25498 Federal Register / Vol. 61, No. 99 / Tuesday, May 21, 1996 / Notices

subject of the ANDA is bioequivalent to

the listed drug.

The 1984 amendments included what

is now section 505(j)(6) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 355(j)(6)), which requires

FDA to publish a list of all approved

drugs. FDA publishes this list as part of

the ‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations,’’

which is generally known as the

‘‘Orange Book.’’ Under FDA regulations,

drugs are withdrawn from the list if the

agency withdraws or suspends approval

of the drug’s NDA or ANDA for reasons

of safety or effectiveness, or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (§ 314.162 (21

CFR 314.162)). Regulations also provide

that the agency must make a

determination as to whether a listed

drug was withdrawn from sale for

reasons of safety or effectiveness before

an ANDA that refers to that listed drug

may be approved (§ 314.161(a)(1) (21

CFR 314.161(a)(1))). FDA may not

approve an ANDA that does not refer to

a listed drug.

On May 12, 1995, Reed & Carnrick

Pharmaceuticals submitted a citizen

petition (Docket No. 95P–0128/CP1)

under 21 CFR 10.25(a) and 10.30

requesting that the agency determine

whether hydrocortisone acetate topical

ointment 2.5% was withdrawn from

sale for reasons of safety or effectiveness

and, if the agency determines that the

drug was not withdrawn from sale for

reasons of safety or effectiveness, to

keep the drug in the ‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluations.’’ Hydrocortisone acetate

topical ointment 2.5%, along with the

1% strength, is the subject of approved

NDA 8–917 held by the Upjohn Co.

(Upjohn). On July 28, 1953, Upjohn

obtained approval to market the 2.5%

strength of hydrocortisone acetate

topical ointment. Upjohn withdrew the

drug from sale in 1991.

FDA has reviewed its records and,

under §§ 314.161 and 314.162(c), has

determined that hydrocortisone acetate

topical ointment 2.5% was not

withdrawn from sale for reasons of

safety or effectiveness and will continue

to list hydrocortisone acetate topical

ointment 2.5% in the ‘‘Discontinued

Drug Product List’’ contained in the

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations.’’

The ‘‘Discontinued Drug Product List’’

lists, among other items, drug products

that have been discontinued from

marketing for reasons other than safety

or effectiveness. ANDA’s that refer to

hydrocortisone acetate topical ointment

2.5% may be submitted to the agency.

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12690 Filed 5–20–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93P–0322]

Determination that

Medroxyprogesterone Acetate 100

Milligrams per Milliliter Was Not

Withdrawn From Sale for Reasons of

Safety or Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

that medroxyprogesterone acetate

(Depo-Provera) 100 milligrams per

milliliter (mg/mL) was not withdrawn

from sale for reasons of safety or

effectiveness. This determination will

allow sponsors to submit abbreviated

new drug applications (ANDA’s) for

medroxyprogesterone acetate 100 mg/

mL.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1049.

SUPPLEMENTARY INFORMATION: In 1984,

Congress passed into law the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments), which

authorized the approval of duplicate

versions of drug products approved

under an ANDA procedure. ANDA

sponsors must, with certain exceptions,

show that the drug for which they are

seeking approval contains the same

active ingredient in the same strength

and dosage form as the listed drug,

which is a version of the drug that was

previously approved under a new drug

application (NDA). Sponsors of ANDA’s

do not have to repeat the extensive

clinical testing otherwise necessary to

gain approval of an NDA. The only

clinical data required in an ANDA are

data to show that the drug that is the

subject of the ANDA is bioequivalent to

the listed drug.

The 1984 amendments included what

is now section 505(j)(6) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(j)(6)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations,’’

which is generally known as the

‘‘Orange Book.’’ Under FDA regulations,

drugs are withdrawn from the list if the

agency withdraws or suspends approval

of the drug’s NDA or ANDA for reasons

of safety or effectiveness, or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (§ 314.162 (21

CFR 314.162)). Regulations also provide

that the agency must make a

determination as to whether a listed

drug was withdrawn from sale for

reasons of safety or effectiveness before

an ANDA that refers to that listed drug

may be approved (§ 314.161(a)(1) (21

CFR 314.161(a)(1))). FDA may not

approve an ANDA that does not refer to

a listed drug.

On August 30, 1993, King & Spalding

submitted a citizen petition (Docket No.

93P–0322/CP1) under 21 CFR 10.25(a)

and 10.30 requesting that the agency

determine whether

medroxyprogesterone acetate 100 mg/

mL was withdrawn from sale for reasons

of safety or effectiveness and, if the

agency determines that the drug was not

withdrawn from sale for reasons of

safety or effectiveness, to keep the drug

in the ‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations.’’

Medroxyprogesterone acetate 100 mg/

mL, along with the 400 mg/mL strength,

is the subject of approved NDA 12–541

held by the Upjohn Co. (Upjohn). On

December 1, 1992, Upjohn withdrew

medroxyprogesterone acetate 100 mg/

mL from sale.

FDA has reviewed its records and,

under §§ 314.161 and 314.162(c), has

determined that medroxyprogesterone

acetate 100 mg/mL was not withdrawn

from sale for reasons of safety or

effectiveness and will continue to list

medroxyprogesterone acetate 100 mg/

mL in the ‘‘Discontinued Drug Product

List’’ contained in the ‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluations.’’ The ‘‘Discontinued Drug

Product List’’ lists, among other items,

drug products that have been

discontinued from marketing for reasons

other than safety or effectiveness.

ANDA’s that refer to

medroxyprogesterone acetate 100 mg/

mL may be submitted to the agency.

