Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices 19597

Because of these serious deviations,

FDA concluded that the management at

PCBB did not adequately demonstrate

the ability to operate the establishment

in a manner that assured compliance

with Federal regulations or accepted

standard operating procedures, or to

ensure that personnel were adequately

trained and supervised and had a

thorough understanding of the

procedures that they performed as

required by 21 CFR 600.10(a) and (b)

and 606.20(a) and (b). These conditions

at PCBB were considered to constitute a

danger to public health warranting

license suspension pursuant to 21 CFR

601.5(b) and 601.6(a). FDA accordingly

suspended the firm’s licenses by letter

dated November 6, 1992.

In addition to the suspension of

establishment and product licenses, and

in order to preclude the distribution of

violative units, and to address those

questionable units already in

distribution channels, FDA requested

that PCBB immediately and

concurrently perform the following: (1)

Review test records for antibody to the

human immunodeficiency virus (Type

I), and then identify and defer all donors

who may have been misinterpreted as

suitable due to improper donor reentry

procedures; (2) develop and implement

a plan to identify and defer all donors

who, during the medical history

interview, have provided information

which may deem such donors as

ineligible, and (3) identify and recall all

units collected from such donors, and

notify all consignees of transfusible and

nontransfusible blood and blood

components of the test/medical history

of the units. In a letter to the firm dated

March 9, 1994, FDA concluded that the

recall was complete.

In a letter to FDA dated April 29,

1994, PCBB voluntarily requested that

its licenses be revoked and thereby

waived its opportunity for a hearing.

The agency granted the request in a

letter dated June 3, 1994, which revoked

the establishment and product licenses.

FDA has placed copies of the letters

relevant to the license revocation on file

under the docket number found in

brackets in the heading of this

document with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857. These documents are available

for public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Accordingly, under 21 CFR 601.5,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68), the establishment license

(U.S. License No. 1121) and the product

licenses for the manufacture of Whole

Blood, Red Blood Cells, Platelets, and

Plasma issued to Putnam County Blood

Bank, Inc., Palatka, FL, were revoked,

effective June 3, 1994.

This notice is issued and published

under 21 CFR 601.8 and the

redelegation at 21 CFR 5.67.

Dated: April 11, 1995.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 95–9577 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0090]

Dietary Supplements: Notice of

Withdrawal of Regulatory Guidance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it has withdrawn a number of

import alerts, import bulletins, and

compliance policy guides involving

dietary supplements. FDA has taken

these actions to conform its regulatory

guidance to the changes made to the

Federal Food, Drug, and Cosmetic Act

(the act) by the Dietary Supplement

Health and Education Act (DSHEA).

FOR FURTHER INFORMATION CONTACT:

Loretta A. Branch Carey, Center for

Food Safety and Applied Nutrition

(HFS–456), Food and Drug

Administration, 200 C Street SW.,

Washington, DC 20204, 202–205–5372.

SUPPLEMENTARY INFORMATION: On

October 25, 1994, the President signed

into law the DSHEA (Pub. L. 103–417).

Among the most significant changes in

the act made by the DSHEA is the

addition of section 201(s)(6) (21 U.S.C.

321(s)(6)), which excepts dietary

ingredients of dietary supplements from

coverage under the food additive

provisions of the act (section 3(b) of the

DSHEA). As a result of this change, such

ingredients are no longer subject to a

premarket safety review.

In response to this change, FDA has

reviewed the regulatory guidance that it

issues to its field offices to conform that

guidance to the change. As a result of

this review, FDA has found that it is

appropriate to withdraw the following

import alerts, import bulletins, and

compliance policy guides because they

are no longer consistent with the act.

A. Compliance Policy Guides

1. CPG 7117.04, entitled ‘‘Botanical

Products for use as Food’’

2. CPG 7118.01, entitled ‘‘Dietary

Supplements-Misbranding Nutritionally

Insignificant Ingredients’’

B. Import Alerts

1. 24–14 Products containing Bracken

2. 26–02 Flaxseed/Linseed Oil

3. 54–03 Carnitine

4. 54–05 Ultra Bios 2000 Food Supplement

5. 66–02 Ginseng

6. 66–04 Oil of Evening Primrose

C. Import Bulletins

1. 31–B01 Selfheal Flower, Prunella

Vulgaris

2. 54–B06 Tricosanthis

3. 66–B62 Ephedra

The Agency continues to review and

revise the remaining related import

alerts, bulletins, and compliance policy

guides, in order to comply with DSHEA.

FDA notes that it does not usually

give notice in the Federal Register of its

issuance or withdrawal of import alerts

or bulletins. It is doing so in this

instance, however, because of the ongoing congressional interest in FDA’s

implementation of the DSHEA. FDA

advises that issuing this notice does not

mark any type of change in the agency’s

usual procedures for issuing or

withdrawing these alerts or bulletins.

In response to the DSHEA, FDA has

also reassessed its general enforcement

priorities with respect to dietary

supplements. FDA advises that in

enforcing the act with respect to these

products, its primary focus is likely to

be, as it always has been, on safety

concerns. The agency advises, however,

that its regulatory priorities are subject

to adjustment in response to changing

circumstances. For example, the

labeling of dietary supplements will

likely be given a higher priority by the

agency after December 31, 1996, when

compliance with FDA’s nutrition

labeling and nutrient content claim

regulations for dietary supplements is to

begin.

Dated: April 13, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9702 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 84N–0102]

Cumulative List of Orphan-Drug and

Biological Designations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.
19598 Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a cumulative list of

designated orphan drugs and biologics

as of December 31, 1994. FDA has

announced the availability of previous

lists, which are brought up to date

monthly, identifying the drugs and

biologics granted orphan-drug

designation pursuant to the Federal

Food, Drug, and Cosmetic Act (the act).

