Office ADP), other Office ADPs if those Offices will clear the final document, all members of the Working Group, and other key players, as appropriate. Depending on the complexity of the regulation, more than one review cycle for the Preamble may be necessary.
  • Consolidates comments on the draft Preamble and disseminates consolidated comments to the Champion, Lead Office (including the Lead Office ADP), and the Working Group, if applicable, as well as all other appropriate key players.
  • Schedules meetings, as needed, to resolve comments on the draft Preamble.
  • Revises draft Preamble consistent with agreed upon comments.

 B. The Lead Office, including the Champion and ADP:

  • Review Preamble Language and provide RPS Project Officer with comments by the specified date.

C. Other Office ADPs:

  • Review Preamble Language and provide RPS Project Officer with comments by the specified date.

D. Working Group:

  • Reviews Preamble Language and provides RPS Project Officer with comments by the specified date.

VII. CBER Clearance of a Regulation

A. The RPS Project Officer:

  • Sends the regulation, and accompanying CBER Clearance Record to the following in sequential order:
    • RPS Team Leader (2 weeks standard review)
    • RPS Director (2 weeks standard review)
    • CBER Offices and FDA Centers/Offices, as applicable – The RPS Project Officer requests review and comments from the Offices by a specific date, typically within two to four weeks (depending on the size of the rule).
    • CBER ADP – The RPS Project Officer consolidates all of the comments received from the individual Offices/Centers and sends these comments to the Champion and to the CBER ADP for review within two to four weeks.
  • Provides the Champion the consolidated commentsreceived from the CBER Offices, FDA Center(s), and the CBER ADP.
  • If needed, the RPS Project Officer may schedule meetings with the appropriate parties to discuss comments.
  • The RPS Project Officer incorporates agreed upon comments and revisions and produces a revised regulation.

B. The Champion:

  • The Champion consults with other appropriate staff in the Lead Office in considering all comments submitted by other CBER Offices, FDA Center(s) (if applicable), and the CBER ADP.

VIII. Final Agency Clearance of a Regulation

A. The RPS Project Officer:

Within CBER, the RPS Project Officer sends the regulation, and accompanying Blue Sheet, to the following, in sequential order:

  • RPS Team Leader
  • RPS Director
  • CBER Lead Office and other CBER Offices (as appropriate)
  • CBER Associate Director for Policy
  • CBER Center Director
  • Other FDA Centers/Offices affected by the regulation. The RPS Project Officer may request clearance from other FDA Centers/Offices concurrent with CBER Director clearance.

Once CBER clears the regulation, the RPS Project Officer sends the regulation and accompanying Blue Sheet to the following, in sequential order:

  • PRA Staff
  • Economics Staff
  • Office of Chief Counsel (OCC)
  • Office of Policy: Regulations Policy Management Staff (RPMS) and Regulations Editorial Staff (RES)

B. Office of Chief Counsel (OCC)

If OCC makes any changes to the regulation during its sign-off, OCC sends the document back to RPS. Once the RPS Project Officer makes OCC’s requested changes and receives OCC final signoff, the regulation proceeds to the next level of clearance. If OCC’s sign-off results in significant changes to the regulation, it may be necessary to re-circulate the document through CBER, on a limited basis.

C. Office of Policy

Within the Office of Policy, the Regulations Policy Management Staff (RPMS) and the Regulations Editorial Staff (RES), facilitate the regulation’s final review and publication.

C.1. RPMS and RES

  • RPMS reviews the regulation for conformance with FDA policies and gives the document to RES for preparation in the FR format.
  • RES edits the document in accordance with the FR format. If RES makes substantive changes to the document, RES contacts the RPS Project Officer to discuss these changes. Depending on the nature of the changes, a new round of clearance of the document within CBER and OCC may be required. After fully editing the document, RES returns the regulation to RPMS. The RPS Project Officer should request that RPMS provide a copy of RES’ editorial changes.
  • Once RPMS receives the formatted document from RES, RPMS forwards the document to the appropriate official for signature. Typically, the Assistant Commissioner for Policy signs the document but depending on the regulation’s significance, the Commissioner or the Secretary for the Department of Health and Human Services (DHHS) may sign the regulation.
  • RPMS coordinates the review of regulations by DHHS and OMB. RPMS sends the regulation to DHHS before OMB. Each quarter (calendar year), RPMS requests that RPS provide an OMB Write-up and Work Plan for any regulation that is expected to clear FDA by the specified time period. The RPS Project Officer is responsible for drafting the OMB Write-up and Work Plan. The OMB Write-up and Work Plan are needed for most rulemakings and are used by FDA, DHHS, and OMB to determine the significance of a document and the necessity of DHHS and OMB review and sign-off. The RPS Team Leader and/or Director should review the OMB Write-up and Work Plan before it is forwarded to RPMS by the RPS Team Leader.

