Federal Register / Vol. 60, No. 99 / Tuesday, May 23, 1995 / Notices 27321

Food and Drug Administration

[Docket Nos. 91P–0186 and 93P–0306]

Proposed Warning Labels for IronContaining Products; FDA Report on

Consumer Research; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a report entitled

‘‘Consumer Research on Proposed

Warning Labels for Iron-Containing

Products,’’ which describes the results

of research conducted by the agency to

evaluate consumer understanding of the

proposed warning labels for ironcontaining products. FDA is inviting

comments on the findings in this report.

DATES: Written comments by July 24,

1995.

ADDRESSES: Submit written comments

and requests for single copies of

‘‘Consumer Research on Proposed

Warning Labels for Iron-Containing

Products’’ to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

Comments and requests should be

identified with the docket number

found in brackets in the heading of this

document. Send two self-addressed

adhesive labels to assist that office in

processing your requests. After the

comment period shown above, copies of

the document will be available at cost

from the Freedom of Information Staff

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857.

‘‘Consumer Research on Proposed

Warning Labels for Iron-Containing

Products’’ and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

FOR FURTHER INFORMATION CONTACT:

Raymond E. Schucker, Center for Food

Safety and Applied Nutrition (HFS–

725), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5657.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 6, 1994 (59

FR 51030), FDA issued a proposal (‘‘the

initial proposal’’) on actions that it

tentatively concluded were necessary to

stop the recent epidemic of pediatric

poisonings from over consumption of

iron-containing products. In the Federal

Register of February 16, 1995 (60 FR

8989), the agency issued a

supplementary proposal to clarify

changes in its legal authority with the

passage of the Dietary Supplement

Health and Education Act (Pub. L. 103–

417).

In the initial proposal, FDA

announced that it may conduct focus

group research to evaluate consumer

understanding of the proposed warning

messages and to ensure that the

messages are not misleading. FDA has

conducted this research. Consumers

provided feedback as to their

understanding of the proposed warnings

and the degree to which the specific

wording of the messages was believable,

relevant, confusing, or irritating.

Additional warning messages were

created as a result of public comment on

the proposed rule, and these messages

were also evaluated in the focus groups.

FDA stated in the initial proposal that

it would make a report of the results of

this research available for public

comment before it issued the final

regulations. The research report is now

available for public comment.

Dated: May 18, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 95–12605 Filed 5–22–95; 8:45 am]

BILLING CODE 4160–01–F

Public Health Service

Announcement of Availability of Funds

for Family Planning Service Grants

AGENCY: Public Health Service, HHS.

ACTION: Notice.

SUMMARY: The Office of Population

Affairs announces the availability of

funds for FY 1996 family planning

services grant projects under the

authority of Title X of the Public Health

Service Act (42 U.S.C. 300, et seq.) and

solicits applications for competing grant

awards to serve the areas and/or

populations set out below. Only

applications which propose to serve the

populations and/or areas set out below

will be accepted for review and possible

funding.

OMB Catalog of Federal Domestic

Assistance 93.217.

DATES: Application due dates vary. See

Supplementary Information below.

ADDRESSES: Additional information may

be obtained from and completed

applications should be sent to the

appropriate Regional Health

Administrator at the address below:

Region I—(Connecticut, Maine,

Massachusetts, New Hampshire,

Rhode Island, Vermont): DHHS/PHS

Region I, John F. Kennedy Federal

Building, Government Center, Room

1400, Boston, MA 02203

Region II—(New Jersey, New York,

Puerto Rico, Virgin Islands): DHHS/

PHS Region II, 26 Federal Plaza,

Room 3337, New York, NY 10278

Region III—(Delaware, District of

Columbia, Maryland, Pennsylvania,

Virginia, W. Virginia DHHS/PHS

Region III, 3535 Market Street,

Philadelphia, PA 19101

Region IV—(Alabama, Florida, Georgia,

Kentucky, Mississippi, N. Carolina, S.

Carolina, Tennessee): DHHS/PHS

Region IV, 101 Marietta Tower, Suite

1106, Atlanta, GA 30323

Region V—(Illinois, Indiana, Michigan,

Minnesota, Ohio, Wisconsin): DHHS/

PHS Region V, 105 West Adams

Street, 17th Floor, Chicago, IL 60603

Region VI—(Arkansas, Louisiana, New

Mexico, Oklahoma, Texas): DHHS/

PHS Region VI 1200 Main Tower

Building, Room 1800, Dallas, TX

75202

Region VII—(Iowa, Kansas, Missouri,

Nebraska): DHHS/PHS Region VII,

601 East 12th Street, 5th Fl. W.,

Kansas City, MO 64106

Region VIII—(Colorado, Montana, N.

