Federal Register / Vol. 62, No. 49 / Thursday, March 13, 1997 / Notices 11899

Dated: March 5, 1997

William K. Hubbard,

Associate Commissioner for Policy

Coordination

[FR Doc. 97–6356 Filed 3–12–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0192]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

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.

DATES: Submit written comments on the

collection of information by April 14,

1997.

ADDRESSES: Submit written comments

on the collection of information to

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Linda L. Brna, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–3158.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3507), FDA has submitted the

following proposed collection of

information to OMB for review and

clearance:

Application to Market a New Drug,

Biologic, or an Antibiotic Drug for

Human Use; Use of Form FDA 356h

FDA is the Federal agency charged

with the responsibility for determining

that drugs, including antibiotic drugs,

and biologics are safe and effective.

Manufacturers of a drug, biologic, or an

antibiotic drug for human use must file

applications for FDA approval of the

product prior to introducing it into

interstate commerce. Statutory authority

for the collection of this information is

provided by sections 505(a), (b), and (j)

and 507 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 355(a),

(b), and (j) and 357) and section 351 of

the Public Health Service Act (PHS Act)

(42 U.S.C. 262). All manufacturers of

new drugs and antibiotics for human

use regulated under the act must submit

an application for review and approval

to the Center for Drug Evaluation and

Research (CDER) or the Center for

Biologics Evaluation and Research

(CBER) prior to marketing a drug or

antibiotic in interstate commerce (21

CFR 314.50). All manufacturers of

generic drugs, including generic

antibiotic drugs for human use,

regulated under the act must submit an

abbreviated new drug application

(ANDA) to CDER or CBER or an

abbreviated antibiotic drug application

(AADA) to CDER for review and

approval prior to marketing a generic

drug in interstate commerce (21 CFR

314.94). Most manufacturers of

biological products regulated under the

PHS Act must submit an establishment

license application and a product

license application or a biologics license

application for review and approval to

CBER prior to marketing a biological

product in interstate commerce (21 CFR

601.2). 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.

Manufacturers of a drug, biologic, or an

antibiotic drug for human use are

required to file supplemental

applications for all important changes to

applications previously approved prior

to implementing such changes (21 CFR

314.70, 314.71, 314.97, and 601.12).

Form FDA 356h has been revised for

CDER-regulated products to include

identification of different types of

supplemental applications. It has also

been modified to include a section for

establishment information pertaining to

CBER-regulated products and the CBER

licensing process.

The information provided by

manufacturers with the revised

application form is necessary for FDA to

carry out its mission of protecting the

public health and helping to ensure that

drugs, biologics, and antibiotics for

human use have been shown to be safe

and effective. Form FDA 356h was

developed initially as a checklist to

assist manufacturers in filing a drug

application and has been previously

used only by manufacturers of products

regulated under the act. The revised

form has been harmonized for use by

manufacturers of products regulated

under the act or under the PHS Act and

will be used by industry regulated by

both CDER and CBER. The harmonized

application form serves primarily as a

checklist for firms to gather and submit

to the agency studies and data that have

been completed. The checklist helps to

ensure that the application is complete

and contains all the necessary

information, so that delays due to lack

of information may be eliminated. The

form will also provide key information

to the agency for efficient handling and

distribution to the appropriate staff for

review. The revised form will replace a

number of different application forms

that are now used for these products

and is intended to help harmonize the

application process.

In the Federal Register of October 1,

1996 (61 FR 51285), the agency

requested comments on the proposed

collection of information using the

harmonized application form. FDA

received five responses to the docket, all

of which were generally supportive of

the harmonized application form. One

comment expressed concern that the

requirement to select a single

supplement type on the form would

result in an increased reporting burden.

The comment indicated that selection of

a single supplement type would require

the filing of multiple supplements in

order to respond to an agency

information request letter containing

several diverse issues. The comment

may have misunderstood the distinction

between a supplement to an approved

application and an amendment to a

pending application. A response to an

agency information request letter is an

amendment to a pending application, no

matter how many individual subjects

are addressed. This is clarified in the

instruction sheet for the form.

