# Presentation: 525569

## SHARINGINFORMATION WITH THE PUBLIC

- Kathleen Swisher, J.D., R.N.
- Director, Regulations & Policy Staff
- Center for Biologics Evaluation & Research
- Food and Drug Administration

## Communication Tools Available to FDA

**Federal Register Notices and Regulations ****(21 CFR 10.80)**
**Announcing the availability of level 1 guidance documents and regulations**
**Participation in or holding public meetings and workshops **
**	****(21 CFR 10.115 (g))**

- Regulations & Policy Staff, CBER

## Communication Tools Available to FDA (continued)

**Meetings and correspondence with interested persons outside FDA ****(21 CFR 10.65)**
**Participation in outside standard-setting activities ****(21 CFR 10.95)**
**Posting documents on the Internet**
**Opening a docket for comments on a matter**

- Regulations & Policy Staff, CBER

## Why is FDA Unable to Share Certain Information?

**FDA’s ability to share information about draft Federal Register notices and regulations is regulated under **
**	****21 CFR 10.80 **

- Regulations & Policy Staff, CBER

**21 CFR 10.80:**
**During the idea or concept phase before it is determined that a proposed rule or draft guidance will be prepared, FDA is free to discuss with an interested person ideas, recommendations, and supporting information.**
- Regulations & Policy Staff, CBER

- Regulations & Policy Staff, CBER

**21 CFR 10.80:**
**Once it is determined that a draft guidance or proposed regulation will be prepared, only the general concepts may be discussed by FDA.  **
**FDA cannot discuss the details at this stage of document development.**
- Regulations & Policy Staff, CBER

- Regulations & Policy Staff, CBER

**21 CFR 10.80:**
**FDA cannot give individual persons or firms selective access to draft documents.**
**“****A draft of a final notice or regulation or its preamble, or any portion of either, may be furnished to an interested person outside the executive branch only if it is made available to all interested persons . . .”**
**	****(21 CFR 10.80(d)(2))**
- Regulations & Policy Staff, CBER

- Regulations & Policy Staff, CBER

## Access to Information

**CBER Web Sites**
**Annual Guidance Agenda**
**http://www.fda.gov/cber/gdlns/guidagenda04.pdf**
**CBER Blood**
**http://www.fda.gov/cber/blood.htm**
**CBER Blood Guidances**
**http://www.fda.gov/cber/blood/bldguid.htm**
**CBER Guidances/Guidelines/Points to Consider**
**http://www.fda.gov/cber/guidelines.htm**

- Regulations & Policy Staff, CBER

## References

**Annual Guidance Agenda**** **
**	****(69 FR 41510, July 9, 2004)**
**    ****Provides a list of possible topics for future guidance document development or revision.**** **
**Semiannual Regulatory Agenda**
**    ****(69 FR 37427, June 28, 2004)**
**	****S****emiannual publication of an inventory of all rulemaking actions under development or review by Federal departments and agencies.**

- Regulations & Policy Staff, CBER

## Citations

**21 CFR 10.80**** **
**	****Dissemination of draft Federal Register notices and regulations**
**21 CFR 10.115**
**	****Good guidance practices**

- Regulations & Policy Staff, CBER

## Contacts 

**Regulations and Policy Staff**
**301-827-6210**
**Office of Communication, Training and Manufacturers Assistance**
**301-827-2000**

- Regulations & Policy Staff, CBER