Federal Register / Vol. 62, No. 219 / Thursday, November 13, 1997 / Rules and Regulations 60781

Issued in Kansas City, MO, on November

4, 1997.

Herman J. Lyons, Jr.,

Manager, Air Traffic Division, Central Region.

[FR Doc. 97–29833 Filed 11–12–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

New Animal Drugs for Use in Animal

Feeds; Salinomycin and Bacitracin

Zinc

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 two abbreviated new animal

drug applications (ANADA’s) filed by

Alpharma Inc. The ANADA’s provide

for using approved salinomycin and

bacitracin zinc Type A medicated

articles to make Type C medicated

broiler chicken feeds used for the

prevention of coccidiosis and for

increased rate of weight gain. This

document is also amending the animal

drug regulations to reflect the correct

sponsor name for Alpharma Inc.

EFFECTIVE DATE: November 13, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is sponsor of

ANADA’s 200–204 and 200–210 that

provide for combining approved

salinomycin and bacitracin zinc Type A

medicated articles to make Type C

medicated broiler feeds containing

salinomycin 40 to 60 grams per ton (g/

t) and bacitracin zinc 10 to 50 g/t. The

Type C medicated feed is used for the

prevention of coccidiosis caused by

Eimeria tenella, E. necatrix, E.

acervulina, E. brunetti, E. mivati, and E.

maxima, and for increased rate of

weight gain.

ANADA 200–204, filed by Alpharma

Inc., provides for using approved BIO–

COX (Hoffmann-LaRoche Inc.’s

salinomycin NADA 128–686) and

ALBAC (Alpharma Inc.’s bacitracin

zinc ANADA 200–223) Type A

medicated articles to make the

combination drug Type C medicated

feeds. ANADA 200–210, also filed by

Alpharma Inc., provides for using

approved SACOX (Hoechst-Roussel

Vet’s salinomycin ANADA 200–075)

and ALBAC (Alpharma Inc.’s

bacitracin zinc ANADA 200–223) Type

A medicated articles to make the

combination drug Type C medicated

feeds.

Alpharma Inc.’s ANADA 200–204 is

approved as a generic copy of

Hoffmann-LaRoche, Inc.’s NADA 139–

235. Alpharma Inc.’s ANADA 200–210

is approved as a generic copy of

Hoechst-Roussel Vet’s ANADA 200–

089. The ANADA’s are approved as of

September 19, 1997, and the regulations

are amended in 21 CFR

558.550(b)(1)(vii)(c) to reflect the

approvals. The basis for approval is

discussed in the freedom of information

summaries.

FDA is also amending the animal drug

regulations in 21 CFR 510.600(c)(1) and

(c)(2) to reflect the correct firm name for

Alpharma Inc.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of these applications 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.

FDA has determined under 21 CFR

25.33(a)(1) that these actions are of a

type that do not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 558

Animal drugs, Animal feeds.

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 510 and 558 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

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

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) in the entry

for ‘‘ALPHARMA INC.’’ and in

paragraph (c)(2) in the entry for

‘‘046573’’ by removing the name

‘‘ALPHARMA INC.’’ and adding in its

place ‘‘Alpharma Inc.’’

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR

part 558 continues to read as follows:

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

§ 558.550 [Amended]

4. Section 558.550 Salinomycin is

amended in paragraph (b)(1)(vii)(c) by

removing ‘‘No. 000004’’ and adding in

its place ‘‘Nos. 000004 and 046573’’.

Dated: October 30, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–29905 Filed 11–12–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Departmental Offices

31 CFR Part 1

Privacy Act of 1974; Implementation

AGENCY: Departmental Offices, Treasury.

ACTION: Final Rule.

SUMMARY: In accordance with the

requirements of the Privacy Act of 1974,

as amended, 5 U.S.C. 552a, the

Department of the Treasury gives notice

of an amendment to exempt the system

of records entitled, ‘‘Integrated Data

Retrieval System (IDRS) Security Files—

Treasury/IRS 34.018,’’ from certain

provisions of the Privacy Act.

EFFECTIVE DATE: November 13, 1997.

