Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 4165

summary of the comments and the

agency’s response to them is provided

below:

(1) One comment concurred with

FDA’s proposal to remove the separate

regulation on IDE’s for IOL’s contained

in part 813. However, because part 813

contains some provisions that are not

reflected in part 812, the comment

suggested that FDA identify what, if

any, additional information FDA would

require IDE submissions for IOL’s to

include.

Under the final rule, any requirements

unique to part 813 would no longer

apply. The content of IDE submissions

for IOL’s only need to include

information required in IDE

submissions for investigational devices

generally. For example, with respect to

institutional review boards (IRB’s)

(referred to in part 813 as institutional

review committees), the sponsor will

only be required to submit the

information required by § 812.20(b)(6)

and not that required by § 813.20(b)(7).

(2) Both comments recommended that

FDA provide in the final rule a

mechanism for IOL clinical

investigations that are in progress before

the final rule becomes effective to

continue under part 813 until those

investigations are completed or

terminated. One comment also noted

that, because investigators have not

signed statements agreeing to conform

to part 812, application of the

requirements of part 812 to ongoing IOL

studies would create confusion and add

to the cost of the ongoing studies.

FDA does not believe that the

continuation of part 813 requirements

for existing studies is necessary. The

differences between parts 812 and 813

are relatively minor. Investigators who

are in compliance with part 813 will

also generally be in compliance with

part 812. Sponsors may seek a waiver

under part 812, if there are any

difficulties as a result of the change

from part 813 to part 812. FDA, however

does not anticipate any difficulties.

(3) Both comments emphasized that

part 812 has certain requirements that

are not included in part 813. For

example, § 812.150(b)(4) requires the

sponsor to submit a semi-annual

investigator list to FDA; § 812.150(b)(5)

requires the sponsor to submit annual

progress reports to all reviewing IRB’s;

and § 812.150(b)(8) requires the sponsor

to submit to FDA a copy of any report

by an investigator under § 812.150(a)(5)

within 5 working days of receipt. Both

comments requested that these

additional rules not be imposed on IOL

studies conducted under part 812.

FDA does not believe that

maintaining this type of distinction is

necessary. Experience over the past 15

years has shown that the requirements

of part 812 are reasonable and that

sponsors of investigations under part

812 have not had undue difficulty

complying with these provisions. As

noted in section II (2) of this document,

part 812 contains a waiver provision

that can be utilized on a case-by-case

basis, if needed.

(4) One comment asked how IRB’s

would be notified of the new rule.

FDA will send letters to sponsors of

all active IOL IDE investigations, and

the agency will request that sponsors

inform investigators and IRB’s of the

change. Additionally, FDA will

publicize the new rule at the regional

IRB meetings and at other appropriate

forums.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) 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.

IV. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the final rule removes

existing regulations on investigational

studies of IOL’s and requires such

investigations to be conducted under

the IDE regulations in part 812

applicable to medical devices generally,

the agency certifies that the final rule

will not impose any significant new

burdens on sponsors and investigators

of IOL’s and will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

List of Subjects

21 CFR Part 812

Health records, Medical devices,

Medical research, Reporting and

recordkeeping requirements.

21 CFR Part 813

Medical devices, Medical research,

Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, chapter I of title 21

of the Code of Federal Regulations is

amended in 21 CFR parts 812 and 813

as follows:

PART 812—INVESTIGATIONAL

DEVICE EXEMPTIONS

1. The authority citation for 21 CFR

part 812 continues to read as follows:

Authority: Secs. 301, 501, 502, 503, 505,

506, 507, 510, 513–516, 518–520, 701, 702,

704, 721, 801 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 331, 351, 352, 353,

355, 356, 357, 360, 360c–360f, 360h–360j,

371, 372, 374, 379e, 381); secs. 215, 301, 351,

354–360F of the Public Health Service Act

(42 U.S.C. 216, 241, 262, 263b–263n).

§ 812.2 [Amended]

2. Section 812.2 Applicability is

amended by removing paragraph (c)(8).

PART 813—INVESTIGATIONAL

EXEMPTIONS FOR INTRAOCULAR

LENSES

Part 813 [Removed and Reserved]

3. Part 813, consisting of §§ 813.1

through 813.170, is removed and

reserved.

Dated: January 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–2169 Filed 1–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF EDUCATION

34 CFR Part 75

RIN 1880–AA61

Direct Grant Programs

AGENCY: Department of Education.

ACTION: Final regulations.

SUMMARY: The Secretary amends the

Department’s regulations on direct grant

programs to expand the basis for

selecting applications for new grants to

include a recipient’s previous
4166 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

performance under any Department

grant program as well as its failure to

submit a final performance report or

submission of a report of unacceptable

quality. The Secretary has decided not

to amend the regulations to change the

date by which applications are

considered received by the Department

of Education. These amendments to the

final regulations are part of the

Department’s continuing effort to

improve the discretionary grantmaking

process.

EFFECTIVE DATE: These regulations take

effect February 28, 1997.

FOR FURTHER INFORMATION CONTACT:

Ronelle Holloman, U.S. Department of

Education, 600 Independence Avenue,

S.W., Room 3636, ROB–3, Washington,

D.C. 20202–4248. Telephone: (202) 205–

3501. Individuals who use a

telecommunications device for the deaf

(TDD) may call the Federal Information

Relay Service (FIRS) at 1–800–877–8339

between 8 a.m. and 8 p.m., Eastern time,

Monday through Friday.

SUPPLEMENTARY INFORMATION: On

September 20, 1995, the Secretary

published in the Federal Register (60

FR 48844) a notice of proposed

rulemaking (NPRM) proposing to revise

sections in the Education Department

General Administrative Regulations

(EDGAR) regarding the deadline date for

applications and how the Secretary

selects applications for new grants.

These proposed amendments were

expected to reduce the processing time

for discretionary grants, improve the

quality of the final performance report

and increase the ability of the

Department to ensure that qualified

applicants receive grants.

The significant difference between the

NPRM and this final regulation is the

deletion of the amendment that would

have changed the requirement for

meeting the deadline date for a

competition from the postmarked date

to the date the application is actually

received. Most commenters opposed

this change for one or both of the

following reasons: (1) those applicants

closest in proximity to the Washington,

D.C. metropolitan area would have an

unfair advantage; and (2) the change

would cause additional cost burdens to

recipients. Although the Department did

receive several responses in support of

the change, from commenters who felt

that the change would not cause

additional hardship and would be fair if

ED allowed for reasonable exceptions to

the rule, the Secretary decided not to

implement this proposed change at this

time.

The final regulation changes how the

Secretary selects applications for new

grants (34 CFR 75.217). The regulation

expands the basis for selection to

include a recipient’s prior performance

under any Department program,

including use of funds and the

applicant’s failure to submit a final

performance report or the submission of

a report of unacceptable quality. The

Department’s motivation for this change

is to promote accountability and good

stewardship. The change will require a

stronger commitment from a recipient to

submit a final performance report and

allow ED the opportunity to inform the

general public and the educational

community of successful project

outcomes. The majority of commenters

who responded agreed with the change

and felt that this change would set a

precedent for sound performance and

accountability. Further details of the

comments received are discussed below.

Analysis of Comments and Changes

In response to the Secretary’s

invitation in the NPRM, 44 parties

submitted comments on the proposed

regulations. An analysis of the

comments and of the resulting changes

in the regulations since the publication

of the NPRM follows. Substantive issues

are discussed under the section of the

regulations to which they pertain.

Technical and other minor changes—

and suggested changes the Secretary is

not legally authorized to make under the

applicable statutory authority—are not

addressed.

Section 75.217 How the Secretary

selects applications for new grants.

Comments: The Department received

a total of 11 comments on this section.

The majority of commenters agreed with

this change and felt that an institution

that received grant funds should be held

accountable for meeting the objectives

of the grant.

Discussion: The Secretary agrees.

Accountability is important to ensure

progress and success. The submission of

a final report provides opportunity for

the general public to know that their tax

dollars were spent wisely and provides

the educational community with the

opportunity to replicate a successful

project. The failure to meet all of the

obligations in a previous grant would

alert the Department that something

could be seriously wrong and ED would

conduct a further review before funds

could be granted in the future.

Changes: None

Comments: One commenter disagreed

with the proposed change because the

commenter thought it was unfair to

penalize an entity for the acts of one

individual and that ED does not have

standards for report quality.

Discussion: This amendment

broadened the range of information the

Secretary could consider in selecting

new grants. The criteria for selection of

new grants are established in

regulations of the Department. The

Secretary does not agree that there need

to be separate criteria for reports. In fact,

the Secretary has avoided any effort to

narrowly circumscribe final reports.

This is consistent with the Department’s

new reengineered grants process that

encourages a partnership with its

recipients and supports flexibility in the

administration of their projects. In filing

an interim or final report the grantee

must demonstrate that it is making

substantial progress toward meeting the

objectives of the grant or that it has met

the objectives of the grant. A report will

be considered substandard if it fails to

address how the recipient met the

objectives of a grant or, if it failed to

meet any objectives, how it will take

steps to improve the project and meet

the objectives.

Changes: None

Comments: Several commenters

agreed with the proposed change but

expressed two similar concerns: (1) How

long will a recipient’s past poor

performance be considered by the

Department? (2) What mechanism will

be used to allow applicants to receive

further funding?

Discussion: Generally, in most cases

where poor performance has been an

issue, the Department relied on the

high-risk procedures authorized under

§§ 74.14 and 80.12 of the Education

Department General Administrative

Regulations (EDGAR). Under the highrisk regulations, ED may impose

additional conditions on a recipient to

help ensure proper performance.

However, there are rare cases where an

applicant poses such a risk of misuse of

Federal funds that no award should be

made. This regulation is intended to be

used in those rare cases. ED is aware

that recipients face unexpected

challenges, some of which can cause a

recipient to perform poorly on a grant;

therefore, when making future funding

decisions, ED will consider any

extenuating circumstances on a case-bycase basis.

Paperwork Reduction Act of 1995

These regulations have been

examined under the Paperwork

Reduction Act of 1995 and have been

found to contain no information

collection requirements.

Assessment of Educational Impact

In the notice of proposed rulemaking,

the Secretary requested comments on

whether the proposed regulations would
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 4167

require transmission of information that

is being gathered by or is available from

any other agency or authority of the

United States.

Based on the response to the proposed

rules and on its own review, the

Department has determined that the

regulations in this document do not

require transmission of information that

is being gathered by or is available from

any other agency or authority of the

United States.

List of Subjects in 34 CFR Part 75

Education Department, Discretionary

grant programs—education,

Continuation funding, Grant

administration, Incorporation by

reference, Reporting and recordkeeping

requirements, Performance reports,

Unobligated funds.

Dated: January 23, 1997.

Richard W. Riley,

Secretary of Education.

(Catalog of Federal Domestic Assistance

Number does not apply)

The Secretary amends Part 75 of Title

34 of the Code of Federal Regulations as

follows:

PART 75—DIRECT GRANT

PROGRAMS

1. The authority citation for Part 75

continues to read as follows:

Authority: 20 U.S.C. 1221e–3 and 3474,

unless otherwise noted.

2. Section 75.217 is amended by

revising paragraph (d)(3) to read as

follows:

§ 75.217 How the Secretary selects

applications for new grants.

* * * * *

(d) * * *

(3) Any other information—

(i) Relevant to a criterion, priority, or

other requirement that applies to the

selection of applications for new grants;

(ii) Concerning the applicant’s

performance and use of funds under a

previous award under any Department

program; and

(iii) Concerning the applicant’s failure

under any Department program to

submit a performance report or its

submission of a performance report of

unacceptable quality.

