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.