20774 Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Proposed Rules

northeast corner of sec. 8, T. 2 S., R. 8

E.; then south to the southeast corner of

sec. 8, T. 2 S., R. 8 E.; then east to the

northeast corner of sec. 16, T. 2 S., R.

8 E.; then south to the southeast corner

of sec. 28, T. 2 S., R. 8 E.; then west to

the southeast corner of sec. 29, T. 2 S.,

R. 8 E.; then south to the southeast

corner of sec. 32, T. 2 S., R. 8 E.; then

west to the Maricopa/Pinal County line;

then north along the Maricopa/Pinal

County line to the point of beginning;

and

Beginning at the intersection of the

Maricopa/Pinal County line and the

northeast corner of sec. 5, T. 3 S., R. 6

E.; then south to the southeast corner of

sec. 32, T. 3 S., R. 6 E.; then west to the

southwest corner of sec. 34, T. 3 S., R.

5 E.; then north to the southwest corner

of sec. 3, T. 3 S., R. 5 E.; then west to

the southwest corner of sec. 6, T. 3 S.,

R. 5 E.; then north to the Maricopa/Pinal

County line; then east along the

Maricopa/Pinal County line to the point

of beginning; and

Beginning at the southeast corner of

sec. 5, T. 6 S., R. 4 E.; then west to the

southwest corner of sec. 5, T. 6 S., R. 3

E.; then north to the southwest corner of

sec. 28, T. 5 S., R. 3 E.; then west to the

southwest corner of sec. 25, T. 5 S., R.

2 E.; then north to the southwest corner

of sec. 24, T. 5 S., R. 2 E.; then west to

the southwest corner of sec. 23, T. 5 S.,

R. 2 E.; then north to the northwest

corner of sec. 35, T. 4 S., R. 2 E.; then

east to the northwest corner of sec. 36,

T. 4 S., R. 2 E.; then north to the

northwest corner of sec. 25, T. 4 S., R.

2 E.; then east to the northwest corner

of sec. 29, T. 4 S., R. 3 E.; then north

to the northwest corner of sec. 20, T. 4

S., R. 3 E.; then east to the northeast

corner of sec. 21, T. 4 S., R. 4 E.; then

south to the northeast corner of sec. 4,

T. 5 S., R. 4 E.; then east to the northeast

corner of sec. 3, T. 5 S., R. 4 E.; then

south to the southeast corner of sec. 22,

T. 5 S., R. 4 E.; then west to the

southeast corner of sec. 21, T. 5 S., R.

4 E.; then south to the point of

beginning.

The following individual fields in

Pinal County are regulated areas:

307012207 309033507 309042621

308102604 309042544 309050104

308102605 309042545 309050109

309021801 309042601 309050122

309021804 309042607 309050207

309021812 309042619 309050209

309031304 309042620

Yuma County. The following

individual fields in Yuma County are

regulated areas:

321010208 321040405 323030401

321010210 321040911 323030402

321010211 321040912 323030403

321010224 321040915 323030404

321010301 321040917 323030405

321010302 321040918 323030406

321011103 321040921 323030501

321033501 321040922 323030502

321033502 321041903 323030512

321033503 321041904 323030513

321033516 321041908 323030514

321033517 321041919 323030515

321033518 321042903 323030521

321033519

* * * * *

4. In § 301.89–12, paragraph (a) would

be revised to read as follows:

§ 301.89–12 Cleaning and disinfection.

(a) Mechanized harvesting equipment

that has been used to harvest host crops

that test positive for Karnal bunt and

seed conditioning equipment that has

been used in the production of any host

crops must be cleaned and disinfected

in accordance with § 301.89–13(a) prior

to movement from a regulated area.

* * * * *

Done in Washington, DC, this 12th day of

April 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–9670 Filed 4–17–00; 8:45 am]

BILLING CODE 3410–34–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 210, 211, 820, and 1271

[Docket No. 97N–484S]

Suitability Determination for Donors of

Human Cellular and Tissue-Based

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening for

90 days the comment period for the

proposed rule concerning suitability

determinations for donors of human

cellular and tissue-based products. The

proposed rule was published in the

Federal Register of September 30, 1999

(64 FR 52696). This action is being

taken in response to requests for an

extension to allow interested parties,

including State and local officials,

additional time for review and to submit

comments.

DATES: Submit written comments on the

proposed rule by July 17, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 30, 1999

(64 FR 52696), FDA published a

proposed rule to require manufacturers

of human cellular and tissue-based

products to screen and test the donors

of cells and tissue used in those

products for risk factors for and clinical

evidence of relevant communicable

disease agents and diseases. As part of

that regulatory action, the agency

proposed to amend the current good

manufacturing practice regulations that

apply to human cellular and tissuebased products regulated as drugs,

medical devices, and/or biological

products to incorporate the new donorsuitability procedures into existing good

manufacturing practice regulations.

Interested persons were given until

December 29, 1999, to submit written

comments on the proposed rule.

On November 19, 1999, a comment

was submitted to the docket by a

professional association requesting a 60-

day extension of the comment period on

the proposed rule. The comment

requests additional time to allow an ad

hoc group of experts assembled by the

organization to complete the collection

and analysis of scientific data on

transmissible spongiform

encephalopathies and Creutzfeld-Jakob

Disease. The association also noted the

recent publication of the proposed rule

entitled ‘‘Standards for Privacy of

Individually Identifiable Health

Information’’ by the Department of

Health and Human Services (64 FR

59918, November 3, 1999), and

requested an opportunity to evaluate the

potential impact of that proposed rule in

relation to the September 30, 1999,

proposed rule. On December 1, 1999, a

second comment requested an extension

to at least January 31, 2000.

In addition, FDA has learned that the

State of California and other

jurisdictions have enacted legislation

and issued regulations governing tissue

donor suitability. Because those laws

might conflict with provisions in the

September 30, 1999, proposed rule, FDA

has invited State officials to participate

in this rulemaking. The agency would

appreciate comment on: (1) The need for

uniform national standards for donor

suitability determinations to prevent

communicable disease transmission

Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Proposed Rules 20775

through human cellular and tissuebased products, (2) the scope of such

proposed national requirements and

their impact upon State laws, (3) FDA’s

proposal not to preempt State laws on

legislative consent for cornea

transplants, and (4) any issues raised by

this proposed rule possibly affecting

State laws and authorities. To allow

sufficient time for this to occur, as well

as to allow all interested persons

additional time to evaluate information

and submit meaningful comments, the

agency is reopening the comment period

for 90 days.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding the

proposed rule by July 17, 2000. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The proposed rule and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: April 10, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–9581 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

25 CFR Part 70

RIN 1076–AD98

Certificate of Degree of Indian or

Alaska Native Blood

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Proposed rule.

SUMMARY: This rule will establish

documentation requirements and

standards for filing, processing, and

issuing a Certificate of Degree of Indian

or Alaska Native Blood (CDIB) by the

Bureau of Indian Affairs (Bureau). This

rule will provide the policies and

standards that will allow the Bureau to

issue, amend, or invalidate CDIBs. The

Bureau issues CDIBs to assist

individuals in establishing their

eligibility for programs and services

based upon their status as American

Indians and/or Alaska Natives.

DATES: Send your comments to reach us

on or before July 17, 2000.

We plan to hold consultations on this

proposed rule. The dates of the

consultations are:

April 14, 2000, in Anchorage, Alaska;

May 10, 2000, in Rapid City, South

Dakota; and

May 24, 2000, in Albuquerque, New

Mexico.

See SUPPLEMENTARY INFORMATION for

the addresses of the consultations. Each

meeting will begin at 9:00 a.m. and end

at 4:00 p.m (local time).

ADDRESSES: You may mail comments to

Karen Ketcher, Branch of Tribal

Operations, Eastern Oklahoma Region,

Department of the Interior, Bureau of

Indian Affairs, 101 North 5th Street,

Muskogee, OK 74401. You may also

hand-deliver comments to us at Room

426, at the same address. For

information about filing comments

electronically, see the SUPPLEMENTARY

INFORMATION section under ‘‘Electronic

access and filing address.’’ Comments

will be available for inspection at this

electronic address from 9:00 a.m. to 3:00

p.m. Central Standard time, Monday

through Friday beginning approximately

two weeks after publication of this

proposed rule in the Federal Register.

FOR FURTHER INFORMATION CONTACT:

Karen Ketcher, Tribal Operations,

Eastern Oklahoma Region, Bureau of

Indian Affairs, 918–687–2313.

Individuals who use a

telecommunications device for the deaf

(TDD) may call the Federal Information

Relay Service at 1–800–877–8339

between 8:00 a.m. and 4:00 p.m. Central

Standard time, Monday through Friday,

excluding Federal holidays.

SUPPLEMENTARY INFORMATION

I. Public Comment Procedures

Electronic Access and Filing Address

You may access an electronic version

of this proposed rule through our home

page (www.doi.gov/bia/otshome.html).

You may also comment via the Internet

to: Karen Ketcher@bia.gov. Please also

include ‘‘Attention: 1076–AD98’’ and

your name and return address in your

Internet message. If you do not receive

a confirmation from the system that we

have received your Internet message,

contact us directly at 918–687–2313.

Written Comments

Written comments on the proposed

rule should be specific, should be

confined to issues pertinent to the

proposed rule, and should explain the

reason for any change you recommend.

Where possible, you should reference

the specific section or paragraph of the

proposal you are addressing. We may

not consider or include in the

Administrative Record for the final rule

comments which we receive after the

close of the comment period (See DATES)

or comments delivered to an address

other than those listed above (See

ADDRESSES). Comments, including

names, street addresses, and other

contact information of respondents, will

be available for public review at this

address during regular business hours

(7:45 a.m. to 4:15 p.m. Central Standard

time), Monday through Friday, except

Federal holidays. We will also post all

comments on the regulation’s Internet

page at the end of the comment period.

Individual respondents may request

confidentiality. If you wish to request

that we consider withholding your

name, street address, and other contact

information (such as Internet address,

FAX or phone number) from public

review or from disclosure under the

Freedom of Information Act, you must

state this prominently at the beginning

of your comment. We will make

available for public inspection in their

entirety all submissions from

organizations or businesses, and from

individuals identifying themselves as

representatives or officials of

organizations or businesses.

Consultations

We will hold consultations at the

following locations on the dates and

times specified:

April 14, 2000, in Anchorage, Alaska,

at the Holiday Inn, 239 W. 4th Avenue,

Anchorage, Alaska 99501;

May 10, 2000, in Rapid City, South

Dakota at the Best Western Ramkota

Hotel, 2111 North LaCrosse Street,

Rapid City, South Dakota 57701; and,

May 24, 2000, in Albuquerque, New

Mexico at the Best Western Winrock

Inn, 18 Winrock Center, Albuquerque,

New Mexico 87110.

Any person who wants to participate

in a particular consultation should

notify Karen Ketcher, the person

identified under FOR FURTHER

INFORMATION CONTACT at least one week

before the consultation. If no one

expresses an interest in participating in

a consultation at a given location by that

date, we will not hold that consultation.

If only one person expresses an interest,

we may hold a public meeting rather

than a consultation, and we will include

the results in the Administrative

Record. If we hold a consultation, we

will continue the consultation until

everyone who wants to testify has done

so. In order to assist the transcriber and

to ensure an accurate record, we request

that you give the transcriber a copy of

your testimony. In order to assist us in

preparing appropriate responses/

answers to your questions, we also ask

that if you plan to testify, please submit