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 an

opportunity for public comment on the proposed collection of certain

information by the agency. Under the Paperwork Reduction Act of 1995

(the PRA), Federal agencies are required to publish notice in the

Federal Register concerning each proposed collection of information,

including each proposed reinstatement of an existing collection of

information, and to allow 60 days for public comment in response to the

notice. This notice solicits comments on the use of establishment

license application (ELA) and product license application (PLA) forms

by manufacturers of biological products.

DATES: Submit written comments on the collection of information by

August 4, 1998.

ADDRESSES: Submit written comments on the collection of information to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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: Under the PRA (44 U.S.C. 3501-3520), Federal

agencies must obtain approval from the Office of Management and Budget

(OMB) for each collection of information they conduct or sponsor.

``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests or requirements that members of

the public submit reports, keep records, or provide information to a

third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))

requires Federal agencies to provide a 60-day notice in the Federal

Register concerning each proposed collection of information, including

each proposed reinstatement of an existing collection of information,

before submitting the collection to OMB for approval. To comply with

this requirement, FDA is publishing notice of the proposed collection

of information listed below.

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

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 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 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.

[[Page 30763]]

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.

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: May 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-14916 Filed 6-4-98; 8:45 am]

BILLING CODE 4160-01-F