FDA has also considered the comment

submitted by Upjohn, dated November

19, 1993, opposing an FDA

determination that

medroxyprogesterone acetate 100 mg/

mL was withdrawn from the market for

reasons other than safety or

effectiveness. The comment does not

contain any information indicating that

the drug was withdrawn for reasons of

safety or effectiveness, but rather

indicates that Upjohn did not perceive

a need to keep medroxyprogesterone
Federal Register / Vol. 61, No. 99 / Tuesday, May 21, 1996 / Notices 25499

acetate in a 100 mg/mL strength on the

market because the 400 mg/mL strength,

which Upjohn also marketed, was

viewed as a more convenient strength

for the approved indication of

adjunctive therapy and palliative

treatment of inoperable recurrent and

metastatic endometrial or renal

carcinoma.

Dated: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–12760 Filed 5–21–96; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Mental Health;

Notice of Meeting

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

following National Institute of Mental

Health Special Emphasis Panel.

The meeting will be open to the

public to provide concept review of

proposed contract or grant solicitations.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

inform the contact person named below

in advance of the meeting.

Name of Committee: National Institute of

Mental Health Special Emphasis Panel

(Telephone Conference Call)

Date: May 22, 1996.

Time: 1:30 p.m.

Place: Parklawn Building, Room 9–105,

5600 Fishers Lane, Rockville, MD 20857.

Agenda: To provide concept review for a

contract project entitled ‘‘Pilot Study of

Verapamil in Females with Bipolar

Disorder.’’

Contact Person: Michael J. Moody,

Contracts Review Coordinator, Parklawn

Building, Room 9–105, 5600 Fishers Lane,

Rockville, MD 20857, Telephone 301, 443–

3367.

This notice is being published less

than 15 days prior to the above meeting

due to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

Dated: May 16, 1996.

Anna Snouffer,

Committee Management Specialist, NIH.

[FR Doc. 96–12857 Filed 5–17–96; 1:41 pm]

BILLING CODE 4140–01–M

Substance Abuse and Mental Health

Services Administration

Programmatic Supplement to the

Cooperative Agreement With the

National Association of State Mental

Health Program Directors

AGENCY: Center for Mental Health

Services (CMHS), Substance Abuse and

Mental Health Services Administration

(SAMHSA), HHS.

ACTION: Planned single-source

supplemental award to assist State

mental health, substance abuse, and

Medicaid officials to develop pragmatic

performance measures and outcome

indicators for use in Medicaid managed

behavioral health care contracting.

SUMMARY: This notice is to provide

information to the public concerning a

planned programmatic supplement to

an ongoing cooperative agreement

between the Substance Abuse and

Mental Health Services

Administration’s (SAMHSA) Center for

Mental Health Services (CMHS) and the

National Association of State Mental

Health Program Directors (NASMHPD).

The ongoing cooperative agreement

funds the Technical Assistance Center

for State Mental Health Planning. The

programmatic supplement is being

provided to address a need that arose

from the recommendations of the

SAMHSA Conference—Partnerships for

Change. The conference highlighted

national and State trends in organizing

and financing public mental health and

substance abuse care. Federal and State

officials received strong encouragement

to expand their collaboration across

levels of government and between

mental health, substance abuse, and

Medicaid agencies to prepare for rapid

changes in their roles, responsibilities,

and funding. A particularly acute need

identified was a core set of quality

assurance and performance measures

that public purchasers of managed

behavioral health care services could

use to monitor the new contracting

mechanism. In the absence of a core set

of measures, it is possible that persons

with severe and persistent mental

illnesses, chronic substance abuse

disorders, and children and adolescents

with serious emotional problems may be

placed into managed care systems with

inadequate safeguards and controls. In

fact, the network of community-based

services that has been developed with

great difficulty over the last three

decades may be jeopardized if public

sector managed care contracts lack

essential performance standards and

quality assurance guidelines.

The NASMHPD Board of Directors, in

close collaboration with the NASMHPD

Research Institute, and the Boards of

Directors of the National Association of

State Alcohol and Drug Abuse Directors

(NASADAD) and the American Public

Welfare Association (APWA), have all

identified as their top mutual priority

the development of performance

measurement indicators that could be

used by States that are letting contracts

for Medicaid managed behavioral health

care. NASMHPD, which represents the

State mental health agencies in every

State, has a long history of facilitating

the voluntary collection of uniform

mental health data across States.

NASMHPD has worked with State

mental health agencies and CMHS on

the Mental Health Statistics

Improvement Program (MHSIP) to foster

the collection, analysis, and reporting of

data which are useful for systems

management, policy decisions,

evaluation, performance assessment,

and research in the States, as well as

nationally. State health care reform

efforts and the introduction of managed

care financial arrangements have placed

new demands on States for quality

assurance and accountability

information. NASMHPD’s Technical

Assistance Center cooperative

agreement with CMHS represents a

unique capacity that does not exist

anywhere else. The NASMHPD

Technical Assistance Center works

closely with every State mental health

agency. A supplement to the existing

cooperative agreement will allow the

NASMHPD Technical Assistance Center

to develop a consensus among State

mental health, substance abuse, and

Medicaid agencies around the collection

of information about managed care that

can be used internally by States for

quality assurance and contract

monitoring purposes, while, at the same

time, assuring cooperation across States

so that data items and data collection

procedures are uniform so that valid

national and cross-state comparisons

can be made. Therefore, SAMHSA’s

CMHS has determined that a

supplement to the existing cooperative

agreement with NASMHPD should be

made to carry out this important work.

This notice is not a request for

applications; only NASMHPD is eligible

to apply for the supplement to the

existing cooperative agreement. If the

NASMHPD supplemental application is

recommended for approval by the

Special Review Committee, funds will

be made available.

Authority: The programmatic supplement

to the ongoing cooperative agreement will be

made under the authority of Section 1948(a)