Dakota, S. Dakota, Utah, Wyoming):

DHHS/PHS Region VIII, 1961 Stout

Street, Denver, CO 80294

Region IX—(Arizona, California,

Hawaii, Nevada, Commonwealth of

the Northern Mariana Islands,

American Samoa, Guam, Republic of

Palau, Federated States of Micronesia,

Republic of the Marshall Islands):

DHHS/PHS Region IX, 50 United

Nations Plaza, Room 327, San

Francisco, CA 94102

Region X—(Alaska, Idaho, Oregon,

Washington): DHHS/PHS Region X,

Blanchard Plaza, 2201 Sixth Avenue,

M/S RX–20, Seattle, WA 98121.

FOR FURTHER INFORMATION CONTACT:

Regional Grants Management Officers:

Region I, Mary O’Brien—617/565–1482;

Region II, Steven Wong—212/264–4496;

Region III, Marty Bree—215/596–6653;

Region IV, Wayne Cutchins—404/331–

2597; Region V, Lawrence Poole—312/

353–8700; Region VI, Joyce Bailey—

214/767–3879; Region VII, Michael

Rowland—816/426–2924; Region VIII,

Susan A. Jaworowski—303/844–4461;

Region IX, Ken Souza—415/556–8187;

Region X, Jim Tipton—206/615/2473.

Regional Program Consultants for

Family Planning: Region I, James

Sliker—617/565–1452; Region II,

Margaret Lee—212/264–2571; Region

III, Elizabeth Reed—215/596–6686;

Region IV, Christino Rodrigues—404/

331–5254; Region V, George

Hockenberry—312/535–1700; Region

VI, Paul Smith—214/767–3072; Region
27322 Federal Register / Vol. 60, No. 99 / Tuesday, May 23, 1995 / Notices

VII, Susan Moskosky—816/426–2924;

Region VIII, John J. McCarthy, Jr.—303/

844–5955; Region IX, James Hauser—

415/556–7117; Region X, Karen

Matsuda—206/615–2501.

SUPPLEMENTARY INFORMATION: Title X of

the Public Health Service Act, 42 U.S.C.

300, et seq., authorizes the Secretary of

Health and Human Services (HHS) to

award grants to public or private

nonprofit entities to assist in the

establishment and operation of

voluntary family planning projects to

provide a broad range of acceptable and

effective family planning methods and

services (including natural family

planning methods, infertility services,

and services for adolescents). The

statute requires that, to the extent

practicable, entities shall encourage

family participation. Also, Title X funds

may not be used in programs where

abortion is a method of family planning.

Implementing regulations appear at 42

CFR Part 59 Subpart A.

On February 5, 1993, HHS published

at 58 FR 7462 an interim rule that

suspends the 1988 Title X rules,

pending the promulgation of new

regulations. The principal effect of this

action was to suspend the definitions of

‘‘family planning,’’ ‘‘grantees,’’

‘‘prenatal care,’’ ‘‘Title X,’’ ‘‘Title X

Program,’’ and ‘‘Title X Project’’

presently found at 42 CFR 59.2 and 42

CFR 59.7–59.10. Proposed rules were

also published at 58 FR 7464 on the

same date. During the pendency of

rulemaking, the compliance standards

that were in effect prior to the issuance

of the 1988 rule, including those set out

in the 1981 Family Planning Guidelines,

are being used to administer the

program. Copies of the pre-1988

compliance standards are available from

the Regional Program Consultants listed

above.

The Title X program has established

these five priorities:

(1) Increasing outreach to women not

likely to seek services, including

homeless persons, disabled persons,

substance abusers and adolescents;

(2) Expanding the comprehensiveness of

reproductive health services,

including STD and cancer screening

and prevention, increased

involvement of male partners, HIV

prevention, education and counseling,

and substance abuse screening and

referral;

(3) Serving adolescents, including more

community education, emphasis on

postponement of sexual activity, and

more accessible provision of

contraceptive counseling and

contraception;

(4) Eliminating disincentives to provide

high-cost but highly effective

contraceptives such as Norplant and

Depo-Provera, serving high risk (and

high-unit cost) clients, and providing

nonrevenue-generating services such

as community education and

prevention services; and

(5) Emphasizing training and retention

of family planning nurse

practitioners, particularly minority

nurse practitioners and nurse

practitioners serving disadvantaged

and medically underserved

communities.

These program priorities represent

overriding goals which are being

pursued to the extent that funding

increases or increases in program

efficiency allow. Some funding may be

available to Title X grantees to improve

and expand services.

