[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