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:
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices 49697

HCFA, Office of Information Services,

nformation Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: September 15, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards Health Care

Financing Administration.

[FR Doc. 97–25218 Filed 9–22–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences Division of Intramural

Research; Proposed Data Collection

Available for Public Comment and

Recommendation

In compliance with the requirement

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

Paperwork Reduction Act of 1995 for

opportunity for public comment on

proposed data collection projects, the

National Institute of Environmental

Health Sciences (NIEHS) will publish

periodic summaries of proposed

projects. To request more information

on the proposed project or to obtain a

copy of the data collection plans and

instruments, call the NIEHS Project

Clearance Liaison, at (919) 541–5047.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

This notice regards a request for OMB

processing for a proposed study: The

Johnston County ADHD Study:

Environmental, Reproductive and

Familial Risk Factors for Attention

Deficit/Hyperactivity Disorder in

accordance with 5 CFR 1320.13 of the

OMB guidelines. We received

emergency OMB clearance in June 1997

for conducting a pilot study for this

study which is being conducted June

1997–November 1997. The OMB

clearance for the pilot study expires in

November 1997. We are now applying

for clearance for the full study which we

anticipate beginning in January 1998.

New—Proposed Project: The Johnston

County ADHD Study: Environmental,

Reproductive and Familial Risk Factors

for Attention-Deficit/Hyperactivity

Disorder. For the proposed study we

plan to collect questionnaire data from

350 teachers and 2400 parents. Data will

be collected over two years. Teachers

will use a brief symptom checklist to

screen all the children in their class;

about 8,000 children will be screened in

all. We will conduct telephone

interviews with the mothers or

guardians of children identified as

possible cases and a 15% random

sample of control children. If children

meet DSM–IV criteria for ADHD after

both screens, they will be considered

cases. The primary hypotheses of the

study are that preterm delivery and

other reproductive risk factors increase

risk of ADHD and childhood lead

exposure (measured in shed baby teeth)

increases risk of ADHD. In year two of

the study we will use cheek swabs to

collect DNA from 1,200 mothers, 1,200

children, 1,200 siblings and 1,200

fathers to study possible genetic or

familial risk factors for ADHD. The data

collected in this study will allow us to

describe the prevalence of Attention

Deficit/Hyperactivity Disorder in

Johnston County, how prevalence varies

by demographic profile, and to identify

environmental, reproductive and

familial risk factors for the disorder.

Type respondent

Estimated

number of respondents

Estimated

number of responses

Average # responses per respondentAverage burden hours per

response

Total burden

hours

Teachers ............................................................................. 350 10,150 29 .18 1827

Mother/guardian .................................................................. 2400 13,200 5.5 .32 4224

Father .................................................................................. 1,200 1,000 1 .17 204

Study child .......................................................................... 1,200 1,000 1 .17 204

Sibling ................................................................................. 1,200 1,200 1 .17 204

Total Burden: 6,663 hours.

Total Burden per Year: 3,331.5 hours.

REQUEST FOR COMMENTS: Written

comments and/or suggestions from the

public and affected agencies should

address one or more of the following

points: (1) Evaluate whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) Evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and (4) Minimize the burden

of the collection of information on those

who are to respond, including the use

of appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact: Dr. Andrew

Rowland, Senior Staff Fellow, NIEHS,

DIR/EDMP/Epidemiology Branch, PO

Box 12233, RTP, NC 27709, or call nontoll free number (919) 541–7886.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before November 21,

1997.

Dated: September 10, 1997.

Charles Leasure,

Associate Director for Management, NIEHS.

[FR Doc. 97–25150 Filed 9–19–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMNET OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; Notice of Meetings

Pursuant to Public Law 92–463,

notice is hereby given of the meetings of

the National Center for Research

Resources Initial Review Group and the

Scientific and Technical Review Board

on Biomedical and Behavioral Research

Facilities, National Center for Research