Federal Register / Vol. 63, No. 84 / Friday, May 1, 1998 /Rules and Regulations 24107

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(ii)), this

approval for food-producing animals

qualifies for 3 years of marketing

exclusivity beginning January 28, 1998,

because the application contains

substantial evidence of the effectiveness

of the drug involved, studies of animal

safety or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval and

conducted or sponsored by the

applicant.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects

21 CFR Part 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 522 and 556 are amended as

follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 522.2120 [Amended]

2. Section 522.2120 Spectinomycin

injection is amended by revising the

heading to read ‘‘Spectinomycin

dihydrochloride injection.’’

3. Section 522.2121 is added to read

as follows:

§ 522.2121 Spectinomycin sulfate solution.

(a) Specifications. Each milliliter of

sterile aqueous solution contains

spectinomycin sulfate tetrahydrate

equivalent to 100 milligrams of

spectinomycin.

(b) Sponsor. See 000009 in

§ 510.600(c) of this chapter.

(c) Related tolerances. See § 556.600

of this chapter.

(d) Conditions of use—(1) Cattle—(i)

Dose. 10 to 15 milligrams per kilogram

of body weight, at 24-hour intervals for

3 to 5 consecutive days.

(ii) Indications for use. For the

treatment of bovine respiratory disease

(pneumonia) associated with Pasteurella

haemolytica, P. multocida, and

Haemophilus somnus.

(iii) Limitations. For subcutaneous

injection in the neck. Do not inject more

than 50 milliliters at each site. Do not

slaughter within 11 days of last

treatment. Do not use in female dairy

cattle 20 months of age or older. Use in

this class of cattle may cause residues in

milk. A withdrawal period has not been

established for this product in preruminating calves. Do not use in calves

to be processed for veal. Federal law

restricts this drug to use by or on the

order of a licensed veterinarian.

(2) [Reserved]

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

4. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

5. Section 556.600 is revised to read

as follows:

§ 556.600 Spectinomycin.

(a) Acceptible daily intake (ADI). The

ADI for total residues of spectinomycin

is 25 micrograms per kilogram of body

weight per day.

(b) Chickens and turkeys. A tolerance

of 0.1 part per million (ppm) for

negligible residues of spectinomycin in

uncooked edible tissues of chickens and

turkeys is established.

(c) Cattle. A tolerance of 4 ppm for

parent spectinomycin (marker residue)

in kidney (target tissue) is established.

A tolerance of 0.4 ppm for parent

spectinomycin in cattle muscle is

established.

Dated: April 22, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–11686 Filed 4–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Part 41

[Public Notice 2793]

Documentation of Nonimmigrants

Under the Immigration and Nationality

Act, as Amended—Fees for

Application and Issuance of

Nonimmigrant Visas

AGENCY: Department of State.

ACTION: Interim rule with request for

comments.

SUMMARY: This rule results from a recent

amendment to the law. It permits the

Secretary of State to waive the visa fees

for a nonimmigrant alien who will be

engaged in charitable activities in the

United States, subject to criteria the

Secretary sets up. This provision

became effective on the date of

enactment. This rule implements that

amendment.

DATES: This interim rule is effective May

1, 1998. Written comments are invited

and must be received on or before June

30, 1998.

ADDRESSES: Written comments may be

submitted, in duplicate, to the Chief,

Legislation and Regulations Division,

Visa Services, Department of State,

Washington, D.C. 20520–0106.

FOR FURTHER INFORMATION CONTACT: H.

Edward Odom, Chief, Legislation and

Regulations Division, Visa Services,

Department of State, Washington, D.C.

20520–0106, (202) 663–1204.

SUPPLEMENTARY INFORMATION: Section 2

of Pub. L. 105–54 of October 7, 1997,

amended section 281 of the Immigration

and Nationality Act, as amended, (INA),

by adding a sentence providing for the

waiver or reduction of nonimmigrant

visa fees under certain circumstances

for aliens coming to the United States to

engage in charitable activities.

Current rules relating to

nonimmigrant visa fees are contained in

22 CFR 41.107 subsection (c) which

describes certain aliens exempted from

fees. This rule expands that subsection

to include those individuals who are

coming primarily for charitable

purposes or for purposes related thereto.

As Senator Abraham (a co-sponsor)

stated in the Senate discussion of the

amendment of INA 281, ‘‘It is not in the

U.S. interest to impose fees that inhibit

or otherwise burden individuals who

seek to help our communities.’’ It is in

this spirit underlying the legislation that

this interim rule has been developed.

The statute provides that the waiver

or reduction of fees for application and

issuance of a nonimmigrant visa is

subject to criteria prescribed by the

Secretary of State, including the

duration of stay and the financial

burden upon the charitable

organization.In keeping with that

injunction, it is deemed appropriate to

require prospective beneficiary

charitable organizations to request the

relief to be provided because of the

financial burden and to furnish

sufficient information to establish that

the alien(s) concerned will be engaged

in activities which motivated the
24108 Federal Register / Vol. 63, No. 84 / Friday, May 1, 1998 /Rules and Regulations

enactment of this provision. The request

should be furnished in writing, inter

alia to provide documentation

reconciling the number of visas issued

with the lesser amount of fees collected.

Thus, the current text of 22 CFR

41.107(c) will become ‘‘(c)(1)’’ and a

new (c)(2) will set forth the data

required to support the waiver of the

fees. These include, in (c)(2)(i),

disclosure of whether the organization,

if U.S.-based, is tax exempt as a

charitable organization under 26 U.S.C.

