64226 Federal Register / Vol. 65, No. 208 / Thursday, October 26, 2000 / Notices

Dated: October 13, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27452 Filed 10–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0282]

Revised 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 revised 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

(IND) application is placed on clinical

hold. The revised guidance reflects

amendments to FDA’s clinical hold

regulations, includes the definition of a

commercial IND, and discusses the

agency’s policy on resolving clinical

trial issues that are not related to the

imposition of a clinical hold.

DATES: 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 (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Comments are to be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Linda S. Carter (HFD–101), Center for

Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

6578; or Robert A. Yetter (HFM–10),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

0373.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a revised

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.

Section 117(3)(c) of the Modernization

Act is codified in the Federal Food,

Drug, and Cosmetic Act at section

505(i)(3)(c) (21 U.S.C. 355(i)(3)(c)). In

addition, the agency committed to user

fee performance goals incorporating the

same response time. In the Federal

Register of December 14, 1998 (63 FR

68676), FDA amended its clinical hold

regulations in § 312.42(e) (21 CFR

312.42(e)) to include this 30-day

response requirement. 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.

In the Federal Register of May 14,

1998 (63 FR 26809), FDA published a

notice announcing the availability of the

original guidance and soliciting

comments. Two comments on the

guidance were submitted to the docket.

After considering the comments, FDA is

issuing a revised guidance.

The revised guidance: (1) Reflects

amendments to FDA’s clinical hold

regulations, stating that FDA will

respond in writing within 30-calendar

days of receipt of a sponsor’s request to

release a clinical hold and complete

response to the issue(s) that led to the

clinical hold (§ 312.42(e)); (2) includes

the definition of a commercial IND and

clarifies that the Prescription Drug User

Fee Act goals apply only to commercial

IND’s, although the 30-calendar day

response applies to all IND clinical hold

complete responses; and (3) states that

clinical trial issues that are not related

to the imposition of a clinical hold may

be discussed in the letter placing the

trial on clinical hold, but will be clearly

marked as nonhold issues and that a

sponsor’s response to such nonhold

issues should be addressed in a separate

amendment to the IND.

The collection of information

contained in the revised guidance has

been approved by the Office of

Management and Budget under OMB

control number 0910–0445.

This revised guidance document

supersedes the original guidance. This

Level 1 guidance document is being

issued consistent with FDA’s good

guidance practices (65 FR 56468,

September 19, 2000). The revised

guidance represents the agency’s current

thinking on the submission of 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

and regulations.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the

guidance at any time. 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: October 13, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27453 Filed 10–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–304 and 304a]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Reconciliation