Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Notices 23717

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Standard No. No. of Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records

Hours per Recordkeeper Total Hours

3, 4, and 62 ............................................ 500 1 500 5 2,500

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

2The standards incorporate the best program management practices currently in use in the regulatory community. The recommended policies,

procedures, and standard operating procedures contained in the various national standards are considered usual and customary management

practices for State, local, and tribal agencies that regulate the retail segment of the food industry.

Dated: May 4, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11618 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–0239]

Agency Information Collection

Activities; Announcement of OMB

Approval; Request for Resolution of

Scientific Disputes Concerning the

Regulation of Medical Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Request for Resolution of Scientific

Disputes Concerning the Regulation of

Medical Devices’’ 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 February 8, 2001 (66

FR 9585), 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 0910–0467. The

approval expires on April 30, 2004. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.

Dated: May 3, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11583 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0179]

Purina Mills, Inc., et al.; Withdrawal of

Approval of New Animal Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 11 new animal drug

applications (NADAs) listed below. In a

final rule published elsewhere in this

issue of the Federal Register, FDA is

amending the animal drug regulations to

remove the portions reflecting approval

of the NADAs because the products are

no longer manufactured or marketed.

DATES: Withdrawal of approval is

effective May 21, 2001.

FOR FURTHER INFORMATION CONTACT:

Pamela K. Esposito, Center for

Veterinary Medicine (HFV–210), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

5593.

SUPPLEMENTARY INFORMATION: The

following sponsors have requested that

FDA withdraw approval of the NADAs

listed below because the products are no

longer manufactured or marketed:

Sponsor NADA No. Product

(Drug)

21 CFR Cite Affected

(Sponsor Drug Labeler Code)

Purina Mills, Inc., P.O. Box 66812, St.

Louis, MO 63166–6812.

NADA 48–915 Purina Bot Control (trichlorfon) 520.2520a (017800)

Golden Sun Feeds, Inc., 111 South Fifth

St., Estherville, IA 51334.

NADA 97–567 Tylan 10 Premix (tylosin phosphate).558.625(b)(17) (021780)

.................................................................... NADA 97–615 Swine Med-A-Mix TS 8000 Pre

mix, Tylan 5, 10, 20, 40 Sulfa-G (tylosin

phosphate and sulfamethazine).

558.630(b)(4) and (b)(10) (021780)

Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318–1093.NADA 110–440 Hygromix Hygrowormer

Hyanthelmix (hygromycin B).

558.274(a)(2), (a)(3), (a)(4), (c)(1)(i), and

(c)(1)(ii) (016968)

Steris Laboratories, Inc., 620 North 51st

Ave., Phoenix, AZ 85043–4705.

NADA 44–585 Oxytocin Injection ........................ 522.1680 (000402)

.................................................................... NADA 45–578 Lidocaine Hydrochloride with

Epi-nephrine Injection 2%.

522.1258 (000402)

.................................................................... NADA 45–737 Sodium Pentobarbital Injection ... 522.1704(b) (000402)

.................................................................... NADA 45–848 Phenylbutazone Injection ............ 522.1720 (000402)

.................................................................... NADA 110–349 Dexamethasone Injection ......... 522.540(c)(2) (000402)