Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices 27147

Dated: May 9, 2001.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention.

[FR Doc. 01–12373 Filed 5–15–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. ACYF/HS

2001–07A]

Fiscal Year 2000 Discretionary

Announcement for Head Start Family

Worker Training and Credentialing

Initiative; Availability of Funds and

Request for Applications

AGENCY: Administration for Children,

Youth, and Families, ACF, DHHS.

ACTION: Notice; Correction.

SUMMARY: This document contains a

correction to the Notice that was

published in the Federal Register on

Thursday, May 3, 2001, Part II. On page

22294, first column (Item D), the August

1, 2001 closing date for the submission

of applications is incorrect. The correct

closing time and date for receipt of

applications is 5 p.m. EDT on July 2,

2001.

FOR FURTHER INFORMATION CONTACT: The

ACYF Operation Center at 1–800–351–

2293 for referral to the appropriate

contact person in ACYF for

programmatic questions or send an email to hs@icgnet.com

Dated: May 10, 2001.

James A. Harrell,

Acting Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 01–12283 Filed 5–15–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0050]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Premarket

Approval of Medical Devices

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 June 15,

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:

I. Background

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

FDA has submitted the following

proposed collection of information to

OMB for review and clearance.

Premarket Approval of Medical

Devices—21 CFR Part 814 (OMB

Control No. 0910–0231)—Extension

Section 515 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360(e)) sets forth the requirements for

premarket approval of certain class III

medical devices. Class III devices are

either preamendments devices that have

been classified into class III,

postamendments devices that are not

substantially equivalent to a

preamendments device, or transitional

devices. Class III devices are devices

such as implants, life sustaining or life

supporting devices, or devices which

otherwise present a potentially

unreasonable risk of illness or injury, or

for which are of substantial importance

in preventing impairment of human

health. Most premarket approval

applications (PMAs) are for

postamendments class III devices.

Under section 515 of the act, an

application must contain several pieces

of information including full reports of

all information concerning

investigations showing whether the

device is reasonably safe and effective.

The application should also include a

statement of components, ingredients,

and properties and of the principle or

principles of operation of such a device

and should also include a full

description of the methods used in, and

the facilities and controls used for the

manufacture and processing of the

device; and labeling specimens.

The implementing regulations,

contained in part 814 (21 CFR part 814),

further specify the contents of a PMA

for a class III medical device and the

criteria FDA employs in approving,

denying, or withdrawing approval of a

PMA and supplements to PMAs. The

regulation’s purpose is to establish an

efficient and thorough procedure for

FDA’s review of PMAs and supplements

to PMAs for certain class III (premarket

approval) medical devices. The

regulations contained in part 814

facilitate the approval of PMAs and

supplements to PMAs for devices that

have been shown to be reasonably safe

and effective and otherwise meet the

statutory criteria for approval. The

regulations also ensure the disapproval

of PMAs and supplements to PMAs for

devices that have not been shown to be

reasonably safe and effective and that do

not otherwise meet the statutory criteria

for approval.

The Food and Drug Modernization

Act of 1997 (FDAMA) (Public Law 105–

115) was enacted on November 21,

1997, to implement revisions to the act

by streamlining the process of bringing

safe and effective drugs, medical

devices, and other therapies to the U.S.

market. Several provisions of this act

affect the PMA process, such as section

515(d)(6) of the act. This section

provided that PMA supplements were

required for all device changes that

affect safety and effectiveness of a

device unless such changes are

modifications to manufacturing

procedures or method of manufacture.

This type of manufacturing change

requires a 30-day notice, or where FDA

finds such notice inadequate, a 135-day

PMA supplement.

To make the PMA process more

efficient, FDA has in the past 3 years

made changes to the PMA program

based on comments received, has

complied with changes to the program

mandated by FDAMA and has worked

towards completion of its PMA

reinvention efforts.

Respondents to this information

collection are persons filing a PMA

application or a PMA supplement with

FDA for approval of certain class III

medical devices. Part 814 defines a

person as any individual, partnership,

corporation, association, scientific or

academic establishment, government

agency or organizational unit, or other

legal entity. These respondents include

entities meeting the definition of

manufacturers such as manufacturers of

commercial medical devices in

distribution prior to May 28, 1976 (the

enactment date of the Medical Device

Amendments). Additionally, hospitals

that reuse single use devices (SUDs) are

27148 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices

also included in the definition of

manufacturers. For the next 3 years, it

is expected that FDA will receive four

PMA applications from hospitals that

remanufacture SUDs. This figure has

been included in table 1 of this

document as part of the reporting

burden in § 814.15.