501(c) or, if foreign, is equivalently

recognized as a charitable organization

in the country in which based. Section

41.107(c)(2)(ii) requires that the

activities in which the alien(s) will

engage will be charitable in nature,

providing assistance to the poor and

needy including, but not limited to,

those activities identified in the

legislation. Section 41.107(c)(2)(iii)

requires such identifying information as

the location in which the services will

be provided and the number of and

identifying data regarding each of the

alien(s) concerned. Finally,

§ 41.107(c)(2)(iv) seeks data on the

proposed duration of the temporary stay

of the alien(s) in the United States,

which should be commensurate with

both the classification in which the

alien(s) will be applying and the

purposes for which the alien(s) will be

entering the United States.

Regulatory Analysis and Notices

Interim Rule

The implementation of this rule as an

interim rule, with a 60-day provision for

post-promulgation public comments, is

based on the ‘‘good cause’’ exceptions

set forth at 5 U.S.C. 553(b)(3)(B) and

553(d)(3). The provision of law being

implemented became effective on

enactment on October 7, 1997. It

provides a benefit to institutions that it

is in the interest of the United States as

determined by Congress to benefit.

Delay of the benefit for public notice

and comment is unnecessary and

inconsistent with the intent of the law.

The Regulatory Flexibility Act

Pursuant to § 605 of the Regulatory

Flexibility Act, the Department has

assessed the potential impact of this

rule, and the Assistant Secretary for

Consular Affairs hereby certifies, that it

is not expected to have a significant

economic impact on a substantial

number of small entities and will

benefit those that are charitable

organizations.

E.O. 12988 and E.O. 12866

This rule has been reviewed as

required under E.O. 12998 and

determined to be in compliance

therewith. This rule is exempt from

review under E.O. 12866, but has been

reviewed internally by the Department

to ensure consistency therewith. The

rule does not directly affect states or

local governments or Federal

relationships and does not create

unfunded mandates.

5 U.S.C. Chapter 8

As required by 5 U.S.C., chapter 8, the

Department has screened this rule and

determined that it is not a major rule, as

defined in 5 U.S.C. 80412.

Paperwork Reduction Act

While charitable organizations

requesting this benefit will have to

apply with information matching their

situation to legal requirements, that

information will be used for agency

decisions on individual visas and not

used for public dissemination or

statistical purposes.

List of Subjects in 22 CFR Part 41

Aliens, Nonimmigrants, Passports,

Visas.

In view of the foregoing, 22 CFR part

41 is amended as follows:

PART 41—[AMENDED]

1. The authority citation for part 41

continues to read:

Authority: 8 U.S.C. 1104.

2. Section 41.107 is amended by

redesignating paragraph (c) as paragraph

(c)(1) and adding a new paragraph (c)(2)

to read as follows:

§ 41.107 Visa fees.

* * * * *

(c) * * *

(2) The consular officer shall waive

the nonimmigrant visa application and

issuance fees for an alien who will be

engaging in charitable activities for a

charitable organization upon the written

request of the charitable organization

claiming that it will find the fees a

financial burden, if the consular officer

is satisfied that:

(i) The organization seeking relief

from the fees is, if based in the United

States, tax-exempt as a charitable

organization under the provisions of

section 501(c)(3) of the Internal Revenue

Code (26 U.S.C. 501(c)(3)); if a foreign

organization based outside the United

States, it establishes that it is recognized

as a charitable institution by the

government of the country in which it

is based under criteria substantially

similar to those of section 501(c)(3), and

(ii) The charitable activities in which

the alien will engage are specified and

will be a part of, or will be related to

and in support of, the organization’s

provision of services, including but not

limited to health care, food and housing,

job training, and similar direct services

and assistance to the poor and needy,

and

(iii) The request includes the location

of the proposed activities, the number

and identifying data of each of the

alien(s) who will be applying for visas,

and

(iv) The proposed duration of the

alien(s)’s temporary stay in the United

States is reasonably consistent with the

charitable purpose for which the alien(s)

seek to enter the United States.

* * * * *

Dated: April 15, 1998.

Donna J. Hamilton,

Acting Assistant Secretary for Consular

Affairs.

[FR Doc. 98–11533 Filed 4–30–98; 8:45 am]

BILLING CODE 4710–06–P

DEPARTMENT OF JUSTICE

28 CFR Part 51

[Order No. 2149–98]

RIN 1190–AA35

Procedures for the Administration of

Section 5 of the Voting Rights Act of

1965, as Amended; Revision of

Procedures

AGENCY: Department of Justice.

ACTION: Final rule.

SUMMARY: The Department of Justice is

revising its administrative guidelines

regarding preclearance of voting

changes under Section 5 of the Voting

Rights Act of 1965. The amendment is

necessary to conform the Department’s

guidelines with recent case law.

DATES: Effective May 1, 1998.

FOR FURTHER INFORMATION CONTACT:

David H. Hunter, Attorney, Voting

Section, Civil Rights Division, 202–307–

2898, 1–800–253–3931, or

david.h.hunter@usdoj.gov.

SUPPLEMENTARY INFORMATION: Section 5

of the Voting Rights Act of 1965, as

amended, 42 U.S.C. 1973c, requires

certain jurisdictions (listed in the

appendix to the Procedures) to obtain

‘‘preclearance’’ from either the United

States District Court for the District of

Columbia or from the United States

Attorney General before implementing

any new standard, practice, or

procedure that affects voting.

The Supreme Court held in Reno v.

Bossier Parish School Board, 117 S.Ct.