Federal Register / Vol. 66, No. 122 / Monday, June 25, 2001 / Notices 33709

SUPPLEMENTARY INFORMATION:

Purpose and Background

The purpose of this announcement is

to add 23 additional ports to the list of

United States ports at which CDC will

conduct rodent infestation inspections

of ships, and issue Deratting and

Deratting Exemption Certificates. While

the United States does not require these

certificates for ships to enter its

seaports, CDC currently provides rodent

infestation inspections and issues

Deratting and Deratting Exemption

Certificates for ships at 11 major ports

upon request. These ports include:

Baltimore, MD; Honolulu, HI; Houston,

TX; Jacksonville, FL; Los Angeles, CA;

Miami, FL; New Orleans, LA; New York,

NY; San Francisco, CA; Savannah, GA;

and Seattle, WA. Article 17 of the

International Health Regulations,

published by the World Health

Organization, Geneva, Switzerland,

requires that each Health

Administration provide these services,

and Article 82 outlines the criteria for

charging fees. 42 CFR 71.46 authorizes

the performance of these services by

PHS as carried out by CDC. For many

years, CDC provided these services at no

cost to the owners or agents of ships

requesting them. Consistent with the

practice of most foreign countries and to

reduce the cost of the inspection

program, beginning on October 1, 1997,

CDC consolidated its inspection

activities to include only the ports listed

above [63 FR 17427]. Further, beginning

on June 6, 1999, CDC imposed user fees

for inspections conducted at the above

listed ports [64 FR 24658]. Now that the

cost of providing these services is being

passed along as a charge to those

receiving them, and in the interest of

facilitating the expeditious and

economical movement of ships between

the United States and countries that

require a Deratting or Deratting

Exemption Certificate for entry into

their ports, CDC published a Federal

Register notice on September 13, 2000

[65 FR 55253], soliciting requests to add

additional ports to the list at which

services will be provided.

Comments Received

A small number of comments were

received during the comment period.

Most of the comments included a

request that CDC return to the past

practice of conducting rodent

infestation inspections and issuing

deratting exemption certificates at

virtually all U.S. seaports and/or a list

of ports where inspection services

would be most beneficial to them.

Convenience and economy were cited as

reasons for the addition of ports. One

municipality cited a potential economic

benefit to the community if inspections

were available and additional traffic

attracted because of their availability.

None of the comments included the

estimated number of inspections for the

ports requested, and few provided an

estimate of cost savings to the shipping

industry. This supporting information

was requested in the Federal Register

notice.

Conclusion

In deciding where to expand these

services, CDC considered the

information submitted by respondents,

the estimated demand for services, and

the availability and suitability of

potential vendors.

Effective July 1, 2001, rodent

infestation inspections of ships will be

conducted, and Deratting and Deratting

Exemption Certificates issued at the

following U.S. seaports. Inspections will

be conducted upon request, subject to

the availability of a CDC-designated

inspector. A user fee of $150 will

continue to be applicable to all rodent

infestation inspections conducted by

CDC or its vendors.

Boston, MA

New York, NY/Northern NJ

Philadelphia, PA

Norfolk/Hampton Roads Area, VA

Charleston, SC

Savannah, GA

Brunswick, GA

Jacksonville, FL

Cape Canaveral, FL

Port Everglades, FL

Miami, FL

Tampa, FL

Panama City, FL

Pensacola, FL

Mobile, AL

Pascagoula/Gulfport, MS

New Orleans/Metarie, LA

Beaumont/Port Arthur/Orange, TX

Houston/Galveston/Texas City, TX

Corpus Christi, TX

Brownsville/Port Isabel, TX

Chicago, IL

Toledo, OH

Detroit, MI

Cleveland, OH

San Diego/Pt. Hueneme, CA

Los Angeles/Long Beach/El Segundo,

CA

San Francisco Bay Area, CA

Portland, OR

Seattle, WA

Tacoma, WA

Kalama, WA

Honolulu, HI

San Juan, PR

Dated: June 19, 2001.

