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