30732 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 / Notices

with which a company deals—

companies using highly sensitive

information may be held to a higher

standard of verification. Because

verification may be costly for business,

work needs to be done to arrive at

appropriate, cost-effective ways to

provide companies with the means to

provide verification.

3. Consequences. For self-regulation

to be effective, failure to comply with

fair information practices should have

consequences. Examples of such

consequences include cancellation of

the right to use a certifying seal or logo,

posting the name of the non-complier

on a ‘‘bad-actor’’ list, or disqualification

from membership in an industry trade

association. Non-compliers could be

required to pay the costs of determining

their non-compliance. Ultimately,

sanctions should be stiff enough to be

meaningful and swift enough to assure

consumers that their concerns are

addressed in a timely fashion. When

companies make assertions that they are

abiding by certain privacy practices and

then fail to do so, they may be liable for

deceptive practices and subject to action

by the Federal Trade Commission or

appropriate bank or financial regulatory

authority.

Shirl Kinney,

Deputy Assistant Secretary and

Administrator.

[FR Doc. 98–15063 Filed 6–4–98; 8:45 am]

BILLING CODE 3510–60–P

DEPARTMENT OF COMMERCE

Patent and Trademark Office

Patent Term Extension

ACTION: Proposed collection; comment

request.

SUMMARY: The Department of Commerce

(DOC), as part of its continuing effort to

reduce paperwork and respondent

burden, invites the general public and

other Federal agencies to comment on

the continuing information collection,

as required by the Paperwork Reduction

Act of 1995, Public Law 104–13 (44

U.S.C. 3506(c)(2)(A)), and by the Patent

and Trademark Office (Office) in the

performance of its statutory functions of

processing applications for patent term

extension as required by the HatchWaxman Act, 35 U.S.C. 156.

DATES: Written comments must be

submitted on or before August 4, 1998.

ADDRESSES: Direct all written comments

to Linda Engelmeier, Departmental

Forms Clearance Officer, Department of

Commerce, Room 5327, 14th and

Constitution Avenue, NW, Washington,

DC 20230.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information

should be directed to the attention of

Karin L. Tyson, at the Special Program

Law Office, Office of the Deputy

Assistant Commissioner for Patent

Policy and Projects, Washington DC

20231, by telephone at (703) 305–9285

or by facsimile transmission to (703)

308–6916.

SUPPLEMENTARY INFORMATION:

I. Abstract

The Patent and Trademark Office

(Office), together with the Secretary of

Health and Human Services and the

Department of Agriculture administers

the Hatch-Waxman Act, e.g. 35 U.S.C.

156. This Act permits the Office to

restore the patent term lost due to

certain types of regulatory review by the

Food and Drug Administration or the

Department of Agriculture. Only patents

for drug products, medical devices, food

additives, and color additives are

eligible for extension. The maximum

length that a patent may be extended

(the maximum of patent term that may

be restored) is five years.

The Hatch-Waxman Act requires that

an application for patent term extension

be filed with the Office within 60 days

of a product (approved product) that

was subject to regulatory review

receiving permission for commercial

marketing or use from the Food and

Drug Administration or the Department

of Agriculture. Under 35 U.S.C.

156(d)(1), an application for patent term

extension must identify the approved

product, the patent to be extended, and

the claims of the patent that claim the

approved product, a method of use of

the approved product, or a method of

manufacturing the approved product. It

must also set forth sufficient

information for the Commissioner of the

Patent and Trademark Office to

determine the eligibility of the patent

for extension and to enable the

Commissioner and the Secretary of

Health and Human Services or the

Department of Agriculture to determine

the length of extension. In addition, the

application for patent term extension

must provide a brief description of the

activities undertaken by the applicant

during the regulatory review period

with respect to the approved product

and the significant dates of these

activities. If the information supplied is

not sufficient for the Commissioner to

determine the eligibility of the patent

for extension, the rights that will be

derived from the extension, or the

period of extension, the Commissioner

may regard the application as informal

and the applicant may provide a

response, addressing any deficiencies.

In addition, the Commissioner may

require additional information; for

example, to identify the holder of the

regulatory approval or to elect a single

patent for extension. An applicant may

file a written declaration of withdrawal

of an application for patent term

extension. If a patent is finally

determined not to be eligible for patent

term extension, an applicant for patent

term extension may request

reconsideration of this decision.

Under 35 U.S.C. 156(d)(5), an interim

extension for a patent may be granted if

the regulatory review of a product is in

the approval phase (i.e., the regulatory

review period referenced in 35 U.S.C.

156(d)(5)(A) has begun), but the

approval phase is expected to extend

beyond the original expiration date of

the patent. An application for interim

extension is required to be filed in the

period beginning six months and ending

fifteen days before the term of the patent

is set to expire. An application for

interim extension must identify the

product subject to regulatory review, the

Federal Statute which requires its

review, the patent for which interim

extension is sought, including each

claim of the patent which claims the

product under regulatory review or a

method of using or manufacturing the

product, and information to enable the

Commissioner to determine eligibility

for extension under 35 U.S.C. 156(a)(1),

(a)(2) and (a)(3). In addition, an

application for interim extension must

provide a brief description of the

activities undertaken by the applicant

during the applicable regulatory review

period to date and the significant dates

applicable to such activities. If the

information supplied is not sufficient

for the Commissioner to determine the

eligibility of the patent for interim

extension or the rights that will be

derived from the interim extension, the

Commissioner may regard the

application as informal and the

applicant may provide a response,

addressing any deficiencies. In addition,

the Commissioner may require

additional information.

Under 35 U.S.C. 156(e)(2), an interim

extension may be granted if the term of

a patent for which an application for

patent term extension has been

submitted under 35 U.S.C. 156(d)(1),

and which is eligible for extension,

would expire before a certificate of

extension is issued.
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 / Notices 30733

II. Method of Collection

By mail, facsimile transmission, or

hand carried to the Patent and

Trademark Office.

III. Data

OMB Number: 0651–0020.

Type of Review: Renewal with change.

Affected Public: Individuals or

households, businesses or other forprofit, not-for-profit institutions, farms,

state, local or tribal governments, and

the Federal Government.

Estimated Number of Respondents:

57.

Estimated Time Per Response: It is

estimated to take the public 20 to 25

hours to complete an application for

patent term extension under 35 U.S.C.

156(d)(1), an application for interim

patent term extension under 35 U.S.C.

156(d)(5), or to petition for review of a

final eligibility decision. In addition, it

is estimated to take the public 1 to 2

hours to file a request for an interim

extension under 35 U.S.C. 156(e)(2), to

respond to a requirement for additional

information, and to file a written

declaration of withdrawal. There are no

forms associated with this information

collection.

Estimated Total Annual Respondent

Burden Hours: 1,302 hours per year.

Estimated Total Annual Respondent

Cost Burden: $227,850 per year.

Title of form Form Nos.

Estimated time

for response

(hours)

Estimated annual burden

hours

Estimated annual responses

Application to Extend Patent Term under 35 U.S.C.

156(d)(1).

No Forms Associated ............. 25 1,250 50

Request for Interim Extension under 35 U.S.C. 156(e)(2) ..... No Forms Associated ............. 1 1 1

Petition to Review Final Eligibility Decision ............................ No Forms Associated ............. 25 25 1

Application for Interim Extension under 35 U.S.C. 156(d)(5) No Forms Associated ............. 20 20 1

Response to Requirement to Elect ......................................... No Forms Associated ............. 1 2 2

Response to Request to Identify Holder of Regulatory Approval.No Forms Associated ............. 2 2 1

Declaration to Withdraw an Application To Extend Patent

Term.

No Forms Associated ............. 2 2 1

Totals ................................................................................ ................................................. ........................ 1,302 57

IV. Request for Comments

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden

(including hours and cost) of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Comments submitted in response to

this notice will be summarized or

included in the request for OMB

approval of this information collection;

they will also become a matter of public

record.

Dated: June 1, 1998.

Linda Engelmeier,

Departmental Forms Clearance Officer, Office

of Management and Organization.

[FR Doc. 98–14946 Filed 6–4–98; 8:45 am]

BILLING CODE 3510–16–P

COMMITTEE FOR THE

IMPLEMENTATION OF TEXTILE

AGREEMENTS

Adjustment of Import Limits for Certain

Cotton and Man-Made Fiber Textile

Products Produced or Manufactured in

Pakistan

June 1, 1998.

AGENCY: Committee for the

Implementation of Textile Agreements

(CITA).

ACTION: Issuing a directive to the

Commissioner of Customs increasing

limits.

EFFECTIVE DATE: June 8, 1998.

FOR FURTHER INFORMATION CONTACT: Ross

Arnold, International Trade Specialist,

Office of Textiles and Apparel, U.S.

Department of Commerce, (202) 482–

4212. For information on the quota

status of these limits, refer to the Quota

Status Reports posted on the bulletin

boards of of each Customs port or call

(202) 927–5850. For information on

embargoes and quota re-openings, call

(202) 482–3715.

SUPPLEMENTARY INFORMATION:

Authority: Section 204 of the Agricultural

Act of 1956, as amended (7 U.S.C. 1854);

Executive Order 11651 of March 3, 1972, as

amended.

The current limits for certain

categories are being increased for

carryover.

A description of the textile and

apparel categories in terms of HTS

numbers is available in the

CORRELATION: Textile and Apparel

Categories with the Harmonized Tariff

Schedule of the United States (see

Federal Register notice 62 FR 66057,

published on December 17, 1997). Also

see 62 FR 63524, published on

December 1, 1997.

Troy H. Cribb,

Chairman, Committee for the Implementation

of Textile Agreements.

Committee for the Implementation of Textile

Agreements

June 1, 1998.

Commissioner of Customs,

Department of the Treasury, Washington, DC

20229.

Dear Commissioner: This directive

amends, but does not cancel, the directive

issued to you on November 25, 1997, by the

Chairman, Committee for the Implementation

of Textile Agreements. That directive

concerns imports of certain cotton and manmade fiber textile products, produced or

manufactured in Pakistan and exported

during the twelve-month period which began

on January 1, 1998 and extends through

December 31, 1998.

Effective on June 8, 1998, you are directed

to increase the limits for the following

categories, as provided for under the Uruguay

Round Agreement on Textiles and Clothing:

Category Adjusted limit 1

237 ........................... 442,316 dozen.

239pt. 2 ..................... 1,910,245 kilograms.

335/635 .................... 373,963 dozen.

336/636 .................... 486,778 dozen.

341/641 .................... 796,170 dozen

342/642 .................... 394,062 dozen.