Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Proposed Rules 7395

§ 808.52 Alaska.

To the extent that the age restriction

on the sale and exchange of cigarettes

and smokeless tobacco found in Alaska

Statutes, sections 11.76.100(a), is

preempted under section 521(a) of the

act, the Food and Drug Administration

has exempted it from preemption under

section 521(b) of the act.

4. New § 808.94 is added to subpart C

to read as follows:

§ 808.94 Utah.

To the extent that the age restriction

on sales of cigarettes and smokeless

tobacco found in the Utah Code

Annotated, section 76–10–104, is

preempted under section 521(a) of the

act, the Food and Drug Administration

has exempted it from preemption under

section 521(b) of the act.

Dated: February 7, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–4045 Filed 2–13–97; 2:19 pm]

BILLING CODE 4160–01–F

21 CFR Part 808

[Docket No. 96N–0249]

RIN 0910–AB03

Medical Devices; Opportunity for Oral

Hearing on Proposed Action on

Applications for Exemption From

Preemption From Cigarette and

Smokeless Tobacco Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of opportunity for oral

hearing.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for interested persons to

request an oral hearing on a proposed

rule that would grant exemption from

Federal preemption for certain cigarette

and smokeless tobacco requirements in

various States. The proposed rule is

published elsewhere in this issue of the

Federal Register.

DATES: Requests for an oral hearing by

March 21, 1997.

ADDRESSES: Written requests to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Anne M. Kirchner, Office of Policy (HF–

23), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–5321.

SUPPLEMENTARY INFORMATION: FDA’s

regulation in § 808.25 (21 CFR 808.25)

provides procedures for processing

applications for exemption from Federal

preemption of State and local

requirements applicable to medical

devices under section 521 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360k). Section 808.25(c)

provides that, when FDA issues in the

Federal Register a proposed rule either

to grant or to deny a request for

exemption from preemption, the agency

will also issue in the Federal Register

a notice of opportunity for interested

persons to request an oral hearing before

FDA to present views on the application

and the proposed rule.

Elsewhere in this issue of the Federal

Register, FDA is issuing a proposed rule

responding to the following applications

for exemption from preemption:

(1) An application from the State of

Alabama for exemption from

preemption for section 13A–12–3 of the

Alabama Code;

(2) An application from the State of

Alaska for exemption from preemption

for sections 11.76.100 and 11.76.105 of

the Alaska Statutes;

(3) An application from the State of

Utah for exemption from preemption for

section 76–10–104 of the Utah Code

Annotated; and

(4) An application from the State of

Washington for exemption from

preemption for section 26.28.080 of the

Revised Code of Washington and for

section 314–10–050 of the Washington

Administrative Code.

Therefore, in accordance with

§ 808.25(c), FDA is announcing an

opportunity for interested persons to

request an oral hearing on its proposal

to grant exemption from Federal

preemption for certain State

requirements pertaining to cigarettes

and smokeless tobacco.

FDA advises that, under § 808.25(d),

any request for a hearing is required to

be submitted to the Dockets

Management Branch (address above)

and to include an explanation of why an

oral hearing, rather than submission of

written comments only, is essential to

the presentation of views on the

application for exemption from

preemption and on the proposed

regulation. Further, to ensure

expeditious review of requests for an

oral hearing and final action on the

applications for exemption and on the

proposed rule, FDA has limited the

period for requesting an oral hearing to

30 days from the date of publication of

the proposed rule and this notice in the

Federal Register.

Under § 808.25(e), if a timely request

for a hearing is made, FDA will review

the request and will determine whether

a hearing should be granted. If FDA

determines that an oral hearing should

be held, it will announce the time, date,

and place of the hearing in a future

issue of the Federal Register. The

procedures that will govern any such

oral hearing are those applicable to a

public hearing under part 15 (21 CFR

part 15) of FDA’s administrative

practices and procedures regulations.

Interested persons may, on or before

March 21, 1997, submit to the Dockets

Management Branch (address above)

written requests for an oral hearing on

this matter. Two copies of any requests

are to be submitted, except that

individuals may submit one copy.

Requests are to be identified with the

docket number found in brackets in the

heading of this document. Received

requests may be seen in the office above

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

through Friday.

This notice is issued under FDA’s

authority in section 521 of the act and

under authority delegated to the

Commissioner of Food and Drugs (21

CFR 5.10).

Dated: February 7, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–4046 Filed 2–13–97; 2:19 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

25 CFR Part 40

RIN 1076–AA10

Grant Program for Higher Education

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Proposed rule.

SUMMARY: The Bureau of Indian Affairs

(BIA) is proposing to amend its

regulations on Higher Education Grant

Programs to improve the clarity of the

regulations and understanding of the

public as mandated by Executive Order

12866.

DATES: Comments must be received on

or before May 20, 1997.

ADDRESSES: Mail comments to Joann S.

Morris, Director, Office of Indian

Education Programs, Bureau of Indian

Affairs, Department of the Interior, 1849

C St. NW., Mail Stop 3512–MIB,

Washington, DC 20240; or, hand deliver

them to Room 3512 at the above

address. Comments will be available for

inspection at this address from 9 a.m. to

4 p.m., Monday through Friday

beginning approximately March 5, 1997.
7396 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Proposed Rules

FOR FURTHER INFORMATION CONTACT:

Garry R. Martin, Office of Indian

Education Programs, Bureau of Indian

Affairs at telephone (202) 219–1128.

SUPPLEMENTARY INFORMATION: The

authority to issue rules and regulations

is vested in the Secretary of the Interior

by 5 U.S.C. 301 and sections 463 and

465 of the Revised Statutes, 25 U.S.C. 2

and 9.

Publication of the proposed rule by

the Department of the Interior

(Department) provides the public an

opportunity to participate in the

rulemaking process. Interested persons

may submit written comments regarding

the proposed rule to the location

identified in the ADDRESSES section of

this document.

Executive Order 12778

The Department has certified to the

Office of Management and Budget

(OMB) that the proposed rule meets the

applicable standards provided in

sections 2(a) and 2(b)(2) of Executive

Order 12778.

Executive Order 12866

This proposed rule is not a significant

regulatory action under Executive Order

12866.

Regulatory Flexibility Act

This proposed rule will not have a

significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.).

Executive Order 12630

The Department has determined that

this proposed rule does not have

‘‘significant’’ takings implications. The

proposed rule does not pertain to taking

of private property interests, nor does it

impact private property.

Executive Order 12612

The Department has determined that

this proposed rule does not have

significant federalism effects because it

pertains solely to Federal-tribal relations

and will not interfere with the roles,

rights and responsibilities of states.

NEPA Statement

The Department has determined that

this proposed rule does not constitute a

major Federal action significantly

affecting the quality of the human

environment and that no detailed

statement is required pursuant to the

National Environmental Policy Act of

1969.

Unfunded Mandates Act of 1995

This proposed rule imposes no

unfunded mandates on any

governmental or private entity and is in

compliance with the provisions of the

Unfunded Mandates Act of 1995.

Paperwork Reduction Act of 1995

As required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

3507(d)), the Department of the Interior

has submitted a copy of these sections

to the Office of Management and Budget

(OMB) for its review.

All information is to be collected

annually from each applicant. The

annual reporting and record keeping

burden for this collection of information

is estimated to average 4 hours for each

response for 22 respondents, including

the time for reviewing instructions,

searching existing data sources,

gathering and maintaining the data

needed, and completing and reviewing

the collection of information. The total

annual reporting and record keeping

burden for this collection is estimated to

be 76 hours.

Organizations and individuals

desiring to submit comments on the

information collection requirement

should direct them to the Office of

Information and Regulatory Affairs,

OMB, Room 10202, New Executive

Office Building, Washington, DC 20503;

Attention: Interior Desk Officer.

The Department considers comments

by the public on this proposed

collection of information in:

Evaluating whether the proposed

collection of information is necessary

for the proper performance of the

functions of the Department, including

whether the information will have

practical utility;

Evaluating the accuracy of the

Department’s estimate of the burden of

the proposed collection of information,

including the validity of the

methodology and assumptions used;

Enhancing the quality, usefulness,

and clarity of the information to be

collected; and

Minimizing the burden of the

collection of information on those who

are to respond; including through the

use of appropriate automated,

electronic, mechanical, or other

collection techniques or other forms of

information technology.

OMB is required to make a decision

concerning the collection of information

contained in these proposed regulations

between 30 and 60 days after

publication of this document in the

Federal Register. Therefore, a comment

to the OMB is best assured of having full

effect if OMB receives it within 30 days

of publication. This does not affect the

deadline for the public to comment to

the Bureau of Indian Affairs on the

proposed regulations.

Drafting Information: The primary author

of this document is Garry R. Martin, Office

of Indian Education Programs, Bureau of

Indian Affairs, Department of the Interior.

List of Subjects in 25 CFR Part 40

Indians—education, Indians—

educational assistance.

For the reasons given in the preamble,

Part 40 of Title 25, chapter I of the Code

of Federal Regulations is proposed to be

revised as set forth below.

PART 40—HIGHER EDUCATION

GRANT PROGRAM

Sec.

40.1 What special terms apply?

40.2 What is the purpose of this part?

40.3 Who is eligible for a higher education

grant?

40.4 How do I apply for a higher education

grant?

40.5 How is my application reviewed?

40.6 How will I be notified if I am awarded

a grant?

40.7 How will I receive the grant?

40.8 How long does my financial aid last?

40.9 What happens if I withdraw from

school?

40.10 How do I appeal a grant decision?

40.11 What records are kept for the grant

program?

40.12 How does a tribe estimate allowable

administrative costs?

40.13 May a tribe prioritize its higher

education grant program?

40.14 Are there requirements for

information collection?

Authority: 25 U.S.C. 2, 9, and 13;

Reorganization Plan No. 3 of 1950 (65 Stat.

1262)

§ 40.1 What special terms apply?

Academic year means a period of time

in which a full-time student is expected

to complete the equivalent of at least

two semesters, two trimesters, or three

quarters at a institution that measures

academic process in credit hours.

Accreditation means the certification

of an institution of higher education by

a sanctioned national or regional

accrediting agency or association

recognized by the Secretary of

Education.

BIA means the Bureau of Indian

Affairs.

Campus-based aid means the Federal

financial aid programs (i.e.,

Supplemental Educational Opportunity

Grants (SEOG), College Work-Study

(CWS), and Perkins Loan) administered

by the financial aid office.

Certificate of Agreement means a

written agreement between a grant

recipient and the higher education

program describing how a recipient

pays back grants when the recipient

does not meet the requirements in 25

CFR 40.8 and 40.9.

Continuing student means a grant

recipient who is currently enrolled in an
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Proposed Rules 7397

eligible institution and is maintaining

satisfactory progress in his or her course

of study according to the institution’s

standards of satisfactory progress.

Director means the Director, Office of

Indian Education Programs, Bureau of

Indian Affairs.

Education Line Officer means a

Bureau of Indian Affairs official

designated as an Agency

Superintendent for Education or an

Education Program Administrator.

Eligible institution means an

institution of higher education that is

accredited by a national or regional

accrediting agency or is a candidate for

accreditation, or is a tribally controlled

community college.

Financial aid office means the office

of an institution of higher education that

has responsibility for institutionally

administered financial aid.

Financial aid package means the

institution’s documents that identify the

amounts and types of financial aid

awarded by the institution and the

amount of unmet need.

Full time student means an enrolled

student who is carrying a full time

academic work load (other than

correspondence course) as determined

by the eligible institution.

Higher education grant package

means documents required to identify,

eligibility for assistance obtainable

through federally recognized tribal

offices, or BIA offices. This package is

available from tribal Higher Education

Grant Programs local Office of Indian

Education Programs.

Higher Education Office means a

Bureau Education Line Office, tribal or

tribal organization administering funds

appropriated to the Bureau for higher

education grants to eligible students.

Indian means a person who is a

member of or is at least one-quarter

degree Indian blood descendant of a

member of an Indian tribe that is

eligible for the special programs and

services provided by the United States

through the Bureau of Indian Affairs to

Indians because of their status as

Indians.

Indian tribe means any Indian Tribe,

Band, Nation, Rancheria, Pueblo,

Colony or Community, including any

Alaska Native village, that is recognized

by the United States Government,

through the Secretary of the Interior, for

special programs and services provided

by the Secretary to Indians because of

their status as Indians.

Mitigating circumstances means a

circumstance, such as, a student’s

medical diagnosed condition impairing

the ability to continue a course of study

documented by his or her physician, or

any other undue hardship that

significantly hinders a student’s

academic progress.

Near reservation means those areas or

communities next to reservations that

are designated by the Assistant

Secretary—Indian Affairs upon

recommendations of the local BIA

Superintendent with input of the

affected tribal governing body.

Program plan means an

individualized course of study in which

the student, in conjunction with the

degree granting institution of higher

education, outlines the required courses

for the desired degree.

Unmet need means the difference

between the student’s cost of education

and the resources available to defray

those costs.

You means the grant applicant or

potential applicant.

§ 40.2 What is the purpose of this part?

The BIA Grant Program for Higher

Education, administered under the

authority of the Snyder Act of

November 2, 1921 (25 U.S.C. 13),

provides financial assistance to eligible

Indian students who have unmet

financial needs as determined by the

eligible institution’s Financial Aid

Office. All grants made under this part

shall be subject to availability of

appropriations.

§ 40.3 Who is eligible for a higher

education grant?

To be eligible for a higher education

grant:

(a) You must be a member of a

federally recognized Indian tribe eligible

for the programs provided to Indians by

the BIA, or be a one-quarter degree

blood descendant of such a member;

(b) You must be admitted to an

institution of higher education that is

accredited by national or regional

accrediting agency, is a candidate for

accreditation, or is an eligible

institution;

(c) You must apply for all available

campus-based aid by an established due

date; and

(d) You must have unmet need (the

difference between the cost of your

education and your resources for

defraying that cost) as determined by

the eligible institution’s financial aid

office.

§ 40.4 How do I apply for a higher

education grant?

(a) You must have the institution’s

financial aid office prepare and certify

an application package for financial aid.

The package must include:

(1) A letter of acceptance from your

institution (required only if you are a

new, transfer, or a previously suspended

student);

(2) A completed BIA form for

applying for a higher education grant;

(3) A Certificate of Indian Blood (CIB)

from your tribe or from the BIA

certifying that you are a member of a

tribe or have documentation to support

a claim to Indian descent by blood

quantum;

(4) A high school transcript or General

Education Development (GED) high

school equivalency certificate;

(5) Grades, transcripts or progress

reports from previous term/year of

attendance (continuing students); and

(6) A statement agreeing to repay the

grant if you fail to enroll, withdraw or

are expelled, unless there are mitigating

circumstances.

(b) This package must be submitted to

the BIA or tribal organization

administering the program for your tribe

by the due date set by that organization.

If your application arrives after the due

date, your application will be

considered only if funds remain

available.

(c) You must submit a separate

application for a summer school

program.

§ 40.5 How is my application reviewed?

The BIA or tribal organization

administering the program for your tribe

reviews your application. The BIA or

tribal organization will:

(a) Determine your unmet need, using

information from your institution’s

financial aid office;

(b) Approve your eligibility for a grant

according to your tribe’s priority plan;

and

(c) Within availability of funds, fund

no more than your unmet need.

§ 40.6 How will I be notified if I am

awarded a grant?

The BIA or tribal organization

administering the program for your tribe

will tell you and your institution’s

financial aid office in writing of its

approval or denial.

§ 40.7 How will I receive the grant?

(a) The BIA or tribal organization

administering the program will issue

your grant to your institution’s financial

aid office.

(b) Your institution’s financial aid

office will distribute the grant money

according to its policy on disbursement.

§ 40.8 How long does my financial aid

last?

(a) If your undergraduate degree or

Certificate program requires four or

fewer academic years, you may take

extra years to complete the program, but

you must finish a degree in no more

than five academic years.
7398 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Proposed Rules

(b) If your undergraduate degree or

certificate program normally requires

more than four academic years, you may

take extra years to complete the

program, but you must finish a degree

in six academic years.

(c) The BIA or tribal organization

administering the program may waive

the time limits for hardship caused by

special circumstances.

(d) To remain eligible for continued

funding, you must submit a grade report

or transcript for each term to the BIA or

tribal organization administering the

program.

§ 40.9 What happens if I withdraw from

school?

(a) You will be required to pay back

any portion of the grant you receive if

you, without mitigating circumstances,

fail to enroll, withdraw or are expelled

before the completion of a term.

(b) Within ten days of your failure to

enroll or withdrawal or expulsion you

will be required to submit to the BIA or

tribal organization administering the

program:

(1) The date of your failure to enroll,

withdrawal or expulsion;

(2) A written statement with

supporting documentation stating your

reasons for a failure to enroll,

withdrawal or expulsion including

mitigating circumstances; and

(3) A copy of your request to the

institution that all remaining grant

funds be returned to the BIA.

(c) The Bureau of Indian Affairs or

tribal organization administering the

program will notify you in writing of

arrangements to pay the balance of

funds based upon a Certificate of

Agreement between you and the

organization awarding your grant or

grant you a waiver from repayment

based upon mitigating circumstances.

§ 40.10 How do I appeal a grant decision?

You may appeal the decisions of any

BIA official by following the procedures

in 25 CFR part 2, Appeals from

Administrative Actions.

§ 40.11 What records are kept for the grant

program?

(a) The Higher Education Office will

maintain your files, a ledger of all costs,

and related records necessary to identify

all transactions involving expenditure of

funds made available to you under this

program. These records:

(1) Identify your award and status;

(2) Demonstrate your eligibility;

(3) Document the amount of your award

and the manner in which your

unmet need was calculated and

met;

(4) Identify whether your enrollment

was terminated;

(5) Identify collections based upon

Certificates of Agreement; and

(6) Identify waivers from repayment.

(b) By November 1 of each year, the

Education Line Officer will submit a

Higher Education Grant Program

Annual Report for the preceding

academic year to the Director of the

Office of Indian Education Programs.

§ 40.12 How does a tribe estimate

allowable administrative costs?

Tribes and tribal organizations that do

not have a negotiated an indirect cost

rate with the Federal Government may

use no more than 15 percent of available

program funds to pay for indirect

program costs chargeable to the

program.

§ 40.13 May a tribe prioritize its higher

education grant program?

Yes.

(a) A tribe operating a higher

education program may set program

priorities for categories of applicants.

These priorities in order to be given

effect must be set out in the application

materials provided to grant applicants,

and attached to the tribe’s contract or

annual funding agreement. This tribal

program priority plan may include a

listing of priorities, the reasons and

supporting documentation.

(b) If a tribe desires to set a higher

academic standard by increasing the

minimum grade point average, designate

academic hours needed in order to be

classified as a full time student, set

priorities to first serve students residing

near or within the exterior boundaries of

the reservation or on trust or restricted

lands, the tribe may do so.

§ 40.14 Are there requirements for

information collection?

The information collection

requirement contained in this part has

been approved by the Office of

Management and Budget under the

Paperwork Reduction Act of 1995, 44

U.S.C. 3507(d), and assigned clearance

number 1076–0106.

Dated: January 28, 1997.

Ada E. Deer,

Assistant Secretary—Indian Affairs.

[FR Doc. 97–4000 Filed 2–18–97; 8:45 am]

BILLING CODE 4310–02–P

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 286

[DoD 5400.7–R]

DoD Freedom of Information Act

Program Regulation

AGENCY: Department of Defense

ACTION: Proposed rule.

SUMMARY: This proposed revision

provides substantive and administrative

changes to conform to the requirements

of the Electronic Freedom of

Information Act Amendments of 1996, 5

U.S.C. 552, as amended by Public Law

104–231. It also provides guidance to

the Department of Defense on

implementation of this amended law.

DATES: Comments must be received by

April 21, 1997.

ADDRESSES: Forward copies to ASD(PA),

Room 2C757, 1400 Defense Pentagon,

Washington, DC 20301–1400

FOR FURTHER INFORMATION CONTACT: Mr.

C. Talbott, 703–697–1171.

SUPPLEMENTARY INFORMATION:

Executive Order 12866, ‘‘Regulatory

Planning and Review’’

It has been determined that 32 CFR

part 286 is not a significant regulatory

action. The rule does not:

(1) Have an annual effect to the

economy of $100 million or more or

adversely affect in a material way the

economy; a section of the economy;

productivity; competition; jobs; the

environment; public health or safety; or

State, local, or tribal governments or

communities;

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another Agency;

(3) Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs, or the rights and

obligations of recipients thereof; or

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in this Executive Order.

Public Law 96–354, ‘‘Regulatory

Flexibility Act’’ (5 U.S.C. 601)

It has been certified that this rule is

not subject to the Regulatory Flexibility

Act (5 U.S.C. 601) because it would not,

if promulgated, have a significant

economic impact on a substantial

number of small entities. This rule

implements the Freedom of Information

Act (5 U.S.C. 552), a statute concerning

the release of Federal Government

records, and does not economically