11034 Federal Register / Vol. 66, No. 35 / Wednesday, February 21, 2001 / Notices

public. Interested persons may present data,

information, or views, orally or in writing, on

issues pending before the committee. Written

submissions may be made to the contact

person by February 17, 2001. Oral

presentations from the public will be

scheduled between approximately 11:10 a.m.

and 11:40 a.m., and between approximately

2:40 p.m. and 3:10 p.m. on March 5, 2001.

Time allotted for each presentation may be

limited. Those desiring to make formal oral

presentations should notify the contact

person before February 21, 2001, and submit

a brief statement of the general nature of the

evidence or arguments they wish to present,

the names and addresses of proposed

participants, and an indication of the

approximate time requested to make their

presentation.

Closed Committee Deliberations: On March

5, 2001, from approximately 3:30 p.m. to 5

p.m., the meeting will be closed to permit

discussion and review of trade secret and/or

confidential information (5 U.S.C.

552b(c)(4)). This portion will be closed to

permit discussion of these materials.

FDA regrets that it was unable to publish

this notice 15 days prior to the March 5,

2001, Allergenic Products Advisory

Committee meeting. Because the agency

believes there is some urgency to bring these

issues to public discussion and qualified

members of the Allergenic Products Advisory

Committee were available at this time, the

Commissioner of Food and Drugs concluded

that it was in the public interest to hold this

meeting even if there was not sufficient time

for the customary 15-day public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: February 14, 2001.

Bonnie H. Malkin,

Special Assistant to the Senior Associate

Commissioner.

[FR Doc. 01–4230 Filed 2–20–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0057]

Determination That Bethanechol

Chloride Injection and Tablets Were

Not Withdrawn From Sale for Reasons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 bethanechol chloride 5 milligrams

(mg) per milliliter (mL) injection and

bethanechol chloride 5-, 10-, 25-,

and 50-mg tablets, all formerly marketed

by Merck & Co., Inc. (Merck), were not

withdrawn from sale for reasons of

safety or effectiveness. This

determination means that FDA will not

begin procedures to withdraw approval

of abbreviated new drug applications

(ANDA’s) for bethanechol chloride drug

products, and it will also allow FDA to

continue to approve ANDA’s for

bethanechol chloride drug products.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (the 1984

amendments) (Public Law 98–417),

which authorized the approval of

duplicate versions of drug products

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. Sponsors of

ANDA’s do not have to repeat the

extensive clinical testing otherwise

necessary to gain approval of a new

drug application (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 to which the ANDA

refers.

The 1984 amendments include what

is now section 505(j)(7) of the Federal

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

355(j)(7)), 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,’’

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 (21 CFR 314.162).

Under § 314.161(a)(2) (21 CFR

314.161(a)(2)) the agency must make a

determination as to whether a listed

drug was withdrawn from sale for

reasons of safety or effectiveness if

ANDA’s that refer to the drug that was

withdrawn are approved. Section

314.161(d) provides that if FDA

determines that the listed drug was

removed from sale for safety or

effectiveness reasons, the agency will

begin proceedings to withdraw approval

of the ANDA’s that refer to the drug that

was withdrawn from sale.

FDA has received a letter, dated April

7, 2000, from Merck, holder of NDA 6–

536 for bethanechol chloride 5-mg/mL

injection and bethanechol chloride 5-,

10-, 25-, and 50-mg tablets, stating that

Merck has withdrawn those products

from sale. Danbury Pharmacal, Inc.,

Roberts Laboratories, Inc., Glenwood,

Inc., and Sidmak Laboratories, Inc.

(Sidmak), all hold approved ANDA’s

that refer to one or more of Merck’s

bethanechol chloride drug products.

Merck sold its bethanechol chloride

drug products under the trade name of

Urecholine. In their April 7, 2000, letter,

Merck also informed FDA that Merck

has assigned the trademark Urecholine

to Sidmak for use in the sale of

Sidmak’s bethanechol chloride drug

products.

FDA has reviewed its records and,

under § 314.161, has determined that

bethanechol chloride 5-mg/mL injection

and bethanechol chloride 5-, 10-, 25-,

and 50-mg tablets were not withdrawn

from sale for reasons of safety or

effectiveness. Accordingly, the agency

will list Merck’s bethanechol chloride 5-

mg/mL injection and bethanechol

chloride 5-, 10-, 25-, and 50-mg tablets

in the ‘‘Discontinued Drug Product List’’

section of the Orange Book. The

‘‘Discontinued Drug Product List’’

identifies, among other items, drug

products that have been discontinued

from marketing for reasons other than

safety or effectiveness. The approval

status of the ANDA’s that refer to

bethanechol chloride 5-mg/mL injection

and bethanechol chloride 5-, 10-, 25-,

and 50-mg tablets is unaffected. ANDA’s

for bethanechol chloride 5-mg/mL

injection and bethanechol chloride 5-,

10-, 25-, and 50-mg tablets may be

approved by the agency.

Dated: February 14, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4229 Filed 2–20–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–9044]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration