[Federal Register Volume 62, Number 194 (Tuesday, October 7, 1997)]
[Notices]
[Pages 52345-52346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0411]


Bovine Spongiform Encephalopathy (BSE) in Products for Human Use; 
Guidance for Industry on the Sourcing and Processing of Gelatin to 
Reduce Potential Risk; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``The Sourcing and 
Processing of Gelatin to Reduce the Potential Risk Posed by Bovine 
Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human 
Use.'' This guidance is intended to provide information to industry on 
reducing the risk of transmission of BSE in gelatin for human use.

DATES: Submit written comments on this guidance by December 22, 1997.
ADDRESSES: Submit written requests for single copies of the guidance 
document to the Executive Secretariat (HF-40), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your 
request. Submit written comments on the guidance document to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Linda H. Gangloff, Executive 
Secretariat (HF-40), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4450.

SUPPLEMENTARY INFORMATION: In 1994, representatives of the gelatin 
industry presented preliminary data to FDA concerning an experimental 
study of the infectivity of tissue infected with a transmissible 
spongiform encephalopathy (TSE). TSE's are rare, fatal, neurological 
diseases that occur in a number of animals (e.g., scrapie in sheep) and 
in humans (e.g., Creutzfeldt-Jakob disease). Based on the data 
presented, FDA decided that recommendations concerning bovine 
ingredients from countries that have reported BSE in FDA-regulated 
products would not include gelatin. A notice in the Federal Register of 
August 29, 1994 (59 FR 44584), summarized FDA's recommendations to 
reduce any potential BSE risk to humans from FDA-regulated products and 
clarified that FDA did not object at that time to gelatin for human use 
produced from bovine materials from countries reporting BSE.
    FDA is committed to amending previous guidance to industry as new 
information becomes available. On April 23 and 24, 1997, FDA's TSE 
Advisory Committee discussed information on gelatin manufacturing 
practices and final results of the research study. At the end of the 
meeting, a majority of the advisory committee members agreed that 
current scientific evidence did not justify continued exemption of 
gelatin from restrictions recommended by FDA for other bovine-derived 
materials from BSE countries. They also stated that the potential risk 
of BSE transmission from bovine-derived gelatin varies depending on the 
country of origin of the raw materials, type of tissue used, the 
gelatin processes used, and the route of administration or exposure.
    FDA has adopted ``Good Guidance Practices'' (GGP's) that set forth 
the agency's policies and procedures for the development, issuance, and 
use of guidance documents (62 FR 8961, February 27, 1997). The guidance 
announced in this document is issued as a Level 1 guidance consistent 
with GGP's. The agency is accepting public comments, but it is 
implementing this guidance immediately because of public health 
concerns related to the use of gelatin. This guidance represents the 
agency's current thinking on reducing the potential risk of 
transmission of BSE related to the use of gelatin in FDA-regulated 
products for human use. It does not create or confer any rights for or 
on any person and does not operate to bind the FDA or the public. An 
alternative approach may be used if such an approach satisfies the 
requirements of the applicable statute, regulations, or both.
    Interested persons may, on or before December 22, 1997, submit to 
the Dockets Management Branch (address above) written comments 
regarding this notice. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this

[[Page 52346]]

document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.
    Persons with access to the Internet may obtain the guidance 
document using the World Wide Web (WWW). For WWW access, go to ``http:/
/www.fda.gov/opacom/morechoices/industry/guidance/gelguide.htm''.

    Dated: October 1, 1997.
Michael A. Friedman,
Lead Deputy Commissioner for the Food and Drug Administration.
[FR Doc. 97-26501 Filed 10-2-97; 12:02 pm]
BILLING CODE 4160-01-F