Federal Register / Vol. 65, No. 108 / Monday, June 5, 2000 / Notices 35651

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Changes to an Approved NDA or

ANDA’’ has been approved by the Office

of Management and Budget (OMB)

under the Paperwork Reduction Act of

1995.

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 the

Federal Register of January 6, 2000 (65

FR 779), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0431. The

approval expires on February 28, 2001.

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: May 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–13891 Filed 6–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0725]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Interstate

Shellfish Dealers Certificate

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 5,

2000.

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: 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.

Interstate Shellfish Dealers

Certificate—(OMB Control Number

0910–0021)—Extension

Under 42 U.S.C. 243, FDA is required

to cooperate with and aid State and

local authorities in the enforcement of

their health regulations and is

authorized to assist States in the

prevention and suppression of

communicable diseases. Under this

authority, FDA participates with State

regulatory agencies, some foreign

nations, and the molluscan shellfish

industry in the National Shellfish

Sanitation Program (NSSP). The NSSP is

a voluntary, cooperative program to

promote the safety of molluscan

shellfish by providing for the

classification and patrol of shellfish

growing waters and for the inspection

and certification of shellfish processors.

Each participating State and foreign

nation monitors its molluscan shellfish

processors and issues certificates for

those that meet the State or foreign

shellfish control authority’s criteria.

Each participating State and nation

provides a certificate of its certified

shellfish processors to FDA on Form

FDA 3038, ‘‘Interstate Shellfish Dealer’s

Certificate.’’ FDA uses this information

to publish the ‘‘Interstate Certified

Shellfish Shippers List,’’ a monthly

comprehensive listing of all molluscan

shellfish processors certified under the

cooperative program. If FDA did not

collect the information necessary to

compile this list, participating States

would not be able to identify and keep

out shellfish processed by uncertified

processors in other States and foreign

nations. Consequently, the NSSP would

not be able to control the distribution of

uncertified and possibly unsafe shellfish

in interstate commerce, and its

effectiveness would be nullified.

In the Federal Register of March 7,

2000 (65 FR 12013), the agency

requested comments on the proposed

collections of information. No

significant comments were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Form No. No. of

respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

FDA 3038 35 58 2,036 .10 204

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

35652 Federal Register / Vol. 65, No. 108 / Monday, June 5, 2000 / Notices

This estimate is based on the number

of certificates received in 1999.

Dated: May 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–13890 Filed 6–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–2552–96]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Hospital and

Health Care Complex Cost Report and

supporting Regulations in 42 CFR

413.20 and 413.24; Form No.: HCFA–

2552–96 (OMB 0938–0050); Use: Form

HCFA–2552–96 is the form used by

hospitals participating in the Medicare

program. This form reports the health

care costs used to determine the amount

of services rendered to Medicare

beneficiaries; Frequency: Annually;

Affected Public: Businesses or other forprofit; Not-for-profit institutions;

Number of Respondents: 7,000; Total

Annual Responses: 7,000; Total Annual

Hours: 4,629,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: May 25, 2000.

John P. Burke III,

Reports Clearance Officer, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–13981 Filed 6–2–00; 8:45 am]

BILLING CODE 4120–03–P ]

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–0294]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the Proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New; Title of Information

Collection: Hospital Condition of

Participation; Identification of Potential

Organ, Tissue, and Eye Donors and

Transplant Hospitals’ Provision of

Transplant-Related Data and Supporting

Regulations at 42 CFR 482.45; Form No.:

HCFA–R–0294 (OMB# 0938-NEW); Use:

Hospitals must document that they have

protocols for referral of organ, tissue,

and eye donors and that they have

contacted the organ procurement

organization and (in some cases) the

tissue bank and/or eye bank about every

death or imminent death so that

surveyors can verify that the hospital is

in compliance with the Medicare/

Medicaid conditions of participation for

hospitals; Frequency: On occasion;

Affected Public: Business or other forprofit, Not-for-profit institutions;

Number of Respondents: 6,100; Total

Annual Responses: 1,491,700; Total

Annual Hours: 146,070.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: May 25, 2000.

John P. Burke III,

Reports Clearance Officer, HCFA Office of

Information Services, Security and Standards

Group, Division of HCFA Enterprise

Standards.

[FR Doc. 00–13982 Filed 6–2–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–1728–94]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the