Maternal and Child Health (MCH) Project Grants

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Health Resources and Services Administration

42 CFR Part 51a

RIN 0905-AD88

Maternal and Child Health (MCH) Project Grants

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final rule.

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SUMMARY: This final rule amends existing regulations governing the

Maternal and Child Health (MCH) Federal Set-Aside programs under

sections 502(a) and 502(b) of Title V of the Social Security Act (42

U.S.C. 702(a) and 702(b)). This rule revises the regulations to:

increase flexibility to fit changing policy concerns; implement

requirements established under the Omnibus Budget Reconciliation Act of

1989 (OBRA '89) addressing collection of data from funded projects, and

make other changes that are technical or clarifying in nature. The rule

updates the existing regulations in accord with current Department

policy and statutory amendments made to sections 501(a), 502(a),

502(b), and 506(a)(3).

EFFECTIVE DATE: This regulation is effective August 18, 1994.

FOR FURTHER INFORMATION CONTACT:

Lynn Squire, Legislative Officer, Maternal and Child Health Bureau,

HRSA, HHS, Office of Program Development, Parklawn Building, room 18-

20, 5600 Fishers Lane, Rockville, MD 20857; telephone number: 301-443-

2778.

SUPPLEMENTARY INFORMATION: On July 21, 1993, the Secretary published in

the Federal Register (58 FR 38995) a Notice of Proposed Rulemaking

(NPRM) proposing to revise existing regulations governing the MCH

Federal Set-Aside programs to bring them into conformity with current

Department policy and statutory amendments to these programs. The

Maternal and Child Health (MCH) Services Block Grant is the only

federally authorized program devoted exclusively to maternal and child

health. First authorized under Title V of the Social Security Act (the

Act) in 1935 and reorganized as a block grant under the Omnibus Budget

Reconciliation Act of 1981 (Pub. L. 97-35), the program provides funds

primarily to States to develop the maternal and child health

infrastructure and public health system which supports the

establishment of community-based, family-centered systems of

preventive, primary and specialized care that coordinate and integrate

public and private sector resources for women of childbearing age,

infants, children, adolescents, and families, particularly those who

are low income, have limited access to care, or have a child with

special health care needs.

Sections 502(a) and 502(b) of Title V, as amended by the Omnibus

Budget Reconciliation Act (OBRA) of 1989 (Pub. L. 101-239), govern the

MCH Federal Set-Aside programs. These sections require that specified

portions of the annual appropriation for the MCH Block Grant be set

aside and retained by the Secretary to support projects in designated

categories. Section 502(a) established the federal set-aside for

Special Projects of Regional and National Significance (SPRANS), which

supports grants, contracts, and cooperative agreements for: training;

research; genetic disease and newborn screening; hemophilia treatment

centers; and special Maternal and Child Health Improvement Projects

(MCHIP). Section 502(b) was authorized under section 6502(a)(3)(b) of

OBRA '89. It establishes a set-aside, consisting of 12.75 percent of

annual appropriated amounts above $600 million, for special projects

termed ``Community Integrated Service Systems (CISS)'' projects. The

purposes of these special projects are identified under section

501(a)(3) of the Act. They include the development and expansion of:

maternal and infant home visiting programs; programs to increase the

numbers of obstetricians and gynecologists participating in Titles V

and XIX; integrated MCH service delivery systems; MCH centers operating

under not-for-profit hospitals; rural MCH projects; and outpatient and

community based services for children with special health care needs.

Regulations published at 51 FR 7726, March 5, 1986 (and codified at 42

CFR 51a), focus only on the SPRANS federal set-aside under 502(a). The

regulations have not been revised since their initial publication.

The NPRM proposed to: (1) Replace references to ``crippled

children'' with ``children with special health care needs'' in all

sections of the regulations, as mandated under section 9527 of COBRA;

