Federal Register / Vol. 66, No. 10 / Tuesday, January 16, 2001 / Notices 3605

Dated: January 8, 2001.

James Scanlon,

Director, Division of Data Policy, Office of

the Assistant Secretary for Planning and

Evaluation.

[FR Doc. 01–1188 Filed 1–12–01; 8:45 am]

BILLING CODE 4151–05–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1679 ]

Draft Compliance Policy Guidance for

FDA Employees and Industry on Blood

Donor Incentives; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft compliance

policy guidance entitled ‘‘Sec. 230.150

Blood Donor Incentives.’’ The draft

guidance is intended to provide

guidance to FDA employees and

industry for evaluating blood donor

incentives that may consist of cash or

other incentives.

DATES: Submit written comments on the

draft guidance by March 19, 2001.

General comments on agency guidance

documents may be submitted at any

time.

ADDRESSES: Submit written requests for

single copies of the draft guidance to the

Division of Compliance Policy (HFC–

230), Office of Regulatory Affairs, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send two

self-addressed adhesive labels to assist

that office in processing your request.

You may fax your request to 301–827–

0852. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the guidance. Submit written

comments on this draft guidance to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

JoAnne C. Marrone, Division of

Compliance Policy (HFC–230), Office of

Regulatory Affairs, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1242.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 13,

1978 (43 FR 2142), FDA published a

final rule requiring that blood and blood

products intended for transfusion

include a statement on the labels that

indicated whether the products were

collected from paid or volunteer donors.

This labeling requirement appears at

§ 606.121(c)(5) (21 CFR 606.121(c)(5)).

The regulation defines a ‘‘paid donor’’

as a person who receives monetary

payment for a blood donation

(§ 606.121(c)(5)(i)). A volunteer donor is

a person who does not receive monetary

payment for a blood donation

(§ 606.121(c)(5)(ii)). The regulation also

defines certain benefits that do not

constitute monetary payment. Those

benefits, described in

§ 606.121(c)(5)(iii), include time off

from work, membership in blood

assurance programs, and cancellation of

non-replacement fees, as long as the

benefits are not readily convertible to

cash. Products collected from blood

donors who have received such

incentives may be labeled with the

‘‘volunteer donor’’ classification

statement.

The requirement that the label of a

blood product indicate whether the

product came from a volunteer or a paid

donor applies only to blood and blood

components intended for transfusion. It

does not apply to products that will be

used for further manufacturing, such as

Source Plasma.

If the donor receives an incentive

other than cash, the incentive must be

evaluated to determine if it is readily

convertible to cash. The draft guidance

document provides FDA employees and

industry with some examples of

incentives and identifies some factors to

consider when determining whether an

incentive is readily convertible to cash.

The draft guidance advises FDA

employees that they may cite deviations

from blood and blood product labeling

requirements on Form FDA 483

(inspectional observations).

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on blood donor incentives. The draft

guidance is not intended for

implementation at this time. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the applicable statute,

regulations, or both.

The agency has adopted good

guidance practices (GGP’s) which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (65 FR 56468, September 19,

2000 ). This draft guidance document is

being issued as Level 1 guidance

consistent with GGP’s.

III. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance by March 19, 2001.

Submit to the contact person (address

above) written comments regarding this

draft guidance after March 19, 2001.

Such comments will be considered

when the draft guidance is finalized.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The guidance document and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

IV. Electronic Access

Persons interested in obtaining a copy

of the draft guidance on the Internet

may access the draft at http://

www.fda.gov/ora/compliancelref/cpg/

default.htm.

Dated: January 5, 2001.

Dennis E. Baker,

Associate Commissioner for Regulatory

Affairs.

[FR Doc. 01–1127 Filed 1–12–01; 8:45 am]

BILLING CODE: 4160–01–S

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4633–N–01]

Revisions to PHA Project-Based

Assistance Program; Initial Guidance

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Notice.

SUMMARY: The HUD Appropriations Act

for Fiscal Year 2001 amends the existing

laws that govern the amount of tenantbased housing choice voucher funding

that may be used for project-based

assistance. HUD plans to issue a rule

revising the project-based program

regulations at 24 CFR part 983 in

accordance with the new law. However,

many of the statutory changes do not

involve or require agency discretion on

implementation of the new law, and are

immediately effective. This notice

provides guidance to public housing

agencies (PHAs) and other interested

members of the public on those

provisions that are effective

immediately, and identifies statutory

changes that require further rulemaking.

FOR FURTHER INFORMATION CONTACT:

Gerald J. Benoit, Office of Public and