FOR FURTHER INFORMATION CONTACT:

Michael Sincavage, Director, 6103/

Privacy Operations, Governmental

Liaison & Disclosure, Internal Revenue

Service at (202) 622–6240.

SUPPLEMENTARY INFORMATION: The

Department of the Treasury published a

notice of a proposed rule exempting a

system of records from certain

provisions of the Privacy Act of 1974, as

Amended, at 60 FR 40797, dated August

10, 1995. The Internal Revenue Service

published an alteration to the system

notice on July 31, 1995, at 60 FR 30972.

Under 5 U.S.C. 552a(k)(2), the head of

an agency may promulgate rules to

exempt any system of records within the

agency from certain provisions of the
60782 Federal Register / Vol. 62, No. 219 / Thursday, November 13, 1997 / Rules and Regulations

Privacy Act of 1974 if the system is

investigatory material compiled for law

enforcement purposes. The Internal

Revenue Service has as its principal

function enforcement of the tax law of

the United States. System of records

Treasury/IRS 34.018—Integrated Data

Retrieval System Security Files,

contains records that enable the Service

to investigate and monitor the activities

of its employees to ensure the protection

and confidentiality of tax return

information. The information in this

system is used in investigations relating

to unauthorized use of the Integrated

Data Retrieval Files.

The proposed rule requested that

public comments be sent to the Director,

Office of Disclosure, Internal Revenue

Service no later than September 11,

1995. No comments pertaining to the

proposed rule were received by the

Office of Disclosure. Accordingly, the

Department of the Treasury is hereby

giving notice that the system of records

entitled, ‘‘Integrated Data Retrieval

System (IDRS) Security Files—Treasury/

IRS 34.018,’’ is exempt from certain

provisions of the Privacy Act. The

following are the reasons why certain

systems of records maintained by the

Internal Revenue Service are exempt

pursuant to 5 U.S.C. 552a(k)(2) of the

Privacy Act of 1974.

(1) 5 U.S.C. 552a(c)(3). This provision

of the Privacy Act provides for the

release of the disclosure accounting

required by 5 U.S.C. 552a(c)(1) and (2)

to the individual named in the record at

his request. The reasons for exempting

systems of records from the foregoing

provision are as follows:

(i) The release of disclosure

accounting would put the subject of an

investigation on notice of the existence

of an investigation and that such person

is the subject of that investigation;

(ii) Such release would provide the

subject of an investigation with an

accurate accounting of the date, nature,

and purpose of each disclosure and the

name and address of the person or

agency to whom the disclosure is made.

The release of such information to the

subject of an investigation would

provide the subject with significant

information concerning the nature of the

investigation and could result in the

altering or destruction of documentary

evidence, the improper influencing of

witnesses, and other activities that

could impede or compromise the

investigation. In the case of a delinquent

account, such release might enable the

subject of the investigation to dissipate

assets before levy;

(iii) Release to the individual of the

disclosure accounting would alert the

individual as to which agencies were

investigating this person and the scope

of the investigation, and could aid the

individual in impeding or

compromising investigations by those

agencies.

(2) 5 U.S.C. 552a(d)(1),(2),(3), and (4),

(e)(4)(G) and (H) and (f). These

provisions of the Privacy Act relate to

an individual’s right to notification of

the existence of records pertaining to

such individual; requirements for

identifying an individual who requests

access to records; the agency procedures

relating to access to records and the

contest of the information contained in

such records; and the civil remedies

available to the individual in the event

of adverse determinations by an agency

concerning access to or amendment of

information contained in such record

systems. The reasons for exempting

systems of records from the foregoing

provisions are as follows: To notify an

individual at the individual’s request of

the existence of records in an

investigative file pertaining to such

individual or to grant access to an

investigative file could interfere with

investigative and enforcement

proceedings; deprive co-defendants of a

right to a fair trial or an impartial

adjudication; constitute an unwarranted

invasion of the personal privacy of

others, disclose the identity of

confidential sources and reveal

confidential information supplied by

such sources; and disclose investigative

techniques and procedures.

