Agency Information Collection Activities; Submission for OMB Review; Comment Request; 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0192]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request; 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

proposed collection of information listed below has been submitted to

the Office of Management and Budget (OMB) for review and clearance

under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by

October 5, 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.

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: In compliance with section 3507 of the PRA

(44 U.S.C. 3507), FDA has submitted the following proposed collection

of information to OMB for review and clearance.

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--Extension)

FDA is the Federal agency charged with responsibility for

determining that drugs and biological products are safe and effective.

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 and effective. The

uniform format of the forms provides for orderly, efficient review by

the Center for Biologics Evaluation and Research (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 the collection of

this information is provided by 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 product license application (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 provide

additional standards for human blood and blood products, which require

submission of certain information 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 provided under the burden estimated for

Secs. 601.2 and 601.12 and the application form in approved 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 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 will 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

[[Page 47300]]

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.

This collection of information involves 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 using CBER's license application forms under OMB control

number 0910-0124 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. The approval

for OMB control number 0910-0338 expires on April 30, 2000. The

announcement of OMB's approval was published in the Federal Register of

May 19, 1997 (62 FR 27262).

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

portion of the reporting burden for 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 hours. The other 73,200 hours would account for manufacturers

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

still need to use other license application forms. FDA expects that all

manufacturers of biological products will begin to use Form FDA 356h

during 1998.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden1

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No. of

21 CFR Section Forms No. of Responses per Total Annual Hours per Total Hours

Respondents Respondent Responses Response

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601.2 and 601.12 FDA 2599, 376 4.9 1,830 40 73,200

2599a, 2600,

2600b, 3066,

3086, 3096,

3098, 3098a,

3098b, 3098c,

3098d, 3098e,

3210, 3213,

3214, and

3314

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

Dated: August 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-23838 Filed 9-3-98; 8:45 am]

BILLING CODE 4160-01-F