16376 Federal Register / Vol. 60, No. 61 / Thursday, March 30, 1995 / Rules and Regulations

eligible individual’s Federal benefit rate

and one-third of that rate is counted as

income not subject to any income

exclusions. The one in the medical

institution cannot receive more than the

rate described in § 416.414(b)(3)(i).

(c) Both members of a couple are

subject to the presumed value rule. If

the presumed value rule applies to both

of you, we value any food, clothing, or

shelter you and your spouse receive at

one-third of the Federal benefit rate for

a couple plus the amount of the general

income exclusion (§ 416.1124(c)(12)),

unless you can show that their value is

less as described in § 416.1140(a)(2).

(d) One member of a couple is subject

to the presumed value rule and the

other is in a medical institution. If one

of you is subject to the presumed value

rule and the other is temporarily absent

from the household as provided in

§ 416.1149(c)(1) (in a medical institution

that receives Medicaid payments for his

or her care (§ 416.211(b)), we compute

your benefits as if you were separately

eligible individuals (see § 416.414(b)(3)).

This begins with the first full calendar

month that one of you is in the medical

institution (§ 416.211(b)). We value any

food, clothing, or shelter received by the

one outside of the medical institution at

one-third of an eligible individual’s

Federal benefit rate, plus the amount of

the general income exclusion

(§ 416.1124(c)(12)), unless you can show

that their value is less as described in

§ 416.1140(a)(2). The one in the medical

institution cannot receive more than the

rate described in § 416.414(b)(3)(i).

17. The authority citation for subpart

R continues to read as follows:

Authority: Secs. 1102, 1614 (b) (c), and (d),

and 1631 (d)(1) and (e) of the Social Security

Act; 42 U.S.C. 1302, 1382c (b), (c), and (d),

and 1383 (d)(1) and (e).

18. In § 416.1801(c), the definition of

‘‘eligible spouse’’ is revised to read as

follows:

§ 416.1801 Introduction.

* * * * *

(c) * * *

Eligible spouse means a person—

(1) Who is eligible for SSI,

(2) Whom we consider the spouse of

another person who is eligible for SSI,

and

(3) Who was living in the same

household with that person on—

(i) The date of filing an application for

benefits (for the month of an

application);

(ii) The date a request for

reinstatement of eligibility is filed (for

the month of such request); or

(iii) The first day of the month, for all

other months. An individual is

considered to be living with an eligible

spouse during temporary absences as

defined in § 416.1149 and while

receiving continued benefits under

section 1611(e)(1) (E) or (G) of the Act.

* * * * *

19. In § 416.1802, paragraph (b) is

revised to read as follows:

§ 416.1802 Effects of marriage on

eligibility and amount of benefits.

* * * * *

(b) If you have an eligible spouse—

(1) Counting income. If you apply for

or receive SSI benefits and have an

eligible spouse as defined in

§ 416.1801(c), we will count your

combined income and calculated the

benefit amount for you as a couple.

Section 416.412 gives a detailed

statement of the amount of benefits and

subpart K of this part explains how we

count income for an eligible couple.

(2) Counting resources. If you have an

eligible spouse as defined in

§ 416.1801(c), we will count the value of

your combined resources (money and

property), minus certain exclusions, and

use the couple’s resource limit when we

determine your eligibility. Section

416.1205(b) gives a detailed statement of

the resource limit for an eligible couple.

* * * * *

20. Section 416.1806 is revised to read

as follows:

§ 416.1806 Whether you are married and

who is your spouse.

(a) We will consider someone to be

your spouse (and therefore consider you

to be married) for SSI purposes if—

(1) You are legally married under the

laws of the State where your and his or

her permanent home is (or was when

you lived together);

(2) We have decided that either of you

is entitled to husband’s or wife’s Social

Security insurance benefits as the

spouse of the other (this decision will

not affect your SSI benefits for any

month before it is made); or

(3) You and an unrelated person of

the opposite sex are living together in

the same household at or after the time

you apply for SSI benefits, and you both

lead people to believe that you are

husband and wife.

