Federal Register / Vol. 63, No. 93 /Thursday, May 14, 1998 /Rules and Regulations 26717

553, or by any other law, a Regulatory

Flexibility Analysis under the

Regulatory Flexibility Act is not

required and was not prepared.

D. This rule involves collections of

information subject to the Paperwork

Reduction Act and cleared by the Office

of Management and Budget under

control number 0648–0119. The

estimated response times for these

requirements are 480 hours for

management program approval and 8

hours for program amendment and

routine program changes. The response

estimates shown include the time for

reviewing instructions, searching

existing data sources, gathering and

maintaining needed data, and

completing and reviewing the collection

of information. Notwithstanding any

other provision of the law, no person is

required to respond to, nor shall any

person be subject to penalty for failure

to comply with, a collection of

information, subject to the requirements

of the PRA, unless that collection of

information displays a currently valid

OMB control number.

E. NOAA has concluded that this

regulatory action does not constitute a

major federal action significantly

affecting the quality of the environment.

Therefore, an environmental impact

statement under the National

Environmental Policy Act, 43 U.S.C.

4321 et seq. is not required.

F. This rule contains no mandates,

under the provisions of Title II of the

Unfunded Mandates Reform Act of 1995

(UMRA), Public Law 104–4, for state,

local, or tribal governments or the

private sector. Thus, this rule is not

subject to the requirements of sections

202 and 205 of the UMRA.

G. NOAA has concluded that this

regulatory action does not have

sufficient federalism implications to

warrant the preparation of a Federalism

Assessment under Executive Order

12612.

List of Subjects in 15 CFR Part 921

Administrative practice and

procedure, Coastal zone, Grant

programs—Natural resources, Reporting

and recordkeeping requirements.

Dated: May 11, 1998.

Nancy Foster,

Assistant Administrator for Ocean Services

and Coastal Zone Management.

For the reasons set forth in the

Preamble, 15 CFR part 921 is amended

as follows:

PART 921—NATIONAL ESTUARINE

RESEARCH RESERVE SYSTEM

REGULATIONS

1. The authority citation for part 921

continues to read as follows:

Authority: Section 315 of the Coastal Zone

Management Act, as amended (16 U.S.C.

1461).

2. Paragraph (f) of § 921.1 is amended

by revising the fourth sentence to read

as follows:

§ 921.1 Mission, goals and general

provisions.

* * * * *

(f) * * * Notwithstanding any

financial assistance limits established

by this Part, when financial assistance is

provided from amounts recovered as a

result of damage to natural resources

located in the coastal zone, such

assistance may be used to pay 100

percent of all actual costs of activities

carrier out with this assistance, as long

as such funds are available. * * *

* * * * *

3. Paragraph (a) of § 921.10 is

amended by adding a new sentence,

after the third sentence, to read as

follows:

§ 921.10 General.

(a) * * * Notwithstanding the above,

when financial assistance is provided

from amounts recovered as a result of

damage to natural resources located in

the coastal zone, such assistance may be

used to pay 100 percent of all actual

costs of activities carried out with this

assistance, as long as such funds are

available. * * *

4. Paragraph (b) of § 921.10 is

amended by adding a new sentence,

after the last sentence, to read as

follows:

§ 921.10 General.

(b) * * * Notwithstanding the above,

when financial assistance is provided

from amounts recovered as a result of

damage to natural resources located in

the coastal zone, such assistance may be

used to pay 100 percent of all actual

costs of activities carrier out with this

assistance, as long as such funds are

available.

5. Section 921.20 is amended by

revising the last sentence to read as

follows:

§ 921.20 General

* * * In any case, the amount of

Federal financial assistance provided to

a coastal state with respect to the

acquisition of lands and waters, or

interests therein, for any one National

Estuarine Research Reserve may not

exceed an amount equal to 50 percent

of the costs of the lands, waters, and

interests therein or $5,000,000,

whichever amount is less, except when

the financial assistance is provided from

amounts recovered as a result of damage

to natural resources located in the

coastal zone, in which case the

assistance may be used to pay 100

percent of all actual costs of activities

carrier out with this assistance, as long

as such funds are available.

6. Section 921.31 is amended by

revising the fourth sentence to read as

follows:

§ 921.31 Supplemental acquisition and

development awards.

* * * Acquisition awards for the

acquisition of lands or waters, or

interests therein, for any one reserve

may not exceed an amount equal to 50

percent of the costs of the lands, waters,

and interests therein of $5,000,000,

whichever amount is less, except when

the financial assistance is provided from

amounts recovered as result of damage

to natural resources located in the

coastal zone, in which case the

assistance may be used to pay 100

percent of all actual costs of activities

carrier out with this assistance, as long

as such funds are available. * * *

[FR Doc. 98–12880 Filed 5–13–98; 8:45 am]

BILLING CODE 3510–08–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0274]

Food Labeling; Petitions for Nutrient

Content and Health Claims, General

Provisions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to define the conditions

under which certain petitions for

nutrient content and health claims shall

be deemed to be denied and to codify

the statutory timeframe within which

the agency will complete rulemakings

on such petitions. FDA is taking this

action in response to the Food and Drug

Administration Modernization Act of

1997 (FDAMA).

