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
30764 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 / Notices

introduction into interstate commerce,

for commercial distribution of a device

intended for human use.

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:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

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.

Premarket Notification Submission

510(k), Subpart E—(OMB Control

Number 0910–0120—Reinstatement)

Section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360(k)) and the implementing

regulation, 21 CFR 807.81, 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

introduction into interstate commerce,

for commercial distribution of a device

intended for human use.

Section 510(k) of the act allows for

exemptions to the 510(k) submissions,

i.e., a premarket notification submission

would not be required if FDA

determines that premarket notification

is not necessary for the protection of the

public health, and they are specifically

exempted through the regulatory

process. Under 21 CFR 807.85,

‘‘Exemption from premarket

notification,’’ a device is exempt from

premarket notification if the device

intended for introduction into

commercial distribution is not generally

available in finished form for purchase

and is not offered through labeling or

advertising by the manufacturer,

importer, or distributor for commercial

distribution. In addition, the device

must meet one of the following

conditions: (1) It is intended for use by

a patient named in order of the

physician or dentist (or other specially

qualified persons), or (2) it is intended

solely for use by a physician or dentist

and is not generally available to other

physicians or dentists.

A commercial distributor who places

a device into commercial distribution

for the first time under their own name

and a repackager who places their own

name on a device and does not change

any other labeling or otherwise affect

the device, shall be exempted from

premarket notification if the device was

legally in commercial distribution

before May 28, 1976, or a premarket

notification was submitted by another

person.

The information collected in a

premarket notification is used by the

medical, scientific, and engineering

staffs of FDA in making determinations

as to whether or not devices can be

allowed to enter the U.S. market. The

premarket notification review process

allows for scientific and/or medical

review of devices, subject to section

510(k) of the act, to confirm that the

new devices are as safe and as effective

as legally marketed predicate devices.

This review process, therefore, prevents

potentially unsafe and/or ineffective

devices, including those with fraudulent

claims, from entering the U.S. market.

This information will allow FDA to

collect data to ensure that the use of the

device will not present an unreasonable

risk for the subject and will not violate

the subject’s rights. The respondents to

this information collection will

primarily be medical device

manufacturers and businesses.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—Estimated Annual Reporting Burden1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

807.81 and 807.87 5,000 1 5,000 80 400,000

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Response Total Hours

807.93 2,000 10 20,000 0.5 10,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 / Notices 30765

FDA has based these estimates on

conversations with industry and trade

association representatives, and from

internal review of the documents listed

in Tables 1 and 2 of this document.

Based on the trend in the past 3 years,

an estimated 5,000 submissions are

expected each year. FDA’s

administrative and technical staff, who

are familiar with the requirements for

submission of premarket notifications,

estimate that an average of 80 hours are

required to prepare a submission

(exclusive of preparing clinical data,

research, etc.). FDA, therefore, estimates

that a total of 400,000 hours of effort is

required for the 5,000 submissions. It is

also estimated that the respondents will

receive requests for an average of 20,000

documents. At an estimated one-half

hour to process these documents, an

additional 10,000 recordkeeping hours

are expected for this program.

Dated: May 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14917 Filed 6–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0182]

KV Pharmaceutical Co.; Withdrawal of

Approval of Two Abbreviated New

Drug Applications and One

Abbreviated Antibiotic Application

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of two abbreviated new drug

applications (ANDA’s) and one

abbreviated antibiotic drug application

(AADA) held by KV Pharmaceutical Co.

(KV), 2503 South Hanley Rd., St. Louis,

MO 63144. This action is being taken

because the applications contain untrue

statements of material fact, and the

drugs covered by these applications lack

substantial evidence of effectiveness.

EFFECTIVE DATE: June 5, 1998.

FOR FURTHER INFORMATION CONTACT:

David T. Read, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 26, 1995 (60 FR

32982), FDA published a notice offering

an opportunity for a hearing (NOOH) on

a proposal to withdraw approval of the

following abbreviated applications:

AADA 62–047, Erythromycin

Ethylsuccinate Oral Suspension, 200

and 400 milligrams (mg);

ANDA 71–929, Disopyramide

Phosphate Extended Release Capsules,

100 mg; and

ANDA 86–538, Nitroglycerin

Extended Release Capsules, 2.5 mg.

The grounds for the proposed

withdrawals were: (1) That the

applications contained untrue

statements of material fact, and (2) that

based upon new information evaluated

together with the evidence available

when the applications were approved,

there is a lack of substantial evidence

that the drugs will have the effect they

purport or are represented to have under

the conditions of use prescribed,

recommended, or suggested in their

labeling.

On July 26, 1995, KV requested a

hearing. Subsequently, in a letter dated

August 25, 1995, KV withdrew its

request for a hearing and requested

withdrawal of these applications

because the products are no longer

being marketed. (AADA 62–047 was

inadvertently included in a previous

Federal Register notice (61 FR 13506,

March 27, 1996) that withdrew a large

number of applications based on the

request of the applicants.)

Based on the information presented in

the June 26, 1995, notice, the Director of

the Center for Drug Evaluation and

Research, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 355(e)) and under

authority delegated to her (21 CFR 5.82),

finds that the applications listed above

contain untrue statements of material

fact (21 U.S.C. 355(e)(5)); and that on

the basis of new information before her

with respect to the drugs, evaluated

together with the evidence available to

her when the applications were

approved, there is a lack of substantial

evidence that the drugs will have the

effects they purport or are represented

to have under the conditions of use

prescribed, recommended, or suggested

in their labeling (21 U.S.C. 355(e)(3)).

Therefore, approval of the

applications listed above, and all their

amendments and supplements, is

hereby withdrawn, effective June 5,

1998. Distribution of these products in

interstate commerce without an

approved application is illegal and

subject to regulatory action.

Section 505(j)(7)(C) of the act requires

that FDA immediately remove from its

approved product list (‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluation’’) (‘‘the list’’) any drug whose

approval was withdrawn for grounds

described in the first sentence of section

505(e) of the act. Such grounds apply to

this withdrawal. Notice is hereby given

that the drugs covered by these

applications are removed from the list.

Dated: May 28, 1998.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 98–14914 Filed 6–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Food Advisory Committee;

Amendment of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

amendment to the notice of meeting of

the Food Advisory Committee. This

meeting was announced in the Federal

Register of May 12, 1998 (63 FR 26194).

The amendment is being made to reflect

a change in the Procedure portion of the

meeting notice. The organization and

time of the oral presentations have been

changed. All oral presentations will be

made on June 16, 1998. There are no

other changes.

FOR FURTHER INFORMATION CONTACT:

Lynn A. Larsen, Center for Food Safety

and Applied Nutrition (HFS–5), 202–

205–4727, or Catherine M. DeRoever

(HFS–22), 202–205–4251, FAX 202–

205–4970, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 10564.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 12, 1998 (63 FR

26194), FDA announced that oral

presentations from the public during the

Food Advisory Committee meeting

would be scheduled in three sessions

over 2 days. However, all oral

presentations have been combined into

one session. On page 26195, in the first

column, the Procedure portion of this

meeting notice is amended to read as

follows:

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by June 5, 1998. All oral

presentations are scheduled in a