Federal Register / Vol. 60, No. 59 / Tuesday, March 28, 1995 / Rules and Regulations 15871

or warnings. Finally, in § 5.63, FDA is

deleting the Director, St. Louis Branch

from those FDA officials authorized to

perform and to designate other officials

to perform all of the functions of the

Commissioner of Food and Drugs

relating to detention of meat, poultry,

eggs, and related products.

In § 5.37(a), FDA is changing the

reference to ‘‘section 306’’ of the Federal

Food, Drug, and Cosmetic Act to read,

‘‘section 309’’ to reflect renumbering

accomplished by Pub. L. 102–282. In

§ 5.37(b), FDA is changing the reference

to ‘‘section 360C(d) of the Public Health

Service Act’’ to read ‘‘section 539(d) of

the Federal Food, Drug, and Cosmetic

Act’’ to reflect a redesignation

accomplished by Pub. L. 101–629.

Further redelegation of the authority

delegated is not authorized at this time.

Authority delegated to a position by title

may be exercised by a person officially

designated to serve in such position in

an acting capacity or on a temporary

basis.

List of Subjects in 21 CFR Part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 5 is

amended as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR

part 5 continues to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7

U.S.C. 138a, 2271; 15 U.S.C. 638, 1261–1282,

3701–3711a; secs. 2–12 of the Fair Packaging

and Labeling Act (15 U.S.C. 1451–1461); 21

U.S.C. 41–50, 61–63, 141–149, 467f, 679(b),

801–886, 1031–1309; secs. 201–903 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321–394); 35 U.S.C. 156; secs. 301,

302, 303, 307, 310, 311, 351, 352, 354, 361,

362, 1701–1706; 2101, 2125, 2127, 2128 of

the Public Health Service Act (42 U.S.C. 241,

242, 242a, 242l, 242n, 243, 262, 263, 263b,

264, 265, 300u–300u–5, 300aa–1, 300aa–25,

300aa–27, 300aa–28); 42 U.S.C. 1395y,

3246b, 4332, 4831(a), 10007–10008; E.O.

11490, 11921, and 12591; secs. 312, 313, 314

of the National Childhood Vaccine Injury Act

of 1986, Pub. L. 99–660 (42 U.S.C. 300aa–1

note).

2. Section 5.36 is revised to read as

follows:

§ 5.36 Certification following inspections.

Regional Food and Drug Directors and

District Directors are authorized to issue

certificates of sanitation under § 1240.20

of this chapter.

3. Section 5.37 is amended by revising

the introductory text of paragraph (a), by

revising paragraph (a)(4)(iii), by adding

new paragraphs (a)(6)(v) through

(a)(6)(viii), by revising the introductory

text of paragraph (b), and by revising the

introductory text of paragraph (b)(5) to

read as follows:

§ 5.37 Issuance of reports of minor

violations.

(a) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

under section 309 of the Federal Food,

Drug, and Cosmetic Act regarding the

issuance of written notices or warnings:

* * * * *

(4) * * *

(iii) The Director, Division of

Compliance, Office of Surveillance and

Compliance, CVM.

* * * * *

(6) * * *

(v) The Director, Northeast Regional

Laboratory, Northeast Region.

(vi) The Director, Southeast Regional

Laboratory, Southeast Region.

(vii) The Director, Winchester

Engineering and Analytical Center.

(viii) The Director, National Forensic

Chemistry Center.

(b) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

under section 539(d) of the Federal

Food, Drug, and Cosmetic Act regarding

the issuance of written notices or

warnings:

* * * * *

(5) Regional Food and Drug Directors;

District Directors; the Director, St. Louis

Branch; the Director, Northeast Regional

Laboratory, Northeast Region; the

Director, Southeast Regional Laboratory,

Southeast Region; the Director,

Winchester Engineering and Analytical

Center; and the Director, National

Forensic Chemistry Center, when such

functions relate to:

* * * * *

4. Section 5.63 is amended by revising

the introductory text to read as follows:

§ 5.63 Detention of meat, poultry, eggs,

and related products.

The Regional Food and Drug Directors

and District Directors are authorized to

perform and to designate other officials

to perform all of the functions of the

Commissioner of Food and Drugs under:

* * * * *

Dated: March 17, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–7574 Filed 3–27–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 184

[Docket No. 93P–0024]

Diacetyl Tartaric Acid Esters of Monoand Diglycerides; Revision of Common

or Usual Name

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revising its

regulations to recognize the acronym

‘‘DATEM’’ as the alternate common or

usual name of the ingredient diacetyl

tartaric acid esters of mono- and

diglycerides. This action responds to a

citizen petition submitted by Grindsted

Products Co. requesting approval of the

alternate name.

EFFECTIVE DATE: April 27, 1995.

FOR FURTHER INFORMATION CONTACT:

Gerad L. McCowin, Office of Food

Labeling (HFS–151), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4561.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 1,

1994 (59 FR 61560), FDA published a

proposal to revise § 184.1101(a) and (e)

(21 CFR 184.1101(a) and (e)) on diacetyl

tartaric acid esters of mono- and

diglycerides to provide for the use of the

acronym ‘‘DATEM’’ in food labeling as

the alternate common or usual name of

this ingredient. The proposal was issued

in response to a citizen petition

submitted by Grindsted Products Co. No

comments were received by the agency

in response to the proposal.