Appendix 6 contains the OMB Write-up template and instructions on how to complete the template. Refer to the “Steps in Regulation Development” section of this SOPP for information on how to draft a Work Plan (Appendix 3).

D. DHHS and OMB

  • If DHHS determines that a regulation is significant or not significant but review is warranted, DHHS conducts a review of the regulation. There is no established deadline by which DHHS must complete its review.
  • If OMB determines that a regulation is significant, OMB has a 90 day formal review period to conduct its review and may request a 30 day extension.
  • Once DHHS and OMB reviews are complete, their comments are forwarded to RPS by RPMS. The RPS Project Officer works with the Champion, the Lead Office, and others as appropriate (e.g., Economics Staff), to address DHHS and OMB comments. The RPS Director and/or Team Leader reviews the responses and consults with the CBER ADP and OCC as appropriate.
  • DHHS requests that FDA submit responses to all DHHS comments at the same time. For those comments that FDA accepts, track changes on the document are acceptable. For those DHHS comments that FDA does not accept or where further explanation is needed, FDA submits a memorandum to DHHS outlining its responses.

IX. Publication in the Federal Register

 A. RPMS

  • Forwards the regulation to the OFR for publication once the regulation has cleared all levels, including DHHS and OMB, if applicable.

B. OFR

  • Schedules an FR publication date for the regulation.

C. RPS

  • Sends an email informing the CBER Director, CBER ADP, Office ADPs, and other relevant parties, of the scheduled publication date.

C.1. The RPS Project Officer

  • Prepares the rulemaking’s reference package. Any references that are included in a rulemaking must be submitted to the Division of Dockets Management (DDM) prior to display and publication of the rule (21 CFR 10.40). The RPS Project Officer is responsible for requesting the references from the Lead Office, preparing the reference package, and submitting this package to DDM, before the regulation goes on display at the OFR.

X. Compiling the Administrative Record

 A. The RPS Project Officer:

  • Must continually compile the substantive information that FDA considered or relied on when developing the rulemaking. This information makes up the rulemaking’s Administrative Record (21 CFR 10.3(a)).
  • Completes a rulemaking’s Administrative Record generally within 2 months of the rule’s publication in the FR. Depending on the complexity of the rulemaking, this timeframe may vary.
  • Discusses and obtains approval from, the RPS Director for any Administrative Record the RPS Project Officer believes cannot be compiled within 2 months. In these cases, the RPS Director should identify an estimated timeframe by which the Administrative Record should be compiled.

B. RPS Director:

  • Identifies an appropriate time for completion of a rulemaking’s Administrative Record when the RPS Project Officer believes it cannot be compiled within 2 months.

6. References

Administrative Procedure Act (APA)
Public Health Service Act (PHS)
Federal Food, Drug, and Cosmetic Act (FD&C)

7. Appendices

Appendix 1: Definitions
Appendix 2: Regulation Concept Paper Template
Appendix 3: Work Plan Template
Appendix 4: CBER Clearance Record
Appendix 5: Blue Sheet (Final Clearance) Record
Appendix 6: OMB Write-up Instructions and Template

8. Effective Date

This SOPP is effective upon posting on the CBER internet.

9. History

Comment/

Revision

Approved By

Approval Date

Version Number

Comment

RPS/ADP

Robert A. Yetter, PhD

Oct 29, 2008

1

Original

Appendix 1: Definitions

Champion: Member of the initiating (Lead) CBER Office that is the primary Office contact for a regulation in development.

Code of Federal Regulations (CFR): The codification of the general and permanent rules published in the FR by the executive departments and agencies of the Federal Government.

