27092 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 / Notices

Dated: May 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12897 Filed 5–14–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0456]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Conditions for the Use of Narcotic

Drugs for Treatment of Narcotic

Addiction, Reporting and

Recordkeeping Requirements,’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 25, 1997

(62 FR 62773), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0140. The

approval expires on April 30, 2001.

Dated: May 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12902 Filed 5–14–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0287]

Guidance for Industry on Buspirone

Hydrochloride Tablets In Vivo

Bioequivalence and In Vitro

Dissolution Testing; 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 ‘‘Buspirone Hydrochloride

Tablets In Vivo Bioequivalence and In

Vitro Dissolution Testing.’’ This is

revision 1 of the guidance. The guidance

has been revised to reflect the recent

availability of buspirone hydrochloride

tablets in 15-milligram dosage forms.

Bioequivalence is tested using the

highest available dosage of the reference

listed drug. The revised guidance also

notes the nonlinearity of buspirone at

multiple-dosing.

DATES: Written comments on agency

guidance documents may be submitted

at any time.

ADDRESSES: Copies of this guidance for

industry are available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm’’. Submit written requests for

single copies of ‘‘Buspirone

Hydrochloride Tablets In Vivo

Bioequivalence and In Vitro Dissolution

Testing’’ 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 this

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:

Sikta Pradhan, Center for Drug

Evaluation and Research (HFD–652),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–5847.

SUPPLEMENTARY INFORMATION: This

guidance document is a level 2 guidance

document consistent with FDA’s good

guidance practices (62 FR 8961,

February 27, 1997). It represents the

agency’s current thinking on buspirone

hydrochloride tablets in vivo

bioequivalence and in vitro dissolution

testing. 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 submit written

comments on the guidance at any time

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 K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12903 Filed 5–14–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0276]

Guidance for Industry on Standards for

the Prompt Review of Efficacy

Supplements, Including Priority

Efficacy Supplements; 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 ‘‘Standards for the Prompt

Review of Efficacy Supplements,

Including Priority Efficacy

Supplements.’’ As required by the Food

and Drug Administration Modernization

Act of 1997 (Modernization Act), this

guidance for industry describes the

standards for the prompt review of

efficacy supplements. It also is intended

to define those efficacy supplements

that are eligible for priority review.

DATES: Written comments may be

submitted on the guidance document by

August 13, 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,
Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 / Notices 27093

1See U.S. Congress, Senate Committee on Labor

and Human Resources, ‘‘Food and Drug

Administration Modernization Act of 1997,’’ S.

Rept. 105–43 on S. 830, pp. 41–42, 105th Cong., 1st

sess., 1 July 1997; and House Committee on

Commerce, ‘‘Prescription Drug User Fee

Authorization and Drug Regulation Act of 1997,’’ H.

Rept. 105–310 on H.R. 1411, pp. 63–64, 105th

Cong., 1st sess., 7 October 1997.

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 below.

FOR FURTHER INFORMATION CONTACT:

Joseph P. Griffin, Center for Drug

Evaluation and Research (HFD–7),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–594–2041, or

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852–1448, 301–827–0373.

SUPPLEMENTARY INFORMATION: Section

403(a) of the Modernization Act requires

that FDA publish in the Federal

Register standards for the ‘‘prompt

review of supplemental applications

submitted for approved articles * * *.’’

The legislative history indicates that

this provision was directed at certain

types of efficacy supplements, i.e.,

supplemental applications proposing to

add a new use of an approved drug to

the product labeling.1 Section 403(b)(3)

of the Modernization Act requires that

FDA provide guidance to define

supplemental applications that are

eligible for priority review. This

guidance document fulfills both

Modernization Act requirements.

Section 101 of the Modernization Act

reauthorized for an additional 5 years,

with certain technical changes, the user

fee program described in the

Prescription Drug User Fee Act of 1992.

Section 101 of the Modernization Act

directed that the user fees authorized by

the amendments in that subtitle be

dedicated toward expediting the drug

development process and the review of

human drug applications as set forth in

the performance goals identified in

letters from the Secretary of Health and

Human Services to the chairman of the

Committee on Commerce of the House

of Representatives and the chairman of

the Committee on Labor and Human

Resources of the Senate, as set forth in

the Congressional Record. The

referenced performance goals include

standards for the review of efficacy

supplements and distinguish between

priority and standard supplements. The

guidance also defines ‘‘priority’’ for

purposes of applying the performance

goals.

The guidance document is being

issued as a Level 1 guidance consistent

with FDA’s good guidance practices (62

FR 8961, February 27, 1997). It is being

implemented 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 document represents

the agency’s current thinking on the

standards for the prompt review of

efficacy supplements. 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 document 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 document and

received comments are available for

public examination in the office above

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

through Friday.

Dated: May 8, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12900 Filed 5–14–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0100]

Guidance for Industry on Providing

Clinical Evidence of Effectiveness for

Human Drugs and Biological Products;

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 ‘‘Providing Clinical Evidence of

Effectiveness for Human Drug and

Biological Products.’’ The purpose of

this guidance is to clarify what clinical

evidence of effectiveness should be

provided in new drug applications,

biological product license applications,

and supplemental applications for new

uses of drugs and biologics. The

guidance is also intended to fulfill the

requirements of certain provisions of the

Food and Drug Administration

Modernization Act of 1997 (the

Modernization Act).

DATES: General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: An electronic version of this

guidance is available via the Internet at

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

index.htm and at http://www.fda.gov/

cber/guidelines.htm. Submit written

comments on this guidance to the

Dockets Management Branch (HFA–

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.

FOR FURTHER INFORMATION CONTACT:

Joseph P. Griffin, Center for Drug

Evaluation and Research (HFD–5), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5400.

SUPPLEMENTARY INFORMATION: The draft

guidance for industry entitled

‘‘Providing Clinical Evidence of

Effectiveness for Human Drug and

Biological Products’’ (the draft

guidance) was initially developed as

part of an effort to get more information

about valid uses of marketed drugs into

the labeling of these drugs. Uncertainty

on the part of the industry about the

evidentiary requirements for

demonstrating effectiveness for a

supplemental indication was believed to

be an obstacle to sponsors submitting

applications for supplemental

indications. The draft guidance was

intended to clarify the amount and

types of evidence that could be used to

demonstrate effectiveness and thereby

facilitate submission of additional

supplemental applications. In the

Federal Register of March 21, 1997 (62

FR 13650), FDA announced the

availability of the draft guidance. The

notice gave interested persons an

opportunity to submit comments by

May 20, 1997.

On November 21, 1997, the President

signed the Modernization Act (Pub. L.

105–115), which addressed both the

standards for providing clinical

evidence of effectiveness and the

evidentiary requirements for

supplemental applications. Section 115

of the Modernization Act amended the

definition of substantial evidence in

section 505(d) of the Federal Food,