(b) if more than one person would

qualify as your husband or wife under

paragraph (a) of this section, we will

consider the person you are presently

living with to be your spouse for SSI

purposes.

§ 416.1811 [Removed]

21. Section 416.1811 is removed.

22. In § 416.1830, paragraph (a) is

revised to read as follows:

§ 416.1830 When we stop considering you

and your spouse an eligible couple.

* * * * *

(a) The calendar month after the

month you stopped living with your

eligible spouse, or

* * * * *

23. In § 416.1832, paragraphs (c) and

(d) are revised to read as follows:

§ 416.1832 When we consider your

marriage ended.

* * * * *

(c) We decide that either of you is not

a spouse of the other for purposes of

husband’s or wife’s social security

insurance benefits, if we considered you

married only because of

§ 416.1806(a)(2); or

(d) You and your spouse stop living

together, if we considered you married

only because of § 416.1806(a)(3).

[FR Doc. 95–7847 Filed 3–29–95; 8:45 am]

BILLING CODE 4190–29–M

Food and Drug Administration

21 CFR Part 450

[Docket No. 94N–0302]

Antibiotic Drugs; Bleomycin Sulfate;

Withdrawal of Regulation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; withdrawal of

regulation.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing a

regulation that established standards for

an antibiotic drug, nonsterile bleomycin

sulfate bulk drug substance. This action

is taken to allow interested persons an

opportunity to comment on the

standards for nonsterile bleomycin

sulfate bulk drug substance. In a future

issue of the Federal Register, the agency

will issue a proposed rule setting forth

standards for bulk nonsterile bleomycin

sulfate.

EFFECTIVE DATE: March 30, 1995.

FOR FURTHER INFORMATION CONTACT:

Tamar S. Nordenberg, Center for Drug

Evaluation and Research (HFD–366),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–2041.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 4, 1994 (59

FR 50484), FDA published a new

antibiotic regulation setting forth

standards for a nonsterile bleomycin

sulfate bulk drug substance (21 CFR

450.10). This was published as a final

rule to become effective on November 3,

1994. This new regulation differed from
Federal Register / Vol. 60, No. 61 / Thursday, March 30, 1995 / Rules and Regulations 16377

the monograph standards for sterile

bleomycin sulfate bulk drug, set forth in

21 CFR 450.10a, in two respects: The

new regulation did not require sterility

at the bulk stage, and the new regulation

did not require testing for pyrogens at

the bulk stage.

Bristol-Myers Squibb Co., the sponsor

of the innovator product, filed a petition

for stay pursuant to 21 CFR 10.35,

objecting to FDA’s decision to

promulgate the new regulation without

notice and a prior opportunity for

public comment. On November 9, 1994,

FDA agreed to stay the effective date of

the monograph for nonsterile bleomycin

sulfate bulk drug substance to

reconsider the manner in which the

agency promulgated the new

monograph. A copy of FDA’s letter

notifying Bristol-Myers Squibb Co. of

the stay is on file in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857. In the Federal Register of March

1, 1995 (60 FR 11026), FDA published

a stay of the monograph for nonsterile

bleomycin sulfate bulk drug substance.

Because of the issues that may arise

based on the coexistence of alternative

standards for nonsterile bleomycin

sulfate bulk drug and sterile bleomycin

sulfate bulk drug, and because several

manufacturers have demonstrated an

interest in manufacturing bulk

bleomycin sulfate and finished dosage

forms for the drug, FDA finds that it is

appropriate to provide an opportunity

for public comment on the standards.

Therefore, FDA is withdrawing the

regulation for nonsterile bleomycin

sulfate bulk drug substance, and will

propose a new regulation setting forth

standards for nonsterile bleomycin

sulfate bulk drug substance in a future

issue of the Federal Register.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 450 is

amended as follows:

List of Subjects in 21 CFR Part 450

Antibiotics.

PART 450—ANTITUMOR ANTIBIOTIC

DRUGS

1. The authority citation for 21 CFR

part 450 continues to read as follows:

Authority: Sec. 507 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 357).

§ 450.10 [Removed]

2. Section 450.10 Bleomycin sulfate is

removed.

Dated: March 18, 1995.