 Codified Language: The section of a rulemaking that has a binding effect and sets out FDA’s additions and/or changes to the CFR.

 Direct Final Rule (DFR): A final rule issued without a notice of proposed rulemaking (NPRM) that is to take effect without further action at a specified future date unless someone submits a substantive adverse comment to the rule. When FDA issues a DFR, the agency simultaneously issues a proposed rule in the event that a substantive adverse comment is submitted. If a substantive adverse comment is submitted, FDA will revert to a NPRM. FDA issues a direct final rule when the action covered by the rule is non-controversial and is not likely to elicit adverse comments. If no substantive adverse comment is received, FDA issues a notice in the FR noting the date on which the DFR goes into effect.

 Federal Register (FR): Published by the Office of the Federal Register (OFR), the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as Executive Orders and other presidential documents.

 Final Rule: The regulation finalized for implementation, published in the FR (preamble and codified), and codified in the CFR.

Interim Final Rule (IFR): A final rule that takes effect immediately or on short notice without a NPRM but on which FDA invites comments and may change the rule based on the comments received. An interim final rule is usually followed by a final rule which may include revisions made as a result of FDA’s consideration of the comments.

Preamble: Analysis preceding a proposed or final rule that clarifies the intention of the rulemaking and any ambiguities regarding the rule. Responses to comments made on a proposed rule are published in the preamble preceding the final rule. Preambles are published only in the FR and do not have a binding effect.

 Proposed Rule/Notice of Proposed Rulemaking (NPRM): An agency process, subject to public notice and comment, for formulating, amending, or withdrawing a regulation. A proposed rule provides FDA’s suggested regulatory changes to the CFR. It also provides the public with notice of and an opportunity to comment on the regulatory changes being undertaken by the agency.

 Regulation (21 CFR 10.3(a)): An agency rule of general or particular applicability and future effect issued under a law administered by the Commissioner or relating to administrative practices and procedures. In accordance with 21 CFR 10.90(a), each agency regulation will be published in the Federal Register and codified in the Code of Federal Regulations.

Rule: The terms “rule” and “regulation” are interchangeable for the purposes of this SOPP.

 Rulemaking: The process used by CBER to formulate, amend, or withdraw a rule or regulation.

RPS: An acronym for CBER’s Regulations and Policy Staff.

RPS Project Officer: Member of RPS assigned to a certain project with primary responsibility for coordination of the regulation development process for that project.

Appendix 2: Regulation Concept Paper Template

Instructions: Document should be no more than two pages long.

I. What is the issue?

Enter one or two sentences outlining the issue to be addressed by the rulemaking.

II. What is the priority?

Enter the priority of the rulemaking; e.g., low, medium, or high. Justify your selection in this field.

 III. What are the key elements of the proposed action?

Enter one or two paragraphs discussing the key elements of the proposal including any other regulatory options considered and why they were rejected; why you recommend addressing the issue this way, as opposed to taking another action or no action; what resistance we may encounter to the rulemaking (e.g., challenges to legal authority, strong opposition from a particular group); how the rule will be enforced; and any anticipated public response to the rulemaking.

IV. Under what statutory and regulatory authority is the rulemaking being instituted?

Enter one sentence referencing the legal authority for the rulemaking (OCC should be consulted on the agency’s legal authority).

V. How does the rulemaking support FDA’s mission?

Enter one sentence describing how the rulemaking furthers the agency’s (Strategic Action Plan) public health mission.

VI. Who are the principal authors and initiating CBER Office/Division?

Identify the most appropriate person to facilitate the rulemaking (the “Champion” and the CBER Office and Division; and others who might be important for consultation purposes (e.g., information technology expertise, review management expertise, etc.).

VII. What is the projected timeline for publication?

Identify how long you think it will take to develop and implement the rulemaking. Include how long you think it will take to get the rule out of the lead office.

VIII. Is there a mandatory deadline by which the rulemaking must be published?

Yes or no. If yes, provide one sentence explanation.

IX. What components within FDA will the rulemaking affect?

Identify both the CBER and agency components you expect should be included in the rulemaking, as well as those components that may be affected upon its implementation. Identify other agencies you expect should review the rule.

X. Will a guidance or other document (e.g., citizen petition response) accompany the rulemaking?

Yes or no. If yes, provide an explanation.

