Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Notices 44975

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Dissolution Testing of

Immediate Release Solid Oral Dosage

Forms’’ 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

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

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

guidance for industry entitled

‘‘Dissolution Testing of Immediate

Release Solid Oral Dosage Forms.’’ The

purpose of this guidance document is to

provide: (1) General recommendations

for dissolution testing, (2) approaches

for setting dissolution specifications

related to biopharmaceutic

characteristics of the drug substance, (3)

statistical methods for comparing

dissolution profiles, and (4) a process to

help determine when dissolution testing

is sufficient to grant a waiver for an in

vivo bioequivalence study. Three

categories of dissolution test

specifications for immediate release

drug products are described in the

guidance: (1) Single-point specifications

as routine quality control tests; (2) twopoint specifications for characterizing

the quality of the product and as a

routine quality control test for certain

types of drug products; and (3)

dissolution profile comparison for

accepting product sameness under

scale-up and postapproval related

changes (SUPAC), to waive

bioequivalence requirements for lower

strengths of a dosage form, and to

support waivers of other bioequivalence

requirements.

This document also provides

recommendations for dissolution tests

to help ensure continuous drug product

quality and performance after certain

postapproval manufacturing changes.

This guidance document represents

the agency’s current thinking on the

dissolution testing of immediate release

solid oral dosage forms. 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 and requests are to be

identified with the docket number

found in brackets in the heading of this

document. The guidance document and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

An electronic version of this guidance

is also available on the Internet at http:/

/www.fda.gov/cder/guidance.htm.

Dated: August 15, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–22422 Filed 8–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–3010]

Draft Guidance for Industry on Testing

Limits in Stability Protocols for

Standardized Grass Pollen Extracts;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry on Testing Limits in Stability

Protocols for Standardized Grass Pollen

Extracts (July 1997).’’ This draft

guidance document is intended to

provide information to manufacturers

regarding the development of stability

studies to determine the shelf life of

standardized grass pollen extracts to

help ensure the safety, purity, and

potency of these products.

DATES: Written comments may be

submitted at any time, however, to

ensure comments are considered for the

next revision they should be submitted

by October 24, 1997.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for Industry

on Testing Limits in Stability Protocols

for Standardized Grass Pollen Extracts

(July 1997)’’ to the Center for Biologics

Evaluation and Research, Food and

Drug Administration, Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

1401 Rockville Pike, Rockville, MD

20852–1448. Send one self-addressed

adhesive label to assist that office in

processing your request. The draft

guidance document may also be

obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Timothy W. Beth, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance document entitled ‘‘Guidance

for Industry on Testing Limits in

Stability Protocols for Standardized

Grass Pollen Extracts (July 1997).’’ The

draft guidance document provides a

discussion of issues that should be

considered in the development of

stability protocols for allergenic extracts

derived from grass pollen for diagnostic

and immunotherapeutic uses.

The draft guidance document is

intended to provide information to

manufacturers regarding stability

studies on grass pollen extracts. Such

stability studies are used to empirically

determine the shelf life of the product.

This draft guidance document does not,

however, change lot release criteria for

these products. Issues addressed in the

draft guidance document include but

are not limited to: (1) Current lot release

criteria, (2) lot release versus stability

protocol, (3) modified stability protocol,

(4) retesting, (5) dealing with test

failure, and (6) extension of dating.

As with other guidance documents,

FDA does not intend this draft guidance

document to be all-inclusive and

cautions that not all information may be

applicable to all situations. The draft

guidance document is intended to

provide information and does not set

forth requirements. The methods and

procedures presented in the draft

guidance document are suggestions.

FDA anticipates that sponsors and

investigators may develop alternative

methods and procedures and discuss

them with FDA. FDA may find those

alternative methods and procedures

acceptable. FDA recognizes that
44976 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Notices

advances will continue in the area of

allergenic extracts and that this

document may become outdated as

those advances occur. This draft

guidance document represents the

agency’s current thinking on testing

limits in stability protocols for

standardized grass pollen extracts. 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 submit written

comments on the draft guidance

document to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. The draft 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. Comments

received will be considered in

determining whether further revision of

the draft guidance document is

warranted.

Persons with access to the INTERNET

may obtain the draft guidance document

by using the World Wide Web (WWW).

For WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’.

Dated: August 15, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–22421 Filed 8–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Notice of Listing of Members of the

Food and Drug Administration’s Senior

Executive Service Performance Review

Board

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) announces the

persons who will serve on the FDA

Performance Review Board (PRB). This

action is being taken in accordance with

Title 5 U.S.C. 4314(c)(4), which requires

that members of performance review

boards be appointed in a manner to

ensure consistency, stability, and

objectivity in performance appraisals,

and requires that notice of the

appointment of an individual to serve as

a member be published in the Federal

Register.

FOR FURTHER INFORMATION CONTACT:

Arlene S. Karr, Office of Human

Resources and Management Services

(HFA–408), Food and Drug

Administration, 5600 Fishers Lane, rm.

7B–32, Rockville, MD 20857, 301–827–

4183.

The following persons will serve on the

FDA PRB, which oversees the

evaluation of performance appraisals of

FDA’s Senior Executive Service (SES)

members:

Michael A. Friedman, M.D.,

Chairperson

Robert J. Byrd

Margaret J. Porter

Sharon Smith Holston

Mary K. Pendergast

William B. Schultz

Dated: August 14, 1997.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

[FR Doc. 97–22420 Filed 8–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA 1763, 2088 and

R–142]

Agency Information Collection

Activities: Submission for OMB

Review; 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 summaries 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.

1. Type of Information Collection

Request: Reinstatement, without change,

of a previously approved collection for

which approval has expired; Title of

Information Collection: Request for

Termination of Premium Hospital and/

or Supplementary Medical Insurance

and Supporting Regulations in 42 CFR

406.28 and 407.27; Form No.: HCFA–

1763 (OMB No. 0938–0025); Use: The

HCFA–1763 is used by beneficiaries to

request voluntary termination from

premium hospital and/or

supplementary medical insurance.

Frequency: One time only; Affected

Public: Individuals or Households and

Federal Government; Number of

Respondents: 14,000; Total Annual

Responses: 14,000; Total Annual Hours:

5,833.

2. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Outpatient

Rehabilitation Cost Report and

Supporting Regulations in 42 CFR

413.20 and 413.24 Form No.: HCFA–

2088 (OMB No. 0938–0037); Use: This

form is used by Outpatient

Rehabilitation Facilities to report their

health care costs to determine the

amount reimbursable for services

furnished to Medicare beneficiaries.

Frequency: Annually; Affected Public:

Business or other for-profit, Not-forprofit institutions, and State, Local or

Tribal Government; Number of

Respondents: 4,298; Total Annual

Responses: 4,298; Total Annual Hours:

429,800.

3. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Information

Collection Requirements Contained in

BPD–393, Examination and Treatment

for Emergency Medical Conditions and

Women in Labor and Supporting

Regulations Contained in 42 CFR

488.18, 489.20 and 489.24; Document

No.: HCFA–-R–142 (OMB# 0938–0667);

Use: The Information Collection

Requirements contained in BPD–393,

Examination and Treatment for

Emergency Medical Conditions and

Women in Labor contains requirements

for hospitals to prevent them from

inappropriately transferring individuals

with emergency medical conditions, as

mandated by Congress. HCFA will use

this information to help assure

compliance with this mandate and

protect the public. This information is

not contained elsewhere in regulations.

Frequency: On occasion; Affected

Public: Individuals or Households, Notfor-profit institutions, Federal