The Administration’s FY 1996 budget

request for this program is $198.9

million. This amount represents a three

percent increase over the FY 1995

appropriation of $193.3 million, of

which $179.6 million will be made

available to Title X service grantees.

Approximately 17 percent of the funds

appropriated for FY 1996 and made

available to Title X service grantees will

be used for competing grants. The

remaining funds will be used for noncompeting continuation grants. This

program announcement is subject to the

appropriation of funds and is a

contingency action being taken to

ensure that, should funds become

available for this purpose, they can be

awarded in a timely fashion consistent

with the needs of the program as well

as to provide for the distribution of

funds throughout the fiscal year. Since

the precise funding levels for FY 1996

are uncertain at this point, the funding

levels set out below are based on the FY

1994 appropriation level. However, it is

expected that funding levels will be

increased, if the appropriation for FY

1996 increases.

For FY 1995, the entire $179.6 million

will be allocated among the 10 DHHS

regions, and will in turn be awarded to

public and private non-profit agencies

located within the regions. Each

regional office is responsible for

evaluating applications, establishing

priorities, and setting funding levels

according to criteria in 42 CFR 59.11.

This notice announces the availability

of funds to provide family planning

services in 16 States, the Navajo

Reservation, and the Commonwealth of

the Northern Mariana Islands.

Competing grant applications are

invited for the following areas:

Populations or areas to be served

Number of

grants to be

awarded

FY 1994

funding

Application

due date

Grant funding

date

Region I:

Connecticut ................................................................................................... 1 $1,486,000 9/1/95 1/1/96

Boston, MA .................................................................................................... 1 1,226,000 3/1/96 7/1/96/

Southeastern MA .......................................................................................... 1 712,000 9/1/95 1/1/96

Western MA .................................................................................................. 1 662,000 9/1/95 1/1/96

Central MA .................................................................................................... 1 501,000 9/1/95 1/1/96

Northeastern MA ........................................................................................... 1 746,000 3/1/96 7/1/96

Maine ............................................................................................................. 1 1,089,000 3/1/96 7/1/96

New Hampshire ............................................................................................. 1 637,000 3/1/96 7/1/96

Rhode Island ................................................................................................. 1 415,000 3/1/96 7/1/96

Vermont ......................................................................................................... 1 541,000 9/1/95 1/1/96

Region V:

St. Paul, MN .................................................................................................. 1 235,000 9/1/95 1/1/96

Cleveland, OH ............................................................................................... 1 1,346,000 12/1/95 4/1/96

Region VI:

Oklahoma ...................................................................................................... 1 2,639,000 8/1/95 12/1/95

Texas ............................................................................................................. 1 9,426,000 12/1/95 4/1/96

Region VII:

Missouri ......................................................................................................... 1 3,517,000 12/1/95 4/1/96

Nebraska ....................................................................................................... 1 1,168,000 3/1/96 7/1/96
Federal Register / Vol. 60, No. 99 / Tuesday, May 23, 1995 / Notices 27323

Populations or areas to be served

Number of

grants to be

awarded

FY 1994

funding

Application

due date

Grant funding

date

Region VIII:

North Dakota ................................................................................................. 1 470,000 3/1/96 7/1/96

Utah ............................................................................................................... 1 140,000 3/1/96 7/1/96

Region IX:

Navajo Reservation-AZ ................................................................................. 1 511,000 3/1/96 7/1/96

Hawaii ............................................................................................................ 1 874,000 3/1/96 7/1/96

Clark County, NV .......................................................................................... 1 584,000 9/1/95 1/1/96

Commonwealth of the Northern Marianas Islands ....................................... 1 67,000 9/1/95 1/1/96

Total ........................................................................................................... 22 28,992,000 ....................... .......................

Applications must be postmarked or,

it not sent by U.S. mail, received at the

appropriate Grants Management Office

no later than close of business on

application due dates listed above.

Private metered postmarks will not be

acceptable as proof of timely mailing.

Applications which are postmarked or,

if not sent by U.S. mail, delivered to the

appropriate Grants Management Office

later than the application due date will

be judged late and will not be accepted

for review. (Applicants should request a

legibly dated postmark from the U.S.

Postal Service.) Applications which do

not conform to the requirements of this

program announcement or do not meet

the applicable regulatory requirements

at 42 CFR part 59, subpart A will not be

accepted for review. Applicants will be

so notified, and the applications will be

returned.