(2) change the heading and revise the wording in Sec. 51a.1 to reflect

the intent of the section, which is to expand the regulation's

applicability to the CISS program under section authorized under

section 502(b)(1)(A) of the Act by OBRA '89; (3) In Sec. 51a.3, change

the language to clarify and more clearly distinguish between

eligibility requirements for applicants for research, training, and

other grant categories under the Federal Maternal and Child Health Set-

Aside program; (4) make minor wording changes in Sec. 51a.4, to better

describe the application process and to more clearly distinguish

between requirements for research applications and those for other

grant categories; (5) amend Sec. 51a.5 to incorporate into the

Secretary's funding decisions consideration of MCH-related Healthy

People 2000 objectives, as required by OBRA '89 under section 501(a) of

the Act. The amended Sec. 51a.5 would also incorporate a statutory

funding preference for certain CISS project strategies in areas of high

infant mortality, as required by OBRA '89 under section 502(b)(2) of

the Act. In addition, to better reflect the diversity of project

categories for which applications are currently solicited and their

responsiveness to changing needs, the NPRM proposed to replace obsolete

and inflexible evaluation criteria in the section. The new criteria

would be consistent with Part 116 of the PHS Grants Administration

Manual, applicable to decisions on funding awards, while increasing

opportunities for the Secretary to develop criteria as needed for

specific project categories. Category-specific evaluation criteria

would be published in program announcements and/or application

guidances; (6) In Sec. 51a.7, make technical changes to eliminate

obsolete references as a result of changes in Department regulations,

and to correct other errors in references; and (7) add a new Sec. 51a.8

to set out conditions which grantees must meet. Requirements in

paragraph (a) would implement amendments to section 506(a)(3) of the

Act made by OBRA '89, which address collection of data from funded

SPRANS projects concerning the number of individuals served or trained,

as appropriate.

In addition, the NPRM proposed information collections which have

been approved by the Office of Management and Budget (OMB) under the

Paperwork Reduction Act of 1980 and assigned control number 0915-0169.

It also proposed to add a provision giving the Secretary discretion to

impose such additional conditions on grantees as the Secretary views as

necessary, using language identical to that in many other PHS grant

program regulations. Additionally, technical and ministerial revisions

were proposed to bring existing regulations into compliance with

current major departmental policy initiatives and grants policy

language.

The public comment period on the proposed regulations closed on

September 20, 1993. The Department received 4 letters of public comment

on this NPRM. All significant comments have been considered and

discussed. Comments relating to the information collection requirements

in Sec. 51a.8 highlight the Department's responsibility to provide

grantees with clear and explicit instructions for completing prescribed

forms. There are no substantive differences between the proposed rule

and the final rule as a result of our review of public comments.

The comments received on the proposed rule and the Department's

responses to the comments are discussed below under the section numbers

of the regulations affected.

Part 51a--Project Grants for Maternal and Child Health

One respondent expressed support for the proposed replacement of

all references to ``crippled'' children in all sections of the

regulation to ``children with special health care needs.'' The

Department is making this change to conform with Section 9527 of the

Consolidated Omnibus Reconciliation Act of 1985 (COBRA) [Pub. L. 99-

272], which substitutes the term `Children with Special Health Care

Needs' for `Crippled Children' throughout Title V.

Section 51a.5 What criteria will DHHS use to decide which projects to

fund?

One respondent was concerned that some potential SPRANS and CISS

applicants do not work closely enough or early enough with the State

Title V agency in developing their grant proposals. This respondent

suggested adding ``the quality of coordination with the state Title V

program'' to the criteria used by the Department to review projects for

funding.

The Department wishes to stress that it considers a key objective

of these new rules to be the elimination of obsolete and overly-rigid

evaluation criteria in order to better accommodate the broad diversity

of project categories in which grants are awarded; in recent years, the

number of separate categories and subcategories has exceeded 35.

Limiting regulatory review criteria to the minimum required by Part 116

of the Public Health Service (PHS) Grants Administration Manual does

not affect the Department's ability to publish in annual program

announcements and/or application guidelines additional criteria for any

grant category. This limitation is also consistent with Executive Order

12875 of October 26, 1993, which discourages executive departments from

promulgating any regulation ``that is not required by statute and that

creates a mandate upon a State, local, or tribal government''.

The Department will include category-appropriate review criteria in

the application guidelines it distributes for each grant category. Most

demonstration grant categories can be expected to contain review

criteria relating to meaningful and timely consultation and

collaboration by applicants with the State Title V agency, as well as

with other State, local, and tribal governments regarding matters that

uniquely affect their communities. The Department notes, however, that

the statute does not condition awards under the MCH Federal Set-Aside

programs on coordination with the State Title V agency and that such

coordination may not be relevant for every grant category. The

statutory emphasis on ``regional and national significance'' reflects

Congressional intent that some categories should properly serve

interests beyond those of the host State. Because both categorical

diversity and changing priorities over time are fully accommodated by

customizing annual announcements and/or guidelines, the Department is

making no changes to the review criteria in this section.