II. Conclusion

The agency received no comments on

the proposed rule. Thus, the agency

concludes that, for the reasons set forth

in its proposal, it is appropriate to revise

§ 184.1101 (e) governing generally

recognized as safe (GRAS) food

substances to provide for the use of the

acronym ‘‘DATEM’’ as the alternate

common or usual name of the ingredient

diacetyl tartaric acid esters of monoand diglycerides on food labeling. The

agency concludes that there has been

sufficient exposure to the term

‘‘DATEM’’ to allow the American

consumer to recognize and understand

the meaning of this term. The term

‘‘DATEM’’ is acceptable and favorable to

both industry and the consumer and,

therefore, should be allowed to be used

interchangeably with the term ‘‘diacetyl

tartaric acid esters of mono- and

diglycerides.’’
15872 Federal Register / Vol. 60, No. 59 / Tuesday, March 28, 1995 / Rules and Regulations

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(9) and (a)(11) that this

action is of a type that does not

individually or cumulatively have a

significant effect on the human

environment. FDA did not receive any

comments on this issue and, thus, is

aware of no reason to alter this

determination.

IV. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354). 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 FDA did not receive

any comments or new information on

this issue, the agency certifies that the

final rule 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 in 21 CFR Part 184

Food ingredients.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 184 is

amended as follows:

PART 184—DIRECT FOOD

SUBSTANCES AFFIRMED AS

GENERALLY RECOGNIZED AS SAFE

1. The authority citation for 21 CFR

part 184 continues to read as follows:

Authority: Secs. 201, 402, 409, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 371).

2. Section 184.1101 is amended by

revising paragraphs (a) and (e) to read as

follows:

§ 184.1101 Diacetyl tartaric acid esters of

mono- and diglycerides.

* * * * *

(a) Diacetyl tartaric acid esters of

mono- and diglycerides, also know as

DATEM, are composed of mixed esters

of glycerin in which one or more of the

hydroxyl groups of glycerin has been

esterified by diacetyl tartaric acid and

by fatty acids. The ingredient is

prepared by the reaction of diacetyl

tartaric anhydride with mono- and

diglycerides that are derived from edible

sources.

* * * * *

(e) Labeling: The acronym ‘‘DATEM’’

may be used on food labeling as the

alternate common or usual name for the

ingredient diacetyl tartaric acid esters of

mono- and diglycerides.

Dated: March 17, 1995.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–7616 Filed 3–27–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 886

[Docket No. 94M–0260]

Medical Devices; Exemptions From

Premarket Notification for Certain

Classified Devices; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of December 7, 1994 (59 FR

63005). The document exempted 148

generic types of class I devices from the

requirement of premarket notification,

with limitations. The document was

published with an error in the codified

section. This document corrects that

error.

EFFECTIVE DATE: January 6, 1995.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ–84), Food

and Drug Administration, 2094 Gaither

Rd., Rockville, MD 20850, 301–594–

4765, ext. 157.

In FR Doc. 94–30025, appearing on

page 63005 in the Federal Register of

Wednesday, December 7, 1994, the

following correction is made:

§ 886.4350 [Corrected]

On page 63013, in the third column,

in § 886.4350, paragraph (b) is corrected

by removing the words ‘‘only when the

device meets the ANSI standard on

optic radiation limits.’’

Dated: March 17, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–7512 Filed 3–27–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

Bureau of Consular Affairs

22 CFR Part 41

[Public Notice 2177]

VISAS: Passports and Visas Not

Required for Certain Nonimmigrants

AGENCY: Bureau of Consular Affairs,

Department of State.

ACTION: Interim rule with request for

comments.

SUMMARY: This interim rule extends the

Visa Waiver Pilot Program to September

30, 1996 and creates a new probationary

status for certain countries which meet

the requirements for that status under

the Visa Waiver Pilot Program and

which are designated by the Secretary of

State and the Attorney General, acting

jointly, as countries whose nationals

benefit from the waiver of the

nonimmigrant B–1/B–2 visa

requirement. The extension of time for

the Visa Waiver Pilot Program applies to

those countries already in the program

as well as to any countries which may

be designated thereunder in the future.

A statistical analysis was made to

determine which countries could

become visa waiver pilot countries with

probationary status. As a result of that

initial analysis it has been determined

that Ireland, currently, is the only

county which meets the criteria set forth

for such countries.

DATES: This interim rule is effective on

April 1, 1995. Written comments are

invited and must be received on or

before May 30, 1995.

ADDRESSES: Written comments may be

submitted, in duplicate, to the Chief,

Legislation and Regulations Division,

Visa Services, Department of State,

Washington, DC 20522–0113.

FOR FURTHER INFORMATION CONTACT:

Stephen K. Fischel, Chief, Legislation

and Regulations Division, Visa Office,

Department of State, Washington, DC

20522–0113 (202) 663–1204.

SUPPLEMENTARY INFORMATION: This

interim rule amends part 41, title 22 of

the Code of Federal Regulations

concerning visas for nonimmigrants

pursuant to section 217 of the

Immigration and Nationality Act (INA),

8 U.S.C. 1187, as amended by Pub. L.

103–415, 108 Stat. 4299, approved: 10/