DATES: This regulation is effective May

14, 1998. Submit written comments by

June 15, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch
26718 Federal Register / Vol. 63, No. 93 /Thursday, May 14, 1998 /Rules and Regulations

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Hilario R. Duncan, Center for Food

Safety and Applied Nutrition (HFS–24),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202–

205–8281.

SUPPLEMENTARY INFORMATION: On

November 21, 1997, President Clinton

signed into law FDAMA (Pub. L. 105–

115). Section 302 of FDAMA amended

section 403(r)(4)(A)(i) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 343(r)(4)(A)(i)) so that certain

nutrient content claim and health claim

petitions are deemed denied if FDA

does not act by certain deadlines. In

particular, under amended section

403(r)(4)(A)(i) of the act, if FDA fails to

make a filing decision on either type of

petition within 100 days of receipt of

the petition by the agency, the petition

shall be deemed to be denied unless an

extension is mutually agreed upon by

FDA and the petitioner. If the petition

is deemed to be denied in this manner

without filing, the petition shall not be

made available to the public. In

addition, if FDA fails to issue a

proposed rule within 90 days of filing

of either type of petition, that petition

shall be deemed to be denied unless an

extension is mutually agreed upon by

FDA and the petitioner. Accordingly,

FDA is amending §§ 101.69(m) and

101.70(j) (21 CFR 101.69(m) and

101.70(j)) to include the statutory

language, i.e., ‘‘Secretary’’ is replaced

with ‘‘FDA’’ in the appropriate places in

the regulations. For consistency, FDA

also is making a few editorial changes

in § 101.69, i.e., replacing ‘‘the

Commissioner of Food and Drugs’’ with

‘‘FDA’’ in the appropriate places in the

regulation.

Under amended section 403(r)(4)(A)(i)

of the act, FDA also must publish a final

rule within 540 days of receipt of the

petition, or FDA is required to provide

the relevant House and Senate

legislative committees with the reasons

for failing to do so. Accordingly, FDA is

amending §§ 101.69(m) and 101.70(j) to

state that rulemakings on health and

certain nutrient content claim petitions

shall be completed within 540 days of

receipt of those petitions. The agency

notes that § 101.70(j) provides that a

final rule in response to a health claim

petition will be published by FDA

within 270 days of the date of

publication of the proposal but that, for

cause, the agency may extend the period

for agency action no more than twice

with each extension being for no more

than 90 days. In view of amended

section 403(r)(4)(A)(i) of the act, the

agency advises that, to ensure final

action shall be within 540 days of the

date of receipt of the petition, the

agency may be limited to only one such

extension for cause, and such extension

may be limited to fewer than 90 days.

Additionally, the agency is taking this

opportunity to correct and clarify some

inconsistent references in § 101.69 to

FDA and to the Commissioner of Food

and Drugs so that all references are to

the FDA.

The agency has determined under 21

CFR 25.30(k) 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.

FDA has examined the economic

implications of this final rule under

Executive Order 12866. Executive Order

12866 directs agencies to assess all costs

and benefits of available regulatory

alternatives and, when regulation is

necessary, to select the regulatory

approach that maximizes net benefits

(including potential economic,

environmental, public health and safety

effects; distributive impacts; and

equity). Executive Order 12866

classifies a rule as significant if it meets

any one of a number of specified

conditions, including having an annual

effect on the economy of $100 million

or adversely affecting in a material way

a sector of the economy, competition, or

jobs, or if it raises novel legal or policy

issues. The agency finds that this final

rule is not a significant rule as defined

by Executive Order 12866. No analysis

is required for this rule under the

Regulatory Flexibility Act (5 U.S.C.

601–612) because, as discussed in this

document, FDA is issuing it without

publishing a general notice of proposed

rulemaking.

Finally, in accordance with the Small

Business Regulatory Enforcement

Fairness Act, the administrator of the

Office of Information and Regulatory

Affairs of the Office of Management and

Budget has determined that this final

rule is not a major rule for the purpose

of congressional review.

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

Because the amendments set forth in

this document incorporate the language

of section 302 of FDAMA into §§ 101.69

and 101.70, FDA finds, for good cause,

that notice and public procedure are

unnecessary and, therefore, are not

required under 5 U.S.C. 553.

Nonetheless, under 21 CFR 10.40(e),

FDA is providing an opportunity for

comment on whether the regulations set

forth in this document should be

modified or revoked. Interested persons

may, on or before June 15, 1998, submit

to the Dockets Management Branch

(address above) written comments

regarding this final rule. 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. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday though Friday.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 101 is

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 331, 342, 343, 348, 371.