In the Federal Register of February 8,

2001 (66 FR 9582), the agency requested

comments on the proposed collection of

information. No comments were

received.

The total estimated reporting and

recordkeeping burden for this

information collection is 107,321 hours.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section No. of respondents Annual rrequency per

response

Total annual responses Hours per response Total hours

814.15, 814.20, and 814.37 62 1 62 837 51,894

814.39(f) 487 1 487 66 32,142

814.82 43 1 43 66 5,805

814.84 43 1 43 10 430

Section 201 (FDAMA) 10 1 10 10 100

Section 202 (FDAMA) 15 1 15 10 150

Section 205 (FDAMA) 8 1 8 50 400

Section 208 (FDAMA) 26 1 26 30 780

Section 209 (FDAMA) 8 1 8 40 320

Total 92,021

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 recordkeeper Total hours

814.82(a)(5) and (a)(6) 900 1 900 17 15,300

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

The industry-wide burden estimate

for PMAs is based on an FDA actual

average fiscal year annual rate of receipt

of 62 PMA original applications and 487

PMA supplements, using fiscal year

1996 through 2000 data.

The burden data for PMAs is based on

data provided by manufacturers by

device type and cost element in an

earlier study. The specific burden

elements for which FDA has data are as

follows: (1) Clinical investigations: 67

percent of total burden estimate; (2)

submission of additional data or

information to FDA during a PMA

review: 12 percent; (3) additional device

development cost (e.g., testing): 10

percent; and (4) PMA and PMA

supplement preparation and

submissions, and development of

manufacturing and controls data: 11

percent.

II. Paperwork Burden Estimate

The burden estimates were derived by

consultation with FDA and industry

personnel. FDA’s estimates are based on

actual data collected from industry over

the past 3 years. An evaluation of the

type and scope of information requested

was also used to derive some time

estimates. For example, disclosure

information primarily requires time

only to update and maintain existing

manuals.

A. Reporting/Disclosure

The reporting burden can be broken

out by certain sections of the PMA

regulation: (1) § 814.15 Research

conducted outside the United States; (2)

§ 814.20 Application; and (3) § 814.37

PMA amendments and resubmitted

PMA’s.

The majority of the burden—51,894

burden hours—is due to the above three

requirements. Included in these three

requirements are the conduct of

laboratory and clinical trials as well as

the analysis, review, and physical

preparation of the PMA application.

FDA estimates that 62 manufacturers

(including hospital remanufacturers of

single use devices) will be affected by

these requirements based on actual

average FDA receipt of new PMA

applications in years 1996 through

2000. FDA’s estimate of the hours per

response (837) was derived through

FDA’s experience and consultation with

industry and trade associations.

Included in these three requirements are

the conduct of laboratory and clinical

trails as well as the analysis, review,

and physical preparation of the PMA

application. In addition, FDA has based

its estimate on the results of an earlier

study that these requirements account

for the bulk of the burden identified by

manufacturers.

1. § 814.39(f)—PMA Supplements:

32,142 Burden Hours

FDA believes that the amendments

mandated by FDAMA for § 814.39(f),

permitting the submission of the 30-day

notices in lieu of regular PMA

supplements, will result in an

approximate 10 percent reduction in the

total number of hours as compared to

regular PMA supplements. As a result,

FDA estimates that 32,142 hours of

burden are needed to complete the

requirements for regular PMA

supplements.

2. § 814.82—Postapproval requirements:

5,805 Burden Hours

Postapproval requirements concern

approved PMAs that were not

reclassified and require a periodic

report. In the last decade (1991 to 2000),

the range of PMAs that fit this category

averaged approximately 43 per year (70

percent of the 62 periodic submissions).

Most approved PMAs have been subject

to some postapproval study

requirement. Approximately half of the

average submitted PMAs (31) require

associated postapproval studies (i.e.,

followup of patients used in clinical

trials to support the PMA or additional

preclinical information) that is laborintensive to compile and complete, and

the other PMAs require minimal

information. Based on its experience

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices 27149

and on consultation with industry, FDA

estimates that preparation of reports and

information required by this section

require 5,805 hours (135 hours per

respondent).

