33376 Federal Register / Vol. 63, No. 117 /Thursday, June 18, 1998 / Notices

is intended to provide recommendations

to sponsors of NDA’s, ANDA’s, and

supplements who intend to perform,

during either the preapproval or

postapproval period, bioavailability and

bioequivalence studies for topical

dermatological drug products.

The definitions of ‘‘bioavailability’’

and ‘‘bioequivalence,’’ the requirements

for submitting such data in NDA’s,

ANDA’s, and supplements, and the

types of in vivo studies that are

acceptable to establish bioavailability

and bioequivalence are set forth in CFR

part 320. These regulatory definitions

and requirements reflect requirements

in the Federal Food, Drug, and Cosmetic

Act and other agency regulations.

Generally, bioavailability and

bioequivalence of a drug product can be

assessed through measurement of the

active moiety(ies)/active ingredient(s) in

an accessible biologic fluid such as

blood, plasma, and urine. For some drug

products, including topical

dermatological drug products, it is not

possible to use pharmacokinetic

measurements of the active moiety(ies)/

active ingredient(s) in blood, plasma, or

urine to document bioequivalence

because topical dermatological products

generally do not produce measurable

concentrations in extracutaneous

biological fluids. This draft guidance

document proposes other methods to

establish bioavailability and

bioequivalence, including the following

types of studies: (1) Clinical studies; (2)

pharmacodynamic studies; (3)

dermatopharmacokinetic studies; and

(4) in vitro studies. These approaches

are discussed at 21 CFR 320.24,

although these regulations do not

provide specific methodologic

approaches. In addition to general

comments, FDA welcomes the

submission of data that support or refute

the use of any of these approaches,

especially dermatopharmacokinetic

approaches, in the documentation of

bioavailiability and bioequivalence of

topical dermatological drug products.

FDA also welcomes the submission of

relevant clinical,

dermatopharmacokinetic, and in vitro

release data for further evaluation of

these approaches in the guidance. At

some time following receipt of public

comments and other information to this

draft guidance, FDA intends to discuss

the guidance and the public response to

the guidance before a joint meeting of

the Advisory Committee for

Pharmaceutical Science and the

Dermatologic and Ophthalmic Drugs

Advisory Committee.

This draft guidance is a level 1 draft

guidance document consistent with

FDA’s good guidance practices (62 FR

8961, February 27, 1997). It represents

the agency’s current thinking on

bioavailability and bioequivalence

approaches for topical dermatological

drug products. 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.

Submit written requests for single

copies of the draft guidance 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

self-addressed adhesive label to assist

that office in processing your requests.

Requests should be identified with the

docket number found in brackets in the

heading of this document. Copies of the

draft 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: June 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16141 Filed 6–17–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–SP–0001]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration.

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: Medicaid PostEligibility Preprint and Supporting

Regulations in 42 CFR 430.10; Form

No.: HCFA–SP–0001 (OMB# 0938–

0673); Use: The post-eligibility preprint

is part of the comprehensive statement

that a State submits to show that it is

meeting the requirements for Federal

funding of its Medicaid program. It

comprises part of each State’s Plan

which outlines the mandatory and

optional aspects of a State’s Medicaid

program. Accurate submission of this

information is necessary in order for

States to receive Federal funding.;

Frequency: On occasion; Affected

Public: State, local or tribal government

and Federal Government; Number of

Respondents: 56; Total Annual

Responses: 56; Total Annual Hours:

280.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, 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 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: June 9, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 98–16148 Filed 6–17–98; 8:45 am]

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