XI. Does the rulemaking individually or cumulatively have a significant effect on the human environment that would require an Environmental Assessment or Environmental Impact Statement?

See 21 CFR part 25, and 21 CFR § 25.31.

Yes or no.

 XII. Are there economic considerations?

Yes or no. If yes, provide an explanation.

Assess whether the regulatory action chosen is the most cost effective in light of other regulatory alternatives. (E.O. 12866).

Assess whether the rulemaking will have a substantial impact on small businesses. (Regulatory Flexibility Act).

Assess whether implementation of the rulemaking by local governments or the private sector would result in aggregated costs exceeding the current threshold ($127 million). (Unfunded Mandates Reform Act).

Are there new paperwork burdens triggered by the rulemaking?

Yes or no. If yes, provide an explanation.

Enter one sentence considering whether new paperwork burdens will be triggered by the rulemaking. Approved information collections may be referenced at http://intranet.fda.gov/omp/pra/Approved_ICRs.htm#CBER on the Intranet.

XIII. Anything Else?

Provide any additional pertinent information.

XIV. Approval Signature(s) and Date

Obtain appropriate signature(s) (e.g., Office Director), and date

Appendix 3: Work Plan Template

WORK PLAN (HHS LIST #)

Title of Regulation (Action) – FRDTS #

  • Concepts Drafted
 Date:
    • Cleared by Center (At Appropriate Level)
Date:
    • Cleared by OCC
 Date:
    • Cleared by Economics/Paperwork
Date:
    • Cleared by OC (If Appropriate)
Date:
    • Department Briefing/Cleared by
      Department (If Appropriate)
Date:
  • Codified Drafted Date:
Date:
    • Codified Cleared by Center
 Date:
    • Codified Cleared by OCC staff level
 Date:
    • Codified Cleared by other Centers/Agencies Offices (If Applicable)
Date:
  • Paperwork (including supporting statement) and Economic Sections Drafted
Date:
  • Preamble Drafted
Date:
    • Preamble Cleared by Center
 Date:
    • Preamble Cleared by OCC staff level
 Date:
    • Preamble Cleared by other Centers/Agencies/
      • Offices
Date:
  • Full Document Completed
Date:
Blue Sheet Clearance  
  • Final Economic Clearance
Date:
  • Paperwork Clearance (Information Collection
    Requirement)
Date:
  • Final Clearance by Center Director
Date:
  • Final Clearance by other Centers/Agencies/Offices
    (If Applicable)
Date:
  • Final OCC Clearance
 Date:
  • Office of Policy Clearance and Signature
    (Includes RPMS/RES review and editing)
Date:
  • Commissioner Signature (If Appropriate)
Date:
  • Sent to DHHS
 Date:

Appendix 4: CBER Clearance Record

CLEARANCE RECORD

 

1. FRDTS #/CTS #

 

2. TYPE OF ISSUANCE

 

3. SUBJECT OF ISSUANCE

 

4a. PROJECT OFFICER (Name and Organization)

[Insert Name], HFM-17

 

b. BUILDING AND ROOM NO.

WOCI - 500N

 

c. PHONE NO.

827-[fill in]

827-9434 (FAX)

 

5. PURPOSE (Changes in policy or procedures, instructions or forms cancelled, revised or created)

 

Please review the attached [insert type of document(s)], and return the signed Clearance Record or equivalent and any comments to insert name by insert date. Please distribute this document to other interested persons within your office for review, as appropriate. We request that comments from each office be consolidated and submitted under the signature of the office director or designee.

 

Individuals receiving FYI copies are welcome to comment.

 

6. ORIGINATING OFFICE CLEARANCE

 

 

a. TYPED NAME, TITLE AND ORGANIZATION

[Insert Name], HFM-17

Regulations and Policy Staff

CBER/OD/RPS

 

b. SIGNATURE

 

 

 

c. DATE SIGNED

 

7. CONCURRENT CLEARANCE ROUTING (Copy to each clearance point)

 

 

 

SIGN UNDER APPROPRIATE COLUMN

 

 

 

 

NAME/MAILING SYMBOL

 

 

CONCUR

 

 

 

 

CONCUR

(recommended changes attached)

 

 

DO NOT CONCUR

(reasons attached)

 

 

CLEARANCE DATE

 

[NAME] HFM-10

 

 

 

 

 

 

 

 

 

[NAME] HFM-210

 

 

 

 

 

 

 

 

 

[NAME] HFM-300

 

 

 

 

 

 

 

 

 

[NAME] HFM-400

 

 

 

 

 

[NAME] HFM-600

 

 

 

 

 

 

 

 

 

[NAME] HFM-700

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FYI COPIES TO: [NAME] HFM-1; [NAME] HFM-1; [NAME] HFM-4; [NAME] HFM-6; [NAME] HFM-25; [NAME] HFM-30; [NAME] HFM-40


 

Appendix 5: Blue Sheet (Final Clearance) Record

Federal Register Document Final Clearance Records

Appendix 6: OMB Write-up Instructions and Template

HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION1

Title: Initial Caps for Significant Words, No Period after the Title

 Significance of Regulation2: Two choices: "Not Significant under Executive Order 12866" or "Significant under paragraph [insert ¶ number] of Executive Order 12866 § 3(f)".3 If the action is a Final Rule, add "The proposed rule was classified as [insert either "Significant" or "not Significant"] on OMB List [insert list number]."

**normally, if an ANPRM or NPRM was "Significant", the subsequent FR will be "Significant". If you think the FR is "Not Significant", state why.

ex: "Significant under paragraph 4 of Executive Order 12866 § 3(f). The proposed rule was determined to be "Significant" on OMB List 39."

ex: "Not significant under Executive Order 12866. Although the proposed rule was deemed significant on OMB List 19, the proposal did not raise any controversial issues, and the agency did not receive any significant adverse comments. Therefore, the final rule is virtually identical to the proposal."

HHS Review4: State (in a sentence or two) whether HHS review is warranted [i.e., whether it is important, sensitive, controversial, precedent setting, etc.].

ex: "HHS review is warranted because this final rule impacts the entire human cell, tissue, and cellular and tissue-based product industry."

ex: "HHS waived review of the NPRM."

ex: "Not warranted. These are purely technical amendments."

Upcoming Action: Options include "Advanced Notice of Proposed Rule Making", "Notice of Proposed Rulemaking", "Proposed Rule", "Direct Final Rule", "Final Rule", "Interim Final Rule", etc.

RIN: 0910-????.5 FRDTS No.: self-explanatory.6

Statutory/Judicial Deadline: Indicate "None" or insert date of the statutory or judicial deadline. Any deadline should be verified by the appropriate OCC/Division leader.

Purpose: Insert a clear and concise statement (~one paragraph) of why the regulation is being issued and/or what it is expected to accomplish.

Description: Insert a clear and concise statement (less than one page) of exactly what the regulation will do and, if relevant, how it will do it.

Issues: Briefly describe potential controversy; legal or policy issues; statutory requirements; whether the regulation was drafted in response to a petition, a court order, or a Congressional directive; the extent of administrative discretion allowed by the statute in addressing issues; etc. This section is also a catch-all for any interesting/useful information that doesn't fit elsewhere.

Impact: Identify, and quantify if possible, both costs and benefits, briefly describing who will be affected, how, and to what extent (if known). Issues include who wins, who loses, who cares; congressional concerns; impact on non-HHS programs; impact on small businesses; impact on State, local or tribal governments; and why this action is important, sensitive, controversial, or precedent setting.

Budget Implications: Indicate "None"or include an explanation (limited to implications for FDA) of effect on outlays, number of years and awards, administrative overhead, or other relevant measures. May include savings as well as costs.

ex: "FDA estimates the first year implementation to cost $5 million (FY 2005)."

Paperwork: Indicate "None" or explain paperwork burdens imposed by the regulation, including positive and negative effects.7

ex: "The proposed rule would impose additional reporting and record keeping requirements, a paperwork burden estimated at [insert number of] hours. The document will include a burden chart and solicit comments on these proposed requirements."

ex: "Based upon the number of Adverse Experience Reports submitted to the agency from 1987 to 1995, we estimate an average reduction of approximately 225 reports per year."

ex: "The proposed rule imposes a labeling requirement, which is a third party disclosure subject to review under the Paperwork Reduction Act. A package on the information collection requirements will be submitted to OMB for approval."