2. Section 101.69 is amended in

paragraph (c) by removing ‘‘FDA’s

Center for Food Safety and Applied

Nutrition’’ and adding in its place ‘‘the

Food and Drug Administration’s (FDA)

Center for Food Safety and Applied

Nutrition’’; in paragraph (d) by

removing ‘‘the Food and Drug

Administration’’ and adding in its place
Federal Register / Vol. 63, No. 93 /Thursday, May 14, 1998 /Rules and Regulations 26719

‘‘FDA’’; and in paragraphs (l), (m)(4),

(n)(3) and (n)(4), and (o)(3) and (o)(4) by

removing ‘‘the Commissioner of Food

and Drugs’’, wherever it appears, and

adding in its place ‘‘FDA’’; by revising

paragraph (m)(3); and by adding

paragraphs (m)(4)(iii) and (m)(5) to read

as follows:

§ 101.69 Petitions for nutrient content

claims.

* * * * *

(m) * * *

(3) Within 100 days of the date of

receipt of the petition, FDA will notify

the petitioner by letter that the petition

has either been filed or denied. If

denied, the notification shall state the

reasons therefor. If filed, the date of the

notification letter becomes the date of

filing for the purposes of section

403(r)(4)(A)(i) of the act. If FDA does not

act within such 100 days, the petition

shall be deemed to be denied unless an

extension is mutually agreed upon by

the FDA and the petitioner. A petition

that has been denied, or has been

deemed to be denied without filing,

shall not be made available to the

public. A filed petition shall be

available to the public as provided

under paragraph (g) of this section.

* * * * *

(4) * * *

(iii) If FDA does not act within 90

days of the filing date, the petition shall

be deemed to be denied unless an

extension is mutually agreed upon by

FDA and the petitioner.

(5) If FDA issues a proposal, the

rulemaking shall be completed within

540 days of the date of receipt of the

petition.

* * * * *

3. Section 101.70 is amended by

revising paragraph (j)(2), by adding

paragraph (j)(3)(iii), and by revising

paragraph (j)(4)(ii) to read as follows:

§ 101.70 Petitions for health claims.

* * * * *

(j) * * *

(2) Within 100 days of the date of

receipt of the petition, FDA will notify

the petitioner by letter that the petition

has either been filed for comprehensive

review or denied. The agency will deny

a petition without reviewing the

information contained in ‘‘B. Summary

of Scientific Data’’ if the information in

‘‘A. Preliminary Requirements’’ is

inadequate in explaining how the

substance conforms to the requirements

of § 101.14(b). If the petition is denied,

the notification will state the reasons

therefor, including justification of the

rejection of any report from an

authoritative scientific body of the U.S.

Government. If filed, the date of the

notification letter becomes the date of

filing for the purposes of this regulation.

If FDA does not act within such 100

days, the petition shall be deemed to be

denied unless an extension is mutually

agreed upon by FDA and the petitioner.

A petition that has been denied, or has

been deemed to be denied, without

filing will not be made available to the

public. A filed petition will be available

to the public to the extent provided

under paragraph (e) of this section.

(3) * * *

(iii) If FDA does not act within 90

days of the filing date, the petition shall

be deemed to be denied unless an

extension is mutually agreed upon by

FDA and the petitioner.

(4) * * *

(ii) For cause, FDA may extend, no

more than twice, the period in which it

will publish a final rule; each such

extension will be for no more than 90

days. FDA will publish a notice of each

extension in the Federal Register. The

document will state the basis for the

extension, the length of the extension,

and the date by which the final rule will

be published, which date shall be

within 540 days of the date of receipt of

the petition.

Dated: May 6, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12832 Filed 5–13–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Mine Safety and Health Administration

30 CFR Part 100

RIN 1219–AB03

Civil Penalties; Correction

AGENCY: Mine Safety and Health

Administration, Labor.

ACTION: Final rule; correction.

SUMMARY: This document corrects the

RIN number to the final rule for criteria

and procedures for proposed assessment

of civil penalties published in the

Federal Register on April 22, 1998.

EFFECTIVE DATE: May 14, 1998.

FOR FURTHER INFORMATION CONTACT:

Patricia W. Silvey, Director, Office of

Standards, Regulations, and Variances,

MSHA, (703) 235–1910.

SUPPLEMENTARY INFORMATION: On April

22, 1998, (63 FR 20032) MSHA

published a final rule on criteria and

procedures for proposed assessment of

civil penalties. This document corrects

an error that appears on the front page

of the notice. The RIN number 1219–

AA49 is corrected to read 1219–AB03.

Patricia W. Silvey,

Director, Office of Standards, Regulations,

and Variances.

[FR Doc. 98–12759 Filed 5–13–98; 8:45 am]

BILLING CODE 4510–43–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 9

[FRL–6013–2]

OMB Approval Numbers Under the

Paperwork Reduction Act

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: In compliance with the

Paperwork Reduction Act (PRA), this

technical amendment amends the table

that lists the Office of Management and

Budget (OMB) control numbers issued

under the PRA for the Urban Bus

Rebuild Requirements.

EFFECTIVE DATE: This final rule is

effective June 15, 1998.

FOR FURTHER INFORMATION CONTACT:

William Rutledge, Engine Programs and

Compliance Division (Mail Code 6403–

J), U.S. Environmental Protection

Agency, Washington, DC 20460.

Telephone: (202) 564–9297.