34684 Federal Register / Vol. 66, No. 126 / Friday, June 29, 2001 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0114]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Patent

Term Restoration, Due Diligence

Petitions, Filing, Format, and Content

of Petitions

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 July 30,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

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

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In

compliance with section 44 U.S.C. 3507,

FDA has submitted the following

proposed collection of information to

OMB for review and clearance.

Patent Term Restoration, Due Diligence

Petitions, Filing, Format, and Content of

Petitions—Part 60 (21 CFR Part 60)

(OMB Control Number 0910–0233)—

Extension

FDA’s patent extension activities are

conducted under the authority of the

Drug Price Competition and Patent

Term Restoration Act of 1984 and the

Animal Drug and Patent Term

Restoration Act of 1988 (35 U.S.C. 156).

New human drug, animal drug, human

biological, medical device, food

additive, or color additive products

regulated by FDA must undergo FDA

safety, or safety and effectiveness

review, before marketing is permitted.

Where the product is covered by a

patent, part of the patent’s term may be

consumed during this review, which

diminishes the value of the patent. In

enacting 35 U.S.C. 156, Congress sought

to encourage development of new, safer,

and more effective medical and food

additive products. It did so by

authorizing the U.S. Patent and

Trademark Office (PTO) to extend the

patent term by a portion of the time

during which FDA’s safety and

effectiveness review prevented

marketing of the product. The length of

the patent term extension is generally

limited to a maximum of 5 years, and

is calculated by PTO based on a

statutory formula. When a patent holder

submits an application for patent term

extension to PTO, PTO requests

information from FDA, including the

length of the regulatory review period

for the patented product. If PTO

concludes that the product is eligible for

patent term extension, FDA publishes a

notice that describes the length of the

regulatory review period, and the dates

used to calculate that period. Interested

parties may request, under § 60.24,

revision of the length of the regulatory

review period, or may petition, under

§ 60.30, to reduce the regulatory review

period by any time where marketing

approval was not pursued with ‘‘due

diligence.’’ The statute defines due

diligence as ‘‘that degree of attention,

continuous directed effort, and

timeliness as may reasonably be

expected from, and are ordinarily

exercised by, a person during a

regulatory review period.’’ As provided

in § 60.30(c), a due diligence petition

‘‘shall set forth sufficient facts,

including dates if possible, to merit an

investigation by FDA of whether the

applicant acted with due diligence.’’

Upon receipt of a due diligence petition,

FDA reviews the petition and evaluates

whether any change in the regulatory

review period is necessary. If so, the

corrected regulatory review period is

published in the Federal Register. A

due diligence petitioner not satisfied

with FDA’s decision regarding the

petition may, under § 60.40, request an

informal hearing for reconsideration of

the due diligence determination.

Petitioners are likely to include persons

or organizations having knowledge that

FDA’s marketing permission for that

product was not actively pursued

throughout the regulatory review

period. The information collection for

which an extension of approval is being

sought is the use of the statutorily

created due diligence petition.

Since 1992, five requests for revision

of the regulatory review period have

been submitted under § 60.24. One

regulatory review period has been

altered. No due diligence petitions have

been submitted to FDA, under § 60.30,

and consequently there have been no

requests for hearings, under § 60.40,

regarding the decisions on such

petitions.

In the Federal Register of March 23,

2001 (66 FR 16249), the agency

requested comments on the proposed

collection of information. There were no

comments received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

No. of Responses

per Respondent

Total Annual

Responses

Hours per

Response Total Hours

60.24(a) .......................................................... 1 1 1 100 100

60.30 .............................................................. 0 0 0 0 0

60.40 .............................................................. 0 0 0 0 0

Total ............................................................... 100

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

Federal Register / Vol. 66, No. 126 / Friday, June 29, 2001 / Notices 34685

Dated: June 25, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–16323 Filed 6–28–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0153]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Voluntary

Registration of Cosmetic Product

Establishments

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 July 30,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

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

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Voluntary Registration of Cosmetic

Product Establishments—21 CFR Part

710 (OMB Control Number 0910–

0027)—Extension

Under the Federal Food, Drug, and

Cosmetic Act (the act), cosmetic

products that are adulterated under

section 601 of the act (21 U.S.C. 361) or

misbranded under section 602 of the act

(21 U.S.C. 362) may not be distributed

in interstate commerce. To assist FDA in

carrying out its responsibility to regulate

cosmetics, FDA requests that

establishments that manufacture or

package cosmetic products register with

the agency on Form FDA 2511 entitled

‘‘Registration of Cosmetic Product

Establishment.’’ Regulations providing

procedures for the voluntary registration

of cosmetic product establishments are

found in 21 CFR part 710.

Since mandatory registration of

cosmetic establishments is not

authorized by statute, voluntary

registration provides FDA with the best

information available about the location,

business trade names used, and the type

of activity (manufacturing or packaging)

of cosmetic product establishments that

participate in this program. In addition,

the registration information is an

essential part of planning onsite

inspections to determine the scope and

extent of noncompliance with

applicable provisions of the act. The

registration information is used to

estimate the size of the cosmetic

industry regulated. Registration is

permanent, although FDA requests that

firms submit an amended registration on

Form FDA 2511 if any of the

information originally submitted

changes.

FDA uses registration information as

input for a computer data base of

cosmetic product establishments. This

database is used for mailing lists to

distribute regulatory information or to

invite firms to participate in workshops

on topics in which they may be

interested.

In the Federal Register of April 13,

2001 (66 FR 19175), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Part Form No. of Respondents Annual Frequency

per Response

Total Annual Responses Hours per Response Total Hours

710 FDA 2511 50 1 50 0.4 20

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

The burden estimates are based on

past experience and on discussions with

registrants during routine

communications. FDA receives an

average of 50 registration submissions

annually. There has been no change

over the past 16 years in the number of

submissions of Form FDA 2511 or in the

time it takes to complete this form.

Dated: June 22, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–16324 Filed 6–28–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0154]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Color

Additive Certification Requests and

Recordkeeping

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 July 30,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

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

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA