40100 Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices

impact minority and disadvantaged

citizens in America; and

7. The MHPF member institutions

were founded specifically to improve

the health status of medically

underserved African Americans and

other ethnic minority groups, and play

a critical role in building the nation’s

health care workforce.

C. Availability of Funds

Approximately $200,000 is available

in FY 2000 to fund this cooperative

agreement. Sub-awards will be funded

through CDC and ATSDR. A cumulative

award of approximately $2,000,000 to

the MHPF is expected during FY 2000.

Subawards will range from $25,000 to

$450,000. It is expected that the awards

will begin on September 30, 2000.

Funding estimates may vary and are

subject to change. Continuation awards

within the project period will be made

on the basis of satisfactory progress and

the availability of funds.

Applications that exceed the funding

cap of $450,000 will be excluded from

the competition and returned to the

applicant.

D. Where To Obtain Additional

Information

A complete program description and

information on application procedures

are contained in the application

package. Business management

technical assistance may be obtained

from Sheri Disler, Senior Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 2920

Brandywine Road, Room 3000, MS E–

15, Koger Center, Colgate Building,

Atlanta, Georgia 30341–3724.

Telephone 770–488–2756. E-mail

address sjd9@cdc.gov.

Program technical assistance may be

obtained from Karen E. Harris, Senior

Advisor for Research Projects, Office of

the Associate Director for Minority

Health, Office of the Director, Centers

for Disease Control and Prevention,

1600 Clifton Road, Northeast, Mailstop

D–39, Atlanta, Georgia 30333.

Telephone (404) 639–4313, E-mail

address keh2@cdc.gov.

Dated: June 23, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–16437 Filed 6–28–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0914]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Importer’s

Entry Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by July 31,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezutto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Importer’s Entry Notice (OMB Control

Number 0910–0046)—Extension

Section 801 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

381) charges FDA with the following

responsibilities: (1) Ensuring that

foreign-origin FDA-regulated foods,

drugs, cosmetics, medical devices, and

radiological health products offered for

import into the United States meet the

same requirements of the act as do

domestic products; and (2) preventing

shipments from entering the country if

they are not in compliance.

The information collected by FDA

consists of the following: (1) Product

code, an alpha-numeric series of

characters that identifies each product

FDA regulates; (2) FDA country of

origin, the country where the FDAregistered or FDA-responsible firm is

located; (3) FDA manufacturer, the party

who manufactured, grew, assembled, or

otherwise processed the goods (if more

than one, the last party who

substantially transformed the product);

(4) shipper, the party responsible for

packing, consolidating, or arranging the

shipment of the goods to their final

destination; (5) quantity and value of

the shipment; and (6) if appropriate,

affirmation of compliance, a code that

conveys specific FDA information, such

as registration number, foreign

government certification, etc. This

information is collected electronically

by the entry filer via the U.S. Customs

Service’s Automated Commercial

System at the same time he/she files an

entry for import with the U.S. Customs

Service. FDA uses the information to

make admissibility decisions about

FDA-regulated products offered for

import into the United States.

The annual reporting burden is

derived from the basic processes and

procedures used in fiscal year (FY)

1995. The total number of entries

submitted to the automated system in

FY 1999 was 5,077,493. The total

number of entries less the disclaimer

entries will represent the total FDA

products entered into the automated

system. A total of 51 percent of all

entries entered into the automated

system were entries dealing with FDAregulated products. The number of

respondents is a count of filers who

submit entry data for foreign-origin

FDA-regulated products. The estimated

reporting burden is based on

information obtained by FDA contacting

some potential respondents. Disclaimer

entries are not FDA commodities.

FDA estimates the burden of this

collection of information as follows:

Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices 40101

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

No. of Respondents

Annual

Frequency

per Response

Total Annual Responses Hours per

Response Total Hours

3,886 652 2,533,355 .14 354,669

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

In theFederal Register of March 22,

2000 (65 FR 15340), the agency

requested comments on the proposed

collections of information. No

comments were received.

Dated: June 22, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16396 Filed 6–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0836]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Environmental Impact Considerations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by July 31,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Environmental Impact

Considerations—Part 25 (21 CFR Part

25)—(OMB Control Number 0910–

0322)—Extension

FDA is requesting OMB approval for

the reporting requirements contained in

FDA’s regulation ‘‘Environmental

Impact Considerations’’ (part 25).

The National Environmental Policy

Act (NEPA) (42 U.S.C. 4321–4347) states

national environmental objectives and

imposes upon each Federal agency the

duty to consider the environmental

effects of its actions. Section 102(2)(C)

of NEPA requires the preparation of an

environmental impact statement (EIS)

for every major Federal action that will

significantly affect the quality of the

human environment.

FDA’s NEPA regulations are at part

25. All applications or petitions

requesting agency action require the

submission of an Environmental

Assessment (EA) or a claim of

categorical exclusion. Section 25.15(a)

and (d) specify the procedures for

submitting to FDA a claim for a

categorical exclusion (certain classes of

FDA-regulated actions have little or no

potential to cause significant

environmental effects and are excluded

from the requirements to prepare an EA

or EIS). Section 25.40(a) and (c) specify

the content requirements for EA’s for

nonexcluded actions.

This collection of information is used

by FDA to assess the environmental

impact of agency actions and to ensure

that the public is informed of

environmental analyses. Firms wishing

to manufacture and market substances

regulated under statutes for which FDA

is responsible must, in most instances,

submit applications requesting

approval. Environmental information

must be included in such applications

(when not eligible for categorical

exclusion) for the purpose of

determining whether the proposed

action may have a significant impact on

the environment. Where significant

adverse effects cannot be avoided, the

agency uses the submitted information

as the basis for preparing and

circulating to the public an EIS, made

available through a Federal Register

notice also filed for comment at the

Environmental Protection Agency. The

final EIS including the comments

received is reviewed by the agency to

weigh environmental costs and benefits

in determining whether to pursue the

proposed action or some alternative that

would reduce expected environmental

impact. When the agency finds that no

significant environmental effects are

expected, the agency prepares a finding

of no significant impact (FONSI).

I. Estimated Annual Reporting Burden

for Human Drugs

Under 21 CFR 312.23(a)(7)(iv)(e), 21

CFR 314.50(d)(1)(iii), and 21 CFR

314.94(a)(9)(i), each investigational new

drug application (IND), new drug

application (NDA), and abbreviated new

drug application (ANDA) must contain

a claim for categorical exclusion under

§ 25.30 or § 25.31 or an EA under

§ 25.40. In 1998, FDA received 2,427

IND’s from 1,874 sponsors, 129 NDA’s

from 80 applicants, 2,500 supplements

to NDA’s from 238 applicants, 345

ANDA’s from 101 applicants, and 3,713

supplements to ANDA’s from 165

applicants. FDA estimates that it

receives approximately 9,094 claims for

categorical exclusions as required under

§ 25.15(a) and (d), and 20 EA’s as

required under § 25.40(a) and (c). Based

on information provided by the

pharmaceutical industry, FDA estimates

that it takes sponsors or applicants

approximately 8 hours to prepare a

claim for a categorical exclusion and

approximately 3,400 hours to prepare an

EA.