Applications will be evaluated on the

following criteria:

(1) The number of patients and, in

particular, the number of low-income

patients to be served;

(2) The extent to which family planning

services are needed locally;

(3) The relative need of the applicant;

(4) The capacity of the applicant to

make rapid and effective use of the

Federal assistance;

(5) The adequacy of the applicant’s

facilities and staff;

(6) The relative availability of nonFederal resources within the

community to be served and the

degree to which those resources are

committed to the project; and

(7) The degree to which the project plan

adequately provides for the

requirements set forth in the Title X

regulations

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS—led national activity for setting

priority areas. This announcement is

related to the priority areas of Family

Planning. A midcourse review of the

objectives is presently ongoing, and the

proposed revisions are contained in a

draft report. A notice of Availability and

Request for Comment on the Healthy

People 2000 Midcourse Revisions was

published in the Fedeal Register on

October 3, 1994 (59 FR 50253). Requests

for copies of the Draft for Public Review

and Comment: Healthy People 2000

Midcourse Revisions can be faxed to

(301) 594–5981 or mailed to: OFP/OPA,

East-West Towers, Suite 200, 5600

Fishers Lane, Rockville, MD 20857. A

new PHS report, Healthy People 2000

Midcourse Review and Revisions,

featuring the final revisions and status

report on progress in achieving targets

for the year 2000, will be published in

1995.

The Public Health Service strongly

encourages all grant recipients to

provide a smoke-free workplace and

promote the non-use of all tobacco

products. This is consistent with the

PHS mission to protect and advance the

physical and mental health of the

American people.

Application Requirements

Application kits (including the

application form, PHS 5161—approved

by OMB under control number 0937–

0189) and technical assistance for

preparing proposals are available from

the regional offices. An application

must contain: (1) A narrative

description of the project and the

manner in which the applicant intends

to conduct it in order to carry out the

regulations of the law and regulations;

(2) a budget that includes an estimate of

project income and costs, with

justification for the amount of grant

funds requested; (3) a description of the

standards and qualifications that will be

required for all personnel and facilities

to be used by the project; and (4) such

other pertinent information as may be

required by the Secretary as specified in

the application kit. In preparing an

application, applications should

respond to all applicable regulatory

requirements.

Application Review and Evaluation

Each regional office is responsible for

establishing its own review process.

Applications must be submitted to the

appropriate regional office at the

address listed above. Staff are available

to answer questions and provide limited

technical assistance in the preparation

of grant applications.

Grant Awards

Grant projects are generally approved

for 3 to 5 years with an annual noncompetitive review of a continuation

application to obtain continued support.

Non-competing continuation awards are

subject to factors such as the project

making satisfactory progress and the

availability of funds. In all cases,

continuation awards require a

determination by HHS that continued

funding is in the best interest of the

Federal Government.

Review Under Executive Order 12372

Applicants under this announcement

are subject to the review requirements of

Executive Order 12372, State Review of

applications for Federal Financial

Assistance, as implemented by 45 CFR

part 100. As soon as possible, the

applicant should discuss the project

with the State Single Point of Contact

(SPOC) for each State to be served. The

application kit contains the currently

available listing of the SPOCs which

have elected to be informed of the

submission of applications. For those

States not represented on the listing,

further inquiries should be made by the

applicant regarding the submission to

the Grants Management Office of the

appropriate region. State Single Point of

Contact comments must be received by

the regional office 30 days prior to the

funding date to be considered.

When final funding decisions have

been made, each applicant will be

notified by letter of the outcome of its

application. The official document

notifying an applicant that a project

application has been approved for

funding is the Notice of Grant Award,
27324 Federal Register / Vol. 60, No. 99 / Tuesday, May 23, 1995 / Notices

which specifies to the grantee the

amount of money awarded, the

purposes of the grant, and terms and

conditions of the grant award.

Dated: May 17, 1995.

Felicia H. Stewart,

Deputy Assistant Secretary for Population

Affairs.

[FR Doc. 95–12556 Filed 5–22–95; 8:45 am]

BILLING CODE 4160–17–M

ADVISORY COMMISSION ON

INTERGOVERNMENTAL RELATIONS

Proposed Criteria for Reviewing and

Making Recommendations on Federal

Mandates

ACTION: Notice of proposed criteria.

SUMMARY: The Advisory Commission on

Intergovernmental Relations (ACIR) is

soliciting public comments on its

proposed criteria for investigating and

reviewing existing federal mandates and

formulating recommendations to

modify, suspend, or terminate specific

mandates on State, local, or Tribal

governments.

DATES: Comments must be received by

June 22, 1995.

ADDRESSES: Comments should be sent to

Philip M. Dearborn, Director,

Government Finance Research, ACIR,

800 K Street NW., Suite 450 South,

Washington, DC 20575.

FOR FURTHER INFORMATION CONTACT:

Philip Dearborn at 202/653–5538.

