[Federal Register: May 15, 2001 (Volume 66, Number 94)]
[Notices]
[Page 26867-26868]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my01-79]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Forms for Registration of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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Forms for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 The draft guidance is intended to assist establishments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requirements; this draft guidance will also assist those private label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DATES: Submit written comments on this draft guidance document by July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ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Dockets Management Branch (HFA-305), Food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to the draft guidance document.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, yetter@cber.fda.gov.
For veterinary drugs: Lowell Fried, Center for Veterinary Medicine
(HFV-212), Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 301-827-0165, lfried@cvm.fda.gov.
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