[Federal Register Volume 66, Number 94 (Tuesday, May 15, 2001)]
[Notices]
[Pages 26867-26868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12179]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0192]


Draft Guidance for Industry on Forms for Registration of 
Producers of Drugs and Listing of Drugs in Commercial Distribution; 
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availability of a draft guidance for industry entitled ``Forms for 
Registration of Producers of Drugs and Listing of Drugs in Commercial 
Distribution.'' The draft guidance is intended to assist establishments 
that are required to register (``registrants'') and submit listing 
information for drugs and biological products in obtaining and 
submitting the necessary forms to meet registration and listing 
requirements; this draft guidance will also assist those private label 
distributors that are not required to register, but elect to submit 
designated information directly to FDA. FDA proposes to make available 
through the Internet, rather than through conventional mail, the 
following registration and listing forms: Form FDA 2656 (Registration 
of Drug Establishment), Form FDA 2656e (Annual Update of Drug 
Establishment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 
(Registered Establishments' Report of Private Label Distributors).

DATES: Submit written comments on this draft guidance document by July 
16, 2001. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    For human drugs: Kathy Smith, Center for Drug Evaluation and 
Research (HFD-90), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-1086.
    For biological drugs: Robert A. Yetter, Center for Biologics 
Evaluation and Research (HFM-10), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-0373, [email protected].
    For veterinary drugs: Lowell Fried, Center for Veterinary Medicine 
(HFV-212), Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 301-827-0165, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under part 207 (21 CFR part 207), as authorized and required by 
section 510 of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 360) and sections 351 and 361 of the Public Health Service Act 
(PHS Act) (42 U.S.C. 262 amd 264), establishments (e.g. manufacturers, 
repackers, and relabelers) engaged in the manufacture, preparation, 
propagation, compounding, or processing of human drugs, veterinary 
drugs, and biological products, with certain exceptions, are required 
to register and submit listing information.
    Under part 207, these ``registrants'' use Form FDA 2656 to submit 
establishment registration information and to submit annual re-
registration information (FDA had also used Form FDA 2656e for annual 
re-registration, but this form will no longer be necessary); private 
label distributors use Form FDA 2656 to obtain a labeler code; 
registrants and, in some cases, private label distributors use Form FDA 
2657 to submit listing information for drugs and biological products 
and to update listing information; and registrants use Form FDA 2658 to 
submit listing information for private label distributors (FDA has also 
used the compliance verification report for updating listing 
information). Registrants will use new Form FDA 3356 to submit 
establishment and listing information for those human cells, tissues, 
and cellular and tissue-based products regulated as drugs and/or 
biological products under the act and section 351 of the PHS Act 
beginning January 21, 2003.
    If a registrant or private label distributor prefers to receive any 
of these forms through conventional mail, they may direct such requests 
to the designated agency contacts. Under the draft guidance, 
information previously submitted on Form FDA 2656e would be submitted 
on Form FDA 2656. Distribution of these forms through the Internet will 
reduce administrative costs to the agency. The draft guidance also 
contains registration information applicable to human cells, tissue, 
and cellular and tissue-based product establishments.
    The draft guidance explains that, unless specifically requested 
otherwise, FDA is discontinuing the conventional mailing of these forms 
to registrants and private label distributors. These forms are 
available on the Internet. Registrants, and if appropriate, private 
label distributors must continue to submit completed forms to FDA in 
accordance with the registration and listing requirements in part 207. 
The draft guidance explains where to obtain the forms on the Internet, 
how to make changes to information, and where to submit completed 
forms.
    Internet availability of these forms (instead of availability by 
conventional mail) is part of an agency initiative to use modern 
technology to facilitate the submission of establishment registration 
and listing information. FDA is developing software to make possible 
the electronic submission of the requisite registration and listing 
information for drugs and biological products. The agency plans to 
propose rulemaking that would revise the requirements for registration 
and listing and would require registrants to submit this information 
electronically.
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115; 65 FR 56468, 
September 19, 2000). This draft guidance represents the agency's 
current thinking on this topic. 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 statutes and regulations.

[[Page 26868]]

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments regarding the draft guidance. Written comments should be 
submitted to the Dockets Management Branch (address above). 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. 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.

III. Electronic Access

    Comments may also be submitted electronically on the Internet at 
http://www.fda.gov/dockets/ecomments. Once on this Internet site, 
select the relevant ``docket number'' and follow the directions. Copies 
of this draft guidance for industry are available on the Internet at 
http://www.fda.gov/cder/guidance/index.htm.

    Dated: May 7, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12179 Filed 5-14-01; 8:45 am]
BILLING CODE 4160-01-S