24106 Federal Register / Vol. 63, No. 84 / Friday, May 1, 1998 /Rules and Regulations

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding an entry for

‘‘Marsam Pharmaceuticals, Inc.,’’ and in

the table in paragraph (c)(2) by

numerically adding an entry for

‘‘000209’’ to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Marsam Pharmaceuticals, Inc., Bldg. 31,

24 Olney Ave., Cherry Hill, NJ 08034.

000209

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

000209 Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034.

* * * * * * *

PART 529—CERTAIN OTHER DOSAGE

FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 529 continues to read as follows:

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

2. Section 529.1186 is amended by

revising paragraph (b) to read as follows:

§ 529.1186 Isoflurane.

* * * * *

(b) Sponsors. See Nos. 000074,

000209, 010019, 012164, and 059258 in

§ 510.600(c) of this chapter.

* * * * *

Dated: April 22, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–11685 Filed 4–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Implantation or Injectable Dosage

Form New Animal Drugs;

Spectinomycin Solution

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Pharmacia

& Upjohn Co. The NADA provides for

veterinary prescription use of

spectinomycin solution as a

subcutaneous injection in cattle for

treatment of bovine respiratory disease.

EFFECTIVE DATE: May 1, 1998.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: Pharmacia

& Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

NADA 141–077 that provides for

veterinary prescription use of AdspecTM

(spectinomycin) sterile solution for

cattle, by subcutaneous injection in the

neck, for treatment of bovine respiratory

disease (pneumonia) associated with

Pasteurella haemolytica, P. multocida,

and Haemophilus somnus. The NADA

is approved as of January 28, 1998, and

the regulations are amended by adding

§ 522.2121 (21 CFR 522.2121) to reflect

the approval.

A tolerance for residues of

spectinomycin in edible tissues of cattle

has not been previously established.

The regulations are amended in 21 CFR

556.600 to provide a tolerance for

spectinomycin residues in cattle kidney

(target tissue) and in cattle muscle.

FDA is also amending the regulations

to provide for the acceptable daily

intake (ADI) for total residues of

spectinomycin. The ADI is the amount

of total drug residue that can be

consumed by humans every day.

Previously, FDA had provided for safe

concentrations, which represent the ADI

corrected for consumption. The safe

concentrations were confusing because

few individuals understood the

relationship between safe concentration,

a value representing total residues, and

tolerance, the part of the drug residue in

a given tissue that is detected by an

analytical method. To eliminate this

confusion, FDA is codifying the ADI.

Also, the heading of § 522.2120

Spectinomycin injection (21 CFR

522.2120) is revised to ‘‘§ 522.2120

Spectinomycin dihydrochloride

injection’’ to clarify the difference

between § 522.2120 and § 522.2121

Spectinomycin sulfate solution.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 514.11(e)(2)(ii)), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.
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