[Federal Register Volume 62, Number 130 (Tuesday, July 8, 1997)]
[Notices]
[Pages 36558-36560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17717]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0192]
Revised Form FDA 356h, Application to Market a New Drug,
Biologic, or an Antibiotic Drug for Human Use; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised Form FDA 356h entitled ``Application to
Market a New Drug, Biologic, or an Antibiotic Drug for Human Use.''
This revised form is intended to be used by applicants for a wide range
of products regulated by the Center for Biologics Evaluation and
Research (CBER) and the Center for Drug Evaluation and Research (CDER)
under the Public Health Service Act (the
[[Page 36559]]
PHS Act) and the Federal Food, Drug, and Cosmetic Act (the act). The
revised form is also intended to standardize the application form, to
reduce the time required to prepare applications, and to expedite
review by FDA staff. This action is part of FDA's continuing effort to
achieve the objectives of the President's ``Reinventing Government''
initiatives, and is intended to reduce unnecessary burdens for industry
without diminishing public health protection.
DATES: Written comments may be submitted at any time. Applicants
submitting new drug applications (NDA's), abbreviated new drug
applications (ANDA's), abbreviated antibiotic drug applications
(AADA's), applications for products specified in Sec. 601.2(c) (21 CFR
601.2(c)), or for autologous somatic cell therapy products will be
required to use revised Form 356h beginning January 8, 1998.
ADDRESSES:
CBER Information: Submit written requests for single copies of the
revised Form FDA 356h 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 . Send one self-addressed adhesive label to assist that
office in processing your requests. The form 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.
CDER Information: Submit written requests for single copies of the
revised Form FDA 356h to the Drug Information Branch (HFD-210), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4573. Send one self-
addressed adhesive label to assist that office in processing your
request.
Submit written comments and requests for single copies of the
revised Form FDA 356h to the Dockets Managements Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20857. See the SUPPLEMENTARY INFORMATION section for electronic access
to the revised Form FDA 356h.
FOR FURTHER INFORMATION CONTACT:
CBER: Robert A. Yetter, Center for Biologics Evaluation and
Research (HFM-10), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-0381.
CDER: Jean A. Yager, Center for Drug Evaluation and Research (HFD-
9), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-594-5480.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the revised Form FDA 356h,
``Application to Market a New Drug, Biologic, or an Antibiotic Drug for
Human Use.'' Form FDA 356h, dated October 1993, has been revised to
create the new harmonized Form 356h that eventually will replace 20
application forms for licensed products regulated by CBER and former
Form FDA 356h, dated October 1993, that was used for products regulated
by CDER. As outlined in the President's November 1995, National
Performance Review ``Reinventing the Regulation of Drugs Made From
Biotechnology,'' FDA will use a single harmonized application form for
all drug and licensed biological products. FDA subsequently developed a
draft form that was made available for public comment in the Federal
Register of October 1,1996 (61 FR 51285). Comments were received and
considered and then revisions were made to the form based on some of
the comments. A notice of request for comment to the Office of
Management and Budget (OMB) on this information gathering was published
in the Federal Register of March 13, 1997 (62 FR 11899). This
information collection requirement was approved and assigned OMB
control No. 0910-0338. The expiration date for this approval is April
30, 2000. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
Currently, CBER uses three establishment license application forms:
Form FDA 3210, ``Application for Establishment License for Manufacture
of Biological Products;'' Form FDA 2599, ``Establishment License
Application for the Manufacture of Blood and Blood Components;'' and
Form FDA 2599a, ``Supplement to Establishment License Application for
the Manufacture of Blood and Blood Components.'' As announced in the
Federal Register of May 14, 1996 (61 FR 24313), CBER also is using
interim Form FDA 3439, pending availability of the harmonized form for
biotechnology products specified in Sec. 601.2(c). Sixteen product
license application forms are currently in use by CBER as follows: Form
FDA 2600, ``Product License Application for the Manufacture of Source
Plasma;'' Form FDA 2600b, ``Product License Application for Therapeutic
Exchange Plasma;'' Form FDA 3066, ``Product License Application for
Manufacture of Blood Grouping Reagents;'' Form FDA 3086, ``Product
License Application for the Manufacture of Reagent Red Blood Cells;''
Form FDA 3096, ``Product License Application for the Manufacture of
Anti-Human Globulin;'' Form FDA 3098, ``Product License Application for
the Manufacture of Whole Blood and Blood Components;'' Form FDA 3098a,
``Product License Application for Red Blood Cells;'' Form FDA 3098b,
``Product License Application for Plasma;'' Form FDA 3098c, ``Product
License Application for Platelets;'' Form FDA 3098d, ``Product License
Application for Cryoprecipitated Antihemophilic Factor;'' Form FDA
3098e, ``The Manufacture of Products Prepared by Cytapheresis;'' Form
FDA 3211, ``Application for License for the Manufacture of Viral and
Rickettsial Vaccines;'' Form FDA 3212, ``Application for License for
the Manufacture of Bacterial Vaccines and Antigens;'' Form FDA 3213,
``Application for License for the Manufacture of Allergenic Products;''
Form FDA 3214, ``Application for the Manufacture of a Human Plasma
Derivative;'' and Form FDA 3314, ``Product License Application for the
Manufacture of Human Immunodeficiency Virus for In-Vitro Diagnostic
Use.''
