Federal Register / Vol. 60, No. 238 / Tuesday, December 12, 1995 / Notices 63721

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0346]

Akorn, Inc., et al.; Withdrawal of

Approval of NADA’s

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of five new animal drug

applications (NADA’s). Three NADA’s

are held by Akorn, Inc., and one each

is held by Parke-Davis, Division of

Warner-Lambert Co., and Veterinary

Research and Development, Inc. The

firms notified the agency in writing that

the animal drug products were no

longer marketed and requested that

approval of the applications be

withdrawn. In a final rule published

elsewhere in this issue of the Federal

Register, FDA is amending the

regulations by removing the entries

which reflect approval of the NADA’s.

EFFECTIVE DATE: December 22, 1995.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: The

sponsors of the applications listed in the

table in this document have informed

FDA that these animal drug products are

no longer marketed and have requested

that FDA withdraw approval of the

applications.

NADA No. Drug name Sponsor name and address

6–032 ....................................... Diphenylhydantoin sodium capsules ............................. Parke-Davis, Division of Warner-Lambert Co., 201

Tabor Rd., Morris Plains, NJ 07950

12–444 ..................................... Sterile prednisolone suspension ................................... Akorn, Inc., 100 Akorn Dr., Abita Springs, LA 70420

94–978 ..................................... Phenylbutazone injection .............................................. Do.

110–046 ................................... Dexamethasone injection .............................................. Do.

140–904 ................................... Copper disodium edetate injection ................................ Veterinary Research and Development, Inc., P.O. Box

1299, Truckee, CA 95734

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Center for Veterinary Medicine (21 CFR

5.84), and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADA’s 6–032, 12–444, 94–

978, 110–046, and 140–904 and all

supplements and amendments thereto is

hereby withdrawn, effective December

22, 1995.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is removing 21 CFR 520.704, 522.514,

and 522.1880, and amending 21 CFR

510.600(c), 522.540, and 522.1720 to

reflect the withdrawal of approval of the

above mentioned NADA’s.

Dated: December 4, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–30122 Filed 12–11–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95D–0370]

Revised Compliance Policy Guides

(CPG’s); Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revision of two CPG’s. The CPG’s are

being revised because they contain

outdated information and misprinted

regulatory guidance. This action is being

taken to ensure that FDA’s CPG’s

accurately reflect FDA policy and to

limit confusion.

DATES: Effective December 12, 1995.

Written comments may be submitted at

any time.

ADDRESSES: Submit written requests for

single copies of CPG Sec. 545.400

‘‘Pottery (Ceramics); Imported and

Domestic—Cadmium Contamination’’

(CPG 7117.06), and CPG Sec. 545.450

‘‘Pottery (Ceramics); Imported and

Domestic—Lead Contamination’’ (CPG

7117.07) to the Director, Division of

Compliance Policy (HFC–230), Office of

Enforcement, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Submit written comments on CPG Sec.

545.400 ‘‘Pottery (Ceramics); Imported

and Domestic—Cadmium

Contamination’’ (CPG 7117.06) and CPG

Sec. 545.450 ‘‘Pottery (Ceramics);

Imported and Domestic—Lead

Contamination’’ (CPG 7117.07) to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr., Rockville

MD, 20857. Requests and comments

should be identified with the docket

number found in brackets in the

heading of this document. A copy of

CPG Sec. 545.400 ‘‘Pottery (Ceramics);

Imported and Domestic—Cadmium

Contamination’’ (CPG 7117.06) and CPG

Sec. 545.450 ‘‘Pottery (Ceramics);

Imported and Domestic—Lead

Contamination’’ (CPG 7117.07) and

received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Ronald C. Varsaci, Center for Food

Safety and Applied Nutrition (HFS–

022), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–4251.

SUPPLEMENTARY INFORMATION: FDA is

revising the following two CPG’s

because they contain outdated

information or misprinted regulatory

guidance: (1) CPG Sec. 545.400 ‘‘Pottery

(Ceramics); Imported and Domestic—

Cadmium Contamination’’ (CPG

7117.06), and (2) CPG Sec. 545.450

‘‘Pottery (Ceramics); Imported and

Domestic—Lead Contamination’’ (CPG

7117.07).

The guidance for flatware and small

hollowware in CPG Sec. 545.400 and for

pitchers in CPG Sec. 545.450 was

mistakenly printed as 0.05 instead of 0.5

microgram/milliliter. The CPG’s are also

being revised to specify current

methodologies in the Official Methods

of Analysis of the Association of Official

Analytical Chemists International

(AOAC) and to include the American

Society for Testing Materials (ASTM)

and Laboratory Information Bulletin

(LIB) methodologies. The CPG provides

guidance on recommending legal

actions and on when entries of potteries

should be detained based on cadmium

or lead contamination. To minimize any

confusion that may exist, FDA has

decided to issue revisions.
63722 Federal Register / Vol. 60, No. 238 / Tuesday, December 12, 1995 / Notices

Dated: December 5, 1995.

