Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practices for Blood and Blood Components; Notification of Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV Infection

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-2250]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request; Current Good Manufacturing Practices for Blood

and Blood Components; Notification of Consignees Receiving Blood and

Blood Components at Increased Risk for Transmitting HIV Infection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the

proposed collection of information listed below has been submitted to

the Office of Management and Budget (OMB) for review and clearance

under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by

December 6, 1999.

ADDRESSES: Submit written comments on the collection of information to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:

Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of

Information Resources Management (HFA-250), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has

submitted the following proposed collection of information to OMB for

review and clearance.

Current Good Manufacturing Practices for Blood and Blood

Components; Notification of Consignees Receiving Blood and Blood

Components at Increased Risk for Transmitting HIV Infection--21 CFR

606.100, 606.160, 610.46, and 610.47 (OMB Control No. 0910-0336)--

Extension

Under the biologics licensing and quarantine provisions of the

Public Health Service Act (42 U.S.C. 262-264) and the general

administrative provisions of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 351-353, 355-360, and 371-374), FDA has the authority to

issue regulations designed to protect the public from unsafe or

ineffective biological products and to issue regulations necessary to

prevent the introduction, transmission, or spread of communicable

diseases. FDA has implemented an extensive system of donor screening

and testing procedures performed by blood establishments before,

during, and after donation, to help prevent the transfusion of blood

products that are at increased risk for transmitting human

immunodeficiency virus (HIV). HIV is the virus that causes acquired

immune deficiency syndrome (AIDS), a communicable disease that can be

transmitted through transfusion. Despite the best practices of blood

establishments, however, a person may donate blood early in infection,

during the period when the antibody to HIV is not detectable by a

screening test, but HIV is present in the donor's blood (a so-called

``window'' period). If the donor attempts to donate blood at a later

date, the test for antibody to HIV may, at that time, be repeatedly

reactive. Therefore, FDA believes such circumstances require

clarification of the donor's status through testing with a more

specific antibody test and procedures to ``lookback'' at prior

collections.

FDA issued regulations that require blood establishments to follow

written standard operating procedures (SOP's) when the blood

establishments have collected Whole Blood, blood components, Source

Plasma, and Source Leukocytes later determined to be at increased risk

for transmitting HIV. When a donor who previously donated blood is

tested on a later donation, and tests repeatedly reactive for antibody

to HIV, the regulations require blood establishments to perform more

specific testing using a licensed test, and notify consignees who

received Whole Blood, blood components, Source Plasma, and Source

Leukocytes from prior collections so that appropriate action is taken.

Blood establishments and consignees are required to quarantine

previously collection Whole Blood, blood components, Source Plasma, and

Source Leukocytes from such donors, and if appropriate, notify

transfusion recipients. Upon completion of more specific testing,

hospital transfusion services that do not participate in Medicare, and

are therefore not subject to Health Care Financing Administration's

(HCFA's) regulations, are required to take steps to notify transfusion

recipients, as appropriate. These regulations are intended to help

ensure the continued safety of the blood supply by providing necessary

information is provided to users of blood and blood components and

appropriate notification of recipients of transfusion at increased risk

for transmitting HIV infection.

Section 606.100(b)(19) (21 CFR 606.100(b)(19)) requires written

SOP's for the following procedures: (1) Review prior donations of blood

and blood products from donors with no previous history of antibody to

HIV who subsequently test repeatedly reactive for the antibody to HIV;

(2) quarantine in-house blood and blood products; (3) notify consignees

regarding the need to quarantine such products; (4) determine the

suitability for release of such products from quarantine; (5) notify

consignees of such products with antibody testing results from

``lookback'' donors; and (6) notify attending physicians so that

transfusion recipients are informed that they may have received blood

and blood components at increased risk for transmitting HIV. Section

606.160(b)(1)(vii) (21 CFR 606.160(b)(1)(vii)) requires records to

relate the donor with the unit number of each previous donation from

that donor. Section 606.160(b)(1)(viii) requires records of quarantine,

notification, testing, and disposition performed under Secs. 610.46 and

610.47 (21 CFR 610.46 and 610.47). Section 610.46(a) requires blood

establishments to notify consignees, within 72 hours, of repeatedly

reactive tests results so that previously collected blood and blood

components are appropriately quarantined. Section 610.46(b) requires

blood establishments to notify consignees of licensed, more specific

test results for HIV within 30-calendar days after the donors's

repeatedly reactive test. Section 610.47(b) requires transfusion

services not subject to HCFA regulations to notify physicians of prior

donation recipients or to notify recipients themselves of the need for

HIV testing and counseling. There are approximately 3,076 registered

blood establishments that annually collect an estimated 24 million

units of Whole Blood and Source Plasma, and that are required to follow

FDA ``lookback'' procedures. Of these establishments, approximately 180

are registered transfusion services that are not subject to HCFA's

``lookback'' regulations.

The following reporting and recordkeeping estimates are based on

information provided by industry, and FDA experience. In Table 1 of

this document, it is estimated that an average of 60 repeat donors per

establishment will test repeatedly reactive annually. This estimate

results in a total number of 184,560 notifications of these test

results to consignees by blood establishments for the purpose of

quarantine of affected products, and another 184,560

[[Page 60213]]

notifications to consignees of subsequent test results. It is estimated

that transfusion services not subject to HCFA's regulations will need

to notify physicians, or in some cases recipients, an average of 16

times per year resulting in a total number of 2,880 notifications. FDA

estimates an average of 10 minutes per notification of consignees,

physicians, and recipients. The estimate of one-half hour for

Sec. 610.47(b) is based on the minimum requirement of three attempts to

notify recipients by transfusion services. In Table 2 of this document,

the estimate of 154 recordkeepers and 160 records is based on the

estimate that the requirement is already implemented voluntarily by

more than 95 percent of the facilities, which collect 98 percent of the

Nation's blood supply. FDA estimates that it takes approximately 5

minutes to document and maintain the records to relate the donor with

the unit number of each previous donation. The establishment of SOP's

under Sec. 606.100(b)(19) is a one-time burden. The maintenance of the

SOP's is considered usual and customary business practice, therefore no

burden is calculated for the preparation and updating of the SOP.

In the Federal Register of August 3, 1999 (64 FR 42132), the agency

requested comments on the proposed collections 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\

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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610.46(a) 3,076 60 184,560 0.17 31,375

610.46(b) 3,076 60 184,560 0.17 31,375

610.47(b) 180 16 2,880 0.5 1,440

Total 64,190

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

information.

Table 2.--Estimated Annual Recordkeeping Burden \1\

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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606.160(b)(1)(vii) 154 160 24,640 12.8 1,971

606.160(b)(1)(viii) 3,076 60 184,560 4.8 14,765

Total 16,736

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

information.

Dated: October 27, 1999.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.

[FR Doc. 99-28808 Filed 11-3-99; 8:45 am]

BILLING CODE 4160-01-F