Murray M. Lumpkin,

Deputy Director, Center for Drug Evaluation

and Research.

[FR Doc. 95–7802 Filed 3–29–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of the Secretary

24 CFR Subtitle A, Appendices A and

B, and Parts 91, 248, 570, 572, 582, 583,

882, 889 and 890

[Docket No. R–94–1731; FR–3611–F–08]

RIN 2501–AB72

Consolidated Plan for Community

Planning and Development Programs:

Conforming Changes to Program

Regulations

AGENCY: Office of the Secretary, HUD.

ACTION: Final rule; technical

amendment.

SUMMARY: This rule amends the

Department’s existing regulations for

programs that refer to the

Comprehensive Housing Affordability

Strategy (CHAS) to replace references to

the CHAS with references to the

document that has replaced it—the

Consolidated Plan. A final rule was

published on January 5, 1995, that

revised 24 CFR part 91 to replace the

CHAS with the consolidated plan as the

document that embodies a jurisdiction’s

determination of housing needs and

planned use of HUD funds to meet those

needs.

EFFECTIVE DATE: February 6, 1995.

FOR FURTHER INFORMATION CONTACT:

Joseph F. Smith, Director, Policy

Coordination, Office of Community

Planning and Development, 451

Seventh Street SW., Washington, DC

20410–7000, telephone (202) 708–1283

(voice) or (202) 708–2565 (TDD). (These

are not toll-free telephone numbers.)

Copies of this rule will be made

available on tape or large print for those

with impaired vision that request them.

They may be obtained at the above

address.

SUPPLEMENTARY INFORMATION:

I. Background

A final rule providing for a

consolidated plan and a single

performance report for all HUD

community planning and development

formula grant programs was published

on January 5, 1995, effective February 6,

1995, which affects determinations of

consistency of applications for funding

for other programs, as described in 24

CFR 91.2(b). The programs affected, for

which conforming changes are

necessary to published program

requirements, are HOPE for Public and

Indian Housing Homeownership

Program (‘‘HOPE 1’’) (program

guidelines codified as Appendix A to

Subtitle A of 24 CFR), HOPE for

Homeownership of Multifamily Units

Program (‘‘HOPE 2’’) (program

guidelines codified as Appendix B to

Subtitle A of 24 CFR), Lead-Based Paint

Hazard Reduction Program (Part 35),

Prepayment of Low Income Housing

Mortgages (Part 248), HOPE for

Homeownership of Single Family

Homes Program (Part 572), Shelter Plus

Care Program (Part 582), Supportive

Housing Program (Part 583), Section 8

Moderate Rehabilitation Single Room

Occupancy Program for Homeless

Individuals (Part 882, Subpart H),

Supportive Housing for the Elderly

Program (Part 889), and Supportive

Housing for Persons With Disabilities

Program (Part 890). The regulations (or

guidelines, in the case of HOPE 1 and

HOPE 2) for all of these programs are

amended by this rule, except for the

Lead-Based Paint Hazard Reduction

Program, for which a separate

rulemaking is underway.

In addition, the Community

Development Block Grant (CDBG)

program regulations are being amended

in this rule to make the provision in the

CDBG rule concerning the deadline for

submitting the consolidated plan

consistent with the provision in the

consolidated plan rule. (Section 91.15

provides that a consolidated plan must

be submitted no later than August 16 of

the federal fiscal year for which funding

is sought, whereas § 570.304(c)(1) states

that the first working day of September

is the deadline.)

Another technical correction being

made in this rule is to remove from 24

CFR part 91 a provision that conflicts

with a State CDBG program provision.

(Section 570.483(d) prescribes the

manner in which States meet the

requirements for funding an activity

under the ‘‘urgent need’’ national

objective. Section 91.320(g)(1)(i) of the

consolidated plan rule prescribes

another method.) The Department

wishes to preserve the method specified

in the CDBG State program regulation,

so this rule removes the provision from

the consolidated plan rule.

II. Justification for Final Rule

In general, the Department publishes

a rule for public comment before issuing

a rule for effect, in accordance with its

own regulations on rulemaking, 24 CFR