3042 Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 / Notices

Dated: January 19, 1996.

Michael G. Beatrice,

Deputy Director, Center for Biologics

Evaluation and Research.

[FR Doc. 96–1656 Filed 1–29–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0369]

Memorandum on the

Recommendations for Donor

Screening With a Licensed Test for

HIV–1 Antigen; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a memorandum to all

registered blood and plasma

establishments, dated August 8, 1995. In

the memorandum, the Center for

Biologics Evaluation and Research

(CBER) recommends the

implementation of donor screening tests

for human immunodeficiency virus,

type 1 (HIV–1) antigen(s) using licensed

tests that are approved for donor

screening. FDA is recommending the

implementation of HIV–1 antigen

screening because of the benefit that it

will provide to a small number of blood

product recipients, as a partial

preventive measure against the

possibility of any increase in HIV–1

‘‘window period’’ donations and to

decrease the virus burden in plasma

pools for fractionation. FDA expects

HIV–1 antigen testing will reduce, but

not eliminate, the residual risk of HIV–

1 from transfusion and, therefore,

regards such screening as only an

interim measure pending the

availability of more advanced test

methodology.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of the memorandum to the

Congressional and Consumer Affairs

Branch (HFM–12), Center for Biologics

Evaluation and Research, Food and

Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448, or call

FDA’s automated information system at

800–835–4709. Send one self-addressed

adhesive label to assist that office in

processing your requests. Submit

written comments on the memorandum

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

memorandum and received comments

are available for public examination in

the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Persons with access to INTERNET

may request the memorandum be sent

by return E-mail by sending a message

to

‘‘HIVANTIGEN@A1.CBER.FDA.GOV’’.

The memorandum may also be obtained

through INTERNET via File Transfer

Protocol (FTP). Requestors should

connect to the Center for Drug

Evaluation and Research (CDER) using

the FTP. CBER documents are

maintained in a subdirectory called

CBER on the server,

‘‘CDVS2.CDER.FDA.GOV’’

(150.148.24.202). The ‘‘READ.ME’’ file

in that subdirectory describes the

available documents which may be

available as an ASCII text file (*.TXT),

or a WordPerfect 5.1 document (*.w51),

or both. A sample dialogue for obtaining

the ‘‘READ.ME’’ file with a text-based

FTP program would be:

FTP CDVS2.CDER.FDA.GOV

LOGIN: ANONYMOUS

<ANY PASSWORD> <‘‘Your E-mail

address’’>

BINARY

CD CBER

GET READ.ME

EXIT

The memorandum may also be

obtained by calling the CBER FAX

Information System (FAX—ON—

DEMAND) at 301–594–1939 from a

touch tone telephone.

FOR FURTHER INFORMATION CONTACT: Paul

A. Mied, Center for Biologics Evaluation

and Research (HFM–310), Food and

Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448, 301–

827–3008.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

memorandum to all registered blood

and plasma establishments, dated

August 8, 1995, recommending the

implementation of donor screening for

HIV–1 antigen with a licensed test

approved for this use. As of August 8,

1995, there were no tests for HIV–1

antigen(s) approved for donor screening.

However, FDA issued these

recommendations in advance of the

availability of such tests in order to

provide blood and plasma

establishments with maximum time to

prepare for implementation of this

testing. These recommendations

supersede some of the rationale/

recommendations provided in a

previous FDA memorandum dated

October 4, 1989, following licensure of

the first test for HIV–1 antigen(s).

Based on the data available in 1989,

FDA did not approve HIV–1 antigen

testing for routine donor screening.

Recently, however, the role of HIV–1

antigen testing in the donor setting has

been reconsidered for several reasons.

For instance, there have been four

documented instances of HIV–1

transmission by HIV–1 antigen positive

blood donations from three HIV–1

antibody negative donors. Also, based

on recent estimates of the antibody

negative infectious ‘‘window period,’’

the residual risk of HIV transmission by

screened blood, and the efficacy of

antigen testing to detect seronegative,

infectious donations, it has been

estimated that donor screening by HIV–

1 antigen can be expected to prevent up

to 25 percent of the current ‘‘window

period’’ cases or about 5 to 10 cases of

transfusion associated HIV infection per

year.

