44974 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Notices

request. Any individual who requires

special assistance, such as sign language

interpretation or other reasonable

accommodations, should contact Ann

Borlo at (301) 986–4870 no later than

November 1, 1997.

Dated: August 19, 1997.

Daniel C. Montoya,

Executive Director, Presidential Advisory

Council on HIV and AIDS, Office of National

AIDS Policy.

[FR Doc. 97–22533 Filed 8–22–97; 8:45 am]

BILLING CODE 3195–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration on Aging

Agency Recordkeeping/Reporting

Requirements Under Emergency

Review by the Office of Management

and Budget (OMB)

The Department of Health and Human

Services has submitted the following

(see below) emergency processing

public information clearance request

(ICR) to the Office of Management and

Budget (OMB) for review and clearance

under the Paperwork Reduction Act of

1995 (P.L. 104–13, 44 U.S.C. Chapter

35).

Title: State Annual Long-Term Care

Ombudsman Report.

OMB Number: 0985–0005.

Instrument Number of respondents Number of responses per year

Average

burden

hours per

respondent

Total burden hours

State Annual Long-Term Care Ombudsman Report.52 State Agencies on Aging ............. Once per respondent per year ......... 173 9,000

Description: To revise an existing

information collection for States to use

in reporting on activities of their LongTerm Care Ombudsman Programs as

required under Section 712(b) and (h) of

the Older Americans Act, as amended;

the revisions:

(1) Modify the wording of some of the

complaint categories to assist

respondents in categorizing some

complaints which were being placed

under ‘‘other;’’ and

(2) Stipulate that several narrative

responses which have not changed since

the previous report do not need to be

repeated.

The reporting system is for fiscal year

1997–99.

Additional Information: The AoA is

requesting that OMB grant a 180-day

approval for this information collection

under procedures for emergency

processing by August 29, 1997. A copy

of this individual ICR, with applicable

supporting documentation, may be

obtained by calling the Administration

on Aging, Reports Clearance Officer,

Sharon Matthews at (202) 205–2814.

Comments and questions about the

ICR should be directed to the Office of

Information and Regulatory Affairs,

Attn: Allison Herron Eydt, OMB Desk

Officer, Office of Management and

Budget, Room 10325, Washington, DC

20503.

Dated: August 14, 1997.

Alicia Valadez Ors,

Director, Office of Governmental Affairs and

Elder Rights, Administration on Aging.

[FR Doc. 97–22417 Filed 8–22–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 91F–0032]

Th. Goldschmidt A.G.; Withdrawal of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 1B4244) proposing that the food

additive regulations be amended to

provide for the safe use of silicone

acrylate resins in coatings for metal

substrates, polyolefin films, and paper

and paperboard intended for use in

contact with food.

FOR FURTHER INFORMATION CONTACT:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 4, 1991 (56 FR 9012), FDA

announced that a food additive petition

(FAP 1B4244) had been filed by Th.

Goldschmidt A.G. (currently c/o Keller

and Heckman, 1001 G St. NW., suite 500

West, Washington, DC 20001). The

petition proposed to amend the food

additive regulations to provide for the

safe use of silicone acrylate resins for

use in coatings for metal substrates,

polyolefin films, and paper and

paperboard intended for use in contact

with food. Th. Goldschmidt A.G. has

now withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: August 7, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–22554 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–0331]

Guidance for Industry on Dissolution

Testing of Immediate Release Solid

Oral Dosage Forms; 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 ‘‘Dissolution Testing of

Immediate Release Solid Oral Dosage

Forms.’’ The purpose of this guidance

document is to provide general

recommendations for dissolution

testing, approaches for setting

dissolution specifications related to

biopharmaceutic characteristics of the

drug substance, statistical methods for

comparing dissolution profiles, and a

process to help determine when

dissolution testing is sufficient to grant

a waiver for an in vivo bioequivalence

study. This guidance document also

provides recommendations for

dissolution tests to help ensure

continuous drug product quality and

performance after certain postapproval

manufacturing changes.