Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0192]

Agency Information Collection Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a

proposed collection of information has been submitted to the Office of

Management and Budget (OMB) for emergency processing under the

Paperwork Reduction Act of 1995 (the PRA). The purpose of the proposed

collection of information is to enable manufacturers of biological

products to use specific establishment and product license application

(PLA) forms in submissions seeking FDA approval of their products.

DATES: Submit written comments on the collection of information by

April 20, 1998.

ADDRESSES: Submit written comments on the collection of information to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:

Desk Officer for FDA. All comments should be identified with the docket

number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of

Information Resources Management (HFA-250), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of

this proposed collection of information under section 3507(j) of the

PRA and 5 CFR 1320.13 because the information is essential to the

agency's mission. The agency cannot reasonably comply with the normal

clearance provisions of the PRA of 1995 because the use of normal

clearance procedures is reasonably likely to prevent or disrupt the

collection of information.

With respect to the following collection of information, FDA

invites comments on: (1) Whether the proposed collection of information

is necessary for the proper performance of FDA's functions, including

whether the information will have practical utility; (2) the accuracy

of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

Establishment and Product License Applications: Forms FDA 2599,

2599a, 2600, 2600b, 3066, 3086, 3096, 3098, 3098a, 3098b, 3098c,

3098d, 3098e, 3210, 3213, 3214, and 3314--21 CFR 601.2 and 601.12--

(OMB Control Number 0910-0124--Reinstatement)

FDA is the Federal agency charged with responsibility for insuring

the safety and effectiveness of drugs and the safety, purity, and

potency of biological products. Manufacturers of biological products

for human use must file an application for FDA approval of the product

prior to introducing it into interstate commerce. The information

provided by manufacturers on these license application forms is

necessary for FDA to carry out its mission of protecting the public

health and helping to ensure that biologics for human use have been

shown to be safe, pure, and potent. The uniform format of the forms

provides for orderly, efficient review by

[[Page 17184]]

the Center for Biologics Evaluation and Review (CBER) staff and

expedites the licensing process as well as documenting for future

reference the methods and procedures that have been approved for use at

each manufacturing location. Statutory authority for this collection of

information is found in section 351 of the Public Health Service Act

(the PHS Act) (42 U.S.C. 262).

Section 601.2 (21 CFR 601.2) requires that manufacturers of

biological products regulated under the PHS Act submit an establishment

license application (ELA) and a PLA, or a biologic license application

(BLA) to CBER for review and approval prior to marketing a biological

product in interstate commerce. Blood and blood components fall within

the category of biological products. All establishments collecting and/

or preparing blood and blood components for sale or distribution in

interstate commerce are subject to the licensing application provisions

of section 351 of the PHS Act. Section 601.12 (21 CFR 601.12) requires

manufacturers of a biologic for human use to file supplemental

applications for all important changes to applications previously

approved prior to implementing such changes. In addition to Secs. 601.2

and 601.12, other regulations impose additional standards relating to

certain information submitted in a license application, including 21

CFR 640.17, 640.21(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and

(b)(2), and 680.1(b)(2)(iii) and (c). The information collection

requirements in the preceding regulations and their associated

reporting burdens are included with the burdens estimated for

Secs. 601.2 and 601.12 and cleared, together with application form

356h, under OMB control number 0910-0338.

As outlined in the President's November 1995 National Performance

Review's document entitled ``Reinventing the Regulation of Drugs Made

From Biotechnology,'' FDA intends to use a single harmonized

application form for all drug and licensed biological products. FDA

revised Form FDA 356h, ``Application to Market a New Drug, Biologic, or

an Antibiotic Drug for Human Use,'' for this purpose and announced its

availability in the Federal Register of July 8, 1997 (62 FR 36558).

This notice described FDA's intent to phase in the use of the new Form

FDA 356h for all biological products and stated that applicants

submitting new drug applications (NDA's), abbreviated new drug

applications (ANDA's), abbreviated antibiotic drug applications

(AADA's), and biologics license applications (BLA's) for biologic

products specified in Sec. 601.2(c) could begin to use the new Form FDA

356h immediately. The notice also advised such applicants that they

would be required to use revised Form FDA 356h beginning January 8,

1998. In the interim period, the old Form FDA 356h and the new Form FDA

356h were to be acceptable alternatives for NDA's, ANDA's, AADA's, and

BLA's.

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 chemistry, manufacturing, and controls

section, and establishment description section 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. Until further notice, if the biological product is not

specified in Sec. 601.2(c), applicants should continue to submit an ELA

and a PLA application on the CBER forms listed below in this notice.

Because all applicants have not completed the transition to Form

FDA 356h, this notice seeks clearance for the continued use of the

following forms: Form FDA 2599, ``Establishment License Application for

the Manufacture of Blood and Blood Components;'' Form FDA 2599a,

``Supplement to Establishment License Application for the Manufacture

of Blood and Blood Components;'' 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 3210,

``Application for Establishment License for Manufacture of Biological

Products;'' 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.''

Respondents to this collection of information are manufacturers of

biological products. The reporting burden for the current collection of

information was reported to OMB as part of the total burden for the

agency's collection of information using Form FDA 356h. This collection

of information using Form FDA 356h was assigned OMB control number

0910-0338 and approved by OMB on April 23, 1997.

Under OMB control number 0910-0338, FDA estimated that CBER's

portion of the reporting burden for the collection of information using

Form FDA 356h was 76,200 hours. The 76,200 hours reflected the future

use of Form FDA 356h by all manufacturers of biological products. The

number of manufacturers of biological products that are already using

Form FDA 356h would account for approximately 3,000 hours of the total

burden. Thus, the other 73,200 hours would account for manufacturers

who have not completed the transition to using Form FDA 356h and who

still need to use the other license application forms described in this

notice. FDA expects that all manufacturers of biological products will

begin to use Form FDA 356h during 1998.

Dated: April 1, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-9101 Filed 4-7-98; 8:45 am]

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