15870 Federal Register / Vol. 60, No. 59 / Tuesday, March 28, 1995 / Rules and Regulations

2The one-month extension in the Form No. 1

filing deadline applies both to the electronic filing

requirement and the paper copy filing requirement.

The software was designed to collect

Form No. 1 data, perform an edit-check

of the entered data, print the Form No.

1, and produce a data diskette to file

with the Commission. The software

fulfills these design objectives.

The parties contend the software is

not compatible with different types of

printers. The software is compatible

with all Hewlett Packard (HP) Laser Jet

printers and those printers which

emulate the HP standards. We were not

able to anticipate all printer and printer

configurations preferred by respondents.

However, by using the HP standards, we

were able to cover most of the

respondents’ printer requirements.

The parties contend the software is

not designed to operate in a local area

network (LAN) environment and,

because it is not LAN-compatible, many

companies will have to enter data twice.

The software was not specifically

designed to operate in a LAN

environment because some respondents

do not have LAN capability. Also, for

those respondents that do have LANs,

there are a variety of LANs in use.

Ultimately, if a LAN version of the

software were developed, it would

require reprogramming of the software

so that it would operate on any LAN.

This does not mean that the software is

not LAN compatible; in fact, the

Commission has successfully loaded the

software on the Commission’s LAN and

used it without problems. Also, several

respondents have reported that they

have been successful in operating the

software on their LANs. Further, a lack

of LAN compatibility does not mean

that data must be entered twice by

respondents. The software can be

loaded on any number of personal

computers where the data can be

entered and stored in data files and

subsequently transferred to one central

personal computer.

The parties contend creation of ASCII

files to import data is difficult and

tedious. The creation of properly

delimited ASCII files for the importing

of data is difficult until a user becomes

familiar with the procedure. The users’

manual addresses this issue and

recognizes that the necessary steps are

complex. Users should consult with or

seek assistance from their data

processing or computer departments.

Additionally, the general import feature

was designed as an alternative data

entry process (i.e., there is no

requirement that it be used).

The parties contend prior year data

cannot be accessed for beginning

balances, requiring re-keying of data

each year. This is a correct statement,

and this is one of the software changes

that we are considering for future

software versions. This is not a problem

for the 1994 reporting year, however,

since this is the first year the software

is being used and there is no prior year

data to be accessed.

The parties contend state schedules

identical to Form No. 1 cannot be

copied with a name change, forcing

complete data re-keying. This is a

correct statement. However, the

software is designed to not allow

changes to the schedule pages. Some of

the biggest problems with Form No. 1

reporting compliance have been where

respondents have changed schedule

formats and not reported consistent

with the Form No. 1 reporting

requirements. In some cases, in fact,

required data were omitted or the

modified formats made the reported

data of limited or no use.

The parties contend there are no page

up/page down keys, forcing numerous

key strokes to get to the top or bottom

of a page. This is a correct statement.

The software was designed for data

collection and if data entry is done one

data field at a time, the page up/down

keys are extraneous to the function.

Finally, the parties contend footnotes

cannot reference multiple lines, only

one field of data. This is a correct

statement. The software was

intentionally designed so that each

individual data element could be

footnoted separately and each footnote

could be ‘‘linked’’ with the respective

data element in the Commission’s Form

No. 1 database.

Nevertheless, while the Commission

will continue to require the electronic

reporting of Form No. 1 for the 1994

reporting year, the Commission

recognizes that this will be the first year

for such filings and additional time may

be necessary to prepare such filings.

Accordingly, the Commission will

extend the deadline for filing Form No.

1 for the 1994 reporting year by one

month, to on or before May 31, 1995.2

The Commission Orders

The requests for reconsideration of

Order No. 574 are hereby denied.

However, the deadline for the

submission of Form No. 1 (both

electronic and paper copies) for the

1994 reporting year is hereby extended

from on or before April 30, 1995, to on

or before May 31, 1995.

By the Commission.

Lois D. Cashell,

Secretary.

[FR Doc. 95–7588 Filed 3–27–95; 8:45 am]

BILLING CODE 6717–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

Delegations of Authority and

Organization

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations for delegations of authority

from the Commissioner of Food and

Drugs to reflect recent changes to

organizational structures within FDA; to

update the titles of certain officials; and

to reflect changes in the location and

numbering of certain statutory

provisions.

EFFECTIVE DATE: March 28, 1995.

FOR FURTHER INFORMATION CONTACT:

Edna Morgan, Division of Management

Systems and Policy (HFA–340), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

4976.

SUPPLEMENTARY INFORMATION: FDA is

amending certain regulations for

delegations of authority in 21 CFR part

5 to reflect recent changes to

organizational structures within FDA.

This document removes obsolete titles

and adds new titles of certain officials

in various regions, districts, etc., as well

as the Center for Veterinary Medicine

(CVM) under the new organizational

structure. The document also reflects

the changes in the location and

numbering of certain statutory

provisions. The sections affected are as

follows:

Section 5.36 Certification following

inspections (21 CFR 5.36); § 5.37

Issuance of reports of minor violations

(21 CFR 5.37); and § 5.63 Detention of

meat, poultry, eggs, and related

products (21 CFR 5.63).

In § 5.36, FDA is deleting the Director,

St. Louis Branch from those FDA

officials authorized to issue certificates

of sanitation. In § 5.37(a)(4)(iii), FDA is

deleting the Deputy Director, Division of

Compliance, Office of Surveillance and

Compliance, Center for Veterinary

Medicine, from the list of officials

authorized to issue certain written

notices or warnings. In § 5.37(a)(6) and

(b)(5), FDA is adding the Directors of the

Northeast Regional Laboratory,

Southeast Regional Laboratory,

Winchester Engineering and Analytical

Center, and National Forensic

Chemistry Center to authorize these

officials to issue certain written notices
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.’’