[Federal Register Volume 62, Number 142 (Thursday, July 24, 1997)]
[Notices]
[Page 39904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19426]



  Federal Register / Vol. 62, No. 142 / Thursday, July 24, 1997 / 
Notices  

[[Page 39904]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95D-0415]


Guidance for Industry: Changes To An Approved Application For 
Specified Biotechnology and Specified Synthetic Biological Products; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled, ``Guidance for Industry: 
Changes To An Approved Application For Specified Biotechnology and 
Specified Synthetic Biological Products.'' The guidance document is 
intended to assist manufacturers in determining which reporting 
mechanism is appropriate for a change to an approved license 
application under the final rule ``Changes To An Approved 
Application,'' issued elsewhere in this issue of the Federal Register. 
In a separate document also published in this issue of the Federal 
Register, FDA is announcing the availability of a guidance document 
entitled, ``Guidance for Industry: Changes To An Approved Application: 
Biological Products,'' to assist applicants in determining how they 
should report changes to an approved license application for biologic 
products other than specified biotechnology and specified synthetic 
biological products under the final rule. The guidance document 
announced in this notice revises the draft guidance entitled, ``Draft 
Guidance; Changes To An Approved Application for Well-Characterized 
Therapeutic Recombinant DNA-Derived and Monoclonal Antibody 
Biotechnology Products'' announced in the Federal Register of January 
29, 1996 (61 FR 2748).

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled, ``Guidance for Industry: Changes To An Approved 
Application For Specified Biotechnology and Specified Synthetic 
Biological Products'' to the Office of Communication, Training and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, or Center for Drug Evaluation and Research (HFD-210), 
Drug Information Branch, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. The guidance document 
may also be obtained by mail by calling the CBER Voice Information 
System at 1-800-835-4709 or 301-827-1800, or by fax by calling the FAX 
Information System at 1-888-CBER-FAX or 301-827-3844. 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:
    Valerie A. Butler, Center for Biologics Evaluation and Research 
(HFM-630), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-594-3074, or
    Yuan Yuan Chiu, Center for Drug Evaluation and Research (HFD-800), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-0260.
SUPPLEMENTARY INFORMATION:
    The guidance document announced in this notice represents the 
agency's current thinking on changes to an approved application for 
specified biotechnology and specified synthetic biological products 
listed in 21 CFR 601.2(c), recombinant DNA-derived protein/polypeptide 
products approved under the Federal Food, Drug, and Cosmetic Act (the 
act), and complexes or conjugates of a drug with a monoclonal antibody 
approved under the act. It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute, regulations, or both.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding the 
guidance 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. A copy of the guidance document and received comments 
are available for public examination 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 by using the World Wide Web (WWW), or bounce-back e-mail. For 
WWW access, connect to CBER at ``http://www.fda.gov/cber/
cberftp.html''. To receive the guidance document by bounce-back e-mail, 
send a message to ``[email protected]''.
    Received comments will be considered in determining whether further 
revision of the guidance document is warranted.

    Dated: May 28, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-19426 Filed 7-23-97; 8:45 am]
BILLING CODE 4160-01-F