Federal Register / Vol. 63, No. 117 /Thursday, June 18, 1998 / Notices 33375

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0381]

Draft Guidance for Industry on

Providing Regulatory Submissions in

Electronic Format—NDA’s; Reopening

of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; reopening of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening until

July 8, 1998, the comment period for a

notice announcing the availability of a

draft guidance for industry entitled

‘‘Providing Regulatory Submissions in

Electronic Format—NDA’s’’ that

appeared in the Federal Register of

April 8, 1998 (63 FR 17184). FDA is

taking this action in response to a

request for an extension and to allow

interested parties additional time for

review and to submit comments.

DATES: Written comments by July 8,

1998. General comments on the agency

guidance documents are welcome at any

time.

ADDRESSES: Copies of the draft guidance

for industry are available on the Internet

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

index.htm. 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single copies of the draft guidance to the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 selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the draft

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; ESUB@CDER.fda.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 8, 1998 (63 FR

17184), FDA’s Center for Drug

Evaluation and Research (CDER)

published a notice announcing the

availability of a draft guidance for

industry entitled ‘‘Providing Regulatory

Submissions in Electronic Format—

NDA’s.’’ The draft guidance is intended

to assist applicants who wish to submit

new drug applications (NDA’s) in

electronic format. Although voluntary,

submissions of NDA’s in electronic

format should reduce the amount of

paperwork for applicants and the

agency. The April 8, 1998, notice

invited interested persons to submit

written comments on the draft guidance

within 60 days.

On April 20, 1998, FDA received a

letter from Pharmaceutical Research and

Manufacturers of America, requesting

that the agency extend the comment

period on the draft guidance 90 days. In

addition, in the Federal Register of June

1, 1998 (63 FR 29741), FDA’s Center for

Biologics Evaluation and Research

(CBER) published a draft guidance for

industry entitled ‘‘Guidance for

Industry: Electronic Submissions of a

Biologics License Application (BLA) or

Product License Application (PLA)/

Establishment License Application

(ELA) to the Center for Biologics

Evaluation and Research.’’

Because a number of NDA sponsors

have expressed the wish to see the draft

guidance become final as soon as

possible and because the agency

considers this to be a dynamic

document, which will be updated in the

future, the agency does not believe it is

necessary to extend the comment period

an additional 90 days. However, the

agency agrees that an additional period

will provide time for interested parties

to review both CDER and CBER’s

guidances. Therefore, the agency is

reopening the comment period for an

additional 30 days, until July 8, 1998.

Interested persons may, on or before

July 8, 1998, submit to the Dockets

Management Branch (address above)

written comments on the draft guidance.

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 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 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16140 Filed 6–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0388]

Draft Guidance for Industry on Topical

Dermatological Drug Product NDA’s

and ANDA’s—In Vivo Bioavailability,

Bioequivalence, In Vitro Release and

Associated Studies; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Topical

Dermatological Drug Product NDA’s and

ANDA’s—In Vivo Bioavailability,

Bioequivalence, In Vitro Release and

Associated Studies.’’ The draft guidance

is intended to provide recommendations

to sponsors of new drug applications

(NDA’s), abbreviated new drug

applications (ANDA’s), and

supplements who intend to perform

bioavailability and bioequivalence

studies for topically applied

dermatological drug products during

either the preapproval or postapproval

period. The agency is seeking comments

on the draft guidance.

DATES: Written comments may be

submitted on the draft guidance by

August 17, 1998. General comments on

the agency guidances are welcome at

any time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm’’ .

Submit written comments on this

draft guidance to the Dockets

Management Branch (HFD–305), Food

and Drug Administration, 12420

Parklawn Dr., rm 1–23, Rockville, MD.

20857. 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.

FOR FURTHER INFORMATION CONTACT:

Vinod P. Shah, Center for Drug

Evaluation and Research (HFD–350),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5635.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Topical

Dermatological Drug Product NDA’s and

ANDA’s—In Vivo Bioavailability,

Bioequivalence, In Vitro Release and

Associated Studies.’’ The draft guidance
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]

BILLING CODE 4160–01–F

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]

BILLING CODE 4120–03–P