Federal Register / Vol. 63, No. 93 /Thursday, May 14, 1998 / Notices 26809

ADDRESSES: Copies of this guidance for

industry are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm, or http://www.fda.gov/cber/

guidelines.htm. Submit written

comments on this guidance to the

Dockets Management Branch (HFD–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. After the comment period,

comments may be submitted to one of

the centers at the address below.

FOR FURTHER INFORMATION CONTACT:

Murray M. Lumpkin, Center for Drug

Evaluation and Research (HFD–

002), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

5400, or

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

1401 Rockville Pike, Rockville, MD

20852–1448, 301–827–0373.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled

‘‘Classifying Resubmissions in Response

to Action Letters.’’ In the Prescription

Drug User Fee Act of 1992 (PDUFA),

FDA committed to certain user fee

performance goals, including the goal of

responding to an applicant’s

resubmission of an original NDA or LA

in 6 months or less. In her letter to

Congress regarding the reauthorization

of PDUFA in November 1997 as part of

the Food and Drug Administration

Modernization Act of 1997

(Modernization Act), the Secretary of

Health and Human Services committed

FDA to recognizing two classes of

resubmissions: Class 1 and Class 2. This

guidance describes the classification of

resubmissions as Class 1 or Class 2

based on the information submitted by

the applicant in response to the action

letter. In addition, the guidance

specifies the percentages of

resubmissions in each class that will be

reviewed and acted upon within a

certain time period from the date the

resubmission is received by FDA, based

on the fiscal year in which the

resubmission is received.

This guidance is being implemented

immediately without prior public

comment because the guidance is

needed to implement the Modernization

Act. However, the agency wishes to

solicit comment from the public and is

providing a 90-day comment period and

establishing a docket for the receipt of

comments.

This guidance is issued as a Level 1

guidance consistent with FDA’s good

guidance practices (62 FR 8961,

February 27, 1997). It represents the

agency’s current thinking on classifying

resubmissions in response to action

letters. 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 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 are to be identified

with the docket number found in

brackets in the heading of this

document. The guidance and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: May 8, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12830 Filed 5–13–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0282]

Guidance for Industry on Submitting

and Reviewing Complete Responses to

Clinical Holds; 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 ‘‘Submitting and Reviewing

Complete Responses to Clinical Holds.’’

This guidance describes how to submit

a complete response if an

investigational new drug application is

placed on clinical hold.

DATES: Written comments may be

submitted on this guidance document

by August 12, 1998. General comments

on agency guidance documents are

welcome at any time.

ADDRESSES: Copies of this guidance for

industry are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm; or http://www.fda.gov/cber/

guidelines.htm. Submit written

comments on this guidance to the

Dockets Management Branch (HFD–

305), Food and Drug Administration,

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

MD. 20857. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. After the comment period,

comments may be submitted to one of

the centers at the addresses that follow.

FOR FURTHER INFORMATION CONTACT:

Murray M. Lumpkin, Center for Drug

Evaluation and Research (HFD–

002), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

5400; or

Robert A. Yetter, Center for Biologics

Evaluation and Research, 1401

Rockville Pike, Rockville, MD

20852–1448, 301–827–0373.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled

‘‘Submitting and Reviewing Complete

Responses to Clinical Holds.’’ Section

117 of the Food and Drug

Administration Modernization Act of

1997 (Modernization Act), signed into

law by President Clinton on November

21, 1997, provides that a written request

that a clinical hold be removed shall

receive a decision in writing, specifying

the reasons for that decision, within 30

days after receipt of such request. In

addition, the agency committed to user

fee performance goals incorporating the

same response time. This guidance

describes how sponsors should submit

responses to clinical holds so that they

may be identified as complete responses

and the agency can track the time to

response.

This guidance document is being

implemented immediately without prior

public comment because the guidance is

needed to implement the Modernization

Act. However, the agency wishes to

solicit comment from the public and is

providing a 90-day comment period and

establishing a docket for the receipt of

comments.

This guidance for industry is a Level

1 guidance consistent with FDA’s Good

Guidance Practices (62 FR 8961,

February 27, 1997). It represents the

agency’s current thinking on submitting

complete responses to clinical holds. 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.

The guidance and comments received

in the Dockets Management Branch

(address above) are available for public

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

Monday through Friday.
26810 Federal Register / Vol. 63, No. 93 /Thursday, May 14, 1998 / Notices

Dated: May 8, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12831 Filed 5–13–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–229]

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: Extension of a currently

approved collection; Title of

Information Collection: Development of

an Assessment System for post Acute

Care; Form No.: HCFA–R–229, OMB

#0938–0720; Use: The Minimum Data

Set- Post Acute Care (MDS–PAC) will be

used to establish patient case mix

groups including classes of patients in

the rehabilitation facility for the

payment system. It will also provide

data and seek input from the

rehabilitation industry for HCFA to

formulate policy and promulgate

regulations. Frequency: On occasion;

Affected Public: Individuals or

Households, Business or other for-profit,

Not-for-profit; Number of Respondents:

10,465; Total Annual Responses:

10,465; Total Annual Hours: 23,301.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, 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:

HCFA, Office of Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: May 5, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 98–12766 Filed 5–13–98; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–250 through

HCFA–254]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

AGENCY: Health Care Financing

Administration, HHS

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 this 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.

We are, however, requesting an

emergency review of the information

collections referenced below. In

compliance with the requirement of

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

Reduction Act of 1995, we have

submitted to the Office of Management

and Budget (OMB) the following

requirements for emergency review. We

are requesting an emergency review

because the collection of this

information is needed before the

expiration of the normal time limits

under OMB’s regulations at 5 CFR, Part

1320. This is necessary to collect

information from beneficiaries on health

insurance coverage that is primary to

Medicare. Collection of this information

allows HCFA to identify those Medicare

beneficiaries who have other group

health insurance that would pay before

Medicare, resulting in savings to the

Medicare Trust Fund. The annual

savings from the Medicare Secondary

Payer (MSP) program are more than $3

billion per year. Emergency approval is

needed to prevent a disruption in the

information collection and to continue

the savings to the Medicare Trust Fund.

We cannot reasonably comply with the

normal clearance procedures because

public harm is likely to result because

eligible individuals may not receive the

health insurance protections under the

statute.

HCFA is requesting OMB review and

approval of this collection 15 working

days after the publication of this

Federal Register notice, with a 180-day

approval period. Written comments and

recommendations will be accepted from

the public if received by the individuals

designated below 14 working days after

the publication of this notice. During

this 180-day period, we will publish a

separate Federal Register notice

announcing the initiation of an

extensive 60-day agency review and

public comment period on these

requirements. We will submit the

requirements for OMB review and an

extension of this emergency approval.

Type of Information Request:

Reinstatement, without change, of a

previously approved collection for

which approval has expired;

Title of Information Collection:

Medicare Secondary Payer Information

Collection and Supporting Regulations

in 42 CFR 489.20;

Form Number: HCFA–250 through

HCFA–2545 (OMB approval #: 0938–

0214);

Use: Medicare Secondary Payer (MSP)

is essentially the same concept known

in the private insurance industry as

coordination of benefits, and refers to

those situations where Medicare does

not have primary responsibility for

paying the medical expenses of a

Medicare beneficiary. HCFA contracts

with health insuring organizations,

herein referred to as intermediaries and

carriers, to process Medicare claims.

HCFA charges its Medicare

intermediaries and carriers with various

tasks to detect MSP cases; develops and

disseminates tools to enable them to