SBREFA: Indicate "This is not a major rule", or describe how it meets the criteria for what is a major rule under SBREFA8.

ex: "Because expenditure could exceed $300 million, this rule is a major rule."

Federalism Implications: “None” or describe.9

 Public Comments: For actions providing a comment period, include the length of the comment period. For actions where a public comment period was previously provided, include a brief statement of the nature and extent of the major comments and the changes made, if any, in response to those comments; identify any other outreach, including that with State and local government.

ex: "The proposal will provide 90 days for public comment."

ex: " The agency received four comments on the proposed rule. The comments did not result in any changes to the final rule."

 ex: "FDA received over 35 comments on the proposed rule, which resulted in the following revisions: [list revisions] …"

Regulation Roll-Out: Three choices: “Not recommended at this time”, "To be determined", or “Recommended. [State reason]”.

ex: "Recommended due to recent interest from the Press and Congress."

 Contact Person: [Insert name of RPMS Desk Officer responsible for the document], Office of Policy, Regulations Policy and Management Staff, 301-827-3480.

 **Notes:

  • Insert 2 spaces after colons and periods.
  • Write-ups should be clear, concise, and brief (not exceeding 2 pages total).
  • Omitted or incomplete items will delay the process.
  • If you have any questions about the list process (e.g., where to find the OMB list number), contact Darlease Hyman at RPMS

Footnotes

1 Write-ups are due to the Department one month before the beginning of each quarter. Include all rules expected to be cleared by FDA by the end of the next quarter (i.e., within 6 months after the write-up is due).

2 exemptions [E.O. 12866 §3(d) and Guidance for Implementing E.O. 12866 Appendix C]:

  • regs under 5 U.S.C. §§556, 557 (formal rulemaking hearings)
  • regs pertaining to a military or foreign affairs function of the US (other than procurement...)
  • regs limited to agency organization, management, personnel matters
  • other categories exempted by OIRA
  • agency notices of funds availability
  • medical device reclassifications to less stringent categories
  • OTC monographs, unless they may be precedent-setting or have large adverse effects on consumers
  • Final rules for which no comments were received and which do not differ from the NPRM

3 E.O. 12866 §3(f): "Significant regulatory action" means any regulatory action that is likely to result in a rule that may:

  • have an annual effect on the economy of $100 million or more oradversely affect in a material way the economy, a sector of the economy, productivity, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
  • create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
  • materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
  • raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order.

4 Things specifically exempt from HHS review if routine in nature (not exempt if they may cause controversy or become of particular interest to outside parties such as the press or Congress):

  • device classifications - which category of control covers a particular device
  • regs stating the effective date for required premarket approval applications of certain class III medical devices
  • regs containing OTC monographs
  • final rules for which no substantive comments were received on the NPRM and which are substantially similar to the NPRM [on a case by case basis: FDA will notify HHS about these final rules a day or two before they are forwarded to the OMB for review or the OFR for publication so that HHS can determine if its review is warranted].

5 "RIN" is the Regulation Indentifier Number published in the Unified Agenda/Regulatory Plan. If a RIN has not been assigned, the Center/Office should obtain one by contacting RPMS. OMB requires a RIN for documents they review.

6 Obtain number through FRDTS contact in Center/Office.

7 A "paperwork burden" is any collection of information from 10 or more persons. A collection of information is asking identical questions to ten or more persons, whether the response is mandatory, voluntary, or required to obtain or retain a benefit. It can be in any format (e.g., survey, telephone call, etc.). Any recordkeeping, reporting, or disclosure requirement contained in a rule of general applicability is deemed to involve ten or more persons. (5 CFR 1320.3(c)(4)(i)).

8 Under SBREFA [5 U.S.C. § 804(2)], a "major rule" is defined as a rule that has resulted in or is likely to result in‑‑

  • an annual effect on the economy of $100,000,000 or more;
  • a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or
  • significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States‑based enterprises to compete with foreign‑based enterprises in domestic and export markets.

9 E.O. 13132 defines "Federalism implications" as actions that "have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government."

Appendix 6: OMB Write-up Template
OMB Writeup Template

 

 
Updated: October 30, 2008