ADDRESSES: Copies of the list of current

orphan-drug designations and of any

future lists are or will be available from

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and the Office of

Orphan Products Development (HF–35),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–4718.

FOR FURTHER INFORMATION CONTACT:

Peter L. Vaccari, Office of Orphan

Products Development (HF–35), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

4718.

SUPPLEMENTARY INFORMATION: FDA’s

Office of Orphan Products Development

(OPD) reviews and acts on applications

submitted by sponsors seeking orphandrug designation under section 526 of

the act (21 U.S.C. 360bb). In accordance

with this section of the act, which

requires public notification of

designations, FDA maintains a list of

designated orphan drugs and biologics.

This list is made current on a monthly

basis and is available upon request from

OPD (contact identified above). At the

end of each calendar year, the agency

publishes an up-to-date cumulative list

of designated orphan drugs and

biologics, including the names of

designated compounds, the specific

disease or condition for which the

compounds are designated, and the

sponsors’ names and addresses. The

cumulative list of compounds receiving

orphan-drug designation through 1988

was published in the Federal Register of

April 21, 1989 (54 FR 16294). This list

is available on request from FDA’s

Dockets Management Branch (address

above). Those requesting a copy should

specify Docket No. 84N–0102, which is

the docket number for this notice.

The list that is the subject of this

notice consists of designated orphan

drugs and biologics through December

31, 1994, and, therefore, brings the May

9, 1994 (59 FR 23888) publication up to

date.

The orphan-drug designation of a

drug or biologic applies only to the

sponsor who requested the designation.

Each sponsor interested in developing

an orphan drug or biologic must apply

for orphan-drug designation in order to

obtain exclusive marketing rights. Any

request for designation must be received

by FDA before the submission of a

marketing application for the proposed

indication for which designation is

requested. (See 53 FR 47577, November

23, 1988.) Copies of the regulations (see

57 FR 62076, December 29, 1992) for

use in preparing an application for

orphan-drug designation may be

obtained from OPD (address above).

The names used in the cumulative list

for the drug and biological products that

have not been approved or licensed for

marketing may not be the established or

proper names approved by FDA for

those products if they are eventually

approved or licensed for marketing.

Because these products are

investigational, some may not have been

reviewed for purposes of assigning the

most appropriate established proper

name.

Dated: April 13, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9700 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Notice of Filing of Annual Report of

Federal Advisory Committee

Notice is hereby given that pursuant

to section 13 of Public Law 92–463, the

Annual Report for the following Health

Resources and Service Administration’s

Federal Advisory Committees have been

filed with the Library of Congress:

Departments of Family Medicine Review

Committee

Faculty Development Review Committee

Graduate Training in Family Medicine

Review Committee

Predoctoral Training Review Committee

Residency Training Review Committee

Copies are available to the public for

inspection at the Library of Congress

Newspaper and Current Periodical

Reading Room, Room 1026, Thomas

Jefferson Building, Second Street and

Independence Avenue SE., Washington,

D.C. Copies may be obtained from: Ms.

Sherry Whipple, Executive Secretary,

Room 9A–27, Parklawn Building, 5600

Fishers Lane, Rockville, Maryland

20857, Telephone (301) 443–6874.

Dated: April 14, 1995.

Jackie E. Baum,

Advisory Committee Management Officer,

HRSA.

[FR Doc. 95–9699 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Institute of Neurological

Disorders and Stroke; Notice of

Meetings

Pursuant to Pub. L. 92–463, notice is

hereby given of meetings of the National

Institute of Neurological Disorders and

Stroke (NINDS).

The National Advisory Neurological

Disorders and Stroke Council and its

subcommittee meetings will be open to

the public as indicated below.

Attendance by the public will be limited

to space available.

The meetings will be closed to the

public as indicated below in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

and sec. 10(d) of Pub. L. 92–463, for the

review, discussion and evaluation of

individual grant applications. These

applications and discussions could

reveal confidential trade secrets or

commercial property such as patentable

material, and personal information

concerning individuals associated with

the applications, the disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy.

Summaries of meetings, rosters of

committee members, and other

information pertaining to the meetings

can be obtained from the Executive

Secretary or the Scientific Review

Administrator indicated. Individuals

who plan to attend and need special

assistance, such as sign language

interpretation or other reasonable

accommodations, should contact the

Executive Secretary listed for the

meeting.

Name of Committee: The Planning

Subcommittee of the National Advisory

Neurological Disorders and Stroke Council.

Date: May 31, 1995.

Place: National Institutes of Health,

Building 31, Conference Room 8A28, 9000

Rockville Pike, Bethesda, MD 20892.

Open: 1:30 p.m.–3 p.m.

Agenda: To discuss program planning and

fiscal matters.

Closed: 3 p.m.–recess.

Name of Committee: National Advisory

Neurological Disorders and Stroke Council.

Dates: June 1–2, 1995.

Place: National Institutes of Health,

Building 1, Wilson Hall, 9000 Rockville Pike,

Bethesda, MD 20892.

Open: June 1, 9 a.m.–2 p.m.

Agenda: A report by the Director, NINDS;

a report by the Director, Division of

Extramural Activities, NINDS; and a

presentation by an NINDS grantee.

Closed: June 1, 2 p.m.–recess; June 2, 8:30

a.m.–adjournment.

Executive Secretary: Constance W. Atwell,

Ph.D., Director, Division of Extramural

Activities, NINDS, National Institutes of