* * * * *

[FR Doc. 97–2196 Filed 1–28–97; 8:45 am]

BILLING CODE 4000–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[PA 055–4038; FRL–5653–7]

Approval and Promulgation of Air

Quality Implementation Plans;

Pennsylvania; Approval of a NOX

RACT Determination for International

Paper Company—Hammermill Papers

Division—Lockhaven

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is approving a State

Implementation Plan (SIP) revision

submitted by the Commonwealth of

Pennsylvania. This revision establishes

and requires reasonably available

control technology (RACT) on

International Paper Company—

Hammermill Papers Division, a major

source of nitrogen oxide (NOX)

emissions. Additionally, it limits the

volatile organic compound (VOC)

emissions at this facility to no more

than 50 tons per year; thereby making

this facility a synthetic minor VOC

source. The intended effect of this

action is to approve a source-specific

operating permit for the emission units

at International Paper—Hammermill

Division—Lockhaven, located in

Clinton County, Pennsylvania. This

action is being taken under section 110

of the Clean Air Act.

EFFECTIVE DATE: This final rule is

effective on February 28, 1997.

ADDRESSES: Copies of the documents

relevant to this action are available for

public inspection during normal

business hours at the Air, Radiation,

and Toxics Division, U.S.

Environmental Protection Agency,

Region III, 841 Chestnut Building,

Philadelphia, Pennsylvania 19107; the

Air and Radiation Docket and

Information Center, U.S. Environmental

Protection Agency, 401 M Street, SW,

Washington, DC 20460; and

Pennsylvania Department of

Environmental Protection, Bureau of Air

Quality, P.O. Box 8468, 400 Market

Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT:

Cynthia H. Stahl, (215) 566–2180, at the

EPA Region III office or via e-mail at

stahl.cynthia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On April

9, 1996 (61 FR 15709), EPA published

a direct final rulemaking notice and the

accompanying notice of proposed

rulemaking (NPR) (61 FR 15744) for the

Commonwealth of Pennsylvania

pertaining to the VOC and NOX RACT

determinations for 21 sources. One of

these sources was International Paper

Company—Hammermill Papers

Division—Lockhaven (IP—Lockhaven),

located in Clinton County,

Pennsylvania. On June 28, 1996, adverse

comments were submitted to EPA by the

New York Department of Environmental

Conservation (NYDEC) pertaining to the

RACT determination for IP—Lockhaven.

The formal SIP revision for IP—

Lockhaven was submitted by

Pennsylvania on April 19, 1995.

Pennsylvania Department of

Environmental Protection (PADEP) also

submitted comments to EPA on the IP—

Lockhaven RACT determination.

NYDEC Comments

New York Department of

Environmental Conservation

commented that while they agreed with

EPA’s determination that RACT for the

two 350 mmBTU/hr coal-fired stoker

boilers was the operation and

maintenance of the boilers in

accordance with manufacturer’s

specifications and good air pollution

control practices, they disagreed with

the accompanying emission limit of 0.7

lbs NOX/mmBTU, averaged over a 30

day period, that was also determined to

be RACT for these boilers. NYDEC

stated that since the AP–42 emission

factor estimates NOX emissions for this

type of unit at 0.56 lbs/mmBTU, the

limit of 0.7 lbs/mmBTU was too high.

NYDEC concludes that in the absence of

supporting data, the AP–42 emission

rate should become the SIP emission

rate for these boilers.

Pennsylvania Comments

Pennsylvania Department of

Environmental Protection submitted

comments to EPA on July 16, 1996

stating that the proposed RACT

emission limits of 0.7 lbs NOX/mmBTU

for the two boilers at IP—Lockhaven

were established based on actual

emissions data. The 30 day average CEM

data recorded for boiler #1 was 0.61 lbs/

mmBTU with the range as 0.52 to 0.67

lbs/mmBTU. The 30 day average CEM

data recorded for boiler #2 was 0.58 lbs/

mmBTU with the range as 0.53 to 0.60

lbs/mmBTU. Since a year’s worth of

certified data was not available at the

time that DEP issued the permit to IP—

Lockhaven (December 1995, OP 18–

0005), DEP established the limit of 0.7

lbs/mmBTU to allow a buffer to account

for the limited emission data. DEP also

states that condition #6 of the IP permit

allows the Department to revise the NOX

emission limits based on future CEM

data. Furthermore, DEP states that since

the permit was issued, the IP boilers

have recorded exceedances and were