3. § 814.84—Reports: 430 Burden Hours

Postapproval requirements described

in § 814.82 (above) require a periodic

report. FDA has determined

respondents meeting the criteria of

§ 814.84 will submit reports on a

periodic basis. As stated previously, the

range of PMAs fitting this category

averaged approximately 43 per year.

These reports have minimal information

requirements. FDA estimates that

respondents will construct their report

and meet their requirements in

approximately 10 hours. This estimate

is based on FDA’s experience and on

consultation with industry. FDA

estimates that the periodic reporting

required by this section take 430 hours.

The total hours for statutory burden is

1,750. This burden estimate was based

on actual real FDA data tracked from

January 1, 1998, to the present, and an

estimate was derived to forecast future

expectations with regard to this

statutory data.

B. Recordkeeping

The recordkeeping burden in this

section involves the maintenance of

records used to trace patients and the

organization and indexing of records

into identifiable files to ensure the

device’s continued safety and

effectiveness. These records would be

required only of those manufacturers

who have an approved PMA and who

had original clinical research in support

of that PMA. For a typical year’s

submissions, 70 percent of the PMAs are

eventually approved and 75 percent of

those have original clinical trial data.

Therefore, approximately 43 PMAs a

year (62 annual submissions times 70

percent) would be subject to these

requirements. Also, because the

requirements apply to all active PMAs,

all holders of active PMA applications

must maintain these records. PMAs

have been required since 1976, and

there are 900 active PMAs that could be

subject to these requirements, based on

actual FDA data. Each study has

approximately 200 subjects, and, at an

average of 5 minutes per subject, there

is a total burden per study of 1,000

minutes, or 17 hours. The aggregate

burden for all 900 holders of approved

original PMAs, therefore, is 15,300

hours (900 approved PMAs with clinical

data x 17 hours per PMA).

The applicant determines which

records should be maintained during

product development to document and/

or substantiate the device’s safety and

effectiveness. Records required by the

current good manufacturing practices

for medical devices regulation (21 CFR

part 820) may be relevant to a PMA

review and may be submitted as part of

an application. In individual instances,

records may be required as conditions to

approval to ensure the device’s

continuing safety and effectiveness.

Dated: May 11, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12277 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E–1412]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Uvasorb HA88

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for Uvasorb

HA88 and is publishing this notice of

that determination as required by law.

FDA has made the determination

because of the submission of an

application to the Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

that claims that food additive.

ADDRESSES: Submit written comments

and petitions to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Regulatory Policy

Staff (HFD–007), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5645.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and

Patent Term Restoration Act (Public

Law 100–670) generally provide that a

patent may be extended for a period of

up to 5 years as long as the patented

item (human drug product, animal drug

product, medical device, food additive,

or color additive) was subject to

regulatory review by FDA before the

item was marketed. Under these acts, a

product’s regulatory review period

forms the basis for determining the

amount of extension an applicant may

receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For food additives,

the testing phase begins when a major

health or environmental effects test

involving the food additive begins and

runs until the approval phase begins.

The approval phase starts with the

initial submission of a petition

requesting the issuance of a regulation

for use of the food additive and

continues until FDA grants permission

to market the food additive product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted, as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a food additive will include all of the

testing phase and approval phase as

specified in 35 U.S.C. section

156(g)(2)(B).

FDA recently approved for marketing

the food additive Uvasorb HA88.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for Uvasorb

HA88 (U.S. Patent No. 4,477,615) from

3V Partecipazioni Industriali S.p.A., and

the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

August 4, 2000, FDA advised the Patent

and Trademark Office that this food

additive had undergone a regulatory

review period and that the approval of

Uvasorb HA88 represented the first

permitted commercial marketing or use

of the product. Subsequently, the Patent

and Trademark Office requested that

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

Uvasorb HA88 is 3,482 days. Of this

time, 684 days occurred during the

testing phase of the regulatory review

period, and 2,798 days occurred during

the approval phase. These periods of

time were derived from the following

dates:

1. The date a major health or

environmental effects test (test)

involving this food additive additive

product was begun: November 2, 1989.

FDA has verified the applicant’s claim

that the test was begun on November 2,

1989.

2. The date the petition requesting the

issuance of a regulation for use of the

additive (petition) was initially