CDER currently uses one application form, Form FDA 356h,
``Application to Market a New Drug for Human Use or an Antibiotic Drug
for Human Use,'' dated October 1993. FDA intends eventually to replace
all 20 application forms listed above with one harmonized application
form for all biological products and drugs subject to premarket
approval. FDA believes that a harmonized application format will allow
companies to provide higher quality submissions, reduce preparation
time, expedite review by FDA, and easily adapt to electronic
submissions when that becomes possible and practical. FDA intends to
phase in the use of the new Form FDA 356h as described in this notice.
This action is part of FDA's continuing effort to achieve the
objectives of the President's ``Reinventing Government'' initiatives.
One goal of these initiatives is to harmonize regulations administered
by FDA in an effort to reduce unnecessary burdens for industry without
diminishing public health protection.
[[Page 36560]]
Use of the new harmonized Form FDA 356h when fully implemented will
allow a biologic product manufacturer to submit one biologic license
application instead of two separate applications (product license
application (PLA) and establishment license application (ELA)).
Applicants submitting an NDA, ANDA, or AADA may begin to use the
new Form FDA 356h immediately. However, such applicants will be
required to use the new Form FDA 356h beginning January 8, 1998. In the
interim period the old Form FDA 356h, interim Form FDA 3439, and the
new Form FDA 356h are all acceptable alternatives for NDA's, ANDA's,
and AADA's.
For products currently submitted in the form of a biologics license
application under section 351 (42 U.S.C. 262) of the PHS Act, including
the biotechnology products specified in Sec. 601.2(c), and autologous
somatic cell therapy products, applicants may begin to use the new form
immediately. The new Form FDA 356h will be required for products
specified in Sec. 601.2(c), and autologous somatic cell therapy
products beginning January 8, 1998. Before this effective date, interim
Form FDA 3439 is an acceptable alternative. Guidance documents entitled
``Guidance for Industry for the Submission of Chemistry, Manufacturing,
and Controls Information for a Therapeutic Recombinant DNA-Derived
Product or a Monoclonal Antibody Product for In Vivo Use'' (61 FR
56243, October 31, 1996); ``Guidance for the Submission of Chemistry,
Manufacturing, and Controls Information and Establishment Description
for Autologous Somatic Cell Therapy Products'' (62 FR 1460, January 10,
1997); and ``Guidance for Industry for the Submission of Chemistry,
Manufacturing and Controls Information for Synthetic Peptide
Substances'' (available via the CDER home page at http://www.fda.gov/
CDER and select the ``Regulatory Guidance'' section) are available to
assist applicants in preparing the chemistry, manufacturing, and
controls (CMC) and establishment description sections of the
application.
Until further notice, if the biological product is not specified in
Sec. 601.2(c) or is not an autologous somatic cell therapy product,
applicants should continue to use the forms listed in this notice
currently in use by CBER. For these other biological products,
including vaccines, blood and blood components, in vitro diagnostic
test kits used to screen the blood supply, naturally derived protein
products, allergenic products, and all other biological products, a PLA
and an ELA should continue to be submitted. In future Federal Register
notices, FDA will advise applicants for the products not yet using the
new Form FDA 356h, when they may voluntarily begin, and when they will
be required to use the new Form FDA 356h. FDA is in the process of
preparing guidance documents on the content and format of the CMC and
establishment description sections of the new Form FDA 356h for those
biological products not yet using the new form. As these guidance
documents are completed, FDA will begin accepting the new Form FDA
356h.
The harmonized Form FDA 356h solicits information from the
applicant in the following areas: (1) General applicant information,
(2) product description, (3) application information, (4) establishment
information, and (5) cross references to other applications. In
addition, the form solicits 19 items, including information regarding
labeling, CMC#, nonclinical and clinical information, patent
information, establishment description information, plus
certifications.
II. Requests for Comments
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the new
harmonized Form FDA 356h. 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 office above
between 9 a.m. and 4 p.m., Monday through Friday.
FDA will consider any comments received in determining whether
revisions to the Form FDA 356th are warranted.
III. Electronic Access
An electronic version of this form is also available via Internet
using the World Wide Web (WWW). For access, connect to the FDA Form
Distribution Page at http://aosweb.psc.dhhs.gov/forms/fdaforms.htm.
Dated: June 30, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-17717 Filed 7-7-97; 8:45 am]
BILLING CODE 4160-01-F