Revised Form FDA 356h, Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use; Availability

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