(3) 5 U.S.C. 552a(e)(4)(I). This

provision of the Privacy Act requires the

publication of the categories of sources

of records in each system of records. In

cases where an exemption from this

provision has been claimed, the reasons

are as follows:

(i) Revealing categories of sources of

information could disclose investigative

techniques and procedures;

(ii) Revealing categories of sources of

information could cause sources who

supply information to investigators to

refrain from giving such information

because of fear of reprisal, or fear of

breach of promises of anonymity and

confidentiality.

(4) 5 U.S.C. 552a(e)(1). This provision

of the Privacy Act requires each agency

to maintain in its records only such

information about an individual as is

relevant and necessary to accomplish a

purpose of the agency required to be

accomplished by statute or executive

order. The reasons for exempting

systems of records from the foregoing

provisions are as follows:

(i) The Internal Revenue Service will

limit its inquiries to information which

is necessary for the enforcement and

administration of tax laws. However, an

exemption from the foregoing provision

is needed because, particularly in the

early stages of a tax audit or other

investigation, it is not possible to

determine the relevance or necessity of

specific information.

(ii) Relevance and necessity are

questions of judgement and timing.

What appears relevant and necessary

when collected may subsequently be

determined to be irrelevant or

unnecessary. It is only after the

information is evaluated that the

relevance and necessity of such

information can be established with

certainty.

(iii) When information is received by

the Internal Revenue Service relating to

violations of law within the jurisdiction

of other agencies, the Service processes

this information through Service

systems in order to forward the material

to the appropriate agencies.

As required by Executive Order

12866, it has been determined that this

final rule is not a significant regulatory

action and, therefore, does not require a

regulatory impact analysis.

Pursuant to the requirements of the

Regulatory Flexibility Act, 5 U.S.C. 601–

612, it is hereby certified that this rule

will not have significant economic

impact on a substantial number of small

entities. The final rule imposes no

duties or obligations on small entities.

In accordance with the provisions of

the Paperwork Reduction Act of 1995,

the Department of the Treasury has

determined that this rule will not

impose new record keeping,

application, reporting, or other types of

information collection requirements.

List of Subjects in 31 CFR Part 1

Privacy.

Part 1 of Title 31 of the Code of

Federal Regulations is amended as

follows:

1. The authority citation for Part 1

continues to read as follows:

Authority: 5 U.S.C. 301 and 31 U.S.C. 321.

Subpart A also issued under 5 U.S.C. 552 as

amended. Subpart C also issued under 5

U.S.C. 552a.

§ 1.36 [Amended]

2. Section 1.36 of Subpart C is

amended by adding the following text in

numerical order under the heading THE

INTERNAL REVENUE SERVICE:

* * * * *

(b) * * *

(1) * * *

Name of System No.

* * * * *

Integrated Data Reporting System

(IDRS) Security Files .................. 34.018
Federal Register / Vol. 62, No. 219 / Thursday, November 13, 1997 / Rules and Regulations 60783

Name of System No.

* * * * *

* * * * *

Dated: October 3, 1997.

Alex Rodriguez,

Deputy Assistant Secretary (Administration)

[FR Doc. 97–29794 Filed 11–12–97; 8:45 am]

Billing Code: 4830–01–F

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 17

RIN 2900–AI84

Grants to States for Construction or

Acquisition of State Home Facilities

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

SUMMARY: This document amends the

‘‘Medical’’ regulations regarding

applications for grants to States for the

construction or acquisition of State

home facilities. VA awards grants based

on a priority ranking system. Usually,

the higher priority applications deplete

the available funding to the extent that

the lowest ranking application to be

offered funding is offered only a partial

grant. This final rule provides that if the

lowest ranking grant application

receives only a partial grant in a fiscal

year and if such grant award is partial

solely because VA has insufficient funds

for a full grant, the application would be

placed at the top of the list within its

priority group for the next fiscal year.

Often applicants are hesitant to accept

a partial grant because of the

uncertainty of receiving an additional

grant the next fiscal year. This final rule

will encourage States to accept a partial

grant by creating the likelihood that the

State would receive an additional grant

in the subsequent fiscal year.

Accordingly, this will help ensure that

VA would be able to award grants to

higher priority applicants that might

otherwise reject partial funding.