SUPPLEMENTARY INFORMATION: The

Advisory Commission on

Intergovernmental Relations (ACIR, 42

U.S.C. 4271) is charged in Sec. 302 of

the Unfunded Mandates Reform Act of

1995 (Pub. L. 104–4, 109 Stat. 67) with

investigating and reviewing the role of

Federal mandates in intergovernmental

relations and formulating

recommendations to modify, suspend,

or terminate specific mandates on State,

local, or Tribal governments.

Section 302 defines ‘‘Federal

mandate’’ very broadly for the purposes

of the ACIR review as ‘‘any provision in

statute or regulation or any Federal

court ruling that imposes an enforceable

duty on State, local, or Tribal

governments including a condition of

Federal assistance or a duty arising from

participation in a voluntary Federal

program.’’

ACIR will select for in-depth review

those Federal mandates generally

recognized as creating significant

concerns within the intergovernmental

system. In accordance with Public Law

104–4, ACIR will give review priority to

mandates that are subject to judicial

proceedings in Federal courts. To

formulate its recommendations, ACIR

will evaluate each mandate to determine

the specific conditions causing concern.

The Commission will make the final

decisions about which mandates it will

review based on two types of criteria:

(1) Those that provide a basis for

identifying mandates of significant

concern; and

(2) Those that provide a basis for

formulating recommendations to

modify, suspend, or terminate specific

mandates that are of concern.

Criteria for Identifying Mandates of

Significant Concern

In general, Federal mandates will be

selected for intensive review if they

have one or more of the following

characteristics:

1. The mandate requires State, local,

or Tribal governments to expend

substantial amounts to their own

resources in a manner that significantly

distorts their spending priorities. This

addresses mandates that require more

than incidental amounts of spending. It

will not include all Federal mandates

that require governments to spend

money.

2. The mandate establishes terms or

conditions for Federal assistance in a

program or activity in which State,

local, or Tribal governments have little

discretion over whether or not to

participate. This will include mandates

in entitlements and discretionary

programs. It will exclude conditions of

grants in small categorical programs that

are distributed on the basis of annual or

periodic applications and that are

received only by a limited number of

governments.

3. The mandates abridges historic

powers of State, local, or Tribal

governments, the exercise of which

would not adversely affect other

jurisdictions. This will include

mandates that have an impact on

internal State, local, and Tribal

government affairs related to issues not

widely acknowledged as being of

national concern and for which the

absence of the mandate would not

create adverse spillover effects.

4. The mandate imposes compliance

requirements that make it difficult or

impossible for State, local, and Tribal

governments to implement.

Implementation delays, issuance of

court orders, or assessment of fines may

be indicative of mandate requirements

that go beyond State, local, or Tribal

fiscal resources, or administrative or

technological capacity, after reasonable

efforts at compliance have been made.

5. The mandate has been the subject

of widespread objections and

complaints by State and local

governments and their representatives.

This will include mandates that are

based on problems of national scope,

but are not federally funded.

Criteria for Formulating

Recommendations

ACIR will investigate the specific

characteristics of each mandate causing

significant concern in order to formulate

a recommendation to modify, suspend,

or terminate the mandate. For purposes

of formulating such recommendations,

ACIR will focus on specific provisions

in laws, regulations, or court orders.

When a mandate affects a State or

local program that directly competes

with a comparable private sector

activity, ACIR will consider the effects

on both the government and private

sector in making its recommendation.

ACIR also will consider (1) impacts of

mandates on working men and women

and (2) mandates for utilization of

metric systems.

ACIR will investigate each mandate

selected for intensive review to

determine whether or not they have one

or more of the following characteristics:

1. Federal Intrusion

• Requirements are not based on

demonstrated national needs.

• Requirements are related to issues

not widely recognized as national

concerns or as being within the

appropriate scope of Federal activities.

• Requirements are based on

problems of national scope, but which

State, local, or Tribal governments have

been able or willing to solve effectively,

either independently or through

voluntary cooperation.

• Requirements are based on

problems of national scope, but are not

federally funded.

These mandates should be terminated

or modified to express non-binding

national guidelines. In some instances,

the basis provision could be retained in

Federal law, but compliance could be

made voluntary.

2. Unnecessarily Rigid

• Provisions do not permit

adjustments to the circumstances or

needs of individual jurisdictions.

• Provisions restrict flexibility to use

less costly or less onerous alternative

procedures to achieve the goal of the

mandate.

• Provisions do not allow

governments to set implementation or

compliance priorities and schedules,

taking into account risk analysis,

greatest benefit, or other factors.

These mandates should be modified

to provide options, waivers, or

exemptions, or be terminated.