[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]


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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.

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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