[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