49694 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before October 23, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: August 26, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25180 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0318]

Revised Precautionary Measures to

Reduce the Possible Transmission of

Creutzfeldt-Jakob Disease (CJD) by

Blood and Blood Products; Guidance

Document; 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 ‘‘Revised Precautionary

Measures to Reduce the Possible

Transmission of Creutzfeldt-Jakob

Disease (CJD) by Blood and Blood

Products,’’ dated December 11, 1996.

The guidance document is intended to

provide recommendations to the blood

industry and may include information

useful to other interested persons.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Revised Precautionary

Measures to Reduce the Possible

Transmission of Creutzfeldt-Jakob

Disease (CJD) by Blood and Blood

Products’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The guidance document may also be

obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Joseph Wilczek, Center for Biologics

Evaluation and Research (HFM–350),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–3514.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance document entitled ‘‘Revised

Precautionary Measures to Reduce the

Possible Transmission of CreutzfeldtJakob Disease (CJD) by Blood and Blood

Products,’’ dated December 11, 1996,

and sent to all registered blood and

plasma establishments and all

establishments engaged in

manufacturing plasma derivatives.

The guidance document updates and

supersedes the FDA guidance

documents of August 8, 1995, entitled

‘‘Disposition of Products Derived from

Donors Diagnosed with, or at Known

High Risk for, Creutzfeldt-Jakob

Disease’’ and ‘‘Precautionary Measures

to Further Reduce the Possible Risk of

Transmission of Creutzfeldt-Jakob

Disease by Blood and Blood Products,’’

and the November 25, 1987, guidance

document entitled ‘‘Deferral of Donors

Who Have Received Human PituitaryDerived Growth Hormone.’’

The guidance document presents

recommendations for donor deferral,

product disposition, recipient

notification, and labeling. The

recommendations were developed after

considering donor and product risk

factors and the impact such

recommendations could have on the

availability of blood and blood

products. Topics addressed in the

guidance document include: (1)

Recommended questions that will help

identify donors at an increased risk for

CJD; (2) recommended actions to take

when a donor is identified to be at an

increased risk for developing CJD; (3)

recommended actions to take when a

donor is subsequently diagnosed with

CJD; (4) recommendations for recipient

notification and counseling; (5)

recommendations for disposition of

implicated products; and (6)

recommendations for the labeling of

implicated products intended for

research or further manufacture into

non-injectable products. The guidance

document also includes FDA’s

recommendations regarding ‘‘lookback’’

notification of persons possibly exposed

to CJD contaminated blood or blood

products.

As with other guidance documents,

FDA does not intend this document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. It is intended to provide

recommendations and does not set forth

requirements. In response to public

comment, development of suitable

alternatives or other new information,

FDA may revise the guidance document

at anytime to improve its usefulness.

Any revisions to this guidance

document will be announced in the

Federal Register. The recommendations

in the guidance document represent the

agency’s current thinking on

precautionary measures to use to reduce

the possible transmission of CJD by

blood and blood products. 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 requirements of the

applicable statute, regulations, or both.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the

guidance document. 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. Any

comments previously submitted to the

Division of Blood Applications (HFM–

370), CBER, FDA, do not have to be

resubmitted. Comments previously

submitted will be filed with the Dockets

Management Branch (address above)

under the docket number in the heading

of this document. The guidance

document 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 revision is warranted.

Persons with access to the Internet

may obtain the guidance document
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices 49695

using the World Wide Web (WWW). For

WWW access, connect to CBER’s site at

‘‘http://www.fda.gov/cber/memo.htm’’.

Dated: September 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25181 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0319]

Interim Recommendations for Deferral

of Donors at Increased Risk for HIV–1

Group O Infection; Guidance

Document; 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 ‘‘Interim Recommendations for

Deferral of Donors at Increased Risk for

HIV–1 Group O Infection,’’ dated

December 11, 1996. The guidance

document, which discusses the

appearance in 1996 of two cases of HIV–

1 Group O infection in the United

States, is intended to provide interim

measures to reduce the risk of HIV–1

Group O transmission by blood and

blood products pending the licensure of

test kits specifically labeled for

detection of antibodies to HIV–1 Group

O viruses. The guidance document

recommends adding three questions to

screening questionnaires used to

exclude donors at high risk of HIV–1

infection.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Interim

Recommendations for Deferral of

Donors at Increased Risk for HIV–1

Group O Infection’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. The guidance document may

also be obtained by mail by calling the

CBER Voice Information System at 1–

800–835–4709 or 301–827–1800, or by

fax by calling the FAX Information

System at 1–888–CBER–FAX or 301–

827–3844.

FOR FURTHER INFORMATION CONTACT:

Joseph Wilczek, Center for Biologics

Evaluation and Research (HFM–350),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–3514.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance document entitled ‘‘Interim

Recommendations for Deferral of

Donors at Increased Risk for HIV–1

Group O Infection.’’ It was dated

December 11, 1996, and sent to all

registered blood and plasma

establishments. The guidance

document, which discusses the

appearance in 1996 of two cases of HIV–

1 Group O infection in the United

States, recommends adding three

questions to screening questionnaires

used to exclude donors at high risk for

HIV–1 infection. These

recommendations are intended to be

interim measures to reduce the risk of

HIV–1 Group O transmission by blood

and blood products pending the

licensure of test kits specifically labeled

for detection of antibodies to HIV–1

Group O viruses.

As with other guidance documents,

FDA does not intend this guidance

document to be all-inclusive and

cautions that not all information may be

applicable to all situations. It is

intended to provide recommendations

and does not set forth requirements. In

response to public comment,

development of suitable alternatives or

other new information, FDA may revise

this guidance document at any time to

improve its usefulness. Any revisions to

this document will be announced in the

Federal Register. The recommendations

in the document represent the agency’s

current thinking on screening and

deferral of donors at increased risk for

HIV–1 Group O infection. 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 requirements of the

applicable statute, regulations, or both.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the guidance document.

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. Any comments previously

submitted to the Division of Blood

Applications (HFM–370), CBER, FDA,

do not have to be resubmitted.

Comments previously submitted will be

filed with the Dockets Management

Branch (address above) under the

docket number in the heading of this

document. The document 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 revision is

warranted.

Persons with access to the Internet

may obtain the document by using the

World Wide Web (WWW). For WWW

access, connect to CBER’s site at ‘‘http:/

/www.fda.gov/cber/memo.htm’’.

Dated: September 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25128 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0381]

Guidance for Industry on Archiving

Submissions in Electronic Format—

NDA’s; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Archiving Submissions in

Electronic Format—NDA’s.’’ This

guidance is intended to describe how to

submit records and other documents in

electronic format to the Center for Drug

Evaluation and Research (CDER) for

archival purposes. Guidance is provided

on submitting case report forms and

case report tabulations as part of new

drug applications (NDA’s). This is the

first in a series of guidances for industry

that will address archiving NDA

submissions in electronic format.

Guidance for industry on other

submission types will be made available

as they are completed. The submission

of records in electronic format should

reduce the amount of paperwork for

applicants and the agency. Submissions

in electronic format are voluntary.

DATES: Written comments may be

submitted at any time.