Also, this final rule provides that the

applicant receiving partial funding and

receiving priority as proposed will not

be required to submit a second

application for additional funds in the

subsequent fiscal year, but could be

required to update information already

submitted. The first application would

normally be adequate because the grant

award in the second fiscal year would

be for the same project which received

the partial grant award.

Further, the final rule provides that

the total amount awarded for the

application may not exceed 65 percent

of the total cost of the project as

determined at the time of the second

grant award for that grant application.

This is consistent with the statutory

requirement that limits grant awards to

no more than 65 percent of the

estimated cost construction or

acquisition.

DATES: Effective Date: December 15,

1997.

FOR FURTHER INFORMATION CONTACT: Ms.

Kathleen Greve, Geriatrics and Extended

Care Strategic Healthcare Group, (202)

273–8534.

SUPPLEMENTARY INFORMATION: In a

document published in the Federal

Register on July 29, 1997 (62 FR 40492),

VA proposed to amend the ‘‘Medical’’

regulations in 38 CFR part 17 as set

forth in the SUMMARY portion of this

document. The document provided a

60-day comment period, which ended

on September 29, 1997. Three

commentors submitted comments, all of

whom expressed full approval for the

provisions of the proposed rule.

Based on the rationale set forth in the

proposed rule and this document, the

provisions of the proposed rule are

adopted as a final rule without change.

The Secretary hereby certifies that the

adoption of this final rule will not have

a significant economic impact on a

substantial number of small entities as

they are defined in the Regulatory

Flexibility Act, 5 U.S.C. 601–612. The

rule will affect grants to States and will

not directly affect small entities.

Therefore, pursuant to 5 U.S.C. 605(b),

this rule is exempt from the initial and

final regulatory flexibility analyses

requirements of secs. 603 and 604.

The Catalog of Federal Domestic

Assistance program number for this

document is 64.005.

List of Subjects in 38 CFR Part 17

Administrative practice and

procedure. Alcohol abuse, Alcoholism,

Claims, Drug abuse, Foreign relations,

Government contracts, Grant programshealth, Grant programs-veterans, Health

care, Health facilities, Health

professions, Health records, Homeless,

Medical and dental schools, Medical

devices, Medical research, Mental

health programs, Nursing homes,

Philippines, Reporting and

recordkeeping requirements,

Scholarships and fellowships, Travel

and transportation expenses, Veterans.

Approved: November 3, 1997.

Hershel W. Gober,

Acting Secretary of Veterans Affairs.

For the reasons set forth above, 38

CFR part 17 is amended as set forth

below:

PART 17—MEDICAL

1. The authority citation for part 17

continues to read as follow:

Authority: 38 U.S.C. 501, 1721, unless

otherwise noted.

2. In § 17.212, paragraph (d) is added

and the authority citation for the section

is revised to read as follows:

§ 17.212 Scope of grants program.

* * * * *

(d)(1) Notwithstanding paragraph (c)

of this section and the provisions for

ranking projects within a priority group

in § 17.213(c)(3)(i), the Secretary shall

give an application first priority within

the priority group to which it is

assigned on the list of projects

established under § 17.213(d) for the

next fiscal year if:

(i) the State has accepted a grant for

that application as of August 15 of the

current fiscal year that is less than the

amount that the Secretary would have

awarded if VA had sufficient grant

funds to award the grant in such amount

in that fiscal year; and

(ii) the application is the lowest

ranking application on the priority list

for the current fiscal year for which

grant funds are available as of August 15

of that year.

(2) The Secretary shall not require a

State to submit a second grant

application for a project which receives

priority under paragraph (d)(1) of this

section but may require the State to

update information already submitted in

the application for the project. The

Secretary shall determine the amount of

a second grant at the time of the award

of that grant. In no case shall the total

amount awarded for the application

exceed 65 percent of the total cost of the

project as determined at the time of the

second grant award for that grant

application.

(Authority: 38 U.S.C. 8135(b))

[FR Doc. 97–29788 Filed 11–12–97; 8:45 am]

BILLING CODE 8320–01–M