Federal Register / Vol. 60, No. 240 / Thursday, December 14, 1995 / Notices 64167

Dated: December 7, 1995.

Clifton R. Gaus, Sc.D.,

Administrator.

[FR Doc. 95–30478 Filed 12–13–95; 8:45 am]

BILLING CODE 4160–90–M

Food and Drug Administration

[Docket No. 95G–0389]

Aplin & Barrett Ltd.; Filing of Petition

for Affirmation of GRAS Status

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Aplin & Barrett Ltd., has filed a

petition (GRASP 5G0417) proposing to

affirm that nisin preparation is generally

recognized as safe (GRAS) as an

antimicrobial agent in sauces and

nonstandardized salad dressings.

DATES: Written comments by February

27, 1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Mary E. LaVecchia, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3072.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(secs. 201(s) and 409(b)(5) (21 U.S.C.

321(s) and 348(b)(5)) and the regulations

for affirmation of GRAS status in §

170.35 (21 CFR 170.35), notice is given

that Aplin & Barrett Ltd.,

c/o 700 13th St. NW., suite 1200,

Washington, DC 20005, has filed a

petition (GRASP 5G0417) proposing that

nisin preparation be affirmed as GRAS

for use as an antimicrobial agent in

sauces and nonstandardized salad

dressings.

The petition has been placed on

display at the Dockets Management

Branch (address above).

Any petition that meets the

requirements outlined in §§ 170.30 (21

CFR 170.30) and 170.35 is filed by the

agency. There is no prefiling review of

the adequacy of data to support a GRAS

conclusion. Thus, the filing of a petition

for GRAS affirmation should not be

interpreted as a preliminary indication

of suitability for GRAS affirmation.

The potential environmental impact

of this action is being reviewed. If the

agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Interested persons may, on or before

February 27, 1996, review the petition

and file comments with the Dockets

Management Branch (address above).

Two copies of any comments should be

filed and should be identified with the

docket number found in brackets in the

heading of this document. Comments

should include any available

information that would be helpful in

determining whether the substance is,

or is not, GRAS for the proposed use. In

addition, consistent with the regulations

promulgated under the National

Environmental Policy Act (40 CFR

1501.4(b)), the agency encourages public

participation by review of and comment

on the environmental assessment

submitted with the petition that is the

subject of this notice. A copy of the

petition (including the environmental

assessment) and received comments

may be seen in the Dockets Management

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

Monday through Friday.

Dated: November 21, 1995.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 95–30500 Filed 12–13–95; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

Public Information Collection

Requirements Submitted for Public

Comment and Recommendations

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, has submitted to the

Office of Management and Budget

(OMB) the following proposals for the

collection of information. 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: Revision of a currently

approved collection; Title of

Information Collection: Reconciliation

of State Invoice (Formerly: Remittance

Advice Report) and Prior Quarter

Adjustment Statement; Form No.:

HCFA–304, HCFA–304a; Use: The

Omnibus Budget Reconciliation Act of

1990 requires drug labelers to enter into

and have in effect a rebate agreement

with HCFA for States to receive funding

for drugs dispensed to Medicaid

recipients.

The regulation at 42 CFR 447.534

requires labelers to report specific drug

rebate data to States when payment is

made; Affected Public: Business or other

for profit; Number of Respondents: 520;

Total Annual Responses: 2,080; Total

Annual Hours Requested: 170,560. To

request copies of the proposed

paperwork collection referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collection should be sent

within 60 days of this notice direct to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Planning and

Analysis Staff, Attention: Linda

Mansfield, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: December 7, 1995.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 95–30475 Filed 12–13–95; 8:45 am]

BILLING CODE 4120–03–P

Public Information Collection

Requirements Submitted for Public

Comment and Recommendations

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