Agency Information Collection Activities: Proposed Collection; 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: Proposed Collection;

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.

-----------------------------------------------------------------------

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

opportunity for public comment on the proposed collection of certain

information by the agency. Under the Paperwork Reduction Act of 1995

(the PRA), Federal agencies are required to publish notice in the

Federal Register concerning each proposed collection of information,

including each proposed collection extension of an existing collection

of information, and to allow 60 days for public comment in response to

the notice. This notice solicits comments on information collection

provisions relating to the regulation of FDA's current good

manufacturing practices for blood and blood components; notification of

consignees receiving blood and blood components at increased risk for

transmitting human immunodeficiency virus (HIV) infection.

DATES: Submit written comments on the collection of information by

October 4, 1999.

ADDRESSES: Submit written comments on the collection of information to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should

be identified with the docket number found in brackets in the heading

of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal

agencies must obtain approval from the Office of Management and Budget

(OMB) for each collection of information they conduct or sponsor.

``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests or requirements that members of

the public submit reports, keep records, or provide information to a

third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))

requires Federal agencies to provide a 60-day notice in the Federal

Register concerning each proposed collection of information, including

each proposed extension of an existing collection of information,

before submitting the collection to OMB for approval. To comply with

this requirement, FDA is publishing notice of the proposed collection

of information set forth in this document.

With respect to the following collection of information, FDA

invites comments on: (1) Whether the proposed collection of information

is necessary for the proper performance of FDA's functions, including

whether the information will have practical utility; (2) the accuracy

of FDA's estimate of the

[[Page 42133]]

burden of the proposed collection of information, including the

validity of the methodology and assumptions used; (3) ways to enhance

the quality, utility, and clarity of the information to be collected;

and (4) ways to minimize the burden of the collection of information on

respondents, including through the use of automated collection

techniques when appropriate, and other forms of information technology.

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 Number 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 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 24,000,000 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, 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 notifications to consignees of subsequent

test results. It is estimated that transfusion services not subject to

HCFA 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, 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.

FDA estimates the burden of this collection of information as

follows:

[[Page 42134]]

Table 1.--Estimated Annual Reporting Burden\1\

----------------------------------------------------------------------------------------------------------------

Annual

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

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

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

information.

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

----------------------------------------------------------------------------------------------------------------

Annual

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

Recordkeepers Recordkeeping Records Recordkeeper

----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

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

information.

Dated: July 27, 1999

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning and Legislation.

[FR Doc. 99-19794 Filed 8-2-99; 8:45 am]

BILLING CODE 4160-01-F