[Federal Register Volume 61, Number 19 (Monday, January 29, 1996)]
[Proposed Rules]
[Pages 2749-2750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1583]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 600 and 601

[Docket No. 95D-0052]


Changes To An Approved Application; Draft Guidance; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document entitled ``Draft Guidance; 
Changes to An Approved Application.'' The draft guidance is intended to 
assist applicants in determining how they should report changes to an 
approved license application under the proposed revision to the 
biologics regulations issued elsewhere in this issue of the Federal 
Register. FDA does not intend for this draft guidance to be used at 
this time. The agency is providing this guidance at this time for 
public comment only.

DATES: Written comments by April 29, 1996.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Draft Guidance; Changes to An Approved 
Application'' to the Congressional and Consumer Affairs Branch (HFM-
12), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, or call 
FDA's automated information system at 800-835-4709. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Two copies of any comments are 
to be submitted, except that individuals may submit one copy. Requests 
and comments should be identified with the docket number found in 
brackets in the heading of this document. A copy of the draft guidance 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday. -
    Persons with access to INTERNET may request that the draft guidance 
document be sent by return E-mail by sending a message to 
``[email protected]''. The draft guidance document may also be 
obtained through INTERNET via File Transfer Protocol (FTP). Requestors 
should connect to the Center for Drug Evaluation and Research (CDER) 
using the FTP. The Center for Biologics Evaluation and Research (CBER) 
documents are maintained in a subdirectory called CBER on the server, 
``CDVS2.CDER.FDA.GOV'' (150.148.24.202). The ``READ.ME'' file in that 
subdirectory describes the available documents which may be available 
as an ASCII text file (*.TXT), or a WordPerfect 5.1 document (*.w51), 
or both. A sample dialogue for obtaining the READ.ME file with a text-
based FTP program would be:
    FTP CDVS2.CDER.FDA.GOV
    LOGIN: CHANGES
     <``Your E-mail address''>
    BINARY
    CD CBER
    GET READ.ME
    EXIT
    The draft guidance document may also be obtained by calling the 
CBER FAX Information System (FAX-ON-DEMAND) at 301-594-1939 from a 
touch tone telephone.
FOR FURTHER INFORMATION CONTACT:
    Tracey H. Forfa or Timothy W. Beth, 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-510), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-3510.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 6, 1995 (60 
FR 17535), FDA published a guidance document intended to provide 
guidance to applicants on which changes in manufacturing procedures and 
establishments may be implemented with and/or without prior approval by 
the Director, CBER under Sec. 601.12 (21 CFR 601.12). The Federal 
Register notice and guidance document were intended to reduce the 
burden of reporting changes on manufacturers and to facilitate the 
approval process. -
    In a continuing effort to achieve the reduction in reporting burden 
and to respond to comments received on the April 6, 1995, guidance 
document, FDA is proposing a revision to Sec. 601.12 published 
elsewhere in this edition of the Federal Register. In addition, FDA is 
announcing the availability of a draft guidance document entitled, 
``Changes to An Approved Application.'' The guidance document sets 
forth CBER's current interpretation of the proposed rule to amend 
Sec. 601.12 as it applies to biologic products other than those 
considered to be well-characterized therapeutic recombinant DNA-derived 
and monoclonal antibody biotechnology products. The reporting 
mechanisms proposed in the rule are based on the potential for the 
change to affect a product's safety, purity, potency, and 
effectiveness. In a separate document also published in this issue of 
the Federal Register, FDA is announcing 

[[Page 2750]]
the availability of a guidance document to assist applicants in 
determining how they should report changes to an approved application 
for a well-characterized therapeutic recombinant DNA-derived and 
monoclonal antibody biotechnology product under the proposed rule. -
    The guidance document will provide guidance to applicants in 
determining how a change to a product, production process, equipment, 
facility, responsible personnel, or labeling should be reported to FDA 
under the proposed revision to Sec. 601.12. -
    As stated previously, FDA is providing this draft guidance document 
for comment only. The document is not intended to be used at this time. 
FDA intends to review the comments received on the proposed rule and 
this draft guidance document and issue a final rule prescribing the 
requirements for the reporting changes to an approved license 
application. A revised guidance document would also be made available 
at the time of issuance of the final rule. As with other procedural 
guidance documents, FDA does not intend that this guidance document 
would be all-inclusive. Alternative approaches could be warranted in 
specific situations, and certain aspects might not be applicable to all 
situations. If an applicant believed the reporting procedure described 
in this guidance document was inapplicable to a specific change for a 
particular product, the applicant could provide, for CBER's 
consideration, information supporting an alternative categorization. An 
applicant also could discuss proposed changes with the agency to 
prevent expenditure of money and effort on activities that later might 
be determined to be unacceptable by FDA. The Center for Biologics 
Evaluation and Research would continue to review submissions on a case-
by-case basis. This document would not bind FDA and would not create or 
confer any rights, privileges, or benefits on or for any person, but 
would be intended for guidance.
    Interested persons may, on or before April 29. 1996, submit to the 
Dockets Management Branch (address above) comments on the draft 
guidance document. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments and information 
are to be identified with the docket number found in brackets in the 
heading of this document. The draft guidance ``Changes to An Approved 
Application'' and received comments are available for public 
examination in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.
    FDA plans to hold an open public meeting during the comment period 
to discuss the proposed revision to Sec. 601.12 and the draft guidance 
document. The time and location of this meeting will be announced in an 
upcoming issue of the Federal Register.
    FDA will consider any comments received in determining whether 
revisions to the guidance document are warranted. FDA will announce the 
availability of any revised guidance document in the Federal Register.

    Dated: January 16, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-1583 Filed 1-25-96; 10:43 am]
BILLING CODE 4160-01-F#