1. Development of Guidance Documents Jennifer Scharpf, M. P. H
Development of Guidance Documents Jennifer Scharpf, M.P.H. Associate Director for Policy and Communication Office of Blood Research and Review, CBER September 15, 2009

2. FDA Good Guidance Practices (GGP)
Food and Drug Administration Modernization Act (1997) established GGP, including provision for public participation and comment
GGP are FDA’s policies and procedures for developing, issuing and using guidance documents
FDA codified policies and procedures for development and issuance of guidance documents in 21 CFR
Annual Guidance Agenda publishes in the Federal Register
Executive Order and the OMB Bulletin on Agency Good Guidance Practices (2007) provides opportunity for interagency coordination and review of significant guidance documents
CBER SOPP 8002: Procedures for Preparation, Routing and Issuance of Guidance Documents
Plain Language
Information Collection Burdens (Paperwork Reduction Act)
Communication with the Public (21 CFR 10.80)

3. Guidance Documents
Documents prepared for FDA staff, applicants, sponsors, and the public that describe the agency’s policy or interpretation of a policy on a regulatory issue including, but not limited to, documents that relate to the following:
Design, production, labeling, promotion, manufacturing and testing of regulated products;
Processing, content and evaluation or approval of submissions;
Inspection and enforcement policies

4. Guidance Documents
Do not include documents that relate to the following:
Internal FDA procedures
Agency reports
General information provided to consumers or health professionals
Speeches, media interviews and press materials
Journal articles or editorials
Warning letters
Memorandum of Understanding
Other communication or actions taken by individuals, at FDA or directed to individuals persons or firms

5. Guidance Documents
Although guidance documents do not legally bind the public or FDA, they represent the agency’s current thinking on matters under our jurisdiction
FDA employees may depart from guidance documents only with appropriate justifications and supervisory concurrence (21 CFR (d)(3))
Any consistent deviation from a guidance document indicates that it should be revised

6. Guidance Documents
Guidance documents do not establish legally enforceable rights or responsibilities
You may choose to use an approach other that the one set forth in guidance, provided the approach complies with relevant statutes and regulations (21 CFR (d)(2))
FDA will discuss an alternative approach with you to ensure that it complies with relevant statutes and regulations

7. Guidance Documents
FDA may not use documents or other means of communication that are excluded from the definition of guidance document to informally communicate new or different regulatory expectations to a broad public audience for the first time. GGP must be followed whenever regulatory expectations that are not readily apparent from the statute or regulations are first communicated to a broad public audience. (21 CFR (e))

8. Level 1 Guidance Documents
Definition (21 CFR (c)(1))
Set forth initial interpretations of statutory or regulatory requirements
Set forth changes in interpretation or policy that are of more than minor in nature
Include complex scientific issues
Cover highly controversial issues

9. Level 1 Guidance Documents
Procedures for development and issuance (21 CFR (g))
Notice of availability in the Federal Register
Issued in draft format and request public comment before implemented
Comment period is usually days; however, public can submit comments at any time
FDA reviews comments and issues a final guidance
Exception to public comment when FDA finds prior public participation is not feasible or appropriate

10. Level 2 Guidance Documents
Definition (21 CFR (c)(2))
Set forth existing practices or minor changes in interpretation or policy
Level 2 guidance documents include all guidance documents that are not classified as Level 1

11. Level 2 Guidance Documents
Procedures for development and issuance
Does not require notice of availability in the Federal Register
Immediately implemented unless FDA indicates otherwise
Invites public comment

12. Communication with the Public
21 CFR (g)
When considering developing guidance, FDA may freely discuss issue with the public
FDA may hold a scientific workshop, advisory committee meeting or public meeting before drafting the guidance
FDA may hold a public meeting after issuing a draft guidance

13. Communication with the Public
21 CFR 10.80
Once preparation of a draft guidance document has been initiated, specifics of the guidance should not be discussed with the public
Once the guidance has been issued in draft, we may discuss generally the issues related to the draft guidance; but we may not discuss issues related to our specific intentions regarding the final guidance

14. Recently Published Documents
Guidance for Industry: Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection (8/2009)
Guidance for Industry: NAT to Reduce Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products (7/2009)
Draft Guidance for Industry: Use of Serological Tests to Reduce Risk of Transmission of Trypanosoma cruzi in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues and Tissue-Based Products (3/2009)

15. Recently Published Documents
Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) (5/2008)
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (3/2008)

16. Resources CBER Guidance Documents Blood Guidance Documents
Blood Guidance Documents
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Federal Dockets Management System
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17. Conclusions
FDA good guidance practices establish procedures and policies to develop and issue guidance documents and communicate with stakeholders
FDA encourages public participation in the development of guidance documents
CBER has an active guidance development program that includes strategic planning and responds to emerging needs