Federal Register / Vol. 66, No. 2 / Wednesday, January 3, 2001 / Notices 375

the in-house technical capability to

convert their operations or might find

the prospective investments in sterile

production technologies to be

unattractive. Because each nonsterile

product will require an annual report

(21 CFR 314.81(b)(2)(iv), the number of

annual responses for nonsterile

products has increased to seven. Based

on a review of FDA’s past experience

with applicants submitting

supplemental applications under

§ 314.97, we estimate 160 hours to

prepare a supplemental application.

Therefore, due to the increased estimate

of respondents, the total hours for the

annual reporting burden for

manufacturers of nonsterile products

has increased from 800 hours in the

proposed rule to 1,120 hours in the final

rule. The agency’s review of the

estimated reporting burden for

manufacturers of sterile products in the

proposed rule and its experience with

the annual reporting burden for

manufacturers of sterile products

supported the estimate provided in the

proposed rule. Therefore, the estimated

reporting burden for manufacturers of

sterile products is the same as in the

proposed rule.

Respondents to this information

collection are businesses engaged in the

manufacture of aqueous-based drug

products for oral inhalation.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.–ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours

314.97 7 1 7 160 1,1202

314.70 2 1 2 20 403

Total 1,160

1There are no capital costs or operating and maintenance associated with this collection of information.

2 Reporting burden for manufacturers of nonsterile products.

3 Reporting burden for manufacturers of sterile products.

Because of the estimated increase

from the proposed rule to the final rule

in the number of respondents for

nonsterile products, the number of

recordkeepers in the recordkeeping

burden of table 2 has increased by two

from the proposed rule. FDA estimated

a total of seven recordkeepers in the

proposed rule and now estimates a total

of nine recordkeepers as a result of new

data collected by ERG. The proposed

rule estimated 2 hours per record, and

FDA’s review of that estimate and its

experience with the control and

validation of microbiological

contamination supports this proposed

estimate. Therefore, the total number of

hours for the recordkeeping burden has

increased from 14 hours to 18 hours.

TABLE 2.–ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of Recordkeepers

Annual Frequency

per Recordkeepers

Total Annual

Records Hours per Record Total Hours

211.113(b) 9 1 9 2 18

Total 18

In the Federal Register of September

18, 2000 (65 FR 56314), the agency

requested comments on the proposed

collections of information. No

comments were received.

Dated: December 26, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–48 Filed 1–2–01; 8:45 am]

BILLING CODE: 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99F–2081]

Troy Corp.; Filing of Food Additive

Petition; Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

filing notice for a food additive petition

filed by Troy Corp. to indicate that the

petitioner has proposed that the food

additive regulations be amended to

provide for the safe use of butanedioic

acid, sulfo-1,4-diisodecyl ester,

ammonium salt as a surface active agent

in adhesives, in pressure-sensitive

adhesives, and in paper and paperboard

intended to contact food.

FOR FURTHER INFORMATION CONTACT:

Mark A. Hepp, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3098.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 2, 1999 (64 FR 36021), FDA

announced that a food additive petition

(FAP 9B4678) had been filed by Troy

Corp., c/o S. L. Graham & Associates,

1801 Peachtree Lane, Bowie, MD 20721.

The petition proposed to amend the

food additive regulations in § 175.125

Pressure-sensitive adhesives (21 CFR

175.125) to provide for the safe use of

butanedioic acid, sulfo-1,4-diisodecyl

ester, ammonium salt as a surface active

agent in pressure sensitive adhesives.

Subsequent to the publication of the

filing notice, the petition was amended

to include a proposal to further amend

the food additive regulations in 21 CFR

175.105 Adhesives, 21 CFR 176.170

Components of paper and paperboard

in contact with aqueous and fatty food,

21 CFR 176.180 Components of paper

and paperboard in contact with dry

foods, and 21 CFR 178.3400 Emulsifiers

and/or surface active agents to provide

for the safe use of butanedioic acid,

sulfo-1,4-diisodecyl ester, ammonium

salt as a surface active agent in

adhesives, and in paper and paperboard

intended to contact food.

Therefore, FDA is amending the filing

notice of July 2, 1999, to indicate that

the petitioner requests that the food

376 Federal Register / Vol. 66, No. 2 / Wednesday, January 3, 2001 / Notices

additive regulations be amended to

provide for the safe use of butanedioic

acid, sulfo-1,4-diisodecyl ester,

ammonium salt as a surface active agent

in adhesives, in pressure sensitive

adhesives, and in paper and paperboard

intended to contact food.

The agency had previously

determined under 21 CFR 25.32(i) that

this action is of a type that does not

individually or cumulatively have a

significant effect on the human

environment. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

Dated: November 22, 2000.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 01–47 Filed 1–2–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2089–N]

RIN 0938–AK33

State Children’s Health Insurance

Program; Final Allotments to States,

the District of Columbia, and U.S.

Territories and Commonwealths for

Fiscal Year 2001

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice sets forth the final

allotments of Federal funding available

to each State, the District of Columbia,

and each U.S. Territory and

Commonwealth for fiscal year (FY) 2001

under title XXI of the Social Security

Act (the Act).

Established by section 4901 of the

Balanced Budget Act of 1997, and

amended by the Medicare, Medicaid

and SCHIP Balanced Budget Refinement

Act of 1999, title XXI of the Act

authorizes payment of Federal matching

funds to States, the District of Columbia,

and U.S. Territories and

Commonwealths to initiate and expand

health insurance coverage to uninsured,

low-income children under a new State

Children’s Health Insurance Program

(SCHIP). States may implement SCHIP

through a separate State program under

title XXI, an expansion of a State

Medicaid program under title XIX, or a

combination of both.

Copies: To order copies of the Federal

Register containing this document, send

your request to: New Orders,

Superintendent of Documents, P.O. Box

37194, Pittsburgh, PA 15250–7954.

Specify the date of the issue requested

and enclose a check or money order

payable to the Superintendent of

Documents, or enclose your Visa or

Master Card number and expiration

date. Credit card orders can also be

placed by calling the order desk at (202)

512–1800 or by faxing to (202) 512–

2250. The cost for each copy is $8.00.

As an alternative, you can view and

photocopy the Federal Register

document at most libraries designated

as Federal Depository Libraries and at

many other public and academic

libraries throughout the country that

receive the Federal Register.

This Federal Register document is

also available from the Federal Register

online database through GPO Access, a

service of the U.S. Government Printing

Office. The Website address is: http://

www.access.gpo.gov/nara/index.html.

FOR FURTHER INFORMATION CONTACT:

Richard Strauss, (410) 786–2019.

SUPPLEMENTARY INFORMATION:

I. Purpose of This Notice

This notice sets forth the allotments

available to each State, the District of

Columbia, and each U.S. Territory and

Commonwealth for FY 2001 under title

XXI of the Social Security Act (the Act).

Final allotments for a fiscal year are

available to match expenditures under

an approved State child health plan for

3 fiscal years, including the year for

which the final allotment was provided.

Federal funds appropriated for title XXI

are limited, and the law specifies a

formula to divide the total annual

appropriation into individual allotments

available for each State, the District of

Columbia, and each U.S. Territory and

Commonwealth with an approved child

health plan.

Section 2104(b) of the Act indicates

that ‘‘the Secretary shall allot to each

State * * * with a State child health

plan approved under this title.’’ This

language requires States, the District of

Columbia, and U.S. Territories and

Commonwealths to have an approved

child health plan for the fiscal year in

order for the Secretary to provide an

allotment for that fiscal year. All States,

the District of Columbia, and U.S.

Territories and Commonwealths had

approved plans at the beginning of FY

2001. Therefore, the FY 2001 allotments

contained in this notice pertain to all

States, the District of Columbia, and

U.S. Territories and Commonwealths.

II. Methodology for Determining Final

Allotments for States, the District of

Columbia, and U.S. Territories and

Commonwealths

This notice specifies in the Table

under section III, the final FY 2001

allotments available to individual

States, the District of Columbia, and

U.S. Territories and Commonwealths for

child health assistance expenditures

under approved State child health

plans. As discussed below, the FY 2001

final allotments have been calculated to

reflect the methodology for determining

an allotment amount for each State, the

District of Columbia, and each U.S.

Territory and Commonwealth as

prescribed by the Balanced Budget

Refinement Act of 1999 (BBRA) (Pub. L.

106–113), enacted on November 29,

1999.

Section 2104(a) of title XXI provides

that, for purposes of providing

allotments to the 50 States and the

District of Columbia, the following

amounts are appropriated:

$4,295,000,000 for FY 1998;

$4,275,000,000 for each FY 1999

through FY 2001; $3,150,000,000 for

each FY 2002 through 2004;

$4,050,000,000 for each FY 2005

through 2006; and $5,000,000,000 for

FY 2007. However, under section

2104(c) of the Act, 0.25 percent of the

total amount appropriated each year is

available for allotment to the U.S.

Territories and Commonwealths of

Puerto Rico, Guam, the Virgin Islands,

American Samoa, and the Northern

Mariana Islands. The total amounts are

allotted to the U.S. Territories and

Commonwealths according to the

following percentages: Puerto Rico, 91.6

percent; Guam, 3.5 percent; the Virgin

Islands, 2.6 percent; American Samoa,

1.2 percent; and the Northern Mariana

Islands, 1.1 percent.

For FY 2001, title XXI, as amended by

the BBRA, provides an additional

$34,200,000 for allotment to the U.S.

Territories and Commonwealths.

Therefore, the total amount available for

allotment to the U.S. Territories and

Commonwealths in FY 2001 is

$44,887,500 (that is, $34,200,000 plus

$10,687,500 (0.25 percent of the FY

2001 appropriation of $4,275,000,000)).

Furthermore, under sections 4921 and

4922 of the Balanced Budget Act of 1997

(BBA) (Public Law 105–33), enacted on

August 5, 1997, the total amount

available for allotment to the 50 States

and the District of Columbia is reduced

by an additional total of $60,000,000;

$30,000,000 to the Public Health Service

for a special diabetes research program

for children with Type I diabetes, and

$30,000,000 for special diabetes