This respondent also suggested that priorities for funding within

the SPRANS and CISS programs be determined in consultation with State

Title V programs. Agency discretion in selection of priorities for

funding in both the SPRANS and CISS programs is actually extremely

limited. The major SPRANS categories are identified in section 502(a)

and CISS project categories are specified in some detail in sections

and 502(b) of Title V. Subcategories and priorities under SPRANS can

change from year to year; typically, however, they are designed to

fulfill specific Congressional or Administration program directives.

The Department has an established mechanism for soliciting comments

from the public on proposed priorities for Title V grant programs.

Annual announcements of the availability of funding for SPRANS and CISS

invite public comment on the published program priorities. When

application deadlines prevent consideration of public comments in

developing priorities for the current fiscal year, they are considered

for the following fiscal year. In addition, numerous formal and

informal opportunities currently exist for consultation and exchanges

of views on grant priorities between the Department's central and

regional office officials and State Title V programs and their chosen

representatives.

One respondent pointed out a misprint in the NPRM listing of CISS

funding preferences, which is corrected in the final regulation. The

misprint resulted in incorrectly combining two separate statutory

categories--integrated maternal and child health service systems and

maternal and child health centers operating under the direction of not-

for-profit hospitals--and in omitting the category of outpatient and

community based services for children with special health care needs.

Section 51a.8 What other conditions apply to these grants?

OBRA '89 added a requirement (under sec. 506(a)(3) of the Act) for

annual collection of data from SPRANS and CISS project grants,

including: (1) Information on the number of individuals served or

trained; (2) a copy of any evaluation conducted by the recipient; and

(3) a list of Healthy Children 2000 objectives addressed by the project

and data on how the project met the objectives.

Two respondents raised concerns regarding the applicability of

individual-oriented reporting requirements to projects whose objectives

or activities are primarily population-based, such as infrastructure

building, needs assessment, quality control, or policy development. The

Department appreciates these concerns. To accommodate variations in the

targeting of the major types of SPRANS/CISS grants, the Department has

developed and OMB has approved for a one-year period, through November

1994, a ``SPRANS/CISS Uniform Data Collection Instrument'' for use in

this annual data collection, which will usually take place in the

spring of each fiscal year. Following the submission by SPRANS/CISS

grantees of their completed data forms, the Maternal and Child Health

Bureau (MCHB) will compile the data in compliance with the legislative

mandate for information on the number of persons served or trained.

Four separate SPRANS/CISS Uniform Data Collection Instrument forms have

been designed for use in FY 1994, customized for projects focusing on:

(1) Training; (2) research; (3) data analysis; and (4) other

discretionary grants. The development of the forms to be used in this

information collection was guided by an active data development

committee within the MCHB. The forms were sent to all Public Health

Service Regional Offices for review. In addition, draft data collection

instruments were disseminated in FY 1993 for field testing to nine

institutions representing each major type of SPRANS/CISS grantee, i.e.

training, research, genetics, hemophilia, and MCH improvement projects.

Smoke Free Workplace

Public Law 103-227, enacted on March 31, 1994, prohibits smoking in

certain facilities in which minors will be present. The Department of

Health and Human Services is now preparing to implement the provision

of that law. Until those implementation plans are in place, PHS

continues to strongly encourage all grant recipients to provide a smoke

free workplace and promote the nonuse of all tobacco products.

Regulatory Flexibility Act and Executive Order 12866

These regulations govern a financial assistance program in which

participation is voluntary. The Department believes that the resources

required to implement the new requirements in this final rule are

minimal. In accordance with the requirements of the Regulatory

Flexibility Act of 1980, the Secretary certifies that these regulations

will not have a significant economic impact on a substantial number of

small entities.

The Department also has determined that this rule is not a major

rule under Executive Order 12866; therefore, a regulatory impact

analysis is not required. The rule will not exceed the threshold level

of $100 million established in section (b) of Executive Order 12866.

Paperwork Reduction Act

This rule contains information collections which have been approved

by the Office of Management and Budget (OMB) under the Paperwork

Reduction Act of 1980 and assigned control number 0915-0169. The title,

description, and respondent description of the information collections

are shown below with an estimate of the annual reporting, notification

and recordkeeping burdens. Included in the estimate is the time for

reviewing instructions, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

collection of information.

Title: SPRANS/CISS Uniform Data Collection Instrument.

Description: Information will be collected from funded projects to

enable the Secretary to respond to congressional reporting mandates

required by OBRA '89 concerning individuals served or trained by

projects, their responsiveness to Healthy Children 2000 objectives, and

their evaluation status.

Description of Respondents: Recipients of SPRANS and CISS project

awards.

