Federal Register / Vol. 63, No. 110 /Tuesday, June 9, 1998 / Notices 31513

(b) Culture-derived impurities include

inducers (polynucleotides, viruses)

antibiotics, serum, other media components.

(c) Downstream-derived impurities include

enzymes, chemical/biochemical processing

reagents (e.g., cyanogen bromide, guanidine,

oxidizing and reducing agents), inorganic

salts (e.g., heavy metals, arsenic, non metallic

ion), solvents, carrier/ligands (e.g.,

monoclonal antibodies), other leachables.

6.2.2 Product-related impurities

The following represents the most

frequently encountered molecular variants of

the desired product and lists relevant

technology for their assessment:

(a) Truncated forms. Cellular peptidases

may catalyze the removal of amino acids or

catalyze internal cleavages. This may be

detected by HPLC or SDS–PAGE. Peptide

mapping may be useful, depending on the

property of the variant.

(b) Deamidated, isomerized, mismatched

S–S linked, oxidized forms may need

considerable effort in isolation and

characterization in order to identify the type

of chemical modification(s) and amino acid

residue(s) involved. Chromatographic and/or

electrophoretic methods (e.g., HPLC,

capillary electrophoresis, mass spectroscopy,

circular dichroism) may be utilized to isolate

and characterize such variants.

(c) The category of aggregates includes

dimers and higher multiples of the molecular

entity. These are generally resolved from the

active moiety and quantitated by size

exclusion chromatography (e.g., SE–HPLC).

Degradants identified from stability studies

as being generated in significant amounts

should be tested for and monitored against

appropriately established acceptance criteria.

Dated: June 2, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15193 Filed 6–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0285]

Sanofi Pharmaceuticals, Inc., et al.;

Withdrawal of Approval of 21 New

Drug Applications and 62 Abbreviated

New Drug Applications; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

document that appeared in the Federal

Register of May 12, 1998 (62 FR 26191).

The document announced the

withdrawal of approval of 21 new drug

applications (NDA’s) and 62 abbreviated

new drug applications (ANDA’s). The

document was published with an error

in the identification of NDA for Pipanol

Powder and Tablets (trihyphenidyl)

held by Sanofi Pharmaceuticals, Inc.

This document corrects that error.

EFFECTIVE DATE: June 11, 1998.

FOR FURTHER INFORMATION CONTACT:

Olivia A. Pritzlaff, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

In FR Doc. 98–12613, appearing on

page 26191 in the Federal Register of

Tuesday, May 12, 1998, the following

correction is made:

On page 26191, in the table, in the

first column, the first entry ‘‘NDA 4–

496’’ is corrected to read ‘‘NDA 7–796’’.

Dated: June 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15338 Filed 6–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0532]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Radioactive Drug Research Committee

(RDRC) Report on Research Use of

Radioactive Drug Membership Summary

and Radioactive Drug Research Use of

Radioactive Drug Study Summary’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 9, 1998 (63

FR 1484), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(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 0910–0053. The

approval expires on May 31, 2001.

Dated: June 2, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15191 Filed 6–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1044–N]

Medicare Program; June 22, 1998,

Meeting of the Practicing Physicians

Advisory Council

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Practicing Physicians Advisory

Council. This meeting is open to the

public.

DATES: The meeting is scheduled for

June 22, 1998, from 8:30 a.m. until 5

p.m., E.S.T.

ADDRESSES: The meeting will be held in

Room 800, 8th Floor, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT:

Aron Primack, MD, MA, FACP,

Executive Director, Practicing

Physicians Advisory Council, Room

435–H, Hubert H. Humphrey Building,

200 Independence Avenue, S.W.,

Washington, DC 20201, (202) 690–7874

SUPPLEMENTARY INFORMATION: The

Secretary of the Department of Health

and Human Services (the Secretary) is

mandated by section 1868 of the Social

Security Act to appoint a Practicing

Physicians Advisory Council (the

Council) based on nominations

submitted by medical organizations

representing physicians. The Council

meets quarterly to discuss certain

proposed changes in regulations and

carrier manual instructions related to

physicians’ services, as identified by the

Secretary. To the extent feasible and

consistent with statutory deadlines, the

consultation must occur before

publication of the proposed changes.

The Council submits an annual report

on its recommendations to the Secretary

and the Administrator of the Health