45670 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices

provide industry and regulators with

current information concerning changes

in the regulation of medicated feeds

including the Animal Medicinal Drug

Use Clarification Act, veterinary feed

directives, feed mill licensing and

current good manufacturing practices

for medicated feeds. The training

workshop is being conducted in

cooperation with the California

Department of Food and Agriculture

(CDFA) and the Association of

American Feed Control Officials

(AAFCO).

DATES: The 2-day training workshop

will be held on September 23, 1997,

from 8 a.m. to 5 p.m., and September 24,

1997, from 8:30 a.m. to 3 p.m.

ADDRESSES: The workshop will be held

at the Delta King Hotel, 1000 Front St.,

Old Sacramento, CA 95814.

FOR FURTHER INFORMATION CONTACT:

For information regarding this notice:

Mark Roh, Food and Drug

Administration, Oakland Federal

Bldg., 1301 Clay St., Oakland, CA

94612, 510–637–3980; or Karen

Robles, Food and Drug

Administration, 801 ‘‘I’’ St., rm.

443, Sacramento, CA 95814, 916–

498–6400, ext. 14; or

For information regarding registration

and the workshop: Steven Wong,

GMP Training Workshop

Coordinator, California Dept. of

Food & Agriculture, Feed

Inspection Program, 1220 ‘‘N’’ St.,

rm. A–472, Sacramento, CA 95814,

916–654–0574, FAX 916–653–2407.

SUPPLEMENTARY INFORMATION: This

training workshop is to further assist the

medicated feed industry and Federal

and State regulators with interpretation

and understanding of the current

regulations concerning medical feed

mills. Attention will also be given to

recent and proposed changes in the

regulatory procedures and policy.

Registration is being handled by

AAFCO. AAFCO is collecting a minimal

registration fee of $50.00 to cover the

cost of the facility and preparation of

course materials. Space is limited and

early registration is recommended.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22979 Filed 8–25–97; 4:44 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

System Suitability (Validation) of

Chromatographic Analysis/Out-ofSpecification Results; Notice of Public

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing that it will hold a

series of two public meetings that will

be offered in two locations. The topics

to be discussed are validating

chromatographic systems and

evaluating out-of-specification test

results.

Date and Time: The public meetings

will be held on September 12, 1997, 8

a.m. to 12 m. and 1 p.m. to 4 p.m.; and

September 24, 1997, 2 p.m. to 5:30 p.m.

(both meetings).

Location: On September 12, 1997, the

meetings will be held at the

Independence Seaport Museum Penn’s

Landing, 211 South Columbus Blvd.,

and Walnut St., Philadelphia, PA, 215–

413–8622, FAX 215–925–6713. On

September 24, 1997, the meetings will

be held at the Hyatt Regency Bethesda,

One Bethesda Metro Center, Bethesda,

MD, 301–657–1234, FAX 301–657–

6453.

Contact: Richard A. Baldwin, Division

of Field Science (HFC–141), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

6388, FAX 301–443–5153.

Registration: Registration for the

September 24, 1997, meetings is

required through the Parenteral Drug

Association. For more information on

how to register, contact the Parenteral

Drug Association at 301–986–0293, or email info@pda.org.

SUPPLEMENTARY INFORMATION: On

September 12, 1997, FDA’s Office of

Regulatory Affairs and the Office of

External Affairs are cosponsoring two

meetings entitled ‘‘System Suitability

(Validation) for Chromatographic

Analysis’’ and ‘‘Out-of Specification

Results.’’ On September 24, 1997, FDA,

in cooperation with the Parenteral Drug

Association, will offer the same

meetings in Bethesda MD. The goal of

these meetings is to provide consistent

practices and procedures between FDA

and the pharmaceutical industry.

Requests for handouts are available

from the Division of Field Science.

Submit requests to Denise Jones,

Division of Field Science (HFC–141),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857.

If you need special accommodations

due to a disability, please notify the

contact person at least 7 days in

advance.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22978 Filed 8–25–97; 4:44 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Potency and Dosage of Von Willebrand

Factor Concentrates; Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing a public workshop

entitled ‘‘FDA Sponsored Workshop on

Potency and Dosage of von Willebrand

Factor Concentrates (vWF).’’ The topics

to be discussed include potency assays

and standards for vWF concentrates;

pharmacokinetic studies and clinical

trials of vWF concentrates; the

correlation of dosage regimens with

clinical outcome; and labeling of vWF

concentrates.

Date and Time: The workshop will be

held on September 26, 1997, 8 a.m. to

5 p.m.

Location: The workshop will be held

at Jack Masur Auditorium, National

Institute 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:

FDA has the responsibility of

ensuring that product labeling provides

information about product potency and

dosage. In the case of replacement

therapy for deficiencies in coagulation

factor activity, this has been done by

assessing the potency of a product

relative to a defined standard, and by

measuring the pharmacokinetics of the

product. This information has been used

to establish a dosage that will raise the

concentration of circulating coagulation

activity to a targeted level for a known

period of time. Clinical trials establish

the clinical benefit of a given dosage

regimen. This model has been difficult

to apply to products submitted to FDA

for licensure for the treatment of vWF

because there is no standardized in vitro

test for vWF potency; there is no vWF