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.
49696 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices

ADDRESSES: Submit written requests for

single copies of the guidance for

industry entitled ‘‘Archiving

Submissions in Electronic Format—

NDA’s’’ to the Drug Information Branch

(HFD–210), Center for Drug Evaluation

and Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Kenneth Edmunds, Center for Drug

Evaluation and Research (HFD–350),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3276, e-mail:

ESUB@CDER.fda.gov.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled

‘‘Archiving Submissions in Electronic

Format—NDA’s.’’ Traditionally, FDA

has required that regulatory

submissions, such as investigational

new drug applications and NDA’s, be

submitted as paper documents. The

regulations in part 314 (21 CFR part

314), for example, set forth the

requirements and procedures for

submitting applications to obtain

approval for the marketing of new drugs

to FDA. These regulations require the

submission of three copies of an

application for marketing approval: (1)

A complete archival copy, (2) a review

copy, and (3) a field copy (§ 314.50(k)).

In the Federal Register of March 20,

1997 (62 FR 13430), FDA published the

Electronic Records; Electronic

Signatures regulation that provides for

the voluntary submission of parts or all

of an application, as defined in the

relevant regulations, in electronic

format without an accompanying paper

copy (21 CFR part 11). The agency also

established public docket number 92S–

0251 so the agency can maintain a list

of the specific types of records and

submissions that can be accepted in

electronic format (62 FR 13467, March

20, 1997). The agency unit(s) that are

prepared to receive electronic

submissions are to identify themselves

in that docket. The regulation states that

persons should consult with the

intended agency receiving unit for

details on how to proceed with the

electronic submission. The guidance is

intended to reduce the need on the part

of sponsors to consult CDER for details

on archiving electronic submissions.

The guidance specifically addresses the

NDA and includes subsections on how

to submit case report forms and case

report tabulations in electronic format to

CDER for the archive. Conforming to the

guidance in this document will help

ensure that submissions provided to

CDER in electronic format can be

accessed, handled, reviewed, and

maintained efficiently.

The guidance is the first in a series

that will be issued on archiving

electronic submissions to CDER. As a

result, it is not all inclusive. CDER

anticipates that, as this effort proceeds,

sponsors, investigators, and CDER staff

may develop alternative and more

effective procedures for submitting

electronic applications for the archive.

For this reason, the guidance will be

updated periodically.

The guidance represents the agency’s

current thinking on electronic

submissions for the archive for NDA’s.

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 requirement

of the applicable statute, regulations, or

both.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments and requests are to be

identified with the docket number

found in brackets 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.

An electronic version of the guidance

also is available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm’’.

Dated: September 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25126 Filed 9–17–97; 4:58 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–304A]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) the

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Reconciliation

of State Invoice and Prior Quarter

Adjustment Statement; Form No.:

HCFA–304A; Use: In response to a need

for improved data exchange between

drug labelers and States, HCFA, in

conjunction with outside consultants,

developed the Reconciliation of State

Invoice (ROSI), form HCFA–304, and

the Prior Quarter Adjustment Statement

(PQAS), form HCFA–304A. The ROSI is

to be used by Drug Labelers when

responding to State invoices of current

quarter utilization data only and

functions as a reconciliation report to

assure accurate rebate payments. The

PQAS is used by labelers to report only

on prior quarter actions/payments. Prior

quarter activity includes changes to

utilization data submitted by States,

revisions to previously disputed units,

and prior period adjustments (URA

changes). Both forms assist in reducing

disputes by standardizing data exchange

and improving communication between

Drug labelers and States. Frequency:

Quarterly; Affected Public: Business or

other for-profit; Number of

Respondents: 365; Total Annual

Responses: 1,460; Total Annual Hours:

132,120.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address: