77384 Federal Register / Vol. 65, No. 238 / Monday, December 11, 2000 / Notices

B surface antigen (HBsAg). Section

610.40(b)(4) (21 CFR 610.40(b)(4))

permits preapproved or emergency

shipments of blood products for further

manufacturing before the test for HBsAg

is completed. To obtain approval for

such shipments, the collection facility

must submit a description of the control

procedures to be used by the collection

facility and manufacturer. Proper

control procedures are essential to

ensure the safe shipment, handling, and

quarantine of untested or incompletely

tested blood products, communication

of test results, and appropriate use or

disposal of the blood products based on

the test results. Section 610.40(d)(1)(v)

and (d)(2)(iv) requires that a collection

facility notify FDA of shipments of

HBsAg reactive source blood, plasma, or

serum for manufacturing into hepatitis

B vaccine and licensed or unlicensed in

vitro diagnostic biological products,

including clinical chemistry control

reagents. The reporting requirements

inform FDA of the shipment of

potentially infectious biological

products that may be capable of

transmitting disease. FDA’s monitoring

of such activity is essential should any

deviations occur that may require

immediate corrective action to protect

public safety.

The respondents for this information

collection are the blood collection

facilities that ship hepatitis B reactive

products. Only a few firms are actually

engaged in shipping hepatitis B reactive

products and making the reports

required by § 610.40. Also, there are

very few to no emergency shipments per

year related to further manufacturing

and the only product currently shipped

prior to completion of hepatitis B testing

is a licensed product, Source

Leukocytes. Shipments of Source

Leukocytes are preapproved under the

product license applications and do not

require notification of shipment.

Currently, there have been no

respondents reporting emergency or

preapproved shipments (§ 610.40(b)).

However, FDA is listing one report per

year for emergency or preapproved

shipments to account for the possibility

of future emergency shipments. The

estimated number of respondents and

total annual responses under § 610.40(d)

are based on the annual average of

reports submitted to FDA in 1999. The

hours per response are based on past

FDA experience.

In the Federal Register of September

7, 2000 (65 FR 54282), the agency

requested comments on the proposed

collection of information. No significant

comments were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section No. of

Respondents

Annual Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

610.40(b) 2 1 1 0.5 0.5 11

610.40(d) 3 12 1.83 22 0.5 11.5

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2The notice involves a brief letter and an enclosure. The letter identifies who is making the shipment, to whom shipped, the nature of the

emergency, the kind and quantity shipped, and date of shipment. The enclosure is a copy of the shippers written standard operating procedures

for handling, labeling storage, and shipment of contaminated (contagious) product. The burden for development and maintenance of standard operating procedures is approved under OMB Control No. 0910–0116. 3The notice of reactive product shipment is limited to information on: The identity of the kind and amount of source material shipped, the name

and address of the consignee, the date of shipment, and the manner in which the source material is labeled.

FDA has calculated no additional

burden in this information collection

package for the labeling requirements in

§ 610.40(d) because the information and

statements on the label necessary for

public disclosure and safety are

provided by FDA in these regulations.

Under 5 CFR 1320.3(c)(2), the public

disclosure of information originally

supplied by the Federal Government to

the recipient for the purpose of

disclosure to the public is not a

collection of information.

Dated: December 5, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–31481 Filed 12–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Notice of Meetings

Pursuant to Public Law 92–463,

notice is hereby given of the following

meetings of SAMHSA Special Emphasis

Panels I in December 2000.

A summary of the meetings and a

roster of the members may be obtained

from: Ms. Coral Sweeney, Review

Specialist, SAMHSA, Office of Policy

and Program Coordination, Division of

Extramural Activities, Policy, and

Review, 5600 Fishers Lane, Room 17–

89, Rockville, Maryland 20857.

Telephone: 301–443–2998.

Substantive program information may

be obtained from the individual named

as Contact for the meeting listed below.

The meetings will include the review,

discussion and evaluation of individual

grant applications. These discussions

could reveal personal information

concerning individuals associated with

the applications. Accordingly, these

meetings are concerned with matters

exempt from mandatory disclosure in

Title 5 U.S.C. 552b (6) and 5 U.S.C.

App.2, § 10(d).

Committee Name: SAMHSA Special

Emphasis Panel I (SEP I).

Meeting Date: December 11–15, 2000.

Place: Bethesda Marriott, 5151 Pooks Hill

Road, Bethesda, MD 20814.

Closed: December 11, 2000 to

Adjournment.

Panel: Community Action Grants, PA 00–

003 2 Committees.

Contact: Diane McMenamin, Director,

Division of Extramural Activities, Policy and

Review, Parklawn Building, 5600 Fishers

Lane, Room 1789, Rockville, Maryland

20857.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

Dated: November 27, 2000.

Coral Sweeney,

Review Specialist, Substance Abuse and

Mental Health Services Administration.

[FR Doc. 00–31409 Filed 12–8–00; 8:45 am]

BILLING CODE 4162–20–U