[Federal Register Volume 59, Number 137 (Tuesday, July 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17218]
[[Page Unknown]]
[Federal Register: July 19, 1994]
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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]
BILLING CODE 4160-15-M