Gary Dykstra,

Acting Associate Commissioner for

Regulatory Affairs.

[FR Doc. 95–30171 Filed 12–11–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Dental Research;

Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Dental Research

Special Emphasis Panel (SEP) meetings:

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R03 Small Grants—96–05 (Teleconference).

Dates: December 13, 1995.

Time: 1 pm.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892.

Contact Person: Dr. William Gartland,

Scientific Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesta, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

Research Projects, Small Business Grants,

and Conference Grants—96–06.

Dates: December 14, 1995.

Time: 8 am.

Place: Bethesda Marriott Hotel, 5151 Pooks

Hill Road, Bethesda, MD 20814.

Contact Person: Dr. George Hausch, Chief,

Grants Review Section, 4500 Center Drive,

Natcher Buidling, Room 4AN–44F, Bethesda,

MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

This notice is being published less

than fifteen days prior to the above

meetings due to the urgent need to meet

timing limitations imposed by the

review and funding cycle.

Name of SEP: National Institute of Dental

Research Special, Emphasis Panel–Review of

Oral Cancer Centers—96–07.

Dates: January 7–11, 1996.

Time: 8 am.

Place: Hyatt Regency Bethesda, One

Bethesda Metro Center, Bethesda, MD 20814.

Contact Person: Dr. Yong Shin, Scientific

Review Administrator, 4500 Center Drive,

Natcher Building, Room 4AN–44F, Bethesda,

MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

the Conference Grants—97–10

(Teleconference).

Dates: January 18, 1996.

Time: 11 am.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20802.

Contact Person: Dr. George Hausch, Chief,

Grants Review Section, 4500 Center Drive,

Natcher Building, Room 4AN–44F, Bethesda,

MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

Coop Agreement Applications—96–08.

Dates: January 23–24, 1996.

Time: 8 am.

Place: Bethesda Marriott Hotel, 5151 Pooks

Hill Road, Bethesda, MD 20814.

Contact Person: Dr. Philip Washko,

Scientific Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesda, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

The meetings will be closed in

accordance with the provision set forth

in secs. 552b(c)(4) and 552b(c)(6), Title

5, U.S.C. Applications and/or proposals

and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material

and personal information concerning

individuals associated with the

applications and/or proposals, the

disclosure of which would constitute a

clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.121, Oral Diseases and

Disorders Research)

Dated: December 7, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–30303 Filed 12–11–95; 8:45 am]

BILLING CODE 4140–01–M

Division of Research Grants; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Division

of Research Grants Special Emphasis

Panel (SEP) meetings.

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Clinical Sciences.

Date: December 12, 1995.

Time: 5:15 p.m.

Place: NIH, Rockledge 2, Room 4104,

Telephone Conference.

Contact Person: Dr. Priscilla Chen,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4104, Bethesda,

Maryland 20892, (301) 435–1787.

Name of SEP: Biological and Physiological

Sciences.

Date: December 13, 1995.

Time: 4 p.m.

Place: NIH, Rockledge 2, Room 4148,

Telephone Conference.

Contact Person: Dr. Philip L. Perkins,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4148, Bethesda,

Maryland 20892, (301) 435–1787.

This notice is being published less

than 15 days prior to the above meetings

due to the urgent need to meet timing

limitations imposed by the grant review

and funding cycle.

The meetings will be closed in

accordance with the provisions set forth

in secs. 552b(c)(4) and 552b(c)(6), Title

5, U.S.C. Applications and/or proposals

and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material

and personal information concerning

individuals associated with the

applications and/or proposals, the

disclosure of which would constitute a

clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance

Program Nos. 93.306, 93.333, 93.337, 93.393–

93.396, 93.837–93.844, 93.846–93.878,

93.892, 93.893, National Institutes, of Health,

HHS).

Dated: December 6, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–30304 Filed 12–11–95; 8:45 am]

BILLING CODE 4140–01–M

Substance Abuse and Mental Health

Services Administration

Office for Women’s Services; Notice of

Meeting

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the Advisory Committee for Women’s

Services of the Substance Abuse and

Mental Health Services Administration

(SAMHSA) in January 1996.

The meeting of the Advisory

Committee for Women’s Services will

include a discussion of and update on

policy and program issues relating to

women’s substance abuse and mental

health service needs at SAMHSA,

including the SAMHSA fiscal year 1996

budget and reauthorization; regional

meetings on SAMHSA’s proposed

Performance Partnership Grants;

SAMHSA policy on inclusion and

attention to the needs of women and

racial/ethnic minority populations;

activities of the National Women’s

Resource Center for the Prevention and

Treatment of Alcohol, Tobacco and

Other Drug Abuse and Mental Illness;

monitoring the impact of change at

HHS; and a discussion of data collection

pertaining to women.

A summary of the meeting and/or a

roster of committee members may be

obtained from: Pamela J. McDonnell,