[Federal Register Volume 60, Number 164 (Thursday, August 24, 1995)]
[Notices]
[Page 44036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20964]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0131]


``Point to Consider in the Manufacture and Testing of Therapeutic 
Products for Human Use Derived From Transgenic Animals (1995);'' 
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 points to consider (PTC) document entitled, ``Points 
to Consider in the Manufacture and Testing of Therapeutic Products for 
Human Use Derived From Transgenic Animals (1995).'' The PTC document is 
intended to assist manufacturers in the production of safe, pure, 
potent, and effective therapeutic products for human use that are 
derived from transgenic animals. The PTC document is also intended to 
help sponsors assure the quality and consistency of data submitted in 
connection with an investigational new drug application (IND), product 
license application (PLA), establishment license application (ELA) or 
new drug application (NDA).

DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the PTC 
document to the Congressional and Consumer Affairs Branch (HFM-12), 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send two self-addressed adhesive labels to assist that office in 
processing your requests. Persons with access to the INTERNET may 
request this document from ``CBER [email protected].'' The document 
may also be obtained by calling the CBER FAX Information System at 301-
594-1939 from a FAX machine with a touch tone phone attached or built 
in. Submit written comments on the PTC document to the Dockets 
Management Branch (HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857. Two copies of any comments are to be submitted, except that 
individuals may submit one. Requests and comments should be identified 
with the docket number found in brackets in the heading of this 
document. A copy of the PTC document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Timothy Beth, Center for Biologics 
Evaluation and Research (HFM-635), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a PTC 
document entitled ``Points to Consider in the Manufacture and Testing 
of Therapeutic Products for Human Use Derived From Transgenic Animals 
(1995).'' The PTC document provides a discussion of issues that should 
be considered in the development of therapeutic products derived from 
transgenic animals. A transgenic animal is an animal with an altered 
genome produced by introduction of deoxyribonucleic acid (DNA) through 
human intervention. The PTC document addresses issues such as the 
structure of the gene product, the fidelity of inheritance, the 
consistency of expression, and the avoidance of contamination by drugs, 
chemicals, and adventitious agents. Specific topics discussed in the 
PTC document include: (1) Generation and characterization of the 
transgene constructs; (2) creation and characterization of the 
transgenic founder animal; (3) establishment of a reliable and 
continuous source of transgenic animals; (4) generation and selection 
of production herds; (5) maintenance of transgenic animals; (6) 
purification and characterization of the transgenic product; (7) 
analysis of product quality; and (8) preclinical safety evaluation. The 
PTC document contains a reference section that lists laws, regulations, 
guidances, guidelines, PTC's and policies which may be applicable and 
should be considered when manufacturing therapeutic products for human 
use from transgenic animals.
    As with other PTC documents, FDA does not intend this PTC document 
to be all-inclusive and cautions that not all information may be 
applicable to all situations. The PTC document is intended to provide 
information and does not set forth requirements. The methods and 
procedures cited in the PTC document are suggestions. FDA anticipates 
that sponsors and investigators may develop alternative methods and 
procedures, and discuss them with FDA. FDA may find those alternative 
methods and procedures acceptable. FDA recognizes that advances will 
continue in the area of human therapeutic products derived from 
transgenic animals and that this document may become outdated as those 
advances occur. The PTC document does not bind FDA and does not create 
or confer any rights, privileges, or benefits on or for any person, but 
is intended merely for guidance.
    FDA is making available the PTC document in association with its 
responsibility to regulate drugs, medical devices, and biological 
products intended for human use. The PTC document is neither a 
regulation nor a guideline, but is an FDA compilation of information 
and suggestions on the subject of manufacturing therapeutic products 
for human use derived from transgenic animals. All applicable Federal 
laws and regulations must be followed and adhered to when manufacturing 
therapeutics for human use.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the PTC document. 
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 document. Received 
comments may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.
    Received comments will be considered in determining whether further 
revision of the PTC document is warranted.

    Dated: August 17, 1995.
William K. Hubbard,
Deputy Commissioner for Policy.
[FR Doc. 95-20964 Filed 8-23-95; 8:45 am]
BILLING CODE 4160-01-F