21768 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

7.42 1,933 1 1,933 1.8 3,479

7.46 and 7.49 1,933 1 1,933 4.0 7,732

7.53 1,933 1 1,933 36.0 69,588

7.55(b) 1,933 1 1,933 2.0 3,866

Total 84,665

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

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10707 Filed 4–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1489]

Agency Information Collection

Activities; Announcement of OMB

Approval; Sterility Requirements for

Aqueous-Based Drug Products for

Oral Inhalation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information

entitled‘‘Sterility Requirements for

Aqueous-Based Drug Products for Oral

Inhalation’’ 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 September 18, 2000

(65 FR 56314), 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 0910–0353. The

approval expires on March 31, 2004. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10708 Filed 4–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0511]

Agency Information Collection

Activities; Announcement of OMB

Approval; Hazard Analysis and Critical

Control Point (HACCP); Procedures for

the Safe and Sanitary Processing and

Importing of Juice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Hazard Analysis and Critical Control

Point (HACCP); Procedures for the Safe

and Sanitary Processing and Importing

of Juice’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

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 the

Federal Register of January 19, 2001 (66

FR 6138 at 6194), 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 0910–0466. The

approval expires on March 31, 2004. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10709 Filed 4–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1502]

Agency Information Collection

Activities; Announcement of OMB

Approval; Adverse Experience

Reporting for Licensed Biological

Products and General Records

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Adverse Experience Reporting for

Licensed Biological Products and

General Records’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 26, 2000

(65 FR 81528), 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,