374 Federal Register / Vol. 66, No. 2 / Wednesday, January 3, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

21 CFR Section Number of

Respondents

Number fo Responses per

Respondent

Total Annual

Responses

Hours per

Response Total Hours

MARKETING EXCLUSIVITY INFORMATION

314.50(j)

314.54(a)(1)(vii)

314.70(f) 92 2.7 250 2 500

NOTIFICATION OF DATE OF COMMERCIAL MARKETING;

ENTRY OF THE ORDER OR JUDGEMENT; FILING OF

LEGAL ACTION

314.107(c)(4),(e)(2)(iv),(f)(2), and (f)(3) 34 2 71 1 71

TOTAL 3,083

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

Dated: December 26, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–45 Filed 1–2–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1505]

Agency Information Collection

Activities; Announcement of OMB

Approval; Guidance for Industry on

How to Use E–Mail to Submit a Notice

of Intent to Slaughter for Human Food

Purposes

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Guidance for Industry on How to Use

E–Mail to Submit a Notice of Intent to

Slaughter for Human Food Purposes’’

has been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 21, 2000

(65 FR 57192), 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 0910–0450. The

approval expires on November 30, 2003.

A copy of the supporting statement for

this information collection is available

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

ohrms/dockets.

Dated: December 26, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–46 Filed 1–2–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1489]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Sterility

Requirements for Aqueous-Based

Drug Products for Oral Inhalation

(Formerly Known and Approved Under

Sterility Requirements for Inhalation

Solution Products) (OMB Control

Number 0910–0353)

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 February 2,

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 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Sterility Requirements for AqueousBased Drug Products for Oral

Inhalation (Formerly Known and

Approved Under Sterility Requirements

for Inhalation Solution Products) (OMB

Control Number 0910–0353)

Sections 314.70(b) and 314.97 (21

CFR 314.70(b) and 314.97) require that

all aqueous-based drug products for oral

inhalation, including those currently

approved, be manufactured sterile.

Respondents will be required to submit

a supplemental application under

§ 314.70(b) or § 314.97, describing their

new manufacturing process for

achieving sterility of their aqueousbased drug products for oral inhalation.

FDA needs this information to

determine compliance with this new

regulation and will use information

collected to make decisions on approval

of supplemental applications.

Based on new information collected

by its contractor, ERG, FDA has revised

its estimate of the number of

respondents in the original proposal for

reporting and recordkeeping burden.

Because the respondents have changed,

the estimate of the total hours have

changed. In the proposed rule it was

estimated that there were 5

manufacturers, while the final rule

estimates there are 8 manufacturers with

11 nonsterile products based on new

data collected by ERG. However, four of

the manufacturers are projected to cease

manufacturing, leaving four companies

manufacturing seven products. These

companies are projected to cease

manufacturing because they may lack