30762 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 / Notices

Dated: June 3, 1998.

Jennifer J. Johnson,

Secretary of the Board.

[FR Doc. 98–15158 Filed 6–3–98; 2:12 pm]

BILLING CODE 6210–01–P

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.

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 §§ 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 §§ 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 § 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.
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 / Notices 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

§ 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

21 CFR Section Forms No. of

Respondents

No. of

Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

601.2 and 601.12 FDA 2599, 2599a, 2600,

2600b, 3066, 3086, 3096,

3098, 3098a, 3098b,

3098c, 3098d, 3098e,

3210, 3213, 3214, and

3314

376 4.9 1,830 40 73,200

1There 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0336]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

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, and each proposed

reinstatement of an existing collection,

and to allow 60 days for public

comment in response to the notice. This

notice solicits comments on premarket

notification submission 510(k), subpart

E, to require a person/manufacturer who

intends to market a medical device to

submit a premarket notification

submission to FDA at least 90 days

before proposing to begin the

introduction, or delivery for