Thena M. Durham,

Director, Executive Secretariat, Office of the

Director, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 01–15825 Filed 6–22–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: State Council on Developmental

Disabilities Program Performance

Report.

OMB No. 0980–0172.

Description: A Developmental

Disabilities Council Program

Performance Report is required by

federal statute. Each State

Developmental Disabilities Council

must submit an annual report for the

preceding fiscal year of activities and

accomplishments. Information provided

in the Program performance Report will

be used (1) in the preparation of the

Annual Report to the President, the

Congress, and the National Council on

Disabilities and (2) to provide a national

perspective on program

accomplishments and continuing

challenges.

Respondents: State, Local or Tribal

Government

Annual Burden Estimates:

Instrument Number of

respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

State Council on Developmental Disabilities Program Performance Report .. 55 1 44 2420

Estimate Total Annual Burden Hours:

2420.

In compliance with the requirements

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Administration for Children and

33710 Federal Register / Vol. 66, No. 122 / Monday, June 25, 2001 / Notices

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

370 L’Enfant Promenade, SW.,

Washington, DC 20447, Attn: ACF

Report Clearance Officer. All requests

should be identified by the title of the

information collection.

The Department specifically requests

comments 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 of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collection; and (3)

ways to minimize the burden of the

collection information on respondents,

including through the use of automated

collection techniques or other forms of

information technology. Consideration

will be given to comments and

suggestions within 60 days of this

publication.

Dated: June 19, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–15802 Filed 5–22–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0129]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Implementation of the Biomaterials

Access Assurance Act of 1998

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 25,

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.

Implementation of the Biomaterials

Access Assurance Act of 1998

The Biomaterials Access Assurance

Act of 1998 (BAA98) (21 U.S.C. 1601–

1606) establishes a mechanism to

protect biomaterial suppliers of

implanted medical devices from

liability in civil actions. BAA98

includes exceptions for when protection

from liability is not available to

suppliers. One of those exceptions is

when a supplier acts as a manufacturer

of the implanted device. BAA98 says

that a biomaterials supplier may be

considered a manufacturer of a medical

device if the supplier is the subject of

an FDA declaration that the supplier

was required to register under section

510 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360)

and failed to do so, or was required to

list its device under section 520(j) of the

act (21 U.S.C. 360(j)) and failed to do so.

BAA98 allows persons to petition

FDA for a declaration that a biomaterials

supplier should have registered its

establishment or listed its device with

FDA, and failed to do so. Petitioners are

requested to include information about

the prerequisites for filing a petition.

This information includes the following:

(1) A civil suit has been filed in State

or Federal court alleging that an implant

directly or indirectly caused harm; (2)

the suit was filed after August 13, 1998;

and (3) the manufacturer of the implant

was named as a party to the civil action.

Petitioners are also requested to include

information to identify the following: (1)

The final product and how it is

intended to be used, (2) the activities

the supplier performs on the device, and

(3) the name as well as type of entity or

person to which the supplier sends the

device. These draft reporting

requirements are intended to provide

FDA with sufficient information to

show that the prerequisites for filing the

petition are met and determine whether

a biomaterial supplier should have

registered its establishment or listed its

device with FDA, and failed to do so.

In the Federal Register of April 2,

2001 (66 FR 17562), 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

No. of Respondents Annual Frequency per

Response

Total Annual

Responses Hours per Response Total Hours

5 1 5 15

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

BAA98 became effective August 13,

1998. Up until the current date, no

petitions for declaration have been filed

with FDA. However, FDA believes that

in future years a handful (estimated at

5) of petitioners may file with the

agency. FDA estimates that respondents

would take approximately 1 hour to

gather the requisite information and

draft a petition. The likely respondents

to this collection of information are

persons involved in civil actions based

on harm arising from an implanted

medical device.