Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Notices 56193

Dated: October 23, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–28599 Filed 10–28–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biologics License Application for

Blood Products, and Reporting

Changes to an Approved Application;

Public Workshop

AGENCY: Food and Drug Administration.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing a public workshop

entitled ‘‘Workshop on the Biologics

License Application (BLA) for Blood

Products, and Reporting Changes to an

Approved Application.’’ The topics to

be discussed include completing Form

FDA 356h; chemistry, manufacturing,

and controls information; establishment

information; changes requiring

supplement submission and approval;

changes requiring supplement

submission at least 30 days prior to

distribution; changes to be described in

an annual report; and comparability

protocols.

Date and Time: The workshop will be

held on December 2, 1997, 8:30 a.m. to

5 p.m.

Location: The workshop will be held

at Jack Masur Auditorium, National

Institutes of Health, 8800 Rockville

Pike, Bldg. 10, Bethesda, MD 20892.

Contact: Joseph Wilczek, Center for

Biologics Evaluation and Research

(HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3514, FAX 301–827–2843.

SUPPLEMENTARY INFORMATION: The

public workshop is intended for firms

which manufacture or intend to

manufacture licensed human blood

products, including products for

transfusion and source materials for

further manufacture. The workshop is

also intended for firms planning to

supplement their current license for

additional products or modifications to

current products.

The goals for the workshop are to

provide guidance on the application

procedures, forms, and documentation

needed for the single BLA and guidance

on how changes to approved

applications are to be reported to the

FDA.

Registration: Early registration is

recommended on or before Friday,

November 21, 1997. Mail or fax

registration information (including

name, title, firm name, address,

telephone, and fax number) to Michelle

Priester Healy, Conference Management

Associates, Inc., 1010 Wayne Ave., suite

450, Silver Spring, MD 20910, 301–585–

8203, FAX 301–585–1186, e-mail

confmgmtmd@aol.com. Registration at

the site will be done on a space

available basis on the day of the

workshop, beginning at 7:30 a.m. There

is no registration fee for the workshop.

If you need special accommodations

due to a disability, please contact

Michelle Priester Healy at least 7 days

in advance.

Transcripts: Transcripts of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

Dated: October 23, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–28671 Filed 10–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97P–0220]

Determination That Pseudoephedrine

Hydrochloride 120-Milligram ExtendedRelease Capsules Over-the-Counter

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 pseudoephedrine hydrochloride

(Sudafed 12-Hour Capsules) 120-

milligram (mg) extended-release

capsules over-the-counter (OTC) were

not withdrawn from sale for reasons of

safety or effectiveness. This

determination will allow FDA to

approve abbreviated new drug

applications (ANDA’s) for

pseudoephedrine hydrochloride 120-mg

extended-release capsules.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, 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 (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 (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.

In a citizen petition dated June 3,

1997, and an amendment dated June 24,

1997 (Docket Nos. 97P–0220/CP1 and

97P–0220/AMD1), submitted under 21

CFR 10.30 and 314.161(a)(3), Eurand

America, Inc., requested that the agency

determine whether pseudoephedrine

hydrochloride 120-mg extended-release

capsules (OTC) were withdrawn from

sale for reasons of safety or

effectiveness. Pseudoephedrine

hydrochloride 120-mg extended-release

capsules, OTC (Sudafed 12-Hour

Capsules) were the subject of approved

NDA 17–941 held by Burroughs

Wellcome Co. Burroughs Wellcome