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.

40102 Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response

Total Burden

Hours

25.15(a) and (d) 2,039 4.46 9,094 8 72,752

25.40(a) and (c) 20 1 20 3,400 68,000

Total 140,752

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

II. Estimated Annual Reporting Burden

for Human Foods

Under 21 CFR 71.1, 170.39, and 171.1,

food additive petitions, color additive

petitions, and requests for exemption

from regulation as a food additive must

contain a claim of categorical exclusion

under § 25.30 or § 25.32 or an EA under

§ 25.40. In 1998, FDA received 57 food

additive petitions, 9 color additive

petitions, and 26 threshold of regulation

exemption requests. FDA estimates that

it received approximately 80 claims of

categorical exclusions as required under

§ 25.15(a) and (d), and 12 EA’s as

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

estimates that it takes petitioners or

requesters approximately 8 hours to

prepare a claim of categorical exclusion

and approximately 210 hours to prepare

an EA.

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN FOODS 1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response

Total Burden

Hours

25.15(a) and (d) 44 1.8 8.0 8 640

25.40(a) and (c) 11 1.1 12 210 2,520

Total 3,160

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

The Food and Drug Administration

Modernization Act of 1997 (Public Law

105–115) amended section 409 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 348) to establish a

premarket notification process as the

primary method for authorizing a new

use of a food additive that is a food

contact substance. Section 409(h)(6) of

the act defines a food contact substance

as any substance intended for use as a

component of materials used in

manufacturing, packing, packaging,

transporting, or holding food if such use

is not intended to have any technical

effect in food. Under the notification

process, FDA must be notified at least

120 days prior to the marketing of a food

contact substance. If FDA does not

object within 120 days to the use of a

food contact substance that is the

subject of a notification, the substance

may be legally marketed for the notified

use. FDA expects that the majority of

new uses of food contact substances that

will be the subject of premarket

notifications would previously have

been regulated under the food additive

petition process or exempted from the

requirement of a regulation under the

threshold of regulation process. FDA

has provided in a separate Federal

Register notice an opportunity for

public comment on the collection of

information associated with the

premarket notification program,

including environmental information

requirements (64 FR 61648, November

12, 1999).

III. Estimated Annual Reporting

Burden for Medical Devices

Under 21 CFR part 814, premarket

approvals (original PMA’s and

supplementals) must contain a claim for

categorical exclusion under § 25.30 or

§ 25.31 or an EA under § 25.40. In 1998,

FDA received 568 claims (original

PMA’s and supplementals) for

categorical exclusions as required under

§ 25.15(a) and (d), and 0 (zero) EA’s as

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

on information provided by less than 10

sponsors, FDA estimates that it takes

approximately less than 1 hour to

prepare a claim for a categorical

exclusion and an unknown number of

hours to prepare an EA.

TABLE 3.—ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES 1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response

Total Burden

Hours

25.15(a) and (d) 94 6 568 1 568

25.40(a) and (c) 0 0 0 0 0

Total 568

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

Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices 40103

IV. Estimated Annual Reporting Burden

for Biological Products

Under 21 CFR 312(a)(7)(iv)(c) and

601.2(a), IND and biologics license

applications must contain a claim for

categorical exclusion under § 25.30 or

§ 25.31 or an EA under § 25.40. In 1998,

FDA received 492 IND’s from 278

sponsors, 78 license applications from

20 applicants, and 903 supplements to

license applications from 190

applicants. FDA estimates that

approximately 10 percent of these

supplements would be submitted with a

claim for categorical exclusion or an EA.

FDA estimates that it receives

approximately 660 claims for categorical

exclusion as required under § 25.15(a)

and (d), and 2 EA’s as required under

§ 25.40(a) and (c). Based on information

provided by industry, FDA estimates

that it takes sponsors and applicants

approximately 8 hours to prepare a

claim for categorical exclusion and

approximately 3,400 hours to prepare an

EA.

TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS 1

21 CFR Section No. of

Respondents

Annual Frequency per

Response

Total Annual

Responses

Hours per

Response

Total Burden

Hours

25.15(a) and (d) 317 2 660 8 5,280

25.40(a) and (c) 2 1 2 3,400 6,800

Total 12,080

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

V. Estimated Annual Reporting Burden

for Animal Drugs

Under 21 CFR 514.1(b)(14) new

animal drug applications (NADA’s) and

abbreviated new animal drug

application (ANADA), 514.8(a)(1)

supplemental NADA’s and ANADA’s,

511.1(b)(10) investigational new animal

drug applications, 570.35(c)(1)(viii)

generally recognized as safe, affirmation

petitions, and 571.1(c) food additive

petitions must contain a claim for

categorical exclusion under § 25.30 or

§ 25.31 or an EA under § 25.40. Since

the last OMB approval of the subject

collections of information, the Center

for Veterinary Medicine has received

approximately 545 claims for categorical

exclusions as required under § 25.15(a)

and (d), and 32 EA’s as required under

§ 25.40(a) and (c). Based on information

provided by industry, FDA estimates

that it takes sponsors/applicants

approximately 8 hours to prepare a

claim for a categorical exclusion and

approximately 2,160 hours to prepare an

EA.

TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response

Total Burden

Hours

25.15(a) and (d) 194 2.8 545 8 4,360

25.40(a) and (c) 29 1.1 32 2,160 69,120

Total 73,480

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

Based on information provided by

industry, FDA estimates that the

combined burden for the Environmental

Impact Considerations—Part 25 are as

follows:

TABLE 6.—ESTIMATED ANNUAL REPORTING BURDEN FOR ALL CENTERS 1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response

Total Burden

Hours

25.15(a) and (d) 2,688 17.06 10,875 33 83,600

25.40(a) and (c) 62 4.02 66 9,170 146,440

Total 2,750 21.08 10,941 9,203 230,040

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

40104 Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices

In the Federal Register of March 13,

2000 (65 FR 13405), 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. 00–16398 Filed 6–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Pharmacy Compounding Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Pharmacy

Compounding Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 13 and 14, 2000, 8:30 a.m.

to 5 p.m.

Location: CDER Advisory Committee

conference room 1066, 5630 Fishers

Lane, Rockville, MD.

Contact Person: Jayne E. Peterson or

Tony A. Slater, Jr., Center for Drug

Evaluation and Research (CDER) (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–7001, e-mail:

PETERSONJ@CDER.FDA.GOV, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12440.

Please call the Information Line for upto-date information on this meeting.

Agenda: On July 13, 2000, the

committee will review five drug

products for inclusion on a list of drug

products that cannot be compounded

because they have been withdrawn or

removed from the market because such

drug products or components of such

drug products have been found to be

unsafe or not effective (see 21 CFR

216.24 (64 FR 10944, March 8, 1999))

whereby FDA amended its regulations

to include such a list of drug products).

In the Federal Register of January 4,

2000 (65 FR 256), FDA published a

proposed rule amending these

regulations to add two drug products to

the list: (1) Aminopyrine (all drug

products containing aminopyrine) and

(2) astemizole (all drug products

containing astemizole). In addition to

these two drug products, the committee

will review the following three drug

products: (1) Grepafloxacin (all drug

products containing grepafloxacin), (2)

troglitazone (all drug products

containing troglitazone), and (3)

cisapride (all drug products containing

cisapride). Beginning at approximately

10 a.m., and continuing on July 14,

2000, at approximately 8:30 a.m., the

committee will discuss and provide

FDA with advice about drug products

that present demonstrable difficulties

for compounding that reasonably

demonstrate an adverse effect on the

safety or effectiveness of those drug

products.

Procedure: Interested persons may

present data, information, or views,

orally or in writing on issues pending

before the committee. Written

submissions may be made to the contact

person by July 3, 2000. On July 13,

2000, oral presentations from the public

will be scheduled between

approximately 1 p.m. and 2 p.m. On

July 14, 2000, oral presentations from

the public will be scheduled between

approximately 8:30 a.m. and 9:30 a.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 3, 2000,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

FDA regrets that it was unable to

publish this notice 15 days prior to the

July 13 and 14, 2000, Pharmacy

Compounding Advisory Committee

meeting. Because the agency believes

there is some urgency to bring these

issues to public discussion and

qualified members of the Pharmacy

Compounding Advisory Compounding

Advisory Committee meeting were

available at this time, the Commissioner

of Food and Drugs concluded that it was

in the public interest to hold this

meeting even if there was not sufficient

time for the customary 15-day public

notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 20, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16397 Filed 6–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1313]

Draft Guidance for Industry on How to

Use E–Mail to Submit a Notice of Final

Disposition of Animals Not Intended

for Immediate Slaughter; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance for

industry (#86) entitled ‘‘How to Use E–

Mail to Submit a Notice of Final

Disposition of Animals Not Intended for

Immediate Slaughter’’ in the Center for

Veterinary Medicine (CVM). This draft

guidance is neither final nor is it in

effect at this time. The draft guidance

document is intended to provide

guidance to new animal drug sponsors

(sponsors) on how to submit a notice of

final disposition of animals not

intended for immediate slaughter

(NFDA) as an e-mail attachment by

Internet. These electronic submissions

are part of CVM’s ongoing initiative to

provide a method for paperless

submissions. This draft guidance

implements provisions of the

Government Paperwork Elimination Act

(GPEA).

DATES: Submit written comments on the

draft guidance at any time, however,

comments should be submitted by

August 28, 2000 to ensure their

adequate consideration in preparation of

the final document. Submit written

comments on the information collection

requirements by August 28, 2000.

ADDRESSES: Submit written comments

on the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Comments should be identified with the

full title of the draft guidance document

and the docket number found in

brackets in the heading of this

document.

Copies of the draft guidance

document entitled ‘‘How to Use E–Mail

to Submit a Notice of Final Disposition

of Animals Not Intended for Immediate

Slaughter’’ may be obtained on the