69778 Federal Register / Vol. 65, No. 224 / Monday, November 20, 2000 / Notices

I. Background

FDA is announcing the availability of

a guidance document entitled

‘‘Guidance for Reviewers: Potency

Limits for Standardized Dust Mite and

Grass Allergen Vaccines: A Revised

Protocol’’ November July 2000. The

guidance document provides

information to FDA reviewers regarding

broader relative potency limits for CBER

evaluation of standardized dust mite

and grass allergen vaccines submitted to

CBER for lot release. Issues addressed in

the guidance document include, but are

not limited to, the following: (1)

Diagnostic equivalence, (2) theraputic

equivalence, (3) safety equivalence, (4)

lot-to-lot variation in allergen vaccine

potency, and (5) current and broadened

CBER release limits for standardized

dust mite and grass allergen vaccines

submitted to CBER for lot release. The

guidance document announced in this

notice finalizes the draft guidance

entitled, ‘‘Guidance for Reviewers:

Potency Limits for Standardized Dust

Mite and Grass Allergen Vaccines: A

Revised Protocol’’ that was announced

in the Federal Register on February 15,

2000 (65 FR 7557).

This guidance document represents

the agency’s current thinking with

regard to the potency limits for

standardized dust mite and grass

allergen vaccines. 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 statutes

and regulations. As with other guidance

documents, FDA does not intend this

document to be all-inclusive and

cautions that not all information may be

applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

guidance document. Two copies of any

comments are to be submitted, except

individuals may submit one copy.

Comments should be identified with the

docket number found in the brackets in

the heading of this document. A copy of

the document and received comments

are available for public examination in

the Dockets Management Branch

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

through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cber/guidelines.htm.

Dated: October 13, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29537 Filed 11–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–3010]

‘‘Guidance for Industry: 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 document entitled

‘‘Guidance for Industry: Testing Limits

in Stability Protocols for Standardized

Grass Pollen Extracts’’ dated November

2000. The guidance document provides

information on developing stability

protocols for standardized grass pollen

extracts. The development of suitable

stability studies is necessary to

determine the shelf life of standardized

grass pollen extracts to help ensure the

safety, purity, and potency of these

products. The guidance document

announced in this notice finalizes the

draft guidance entitled ‘‘Guidance for

Industry on Testing Limits in Stability

Protocols for Standardized Grass Pollen

Extracts’’ that was announced in the

Federal Register of August 25, 1997.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Guidance for Industry: Testing Limits

in Stability Protocols for Standardized

Grass Pollen Extracts’’ dated November

2000 to the Office of Communication,

Training, and Manufacturers Assistance

(HFM–40), Center for Biologics

Evaluation and Research (CBER), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448. Send one self-addressed adhesive

label to assist the office in processing

your requests. The 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.

See the SUPPLEMENTARY INFORMATION

section for electronic access to the

guidance document.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Joseph L. Okrasinski, Center for

Biologics Evaluation and Research

(HFM–17), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a document entitled ‘‘Guidance for

Industry: Testing Limits in Stability

Protocols for Standardized Grass Pollen

Extracts’’ dated November 2000. The

guidance document is intended to

provide information to manufacturers

regarding stability studies on grass

pollen extracts. Such stability studies

are used to determine the shelf life of

the product. This guidance document

does not, however, change lot release

criteria for these products. Issues

addressed in the 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. The guidance

document announced in this notice

finalizes the draft guidance entitled

‘‘Guidance for Industry on Testing

Limits in Stability Protocols for

Standardized Grass Pollen Extracts’’ that

was announced in the Federal Register

of August 25, 1997 (62 FR 44975).

This guidance document represents

the agency’s current thinking with

regard to the testing limits in stability

protocols for standardized grass pollen

extract. 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 statutes and

regulations. As with other guidance

documents, FDA does not intend this

document to be all-inclusive and

cautions that not all information may be

applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Comments

Interested persons may, at any time,

submit written comments to the Dockets

Management Branch (address above)

regarding this guidance document. Two

Federal Register / Vol. 65, No. 224 / Monday, November 20, 2000 / Notices 69779

copies of any comments are to be

submitted, except individuals may

submit one copy. Comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the document and

received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cber/guidelines.htm.

Dated: November 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29535 Filed 11–12–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Year 2000 Community

Health Center and National Health

Service Corps User/Visit Survey (OMB

No. 0915–0185)—Reinstatement, With

Change

The purpose of this study is to

conduct a sample survey which has

three components: (1) A pilot study,

including an evaluation of both

retrospective and prospective sampling

methodologies; (2) a personal interview

survey of Community Health Center

(CHC) and National Health Service

Corps (NHSC) site users; and (3) a

record-based study of visits to CHCs and

NHSC sites. CHCs and NHSC sites serve

predominantly poor minority medically

underserved populations. The proposed

user and visit survey will collect indepth information about CHC and

NHSC site users, their health status, the

reasons they seek care, their diagnoses,

and the services utilized in a medical

encounter.

The Year 2000 User/Visit Survey was

developed using similar questionnaire

methodology from the 1995 User/Visit

Survey in conjunction with a contractor

and will allow longitudinal

comparisons for CHCs with the 1995

version of the survey data, including

monitoring of process outcomes over

time. The Year 2000 User/Visit Survey

is the first year that NHSC non-grantee,

freestanding sites will be surveyed.

The estimated response burden for the

pilot test is as follows:

Form Number of respondents

Responses

per

respondent

Total

respondents

Hours per

response

Total burden

hours

Site Induction ....................................................... 10 (sites) .................................... 1 10 1 10

Site Sampling Methods: Retrospective & Prospective.10 (sites) .................................... 1 10 1.5 15

User Survey Tracing Procedures ........................ 20 users at 10 sites ................... 1 200 .5 100

User Survey ......................................................... 3 users at 10 sites ..................... 1 30 2.25 67.5

Visit Survey .......................................................... 10 (sites) .................................... 30 300 .5 150

Total .......................................................... 260 ............................................. 550 342.5

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

John Morrall, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington, DC

20503.

Dated: November 13, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–29539 Filed 11–17–00; 8:45 am]

BILLING CODE 4160–15–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 concerning

opportunity for public comment on

proposed collections of information, the

Substance Abuse and Mental Health

Services Administration will publish

periodic summaries of proposed

projects. To request more information

on the proposed projects or to obtain a

copy of the information collection

plans, call the SAMHSA Reports

Clearance Officer on (301) 443–7978.

Comments are invited on: (a) Whether

the proposed collections of information

are necessary for the proper

performance of the functions of the

agency, including whether the

information shall have practical utility;

(b) the accuracy of the agency’s estimate

of the burden of the proposed collection

of information; (c) ways to enhance the

quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Proposed Project: Substance Abuse

Prevention and Treatment (SAPT)

Block Grant Application Guidance and

Instructions, FY 2002—2004 (OMB No.

0930–0080, Revision)—Sections 1921

through 1935 of the Public Health

Service Act (U.S.C. 300x–21 to 300x–35)