In September 1994, FDA sponsored a

‘‘Conference on the Feasibility of

Genetic Technology to Close the HIV

Window in Donor Screening.’’ Although

the majority of participating experts

expressed the opinion that genetic

techniques were not ready for use in

mass screening, the meeting did spark

renewed interest in considering other

direct viral detection methods for donor

screening, such as HIV–1 antigen testing

as an interim measure to further reduce

current low risk of
Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 / Notices 3043

HIV–1 transmission through

transfusions of blood and blood

products. To further address direct viral

detection methods, FDA brought the

issue of donor screening for HIV–1

antigen to a public meeting of the Blood

Products Advisory Committee (BPAC)

in June 1995. After hearing the most

recent available data on HIV–1 risk in

the blood supply, the estimated efficacy

of antigen screening, and other issues

bearing on a risk/benefit assessment, 9

of the 15 BPAC members present were

of the opinion that donor screening for

HIV–1 antigen by candidate test kits is

not likely to provide a significant public

health benefit which outweighs the

potential risks. After considering the

available information and the opinions

of the BPAC members, FDA

recommended that blood establishments

should implement donor screening for

HIV–1 antigen using licensed tests that

are approved for this indication. FDA

recommended implementation of HIV–1

antigen screening because of the benefit

that it will provide to a small number

of blood product recipients, as a partial

preventive measure against the

possibility of any increase in HIV–1

‘‘window period’’ donations and to

decrease the virus burden in plasma

pools for fractionation.

FDA recommended that the screening

for HIV–1 antigen(s) be implemented

within 3 months of the commercial

availability of the first such test

approved for donor screening for all

donations of Whole Blood, blood

components, Source Leukocytes and

Source Plasma, and all such inventoried

units available for release. FDA also

recommended that consigned withindate units intended for transfusion and

still in the consignee’s inventory be

either replaced with screened units or

tested for HIV–1 antigen(s) as soon as

feasible. The memorandum included

additional recommendations and

information on the following: (1)

Disposition and labeling of units; (2)

donor deferral; (3) Public Health Service

recommendations for donor notification

and counseling; (4) exclusion/retrieval

of potentially contaminated units from

prior collections and notification of

consignees; and (5) notification of

consignees of neutralization test results.

Because HIV–1 antigen testing will

reduce, but not eliminate, the residual

risk of HIV–1 from transfusion, FDA

regards such screening as an interim

measure pending the availability of

better technology for this purpose. FDA

encourages continued development of

new methods to further reduce the risk

of HIV transmissions in the ‘‘window

period.’’

As with other memoranda, FDA does

not intend this document to be allinclusive and cautions that not all

information may be applicable to all

situations. The memorandum is

intended to provide information and

does not set forth new requirements.

The procedures cited in the

memorandum are recommendations.

FDA anticipates that blood and plasma

establishments may develop alternative

procedures and discuss them with FDA.

FDA may find those alternative

procedures acceptable. FDA recognizes

that the scientific technology for

controlling the risk of transmission of

HIV by blood and blood products may

continue to advance and that this

document may become outdated as

those advances occur. The

memorandum does not bind FDA and

does not create or confer any rights,

privileges, or benefits on or for any

private person, but is intended merely

for guidance.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the memorandum. 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. A copy of the memorandum

and received comments may be seen in

the office above between 9 a.m. and 4

p.m., Monday through Friday.

Received comments will be

considered in determining whether

further revisions to the memorandum

are warranted.

Dated: January 22, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–1657 Filed 1–29–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93D–0398]

Microbiological Testing for

Antimicrobial Food-Animal Drugs;

Final Guidance; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Microbiological Testing of

Antimicrobial Drug Residues in Food.’’

The availability of the draft guideline

was announced on January 6, 1994; this

final guidance document addresses the

comments submitted on the draft

guideline. The final guidance document,

which was prepared by the Center for

Veterinary Medicine (CVM), addresses

human food safety issues that may be

associated with food-animal

antimicrobial drug products. This

guidance document also provides points

to consider when determining which

antimicrobials may require

supplemental testing and recommends

test procedures for establishing that

antimicrobial drug residues will not

cause intestinal microflora perturbations

in the consumer.

DATES: Written comments on the

guidance document may be submitted at

any time.

ADDRESSES: Submit written requests for

single copies of the final guidance

document ‘‘Microbiological Testing of

Antimicrobial Drug Residues in Food,’’

to the Communications and Education

Branch (HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1755.

Send two self-addressed adhesive labels

to assist that office in processing your

requests. Submit written comments to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1-23, Rockville,

MD 20857. Requests and comments

should be identified with the docket

number found in brackets in the

heading of this document. A copy of the

guidance document and received

comments may be seen at the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Haydee Fernandez, Center for

Veterinary Medicine (HFV–154), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1684.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of the final

guidance document entitled

‘‘Microbiological Testing of

Antimicrobial Drug Residues in Food.’’

In evaluating the safety of new animal

drugs, the agency must determine,

among other things, their cumulative

effect in man or other animal as

required by section 512(d)(2)(B) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360b(d)(2)(B)). The

guidance document describes the testing

that may be necessary to establish that

antimicrobial drug residues in food will

be safe and will not cause intestinal

microflora perturbations in the

consumer.

In the Federal Register of January 6,

1994 (59 FR 754), FDA issued a notice

of availability of the draft guideline

entitled ‘‘Microbiological Testing of