There were also a number of editorial

comments on the form itself. Some of

these have resulted in minor

modifications to the form. Other

editorial comments and requests for

clarification are addressed in the

instructions for use of the form.

FDA estimates the burden of this

collection of information as follows:
11900 Federal Register / Vol. 62, No. 49 / Thursday, March 13, 1997 / Notices

Estimated Annual Reporting Burden

Type of Response1 No. of

Respondents2

Annual

Frequency per

Response3

Total Annual

Responses4

Hours per

Response Total Hours

NDA5 162 22.9 3,715 40 148,600

ANDA6 and AADA7 350 18.6 6,517 40 260,680

ELA8 and PLA9 391 4.9 1,905 40 76,200

Total Burden Hours 485,480

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

1 Includes original applications and their amendments and supplemental applications

2 Number of sponsors submitting applications during fiscal year (FY) 95

3Average number of applications submitted per sponsor

4Total applications submitted during FY 95

5 New Drug Application (includes applications for new antibiotic drugs)

6Abbreviated New Drug Application

7Abbreviated Antibiotic Drug Application

8Establishment License Application

9Product License Application

In FY 95, CDER received a total of

10,232 submissions and CBER received

1,905 submissions that would require

use of this application form. FDA

estimates that 40 hours would be

needed for an industry regulatory affairs

specialist to fill out the harmonized

form, collate the documentation, and

submit the application to CDER or

CBER.

Dated: March 6, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6360 Filed 3–12–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 84N–0102]

Cumulative List of Orphan Drug and

Biological Designations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a cumulative list of

designated orphan drugs and biologics

as of December 31, 1996. FDA has

announced the availability of previous

lists, which are brought up-to-date

monthly, identifying the drugs and

biologicals granted orphan-drug

designation under the Federal Food,

Drug, and Cosmetic Act (the act).

ADDRESSES: Copies of the list of current

orphan-drug designations and of any

future lists are or will be available from

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, and the Office of

Orphan Products Development (HF–35),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3666.

FOR FURTHER INFORMATION CONTACT:

Peter L. Vaccari, Office of Orphan

Products Development (HF–35), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

0983.

SUPPLEMENTARY INFORMATION: FDA’s

Office of Orphan Products Development

(OPD) reviews and takes final action on

applications submitted by sponsors

seeking orphan-drug designation under

section 526 of the act (21 U.S.C. 360bb).

In accordance with this section of the

act, which requires public notification

of designations, FDA maintains a list of

designated orphan drugs and

biologicals. This list is made current on

a monthly basis and is available upon

request from OPD (contact identified

above). At the end of each calendar year,

the agency publishes an up-to-date

cumulative list of designated orphan

drugs and biologicals, including the

names of designated compounds, the

specific disease or condition for which

the compounds are designated, and the

sponsors’ names and addresses.

The list that is the subject of this

notice consists of designated orphan

drugs and biologicals through December

31, 1996, and, therefore, brings the April

22, 1996 (61 FR 17708) publication up

to date. This list is available on request

from FDA’s Dockets Management

Branch (address above). Those

requesting a copy should specify the

docket number found in brackets in the

heading of this document.

The orphan-drug designation of a

drug or biological applies only to the

sponsor who requested the designation.

Each sponsor interested in developing

an orphan drug or biological must apply

for orphan-drug designation in order to

obtain exclusive marketing rights. Any

request for designation must be received

by FDA before the submission of a

marketing application for the proposed

indication for which designation is

requested. (See 53 FR 47577, November

23, 1988.) Copies of the regulations (see

57 FR 62076, December 29, 1992) for

use in preparing an application for

orphan-drug designation may be

obtained from OPD (address above).

The names used in the cumulative list

for the drug and biological products that

have not been approved or licensed for

marketing may not be the established or

proper names approved by FDA for

these products if they are eventually

approved or licensed for marketing.

Because these products are

investigational, some may not have been

reviewed for purposes of assigning the

most appropriate established proper

name.

Dated: March 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6357 Filed 3–12–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0283]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information

regarding Regulations under the Federal

Import Milk Act, has been approved by

the Office of Management and Budget

(OMB), under the Paperwork Reduction