Estimated Annual Reporting and Recordkeeping Burden:

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No. of Responses per Hours per

Section respondents respondent response Total hours

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Reporting:

Sec. 51a.8.................................. 580 1 4 2,320

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Total Burden.............................. .............. .............. .............. 2,320

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We received one comment on the estimated annual reporting burden

published in the NPRM. The estimate of four hours per response was

based on initial information provided to MCHB by a sampling of

grantees' data specialists. Feedback from the field test has confirmed

the general accuracy of the estimated burden. Prior to expiration of

OMB approval for this data collection, in November 1994, the utility of

the data instrument will be reviewed and an analysis of grantee

experience in complying with the requirements will be done. The

estimated reporting burden remains the same as in the proposed rule.

List of Subjects in 42 CFR Part 51a

Grand programs--health, Health care, Health professions,

Handicapped, Maternal and child health.

Dated: April 12, 1994.

Philip R. Lee,

Assistant Secretary for Health.

Approved: July 7, 1994.

Donna E. Shalala,

Secretary.

(Catalog of Federal Domestic Assistance, No. 93.110, Maternal and

Child Health Consolidated Federal Programs).

Accordingly, 42 CFR Part 51a is amended as set forth below:

PART 51a--PROJECT GRANTS FOR MATERNAL AND CHILD HEALTH

1-2. The authority citation for Part 51a is revised to read as

follows:

Authority: Sec. 1102 of the Social Security Act, 49 Stat. 647

(42 U.S.C. 1302); sec. 502(a), 502(b)(1)(A), and 506(a)(3) of the

Social Security Act, 95 Stat. 819-20 (42 U.S.C. 702(a), 702(b)(1)(A)

and 706(a)(3)).

3. Section 51a.1 is revised to read as follows:

Sec. 51a.1 To which programs does this regulation apply?

The regulation in this part applies to grants, contracts, and other

arrangements under section 502(a) and 502(b)(1)(A) of the Social

Security Act, as amended (42 U.S.C. 702(a) and 702(b)(1)(A)), the

Maternal and Child Health (MCH) Federal Set-Aside project grant

programs. Section 502(a) authorizes funding for special projects of

regional and national significance (SPRANS), research and training

projects with respect to maternal and child health and children with

special health care needs (including early intervention training and

services development); genetic disease testing, counseling and

information programs; comprehensive hemophilia diagnostic and treatment

centers; projects for screening and follow-up of newborns for sickle

cell anemia and other genetic disorders; and special maternal and child

health improvement projects. Section 502(b)(1)(A) authorizes funding

for projects termed community integrated service system (CISS) projects

for the development and expansion of: maternal and infant health home

visiting; projects to increase the participation of obstetricians and

pediatricians in title V and title XIX programs; integrated maternal

and child health service systems; maternal and child health centers

operating under the direction of not-for-profit hospitals; rural

maternal and child health programs; and outpatient and community-based

services programs for children with special health care needs.

4. Section 51a.3 is revised to read as follows:

Sec. 51a.3 Who is eligible to apply for Federal funding?

(a) With the exception of training and research, as described in

paragraph (b) of this section, any public or private entity, including

an Indian tribe or tribal organization (as those terms are defined at

25 U.S.C. 450b) is eligible to apply for federal funding under this

Part.

(b) Only public or nonprofit private institutions of higher

learning may apply for training grants. Only public or nonprofit

institutions of higher learning and public or private nonprofit

agencies engaged in research or in programs relating to maternal and

child health and/or services for children with special health care

needs may apply for grants contracts or cooperative agreements for

research in maternal and child health services or in services for

children with special health care needs.

5. Section 51a.4 is revised to read as follows:

Sec. 51a.4 How is application made for Federal funding?

An application for funding under the MCH Federal Set-Aside project

grant programs must be submitted to the Secretary at such time and in

such manner as the Secretary may prescribe. It must include a budget

and narrative plan of the manner in which the project will meet each of

the requirements prescribed by the Secretary. The plan must describe

the project in sufficient detail to identify clearly the nature, need,

and specific objectives of, and methodology for carrying out, the

project. (Approved by the Office of Management and Budget under control

number 0915-0050)

6. Section 51a.5 is revised to read as follows:

Sec. 51a.5 What criteria will DHHS use to decide which projects to

fund?

(a) The Secretary will determine the allocation of funds available

under sections 502(a) and 502(b)(1)(A) of the Act for each of the

activities described in Sec. 51a.1.

(b) Within the limit of funds determined by the Secretary to be

available for each of the activities described in Sec. 51a.1, the

Secretary may award Federal funding for projects under this part to

applicants which will, in his or her judgment, best promote the purpose

of title V of the Social Security Act and address achievement of

Healthy Children 2000 objectives,\1\ taking, the following factors into

account:

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\1\Healthy Children 2000: National Health Promotion and Disease

Prevention Objectives Related to Mothers, Infants, Children,

Adolescents, and Youth is a special compendium of health status

goals and national health objectives affecting mothers, infants,

children, adolescents, and youth originally published in Healthy

People 2000 in September 1990. Potential applicants may obtain a

copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0

or Healthy People 2000 (Summary Report; Stock No. 017-001-00473-1)

through the Superintendent of Documents, Government Printing Office

Washington, DC 20402-9325, (telephone: 202 783-3238).

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(1) The extent to which the project will contribute to the

advancement of maternal and child health and/or improvement of the

health of children with special health care needs;

(2) The extent to which the project is responsive to policy

concerns applicable to MCH grants and to program objectives,

requirements, priorities and/or review criteria for specific project

categories, as published in program announcements or guidance

materials.

(3) The extent to which the estimated cost to the Government of the

project is reasonable, considering the anticipated results;

(4) The extent to which the project personnel are well qualified by

training and/or experience for their roles in the project and the

applicant organization has adequate facilities and personnel; and

(5) The extent to which, insofar as practicable, the proposed

activities, if well executed, are capable of attaining project

objectives.

(c) For the following types of CISS projects, preference for

funding will be given to qualified applicants in areas with a high

infant mortality rate (relative to the latest average infant mortality

rate in the United States or in the State in which the area is

located):

(1) Projects for the development and expansion of maternal and

infant health home visiting;

(2) Projects to increase the participation of obstetricians and

pediatricians in title V and title XIX programs;

(3) Integrated maternal and child health service systems;

(4) Maternal and child health centers operating under the direction

of not-for-profit hospitals;

(5) Rural maternal and child health programs; and

(6) Outpatient and community based services for children with

special health care needs.

7. Section 51a.7(a) is revised to read as follows:

Sec. 51a.7 What other DHHS regulations apply?

(a) Several other DHHS regulations apply to awards under this part.

These include, but are not limited to:

42 CFR Part 50--Policies of general applicability:

Subpart B--Sterilization of persons in federally assisted family

planning projects.

Subpart C--Abortions and related medical services in federally

assisted programs of the Public Health Service.

Subpart E--Maximum allowable cost for drugs.

45 CFR Part 76--Governmentwide debarment and suspension

(nonprocurement) and governmentwide requirements for drug-free

workplace (grants).

45 CFR Part 80--Nondiscrimination under programs receiving Federal

assistance through the Department of Health and Human Service--

Effectuation of title VI of the Civil Rights Act of 1964.

45 CFR Part 81--Practice and procedure for hearings under Part 80

of this title.

45 CFR Part 84--Nondiscrimination on the basis of handicap in

programs and activities receiving or benefiting from Federal financial

assistance.

45 CFR Part 86--Nondiscrimination on the basis of sex in education

programs and activities receiving or benefiting from Federal financial

assistance.

45 CFR Part 91--Nondiscrimination on the basis of age in HHS

programs or activities receiving Federal financial assistance.

45 CFR Part 93--New restrictions on lobbying.

(b) In addition to the above regulations, the following apply to

projects funded through grants:

42 CFR Part 50--Policies of general applicability:

Subpart D--Public Health Service grant appeals procedure.

45 CFR Part 16--Procedures of the Departmental Grant Appeals Board.

45 CFR Part 74--Administration of grants to nonprofit

organizations.

45 CFR Part 75--Informal grant appeals procedures.

45 CFR Part 92--Administration of grants to State and local

governments.

* * * * *

8. Section 51a.8 is added to read as follows:

Sec. 51a.8 What other conditions apply to these grants?

(a) Recipients of project grants will be required to submit such

additional information to the Secretary on an annual basis as the

Secretary determines, including:

(1) the number of individuals served or trained, as appropriate

under the project;

(2) a copy of any evaluation conducted by the recipient; and

(3) a list of Healthy Children 2000 objectives addressed by the

project and data on how the project contributed toward meeting the

objectives.

(b) The Secretary may at the time of award of project grants under

this Part impose additional conditions, including conditions governing

the use of information or consent forms, when, in the Secretary's

judgment, they are necessary to advance the approved program, the

interest of public health, or the conservation of grant funds.

[FR Doc. 94-17218 Filed 7-18-94; 8:45 am]

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